PREPARATION OF HUMAN IMMUNOGLOBULIN FOR INTRAVENOUS INJECTION CONTAINING GELATIN DERIVATIVE

摘要

PURPOSE:To obtain a pharmaceutical for the intravenous injection having the suppressed formation of flocculants and increase in the anticomplementary activity and the stability without side effects, by adding a gelatin derivative to an immunoglobulin (IgG) without containing a flocculant. CONSTITUTION:A gelatine derivative selected from (i) a succinylated gelatin prepared by succinylating decomposed gelatin with succinic anhydride, (ii) gelatin, having urea blinkages, and prepared by reacting the decomposed gelatin with a diisocyanate or (iii) a derivative prepared by condensing gelatin with glyoxal, and oxidizing the resultant condensation product, is added to an immunoglobulin (IgG) obtained by fractionating a human blood plasma and containing no flocculants to give IgG for the intravenous injection. The amount of the gelatin derivative is 10-4-101% for preventing the surface denaturation in the case of a liquid pharmaceutical, 1-200% based on the weight of the IgG for preventing the thermal deterioration and 10-120% based on the weight of the IgG for suppressing the deterioration due to the freeze-drying.