INTRAVENOUS ANTI-ALLERGIC IMMUNOGLOBULIN PREPARATION AND METHOD FOR ITS PREPARING Russian patent published in 2004 - IPC

FIELD: biotechnology, medicinal industry.

SUBSTANCE: invention relates to producing medicinal biological preparations and can be used in preparing anti-allergic immunoglobulins designated for intravenous administration. Filtrate III is prepared by fractionation using Cohn's VI method, pH value is brought about to 4.65-5.35 and polyethylene glycol with molecular mass 4 000-6 000 Da is added to the concentration 0.05-0.20% in the supernatant B solution. Then method involves ultrafiltration and diafiltration on polysulfone membranes with retention limit 30-100 kDa at pH = 4.65-5.35 and ionic strength 0.015 M, not above. Maltose in the concentration 9-11% is used as a stabilizing agent and the preparation containing monomeric anti-allergic immunoglobulin for intravenous administration is prepared. The preparation represents immunoglobulin G with electrophoretic purity 99%, not less, protein concentration in the solution 2.5%, not less, anticomplementary activity above 10 mg/2CH50 having the following molecular-mass distribution: aggregates, 0.5%, not above; monomers, 90%, not less; fragments, 5%, not above, with anti-allergic activity 95 ± 3.5%. Invention provides preparing monomeric anti-allergic immunoglobulin with low anticomplementary activity and stable in storing.

EFFECT: improved preparing method, valuable properties of preparation.

2 cl, 3 tbl, 2 ex