“一测多评”法用于栀子金花丸多成分含量测定的可行性研究

目的：利用一个对照品同步测定栀子金花丸中10种成分的含量，探讨“一测多评”技术在中成药不同类型化合物质量评价中应用的可行性。 方法：以栀子金花丸为研究对象，采用高效液相色谱法，以大黄素为内参物，在254 nm检测波长下，建立小檗碱、黄芩苷、汉黄芩苷、黄芩素、芦荟大黄素、汉黄芩素、大黄酸、大黄酚、大黄素甲醚与大黄素间的相对校正因子。采用外标法测定栀子金花丸中大黄素的含量，通过待测成分间的相对校正因子计算栀子金花丸中其他9种成分的含量；并将“一测多评”法的计算值与外标法实测值用相对误差进行评价，以验证“一测多评”法的技术可行性和方法适用性。 结果：2种计算结果没有显著性差异，相对误差<5%。 结论：“一测多评”的质量评价模式可用于栀子金花丸中3种不同类型化合物的多指标同步质量评价。

Feasibility study of QAMS for quantitative analysis of multiple structural types of ingredients in Zhizi Jinhua pill

Objective: To study the technical feasibility of QAMS to determine different structural types of ingredients in Zhizi Jinhua pill, a Chinese patent medicine. Method: Emodin was chosen as the internal reference substance. The relative correction factors (RCF) of berberine, baicalin, wogonoside, baicalein, aloe-emodin, wogonin, rhein, chrysophanol and physcion to emodin were calculated with the peak areas determined at 254 nm. The ruggedness of these RCFs was validated. The contents of emodin in the samples of Zhizi Jinhua pill were determined by using the external standard method, and the contents of the other nine ingredients were calculated by their RCFs. The contents of these ten ingredients in all samples were also determined by the external standard method. Result: No significant differences were observed between the quantitative results of the two methods. The obtained RCFs were credible. Conclusion: The established QAMS method can be used for quantitative determination of different structural types of multi-compounds in Zhizi Jinhua pill. It can provide reference for the quality control of Chinese patent medicine.