| 摘要 |
FIELD: medicine, preparative immunology. ^ SUBSTANCE: invention relates to a method for preparing IgG (immunoglobulin G) from blood plasma for medicinal using. Method involves the following steps: (1') removal of albumin with preparing IgG fraction followed by carrying out step (I) wherein IgG fraction prepared at stage (1') is concentrated; (2') this IgG fraction is purified on anion-exchange resin and unbound IgG fraction is collected; (3') this unbound IgG fraction is purified on cation-exchange resin and bound IgG fraction is collected and step (II) is carried out wherein pH value of IgG fraction eluted from cation-exchange resin at step (3') is brought about to 4 ± 0.1 and during all steps of the method pH value is maintained less 6.0; (4') virus in IgG fraction prepared from IgG fraction collected at step (3') is inactivated by using chemical reagents at temperature 30° ± 2°C for at least 4 h. Method provides preparing IgG that possesses anti-complementary activity less 1 titer value of complement providing 50% hemolysis (CH50)/mg of immunoglobulin. ^ EFFECT: improved preparing method. ^ 7 cl, 1 dwg, 2 ex |
