二甲双胍片在中国健康男性志愿者中的药代动力学及其生物利用度  

Pharmacokinetics and relative bioavailability of metformin tablet in Ch inese healthy male volunteers

作　　者：赵华琪[1] 孙华[2] 陈波[2] 裘福荣[2] 

机构地区：[1]苏州大学附属第一医院药剂科 [2]皖南医学院弋矶山医院

出　　处：《中国临床药理学与治疗学》2003年第6期666-668,共3页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的 :研究中国健康志愿者口服二甲双胍片的人体药代动力学和相对生物利用度。方法 :18名健康志愿受试者随机双交叉口服二甲双胍受试药和参比药各 10 0 0mg ,阳离子交换柱HPLC法测定血浆中二甲双胍浓度。结果 :受试药及参比药药代动力学参数分别为T1 2 2 .9± 0 .2与 3.0± 0 .5h ;Cmax1.8± 0 .5与 1.7± 0 .3mg·L-1;Tmax1.6± 0 .7与 2 .4± 0 .8h ;AUC0～ 12 8.6± 1.9与 8.6± 2 .0mg·h-1·L-1。受试药相对生物利用度为 10 2± 14 %。结论 :试验药和参比药药动学参数相似 。AIM: To study the pharmacokinetics and relative bioavailabli ty of metformin tablets in Chinese healthy male volunteers. METHODS: Eighteen male healthy volunteers received 1 000 mg metformin tablet orally a ccording to a crossover design. Drug concentrations in plasma were determined by high performance liquid chromatography with cation-exchange technique. RESULTS: The pharmacokinetic parameters of tested and reference tablet s were as follows: T 1/2 2.9 ± 0.2 and 3.0 ± 0. 5 h, C max 1.8 ± 0.5 and 1.7 ± 0.3 mg·L -1 , T max 1.6 ± 0.7 and 2.4 ± 0.8 h, and AUC 0～12 8.6 ± 1.9 and 8.6 ± 2.0 mg·h -1 ·L -1 . T he relative bioavailability of metformin tablets was 102±14%. CONCLUSIO N: The tested and reference preparations of metformin show bioequivalenc e.

关 键 词：药理学 二甲双胍 HPLC 药代动力学生 物利用度 

分 类 号：R969.4[医药卫生—药理学] R969.1[医药卫生—药学]