中药质量是中医药事业和产业高质量发展的重要基石。在新的形势下，如何科学理性地认识中药质量的总体形势和存在问题，如何破解长期制约中药现代化发展的质量控制与标准化问题？从底层逻辑出发，重新审视中药物质内涵的特质性与质控策略的合理性，并在原来基础上补充修改提出新的“中药大质量观”，即一组创新认知、两级监管尺度、三维品质内涵、四象过程质控策略、五级质控力证据体。希冀为破解中药质量评控与标准化难题提供新理论、新策略、新方法。

The quality of traditional Chinese medicine (TCM) is a crucial cornerstone for the high-quality development of TCM industry and practice. Under the new situation, how can we develop a scientific and rational understanding of the overall state and existing challenges related to the quality of TCM? Furthermore, how can we solve the problems of quality control and standardization that have long restricted the modernization of TCM? From the perspective of underlying logic, this paper re-examines the characteristics of material connotation of TCM and the rationality of quality control strategies, and supplements and modifies the previous understanding to propose a new “macro-quality view” for TCM by supplementing and modifying the previous understanding. This perspective encompasses: a set of innovative cognitions, two-tier regulatory scales, three-dimensional quality connotations, four-phase process quality control strategies, and five-level evidence system for quality control effectiveness. It is hoped that this new perspective will offer novel theories, strategies, and methods for tackling the challenges associated with the quality evaluation and standardization of TCM.

R28

中央本级重大增减支项目"名贵中药资源可持续利用能力建设项目"(2060302);国家自然科学基金重点项目(81930110);国家自然科学基金重点项目(82230118)