目的 建立指纹图谱与一测多评(QAMS)结合的考察模式, 验证该方法在制剂质量评价中应用的准确性和可行性。方法 以参芎养心颗粒为研究对象, 以葛根素为参照物建立参芎养心颗粒HPLC指纹图谱, 计算该成分与阿魏酸、橙皮苷、丹酚酸B、甘草酸铵、五味子醇甲的相对校正因子, 并计算其量, 实现QAMS。同时对QAMS的计算值与外标法实测值进行比较, 以确证QAMS法的可行性和科学性。结果 建立了参芎养心颗粒HPLC特征指纹图谱共有模式, 标定了17个共有峰, 指认了其中6个共有峰, 10批参芎养心颗粒的相似度均大于0.99。10批参芎养心颗粒中6个主要成分的计算值与实测值间无显著差异。结论 QAMS结合指纹图谱的质量控制模式在参芎养心颗粒中得到验证, 该方法快速准确灵敏, 可为参芎养心颗粒定量测定和指纹图谱质量控制提供参考。

Objective To establish a new method for the quality evaluation of Shenxiong Yangxin Granule by fingerprint and quantitative analysis of multi-components by single marker method (QAMS) and validate its accuracy and feasibility for the application in preparation. Methods The quality evaluation method was established and validated with was selected as markers of ingredients to HPLC fingerprint was established with Shenxiong Yangxin Granule as study object and puerarin as internal reference to determine the contents of other components (ferulic acid, hesperidin, salvianolic acid B, ammonium glycyrrhizinate, and schisandrin) according to the relative correction factor. The accuracy and feasibility of QAMS was evaluated by comparison on the results between the measured value and calculation value by external standard method and QAMS. Results Seventeen common peaks were identified in the HPLC characteristic fingerprint, six components were verified in ten batches of Shenxiong Yangxin Granule, good similarities with correlation coefficients higher than 0.99 were found in the fingerprints. There was no significant difference between the quantitative results of the six ingredients in the ten batches by external standard method and QAMS. Conclusion The method of fingerprint combined with QAMS has been verified in Shenxiong Yangxin Granule, which could be used as a reference for the quality control of multiple components determination and fingerprint chromatography for Shenxiong Yangxin Granule in future.