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《Chinese Journal of Blood Transfusion》 2014-06
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A preliminary comparison on pharmacokinetics between a domestic rhFⅧ and a commercial drag xynthain hemophilia A mice

LIU Liang;GU Ruolan;ZHU Xiaoxia;MENG Zhiyun;WU Zhuona;GAN Hui;DOU Guifang;Institute of Transfusion Medicine,Academy of Military Medical Sciences;  
Objective: To perform a preliminary study of preclinical pharmacokinetics of a domestic recombinant human coagulation factor Ⅷ( rhFⅧ). Methods A chromogenic activity assay to determine the plasma FⅧ∶ C activity was established and optimized. A commercially available rFⅧ product,Xyntha,was selected to be the reference drug. Hemophilia A mice were i. v. administrated of 280 IU·kg- 1rhFⅧ or Xynthaand the blood samples( 30 μL /each mice,six blood samples per time point) were collected from the orbital plexus in the interval of 0,0. 083,1,3,6,9,24,36 and 48 h post-administration. The FⅧ∶ C level of blood samples were assayed and then the pharmacokinetic parameters were calculated. Results The FⅧ: C level of blood samples on different time points( 0. 083,1,3,6,9,24,36,48 h) were 3. 218 ± 1. 511 vs 3. 616 ±1. 504,2. 089 ± 0. 593 vs 2. 786 ± 1. 157,1. 953 ± 0. 546 vs 1. 942 ± 0. 807,0. 613 ± 0. 360 vs 1. 025 ± 0. 321,0. 515 ± 0. 370vs 0. 894 ± 0. 297,0. 187 ± 0. 082 vs 0. 310 ± 0. 108,0. 061 ± 0. 038 vs 0. 115 ± 0. 040,0. 043 ± 0. 042 vs 0. 023 ± 0. 012 IU·mL- 1( P 0.05) after administration of 280 IU·kg- 1rhFⅧ and Xyntharespectively. the main pharmacokinetic parameters were as follows: the t1 /2( h) were 8.83 vs 9.15,AUC0-t( h·IU·mL- 1) were 19.67 vs 27.70,Vd were 176.37 vs132. 00 mL·kg- 1,CL( mL·h- 1·kg- 1) were 13.85 vs 10.00,MRT0-t( h) were 8.64 and 9.62 for rhFⅧ and Xyntha,respectively. Conclusion Comparing with the commercial drug Xyntha,the rhFⅧ has the similar and comparable pharmacokinetics performance in the HA mice after a single intravenous administration of 280 IU·kg- 1.
【Fund】: 国家“十二五”重大新药创制专项(2011ZX11202)
【CateGory Index】: R969.1
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