摘要 |
PURPOSE:To carry out viral inactivation of the titled globulin, by heating natural type immunoglobulin for intravenous administration in the presence of a specific stabilizer. CONSTITUTION:Natural type immuno(gamma)globulin for intravenous administration, e.g. obtained by fractionating blood plasma proteins, etc., such as IgG, IgA or IgM, is a dry state is heated in the presence of a stabilizer consisting of at least one saccharide selected from sorbitol and saccharose and albumin under condition of <=3% moisture content until contaminating viruses are inactivated to carry out viral inactivation of the natural type immunoglobulin for intravenous administration. The above-mentioned stabilizer is used in an amount to give concentrations of 1-5wt/vol% saccharide and 0.5-5wt/vol% albumin based on a 0.01-2wt/vol% solution of monoclonal immunoglobulin or 2-8wt/vol% solution of polyclonal immunoglobulin.
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