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10名健康志愿者随机交叉给药,分别口服150mg来考察国产与进口复方阿米三嗪片进行相对生物利用度研究。采用高效液相色谱法测定血浆中阿米三嗪和萝巴新的浓度,经3P97程序处理拟合,两者皆符合口服给药二室开放模型,国产与进口两种片剂中阿米三嗪的AUC分别为35008.75±2577.14μg·h·L-1 和34174.91±2335.17μg·h·L-1,Tmax 分别为3.64±0.66h和3.81±0.76h ,Cmax 分别为830.31±77.97μg·L -1和816.76±70.07μg·L -1;国产与进口两种片剂中萝巴新AUC分别为1141.99±116.69μg·h·L-1 和1116.15±81.85μg·h·L-1,Tmax 分别为1.25±0.24h和1.27±0.22h,Cmax 分别为385.17±86.26μg·L -1和374.04±71.71μg·L -1 ,经配对t-检验,阿米三嗪和萝巴新在两种片剂中的各药代动力学参数均无显著性差异(P>0.05)。用梯形法计算国产与进口片中阿米三嗪的AUC0 -t 分别为32429.35±3324.41μg·h·L -1和31334.65±2982.17μg·h·L -1,萝巴新的AUC0 -t 分别为1176.55±148.96μg·h·L -1和1145.44±119.25μg·h·L-1,国产复方阿米三嗪的相对生物利用度为103.53%±5.00 %(阿米三嗪)和102.68%±6.38 %(萝巴新)。对两制剂中阿米三嗪和萝巴新梯形法计算的AUC0 -t 及实测的Cmax 、Tpeak 进行方差分析、双单侧检验
Ten healthy volunteers were randomized to receive oral administration of 150 mg orally to study the relative bioavailability of the domestic and imported compound amilizarin tablets. Plasma concentrations of amilotriazine and radapus were determined by high performance liquid chromatography (HPLC), and were processed by 3P97 program. Both of them were in accordance with the two-compartment open model of oral administration. The three domestic and imported tablets, The AUC of azines were 35008.75 ± 2577.14μg · h · L-1 and 34174.91 ± 2335.17μg · h · L-1, respectively. The Tmax values were 3.64 ± 0.66h and 3.81 ± 0.76h, respectively, and the Cmax values were 830.31 ± 77.97μg · L - 1 and 816.76 ± 70.07 μg · L -1, respectively. The new AUC of domestic and imported tablets were 1141.99 ± 116.69 μg · h-1 and 1116.15 ± 81.85 μg · h · L-1, respectively, and the Tmax values were 1.25 ± 0.24h and 1.27 ± 0.22h, Cmax were 385.17 ± 86.26μg · L -1 and 374.04 ± 71.71μg · L -1 respectively.After the paired t-test, In each pharmacokinetic parameters were no significant difference (P> 0.05). The trapezoidal method was used to calculate the AUC0-t of amilotriazine in domestic and imported tablets respectively was 32429.35 ± 3324.41μg · h · L -1 and 31334.65 ± 2982.17μg · h · L -1, and the AUC0-t of radorubin were 1176.55 ± 148.96μg · h · L -1 and 1145.44 ± 119.25μg · h · L -1, respectively. The relative bioavailability of the domestic compound amilizines was 103.53% ± 5.00% (amltrizine) and 102.68% ± 6.38 % (Robertson). The AUC0-t and the measured Cmax and Tpeak calculated by amikacin and radavan trapezoid method were analyzed by ANOVA and double unilateral test