注射用米卡芬净在中国健康受试者体内的药代动力学

Pharmacokinetics of micafungin in Chinese healthy volunteers

目的评价单次静脉滴注3种不同剂量米卡芬净钠在中国健康受试者体内的的药代动力学。方法 12名健康受试者,男女各半,用三周期自身三交叉试验,分别静脉滴注3个不同剂量米卡芬净钠(50,100,150 mg),滴注60 min,采集不同时间的血样,分离血清,用HPLC方法测定米卡芬净血药浓度。结果 3个剂量米卡芬净的主要药代动力学参数如下:Cmax分别为(2.68±0.35),(5.53±0.66),(8.26±1.61)μg.mL-1;t1/2分别为(12.59±3.49),(13.46±1.25),(14.79±2.33)h;AUC0-72分别为(31.76±6.78),(78.20±11.78),(124.03±24.59)μg.h.mL-1。结论米卡芬净在中国人群和非中国人群中不存在种族差异,临床使用可参照国外剂量。

Objective To investigate the pharmacokinetics of micafungin after intravenous in 3 different single dose in healthy Chinese people.Methods Twelve volunteers were assigned into three different dose of micafungin with randomized,three period cross-over method.Serum was separated and HPLC methods were used to determine the concentrations of micafungin in serum.Results The main pharmacokinetic parameters of the three different dose（50 mg/60 min,100 mg/60 min,150 mg/ 60 min）were as follows：Cmax were（2.68±0.35）,（5.53±0.66）,（8.26±1.61） μg·mL-1;t1/2 were（12.59±3.49）,（13.46±1.25）,（14.79±2.33h）;AUC0-72 were（31.76±6.78）,（78.20±11.78）,（124.03±24.59） μg·h·mL-1,respectively.Conclusion There was no significant differences in pharmacokinetics parameters of micafungin between Chinese and other rations.