降脂护肝胶囊质量标准研究

目的：建立降脂护肝胶囊的质量标准。方法：采用薄层色谱法鉴别降脂护肝胶囊中山楂、葛根;高效液相色谱法测定熊果酸的含量。HPLC法采用Symmetry C18（3.9 mm×150 mm,5μm）色谱柱,以乙腈-甲醇-0.5%醋酸铵（69∶12∶19）为流动相;流速：0.8 ml/min;检测波长：220 nm。结果：TLC鉴别图谱斑点清晰,阴性无干扰;熊果酸进样量在0.48～14.4μg范围内呈良好线性关系（r=0.999 9）,平均加样回收率及RSD分别为98.43%和0.57%（n=5）。结论：采用TLC法和HPLC法控制降脂护肝胶囊质量的方法简便快速、准确可靠、重复性好,专属性强。

Research on quality standard of Jiangzhi Hugan Capsules

Objective：To establish a method for quality control of Jiangzhi Hugan Capsules.Methods：Fructus crataegi and Radix puerariae in Jiangzhi Hugan Capsules was identified by TLC.Ursolic acid was determined by HPLC.The symmetry C18 column（3.9 mm×150 mm,5 μm） was used with a mobile phase of acetonitrile-methanol-0.5% ammonium acetate（69∶12∶19） and a flow rate of 0.8 ml/min,at the detection wavelength of 220 nm.Results：The picture of TLC was clear and negative control had no interference.The method of HPLC showed good linear relation（r=0.999 9） in the range of 0.48-14.4 μg for ursolic acid.The average recovery was 98.43% whit a RSD of 0.57%.Conclusion：TLC and HPLC method are convenient,fast,accurate,repeatable and special,and can be used to control Jiangzhi Hugan Capsules.