儿童剂量不含硫柳汞的流感病毒裂解疫苗的制备及其稳定性研究

摘要

目的：探讨儿童剂量不添加防腐剂的流感疫苗制备及其稳定性。方法将 H1N1、H3N2、B型流感病毒接种于鸡胚尿囊液中制备儿童剂量的3批不含硫柳汞的流感病毒裂解疫苗，进行疫苗的稳定性试验。分别采用单向免疫扩散法（SRID）及酶联免疫吸附测定（ELISA）检测血凝素及卵清蛋白浓度，并检测疫苗总蛋白浓度、外观、无菌试验、内毒素、游离甲醛及 pH值等。结果疫苗p H值为7．2，总蛋白浓度为182～189 m g/m L。2～8℃保存3、6、9、12、18个月及（37．0±2．0）℃放置7、14 d ， H1N1、H3N2及B血凝素浓度有所下降，但最终均保持在6．0μg/0．25 mL以上。结论不添加硫柳汞的流感疫苗稳定性符合《中国药典》（2010版）标准，提高了疫苗的安全性。%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) .