| 摘要 |
PURPOSE:The titled monomer, obtained by treating IgG derived from humans with an acid under specific conditions, and removing dimer and/or polymer of the IgG, and capable of intravenous injection. CONSTITUTION:IgG monomer, obtained by treating a 0.2-20wt/vol% solution of human IgG containing dimer and/or polymer thereof as an impurity with an acid at 3.7-4.3pH for 30min-20hr to dissociate the human IgG polymer into monomer thereof, and capable of intravenous injection. Preferably, 0.5-20wt/ vol% at least one stabilizer selected from inorganic salts, e.g. NaCl or KCl, saccharides, e.g. glucose, fructose or sorbitol, proteins, e.g. albumin or gelatin, and organic acid salts, e.g. oxalates or citrates, is added thereto to prevent the denaturation of IgG. The presence of the stabilizer intact after the production of the IgG is preferred from the viewpoint of storage stability of the IgG.
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