RU2017102325A - Препарат рокурония с улучшенной стабильностью - Google Patents

Препарат рокурония с улучшенной стабильностью Download PDF

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RU2017102325A
RU2017102325A RU2017102325A RU2017102325A RU2017102325A RU 2017102325 A RU2017102325 A RU 2017102325A RU 2017102325 A RU2017102325 A RU 2017102325A RU 2017102325 A RU2017102325 A RU 2017102325A RU 2017102325 A RU2017102325 A RU 2017102325A
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rocuronium
buffer solution
drug
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RU2017102325A
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RU2705996C2 (ru
RU2017102325A3 (ru
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Ютака ИЦУДЗИ
Хиронори НАГАХАРА
Кейсуке ДЗИНБО
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Маруиси Фармасьютикал Ко., Лтд.
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    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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Claims (13)

1. Препарат рокурония в жидкой форме, содержащий рокуроний и буферный раствор, и имеющий pH 3,5 или менее.
2.Препарат рокурония по п. 1, имеющий pH от 2,5 до 3,5.
3.Препарат рокурония по п. 1 или 2, имеющий pH от 2,8 до 3,2.
4.Препарат рокурония по любому из пп. 1-3, где буферный раствор является, по меньшей мере, одним видом выбранным из формиатного буферного раствора, ацетатного буферного раствора, цитратного буферного раствора, тартратного буферного раствора, фталатного буферного раствора, фосфатного буферного раствора, буферного раствора на основе лимонной кислоты и фосфата и глицинового буферного раствора.
5.Препарат рокурония по любому из пп. 1-4, где буферный раствор является, по меньшей мере, одним видом, выбранным из буферного раствора на основе лимонной кислоты и гидроксида натрия, буферного раствора на основе винной кислоты и гидроксида натрия, буферного раствора на основе калий водород фталата и соляной кислоты и буферного раствора на основе глицина и соляной кислоты.
6.Препарат рокурония по любому из пп. 1-5, где pH составляет от 2,5 до 3,5 и буферный раствор является буферным раствором на основе глицина и соляной кислоты, концентрация которых составляет 0,01 M или выше.
7.Препарат рокурония по любому из пп. 1-6, уровень образовавшейся сопутствующей рокуронию примеси С в котором после 6-месячного хранения при 40°C составляет 5% или менее.
8.Препарат рокурония по любому из пп. 1-7, который является инъекцией.
9.Препарат рокурония по п. 8, уровень образовавшейся сопутствующей рокуронию примеси С в котором после 6-месячного хранения при 40°C составляет 5% или менее и который не вызывает или вызывает меньшую боль при инъекции и сосудистом раздражении.
10.Препарат рокурония по любому из пп. 1-9, который хранится при комнатной температуре.
11. Способ увеличения или улучшения стабильности препарата рокурония посредством корректировки рН препарата рокурония в жидкой форме, содержащего рокуроний и буферный раствор, до 3,5 или менее, так что уровень образовавшейся сопутствующей рокуронию примеси С после 6-месячного хранения при 40°C составлял 5% или менее.
12. Способ предотвращения или уменьшения как боли при инъекции, так и сосудистого раздражения, вызванного инъекционным препаратом рокурония и для увеличения или улучшения стабильности инъекционного препарата рокурония, так чтобы уровень образовавшейся сопутствующей рокуронию примеси С после 6-месячного хранения при 40°C составлял 5% или менее, посредством корректировки рН инъекционного препарата рокурония в жидкой форме, содержащего рокуроний и буферный раствор, до 3,5 или менее.
13.Способ по п. 11 или 12, где препарат получают, таким образом, чтобы он мог храниться при комнатной температуре.
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