论文部分内容阅读
评价单剂量和多剂量硫辛酸分散片在12名健康受试者体内的药代动力学特点。单剂量试验采用3×3拉丁方试验设计,受试者分别服用0.2、0.3和0.4 g的硫辛酸分散片,评价硫辛酸药代动力学参数的剂量相关性;多剂量试验中,受试者连服7天硫辛酸分散片(0.3 g/day),评价多次用药后药代动力学特点。结果显示,硫辛酸基本符合两室模型特点,在0.2–0.4 g范围内,硫辛酸AUC具有明显剂量相关性,而Vd/F,CL/F,MRT,t1/2和tmax在各剂量组间无显著性差异。多次用药后,硫辛酸主要药代动力学参数与单次同剂量组无显著性差异,药物在体内无蓄积。
Pharmacokinetic characteristics of single and multiple dose lipoic acid dispersible tablets in 12 healthy subjects were evaluated. Single-dose trials using 3 × 3 Latin square design, subjects were taking 0.2,0.3 and 0.4 g of lipoic acid dispersion tablets, lipoic acid pharmacokinetic parameters to evaluate the dose-dependent; multiple-dose test, the subjects Even for 7 days lipoic acid dispersion tablets (0.3 g / day), evaluation of pharmacokinetic characteristics after multiple doses. The results showed that lipoic acid is basically consistent with the characteristics of two-compartment model, in the range of 0.2-0.4 g, lipoauric AUC has a significant dose-related, and Vd / F, CL / F, MRT, t1 / 2 and tmax in each dose group No significant difference. After repeated administration, the main pharmacokinetic parameters of lipoic acid had no significant difference with the single dose group, and the drug did not accumulate in the body.