盐酸二甲双胍肠溶片的药动学及生物等效性研究.doc

盐酸二甲双胍肠溶片的药动学及生物等效性研究高洁1*,曲素新2(11青岛市市南区八大峡社区卫生服务中心,青岛市266002;21青岛市儿童医院,青岛市266002)中图分类号R96911文献标识码A文章编号1001-0408(2009)20-1552-02摘要目的:研究盐酸二甲双胍肠溶片的药动学和相对生物利用度,。方法:采用高效液相色谱法测定261000mg后的经-时血药浓度,计算主要药动学参数以及国产制剂的相对生物利用度。结果:-时曲线符合一室模型,(8415±(0177±其主要药动学参数:Cmax分别为(8419±1614)、1318)g,(0107)、0108)h,t1/2ke分别为-1(1190±(1179±0117)、0119)h,AUC0~t分别为(191)7)μg・h・L,AUC0~∞分别为(17917±1812)、-1(17314±1912)μg・h・L。(10910±712)%。结论:国产与进口盐酸二甲双胍肠溶片生物等效。关键词;药动学;icsandBioequivalenceofMetforminHydrochlorideEnteric-coatedTabletsGAOJie(munityHealthServiceCenter,Qingdao266002,China)QUSu-xin(QingdaoMunicipalChildren’sHospital,Qingdao266002,China)OBJECTIVE:icsandrelativebioavailabilityofmetforminhydrochlorideenteric-coatedtabletsandvalidatethebioequivalencebetweenthedomesticandtheimportedmetforminhydrochlorideenteric-coatedtablets1METHODS:Anoralsingledose(1000mg)ofdomesticorimportedmetforminhydrochlorideenteric-coatedtabletswasgivento26healthyvolunteersinarandomizedcrossoverstudy1Thetime-put2ed1RESULTS:Theconcentration-timecurvesofthetwokindsofmetforminhydrochlorideenteric-icparametersofthedomesticvs1theimportedmetforminhy2-1-1drochlorideenteric-coatedtabletswereasfollows:Cmax(8419±1614)μg・Lvs1(8415±1318)μg・L;tmax(0167±0107)h-1vs1(0177±0108)h;t1/2Ke(1190±0117)hvs1(1179±0119)h;AUC0~t(16119±1618)μg・h・Lvs1(15712±1917)μg・h・-1-1-1L;AUC0~∞(17917±1812)μg・h・Lvs1(17314±1912)μg・h・L1Therelativebioavailabilityofthedomesticenteri