单次静滴重组葡激酶在健康人体的药代动力学  

Pharmacokinetics of recombinant staphylokinase in Chinese healthy volunteers after a single dose administration

作　　者：杨丽[1] 张駋 翟所迪[1] 李海燕[2] 张福春[2] 陈凤荣[2] 郭静萱[2] 

机构地区：[1]北京大学第三医院药剂科,北京100083 [2]北京大学第三医院心内科,北京100083

出　　处：《中国临床药理学杂志》2007年第2期97-100,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究重组葡激酶（r-SAK）（抗急性心肌梗死药）单次静脉给药后在健康人体内的药代动力学。方法24例健康受试者随机分为3组（5，10，15mg剂量组），建立双抗体酶联免疫吸附法（ELISA），测定r-SAK的血药浓度，用3P97药代动力学软件进行数据处理。结果r-SAK符合二房室一级消除模型，％为6．68-23．19L，AUC0-t为1．39-3．59μg·h·mL^-1,为1．35～4．37h。结论建议临床给药方法为r-SAK10mg、30min内静脉输注。Objective To investigate the pharmacokinetics of recombinant staphylokinase （r- SAK） by intravenous administration in healthy Chinese volunteers. Methods Twenty -four volunteers were divided into three groups, each group received a dose of 5,10,15 mg r - SAK iv infusion, respectively. The plasma concentrations of r - SAK were detec- ted by dual antibody enzyme linked immunosorbent assay method. The pharmacokinetic parameters were calculated with 3P97 program. Results The pharmacokinetics of r - SAK was adapted to two - compartment first order elimination model. The pharmacokinetic parameters were as follows： Vc was 6.68-23. 19 L, AUCo-t was 1.39-3.59μg · h · mL^-1 , t1/2β was 1.35 -4.37 L, respectively. Conclusion It showed that intravenous administration of 10 mg r- SAK in 30 minutes was suggested.

关 键 词：重组葡激酶 药代动力学 酶联免疫吸附法 

分 类 号：R969.1[医药卫生—药理学] R972.6[医药卫生—药学]