Gamma-globulin preparation for intravenous administration, process for production thereof and process for preparation of gamma-globulin of low anticomplementary activity

摘要

Conventional techniques of purifying gamma-globulin from human blood suffer from a variety of disadvantages, not least being problems associated with the removal of impurities of high anticomplementary activity. A gamma-globulin of an anticomplementary activity of lower than 20% (C'H_so value) in now prepared by forming a suspension of a pH of 7.0 to 9.0 of Cohn's Fraction II for said gamma-globulin in an aqueous solution of a monosaccharide, disaccharide or sugar alcohol, adding thereto dextran of an average molecular weight of 10,000 to 70,000 to produce an aqueous 2 to 10% wt./vol. solution of dextran and, after removing the thus formed precipitate, adding ammonium sulfate to the remaining mother liquor thereby to precipitate said gamma-globulin. A gamma-globulin preparation containing a gamma-globulin of such low anticomplementary activity is stabilized by specific amounts of L-arginine, L-lysine or a pharmaceutically acceptable salt thereof. The gamma-globulin and the preparation, which may be lyophilized, can be employed for intravenous administration to humans.