中药复方制剂质量控制与评价的监管科学  

Regulatory Science of Quantity Control and Evaluation of Compound Preparations of Traditional Chinese Medicine

作　　者：曾瑾[1,3] 陈平 刘阳 张璐 华桦[1,3] 戴瑛 易进海[1] 杨安东 张爱军[1] 方清茂 李青苗[1] 杨军[1] 马双成[2] 赵军宁[1] ZENG Jin;CHEN Ping;LIU Yang;ZHANG Lu;HUA Hua;DAI Ying;YI Jinhai;YANG Andong;ZHANG Aijun;FANG Qingmao;LI Qingmiao;YANG Jun;MA Shuangcheng;ZHAO Junning(Sichuan Academy of Chinese Medical Sciences,Key Laboratory of Biological Evaluation of Quality of Traditional Chinese Medicine of National Administration of Traditional Chinese Medicine,Sichuan Engineering Technology Research Center for System Development of Genuine Medicinal Materials,Sichuan Key Laboratory of Translational Chinese Medicine,Chengdu 610041;National Key Laboratory of Drug Regulatory Science,National Institutes for Food and Drug Control,National Medical Products Administration,Beijing 100037;Sichuan Institute for Translational Chinese Medicine,Chengdu 610041)

机构地区：[1]四川省中医药科学院,国家中医药管理局中药质量生物评价重点研究室,四川省道地药材系统开发工程技术研究中心,中医药转化医学四川省重点实验室,成都610041 [2]国家药品监督管理局,中国食品药品检定研究院,药品监管科学全国重点实验室,北京100037 [3]四川省中医转化医学中心,成都610041

出　　处：《中药药理与临床》2024年第2期17-22,共6页Pharmacology and Clinics of Chinese Materia Medica

基　　金：四川省国际科技创新合作/港澳台科技创新合作项目(编号:2022YFH0109);四川省科技计划重点研发项目(编号:2020YFS0566)。

摘　　要：中药复方制剂质量控制的核心在于量质传递,即指在中药制剂的生产过程中,可量化或质量可控的药用植物从饮片或提取物、中间体到制剂的传递过程,以全链条质量控制为目的确保中药安全与疗效。本文基于中药质量控制、评价研究现状及监管挑战,探讨符合中药特点的质量控制与评价的监管新方法,并以古代经典名方新药转化实践案例,提出建立符合中药特点的复方制剂质量评价新工具、新标准、新方法在中药复方制剂质量控制和生产实践中的应用前景,为进一步推进中药监管科学在中药质量可控性和安全监管,解决中药质量监管中的基础性和关键性问题提供参考。The core of quality control of compound preparations of traditional Chinese medicine(TCM)lies in quality transfer,which refers to the transfer process of medicinal substances with controllable quantity or quality from decoction pieces,extracts,intermediates,to preparations in the production process of TCM preparations.The purpose is to ensure the safety and effectiveness of TCM by quality control throughout the whole chain.Based on the current status of TCM quality control and evaluation research,as well as regulatory challenges,this paper discussed the new regulatory methods of quality control and evaluation in line with the characteristics of TCM.The paper investigated the practice case of transforming ancient famous prescriptions into new drugs and put forward the application prospect of establishing new tools,new standards,and new methods for quality evaluation of compound preparations in line with the characteristics of TCM in the quality control and production practice of TCM compound preparations.The results can provide a reference for promoting the quality controllability and safety regulatory of TCM by TCM regulatory science and solving the basic and key problems in TCM quality regulatory.

关 键 词：中药复方制剂新药 质量控制与评价 中药监管科学 中药全链条质量安全监管 

分 类 号：R288[医药卫生—中药学]