高欣胶囊的质量标准研究

Studies of the Quality Standard for Gaoxin Capsule

目的建立高欣胶囊的质量标准。方法采用薄层色谱法对淫羊藿、蒺藜药材进行定性鉴别;采用高效液相色谱法测定高欣胶囊中淫羊藿苷的含量。Agilent 1100高效液相色谱仪,Kromasil C18色谱柱（250 mm×4.6 mm,5μm）;流动相：乙腈-1%醋酸水溶液（21∶79）;流速：1 ml/min;检测波长：270 nm;柱温：室温。结果薄层色谱鉴别方法专属性强;淫羊藿苷在0.209~1.045μg范围内呈良好线性关系,线性方程：Y=3624.3X＋2.2888,r=0.9999,平均加样回收率为100.07%,RSD为1.44%。结论本质量标准方法简单、操作简便、结果准确、重复性好,可有效控制高欣胶囊的质量。

Objective To establish a quality control standard for Gaoxin Capsule.Methods The thin liquid chromatography was used to identify the botanical drugs of Herba Epimedii and Tribulus Terrestris and the high performance liquid chromatography method was applied to determine the content of icariin in Gaoxin Capsule,based on a Kromasil C18 column（250 mm × 4.6 mm,5 μm） with an elution solvent system composed of acetonitrile-1% acetic acid water solution（21∶79） at a flow rate of 1 ml/min.The detection wavelength was set at 270 nm and the column temperature was at room temperature.Results The two botanical drugs could be identified by the established standard with high specificity.The calibration curve of icariin was linear with in the range of 0.209 to 1.045 μg and the correlation coefficient was 0.9999.The average recovery ratio and relative standard deviation were 100.07% and 1.44%,respectively.Conclusion This quality standard is easy,user-friendly,accurate and reproducible,which can be used for quality control of Gaoxin Capsule.