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THE AYURVEDIC PHARMACOPOEIA
OF INDIA
K V GOPINATH M Pharm PhD,CPhT
Tirumala Tirupati Devasthanams
TIRUPATI
e-mail:gopinath.karnam@gmail.com
THE AYURVEDIC PHARMACOPOEIA
OF INDIA
The Ayurvedic Pharmacopoeia of India
• official book of standards for single drug and its
formulations
or
• compilation of various ayurvedic pharmaceutical
formulation(s) i.e. formulas and methods of
preparations
Ayurveda Pharmacopoeia
committee
 1st
established in 1962 by Government of India
 APC was first functional unit at department of Ayush
 In April 2006, it was shifted under Central Council for
Research in Ayurveda and Sidda
Other Official Monographs
 German Commission E Monographs
 European Scientific Cooperative for phytotherapy
(ESCOP)
 The American Herbal Pharmacopoeia
 WHO Monographs
 USP Monographs
APC - Functions
 To prepare Ayurvedic Pharmacopoeia of India of single
and compound drugs
 To prescribe the working standards for compound
Ayurvedic formulations including tests for identity,
purity, strength and quality so as to ensure uniformity of
the finished formulations
APC - Functions
 Keeping in view the time constraint, to identify such
methods, procedures and plan of work as would enable to
publish the formulary and standards of all commonly
used drugs to be brought out in a phased manner
 To prepare remaining parts of the official formulary of
compound preparations from the classical texts including
standardized composition of reputed institution
APC - Functions
 To develop and standardize methods of preparations,
dosage form, toxicity profile etc
 To develop quality standards, safety, efficacy profile of
intermediates likes extracts of Ayurvedic raw drugs
 To develop the quality standards, safety, efficacy profile
of different parts of the plants; as well as to include new
plants as Ayurvedic drugs
APC - Functions
 Any other matter relating to the quality standards, shelf
life, identification, new formulations etc.
 Targets Focus of the Committee
– To evolve standards for single drug and Ayurveda
Formulations as in official book
– To prepare drafts SOP of Ayurvedic Formularies of
India from the classical texts and other authentic
sources
CONTRIBUTING LABORATORIES
& INSTITUTIONS
 University Institute of Pharmaceutical Sciences, Punjab
University,Chandigarh
 National Institute Pharmaceutical Education and
Research(NIPER),Mohali
 Captain Srinivasa Murty Drug Research Institute Ayurveda
(CSMDRIA), Chennai
 B. V. Patel, Pharmaceutical Education, & Research
Development (PERD) Centre, Ahmadabad
 National Botanical Research Institute, (Council of Scientific &
Industrial Research), Lucknow
 Ram Narayan Ruia College, Matunga, Mumbai
Central Council for Research in
Ayurveda and Sidda (CCRAS)
 Established in 1978
 To carry out research in Ayurveda and Sidda
 Engrossed in developing safe, effective, appropriate and
cost effective formulations for priority diseases
 Financing of fundamental research projects of industry
and institutions (35 labs)
Projects under APC
 Development of pharmacopoeial standards for single
drugs and its formulations
 Isolation of marker compounds of medicinal plants
 Comparative phyto-chemical screening of roots and
barks vs aerial parts
 Preparation of Hindi version of API
 Biological Activity studies of plant extracts
 Extra Ayurvedic Pharmacopoeia of India
Projects under APC
 To identify methods & procedures for publication of
standards of all commonly used formulations of AFI
 Information on Ayurvedic Formulations regarding
- Distinguishing characters
-Method of preparation and dosage
-Method of administration with Anupana
-Toxicity
Projects under APC
 To develop quality standards, shelf life, identification,
New formulations including safety efficacy of
intermediates plant extracts
 All other activities as mentioned in functions of APC
Ayurvedic Formulary of India-
Publications
AFI Year Number of
Formulations
Part I 1978 444
Part II 2000 191
Part III Draft stage (Hindi &
Eng)
-
Ayurvedic Pharmacopoeia of India -
Publications
Ayurvedic Pharmacopoeia of India – Part 1
Volume Year of publishing Number of Monographs
I 1990 80
II 1999 78
III 2001 100
IV 2004 68
V 2006 92
VI 2008 101
VII 2008 21 (minerals & metals)
Ayurvedic Pharmacopoeia of India – Part 1I
I 2007 50
II 2008 51
III 2010 51
Ayurvedic Pharmacopoeia of
India -Atlas Publications
 TLC Atlas of Pharmacopoeial drugs (API-Part I,
volume I
 Micro & Macroscopic atlas of Pharmacopoeial drugs
(API-Part I, volume V
e – Book Publications of AFI
AFI Number of Monographs
Part – I & II 635
Part I, Volume I - V 418
Part I, Volume VI 101
Part II, Vol I 50
Part II, Vol II 51
Ayurvedic Pharmacopoeia
Committee & PLIM
 In 2010-Pharmacopoeia Laboratory for
Indigenous Medicines (PLIM)
 Autonomous body for Indian Medicine (Ayurveda,
sidda, & Unani) to evolve the standards under the
guidance of APC
 To analyze product samples picked up by the drug
inspectors
PLIM - Objectives
 To set and validate standards of drug(s)
 To provide reference standards
 To impart training to drug inspectors and analysts
 To provide support APC
 As a result I volume of API ,1990 with 80 monographs
A Typical Ayurvedic
Pharmacopoeia of India
 Title Name of the Drugs
 Introductory Para Synonyms
 Italics Odour and Taste
 Mesh Number Weights and Measures
 Identity, Purity and Strength
 Limits for Heavy Metals
 Thin Layer Chromatography (T.L.C.)
 Quantities to be weighed for Assays and Tests
 Constant Weight Constituents
 Percentage of Solutions Percentage of alcohol .
A Typical Ayurvedic
Pharmacopoeia of India
 Temperature
 Solutions
 Reagents and Solutions
 Solubility:
-Very soluble Less than 1 part
- Freely soluble From 1 to 10 parts
-Soluble From 10 to 30 parts
-Sparingly soluble From 30 to 100 parts
-Slightly soluble From 100 to 1000 parts
-Very slightly soluble From 1000 to 10,000 parts
-Practically insoluble More than 10,000 parts
A Typical Ayurvedic
Pharmacopoeia of India
 Therapeutic uses and important formulations
 Doses
 Abbreviations of technical terms
 Storage conditions
Ayurvedic Pharmacopoeia of India
 A total of 8 volumes of API-I has been published with
540 medicinal plants + other
 API volume 7 deals with minerals and metals
 A total 2111 monographs published
Ayurvedic Pharmacopoeia of
India -II
 The compendium Part I & II contain a total of 63518 of
monographs under 21 categories of commonly used
formulations
 A typical monograph contain:
-Name of the formulation; -definition
-Formulation/Composition
-Method of preparation Description
-Identification ; -Physicochemical parameters
-Storage; -Therapeutic uses
-Dose ; -Anupana
API- Part II Appendices
 Standards for the major contaminants
 Limits for heavy metals
 Limits for microbes
 Limits for Aflatoxins
 Limits for pesticides
Conclusion
 The Ayurvedic Pharmacopoeia is a book of Ayurveda
monographs give sources, Physical properties,
microscopic, macroscopic characters, identity tests,
constituents, approved therapeutic uses, minimum and
maximum doses, color photographs, chemical formulae,
and standards of quality of crude drugs including its
formulations
 The aim has been set standards for quality, efficacy and
safety in order that the many traditional herbs meet legal
requirement
Ayurveda pharmacopoeia

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Ayurveda pharmacopoeia

  • 1. THE AYURVEDIC PHARMACOPOEIA OF INDIA K V GOPINATH M Pharm PhD,CPhT Tirumala Tirupati Devasthanams TIRUPATI e-mail:gopinath.karnam@gmail.com
  • 2. THE AYURVEDIC PHARMACOPOEIA OF INDIA The Ayurvedic Pharmacopoeia of India • official book of standards for single drug and its formulations or • compilation of various ayurvedic pharmaceutical formulation(s) i.e. formulas and methods of preparations
  • 3. Ayurveda Pharmacopoeia committee  1st established in 1962 by Government of India  APC was first functional unit at department of Ayush  In April 2006, it was shifted under Central Council for Research in Ayurveda and Sidda
  • 4. Other Official Monographs  German Commission E Monographs  European Scientific Cooperative for phytotherapy (ESCOP)  The American Herbal Pharmacopoeia  WHO Monographs  USP Monographs
  • 5. APC - Functions  To prepare Ayurvedic Pharmacopoeia of India of single and compound drugs  To prescribe the working standards for compound Ayurvedic formulations including tests for identity, purity, strength and quality so as to ensure uniformity of the finished formulations
  • 6. APC - Functions  Keeping in view the time constraint, to identify such methods, procedures and plan of work as would enable to publish the formulary and standards of all commonly used drugs to be brought out in a phased manner  To prepare remaining parts of the official formulary of compound preparations from the classical texts including standardized composition of reputed institution
  • 7. APC - Functions  To develop and standardize methods of preparations, dosage form, toxicity profile etc  To develop quality standards, safety, efficacy profile of intermediates likes extracts of Ayurvedic raw drugs  To develop the quality standards, safety, efficacy profile of different parts of the plants; as well as to include new plants as Ayurvedic drugs
  • 8. APC - Functions  Any other matter relating to the quality standards, shelf life, identification, new formulations etc.  Targets Focus of the Committee – To evolve standards for single drug and Ayurveda Formulations as in official book – To prepare drafts SOP of Ayurvedic Formularies of India from the classical texts and other authentic sources
  • 9. CONTRIBUTING LABORATORIES & INSTITUTIONS  University Institute of Pharmaceutical Sciences, Punjab University,Chandigarh  National Institute Pharmaceutical Education and Research(NIPER),Mohali  Captain Srinivasa Murty Drug Research Institute Ayurveda (CSMDRIA), Chennai  B. V. Patel, Pharmaceutical Education, & Research Development (PERD) Centre, Ahmadabad  National Botanical Research Institute, (Council of Scientific & Industrial Research), Lucknow  Ram Narayan Ruia College, Matunga, Mumbai
  • 10. Central Council for Research in Ayurveda and Sidda (CCRAS)  Established in 1978  To carry out research in Ayurveda and Sidda  Engrossed in developing safe, effective, appropriate and cost effective formulations for priority diseases  Financing of fundamental research projects of industry and institutions (35 labs)
  • 11. Projects under APC  Development of pharmacopoeial standards for single drugs and its formulations  Isolation of marker compounds of medicinal plants  Comparative phyto-chemical screening of roots and barks vs aerial parts  Preparation of Hindi version of API  Biological Activity studies of plant extracts  Extra Ayurvedic Pharmacopoeia of India
  • 12. Projects under APC  To identify methods & procedures for publication of standards of all commonly used formulations of AFI  Information on Ayurvedic Formulations regarding - Distinguishing characters -Method of preparation and dosage -Method of administration with Anupana -Toxicity
  • 13. Projects under APC  To develop quality standards, shelf life, identification, New formulations including safety efficacy of intermediates plant extracts  All other activities as mentioned in functions of APC
  • 14. Ayurvedic Formulary of India- Publications AFI Year Number of Formulations Part I 1978 444 Part II 2000 191 Part III Draft stage (Hindi & Eng) -
  • 15. Ayurvedic Pharmacopoeia of India - Publications Ayurvedic Pharmacopoeia of India – Part 1 Volume Year of publishing Number of Monographs I 1990 80 II 1999 78 III 2001 100 IV 2004 68 V 2006 92 VI 2008 101 VII 2008 21 (minerals & metals) Ayurvedic Pharmacopoeia of India – Part 1I I 2007 50 II 2008 51 III 2010 51
  • 16. Ayurvedic Pharmacopoeia of India -Atlas Publications  TLC Atlas of Pharmacopoeial drugs (API-Part I, volume I  Micro & Macroscopic atlas of Pharmacopoeial drugs (API-Part I, volume V
  • 17. e – Book Publications of AFI AFI Number of Monographs Part – I & II 635 Part I, Volume I - V 418 Part I, Volume VI 101 Part II, Vol I 50 Part II, Vol II 51
  • 18. Ayurvedic Pharmacopoeia Committee & PLIM  In 2010-Pharmacopoeia Laboratory for Indigenous Medicines (PLIM)  Autonomous body for Indian Medicine (Ayurveda, sidda, & Unani) to evolve the standards under the guidance of APC  To analyze product samples picked up by the drug inspectors
  • 19. PLIM - Objectives  To set and validate standards of drug(s)  To provide reference standards  To impart training to drug inspectors and analysts  To provide support APC  As a result I volume of API ,1990 with 80 monographs
  • 20. A Typical Ayurvedic Pharmacopoeia of India  Title Name of the Drugs  Introductory Para Synonyms  Italics Odour and Taste  Mesh Number Weights and Measures  Identity, Purity and Strength  Limits for Heavy Metals  Thin Layer Chromatography (T.L.C.)  Quantities to be weighed for Assays and Tests  Constant Weight Constituents  Percentage of Solutions Percentage of alcohol .
  • 21. A Typical Ayurvedic Pharmacopoeia of India  Temperature  Solutions  Reagents and Solutions  Solubility: -Very soluble Less than 1 part - Freely soluble From 1 to 10 parts -Soluble From 10 to 30 parts -Sparingly soluble From 30 to 100 parts -Slightly soluble From 100 to 1000 parts -Very slightly soluble From 1000 to 10,000 parts -Practically insoluble More than 10,000 parts
  • 22. A Typical Ayurvedic Pharmacopoeia of India  Therapeutic uses and important formulations  Doses  Abbreviations of technical terms  Storage conditions Ayurvedic Pharmacopoeia of India  A total of 8 volumes of API-I has been published with 540 medicinal plants + other  API volume 7 deals with minerals and metals  A total 2111 monographs published
  • 23. Ayurvedic Pharmacopoeia of India -II  The compendium Part I & II contain a total of 63518 of monographs under 21 categories of commonly used formulations  A typical monograph contain: -Name of the formulation; -definition -Formulation/Composition -Method of preparation Description -Identification ; -Physicochemical parameters -Storage; -Therapeutic uses -Dose ; -Anupana
  • 24. API- Part II Appendices  Standards for the major contaminants  Limits for heavy metals  Limits for microbes  Limits for Aflatoxins  Limits for pesticides
  • 25. Conclusion  The Ayurvedic Pharmacopoeia is a book of Ayurveda monographs give sources, Physical properties, microscopic, macroscopic characters, identity tests, constituents, approved therapeutic uses, minimum and maximum doses, color photographs, chemical formulae, and standards of quality of crude drugs including its formulations  The aim has been set standards for quality, efficacy and safety in order that the many traditional herbs meet legal requirement