肠炎宁片定性定量方法研究

Quality standard of Changyanning tablet

目的：建立肠炎宁片质量标准。方法：采用薄层色谱法对黄毛耳草进行薄层鉴别研究，采用HPLC建立鸡矢藤苷甲酯的含量测定方法，色谱柱为AgilentHC—C18柱，流动相为乙腈-水（7：93），测定波长为238nm。结果：黄毛耳草在其色谱条件下获很好分离；鸡矢藤苷甲酯在22．08～552μg·mL^-1范围内浓度与峰面积呈良好线性关系，平均回收率为98．3％（n=7），RSD为1．38％。结论：此方法简便、快速、重复性好，可作为该制剂的质量控制方法。

Objective：To establish the quality standard of Changyanning tablets. Methods：Herba hedyotis chrysotrichae was identified by TLC. The content of scandoside methyl ester was determined by a HPLC assay. The separation was performed on an Agilent HC-C18column with the mobile phase consisting of acetonitrile-water （7： 93）. The detection wavelength was 238 rim. Results： Herba hedyotis chrysotrichae was separated very well. There is a good linearity in the range of 22.08 -552 μg· mL^-1 for scandoside methyl ester. The average recovery was 98.3% （n = 7 ） , and RSD was 1.38%. Conclusion ： This method is simple, rapid, reproducible, and can be used for the control of the quality of Changyanning tablet.