Phytopharmacueticals.pdf for pharmacy students

PHYTO PHARMACUETICALS
Scope and Objectives :
•This subject gives the student the knowledge regarding
 Herbal drug industry
Quality of raw material
Guidelines for quality of herbal drugs, herbal cosmetics,
Guidelines for quality of herbal drugs, herbal cosmetics,
nutraceutical etc.
•The subject also emphasizes on
Good Manufacturing Practices (GMP)
Patenting and regulatory issues of herbal drugs.

•The term phyto-pharmacon / phyto-pharmaceutical is derived from the
Greek designations phytón for plant and phármakon for medicine.
•Basically, these are herbal remedies which are prepared from herbal
substances like dried plant parts such as leaves, blossom, herb, bark, or
the roots traditionally already known to cure undesired conditions or
illnesses.
illnesses.
•Herbal medicinal products can be variable in their composition. Therefore,
to obtain consistent efficacy and safety, standardized medicinal plant
extracts are being used.
•In general, herbal medicinal products are better tolerated and provide a
superior benefit-risk ratio to synthetic drugs.

•Therefore, evidence-based phyto-pharmaceuticals increasingly mentioned
in clinical practice guidelines are first-line therapy in various diseases and
indications
•Highest quality (GMP), clinically confirmed efficacy and best tolerability
and safety of standardized or quantified medicinal plant extracts are key
measures for a successful phytotherapy approach.
measures for a successful phytotherapy approach.
•Other than food supplements or botanicals phyto-pharmaceuticals have to
follow comparable regulatory guidelines as conventional drugs. Therefore,
a high level of scientific evidence supports their efficacy and safety.
.

Objectives: upon compiletion of this ppt the student should be able
to:
1. Understand raw material as source of herbal drugs from cultivation to
herbal drug product
2. Understand about the methods for selection, identification and
authentication of herbal drugs
3. Know about the processing of herbal and medicinal plants.
 Learning outcomes: the student will be able to:
HERBS AS RAW MATERIALS
 Learning outcomes: the student will be able to:
1. Learn the definition of herbs as raw material, herbs, herbal medicinal
products and sources of herbs.
2. Learn about the methods for selection, identification and authentication
methods for herbal materials.
3. Learn about the processing methods of herbal drugs.
4. Learn about the safety parameters for herbal drugs

Medicinal and aromatic plans constitute a major part of the flora, which provides
raw materials for use in the pharmaceuticals, cosmetics and drug industries.
In one of the studies by WHO, it is estimated 80 percent of the population of
developing countries relies on traditional plant based medicines for their health
requirements.
India and China are the two major producing countries having 40 percent of the
global biodiversity and availability of rare species.
Introduction
These are well known as the home of medicinal and aromatic crops that constitute
a segment of the flora and provide raw materials to the pharmaceutical, cosmetics,
fragrance, flavor etc. industries.
From the trade data available, it is clear that the global market for medicinal plants
has always been large and has been on increase in the recent past.

Introduction
Herbs have used in the traditional system of medicine since time immemorial to
alleviate human illness and for the maintenance of general health.
The interest of people in herbal medicines has increased significantly in both
developed and developing countries.
The WHO Traditional medicine (TM) strategy 2014-2023 focuses on promoting the
safety, efficacy, and quality of TM by expanding the knowledge base and providing
guidance on regulatory and quality assurance standards
In 2012 , 119 WHO members states were regulating herbal medicines.

Herbs: It is defined as any plant with leaves, seeds or flowers used for flavoring, food,
medicine or perfume.
Herbal medicine: Practice of using herbs and herbal preparations to maintain health
and to prevent, alleviate or cure disease or a plant or plant part or an extract or mixture of
these used in herbal medicine.
Herbal medicinal products: these are medicinal products where the active ingredient
consists mainly of herbal substances.
Definition
Herbal drug preparations: They are prepared from herbal materials by different
process, which is extraction with various solvents, purification, concentration and other
processes. It includes such as powders, extracts and juices.
Finished herbal products: Finished herbal products consist of one or more herbal
preparations made from one or more herbs (i.e. from different herbal preparations made
of the same plant as well as herbal preparations from different plants. Products containing
different plant materials are called “mixture herbal products”.

Definition
Phytopharmaceutical drug is defined as purified and
standardized fraction with defined minimum four bio-active or
phytochemical compounds (qualitatively and quantitatively
assessed) of an extract of medicinal plant or its part, for internal
or external use of human beings or animals for diagnosis ,
treatment, mitigation, or prevention of any disease or disorder
but does not include administration by parenteral route.

Phytopharmacueticals.pdf for pharmacy students

SELECTION
• Selection of medicinal plant is very important parameter which
influence the result of final product.
• Albuquerque and Hanazaki in 2006 provide the method for
selecting medicinal plants
SELECTION, IDENTIFICATION AND AUTHENTICATION OF
HERBAL DRUGS
selecting medicinal plants
The methods are :
• Randomization
• Ecological
• Chemotaxonomic (Phytogenetic)
• Etheno directed

Steps involved in processing of Herbal Drugs
Selection of Herbs
↓
Identification & Authentication
↓
Cultivation of Herbs
↓
Collection of Herbs
↓
Processing of Herbal Raw Material

1.Selection of herbs
•The species or botanical variety selected for cultivation
should be the same as specified in the official
Pharmacopoeia or national documents.
•In case of newly introduced medicinal plants, the
•In case of newly introduced medicinal plants, the
variety selected for cultivation should be identified and
documented.

IDENTIFICATION
Identification tests should be specific for the herbal material and are
usually a combination of three or more of the following:
• Macroscopic characters
• Microscopic characters
• Chromatographic procedures
• Chemical reactions
AUTHENTICATION
AUTHENTICATION
•Especially useful in cases of drugs that are frequently
substituted or adulterated with other varieties which are
morphologically and chemically indistinguishable.
•Several herbal drugs in the market still cannot be identified or
authenticated based on their morphological or histological
characteristics. Use of wrong drugs may be ineffective or it may worsen
the condition
if two drugs are very similar we do this

good aculartar practices to grow your plants well like well soil and not too much or too little water and to
get good species plant full of active consitutents in them then our formulation is good

Cultivation of medicinal plants
Cultivation of medicinal plants requires intensive care and management as various
factors such as environment, soil, irrigation pests, etc, play a vital role. These factors
vary from one plant to another.
Scientific documented methods should be followed, if no data available traditional
methods should be adopted and a systematic method should be developed through
research Good agricultural practices in cultivation (GACP) and conservation
agriculture (CA) which aims to improve, conserve and make more efficient use of
natural resources
Collection of herbs
For the collection of medicinal plants, a proper time should be selected. Herbs are
selected for collection at a stage when they yield the maximum amount of chemical
constituents.
Skilled labour should be employed as they are trained to identify and select the herbs at
a proper stage. The age of the plant also plays a vital factor for their selection.
Diseased plants should be rejected.
Season of collection should also be given due consideration while selecting the plants
for collection.

in a plants theres so many biological reaction happens and you have to pick it at a paticular
time and if before it nothing happens and after it it will reaction to others so by that we know if
its a perfect time ot not

rhizomes will have not have root hairs

Simple herbal dosage forms may be prepared either from herbal materials
(such as unprocssed seeds or plant exudates) or herbal preparations (such
as jground powders and dried extracts) ready for administration to patients.
These herbal dosage forms, produced under GMP conditions, include
decoctions, tea bags, granules, syrups, ointments or creams, inhalations,
Processing of Herbal raw materials
Processing of Herbal raw materials
patches, capsules, tablets and pills, among others.
Primary processing:
It includes simple procedures by which the herbs are prepared like sorting
of different parts, garbling, cleaning, drying, etc.
•Garbling: This process is desired when sand, dirt and foreign part of the same
plant, not constituting drug are required to be removed.
this all done for some plants some and not the other ones

 The process may involve procedures such as removing dirt and foreign
Substances, peeling of barks, sieving, trimming, removal of hairs from
roots, remove of seeds from fruits, stripping of leaves from s t e m s .
 Excessive stems in case of lobelia and stramonium need to be removed
 Stalks in case of cloves are to be deleted
 Drugs constituting rhizomes need to be carefully removed from roots and
rootlets.
 Pieces of iron must be removed with the help of magnet in case of
castor seeds
 Pieces of bark should be removed by peeling as in gum acacia
•Washing:
 After garbling the herbal raw material should be cleaned well to remove the
traces of remaining soil, dirt and other impurities from the surface.
 The roots, rhizomes and tubers are washed with clean water.
 During process, scrapping and brushing may be necessary.
•Parboiling:
 After washing, certain herbal raw materials need to undergo parboiling
process in which they are put in boiling water for a short period.

 This may help in improving the storage life of the raw material
and prevent insect/ mould contamination.
Leaching:
 Some impurities can be removed by subjecting the plant material
under running water known as leaching.
 However the duration of leaching should be controlled to prevent the
loss of chemical constituents present in the drug.
Drying:
 In some cases, the plant material should be thoroughly dried after
 In some cases, the plant material should be thoroughly dried after
washing in order to prevent thedeterioration and degradation of
active constituents.
 They must be dried as soon as possible to remove moisture and
reduce the damage due to microbial or mould infestation.
 Drying also prevents the activation of certain enzymes which
may otherwise degrade the active ingredients and also facilitate
grinding and milling of the raw material.
 Depending on the drug & nature of ingredients, different drying
methods can be used which are as follows:

I) Natural drying
a) Sun drying
• Most herbal raw material can be dried in open air under direct sunshine provided
the climate is suitable.
b)Shade drying
• Some medicinal plants cannot be directly exposed to sunlight, hence need to be dried
under shade.
• This drying process is slow but helps in minimizing loss of colour, volatile oils and
aromatic components from being evaporated
2) Artificial drying
► Drying by artificial heat is more rapid than open air drying and is necessary in
rainy season and regions where there is high humidity.
► The temperature and equipment's used for drying depends on the physical and
chemical nature of the drug and its constituents.

□ Secondary processing
• The secondary processing differs from one herb to another depending on
the nature of active ingredients as well as therapeutic properties.
• Secondary processing includes techniques such as removal of foreign substances,
prevention of microbial / infestation, enhancing the efficacy of drugs, reducing the
toxicity, extraction using suitable solvents, cone. & drying of extracts.
Cutting, Sectioning and Communition :
• After thoroughly drying, the herbal materials are processed by cutting and sectioning
into smaller sizes which are convenient for storage as well as extraction.
• It may be small particles, coarse powder or fine powder

Aging /Sweating:
• Aging refers to storing the raw material for a specified time after harvesting.
• It is generally done under sun or in shade for up to a year.
• During the process of aging excessive water is evaporated & enzymatic
reactions may occur to alter the chemical composition
of herbal material.
Example: Cascara bark should be aged for at least one year prior to use in medicinal
Example: Cascara bark should be aged for at least one year prior to use in medicinal
preparations to reduce its irritant effects.
Sweating is done by subjecting the herbal materials at a temperature
between 45 to 65°C with high humidity for a period ranging from one week to few
months.
• The herbal materials are stacked between woolen blankets or other kind of cloth.
• The sweating process is considered a hydrolytic and oxidative process in which
some of the chemical ingredients of the herbs are hydrolysed or oxidized.

Infusion:
• It is a liquid preparation obtained by extracting herbal materials with either
cold or hot water without boiling. Other solvents may also be used.
Decoction:
• It is a liquid preparation obtained by boiling the herbal materials with water
Fluid extract
•It is a liquid preparation obtained by maceration or percolation of herbal materials
in alcohol. The ratio will be one part of liquid containing one part of herbs (1:1).
in alcohol. The ratio will be one part of liquid containing one part of herbs (1:1).
Tinctures
• It is a dilute alcoholic extract of herbal materials typically made up of 1 part of
herbal material with 5 to 10 parts of the solvent
Powdered extract
•It is a form of herbal preparation which is processed into dried, granulated or
powdered materials

Phytopharmacueticals.pdf for pharmacy students

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Phytopharmacueticals.pdf for pharmacy students