益心复脉颗粒HPLC特征图谱建立及9种成分含量测定  

Establishment of HPLC characteristic chromatograms and content determination of nine constituents for Yixin Fumai Granules

作　　者：迟欣如 陈正伟 李捷 吴爱英 尹丽华 刘红兵[1,3] 卢京光 CHI Xin-ru;CHEN Zheng-wei;LI Jie;WU Ai-ying;YIN Li-hua;LIU Hong-bing;LU Jing-guang(Ministry of Education Key Laboratory for Marine Drugs,Ocean University of China,Qingdao 266003,China;Qingdao Municipal Institute for Food and Drug Control,Qingdao 266000,China;National Medical Products Administration Key Laboratory for Quality Research and Evaluation of Marine Traditional Chinese Medicines,Qingdao 266000,China)

机构地区：[1]中国海洋大学海洋药物教育部重点实验室,山东青岛266003 [2]青岛市食品药品检验研究院,山东青岛266000 [3]国家药品监督管理局海洋中药质量研究与评价重点实验室,山东青岛266000

出　　处：《中成药》2025年第1期1-6,共6页Chinese Traditional Patent Medicine

基　　金：国家药典委员会《中国药典》药品标准提高任务(559);国家药品监督管理局海洋中药质量研究与评价重点实验室课题资助(HYZY-ZZKT-2022002);中药有效性安全性评价及全过程质量控制研究项目(NMPAJGKX-2023-0062)。

摘　　要：目的建立益心复脉颗粒HPLC特征图谱,并测定丹参素钠、原儿茶醛、绿原酸、毛蕊异黄酮葡萄糖苷、阿魏酸、迷迭香酸、丹酚酸A、丹酚酸B、五味子醇甲的含量。方法分析采用Acutfex PA-C_(18)色谱柱(4.6 mm×250 mm,5μm);流动相乙腈-0.1%磷酸,梯度洗脱;体积流量1.0 mL/min;柱温35℃;检测波长210、250、280、320 nm。再进行聚类分析和主成分分析。结果15批样品特征图谱中有11个特征峰,相似度均大于0.980。9种成分在各自范围内线性关系良好(r≥0.9996),平均加样回收率97.60%~107.02%,RSD 0.78%~1.87%。各批样品聚为4类,2个主成分累积方差贡献率为89.454%。结论该方法灵敏度高,重复性好,可为评价和控制益心复脉颗粒质量提供参考。AIM To establish the HPLC characteristic chromatograms for Yixin Fumai Granules,and to determine the contents of sodium danshensu,protocatechualdehyde,chlorogenic acid,calycosin-7-O-β-D-glucoside,ferulic acid,rosalinic acid,salvianolic acid A,salvianolic acid B,schisandrol A.METHODS The analysis was performed on a 35℃thermostatic Acutfex PA-C_(18) column(4.6 mm×250 mm,5μm),with the mobile phase comprising of acetonitrile-0.1%phosphoric acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelengths were set at 210,250,280,320 nm.Subsequently,cluster analysis and principal component analysis were performed.RESULTS There were 11 characteristic peaks in the characteristic chromatograms for 15 batches of samples with the similarities of more than 0.980.Nine constituents showed good linear relationships within their own ranges(r≥0.9996),whose average recoveries were 97.60%-107.02%with the RSDs of 0.78%-1.87%.Various batches of samples were clustered into 4 categories,2 principal components demonstrated the accumulative variance contribution rate of 89.454%.CONCLUSION This sensitive and reproducible method can provide a reference for the quality evaluation and control of Yixin Fumai Granules.

关 键 词：益心复脉颗粒 HPLC特征图谱 化学成分 含量测定 聚类分析 主成分分析 

分 类 号：R927.2[医药卫生—药学]