摘要
目的研究利巴韦林片在健康人体的药代动力学特征及其相对生物等效性。方法24名男性健康志愿者以标准二阶段交叉设计自身对照试验法,分别单剂量口服2种利巴韦林片,采用液相色谱-串联质谱法测定受试者服药后72h内血浆中利巴韦林的浓度。结果受试品和参比品利巴韦林主要的药代动力学参数Tmax分别为3.55±3.06、2.84±2.89h,Cmax分别为:214.12±89.21、223.89±116.83μg·L-1;AUC(0-72h)为5252.63±1896.66、5239.36±2708.07μg·h·L-1,受试品的相对生物利用度为110.5%。结论2种利巴韦林制剂在健康志愿者体内具有生物等效性。
Aim To study the pharmacokinetics and bioequivalence of ribavirin tablets in healthy volunteers. Methods A single oral dose of two kinds of ribavirin was given to 24 healthy volunteers in a randomized two-period crossover study. The concentrations of ribavirin in plasma were determined by the liquid chromatography-tandem mass spectrometry （LC-MS-MS） method. Results The main pharmacokinetic parameters of test and reference were as follows ： Tmax was 3.55 3.06 and 2.84 ± 2.89h, Cmax 214. 12 ± 89.21 and 223.89 ± 116.83μg·L^-1, AUC（0-72h） 5252.63 ± 1896.66 and 5 239.36 ± 2708.07μg·h·L^-1, respectively. The relative bioavailability of the tested drug was 110.5 %. Conclusion The two kinds of ribavirin were bioequivalent in healthy volunteers.
出处
《解放军药学学报》
CAS
2005年第4期277-280,共4页
Pharmaceutical Journal of Chinese People's Liberation Army
关键词
利巴韦林
液相色谱-串联质谱法
药代动力学
生物等效性
Ribavirin
Liquid chromatography-tandem mass spectrometry
Pharmacokinetics
Bioequivalence
