| 摘要 |
FIELD: medicine, pharmacy. SUBSTANCE: invention relates to stable, albumin-free preparation of recombinant factor VIII (rFVIII) in lyophilized form. Preparation comprises both crystalline and amorphous components and after dilution with water it comprises about from 65 to 400 mM of glycine, up to 50 mM of histidine, from 15 to 60 mM of sucrose, from 1 to 50 mM of sodium chloride, up to 5 mM of calcium chloride and from 50 to 1500 IU/ml of rFVIII. After dilution with water the most preferable formula comprises about 290 mM of glycine, 20 mM of histidine, 30 mM of sucrose, 30 mM of sodium chloride, 2.5 mM of calcium chloride and from 50 to 1500 IU/ml of rFVIII. Content of residual water in lyophilized preparation is from 1 to 3 weight % but preferably about 1 weight %. EFFECT: prolonged storage time of composition. 4 cl, 1 dwg
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