一测多评法测定蒙成药三子散中4种成分的含量

Determination of Four Components in Mongolian Medicine Sanzisan by Quantitative Analysis of Multi-components via Single Marker Method

采用高效液相色谱法(HPLC),以栀子苷为对照品,外标法测定其在三子散中的量,并分别测定栀子苷与没食子酸、绿原酸、诃黎勒酸的相对校正因子,并通过相对校正因子计算后三种成分的含量,实现一测多评;同时,采用外标法测定三子散中没食子酸、绿原酸、诃黎勒酸的含量,并比较2种方法所得计算结果的差异,10批三子散中4种成分的外标法测定结果与相对校正因子法计算结果无显著性差异,说明一测多评法可以应用于三子散的多指标质量评价。

In this study, a new strategy for quantitative analysis of multi-components via single marker（QAMS） was developed and validated to analyze four components （ geniposide, gallic acid, chlorogenic acid and chebulagic acid） in Sanzisan by HPLC. The QAMS method was based on the relative correction factor（RCF） between each analyte and single standard within certain concentration ranges. In the present study,geniposide was selected as the internal reference substance. The RCFs values between geniposide and the other three components were investigated using three different types of chromatographic columns. The content of other three components were calculated by RCFs,respectively. Meanwhile,the content of the four analytes was also determined by a conventional external standard method to compare with QAMS method. Finally,the relative error which were all under 3% revealed that there was no significant difference between the QAMS method and the external standard method. The QAMS method established in this study solved the problem of the availability and high cost of some standard substances, and would be useful for providing an efficient and feasible quality assessment method for Sanzisan.