Abhi ppt for herbal drug standarization

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Abhi ppt for herbal drug standarization

  1. 1. Standardization & Quality Control of Herbal Drugs Abhisheak Sharma Phytochemist National Institute of Ayurveda, Jaipur (Raj)
  2. 2. Pharma Industry 750 billion (US $) Global Growth rate 7% 6 billion (US $) Indian 8 % by volume 13 % in terms of value Annual growth >10% 30000 registered units Top 35 companies contribute 75% Market leader 7% 50000 branded formulations
  3. 3. Drug Development Regulatory Post Preclinical Phase IIILead Identification Phase I Phase II Submission/ marketing Developme Clinical Trial / optimization Clinical Trial Clinical Trial launch of drug Surveillance nt molecule study  Costs US $ 1 billion  > 10 years, to develop a drug  (1 molecule becomes drug out of 5000 new molecules)  Average life of drug ~ 3 years  60% of the drugs fails in the market
  4. 4. Herbal Medicine  Over 80 % of world population depends upon traditional medicines  Plant based medicines 62 billion US$ (Global market)  Plant based medicines 1.0 billion US$ (Indian market)  Annual growth up to 15%MEDI CI NES ACCO UNT FOR 30–40% OF HE ALTH EXPENDIT URE
  5. 5. India: 8th largest country > 47000 Plant sps. > 7500 sps.cited as Medicinal Plants 800 sps. claimed to be used 120 sps. used in large scale (1.65% of Med. Plants, 0.25 total sps.)HUGE UNTAPPED POTENTIAL, UNEXPLORED SCIENTIFICALLY
  6. 6. Herbal export: > Rs.1000 crores Target: Rs. 5000 crores (2010) Rs.10000 crores (2012)STANDARDIZATION & QUALITY CONTROL AS PER INTERNATIONAL NORMS INEVITABLE
  7. 7. Advantages/Interest in Natural Products Used as such as Phytomedicine, dietary supplements, food/ beverage ingredients Important source of new drug discovery (Broader distribution of molecular properties viz. mass, partition coefficient, ring systems)
  8. 8. Quality Control of Herbal Medicines Complex  Heterogeneous composition: tasks whole plant, parts, extract  Crude drug scenario: unorganized, wild sources, unsystematically collected by poor/illiterate  No authentication/identification Intentionally/unintentionally adulterated products
  9. 9. Identification Botanical identification: Controversy >500 phyllanthus sps. P. amarus & P. debilis →hepatoprotective activity (phyllanthin & hypophyllanthin) many sps. devoid of lignans Adulteration: similar in morphology when dried (stem bark of Saraca indica adulterated with polyalthia longifolia) Foreign organic & inorganic matter to increase wt.
  10. 10. EnvironmentalPhytochemical Variations factors  Seasonal changes: temperature, rainfall, photo-periodis etc. (Nicotiana rustica (20), Cassia angustifolia (drought))  Geographical variation: Gentiana lutea, Aconitum napalus, N. inflata  Age of the plant: Comphor accumulates in heartwood, as trees ready for collections after 40 year  Genetic factors: Acorus calamus  Edaphic factors: soil Ph, soil composition, macro/micro nutrients
  11. 11. STANDADIZATION / QUALITY CONTROL OF HERBAL DRUGSBOTANICAL ORGANOLEPTIC PHYSICAL BIOLOGICAL CHEMICAL Process of delivering a product with a specified Microbial •Shape • Toxicological studies minimum level of one or more plant constituents Qualitative Chromatography /Contamination • Moist. Cont. • Pharmacological activities Spectroscopy etc. • Macroscopic Color •External • Odor •• Sec. Metabolites • Extrac. Sec. MetabolitesValues •Marking • Taste• DNA Finger printing • Ash Values • Heavy metal • Fracture • Fluores. Analy. To establish consistent potency & to ensure full • Pesticide residue •Qualitative • Mycotoxin • Quantitative spectrum of bioactive constituents (markers) from batch Microscopic Quantitative • SEM Studies to batch • Powder Studies
  12. 12.  EXTRACTION OF PLANT MATERIAL SEPARATION AND ISOLATION OF CONSTITUENTS QUALITATIVE AND QUANTITATIVE ANALYSIS CHARACTERIZATION OF ISOTATED COMPOUNDS
  13. 13.  Carbohydrate Protein & Amino Acids Lipid Alkaloid Glycoside Terpenoid Tannins
  14. 14. ChromatographyGroup of biphasic Separation techniquesFastest growing analytical techniquesAdsorption: TLC, PLC, Column, HPLC, HPTLCPartition: Paper, Electrophoresis, column, HPLC, GLCIon exchange, Size exclusion
  15. 15. HPLC INSTRUENTATION
  16. 16. ALUMINA SILICA GELULTRA VIOLET ABSORBANCE TIME (Minutes) TIME (Minutes)
  17. 17. Ginkgo biloba Column Silica column, 5 µm, 50 x 2.1 mm Mobile Phase A: 0.1 % Formic acid B: MeOH + 0.1 % Formic acid Gradient 5 to 100% B in 15 min Flow rate 0.3 mL/min Detection ESI Temprature 30 °C1). Bilobalide, 2). Unknown (bilobalide), 3). Ginkgolide C, 4).Unknown (ginkgolide C) , 5). Unknown (ginkgolide A), 6).Ginkgolide A, 7). Ginkgolide B, 8). Unknown (ginkgolide A), 9).Quercetin, 10). Kaempferol, 11). Unknown Kaempferol
  18. 18. Pesticides Column Silica based C18 Column, 5 µm, 150 x 4.6 mm Mobile Phase A: H2O2 + 0.1% TFA B: MeOH + 0.1% TFA Isocratic 5 to 100% B in 20 min Flow rate 1mL/min Detection UV at 254 nm Temprature 25 °C1). Promentryn, 2). Tebuthiuron, 3). Atrazine, 4).Propazine, 5). Propanil, 6). Chlorthaldimethyl
  19. 19. HPTLC imagesLane 1, ginsenosides referencesubstances mixture (from bottom totop): ginsenoside-Rb1, -Re, -Rg1, -Rf, pseudoginsenoside-F11;Lane 2, White Panax ginseng root;Lane 3, Red Panax ginseng;Lane 4, American ginseng (P.quincefolius)Lane 5, Tienchi ginseng (P.notoginseng).
  20. 20. Conclusions Herbs possess enormous healing power & only a part is known to mankind Can generate employment & revenue Great market potential Superior quality of crude drugs &finished products needed It is essential to ensure quality Control at all levels for standardization, efficacy, safety and consistency
  21. 21. Questions?

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