WHO Guidelines for Herbal Drug Standardization

G.Sunny GraceG.Sunny Grace 100809885017 100809885017 M.Pharm 1/1 M.Pharm 1/1 OUCTOUCT

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

products3. 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 evaluationThe 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*MDIWhere 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

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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.

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