益心舒颗粒HPLC指纹图谱的建立及多成分含量测定

HPLC Fingerprint and Multi-component Content Determination of Yixinshu Granules

目的:建立益心舒颗粒HPLC指纹图谱,并同时测定毛蕊异黄酮葡萄糖苷、阿魏酸、五味子醇甲、人参皂苷Rg1、人参皂苷Re、丹酚酸B、人参皂苷Rb17个成分的含量。方法:该样品粉末用75%甲醇提取液提取,采用Agilent Poroshell 120EC-C18色谱柱(250 mm×4.6 mm,5μm),流动相乙腈(A)-0.1%甲酸溶液(B),梯度洗脱;检测波长为205,280 nm,柱温:30℃,流速:1.0 ml·min^(-1),进样量:10μl。结果:15批样品中有22个共有峰,相似度均大于0.97。毛蕊异黄酮葡萄糖苷、阿魏酸、五味子醇甲、人参皂苷Rg1、人参皂苷Re、丹酚酸B在各自范围内线性关系良好(r≥0.9994),15批益心舒颗粒中上述7个成分的含量分别为1.0240~1.7960 mg·g^(-1)、0.6532~0.9962 mg·g^(-1)、1.8560~3.1630 mg·g^(-1)、0.4696~0.7841 mg·g^(-1)、0.5471~0.9258 mg·g^(-1)、1.1420~2.2310 mg·g^(-1)、1.0320~1.5240 mg·g^(-1)。结论:所建立方法稳定简单,多成分含量测定结合指纹图谱分析为全面评价益心舒颗粒的产品质量提供了依据。

Objective:To establish HPLC fingerprint of Yixinshu granules and simultaneously determine the contents of calycosin7-O-β-D-glucopyranoside,ferulic acid,schisandrin,ginsenoside Rg1,ginsenoside Re,salvianolic acid B and ginsenoside Rb1.Methods:The analysis of methanol(75%)extract of the drug was performed on a 30℃thermostatic Agilent Poroshell 120 EC-C18 column(250 mm×4.6 mm,5μm)with the mobile phase comsisting of acetonitrile-0.1%formic acid flowing at 1.0 ml·min^(-1)in a gradient elution mode.The detection wavelengths were set at 205 nm and 280 nm.Results:There were twenty-two common peaks in the fingerprints of fifteen batches of samples with the similarities above 0.97.The linearity relationships for calycosin 7-O-β-D-glucopyranoside,ferulic acid,schisandrin,ginsenoside Rg1,ginsenoside Re,salvianolic acid B and ginsenoside Rb1 were good(r≥0.9994),and the contents of the above-mentioned components in 15 batches of preparations were 1.0240-1.7960 mg·g^(-1),0.6532-0.9962 mg·g^(-1),1.8560-3.1630 mg·g^(-1),0.4696-0.7841 mg·g^(-1),0.5471-0.9258 mg·g^(-1),1.1420-2.2310 mg·g^(-1)and 1.0320-1.5240 mg·g^(-1),respectively.Conclusion:The method is simple and accurate,which provides reference for the quality control of Yixinshu granules.