CAJ | 학술논문

目的：研究注射用头孢替坦二钠在中国健康人体的药代动力学。方法用开放、随机、平行、单次、单周期试验设计。30名健康受试者，男女各半，分为3组分别静脉滴注头孢替坦二钠0.5，1.0，2.0 g，用液相色谱-串联质谱测定血药浓度；用DAS 2.1软件计算药代动力学参数。结果3个剂量头孢替坦二钠的主要药代动力学参数：cmax分别为（65.25±19.84），（118.06±20.54）和（231.24±66.75）mg· L-1；tmax分别为（0.99±0.09），（0.98±0.08）和（0.97±0.12）h；t1/2分别为（4.44±0.72），（3.93±0.46）和（4.18±0.73）h；AUC0-t分别为（263.58±63.81），（421.93±48.87）和（896.99±249.78） mg· L-1· h-1。1.0 g剂量组给药后同时收集尿液，24 h尿排率为（65.62±10.23）％。结论头孢替坦二钠的血药浓度-时间曲线符合二室模型，其剂量在0.5～2.0g安全。
목적：연구주사용두포체탄이납재중국건강인체적약대동역학。방법용개방、수궤、평행、단차、단주기시험설계。30명건강수시자，남녀각반，분위3조분별정맥적주두포체탄이납0.5，1.0，2.0 g，용액상색보-천련질보측정혈약농도；용DAS 2.1연건계산약대동역학삼수。결과3개제량두포체탄이납적주요약대동역학삼수：cmax분별위（65.25±19.84），（118.06±20.54）화（231.24±66.75）mg· L-1；tmax분별위（0.99±0.09），（0.98±0.08）화（0.97±0.12）h；t1/2분별위（4.44±0.72），（3.93±0.46）화（4.18±0.73）h；AUC0-t분별위（263.58±63.81），（421.93±48.87）화（896.99±249.78） mg· L-1· h-1。1.0 g제량조급약후동시수집뇨액，24 h뇨배솔위（65.62±10.23）％。결론두포체탄이납적혈약농도-시간곡선부합이실모형，기제량재0.5～2.0g안전。
Objective To study the pharmacokinetics of cefotetan diso-dium injection in Chinese healthy volunteers.Methods The study was designed as an open , randomized , parallel and single-dose single cycle study.Thirty healthy volunteers were divided into three groups.Each group included five volunteers male and five female volunteers.The vol-unteers in different groups were administered with single dose of 0.5 , 1.0 or 2.0 g cefotetan disodium , respectively.Plasma concentrations of cefotetan disodium were determined by LC -MS/MS method.The phar-macokinetic parameters of cefotetan disodium were calculated by DAS version 2.1 software.Results The main pharmacokinetic parameters of three doses (0.5, 1.0, 2.0 g)of cefotetan disodium were as follows:cmax were(65.25 ±19.84), (118.06 ±20.54), (231.24 ±66.75)mg· L-1;tmax were(0.99 ±0.09), (0.98 ±0.08), (0.97 ±0.12)h; t1/2 were(4.44 ±0.72 ), (3.93 ±0.46 ), (4.18 ±0.73 ) h; AUC0-t were ( 263.58 ± 63.81 ) , ( 421.93 ± 48.87 ) , ( 896.99 ± 249.78 ) mg· L-1 · h -1 , respectively.Urinary recovery rate within 24 h was (65.62 ±10.23 )%.Conclusion The plasma concentration - time curve fits two compartment model.The safe dose was 0.5-2.0 g.