23价肺炎链球菌荚膜多糖疫苗的研制

Development of 23-valent pneumococcal capsular polysaccharide vaccine

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.

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.