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新規のアルブミンを含有していない第VIII因子処方物
专利权人:
バクスター・インターナショナル・インコーポレイテッド
发明人:
ベスマン, マーク,ブジョンソン, エリック,ジャミール, フェロツ,カシ, ラメシュ,ピカル, マイケル,チェサロフ, セルゲイ,カーペンター, ジョン
申请号:
JP2000599425
公开号:
JP5149470B2
申请日:
2000.02.22
申请国别(地区):
JP
年份:
2013
代理人:
摘要:
A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine 1 mM to 5 mM calcium salt 100 mM to 300 mM NaCl and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine 1 mM to 5 mM calcium salt 100 mM to 300 mM NaCl and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine 1 mM to 5 mM calcium salt and a buffering agent.
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