摘要
目的评价细胞工厂工艺连续生产的口服脊髓灰质炎减毒活疫苗（人二倍体细胞）的稳定性。方法疫苗在-20℃放置24个月,检测病毒滴度、外观、抗生素残留量、无菌性,及对病毒血清型进行鉴别;2~8℃放置12个月检测疫苗稳定性;室温放置7周、37℃放置7 d检测加速热稳定性并冻融的稳定性。结果该疫苗-20℃可贮存24个月以上,2~8℃有效期可延长至12个月,且冻融不会影响疫苗的稳定性。结论疫苗质量稳定,各项检测结果均符合《中华人民共和国药典》三部（2010版）及企业《口服脊髓灰质炎减毒活疫苗（人二倍体细胞）注册标准》。
Objective To evaluate the stability of poliomyelitis vaccine in dragee candy （ human diploid cell）, live, which is produced consecutively by using cell factory units. Methods The vaccine was stored at -20 ℃ for 24 months, the vac- cine titer （ CCIDso ）, appearance, residual antibiotics, sterility and identification of serotypes for virus seeds were tested. The evaluation of vaccine stability stored at 2-8 ℃ for 12 months. , the accelerated thermal stability assay at room tempera- ture for 7 weeks and at 37 ℃ for 7 days were performed, respretively. Results The duration of vaccine is at least 24 months stored at -20 ℃ , the shelf life of vaccine can extend to 12 months stored at 2-8℃ , and freezing-thawing cycles have little effect on vaccine＇ s stability. Conclusion The quality of the vaccine is stable, the test results are complied with requirements of poliomyelitis vaccine in dragee candy （human diploid cell） , live in （（Pharmacopeia of People＇ s Republic of China））（ Volume Ⅲ ） （Edition： 2010） and TiantanBio licensed standard for poliomyelitis vaccine in dragee candy （human diploid cell） , live.
出处
《微生物学免疫学进展》
2014年第4期50-56,共7页
Progress In Microbiology and Immunology
基金
重大新药创制"疫苗综合性技术研究开发大平台建设"(2013ZX09402302)
