第6代百日咳疫苗效力国家标准品的建立  

Establishment of The Sixth Generation of National Standard for Potency Assay of Pertussis Vaccine

作　　者：骆鹏[1] 沈立濛[2] 孙琦[3] 徐永革 祖俊[5] 徐颖华[1] 王丽婵[1] 卫辰[1] 侯启明[1] 史峥[2] 郁佳俊[2] 叶娟[3] 郭玉芬[3] 高慧 潘海龙 刘玲[5] 杨邦玲[5] 张庶民[1] 

机构地区：[1]中国食品药品检定研究院血清室,北京100050 [2]上海生物制品研究所,上海200052 [3]北京生物制品研究所,北京100024 [4]成都生物制品研究所,成都610063 [5]武汉生物制品研究所,武汉430046

出　　处：《中国生物制品学杂志》2011年第11期1303-1305,1312,共4页Chinese Journal of Biologicals

基　　金："艾滋病和病毒性肝炎等重大传染病防治"科技重大专项(2009ZX10004-804)

摘　　要：目的建立第6代百日咳疫苗效力国家标准品。方法选用百日咳菌株(沪64-21),发酵罐培养,收获的百日咳菌液经脱毒灭活后,分装冻干,作为备选品,按《中国药典》三部(2010版)进行无菌试验、血清学试验、水分含量及百日咳特异性毒性检测。以WHO标准品PWIS和中国百日咳疫苗效力国家标准品3号、5号为标准,经5个实验室进行协作标定,并考察其效力稳定性。结果该备选标准品的各项检测指标均符合国家标准品的规定;经协作标定45次,分别以国家标准品3号、5号和WHO标准品为标准进行量值溯源,标定结果差异无统计学意义(P>0.05);最终合并效价为13 IU/ml(95%CI=12.23～13.26 IU/ml);保存期内标准品的效力稳定。结论该备选标准品各项指标均符合要求,可作为新的第6代百日咳疫苗效力国家标准品使用。Objective To establish the sixth generation of national standard for potency assay of pertussis vaccine in China. Methods Pertussis bacterial strain Hu64-21 was cultured in fermenter, and the harvested liquid was detoxified, inactivated, filled and lyophilized then used as a candidate which was subjected to sterility test, serological test, moisture determination and pertussis specificity test according to the requirements in Chinese Pharmacopeia （Volumem, 2010 edition）. The candidate was calibrated col- laboratively by five laboratories using WHO standard PWIS as well as national standards No. 3 and No. 5 as standards, and evaluated for stability of potency. Results All the quality indexes of the candidate met the requirements for national standard. The results of 45 calibrations were traced to their sources using WHO standard PWIS as well as national standards No. 3 and No. 5 as standards respectively, and showed no significant difference （P 〉 0. 05）. The final potency of the candidate standard was determined as 13 IU / ml （95% CI = 12. 23 - 13.26 IU/ml）, which was stable during storage. Conclusion The candidate of which all the quality indexes met the relevant requirements may be served as the sixth generation of national standard for potency assay of pertussis vaccine.

关 键 词：百日咳疫苗 效力标准品 

分 类 号：R378.42[医药卫生—病原生物学]