吸附无细胞百日咳、白喉、破伤风联合疫苗的研究

发布时间：2018-08-03 13:43

【摘要】： 本论文的主要工作是对百日咳I相菌种(58003;CS)、白喉棒状杆菌(38007)、破伤风芽孢杆菌菌种(64008)的种子库建立及检定,确认种子批的质量完全符合现行药典的质量要求。对无细胞百日咳原液、白喉精制类毒素和破伤风精制类毒素的培养基、培养条件、解毒工艺、分离提纯工艺进行了比较试验研究,对生产工艺进行了优化,选择并确定了能保持生产过程一致性、并且可适应规模化生产无细胞百日咳原液、白喉精制类毒素和破伤风精制类毒素的工艺条件。按照此工艺生产的疫苗各项指标完全符合药典的质量要求。同时我们还对疫苗的安全性进行进行评价,动物急性特异性毒性、动物长期特异性毒性研究及动物异常毒性研究结果表明疫苗没有外源性毒性物质,是安全的。
[Abstract]:The main work of this paper is to establish and verify the seed bank of pertussis phase I strain (58003CS), Corynebacterium diphtheria (38007) and Bacillus tetanus strain (64008). The culture medium, culture conditions, detoxification technology, separation and purification of acellular pertussis, diphtheria refined toxoid and tetanus toxoid were studied. The process conditions of producing acellular pertussis, diphtheria and tetanus toxoid were selected and determined. The vaccines produced according to this process meet the quality requirements of the Pharmacopoeia. At the same time, we also evaluated the safety of the vaccine. The results of animal acute specific toxicity, animal long-term specific toxicity study and animal abnormal toxicity study showed that the vaccine was safe without exogenous toxic substances.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2007
【分类号】：R392

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