Lecture 1
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The document discusses guidelines for quality control and standardization of herbal medicines provided by the World Health Organization (WHO). It defines key terms like quality, safety, purity and potency. It outlines the need for quality control to reduce adulteration and ensure proper authentication, validation of claims, and safety. The WHO guidelines provide standardization procedures for herbal drugs, including definitions, authentication, absence of contaminants, microscopic and chromatographic analysis. It also discusses analytical procedures like botanical, physicochemical, biological and toxicological parameters for testing herbal medicines.
Lecture 1
- 2. Contents • Definition of natural products • Importance of herbal medicine • Definitions of relevant terms • Needs to quality control • Problems facing the quality control • WHO guidelines for standardization of natural products • Analytical procedures
- 3. • are chemical compound or substance produced by a living organism Natural products
- 4. Importance of Herbal medicine • Over 80 % of world population depends upon traditional herbal medicines • Plant based medicines 62 billion $ (globalmarket) • Plant based medecine 1 billion US$ (indian market) • Annual growth up to 15 % • Medecines account for 30-40 % of . Health expenditure
- 5. 5 The definitions of terms that will be encountered in the discussion are given: Quality : status of a drug that is determined by identity, purity, content, and other chemical, physical or biological properties Safety : to assure the drug didn’t have any hazardous effect Purity: not contaminated with potentially harmful substances Potency: is the content of active constituents within the defined limits? Identity: is the herb the one it should be? Quality control: it refers to processes involved in maintaining the quality and validity of a manufactured Definitions of relevant terms
- 6. 6 Definition continued… Herbal preparations are preparations obtained by scientific treatments such as extraction, distillation, fractionation, purification, or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils and processed exudates
- 7. Herbal substances are precisely defined by the plant part used (leaves, stems, rhizomes, roots and bark) Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances Definition continued…
- 8. Markers are chemically defined constituents or groups of constituents of a herbal substance, which are of interest for control purposes, independent of whether they have any therapeutic activity
- 9. Need of quality control • Quality control standardization • Reduce adulterations with substandard drugs • Improper authentication • Scientific validation of the therapeutic claims • Identity, purity, efficacy and safety • Customer satisfaction and confidence
- 11. WHO Guidelines for Quality Control & Standardization of Herbal Drugs
- 12. Standardization of herbal drugs crude plant parts / plant material Definition: − name of plant − part of plant − Nature/condition of material: whole, powdered, fresh, dried, etc Authentication/confirmation of: − Correct geographical origin − Correct stage of growth Absence of foreign matter: − other plant parts or materials − soil, stones, dust − insects and other animal matter (as determined by microscopy, macroscopy, chromatography) Microscopic characteristics confirming identity: − qualitative features − quantitative features, (e.g. stomatal number) Radioactive contamination limits: arising from environmental pollution or microbial decontamination procedures Assay: for materials containing constituents of known therapeutic activity, or known unique (marker) compounds. Non-specific assay methods for groups of compounds may be used where specific assay methods are not available for single compounds 12
- 13. Processed plant materials/non-plant materials (extracts, tinctures, comminutions etc.) Definition: liquid, solid, etc Organoleptic characteristics: − Macroscopy − Smell − Taste − Texture − Colour Chromatographic profile using more than one method: − to confirm presence of unique compounds (markers) − to confirm characteristic TLC chromatogram − to confirm characteristic HPTLC chromatogram (TLC + densitometry = HPTLC) Water content (for hygroscopic materials): Ash values: indicate extent of contamination with inorganic material. Determined by incineration. Values include acid insoluble and sulphated ash Volatile matter: for plants containing volatile oils: − Determined by steam − Distillation Powdered material: test method and acceptable limits for particle size, distribution 13
- 14. continued... If the product is a mix of plant materials, the supplier must provide evidence that each component plant has been individually tested. Heavy metal limits: from environmental pollution and pesticides Microbial contamination limits: microbial contamination arises from cultivation, harvesting, processing and storage: − confirmation of absence of E. coli, S. aureus, P. aeruginosa and − Salmonella − limits for aflatoxins (fungal toxins) Residual solvents from processing Pesticide residue limits: arising from cultivation (FAO and WHO limits) Extractive values: extraction by different solvents indicates proportion of polar and non-polar components Assay: for materials containing constituents of known therapeutic activity, or known unique (marker) compounds; − Non-specific assay methods for groups of compounds may be used14
- 16. Analytical procedures Botanical parameters: – Sensory evaluation: including visual macroscopy/ touch/odour/taste – Foreign matter: including foreign plants, foreign animals, foreign minerals, etc. – Microscopy: including histological observation and measurements 16 *Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002. ** Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub., 2006.
- 17. continued… Physico-chemical methods: − Ash values: Total, acid insoluble, water soluble − Extractive values: in hot water, cold water and ethanol, − Volatile matter: Loss on drying, − Volatile oils: by steam distillation. − Determination of crude fibers, − Determination of moisture content. 17
- 18. continued… Biological parameters: − Bitterness value: unit equivalent bitterness of standard solution of Quinine HCI − Hemolytic property: on ox blood by comparison with standard reference solution of saponin − Astringent property: tannins that bind to standard Frieberg Hide powder − Swelling index: in water − Foaming index: foam height produced by 1g material under specified conditions 18
- 19. continued… Toxicological parameters: These include the various identification procedures: − Arsenic: stain produced on HgBr2 paper in comparison to standard stain − Pesticide residues: including total organic chloride and total organic phosphorus − Heavy metals: like cadmium, mercury and lead − Microbial contaminations: total viable aerobic count of pathogens; viz. Enterobacteriaceae, E. Coli, Salmonella, P. aeruginosa, S. aureous, (e.g. Mellilotus officinalis)* − Aflatoxins: by TLC using standard aflatoxins (B1, B2, G1 and G2) − Radioactive contaminations 19 *Warude D., Patwardhan B. Quality and Regulatory Issues. Journal of Scientific and Industrial Research. Vol. 64, Feb 2005; p. 83-92.
- 20. References − Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002. − EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal Products, EMEA/CVMP/814OO Review. European Agency for the Evaluation of Medicinal Products (EMEA), London, 2005. − Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002. − Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub., 2006. − Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control principles to herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8. − WHO. Quality Control Methods for Medicinal Plant Materials, World Health Organization, Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal Medicines. WHO Regional Publications, Western Pacific Series No 3, WHO Regional office for the Western20
- 21. continued… − WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn. World Health Organization, Geneva, 1981. − WHO. Quality Control Methods for Medicinal Plant Materials. World Health Organization, Geneva, 1999. − WHO. WHO Global Atlas of Traditional, Complementary and Alternative Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World Health Organization, Geneva, 2005. − WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. World Health Organization, Geneva, 2004. − Warude D., Patwardhan B. Batanicals: Quality and Regulatory Issues. Journal of Scientific and Industrial Research. Vol. 64, Feb 2005; p. 83-92. 21
- 22. − The World Health Organization (WHO) is a specialized agency of the United Nations (UN) that is concerned with international public health − It was established on 7 April 1948, with its headquarters in Geneva, Switzerland − WHO is a member of the United Nations Development Group (UNDP) − World Health Organization, provides guidelines for prevention, control, safety, efficacy as well as evaluation and standardisation of herbal materials (e.g. WHO, 2005, 2002a,b, 1999a,b, 1998a,b, 1996a,b, 1990, 1981, 1979)
- 23. THANK YOU 23
Editor's Notes
- #18: Note: In determination of water extractive, chloroform water is used to determine deterioration that occur when water is used to extract plant that contain a lot of sugars or other carbohydrate which can ferment during prolonged extraction procedures.