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Разработка и регистрация лекарственных средств

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ОСОБЕННОСТИ КОНТРОЛЯ ПРЕПАРАТОВ АЛЬБУМИНА ЧЕЛОВЕКА НА СОДЕРЖАНИЕ БАКТЕРИАЛЬНЫХ ЭНДОТОКСИНОВ

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Аннотация

Рассмотрена проблема определения бактериальных эндотоксинов в препаратах альбумина человека. Для повышения безопасности препаратов рекомендован вариант двойного контроля, включающий биологический контроль на кроликах, а так же определение бактериальных эндотоксинов методом ЛАЛ-теста. Описаны причины, обосновывающие необходимость двойного контроля препаратов альбумина человека на содержание пирогенов и бактериальных эндотоксинов, основной из которых является особая природа молекулы альбумина, обратимо связывающая большое количество соединений, в том числе эндотоксины. Изложены известные причины ложноположительных и ложноотрицательных реакций ЛАЛ-теста, а так же универсальный вариант пробоподготовки, включающий разведение, температурную обработку и использование специальных диспергирующих агентов.

Об авторах

Т. В. Кукунина
Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»
Россия


А. Г. Исрафилов
Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»
Россия


М. Л. Романенкова
Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»
Россия


Р. С. Гайнуллина
Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»
Россия


Л. Г. Федько
Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»
Россия


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Для цитирования:


Кукунина Т.В., Исрафилов А.Г., Романенкова М.Л., Гайнуллина Р.С., Федько Л.Г. ОСОБЕННОСТИ КОНТРОЛЯ ПРЕПАРАТОВ АЛЬБУМИНА ЧЕЛОВЕКА НА СОДЕРЖАНИЕ БАКТЕРИАЛЬНЫХ ЭНДОТОКСИНОВ. Разработка и регистрация лекарственных средств. 2018;(2):100-109.

For citation:


Kukunina T.V., Israfilov A.G., Romanenkova M.L., Gaynullina R.S., Fedko L.G. PECULIARITIES OF CONTROL OF HUMAN ALBUMIN DRUGS ON THE CONTENT OF BACTERIAL ENDOTOXINS. Drug development & registration. 2018;(2):100-109. (In Russ.)

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