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目的 建立第 5批百日咳疫苗效力国家标准品。方法 选用百日咳菌株 (编号 5 80 0 4 ) ,采用B G培养基固体培养 ,将培养的百日咳菌液经脱毒灭活后分装冻干。以WHO的效力标准品 # 3和中国效力标准品 # 4为标准进行协作标定。结果 该标准品经 7个实验室协作标定 6 3次 ,最终合并效价为 14IU ml(95 %CI=13 10 9～15 32 0 )。结论 第 5批百日咳疫苗效力标准品各项指标均符合要求 ,可以作为新的国家百日咳效力标准品使用 ,效价拟定为 14IU ml。
Objective To establish the first batch of national standards for pertussis vaccine efficacy. Methods The B. pertussis strain (No. 5 80 0 4) was selected and cultured in B G medium. The pertussis bacilli of the cultured pertussis bacilli were de-inactivated and then lyophilized. The WHO standard of efficacy # 3 and China’s effective standard # 4 as the standard collaboration calibration. Results The standard was calibrated 6 times in 7 laboratories. The final pooled titer was 14IU ml (95% CI = 13 10 9 ~ 15 32 0). Conclusion The fifth batch of pertussis vaccine efficacy standards of the indicators are in line with the requirements, can be used as a new national pertussis efficacy standard, potency formulated as 14IU ml.