新工艺制备Hib结合疫苗原液长期稳定性试验  

Stability Test for Haemophilus Influenzae Type B Conjugate Stock Solution Prepared by New Process

作　　者：朱文勇[1] 王明清[1] 宋绍辉[1] 李双丽 胡文著 廖国阳[1] ZHU Wen-yong;WANG Ming-qing;SONG Shao-hui;LI Shuang-li;HU Wen-zhu;LIAO Guo-yang(Institute of Medical Biology,Chinese Academy of Medical Science&Peking Union Medical College,Yunnan Key Laboratory of Vaccine Research&Development on Severe Infection Disease,Kunming Yunnan 650118,China)

机构地区：[1]中国医学科学院北京协和医学院医学生物学研究所云南省重大传染病疫苗研发重点实验室,云南昆明650118

出　　处：《昆明医科大学学报》2020年第2期12-15,共4页Journal of Kunming Medical University

基　　金：国家自然科学基金资助项目(31500011);北京协和医学院协同创新工程项目(2016-I2M-3-026);云南省创新团队项目(2015HC027);云南省科技计划项目(2017FB039)。

摘　　要：目的在前期开发的b型流感嗜血杆菌(haemophilus influenzae type b,Hib)荚膜多糖提取新工艺及利用1-氰基-4-二甲基氨基吡啶·四氟化硼(1-cyano-4-dimethylaminopyridinium tetrafluoroborate,CDAP)活化的疫苗制备新方法的基础上,评价利用新方法生产的Hib结合疫苗原液的稳定性。方法将疫苗原液在2~8℃条件下放置36个月,根据实验设计,不同时间取样并按照《中国药典》中相应的检测指标、检测方法进行评价。结果新工艺制备的Hib结合疫苗原液在2~8℃储存条件下,大部分指标保持相对稳定,只有分子量大小、高分子结合物含量及效力结果下降,但保存30个月仍符合2010年《中国药典》的相关要求。结论新方法与传统方法生产的Hib结合疫苗原液稳定性基本相同,证明了利用新方法制备Hib结合疫苗的新工艺可以用于扩大生产规模。Objective To evaluate the stability of the conjugate stock solutions of Haemophilus influenzae type B(Hib)on the basis of the newly developed capsular polysaccharide extraction process of Hib and the new vaccine preparation method activated by 1-cyano-4-dimethylaminopyridinium tetrafluoroborate(CDAP).Method The conjugate stock solutions were stored at 2-8℃for 36 months.Samples at different time were evaluated according to the corresponding detection indexes and methods in the Chinese Pharmacopoeia.Results Most of the indicators of the stock solution of Hib conjugated vaccine prepared by the new process remained relatively stable under the storage conditions of 2-8℃.Only the molecular weight,the content of macromolecule conjugates and the efficacy declined.However,all the indicators of stock solution kept for 30 months still met the relevant requirements of the Chinese Pharmacopoeia 2010.Conclusion The stability of the stock solution of the new method was basically the same as that of the traditional method.It is proved that the new technology of preparing Hib conjugated vaccine by the new method can be used to expand the production scale.

关 键 词：新工艺 HIB 原液 稳定性 

分 类 号：R186[医药卫生—流行病学]