雷贝拉唑在健康志愿者体内的药动学及生物利用度研究
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南京市科技发展计划(药学项目)(2011YX001)


The pharmacokinetics and bioavailability of rabeprazole in healthy Chinese volunteers
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    目的:研究健康志愿者单次口服和静脉输注雷贝拉唑20 mg后药动学特征及生物利用度-方法:20名男性健康志愿者,随机分成2组-第1周期分别接受单剂量静脉输注20 mg(输注时间30 min)和单次口服给药(2片,10 mg/片);经7 d清洗期后,2组志愿者接受交叉给药-结果:雷贝拉唑静脉给药后药动学参数如下:t1/2为(62.4 ± 10.7)min,Cmax为(1 308.6 ± 266.4) ng/ml,总清除率为(0.21 ± 0.05)L/min,AUC0-τ和AUC0-∞分别为(99.6 ± 21.9) mg·min/L和 (102.4 ± 23.3) mg·min/L-口服给药后t1/2为(64.2 ± 15.5)min,Cmax为(508.3 ± 180.2) ng/ml,Tmax为229.5 min,Cl为(0.31 ± 0.10)L/min,AUC0-τ和AUC0-∞ 分别为(69.5 ± 20.0) mg·min/L和 (70.6 ± 20.2) mg·min/L-结论:雷贝拉唑在健康志愿者体内的生物利用度为70.1%,雷贝拉唑口服给药的总清除率显著大于静脉给药时的总清除率(P < 0.01)-

    Abstract:

    Objective:To investigate the pharmacokinetics and bioavailability of rabeprazole in healthy Chinese volunteers. Methods: A total of 20 male subjects were recruited and randomly assigned at the beginning of the study to receive a single dose of rabeprazole(20 mg) administrated either intravenously or orally. Following a 7-day washout period,all subjects received another 20 mg dose via the alternate route. Intravenous dose was given in constant infusion over 30 min,and the oral dose was given in two 10 mg tablets. Results: In intravenous administration,the terminal half-life was (62.4 ± 10.7) min;the Cmax was (1 308.6 ± 266.4) ng/ml;the total body clearance was (0.21±0.05) L/min;the AUC0-τ and AUC0-∞ were (99.6 ± 21.9) mg·min/L and (102.4 ± 23.3) mg·min/L,respectively. In oral administration,the half-life was (64.2 ± 15.5) min;the Cmax was(508.3 ± 180.2) ng/ml;Tmax was attained at about 229.5 min;the total body clearance was (0.31 ± 0.10) L/min;the AUC0-τ and AUC0-∞ were (69.5 ± 20.0) mg·min/L and (70.6 ± 20.2)mg·min/L,respectively. Conclusion: The bioavailability of rabeprazole was estimated to be 70.1% in healthy Chinese volunteers. The total body clearance after oral administration was significantly higher than that after intravenous administration (P < 0.01).

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吴德芹,陈安九,王永庆,王德旺,张宏文,李子艳.雷贝拉唑在健康志愿者体内的药动学及生物利用度研究[J].南京医科大学学报(自然科学版),2012,(1):50-52

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  • 收稿日期:2011-07-12
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