中药配方颗粒临床综合评价维度和方法的现状分析  

Current Situation of Dimensions and Methods for Comprehensive Clinical Evaluation of Traditional Chinese Medicine Formula Granules

作　　者：翟常吉 陈盛君[3] 王化龙 李根林[1,2] 李寒冰 吴宿慧[1,2] ZHAI Chang-ji;CHEN Sheng-jun;WANG Hua-long;LI Gen-lin;LI Han-bing;WU Su-hui(Henan University of Chinese Medicine,Zhengzhou 450046,China;Henan Health Aging Industry Engineering Research Center,Zhengzhou 450046,China;Jiangyin Tianjiang Pharmaceutical Co.,Ltd.,Wuxi 214400,China)

机构地区：[1]河南中医药大学,河南郑州450046 [2]河南省健康衰老产业工程研究中心,河南郑州450046 [3]江阴天江药业有限公司,江苏无锡214400

出　　处：《中国现代中药》2024年第11期2017-2026,共10页Modern Chinese Medicine

基　　金：国家重点研发计划项目(2020YFE0201800);河南省科技攻关计划项目(202102310188)。

摘　　要：《关于结束中药配方颗粒试点工作的公告》(2021年第22号)的发布,以及中药配方颗粒部分国家标准的实施,表明我国中药配方颗粒产业将进入一个全新的发展阶段。近年来,药品临床综合评价受到越来越多的关注,中药配方颗粒的应用越来越多,开展中药配方颗粒临床综合评价势在必行。目前中药配方颗粒的研究主要侧重于与中药饮片的一致性及其质量控制等方面,其临床综合评价维度和方法尚在建立之中。通过归纳总结现有的药品临床综合评价维度和方法,同时考虑到中药配方颗粒不同于化学成分相对单一的化学药,又区别于中药饮片、中成药,并结合中药配方颗粒的质量稳定性和中医药特色,提出建立适宜中药配方颗粒的临床综合评价维度和方法,为广泛开展中药配方颗粒临床综合评价提供参考。With the release of the Announcement on Ending the Pilot Work of Traditional Chinese Medicine Formula Granules(No.22 of 2021)and the implementation of some national standards for traditional Chinese medicine(TCM)formula granules,the TCM formula granule industry will enter a new stage of development.In recent years,the comprehensive clinical evaluation of drugs has received more attention,and the application of TCM formula granules is increasing,so it is necessary to carry out the comprehensive clinical evaluation of TCM formula granules.At present,the research on TCM formula granules mainly focuses on the consistency with TCM decoction pieces and their quality control,and dimensions and methods for comprehensive clinical evaluation are still being established.The existing dimensions and methods for comprehensive clinical drug evaluation were summarized.At the same time,since TCM formula particles are different from conventional drugs and are unique compared with TCM decoction pieces and Chinese patent medicine,the quality stability of the TCM formula granules and TCM characteristics were emphasized,and appropriate dimensions and methods for comprehensive clinical evaluation of TCM formula granules were put forward,so as to provide a reference for extensive comprehensive clinical evaluation of TCM formula granules.

关 键 词：中药配方颗粒 临床综合评价 研究现状 评价维度 评价方法 

分 类 号：R286[医药卫生—中药学]