– Sumit Goel.

PHARMACOPOEIA (Greek – pharmakon: drug; poies: to make) means a book, containing the formulae and methods of preparation of medicines used in the treatment of disease. A homoeopathic pharmacopoeia necessarily deals with descriptions and preparations of medicines used for treating patients homoeopathically.

It is the supreme authoritative book, published by an authority, government of any country that deals with the rules and regulations of standardization of drug substances. It contains directions for collection of drug substances from different sources, their preparation, preservation and standards that determine their strength and purity.

It is officially published by the authority of the government of a country or any medical or pharmaceutical association, constituted or authorized by the government. A pharmacopoeia published by an authority is termed as ‘official’ and one that is published by any person, other than an authority is ‘unofficial’.

The pharmacy of the older schools, on account of the complicated nature of its directions, has in all countries required the sanction of their official pharmacopoeias. These works vary essentially from each other not only in different states, but also in their different editions. This however does not apply to the simple and more scientific homoeopathic pharmacy. For this reason, one homoeopathic pharmacopoeia suffices for all countries. INDEED THERE OUGHT TO BE BUT ONE.

A standard pharmacopoeia enables the practitioner to rely with confidence upon remedies prepared everywhere in a proper and uniform manner and to place in his hands a trustworthy guide for this end. The object of the Homoeopathic Pharmacopoeia is to list remedies used in homoeopathic treatment and give adequate instructions as to their identity and preparation, aiming to give preference to preparations of the drug similar to those used in the original provings.

Since in homoeopathy, only one remedy is ever to be administered at a time, the homoeopathic pharmacopoeia, unlike that of the Old School, has nothing to do with complicated formulas and mixtures, but occupies itself exclusively with the preparation of simple medicinal substances. It must however take care that this is done in the most simple, direct, efficacious and precise manner. The efficacy can manifest itself only at the bedside and not by means of chemical tests or material agencies. This is the reason why homoeopathic practitioners were obliged to prepare their own remedies and make their preparation a matter of personal trust. It became impossible, in due course of time for the busy practitioner to prepare and dispense his own medicines, with the ever increasing number of remedies gaining entry into the Materia Medica. The pressure and force of circumstances made it necessary for the profession to come out with its own Pharmacopoeia.

HISTORY AND DEVELOPMENT OF HOMOEOPATHIC PHARMACOPOEIAS

The history of pharmacopoeias involves the history of pharmacy, for as pharmacopoeias evolved from crude handbooks to the present works of high scientific value, even so as the practice of homoeopathic pharmacy progressed from preparation of medicines by Hahnemann himself to the standardized medications produced on a large scale.

* Besides being a discoverer of a new system of therapy, Hahnemann was the pioneer of ‘Experimental Pharmacology’ as he was the first to ascertain the positive effects of drugs on healthy human beings. The fruits of his labour in the field of Pharmacology or Pharmacodynamics are preserved in

(a) Materia Medica Pura

(b) Chronic Diseases, Their Peculiar Nature And Their Homoeopathic Cure

Though he left no special book on pharmacopoeia, his scattered records served as the basis of the homoeopathic pharmacopoeias of the future.

* In 1805, Hahnemann published the results of his observations for fifteen years in his ”Fragmenta de Viribus Medicamentorum Positivis sive in sano corpore humano observatatis”. Between the years 1811 and 1833 were published his ”Materia Medica Pura” followed ” Chronic Diseases ”. In all of these publications, general and special instruction was given for the preparation of the remedies.

* 1825 : From records, Dr. Caspari (Leipzig, Germany) first published the first Dispensatory of Homoeopathic Pharmacopoeia.

* 1829 : Hartmann – Pharmacopoeia Homoeopathica

* * 1842 : Jahr – New Homoeopathic Pharmacopoeia and Posology, or the preparation of homoeopathic medicines and the administration of doses.

* 1870 : The first British Homoeopathic Pharmacopoeia was published by the British Homoeopathic Society, London.

* 1872 : Schwabe – Pharmacopoeia Homoeopathica Polyglottica.

* 1876 : United States Homoeopathic Pharmacopoeia – 1st edition

* 1882 : American Homoeopathic Pharmacopoeia – Compiled and by published by Boericke and Tafel, New York and Philadelphia

* 1884 : American Homoeopathic Dispensatory

* 1897 : Otis Clap & Son Inc. Agent, Boston, U.S.A. published the first Pharmacopoeia of the

American Institute of Homoeopathy, published for the Committee on Pharmacopoeia of the American Institute of Homoeopathy.

* 1898 – Pharmacopie Homoeopathique Francaise

* 1901 : 2nd edition of the Pharmacopoeia of the American Institute of Homoeopathy was published and the title changed to “Homoeopathic Pharmacopoeia of the United States”.

HOMOEOPATHIC PHARMACOPOEIA OF THE UNITED STATES (HPUS)

In 1882, the ‘American Homoeopathic Pharmacopoeia’ was compiled and published by Boericke and Tafel, New York and Philadelphia. Otis Clap & Son Inc. Agent, Boston, U.S.A. published the first Pharmacopoeia of the American Institute of Homoeopathy, published for the Committee on Pharmacopoeia of the American Institute of Homoeopathy in 1897. In 1901, a 2nd edition of the Pharmacopoeia of the American Institute of Homoeopathy was published and the title changed to “Homoeopathic Pharmacopoeia of the United States.

THE HOMOEOPATHIC PHARMACOPOEIA OF THE UNITED STATES is published under the direction of THE COMMITTEE ON PHARMACOPOEIA of the AMERICAN INSTITUTE OF HOMOEOPATHY. By the final passage (June 1938) of the Food, Drugs and Cosmetic Act (commonly known as the Pure Food Law), the Homoeopathic Pharmacopoeia of the United States became the sole authority in the United States for the preparation of all remedies claiming to be homoeopathic.

The provings of homoeopathic medicine are to reported to the Pharmacopoeia Committee of the American Institute of Homoeopathy when, if the provings appear to be adequate and the demand for the medicine by the pharmacists sufficient to warrant the manufacture and stocking of the medicine, it may be listed in the Homoeopathic Pharmacopoeia. New remedies are admitted to the Pharmacopoeia only after provings have been made and a sufficient demand has arisen to justify their insertion. A remedy is deleted from the Pharmacopoeia when there is no longer a sufficient demand for it to justify its preparation and retention in the pharmacies.

In reality, the HPUS has consisted of several different books:

* The HPUS, Eighth Edition, Volume I (1979);

* The Compendium of Homeotherapeutics (1974); and

* Supplement “A” of the HPUS Eighth Edition (1982).

To eliminate difficulties presented by this system, the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) decided to republish these texts into one compilation to be known as the Homoeopathic Pharmacopoeia of the United States Revision Service.

The Revision Service, appropriately updated, thus constitutes the official compendium of homeopathy. To be consistent with the Federal Food, Drug, and Cosmetic Act, the official name of the Revision Service is the “Homoeopathic Pharmacopoeia of the United States / Revision Service.” The official abbreviation is “HPRS.”

GERMAN HOMOEOPATHIC PHARMACOPOEIA (HAB)

Dr. Caspari of Leipzig, Germany published the first Homoeopathic Pharmacopoeia. He published a “Dispensatorium Homoeopathicum”, thereby giving the first idea of homoeopathic pharmacopoeias.

Dr. Willmar Schwabe founded the Homoeopathic Central Pharmacy to manufacture and sell homoeopathic medicines in 1866. He created precise standards for homoeopathic pharmaceutical production, which was published in 1872 as Pharmacopoeia Homoeopathica Polyglotta.

In 1880, the second edition (English edition) of this work was published. In 1929, the 2nd English edition was published. This was later revised and is known today as “Dr. Willmar Schwabe Homoeopathisches Arzneibuch” which was subsequently accepted as the official German Homoeopathic Pharmacopoeia (HAB). Today HAB serves as an international reference standard for homoeopathic medicines.

BRITISH HOMOEOPATHIC PHARMACOPOEIA (BHP)

The first British Homoeopathic Pharmacopoeia was published in 1870 by the British Homoeopathic Society, London. The second edition of the British Homoeopathic Pharmacopoeia was published in 1876. It is to be noted that the British Homoeopathic Pharmacopoeia is not an official Pharmacopoeia of U.K. – it is by virtue of its intrinsic merit and worth, that it is accepted by the homoeopathic profession of England and abroad.

M. BHATTACHARYA AND CO.’S HOMOEOPATHIC PHARMACOPOEIA

In India, M. Bhattacharya and Co. made the first attempt in this line by the publication of ‘Pharmaceutists Manual’ in 1892. It has run into many editions, the tenth one being published in 1944. A thoroughly revised and enlarged twelfth edition of it was published in July 1962 under the name of “M. Bhattacharya and Co.’s Homoeopathic Pharmacopoeia. The 14th edition was published in 1980. This work, though valuable is not officially recognized by the Government of India.

HOMOEOPATHIC PHARMACOPOEIA OF INDIA (H.P.I.)

(MINISTRY OF HEALTH AND FAMILY WELFARE, GOVERNMENT OF INDIA)

HPI is included in the Second Schedule of Drugs and Cosmetics Act 1940. The proposal to set up a Homoeopathic Pharmacopoeia Committee was initiated by the Homoeopathic Advisory Committee in the year 1956. The Government of India constituted the Homoeopathic Pharmacopoeia Committee in September 1962. The functions of the Committee were –

(i) To prepare a Pharmacopoeia of Homoeopathic drugs, whose therapeutic usefulness has been proved, on the lines of the American, German and British Pharmacopoeias;

(ii) To lay down principles and standards for the preparation of homoeopathic drugs;

(iii) To lay down tests for identity, quality and purity; and

(iv) Such other matters as are incidental and necessary for the preparation of a homoeopathic pharmacopoeia.

In the course of compiling the HPI, the Indian Pharmacopoeia, the American Homoeopathic Pharmacopoeia, the British Homoeopathic Pharmacopoeia, the Homoeopathic Pharmacopoeia of the United States and the German Homoeopathic Pharmacopoeia are consulted.

Worked out standards are released by the Ministry of Health and Family Welfare in the form of Homoeopathic Pharmacopoeia of India (HPI)

VARIOUS VOLUMES OF HPI

Volume I – 1971 – 180 drugs

Volume II – 1974 – 100 drugs

Volume III – 1978 – 105 drugs

Volume IV – 1984 – 107 drugs

Volume V – 1986 – 114 drugs

Volume VI – 1990 – 104 drugs

MONOGRAPHS

The general plan of pharmacopoeias is to lay down the direction for the selection and preparation of drugs that are thoroughly adapted to the purpose of homoeopathic prescribing. These directions and specifications for each drug are called ‘monographs’.

* The standards of purity and strength are stated in the MONOGRAPHS of the Pharmacopoeia and apply to articles that are intended for medicinal use, but not necessarily to articles that may be sold under the same name for other purposes.

* All statements contained in the monographs constitute standards for the official substances.

* The requirements are not framed to provide against all possible impurities.

A common format is generally employed to describe a drug.

The general pattern of monographs has the following features.

PLANT

1. Name of remedy with abbreviation

2. Botanical name

3. Family

4. Common names

5. Description

6. Part used

7. Macroscopical

8. Microscopical

9. Identification tests

10. Distribution

11. History and authority

12. Preparation

13. Storage

14. Caution

ANIMAL

1. Name with abbreviation

2. Zoological name

3. Family

4. Common name

5. Description

6. Part used

7. Microscopical

8. Distribution

9. History and authority

10. Preparation

11. Storage

12. Caution

CHEMICAL

1. Name with abbreviation

2. Symbol

3. Molecular weight

4. English name

5. Description

6. Identification

7. Reaction

8. Limit tests

9. Assay

10. History and authority

11. Preparation

12. Storage

13. Caution

NOSODE

1. Name with abbreviation

2. Microbiological name

3. History and authority

4. Biological distribution

5. Source of preparation of homoeopathic drugs

6. Description / Morphology of the organism

7. Cultural characteristics

8. Resistance and metabolism

9. Biochemical reactions

10. Preparation

11. Storage

12. Caution

* Description, identification tests, as well as method of assay for establishment of purity are furnished for drugs of chemical origin.

* The preparation of Homoeopathic mother tincture or substance follows immediately after details of the drug. Method of manufacture of chemical substances – unless specifically described in the monograph, a chemical substance may be prepared by any method provided the substance conforms to the pharmacopoeial standards.

The monograph contains details about

* Name of the drug / remedy

The titles of the monographs are given in conventional Latin names adopted by the homoeopathic profession. The name that is in common usage with the homoeopathic profession all over the world is used as the name of the monograph with its official abbreviation.

* Synonym

Regional name of the drug within and outside the country and the synonym of the original should be clearly indicated. The synonyms, in various languages, are those under which the drug is commonly known and these names cannot be considered to have the same significance as the main title.

* The official description

Under the heading ‘Description’, a complete morphological description for the purpose of identification of the drug is given. The morphological characters that can be easily distinguished and those characters that can differentiate the source amongst the various species or varieties of the same family should be mentioned categorically so that no confusion results while collecting the material. Though morphologically correct, the different developmental stages of the plant can alter the constituents of a particular specimen and therefore efforts should me made to fix the developmental stage as one of the parameters for collection. Standardization of source material is therefore very imperative. In HPI, a significant inclusion is seen. The identification characters are presented more elaborately, giving macroscopic and microscopic descriptions of the source material and parts employed in the preparation of mother tincture.

In case of drugs of chemical origin, description, identification tests, as well as method of assay for establishment of purity are incorporated.

* Part used

Under the heading ‘Parts used’, are given the substances that are to be employed as a unit of preparation. As far as possible, the original parts used in the preparation at the time of its proving should be included. Whether these are used in the fresh or the dried state should be stated. The season of collection and the age of the plant used are important.

* Identification

The tests described under this heading are provided only as an aid to identification. They are not in all cases sufficient to establish proof of identity.

* Distribution

Soil and environmental conditions in which the plant grows should be included.

* Authority and history

Full details of this point are essential. These should include the original literature relating to provings and their various references. The first prover is mentioned in the first place and the remaining authorities in alphabetical order.

* Preparation

The preparation of Homoeopathic mother tincture or substance follows immediately after details of the drug. Method of manufacture of chemical substances – unless specifically described in the monograph, a chemical substance may be prepared by any method provided the substance conforms to the pharmacopoeial standards.

* Storage

Different types of storage may have profound effect on the quality. Hence mentioned, if necessary.

HOMOEOPATHIC PHARMACY LITERATURE

* ESSAY ON A NEW PRINCIPLE FOR ASCERTAINING THE CURATIVE POWERS OF DRUGS 1796 – Hufeland’s Journal for Practising Physicians, Lesser Writings.

This was the first public announcement of the new principle of homoeopathy.

* FRAGMENTA DE VIRIBUS MEDICAMENTORUM POSITIVIS SIVE IN SANO CORPORE HUMANO OBSERVATIS – Leipzig, 2 parts – 1805

The first collection of Drug Provings on the healthy body. It contains pathogenesis of 27 drugs.

* THE LESSER WRITINGS – SAMUEL HAHNEMANN

It is necessary to study not only Hahnemann’s larger works – Organon of Medicine, Materia Medica Pura and Chronic Diseases, but also his miscellaneous medical writings that are collected in one volume, The Lesser Writings. One can trace here, the gradual and progressive development of the homoeopathic doctrine.

* ORGANON OF MEDICINE

1810 – 1ST EDITION

1819 – 2ND EDITION

1824 – 3RD EDITION

1829 – 4TH EDITION

1833 – 5TH EDITION

1921 – 6TH EDITION

* MATERIA MEDICA PURA

The word ‘Pura’ annexed to the title offers a challenge of purity to its counterpart of the traditional school. It consists of six volumes, two of which, viz. Vols. I and II had reached a third edition, while the remainder did not get beyond the second. This was translated from the latest German editions by Dudgeon, with annotations by Richard Hughes.

It contains the pathogenesis of drug substances, observed by experiments made by Hahnemann and other healthy disciples and colleagues, also giving directions as to their mode of preparation.

The dates of the publication of these volumes are as follows: –

1ST EDITION

Vol I – 1811

Vol II – 1816

Vol III – 1817

Vol IV – 1818

Vol V – 1819

Vol VI – 1821

2ND EDITION

Vol I – 1822

Vol II – 1824

Vol III – 1825

Vol IV – 1825

Vol V – 1826

Vol VI – 1827

3RD EDITION

Vol I – 1830

Vol II – 1833

* THE CHRONIC DISEASE – THEIR PECULIAR NATURE AND THEIR HOMOEOPATHIC CURE Translated from the second enlarged German edition of 1835 by Louis H. Tafel with annotations by Richard Hughes.

Vol I, II, III – 1828

Vol IV – 1830

2ND EDITION

Vol I, II – 1835

Vol III – 1837

Vol IV – 1838

Vol V – 1839

THE IDEAL OF ANY HOMOEOPATHIC PHARMACOPOEIA IS TO GIVE TO THE MANUFACTURER SPECIFIC DIRECTIONS WITH RESPECT TO IDENTIFICATION, COLLECTION, PREPARATION, PRESERVATION OF THE SOURCE MATERIAL AND THE FINISHED PRODUCT AND ENSURE TO THE PHYSICIAN THE AVAILABILITY OF A STANDARD DRUG MATERIAL.

SELF ASSESSMENT

* What is a Pharmacopoeia? Discuss the history and development of homoeopathic pharmacopoeias.

* Discuss various homoeopathic pharmacopoeias

* Discuss Homoeopathic Pharmacopoeia of India (HPI) / HPUS / HAB

* What is a Monograph. Discuss the format for describing monographs.

QUIZ

1. The first homoeopathic pharmacopoeia was published in

(a) 1805

(b) 1825

(c) 1870

(d) 1898

2. The Homoeopathic Pharmacopoeia Committee was constituted in the year

(a) 1940

(b) 1956

(c) 1962

(d) 1971

3. Monographs of drugs does not contain details about

(a) Description

(b) Preparation

(c) Identification

(d) Dynamic action

4. American Homoeopathic Pharmacopoeia was compiled and published by

(a) Boericke and Tafel

(b) Otis Clap and Son Inc. Agent

(c) Dr. Caspari

(d) Willmar Schwabe

5. The first volume of HPI was published in the year

(a) 1956

(b) 1961

(c) 1971

(d) 1974.

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