CAJ | 학술논문

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。
중약질량표준화시기주향세계적통행증。중국요인령세계，기중표준인령당선행。현금중약질량공제화평개모식정축보유무지표、도단지표、재향다지표성분과도，단시여하선준지표성분、여하정준함량범위，의구시중약질량표준연구적병경문제。필자결합근년래재중약활성성분（군）발현이급질량평개연구중적체회，제출“등효성분군”적중약질량공제이념，이“등효성분군”작위중약약효성분표시량，긴구“성분-약효-질량”삼요소，구건이성분위중심、이약효위중심、이질량위핵심적중약질량공제여평개방법체계，이기위실현중약"화학성분청초、약효물질명학、질량은정가공"적목표제공보괄성적연구사로여기술방법。
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.