Homoeopathic Pharmacy-Standardisation of Drug Mother Tincture [Standardisation]:

by K. P. Muzumdar.

Hahnemann enunciated a new principle of therapeutics in his revolutionary article, Essay on a New Principle for Ascertaining the Curative Powers of Drugs, and Some Examinations of the Previous Principles (1796). He was a genius of his times. He was a chemist, pharmacologist, pharmacist and physician. The fruits of his labours in the field of pharmacology or pharmacodynamics are preserved in the monumental volumes of Materia Medica Pura and The Chronic Diseases, their peculiar nature and their homoeopathic cure. He was the first to ascertain the positive effects of potentised drugs on healthy human subjects and to utilize this knowledge in the treatment of diseases. This process of the testing of drugs he called Provings. There is no record of any systematized book giving the method of preparation of these drugs used in his provings. However, he did incorporate some notes on the pharmaceutical procedures in the above-mentioned books in his provings and relevant aphorisms of Organon of Medicine.

Dr. C. Caspari of Leipzig published in 1825 the first Dispensatory containing therein the methods of preparation of drugs. Thereafter Hartmann, La Raja, Widemann, Quin, Winkler, Buchner, Jahr, Gruner, Schimdt, Hamilton and others contributed their mite. The British Homoeopathic Pharmacopoeia (BHP) was first published by the British Homoeopathic Society, London, in 1870. Dr. Wilmar Schwabe a German Homoeopathic Pharmacist, published the Pharmacopoeia Homoeopathica Poliglotta in 1872. It was rendered into English by Suss Hahnemann. The first edition of the Homoeopathic Pharmacopoeia of the United States was published in 1876. Wilmar Schwabe's English edition of Pharmacopoeia Homoeopathica Polyglotta, translated by Stephen, was published in 1880. The third edition of BHP was published in 1882. The American Homoeopathic Pharmacopoeia, compiled by Boericke and Tafel, was published in the same year. Its second edition was published in 1891. The second edition of the English rendering of the German Polyglotta was published in 1929. The current edition of the Homoeopathic Pharmacopoeia of the United States - 7th edition, revised (1964) is widely used by the homoeopathists. The third edition of the German Homoeopathic Pharmacopoeia, 1958, (HAB) is current and is accepted by the Universities, Research Institutes and Pharmaceutical Industry in Germany. A proposal for a new homoeopathic pharmacopoeia (DAB) is- under review of their Government for recognition. It runs into eleven volumes. In India the Government of India constituted a Committee to bring out the Homoeopathic Pharmacopoeia of India. The first volume of the Homoeopathic Pharmacopoeia of India, comprising of 180 drugs was published in 1971; the second volume comprising of 100 drugs was published in 1973; the third volume comprising of 105 drugs was published in 1978; the fourth volume comprising of 107 drugs was published in 1983; the work on the publication of the fifth volume is in progress. In the meantime, volume one and volume two were revised in 1984 and their second editions were brought out.

Out of all these Pharmacopoeias only the Homoeopathic Pharmacopoeia of the United States of America is widely accepted by the Homoeopathic Pharmacists.

Over two thousand drugs are mentioned in the homoeopathic materia medica. Many of these are fully or partially proved. Quite a few, however, are used empirically in practice. All these are not included in the pharmacopoeias. The HPUS describes only 690 drugs in the original text, and 44 in its Appendix. About 250 of them are derived from the mineral source, and the rest of them are from the plant, animal or biological sources. Significant enough is the absence of nosodes; their procurement, their source, their mode of preparation, their storage - all these remain a mystery. However, HPI is making efforts to determine its standard.

The general plan of these pharmacopoeias is to lay down the direction for the selection and preparation of drugs which are thoroughly adapted to the purpose of homoeopathic prescribing. Most of the drugs from the chemical sources have been employed in a pure form. A few, like Calcarea Ostrearum and Hepar Sulphuris Calcareum, have been employed according to the original directions laid down by Hahnemann. It is, however, surprising that we do not know the exact purity standards of these, as used then for the purpose of proving.

A common format has been employed to describe a drug. Under the heading, "Description", a morphological description for the purpose of identification of the drug is given. Under the heading, "Parts used", are given the dried substances which have been employed as a unit of preparation. Indigenous plants are used in their fresh state, and the mother tincture is prepared after ascertaining the moisture content. General instructions (HPI) indicate the method of procuring the plant or animal substance in their fresh state. In the case of the lower potencies of poisonous substances, their permissible dosages, and their mode of storage have been described.

In the Homoeopathic Pharmacopoeia of India (HPI) a significant inclusion is seen. The identification characters have been presented more elaborately, giving macroscopic and microscopic descriptions of the source material and parts employed in the preparation of mother tincture. It also gives the New Modern Method described in the American Pharmacopoeia. In the second volume Hahnemannian Method appears to have been omitted. It is presumed that the Hahnemannian Method of preparation has been omitted as it deals with fresh preparations, and the species specified in the monograph are not available in India and hence cannot be prepared in the fresh state. There is a provision for the periodic revisions to keep the publication upto-date and to present it as a standard work of reference for the pharmacist.

The German Homoeopathic Pharmacopoeia (DAB) has many innovations. The mother tinctures are prepared in accordance with the Hahnemannian directions. They have laid more stress on the finished product. They have accepted Mother Tincture as the final preparation and more chemical tests of a general character are employed to standardize the preparation. The mother tinctures are subjected to analytical tests such as capillary analysis and paper chromatographic analysis. The important physical constituents are described. The characteristic colour reaction tests of mother tincture for specific chemical compounds are given.

The ideal of any homoeopathic pharmacopoeia is to give to the manufacturer specific directions with respect to collection, identification, preparation and preservation of the source material and the finished product, and ensure to the physician the availability of a standard drug material.

Effects of homoeopathic drugs are qualitative and not quantitative. Hahnemannian provings are the only means to obtain these qualitative effects. In order to obtain reproduceable effects at all times, source material of uniform quality is essential. When we study relevant homoeopathic literature critically, we find discrepancies as indicated in the table :

Name of the HAB HPUS Hering Pharmacodynamics Remedy Guiding (Hughes) Symptoms

Anacardium Ripe Resinous

Orient fruits juice from the fruit

Arnica Drug Fresh Fresh plant or Mont. roots plant with dried flower. roots Roots,according to Hering.

Avena Fresh Fresh Sativa blooming seeds plant

Asarum Fresh Fresh

Europium root plant with Entire Plant roots

Chelidonium Fresh Fresh Fresh Majus roots plant root or Fresh Plant collected and fresh before root plant blooming

Croton Tig Ripe Oil from From From Seeds seeds the seeds oil

Carduus Ripe Blooming Whole Equal parts of Mar. Seeds plant or plant root and seeds seeds with shell on.

The morphological characters which can be easily distinguished and those characters, which can differentiate the source amongst the various species or varieties of the same families, 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. The variations in the sources may look apparently very trivial, but they indicate lack of serious scientific thinking. Standardisation of source material is, therefore, very imperative.

It may be quite possible that the medicinal properties of different parts of the plant substances may vary in quantity, with the result that the reactive responses which form the basis of our materia medica may bring out serious qualitative discrepancies. In order to retain the original spirit and the effect of the provings, the identity of the original substances used in the provings must be established. If there is any doubt in coming to a conclusion, it will be necessary to conduct a fresh proving, after standardising the drug substance.

Hahnemann classified the drug material into nine classes. The first four classes are related to the vegetable substances. Classes five and six represent drugs from the chemical source. In class seven substances requiring trituration are described, and in class eight he describes triturations of tinctures. Class nine is related to those fresh vegetable and animal sources which need trituration. His classification was based on the quantity of extractable juice. In the first class he describes the most juicy plants; the second class denotes juicy plants; the third class denotes the least juicy plants; and the fourth class denotes dry plants or those plants whose juices are difficult to extract. He gives a few names of the plants and animals which he has included under each class. The drug strength of these classes is different. It is 1/2, 1/2, 1/6 and 1/10 respectively. There does not appear any rationale for denoting these drug strengths; if one studies their preparation in respect to the ratio of solvents to solute, it sounds most arbitrary. The lack of uniformity in drug strength was due to the different degrees of solvency of different kinds of constituents present in the drug substances in alcohol or water, and the varying quantities of plant moisture in different varieties of plants. Realizing this difficulty the compilers of BHP prepared six tables of dispensing alcohol, mentioning the quantity with an idea of standardising the preparations. Unfortunately, after the third edition, the BHP was not published. AHP in 1888 picked up the idea and introduced the method of calculating the plant moisture before arriving at the quantity of the solvent. AHP claimed that the plant moisture is only a solvent, but Hahnemann claimed the same as part of the drug substance. Probably he felt that without the necessary moisture, the constituent may not remain in the soluble state in the given preparation. So moisture was an important integral component of the contents. Without this moisture, hydrogen ion concentration would change and constituents may vary.

Except in class one, he adds twice the quantity of alcohol to the weight of the extracted juice of the plant material. In the other two classes he adds alcohol in proportion to 1/2 and 1/6 by weight of the material, and in the fourth class he adds alcohol ten times the weight and calls it 1/10. Calling it "drug strength" is arbitrary. What is important is not the quantity of the drug substance but the correct mosaic of the various constituents present in it. It is immaterial then if they are known by 1/2, 1/6, or 1/10 in terms of quantity. This appears rational since the drug action is qualitative and not quantitative.

We cannot expect an absolute conformity of these mother tinctures of plant and animal substances, because these substances themselves vary considerably according to the conditions of life. But to minimise the divergence in their standard at least a uniform method of preparation should be followed. As long as we fail to demonstrate through our provings and clinical results that alterations in the method of preparation are improvements on the original, we may not be justified in making a change, and we should stick to the original directions.

However, at present mother tinctures that are prepared are in accordance with the modern method described in the HPUS. How far these mother tinctures compare with the preparations employed in their original proving is to be seen. The mosaic of the various constituents is important, and is controlled by the genetic make- up of the species concerned. This mosaic is responsible for the quality of its action.

Although Aconite Napellus, A. Ferox, A. Falconari are of the same genus, their proving symptoms show a wide difference, thereby leading us to assume that the drug picture is dependent on the subtle differences between the characteristic mosaics of the different species.

HAB, DAB, and HPI, therefore, did recognize this method of preparation of mother tinctures, but for the reason mentioned earlier, they have deleted it from the second volume.

Hahnemann advocated maceration as a method of preparation of mother tinctures. The American Pharmacopoeia suggests percolation method in addition to the maceration method. Since the quality of the mother tincture in terms of its constituents hardly appears to alter, the method may not be objected to. This is certainly a quicker method of procuring the mother tincture. It is more useful particularly when the drug substance is dry, gummy and mucilagenous.

Hahnemann has given clear instructions with respect to the preparation of potencies upto 30c. He has instructed us to use a new vial every time. However, the HPUS directs that, to avoid any confusion, only one vial marked with two markings - the lower one for the drug substance, and the upper one for the vehicle - shall be employed. These are the "one bottle" potencies. There is the influence of absorption on the wall of the bottle. In addition to this, it states that while preparing the third potency, one part of the second potency be taken up to the mark, ten strokes be given, nine parts of vehicle be added and this be shaken - the third potency is ready. These are contrary to the instructions given by Hahnemann. In this regard Jenichen, Korsikoff, Skinner and the manufacturing chemists of modern times are alike. All these high potencies are manufactured by automatic machines. Unfortunately the exact mode of preparation of these high potencies is not known, nor are there any directions governing their preparation mentioned in the pharmacopoeias. The Ciphers 1m, 10m, 50m, Cm, Mm, are mere denominations without an exact meaning.

It is reported that the Laboratories Homoeopathiques de France have developed an automatic dynamizing machine, of which they have given an exact description and function. This machine takes twelve hours running to produce 5ml of 1m potency. In fact the free availability of such machines, and their use by the homoeopathists is highly desirable from the standardisation point of view.

Uniformity should also be maintained in the nomenclature of the potencies. In Germany and in France, the decimal potency is denoted by suffixing `D', whereas other countries note it as `X'. This often causes confusion.

The procedure of potentisation itself has caused a great controversy in determining the scientificity of Homoeopathy. We should not add further confusion to it.

It is high time that the homoeopathic pharmaceutical industry should make the necessary effort to establish their manufacturing units. Similarly, pharmacopoeias should establish a uniform method to make them truly international in character.

STANDARDIZED PHARMACOPOEIA :

The quality of the homoeopathic drug is determined by the characteristic mosaic of the chemical constituents present in the plant or in the animal species concerned. Any deviation from the characteristic mosaic will be considered as sub-standard, as compared to the one which was used in the original proving.

This characteristic mosaic of a particular drug is likely to be affected by various factors such as : genotype of the species, soil, and the environmental conditions in which the species is grown, method of cultivation and other cultural practices, time of collection, age of the plant, or of the part used.

In determining the standard of the drug the following points should be considered :-

1. Name of the drug/remedy : The name which is in common usage with the homoeopathic profession all over the world shall be used as the name of the monograph.

2. Synonym : Regional name of the drug within and outside the country, and the synonym of the original, should be clearly indicated. The whole information may be included in the appendix.

3. Description : Complete morphological characters of the source which will help identification and will ensure the correct original species should be mentioned. Karyotype studies should be done wherever possible. Microscopic characters of the parts used in the preparation of the remedy will help detect the adulterants. In the case of chemicals special purity tests should be incorporated except in cases where no special instructions are given.

4. Parts Used : 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, since different parts of the same source in fresh or dry state may differ in their chemical mosaic. The season of collection and the age of the whole plant used are important, as the variation n these may alter the mosaic; and, therefore, one should stick to the instruction already mentioned in the pharmacopoeias.

5. Distribution : Soil and the environmental condition in which the plant grows influences the mosaic of the species, and, therefore, this information should be included.

6. Methods of cultivation & other cultural practices.

7. Authority and History : Full details of this point are essential. These should include the original literature relating to provings and their various references.

8. Storage : Different types of storage may have profound effect on the quality of the mosaic. A uniform method should, therefore, be adopted.

9. Preparation : Hahnemann's basis of classification sounds rational, but the method adopted in each class and denoting its strength is not consistent. It would be unjustified at this stage to discard the Hahnemannian method and to adopt modern methods without establishing the fact that it does not materially affect the original composition of the final product. The actions of the homoeopathic remedy are of qualitative nature. Efforts to extract the maximum quantity of the various constituents by using different concentrates of solvents are not necessary. Whatever is extractable in the natural preparation of the solvent and the moisture content should be accepted. In order to adopt a uniform method of preparation, the proportion of alcohol can be taken within a fixed range by calculating the moisture content of the plant concerned, as mentioned in the AHP. The contents thus obtained should not be described in terms of "drug strength" as termed today. The term "drug strength" shall be ascribed only when the quality of the tincture is equated with the quantum of action.

These mother tinctures are alcoholic extracts in a fluid state, containing the various organic and inorganic constituents in a soluble state. The quality of the drugs in terms of their action is determined by the presence of these constituents.

To assess the quality of this mother tincture all known and available methods to detect different constituents of the mosaic should be utilized so that no partners of the mosaic remain undetected.

In order to achieve this some limitations on the concentration of the constituents present should be imposed, so that the dilution of the mother tincture beyond unit may not result in failure of detection of any partner of the mosaic.

Physical Constants :

Colour, odour, sedimentation.

Specific gravity, viscocity, optical rotation. Refractive index.

Behaviour towards UV light. Solid contents. Ash values.

Thin Layer Chromatogram :

Rf values. Behaviour of these spots to UV light. quantitative estimation of these spots.

Chemical Reaction of the Tincture :

Capillary Picture of the Tincture :

Behaviour to UV light of all the zones.

Behaviour to ordinary daylight.

All the natural products have wide variations and, therefore, while fixing the limit care should be taken to analyze varieties of samples and only then the limiting figures should be arrived at. The ultimate standard would be the one which closely resembles in quality to the original mosaic used at the time of the proving.

CONCLUSION :

A review of the available literature on the pharmaceutical aspect of homoeopathy shows clearly that much is yet to be understood and lot is yet to be done to make the scientificity of homoeopathy reliable.

Hahnemann's original procedure should be followed as far as possible. If any change is to be made, the new drug preparation should be standardized and reproving conducted.

A Pharmacopoeia must have uniform contents. The authoritative procedures of collection, preservation, preparation and its analysis to determine its content must be clearly indicated. The analytical test suggested for confirmation should be simple and easily producible, without involvement of much cost for the manufacturer.

Preparation of potencies should be explained and standardized.

Nosodes and Sarcodes should be incorporated.

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