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ВОДНЫЙ РАСТВОР ФАКТОРА VIII
专利权人:
НОВО НОРДИСК А/С (DK)
发明人:
РИШЕЛЬ Кристиан (DK),ЕСПЕРГААРД Кристина (DK),БОГНЕС Аре (DK),КРАРУП Янус (DK)
申请号:
RU2013131911/15
公开号:
RU2013131911A
申请日:
2011.11.30
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A method of stabilizing FVIII in an aqueous solution having a concentration of FVIII of at least 1 ug / ml and pH 5,5-8,5, wherein said method includes maintaining FVIII in an aqueous solution containing a salt at a concentration of at least 300 mM, and glycerol at a concentration of 5-30% .2. A method according to claim 1, wherein said aqueous solution comprises a divalent cation at a concentration of 2-20 mM.3. A method according to claim 1, wherein said aqueous solution contains a detergent in a concentration of 0.05-0.3 g / kg.4. The method of claim 1, wherein the salt is NaCl.5. The method of claim 1, wherein the salt concentration in the aqueous solution is from 300 to 1000 mM.6. A method according to any one of claims 1-5, wherein FVIII is a variant with a truncated B domain, FVIII concentration is at least 1 ug / ml, the salt concentration is about 500 mM, glycerol concentration is 10-20%, the concentration of divalent cation is prmerno 10 mM, the detergent concentration is 0.1-0.2 g / kg, and the pH of the solution is from 6 to 8.7. An aqueous solution of FVIII, containing at least 1 ug FVIII / ml, pH 5,5-8,5, salt at a concentration of at least 300 mM, and glycerol in a concentration of 5-30% .8. A solution according to claim 7, wherein said solution further comprises a detergent in a concentration of 0.05-0.3 g / kg.9. A solution according to claim 7, wherein said solution further comprises a divalent cation at a concentration of 2-20 mM.10. FVIII solution according to claim 7, wherein the salt is NaCl.11. FVIII solution according to claim 7, wherein the salt concentration in the aqueous solution is from 300 to 1000 mM.12. A solution of FVIII according to any of claims 7-11, wherein FVIII is a variant with a truncated B domain, FVIII concentration is at least 1 ug / ml, the salt concentration is about 500 mM, glycerol concentration is 10-20%, the concentration dvuhv1. Способ стабилизации FVIII в водном растворе, имеющем концентрацию FVIII по меньшей ме
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