METHOD FOR PRODUCING IMMUNOGLOBULIN Russian patent published in 2009 - IPC A61K39/395 C07K16/06 

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to manufacturing of medical products. There is disclosed method for producing immunoglobulin G that involves ethanol fractionation of donor plasma to make sediment B and purification of prepared immunoglobulin. The sediment B is dissolved in 0.9% saline pH 5.15 and mixed with acetate buffer solution 2 M and 53% ethanol, and centrifugated. Centrifugate is mixed with sodium hydrocarbonate at solution pH 5.5. After centrifugation, the centrifugate is purified, mixed with acetate buffer solution at pH 5.4, 96% (vol/vol) ethanol and sodium bicarbonate at pH 7.2, centrifugated at minus (10-12)°C. The recovered sediment is dissolved in acetate buffer solution 0.05 M at pH 5.5, added with solvent detergent mixture containing acetate buffer solution 0.05 M at pH 5.5, and 1 wt % tri-n-butylphosphate and 1 wt % polysorbate 80. The mixture is stirred, then diluted with acetate buffer solution 0.05 M at pH 5.5 containing 1 wt % sodium octanoate, sodium chloride 0.15 M and propylene glycol concentrated 0.2 g/l. Immunoglobulin processed in such a way is immobilised and two-stage washed on sulphoprolylcation sorbent by column chromatography followed with elution, ultrafiltration and sterilisation filtration.

EFFECT: invention provides high-degree purification of immunoglobulin G, absence of viruses and stability of ready preparation.

3 cl, 2 ex