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important methods employed in quality control of ayurvedic drugs
The document discusses quality control methods and standardization of Ayurvedic medicines, emphasizing the need for testing to identify drugs, detect adulteration, and establish reference standards. It outlines various evaluation techniques including organoleptic, physical, chemical, and biological assessments to ensure the purity and efficacy of Ayurvedic drugs. The text also covers the significance of pharmacological, toxicological, and microbial screenings in maintaining safety and quality in Ayurvedic practices.
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important methods employed in quality control of ayurvedic drugs
- 1. Dr. Dhanya.R Lecturer Dept. ofDravyaguna vijnana S.N.K.D Trust’s Nallasopara Ayurveda MedicalCollege Important methods in quality control and standardization of Ayurvedic medicines
- 2. Introduction • Quality control-need of the hour • Present protocol for testing of Ayurveda products contain various parameters • PURPOSE OF THESE TESTS • identify the drug • detect adulteration/substitution • provide reference standards for future purposes.
- 3. Standardization & QualityEvaluation of Ayurvedic drugs QUALITY EVALUATION OF AYURVEDIC DRUGS
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- 5. Standardization & QualityEvaluation of Ayurvedic drugs QUALITY EVALUATION OF AYURVEDIC DRUGS
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- 7. Standardization & QualityEvaluation of Ayurvedic drugs QUALITY EVALUATION OF AYURVEDIC DRUGS
- 8. MOISTURE CONTENT FOREIGNMATTER ASH VALUES EXTRACTIVE VALUES Ph, viscosity, refractiv e index, optical rotation etc……. PHYSICAL
- 9. Standardization & QualityEvaluation of Ayurvedic drugs QUALITY EVALUATION OF AYURVEDIC DRUGS
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- 11. Standardization & QualityEvaluation of Ayurvedic drugs QUALITY EVALUATION OF AYURVEDIC DRUGS
- 12. TOXICOLOGICAL SCREENING PHARMACOLOGICAL SCREENING MICROBIALCONTAMINATION BIOLOGICAL
- 13. ORGANOLEPTIC EVALUATION • Colour •Odour • Taste • Texture • Fracture • Use- identification of drug detection of adulteration
- 14. Wavy nature of sarpagandharoot The aromatic odour of umbelliferous fruits
- 15. White tubers ofsatavari Splintery fracture of neem
- 16. Lagu gokshur Brihatgokshur
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- 20. MACROSCOPIC EXAMINATION • withthe naked eye or under low magnification microscope • In these tests the shape and size, external colour and markings, fracture, texture or feel, internal colour and marking, odor, and taste are noted.
- 21. DESCRIPTION OF AMALAKI(API) a) Macroscopic Fruit, globose, 2.5-3.5 cm in diameter, fleshy, smooth with six prominent lines; greenish when tender, changing to light yellowish or pinkish colour when mature, with a few dark specks: taste, sour and astringent followed by delicately sweet taste.
- 22. MICROSCOPIC EXAMINATION • Microscopicalstructure of the drug is analysed • Microscope • Identity of plant • Detection of adulteration
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- 27. MOISTURE CONTENT FOREIGNMATTER ASH VALUES EXTRACTIVE VALUES Ph, viscosity, refractive index, optical rotation etc……. PHYSICAL
- 28. MOISTURE CONTENT • Indicatesthe amount of moisture in the drug • Should be minimum to prevent microbial contamination • Aloes- not more than 10% w/w
- 29. Dean and starkappartus for determination of moisture content
- 30. Ash value- total,acid- insoluble Total ash • Residue remaining after incineration • Represents inorganic salts – either in drug or added deliberately-calcium carbonate, silicates etc… • Criterion for purity
- 32. Acid insoluble ash •Ash insoluble in dil.HCl • Chemicals obtained from incineration of plant inorganic matter like calcium carbonate is soluble in acid whereas incinerated sand chemicals like silicates are insoluble • Represents sand and dirt- silicates…….. • Criterion for purity
- 33. Extractives Principles drawn outof the drug by macerating it with various solvents like water alcohol etc. Indicative of the chemical constituent present in the drug
- 35. o Water solubleExtractive o Alcohol soluble Extractive Water soluble extractive Tannins, sugars, plant acids, mucilage, glycosides etc. Eg: yashtimadhu- not less than 20%w/w
- 36. Alcohol soluble extractive Resin, tannin Official method for assay of hingu Hingu- Not less than 50%w/w
- 37. Ether soluble extractive •Volatile oil, fixed oil, resin • Jatiphal- not less than 25%w/w
- 38. Volatile oil content •Useful for determination of purity of aromatic drugs • Clove- not less than 15%w/w
- 39. Clevenger appratus for determinationof volatile oil
- 40. Foreign organic matter •Drugs should be free from moulds, insects, animal faecal matter and other contaminations such as earth, stones and extraneous material. • Parts other than the part used –same plant or different plant
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- 42. Phytochemical screening • Tofind out the phytoconstituents in the drug. • Drugs are extracted in various solvents • Extracts are checked for the presence of various phytochemicals by chemical tests • Eg: Dragendorff’s reagent- alkaloid- orange brown precipitate
- 43. Soxhlet apparatus Extract Orangered precipitate
- 44. Chromatography • Methods forseparating molecular mixtures that have different affinity to the mutually immiscible phases.
- 46. • TLC(thin layerchromatography) • High Performance Thin Layer Chromatography (HPTLC) • Gas chromatography • Paper chromatography • High Performance Liquid Chromatography (HPLC)
- 47. Uses • profile ofthe chemical constituents of a particular herbal plant is obtained • Identification and Quantification of active ingredients • ‘Fingerprints’ of formulations
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- 50. Quantification of chemicalconstituent Gallic acid-0.453µg Gallic acid-1.36µg
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- 53. Heavy metal determination •Contamination by toxic metals can either be accidental or intentional • the main instrumental method of analysis is atomic absorption spectrophotometry (AAS),
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- 55. • WHO recommendations •Pb- 10 mg/kg Cd- 0.3 mg/kg
- 56. Pesticide residue • Pesticideresidues accumulate from agricultural practices, such as spraying, treatment of soils during cultivation, and administering of fumigants during storage • Limit of acceptable levels of pesticide contamination is provided by various national agencies and WHO.
- 57. MICROBIAL CONTAMINATION PHARMACOLOGICAL SCREENING TOXICOLOGICALSCREENING BIOLOGICAL
- 58. Microbial contamination • Contaminationeither at source or during processing • Maximium possible limits of each organism is given in various texts
- 59. WHO limit fornumber of micro-organisms per gram of material Type of microorgan ism Crude drug for processing Ready for internal use Ready for topical use Salmonellae - nil nil Total aerobic nil 105 107
- 60. Pharmacological screening • Pharmacologicalactivity is used to standardize the drug. • The assays on living animal and on their isolated organs • can indicate the strength of the drug or their preparations. • Biological assays or Bioassay
- 61. Pharmacological screening IN VITRO INVIVO EXPERIMENTAL STUDIES CLINICAL STUDIES
- 62. IN VITRO studymeans studies that are conducted outside living body like in test tubes,petridishes etc… IN VIVO study means studies that are conducting inside living body,like animal experiments.
- 63. Animal studies Commonly usedAnimals: Mice,Rat,Gunea pig,Rabit,Dog,Monkey etc…
- 64. OBJECTIVES OF ANIMALSTUDIES To evaluate 1.Activity 2.Toxicity 3.Mechanism of action 4.Drug metabolism
- 65. CLINICAL STUDY-OBJECTIVES TO EVALUATE: • Safety • Efficacy • Drug metabolism in humans • Safety,quality of life, unpredicted adverse reactions,and new therapeutic applications during wide use in the community.
- 66. Clinical testing • Phase1 (volunteers) • Phase 2 (patients) • Phase 3 (large scale multi-centre) • Phase 4 (post registration monitoring)
- 67. Toxicity studies • Tofind the therapeutic dose and lethal dose • To know the toxic effects of the drug Commonly used Animals: Mice,Rat
- 68. QUALITY EVALUATION OF AYURVEDICDRUGS API STANDARDS TLC ASH VALUE EXTRACTI VES MACROSCOPIC MICROSCOPIC
- 69. Will to implementthese methods
- 70. • Let ushelp humanity and our science by implementing these methods and thereby providing safe, cost effective, affordable therapeutics to the people and also emerge as significant players in the global market place
- 71. THANK YOU FORYOUR ATTENTION