头孢曲松钠-他唑巴坦钠在中国健康志愿者体内的药动学

Pharmacokinetics of ceftriaxone sodium-tazobactam sodium for injection in Chinese healthy male volunteers

目的 研究健康志愿者单剂量静滴头孢曲松钠-他唑巴坦钠后体内的药动学。方法 2 4名健康志愿者随机分成2组,分别单剂量静滴1或2g头孢曲松钠-他唑巴坦钠后,采用HPLC法同时检测头孢曲松钠和他唑巴坦钠血药浓度,DAS软件程序进行数据处理。结果 受试者单剂量静滴1g头孢曲松钠-他唑巴坦钠主要药动学参数cmax分别为(10 6 7±10 6 1)、(8 2 3±1 33)mg·L-1;T1/2 β分别为(10 5 2±1 6 1)、(0 91±0 4 2 )h ;AUC0→t分别为(80 0 98±15 7 0 2 )、(10 37±1 5 3)mg·h·L-1;单剂量静滴2g头孢曲松钠-他唑巴坦钠主要药动学参数cmax分别为(182 4 6±2 4 34)、(15 4 3±2 6 4 )mg·L-1;T1/2 β分别为(9 85±1 2 3)、(0 95±0 5 5 )h ;AUC0→t分别为(12 70 70±171 36 )、(18 4 1±3 4 3)mg·h·L-1。结论 头孢曲松钠-他唑巴坦钠单剂量静滴1或2g后,主要药动学参数β、T1/2 β。

AIM To study the pharmacokinetics of ceftriaxone sodium-tazobactam sodium after intravenous in single dose in Chinese healthy volunteers. METHODS Twenty-four volunteers were randomly divided into 2 groups.The drug concentration of plasma sample from the volunteers after intravenous drip of 1 and 2 g ceftriaxone sodium-tazobactam sodium was determined by HPLC method.The pharmacokinetic parameters were calculated by DAS software. RESULTS The main pharmacokinetic parameters after intravenous drip of 1 g ceftriaxone sodium-tazobactam sodium c maxwere (106.7±10.61)mg·L -1 and (8.23±1.33)mg·L -1;T 1/2β were(10.52±1.61)h and(0.91±0.42)h;AUC 0→twere(800.98±157.02)mg·h·L -1 and(10.37±1.53)mg·h·L -1,respectively.The main pharmacokinetic parameters after intravenous drip of 2 g ceftriaxone sodium-tazobactam sodium c maxwere(182.46±24.34)mg·L -1and (15.43±2.64)mg·L -1;T 1/2βwere(9.85±1.23)h and(0.95±0.55)h;AUC 0→twere(1 270.70±171.36)mg·h·L -1 and (18.41±3.43)mg·h·L -1,respectively. CONCLUSION The plasma concentration-time curve fits two compartment model in 24 healthy volunteers after intravenous drip of 1 and 2 g ceftriaxone sodium-tazobactam sodium.The main pharmacokinetic parameters of ceftriaxone sodium-tazobactam sodium have no significant differences between 1 g group and 2 g group.