FIELD: medicine.
SUBSTANCE: invention refers to chemically and physically stable compositions containing VII factor or polypeptide, related to VII factor, so such compositions can be stored, available and applicable at room temperature. The composition contains effective amount of VII factor polypeptide, and sucrose and polyol combination with humidity about 3% or less. The invention also concerns the method for preparing stable VII factor polypeptide as involving stages of introduction of said VII factor polypeptide in a solution containing sucrose and polyol combination as a stabiliser, and processing of said solution to produce a solid composition. In addition to sucrose and polyol combination, an antioxidant that is, e.g. homocysteine, cysteine, cystathionine, methionine or glutathione, can be added. Polyol represents, e.g. mannitol, sorbite or xylite. There is also disclosed method for treatment of reactive syndrome of VII factor that involves introduction of VII factor combined with sucrose and polyol. There is also offered application of VII factor polypeptide to prepare a medical product used for treatment of reactive syndrome of VII factor. The invention is related to stable compositions of VII factor polypeptide that does not contain degradation products and does not show decreasing activity of VII factor polypeptides if stored in natural conditions within at least 6 months.
EFFECT: improved stability of the composition.
48 cl, 12 ex, 7 tbl
