the different methods employed these days to test the quality of ayurvedic drugs is summarised in the presentation. the presentation aims to give an awareness about basic procedures in quality control of ayurvedic drugs.
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important methods employed in quality control of ayurvedic drugs
1. Dr. Dhanya.R
Lecturer
Dept. of Dravyaguna 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.
20. MACROSCOPIC EXAMINATION
• with the 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.
28. MOISTURE CONTENT
• Indicates the amount of moisture in the drug
• Should be minimum to prevent microbial
contamination
• Aloes- not more than 10% w/w
29. Dean and stark appartus 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 out of the drug by
macerating it with various solvents like water
alcohol etc.
Indicative of the chemical constituent present
in the drug
35. o Water soluble Extractive
o Alcohol soluble Extractive
Water soluble extractive
Tannins, sugars, plant
acids, mucilage, glycosides etc.
Eg: yashtimadhu- not less than 20%w/w
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
42. Phytochemical screening
• To find 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
44. Chromatography
• Methods for separating molecular mixtures
that have different affinity to the mutually
immiscible phases.
46. • TLC(thin layer chromatography)
• High Performance Thin Layer
Chromatography (HPTLC)
• Gas chromatography
• Paper chromatography
• High Performance Liquid
Chromatography (HPLC)
47. Uses
• profile of the chemical constituents of a
particular herbal plant is obtained
• Identification and Quantification of active
ingredients
• ‘Fingerprints’ of formulations
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),
56. Pesticide residue
• Pesticide residues 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.
59. WHO limit for number 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
• Pharmacological activity 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
62. IN VITRO study means 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.
64. OBJECTIVES OF ANIMAL STUDIES
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.
70. • Let us help 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