摘要
目的评价Sabin株脊髓灰质炎灭活疫苗(sabin inactivated poliovirus vaccines,sIPV)与3种玻璃包材的相容性。方法将3批sIPV半成品分别分装至同批中性硼硅玻璃管制西林瓶(2 mL)、预灌封注射器及中性硼硅玻璃管制西林瓶(4 mL),将1批sIPV半成品分别分装至3批上述不同的包材中。分别于(37±2)℃保存14 d、(25±2)℃保存6个月、28℃保存36个月,对疫苗的外观、装量、pH、无菌试验、细菌内毒素、D抗原含量等指标进行检测。计算3种包材sIPV于不同温度下保存不同时间的D抗原回收率,并进行比较。结果3种包材分装的sIPV于不同温度下保存不同时间的各项指标检测结果均合格,且Ⅰ、Ⅱ、Ⅲ型D抗原回收率差异均无统计学意义(P>0.05)。结论sIPV与3种不同玻璃包材均具有良好的相容性。
Objective To investigate the compatibility of Sabin inactivated poliovirus vaccines(sIPV)with three packaging materials.Methods Three batches of final bulk of sIPV were filled into one batch of vials prepared with neutral borosilicate glass(2 mL),one batch of prefilled syringes and one batch of vials prepared with neutral borosilicate glass(4 mL)separately,while one batch of final bulk into three batches of above three kinds containers,and stored at(37±2)℃ for 14 d,at(25±2)℃ for 6 months and at 2~8℃ for 36 months,from which samples were taken and observed for appearance and filling quantity and tested for pH value,sterility,bacterial endotoxin and D antigen content.The recovery rates of D antigen of sIPV in three kinds of containers stored at various temperatures for various time durations were calculated and compared.Results All the indexes of sIPV in three kinds of containers stored at various temperatures for various time durations met the relevant requirements,while the recovery rates of D antigen of typesⅠ,Ⅱ and Ⅲ showed no significant difference(P>0.05).Conclusion The sIPV showed compatibility with three glass packing materials.
作者
平玲
牛杰
张铭润
何陆涛
唐靖月
卢振攀
赵冠华
蔡玮
PING Ling;NIU Jie;ZHANG Ming-run;HE Lu-tao;TANG Jing-yue;LU Zhen-pan;ZHAO Guan-hua;CAI Wei(Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming 650032,Yunnan Province,China)
出处
《中国生物制品学杂志》
CAS
CSCD
北大核心
2021年第7期775-781,共7页
Chinese Journal of Biologicals
基金
国家科技重大专项重大新药创制(2018ZX09737-003)。
关键词
Sabin株脊髓灰质炎灭活疫苗
包材
相容性
Sabin inactivated poliovirus vaccine(sIPV)
Packaging material
Compatibility
