一测多评法在中药多组分质量控制中的应用现状与思考

Application status and thinking of quantitative analysis of multi-components by single marker in quality control of multi-components traditional Chinese medicine

一测多评分析方法可通过一种对照品实现对多种成分的同时测定,被认为是适合中药特点的多指标质量控制与评价模式。目前已经用于中药材、中药饮片及中药制剂的成分测定。简要阐述了一测多评法的原理,系统总结了一测多评法在中药材、中药饮片及中药制剂质量控制中的应用,并对一测多评法存在的问题进行了分析。最后提出建立以活性成分作为指标性成分的一标多测质量控制方法,是符合中药多组分特点的质量控制模式,可以有效用于中药质量控制,具有很好的应用前景。

Quantitative analysis of multi-components by single marker（QAMS） can be used to achieve the simultaneous determination of multiple components through a reference substance, which is considered suitable for the characteristics of Chinese materia medica（CMM）. QAMS has been used for quality control of Chinese herbal medicines, Chinese herbal pieces, and CMM preparations. This paper briefly introduces the principle of QAMS method, and systematically summarizes the application of QAMS method in quality control of Chinese crude drugs, Chinese herbal pieces, and CMM preparation. Finally, it is proposed that active ingredients as an indicator component in QAMS is consistent with the multi-components characteristics of CMM, and it can be effectively used for quality control of CMM and has a good application prospect.