[关键词]
[摘要]
建立科学的中药质量评价体系是保障中药国际化、产业化的关键,通过中药有效性-物质基础-质量控制关联链辨识质量标志成分,将化学物质与临床疗效关联,以此评价中药有效性、安全性,实现中药整体质量评价。从中药质量评价体系发展历程出发,对围绕中药性状的传统质量评价模式及活性成分的现代质量评价模式进行分析,基于质量标志物(quality marker,Q-Marker)与多学科内容有机结合,探讨Q-Marker质量评价模式的建立,提出创新方法导入中药质量评价的发展趋势。
[Key word]
[Abstract]
Establishing a scientific quality evaluation system of traditional Chinese medicine (TCM) is the key to guarantee the internationalization and industrialization of traditional Chinese medicine. It is required to identify the quality marker components through the effectiveness-material basis-quality control chain of TCM, and the chemical substances are associated with clinical efficacy, so as to evaluate the effectiveness and safety of TCM and realize the overall quality evaluation of TCM. Starting from the development process of the quality evaluation system of TCM, the traditional quality evaluation model centering on the characteristics and the modern quality evaluation model of the active ingredients were analyzed. Based on the organic combination of Q-marker and multidisciplinary content, an establishment of quality evaluation model was discussed, and the development trend of quality evaluation of TCM was put forward based on the introduction of innovative methods.
[中图分类号]
R283.6
[基金项目]
国家创新方法专项(2020IM010500)