B.PHARM.
6th SEMESTER
HERBAL DRUG TECHNOLOGY
BP604T.
UNIT-I
Preparation and standardization of Ayurvedic formulations
Wasim Raza Ali Khan
Associate Professor
School of Pharmacy, ITM(SLS) Baroda University
Vadodara(GJ)
Dhataki flowers(Woodfordia
fruticosa)
Ayurvedic medicines are manufactured under
different pharmaceutical process to result in
various dosage forms, such as extracts,
tinctures, decoctions, pills, powders, tablets,
capsules and semisolid pastes, jellies, syrups,
etc. The general standardization protocols to
determine the percentage of active
medicaments could not be followed for
ayurvedic herbal preparations.
The procedures have to be modified in order to
make the preparation safe.
1. Ayurvedic preparations are polyherbal or
herbo-mineral preparations.
2. Even a single herb used in the preparation
contains multiple constituents.
3. Bio-active chemical constituents are not
known in the herbal preparations, and even if
it is known and compared with a marker, it
does not necessarily reflect its connection
with biological effects.
4. The principle of holistic approach does not
permit assaying a single marker.
So the approach has to be made from raw
materials to finished products for the
successful out come.
Raw Material Standardization
Collection: Plants should be collected when their active principles are
maximum.
Botanical identity: Plants should be identified by botanist/ taxonomist to
distinguish from its related species.
Identification of adulterants and substitutes: Quantitative microscopy,
macroscopic and microscopic characters.
Analytical data: (i) Ash values, (ii) Solubility profiles, (iii) Extractives
values, (iv) Loss on drying, (v) Acid values, (vi) Saponification values and
(vii) Foreign matter
Chemical identity tests: Tests for chemical constituents like alkaloids,
glycosides, saponins,
tannins, etc.
Instrumental analysis: Main active constituents are quantified using
chromatographic techniques and spectrophotometric methods.
Pesticide/herbicide residues: Check whether these remedies are
well within the limits.
Absence of mycotoxins or aflatoxins: These toxins should be
absent
Efficacy and toxicity testing.
Standardization of Manufacturing
Process
For liquid/extractive
formulations
01 • Solvent blend composition
02 • Ratio of crude drug to solvent
03 • Temperature
04 • Length of time of extraction
05 • Method of collection of extractives
06 • Method of concentration
07 • Light sensitivity during processing
08 • Storage conditions, precautions during processing
For solid dosage formulation (powders, pills,
capsules, tablets, etc.)
01
• Particle size distribution of drugs
02
• Blending order and time of blending
03
• Granulating fluid, binder concentration, granulating time
04
• Drying temperature and time
05
• Moisture content
06
• Tablet Hardness
07
• Tablet characters, such as disintegration, friability, etc.
08
• Tablet weight and thickness control
09
• Spray rate of film coating solution
Semisolid formulations
Solvent blend composition
Extraction process parameters, such as amount of solvent,
temperature, length of time, method of collection of extractives, etc.
Method of concentration
Semisolid blending time
Blend homogeneity.
Viscosity/Rheological characters
Light sensitivity, storage and other precautions during
processing
Finished products
standardization
• Organoleptic properties: Colour, odour, taste and touch
01
• Physical characteristics: Viscosity, particle size, specific gravity, refractive index, etc.
02
• Chemical characteristics: pH, chemical tests/chemical identity/assay
03
• Biological characteristics: Efficacy and toxicity tests
04
• Microbiological parameters: Total viable count, yeast and mould counts, tests for the absence
05 of pathogenic microorganisms
• Stability testing: To define shelf life of the product
06
• Storage condition
07
• Packaging systems/unit
08
