HPLC法同时测定固本益肠片中5种成分含量  

Simultaneous determination of five components in Guben Yichang tablet by HPLC

作　　者：钱洲 王月德 许庆 安艳苏 毕秋左 张顺平 QIAN Zhou;WANG Yuede;XU Qing;AN Yansu;BI Qiuzuo;ZHANG Shunping(Qujing City Food and Drug Testing Center,Qujing,Yunnan 655000,China)

机构地区：[1]云南省曲靖市食品药品检验检测中心,云南曲靖655000

出　　处：《中国药品标准》2023年第4期438-443,共6页Drug Standards of China

摘　　要：目的:建立HPLC同时测定固本益肠片中儿茶素、表儿茶素、芍药苷、补骨脂素及异补骨脂素含量的方法并为监测该药风险成分提供参考。方法:色谱柱采用依利特Hypersil ODS2柱(4.6 mm×300 mm,5μm);流动相:乙腈(B)-水(A),梯度洗脱,检测波长:240 nm;流速:1.0 mL·min^(-1);柱温:30℃。结果:5种成分均能达到基线分离,且在相应范围内线性关系良好;儿茶素、表儿茶素、芍药苷、补骨脂素及异补骨脂素的平均加样回收率分别为98.22%、96.93%、101.46%、98.60%和100.24%,RSD分别为1.5%、2.1%、2.0%、1.4%和1.0%(n=6)。结论:经方法学验证,本法可为进一步完善固本益肠片质量控制标准,并为监测该药风险成分提供参考。Objective:To establish a method for HPLC to simultaneously determine the contents of catechins,epicatechins,peony glycosides,psoralens and isopsoralens in Guben Yichang tablets,and it was established to provide a reference for monitoring the risk components of the drug.Methods:The column was Hypersil ODS2 column(4.6 mm×300 mm,5μm).Mobile phase:acetonitrile(B)-water(A),gradient elute,detection wavelength:240 nm;Flow rate:1.0 mL·min^(-1).Column temperature:30℃.Results:All five components could achieve baseline separation and had good linear relationships within the corresponding range.The average dosing recoveries of catechins,epicatechins,peony glycosides,psoralens and isopsoralens were 98.22%,96.93%,101.46%,98.60%and 100.24%,and RSD were 1.5%,2.1%,2.0%,1.4%and 1.0%,respectively(n=6).Conclusion:After methodological verification,this method can further improve the quality control standards of Guben Yichang intestinal tablets and provide a reference for monitoring the risk ingredients of the drug.

关 键 词：固本益肠片 高效液相色谱 儿茶素 表儿茶素 芍药苷 补骨脂素 异补骨脂素 含量测定 

分 类 号：R921.2[医药卫生—药学]