the ayurvedic pharmacopoeia of india - ccras ( pdfdrive ) (830801), страница 5
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With the introduction of a uniform system of Ayurvedic education all over thecountry, a process initiated some 50 years ago, there would be some uniformity inthe education in pharmacy, pharmaceutical technology, pharmaceutical chemistry,pharmacognosy and research. With the physician and the patient needing to beassured of the quality of the medicine through research, such an advance inAyurvedic education would have a positive effect.23.
In the absence of official standards published by Government for statutorypurposes, Ayurvedic Pharmaceutical Industry in particular has been experiencingseveral handicaps in implementing in house standards, as in any case, they need tocomply with official standards.24. The publication of the Ayurvedic Formulary of India and the AyurvedicPharmacopoeia of India would now enable the Government to implement theDrugs and Cosmetic Act, 1940 in respect of quality control for the Ayurvedic,Siddha, Unani drug manufacturers, distributed and sold in India, under a licensegranted by it.25.
The Ayurvedic Pharmacopoeia Committee has laid down standards for singledrugs based on experimental data worked out at the PLIM, Ghaziabad and insome of the units of the Central Council for Research in Ayurveda and Siddha.Published scientific literature on the subject, although scanty, has also beencollected and included after due verification.26. The western countries did pass through the same phase over 150 years ago fortheir medicines, their characteristics, methods of preparation and identity, purityand strength.
Research towards this end was vigorous and out of the scientific datacontributed by the scientists in research institutes and industry, thepharmacopoeial monographs of drugs were drafted. As a result pharmacopeiae ofthe western world show considerable uniformity in principles, approach andinformation. Thus, while for compilation of the British Pharmacopoeia,information and scientific data was available, for the compilation of theAyurvedic Pharmacopoeia little information and published data existed and theAyurvedic Pharmacopoeia Committee had to do a lot of spade work.27. The Part I of Ayurvedic pharmacopoeia of India consists of Vol-I, II, III, IV and Vcomprising respectively 80, 78, 100, 68 and 92 monographs prescribing standardsfor Ayurvedic single drugs of plant origin, which go into one or moreformulations admitted to the Ayurvedic Formularies of India, Part-I and Part-II.The Part-II of the Ayurvedic Pharmacopoeia consists of official standards for 50compound formulations present in the Ayurvedic Formulary of India Part-I andPart-II.28.
The title of the monograph for each compound formulation is given in Samskrit,as in the Ayurvedic Formulary of India. This is followed by the Definition,Formulation Composition, Method of Preparation, a brief Description of thecompound formulation, standards for Identity and Purity in so far as they arereflected by microscopy and physico chemical parameters. Other requirementssuch as tests for heavy metals, microbial content have also been prescribed.Information on therapeutic uses, dose, administration and storage is included. Theraw material which complies with the standards of API were selected fordeveloping standards for compound formulations.
In a few cases, where suchstandards were not available, the collaborator developed them and used them asstandards for that raw material.29. The monograph gives limits under Assay, for any one constituent or group ofconstituents like total alkaloids or total volatile oils. In the case of water soluble oralcohol soluble extractives a minimum lower limit has been given. For impuritieslike Ash, Acid insoluble Ash etc, a maximum upper limit has been given.
It is awell known fact that there is wide variation in such values for crude drugs of plantorigin in respect of their chemical contents. Therefore, such variations had to betaken into consideration in laying down minimum and maximum standards for thecompound formulations.30. The General Notices provide guidance for the manufacturers and analysts. Officialdetails of Apparatus, Reagents and solutions, Methods of tests, preparation ofsample for microscopical examination have all been given the Appendices.31. The Committee hopes that with the publication of Ayurvedic Pharmacopoeia ofIndia Part-II (Formulations) Vol.-I, comprising of 50 compound formulations,would serve to exercise quality control and help in the implementation of theDrugs and Cosmetics Act.
It is also expected that such implementation wouldcreate a feedback data, which is essential for improving the standards given in thepharmacopoeia.32. The Committee urges the Government of India to recommend the adoption ofthese monographs for the purpose of defining Method of Preparation, DevelopingStandards for compound formulations for use in their Government,Semi-Government and Government aided institutions and voluntary publicorganizations. The Ayurvedic Pharmacopoeia of India, 2007, Part-II(Formulations), Vol.-I may also be notified by Government as a book of standardsfor implementation of the Drugs and Cosmetics Act, 1940 all over India, just asthe Ayurvedic Pharmacopoeia of India part I, Vol. I, II, III, IV and V have beenincluded in the First Schedule of Drugs & Cosmetics Act 1940.33.
The Ayurvedic Pharmacopoeia Committee records with deep appreciation thecontributions made by the Directors, Officer In-charges, Project Officers andscientific staff of all the collaborating laboratories and Institutions who wereassociated with the project work on developing Pharmacopoeial Standards forformulations allotted to them.34. I am indebted to secretary Department of AYUSH, Ms. Anita Das for her constantinspiration and motivation for this unique work. My sincere thanks and credit toJoint Secretary, Department of AYUSH, Sh.
Shiv Basant for providing constantsupport and strategic plan for completion of this first phase of task andmomentum to on going work.35. It is my duty to place on records our sincere thanks and appreciation to Dept. ofAYUSH, Ministry of Health & Family Welfare, Govt. of India; StateGovernments, Institutions, Councils, Scientists and Ayurvedic Scholars, for theirwhole hearted co-operation in preparing the monographs on compoundformulations. I sincerely thank all members of Ayurvedic PharmacopoeiaCommittee for their dedicated efforts and hard work in finalizing the monographs.My thanks to Prof.
S.S. Handa, Chairman; Dr. S.K. Sharma, Vice-Chairman;Miss. S. S Satakopan, Member; Prof. S.K. Dixit, Member; Prof. Ved VratSharma, Member; Prof. V.K. Kapoor, Member; Dr.(Ms.) Shanta Mehrotra,Member; Dr. P.D. Sethi, Member; Dr. D.R. Lohar, Member; Prof.
M.A. Iyengar,Member; Sh. J. K. Dhing, Member; Dr. J. Mohansundaram, Member; Dr. B. L.Gaur, Member; Prof. Siddhinandan Mishra, Member; Dr. P. K. Prajapati,Member; Dr. Narendra Bhatt, Member; Sh. Ranjit Puranik, Member; Prof. V. K.Joshi, Member; Prof. K.C. Chunekar, Member; Vd. Devender Triguna, Member;Dr.
M.R. Uniyal, Member; Prof. V.V. Prasad, Member and Dr. Karan Vashisth,Expert member for their constant efforts in bringing out this volume. My thanksare also to Dr. MM Padhi, Deputy Director [Tech.]; Shri. Vasantha Kumar, Asst.Director [Chem.] Dr. Pramila Pant, Research Officer [Chem.], Dr. Rajiv Sharma,Senior Scientific Officer [Pharmacognosy], Sri. Ravinder Singh, Research Officer[Chem.], Dr. Jai Prakash, Research Officer [Chem.], Dr. Chhote Lal, Dr.
AKSBhadoria and Dr. MN Rangne, Dr. Bishnu Priya Dhar, Research Officer [Phar],Dr. Galib, Research Officer [Ayu.],Dr. K. Sandhya Rani, S.R.F. [Ayu.] andother associated officers, who contributed a lot in finalizing the volume. I am alsothankful to Mr. Sandeep Kumar, D.E.O., who took pains in typing and arrangingall the technical data into a final shape.Dr. G.S. LavekarDirector CCRAS & Member Secretary, APCINTRODUCTIONThe Ayurvedic system of medicine has been prevalent in India since the Vedicperiod, and still remains the mainstay of medical relief to over 60 per cent of thepopulation of the nation. In earlier times the practitioners of Ayurveda (Vaidya) werethemselves collecting herbs and other ingredients and preparing medicines. For thepurpose of acquiring raw materials Vaidyas now depend on commercial organizationstrading in crude herbal drugs.
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