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目的:比较两种盐酸育亨宾(Yoh)制剂的人体相对生物利用度.方法:采用HPLC测定人血清Yoh浓度.10名健康志愿者po5.4mgYoh,采用自身交叉对照试验,以片剂为对照药(A药)对胶囊(B药),进行人体相对生物利用度比较.结果:B药的相对生物利用度为(95.60土5.84)%.A,B两制剂的Ka分别为(4.27土3.39)和(3.02士1.23)h~-1,吸收迟滞时间(t_0)分别为(0.35士0.24)和(0.33士0.20)h,达峰时间(t_p)分别为(0.94士0.38)和(1.03士0.29)h,峰浓度(c_max)分别为(56.78士27.90)和(51.84士28.46)μg/L,消除半衰期(T_(1/2ke))分别为(1.14±0.50)和(1.04±0.50)h,药-时曲线下面积(AUC)分别为(143.74±114.99)和(135.53±105. 00)(μg·h/L),t检验,两种剂型各参数均无显著性差异(P>0.05).结论:A、B两制剂生物等效.
OBJECTIVE: To compare the relative bioavailability of two Yoh preparations.METHODS: Human serum Yoh concentration was determined by HPLC.The pooled healthy volunteers po5.4mgYoh were used as control The results showed that the relative bioavailability of drug B was (95.60 ± 5.84)%. The Ka of A and B preparations were (4.27 ± 3.39 ) And (3.02 ± 1.23) h ~ (-1), respectively, and the lag time (t_0) were (0.35 ± 0.24) and (0.33 ± 0.20) h respectively and the peak time (t_p) were (0.94 ± 0.38) and (1.14 ± 0.50) and (1.04 ± 0.50) h respectively, and the peak half-life (cmax) were 56.78 ± 27.90 and 51.84 ± 28.46 μg / (AUC) were (143.74 ± 114.99) and (135.53 ± 105.00) (μg · h / L), respectively. There was no significant difference between the two formulations (P> 0.05) ) Conclusion: A, B two formulations bioequivalence.