中成药质量标准研究有关问题思考  

Considerations on investigation on quality standard of Chinese patent medicine

作　　者：聂黎行[1] 吴炎培 刘静[1] 胡晓茹[1] 何风艳[1] 王亚丹[1] 汪祺[1] 于健东[1] 戴忠[1] 魏锋[1] 马双成[1] NIE Li-xing;WU Yan-pei;LIU Jing;HU Xiao-ru;HE Feng-yan;WANG Ya-dan;WANG Qi;YU Jian-dong;DAI Zhong;WEI Feng;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药学学报》2023年第8期2260-2270,共11页Acta Pharmaceutica Sinica

基　　金：国家十三五“重大新药创制”专项(2018ZX09735006);中国食品药品检定研究院关键技术研究基金资助项目(GJJS-2022-7-1)。

摘　　要：中成药是中医药的重要组成部分,其质量直接影响临床用药的安全性和有效性。中成药质量标准是保证中成药质量的重要措施。中成药物质基础复杂,质量影响因素众多,活性成分、量效关系、作用机制有待阐明,因而其标准研究难度较大。本文梳理了中成药的质量现状和中成药标准概况,认为投料问题是当前影响中成药质量的关键问题,充分肯定现行中成药质量标准体系的同时,也要看到仍然存在一定的局限性。基于以上分析,提出了中成药质量标准研究的原则和思路:①坚持以安全为底线,强化中成药标准的风险防控水平;②坚持中医药理论及整体质量观,提高中成药标准的整体控制水平;③注重科技发展和创新,提升中成药标准的质量控制水平;④促进统筹协调,优化中成药标准的管理体系水平;⑤加强评价方法研究,建立等级评价标准,推动中成药高质量发展。最后,对中成药质量标准研究的未来发展方向做出了展望。Chinese patent medicine(CPM)is an important part of traditional and Chinese medicine(TCM).Its quality has direct impact on the safety and effectiveness of clinical use.The quality standard is the pivotal approach to guarantee the quality of CPM.Due to the complex material basis,multitudinous quality influencing factors and unveiled active ingredients,dose-effect relationship and action mechanism,the investigation on quality standard faces many difficulties.This paper surveys the current quality status of CPM and the general situation of CPM standards.At present,the dosing problem has the crucial impact on the quality of CPM.The current quality standard system of CPM is confirmed and the limitations are indicated.Based on the above analysis,the principles and considerations on investigation of quality standard are proposed as follows:①Adhere to safety as the bottom line,strengthen the risk-control ability of the standard of CPM;②Adhere to theory of TCM and comprehensive quality,improve the integrative control level of the CPM standard;③Emphasize technological development and innovation,promote the quality control competence of CPM standard;④Facilitate planning and coordination,optimize the management of the CPM standard system;⑤Reinforce investigation on evaluation method,develop grade evaluation standard,accelerate high-quality development of CPM.Finally,the future perspective oninvestigation of CPM quality standard is prospected.

关 键 词：中成药 质量标准研究 原则 思路 质量现状 标准概况 

分 类 号：R917[医药卫生—药物分析学]