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DRUG FORMS FOR PROTEINS
专利权人:
Ф. ХОФФМАНН-ЛЯ РОШ АГ (CH)
发明人:
МАЛЕР Ханс-Кристиан (CH),РАВУРИ Сатя Кришна Кишоре (CH)
申请号:
RU2012133473/15
公开号:
RU2012133473A
申请日:
2011.01.14
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A liquid pharmaceutical preparation containing protein, a surfactant and at least one antioxidant selected from the group of radical scavengers, chelating agents and chain terminators. A liquid pharmaceutical preparation according to claim 1, characterized in that at least one of said antioxidants is selected from the group of radical acceptors. A liquid pharmaceutical preparation according to claim 2, characterized in that said radical acceptor is selected from ascorbic acid, BHT, BHA, sodium sulfite, p-aminobenzoic acid, glutathione and propyl gallate. The liquid pharmaceutical preparation according to claim 1, characterized in that said protein is a therapeutic protein, preferably an antibody, more preferably a monoclonal antibody. A liquid pharmaceutical preparation according to claim 1, characterized in that said chelating agent is selected from EDTA and citric acid. A liquid pharmaceutical preparation according to claim 1, characterized in that said chain terminator is selected from methionine, sorbitol, ethanol and N-acetylcysteine. A liquid pharmaceutical preparation according to claim 1, characterized in that said surfactant is selected from the group of polysorbate and poloxamer. The liquid pharmaceutical preparation according to claim 7, characterized in that said polysorbate is polysorbate - 20 or polysorbate - 80.9. The use of an antioxidant selected from the group consisting of radical acceptors, chelating agents and chain terminators to prevent the degradation of a surfactant in a liquid pharmaceutical preparation containing protein. 10. Antioxidant use1. Жидкий фармацевтический препарат, содержащий белок, поверхностно-активное вещество и по меньшей мере один антиоксидант, выбранный из группы акцепторов радикалов, хелатирующих агентов и терминаторов цепей.2. Жидкий фармацевтический препарат по п.1, характеризующийся тем, что по меньшей мере один указанный антиоксидант выбран из группы акцепторов радикалов.3. Жидкий фармацевтический препарат по п.2,
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