中国临床药理学杂志2011，Vol.27Issue(3)：184-186,3.
普伐他汀片在健康人体的生物等效性
Bioequivalence of pravastatin tablets in healthy volunteers
张华峰 1戴博 1王健康 1张福成1
作者信息
- 1. 解放军空军总医院药学部,北京,100142
- 折叠
摘要
Abstract
Objective To determine pravastatin concentrations in human plasma and study the pharmacokinetics and bioequivalence of pravastatin tablets.Methods A single oral dose of 40 mg reference and test pravastatin tablets was given to 20 healthy volunteers in a randomized crossover study.The plasma pravastatin concentrations were determined by LC/MS/MS.The pharmacokinetics as well as relative bioavailability were measured.Results The main pharmacokinetic parameters of test and reference pravastatin tablets were as follows: tmax were (0.79 ± 0.28), (0.88 ±0.32) h;Cmax were (55.06 ±22.09 ), (57.75 ±30.47)mg· L- 1; t1/2were ( 2.38 ± 0.69), ( 2.31 ± 0.49) h; AUC0-t were (110.49 ±45.25), (108.81 ±52.16) mg · h · L-1; AUC0-∞ were (115.58 ±47.08),(113.60 ±54.38)mg · h · L-1.The relative bioavailability of pravastatin tablets to reference tablets was (103.76 ±16.70)％.Conclusion The reference and test pravastatin tablets were bioequivalent.关键词
普伐他汀/生物等效性/高效液相色谱-串联质谱分类
医药卫生引用本文复制引用
张华峰,戴博,王健康,张福成..普伐他汀片在健康人体的生物等效性[J].中国临床药理学杂志,2011,27(3):184-186,3.
