重组蛋白多肽药物的临床药代动力学.pdfVIP

Chinese Journal of ew Drugs 2002, Vol. 11 o. 10 2002 11 10 * , ,, ( 军事医学科学院放射医学研究所 生物技术药物代谢实验室, 北京100850) [ ] 扼要介绍重组蛋白 肽类药物的临床药代动力学研究的内容方法和特点综述了重组内皮抑制 素重组糖基化血小板生成素改构肿瘤坏死因子重组糖基化尿激酶原人源化单抗trastuzumab 和重组人肿瘤坏 死因子受体临床药代动力学研究的方法学内容和结果 [] 基因重组蛋白 肽药物; 临床药代动力学; 酶联免疫吸附测定 [] R969. 1 [ ] A [ ] 1003- 3734( 2002) 10- 0750- 07 Clinical pharmacokinetics of recombinant protein or peptides TA G Zhong-ming,LIU Xiu-wen, SO G Ha-i feng,ZHU Bao-zhen ( Laboratoryf or Metabolism of Biotechnology-Derived Drugs, Institute of Radiation Medicine, Academy of Military Medical Sciences, Beij ing 100850, China) [Abstract] The clinical pharmacokinetics on recombinant protein or peptides, including the methodology, contents, and characteristics were introduced in brief. The recombinant endostatin,re- combinant glycosylated thrombopoeitin, recombinant modified tumor necrosis factor alpha,recombinant glycosylated prourokinase,humanized monoclonal antibody trastuzumab,and recombinant human tumor necrosis factor receptor were reviewed with respect to their methodology and pharmacokinetic behav- ior. [Key words] recombinant protein or peptides; clinical pharmacokinetics; enzyme-linked im- munosorbent assay [ 1~ 5] , , 1 , FDA , ( Enbrel, rhu T FRFc) ( ) , , , 1. 1 T FRFc ( etanercept) , ; ( T FR) - 3 75 10 (p75) T FR ,, Fc Fc IgG CH CH 1 2 3 - 1 , , pgmL ng , CH , D A