CAJ | 학술논문

　　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。
　　목적：탐토단제구복리파위림재건강인체적약대동역학연구정황。방법：린선30명신체건강적남성지원자,사용표준이계단교차설계연구법진행자신대조실험,분별단제량구복량충리파위림편진행약대동역학연구,사용액상색보-천련질보검측법대지원자복약후72소시내적혈장양본진행리파위림농도검측。결과：A양품리파위림편적Tmax위(3.56±2.98)소시,Cmax위(209.21±67.21)μg/L,AUC(0-72h)위(5123.21±1562.21)μg.h/L；B양품리파위림편적Tmax위(3.31±2.67)소시,Cmax위(213.9±59.98)μg/L,AUC(0~72h)위(5098.87±1489.32)μg.h/L。량충리파위림편적주요약물동역학삼수,몰유현저성차이,P>0.05,몰유통계학의의。결론：대량충리파위림편진행약대동역학연구발현,량충리파위림편구유생물등효성。
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.