呋塞米片原研药与仿制药溶出曲线的研究  

Research on Dissolution Curves of Generic and Original Furosemide Tablets

作　　者：任璐彤 周刚 高佳丽[3] REN Lutong;ZHOU Gang;GAO Jiali(Inner Mongolia People’s Hospital,Hohhot 010000,China;Inner Mongolia Institute of Pharmaceutical Inspection,Hohhot 010000,China;The Affiliated Hospital of Inner Mongolia Medical University,Hohhot 010000,China)

机构地区：[1]内蒙古自治区人民医院,呼和浩特010000 [2]内蒙古自治区药品检验研究院,呼和浩特010000 [3]内蒙古医科大学附属医院,呼和浩特010000

出　　处：《中国现代应用药学》2020年第14期1681-1686,共6页Chinese Journal of Modern Applied Pharmacy

基　　金：国家食品药品监督管理总局仿制药一致性评价研究项目(食药监办药化管[2013]38号)。

摘　　要：目的建立呋塞米体外溶出度曲线试验方法,进行原研药与仿制药的相似性评价,提高药品一致性。方法绘制溶出度曲线研究原研药在不同溶出介质中的溶出情况,采用f2因子法评价仿制药与原研药的相似性。结果11种国产呋塞米片仿制药与参比制剂无法达到5条溶出曲线f2因子均>50的要求。结论呋塞米片仿制药与原研药5条溶出曲线相差甚多,不符合评价要求,提示国产仿制药在处方或工艺上亟需改进。OBJECTIVE To establish a method for the dissolution curves in vitro,evaluate the similarity between original and generic drugs,improve the consistency and the level of medical service.METHODS Draw the dissolution curve of the original drug research different dissolution conditions of medium.Used f2 factor method to evaluate generic and original drugs similarity.RESULTS Eleven domestic furosemide tablets and reference preparations could not meet the requirements of f2 factors in 5 dissolution curves,all of which were>50.CONCLUSION There is a big difference between the dissolution curves of generic and the original furosemide tablets,which does not conform to evaluation requirements,suggesting that the formulation and production process of generic furosemide need to be improved.

关 键 词：呋塞米片 仿制药 原研药 溶出曲线 F2因子 

分 类 号：R927.1[医药卫生—药学]