芪地胶囊质量标准研究

Study on Quality Standard of Qidi Capsules

目的 建立芪地胶囊质量标准。方法 采用薄层色谱法对黄芪和丹参进行定性鉴别;采用高效液相色谱法测定山萸肉中莫诺苷和马钱苷的含量、牡丹皮中丹皮酚的含量。结果 薄层色谱鉴别斑点清晰,阴性对照无干扰;莫诺苷、马钱苷、丹皮酚分别在8. 114-81. 140μg/ml、8. 058-80. 580μg/ml、8. 148-81. 480μg/ml范围内线性关系良好;平均加样回收率分别为99. 42%、99. 59%、99. 76%,RSD分别为1. 21%、0. 98%、1. 14%(n=6)。结论 建立的标准方法准确可靠、重现性好,可用于芪地胶囊的质量控制。

Objective To establish the quality standard for Qidi capsules.Methods Thin layer chromatography was used for qualitative identification of Astragalus Mongholicus and Salvia Miltiorrhiza.High performance liquid chromatography was used for quantitative determination of Paeonol,the active ingredient of Cortex Moutan,Morroniside and Loganin,the active ingredients of Fructus Corni.Results The spots in thin layer chromatography were clear and no interference appeared in the negative control.The calibration curve of Morroniside,Loganin and Paeonol showed good linear relations over the range of 8.114-81.140μg/ml,8.058-80.580μg/ml,8.148-81.480μg/ml,respectively.The average recovery each was 99.42%,99.59%,99.76%with the RSD of 1.21%,0.98%,1.14%(n=6).Conclusion The method is reliable and accurate with good reproducibility,and can be used for the quality control of Qidi capsules.