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Books > Ayurveda > The Ayurvedic Pharmacopoeia of India (Part-II, Volume-II) Formulations
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The Ayurvedic Pharmacopoeia of India (Part-II, Volume-II) Formulations
The Ayurvedic Pharmacopoeia of India (Part-II, Volume-II) Formulations
Description
From the Jacket

UNSUB STARCHAT TO155223 The Ayurvedic Pharmacopoeia of India, Pt. II (Formulations) Vol. II is a legal document of standards for the quality of Ayurvedic formulations included therein (under the Drug and Cosmetic Act, 1940). This volume comprises 51 monographs on compound formulations. Each monograph contains the definition, formulation composition, indicating the official Ayurvedic name of the ingredient, equivalent scientific name, part/form used and their proportion in the formulation. This also includes method of preparation and description of the product. The identification of product includes microscopy of the ingredients, thin layer Chromatography (TLC) and Chemical tests. The Physico-chemical parameters contain loss of drying, total ash, acid insoluble ash, alcohol soluble extractive, water soluble extractive, pH etc. The indications, therapeutic uses and daily dose along with Anupana is also indicated in the monograph.

This volume is second publication in this series, wherein the pharmacopoeial standards of multiple ingredient formulations have been scientifically described. The standards have been consciously kept modest so that the implementation by the manufacturing companies becomes easily acceptable in order to maintain quality control and batch to batch uniformity. However, the efforts of the manufacturer should be to maintain higher standards of quality than described in this book.

The appendices of this volume contain the details of protocols used in the determination of various standards as well as methods of testing. References of the Ayurvedic literature in its original form are also added in order to authenticate the Ayurvedic standards, referred in each monograph. In the appendix, Ayurvedic definition and method of Sodhana etc. are also given. This book in general is more user friendly for the manufacturers, scientists and students, teachers involved in the standardization of Ayurvedic formulations.

This book is included in the first schedule of Drugs and Cosmetics Act, 1940. Manufacturers are required to follow pharmacopoeial standards and these are mandatory requirements under the Act. Users are welcome to give their suggestions on these monographs so that these suggestions are evaluated and followed in the forthcoming volumes of Ayurvedic Pharmacopoeia of India Part-Il (Formulations).

Introduction

The Ayurvedic system of medicine has been prevalent in India since the Vedic period, and still remains the mainstay of medical relief to over 60 per cent of the population of the nation. In earlier times the practitioners of Ayurveda (Vaidya) were themselves collecting herbs and other ingredients and preparing medicines. For the purpose of acquiring raw materials Vaidyas now depend on commercial organizations trading in crude herbal drugs. Likewise, with passage of time a number of Ayurvedic Pharmaceutical units have come up for the manufacture of Ayurvedic drugs and formulations on commercial scale.

Under the circumstances and responding to opinions of the scientific community after independence, the Govt. of India began a series of measures to introduce a quality control system, from 1964 onwards similar to that existing already under the Drugs and Cosmetics Act, 1940, for western medicine. The Government of India introduced an amendment in 1964 to the Drug and Cosmetics Act 1940, to control to a limited measure the Ayurvedic, Siddha and Unani drugs.

The Act was accordingly amended in 1964, to ensure only a limited control over the production and sale of Ayurvedic medicines namely:-
i. The manufacture should be carried out under prescribed hygienic conditions, under the supervision of a person having prescribed qualifications;
ii. The raw materials used in the preparation of drugs should be genuine and properly identified; and
iii. The formula or the true list of all the ingredients contained in the drugs should be displayed on the label of every container.

To start with, development of standards for the identity, purity and strength of single drugs and those of formulations at a later stage, assumed importance for the effective enforcement of the provision of the Act. If the raw materials to be used in a medicine and stage-by-stage processes of manufacturers are standardised, the final product namely, the compound formulation could be expected to conform to uniform standards. The requirement that the list of ingredients be displayed on the label will enable analysts to verify label claims. It will also ensure that the manufacture do not make false claim. Arrangements to evolve and lay down physical, chemical and biological standards, wherever even necessary, to identify the drugs and ascertain their quality and to detect adulterations are an urgent necessity of the profession. Setting up of Drug Standardisation Units, Research Centres, Drug Testing Institutes and Central Drug Laboratories for Ayurvedic Medicines both at national and regional level for this purpose are therefore, essential. The several Committees appointed by the Government of India to assess and evaluate the status and practice of Ayurvedic Medicine have stressed the importance of preparing an Ayurvedic Pharmacopoeia, which IS precisely a book of standards.

Foreword

With the growing popularity and demand of Ayurvedic Medicines in the country and abroad, availability of quality standards of Ayurvedic formulations has become a top priority for maintaining uniform, safe and quality medicines for the consumption of patients. Evolving Pharmacopoeial standards for Ayurveda, Siddha and Unani Medicine is essential for implementing the relevant provisions under the Drugs and Cosmetic Act, and Rules thereunder. The Ayurvedic Pharmacopoea Committee has been assigned the task of evolving Pharmacopoeial standards of the commonly used formulations in the country.

Bringing out the Pharmacopoeial standards of Ayurvedic formulations requires expertise of various disciplines like Ayurvedic P Pharmacognosy, Pharmacy, Phytochemistry and Pharmaceutical Chemistry. The present volume also contains standard manufacturing procedures including in-process standardization procedures, final product standardization with physico-chemical and chromatographic techniques. It is needless to say that the present volume is the result of untiring efforts of scientists from various laboratories and members of the Pharmacopoeia Committee.

I have no doubt that this publication on Compound. Formulations will provide required technical assistance for manufacturers, regulators, scientists, teachers, researchers and students. I place on record my appreciation for the members for Ayurvedic Pharmacopoeia Committee, Scientists working in various laboratories, Dr. S.K. Sharma, Adviser (Ayurveda), Department of Ayush, Dr. D.R. Lohar, Director, Pharmacopoeia Laboratory for Indian Medicine (PLIM) and his team and Dr. G.S. Lavekar, Director, Central Council for Research in Ayurveda & Siddha (CCRAS) and his team for bringing out this volume. My congratulations to Shri Shiv Basant, Joint Secretary, Department of Ayush whose overall coordination has made this enormous work possible.

 

Preface

In Ayurvedic Formulary of India Part I and Part II there are 636 formulations, out of these nearly 65 percent are solid dosage forms (Curna, Vati, Gutika etc.) about 20 percent are liquid preparations (Asva, Arista, Taila) and about 15 percent are semisolid (Avaleha, Ghrta, Lepa). Each of the formulations contains a number of ingredients, a few even going upto 75. It is observed that nearly 70 percent each of the liquid and semisolid preparations contain over ten ingredients. Since the spectrum of the tests which can be applied to liquids and semisolids for pharmacopoeial monographs are more limited than those available for solids, these preparation are particularly difficult to deal with. Considering the total 636 formulations about 50 percent contain over 10 ingredients. This means that in 318 monographs of solids, semisolids and liquids, standards and tests would involve an average of 25 ingredients in each this is really a complex and formidable task to accomplish. In addition to sheer volume, the unique processing methods used for manufacture, turn a simple mixture of single drugs into a very complex material from which separation and identification let alone estimation of components is no longer an easy and routine affair. It calls for complete knowledge of manufacturing complexities for a pharmaceutical - analytical chemist, for proper appreciation and interpretation of test results. At present, very few generalized quality parameters are adopted. Only a few Ayurvedic drug manufacturers may be having in house standard methods of preparations (SOPs) and quality parameters for finished compound formulations. But there exists no uniformity in the SOPs and quality parameters in the country. This results in lot of variability in quality of the same classical Ayurvedic formulation produced by different manufacturers. An effort has been made now to optimize and to develop uniform SOPs in order to ensure that such differences in quality of the same product produced by different manufacturers are not beyond permissible limits.

Under part I of Ayurvedic Pharmacopoeia of India (on single drug) so far six volumes have been published viz. Vol 1(80 monographs), Vol 11(78 monograph), Vol III (100 Monographs), Vol IV (68 monographs) and Vol V (92 monographs) and Vol VI (101 monographs) for Ayurvedic single drugs of plant origin, which go into one or more compound formulations included in the Ayurvedic Formulary of India, Part-I and Part-TI. The first volume of the Ayurvedic Pharmacopoeia of India, Part-TI published in 2007 contains official standards for 50 compound formulations selected from Ayurvedic Formulary of India, Part-I and Part-Il.

In continuation of the work of the quality standards of classical Ayurvedic compound formulations, the present Vol-IT of the Ayurvedic Pharmacopoeia of India, Part-IT contain official standards for compound formulations included in the Ayurvedic Formulary of India, Part-I and Part-Il.

The title of the monograph for each compound formulation is given in Sanskrit as mentioned in the Ayurvedic Formulary of India. This is followed by the Definition, Formulation Composition, Method of Preparation, a brief Description of the Formulation, Standards for Identity and Purity in so far as these are reflected by microscopy, chromatography (thin layer chromatography or gas liquid chromatography), Physicochemical parameters. Others requirements include limits for heavy metals and microbial load. Information on therapeutic uses, dose, mode of administration and storage is included. Each ingredient of the compound formulations complies with the standards prescribed in the Ayurvedic Pharmacopoeia of India. In a few cases, where pharmacopoeial standards for individual ingredient are not available, the collaborating institute develops standards for such an ingredient before using it in the formulation. The monograph for majority of the compound formulations provides Assay method for and range of limits of any one chemical constituent or group of chemical constituents.

The general notice provide guidance for the Ayurvedic drug manufacturers and analysts. Appendices given in the Pharmacopoeia include details of the apparatus/equipment, reagents, solutions used methods of tests employed and preparations of sample for microscopic examination.

The Ayurvedic Pharmacopoeial Committee hopes that the publication of Ayurvedic Pharmacopoeia of India, Part-Il (formulations) Vol-IT containing quality standards and method of preparation of compound formulation would serve to assist in the implementation of the Drugs and Cosmetic Act and Rules there under. It is also expected that such implementation would generate feedback information which is necessary compound formulations given in this Vol-IT of the Ayurvedic Pharmacopoeia of India, Part-Il.

The Ayurvedic Pharmacopoeial committee urges the Government of India to recommend the adoption of these monographs published in the Ayurvedic Pharmacopoeia of India, Part-II (formulations) — Vol II for the purpose of methods of preparations and quality standards of Ayurvedic compound formulation for use in their Government, Semi government, Government aided institutions and Voluntary public organizations. Ayurvedic Pharmacopoeia of India, Part-II (formulations) Vol-II may also be notified by the Government of India as a book of standards for implementation of Drugs and Cosmetic Act 1940 and Rules there under (as amended from time to time) all over India, just as the Ayurvedic Pharmacopoeia of India Part-I Vol-I, II, III, IV,V, VI and the Ayurvedic Pharmacopoeia of India, Part-TI (formulations), Vol-I have been included in the First Schedule of the Drugs and Cosmetic Act 1940.

 

Contents

 

  Legal Notices xiii
  General Notices xiv
  Preface xxv
  Introduction xxviii
  Monographs
Asava and Arista
 
  General Description 1
1. Abhayarista (A.F.I.-I) 2
2. Amrtarista (A.F.I.-I) 5
3. Aravindasava (A.F.I.-I) 8
4. Asokarista (A.F.I.-I) 10
5. Asvagandhadyarista (A.F.I.-I) 13
6. Babbularista (A.F.I.-II) 16
7. Balarista (A.F.I.-I) 19
8. Dasamularista (A.F.I.-I) 21
9. Draksarista (A.F.I.-I) 25
10. Draksasava (A.F.I.-II) 27
11. Jirakadyarista (A.F.I.-I) 29
12. Kanakasava (A.F.I.-I) 31
13. Khadirarista (A.F.I.-I) 33
14. Kumaryasava (B) (A.F.I.-I) 36
15. Kutajarista (A.F.I.-I) 39
16. Lohasava (A.F.I.-I) 42
17. Mustakarista (A.F.I.-I) 45
18. Parthadyarista (A.F.I.-I) 47
19. Pippalyadyasava (A.F.I.-I) 49
20. Punarnavadyarista (A.F.I.-II) 52
21. Punarnavasava (A.F.I.-I) 55
22. Rohitakarista (A.F.I.-I) 58
23. Sarivadyasava (A.F.I.-I) 60
24. Usirasava (A.F.I.-I) 63
  Avaleha:  
  General Description 66
25. Dasamula Haritaki (A.F.I.-I) 67
26. Draksavaleha (A.F.I.-I) 71
27. Eladya Modaka (A.F.I.-I) 74
28. Madhusnuhi Rasayana (A.F.I.-I) 76
  Curna:  
  General Description 79
29. Bhaskaralavana Curna (A.F.I.-I) 80
30. Gomutra Haritaki (A.F.I.-I) 83
31. Jatiphaladya Curna (A.F.I.-I) 86
32. Narasimha Curna (A.F.I.-I) 88
  Ghrta:  
  General Description 90
33. Dadimadi Ghrta- A (A.F.I.-I) 92
  Dadimadi Ghrta- B (A.F.I.-I) 94
34. Indukanta Ghrta- A (A.F.I.-I) 96
  Indukanta Ghrta- B (A.F.I.-I) 99
35. Maha Triphaladya Ghrta (A.F.I.-I) 102
36. Tiktaka Ghrta- A (A.F.I.-I) 105
  Tikaka Ghrta- B (A.F.I.-I) 108
  Guggulu:  
  General Description 111
37. Goksuradi Guggulu (A.F.I.-I) 112
38. Kancanara Guggulu (A.F.I.-I) 115
39. Laksa Guggulu (A.F.I.-I) 117
40. Pancamrta Loha Guggulu (A.F.I.-II) 119
41. Pancatikta Guggulu Ghrta (A.F.I.-I) 121
42. Punarnava Guggulu (A.F.I.-II) 124
43. Saptavimsatika Guggulu (A.F.I.-I) 127
44. Simhanada Guggulu (A.F.I.-I) 130
45. Trayodasanga Guggulu (A.F.I.-I) 132
46. Triphala Guggulu (A.F.I.-I) 134
47. Vatari Guggulu (A.F.I.-I) 136
48. Vyosadi Guggulu (A.F.I.-I) 138
49. Yogaraja Guggulu (A.F.I.-I) 141
  Taila:  
  General Description 144
50. Sambukadya Taila (A.F.I.-II) 146
  Device:  
51. Ksarasutra 148
  Appendix-1. Apparatus for Tests & Assays 153
  1.1 Nessler Cylinders 153
  1.2. Sieves 153
  1.3 Thermometer 154
  1.4 Ultraviolet Lamps 154
  1.5 Volumetric Glassware 155
  1.6 Weights and Balances 155
  1.7 Muslim Cloth 155
  Appendix-2. Tests and Determinations 156
  2.1 Microscopic Identification 156
  2.2 Determination of Quantitative Data 159
  2.2.1 Net Content 159
  2.2.2 Foreign Matter 159
  2.2.3 Determination of Total Ash 160
  2.2.4 Determination of Acid-Insoluble Ash 160
  2.2.5 Determination of Water-Soluble Ash 160
  2.2.6 Determination of Sulphated Ash 160
  2.2.7 Determination of Alcohol-Soluble Extractive 160
  2.2.8 Determination of Water-Soluble Extractive 161
  2.2.9 Determination of Ether-Soluble Extractive (Fixed Oil Content) 161
  2.2.10 Determination of Moisture Content (Loss on Drying) 161
  2.2.11 Determination of Volatile Oil in Drugs 161
  2.2.12 Special Processes Used In Alkaloidal Assays 163
  2.2.13 Thin Layer Chromatography (TLC) 164
  2.2.14 Starch Estimation (Mont Gomery, 1957) 166
  2.2.15 Sugar Estimation (Mont Gomery, 1957) 167
  2.2.16 Fatty oil Estimation 167
  2.2.17 Protein Estimation (Lowry et al, 1951) 167
  2.2.18 Method for Alkaloid Estimation 167
  2.3 Limits Tests 168
  2.3.1 Limit Test for Arsenic 168
  2.3.2 Limit Test for Chlorides 173
  2.3.3 Limit Test for Heavy Metals 173
  2.3.4 Limit Test for Iron 176
  2.3.5 Limit Test for Lead 176
  2.3.6 Limit Test for Sulphates 178
  2.3.7 Heavy Metals by Atomic Absorption Sepectrophotometry 178
  2.4 Microbial Limit Tests 184
  2.4.1 Total Aerobic Microbial Count 193
  2.4.2 Tests for Specified Micro-organisms 195
  2.5 Pesticide Residues 200
  2.5.1 Qualitative and Quantitative Analysis of Pesticide Residues 201
  2.5.2 Test for Pesticides 203
  2.5.3 Quantitative Analysis 204
  2.6 Gas Chromatography 207
  2.7 Test for Aflatoxin 209
  2.8 Test for the absence of Methanol 211
  Appendic-3. Physical Tests and Determinations 212
  3.1 Refractive Index 212
  3.2 Weight per Milliliter and Specific Gravity 212
  3.3 Determination of pH Value 213
  3.4 Determination of Melting and Congealing Range 214
  3.4.1 Determination of Melting Range 214
  3.4.2 Determination of Congealing Range 216
  3.5 Determination of Boiling Range 217
  3.6 Determination of Optical Rotation 218
  3.7 Determination of Viscosity 220
  3.8 Determination of Total Solids 221
  3.9 Solubility in Water 221
  3.10 Determination of Saponification Value 221
  3.11 Determination of Iodine Value 222
  3.12 Determination of Acid Value 223
  3.13 Determination of Peroxide Value 223
  3.14 Determination of Unsaponifiable Matter 224
  3.15 Detection of Mineral Oil (Holde’s Test) 225
  3.16 Rancidity Test (Kreis Test) 225
  3.17 Determination of Alcohol Content 225
  Appendix-4. Reagents and Solution 230
  Appendic-5. Chemical Tests and Assays 263
  5.1.1 Estimation of Total Phenolics 263
  5.1.2 Estimation of Total Tannins 263
  5.1.3 Estimation of Sugars 264
  5.1.3.1 Nelson- Symogyi Photometric Method 264
  5.1.3.2 Reducing and Non-Reducing sugar 265
  5.1.4 Estimation of Curcumin by TLC Densitometer 266
  5.2.1 Determination of Aluminium 267
  5.2.2 Determination of Borax 268
  5.2.3 Determination of Calcium 268
  5.2.4 Determination of Copper 268
  5.2.5 Determination of Iron (Fe) 269
  5.2.6 Determination of Magnesium 270
  5.2.7 Determination of Mercury 270
  5.2.8 Determination of Silica (SiO2) 270
  5.2.9 Estimation of Sodium and Potassium by Flame Photometry 271
  5.2.10 Determination of Sodium chloride 271
  5.2.11 Determination of Sulphur 271
  5.2.12 Qualitative Reactions of Some Radicals 272
  Appendix-6. Ayurvedic Definitions and Methods 274
  6.1 Kalpana Paribhasa 274
  2.1.1 Kalka 274
  6.1.2 Kvatha/Kasaya 274
  6.1.3 Curna 274
  6.1.4 Putapaka Svarasa 274
  6.1.5 Svarasa 274
  6.1.6 Hima Kasaya 274
  6.2 Samanya Paribhasa 275
  6.2.1 Kajjali 275
  6.2.3 Ksara 275
  6.2.4 Curnodaka 275
  6.2.5 Praksepa 275
  6.2.6 Bhavana 276
  6.2.7. Sodhana 276
  6.2.7.1 Godanti Sodhana 276
  6.2.7.2 Gairika Sodhana 277
  6.2.7.3 Gandhaka Sodhana 277
  6.2.7.4 Guggulu Sodhana 277
  6.2.7.5 Tankana Sodhana 278
  6.2.7.6 Tuttha Sodhana 278
  6.2.7.7 Bhallataka Sodhana 278
  6.2.7.8 Manahsila Sodhana 278
  6.2.7.9 Vatsanabha Sodhana 278
  6.2.7.10 Silajatu Sodhana 279
  6.2.7.11 Haritala Sodhana 279
  6.2.7.12 Hingu Sodhana 279
  6.2.7.13 Vijaya Sodhana 279
  6.2.7.14 Kasisa Sodhana 280
  6.2.7.15 Parada Samanya Sodhana 280
  6.2.7.16 Astasamskara of Parada 280
  6.2.8. Murcchana 284
  6.2.8.1 Murcchana of Eranda Taila 284
  6.2.8.2 Murcchana of Ghrta 285
  6.2.8.3 Murcchana of Taila 286
  6.3 Yantra Paribhasa 287
  6.3.1 Khalva Yantra 287
  6.3.2 Tiryak patana Yantra 287
  6.3.3 Damaru Yantra 287
  6.3.4 Dola Yantra 287
  Appendix-7. Ksarsutra 288
  7.1 Method of Physical Test 288
  7.2 Method of Chemical Test 288
  Appendix-8. Weights and Measures 291
  8.1 Metric Equivalents of Classical Weights and Measures 291
  8.2 Metric System 292
  Appendix-9. Classical Ayurvedic References 293
  Appendix-10. List of Single Drugs used in Formulations, with Latin Nomenclature 316
  10.1 List of Single Drugs of Animal origin used of Formulations, with equivalent English name 316
  10.2 List of Single Drugs of metal/mineral origin used in Formulations, with equivalent English name 316
  10.3 List of Single Drugs of plant origin used in Formulation, with Latin Nomenclature 317
  Appendix-11. Bibliography 322

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The Ayurvedic Pharmacopoeia of India (Part-II, Volume-II) Formulations

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From the Jacket

UNSUB STARCHAT TO155223 The Ayurvedic Pharmacopoeia of India, Pt. II (Formulations) Vol. II is a legal document of standards for the quality of Ayurvedic formulations included therein (under the Drug and Cosmetic Act, 1940). This volume comprises 51 monographs on compound formulations. Each monograph contains the definition, formulation composition, indicating the official Ayurvedic name of the ingredient, equivalent scientific name, part/form used and their proportion in the formulation. This also includes method of preparation and description of the product. The identification of product includes microscopy of the ingredients, thin layer Chromatography (TLC) and Chemical tests. The Physico-chemical parameters contain loss of drying, total ash, acid insoluble ash, alcohol soluble extractive, water soluble extractive, pH etc. The indications, therapeutic uses and daily dose along with Anupana is also indicated in the monograph.

This volume is second publication in this series, wherein the pharmacopoeial standards of multiple ingredient formulations have been scientifically described. The standards have been consciously kept modest so that the implementation by the manufacturing companies becomes easily acceptable in order to maintain quality control and batch to batch uniformity. However, the efforts of the manufacturer should be to maintain higher standards of quality than described in this book.

The appendices of this volume contain the details of protocols used in the determination of various standards as well as methods of testing. References of the Ayurvedic literature in its original form are also added in order to authenticate the Ayurvedic standards, referred in each monograph. In the appendix, Ayurvedic definition and method of Sodhana etc. are also given. This book in general is more user friendly for the manufacturers, scientists and students, teachers involved in the standardization of Ayurvedic formulations.

This book is included in the first schedule of Drugs and Cosmetics Act, 1940. Manufacturers are required to follow pharmacopoeial standards and these are mandatory requirements under the Act. Users are welcome to give their suggestions on these monographs so that these suggestions are evaluated and followed in the forthcoming volumes of Ayurvedic Pharmacopoeia of India Part-Il (Formulations).

Introduction

The Ayurvedic system of medicine has been prevalent in India since the Vedic period, and still remains the mainstay of medical relief to over 60 per cent of the population of the nation. In earlier times the practitioners of Ayurveda (Vaidya) were themselves collecting herbs and other ingredients and preparing medicines. For the purpose of acquiring raw materials Vaidyas now depend on commercial organizations trading in crude herbal drugs. Likewise, with passage of time a number of Ayurvedic Pharmaceutical units have come up for the manufacture of Ayurvedic drugs and formulations on commercial scale.

Under the circumstances and responding to opinions of the scientific community after independence, the Govt. of India began a series of measures to introduce a quality control system, from 1964 onwards similar to that existing already under the Drugs and Cosmetics Act, 1940, for western medicine. The Government of India introduced an amendment in 1964 to the Drug and Cosmetics Act 1940, to control to a limited measure the Ayurvedic, Siddha and Unani drugs.

The Act was accordingly amended in 1964, to ensure only a limited control over the production and sale of Ayurvedic medicines namely:-
i. The manufacture should be carried out under prescribed hygienic conditions, under the supervision of a person having prescribed qualifications;
ii. The raw materials used in the preparation of drugs should be genuine and properly identified; and
iii. The formula or the true list of all the ingredients contained in the drugs should be displayed on the label of every container.

To start with, development of standards for the identity, purity and strength of single drugs and those of formulations at a later stage, assumed importance for the effective enforcement of the provision of the Act. If the raw materials to be used in a medicine and stage-by-stage processes of manufacturers are standardised, the final product namely, the compound formulation could be expected to conform to uniform standards. The requirement that the list of ingredients be displayed on the label will enable analysts to verify label claims. It will also ensure that the manufacture do not make false claim. Arrangements to evolve and lay down physical, chemical and biological standards, wherever even necessary, to identify the drugs and ascertain their quality and to detect adulterations are an urgent necessity of the profession. Setting up of Drug Standardisation Units, Research Centres, Drug Testing Institutes and Central Drug Laboratories for Ayurvedic Medicines both at national and regional level for this purpose are therefore, essential. The several Committees appointed by the Government of India to assess and evaluate the status and practice of Ayurvedic Medicine have stressed the importance of preparing an Ayurvedic Pharmacopoeia, which IS precisely a book of standards.

Foreword

With the growing popularity and demand of Ayurvedic Medicines in the country and abroad, availability of quality standards of Ayurvedic formulations has become a top priority for maintaining uniform, safe and quality medicines for the consumption of patients. Evolving Pharmacopoeial standards for Ayurveda, Siddha and Unani Medicine is essential for implementing the relevant provisions under the Drugs and Cosmetic Act, and Rules thereunder. The Ayurvedic Pharmacopoea Committee has been assigned the task of evolving Pharmacopoeial standards of the commonly used formulations in the country.

Bringing out the Pharmacopoeial standards of Ayurvedic formulations requires expertise of various disciplines like Ayurvedic P Pharmacognosy, Pharmacy, Phytochemistry and Pharmaceutical Chemistry. The present volume also contains standard manufacturing procedures including in-process standardization procedures, final product standardization with physico-chemical and chromatographic techniques. It is needless to say that the present volume is the result of untiring efforts of scientists from various laboratories and members of the Pharmacopoeia Committee.

I have no doubt that this publication on Compound. Formulations will provide required technical assistance for manufacturers, regulators, scientists, teachers, researchers and students. I place on record my appreciation for the members for Ayurvedic Pharmacopoeia Committee, Scientists working in various laboratories, Dr. S.K. Sharma, Adviser (Ayurveda), Department of Ayush, Dr. D.R. Lohar, Director, Pharmacopoeia Laboratory for Indian Medicine (PLIM) and his team and Dr. G.S. Lavekar, Director, Central Council for Research in Ayurveda & Siddha (CCRAS) and his team for bringing out this volume. My congratulations to Shri Shiv Basant, Joint Secretary, Department of Ayush whose overall coordination has made this enormous work possible.

 

Preface

In Ayurvedic Formulary of India Part I and Part II there are 636 formulations, out of these nearly 65 percent are solid dosage forms (Curna, Vati, Gutika etc.) about 20 percent are liquid preparations (Asva, Arista, Taila) and about 15 percent are semisolid (Avaleha, Ghrta, Lepa). Each of the formulations contains a number of ingredients, a few even going upto 75. It is observed that nearly 70 percent each of the liquid and semisolid preparations contain over ten ingredients. Since the spectrum of the tests which can be applied to liquids and semisolids for pharmacopoeial monographs are more limited than those available for solids, these preparation are particularly difficult to deal with. Considering the total 636 formulations about 50 percent contain over 10 ingredients. This means that in 318 monographs of solids, semisolids and liquids, standards and tests would involve an average of 25 ingredients in each this is really a complex and formidable task to accomplish. In addition to sheer volume, the unique processing methods used for manufacture, turn a simple mixture of single drugs into a very complex material from which separation and identification let alone estimation of components is no longer an easy and routine affair. It calls for complete knowledge of manufacturing complexities for a pharmaceutical - analytical chemist, for proper appreciation and interpretation of test results. At present, very few generalized quality parameters are adopted. Only a few Ayurvedic drug manufacturers may be having in house standard methods of preparations (SOPs) and quality parameters for finished compound formulations. But there exists no uniformity in the SOPs and quality parameters in the country. This results in lot of variability in quality of the same classical Ayurvedic formulation produced by different manufacturers. An effort has been made now to optimize and to develop uniform SOPs in order to ensure that such differences in quality of the same product produced by different manufacturers are not beyond permissible limits.

Under part I of Ayurvedic Pharmacopoeia of India (on single drug) so far six volumes have been published viz. Vol 1(80 monographs), Vol 11(78 monograph), Vol III (100 Monographs), Vol IV (68 monographs) and Vol V (92 monographs) and Vol VI (101 monographs) for Ayurvedic single drugs of plant origin, which go into one or more compound formulations included in the Ayurvedic Formulary of India, Part-I and Part-TI. The first volume of the Ayurvedic Pharmacopoeia of India, Part-TI published in 2007 contains official standards for 50 compound formulations selected from Ayurvedic Formulary of India, Part-I and Part-Il.

In continuation of the work of the quality standards of classical Ayurvedic compound formulations, the present Vol-IT of the Ayurvedic Pharmacopoeia of India, Part-IT contain official standards for compound formulations included in the Ayurvedic Formulary of India, Part-I and Part-Il.

The title of the monograph for each compound formulation is given in Sanskrit as mentioned in the Ayurvedic Formulary of India. This is followed by the Definition, Formulation Composition, Method of Preparation, a brief Description of the Formulation, Standards for Identity and Purity in so far as these are reflected by microscopy, chromatography (thin layer chromatography or gas liquid chromatography), Physicochemical parameters. Others requirements include limits for heavy metals and microbial load. Information on therapeutic uses, dose, mode of administration and storage is included. Each ingredient of the compound formulations complies with the standards prescribed in the Ayurvedic Pharmacopoeia of India. In a few cases, where pharmacopoeial standards for individual ingredient are not available, the collaborating institute develops standards for such an ingredient before using it in the formulation. The monograph for majority of the compound formulations provides Assay method for and range of limits of any one chemical constituent or group of chemical constituents.

The general notice provide guidance for the Ayurvedic drug manufacturers and analysts. Appendices given in the Pharmacopoeia include details of the apparatus/equipment, reagents, solutions used methods of tests employed and preparations of sample for microscopic examination.

The Ayurvedic Pharmacopoeial Committee hopes that the publication of Ayurvedic Pharmacopoeia of India, Part-Il (formulations) Vol-IT containing quality standards and method of preparation of compound formulation would serve to assist in the implementation of the Drugs and Cosmetic Act and Rules there under. It is also expected that such implementation would generate feedback information which is necessary compound formulations given in this Vol-IT of the Ayurvedic Pharmacopoeia of India, Part-Il.

The Ayurvedic Pharmacopoeial committee urges the Government of India to recommend the adoption of these monographs published in the Ayurvedic Pharmacopoeia of India, Part-II (formulations) — Vol II for the purpose of methods of preparations and quality standards of Ayurvedic compound formulation for use in their Government, Semi government, Government aided institutions and Voluntary public organizations. Ayurvedic Pharmacopoeia of India, Part-II (formulations) Vol-II may also be notified by the Government of India as a book of standards for implementation of Drugs and Cosmetic Act 1940 and Rules there under (as amended from time to time) all over India, just as the Ayurvedic Pharmacopoeia of India Part-I Vol-I, II, III, IV,V, VI and the Ayurvedic Pharmacopoeia of India, Part-TI (formulations), Vol-I have been included in the First Schedule of the Drugs and Cosmetic Act 1940.

 

Contents

 

  Legal Notices xiii
  General Notices xiv
  Preface xxv
  Introduction xxviii
  Monographs
Asava and Arista
 
  General Description 1
1. Abhayarista (A.F.I.-I) 2
2. Amrtarista (A.F.I.-I) 5
3. Aravindasava (A.F.I.-I) 8
4. Asokarista (A.F.I.-I) 10
5. Asvagandhadyarista (A.F.I.-I) 13
6. Babbularista (A.F.I.-II) 16
7. Balarista (A.F.I.-I) 19
8. Dasamularista (A.F.I.-I) 21
9. Draksarista (A.F.I.-I) 25
10. Draksasava (A.F.I.-II) 27
11. Jirakadyarista (A.F.I.-I) 29
12. Kanakasava (A.F.I.-I) 31
13. Khadirarista (A.F.I.-I) 33
14. Kumaryasava (B) (A.F.I.-I) 36
15. Kutajarista (A.F.I.-I) 39
16. Lohasava (A.F.I.-I) 42
17. Mustakarista (A.F.I.-I) 45
18. Parthadyarista (A.F.I.-I) 47
19. Pippalyadyasava (A.F.I.-I) 49
20. Punarnavadyarista (A.F.I.-II) 52
21. Punarnavasava (A.F.I.-I) 55
22. Rohitakarista (A.F.I.-I) 58
23. Sarivadyasava (A.F.I.-I) 60
24. Usirasava (A.F.I.-I) 63
  Avaleha:  
  General Description 66
25. Dasamula Haritaki (A.F.I.-I) 67
26. Draksavaleha (A.F.I.-I) 71
27. Eladya Modaka (A.F.I.-I) 74
28. Madhusnuhi Rasayana (A.F.I.-I) 76
  Curna:  
  General Description 79
29. Bhaskaralavana Curna (A.F.I.-I) 80
30. Gomutra Haritaki (A.F.I.-I) 83
31. Jatiphaladya Curna (A.F.I.-I) 86
32. Narasimha Curna (A.F.I.-I) 88
  Ghrta:  
  General Description 90
33. Dadimadi Ghrta- A (A.F.I.-I) 92
  Dadimadi Ghrta- B (A.F.I.-I) 94
34. Indukanta Ghrta- A (A.F.I.-I) 96
  Indukanta Ghrta- B (A.F.I.-I) 99
35. Maha Triphaladya Ghrta (A.F.I.-I) 102
36. Tiktaka Ghrta- A (A.F.I.-I) 105
  Tikaka Ghrta- B (A.F.I.-I) 108
  Guggulu:  
  General Description 111
37. Goksuradi Guggulu (A.F.I.-I) 112
38. Kancanara Guggulu (A.F.I.-I) 115
39. Laksa Guggulu (A.F.I.-I) 117
40. Pancamrta Loha Guggulu (A.F.I.-II) 119
41. Pancatikta Guggulu Ghrta (A.F.I.-I) 121
42. Punarnava Guggulu (A.F.I.-II) 124
43. Saptavimsatika Guggulu (A.F.I.-I) 127
44. Simhanada Guggulu (A.F.I.-I) 130
45. Trayodasanga Guggulu (A.F.I.-I) 132
46. Triphala Guggulu (A.F.I.-I) 134
47. Vatari Guggulu (A.F.I.-I) 136
48. Vyosadi Guggulu (A.F.I.-I) 138
49. Yogaraja Guggulu (A.F.I.-I) 141
  Taila:  
  General Description 144
50. Sambukadya Taila (A.F.I.-II) 146
  Device:  
51. Ksarasutra 148
  Appendix-1. Apparatus for Tests & Assays 153
  1.1 Nessler Cylinders 153
  1.2. Sieves 153
  1.3 Thermometer 154
  1.4 Ultraviolet Lamps 154
  1.5 Volumetric Glassware 155
  1.6 Weights and Balances 155
  1.7 Muslim Cloth 155
  Appendix-2. Tests and Determinations 156
  2.1 Microscopic Identification 156
  2.2 Determination of Quantitative Data 159
  2.2.1 Net Content 159
  2.2.2 Foreign Matter 159
  2.2.3 Determination of Total Ash 160
  2.2.4 Determination of Acid-Insoluble Ash 160
  2.2.5 Determination of Water-Soluble Ash 160
  2.2.6 Determination of Sulphated Ash 160
  2.2.7 Determination of Alcohol-Soluble Extractive 160
  2.2.8 Determination of Water-Soluble Extractive 161
  2.2.9 Determination of Ether-Soluble Extractive (Fixed Oil Content) 161
  2.2.10 Determination of Moisture Content (Loss on Drying) 161
  2.2.11 Determination of Volatile Oil in Drugs 161
  2.2.12 Special Processes Used In Alkaloidal Assays 163
  2.2.13 Thin Layer Chromatography (TLC) 164
  2.2.14 Starch Estimation (Mont Gomery, 1957) 166
  2.2.15 Sugar Estimation (Mont Gomery, 1957) 167
  2.2.16 Fatty oil Estimation 167
  2.2.17 Protein Estimation (Lowry et al, 1951) 167
  2.2.18 Method for Alkaloid Estimation 167
  2.3 Limits Tests 168
  2.3.1 Limit Test for Arsenic 168
  2.3.2 Limit Test for Chlorides 173
  2.3.3 Limit Test for Heavy Metals 173
  2.3.4 Limit Test for Iron 176
  2.3.5 Limit Test for Lead 176
  2.3.6 Limit Test for Sulphates 178
  2.3.7 Heavy Metals by Atomic Absorption Sepectrophotometry 178
  2.4 Microbial Limit Tests 184
  2.4.1 Total Aerobic Microbial Count 193
  2.4.2 Tests for Specified Micro-organisms 195
  2.5 Pesticide Residues 200
  2.5.1 Qualitative and Quantitative Analysis of Pesticide Residues 201
  2.5.2 Test for Pesticides 203
  2.5.3 Quantitative Analysis 204
  2.6 Gas Chromatography 207
  2.7 Test for Aflatoxin 209
  2.8 Test for the absence of Methanol 211
  Appendic-3. Physical Tests and Determinations 212
  3.1 Refractive Index 212
  3.2 Weight per Milliliter and Specific Gravity 212
  3.3 Determination of pH Value 213
  3.4 Determination of Melting and Congealing Range 214
  3.4.1 Determination of Melting Range 214
  3.4.2 Determination of Congealing Range 216
  3.5 Determination of Boiling Range 217
  3.6 Determination of Optical Rotation 218
  3.7 Determination of Viscosity 220
  3.8 Determination of Total Solids 221
  3.9 Solubility in Water 221
  3.10 Determination of Saponification Value 221
  3.11 Determination of Iodine Value 222
  3.12 Determination of Acid Value 223
  3.13 Determination of Peroxide Value 223
  3.14 Determination of Unsaponifiable Matter 224
  3.15 Detection of Mineral Oil (Holde’s Test) 225
  3.16 Rancidity Test (Kreis Test) 225
  3.17 Determination of Alcohol Content 225
  Appendix-4. Reagents and Solution 230
  Appendic-5. Chemical Tests and Assays 263
  5.1.1 Estimation of Total Phenolics 263
  5.1.2 Estimation of Total Tannins 263
  5.1.3 Estimation of Sugars 264
  5.1.3.1 Nelson- Symogyi Photometric Method 264
  5.1.3.2 Reducing and Non-Reducing sugar 265
  5.1.4 Estimation of Curcumin by TLC Densitometer 266
  5.2.1 Determination of Aluminium 267
  5.2.2 Determination of Borax 268
  5.2.3 Determination of Calcium 268
  5.2.4 Determination of Copper 268
  5.2.5 Determination of Iron (Fe) 269
  5.2.6 Determination of Magnesium 270
  5.2.7 Determination of Mercury 270
  5.2.8 Determination of Silica (SiO2) 270
  5.2.9 Estimation of Sodium and Potassium by Flame Photometry 271
  5.2.10 Determination of Sodium chloride 271
  5.2.11 Determination of Sulphur 271
  5.2.12 Qualitative Reactions of Some Radicals 272
  Appendix-6. Ayurvedic Definitions and Methods 274
  6.1 Kalpana Paribhasa 274
  2.1.1 Kalka 274
  6.1.2 Kvatha/Kasaya 274
  6.1.3 Curna 274
  6.1.4 Putapaka Svarasa 274
  6.1.5 Svarasa 274
  6.1.6 Hima Kasaya 274
  6.2 Samanya Paribhasa 275
  6.2.1 Kajjali 275
  6.2.3 Ksara 275
  6.2.4 Curnodaka 275
  6.2.5 Praksepa 275
  6.2.6 Bhavana 276
  6.2.7. Sodhana 276
  6.2.7.1 Godanti Sodhana 276
  6.2.7.2 Gairika Sodhana 277
  6.2.7.3 Gandhaka Sodhana 277
  6.2.7.4 Guggulu Sodhana 277
  6.2.7.5 Tankana Sodhana 278
  6.2.7.6 Tuttha Sodhana 278
  6.2.7.7 Bhallataka Sodhana 278
  6.2.7.8 Manahsila Sodhana 278
  6.2.7.9 Vatsanabha Sodhana 278
  6.2.7.10 Silajatu Sodhana 279
  6.2.7.11 Haritala Sodhana 279
  6.2.7.12 Hingu Sodhana 279
  6.2.7.13 Vijaya Sodhana 279
  6.2.7.14 Kasisa Sodhana 280
  6.2.7.15 Parada Samanya Sodhana 280
  6.2.7.16 Astasamskara of Parada 280
  6.2.8. Murcchana 284
  6.2.8.1 Murcchana of Eranda Taila 284
  6.2.8.2 Murcchana of Ghrta 285
  6.2.8.3 Murcchana of Taila 286
  6.3 Yantra Paribhasa 287
  6.3.1 Khalva Yantra 287
  6.3.2 Tiryak patana Yantra 287
  6.3.3 Damaru Yantra 287
  6.3.4 Dola Yantra 287
  Appendix-7. Ksarsutra 288
  7.1 Method of Physical Test 288
  7.2 Method of Chemical Test 288
  Appendix-8. Weights and Measures 291
  8.1 Metric Equivalents of Classical Weights and Measures 291
  8.2 Metric System 292
  Appendix-9. Classical Ayurvedic References 293
  Appendix-10. List of Single Drugs used in Formulations, with Latin Nomenclature 316
  10.1 List of Single Drugs of Animal origin used of Formulations, with equivalent English name 316
  10.2 List of Single Drugs of metal/mineral origin used in Formulations, with equivalent English name 316
  10.3 List of Single Drugs of plant origin used in Formulation, with Latin Nomenclature 317
  Appendix-11. Bibliography 322

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