含硫柳汞成分生物制品的安全问题

The Safety Issue of Biological Products Containing Thimerosal

自1930年以来,在许多生物制品和药品中使用硫柳汞作为防腐剂。由于少量有机汞在理论上具有神经毒性,因此,对于含有硫柳汞的疫苗的使用安全问题引起广泛地关注。目前,没有证据表明婴儿、儿童或成人接种含硫柳汞的疫苗后出现汞中毒。因此,改变生物制品中硫柳汞的含量,应考虑其对制品的质量、有效性、安全性和稳定性方面是否有影响。

Since the 1930s,Thimerosal has been widely used as a preservative in a number of biologics and drug products. Over the past several years ,because of an increasing awareness of the theoretical potential for neuotoxicity of the low levels of organomercurials, the concerns about the use of Thimerosal in vaccines have been raised. At present,there is no evidence of toxicity in infants,children or adults exposed to Thimerosal. As the result,the important impact on the quality ,safety ,efficacy and stability of the biologics shall be carefully considered if the Thimerosal content in the biologics is changed.