| 摘要 |
FIELD: medicine, pharmaceutics.SUBSTANCE: invention relates to field of pharmaceutics. Lyophilised pharmaceutical composition contains IX factor, more than 90% of whose calcium-binding ability are preserved in storage within 6 months at 25°C and tregalose, taken in amount 0.5%-3% by volume. Method of preparing stable dry composition includes stages of mixing IX factor-containing solution with tregalose 0.5%-3% by volume with obtaining cryoprotective solution. Method of pharmaceutical composition lyophilisation includes stages of freezing pharmaceutical composition containing IX factor and tregalose by 0.5%-3% in volume at temperature -40°C or less, burning pharmaceutical composition at temperature approximately from -20°C to -35°C, reduction of pharmaceutical composition temperature to -40°C or less, drying pharmaceutical composition at the first stage of drying at temperature from 5°C to 20°C at lower pressure, drying pharmaceutical composition at the second stage of drying at temperature from 45°C to 55°C at lower pressure. Method of preparing IX factor-containing lyophilised composition ensures preservation of more than 90% of IX factor calcium-binding ability.EFFECT: application of composition on the basis of tregalose in amount 0,5%-3% in volume ensures its stability for 6 months of storage at conditions of 25°C.17 cl, 5 ex, 6 dwg |
