Monograph preparation for Homeopathic Pharmacopeia
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 substances that are intended for medicinal use, but not necessarily to substances 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 pattern of monographs has the following features:
A. Herb based preparations (Plant kingdom)
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
B. Animal and Animal products ( Animal kingdom)
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
C. Minerals and Chemicals
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
D. Disease products and Tissues (Nosodes)
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
E. Diseased products / tissues ( Sarcodes)
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 this heading, 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 be 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 this heading, 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 and therefore mentioned, if necessary.
