| 格列齐特缓释片药物动力学及人体相对生物利用度研究 |
| |
| 引用本文： | 刘茜,杨伦,邸东华,王桂凤,史振鹏,李力.格列齐特缓释片药物动力学及人体相对生物利用度研究[J].中国新药杂志,2008,17(20):1790-1793. |
| |
| 作者姓名： | 刘茜 杨伦 邸东华 王桂凤 史振鹏 李力 |
| |
| 作者单位： | 1. 沈阳药产大学,药分教研室,沈阳110016
2. 沈阳药产大学,高职学院,沈阳110016 |
| |
| 摘 要： | 目的:建立人血浆中格列齐特浓度的LC/MS/MS测定方法,并研究两种格列齐特缓释片的药动学及人体相对生物利用度.方法:采用随机双交叉试验方法,测定18例健康男性志愿者单剂量以及多剂量口服格列齐特缓释片后的血药浓度,并对受试制剂与参比制剂的生物等效性进行评价.结果:单剂量口服受试制剂和参比制剂的Tmax分别为(6.44±1.42)和(6.44±1.15)h;Cmax分别为(730±136)和(735±155)ng·mL-1;t1/2分别为(15.4±4.48)和(14.5±1.91)h;Cl分别为(2.12±0.60)和(2.11±0.70)L·h-1;Vd分别为(45.0±10.2)和(44.5±15.4)L.多剂量口服受试制剂和参比制剂的Tmax分别为(6.11±0.83)和(6.06±0.73)h;Cmax分别为(1 354±420)和(1 324±430)ng·mL-1;Cmin分别为(244±63.2)和(254±59.6)ng·mL-1;Cav分别为(496±182)和(505±218)ng·mL-1.结论:单剂量和多剂量口服格列齐特缓释片后,体内相对生物利用度分别为(98.3±14.3)%和(99.8±8.4)%.经方差分析和双单侧t检验,表明2种制剂在人体内生物等效.
|
| 关 键 词： | 格列齐特 缓释片 液相色谱-质谱联用 生物利用度 |
Pharmacokinetics and relative bioavailability of gliclazide sustained-release tablet in healthy volunteers |
| |
| LIU Qian,YANG Lun,DI Dong-hua,WANG Gui-feng,SHI Zhen-peng,LI Li.Pharmacokinetics and relative bioavailability of gliclazide sustained-release tablet in healthy volunteers[J].Chinese Journal of New Drugs,2008,17(20):1790-1793. |
| |
| Authors: | LIU Qian YANG Lun DI Dong-hua WANG Gui-feng SHI Zhen-peng LI Li |
| |
| Institution: | 1 Department of Parmaceutical Analysis;2 Vocational and Technical School;Shenyang Pharmaceutical University;Shenyang 110016;China |
| |
| Abstract: | Objective: To establish a LC/MS/MS method for determination of gliclazide in human plasma,and to investigate pharmacokinetics and relative bioavailability of gliclazide sustained-release tablet in healthy male volunteers.Methods: In 18 healthy volunteers,single and multiple oral doses of gliclazide sustained-release tablet were administrated in a randomized cross-over design.Plasma concentration of glaclizide was determined by LC/MS/MS method,and pharmacokinetics and relative bioavailability were evaluated.... |
| |
| Keywords: | gliclazide sustained-release tablet LC/MS/MS bioavailability |
| 本文献已被 CNKI 万方数据 等数据库收录！ |
| 点击此处可从《中国新药杂志》浏览原始摘要信息 |
|
