Substances of Plant Origin in Homeopathic Pharmacy: Methodology of Quality Standard Formulation

Abstract

Put into effect, the “Standards of Drug Quality. Main Stipulations” OST 91500.05.001-00 determined the general order in the development, formulation, presentation, expertise, coordination, validation, and denotation of the standards of drug quality and gave the main rules for constructing such standards. Section XIV of this document refers to the structure and formulation of quality standards for homeopathic preparations in various medicinal forms for injection, internal and external administration, including suppositories, ointments, tablets, capsules, and granules. However, no rules are given concerning the structure and formulation of the quality standards for initial substances of plant origin (homeopathic tinctures), as well as of mineral and animal origin, used for further processing into various homeopathic products. There is a stable increase, in the pharmaceutical market, of homeopathic preparations, as manifested by the growing number of registered homeopathic drugs, the development of pharmacopoeial articles for the manufacture of homeopathic tinctures, and the formation of the corresponding database. This requires developing rules governing principles of the structure and formulation of quality standards. At the same time, such work will facilitate the generalization of experience, which is necessary for preparing the first edition of the Russian Homeopathic Pharmacopoeia. Analysis of the state of the art in this field in some foreign countries [1], where the homeopathic method was recognized much earlier than in Russia, shows that the main and the only document determining the quality of parent substances is the collection of general and partial articles (monographs) in the homeopathic pharmacopoeia. Such pharmacopoeias exist in Germany, Great Britain, India, and USA. In France, the 10th edition of the State Pharmacopoeia includes articles for substances used in homeopathy. Articles of the German homeopathic pharmacopoeia [2] include sections determining the quality of the initial raw materials used for preparing tinctures and sections describing tests and criteria for evaluating the quality of the final tinctures. Each article (monograph) is organized as follows.