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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
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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.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2007年第2期97-100,共4页 The Chinese Journal of Clinical Pharmacology
关键词 重组葡激酶 药代动力学 酶联免疫吸附法 recombinant staphylokinase pharmacokinetics enzyme linked immunosorbent assay
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