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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 of Fu Gan Gan Ling capsules. Methods: Thin layer chromatography was used to qualitatively identify trigeminalgia. HPLC was used to determine the content of chlorphenamine maleate and content uniformity. Results: The specificity of thin layer chromatography was negative and non-interfering, which could be used for the qualitative identification of trigeminalgia. Liquid chromatographic conditions could effectively improve the tailing of chromatographic peaks. Chlorphenamine maleate was in the range of 0.103 0 ~ 2.574μg The linear relationship was good (r = 0.999 9) with an average recovery of 102.0% (RSD = 2.08%). Conclusion: The method is simple, accurate, stable and non-interfering and can be used as a quality control method for this preparation.