以“等效成分群”为标示量的中药质量控制体系的构建

"Bioactive Equivalent Combinatorial Components" as Defined Labeled Amount of Active Constituents for Quality Control of Traditional Chinese Medicines

中药质量标准化是其走向世界的通行证。中国要引领世界,其中标准引领当先行。现今中药质量控制和评价模式正逐步由无指标、到单指标、再向多指标成分过渡,但是如何选准指标成分、如何定准含量范围,依旧是中药质量标准研究的瓶颈问题。笔者结合近年来在中药活性成分(群)发现以及质量评价研究中的体会,提出"等效成分群"的中药质量控制理念,以"等效成分群"作为中药药效成分标示量,紧扣"成分-药效-质量"三要素,构建以成分为中心、以药效为重心、以质量为核心的中药质量控制与评价方法体系,以期为实现中药"化学成分清楚、药效物质明确、质量稳定可控"的目标提供普适性的研究思路与技术方法。

Quality control and standardization of traditional Chinese medicines （TCMs） is the key to its globalization. Generally, there is a common practice to select one or more compounds as chemical markers for the purpose of qual-ity assessment. However, how to select chemical markers and how to set the range of effective concentrations are still the bottleneck. The authors proposed a bioactive equivalent combinatorial components （BECCs） as defined labeled amount of active constituents oriented quality control strategy of TCMs based on years of research work. Focusing on the relationship between chemical components efficacy and quality of TCMs, this strategy provides a new perspective and methods to improve quality control of TCMs.