复芪止汗颗粒中黄芪甲苷含量的高效液相色谱—蒸发光检测法测定

Determination of astragaloside Ⅳ in Fuqi Zhihan Granules by HPLC-ELSD

目的建立复芪止汗颗粒中黄芪专属性化学成分黄芪甲苷含量的高效液相-蒸发光散射检测器测定方法,完善和提高质量标准。方法以黄芪甲苷含量为指标,考察了液相色谱法色谱条件、流动相、线性范围、样品制备方法和中药质量标准分析方法验证试验。结果以水为溶剂,加热回流后,用水饱和的正丁醇提取,用氨试液洗涤,正丁醇液蒸干,残渣加甲醇溶解的方法制备供试品,样品的平均回收率为100.0%,RSD为1.5%（n=6）,黄芪甲苷在0.4152-12.456μg范围内线性关系良好。结论该方法准确可靠、重复性好,适用于复芪止汗颗粒的质量控制。

Objective To establish a high performance liquid chromatography-evaporative light-scattering detector（HPLC-ELSD） method to determine astragaloside Ⅳ,one of characteristic compounds in Radix Astragali to enhance quality standard for Fuqi Zhihan Granules.Methods With the content of astragaloside Ⅳ as index,chromatographic conditions,mobile phase,linear range,preparation of sample and analytic method validation text of traditional Chinese medicine were investigated.Results The sample was dissolved by water and refluxed,and then extracted with n-butanol saturated with water,washed with ammonia test solution,n-butanol solution was evaporated,the residue was dissolved in methanol and the preparation of text solution was finished.The average recovery was 100.0% and the RSD was 1.5%（n=6）.The linear range of astragaloside Ⅳ was 0.4152～12.456 μg.Conclusion The method was applicable to quality control of Fuqi Zhihan Granules with good accuracy,reliability and reproducibility.