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    • 10. 发明申请
    • Vaccine formulation with a preservative
    • 用防腐剂配制疫苗
    • US20040258700A1
    • 2004-12-23
    • US10601719
    • 2003-06-23
    • Tine Holland Frimann
    • A61K039/12A61K047/00A61K045/00A61K039/38A61K039/00
    • A61K47/46A61K9/0019A61K39/12A61K39/23A61K47/10A61K2039/5252A61K2039/552A61K2039/55505A61K2039/55577C12N2750/14334C12N2750/14361
    • There is a safety concern about a number of vaccine preservatives in use today, such as formaldehyde, phenol, organic mercury (thiomersal) or betapropiolactone for safety reasons. In a few vaccines, 2-phenoxyethanol has been used as a vaccine perservative, but has not gained widespread use, because the preservative effect is inferior to e.g. thiomersal. Applicant has found that the preservative effect of a mixture of 2-phenoxyethanol and para hydroxybenzoates, (e.g. methyl-, ethyl-, propyl- or butyl-, p-hydroxybenzoate) is more effective than 2-phenoxyethanol alone and that this mixture, called TF-1, exerts a preservative effect which is comparable to that of thiomersal or chloroform in vaccines. Although the preservative effect of TF-1 is satisfactory for securing the microbial stability of the vaccine, none of the constituents in TF-1 are considered as critical in terms of toxicity for the vaccinated animals or humans as chloroform or organic mercury compounds, traditionally used for the same purpose.
    • 出于安全考虑,今天使用的许多疫苗防腐剂如甲醛,苯酚,有机汞(硫柳汞)或β-丙内酯存在安全问题。 在几种疫苗中,2-苯氧基乙醇已经被用作疫苗保乳剂,但是由于防腐剂效果不如例如,所以没有得到广泛的应用。 硫柳汞 申请人已经发现2-苯氧基乙醇和对羟基苯甲酸酯(例如甲基 - ,乙基 - ,丙基 - 或丁基 - 对羟基苯甲酸酯)的混合物的防腐效果比单独的2-苯氧基乙醇更有效,称为 TF-1具有与疫苗中硫柳汞或氯仿相当的防腐效果。 虽然TF-1的防腐效果对于确保疫苗的微生物稳定性而言是令人满意的,但TF-1中的任何成分在接种动物或人类的毒性方面被认为是氯仿或有机汞化合物的传统使用 为了相同的目的