近年来，中药新药创制动力不足严重阻碍产业发展。通过梳理同名同方药注册分类和评审要求，对其注册科学内涵进行分析和思考，提出以临床价值为导向，化学物质基础和临床功效关联为主线的研究思路。在揭示已上市中药中与临床功效和药品品质关联的“化学物质基础”差异性基础上，建立“固有化学成分-体内代谢-生物效应”功效物质成分群的解析研究模式，表征优质、优效中药内涵，以质量标志物统领和提升同名同方药的研制，推动已上市中药的传承创新。

In recent years, the lack of motivation for the creation of new traditional Chinese medicine (TCM) seriously hinders the development of the industry. By combing the registration classification and evaluation requirements of TCM of the same name and prescription, this paper analyzes and considers the scientific connotation of registration of listed TCM, and puts forward the research idea of taking the clinical value as the orientation and the correlation research between chemical substance basis and clinical efficacy as the main line. On the basis of revealing the differences of “chemical material basis” related to clinical efficacy and drug quality in listed TCM, an analytical research model of “inherent chemical composition-in vivo metabolism-biological effect” was established to characterize the connotation of high-quality and excellent-effect TCM. Quality markers were used to guide and improve the development of TCM of the same name and prescription, so as to promote the inheritance and innovation of listed TCM.

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国家重大新药创制计划课题（2017ZX09101002-001）；安徽省中药资源保护与持续利用工程实验室开放课题（TCMRPSU-2022-01）；皖西学院高层次人才科研启动基金（WGKQ2022074）；中国医学科学院医学与健康科技创新工程重大协同创新项目资助（2021-I2M-1-042）；中央高校基本科研业务费专项资金资助项目（3332022063）