摘要
目的评价国产盐酸普卢利沙星片(第4代喹诺酮类抗生素)在健康人体的药代动力学。方法10名健康志愿者单剂量和多剂量口服国产盐酸普卢利沙星片200mg,用液相色谱-串联质谱法测定血药浓度,用Winnonlin计算药代动力学参数。结果单剂量和多剂量给药后,Cmax分别为(1.39±5.10),(1.67±0.23)mg·L-1;tmax分别为(0.93±0.37),(1.07±0.43)h;t1/2ke分别为(6.74±1.09),(7.26±0.53)h;AUC0-∞分别为(6.64±1.68),(11.82±1.32)mg·h·L-1,多剂量AUC0-τ为(8.68±0.79)mg·h·L-1。结论每日2次,连续口服国产盐酸普卢利沙星片11次后,体内有一定蓄积。
Objective To evaluate the pharmacokinetics of prulifloxacin tablets in Chinese healthy volunteers. Methods Ten healthy volunteers were randomized to orally receive single and multiple dose prulifloxacin tablets （200 mg）. The plasma samples were determined by the LC/MS/ MS method. The data were analysised by Winnonlin software. Results The single dose and multiple dose pharmacokinetic parameters were as follows： CmaxWere （1.39 ±5.10） mg · L^-1 and （1.67 ±0.23） mg · L^-1; tmax were （0.93 ±0.37） h and （1.07 ±0.43） h; t1/2ke were （6.74 ± 1.09） h and （7.26 ±0.53） h;AUC0-x were （6.64 ±1.68） ,（11.82 ± 1.32） mg · h · L^-1 The multiple dose AUC0-r was （8.68 ± 0.79） h · mg · L^-1. Conclusion Administration of prulifloxacin tablets twice per day has some accumulation in healthy volunteers ＇s body .
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2007年第2期101-104,共4页
The Chinese Journal of Clinical Pharmacology
