通过对我国已上市中成药药学方面存在的问题进行讨论,对目前中成药再评价存在的问题进行分析,提出了基于中成药工艺与质量控制的中成药再评价模式,该方法是先对已上市中成药工艺合理性、质量标准可控性及产品真实质量稳定性方面存在的问题进行再评价,对明显不合理的品种进行淘汰处理,再对药学方面合理的品种进行药效和临床疗效再评价。该模式可以推动和加速我国上市后中成药的再评价工作,促进中成药产业健康发展。

To provide the reevaluation model of Chinese patent medicines (CPM) in preparation condition and quality standard through the comprehensive analyses on the present problems of CPM on market in China. We explored the Methods and models for the reevaluation of the rationality, controllability, and reliability of CPM based on preparation condition, quality standard, and products. The unreasonable and undesirable varieties of CPM will be eliminated, while the reasonable and desirable varieties will be further studied on pharmacokinetic and pharmacodynamic reevaluation. The model could be beneficial for promoting the CPM reevaluation on market and accelerating the aggressive program in CPM industry in China.