复方感冒灵胶囊质量标准研究

Study on Quality Standard of Compound Ganmaoling Capsules

目的:建立复方感冒灵胶囊的质量标准。方法:采用薄层色谱法,对三叉苦进行定性鉴别;采用HPLC法对马来酸氯苯那敏进行含量测定及含量均匀度检查。结果:该薄层色谱法专属性强、阴性无干扰,可对三叉苦进行定性鉴别;液相色谱条件有效改善了色谱峰拖尾现象,马来酸氯苯那敏在0.103 0～2.574μg范围内线性关系良好(r=0.999 9),平均回收率为102.0%(RSD=2.08%)。结论:该方法简便、准确、稳定且无干扰,可作为该制剂的质量控制方法。

Objective： To establish the quality standard for compound Ganmaoling capsules.Method： Evodia lepta was identified by TLC.The content and content uniformity of chlorphenamine maleate was determined by HPLC.Result： The method of TLC was distinct and highly specific.The chromatographic conditions could effectively improve the streaking.A linearity was obtained within the range of 0.103 0~2.574 μg for chlorphenamine maleate（r=0.999 9）.The average recovery was 102.0%（RSD=2.08%）.Conclusion： The method is simple,sensitivity and stable,and can be used in the quality control of compound Ganmaoling capsules.