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阿片类拮抗药纳美芬注射剂的单剂量和多剂量Ⅰ期临床药代动力学研究
引用本文:廖日房,曾转萍,温预关.阿片类拮抗药纳美芬注射剂的单剂量和多剂量Ⅰ期临床药代动力学研究[J].南方医科大学学报,2008,28(10):1816-1819.
作者姓名:廖日房  曾转萍  温预关
作者单位:1. 中山大学附属第二医院临床药学部,广东,广州,510120
2. 广东药学院流行病与卫生统计教研室,广东,广州,510315
3. 广州市脑科医院临床药理研究所,广东,广州,510520
基金项目:广东省自然科学基金,广东省医学科学技术研究基金,广州市医药卫生科技计划
摘    要:目的 考察静脉推注盐酸纳美芬注射液后在健康人体内的药动学过程.方法 12名健康受试者随机交叉单剂量静脉推注给药2 mg后,分别于给药前和给药后5 min,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,36和48 h采集血样,单剂量试验结束后进人多剂量试验.8名受试者静脉推注给药2mg,连续给药6d,并于给药后的第4,5,6天早上给药前采静脉血,于第6天给药后按设定时间点采集血样,用高效液相色谱-质谱法测定血浆中纳美芬的浓度,并采用PKS药动学程序对试验数据进行处理,求算有关药动学参数.结果 单剂量静脉推注盐酸纳美芬注射液2 mg后,其药-时曲线经拟合符合二室模型,12名健康受试者单剂量给药后其主要药动学参数Cmax,Tmax,T1/2,AUC0-48,AUC0-∞分别为(7.34±1.56)μg·L-1,0.08 h,(12.01±2.20)h,(30.29±9.84)μg·L-1·h,(32.23±9.94)μg·L-1·h,多次静脉推注2 mg后的主要药动学参数Cmax,Tmax,T1/2,AUC0-48,AUC0-∞分别(8.04±1.09)μg·L-1、0.08 h、(12.43±1.44)h、(33.64±9.15)μg·L-1·h和(35.98±9.23)μg·L-1·h,血药浓度波动系数、AUCss和Cav分别为(4.69±1.29)、(19.64±6.20)μg·L-1·h和(1.64±0.52)μg·L-1.结论 盐酸纳美芬注射液单剂量静脉推注2 mg和多次给药2 mg后人体内的药动学行为与国外文献报道基本一致.在连续多次给药时,并未出现蓄积现象,血药浓度第6天达稳态.

关 键 词:纳美芬  药代动力学  高效液相色谱法

Pharmacokinetics of nalmefene after a single or multiple intravenous doses in Chinese healthy volunteers
LIAO Ri-fang,ZENG Zhuan-ping,WEN Yu-guan.Pharmacokinetics of nalmefene after a single or multiple intravenous doses in Chinese healthy volunteers[J].Journal of Southern Medical University,2008,28(10):1816-1819.
Authors:LIAO Ri-fang  ZENG Zhuan-ping  WEN Yu-guan
Institution:LIAO Ri-fang1,ZENG Zhuan-ping2,WEN Yu-guan3 1Department of Clinical Pharmacy,Second Affiliated Hospital of Sun Yat-sen University,Guangzhou 510120,China,2Department of Epidemiology,College of Public Health,Guangdong Pharmacy University,Guangzhou 510315,3Institute of Clinical Pharmacology,Guangzhou Brain Hospital,Guangzhou 510520
Abstract:Objective To investigate the pharmacokinetics of nalmefene after intravenous administration at a single or multiple doses in Chinese healthy volunteers.Methods This open, randomized clinical trial involved 12 healthy volunteers, who received a single-dose(2 mg) nalmefene injection.Before and at different time points after the injection, blood sample were obtained from the subjects.After the single intravenous dose trial, 8 healthy volunteers received intravenous nalmefene at 2 mg once daily for 6 consecutiv...
Keywords:nalmefene  pharmakinetics  liquid chromatograpy/tandem mass spectrometry  
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