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目的评价在中国人群中单次静脉注射匹多莫德后的药动学特征。方法用二重3×3拉丁方交叉试验设计。12名健康受试者单剂量静脉注射匹多莫德200、400、800 mg后,用LC-MS/MS法测定血浆中匹多莫德的浓度,用Win Nolin 6.2.1软件计算其主要药动学参数,用SPSS 19.0软件考察匹多莫德主要药动学参数的剂量线性特征及性别差异。结果匹多莫德200、400、800 mg的主要药动学参数:AUC_(0→t)分别为(17 920±2 068)、(34 771±6 336)、(70 950±10 527)μg·h·L~(-1);ρ_(max)分别为(10 342±1 545)、(18 093±3 589)、(39 120±4 686)μg·L~(-1);t_(1/2)分别为(1.421±0.285)、(1.523±0.414)、(1.643±0.157)h。结论匹多莫德的AUC_(0→t)、ρ_(max)均随剂量增加而线性增加,在200~800 mg内呈线性药动学特征。除200 mg组的ρ_(max)外,其他剂量组别的主要药动学参数在男女之间的差异没有统计学意义(P>0.05)。
Objective To evaluate the pharmacokinetics of pidotomide in Chinese population after a single intravenous injection. Methods The double 3 × 3 Latin square crossover design was used. Twelve healthy subjects received a single dose of 200,400,800 mg pidotimod intravenously. Plasma concentrations of pidotimod were determined by LC-MS / MS. Win Nolin 6.2.1 software was used to calculate the main drug Kinetic parameters, SPSS 19.0 software was used to investigate the main pharmacokinetic parameters of Pidotimod dose-linear characteristics and gender differences. Results The main pharmacokinetic parameters of 200,400,800 mg of pidotimod were: AUC_ (0 → t) were (17 920 ± 2 068), (34 771 ± 6 336) and (70 950 ± 10 527) μg · H · L -1 and ρ max were (10 342 ± 1 545), (18 093 ± 3 589) and (39 120 ± 4 686) μg · L -1, respectively; t_ ( 1/2) were (1.421 ± 0.285), (1.523 ± 0.414) and (1.643 ± 0.157) h, respectively. Conclusion The AUC_ (0 → t) and ρ_ (max) of Pidotimod increased linearly with the increase of dose, and their linear pharmacokinetic characteristics were within 200 ~ 800 mg. Except ρ max of 200 mg group, there was no significant difference in the main pharmacokinetic parameters of other dosage groups between men and women (P> 0.05).