第7批细菌内毒素国家标准品的建立  

Establish the 7th National Standard of Endotoxin

作　　者：蔡彤[1] 张国来[1] 高华[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药事》2010年第9期885-888,共4页Chinese Pharmaceutical Affairs

摘　　要：目的建立第7批细菌内毒素国家标准品。方法冻干制备了2批细菌内毒素国家标准品候选品。以第2批细菌内毒素国际标准品(94/580)为基准,采用凝胶法、动态浊度法和终点显色法3种方法,组织了13家单位进行协作标定。结果与结论通过比较2批候选品标定结果的精密性及对3种标定方法是否存在显著性差异,最终确定其中1批候选品为第7批细菌内毒素国家标准品,效价为10000EU.支-1,批号:150600-200707。Objective Establish the 7th National Standard of Endotoxin. Methods To prepared 2 batches of proposed National Standard of Endotoxin by freeze-dried. We co-calibrate the potency of the proposed preparations against the 2nd international standard（94/580）,using the gel-clot method,kinetic-turbidimetric test and endpoint-chromogenic test. 13 laboratories took part in the collaborative study. Results and Conclusion By comparing precision of two approved candidates＇ calibration results and whether the three results from different methods existed significant differences,we ultimately chose one of the candidates as the 7th National Standard of Endotoxin,which potency is 10000EU/ ampoule and lot is 150600-200707.

关 键 词：细菌内毒素 国家标准品 制备 协作标定 

分 类 号：R927.2[医药卫生—药学] R996.9