消炎退热颗粒质量标准的研究

Studies on quality standard of Xiaoyantuire Granules

目的：建立消炎退热颗粒（大青叶、紫花地丁、甘草等）的质量标准。方法：采用薄层色谱法对大青叶、紫花地丁进行定性鉴别;用HPLC法对制剂中的甘草酸进行定量分析,流动相：乙醇-0.2mol·L^-1醋酸铵溶液-冰醋酸（42∶56∶2）,检测波长：254nm,流速：0.5m L·min^-1。结果：甘草酸在18.56～167.03μg·mL^-1范围内呈良好线性关系,r=0.99995,平均回收率为99.05%,RSD为1.5%。结论：该方法简便、准确,可用于消炎退热颗粒的质量控制。

Objective： To establish the quality standard for Xiaoyantuire Granules （Folium Isatidis, Herba Violae, Radix Glycyrrhizae, etc.）. Methods： The Folium Isatidis, Herba Violae were identified by TLC. The content of glycyrrhizic acid was determined by HPLC. The mobile phase ethanol -0.2mol·L^-1 ammonium acetate solution-acetic acid glacial （42：56：2） and detection at 254nm. The flow rate was 0.5mL·min^-1. Results： The liner range of glycyrrhizic acid was 18.56- 167.03μg·mL^-1, r=0.99995. The average recovery was 99.05%, the RSD was 1.5%. Conclusion： The method was simple, accurate. The method can be used for quality control of the Xiaoyantuire Granules.