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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 determine the concentration of biapenem in human plasma by RP-HPLC and to study the pharmacokinetics of biapenem in healthy volunteers. Methods Twenty-four healthy volunteers received intravenous infusion of biapenem in a single dose (150,300,600 mg). The plasma concentrations were determined by RP-HPLC. Pharmacokinetic parameters were calculated by DAS 2.0 pharmacokinetic software. Results The t1 / 2β of low, medium and high-dose apenem for intravenous injection was 2.13 ± 1.58, 1.23 ± 0.17 and 1.21 ± 0.16 h, respectively, and the Tm ax were 0.86 ± 0.68, 0.68 ± 0.05 and 0.68 ± 0.05 h, Cm ax were 7.75 ± 2.69,17.67 ± 2.62,33.31 ± 7.14 mg.L-1, respectively, and AUC (0-t) were 12.66 ± 2.74,26.79 ± 3.74,50.50 ± 7.77 mg.hL-1, respectively. Conclusions Biapenem injection in healthy volunteers is consistent with the two-compartment model. Cm ax and AUC are linearly correlated with dose.