新形势下的中药大质量观及实践
Proposition and practice of "macro-quality view" in quality control for traditional Chinese medicines under new situation
肖小河 1李寒冰 2赵旭 3柏兆方 4王伽伯5
作者信息
- 1. 解放军总医院第五医学中心全军中医药研究所,北京 100039;解放军总医院第五医学中心肝病医学部研究所,北京 100039;湖南中医药大学中医药精准用药研究中心,湖南 长沙 410208
- 2. 河南中医药大学医学院,河南 郑州 450046
- 3. 解放军总医院第五医学中心全军中医药研究所,北京 100039
- 4. 解放军总医院第五医学中心全军中医药研究所,北京 100039;解放军总医院第五医学中心肝病医学部研究所,北京 100039
- 5. 首都医科大学中医药学院,北京 100069
- 折叠
摘要
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.
Abstract
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.
关键词
中药标准化/质量评控/新策略/中药大质量观/效应成分指数Key words
standardization of traditional Chinese medicine,quality control,new strategies,macro-quality view/effective component index引用本文复制引用
出版年
2025
NETL
NSTL
万方数据