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中药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。
Traditional Chinese medicine injection as an important representative of the modernization of traditional Chinese medicine has become an integral part of the Chinese medicine industry. This paper starts from the bottleneck that restricts the industrial development of traditional Chinese medicine injections, such as the lack of core competence, the low level of R & D and production, the poor quality and safety of pharmaceuticals, and the need to re-evaluate the integrated injection of Chinese traditional medicine after listing and even secondary development. Under the current situation, taking the large variety of TCM injection with good clinical foundation, market foundation and research foundation as the main body of cultivation and evaluation is an important way to concentrate on realizing industrial innovation and development. Different from oral proprietary Chinese medicines, traditional Chinese medicine injections need a higher technical support, quality standards and more timely and effective feedback of clinical information. Therefore, it is necessary to explore and establish a post-marketing overall evaluation research system suitable for traditional Chinese medicine injections. This paper discusses the construction ideas and key points of the overall evaluation research system after the listing of Chinese traditional medicine injections from three aspects: the optimization of evaluation methods, the setting up of collaborative innovation platform of medical research and research institutes and the formation of the overall evaluation research system. Based on the basic research of mechanism and law, Clinical efficacy evaluation and verification, literature and information accumulation and excavation, resource sustainability cultivation and market and industrialization operations to achieve “five in one ” common services to improve the effectiveness of traditional Chinese medicine injections, safety, economy and applicability The ultimate goal.