Experts call for scientific standard system of proprietary Chinese medicines
Experts call for scientific standard system of proprietary Chinese medicines
Proprietary Chinese medicines standards are an integral part of national drug standards. Proprietary pharmaceutical standards, including the State Food and Drug Administration issued "The People's Republic of China Pharmacopoeia", drug registration standards and other pharmaceutical standards. Bureau of Standards awarded other medicines, including proprietary standards, new drugs to positive standards, standards for imported natural medicines and medical institutions set prescription medicine preparation standards, medical standards of Chinese medicine preparations by the provincial food and Cheng Fang Drug Administration approval only approved medical institutions in the units and the rest by the State Food and Drug Administration approval in a nationwide circulation and use. In accordance with standard practice, product standards should be consistent. For proprietary, first of all, the expression should be consistent. In accordance with the "Drug Registration" provides pharmaceutical standards including quality indicators, test methods and production processes and other technical requirements.
Among them, the production process is a standard feature proprietary pharmaceuticals, chemicals are not standard production process requirements. However, imports of natural medicines and a significant number of proprietary Chinese standard does not require production process, even if the provisions of the production process, but also a considerable number of varieties of the production process can not perform. This is because the pharmaceutical companies are difficult to enforce because of the production equipment of different uniform rules, standards of drafting often developed according to their own production facilities process conditions, and other pharmaceutical companies with exactly the same hard, even for the drafting of standards for drug manufacturers, as Equipment changes, can hardly in accordance with the provisions of the original production process of implementing the standard. For example, for the most crowded pill pill production machine production, the amount of honey and traditional crafts are different; In addition, tablet, capsule, granule agent extraction equipment for different solid dosage forms, extract recovery rate is not the same according to the provisions of the production process by adding a fixed percentage of the accessories are made of different amount of traffic, difficult to achieve same piece heavy weight or heavy bags (granule) size, in fact, a number of proprietary tablets, capsules, pharmaceutical standard specification has been canceled provision, but still a considerable number of species retained specification items standard system appears to lack coordination. In addition, a considerable number of proprietary standards and no system of law, namely the production process. Most of these varieties and imported varieties for the exclusive production of varieties of natural medicines. Published proprietary production process has its historical reasons, mainly generic drugs are provided by standard technique of imitation, since the State Food and Drug Administration has changed the management of this wrong notion, to retain the significance worth studying. Of course, the appropriate standard in proprietary Chinese medicine describe the production process can be considered, such as providing solvent, well known Chinese medicine herbs are based mainly on the water boiling, from oral summary, if an exception may affect the potency (and Indication ), as different pharmaceutical manufacturers, or changes in equipment, it should be submitted on the application for registration in accordance with additional drugs, or even in accordance with the requirements of new drugs.
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