FIELD: medicine.
SUBSTANCE: invention relates to liquid defibrotide compositions for use in the treatment and prevention of the venous occlusive disease. The liquid defibrotide composition is characterized in biological activity from 25 to 35 ME/mg of defibrotide and its concentration of at least 80 mg/ml. The specific biological activity of defibrotide is determined by a method including stages of: a) bringing into contact defibrotide, mammalian euglobulin and plasmin-specific substrate that provides measured product as a result of reaction with plasmin, and b) measuring the amount of the resulting product at subsequent time points. Liquid defibrotide compositions can be included in a composition containing 200 mg of defibrotide in 2.5 ml of a buffered aqueous solution for dilution before use, where the composition contains defibrotide with activity from 5000 to 7000 IU, preferably from 5500 to 6500 IU, more preferably from 5600 to 6400 IU.
EFFECT: obtaining compositions for the treatment and prevention of the venous occlusive disease.
19 cl, 3 dwg, 4 tbl
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Authors
Dates
2022-02-08—Published
2017-07-26—Filed