METHOD OF PREPARING IMMUNOGLOBULINS FOR INTRAVENOUS ADMINISTRATION AND OTHER IMMUNOGLOBULIN PREPARATIONS

摘要

FIELD: medicine, preparative biochemistry. SUBSTANCE: invention relates to method of purification of immunoglobulin G from immunoglobulin-containing protein fraction of crude plasma. Indicated method involves sequence of stages among of them anion-exchange chromatography and cation-exchange chromatography are coupled in-line preferably. Acetate buffer with pH value about 5.0-6.0 and molarity about 5-25 mM is used in method of purification preferably. Then invention involves highly purified native immunoglobulin product prepared by indicated method. Invention relates also to immunoglobulin product with purity above 98%, content of monomers and dimmers of IgG are above 98.5%, content of IgA is less 4 mg IgG/l and content of polymers and aggregates is less 0.5%. Indicated product has no detergent, polyethylene glycol (PEG) or albumin as stabilizing agent. Product shows stability and safety with respect to viral activity, it is in liquid form and useful for direct intravenous administration. EFFECT: improved method of preparing, enhanced and valuable properties of product. 25 cl, 2 tbl, 5 ex