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NEW PROTECTIVE COMPOSITIONS FOR RECOMBINANT FACTOR VIII
专利权人:
ОКТАФАРМА АГ (CH)
发明人:
РИППНЕР Брита (SE),ЭСТЕРБЕРГ Йозефин (SE),НИЛЬССОН Ульрика (SE),ИВАРССОН Эльза (SE),АГЕРКВИСТ Ирене (SE)
申请号:
RU2011112787/15
公开号:
RU2011112787A
申请日:
2009.09.03
申请国别(地区):
RU
年份:
2012
代理人:
摘要:
1. Composition without histidine, including! factor VIII (r-factor VIII) of high purity; ! arginine and / or sucrose; ! a surfactant for the prevention or at least inhibition of surface adsorption of factor VIII; ! a certain amount of calcium chloride for the specific stabilization of factor VIII. ! 2. The histidine-free composition according to claim 1, wherein sodium chloride is present as an excipient if arginine and / or sucrose work as a cryo- / lyoprotective substance, but not as an excipient. ! 3. The histidine-free composition according to claim 1, in which there is essentially no sodium chloride, in particular if arginine is used as a cryo-protective substance and a filler. ! 4. The composition according to claim 1, in which the r-factor VIII is a deletion derivative of natural factor VIII, partially or completely lacking the B-domain of natural factor VIII. ! 5. The composition according to claim 1 in lyophilized form. ! 6. The composition according to claim 1 in the form of a solution for lyophilization or in the form of a reconstituted solution obtained from the lyophilized composition and diluent. ! 7. The composition according to any one of claims 2, 4-6, comprising as a cryo-protective substance about 3-15 mg / ml sucrose and about 3-15 mg / ml arginine, provided that at least 6 is present mg / ml cryo- / lyoprotective substance and as a filler from about 10 mg / ml to about 40 mg / ml sodium chloride. ! 8. The composition according to claim 7, in which the cryo-protective substance includes both arginine and sucrose, in particular from about 3 mg / ml to about 10 mg / ml, especially from about 4.5 mg / ml to about 9 mg / ml sucrose, from about 3 mg / ml to about 8 mg / ml, especially from about 4.5 mg / ml to about 6.8 mg / ml arginine and from about 10 to about 40 mg / ml NaCl in1. Композиция без гистидина, включающая ! фактор VIII (r-фактор VIII) высокой чистоты; !аргинин и/или сахарозу; ! поверхностно-активное вещество для профилактики или, по м
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