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奥美沙坦氢氯噻嗪片在中国健康志愿者体中的药代动力学
引用本文:万茜,黄原原,付志敏,谭鸿毅,裴奇,黄志军,阳国平.奥美沙坦氢氯噻嗪片在中国健康志愿者体中的药代动力学[J].中国临床药理学与治疗学,2011,16(4):393-399.
作者姓名:万茜  黄原原  付志敏  谭鸿毅  裴奇  黄志军  阳国平
作者单位:1. 中南大学湘雅三医院,长沙410013,湖南;中南大学湘雅药学院,长沙410013,湖南
2. 中南大学湘雅三医院,长沙410013,湖南
摘    要:目的:研究单次、多次口服奥美沙坦氢氯噻嗪片在中国健康受试者体内的药代动力学。方法:本研究为随机、开放、单次和多次口服给药的单中心试验。12位健康受试者单次和多次口服1片奥美沙坦氢氯噻嗪片(每片含奥美沙坦20 mg,氢氯噻嗪12.5 mg),采用HPLC-MS-MS法测定奥美沙坦和氢氯噻嗪的血浆药物浓度,利用DAS2.0和SPSS 13.0计算药动学参数和进行统计学分析。结果:单次和多次口服给药后奥美沙坦的药动学参数如下:Cmax分别为(489±122)μg/L和(531±125)μg/L,AUC0→t分别为(3468±869)μg.L-1.h和(3557±1209)μg.L-1.h,tmax分别为(2.6±0.5)h和(2.3±0.8)h,t1/2分别为(7.3±4.0)h和(8.3±3.6)h;单次和多次口服给药后氢氯噻嗪的药动学参数如下:Cmax分别为(122±34)μg/L和(182±39)μg/L,AUC0→t分别为(764±211)μg.L-1.h和(1079±361)μg.L-1.h,Cmax分别为(2.2±0.7)h和(1.6±0.6)h,t1/2分别为(6.8±2.3)h和(7.1±1.6)h。结论:奥美沙坦氢氯噻嗪片主要药动学参数单剂量和多剂量给药差异无统计学意义,奥美沙坦和氢氯噻嗪在人体内均无明显蓄积。

关 键 词:奥美沙坦  氢氯噻嗪  药代动力学  LCMS/MS

Pharmacokinetics of compound olmesartan medoxomil and hydrochlorothiazide tablets in Chinese healthy volunteers
WAN Qian,HUANG Yuan-yuan,FU Zhi-min,TAN Hong-yi,PEI Qi,HUANG Zhi-jun,YANG Guo-ping.Pharmacokinetics of compound olmesartan medoxomil and hydrochlorothiazide tablets in Chinese healthy volunteers[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2011,16(4):393-399.
Authors:WAN Qian  HUANG Yuan-yuan  FU Zhi-min  TAN Hong-yi  PEI Qi  HUANG Zhi-jun  YANG Guo-ping
Institution:WAN Qian1,2,HUANG Yuan-yuan1,FU Zhi-min1,TAN Hong-yi1,PEI Qi1 HUANG Zhi-jun1,YANG Guo-ping1The Third Xiangya Hospital of Central South University,Changsha 410013,Hunan,China,2School of Pharmaceutical Sciences of Central South University
Abstract:AIM: To study the pharmacokinetics of compound olmesartan medoxomil and hydrochlorothiazide tablets after multiple oral dose administration in Chinese healthy volunteers. METHODS: In a randomized,open,single-center study,12 Chinese healthy volunteers were randomized to administer a single dose of compound olmesartan medoxomil and hydrochlorothiazide tablets(20 mg/12.5 mg) on day 1 and day 3 to day 9.The concentration in human plasma was determined by LC-MS/MS method and its pharmacokinetic parameters were c...
Keywords:LCMS/MS
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