芪归养血颗粒质控标准研究  

Study on the quality standard of Qigui Yangxue granules

作　　者：席明名[1] 黄和军 XI Ming-ming;HUANG He-jun(Women's Hospital of Nanjing Medical University(Nanjing Maternity and Child Health Care Hospital),Nanjing 210004,China)

机构地区：[1]南京医科大学附属妇产医院(南京市妇幼保健院),210004 [2]南京中医药大学江阴附属医院,214400

出　　处：《中国现代药物应用》2024年第15期170-174,共5页Chinese Journal of Modern Drug Application

摘　　要：目的研究建立芪归养血颗粒质控的标准。方法采用薄层色谱法(TLC)对黄芪、淫羊藿、菟丝子进行定性鉴别,通过超高效液相色谱-蒸发光散射检测器(UPLC-ELSD)测定制剂中黄芪甲苷含量:色谱柱:Acclaim RSLC 120 C_(18)(100 mm×2.1 mm,2.2µm),ELSD,流动相为乙腈-水(32∶68),流速为0.4 ml/min;柱温30℃;进样体积为1μl。结果TLC能特异性鉴别黄芪、淫羊藿、菟丝子。黄芪甲苷的注射量与峰面积具有良好的线性关系,线性范围为0.0826~0.8260µg,r=0.9996;平均回收率为99.19%,相对标准偏差(RSD)为0.74%。结论采用TLC法和UPLC-ELSD检测对芪归养血颗粒分别进行了定性鉴别和定量分析,所建立的方法专属性强,结果准确,可作为芪归养血颗粒的质控方法进行应用。Objective To establish a quality standard for Qigui Yangxue granules.Methods The identification of Astragalus,epimedium and cuscuta was carried out by thin-layer chromatography(TLC).The content of astragaloside iv was determined by ultra-high performance liquid chromatography-evaporative light scattering detector(UPLC-ELSD):Acclaim RSLC 120 C_(18)(100 mm×2.1 mm,2.2μm)was the analytical column,ELSD detector,the mobile phase was acetonitrile-water(32:68)at a flow rate of 0.4 ml/min,column temperature was 30℃,the injection volume was 1μl.Results TLC method could specifically identify Astragalus,epimedium and cuscuta.The injection volume of Astragaloside showed good linear relationship with the peak area in the range of 0.0826-0.8260μg,r=0.9996;the average recovery was 99.19%,with the relative standard deviation(RSD)of 0.74%.Conclusion The qualitative identification and quantitative analysis of Qigui Yangxue granules are carried out by TLC and UPLC-ELSD assays,and the established methods are exclusive and accurate,which can be used for the quality control of Qigui Yangxue granules.

关 键 词：芪归养血颗粒 质控标准 薄层色谱法 超高效液相色谱-蒸发光散射检测法 

分 类 号：R286.0[医药卫生—中药学]