盐酸特拉唑嗪分散片的人体生物利用度

Bioavailability of terazosin hydrochloride dispersible tablets in Chinese healthy volunteers

目的:研究盐酸特拉唑嗪分散片和国产普通片的人体生物等效性。方法:20名健康男性受试者自身交叉单剂量口服盐酸特拉唑嗪分散片和国产普通片,采用高效液相色谱-荧光法测定血浆药物浓度,计算药动学参数,以方差分析与双向单侧t检验进行统计学分析。结果:盐酸特拉唑嗪分散片和国产普通片的Cmax分别为(29.8±9.3)μg.L-1和(31.0±9.8)μg.L-1,tmax分别为(0.8±0.1)h和(1.5±0.9)h,AUC0→t分别为(325.9±75.5)μg.h.L-1和(362.3±105.6)μg.h.L-1。盐酸特拉唑嗪分散片的相对生物利用度为(91.5±26.6)%。结论:2种制剂具有生物等效性。

OBJECTIVE To study the relative bioequivalenee of terazosin HCl dispersible tablets and its domestic conventional tablets in Chinese healthy volunteers. METHODS A single oral dose of 2 mg terazosin HCl was randomly given to 20 healthy volunteers in two-way cross-over design. Plasma concentration of terazosin HCl was determined by HPLC-fluoremetry method. Pharmacokinetics parameters were calculated. The bioequivalence of the two preparations was calculated by analysis of variance and two one side t-test. RESULTS After oral administration, the main pharmacokinetics parameters of test and reference preparations were as follows： Cmax （29. 8 ± 9. 3） and （31.0 ± 9. 8）μg·L^-1, tmax （0. 8± 0. 1 ） and （ 1.5± 0. 9） h, AUC0→t （325. 9 ± 75.5） and （362. 3 ±105.6）μg·h·L^-1, respectively. The relative bioavailability of dispersible tablets was （91.5 ±26. 6） %. CONCLUSION The two preparations were bioequivalent.