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23价肺炎链球菌荚膜多糖疫苗的研制
引用本文:韩菲,曹欣,胡鹏,张明华,郝倩,张美香,任涛,唐秀丽,何佳琦,王婷婷,郑海发,魏文进. 23价肺炎链球菌荚膜多糖疫苗的研制[J]. 国际生物制品学杂志, 2010, 33(1): 134-138. DOI: 10.3760/cma.j.issn.1673-4211.2010.03.005
作者姓名:韩菲  曹欣  胡鹏  张明华  郝倩  张美香  任涛  唐秀丽  何佳琦  王婷婷  郑海发  魏文进
作者单位:北京民海生物科技有限公司肺炎项目组,102600;北京民海生物科技有限公司研发中心,102600;
摘    要:目的 研制23价肺炎链球菌荚膜多糖疫苗.方法 大罐培养1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F、和33F型肺炎链球菌并进行各型荚膜多糖的纯化,制备23价肺炎链球菌荚膜多糖疫苗.结果 经检定各型精制多糖主要质量指标均符合<欧洲药典>(2005年版)要求.结论 已建立起成熟的细菌培养和多糖纯化工艺.

关 键 词:链球菌,肺炎   多糖类,细菌   疫苗   研制   

Development of 23-valent pneumococcal capsular polysaccharide vaccine
HAN Fei,CAO Xin,HU Peng,ZHANG Ming-hua,HAO Qian,ZHANG Mei-xiang,REN Tao,TANG Xiu-li,HE Jia-qi,WANG Ting-ting,ZHENG Hai-fa,WEI Wen-jin. Development of 23-valent pneumococcal capsular polysaccharide vaccine[J]. International Journal of Biologicals, 2010, 33(1): 134-138. DOI: 10.3760/cma.j.issn.1673-4211.2010.03.005
Authors:HAN Fei  CAO Xin  HU Peng  ZHANG Ming-hua  HAO Qian  ZHANG Mei-xiang  REN Tao  TANG Xiu-li  HE Jia-qi  WANG Ting-ting  ZHENG Hai-fa  WEI Wen-jin
Abstract:Objective To prepare 23-valent pneumococcal capsular polysaccharide vaccine. Methods Pneumococci types 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23 F and 33 F were cultivated in the large fermenter and various types of capsular polysaccharides were purified to prepare 23-valent pneumococcal capsular polysaccharide vaccine. Results The main quality indices of the various types of purified polysaccharides conformed to the requirements of European Pharmacopoeia (2005). Conclusion The mature processes of bacterial cultivation and polysaccharide purification are established.
Keywords:PneumococcusPolysaccharides  bacterialVaccinesDevelopment
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