复方感冒灵片质量研究  

Study on quality standard of Fufang Ganmaoling Tablets

作　　者：高咏莉[1] 李国锋 王淑红[1] 李军[1] 

机构地区：[1]深圳市药品检验所,518057 [2]葛兰素史克有限公司

出　　处：《中国现代药物应用》2012年第12期1-2,共2页Chinese Journal of Modern Drug Application

摘　　要：目的建立并完善复方感冒灵片的质量标准。方法采用反相HPLC法,流动相为乙腈-磷酸盐缓冲液,对马来酸氯苯那敏进行含量测定及含量均匀度检查。结果所采用的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0.1003～2.595μg范围内线性关系良好,平均回收率为102.7%(RSD=1.84%)。结论该方法简便、准确,可作为该制剂的质量控制方法。Objective To establish and perfect the quality standard for Fufang Ganmaoling Tablets. Methods HPLC was performed for the determination and content uniformity of cldorphenamine maleate by the mobile phase of acetonitrile-buffer phosphate. Results The Chromatographic conditions had effectively im- proved the trailing phenomenon of peak. A linearity was obtained from 0. 1003-2. 595μg of chlorphenamine maleate ,The average recovery rate was 102.7% （ RSD = 1.84% ）. Conclusion The method was simple and accurate, it can be used as the quality control method for Fufang Ganmaoling Tablets.

关 键 词：复方感冒灵片 含量测定 含量均匀度 

分 类 号：R286.0[医药卫生—中药学]