张晓雨++王燕平++林丽开++商洪才++王永炎

[摘要]中藥注射剂作为中药现代化的重要代表，已成为中医药产业不可或缺的一部分。该文从当前中药注射剂市场核心竞争力不足、研发生产水平不高、药品质量与安全性差等制约产业发展的瓶颈问题出发，指出需要对上市后中药注射剂进行整体性再评价，乃至二次开发。当前形势下，以具有良好临床基础、市场基础和研究基础的中药注射剂大品种为培育与评价主体，是集中力量实现产业创新发展的重要途径。与口服中成药不同，中药注射剂大品种培育需要更高的技术支撑、质量标准与更及时有效的临床信息反馈，因此需要探索构建适合中药注射剂的上市后整体评价研究体系。该文分别从评价方法的优化、医研企协同创新平台的搭建、整体评价研究体系的形成3个层次探讨了中药注射剂上市后整体评价研究体系的构建思路和关键，提出从机制规律基础研究、临床效果评价验证、文献信息积累挖掘、资源可持续性培育以及市场和产业化操作5个方面，实现“五位一体”共同服务于提高中药注射剂有效性、安全性、经济性及适用性的最终目标。

[关键词]中药注射剂；整体评价；中药大品种；协同创新平台

Strategy of constructing postmarket integral evaluation system of

traditional Chinese medicine injection

ZHANG Xiaoyu1， WANG Yanping2*， LIN Likai3， SHANG Hongcai1*， WANG Yongyan1，2

（1. Key Laboratory of Chinese Internal Medicine of Ministry of Education， Dongzhimen Hospital Affiliated to

Beijing University of Chinese Medicine， Beijing 100700， China；

2. Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China；

3. Hospital Management Institution of Wuhan University， Wuhan 430071， China）

[Abstract]As an important representative of modern Chinese medicine， traditional Chinese medicine （TCM） injzection has become an indispensable part of the Chinese medicine industry However， its development is now restricted by the bottleneck of insufficient core competitiveness， lowlevel research and production， even injection quality and the safe use are not guaranteed Thus， it is urgent to reevaluate postmarketing TCM injection generally and to make secondary development Under current circumstances， taking major brands which have good clinical and market foundation， as well as research value， as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry Unlike oral proprietary Chinese medicine， the cultivatation of major brands of TCM injection needs higher technical support， quality standards and more timely feedback Therefore， a postmarket integral evaluation system adaptive to TCM injection is required This article discussed some key points on the construction of a postmarket integral evaluation system of TCM injection in three levels： optimizing evaluation methods， building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises， and finally constructing the integral evaluation system A "five to one" structure has been proposed to enhance TCM injection effectiveness， safety and adaptability on the whole， which are from the following aspects： mechanism research， clinical evidence validation， literature information mining， sustainable development of resources and industrialization operation.endprint

[Key words]traditional Chinese medicine injection；integral evaluation；major brands of Chinese medicine；synergistic innovation platform

《中医药发展战略规划纲要（2016—2030年）》、《“健康中国2030”规划纲要》均指出中医药作为我国独特的卫生资源、经济资源与科技资源，在保障国民健康、促进经济发展中的重要作用。中药注射剂作为中药现代化的重要代表，将中药单方或复方有效成分提纯应用，突破了传统中药给药途径的限制，临床疗效肯定，一定程度上体现了中西医整合的独特优势，已成为中医药产业不可或缺的一部分。……