一测多评法测定苦碟子注射液中4种有机酸类成分含量

Determination of Four Organic Acids in Kudiezi Injection by Quantitative Analysis of Multi-Components by Single-Marker

目的:利用一测多评法建立测定苦碟子注射液中4种有机酸类成分的高效液相色谱分析方法,实现对苦碟子注射液简单、有效的质量控制。方法:以菊苣酸为内参物,测定菊苣酸与单咖啡酰基酒石酸、绿原酸、咖啡酸的相对较正因子,进而计算苦碟子注射液中有机酸的含量,并将一测多评法的计算结果与外标法实测值用相对误差进行评价,以验证一测多评法的准确性。结果:菊苣酸与单咖啡酰基酒石酸、绿原酸、咖啡酸的相对较正因子分别为1.295,1.410,0.8421,采用一测多评法对苦碟子注射液中有机酸类成分含量计算结果与外标法无显著差异,相对误差小于5%。结论:所建立的一测多评法简便、快速、可靠,可用于苦碟子注射液中有机酸类成分含量测定,为苦碟子注射液质量控制提供参考。

Objective： The study was to use the method of quantitative analysis of multi-components by single-marker（ QAMS） in the determination of four organic acids in Kudiezi Injection in order to achieve quality control in a simple and effective way. Methods： Taking chicoric acid as an internal marker to establish relative correction factor（ RCF） between cichoric acid and other organic acids,and the relative correction factors would be used in the calculation of their contents. Relative error was used in the appraisal of the result between external standard method and QAMS. Results： The RCFs between cichoric acid and other organic acids were 1. 295,1. 410,0. 842 1 respectively. The contents which got between external standard method and QAMS had no significant difference and the relative error was less than 5%. Conclusion： The established QAMS method is simple,fast,reliable and can be used in the determination of organic acids in Kudiezi Injection and it can provide a reference of quality control for Kudiezi Injection.