复方感冒灵片质量评价  

Quality evaluation of Compound Ganmaoling Tablets

作　　者：廖嘉仪 吴雪缘[1] 丁佳佳 源淑莹 王琦[1] 曾志坚[1] LIAO Jia-yi;WU Xue-yuan;DING Jia-jia(Jiangmen Institute for Drug Control,Jiangmen 529000,China)

机构地区：[1]江门市药品检验所,广东江门529000

出　　处：《中国处方药》2023年第3期31-34,共4页Journal of China Prescription Drug

摘　　要：目的了解复方感冒灵片的质量有关问题,为监管提供参考。方法随机抽取市售复方感冒灵片,按照法定标准检验;针对法定标准不足,建立高效液相色谱法测定样品的对乙酰氨基酚、咖啡因和马来酸氯苯那敏含量,分析结果,评价样品质量情况。结果共抽检50批次样品,涉及10家生产单位;按法定标准检验,合格率为100%;通过方法学考察,新建立的HPLC法灵敏、准确,样品的对乙酰氨基酚和马来酸氯苯那敏含量均在合理范围内,但同一生产单位的2批样品咖啡因含量远低于处方量。结论样品总体质量状况良好,但存在问题药品,药品质控和检验标准有待提高。Objective To determine the quality of Compound Ganmaoling Tablets,and to provide reference for supervision.Methods Compound Ganmaoling Tablets samples were randomly selected and tested by statutory standards.Basing on the defects of statutory standard,a high performance liquid chromatography method was established to determine the content of acetaminophen,caffeine and chlorpheniramine maleate.We analyze the results to evaluate the quality of samples.Results 50 batches of ten manufacturing enterprises were randomly collected.According to statutory standard,the qualified rate was 100%.The new method is sensitive and accurate.The contents of acetaminophen and chlorpheniramine maleate in the samples were reasonable,while the contents of caffeine in two batches from the same manufacturer were much lower than the prescriptive dosage.Conclusion The overall quality status of the samples is good,but still there are unqualified drugs.Quality control and standards need to be improved.

关 键 词：复方感冒灵片 对乙酰氨基酚 咖啡因 马来酸氯苯那敏 

分 类 号：R286.0[医药卫生—中药学]