口服脊髓灰质炎减毒活疫苗单价半成品在-20℃保存的稳定性

Stability of Monovalent Final Bulk of Oral Live Attenuated Poliomyelitis Vaccine at-20℃

目的评价口服脊髓灰质炎减毒活疫苗单价半成品在-20℃保存的稳定性。方法将-20℃保存1～7年的Ⅰ型、Ⅱ型、Ⅲ型单价疫苗半成品各随机抽取5～11个批次,采用微量细胞病变滴定法进行病毒滴度测定,分析样品的病毒滴度变化。结果Ⅰ、Ⅱ、Ⅲ型单价疫苗半成品保存5年,滴度仍达到《中国药典》三部(2005版)的要求;保存6和7年,Ⅰ型半成品滴度仍符合上述要求,Ⅱ型半成品滴度合格率均为80%,Ⅲ型半成品合格率分别为60%和20%。结论口服脊髓灰质炎减毒活疫苗单价半成品在-20℃下保存具有良好的稳定性,与Ⅰ型、Ⅱ型相比,Ⅲ型稳定性相对较差。

Objective To evaluate the stability of monovalent final bulk of oral live attenuated poliomyehtis vaccine at - 20℃, Methods Store the final bulk of monovalent oral live attenuated poliomyelitis vaccine of types Ⅰ , Ⅱ and Ⅲ at - 20℃ for 1-7 years, Take samples from 5 - 11 batches of final bulk of each type for virus titration every year and analyze the change of virus titers, Results After storage at - 20℃ for 5 years, all the virus titers of final bulk of vaccines of various types met the requirements in Chinese Pharmacopoeia （Volume Ⅲ ,2005 Edition）, After storage for 6 and 7 years,the virus titers of type I still met the requirements, and both the qualification rates of virus titers of type Ⅱ were 80%. However,the qualification rates of type Ⅲ were 60% and 20% re- spectively. Conclusion Oral live attenuated poliomyelitis vaccine showed good stability at - 20℃, Compared with those of types I and H ,the stability of final bulk of type Ⅲ was relatively low.