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    WHO Guidelines For Herbal Drug Standard Is at Ion

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    PhArMaCyGrAdUaTeS
    The document discusses WHO guidelines for standardizing herbal drugs and products. It outlines various parameters for evaluating herbal drugs, including authentication, foreign matter analysis, organoleptic properties, moisture content, extractive values, heavy metals, and microbial contamination. The WHO guidelines recommend quality control of herbal materials including sensory characteristics and microscopic analysis. Guidelines also cover stability assessment, safety evaluation including toxicity and residue limits, and efficacy assessment using ethnomedical information and biological activity. The document emphasizes the need for India to play a leading role in producing standardized Ayurvedic formulations using modern analytical techniques.

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    WHO Guidelines For Herbal Drug Standard Is at Ion

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    PhArMaCyGrAdUaTeS
    3K views14 pages
    The document discusses WHO guidelines for standardizing herbal drugs and products. It outlines various parameters for evaluating herbal drugs, including authentication, foreign matter analysis, organoleptic properties, moisture content, extractive values, heavy metals, and microbial contamination. The WHO guidelines recommend quality control of herbal materials including sensory characteristics and microscopic analysis. Guidelines also cover stability assessment, safety evaluation including toxicity and residue limits, and efficacy assessment using ethnomedical information and biological activity. The document emphasizes the need for India to play a leading role in producing standardized Ayurvedic formulations using modern analytical techniques.

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    WHO Guidelines for Herbal Drug Standard is at Ion

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    The document discusses WHO guidelines for standardizing herbal drugs and products. It outlines various parameters for evaluating herbal drugs, including authentication, foreign matter analysis, organoleptic properties, moisture content, extractive values, heavy metals, and microbial contamination. The WHO guidelines recommend quality control of herbal materials including sensory characteristics and microscopic analysis. Guidelines also cover stability assessment, safety evaluation including toxicity and residue limits, and efficacy assessment using ethnomedical information and biological activity. The document emphasizes the need for India to play a leading role in producing standardized Ayurvedic formulations using modern analytical techniques.

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    Download as ppt, pdf, or txt
    3K views14 pages

    WHO Guidelines For Herbal Drug Standard Is at Ion

    Uploaded by

    PhArMaCyGrAdUaTeS
    The document discusses WHO guidelines for standardizing herbal drugs and products. It outlines various parameters for evaluating herbal drugs, including authentication, foreign matter analysis, organoleptic properties, moisture content, extractive values, heavy metals, and microbial contamination. The WHO guidelines recommend quality control of herbal materials including sensory characteristics and microscopic analysis. Guidelines also cover stability assessment, safety evaluation including toxicity and residue limits, and efficacy assessment using ethnomedical information and biological activity. The document emphasizes the need for India to play a leading role in producing standardized Ayurvedic formulations using modern analytical techniques.

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    WHO Guidelines for Herbal Drug

    Standardization

    G.Sunny Grace
    100809885017
    M.Pharm 1/1
    CONTENTS
     Introduction
     Standardization of
    herbal drugs/products
     Evaluation of herbal
    drugs/products
     WHO guidelines
     Conclusion
     References
    INTRODUCTION
     In recent years , there has
    been great demand for
    plant derived products in
    developed countries.
     Standardisation is used
    to describe all measures,
    which are taken during the
    manufacturing process and
    quality control leading to a
    reproducible quality.
     Evaluation of drug means
    confirmation of its identity
    and determination of its
    quality and purity and
    detection of its
    adulteration.
    Standardization of HerBAL DRUGS/PRODUCTS
     Authentication
     Foreign matter
     Organoleptic evaluation
     Tissues of diagnostic importance
    present in the drug powder
     Ash values and extractive values
     Volatile matter
     Moisture content determination
     Chromatogaphic and
    spectroscopic evaluation
     Determination of heavy metals
     Pesticide residue
     Microbial contamination
     Radioactive contamination
    EVALUATION OF HERBAL
    DRUGS/PRODUCTS
     Biological parameter
    1. Evaluation of adaptogenic activity profile of
    herbal preparation.
    2. Evaluation of antioxidant activity of herbal
    products
    3. Evaluation of microbial contamination reduction
    on plants through technological process of
    decoction and spray dry
    4. Evaluation of nitric oxide scavenging activity of
    selected medicinal plants used in inflammatory
    diseases
    5. The lipid peroxidation inhibitory activity
    Contd…
     Evaluation of marketed polyherbal antidiabetic
    formulations using biomarker charantin
     In vitro and In vivo evaluation of hair growth
    potential of shoe flower
     Clinical evaluation to assess the safety and
    efficacy of coded herbal “Dysmo-off” Vs allopathic
    medicine for treatment of primary dysmenorrhea
     Thermographic Evaluation
     Biochemical Evaluation
     Evaluation of Kutaj-Ghanavati for alkaloidal
    principles
     Organoleptic evaluation
    Classical evaluation
    The quality of raw materials can be tested
    according to following format:
     Name of the drug
     Part of the plant used
     Area of collection
     Distribution details
     Season of Crop
     Time and year of collection
     Pesticide and insecticides
     Condition of the drug
     Form of the drug
    Who gUidelines
     Quality control of crude drugs material, plant preparations
    and finished products: Botanical evaluation- sensory
    characters, foreign organic matter, microscopical,
    histological etc.
     Stability assessment and shelf-life: Physicochemical
    character of drug- Physical and chemical identity,
    chromatographic fingerprints, ash values, extractive values,
    moisture content, volatile oil and alkaloidal assays etc.
     Safety assessment: Toxicity details- pesticide residues,
    heavy metals, microbial contamination pathogens like
    E.coli, Salmonella, P.aeroginosa, S.aureus, etc.
     Assessment of efficacy by ethnomedical informations,
    pharmacological parameters, biological activity profiles etc.
    WHO GUIDELINES FOR GENERAL LIMITS
     Harmful organic matter : Totally free from it
     Innocuous foreign matter : Free from it
     Pesticidal residues, arsenic and heavy metals :
    Max residue limits = BW*ADI*Extn factor
    Safety factor*100*MDI
    Where ADI= Avg daily intake
    BW = Body weight
    MDI= Mean daily intake of drug

     Afflattoxins: Totally free from it


     Radioactive Contaminants: As per recommendations of
    IAEA
    •Microbial contamination
    CONCLUSION
     The subject of herbal drug standardization is massively wide and
    deep. There is so much to know and so much seemingly
    contradictory theories on the subject of herbal medicines and its
    relationship with human physiology and mental function.

     For the purpose of research work on standardization of herbal


    formulations and neutraceuticals a profound knowledge of the
    important herbs found in India and widely used in Ayurvedic
    formulation is of utmost importance.

     India can emerge as the major country and play the lead role in
    production of standardized, therapeutically effective ayurvedic
    formulation. India needs to explore the medicinally important
    plants. This can be achieved only if the herbal products are
    evaluated and analyzed using sophisticated modern techniques of
    standardization such as UV-visible, TLC, HPLC, HPTLC, GC-MS,
    spectrofluorimetric and other methods.
    References
     1.Sagar Bhanu P.S., Zafar R., Panwar R., “Herbal drug standardization”, The Indian Pharmacist, vol.
    4(35), May 2005, 2005, pp.19-22.
     2.Patel P.M., Patel N.M., Goyal R.K., “Evaluation of marketed polyherbal antidiabetic formulations
    uses biomarker charantin”, The Pharma Review, vol.4 (22), June 2006, pp.113.
     3.Patel P.M., Patel N.M., Goyal R.K., “Quality control of herbal products”, The Indian Pharmacist,
    vol.5(45), March 2006, pp.26-30.
     4.Bhutani K.K., “Herbal medicines an enigma and challenge to science and directions for new
    initiatives”, Indian Journal of Natural Products, vol.19 (1), March 2003, pp.3-8.
     5.Kokate C.K., Purohit A.P., Gokhale S.B., “Analytical pharmacognosy”, Pharmacognosy, 30th
    edition, Feb. 2005, pp.1,99.
     6.Shrikumar S., Maheshwari U., Sughanti A., Ravi T.K., “WHO guidelines for herbal drug
    standardization”, 2006.
     7.Ansari S.H., “Standardization of crude drugs”, Essentials of Pharmacognosy, Ist edition, 2005-06,
    pp.14, 581.
     8.Gokhale S.B., Surana S.J., “Fluorescence quenching as a tool for identification and quality control
    of crude drugs”, Planta indica, vol 2 (3), July 2006, pp.47.
     9.Shaw P.C., Pui-Hat Butt P., “Authentication of Panax species and their adulterants by random
    primed polymerase chain reaction”, Planta Medica, vol. 61, 1995, pp.466-469.
     10.Lazarowych N.J., Pekos P., “Use of fingerprinting and marker compounds for identification and
    standardization of botanical drugs: Strategies for applying pharmaceutical HPLC analysis to herbal
    products”, Drug Information Journal, Vol.32, 1998, pp.497-512.
    QUERIES
    questions
    THANK YOU

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