盐酸特比萘芬片的人体生物等效性研究.pdf

1222222222212 ChineseJournalofNewDrugs2008,,史卉妍2,谭志荣1,罗丽芳1,郭栋1,刘英姿1(1中南大学临床药理研究所,长沙410078;2上海美迪西生物医药有限公司,上海201203) [摘要] 目的:评价盐酸特比萘芬片人体生物等效性。方法:18例健康志愿者随机交叉口服单剂量(025g)盐酸特比萘芬片试验制剂与参比制剂,采用LCMS/MS法测定血浆中特比萘芬的血药浓度。结果:-1试验制剂与参比制剂的主要药动学参数Cmax分别为(±)和(±)μg·L,Tmax分别为-1(±)和(±)h,AUC0~72h分别为(±)和(±)μg·h·L,-1AUC0~∞分别为(±)和(±)μg·h·L。试验制剂对参比制剂的相对生物利用度F(以AUC0~72h作为评价依据)为(98±9)%。结论:盐酸特比萘芬片试验制剂与参比制剂生物等效。[关键词] 盐酸特比萘芬片;生物等效性;LCMS/MS法[中图分类号]; [文献标识码]A [文章编号]1003-3734(2008)14-1261-03BioequivalenceofterbinafinehydrochloridetabletsinhealthyvolunteersOUYANGDongsheng1,SHIHuiyan2,TANZhirong1,LUOLifang1,GUODong1,LIUYingzi1(1ClinicalPharmacologyInstituteofCentralSouthUniversity,Changsha410078,China;2ShanghaiMedicilonIncorporation,Shanghai201203,China)[Abstract] Objective::Theplasmaconcentrationsofterbinafinefrom18healthymalevolunteers,,weremeasuredbyLCMS/:icprofilesof-1testandreferenceterbinafinewereCmax,(±)vs(±)μg·L;Tmax,(±)vs-1(±)h;AUC0~72h,(±)vs(±)μg·h·L;AUC0~∞,(±)vs(±)μg·h·L-1,