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中成药生产领域中,名贵中成药中的原料药检测难度很大,为使名贵的中成药质量得到保证,发表以下几点看法。一、保证名贵中成药质量的几点措施 1.科技领域应加强研究中成药中的名贵等细料药材鉴别质控。 2.在制定药品生产标准和药品生产报批中,审核部门要注意强调制定药品鉴别指标,必要时还要强调制定有效成份的定量测定。 3.生产厂家必须严格执行《药品管理法》和G.M.P。 4.在没有全面形成质控的时候,药政、药检部
In the field of Chinese patent medicine production, it is difficult to detect the raw material drugs in expensive proprietary Chinese medicines. In order to ensure the quality of valuable Chinese patent medicines, the following points are expressed. First, to ensure that the quality of expensive Chinese medicines a number of measures 1. The field of science and technology should strengthen the study of proprietary Chinese medicines and other valuables to identify quality control. 2. In the formulation of drug production standards and approval of drug production, the audit department should pay attention to the formulation of drug identification indicators, and if necessary, emphasize the formulation of quantitative determination of effective ingredients. 3. The manufacturer must strictly implement the “Drug Administration Law” and G.M.P. 4. In the absence of a full-scale quality control, the Pharmaceutical and Chemical Inspection Department