Preparation null of the injection possible immune serum globulin inside the vein which the virus non- to life is converted

摘要

PROBLEM TO BE SOLVED: To provide a method for preparing an intravenously injectable immune serum globulin and obtain its preparation. ;SOLUTION: This method for preparing an intravenously injectable immune serum globulin is to reduce anticomplementary activities (ACA) produced by a viral inactivating treatment of an antibody solution. The method comprises bringing the solution into contact with a trialkyl phosphate such as tri-n-butyl phosphate and a surfactant such as sodium cholate under conditions sufficient to substantially reduce the viral activities and then incubating the solution under controlled conditions of the time, pH, temperature and ionic strength so as to reduce the anticomplementary activities to a permissible level. The ACA is reduced to about 60 CH₅₀ units/ml in a preferred embodiment and the incubation is preferably carried out at pH 3.5-5.0 for at least about 10 days at a temperature maintained within the range of 2-50°C. The ionic strength of the solution is preferably about 0.001.;COPYRIGHT: (C)1997,JPO