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STABILIZING EXCIPIENT FOR A VACCINE WITH INACTIVATED WHOLE VIRUSES
专利权人:
САНОФИ ПАСТЕР (FR)
发明人:
ФРАНСОН Ален (FR),ШЕВАЛЬЕ Мишель (FR),МОРЕНО Надеж (FR),КАЛЬВОЗА Эрик (FR),СИГАРИНИ Сандрин (FR),ФАБР Виржини (FR)
申请号:
RU2012118386/15
公开号:
RU2012118386A
申请日:
2010.10.07
申请国别(地区):
RU
年份:
2013
代理人:
摘要:
1. A vaccine composition comprising: a) a preparation of inactivated whole viruses; b) a stabilizing excipient containing: i. buffer solution; ii. a mixture of essential and non-essential amino acids iii. disaccharide; iv. polyol; v. chelating agent vi. urea or a urea derivative; vii. nonionic surfactant. 2. The composition of claim 1, wherein the inactivated whole virus is rabies virus. The composition according to claim 2, characterized in that it also does not contain any whey protein. The composition according to claim 3, characterized in that it also does not contain any exogenous protein of animal origin and preferably does not contain any exogenous substance of animal origin. The composition according to claim 4, characterized in that the virus proteins comprise at least 70% of the total protein contained in the vaccine composition. The composition according to claim 5, characterized in that the concentration of the total protein is ≤100 μg / ml and preferably ≤80 μg / ml. The composition according to claim 6, characterized in that the amount of total protein contained in the effective dose of the vaccine composition is ≤100 μg. The composition according to claim 7, characterized in that the amount of total protein contained in the effective dose of the vaccine composition is in the range from 1 to 50 μg. The composition according to claim 1, characterized in that the stabilizing excipient does not contain any protein or any protein and no peptide, or preferably does not contain any protein, no peptide and no oligopeptide. The composition according to claim 1, characterized in that the mixture of essential and non-essential amino acids contains at least arginine or a salt of arginine and glutamic acid or a salt of glutam1. Вакцинная композиция, содержащая:a) препарат инактивированных целых вирусов;b) стабилизирующий эксципиент, содержащий:i. буферный раствор;ii. смесь незаменимых и заменимых аминокислот;iii. дисахарид;iv. полиол;v. хелатообразующий агент;vi.
来源网站:
中国工程科技知识中心
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