张萌　封亮　贾晓斌

摘要 中药质量的评控问题是制约中药现代化发展的瓶颈，因此有必要在现有检测方法的基础上结合生物评价，继而更为全面地保证中药质量。生物评价是完善中药质量标准、保证临床功效和安全性评价的重要方法，已成为中药质量标准化发展趋势之一。在此处主要论述了近年来基于生物活性与效应基准的中药质量评价技术和已取得的部分研究进展，同时对目前中药质量生物评价研究与应用中存在的主要问题进行探讨，进一步对其未来应用做出展望，从而更好的对中药质量进行控制。

关键词 中药;生物活性;效应基准;质量评价技术;发展现状;展望

Development Status and Prospect of Traditional Chinese Medicine Quality Evaluation Technology Based on Biological Activity and Efficacy Benchmark

ZHANG Meng，FENG Liang，JIA Xiaobin

（School of Traditional Chinese Pharmacy，China Pharmaceutical University，Nanjing 211198，China）

Abstract The evaluation and control of the quality of traditional Chinese medicine（TCM）is the bottleneck that restricts the development of modernization of TCM.Therefore，it is necessary to combine the biological evaluation with the existing detection methods to ensure the quality of TCM more comprehensively.Biological evaluation is an important method to improve the quality standard，and ensure the clinical efficacy and safety evaluation of TCM，which has become one of the development trends of quality standardization of TCM.This paper mainly discusses the quality evaluation technology of TCM based on biological activity and effect benchmarks in recent years and some of the research progress that has been made.Meanwhile，it discusses the main problems existing in the current biological evaluation of TCM quality and its application，and further its future application，making an outlook to better control the quality，so as to better control the quality of TCM.

Keywords Traditional Chinese medicine; Biological activity; Efficacy benchmark; Quality evaluation technique; Development status; Prospect

中图分类号：R285;R284.1文献标识码：Adoi：10.3969/j.issn.1673-7202.2020.15.007

中药质量是中药发挥临床疗效的保障，对于中药质量的控制与评价研究一直是推动中药现代化进程中的重点和难点[1]。中药多组分、多靶点、多途径的特点决定了其物质基础和作用机制的复杂性。随着现代分析技术的飞速发展以及各学科交叉的融合创新，中药质量评价研究有了全方位的进步，经历了从形态鉴别到化学成分定性及定量检测再到全过程动态控制，从单个指标的含量测定到基于指纹图谱的多指标同时测定，从基于对照品的含量测定到一测多评等变化，从整体上对中药质量评价水平进行了提升[2]。然而，仅基于化学基准的中药质量控制模式存在指标性成分难以全面地反映整体质量、与临床有效性及安全性关联不够紧密、不能充分体现中医药特色等问题，仍存在较大的局限性。……