一测多评法测定银黄颗粒中6种咖啡酰奎宁酸的含量

目的:建立以一个对照品同步测定银黄颗粒中6种咖啡酰奎宁酸含量的分析方法及其方法学的验证模式。方法:采用HPLC-DAD以药材中有效成分绿原酸、新绿原酸、隐绿原酸、异绿原酸A、异绿原酸B、异绿原酸C为指标,在一定的线性范围内,建立绿原酸与后5种成分间的相对校正因子(分别为1.21,0.96,0.84,0.90,0.78),并测定绿原酸的含量,用所建立的校正因子计算其他5个成分的含量;同时采用外标法测定银黄颗粒中6种咖啡酰奎宁酸类成分的含量,并比较计算值与实测值的差异,以验证一测多评法的准确性和可行性。结果:建立的校正因子重现性良好,15批银黄颗粒中采用校正因子计算的含量值与外标法实测值之间无显著差异(RSD<5%)。结论:在对照品缺乏的情况下,该方法可以作为一个新模式应用于银黄颗粒中咖啡酰奎宁酸类成分的多成分定量。

Simultaneous Quantitative Analysis of Six Caffeoylquinic Acids in Yinhuang Granules by Multi-Components Assay by Single Marker

Objective: To establish a new method of quality evaluation and validate its feasibility by simultaneous quantitative assay by single marker of six caffeoylquinic acids in Yinhuang Granules. Methods: The new quality evaluation method quantitative analysis of multi-components by single marker (QAMS) was established and validated with six caffeoylquinic acids in 4 varieties of Yinhuang with HPLC-DAD. Six caffeoylquinic acids: chlorogenic acid, neochlorogenic acid, cryptochlorogenic acid, isochlorogenic acid A, B, and C, were selected as indicators to evaluate the quality. In the linear range, related correction factors of the relationship with chlorogenic acid and the other five caffeoylquinic acids (1.21, 0.96, 0.84, 0.90, 0.78) were established and used for content determination of six caffeoylquinic acids in Yinhuang Granules. The method was evaluated by comparing quantitative results between external standard method and QAMS. Results: No significant differences were found in quantitative results of six caffeoylquinic acids in 15 batches of Yinhuang Granules determined by both external standard method and QAMS (RSD < 5%). Conclusion: The new method is feasible for evaluating the quality of Yinhuang Granules by QAMS without enough reference substances.