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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,Vc为6.68~23.19L,AUC0-t为1.39~3.59μg·h·mL-1,t1/2β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 study the pharmacokinetics of recombinant staphylokinase (r-SAK) (anti-acute myocardial infarction) in healthy volunteers after single intravenous administration. Methods Twenty-four healthy volunteers were randomly divided into three groups (5, 10 and 15 mg dose groups), and established a double antibody enzyme-linked immunosorbent assay (ELISA) to measure the plasma concentration of r-SAK. The pharmacokinetic software Data processing. Results The r-SAK was consistent with the two-compartment elimination model. The Vc was 6.68-23.19L, the AUC0-t was 1.39-3.59μg · h · mL-1, and the t1 / 2β was 1.35-4.47h. Conclusion The proposed clinical administration method is r-SAK 10mg, intravenous infusion within 30min.