| 冻干A、C群脑膜炎球菌多糖结合疫苗的稳定性 |
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| 引用本文： | 吴凯,陈燕,樊会兰,周燕美,胡鸿,徐娅妮,代泽友,吴绍学,黄镇.冻干A、C群脑膜炎球菌多糖结合疫苗的稳定性[J].粉末涂料与涂装,2007,20(9):667-668. |
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| 作者姓名： | 吴凯 陈燕 樊会兰 周燕美 胡鸿 徐娅妮 代泽友 吴绍学 黄镇 |
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| 作者单位： | [1]云南沃森生物技术有限公司,昆明650106 [2]玉溪沃森生物技术有限公司,玉溪653100 |
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| 摘 要： | 目的观察冻干A、C群脑膜炎球菌多糖结合疫苗在2~8℃条件下的稳定性。方法将冻干A、C群脑膜炎球菌多糖结合疫苗放置在2~8℃条件下,定期取样,检查其物理外观,检测多糖含量、水分含量和分子大小,并进行鉴别试验以及异常毒性和免疫原性试验,考察其稳定性。结果冻干A、C群脑膜炎球菌多糖结合疫苗于2~8℃保存30个月,各项质量控制指标仍符合该疫苗企业注册标准。结论冻干A、C群脑膜炎球菌多糖结合疫苗在2~8℃条件下,其质量稳定。
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| 关 键 词： | 脑膜炎球菌 多糖结合疫苗 稳定性 |
| 文章编号： | 1004-5503（2007）09-667-02 |
| 收稿时间： | 2007-03-21 |
| 修稿时间： | 2007年3月21日 |
Stability of Freeze-dried Groups A and C Meningococcal Polysaccharide Conjugate Vaccine |
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| WU Kai ,CHEN Yan, FAN Hui-lan, et al.Stability of Freeze-dried Groups A and C Meningococcal Polysaccharide Conjugate Vaccine[J].Chinese Journal of Biologicals,2007,20(9):667-668. |
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| Authors: | WU Kai CHEN Yan FAN Hui-lan |
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| Affiliation: | Wosen Biotechnology Co. Ltd,Kunming 650106, China |
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| Abstract: | Objective To explore the stability of freeze-dried groups A and C meningococcal polysaccharide conjugate vaccine at 2-8℃.Methods Store freeze-dried groups A and C meningococcal polysaccharide conjugate vaccine at 2-8℃ for 30 months.Take samples periodically for inspection of final containers,identity test,abnormal toxicity test,immunogenicity test as well as determination of polysaccharide content,moisture content and molecular size to evaluate the stability of vaccine.Results All the quality control indexes of freeze-dried groups A and c meningococcal polysaccharide conjugate vaccine after storage at 2-8℃ for 30 months met the requirements for product license.Conclusion Freeze-dried groups A and C meningococcal polysaccharide conjugate vaccine showed good stability at 2-8℃. |
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| Keywords: | Meningococcua Polysaccharide conjugate vaccine Stability |
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