针对临床应用的中药开展深入研究与二次开发是中药新药研发的重要途径。2023年国家药品监督管理局施行的《中药注册管理专门规定》细化了中药新药的研发要求，支持研制具有丰富中医临床实践经验的中药新药，也展示了中药优势品种二次开发的发展机遇。结合中药自身内在特点与研发规律，提出了以再评价再发现为基础的中药再创新研发策略，通过系统研究临床高风险制剂、注射剂、中药大品种、临床效方等制剂临床应用的有效性和安全性，提升中药制剂质量安全，为中药的改良研究及二次开发提供参考。在此基础上，进一步发现优效物质组分，为创新中药提供动力，推动中医药现代化的高质量发展。

Further study and secondary development of clinically applied traditional Chinese medicine (TCM) is an important way for the research and development (R&D) of new TCM. In 2023, the National Medical Products Administration issued the Special Regulations on Registration Management of Traditional Chinese Medicine, which refined the R&D requirements of new TCM, supported the development of new TCM with rich experience in TCM clinical practice and demonstrated the development opportunities for the secondary development of superior varieties of TCM. The present study proposed the re-innovation R&D strategy of TCM based on re-evaluation and rediscovery by combining inherent characteristics and R&D principles of TCM. Through systematic research on the effectiveness and safety of clinical applications of clinical high-risk preparations, injections, big brand TCM and clinical prescriptions, it aims to improve the quality and safety of TCM preparations, and to provide references for improvement research and secondary development of TCM. On this basis, further discovery of superior substance components can provide impetus for innovative TCM and promote the high-quality development of modernized TCM.

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国家自然科学基金重点项目(82230117);江苏省科技成果转化专项资金(BA2020077)