2-苯氧乙醇对无细胞百日咳原液及无细胞百白破联合疫苗安全性及免疫原性的影响

Effect of 2-Phenoxyethanol on Safety and Immunogenicity of Bulk Acellular Pertussis Vaccine and Acellular DTP

目的探讨2-苯氧乙醇对无细胞百日咳(aP)原液及无细胞百白破联合疫苗(DTaP)安全性及免疫原性的影响。方法分别制备以2-苯氧乙醇和硫柳汞作为防腐剂的aP原液,并配制以2-苯氧乙醇作为防腐剂的DTaP疫苗,对其安全性及免疫原性进行检测,并检测DTaP疫苗中2-苯氧乙醇的抑菌效果。结果分别以2-苯氧乙醇和硫柳汞作为防腐剂制备的aP原液的安全性及免疫原性各项指标比较,差异均无统计学意义(P>0.05);以2-苯氧乙醇作为防腐剂的DTaP疫苗各项检定指标均符合《中国药典》三部(2005版)要求,DTaP疫苗及于37℃放置1个月的DTaP疫苗经无菌检查均合格。结论 2-苯氧乙醇可替代硫柳汞用作DTaP疫苗的防腐剂。

Objective To investigate the effect of 2-phenoxyethanol on safety and immunogenicity of bulk acellular pertussis（aP） vaccine and acellular DTP（DTaP）.Methods The bulk of aP was formulated using 2-phenoxyethanol and thimerosal as stabilizers and prepared into DTaP respectively.The safety and immunogenicity of bulk aP and DTaP,as well as the bacteriostatic effect of 2-phenoxyethanol in DTaP,were evaluated.Results The bulks of aP prepared using 2-phenoxyethanol and thimerosal as stabilizers showed no significant difference in safety and immunogenicity（P 0.05）.All the indexes of DTaP using 2-phenoxyethanol as stabilizer met the requirements in Chinese Pharmacopoeia（Volume Ⅲ,2005 edition）.Both the DTaP before and after storage at 37℃ for one month were qualified in sterility test.Conclusion 2-Phenoxyethanol may be used as a stabilizer of DTaP instead of thimerosal.