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Getting Degarelix
专利权人:
ФЕРРИНГ Б.В. (NL)
发明人:
ШВАХ Грегойре (DK),НИЛЬССОН Андерс (SE),ГОТТШАЛЬК БЕВИНГ Тина Элизабет (DK),РАСМУССЕН Йон Хольбек (DK),МЁРНСТАМ Биргитта (SE),ТСИРК Андерс (SE),АННБИ Ульф (SE),ФОМСГААРД Йенс (DK)
申请号:
RU2014146272
公开号:
RU2014146272A
申请日:
2013.05.31
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. Lyophilized drug substance degarelix, consisting essentially of degarelix, acetic acid and a residual amount of water, which after dissolving in water in an amount of 20 mg of degarelix in the form of a free base / ml of water containing 2.5 wt. % mannitol, shows a viscosity of up to 3.2 MPa · s inclusive. 2. The lyophilized drug substance degarelix according to claim 1, which after dissolving in water in an amount of 20 mg of degarelix in the form of a free base / ml of water containing 2.5 wt. % mannitol, exhibits a viscosity of 1.15 to 2.0 MPa · s. 3. Lyophilized drug substance degarelix according to any one of paragraphs. 1 or 2, having an acetic acid content of from 4.5 to 10.0% (w / w). 4. The lyophilized drug substance degarelix according to claim 1, having a water content of 10% (w / w) or less. A method of obtaining a medicinal substance degarelix according to any one of paragraphs. 1-4, which includes the steps of: a) purifying degarelix obtained by liquid-phase or solid-phase peptide synthesis to obtain a degarelix solution with a purity of at least 95%; b) evaporating the solvent to concentrate the degarelix solution to obtain aggregated degarelix; c) disaggregating aggregated degarelix c the use of acetic acid; ig) lyophilization of disaggregated degarelix to obtain a medicinal substance of degarelix. 6. The method according to claim 5, wherein the concentration of acetic acid at the end of step (c) is in the range of 15 to 35% (v / v). A method according to claim 5 or 6, wherein the temperature in step (c) is in the range from -5 to 30 ° C. The method according to claim 5, where the concentration of degarelix (in the form of a free base) is in the range from 10 to 35 g / l. A method of obtaining a medicinal substance of degas1. Лиофилизированная лекарственная субстанция дегареликса, состоящая по существу из дегареликса, уксусной кислоты и остаточного количества воды, которая после растворения в воде в количестве 20 мг дегареликса в виде свободного о
来源网站:
中国工程科技知识中心
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http://www.ckcest.cn/home/

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