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目的:研究健康受试者单剂量静脉滴注比阿培南后的药动学特征。方法:30名健康受试者单剂量静脉滴注比阿培南300,600,900mg(各剂量组n=10)后,HPLC法测定其血浆中药物浓度,采用药动学软件DAS进行数据处理计算药动学参数。结果:比阿培南静脉滴注给药后药时曲线符合二室开放模型,低、中、高给药剂量主要药动学参数t1/2分别为(1.23±0.24),(1.1±0.3),(1.02±0.27)h,AUC0-t分别为(40.7±13.5),(77.2±22.1),(129.3±47.5)mg.h.L-1,AUC0-∞分别为(44.8±17.6),(80.1±25.1),(136.6±49.7)mg.h.L-1,CLs分别为(7.6±2.2),(8.1±1.8),(7.9±1.9)L.h-1。结论:受试者静脉滴注比阿培南后,人体耐受性良好,主要药动学参数(AUC0-t)与给药剂量呈良好线性关系,提示比阿培南人体药动学过程为线性动力学过程,其他参数t1/2、CLs经t检验差异均无显著性(P>0.05)。
Objective: To study the pharmacokinetics of single-dose intravenous infusion of biapenem in healthy subjects. Methods: A total of 30 healthy volunteers were injected with Biapenem 300, 600 and 900 mg intravenously (n = 10 in each dose group), the plasma concentrations of which were measured by HPLC and the pharmacokinetics software DAS was used to calculate the pharmacokinetic parameters Learning parameters. Results: The bovine serum albumin (BAP) curve was in accordance with the two-compartment open model after intravenous infusion of biapenem. The main pharmacokinetic parameters t1 / 2 were (1.23 ± 0.24), (1.1 ± 0.3) , (1.02 ± 0.27) h and AUC0-t were (40.7 ± 13.5), (77.2 ± 22.1) and (129.3 ± 47.5) mg.hL-1, respectively. The AUC0-∞ were (44.8 ± 17.6) and (7.6 ± 2.2), (8.1 ± 1.8) and (7.9 ± 1.9) Lh-1, respectively, and (136.6 ± 49.7) mg.hL- CONCLUSIONS: After intravenous infusion of biapenem, the subjects are well tolerated. The main pharmacokinetic parameters (AUC0-t) have a good linear relationship with the dosage, indicating that the pharmacokinetics of biapenem is Linear kinetic process, other parameters t1 / 2, CLs by t test showed no significant difference (P> 0.05).