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复方感冒灵胶囊质量标准研究
引用本文:高咏莉,王淑红. 复方感冒灵胶囊质量标准研究[J]. 中国药师, 2012, 15(4): 474-477
作者姓名:高咏莉  王淑红
作者单位:深圳市药品检验所,广东深圳,518057
基金项目:国家药典委员会2010~2011年标准提高行动计划研究课题
摘    要: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 0~2.574 μg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.

关 键 词:复方感冒灵胶囊  质量标准  薄层色谱  高效液相色谱
收稿时间:2011-12-26
修稿时间:2012-01-29

Study on Quality Standard of Compound Ganmaoling Capsules
Gao Yongli and Wang Shuhong. Study on Quality Standard of Compound Ganmaoling Capsules[J]. China Pharmacist, 2012, 15(4): 474-477
Authors:Gao Yongli and Wang Shuhong
Affiliation:(Shenzhen Institute for Drug Control,Guangdong Shenzhen 518057,China)
Abstract: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.
Keywords:Compound Ganmaoling capsules  Quality standard  TLC  HPLC
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