METHOD FOR PRODUCING IMMUNOGLOBULIN FOR INTRAVENOUS INTRODUCTION OF IMMUNOGLOBULIN M ENRICHED PREPARATION, AND PREPARATION PREPARED BY SUCH METHOD

摘要

FIELD: medicine.SUBSTANCE: group of inventions refers to medicine. A preparation is produced of donor blood plasma by protein fractionation in ethanol at temperature below 0°C (Cohn method); the produced filtrate B (III) is used to recover purified immunoglobulin G; the produced deposition B (III) is used to recover a purified immunoglobulin M enriched concentrate; it is followed by separate decrease of anti-complement activity of immunoglobulin G and immunoglobulin M; then a pharmaceutical composition is prepared by combining immunoglobulins G and M with decreased anti-complement activity by mixing immunoglobulins G and M taken in equal proportions. Decrease of anti-complement activity of immunoglobulins G and M is differentiated. For immunoglobulin G - to the value max. 1 hemolytic unit (CH50) per 1 mg of immunoglobulin by molecular filtration dialysis with the use of purified water at pH 3.8-4.5; for immunoglobulin M to the value max. 1 hemolytic unit (CH50) per 1 mg of immunoglobulin with keeping a semi-finished product at temperature 45±5°C for 24-48 hours. The preparation is to be virus-inactivated and dried.EFFECT: group of invention provides producing the immunoglobulin M enriched preparation with higher IgG biological activity and lower spontaneous anti-complement activity.8 cl, 2 ex, 1 tbl