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STANDARDIZATION OF HERBAL MEDICINES/PRODUCTS:
PREAMBLE:
Herbal medicine is the most primitive traditional approach to the treatment of diseases and ailments. It is called herbal medicine because it involves the use of plants or plant parts. There is no doubt that herbal medicines provided the first basis for therapeutics before the development or advent of orthodox medicine. Despite the fact that, over the years, chemists have synthesized a large number of chemical substances, many of which have proved useful in modern therapeutics, plants still remain potential sources of useful products. Although the medicine prescribed may contain only one single active item, it is often a mixture of many components. Thousands of herbal medicines are used by peoples from every culture and various indigenous medicines are gradually being introduced into modern therapeutics. In developing countries about 80% of the people, especially the rural population, rely on traditional medical remedies for their health care needs. In developed countries, there has been a resurgence of interest in herbal medicines due, to a large extent, on the preference of many consumers for products of natural origin. In addition, manufactured herbal medicines from their countries of origin often follow in the wake of migrants from countries where traditional medicines play an important role. It is important however, to distinguish between herbal medicine supplied by a “qualified” medical practitioner as a result of a consultation and those herbal remedies (in the form of “teas”) freely available to the public for self-medication. DEFINITION:
According to the World Health Organization (WHO), herbal medicines should be regarded as “finished, labelled medicinal products that contain as active ingredients aerial or underground parts of plants or other plant materials or combinations thereof, whether in the crude state or as plant preparations. Plant material includes juices, gums, fatty oils, essential oils and any other substances of this nature. Herbal medicines may contain excipients in addition to the active ingredients. In some countries, herbal medicines may also contain, by tradition, natural organic or inorganic active ingredients which are not of plant origin.Medicines containing plant materials combined with chemically defined active substances including chemically defined isolated constituents of plants are not considered to be herbal medicines”. Problems associated with herbal medicines:
One of the major criticisms levelled against herbal medicines is that they are neither standardized nor are they dispensed to patients in specified doses or in strictly regulated quantities. However it is becoming increasingly clear that the standardization of herbal medicine entails much more than just specifying the amount of the medicine to be taken by the patient. It is also important that every stage of the production process should be standardized.Prior to the current availability of mass- marketed herbal medicines and dietary supplements, herbalists and patients prepared their own herbal medicines. Often the herbal ingredients were grown and obtained locally and compounded by hand into a particular formula or concocted into a simple infusion or decoction. Each product was therefore a unique formulation (because different individuals of the same plant species, grow...