HUMAN IMMUNOGLOBULIN PREPARATION FOR INTRAVENOUS INJECTION CONTAINING HUMAN IMMUNOGLOBULIN MODIFIED WITH POLYETHYLENE GLYCOL

摘要

PURPOSE:To provide the titled preparation containing human immunoglobulin chemically modified with PEG as an active component, stable at a low PEG content compared with conventional preparation for intravenous injection, having high bioactivity, and exhibiting low side effect even in the administration at a high dose for the treatment of immunodeficiency syndrome. CONSTITUTION:A human immunoglobulin (HIG) preparation for intravenous injection is prepared by using a PEG-modified HIG as a component. The PEG is monomethoxyl PEG wherein one terminal OH is activated with cyanuryl chloride, and preferably has a molecular weight of 500-10,000. A stable preparation for intravenous injection having the bioactivity of HIG (antigen-bonding property, immunizing activity, phagocyte-activation activity, etc.) can be produced by bonding a small amount of (preferably 2-8wt%) PEG to HIG. On the other hand, the HIG bonded with a large amount of (preferably 20-50wt%) PEG is effective to stabilize the coexisting nonmodified HIG, and the titled preparation having excellent clinical effect can be obtained by using the modified HIG as a stabilizer.