单剂口服利巴韦林片在健康人体的药代动力学研究探讨

Single Oral Dose of Ribavirin Tablets in Healthy Human Pharmacokinetic Study

目的:探讨单剂口服利巴韦林在健康人体的药代动力学研究情况。方法:遴选30名身体健康的男性志愿者,使用标准二阶段交叉设计研究法进行自身对照实验,分别单剂量口服两种利巴韦林片进行药代动力学研究,使用液相色谱-串联质谱检测法对志愿者服药后72小时内的血浆样本进行利巴韦林浓度检测。结果:A样品利巴韦林片的Tmax为(3.56±2.98)小时,Cmax为(209.21±67.21)μg/L,AUC(0-72h)为(5123.21±1562.21)μg.h/L;B样品利巴韦林片的Tmax为(3.31±2.67)小时,Cmax为(213.9±59.98)μg/L,AUC(0～72h)为(5098.87±1489.32)μg.h/L。两种利巴韦林片的主要药物动力学参数,没有显著性差异,P>0.05,没有统计学意义。结论:对两种利巴韦林片进行药代动力学研究发现,两种利巴韦林片具有生物等效性。

Objective：To investigate the single oral dose of ribavirin in healthy human pharmacokinetic study.Methods：Choose 30 healthy male volunteers,using a standard two phase crossover design study compared experiments,respectively,a single oral dose of two kinds of ribavirin tablets for pharmacokinetic studies,using liquid chromatography-tandem mass spectrometry detection method for volunteers after 72 hours of plasma samples for ribavirin concentration detection.Results：TheA sample piece Tmax to（3.56±2.98） hours,Cmax was（209.21±67.21）μg/L,AUC（0～72h）was（5123.21±1562.21）μg.h/L;B samples of ribavirin tablets Tmax was（3.31±2.67） hours,Cmax is（213.9±59.98）μg/L,AUC（0～72h） to（5098.87±1489.32）μg.h/L.Two piece the main pharmacokinetic parameters,there is no significant difference,P〈0.05,no statistical significance.Conclusion：The two kinds of ribavirin tablets for pharmacokinetic studies found,two kinds of ribavirin tablets bioequivalent.