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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 bioequivalence of terazosin hydrochloride dispersible tablets and domestic common tablets. Methods: Twenty healthy male subjects were randomized to receive oral administration of terazosin hydrochloride dispersible tablets and domestic common tablets. The plasma drug concentration was determined by high performance liquid chromatography-fluorescence method. Pharmacokinetic parameters were calculated by ANOVA and two-way Unilateral t test for statistical analysis. Results: The C max of terazosin hydrochloride tablets and domestic tablets were (29.8 ± 9.3) μg.L-1 and (31.0 ± 9.8) μg.L-1, respectively, and the tmax were (0.8 ± 0.1) 1.5 ± 0.9) h, AUC0 → t were (325.9 ± 75.5) μg.hL-1 and (362.3 ± 105.6) μg.hL-1, respectively. The relative bioavailability of terazosin hydrochloride dispersible tablets was (91.5 ± 26.6)%. Conclusion: The two preparations are bioequivalent.