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.