HUMAN IMMUNOGLOBULIN PREPARATION AGAINST CYTOMEGALOVIRUS FOR INTRAVENOUS INTRODUCTION AND METHOD OF ITS OBTAINING Russian patent published in 2010 - IPC C12P21/02 A61K39/00 

FIELD: medicine.

SUBSTANCE: as feedstock for fractioning used is anticytomegalovirus plasma with activity index not less than 70%. Process of production includes: ultrafiltration of immunoglobulin at ion force not higher than 0.02 and pH value 4.0-5.7 with further diafiltration against distilled water with pH value 3.5-6.0. Immunoglobulin is incubated with maltose of 2-11% concentration at temperature 32-40°C and pH value 4.0-4.8 for 10-36 hours, or with pepsin in dose 1:10^-6-1:10^-5 in presence of 2-11% maltose. After that inactivation/removal of viruses is carried out by immunoglobulin incubation at pH value 4.0-4.4 and/or with application of depth filtration, and/or nanofiltration. Afterpurification of immunoglobulin is performed by methods of: ultrafiltration and/or depth filtration, and/or nanofiltration, and/or anion-exchange chromatography, and/or dialysis. Immunoglobulin stabilisation is carried out with application of sodium chloride and/or maltose, and/or proline, and/or glucose and/or glycerol, whose content provides preparation osmolarity within 270-400 mOcm/kg. In obtained immunoglobulin preparation pH value 5.0-7.5 and protein content 4.5-10.5% are installed.

EFFECT: invention allows to obtain highly avid immunoglobulin preparation against cytomegalovirus for intravenous introduction with improved and stable qualitative quaracteristics.

7 cl, 5 tbl, 4 ex