FIELD: medicine, pharmaceutics.
SUBSTANCE: invention refers to medicine and describes a method for recovery of factor VIII from human blood plasma not identified by related analysis of hepatitis and HIV1/2 viruses consisting in sequential cryoprecipitation, dissolution in an aqueous solution of heparin and solubilisation of a cryoprecipitate, sorption of a prothrombin-converting complex factor by aluminium hydrate, removal of fibrinogen, fibronectin and associated protein by polyethylene glycol-4000, viral inactivation with solvent detergents and preliminary filtration, anion-exchange chromatography, preferentially with EDM-TMAE Fractogel, with elution by a sodium chloride buffer, stabilisation by albumine solution, sterile filtration in membrane filters of pore diameter 0.22 mcm, bottling (200-300 IU/bottle), lyophilisation and second thermal viral inactivation with purification using the aqueous solution of unfractionated heparin of the concentrations equal to 5-100 international units (IU)/ml, preferentially 10-25 IU/ml, polyethylene glycol-4000 in the final concentration 3.5% and acidification of the medium, preferentially to pH 6.6, strong TMAE anion exchangers.
EFFECT: method substantially provides higher effectiveness of purification and specific activity of factor VIII.
1 tbl, 4 dwg, 2 ex
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Authors
Dates
2012-03-27—Published
2010-04-26—Filed