两种盐酸特拉唑嗪片剂人体生物等效性评价

 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20名健康受试者po 2 mg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t_max分别为(1.08±0.54)和(1.18±0.37) h，c_max为(44.44±11.72) μg·L_-1和(41.28±9.77) μg·L_-1，MRT为(9.48±0.76)和(9.36±0.90) h，t_1/2为(10.10±1.45)和(9.77±1.76) h,AUC_{0～36 h}为(372.82±97.44)和(361.57±83.21)μg·h·L_-1。国产盐酸特拉唑嗪片剂的相对生物利用度为(103±13)%。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。

Studies on the bioequivalence of domestic terazosin tablet in healthy volunteers

OBJECTIVE To observe the bioavailability of domestic terazosin tablet and imported tablet.METHOD S 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.