复方氨酚烷胺片质量标准研究  

Study on the Quality Standard of Compound Paracetamol and Amantadine Hydrochloride Tablets

作　　者：何倌发 李春华 彭会娟 艾珊 周结祥 张珊珊 HE Guanfa;LI Chunhua;PENG Huijuan;AI Shan;ZHOU Jiexiang;ZHANG Shanshan(Fuzhou Inspection&Testing Certification Center,Fuzhou Jiangxi 344000,China;Jiangxi Drug Inspection Center,Nanchang Jiangxi 330029,China.)

机构地区：[1]抚州市检验检测认证中心,江西抚州344000 [2]江西省药品检查员中心,江西南昌330029

出　　处：《药品评价》2024年第1期32-35,共4页Drug Evaluation

基　　金：抚州市第一批市级指导性科技计划项目[抚科计字(2021)7号文第73号]。

摘　　要：目的完善复方氨酚烷胺片的质量标准,提高质量标准的质量控制水平。方法建立HPLC法测定杂质对氨基酚的含量;建立HPLC法同时测定对乙酰氨基酚、咖啡因和马来酸氯苯那敏的含量;建立HPLC法同时测定咖啡因和马来酸氯苯那敏的含量均匀度。结果所建立的HPLC法测定对氨基酚杂质、含量均匀度及含量测定的方法,其线性关系均良好,准确可靠,重复性较好。按拟定的标准,19批次复方氨酚烷胺片样品中有1批次样品咖啡因含量测定项目不符合规定,有1批次样品咖啡因含量均匀度项目不符合规定。结论本研究提高和完善了复方氨酚烷胺片的质量控制项目,为更全面控制复方氨酚烷胺片的质量提供方法和参考。Objective To perfect the quality standard of compound paracetamol and amantadine hydrochloride tablets and improve the quality control level of the quality standard.Methods The HPLC method was established for p-aminophenol impurities,the simultaneous determination of paracetamol,caffeine and chlorpheniramine.The HPLC method was established for the simultaneous determination of paracetamol,caffeine and chlorpheniramine,and the HPLC method was established for the simultaneous determination of the content uniformity of caffeine and chlorpheniramine.Results The established HPLC method for the determination of impurities,content and content uniformity has good linear relationship,accuracy,reliability and repeatability.According to the proposed standards,in 19 batches of samples,the content of caffeine in one batch exceeded the standard range,and the content uniformity of caffeine in one batch exceeded the standard range.Conclusion This study improved and perfected the quality control method,and provided the method and reference for more comprehensive quality control of compound paracetamol and amantadine hydrochloride tablets.

关 键 词：质量控制 复方氨酚烷胺片 杂质 含量测定 含量均匀度 

分 类 号：R927.1[医药卫生—药学]