心可舒片的多成分含量测定及特征图谱分析  

Multicomponent contents determination and specific chromatograms of Xinkeshu tablets

作　　者：于金倩 王晓 周万辉[3] 刘伟[1,2] 孙成龙 李丽丽 YU Jinqian;WANG Xiao;ZHOU Wanhui;LIU Wei;SUN Chenglong;LI Lili(Qilu University of Technology(Shandong Academy of Sciences),Shandong Analysis and Test Center,Ji′nan 250014,China;Qilu University of Technology(Shandong Academy of Sciences),School of Pharmaceutical Sciences,Ji′nan 250014,China;Shandong Wohua Pharmaceutical Technology Co.,Ltd.,Weifang 261041,China)

机构地区：[1]齐鲁工业大学(山东省科学院),山东省分析测试中心,济南250014 [2]齐鲁工业大学(山东省科学院),药学院,济南250014 [3]山东沃华医药科技股份有限公司,山东潍坊261041

出　　处：《中国药品标准》2022年第2期214-219,共6页Drug Standards of China

基　　金：中央本级重大增减支项目(No.2060302);“泰山学者”建设工程(No.tsqn202103096)。

摘　　要：目的:建立心可舒片中葛根素、大豆苷、丹酚酸B的含量测定方法,进一步建立特征图谱。方法:使用Symmetry C_(18)色谱柱(4.6 mm×250 mm,5μm),流速为1.0 mL·min^(-1),柱温为25℃,检测波长为287 nm,流动相为乙腈-0.2%甲酸水溶液,梯度洗脱,采用色谱质谱鉴别主要成分,HPLC进行含量测定和特征图谱研究。结果:葛根素、大豆苷、丹酚酸B 3种成分在各自范围内线性关系良好(r≧0.999);它们的加样回收率平均值分别为99.21%、98.91%、98.91%,RSD分别为0.33%、1.72%、0.96%;建立了心可舒片的特征图谱,10批试药相似度>90%。结论:该方法具有较好的稳定性和重复性,可用于心可舒片的质量分析。Objective:To establish an analytical method for the determination of puerarin,daidzein,and salvianolic acid B in Xinkeshu tablets,and further establish their specific chromatograms.Methods:Analysis was performed on a Symmetry C_(18) column(4.6 mm×250 mm,5μm)maintained at 25℃using a gradient mobile phase of acetonitrile-0.2%formic acid delivered at a flow rate of 1.0 mL·min^(-1).HPLC-MS/MS was used for the identification of main components,and HPLC was employed for the content determination and specific chromatogram analysis at the detection wavelength of 287 nm.Results:Three components showed good linearity in their respective concentration ranges(r≧0.999).The average recovery rates for three components were 99.21%,98.91%and 98.91%,with RSD of 0.33%,1.72%and 0.96%,respectively.The specific chromatograms of Xinkeshu tablets were established,and the similarity of 10 batches of test drugs was>90%.Conclusion:This method showed good stability and repeatability,which could be used for the quality analysis of Xinkeshu tablets.

关 键 词：心可舒片 HPLC 含量测定 葛根素 特征图谱 

分 类 号：R921.2[医药卫生—药学]