中国临床药理学与治疗学2004，Vol.9Issue(6)：623-627,5.
复方二甲双胍胶囊在健康受试者体内的药物动力学和相对生物利用度
Pharmacokinetics and relative bioavailability of compound metformin hydrochloride and glibenclamide capsule in healthy Chinese volunteers
印晓星 1张银娣 1丁黎 2沈建平 1李丽敏 1邱俊1
作者信息
- 1. 南京医科大学临床药理研究所,南京,210029,江苏
- 2. 中国药科大学药物分析教研室,南京,210009,江苏
- 折叠
摘要
Abstract
AIM: To compare pharmacokinetics and relative bioavailability of metformin and glibenclamide in compound metformin hydrochloride and glibenclamide capsule (CMGC) with the reference preparations mefformin tablet (MT) and glibenclamide tabet (GT). METHODS: Twenty male healthy volunteers were enrolled in a randomized two-way crossover design with a single-oral dose study. The plasma metformin and glibenclamide concentrations were determined by high performance liquid chromatography (HPLC) and liquid chromatography-mass spectrography (LC-MS), respectively. Pharmacokinetics parameters were calculated and bioequivalability was analyzed by two one-side t-test. RESULTS: The pharmacokinetics parameters of metformin in CMGC and co-administration of metformin/glinbenclamide were as following,respectively: Cmax ( 1.87 + 0.36 and 1.77 + 0.35 )those of glinbenclamide were as following, respectively:(2.3+0.7 and 2.6+0.9) h; AUC0-∞ (0.690+0.228ability of metformin and glibenclamide in CGMC were 95.0% ± 11.5% and 109.6% + 8.8%, respectively.CONCLUSION: The main components of CMGC, metformin and glibenclamide, are bioequivalent to the reference tablets, MT and GT.关键词
二甲双胍/格列本脲/药物动力学/生物利用度Key words
metformin/glibenclamide/pharmacokinetics/bioavailability分类
医药卫生引用本文复制引用
印晓星,张银娣,丁黎,沈建平,李丽敏,邱俊..复方二甲双胍胶囊在健康受试者体内的药物动力学和相对生物利用度[J].中国临床药理学与治疗学,2004,9(6):623-627,5.
