Have A National Standard Proprietary Research Ideas Discussed

BACKGROUNDTraditional Chinese medicine(TCM) imitation is becoming the hot spot of research and development field. The misunderstanding and diversity of TCM imitation is not helpful to ensure the quality of imitation medicine.OBJECTIVETo study the research thought of imitation of TCM to accord with the situation of China, and to promote the enhancement of Chinese prepared medicine which already have government standard.METHODSTake Yinhuang Tablets as model medicine. To discuss research ideas of imitation of TCM through the research and quality evaluation of different producers and different batches of self-made Yinhuang Tablets.(1)Research of imitation of Yinhuang Tablets: analysis on the basic marketing situation of Yinhuang Tablets according to government specification which relevant to imitation medicine, including the research of its technology, quality criteria stability;(2) The quality evaluation of Yinhuang Tablets: Via general quality comparison and research of vitro dissolution, to analysis the inherent quality of different producers and different batches of self-made Yinhuang Tablets; (3)Discussion the research idea of imitation of TCM: Start with imitating variety choosing and relevant laws and regulations, based on the new drug aspect and combine with imitation one's own characteristics, probe into research idea of imitation at the same time.RESULTS(l)Technology is studied, refer to original technology basically, improve film coating, and screen extraction and shaping technical parameter. The technology is feasible and stabilized through trial-produce of 3 batches of big production. Quality standard is improved on the base of original criteria, and have increased honeysuckle, scutellaria TLC identification and HPLC assaying method. Through kept sample common temperature investigation and accelerated test investigation, validity may tentatively decide for 2 years;(2) Through general quality test and analysis of dissolution, Yinhuang Tablets of different manufacturers have great difference in disintegration and content of active ingredient, dissolution rate also have very significant difference. And self-made Yinhuang Tablets quality synthesize appraisement is better than other manufacturers;(3)Imitation medicine need demonstration before go on the market which should the same with new drug. But it is more or less have research foundation, which have the homogeneity of identical variety objectively, but imitation drug is not same as imitated drug, which have different source after allthey have individual source.CONCLUSIONSFrom new drug aspect, confirmation correctly, we should use reasonably finished research foundation, verify, revise, replenish and enhance and on this foundation according to specific kind, which is the important thought way of ensuring imitation medicine quality.