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建立简单高效液相方法测定人血浆及尿液中比阿培南浓度,并进行健康人体比阿培南药代动力学研究。采用C18反相色谱柱,血样0.05M乙酸铵-甲醇(94:6)洗脱,流速1.0mL/min尿样0.05M乙酸铵-甲醇(97.5:2.5)洗脱,流速1.5mL/min。紫外波长300nm。12名男性健康志愿者单次静脉滴注600mg比阿培南(60min),测定比阿培南血样及尿样浓度,Winnonlin软件非房室模型计算药动学参数。血样测定线形范围为0.25mg/L-50mg/L,尿样测定线形范围为0.50mg/L-200mg/L。日内、日间精密度分别低于2.8%和4.6%(血样),2.4%和2.5%(尿样)。血样及尿样采集后立即加入稳定剂MOPS后室温下分别在6小时和8小时内稳定。比阿培南主要药动学参数分别为:Cmax37±6mg/L,t1/21.27±0.21h,AUC0-8h56±8mg/L/h,AUC0-∞为57±8mg/L/h,24小时尿累积排出率为(58±5)%。建立的方法简单、灵敏、重现性好,可用于比阿培南药代动力学研究。
A simple HPLC method was established for the determination of biapenem in human plasma and urine, and the pharmacokinetics of biapenem in healthy volunteers was studied. A C18 reversed-phase column was used to elute the blood sample with 0.05 M ammonium acetate-methanol (94: 6) at a flow rate of 1.0 mL / min and a urine sample of 0.05 M ammonium acetate-methanol (97.5: 2.5) at a flow rate of 1.5 mL / min. UV wavelength 300nm. Twelve male healthy volunteers were given a single intravenous infusion of 600 mg biapenem (60 min), blood levels of biapenem and urine samples were determined, and pharmacokinetic parameters were calculated using the Winnonlin non-compartmental model. Blood samples were measured linear range of 0.25mg / L-50mg / L, urine samples linear range of 0.50mg / L-200mg / L. Intra-day and inter-day precision was less than 2.8% and 4.6% (blood samples), 2.4% and 2.5% (urine samples) respectively. Blood samples and urine samples were collected immediately after the addition of stabilizer MOPS were stable at 6 hours and 8 hours at room temperature. Biapenem main pharmacokinetic parameters were: Cmax37 ± 6mg / L, t1 / 21.27 ± 0.21h, AUC0-8h56 ± 8mg / L / h, AUC0-∞ 57 ± 8mg / L / h, 24 hours urine The cumulative discharge rate was (58 ± 5)%. The established method is simple, sensitive, reproducible and can be used for the study of biapenem pharmacokinetics.