从"解释传统"到"定义现代":中药现代化的四维判据与战略转向OA
From"explaining tradition"to"defining modernity":four-dimensional criteria and strategic shift in modernization of TCM
中药现代化经过三十年持续推进,在质量控制、临床评价、制造技术、标准建设和产业发展等方面取得重要进展.当前中药现代化面临的关键问题,已不再主要是如何借助现代科学持续解释传统经验,而是如何界定中药作为现代医药产品的基本条件.基于此,该文提出中药现代化的四维判据框架,即质量可重现、疗效可验证、数据可建模、过程可审计.四项判据分别对应中药现代化的物质基础、临床基础、认知基础和治理基础的核心要求,共同构成中药进入现代医药体系的基本条件.文章进一步指出,四维判据不仅为界定现代中药提供了分析框架,也将推动中药研发、评价、监管、产业升级以及与国际对接的底层逻辑发生转向.中药现代化的下一阶段,关键不在于以更多技术手段反复证明中药"可以现代化",而在于以可重现、可验证、可建模、可审计的体系能力,重新界定中药作为现代医药产品的基本条件.
After three decades of continuous advancement,TCM modernization has achieved notable progress in quality control,clinical evaluation,manufacturing technology,standard development,and industrial growth.At present,the key challenge that TCM modernization facing is no longer primarily how to explain traditional experience with the assistance of modern science,but how to define the basic conditions under which TCM products can be recognized as modern medical products.In response,this paper proposes a four-dimensional criteria framework for TCM modernization:reproducible quality,verifiable efficacy,model-ready data,and auditable processes.These four criteria correspond respectively to the core requirements of the material,clinical,cognitive,and governance foundations of TCM modernization,and together constitute the basic conditions for integrating TCM into the modern medical system.The paper further explicates that this framework not only provides an analytical basis for defining modern TCM but also implies a strategic shift in the underlying logic of TCM research and development,evaluation,regulation,industrial upgrading,and international integration.The next stage of TCM modernization lies not in repeatedly proving that TCM"can be modernized"through additional technologies,but in redefining TCM as a modern medical product through system capabilities that are reproducible,verifiable,model-ready,and auditable.
钱忠直
国家药典委员会,北京 100061
现代中药中药现代化质量一致性临床证据数据建模全过程追溯监管科学
modern TCMTCM modernizationquality consistencyclinical evidencedata modelingfull-process traceabilityregulatory science
《中国中药杂志》 2026 (15)
4217-4223,7
评论