Inactivation and validation of virus in blood products of human coagulation fac-torⅧ / 药学实践杂志

ABSTRACT

Objective To study effect of virus inactivation/removal treated by solvent/detergent method and dry heating at 80℃, 72 h for inactivation in human coagulation factor Ⅷ.Methods Human coagulation factor Ⅷextracted from healthy human plas-ma were treated by solvent/detergent method and dry heating at 80℃, 72 h for inactivation .The virus inactivation effect was validated by adding the indicator virus ( PRV, Sindbis, HIV, EMCV, PPV).Results The methods could effectively inactivate lipid-enveloped and non lipid-enveloped viruses which could be used for virus inactivation /removal during human coagulation factor Ⅷexperiments , the residual amount of TNBP in production was less than one percent ten thousand (10 ppm), the residual Tween-80 concentration was less than one percent hundred thousand (100 ppm),which all met the safety standards .Conclusion and no significant change was ob-served in the activation and other indicators of human coagulation factor Ⅷ.