A+C群脑脊髓膜炎球菌多糖菌苗生产工艺与内毒素含量研究

Study of production process and endotoxin content of group A+C Meningococcal polysaccharide vaccine

A群及C群流脑多糖抗原用 10 0 0 0 0×g离心或不经超速离心处理 ,经用鲎试验法测定内毒素含量 ,2种工艺生产的A群及C群流脑多糖抗原的内毒素含量均很低。用未经超速离心处理的A群及C群流脑多糖抗原制成的A +C群流脑多糖菌苗 ,经鲎试验法测定 ,内毒素含量也很低 ;经家兔升温法进行热原质试验 ,家兔体温未明显升高。证明A +C群流脑多糖菌苗生产工艺不经 10 0 0 0 0×g离心去除内毒素步骤是可行的。所制备的流脑多糖抗原内毒素含量符合要求。

Group A and C Meningococcal polysaccharide were centrifuged with 100 000×g or not treated with ultracentrifuge.Resulting Group A and C Meningococcal polysaccharide were tested by LAL test,the endotoxin content was very low.There is no difference between two process preparation in endotoxin content.Group A+C Meningococcal polysaccharide vaccine which was prepared by Group A and C Meningococcal polysaccharide without ultracentrifuge was tested by LAL test,the endotoxin content was also very low,the pyrogen of Group A+C Meningococcal polysaccharidevaccine was tested with rabbits,the body temperature of rabbits did not increase significantly.This study indicated production process without ultracentrifuge of Group A+C Meningococcal polysaccharide vaccine is reliable,the endotoxin content of resulting Group A and C Meningococcal polysaccharide are satisfying.