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Lyophilized preparation containing influenza vaccine and method for producing the same
专利权人:
大塚製薬株式会社
发明人:
山下 親正
申请号:
JP2009504039
公开号:
JP5388842B2
申请日:
2008.03.07
申请国别(地区):
JP
年份:
2014
代理人:
摘要:
The present invention aims to provide a freeze-dried preparation in which the influenza vaccine exhibits improved stability. A freeze-dried preparation in which the influenza vaccine exhibits significantly improved stability can be obtained by freeze-drying an aqueous solution that meets the following conditions (A) to (C): (A) (i) an influenza vaccine, (ii) a hydrophobic amino acid, and (iii) arginine and an acid addition salt thereof are incorporated; (B) the proportion of the component (iii) is from 20 to 85% by weight relative to the total amount of the resulting freeze-dried preparation; and (c) the pH is adjusted to be from 8 to 10 by controlling the proportion of arginine and an acid addition salt thereof that form the component (iii).
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