摘要
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)。
AIM To evaluate the pharmacokinetic characteristics of single-dose pidotimod injection in Chinese healthy volunteers. METHODS A double 3 × 3 Latin square crossover study was designed. Totally 12 healthy male and female volunteers received a single intravenous injection of pidotimod 200,400 and 800 mg. The concentrations of pidotimod were determined by LC-MS/MS method. RESULTS The main pharmacokinetic parameters after single-dose （200, 400, 800 mg） were as follows： AUC0→t were （17 920 ± 2 068）, （34 771 ± 6 336） and （70 950 ± 10 527） μg·h·L^-1; ρmax were （ 10 342 ± 1 545）, （ 18 093± 3 589） and （39 120 ± 4 686） μg· L^- 1 ; t 1/2 were （ 1.421 ± 0.285）, （ 1. 523 ± 0.414） and （1.643 ± 0. 157） h, respectively. CONCLUSION After the intravenous injection of single-dose pidotimod （200, 400, 800 mg） , AUC0→t and ρmax of pidotimod increase linearly with the increase of the dose, which show linear pharmacokinetic characteristics within the range of 200 - 800 mg. The main pharmacokinetic parameters of pidotimod are no significant differences between males and females in addition to ρmax of pidotimod 200 mg.
出处
《中国临床药学杂志》
CAS
2016年第3期149-152,共4页
Chinese Journal of Clinical Pharmacy
关键词
匹多莫德
药动学
剂量线性
pidotimod
pharmacokinetics
dose linearity
