发明授权
- 专利标题: Long-term stabilized formulations
- 专利标题(中): 长期稳定配方
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申请号: US09914641申请日: 2000-02-29
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公开(公告)号: US06908610B1公开(公告)日: 2005-06-21
- 发明人: Yasushi Sato
- 申请人: Yasushi Sato
- 申请人地址: JP Tokyo
- 专利权人: Chugai Seiyaku Kabushiki Kaisha
- 当前专利权人: Chugai Seiyaku Kabushiki Kaisha
- 当前专利权人地址: JP Tokyo
- 代理机构: Morgan & Finnegan, LLP
- 优先权: JP11/052314 19990301
- 国际申请: PCT/JP00/01160 WO 20000229
- 国际公布: WO00/51629 WO 20000908
- 主分类号: C12N5/06
- IPC分类号: C12N5/06 ; A61K9/00 ; A61K9/19 ; A61K31/195 ; A61K31/198 ; A61K38/00 ; A61K38/18 ; A61K38/19 ; A61K38/29 ; A61K47/18 ; A61K47/26
摘要:
A stable G-CSF formulation having a residual ratio of G-CSF of 90% or more after long-term storage testing at 25° C. for 3 months or a residual ratio of G-CSF of 90% or more after long-term storage testing at 40° C. for 2 months or a residual ratio of G-CSF of 90% or more after accelerated testing at 50° C. for 1 month or a residual ratio of G-CSF of 90% or more after accelerated testing at 60° C. for 2 weeks and a content of Met-oxidized G-CSF of 1% or less after accelerated testing at 50° C. for 1 month or after accelerated testing at 60° C. for 2 weeks.
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