standardization of ayurvedic formulation

Standardization of Ayurvedic formulations

Dr. Vipin Chaurasiya Pg scholar

VPSV Ayurveda College Kottakkal

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Standardization

• Standardization is a Numerical value or specific property that quantifies the purity and quality of drugs and formulations.

• Standardization of drug means confirmation of its identity and determination of its quality and purity.

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• Identity : biological source of drug

• Quality : Active constituents

• Purity : extent of foreign materials

LEGAL NOTICE OF AFI

Cosmetics Act (1940), Chapter IVA Formulations included in the Ayurvedic

Formulary may also be manufactured as per formulae given in various Ayurvedic Classics.

Standards for the several single drugs of plant, animal and mineral origin included in the Pharmacopoeial List of Single Drugs included as an Appendix to the Ayurvedic Formulary have yet to be worked out. In the manufacture of medicines included in this Formulary, it should be ensured that the Vaidya - in - charge of the Pharmacy has reasonably satisfied himself about the identity and purity of the drugs.

Use of Substitute drugs (Pratinidhi dravyas), wherever the original drugs are not available, is permissible in the Ayurvedic classics and practice. It must, however, be ensured that only the substitutes as are mentioned in the texts or included in the Formulary are used.

Standardization of Churna

• Ayurvedic Parameters :शुष्कपि�ष्टः सुक्ष्मतान्तव�टच्युतश्चूर्ण�ः।

तस्यसमस्तद्रव्या�रि�त्यागादाप्लुतो�योगाच्च कल्कादभेदः॥ (A.S.K.)

अत्यन्तशुष्कं यदद््रवं्य सुपि�षं्ट वस्त्रगालिलतं ।तत्स्याचू्चर्ण/ �जःक्षोदस्तन्मात्रा कर्ष�संमिमता ॥

(S.S.M)

Modern Parameters • Organoleptic evaluation • Microscopic evaluation• Physical analysis• Phytochemical analysis• Particle size• Test for heavy metals & toxins• Microbial contamination• Test for specific pathogen• Test for alfa toxin• Pesticide residue• Shelf life

Standardization of Churna

Organoleptic evaluation: • Colour • Odour • Taste

Microscopic evaluation

Standardization of Churna

• Physical evaluation:• Loss on drying at 105°c• Total ash• Acid insoluble ash• Water soluble extractive • pH

Standardization of Churna

Phytochemical evaluation • Qualitative analysis• TLC• HPTLC & HPLC

Standardization of Churna

Particle size : • Churna : 80-120 mesh.• Kwatha Churna : 40-60 mesh.

Standardization of Churna

Microbial contamination • Total aerobic count • Enterobacteria count • Total fungal count Test for specific pathogen• E.coli• Salrnonella spp.• Pseudomonas spp.

Standardization of Churna

Pesticide residue:Methods : Extraction & PurificationPesticides: • Organochlorine pesticide• Organophosphorus pasticides• Pyrethroids

Standardization of Churna

Taste for aflatoxins by TLC:- B1,B2,G1,G2

Shelf life

Parameters for Standardization of Asava And Arishta

Ayurvedic parameters :• Clear liquid without any forth• Pleasant aromatic odour of alcohol• Should not have sour taste• No effervescence sound• Additive sink to the bottom• Burning candle burns brightly when placed in

or just above the Sandhana Paatra

Parameters for Standardization of Asava And Arishta

• Organoleptic evaluation • Physical evaluation:- pH, Specific gravity at 25°c and total solid• Alcohol content • Reducing sugar• Non- reducing Sugar• Test for Methanol• Total Acidity• Chromatography• Shelf life • Viscosity

Acid Value

• The acid value is the number of mg of Potassium hydroxide required to neutralize the free acid in 1gm of substance.

• Viscosity: Resistance to flow• Apparatus : viscometer

Parameters for standardization of Avaleha

सु�क्वेतन्तुमत्वं स्यदवलेहोऽप्सु मज्जपित ।लिसलि8�त्वं �ीडते मुद्रागन्धवर्ण��सोद्भवः ॥

1. Can be lifted in a spoon as treacle 2. When pressed between fingers,

shows threadness when stretched 3. Sinks in water without getting easily

dissolved4. Finger leaves impression on it

Parameters for standardization of Avaleha

• Organoleptic • Physical • Reducing sugar• Total sugar• Chromatography • Test for heavy metals • Microbial contamination• Shelf life

Parameters for standardization of Avaleha

Physical evaluation: • Loss on drying at 105°c • Total ash• Acid insoluble ash• pH• Specific gravity • Total solid contents• Fat contents

Parameters for standardization of Vati & Gutika

• Organoleptic Parameters : 1. colour 2. Odour

• Total sugar • Reducing sugar • Phytochemical assessment

Parameters for standardization of Vati & Gutika

• Particle size• Identification : Microscopy , HPTLC & TLC• Test for Heavy metals & toxins• Microbial contamination • Pesticide residue

Parameters for standardization of Vati & Gutika

Physical evaluation: • Ash value • Acid insoluble ash• Water insoluble ash• Alcohol soluble extractive • pH• Volatile oil• Melting temperature• Loss on drying

Parameters for standardization of Vati & Gutika

• Pharmaceutical parameters 1. Hardness2. Uniformity in weight 3. Uniformity in diameter4. Friability test 5. Dissolution time 6. Disintegration time

• Disintegration test : liquid medium • Apparatus: Disintegration test apparatus

• Friability test : how much mechanical stress tablets are able to withstand during their manufacturing , distributing and handling

• Hardness: how much force is needed to break .

• Uniformity of weight:• Apparatus: Analytical balance• Tablets which contains <10mg or < 10% W/W

of active ingredient.• Not applicable to tablets which are containing

trace elements

Parameters for standardization of Tailas & Ghritas

वर्तित>वत्स्नेहकल्कः स्यादागुल्या पिवमर्दिद>तः।शब्धहीनोऽग्निCनपिनक्षिक्षप्तः स्नेहः लिसध्दो भवेत्तदा॥

यदा फेनोद्गमस्तैले �ैनशान्तिन्तश्च सर्ति�>पिर्ष ।गन्धवर्ण��सोत्�क्षित्त स्नेहलिसग्निध्दस्तदा भवेत् ।

• Sneha paka:तुल्ये कल्केन पिनया�से भरे्षजानां मृदुः स्मृतः।संयाव इव पिनया�से मध्यो दर्तिव> पिवमुन्चपित ।शीय�मारे्ण तु पिनया�से वत�माने ख�स्त8ा।

Parameters for standardization of Tailas & Ghritas

• Organoleptic : colour, odour • Weight /ml• Viscosity• Iodine value• Saponification• Acid value• Rancidity : fat oxidization

Iodine Value

• The iodine value of substance is the weight of iodine absorbed by 100 part by weight of substance .

• Applicable for liquid substances.

Saponification value

• Number of mg of KOH required to neutralize the fatty acids, resulting from the complete hydrolysis of 1 gm of the oil & fat.

Parameters for standardization of Arka

• Organoleptic• Physical : pH, Volatile matter, SG, Clarity test

Sterility test• Chromatography• Self life

Shelf life assessments

• The time period during which an active pharmaceutical ingredients or finished pharmaceutical products are remain within the approved stability specification , provided that it is stored under condition defined on the containers level.

• Factors : Temperature, Humidity ,Light etc• It can be calculated by mathematic formulation

• AYUSH : Rule 161B (2005)1. Churna & Kwatha Churna : 2 yrs2. Gutika ( herbs) : 3 yrs3. Gutika ( Guggulu) : 5 yrs4. Rasa : 5yrs5. Avaleha : 3 yrs6. Asava & Arista : no expiry date.

Thank you