【摘要】 目的　评价国产和进口盐酸特拉唑嗪片剂在中国人群中的生物等效性。方法　采用高效液相色谱 荧光检测方法测定2 0名健康受试者 po 2mg盐酸特拉唑嗪片后血浆中的盐酸特拉唑嗪浓度。采用 3P97计算药动学参数 ,并评价其生物等效性。结果　国产盐酸特拉唑嗪片剂和进口片剂的tmax分别为 (1 .0 8± 0 .54)和 (1 .1 8± 0 .37)h ,cmax为 (44.44± 1 1 .72 ) μg·L- 1和 (41 .2 8± 9.77) μg·L- 1 ,MRT为 (9.48± 0 .76)和 (9.36± 0 .90 )h ,t1 / 2 为 (1 0 .1 0± 1 .45)和 (9.77± 1 .76)h ,AUC0～ 36h为(372 .82± 97.44)和 (361 .57± 83 .2 1 ) μg·h·L- 1 。国产盐酸特拉唑嗪片剂的相对生物利用度为 (1 0 3± 1 3) %。结论　经统计学分析 ,国产盐酸特拉唑嗪片剂和进口片剂具有生物等效性更多还原

【Abstract】 OBJECTIVE To observe the bioavailability of domestic terazosin tablet and imported tablet.METHODS A single oral dose of 2 mg domestic or imported terazosin tablet was given to 20 healthy volunteers in a randomized crossover study.Terazosin concentrations in plasma were determined by HPLC method.RESULTS The main pharmacokinetics of the two products were as follow: t max (1.08±0.54) and (1.18±0.37) h, c max (44.44±11.72) and (41.28±9.77) μg·L -1 ,MRT (9.48±0.76) and (9.36± 0.90 ) h, t 1/2 (10.10±1.45) and (9.77±1.76) h,AUC 0～36 h (372.82±97.44) and (361.57±83.21) μg·h·L -1 respectively.The relative bioavailability of domestic to imported tablets was (103±13)%.CONCLUSION There was no significant difference between the parameters of two products ( P >0.5).The results demonstrated that the two preparations were bioequivalent.更多还原