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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 a 6th generation national standard pertussis vaccine efficacy. Methods B. pertussis strains (Shanghai 64-21) were cultured in fermenter and the pertussis bacilli harvested after detoxification were inactivated by detoxification and aliquoted for lyophilization. As alternatives, according to the Chinese Pharmacopoeia (2010 edition) Bacterial tests, serological tests, moisture content and pertussis-specific toxicity testing. The WHO standard PWIS and Chinese Pertussis Vaccine efficacy of national standards No. 3, No. 5 as the standard, collaborative calibration by the five laboratories, and examine its efficacy and stability. Results The indexes of this alternative standard were in accordance with the standards of national standards. After 45 times of collaborative calibration, the quantities were traced back to national standards No. 3 and No. 5 and WHO standards respectively, and the difference of calibration results was no (P> 0.05). The final pooled titer was 13 IU / ml (95% CI = 12.23 ~ 13.26 IU / ml). The efficacy of the standard was stable during the storage period. Conclusion The indexes of this alternative standard are all in line with the requirements and can be used as the national standard of the 6th generation pertussis vaccine efficacy.