参松养心胶囊的高效液相色谱指纹图谱研究

Study on HPLC fingerprint of Shensongyangxin capsule

目的:研究参松养心胶囊的指纹图谱,建立其质量控制方法。方法:建立参松养心胶囊HPLC指纹图谱,并在同色谱条件下测定马钱苷和五味子酯甲的含量。色谱柱为Agilent ZORBAX SB-Aq-C18柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.5%的醋酸水溶液,采用梯度洗脱,流速1.0 mL.min-1,检测波长254 nm。采用国家药典委员会《中药色谱指纹图谱相似度评价系统(2004A版)》处理分析。结果:建立了参松养心胶囊的指纹图谱,确立28个共有峰,10批样品相似度较高,马钱苷和五味子酯甲含量分别为0.270%和0.195%。结论:本文建立的指纹图谱与指标成分含量测定相结合,分析方法快速,可用于参松养心胶囊的质量控制。

Objective： To study the fingerprint of Shensongyangxin capsule, and establish the quality control method for the preparation. Methods The chromatography conditions of fingerprint, which can be used for determining the contents of loganin and wuweizi ester A simultaneously, were established. The chromatographic separation was performed on an Agilent ZORBAX SB-Aq-C^8 column （4.6 mm x 250 mm, 5p, m）. The mobile phase was a mixture of acetonitrile-0.5% acetic acid aqueous solution in gradient elution. The flow rate was 1.0 mL. min-1, and the detection wave length was 254 nm. The software of similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine （2004 A） was used for data analysis. Results： There were 28 characteristic peaks in the HPLC fingerprint of Shensongyangxin capsule, and the similarity was high in all often batch samples. The contents of loganin and wuweizi ester A were 0.270% and 0.195%, respectively. Conclusion： The method combining determination of index components with fingerprint analysis is timesaving and can be used for the quality control of Shensongyangxin capsule.