我国中药饮片GMP实施现状及对策探讨

Investigation on the Present Situation and Countermeasures of the Implementation of Chinese Herbal Medicine GMP

目的:为加强我国中药饮片的规范化生产提供建议。方法:通过对2013年9月至2014年9月我国被注销及收回的《药品生产质量管理规范》(GMP)证书的初步统计,分析中药饮片生产成为GMP实施中"重灾区"的原因。结果与结论:2013年9月至2014年9月,我国共有44家中药饮片生产企业的GMP证书被收回,其中1家被注销。从企业角度讲,检验工作困难、原料来源难控制是主要难题,可通过道地药材就近加工、规范上游产业链生产的办法加以解决;从政府角度讲,中药饮片质量标准不完善、GMP规定不能完全适用于中药饮片生产是问题所在。只有实行批准文号管理、完善中药饮片GMP规范体系,才能生产出既符合国情、又继承传统的中药饮片。

OBJECTIVE：To provide suggestions for standardized production of Chinese herbal medicine（CHM）in our country. METHODS：According to the preliminary statistics of Good Manufacturing Practices（GMP）certificates which had been cancelled and repossessed between Sept. 2013 and Sept. 2014 in our country,the reasons of CHM production becoming a serious part in GMP implementation were analyzed. RESULTS CONCLUSIONS：There were totally 44 CHM enterprises GMP certificates were repossessed from Sept. 2013 to Sept 2014,and one of those was cancelled. From the perspective of enterprise,hard inspection work and raw material source control are the major problems. It can be solved by authentic ingredients nearest processing and standardization of upstream industry chain production. From the perspective of government,not perfect quality standard of CHM and not fully application of GMP on CHM production are the problems. The CHM with national conditions and transmissions of traditions can be produced only with the implementation of approval number management and the improvement of CHM GMP standardization system.