| 摘要 |
FIELD: medicine.SUBSTANCE: invention refers to medicine, particularly to immunology and represents a method for preparing a concentrated immunoglobulin preparation for subcutaneous administration involving the purification of Cohn fraction II of human plasma protein contaminants from unstable protein impurities and lipids by fractionation in aqueous solutions, the adsorption of pyrogens by aluminium hydroxide, the solvent/detergent preparation by a mixture of tributyl phosphate and sodium cholate, the removal of virus-inactivating reactants, the neutralisation of pyrogens in the presence of salts, the stabilisation by glycine, wherein the solvent and detergent are removed by depth filtration and ultrafiltration with multiple change of the solvent in the ultrafiltration, in a combination of the concentration of the immunoglobulin solution and he preparation release from the fractionation agent and salts thereof.EFFECT: invention provides higher quality of the preparation ensured by additional neutralisation of pyrogens and the highest possible removal of the solvent/detergent impurities by aqueous solution in the ultrafiltration.3 cl, 2 ex, 1 tbl |
