| Objectives: 60Co-γ radiation method can kill many kinds of micro-organisms, which include blood-transmitted viruses. This method has been used to disinfect and sterilize medical products for a long time. In this study, we try to utilize 60Co-γ radiation to inactivate the virus in plasma protein preparations. The purpose is to develop a new method of virus inactivation for plasma protein preparations and to increase the safety of the preparations.Methods: sindbis virus was selected as the test virus and IVIG preparation as the target protein. Three powerful antioxidant of Vc, Vc-Na and TP were used as protein protectants. The protectant functions were observed about their influence on y radiation to inactivate the viruses in liquid and freeze-drying IVIG, and simultaneously the structure and biological activities of treated IgG molecules were analyzed by gel electrophoresis , HPLC, ITM, SRID, ELISA and Western-blot.Results:1 Applying 60Co-γ radiation to inactivate virus in liquid IMG:6.5LgTCID50 Sindbis virus in liquid IVIG were completely inactivated by 30kGy of 60Co-γ radiation, but molecular structure of IgG is damaged obviously. The content of active antigen in the post-irradiation sample remained only about 30% comparing with that of pre-irradiation. Three protectants, Vc, Vc-Na and TP (0.025-0.2 mg/ml ), in the liquid IVIG didn't have a influence on the effect of Sindbis virus inactivation by y-radiation. Molecular structure of IgG is protected to some extent and there was a decreasing molecular polymerization and fragmentation. The content of active antigen in liquid IVIG with the presence of 0.2mg/ml protectant was nearly 2 times higher than that of liquid IVIG without the protectant, and the protective effects of three protectants was nearly the same on the whole. The virus inactivation effect wasn't influenced either by the addition of 2.5-40mg/ml Vc in the liquid IVIG after treatment with 45 kGy of 60Co-γ radiation. Molecular structure of IgG was further protected and... |
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