肠炎宁口服液质量标准研究

Research on Quality Standards of Changyanning Oral Liquid

目的制订肠炎宁口服液的质量标准。方法用薄层色谱(TLC)法对地锦草作鉴别,用高效液相色谱(HPLC)法测定没食子酸的含量。结果采用薄层色谱法能检出地锦草。没食子酸进样质量浓度在43.92～307.44μg/mL范围内与峰面积积分值呈良好线性关系,r=0.999 7,平均加样回收率为101.12%,RSD为1.69%(n=5)。结论所建立的方法简便可行、重现性好,为肠炎宁口服液的质量标准控制提供了参考。

Objective To establish the quality standards of Changyanning Oral Liquid. Methods Euphorbia humifusa in Changyanning Oral Liquid was identified by TLC and the content of gallic acid was determined by HPLC. Results Euphorbia humifusa was detected by TLC and the content of gallic acid was measured by HPLC. Gallic acid showed the good linear relationship in the range of 43.92 - 307.44 μg/mL, r =0. 999 7,the average recovery rate was 101. 12%, RSD = 1.69% （ n =5）. Conclusion The established method is simple and feasible with good repeatability,and offers good reference for controlling the quality standards of Changyanning Oral Liquid.