比阿培南在健康受试者体内的药物动力学研究

Pharmacokinetics of single dose Biapenem by intravenous drip in healthy volunteers

目的采用RP-HPLC法测定人血浆中比阿培南的浓度,研究比阿培南在健康受试者体内的药动学。方法 24名健康志愿者分组接受单次(150、300、600 mg)静脉滴注比阿培南,应用RP-HPLC法测定血药浓度,通过DAS2.0药动学软件计算药动学参数。结果受试者静注单剂量低、中、高比阿培南的t1/2β分别为2.13±1.58、1.23±0.17、1.21±0.16 h,Tm ax分别为0.86±0.68、0.68±0.05、0.68±0.05 h,Cm ax分别为7.75±2.69、17.67±2.62、33.31±7.14 mg.L-1,AUC(0-t)分别为12.66±2.74、26.79±3.74、50.50±7.77 mg.h.L-1。结论注射用比阿培南在健康人体内的药动学符合二室模型特征,Cm ax和AUC与给药剂量呈线性相关。

OBJECTIVE To develop an HPLC method for determination of Biapenem in human plasma to study the pharmacokinetics of Biapenem in Chinese healthy volunteers.METHODS 24 healthy volunteers were randomly divided into groups,and were administered a single dose(150,300,600 mg) of Biapenem by intravenous drip.Biapenem in plasma was determined by RP-HPLC method,and the pharmacokinetic parameters were calculated by DAS 2.0 software.RESULTS The main pharmacokinetic parameters of a single dose(150、300、600 mg)were as fol...