芪归参胶囊质量标准研究

Study on Quality Standard for QiGuiShen Capsule

目的:建立芪归参胶囊的质量标准。方法:以色谱柱法对制剂中黄芪、当归的主要成份进行定量鉴别,对党参、大枣进行定性鉴别。结果:色谱柱法易于识别,阴性对照无干扰;黄芪甲苷量在0.4212～2.1060μg范围内,阿魏酸在0.0864～0.4323μg范围内皆具有良好的线性关系。结论:该质量标准测定方法操作简便,结果可信,可作为芪归参胶囊质量控制方法。

Objective：To establish quality standard for QiGuiShen capsule.Method：Main ingredients HuangQi（radix astragali） and DangGui（angelica sinensis） in the preparation were identified quantitatively with chromatographic column,Dangshen（root of pilose asiabell） and date were qualitatively identified.Result：This method was exclusive,the negative control had no interference;the contents of astragaloside Ⅳ and ferulic acid showed good linear relationship respectively in the range of 0.4212～2.1060 μg and 0.086 4～0.432 3 μg.Conclusion：The method,simple and reliable,could be taken as quality standard for QiGuiShen capsule.