Research on preparation of influenza virus vaccine without thimerosal for children dose and its stability / 国际检验医学杂志

ABSTRACT

Objective To investigate the preparation of influenza virus vaccine without thimerosal for children dose and its sta-bility .Methods H1N1 ,H3N2 ,B-type influenza virus were inoculated into allantoic fluid to prepare three batches of influenza virus vaccine without thimerosal for children dose and the vaccine stability test was performed .Single radial immunodiffusion(SRID) and enzyme-linked immunosorbent assay(ELISA) were used to detect the concentration of hemagglutinin and egg albumin .Total protein concentration ,appearance ,sterility test ,endotoxin ,free formaldehyde and the pH value of vaccine were also measured .Results The pH value of vaccine was 7 .2 ,with total protein concentration of 182-189 mg/mL .Hemagglutinin concentrations of H1N1 ,H3N2 and B-type influenza virus decreased when they had been placed in 2-8 ℃ for 3 ,6 ,9 ,12 ,18 months or (37 .0 ± 2 .0) ℃ for 7 ,14 days ,however ,they maintained at 6 .0 μg/0 .25 mL or more at last .Conclusion Influenza virus vaccine without thimerosal for chil-dren dose shows improved safty and is accord with the standard of Chinese Pharmacopoeia(2010 edition) .