Pharmacokinetics of recombinant fully human anti -tumor necrosis factor -αamonoclonal antibody in machin
10.13699/j.cnki.1001-6821.2015.07.014
- VernacularTitle:重组抗肿瘤坏死因子－α全人源单克隆抗体在食蟹猴体内的药代动力学研究
- Author:
Xu SUN
1
;
Zuo-Gang LI
;
Nie WEN
;
Yu-Qing XIONG
Author Information
1. 中国食品药品检定研究院 国家药物安全评价监测中心
- Keywords:
recombinant fully human anti -tumor necrosis factor-αamonoclonal antibody;
machin;
pharmacokineic;
bioavailability
- From:
The Chinese Journal of Clinical Pharmacology
2015;(7):532-535
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the pharmacokineics and bioavai-lability of recombinant fully human anti -tumor necrosis factor -α( TNF-α) amonoclonal monoclonal antibody. Method Twenty machins were subcutaneous or intravenous given fully human anti -TNF-αamonoclonal monoclonal antibody (1, 3 or 10 mg· kg -1 ).By using the validated enzyme -linked immuno sorbent assay ( ELISA ) kits for the determination of content of fully human anti -TNF-αamono-clonal monoclonal antibody in the plasma of machines , in order to study the pharmacokineics within 168 h and bioavailability.Result After the subcutaneous administration of 1, 3 and 10 mg· kg -1 of fully human anti-TNF-αamonoclonal monoclonal antibody injection , the AUC0-168 in-creased ( P<0.05 ) , but not the t1/2 , Vz/F, CL/F increased with the dose.The bioavailability of fully human anti -TNF -αamonoclonal monoclonal antibody after subcutaneous administration was 77.5%.Con-clusion In the range of administration concentration of this study , the plasma exposure of fully human anti -TNF-αamonoclonal monoclonal antibody had a linear pharmacokinetic profile in machin within 168 h after administration.Fully human anti -TNF -αamonoclonal mono-clonal antibody was well absorbed with a high bioavability.
