蒲地蓝消炎片质量控制方法研究

目的：建立蒲地蓝消炎片的质量控制方法。方法：采用薄层色谱法定性鉴别，展开剂为醋酸乙酯-丙酮-甲酸-水（13：3．5：1：1．5），用2％FeCl3乙醇溶液显色。采用反相高效液相色谱法测定蒲地蓝消炎片中黄芩苷的含量，色谱条件为Agilent ZORBAXSB C18色谱柱（4．6mm×150mm，5μm），流动相为甲醇-0．2％磷酸水溶液（42：58），检测波长为278nm，流速1．0ml／min，柱温30℃。结果：薄层色谱中供试品与对照品在相应位置上具有相同颜色的斑点。黄芩苷在0．2～2．0ng范围呈良好的线性关系，r=0．9998，回收率为99．65％，RSD为1．60％。结论：本法操作简便快速，分离效果好，稳定性高，重现性好，可全面控制蒲地蓝消炎片的质量。

Determination of Pudilan Xiaoyan Tablets

Objective： To establish a method for determination of Pudilan Xiaoyan tablets. Method： TLC was used in qualitative analysis and the chromatographic condition was as follows： ethyl acetate-acetone-formic acid-water was 13：3.5：1：1.5, colored by 2% FeCl3 solution. RP-HPLC was used to determine the content of Baicalin in Pudilan Xiaoyan Tablets. The chromatographic condition was as follows： Agilent ZORBAXSB-C18 Column was 4.6mm×150mm, 5μm; the mobile phase was methanol-0.2% phosphoric acid solution （42：58）, flow rate was 1.0ml/min and wavelength was at 278nm, and the temperature of column was 30℃. Results： The test samples and their respective reference substances were alike in that the same color chromatographic spots noted at the corresponding place. Baicaline were good linearity over the range of 0.2-2.0μg （r=0.999 8）. The average recovery was 99.65%, RSD,1.60%. Conclusion： The method was simple, sensitive, accurate, and reliable and could be used to overall control the quality of Baicaline in Pudilan Xiaoyan Tablets.