根痛平胶囊的质量标准研究

Study on Quality Standard of Gentongping Capsules

目的:建立根痛平胶囊的质量标准。方法:采用薄层色谱法对该制剂中的葛根和牛膝进行鉴别,采用高效液相色谱法测定制剂中芍药苷的含量。色谱柱:迪马C_(18)(250 mm×4.6 mm,5μm);流动相:甲醇-0.05 mol·L^(-1)磷酸二氢钾水溶液-三乙胺(28:72:0.5);流速:0.8 ml·min^(-1);柱温40℃;检测波长为230 nm。结果:薄层色谱斑点清晰,重现性好;芍药苷的平均加样回收率为98.46%,RSD为1.3%(n=6)。结论:该方法准确可靠,重复性好,为根痛平胶囊的质量控制和评价提供了依据。

Objective： To establish the quality standard for gentongping capsules. Method： Kudzuvine Root and Twotoothed Achy- ranthes Root were identified by TLC,and the content of peoniflorin was determined by HPLC. The Diamonisil Cls （250 mm x4.6 mm, 5 μm） analytic column was used and the mobile phase was mixture of 0. 5% triethylamine/methanol （28%） and 0. 5% triethylamine/ 0. 05 mol. L-1 potassium dihydrogen phosphate water （72 % ）. The detection wavelength was set at 230 nm. Result： The TLC spots were clear and reproducible. The average recovery rate of peoniflorin by HPLC was 98. 46% and RSD was 1.3% （n =6）. Conclusion： The method is reliable and accurate with high reproducibility. It can be used for quality control of gentongping capsules.