解热消炎胶囊指纹图谱“一标多评”定量方法的研究

Study on Multi-components Quantitation by One Reference Substance for Quality Evaluation of Jierexiaoyan Capsule Based on Its Fingerprint

关键词:  解热消炎胶囊  指纹图谱  一标多评  定量方法

Key words:  Jierexiaoyan capsule  fingeprint  multi-components quantitation by one reference substance  quality evalution

摘要:

目的 建立一种利用1个对照品，同步计算测定解热消炎胶囊多成分的定量分析方法。方法 测定解热消炎胶囊的指纹图谱，以黄芩苷峰为基准峰，分别计算绿原酸及栀子苷与其的相对校正因子，外标法测定黄芩苷的含量，用校正因子计算绿原酸及栀子苷的含量；同时与外标法测定结果进行比较，以验证方法可行性和科学性。结果 建立了解热消炎胶囊的含量控制方法，方法结果与外标法测定结果无显著性差异。结论 一标多评法既能同时测定多种成分，又能节约对照品的使用，有望成为适合中药特点的多指标质量评价新模式。

Abstract:

OBJECTIVE To establish a new quality evaluation method for Jierexiaoyan capsule, using one chemical reference substance to calcutate multi-components simultaneously. METHODS Determined the fingerprint of Jierexiaoyan capsule. Employed baicalin as the maker component, relative correction factors of chlorogenic acid to baicalin and geniposide to baicalin were calcatated in chromatographic conditions for determination of three components in Jierexiaoyan capsules. The contents of baicalin were determined by external standard method, and those of chlorogenic acid and geniposide were calculated by baicalin and their relative correction factors. The accuracy of the new method was evaluated by comparing the calculated contents with the determined. RESULTS The analysis methods of Jierexiaoyan capsules were established, and there was no significant difference between the calculated contents and determined contents. CONCLUSION The method of multi- components quantitation by one reference substance can determine multi-components simultaneously and save the chemical reference substance. It is to be a new quality evaluation pattern for Chinese herbal medicines.