乙肝清热解毒片质量标准的改进

Quality standards improvement of Yigan Qingre Jiedu tablets

目的:改进乙肝清热解毒片的质量标准。方法:增加茜草的薄层色谱,修订虎杖的含量测定方法为HPLC法测定虎杖苷的含量。HPLC色谱条件:采用SUNTEK Kromasil C18(4.6 mm×250 mm,5μm)色谱柱,流动相为乙腈-水(18∶82),流速1.0mL.min-1,柱温30℃,检测波长306 nm。结果:茜草的薄层色谱斑点分离良好;虎杖苷的含量测定方法专属性高,虎杖苷峰与其他峰分离良好,0.0615～0.6152μg范围内呈良好的线性关系,加样回收率为98.4%(RSD=1.8%)。结论:通过对乙肝清热解毒片质量标准的改进,使标准更具有专属性,更有利于该产品的质量控制。

Objective：To improve the quality standard of Yigan Qingre Jiedu tablets.Methods：TLC method for identification of Rubiae Radix et Rhizoma was increased,and HPLC method for the content determination of polydatin in Polygoni Cuspidati Rhizoma was revised.HPLC conditions：SUNTEK Kromasil C18（4.6 mm×250 mm,5 μm） column was adopted;The mobile phase was acetonitrile-water（18∶82）,at the flow rate of 1.0 mL·min^-1;The column temperature was 30 ℃,and the detection wavelength was 306 nm.Results：The madder spots were separated by TLC.The content of polydatin was determined by HPLC with the average recovery of 98.36%（RSD=1.8%） in the range of 0.0615-0.6152 μg.Conclusion：The improved standard has more specificity and more advantageous to the product＇s quality control.