盐酸二甲双胍肠溶胶囊人体药动学及生物等效性.doc

盐酸二甲双胍肠溶胶囊人体药动学及生物等效性盐酸二甲双胍肠溶胶囊人体药动学及生物等效性中国医药工业杂志ChineseJournalofPharmaceuticals2008,39(7)盐酸二甲双胍肠溶胶囊人体药动学及生物等效性王华光,朱莹,吴华,潘世芬,郑文婕(,北京100020;,北京100081)?523?摘要:采用双周期随机交叉给药法,比较T2o名健康男性志愿者单剂量口服盐酸二甲双胍肠溶胶囊500mg后的药物动力学,—MS/MS法测定血浆药物浓度,结果表明,受试制剂和参比制剂的主要药物动力学参数为:Cmax为(~)和(+)ng/ml,tm为(+)h和(+)h,AUCo.+24h为(?1027_3)和(+)h?ng?ml,,一为(~)和(~)h?ng?ml...受试制剂的相对生物利用度为(+)%,:盐酸二甲双胍肠溶胶囊;药动学;生物等效性;液相色谱一串联质谱中图分类号:R969文献标识码:A文章编号:1001—8255(2008)07—0523—apsulesinHumanWANGHuaguang,ZHUYing,WUHua,PANShi—fen,ZHENGWen-jie(,BeO’ingChaoyangHospitalAffiliateofCapi~lUniversityofMedicalSciences,&Technology,BeijingInstituteofTechnology,Beijing100081)ABSTRACT:Accordingtoarandomizedtwo—periodcross—overdesign,—MS/:Cma(+)and(+)ng/ml,(?)and(?)h,(+)and(?)h’ng’ml,,AUG.(+)and(?)h’ng’ml,.Therelativebioavailabilityoftestpreparationwas(?)%.:apsule;ics;bioequivalence;LC—MS/MS双胍类降血糖药对糖尿病患者有良好降糖作用,