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目的 :比较国产和进口盐酸格拉司琼片 (Gra)的药物动力学和生物利用度。方法 :按照随机交叉试验方法研究了国产及进口 Gra片在 9名男性自愿者中的药物动力学和相对生物利用度。 po单剂量 2 mg上述两种制剂 ,采用 HPL C-荧光检测法测定给药后不同时间的血药浓度。结果 :国产片和进口片的 tmax分别为 (1.45± 0 .98)和 (1.2 9± 0 .5 2 ) h;cmax分别为 (7.2 3±1.94)和 (6 .78± 2 .86 ) ng/ m l;T1 /2 分别为 (5 .33± 2 .6 5 )和 (5 .43± 2 .32 ) h;Vd 分别为 (2 36 .3± 79.2 5 )和 (30 8.8± 15 4.9) L ;CL分别为 (30 .7± 5 .2 )和 (39.4± 5 .7) L / h;MRT分别为 (6 .41± 2 .10 )和 (6 .73± 1.75 ) h;AU C0→∞ 分别为 (70 .5 5± 5 0 .19)和(6 8.0 9± 42 .6 8) ng· h/ m l。经配对 t检验上述参数差异均无显著意义 (P>0 .0 5 )。国产片相对于进口片的生物利用度为(10 2 .45± 16 .91) %。结论 :2种制剂具有生物等效性。
OBJECTIVE: To compare the pharmacokinetics and bioavailability of domestic and imported granisetron hydrochloride tablets. METHODS: Pharmacokinetics and relative bioavailability of domestic and imported Gra tablets in nine male volunteers were studied according to a randomized crossover test. po A single dose of 2 mg of the above two preparations, using HPL C-fluorescence detection of blood drug concentration at different times after administration. Results: The tmax values of domestic and imported tablets were (1.45 ± 0.98) and (1.2 9 ± 0.52) h respectively; the values of cmax were (7.23 ± 1.94) and (6.78 ± 2.86) ng / ml; T1 / 2 were (5.33 ± 2.65) and (5.43 ± 2.32) h, respectively; Vd was (2.36 ± 3.79.2 5) and L; CL were (30.7 ± 5.2) and (39.4 ± 5.7) L / h respectively; MRT was (6.41 ± 2.10) and (6.73 ± 1.75) → ∞ were (70.55 ± 50.19) and (6 8.09 ± 42.68) ng · h / ml, respectively. Paired t test showed no significant difference in the above parameters (P> 0.05). The bioavailability of domestic tablets relative to imported tablets was (10 2 .45 ± 16 .91)%. Conclusion: The two preparations are bioequivalent.