止咳平喘凝胶剂质量标准研究

Study on Quality Standard of Cough and Dyspnea Relieving Gel

目的：建立止咳平喘凝胶剂质量控制标准。方法：采用高效液相色谱法测定凝胶剂中甲基丁香酚含量，同时对药品外观性状、酸碱度、马兜铃酸I进行检查。结果：本品为淡黄色凝胶；pH值在7．0～8．5之间；马兜铃酸I未检出；甲基丁香酚含量分别为2．06、2．14、2．31mg／g，平均回收率为95．4％，RSD为1．35％。结论：所建立的方法准确、快捷、可控，可作为该制剂的质量控制标准。

Objective： To establish the quality control standard of cough and dyspnea relieving gel. Methods： The contents of methyl eugenol were determined by HPLC,and the appearance,traits,pH value and Aristolochic acid I were examined respectively. Result ： It was faint yellow gel. The pH value was between 7.0 - 8.5. Aristolochic acid I was not detected. The contents of methyl eugenol were 2.06mg/g,2.14mg/g,2.31mg/g,and the average recovery was 95.4%, RSD was 1.35%. Conclusion： This method is precise,rapid,controllable and could be used as quality control standard of cough and dyspnea relieving gel.