API Vol 2
API Vol 2
OF INDIA
THE AYURVEDIC PHARMACOPOEIA
OF INDIA
PART - II (FORMULATIONS)
VOLUME - I
First Edition
GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
DEPARTMENT OF AYURVEDA, YOGA & NATUROPATHY,
UNANI, SIDDHA AND HOMOEOPATHY,
NEW DELHI
2007
CONTENTS
PAGE
LEGAL NOTICES - - XII
GENERAL NOTICES - - XIII
PREFACE - - XXIII
INTRODUCTION - - XXX
MONOGRAPHS
Avaleha:
General Description 1
1. A¾°ā¬gāvaleha ( A.F.I. - II ) 2
2. Bhallātakādi Modaka ( A.F.I. - I) 4
3. Bilvādi Leha ( A.F.I. - I) 7
4. Citraka Harītakī ( A.F.I. - I) 10
5. Cyavanaprāśa ( A.F.I. - I) 13
6. Kalyā´aka leha ( A.F.I. - II ) 17
7. Kūsmāndaka Rasāyana ( A.F.I. - I) 20
8. Mrdvīkādi lehya ( A.F.I. - I) 23
9. Pūga Kha´²a ( A.F.I. - I) 26
10. Sū¨anāvaleha ( A.F.I. - I) 29
11. Vāsāvaleha ( A.F.I. - I) 32
12. Vyāghrī Harītakī ( A.F.I. - II ) 35
Cūr´a:
General Description 38
13. Āmalakyādi Cūr´a ( A.F.I. - I ) 39
14. Avipattikara Cūr´a ( A.F.I. - I ) 41
15. Bālacāturbhadrikā Cūr´a ( A.F.I. - I) 43
16. Elādi Cūr´a ( A.F.I. - I ) 45
17. Hi¬gva¾°aka Cūr´a ( A.F.I. - I ) 47
18. Navāyasa Cūr´a ( A.F.I. - I) 49
19. Nimbādi Cūr´a ( A.F.I. - I) 51
20. Pañcasama Cūr´a ( A.F.I. - I) 53
21. Pu¾yānuga Cūr´a ( A.F.I. - I ) 55
22. Tālīsādya Cūr´a ( A.F.I. - I ) 57
23. Vaiśvānara Cūr´a ( A.F.I. - I ) 59
Gh¨ta:
General Description 61
24. Brāhmī Gh¨ta ( A.F.I. - I ) 63
25. Daśamūla Gh¨°a ( A.F.I. - I) 65
26. Daśamūla¾a°palaka Gh¨°a ( A.F.I. - I) 68
27. Dhātryādi Gh¨°a ( A.F.I. - I) 71
28. Jātyādi Gh¨°a ( A.F.I. - I ) 73
29. Kalyā´aka Gh¨°a ( A.F.I. - I) 75
30. Pañcagavya Gh¨°a ( A.F.I. - I) 78
31. Pañcatikta Gh¨°a ( A.F.I. - I) 80
32. Phala Gh¨°a ( A.F.I. - I ) 82
33. Sārasvata Gh¨°a ( A.F.I. - I) 85
34. Traika´°aka Gh¨°a ( A.F.I. - I ) 87
35. Triphalā Gh¨°a ( A.F.I. - I) 90
Guggulu:
General Description 93
36. Kaiśora Guggulu ( A.F.I. - I ) 94
Gutika:
General Description 97
37. Maricādi Gut#ikā (A.F.I. - I ) 98
āra$Ks / Lava´a
General Description 100
38. Apāmārga Ks$āra ( A.F.I. - I ) 101
39. Arka Lava´a ( A.F.I. - I ) 103
40. Kalyā´aka Ks$āra ( A.F.I. - I ) 105
41. Mūlaka Ks$āra ( A.F.I. - I ) 107
42. Palāśa Ks$āra ( A.F.I. - I ) 109
43. Yava Ks$āra ( A.F.I. - I ) 111
Taila:
General Description 113
44. Balāgu²ūcyādi Taila ( A.F.I. - I) 115
45. Dhānvantara Taila ( A.F.I. - I) 117
46. Gandharvahas°a Taila ( A.F.I. - I) 120
47. Ko°°amcukkādi Taila ( A.F.I. - I) 122
48. K¾īrabalā Taila ( A.F.I. - I) 124
49. Saindhavādi Taila ( A.F.I. - I) 126
Lepa:
General Description 128
50. Dārvī Malahara (Gel) (Based on Charaka Chi. 25/93) 129
In India there are laws dealing with drugs that are the subject of monographs
which follow. These monographs should be read subject to the restrictions imposed by
these laws wherever they are applicable.
It is expedient that enquiry be made in each case in order to ensure that the
provisions of the law are being complied with.
In general, the Drugs & Cosmetics Act, 1940 (subsequently amended in 1964 and
1982), the Dangerous Drugs Act, 1930 and the Poisons Act, 1919 and the rules framed
thereunder should be consulted.
Under the Drugs & Cosmetics Act, the Ayurvedic Pharmacopoeia of India
(A.P.I.), Part-II, Vol. I, is the book of standards for compound formulations included
therein and the standards prescribed in the Ayurvedic Pharmacopoeia of India, Part-II,
(Formulation) Vol. I, would be official. If considered necessary these standards can be
amended and the Chairman of the Ayurvedic Pharmacopoeia Committee’s authorised to
issue such amendements. Whenever such amendments are issued the Ayurvedic
Pharmacopoeia of India, Part-II (Formulation), Vol. I, would be deemed to have been
amended accordingly.
GENERAL NOTICES
Title : The title of the book is “Ayurvedic Pharmacopoeia of India, Part-II (Formulations)
Volume-I. Wherever the abbreviation “API, Pt.-II,Vol.-I” is used, it may be presumed to
stand for the same and the supplements or amendments thereto.
Name of the Formulation: The name given on top of each monograph is in Samskrt, as
mentioned in the Ayurvedic Formulary of India (AFI) and will be considered official.
These names have been arranged in English alphabetical order under each category of
dosage form.
Ingredients and Processes: Formulations are prepared from individual ingredients that
comply with the requirements for those individual ingredients for which monographs are
provided in the volumes of API, Part-I. Where water is used as an ingredient it should
meet the requirements for Potable Water covered by its monograph in the Ayurvedic
Pharmacopoeia of India-Part-I.
Monograph for each formulation includes the full composition together with
directions for its preparation. Such composition and directions are intended for
preparation of small quantities for short-term supply and use. When so prepared, no
deviation from the stated composition and directions is permitted. However, if such a
preparation is manufactured on a large scale with the intention of sale or distribution,
deviations from the directions given are permitted, but maintaining the same ratio as
stated in the monographs with the ingredients complying with the compendial
requirements, and also that the final product meets the following criteria:
(a) complies with all of the requirements stated in the monograph on compound
formulations,
(b) in the composition of certain formulations it has been allowed that a specified part of
the plant may be substituted by another part of the same plant. In such cases the
manufacturer should mention on the label the actual part of the plant used in the
formulation.
(c) wherever an ‘official substitute’ is provided for, deviation from the original
formulation is permitted, using the ‘official substitute’.
(d) wherever a formulation composition specifies a drug that is banned from commerce,
this may be omitted, and the fact mentioned on the label.
If a preparation is intended to be stored over a period of time, deterioration due to
microbial contamination may be inhibited by the addition to the formula of a permitted
preservative. In such circumstances the label should state the concentration of the
preservative and the appropriate storage conditions. It is implied that such a preparation
will be effectively preserved according to the appropriate criteria applied.
The direction that an ingredient in a formulation must be freshly prepared
indicates that it must be prepared and used within 24 hours.
The requirements given in the monographs are not framed to provide against all
impurities, contaminants or adulterants; they provide appropriate limits only for possible
impurities that may be permitted to a certain extent. Material found to contain an
impurity, contaminant or adulterant which is not detectable by means of the prescribed
tests are also to be considered as impurity should rational consideration require its
absence.
Standards: For statutory purposes, the following shall be considered official standards:
Definition, Formulation composition, Identification, Physico-chemical parameters, Assay
and Other requirements.
Description: Statement given under this title is not to be interpreted in a strict sense
although they may help in the evaluation of an article. However substantial departure
form the requirement will not be acceptable.
Capital Letters in the Text: The names of the Pharmacopoeial substances, preparations
and other materials in the text are printed in capital initial letters, and these infer that
materials of Pharmacopoeial quality have been used.
Italics: Italic types are used for Scientific names of the plant drugs and microorganisms,
and for some sub-headings and certain notations of the chemical names. Italic types have
also been used for words which refer to solvent system in TLC procedure, reagents and
substances, processes covered under Appendices. Chemicals and Reagents and
Substances of Processes in Appendices have also been printed in Italics.
Odour and Taste: Wherever a specific odour has been observed it has been mentioned
as characteristic for that formulation, but the description as ‘odourless’ or ‘no odour’ has
generally been avoided in the Description where a substance has no odour. Where a
characteristic odour is said to be present it is examined by smelling the drug directly after
opening the container. If such an odour is discernible, the contents are rapidly transferred
to an open vessel and re-examined after 15 minutes. If odour persists to be discernible,
the sample complies with the description for odour, characteristic for that formulation.
The taste of a drug is examined by taking a small quantity of drug by the tip of
moist glass rod and allowing it on tongue previously moistened with water. This does not
apply in the case of poisonous drugs.
Powder fineness: Wherever the powder of a drug is required, it shall comply with the
mesh number indicated in the Monograph.
Where particle size is prescribed in a Monographs, the specified sieve number are used to
fractionate a weighed representative sample from the container, each fraction weighed
separately, and expressed as a percentage of the weight taken initially, to obtain
compliance with the monograph.
Weights and Measures: The metric system of weights and measures is employed.
Weights are given in multiples or fractions of a gram (g) or of a milligram (mg). Fluid
measures are given in multiples of fraction of milliliter (ml). The amount stated is
approximate but the quantity actually used must be accurately weighed and must not
deviate by more than 10 per cent from the one stated.
Identity, Purity and Strength: Under the heading “Identification”, tests are provided as
an aid to identification and are described in the respective monographs. Microscopical
characters are prescribed for the individual ingredients where these do not exceed ten in
number, added ‘in situ’. Appendix 2.1 gives detailed procedure
The quantitative tests like total ash, acid-insoluble ash, water-soluble ash,
alcohol-soluble extractive, water-soluble extractive, moisture content, volatile oil content
and assays are the parameters upon which the standards of Pharmacopoeia depend.
Except for Assays, which are covered under each monograph, the methods of
determination for others are given in Appendices, with a suitable reference to the specific
appendix.
The analyst is not precluded from employing an alternate method in any instance
if he is satisfied that the method, which he uses will give the same result as the
Pharmacopoeial method described under assay. However, in the event of doubt or dispute
the methods of analysis of the Pharmacopoeia are alone authoritative. Unless otherwise
prescribed, the assays and tests are carried out at a temperature between 200 and 300.
In the performance of assay or test procedures, not less than the specified number
of dosage units should be taken for analysis. Proportionately larger or smaller quantities
than the specified weights and volumes of assay or test substances and Reference
Standards or Standard Preparations may be taken, provided the measurement is made
with at least equivalent accuracy and provided that any subsequent steps, such as
dilutions, are adjusted accordingly to yield concentrations equivalent to those specified
and are made in such manner as to provide at least equivalent accuracy.
Where it is directed in the assay for Tablet formulation to “weigh and powder not
less than” a given number, usually 20, of the tablets, it is intended that a counted number
of tablets shall be weighed and reduced to a fine powder. Likewise, where it is directed
in the assay for Capsules to remove, as completely as possible, the contents of not less
than a given number, usually 20, of the capsules, it is intended that a counted number of
capsules should be carefully opened and the contents quantitatively removed, combined,
mixed, and weighed accurately. The portion of the powdered tablets or the mixed
contents of the capsules taken for assay is representative of the whole tablets or capsules,
respectively, and is, in turn, weighed accurately. The result of the assay is then related to
the amount of active ingredients per tablet in the case of tablets and per capsule in the
case of capsules from the weight of contents of each tablet/capsule.
Limits for Heavy metals, Microbial load, Pesticide residues and Aflatoxins :
Formulations included in this volume are required to comply with the limits for heavy
metals, microbial load, pesticide residues and aflatoxins prescribed in individual
monographs and wherever limit is not given they must comply with the limits given in
Appendix. The methods for determination of these parameters are given in Appendices.
Thin Layer Chromatography (TLC): Under this title, wherever given, the Rf values
given in the monographs are not absolute but only indicative. The analyst may use any
other solvent system and detecting reagent to establish the identity of any particular
chemical constituent reported to be present in the formulation. However in case of dispute
the pharmacopoeial method would prevail. Unless specified in the individual monograph
all TLC have been carried out on pre-coated Silica gelG F254 aluminium plates.
Reference Standards: Reference substance and standard preparation are authentic
substances that have been verified for there suitability for use as standards for comparison
in some assays, tests and TLC of the API.
Constant Weight: The term “constant weight” when it refers to drying or ignition means
that two consecutive weighing do not differ by more than 1.0 mg per gram of the
substance taken for the determination, the second weighing following an additional hour
of drying or further ignition.
Percentage of Solutions – In defining standards, the expression per cent (%), is used,
according to circumstances, with one of the four meanings given below.
Per cent w/w (percentage weight in weight) expresses the number of grams of active
substance in 100 grams of product.
Per cent w/v (percentage weight in volume) expresses the number of grams of active
substance in 100 milliliters of product.
Per cent v/v (percentage volume in volume) expresses the number of milliliters of active
substance in 100 milliliters of product.
Per cent v/w (percentage volume in weight) expresses the number of milliliters of active
substance in 100 grams of product.
Solutions: Unless otherwise specified in the individual monograph, all solutions are
prepared with Purified Water.
Reagents and Solutions: Reagents required for the assay and tests of the Pharmacopoeia
are defined in the Appendix showing the nature, degree of the purity and strength of
solutions to be made from them.
Soluble substances: The following table indicates the meaning of degree of solubilities:
_____________________________________________________________
The term ‘partly soluble’ is used to describe a mixture of which only some of the
components dissolve.
Doses: The doses mentioned in each monograph are in metric system which are the
approximate conversions from classical weights mentioned in Ayurvedic texts. A
conversion table is appended giving classical weights with their metric
equivalents.(Appendix 7) Doses mentioned in the Ayurvedic Pharmacopoeia of India
(API) are intended merely for general guidance and represent, unless otherwise stated, the
average range of quantities per dose which is generally regarded suitable by clinicians for
adults only when administered orally. They are not to be regarded as binding upon the
prescribers.
The medical practitioner will exercise his own judgment and act on his own
responsibility in respect of the amount of the formulation he may prescribe or administer
or on the frequency of its administration. If it is usual to administer a medicine by a
method other than by mouth, the single dose suitable for that method of administration is
mentioned.
Storage: Statement under the heading ‘Storage’ constitutes non-mandatory advice. The
substances and preparations of the Pharmacopoeia are to be stored under conditions that
prevent contamination and, as far as possible, deterioration. Precautions that should be
taken in relation to the effects of the atmosphere, moisture, heat and light are indicated,
where appropriate, in the individual monographs.
Specific directions are given in some monographs with respect to the temperatures
at which Pharmacopoeial articles should be stored, where it is considered that storage at a
lower or higher temperature may produce undesirable results. The conditions are defined
by the following terms.
Cold- Any temperature not exceeding 80 and usually between 20 and 80. A refrigerator is
cold place in which the temperature is maintained thermostatically between 20 and 80.
Cool- Any temperature between 80 and 250. An article for which storage in a cool place
is directed may, alternately, be stored in a refrigerator, unless otherwise specified in the
individual monograph.
Protection from freezing- Where, in addition to the risk of breaking of the container,
freezing results in loss of strength or potency or in destructive alteration of the
characteristics of an article the label on the container bears an appropriate instruction to
protect from freezing.
Containers: The container is the device that holds the article. The immediate container
is that which is in direct contact with the article at all times. The closure is a part of the
container.
The container is designed so that the contents may be taken out for the indented purpose
in a convenient manner. It provides the required degree of protection to the contents from
the environmental hazards.
The container should not interact physically or chemically with the article placed in it so
as to alter the strength, quality or purity of the article beyond the official requirements.
Prior to its being filled, the container should be clean. Special precautions and cleaning
procedures may be necessary to ensure that each container is clean and that extraneous
matter is not introduced into or onto the article.
Light-resistant Container- A light resistant container protects the contents from the
effects of actinic light by virtue of the specific properties of the material of which it is
made. Alternatively, a clear and colourless or a translucent container may be made
light-resistant by means of an opaque (light-resistant) covering and/or stored in a dark
place: in such cases, the label on the container should bear a statement that the opaque
covering or storage in dark place is needed until the contents have been used up.
Single Unit Container- A single unit container is one that is designed to hold a quantity of
the drug product intended for administration as a single finished device intended for use
promptly after the container is opened. The immediate container and/or outer container
or protective packaging is so designed as to show evidence of any tampering with the
contents.
Multiple Unit Container- A multiple unit container is container that permits withdrawals
of successive portions of the contents without changing the strength, quality or purity of
the remaining portion.
gram(s) - - g
milligram(s) - - mg
kilogram(s) - - kg
milliliter(s) - - ml
litre(s) - - l
hour(s) - - h
minute(s) - - min
second(s) - - sec
0C - - 0
Micron - - µ
ortho - - o
meta - - m
para - - p
parts per million - - ppm
parts per billion - - ppb
volume - - vol
weight - - wt
weight in weight - - w/w
weight in volume - - w/v
volume in volume - - v/v
quantity sufficient - - Q.S.
ABBREVIATIONS FOR PARTS OF PLANTS
1. Ayurveda is the most ancient science of life having a holistic health approach. The
preparation of medicines i.e. pharmacy is an integral part of this science, and
evolved from a very rudimentary form. In ancient times, the preparation of
medicine was part of the practising physician’s functions. The preparation of
medicine was limited, selective and at personal level only. Hence the
methodology of preparation and quality parameters more or less differed from
Vaidya to Vaidya. In vedic times the practice of medicine was a personal mission
without any monetary motive, and exclusively for the recovery of ailing people.
Later on, this attitude changed and the profession was followed with a profit
motive. The manufacture of Ayurvedic medicines also began on a larger scale.
Since the last 40 years Ayurvedic practice has assumed business proportions and
the manufacture of Ayurvedic drugs are on a commercial scale.
3. In ancient texts the quality parameters for raw drugs and finished products
including compound formulations are well described and moreover this is in
practices. It is mentioned how to collect the plant material, auspicious day and
specific time with offering prayer to the plant that the material to be procured will
be used for the welfare of the humanity.
Procurement of plant material in a particular time has a strong scientific base, like
for collection of latex, it is advised to collect latex before sunrise to get good
quality and quantity of material. Similarly after procurement of the material, use
of plant material after a specific period of storage is described. For example
Vidanga (Embilia ribes, seeds) are advise are to be used after one year of its
procurement as the percentage of embelin (active phyto-constituents ) will be
stable and quantity will be more compared to freshly procured sample. This
reflects the quality assurance parameters.
6. Śar¬gadhara Sa¼hitā, which was written during 14th AD, gave new dimensions
to Ayurvedic pharmacy. This book is considered as an authoritative text for
Ayurvedic pharmacy. Many new pharmaceutical preparations like Malahara,
Sukta, Phala Varti etc were defined with explanations. The concept of Phala
Varti, though available in Caraka Sa¼hitā, its use was extended to urethral and
vaginal disorders by ²hamalla.
7. Later, Yoga Ratnākara introduced a few innovative drug delivery systems and
pharmaceutical preparations like Sūcikabharana Rasa, which were to be
administered in micro quantities into the blood through scratch made by the tip of
a needle. A detailed description of Satva, extraction with reference to Gu²ūcī
Satva was explained, which is a reductionist approach to dosage forms.
9. The numbers of compound formulations are very huge, even more than 75,000,
and of varied nature, using plant, mineral and animal sources. Another important
characteristic feature of Ayurvedic compound formulations is that of their
availability in different dosage forms such as cūr´a, gu°ī, va°ī, taila, gh¨ta,
kvātha, āsava, avaleha, bhasma, parpa°ī, po°°alī, malahara, lepa, pānaka etc.
12. Any one or more of the above said processes will be integral part of Ayurvedic
drug manufacturing. It is a challenging exercise to define and standardize the
above processes, and establish quality parameters for different ingredients before
and during the manufacturing process as well as for the final product.
13. At present in the industry, very few generalized quality parameters are adopted.
Some pharmaceutical firms may be having their in-house standard method of
operations, and quality parameters for finished compound formulations. But there
is no uniformity in the operating procedures i.e. in the method of preparations.
This is sometimes responsible for one and the same formulation by name having
different qualities in the finished products, and not having reproducibility. An
effort has been made now to optimize the method of preparation, so that such
differences between manufacturer’s products in the market are not beyond
reasonable limits.
14. It was again during the last 100 years of colonial rule, that economic conditions in
India changed, a process of urbanization began and it was during this period that
the Ayurvedic physicians took to cities and lost their contact with forests and drug
sources. It was during this period that as a consequence of better transport
facilities, the crude drug supplying agencies came up and commercial manufacture
of Ayurvedic Medicines on mass scale in factories started. These were the
inevitable consequences of the socio-economic changes in the country. The new
economic set up was such that the Ayurvedic practitioner could no longer process
and prepare his own medicines but had to depend on commercial sources for
supply of crude drugs to whatever extent he needed them. There was, in a way, a
forced division of professional responsibilities where the vaidya had no choice but
to purchase his drugs. Nor had he any means to ascertain the authenticity of the
medicines and formulations supplied to him. There was no Governmental control
on manufacturers to ensure the quality of the marketed medicines prescribed by
vaidyas and administered to their patients.
15. The conditions prevailing in India prior to Independence were quite discouraging
for indigenous medicines to make any progress. But, during the
post-independence era, many scientists took active interest in preserving the
legacy of Ayurveda and other indigenous systems.
17. The Government of Bombay, was especially interested in the survey of resources
of Ayurvedic Drugs, their collection, cultivation, farming, distribution and
standardization. They, therefore had appointed a Committee for Standard and
Genuine Ayurvedic Herbs and Drugs in 1955 and subsequently after receiving its
report, appointed a second committee with fresh set of terms of reference, called
the Committee for Standard Ayurvedic Herbs and Drugs in 1957 both under the
Chairmanship of Vaidya Bapalal Shah, of which Professor A. N. Namjoshi was
the Member Secretary. The Bapalal Committee had very elaborately
recommended the compilation of the Ayurvedic Pharmacopoeia as an urgent
prerequisite for effective control of Ayurvedic Drugs to ensure quality assurance.
Finally Government of India appointed the “Ayurvedic Research Evaluation
Committee”, under the Chairmanship of Dr. K. N. Udupa (1958) which had
strongly highlighted the urgency of the compilation of an Ayurvedic
Pharmacopoeia.
19. After publication of the First and the Second part of the Ayurvedic Formulary of
India Part-III of the Formulary is under preparation.
20. The First and Second Part of the Ayurvedic Formulary of India comprising of
some 444 and 191 formulations respectively cover more than 351 single drugs of
plant origin. This covers about 500 priority drugs of plant origin for which
monographs have been evolved and included in several volumes of Ayurvedic
Pharmacopoeia of India.
21. As a fallout of the growing interest in the renaissance of Ayurveda and the
systematic efforts to investigate into the merits of this ancient science during the
post-independence period, it is of significance that the western or modern system
of medicine, with its formidable armoury of synthetic drugs, chemo-therapeutic
agents and antibiotics, has slowly come to terms with the adverse side effects and
toxicity of synthetic drugs. The western world has now turned its attention to
traditional medicines based on drugs of natural origin. An appreciation of the
basic tenets of Ayurvedic therapeutics, which initially appeared to be rather
abstract and difficult to interpret in terms of modern medical sciences, has now
emerged, resulting in new branches of pharmacology such as pharmacogenomics.
22. With the introduction of a uniform system of Ayurvedic education all over the
country, a process initiated some 50 years ago, there would be some uniformity in
the education in pharmacy, pharmaceutical technology, pharmaceutical chemistry,
pharmacognosy and research. With the physician and the patient needing to be
assured of the quality of the medicine through research, such an advance in
Ayurvedic education would have a positive effect.
24. The publication of the Ayurvedic Formulary of India and the Ayurvedic
Pharmacopoeia of India would now enable the Government to implement the
Drugs and Cosmetic Act, 1940 in respect of quality control for the Ayurvedic,
Siddha, Unani drug manufacturers, distributed and sold in India, under a license
granted by it.
25. The Ayurvedic Pharmacopoeia Committee has laid down standards for single
drugs based on experimental data worked out at the PLIM, Ghaziabad and in
some of the units of the Central Council for Research in Ayurveda and Siddha.
Published scientific literature on the subject, although scanty, has also been
collected and included after due verification.
26. The western countries did pass through the same phase over 150 years ago for
their medicines, their characteristics, methods of preparation and identity, purity
and strength. Research towards this end was vigorous and out of the scientific data
contributed by the scientists in research institutes and industry, the
pharmacopoeial monographs of drugs were drafted. As a result pharmacopeiae of
the western world show considerable uniformity in principles, approach and
information. Thus, while for compilation of the British Pharmacopoeia,
information and scientific data was available, for the compilation of the
Ayurvedic Pharmacopoeia little information and published data existed and the
Ayurvedic Pharmacopoeia Committee had to do a lot of spade work.
27. The Part I of Ayurvedic pharmacopoeia of India consists of Vol-I, II, III, IV and V
comprising respectively 80, 78, 100, 68 and 92 monographs prescribing standards
for Ayurvedic single drugs of plant origin, which go into one or more
formulations admitted to the Ayurvedic Formularies of India, Part-I and Part-II.
The Part-II of the Ayurvedic Pharmacopoeia consists of official standards for 50
compound formulations present in the Ayurvedic Formulary of India Part-I and
Part-II.
28. The title of the monograph for each compound formulation is given in Samskrit,
as in the Ayurvedic Formulary of India. This is followed by the Definition,
Formulation Composition, Method of Preparation, a brief Description of the
compound formulation, standards for Identity and Purity in so far as they are
reflected by microscopy and physico chemical parameters. Other requirements
such as tests for heavy metals, microbial content have also been prescribed.
Information on therapeutic uses, dose, administration and storage is included. The
raw material which complies with the standards of API were selected for
developing standards for compound formulations. In a few cases, where such
standards were not available, the collaborator developed them and used them as
standards for that raw material.
29. The monograph gives limits under Assay, for any one constituent or group of
constituents like total alkaloids or total volatile oils. In the case of water soluble or
alcohol soluble extractives a minimum lower limit has been given. For impurities
like Ash, Acid insoluble Ash etc, a maximum upper limit has been given. It is a
well known fact that there is wide variation in such values for crude drugs of plant
origin in respect of their chemical contents. Therefore, such variations had to be
taken into consideration in laying down minimum and maximum standards for the
compound formulations.
30. The General Notices provide guidance for the manufacturers and analysts. Official
details of Apparatus, Reagents and solutions, Methods of tests, preparation of
sample for microscopical examination have all been given the Appendices.
31. The Committee hopes that with the publication of Ayurvedic Pharmacopoeia of
India Part-II (Formulations) Vol.-I, comprising of 50 compound formulations,
would serve to exercise quality control and help in the implementation of the
Drugs and Cosmetics Act. It is also expected that such implementation would
create a feedback data, which is essential for improving the standards given in the
pharmacopoeia.
32. The Committee urges the Government of India to recommend the adoption of
these monographs for the purpose of defining Method of Preparation, Developing
Standards for compound formulations for use in their Government,
Semi-Government and Government aided institutions and voluntary public
organizations. The Ayurvedic Pharmacopoeia of India, 2007, Part-II
(Formulations), Vol.-I may also be notified by Government as a book of standards
for implementation of the Drugs and Cosmetics Act, 1940 all over India, just as
the Ayurvedic Pharmacopoeia of India part I, Vol. I, II, III, IV and V have been
included in the First Schedule of Drugs & Cosmetics Act 1940.
33. The Ayurvedic Pharmacopoeia Committee records with deep appreciation the
contributions made by the Directors, Officer In-charges, Project Officers and
scientific staff of all the collaborating laboratories and Institutions who were
associated with the project work on developing Pharmacopoeial Standards for
formulations allotted to them.
34. I am indebted to secretary Department of AYUSH, Ms. Anita Das for her constant
inspiration and motivation for this unique work. My sincere thanks and credit to
Joint Secretary, Department of AYUSH, Sh. Shiv Basant for providing constant
support and strategic plan for completion of this first phase of task and
momentum to on going work.
35. It is my duty to place on records our sincere thanks and appreciation to Dept. of
AYUSH, Ministry of Health & Family Welfare, Govt. of India; State
Governments, Institutions, Councils, Scientists and Ayurvedic Scholars, for their
whole hearted co-operation in preparing the monographs on compound
formulations. I sincerely thank all members of Ayurvedic Pharmacopoeia
Committee for their dedicated efforts and hard work in finalizing the monographs.
My thanks to Prof. S.S. Handa, Chairman; Dr. S.K. Sharma, Vice-Chairman;
Miss. S. S Satakopan, Member; Prof. S.K. Dixit, Member; Prof. Ved Vrat
Sharma, Member; Prof. V.K. Kapoor, Member; Dr.(Ms.) Shanta Mehrotra,
Member; Dr. P.D. Sethi, Member; Dr. D.R. Lohar, Member; Prof. M.A. Iyengar,
Member; Sh. J. K. Dhing, Member; Dr. J. Mohansundaram, Member; Dr. B. L.
Gaur, Member; Prof. Siddhinandan Mishra, Member; Dr. P. K. Prajapati,
Member; Dr. Narendra Bhatt, Member; Sh. Ranjit Puranik, Member; Prof. V. K.
Joshi, Member; Prof. K.C. Chunekar, Member; Vd. Devender Triguna, Member;
Dr. M.R. Uniyal, Member; Prof. V.V. Prasad, Member and Dr. Karan Vashisth,
Expert member for their constant efforts in bringing out this volume. My thanks
are also to Dr. MM Padhi, Deputy Director [Tech.]; Shri. Vasantha Kumar, Asst.
Director [Chem.] Dr. Pramila Pant, Research Officer [Chem.], Dr. Rajiv Sharma,
Senior Scientific Officer [Pharmacognosy], Sri. Ravinder Singh, Research Officer
[Chem.], Dr. Jai Prakash, Research Officer [Chem.], Dr. Chhote Lal, Dr. AKS
Bhadoria and Dr. MN Rangne, Dr. Bishnu Priya Dhar, Research Officer [Phar],
Dr. Galib, Research Officer [Ayu.], Dr. K. Sandhya Rani, S.R.F. [Ayu.] and
other associated officers, who contributed a lot in finalizing the volume. I am also
thankful to Mr. Sandeep Kumar, D.E.O., who took pains in typing and arranging
all the technical data into a final shape.
The Ayurvedic system of medicine has been prevalent in India since the Vedic
period, and still remains the mainstay of medical relief to over 60 per cent of the
population of the nation. In earlier times the practitioners of Ayurveda (Vaidya) were
themselves collecting herbs and other ingredients and preparing medicines. For the
purpose of acquiring raw materials Vaidyas now depend on commercial organizations
trading in crude herbal drugs. Likewise, with passage of time a number of Ayurvedic
Pharmaceutical units have came up for the manufacture of Ayurvedic drugs and
formulations on commercial scale.
The Act was accordingly amended in 1964, to ensure only a limited control over
the production and sale of Ayurvedic medicines namely:-
ii. The raw materials used in the preparation of drugs should be genuine and
properly identified; and
iii. The formula or the true list of all the ingredients contained in the drugs
should be displayed on the label of every container.
To start with, development of standards for the identity, purity and strength of
single drugs and those of formulations at a later stage, assumed importance for the
effective enforcement of the provision of the Act. If the raw materials to be used in a
medicine and stage-by-stage processes of manufacturers are standardised, the final
product namely, the compound formulation could be expected to conform to uniform
standards. The requirement that the list of ingredients be displayed on the label will
enable analysts to verify label claims. It will also ensure that the manufacture do not make
false claim. Arrangements to evolve and lay down physical, chemical and biological
standards, wherever even necessary, to identify the drugs and ascertain their quality and
to detect adulterations are an urgent necessity of the profession. Setting up of Drug
Standardisation Units, Research Centres, Drug Testing Institutes and Central Drug
Laboratories for Ayurvedic Medicines both at national and regional level for this purpose
are therefore, essential. The several Committees appointed by the Government of India to
assess and evaluate the status and practice of Ayurvedic Medicine have stressed the
importance of preparing an Ayurvedic Pharmacopoeia, which is precisely a book of
standards.
7. Dr. C.G. Pandit, Director, Indian Council of Medical Research, New Delhi.
Member
14. S.K. Borkar, Drug Controller (India), Directorate General of Health Services,
Member
Government of India, New Delhi.
(a) Single drugs, of whose identity and therapeutic value there is no doubt; and
During the years that followed, Ayurvedic Formulary, Part I and II and Ayurvedic
Pharmacopoeia of India, Part – I, Volume I - V were published, the former containing the
compound formulations from classical Ayurvedic texts prescribed in Schedule - I to the
Drug and Cosmetics Act, and the later, laying down standards for single drugs of plant
origin. Amendment to the provisions introduced in 1982 further strengthen the ASU
system by defining misbranded, adulterated and spurious drugs in the ASU system.
Subsequently under the 10th Five Year Plan a project was initiated by the
Department to develop Method Of Preparation, Standard Operative Procedures,
Pharmacopoeial Standards and Shelf Life of Compound formulations of Ayurveda
appearing in Ayurvedic Formulary of India, Parts I & II.
The work of the Ayurvedic Pharmacopoeia Committee was transferred along with
some technical staff to Central Council for Research in Ayurveda and Siddha, New Delhi
as a secretariat for APC vide letter no. X-19011/6/94-APC (AYUSH),
dated 29th March, 2006.
Prof. A.N. Namjoshi (1972, 1981, 1988 and 1994) and Vaidya I. Sanjeeva Rao
(1998) were Chairman of reconstituted Ayurvedic Pharmacopoeia Committee during the
specified periods.
OFFICIAL MEMBERS
NON-OFFICIAL MEMBERS
OFFICIAL MEMBERS
1. Dr. G.S. Lavekar, AVP; Ph.D. Member-Secretary
Director, (Ex-officio)
Central Council for Research in Ayurveda & Siddha,
61-65, Institutional Area,
D-Block, Janakpuri,
New Delhi – 110 058.
NON-OFFICIAL MEMBERS
Pharmacognosy Sub-Committee
Formulary Sub-Committee
Ayurveda Sub-Committee
(Single Drugs of Plants, Minerals, Metals, Animal origin)
CO-OPTED MEMBERS
1. The term of the Committee shall be for a period of three years from the date of its
first meeting and the members shall hold office for that period.
2. The Chairman of the APC shall have the powers to form sub-committees
whenever required and to co-opt experts from outside for such sub-committees.
3. The Committee shall have the power to frame procedures of functioning.
4. The functions of the Committee shall be as follows:
(i) To prepare Ayurvedic Pharmacopoeia of India of single and compound drugs.
(ii) To prescribe the working standards for compound Ayurvedic formulations
including tests for identity, purity, strength and quality so as to ensure uniformity
of the finished formulations.
(iii) Keeping in view the time constraint, to identify such methods, procedures and
plan of work as would enable to publish the formulary and standards of all
commonly used drugs to be brought out in a phased manner.
(iv) To prepare remaining parts of the official formulary of compound preparations
from the classical texts including standardized composition of reputed institution.
(v) To develop and standardize methods of preparations, dosage form, toxicity profile
etc.
(vi) To develop quality standards, safety, efficacy profile of intermediates likes
extracts of Ayurvedic raw drugs.
(vii) To develop the quality standards, safety, efficacy profile of different parts of the
plants; as well as to include new plants as Ayurvedic drugs.
(viii) Any other matter relating to the quality standards, shelf life, identification, new
formulations etc.
5. The following are the targets focus of the Committee:
(i) To evolve standards of single drugs mentioned in the Ayurvedic Formularies of
India.
(ii) To evolve standards for compound formulations mentioned in the Ayurvedic
Formularies of India & other Ayurvedic formulations of National Priority.
(iii) To prepare drafts SOP of Ayurvedic Formularies of India from the classical texts
and other authentic sources.
CONTRIBUTING LABORATORIES & INSTITUTIONS
The following institutions have carried out the scientific work of Monographs under
APC scheme.
General Descripition:
Jaggery, sugar or sugar-candy is dissolved in the liquid and strained to remove the
foreign particles. This solution is boiled over a moderate fire. When pressed between two
fingers if pāka becomes thready (Tantuvat), or when it sinks in water without getting
easily dissolved, it should be removed from the fire. Fine powders of drugs are then
added in small quantities and stirred continuously to form a homogenous mixture. Ghee
or oil, if mentioned, is added while the preparation is still hot and mixed well. Honey, if
mentioned is added when the preparation becomes cool and mixed well.
The Lehya should neither be hard nor a thick fluid. When pulp of the drugs is
added and ghee or oil is present in the preparation, this can be rolled between the fingers.
When metals are mentioned, the bhasmas of the metals are used. In case of drugs like
Bhallātaka, purification process is to be followed.
The Lehya should be kept in glass or porcelain jars. It can also be kept in a metal
container which does not react with it. Normally, Lehyas should be used within one year.
A ¾¯Ā³GĀVALEHA
(AFI, Part-II, 3:1)
Definition:
Formulation composition:
Method of preparation:
Wash, dry and powder the ingredients 1 to 8 separately and pass through sieve number
85.
Wash and peel Ārdraka, grind it, squeeze the juice and filter it through a muslin cloth to
collect svarasa.
Mix the powdered ingredients 1 to 8 thoroughly, levigate with Ārdraka svarasa and later
dry the mixture.
Add honey and stir thoroughly to form an avaleha.
Pack it in tightly closed containers to protect from light and moisture.
Description:
A blackish brown coloured semisolid sticky paste, odour pleasant, taste bitter, astringent
and spicy.
Identification:
Microscopy:
Take about 5 g, wash thoroughly with water. Pour out the water without loss of material;
repeat the process, each time rejecting the supernatant and keeping the sediment. Take a
few mg of the sediment, stain with iodine solution and mount in 50 per cent glycerin;
clarify a few mg with chloral hydrate wash in water and mount in 50 per cent glycerin.
Observe the following characters in different mounts.
Various types of stone cells solitary or in a group of 12 to 15, with narrow and broad
lumen some filled with prismatic crystals of calcium oxalate, pitted fibre sclereids, pitted
parenchyma, oil cells, group of parenchymatous cells with prismatic crystals of calcium
oxalate, fragments of fibres (Ka°phal); several collapsed epidermal cells, tissue
fragments with yellowish brown contents, and large tannin-filled sacs associated with
vascular bundles (Karka°aś¨¬gī); elongated or spindle shaped stone cells with broad
lumen isolated or in groups of 2 to 8 (Pippalī); fragments of hypodermis in surface view,
stone cells varying in sizes, shapes and thickness, mostly present in groups, interspersed
among parenchyma cells (Marica); groups of parenchymatous cells, densely packed with
starch grains, isolated starch grains, simple, oval to rod shaped, measuring 15 to 70 µ in
length, hilum eccentric, lamellae distinct, yellow coloured oleo resin cells, non-lignified
septate fibres, some of them bearing marks of adjacent cells pressing against them, 30 to
50 µ broad, (Śu´°hī); striated epidermal debris, fragments of vittae in surface view
showing honey comb like epithelial layers, groups of mesocarpic stone cell layer with
polygonal cells not much longer than broad; transversely much elongated thin walled
parenchymatous cell layer, with cells interlocked in a regular V joint with neighbouring
cell (K¨¾´ajīraka); prismatic crystals of calcium oxalate, measuring 70 to 100 µ in dia
and septate fibres (Pu¾kara); papillose epidermal cells in surface view with puckered
radially striated cuticle, epidermal cells with broken trichome bases, unicellular, small
club shaped simple trichomes (Yavānī).
Physico-chemical parameters:
Other requirements:
Definition:
Bhallātakādi Modaka is a solid preparation made in the form of lumps, with the
ingredients given in the Formulation composition.
Formulation composition:
Method of preparation:
Description:
Black coloured roughly spherical lumps, firm, but crushing under pressure, with the
characteristic odour of Bhallātakā and bitter, astringent taste.
Identification:
Microscopy:
Weigh 5 g of the sample, and mix with 50 ml of water in a beaker with gentle warming,
till the sample gets completely dispersed in water. Centrifuge the mixture and decant
supernatant. Wash the sediment with distilled water and centrifuge again. Decant the
supernatant. Collect the sediment. Mount a few mg in 50 per cent glycerine and observe
the following characters.
Fragments of crisscross fibres, epidermal tissue of cells with slightly beaded walls, and
occasionally divided by a thin septa (Pathyā); fragments of epidermis in surface view
with elongated cells having lignified walls and mesocarp tissue showing oil cavities,
(Bhallātaka); cells of endosperm filled with oil globules and aluerone grains,
occasionally sectional view of epidermal debris, with palisade like cells (Tila).
Thin layer Chromatography:
a) Extract 10 g of crushed modaka with 75 ml of methanol under reflux for 30 min. Filter,
concentrate to 10 ml and carry out the thin layer chromatography. Apply 10 µl of the
extract on TLC plate and develop the plate to a distance of 8 cm using toluene : ethyl
acetate : formic acid : methanol (3 : 3 : 0.8 : 0.2 ) as mobile phase. After development,
allow the plate to dry in air and spray with anisaldehyde-sulphuric acid reagent followed
by heating at 1100 for about 10 min. It shows major spots at Rf 0.12 (blue), 0.32 (blue),
0.34 (light brown, gallic acid), 0.45 (blue), 0.52 (light brown), 0.67 (violet), 0.82 (violet)
and 0.90 (violet) under visible light.
b) Extract 10 g of crushed modaka with 75 ml of n-hexane on a water-bath for 30 min.
Filter, concentrate to 10 ml and carry out the thin layer chromatography. Apply 10 µl on
TLC plate and develop the plate to a distance of 8 cm using toluene : ethyl acetate (7 : 3)
as mobile phase. After development, allow the plate to dry in air and spray with
anisaldehyde-sulphuric acid reagent followed by heating 1100 for about 10 min. It shows
major spots at Rf 0.47 (purple), 0.69 (dark blue) and 0.7 (purple) under visible light.
Physico-chemical parameters:
Assay:
The formulation contains not less than 5 per cent gallic acid when assayed by the
following method.
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Caution: In some cases, patients may develop rashes over skin. In such cases, apply
Nārikela Taila or Gh¨ta over the affected part and advise to take Nārikela internally.
BILVĀDILEHA
(AFI, Part-I, 3:18)
Definition:
Bilvādi Leha is a semisolid preparation made with the ingredients in the Formulation
composition given below.
Formulation Composition:
Method of Preparation:
Description:
Dark brown semisolid paste with a spicy pleasant odour and sweet, astringent taste.
Identification:
Microscopy:
Take about 5 g of avaleha and wash twice or thrice with about 20 ml of water, each time
rejecting the supernatant; take a few mg of the sedimented material, stain with iodine
solution and mount in 50 per cent glycerin; clarify a few mg with chloral hydrate and
mount in 50 per cent glycerin. Observe the following characters in different mounts.
Multicellular, multiseriate trichomes, fragments of vittae in surface view showing
epithelial tissue elongated along the long axis of the vittae, and mesocarpic stone cell
layer with cells much longer than broad (Śvetajīraka); groups of slightly wavy
parenchymatous cells, each cell contains 1 to 3 rosette crystal of calcium oxalate, groups
of bulbous perisperm cells packed with starch grains which also shows in the middle tiny
prismatic crystal of calcium oxalate, epidermal and hypodermal cells crossing each other
at right angle (Sūkşmailā); fragments of fibres with very narrow lumen, not over 600 μ
long and not over 45 μ broad, parenchyma cells containing minute acicular crystals of
calcium oxalate, stone cells of varying shapes and sizes with thickened walls on three
sides, oil cells (Tvak); crushed pieces of anther lobes containing pollen grains, pollen
grains tricolporate, measuring 25 to 55 μ in dia, unicellular and multicellular uniseriate
trichomes several showing a funneling tip or branching, groups of endothecial cells of
anther lobe (Nāgakeśara); group of parenchymatous cells, densely packed with starch
grains, isolated starch grains, simple, oval to rod shaped, measuring 15 to 70 μ in length,
hilum eccentric, lamellae distinct, yellow coloured oleo resin cells, non-lignified, septate
fibres some of them bearing marks of adjacent cells pressing against them, 30 to 50 μ
broad, (Śu´°hī); tissue debris consisting of packed regular rows of fibre-sclereids of fairly
uniform size, and narrow scalariformed vessel showing laterally placed simple
perforation (Mustā); lignified cells, isolated or in small groups measuring 130 to 190 µ in
dia with broad lumen, in groups of 2 to 8 (Pippalī); fragments of hypodermis in surface
view with stone cells varying in sizes, shapes and thickness, present in groups,
interspersed among parenchymatous cells (Marica); group of sclerenchymatous cells,
crisscrossing each other, epidermal tissue with fairly large cells showing stomata and
octahedrons of calcium oxalate crystals, large, pentagonal, sclerenchymatous cell layer
(Dhānya).
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Definition:
Citraka Harītakī is a semisolid preparation made with the ingredients in the Formulation
composition given below:
Formulation Composition:
Note: Stem bark of the ingredient number 4 [(a) to (e)] has been used.
Method of Preparation:
Wash, dry and powder the ingredients numbered 1 to 4 (Kvātha dravya) of the
Formulation composition separately and pass through sieve no. 44 to obtain a coarse
powder.
Dry and powder the ingredient number 5 separately and ingredients number 7 to 13
(Prak¾epa dravyas) of the Formulation composition to a fine powder and pass through
sieve no. 85.
Add required amount of water to the Kvātha dravya, heat, reduce to one fourth and filter
through muslin cloth.
Mix all the Kvāthas together. Add Jaggery, boil to dissolve and filter through a muslin
cloth.
Reduce the Kvātha to a thicker consistency by gentle boiling; add cūrņa of Pathyā and stir
thoroughly during the process.
Add the powdered prak¾epa dravya no. 7 to 13 while hot at 500, mix thoroughly to
prepare a homogeneous mass.
Allow to cool to room temperature. Add honey, mix thoroughly.
Pack it in tightly closed containers to protect from light and moisture.
Description:
Blackish brown, semisolid paste with spicy, pleasant odour and bitter-astringent taste.
Identification:
Microscopy:
Take about 5 g of the sample, wash thoroughly and repeatedly in warm water to remove
Guda and Madhu, each time rejecting the supernatant, and saving the residue without
loss. Take the sediment in distilled water, mix thoroughly, allow to settle, and throw off
supernatant. Take a few mg of the sediment, stain with iodine solution, mount in glycerin
(50 per cent); take a few mg of sediment, clear in chloral hydrate, wash, and mount in
glycerine (50 per cent). Observe the following characters in different mounts.
Large parenchyma cells containing elliptical, elongated starch grains, up to 50 μ in length,
with hilum at one end; broad, short vessel debris, resin cells, fragments of non-lignified
septate fibres that show dentation on one wall (Śu´°hī); fragments from hypodermis with
groups of stone cells interspersed among parenchyma tissue from hypodermis, dark
coloured groups of very thick walled polygonal stone cells from testa (Marīca); long
uniseriate multicellular fragile trichomes, spindle shaped, large lumened sclerenchyma
cells, isolated or in small groups (Pippalī); perisperm cells with bulbous projections,
packed with minute starch grains aggregates, carrying tiny prisms or clusters of calcium
oxalate; large, elongated cells of aril tissue (Sūk¾mailā); fragments of fibres with narrow
lumen not over 600 μ long or over 45 μ midwidth, stone cells lignified on three sides
only, parenchyma cells containing minute acicular crystals of calcium oxalate (Tvak);
pieces of leaf epidermis with thick cuticle and sunken stomata, showing stomata and a
few unicellular or bicellular short stout trichomes (Tejapatra); crisscross layers of fibres,
polygonal cells of epidermis showing slight beading and transverse septa, large stone
cells with pits (Harītakī).
Thin layer chromatography:
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Definition:
Note: Stem bark of the ingredients number 1 to 5 of the formulation composition has
been used in place of root.
Method of preparation:
Semisolid, chocolate brown colored sticky paste, taste sweet with non-specific pleasant
odour.
Identification:
Microscopy:
Take about 5 g of the sample, add a defatting solvent to remove Gh¨ta and Taila, repeat
the process till sample is free from greasiness. Wash the defatted sample in warm water
twice. Reject the warm water, add distilled water and stir. Allow to stand and throw off
the supernatant. Take a few mg of the sediment in iodine solution and mount in glycerine
(50 per cent); clear a few mg in chloral hydrate solution, wash in water, and mount in
glycerine. Observe the following characters in the mounts:
Fragments of fibres with very narrow lumen, not over 600 m long and not over 45 m
broad; parenchyma cells containing minute acicular crystal of calcium oxalate, stone cells
of varying shape and size with thick internal walls, smaller ones somewhat rectangular,
40-60 m in length and larger one upto 300 m in length and 25 to 40 m in width, oil cells,
30-50 m in dia (Tvak); groups of slightly wavy parenchymatous cells, each cell contains 1
to 3 rosette crystal of calcium oxalate, groups of perisperm cells bulbous in shape, packed
with starch grains, also showing in the middle tiny prismatic crystal of calcium oxalate,
epidermal and hypodermal cells crossing each other at right angle (Elā); crushed pieces
of anther lobes containing pollen grains, pollen grains tricolporate measuring 25 to 55 m
in dia, groups of beaded epidermal cells of anther lobe, beaded cells of endothecial layer,
unicellular and multicellular uniseriate trichomes, several showing funnel tip or slight
branching (Nāgakeśara); leaf epidermal debris, with thick cuticle, sunken stomata, and
uni-or bicellular short stout trichomes (Tamālapatra); large polygonal perisperm cells,
isolated or in groups of 2 or 3, packed with simple and compound starch grains measuring
2 to 5 m in dia, stone cells measuring 130 to 190 m in dia, with broad lumen in groups of 2
to 8 (Pippalī); angular, sharp edged sandy particles, not affected by conc. sulphuric or
hydrochloric acids and do not polarize light (Tugāk¾īrī).
Physico-chemical parameters:
Assay:
The formulation contains not less than 0.5 per cent of gallic acid when assayed by the
following method.
Estimation of gallic acid: Dissolve, accurately weighed, about 25 mg of gallic acid in 20
ml of methanol and make up the volume with methanol to 25 ml in a volumetric flask.
From this stock solution, prepare standard solutions containing between 1 to 5 µg of
gallic acid per 10 µl. Apply 10 µl each of the standard solutions on TLC plates. Develop
the plate to a distance of 8 cm using toluene : ethyl acetate : formic acid (5 : 5 : 1) as
mobile phase. After development dry the plate in a current of hot air and scan in TLC
scanner at a wavelength of 280 nm. Record the area under the curve for a peak
corresponding to gallic acid and prepare the calibration curve by plotting area under the
curve vs amount of gallic acid.
Extract, accurately weighed, about 20 mg of Cyavanaprāśa with 2 ml of 50 per cent
aqueous methanol. Apply 13 ml of the test solution and 8 µl of gallic acid standard
solution on TLC plate. Develop, dry and scan the plate as described in the preceding
paragraph for calibration curve of gallic acid. Record area under the curve for a peak
corresponding to gallic acid in track of test solution. Calculate the amount of gallic acid
in the test solution using mean area under the curve and the calibration curve of gallic
acid.
Other requirements:
Microbial limit: Appendix 2.4.
Aflatoxin: Appendix 2.7.
Storage: Store in a cool place in tightly closed amber colured containers, protected from
light and moisture.
Therapeutic uses: Kāsa (cough), Śvāsa (Dyspnoea), K¾ata k¾ī´a (Debility due to chest
injury), Svarabheda (hoarseness of voice), K¾aya (Pthisis), H¨droga (Heart disease),
Agnimāndya (loss of appetite), Uroroga (disease of thorax), Vātarakta (Gout), Pipāsā
(thirst), Mūtraroga (urinary diseases), Śukra do¾a (abnormalities in semen), Jarā
(senility/progeriasis). Used as a Rasāyana (rejuvenating agents), Medhya (brain tonic/
nootropic), Sm¨tiprada (memory provider).
Definition:
Method of preparation:
Description:
Semisolid paste, yellowish-brown in color with pungent odour, astringent and salty taste.
Identification:
Microscopy:
Take about 5 g of avaleha, wash thoroughly with n-hexane; repeat twice; take the
sediment and wash with hot water to remove salt. Clarify a few mg with chloral hydrate
and mount in 50 per cent glycerine; boil a few mg in 2 per cent potassium hydroxide
solution , wash, and mount in glycerine; mount a few mg in iodine solution; observe the
following characters in different mounts.
Groups of yellow coloured, suberized, angular parenchymatous cells, patches of pitted
parenchyma with beaded cell walls, pits simple, patches of thick walled, angular cells
filled with very small simple and compound, starch grains, multicellular, multiseriate
trichomes, fragments of vittae (Śvetajīraka); patches of thick walled angular or slightly
wavy parenchyma, pitted parenchyma, parenchymatous cells with reticulate thickenings,
oil cells, unicellular, simple and glandular trichomes and fragments of vittae showing
large polygonal epitheial cells (Ajamodā); groups of parenchymatous cells, densely
packed with starch grains, isolated starch grains, simple, oval to rod shaped, measuring 15
to 70 μ in length, hilum eccentric, lamellae distinct; yellow coloured oleo resin cells,
non-lignified, septate fibres some of them bearing marks of adjacent cells pressing against
them, 30 to 50 μ broad, (Śu´°hī); groups of large perisperm cells packed with minute
starch grains, elongated stone cells measuring 130 to 190 µ in dia with broad lumen
isolated or in groups (Pippalī); groups of polygonal and elongated parenchymatous cells,
orange or brownish resin cells, branched tracheids, inulin crystals (Ku¾°ha); groups of
large parenchymatous tissues with cells filled with spheroidal starch grains which are
mostly single, rarely in 2 or 3 groups, 2 to 10 µ in dia, interrupted by aerenchymatous
space, oil cells with suberized walls (Vacā); crystal fibres and pitted vessels showing
honeycomb structure (Ya¾°himadhu); cells with yellow pigment turning red in sulfuric
acid 50 per cent, and cells with large starch grains, partially gelatinised (Haridrā).
Chemical tests:
a) Treat the avaleha with concentrated sulphuric acid; orange red colour develops
indicating the presence of curcuminoids (Haridrā).
b) Treat the avaleha with 10% solution of sodium hydroxide or potassium hydroxide; red
to violet colour develops indicating the presence of curcuminoids (Haridrā).
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Anupāna: Water.
. .
KŪ½M³±AKA RASĀYANA
(Syn. Kū¾mā´²aka Kha´²a)
(AFI, Part-I, 3:7)
Definition:
.
Kū¾mā´²aka Rasāyana is a semisolid avaleha preparation made with the
ingredients in the Formulation composition given below.
Formulation composition:
1. Kū¾mā´²aka API Benincasa hispida Fresh Fr.
4.8 kg
2. Gh¨ta API Clarified butter from cow’s milk
768 g
3. Kha´²a API Sugar candy
. 4.8 kg
4. . Pippalī API Piper longum
Fr. 96 g
5. ڍ¬gavera (Śu´°hī API) Zingiber
. officinale Rz. 96 g
6. Jīraka (Śveta jīraka API) Cuminum
. cyminum Fr. 96 g
7. Tvak API Cinnamomum
zeylanicum St. Bk. 24 g
8. Elā (Sūksmailā API) Elettaria cardamomum Sd.
24 g
9. Patra (Tejaptra API) Cinnamomum tamala Lf.
24 g
10 Marica API. Piper nigrum Fr.
24 g
11 Dhānya (Dhānyaka API) Coriandrum sativum Fr.
24 g
12 K¾audra (Madhu API) Honey
384 g
13 Jala API Water
Q.S.
Method of preparation:
Semi solid, malleable, sticky preparation, dark brown in color with spicy odour and
pungent, sweet taste.
Identification:
Microscopy:
Weigh about 5 g of the sample, stir with 50 ml of a defatting solvent in a beaker. Pour off
the solvent without loss of material and repeat the process till free from Ghrta. Wash the
sediment in warm water similarly, pour out water. Wash the sediment with distilled water
and centrifuge at medium speed. Decant the supernatant. Take a few mg of the sediment,
warm in chloral hydrate and mount in glycerine (50 per cent). Mount a few mg in iodine
solution. Observe the following characters in different mounts.
Sac-shaped starch grains with eccentric hilum, non-lignified xylem fibres and xylem
vessels with reticulate thickenings (Śu´°hī); multicellular, multiseriate trichomes and
sclereid layer from mesocarp (Jīraka); U-shaped stone cells with thickenings on three
sides (Tvak); bulbous perisperm cells containing starch grains and small prisms of
calcium oxalate within (Elā); fragments of multicellular uniseriate, short, stout trichomes
and leaf epidermal fragments with sunken paracytic stomata (Tejapatra); highly
thickened stone cells with narrow lumen from testa and groups of stone cells interspersed
among parenchyma tissue from hypodermis (Marica); groups of fusiform fibres of
sclerenchyma crisscrossing with each other (Dhānyaka).
Extract 5 g of sample with 75 ml of ethyl acetate under reflux on a water-bath for 30 min.
Filter, concentrate the filtrate to 10 ml and carry out the thin layer chromatography. Apply
10 µl of the extract on two separate TLC plates and develop the plates to a distance of 8
cm using toluene : ethyl acetate (7 : 3) as mobile phase. After development, allow the
plates to dry in air and examine one plate under ultraviolet light at 254 nm. It shows
major spots at Rf 0.11, 0.24 (piperine), 0.42 and 0.47, when observed at 366 nm it shows
major spots at Rf 0.10 (blue), 0.20 (green), 0.24 (blue, piperine), 0.33 (green), 0.37 (blue),
0.48 (blue) and 0.59 (blue). Derivatize the plate with modified Dragendorff’s reagent and
observe under visible light. It shows orange-coloured spots at Rf 0.24 (piperine), 0.27 and
0.83. Spray the second plate with anisaldehyde-sulphuric acid reagent followed by
heating at 1100 for about 10 min and examine under visible and ultraviolet light. Under
visible light, it shows major spots at Rf 0.24 (green, piperine), 0.37 (violet), 0.47 (violet),
0.51 (violet) and 0.59 (violet). Under ultraviolet light (366 nm), it shows major spots at
Rf 0.24, (fluorescent yellow, piperine), 0.26 (red), 0.36 (red), 0.46 (pink), 0.60 (red) and
0.70 (red).
Physico-chemical parameters:
Assay:
The formulation contains not less than 0.008 per cent of piperine when assayed by the
following method.
Estimation of piperine: Dissolve 5 mg of piperine in methanol and make up the volume to
100 ml in a volumetric flask. Pipette out aliquots of 0.8 to 4.8 ml into 10 ml volumetric
flasks and adjust the volume in each flask with methanol to prepare standard solutions of
4 to 24 µg / ml. Apply 10 ml of each standard solution on TLC plate. Develop the plate to
a distance of 10 cm using dichloromethane : ethyl acetate (7.5 : 1) as mobile phase. After
development, dry the plate in air and scan in the TLC scanner at a wavelength of 337 nm.
Note the area under the curve for a peak corresponding to piperine and prepare the
calibration curve by plotting peak area vs concentration of piperine.
Extract, accurately weighed, about 5 g of Kū¾mā´²aka Ras¢yana in 25 ml portions of
ethyl acetate (4 to 5 times), until it tests negative to modified Dragendorff’s reagent.
Filter, concentrate the combined extract and adjust the volume to 25 ml in a volumetric
flask. Apply 10 ml of the test solution on TLC plate. Develop, dry and scan the plate as
described in the preceding paragraph for calibration curve of piperine. Record area under
the curve for a peak corresponding to piperine. Calculate the amount of piperine in the
test solution from the calibration curve of piperine.
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Kāsa (cough); Śvāsa (Dyspnoea); Uraªk¾ata (chest wound); K¾aya
(Pthisis); Purā´ajvara (chronic fever); Raktapitta (bleeding disorder); Chardi (Emesis);
T¨¾´ā (thirst); Jvara (Fever); Śukra k¾aya (deficiency of semen); Daurbalya (weakness);
Kārśya (Emaciation); Svarabheda (hoarseness of voice); Vaivar´ya (discoloration).
Definition:
M¨dvīkādi Leha is a semisolid avaleha preparation made with the ingredients in the
Formulation composition given below.
Formulation composition:
1. M¨dvīkā (Drāk¾ā API) Vitis vinifera Dr. Fr. 50 in number
2. Pippalī API Piper longum Fr. 30 in number
3. Śarkarā API Sugar 48 g
4. Madhu API Honey Q.S.
Method of Preparation:
Description:
Dark brown coloured, semi solid, malleable, sticky preparation with a pungent, slightly
sweet and sour taste.
Identification:
Microscopy:
Take about 5 g of sample, wash in two or three increments of hot water and centrifuge.
Decant the supernatant and mount a small portion of the sediment in 50 per cent
glycerine; observe the following characters. Prisms and raphides of calcium oxalate, cells
filled with pinkish pigment (M¨dvīkā); simple starch grains with concentric hilum and
polygonal perisperm cells filled with starch grains (Pippalī).
Assay:
The formulation contains not less than 2.0 per cent gallic acid when assayed by the
following method.
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Kāsa (cough).
Definition:
Pūga Kha´da is a granular preparation made with the ingredients in the Formulation
composition given below.
Formulation composition:
Method of preparation:
Description:
Light brown granules with pleasant odour and spicy, sweet, acrid and astringent taste.
Identification:
________________________________________________________________________
____
* To maintain the shelf life, cow’s milk is washed off after boiling the Pūga phala. To
meet the milk component of the formulation, Pūga kha´²a should be essentially taken
with milk.
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Definition:
Formulation composition:
Method of preparation:
Semi solid, malleable, dark brown, sticky preparation with spicy odour and pungent,
sweet taste
Identification:
Microscopy:
Weigh about 5 g of the sample, stir with 50 ml of a defatting solvent in a beaker. Pour out
the solvent without loss of material and repeat the process till removal of the Gh¨ta.Wash
the sediment in warm water similarly, and pour out the water. Wash the sediment with
distilled water and centrifuge at medium speed. Decant the supernatant. Take a few mg of
the sediment, warm in chloral hydrate and mount in glycerine (50 per cent). Mount a few
mg in iodine solution. Observe the following characters in different mounts.
Sac-shaped starch grains with eccentric hilum, non-lignified xylem fibres and xylem
vessels with reticulate thickenings (Śu´°hī); multicellular, multiseriate trichomes and
sclereid layer from mesocarp (Jīraka); U-shaped stone cells with thickening on three
sides (Tvak); bulbous perisperm cells containing starch grains and small prisms of
calcium oxalate within (Elā); fragments of multicellular uniseriate short stout trichomes
and leaf epidermal fragments with sunken paracytic stomata (Tejapatra); highly
thickened stone cells with narrow lumen from testa, and groups of stone cells interspersed
among parenchyma tissue from hypodermis (Marica); groups of fusiform fibres of
sclerenchyma crisscrossing with each other (Dhānyaka).
Physico-chemical parameters:
Assay:
The formulation contains not less than 0.003 per cent of piperine, when assayed by the
following method.
Estimation of piperine: Dissolve 5 mg of piperine in methanol and make up the volume to
100 ml in a volumetric flask. From this stock solution, pipette out aliquots of 0.8 to 4.8
ml into 10 ml volumetric flask and make up the volume with methanol to prepare
standard solutions of 4 to 24 µg / ml. Apply 10 ml of each standard solution
(corresponding to 40 to 240 ng of piperine) on TLC plate. Develop the plate to a distance
of 8 cm using dichloromethane : ethyl acetate (7.5 : 1). After development, dry the plate
and scan in a TLC scanner at a wavelength of 337 nm. Record the area under the curve
for a peak corresponding to piperine and prepare the calibration curve by plotting peak
area vs amount of piperine.
Extract accurately weighed about 5 g Sūra´āvaleha in ethyl acetate (25 ml x 5). Filter the
extracts, pool, concentrate and adjust the volume to 25 ml in a volumetric flask. Apply 10
ml of test solution on TLC plate and develop, dry and scan the plate as described in the
proceeding paragraph for calibration curve of piperine. Calculate the amount of piperine
in the test solution from the calibration curve of piperine.
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Definition:
Formulation composition:
Method of preparation:
Dark brown coloured, semi solid, malleable, sticky preparation with odour of ghee; taste
bitter and pungent.
Identification:
Microscopy:
Take about 5 g of sample dissolve in sufficient quantity of n-hexane for removal of ghee.
Repeat the procedure with two further increments of solvent pouring out solvent each
time, wash the sediment with warm water, followed by cold water repeatedly till a clear
sediment is obtained. Take a few mg of the sediment, mount in 50 per cent glycerine and
observe the following characters. Simple starch grains with concentric hilum, abundant
polygonal perisperm cells packed with starch grains (Pippalī); multicellular, uniseriate,
warty covering trichomes, sessile glandular trichomes with quadricellular head, fragments
of lower epidermis showing the presence of diacytic stomata, cigar-shaped crystoliths
(Vāsā).
Extract 5 g of avaleha with 100 ml of methanol under reflux on a water-bath for 30 min.
Filter, concentrate to 25 ml and carry out the thin layer chromatography. Apply 10 µl of
the extract on TLC plate and develop the plate to a distance of 8 cm using ethyl acetate :
methanol : ammonia (8 : 2 : 0.2) as mobile phase. After development, allow the plate to
dry in air and examine under ultraviolet light. It shows major spots at Rf 0.34 (vasicine),
0.74, 0.96 (piperine) under ultraviolet light (254 nm) and at Rf 0.77 (fluorescent blue),
0.89 (blue), 0.96 (fluorescent blue – piperine) under ultraviolet light (366 nm). Derivatise
the plate with modified Dragendorff’s reagent and observe under visible light. It shows
two orange coloured spots at Rf 0.34 and 0.96.
Physico-chemical parameters:
Assay:
The formulation contains not less than 0.2 per cent of vasicine and not less than 0.2 per
cent of piperine when assayed by the following methods.
Estimation of vasicine: Dissolve 2 mg of vasicine in 25 ml of methanol in a volumetric
flask. From this stock solution pipette out aliquots of 2 to 6 ml and make up the volume
to 5 ml in volumetric flasks with methanol. Apply 10 ml of each standard solution
(corresponding to 320 to 960 ng of vasicine) on TLC plate. Develop the plate to a
distance of 8 cm using ethyl acetate : methanol : ammonia (8 : 2 : 0.2) as mobile phase.
After development, dry the plate and scan in TLC scanner at a wavelength of 298 nm.
Note the peak area under the curve for a peak corresponding to vasicine and prepare the
calibration curve by plotting peak area vs amount of vasicine.
Extract accurately weighed about 5 g of Vāsāvaleha in methanol (25 ml x 5). Filter the
extract, pool, concentrate and adjust the volume to 25 ml. Apply 10 ml of test solution on
TLC plate and develop, dry and scan the plate as described in the preceeding paragraph
for calibration curve of vasicine. Calculate the amount of vasicine in the test solution
from the calibration curve of vasicine.
Estimation of piperine: Dissolve 5 mg of piperine in 100 ml of methanol. From this stock
solution, pipette out 0.8 to 4.8 ml aliquots into 10 ml volumetric flasks and make up the
volume with methanol to prepare standard solutions of 4 to 24 µg / ml. Apply 10 ml of
each standard solution (corresponding to 40 to 240 ng) on TLC plate and develop the
plate to a distance of 8 cm using dichloromethane : ethyl acetate (7.5 : 1) as mobile
phase. After development, dry the plate and scan in TLC scanner at a wavelength of 337
nm. Note the peak area under the curve for a peak corresponding to piperine and prepare
the calibration curve by plotting peak area vs amount of piperine.
Extract accurately weighed about 5 g of Vāsāvaleha with ethyl acetate (25 ml x 5). Filter
the extract, pool, concentrate and adjust the volume to 25 ml in a volumetric flask. Apply
10 ml of test solution on TLC plate and develop, dry and scan the plate as described in the
preceding paragraph for calibration curve of piperine. Calculate the amount of piperine in
the test solution from the calibration curve of piperine.
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Definition:
Vyāghrī Harītakī is a semisolid preparation made with the ingredients given in the
Formulation composition.
Formulation composition:
Method of preparation:
A blackish brown, semisolid sticky paste with bitter and astringent taste and spicy
pleasant odour.
Identification:
Microscopy:
Take about 5 g of the Avaleha and wash it with warm water till guda and honey are
removed. Collect the sediment. Clarify a small amount of residue with chloral hydrate
solution, wash in cold water, and mount in glycerin. Take a few mg, add iodine solution
water, and mount in glycerin. Observe following character in different mounts.
Fragments of hypodermis in surface view, stone cells varying in sizes, shapes and
thickness, mostly present in groups interspersed among parenchyma (Marica); fragments
of fibres with very narrow lumen, not over 600 μ long and not over 45 μ broad;
parenchyma cells containing minute acicular crystal of calcium oxalate, stone cells
varying shape and size, smaller ones somewhat rectangular; oil cells present (Tvak);
groups of slightly wavy parenchymatous cells, each cell containing 1 to 3 rosette crystals
of calcium oxalate, groups of perisperm cells bulbous in shape packed with starch grains
which also shows in middle tiny prismatic crystals of calcium oxalate; epidermal and
hypodermal cells crossing each other at right angle (Sūkşmailā); groups of
parenchymatous cells, densely packed with starch grains, isolated starch grains, simple,
oval to rod shaped upto 75 μ in length, hilum eccentric, lamellae distinct; yellow coloured
oleo resin cells, non-lignified, septate fibres some of them bearing marks of adjacent cells
pressing against them (Śu´°hī); stone cells with broad lumen in groups of 2 to 8
(Pippalī); crushed pieces of anther lobes containing pollen grains, each tricolporate
measuring upto 55 μ in dia., groups of epidermal cells of anther lobe (Nāgakeśara);
groups of angular epidermal parenchytamous cells with sunken stomata, oil cells and oil
globules seen, unicellular and bicellular trichomes (Tejapatra).
Extract 5 g of sample with n-hexane (25 ml x 3) under reflux on a water bath for 30 min,
filter, concentrate to 10 ml and carry out thin layer chromatography. Apply 10 µl of the
extract on TLC plate. Develop the plate to a distance of 8 cm using tolune : ethyl acetate
(8 : 2) as mobile phase. After development, allow the plate to dry in air and examine
under ultra violet light (366 nm). It shows major spots at Rf 0.28 (blue), 0.43 and 0.58
(faint blue). Spray the plate with anisaldehyde- sulphuric acid reagent followed by
heating at 1100 about for 10 min. It shows major spots at Rf 0.21 (green), 0.43 (blue) and
0.58 (brown) under visible light.
Physico-chemical parameters:
Loss on drying: Not more than 23.0 per cent, Appendix
2.2.10.
Total ash: Not more than 4.0 per cent, Appendix
2.2.3.
Acid-insoluble ash: Not more than 0.15 per cent, Appendix
2.2.4.
Sulphated Ash: Not more than 0.41 per cent, Appendix
2.2.6.
Alcohol-soluble extractive: Not less than 20.0 per cent, Appendix
2.2.7.
Water-soluble extractive: Not less than 68.7 per cent, Appendix
2.2.8.
pH of 1% aqueous solution : 5.5 and 5.6, Appendix 3.3.
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Dose: 5 to 15 g.
General Descripition:
Drugs according to the formulation composition of the particular cūr´a are
collected, dried, powdered individually and passed through sieve number 85 to prepare a
fine powder. They are mixed in the specified proportion and stored in well closed
container.
The term cūr´a may be applied to the powder prepared by a single drug or a
combination of more drugs.
Raja and K¾oda are the synonyms for cūr´a. Cūr´as may be of plant origin, or
mixed with other ingredients. The following points are to be noted.
If metals / minerals are used, prepare bhasma or sindura of the minerals unless
otherwise mentioned.
In cases where pārada and gandhaka are mentioned, prepare Kajjalī and add other
drugs, one by one, according to the formula.
In general the aromatic drugs like Hi¬gū [Asafoetida] etc. should be fried before
they are converted to fine powders.
Specific care should be taken in case of Salts and Sugars. Formulations with
hygroscopic components should not usually be prepared during rainy seasons. If so,
specific precautions should be taken during storage.
Cūr´as should be stored in air tight containers. Polyethylene and foil packing also
provides damp proof protection.
Special precaution for storage should be taken in cases of formulations with salts, sugars
and Ks$āras.
ĀMALAKYĀDI CŪR³A
(AFI, Part-I, 7:3)
Definition:
Āmalakyādi Cūr´a is a powder preparation made with the ingredients in the Formulation
composition given below.
Formulation composition:
Method of preparation:
Description:
Brown-coloured, smooth powder with pleasant odour and salty, spicy taste. The powder
completely pass on through sieve number 44 and not less than 50 per cent pass on
through sieve number 85.
Identification:
Microscopy:
Take about 2 g of Cūr´a, and wash it thoroughly with water to remove salt, pour out the
water without loss of material and mount in glycerine; warm a few mg with chloral
hydrate, wash and mount in glycerine; treat a few mg with iodine in potassium iodide
solution and mount in glycerine. Observe the following characters in the different
mounts.
Thin walled epidermis with paracytic stomata, brachysclereids with pitted wide lumen,
silica crystals in epidermal cells (Āmalakī); cork cells in surface view, uniseriate and
multiseriate ray parenchyma cells, bifurcated short fibres and pitted vessels (Citraka);
Prismatic and druses of calcium oxalate crystals, groups of sclereids, criss-cross layers of
fibres, thin walled fibres and broad lumen with pegged tip (Harītakī); perisperm cells
packed with starch grains and minute crystals of calcium oxalate, uniseriate multicellular
trichomes (Pippalī).
Extract 4 g of cūr´a in alcohol (25 ml x 3) under reflux on a water-bath for 30 min, filter,
concentrate to 10 ml and carry out the thin layer chromatography. Apply 10 µl of the
extract on TLC plate and develop the plate to a distance of 8 cm using toluene : ethyl
acetate (5 : 2) as mobile phase. After development, allow the plate to dry in air and
examine under ultraviolet light (254 nm). It shows major spots at Rf. 0.43 (light green),
0.50 (green) and 0.85 (pale green).
Physico-chemical parameters:
Assay:
Anupāna: Water.
AVIPATTIKARA CŪR³A
(AFI, Part- I, 7:2)
Definition:
Avipattikara Cūr´a is a powder preparation made with the ingredients in the Formulation
composition given below.
Formulation composition:
Method of preparation:
Description:
Light brown, fine powder, odour characteristic of clove, with a sweet, spicy and
pungent taste. The powder completely pass on through sieve number 44 and not less than
50 per cent pass on through sieve number 85.
Identification:
Physico-chemical parameters:
Other requirements:
Definition:
Bālacaturbhadrikā Cūr´a is a powder preparation made with the ingredients in the Formulation
composition given below:
Formulation composition:
Method of preparation:
Description:
Pale brown powder, odour characteristic of pippali and taste slightly pungent followed by
a tingling sensation. The powder completely pass on through sieve number 44 and not
less than 50 per cent pass on through sieve number 85.
Identification:
Microscopy:
Take a few mg of Cūr´a and warm with chloral hydrate, wash and mount in glycerine;
wash a few mg of Cūr´a in water and mount in glycerine; treat a few mg of Cūr´a with
iodine solution and mount in glycerine; observe the following characters in the different
mounts.
Parenchyma cells with reddish brown contents, starch grains simple, circular to oval upto
30 µ, narrow vessels with lateral simple perforation, walls reticulate, pitted and spiral
vessels, regularly arranged sclereids from scale leaf (Mustā); multicellular uniseriate
trichomes, perisperm cells packed with starch grains and minute crystals of calcium
oxalate, spindle shaped, elongated stone cells with wide lumen (Pippalī); starch grains,
simple and compound with 2 to 4 components, upto 65µ in size, parenchyma cells with
starch grains and cork cells in surface view (Ativi¾ā); collapsed thin walled epidermal
cells, tissue fragments with yellowish brown contents and large tannin containing sacs
associated with vascular bundles (Karka°aś¨¬gī).
Extract 4 g of Cūr´a in alcohol (25 ml x 3) under reflux on a water-bath for 30 min filter, concentrate to 10
ml and carry out the thin layer chromatography. Apply 10 µl of the extract on TLC plate and develop the
plate to a distance of 8cm using toluene : ethyl acetate (5 : 1.5) as mobile phase. After development allow
the plate to dry in air and examine under ultraviolet light (254 nm). It shows major spots at Rf 0.31, 0.37,
0.45, 0.60 (all green), 0.74 (light green) and 0.91 (blue). Under ultraviolet light (366 nm), it shows major
spot at Rf 0.65 (fluorescent blue). Spray the plate with vanillin-sulphuric acid reagent followed by heating
at 1100 for about 10 min and observe under visible light. The plate shows major spots at Rf 0.36, 0.50 (both
grey), 0.61 (blue), 0.68 (grey) and 0.81 (pink).
Physico-chemical parameters:
Loss on drying at 1050: Not more than 9 per cent, Appendix 2.2.10.
Total ash: Not more than 7 per cent, Appendix 2.2.3.
Acid-insoluble ash: Not more than 2.5 per cent, Appendix
2.2.4.
Alcohol-soluble extractive: Not less than 14 per cent, Appendix 2.2.7.
Water-soluble extractive: Not less than 16 per cent, Appendix 2.2.8.
pH (10% aqueous solution): 5 to 5.3, Appendix 3.3.
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and moisture.
Therapeutic uses: Atisāra (Diarrhoea); Chardi (Vomiting); Kāsa (cough); Śvāsa (Dyspnoea); Jvara (fever);
Bāla śo¾a (emaciation in children).
Anupāna: Honey.
ELĀDI CŪR³A
(AFI, Part-I, 7:5)
Definition:
Elādi Cūr´a is a powder preparation made with the ingredients in the Formulation
composition given below.
Formulation composition:
Method of preparation:
Description:
Brown-coloured, smooth powder with characteristic odour of Elā, and a spicy, pungent
taste. The powder completely pass on through sieve number 44 and not less than 50 per
cent pass on through sieve number 85.
Identification:
Microscopy:
Take a few mg of Cūr´a and warm with chloral hydrate, wash and mount in
glycerine; wash a few mg in water and mount in glycerine; treat a few mg with iodine
solution and mount in glycerine; observe the following characters in the different
mounts.
Perisperm cells with bulbous projections, packed with starch grains and also carrying
minute calcium oxalate crystals, fragments of aril tissue with elongated cells and orange
coloured sclerenchymatous cells (Elā); pollen grains tetrahedral, spherical, biconvex,
measuring 15 to 20 μ in dia, spindle shaped fibres, parenchyma with oil cells and anther
wall with cluster crystals of calcium oxalate (Lava¬ga); numerous golden yellow pollen
grains upto 50 μ in dia and fragments of anther wall (Nāgakeśara); circular to oval thin
walled, reddish brown cells of mesocarp, polygonal epicarp cells in surface view (Kola);
endosperm cells packed with minute starch grains in clusters (Śāli); fragments of stellate
hairs, elliptical, oval and circular pollen grains with clear exine, yellowish in colour, upto
30 μ in dia, spiral vessels (Priya¬gu); circular to oval starch grains measuring upto 30 μ
in dia, narrow vessel with scalariform thickness, oblique pore, regular arrangement of
parallel short fibres from scale leaf (Mustā); abundant fragments of thick walled fibres
isolated or associated with pitted vessel with tail (Śveta candana); oval to elongated
stone cells, measuring upto 300 μ in length, perisperm cells packed with starch grains and
minute calcium oxalate crystals, multicellular uniseriate trichome (Pippalī).
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Formulation composition:
Method of preparation:
Description:
Light brown; free flowing powder with a spicy and astringent taste, odour aromatic and
pleasant. The powder completely pass on through sieve number 44 and not less than 50
per cent pass on through sieve number 85.
Identification:
Microscopy:
Take about 5g of Cūr´a and wash thoroughly with destilled water to get rid of salt; allow
the material to settle, and reject the supernatant without loss of material; take a few mg
and stain with iodine solution and mount in 50 per cent glycerine to examine the starch
grains. Clarify a few mg with chloral hydrate and mount in 50 per cent glycerine; boil a
few mg with 2 per cent potassium hydroxide, wash with water and mount in glycerine.
Observe the following character in different mounts.
Stone cells measuring 130 to 190 µ in dia with broad lumen, isolated in groups of 2 to 8
(Pippalī); fragments of inner epidermis of pericarp in surface view, with groups of stone
cells varying in sizes, shapes and thickness, interspersed among parenchymatous
hypodermis (Marica); groups of parenchymatous cells, densely packed with starch
grains, isolated starch grains, simple, oval to rod shaped, measuring 15 to 70 μ in length,
hilum eccentric, lamellae distinct; yellow coloured oleo resin cells, non-lignified, sepatate
fibres some of them bearing marks of adjacent cells pressing against them, 30 to 50 μ
broad, (Śu´°hī); striated epidermal debris, transversely much elongated, thin walled
parenchymatous cells in a regular V joint with neighbouring cell, stone cells from
mesocarpic stone cell layer, not much longer than broad, epithelial cells of vittae arranged
like honey comb (K¨¾´a Jīraka); multicellular large trichomes, stone cells of mesocarpic
stone cell layer much longer than broad (Śveta Jīraka); epicarp tissue with radially
striated or puckered papillose outgrowth, along with anomocytic stomata (Ajamodā).
Physico-chemical parameters:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Navāyasa Cūr´a is a powder preparation made with the ingredients in the Formulation
composition given below.
Formulation composition:
Method of preparation:
Description:
Reddish-brown powder with pungent odour and spicy, pungent taste. All pass through
sieve number 44 and not less than 50 per cent pass through sieve number 85.
Identification:
Microscopy:
Take about 5 g Cūr´a in a small beaker, add water, stir thoroughly and pass through 150
sieve to remove the Bhasma; repeat once more. Take a few mg of the washed Cūr´a and
warm with chloral hydrate, wash and mount in glycerine; wash a few mg in water and
mount in glycerine; treat a few mg with iodine solution and mount in glycerine. Observe
the following characters in different mounts.
Large starch grains, oval shape upto 50 µ in size; spiral vessels and septate non lignified
fibres (Śu´°hī); stone cells of various shapes interspersed with parenchyma cells from
hypodermis (Marica); groups of isolated and spindle shaped stone cells, uniseriate
multicellular trichomes (Pippalī); groups of elongated sclereids with pits and broad
lumen, crisscross fibre tissue, thin walled fibres with broad lumen and pegged tips
(Harītakī); unicellular trichomes with sharp tips and bulbous base, epidermal fragment
with cicatrices (Bibhītaka); thin walled epidermis with paracytic stomata and silica
crystals, brachysclereids with pitted wide lumen, large, irregular thick walled parenchyma
with prominent corner thickening (Āmalakī); scalariform vessels, starch grains upto 30
µ and regularly arranged, parallel sclereids from scale leaf (Mustā); prismatic crystals of
calcium oxalate, spiral vessels and stone cells in different shapes and sizes with
prominent pits from testa and elongated sclereids with broad lumen and pitted walls
(Vi²a¬ga) ; cork cells in surface view and ray parenchyma cells with pits and thin walled
fibres with pointed tips (Citraka).
Assay:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Definition:
Nimbādi Cūr´a is a powder preparation made with the ingredients in the Formulation composition given
below:
Formulation composition:
Method of preparation:
Roast coarsely powdered Saindhava lava´a (number 15) in a stainless steel pan at a low
temperature till it becomes free from moisture. Prepare fine powder and pass through
sieve number 85. Clean, dry and powder the other ingredients 1 to 21 (except number 15)
individually in a pulverizer and sift through sieve number 85 mesh separately. Weigh
separately each ingredient, mix together in specified ratio and pass through sieve number
44 to obtain a homogeneous blend. Pack it in tightly closed containers to protect from
light and moisture.
Description:
Yellowish brown, smooth powder, taste bitter, salty and odour pungent. The powder
completely pass on through sieve number 44 and not less than 50 per cent pass on
through sieve number 85.
Identification:
Thin Layer Chromatography:
Extract 4 g of curna in alcohol (25 ml x 3) under reflux on a water-bath for 30 min filter, concentrate to 10
ml and carry out the Thin Layer Chromatography. Apply 10 µl of the extract on TLC plate and develop the
plate to a distance of 8 cm using toluene : ethyl acetate (5 : 3) as mobile phase. After development of the
plate, allow it to dry in air and examine under ultraviolet light (254 nm). It shows major spots at Rf 0.25
(fluorescent blue), 0.52 (yellow), 0.67and 0.82, (both blue). Under ultraviolet light (366 nm), it shows
major spots at Rf 0.25, 0.52, 0.57, 0.62, 0.72 and 0.82 (all pale blue). Spray the plate with
vanillin-sulphuric acid reagent followed by heating at 1100 for about 10 min and observe under visible
light. The plate shows major spots at Rf 0.72 (grey), 0.82 (pink) and 0.87 (grey).
Test for chloride: Dissolve 1 g of the sample in 10 ml of purified water and filter. Acidify
the filtrate with dilute nitric acid and add 5 per cent w/v silver nitrate solution. A curdy
white precipitate shows the presence of chlorides.
Physico-chemical parameters:
Assay:
Other requirements
Storage: Store in a cool place in tightly closed containers, protected from light and moisture.
Therapeutic uses: Udara (diseases of abdomen); Āmavāta (Rheumatism); Vātarakta
(Gout); Ku¾°ha (diseases of skin).
Definition:
Pa®casama Cūr´a is a powder preparation made with the ingredients in the Formulation composition given
below:
Formulation composition:
Method of preparation:
Description:
Pale brown, smooth powder, odour pungent and taste slightly pungent with tingling
sensation. The powder completely pass on through sieve number 44 and not less than 50
per cent pass on through sieve number 85.
Identification:
Microscopy:
Take about 2 g of the Cūr´a and wash it thoroughly with water to remove the salt without
loss of Cūr´a; using the washed Cūr´a make the following preparations: warm a few mg
in chloral hydrate, wash to remove chloral hydrate and mount in glycerine; mount a few
mg in glycerine; treat a few mg with solution of iodine solution and mount in glycerine:
take a few mg in a watch glass add iodine water, and drain excess of iodine by filter
paper; add a drop of sulphuric acid (2 parts in 1 part water), mount in glycerine to locate
cellulosic fibres. Observe the following characters in the different mounts:
Fragments of septate non-lignified fibres, broad spiral and reticulate vessels and oval
shaped starch grains upto 50 µ in size (Śu´thī); groups of elongated thick walled
sclereids with pits and broad lumen, crisscross thin walled fibres with broad lumen and
pegged tips, polygonal epidermal cells with slight beading and dividing septum
(Harītakī); uniseriate, multicellular trichomes, perisperm cells packed with starch grains
and minute crystals of calcium oxalate, isolated, elongated stone cells with broad lumen
(Pippalī); Prismatic crystals of calcium oxalate and rosette crystals of calcium oxalate,
vessels with regular bordered pits appearing like honey comb, stone cells and thick walled
cellulosic fibres with broken ends and very narrow lumen (Triv¨t).
Physico-chemical parameters:
Loss on drying at 1050: Not more than 10 per cent, Appendix 2.2.10.
Total ash: Not more than 22 per cent, Appendix 2.2.3.
Acid-insoluble ash: Not more than 3 per cent, Appendix 2.2.4.
Alcohol-soluble extractive: Not less than 20 per cent, Appendix 2.2.7.
Water-soluble extractive: Not less than 35 per cent, Appendix 2.2.8.
pH (10% aqueous solution): 4.5 to 4.7, Appendix 3.3.
Assay:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and moisture.
Therapeutic uses: Ādhmāna (flatulence with gurgling sound); Śūla (pain / colic); Āmavāta (Rheumatism);
Arśa (Piles); Udara roga (diseases of abdomen), Vibandha (constipation).
Definition:
Pu¾yānuga Cūr´a is a powder preparation made with the ingredients in the Formulation
composition given below.
Formulation composition:
Method of preparation:
Description:
Reddish brown-coloured fine powder with a pungent odour and a bitter, sweet taste. The
powder completely pass on through sieve number 44 and not less than 50 per cent pass on
through sieve number 85.
Identification
Extract 4 g of cūr´a in alcohol (25 ml x 3) under reflux on a water-bath for 30 min filter,
concentrate to 10 ml and carry out the thin layer chromatography. Apply 10 µl of the
extract on TLC plate and develop the plate to a distance of 8 cm using toluene : ethyl
acetate (5 : 2) as mobile phase. After development, allow the plate, to dry in air and
examine under ultraviolet light (366 nm). It shows major spots at Rf 0.18 (blue), 0.73
(fluorescent blue). Spray the plate with vanillin-sulphuric acid reagent followed by
heating at 1100 for about 10 min and observe under visible light. The plate shows major
spots at Rf 0.13 (grey), 0.27 (purple), 0.33 (yellow), 0.53 (purple), 0.66 and 0.97 (both
purple).
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and moisture.
Definition:
Tālīsādya Cūr´a is a powder preparation made with the ingredients in the Formulation
composition given below.
Formulation composition:
Method of Preparation:
Description:
Creamish white fine powder with pleasant odour and a sweet, spicy and pungent taste.
The powder completely pass on through sieve number 44 and not less than 50 per cent
pass on through sieve number 85.
Identification:
Microscopy:
Take about 2 g of Cūr´a, wash thoroughly in water to remove sugar. Take a few mg of
the washed Cūr´a and warm with chloral hydrate, wash and mount in glycerine; wash a
few mg in water and mount in glycerine; treat a few mg with iodine solution and mount
in glycerine. Observe the following characters in different mounts.
Surface view of epidermis showing sunken stomata with thick cuticle, palisade
parenchymatous fragments, parenchyma cells filled with brown colour cell content
(Tālīsa); beaker shaped stone cells upto 150 μ length, tissue from hypodermis with
polygonal pitted stone cells with interspersed among parenchyma cells, lumen circular
(Marica); large starch grains upto 35 μ in dia, eccentric hilum, reticulate and spiral
vessels, septate fibres non lignified and broad lumen with sharp tips (Śu´°hī); spindle
shaped stone cells with or without a broad lumen, uniseriate multicellular trichome
(Pippalī); perisperm cells with bulbous projections, packed with minute starch grains and
also carrying minute calcium oxalate crystals, fragments of aril tissue from testa, orange
coloured sclerenchymatous cells (Elā); fibres with thick walls narrow lumen upto 720 μ
length, lignified stone cells with thick inner walls, pitted parenchyma, acicular crystals of
calcium oxalate (Tvak).
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and moisture.
Definition:
Vaiśvānara Cūr´a is a powder preparation made with the ingredients in the Formulation
composition given below:
Formulation composition:
Method of preparation:
Description:
Creamish-brown, smooth powder with the characteristic smell of Su´°hi; taste salty,
astringent, bitter, with a tingling sensation. The powder completely pass on through sieve
number 44 and not less than 50 per cent pass on through sieve number 85.
Identification:
Microscopy:
Take about 2 g of Cūr´a, and wash it thoroughly in water to remove salt without loss of
Cūr´a and use the washed Cūr´a as follows; warm a few mg with chloral hydrate, wash
and mount in glycerine; mount a few mg in glycerine; treat a few mg with iodine solution
and mount in glycerine; heat a few mg in 2 per cent aqueous potassium hydroxide, wash
in water, and mount in glycerine. Observe the following characters in different mounts.
Epidermis showing striated cuticle with papillose cells and short glandular outgrowths
(Yavānī); epidermal tissue with radially striated puckered papillose outgrowths
(Ajamodā); broad, reticulate or pitted vessel debris, long non-lignified fibres with septae
and dented along one side, starch grains large, upto 50 µ, oval with eccentric hilum
(Śu´°hī); groups of elongated sclereids with pits and broad lumen, crisscross thin walled
fibres with broad lumen and pegged tips, epidermal tissue with polygonal cells, walls
slightly beaded, and several showing thin transverse septa (Harītakī).
Extract 4 g of sample in alcohol (25 ml x 3) under reflux on a water-bath for 30 min. Filter, concentrate to
10 ml and carry out the thin layer chromotographer Apply 10 µl of the extract on TLC plate, develop the
plate to a distance of 8 cm using toluene : ethyl acetate (5 : 1) as mobile phase. After development of the
plate, allow it to dry in air and examine under ultraviolet light (254 nm). It shows major spots at Rf 0.36,
0.55 (both green), 0.64 (fluorescent blue) and 0.72 (green). Under ultraviolet light (366 nm), it shows major
spots at Rf, 0.52 and 0.63 (both pale blue). Spray the plate with vanillin-sulphuric acid reagent followed by
heating at 1100 for about 10 min and observe under visible light. The plate shows major spots at Rf 0.47,
0.62, 0.76 and 0.97 (all grey).
Test for Chloride: Dissolve 1 g of the curna in 10 ml of deionised water and filter.
Acidify the filtrate with dilute nitric acid and add 5 per cent w/v silver nitrate solution. A
curdy white precipitate appears.
Physico-chemical parameters:
Loss on drying at 1050: Not more than 10 per cent, Appendix 2.2.10.
Total ash: Not more than 15 per cent, Appendix 2.2.3.
Acid-insoluble ash: Not more than 1.8 per cent, Appendix 2.2.4.
Alcohol-soluble extractive: Not less than 34 per cent, Appendix 2.2.7.
Water-soluble extractive: Not less than 42 per cent, Appendix 2.2.8.
Assay:
Other requirements
Storage: Store in a cool place in tightly closed containers, protected from light and moisture.
Therapeutic uses: Ādhmāna (flatulance with gurgling sound); Gulma (abdominal lump); Pari´āmaśūla
(Duodenal ulcer); Āmavāta (Rheumatism); H¨droga (heart disease).
Gh¨tas are preparations in which the Gh¨ta is boiled with prescribed liquid media
[Svarasa / Ka¾āya etc.] and a fine paste [Kalka] of the drugs specified in the formulation
composition. Unless specified otherwise Gh¨ta means Go Gh¨ta.
11. Patra Pāka: It is the process by which the Gh¨ta is augmented or flavored by
certain prescribed substances. The powdered drugs are suspended in a vessel
containing warm, filtered Gh¨ta.
The medicated Gh¨ta will have the odour, colour and taste of the drugs
used in the process. If a considerable amount of milk is used in the
preparation, the Gh¨ta will become thick and may solidify in cold seasons.
Definition:
Brāhmī gh¨ta is a semisolid preparation made with the ingredients in the Formulation
composition given below with Gh¨ta as the basic ingredient.
Formulation composition:
Method of preparation:
Description:
A low melting Gh¨ta, green in colour with soft, unctuous touch, pleasant odour and bitter
taste.
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer, filter, concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm using
toluene : ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows major spots at Rf 0.15 (both grey), 0.28, 0.40 and 0.51
(all light grey) under visible light.
Physico-chemical parameters:
Other requirements:
Definition:
Daśamūla Gh¨ta is a medicated preparation made with the ingredients in the Formulation
composition given below with Gh¨ta as the basic ingredient.
Formulation composition:
Method of preparation:
A low melting Gh¨ta, yellowish green in color with pleasant odour and bitter taste.
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer, filter, concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm using
toluene: ethyl acetate: hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows spots at Rf 0.11 (light grey), 0.38 (light grey), 0.50
(grey), 0.63 (grey), 0.70 (light grey), 0.78 (light grey) and 0.90 (light grey) under visible
light.
Physico-chemical parameters:
Storage: Pack it in tightly closed containers to protect from light and moisture.
Therapeutic uses: Vātaja kāsa (cough due to Vāta do¾a); Kaphaja kāsa (cough due to
Kapha do¾a); Vātakapha roga (diseases due to Vāta Kapha do¾a); Sūtikā roga (Puerperal
disorders) and Hasta pāda dāha (burning sensation in palms & soles).
Definition:
Formulation composition:
Method of preparation:
Description:
A low melting Gh¨ta, yellowish green in color with pleasant odour and bitter and
astringent taste.
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer, filter and concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm using
toluene: ethyl acetate: hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows spots at Rf 0.12 (grey), 0.19 (grey), 0.35 (grey), 0.71
(light brown), 0.8 (brown) and 0.92 (brown) under visible light.
Physico-chemical parameters:
Storage: Pack it in tightly closed containers to protect from light and moisture.
Definition:
Dhātryādi Gh¨ta is a medicated preparation made with the ingredients in the Formulation
composition given below with Gh¨ta as the basic ingredient.
Formulation composition:
Method of preparation:
Description:
Medicated Gh¨ta, greenish yellow in color with pleasant odour and sweet taste.
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer, filter, concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm using
toluene: ethyl acetate: hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows spots at Rf 0.39 (light grey), 0.62 (light grey), 0.68 (light
grey), 0.79 (light grey) and 0.88 (light grey) under visible light.
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Pittaja gulma (lump due to pitta do¾a); Pittaja pā´²u (Anemia due
to pitta do¾a); Mada (intoxication); Mūrchā (Syncope); Madātyaya (alcoholism); Unmāda
(Insanity); Raktapitta (Bleeding disorders); As¨gdara (excessive bledding from vaginal
tract); Vandhyatva (Infertility); Vātarakta (Gout); pittavikāra (disorders of Pitta do¾a) and
Asthisrāva (discharge from bone).
Anupāna: Mixed with equal quantity of sugar and administer with warm milk and warm
water.
JĀTYĀDI GH§TA
(Syn. Vra´a Śodhanādi Gh¨ta)
(AFI, Part-I, 6:11)
Definition:
Jātyādi Gh¨ta is a medicated preparation made with the ingredients in the Formulation
composition given below with Gh¨ta as the basic ingredient.
Formulation composition:
Method of preparation:
Description:
A low melting Gh¨ta, yellowish green in color, unctuous to touch with pleasant odour.
Identification:
Extract 2 g of Jātyādi Gh¨ta with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer, filter, concentrate to 5 ml and carry out thin layer chromatography. Apply
10 µl of the extract on TLC plate and develop the plate to distance of 8 cm using toluene :
ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After development, allow the plate to
dry in air and spray with ethanol-sulphuric acid reagent followed by heating at 1100 for
about 10 min. It shows spots at Rf 0.12 (light grey), 0.29 (grey), 0.5 (dark brown), 0.59
(brown), 0.69 (brown) and 0.85 (light grey).
Physico-chemical parameters:
Other requirements:
Mineral oil: Absent, Appendix
3.15.
Microbial Limits: Appendix 2.4.
Aflatoxins: Appendix 2.7.
Storage: Store in a cool place in tightly closed containers, protected from light and moisture.
Therapeutic uses: For local application in Marmāś¨ta vra´a (Ulcers in vital points);
Kledī vra´a (Oozing / weeping ulcer); Gambhīra vra´a (deep-rooted ulcers); Saruja vra´a
(painful ulcers), Raktaja vra´a (bleeding ulcers); Du¾°a vra´a (non-healing ulcers).
Definition:
Kalyā´aka Gh¨ta is a medicated preparation made with the ingredients in the Formulation
composition given below with Gh¨ta as the basic ingredient.
Formulation composition:
Description:
A low melting Gh¨ta, yellowish green in color with pleasant odour and bitter taste.
Identification:
Extract 2 g of Kalyā´aka Gh¨ta with 20 ml of alcohol at about 400 for 3 h. Cool, separate
the alcohol layer, filter, concentrate to 5 ml and carry out thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm
using toluene : ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After development,
allow the plate to dry in air and spray with ethanol-sulphuric acid reagent followed by
heating at 1100 for about 10 min. It shows spots at Rf 0.12 (grey), 0.25 (light grey), 0.35
(light grey), 0.54 (light grey), 0.76 (brownish grey) and 0.92 (brown) under visible light.
Physico-chemical parameters:
Storage: Pack it in tightly closed containers to protect from light and moisture.
Definition:
Formulation composition:
Method of preparation:
Description:
Identification:
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Apasmāra (Epilepsy); Jvara (fever); Unmāda (Insanity) and Kāmalā
(Jaundice).
Definition:
Pa®catikta Gh¨ta is a medicated preparation made with the ingredients in the Formulation
composition given below with Gh¨ta as the basic ingredient.
Formulation composition:
Method of preparation:
Description:
A low melting Gh¨ta, greenish yellow color with pleasant odour and bitter taste.
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer, filter concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm using
toluene: ethyl acetate: hexane (6: 3: 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows spots at Rf 0.13 (light grey), 0.20 (light grey), 0.28 (light
grey), 0.37 (light grey), 0.57 (light grey) and 0.89 (brown) under visible light.
Physico-chemical parameters:
Other requirements:
Storage: Pack it in tightly closed containers to protect from light and moisture.
Therapeutic uses: Du¾°avra´a (non-healing ulcer); Ku¾°ha (Leprosy/skin diseases);
Vātavyādhi (disorders due to vitiated Vāta do¾a); Pittavyādhi (diseases due to vitiated
Pitta do¾a); Kaphavikāra (disorders due to vitiated Kapha do¾a); K¨mi (worm
infestation); Arśa (Piles) and Kāsa (cough).
Definition:
Phala Gh¨ta is a medicated preparation made with the ingredients in the Formulation
composition given below with Gh¨ta as the basic ingredient.
Formulation composition:
Method of preparation:
Description:
A low melting Gh¨ta, greenish yellow in color with pleasant odour and astringent taste.
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer, filter, concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm using
toluene : ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows spots at Rf 0.094 (light grey), 0.19 (light grey), 0.25
(light grey), 0.28 (light grey), 0.53 (light grey), 0.80 (light grey) and 0.97 (brownish grey)
under visible light.
Physico-chemical parameters:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Śukra vikāra (disorders of the Śukra dhāthu); Yoni vikāra
(disorders of female genital tract); Vandhyatva (Infertility); Garbhi´ī roga (diseases
during pregnancy) and Kārśya (Emaciation); Uttara Vasti (Vaginal Douche)
Dose: 12 g daily in divided doses.
Definition:
Sārasvata Gh¨ta is a medicated preparation made with the ingredients in the Formulation
composition given below with Gh¨ta as the basic ingredient.
Formulation composition:
Method of preparation:
Description:
A low melting Gh¨ta, greenish yellow in color with pleasant odour and bitter taste.
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer, filter, concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm using
toluene : ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows eight spots at Rf 0.09 (light grey), 0.29 (light grey), 0.42
(grey), 0.52 (brown), 0.55 (light grey), 0.59 (light grey), 0.66 (grey) and 0.69 (light grey)
under visible light.
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Improves Vāk (speech), Medhā (intelligence), Sm¨ti (memory) and
Jā°harāgni (appetite)
Dose: 12 g daily in divided dose.
Definition:
Formulation composition:
Method of preparation:
Description: A low melting Gh¨ta, greenish in color with pleasant odour and bitter taste.
Identification:
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Definition:
Triphalā gh¨ta is a medicated preparation made with the ingredients in the Formulation
composition given below with Gh¨ta as the basic ingredient.
Formulation composition:
Method of preparation:
Heat for 3 h with constant stirring maintaining the temperature between 500 and 900
during the first hour of heating. Stop heating and allow to stand overnight.
Start heating next day and observe the boiling mixture for subsidence of froth (phena
śānti) and constantly check the kalka for formation of varti (madhyama pāka lak¾a´a).
Expose the varti to flame and confirm the absence of crackling sound indicating absence
of moisture. Stop heating when the kalka forms into a varti and the froth subsides. Filter
while hot (about 800) through a muslin cloth and allow to cool.
Pack it in tightly closed glass containers to protect from light and moisture.
Description:
A low melting Gh¨ta, green in colour, unctuous to touch with pleasant odour and bitter
taste.
Identification:
Extract 2 g of Triphalā gh¨ta with 20 ml of alcohol at about 400 for 3 h. Cool, separate
the alcohol layer, filter, concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm using
toluene : ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows spots at Rf 0.06 (grey), 0.17 (grey), 0.23 (grey), 0.32
(brownish grey), 0.37 (light grey), 0.43 (light grey), 0.59 (grey), 0.65 (grey), 0.75 (light
grey) and 0.83 (greenish-grey) under visible light.
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Arbuda (tumours); Kāmalā (Jaundice); Timira (Cataract); Visarpa
(Erysepelas); Pradara (excessive vaginal discharge); Netra rujā (pain in eyes); Netra srāva
(Lacrimation); Kāsa (cough); Ka´²ū (itching); Rakta do¾a (disorders of Blood); Śvayathu
(oedema); Khālitya (Alopecia); Keśa patana (falling of hair); Vi¾ama jvara (intermittent
fever); Arma (Pterygium); Śukla netra roga (Eye disorders related to sclera) and Vartma
roga (disorders of eyelids).
Dose: 12 g daily in divided doses. It can also be used in different Netra Kriyā kalpas.
The boiling of Guggulu in Dolā Yantra is carried on until all the Guggulu passes
into the fluid through the cloth. By pressing with fingers, much of the fluid that can pass
through is taken out. The residue in the bundle is discarded. The fluid is filtered and again
boiled till it forms a mass. This mass is dried and then pounded with a pestle in a stone
mortar, adding ghee in small quantities till it becomes waxy.
Guggulu is kept in glass or porcelain jars free from moisture and stored in a cool
place. The potency is maintained for two years when prepared with ingredients of plant
origin and indefinitely when prepared with metals and minerals.
KAIŚORA GUGGULU (Vatī)
(AFI, Part-I, 5:2)
Definition:
Kaiśora Guggulu is a va°ī preparation made with the ingredients in the Formulation
composition given below with Guggulu as the basic ingredient.
Formulation composition:
Method of preparation:
Spherical pills, dark brown in color with pleasant odour, taste astringent and sweetish.
Identification:
Microscopy:
Take about 5 g of the sample, powder it and add n-hexane (20 ml), stir for 10 min
thoroughly over a water-bath; pour out hexane. Repeat the process thrice adding fresh
quantities of hexane; discard hexane. Wash the sediment in hot water thoroughly. Take a
few mg of the washed material, stain with iodine solution and mount in 50 per cent
glycerine. Clarify a few mg with chloral hydrate and mount in 50 per cent glycerine.
Observe the following characters in different mounts.
Groups of parenchymatous epidermal cells having beaded walls, several showing a thin
cross wall, crisscross layer of sclerenchymatous fibres (Har¤takī); short, unicellular, thick
walled trichomes with sharp tips and bulbous bases and fragments of polyhedral
epidermis showing cicatrices (Bibhītaka); thin walled cells of epidermal tissue with
paracytic stomata and containing silica crystals, brachysclereids with pitted wide lumen,
parenchymatous tissue with large irregular thick walled cells showing corner thickenings
(Āmalakī); groups of parenchymatous cells, densely packed with starch grains, isolated
starch grains, simple, oval to rod shaped, measuring 15 to 70 μ in length, hilum eccentric,
lamellae distinct, yellow coloured oleo-resin cells, non-lignified, septate fibres some of
them bearing marks of adjacent cells pressing against them, 30 to 50 μ broad (Śu´°hī);
fragments of inner epidermis in surface view with group of stone cells, interspersed
amidst parenchyma (Marica); spindle shaped or elongated stone cells showing narrow
boundary and broad lumen isolated or in groups of 2 to 8 (Pippalī); groups of polygonal,
non lignified, thick walled brown coloured cells of testa in surface view, palisade like
thick walled cells of testa in transverse view measuring 55 to 80 m in length and 15 to 30
m in width, thick walled polygonal cells filled with yellowish brown content of mesocarp
cells almost square in shape, measuring 25 to 45 m in dia (Vi²a¬ga); cortical
parenchymatous cells containing rosette crystals of calcium oxalate, broken, thick
rod-like cellulosic fibres, fragments of typically honeycomb like pitted vessels, resin
canals lined with epithelium (Triv¨t); cork cells in surface and transverse view several
with tannin or red colouring matter (Dantī); parenchymatous cells filled with starch
grains, starch grains abundant, single and compound, ovoid, elliptical, hilum, mostly
irregular in shape, measuring 5 to 10 m in dia, fragments of bordered pitted vessels
(Gu²ūcī).
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
General Description:
Medicines prepared in the form of tablets or pills are known as Va°i and Gut#ikā.
These are made of one or more drugs of plant, animal or mineral origin. Gut#ikā, Vataka,
Modaka, Pi´²i and Va°i are synonymous terms used in classics for Va°i.
The drugs of plant origin are dried and made into fine powders, separately. The
minerals are made into bhasma or sindura, unless otherwise mentioned. In cases where
pārada and gandhaka are mentioned, Kajjalī is made first and other drugs added, one by
one, according to the formula. These are put into a khalva and ground to a soft paste with
the prescribed fluids. When more than one liquid is mentioned for grinding, they are used
in succession. When the mass is properly ground and is in a condition to be made into
pills, gandha dravyas, like kasturi, karpura, which are included in the formula, are added
and ground again.
The criterion to determine the final stage of the formulation before making pills is
that it should not stick to the fingers when rolled. Pills may be dried in shade or in sun as
specified in the texts.
Pills made of plant drugs when kept in airtight containers can be used for two
years. Pills containing minerals can be used for an indefinite period. Pills and vatis should
not lose their original color, smell, taste and form. When sugar, salt or k¾āra is an
ingredient, the pills should be kept away from moisture.
MARICĀDI GUT#IKĀ
(AFI, Part - I, 12:20)
Definition:
Formulation composition:
Method of preparation:
Description:
Spherical, soft, blackish brown coloured pills with pleasant odour and sweet taste.
Identification:
Microscopy:
Take about five pills, crush, wash with water, clear in chloral hydrate, wash in water and
mount in glycerin (80 per cent) and observe the following characters:
Group of isodiameric or slightly elongated stone cells with moderately thickened walls,
interspersed with thin walled polygonal parenchyma cells (Marica); groups of elongated,
spindle shaped, wide lumened lignified stone cells (Pippalī); groups of stone cells, oval
shape, striated walls with minute central lumen (Dād#ima).
Thin layer chromatography:
Physico-chemical parameters:
Assay:
Not less than 2.83 per cent of piperine when assayed by the following method.
Other requirements:
Microbial Limits: Appendix 2.4.
Aflatoxins: Appendix 2.7.
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
General Description:
Ks$āra are alkaline substances obtained from the water soluble ash of the drugs of
plant origin.
Method of Preparation:
The drugs are cut into small pieces and dried well. The pieces are placed in an
earthen pot and burnt to ash. Water is added to the ash in the ratio of 6:1 and mixed well.
This is allowed to settle down over night and leter strained through a piece of cloth. This
process of straining may be done two or three times till a clear liquid is obtained. This
liquid is then put in an iron or earthen vessel and heated over a moderate fire till water
evaporates completely, leaving a solid salty white substance known as Ks$āra.
Ks$āras are white in colour and hygroscopic in nature therefore should be kept in
air-tight bottles. These last indefinitely.
APĀMĀRGA KS$ĀRA
(AFI, Part-I, 10:2)
Definition:
Apāmārga ks$āra is an off-white alkaline preparation made with the ingredients in the
Formulation composition given below.
Formulation composition:
Method of Preparation:
Description:
Fine powder, passing through sieve number 100; hygroscopic, odour faint and taste
saline; freely soluble in water.
Identification:
Physico-chemical parameters:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Anupāna: Water.
ARKA LAVA³A
(AFI, Part-I, 10:1)
Definition:
Arka Lava´a is a preparation made with the ingredients in the Formulation composition
given below.
Formulation composition:
Method of Preparation:
Description:
A fine powder, passing through sieve number 100; grey in colour, odourless, taste salty.
Identification:
Physico-chemical parameters:
Loss on drying at 1100: Not more than 1 per cent, Appendix 2.2.10.
Acid- insoluble ash: Not more than 3 per cent, Appendix 2.2.4.
pH (10% aqueous solution): 9 to 10, Appendix 3.3.
Assay:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Definition:
Formulation composition:
Method of preparation:
Description:
Fine powder, passing through sieve number 100; hygroscopic, odour less, taste salty.
Identification:
Physico-chemical parameters:
Assay:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Anupāna: Gh¨ta.
MŪLAKA KS$ĀRA
(AFI, Part-I, 10:10)
Definition:
Mūlaka ks$āra is a powder preparation made with the ingredients in the Formulation
composition given below.
Formulation composition:
Method of preparation:
Description: Fine powder, passing through sieve number 100; hygroscopic, odourless,
taste salty; freely soluble in water.
Identification:
Physico-chemical parameters:
Assay:
Sodium: Not less than 4 per cent, Appendix
5.2.9.
Potassium: Not less than 28 per cent, Appendix
5.2.9.
Iron: Not less than 2.2 per cent, Appendix
5.2.5.
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Anupāna: Water.
PALĀŚA KS$ĀRA
(AFI, Part-I, 10:9)
Definition:
Palāśa ks$āra is a white alkaline preparation made with the ingredients in the Formulation
composition given below.
Formulation composition:
Method of preparation:
Description:
Fine powder, passing through sieve number 100; hygroscopic, odourless, taste saline;
freely soluble in water.
Identification:
Physico-chemical parameters:
Assay:
Sodium: Not less than 0.8 per cent, Appendix
5.2.9.
Potassium: Not less than 35 per cent, Appendix
5.2.9.
Iron: Not less than 1.2 per cent, Appendix
5.2.5.
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Agnimāndya (Digestive impairment); Gulma (Abdominal lump);
Plīhyakr$dvr$ddhi (Spleno-hepatomegaly); Mūtrakr$cchra (Dysuria); Aśamarī
(Calculus); Śarkarā (gravel in urine); Grahan$ī (malabsorption syndrome); Ānāha
(distention of abdomen due to obstruction to passage of urine and stool); Vi¾ūcikā
(Gastro-enteritis with piercing pain).
Definition:
Formulation composition:
Method of preparation:
Description:
Greyish white, fine powder, passing through sieve number 100; hygroscopic, odourless,
taste saline; freely soluble in water.
Identification:
An aqueous solution yields the reactions characteristic of sodium and potassium,
Appendix 5.2.12.
Physico-chemical parameters:
Assay:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Ādhmāna (Flatulance); Ānāha (distention of abdomen due to
obstruction to passage of urine and stool); Śūla (pain); Udara (diseases of abdomen);
Gulma (Abdominal lump); Plīhāmaya (Splenic disease); Mūtrakṛ$cchra (Dysuria).
Tailas are preparations in which Taila is boiled with prescribed liquid media
[Svarasa / Ka¾āya Etc.] and a fine paste [Kalka] of the drugs specified in the formulation
composition. Unless specified otherwise Taila means Tila Taila.
10. Pātra pāka: It is the process by which the Taila is augmented or flavored by
certain prescribed substances. The powdered drugs are suspended in a vessel
containing warm, filtered Taila.
The medicated Taila will have the odour, colour and taste of the drugs
used in the process. If a considerable amount of milk is used in the preparation,
the Taila will become thick and may solidify in cold seasons.
Definition:
Balāgu²ūcyādi Taila is a liquid preparation made with the ingredients in the Formulation
composition given below with Tila Taila as the basic ingredient.
Formulation composition:
Method of preparation:
Filter while hot (about 800) through a muslin cloth and allow to cool.
Pack it in tightly closed containers to protect from light and moisture.
Description: A medicated oil, dark reddish brown in color with pleasant odour.
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer and filter. Concentrate to about 5 ml and carry out thin layer
chromatography. Apply 10 µl of the extract on TLC plate. Develop the plate to a distance
of 8 cm using toluene : ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After
development, allow the plate to dry in air and spray with ethanol-sulphuric acid reagent
followed by heating at 1100 for about 10 min. It shows spots at Rf 0.71 (light brown),
0.80 (light brown) and 0.88 (blackish.brown) under visible light.
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Definition:
Dhānvantara Taila is a liquid preparation made with the ingredients in the Formulation
composition given below with Tila Taila as the basic ingredient.
Formulation composition:
Method of preparation:
Note: Stem bark of the ingredients number 7 to 11 of the formulation composition has
been used in place of root.
Start heating next day, stir and constantly check the kalka by rolling between the fingers.
Stop heating when the kalka breaks down into pieces on attempting to form a varti (khara
pāka lak¾a´a), and at the appearance of froth over the oil. Expose the varti to flame and
confirm the absence of crackling sound indicating absence of moisture.
Filter while hot (about 800) through a muslin cloth and allow to cool.
Pack it in tightly closed containers to protect from light and moisture.
Description:
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer and filter. Concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate. Develop the plate to a distance of 8 cm using
toluene : ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows spots at Rf 0.31 (light brown), 0.71 (brown), 0.83 (light
brown) and 0.91 (blackish brown) under visible light.
Physico-chemical parameters:
Other requirements:
Therapeutic uses: Vāta roga (diseases due to Vāta do¾a); Pak¾avadha (Hemiplegia);
Sarvā¬ga vāta (Quadriplegia); Dhātu k¾aya (tissue wasting); Sūtikā roga .
(Puerperal diseases) and Bāla roga (diseases of children). External application for
Abhya¬ga.
Definition:
Gandharvahasta Taila is a liquid preparation made with the ingredients in the Formulation
composition described below with Tila Taila as the basic ingredient.
Formulation composition:
Method of preparation:
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer and filter. Concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate. Develop the plate to a distance of 8 cm using
toluene : ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows spots at Rf 0.45 (light grey), 0.52 (grey), 0.75 (dark
brown) and 0.81 (dark brown) under visible light.
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Definition:
Ko°°amcukkādi Taila is a liquid preparation made with the ingredients in the Formulation
composition given below with Tila Taila as the basic ingredient
Formulation composition:
Method of preparation:
Identification:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer, filter, concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm using
toluene : ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating
1100 for about 10 min. It shows spots at Rf 0.32 (light grey), 0.44 (light grey), 0.53 (light
grey), 0.71 (brown), and 0.80 (brown) under visible light.
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Āmavāta (Rheumatism); Vāta roga (disorders due to Vāta do¾a) and
Angastambha (stiffness of body); External application for Abhya´ga.
¾
K ĪRABALĀ TAILA
Definition:
K¾īrabalā taila is a liquid preparation made with the ingredients in the Formulation
composition given below with Tila Taila as the basic ingredient.
Formulation composition:
Method of preparation:
Extract 2 g of the sample with 20 ml of alcohol at about 400 for 3 h. Cool, separate the
alcohol layer, filter, concentrate to 5 ml and carry out the thin layer chromatography.
Apply 10 µl of the extract on TLC plate and develop the plate to a distance of 8 cm using
toluene : ethyl acetate : hexane (6 : 3 : 1) as mobile phase. After development, allow the
plate to dry in air and spray with ethanol-sulphuric acid reagent followed by heating at
1100 for about 10 min. It shows spots at Rf 0.42 (brown), 0.57 (brown), 0.70 (grey) and
0.80 (light grey) under visible light.
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Vātarakta (Gout); Vāta roga (disorders due to Vāta do¾a); Śukra do¾a
(Vitiation of ºukra dhatu); Rajo do¾a (Menstrual disorders); Kārśya (Emaciation);
Svarabheda (hoarseness of voice). External application for Abhya¬ga, Nasya (nasal
drops), Pāna (oral use), Bastiprayoga (enema).
Definition:
Saindhav¢di Taila is a liquid preparation made with the ingredients in the Formulation
composition given below with tila taila as the basic ingredients.
Formulation composition:
Method of preparation:
Description:
Physico-chemical parameters:
Other requirements:
Storage: Store in a cool place in tightly closed containers, protected from light and
moisture.
Therapeutic uses: Kaphavātaja nā²ī vra´a (Sinus due to Kapha do¾a and Vāta do¾a).
Dose: As prescribed by the physician for Abhya¬ga (External use).
LEPA
Lepas are semi-solid preparations intended for external application to the skin or
certain mucous membranes for emollient, protective, therapeutic or prophylactic purposes
where a degree of occlusion is desired. They usually consist of solutions or dispersions of
one or more medicaments in suitable bases.
The base should not produce irritation or sensitization of the skin, nor should it
retard wound healing; it should be smooth, inert, odourless, physically and chemically
stable and compatible with the skin and with incorporated medicaments.
The proportions of the base ingredients should be such that the ointment is not too
soft or too hard for convenient use. The consistency should be such that the ointment
spreads and softens when stress is applied.
DĀRVĪ MALAHARA (GEL)
(Based on Carak Chikitsa 25/93)
Definition:
Dārvī Malahara is a semisolid preparation made with the ingredients given in the
Formulation composition.
Formulation Composition:
Method of Preparation:
Preparation of Rasanjana:
Rasā®jana is the dried aqueous extract of the roots of Dāruharidrā, (Berberis aristata or
B. asiatica or B. lycium, Fam. Berberidaceae), and is prepared by the following method.
Chop Dāruharidrā into small pieces of about 1 cm thickness. Powder the chopped roots
to a yavkuta (powder whose all particles pass through sieve number 22 and not more than
10 per cent pass through sieve number 44). Weigh the powder and transfer to a suitable
extraction vessel. Add Purified water (5 times the weight of drug), allow to soak
overnight (12 h), followed by gentle boiling for 4 h. Stop the boiling and allow the
contents to settle down. Separate the water layer and filter while hot. Repeat the
extraction two times more using fresh Purified water (4 times the weight of drug).
Remove the water from the combined extract as completely as possible. At this stage the
extract solidifies on cooling. Dry the solidified extract further in an oven, preferably a
vacuum oven at a temperature below 600.
Pack it in tightly closed containers to protect from light and moisture.
Preparation of Dārvī Malahara:
Weigh all the ingredients separately. Mix well the powders of tragacanth and xanthan
gum. Take 50 ml of purified water in a 250-ml container and transfer gum mixture with
continuous stirring to avoid formation of lumps. Keep it aside for 6 h for complete
dispersion and hydration. Dissolve powder of Sphatikā (potash alum) in 10 ml of warm
(600) purified water and add this solution after cooling to gum mixture with stirring.
Dissolve methyl paraben, propyl paraben, disodium edetate in a mixture of 4 ml of
propylene glycol and 6 ml of purified water and heat for 5 min at 600. Cool and add this
solution with continuous stirring to the mixture of gums and alum. Dissolve Rasā®jana in
10 ml of purified water and add to the gel (mixture of gum and alum) and mix well.
Adjust the weight of gel to 100 g with purified water. Adjust the pH between 3.7 and 4.2
with sufficient triethanolamine (approximately 3 to 4 drops). Add 0.1 ml of peppermint
oil or other permissible flavour to the prepared gel and mix well. Fill the gel in
aluminium / plastic tubes.
Description:
Identification:
Test for Berberine: Dissolve about 2 g of Dārvī Malahara in 20 ml of water and filter.
Take about 2 ml of the filtrate and add 1 ml of concentrated nitric acid. A dark red colour
is formed.
Test for Spha°ikā: Dip a spatula in the water solution of Dārvī Malahara. Take it out and
let it dry. Hold spatula in a nonluminous flame; a violet colour is imparted to the flame.
Physico-chemical parameters:
Assay:
Sample contains not less than 0.08 per cent of berberine when assayed by the following
method.
Estimation of Berberine: Dissolve about 25 mg of accurately weighed Berberine
hydrochloride in water and makeup the volume to 25 ml in a volumetric flask. Transfer
1,2,3,4,5 and 6 ml of this stock solution separately to six 25 ml- volumetric flasks and
makeup the volume in each to 25 ml.
Apply in triplicate 1 µl of each dilution on a TLC plate. Develop the plate to a distance of
8 cm using n-propanol : formic acid : water (8.1: 0.1: 1.8) as mobile phase. After
development, dry the plate in air and scan at 343 nm in a TLC scanner. Note the area
under the curve for peak corresponding to berberine and prepare the calibration curve by
plotting peak area vs amount of berberine hydrochloride.
Dissolve accurately weighed about 1 g of Dārvī Malahara in 5 ml of distilled water and
make up the volume to 25 ml in a volumetric flask with distilled water. Filter the
solution and discard the first 5 ml of the solution. Collect the next 5 ml of solution and
use for analysis. Apply 1 µl of solution in triplicate on a TLC plate and develop, dry and
scan the plate as described in preceding paragraph for calibration curve of berberine.
Calculate the amount of berberine in the test solution from the calibration curve of
berberine hydrochloride and determine the concentration of berberine in the Dārvī
Malahara.
Other requirements:
Microbial limits: Appendix. 2.4.
Aflatoxins: Appendix. 2.7.