FIELD: medicine.
SUBSTANCE: invention refers to a method for producing preparations of blood plasma, namely to a method for purifying immunoglobulin solutions produced by alcohol fractionation from admixtures of caprylic acid applicable at the stage of virus inactivation, and can be used in manufacturing of medicinal biological preparations. The presented method involves processing an immunoglobulin solution in caprylic acid concentrated 6÷100 mM at temperature 15÷37°C and agitating for 0.5÷2 hours. The immunoglobulin solution is processed in caprylic acid at max. ionic force 0.03 M and pH 3.9÷4.6; caprylic acid is removed from the immunoglobulin solution by filtration through a carbon filter at temperature 5÷15°C, max. ionic force 0.03 M and pH 3.9÷4.6; the produced solution contains caprylic acid in an amount of no more than 20 mcg/ml; the aggregate amount makes no more than 1%, the min. immunoglobulin yield is 98%.
EFFECT: invention enables improving the technology of safe virus-inactivated immunoglobulin solutions low in residual caprylic acid and high in end product, maintaining their physical-chemical properties and specific activity, with the use of a simple technique.
3 cl, 4 dwg, 3 tbl, 4 ex
Authors
Dates
2015-08-27—Published
2013-12-18—Filed