无细胞百日咳疫苗效价检定用攻击菌液氮保存的稳定性

为了考察无细胞百日咳疫苗效价检定用攻击菌在液氮中保存的稳定性,对液氮保存1~7年的4~9代百日咳攻击菌随机抽取7~11批次样品,采用LD50检测并经统计学处理,分析其样品的毒力变化。试验结果显示,4~9代的百日咳攻击菌液氮保存5年,毒力仍能达到《中华人民共和国药典》三部(2005版)的要求;保存6年和7年,4~7代的百日咳攻击菌毒力仍符合上述要求,8、9代的攻击菌毒力的合格率分别为84%和40%。试验证实,无细胞百日咳效价检定用攻击菌液氮保存5年具有良好的稳定性,可用于无细胞百日咳疫苗的效价检定。

Stability of challenging bacterial strain stored in liquid nitrogen for determination of titer of acellular pertussis vaccine

In order to investigate the stability of challenging strain stored in liquid nitrogen for determination of titer of acellular pertussis vaccine,7~11 batches of challenging strain of passages 4~9 after storage in liquid nitrogen for 1~7 years were sampled and determined for LD50,and the results were analyzed statistically to evaluate the toxicity.The result showed that the toxicity of challenging strain of passages 4～9 met the requirements in Chinese Pharmacopoeia（Volume Ⅲ,2005 edition） after storage for 5 years in liquid nitrogen.After storage for 6 and 7 years,the toxicity of challenging strain of passages 4~7 met the above-mentioned requirements,while the qualification rates of toxicity of passage 8 and 9 are 84% and 40% respectively.It proved good stability of challenging strain after storage in liquid nitrogen for 5 years,which can be used for the determination of titer of acellular pertussis vaccine.