吸附精制百日咳菌苗稳定性的研究

Studies on the Stability of Adsorbed Purified Pertussis Vaccine at Different Temperature

本文对新一代吸附精制百日咳菌苗保存于不同温度条件下的安全和效力稳定性进行了实验，结果表明，９批吸附精制百日咳菌苗经贮存于４～８℃条件下半年、１年、２年和３年后，贮存于常温（１８～２２℃）半年后和贮放于３７℃４０天后，其贮存前后的ＢＷＤＵ／ｍｌ、ＬＰＵ／ｍｌ和ＨＳＵ／ｍｌ间的数值变化，均在制检规程要求的标准数值内，无显著性差异（Ｐ＞０．０５），说明菌苗的毒性无逆转、菌苗的安全性良好。３批吸附精制百日咳菌苗经贮存于４～８℃条件下７个月和２年后、其贮存前后的效力单位间的数值变化，均在制检规程要求的标准数值内，无显著性差异（Ｐ＞０．０５），说明菌苗的效力无下降，菌苗的质量稳定。

The stability of adsorbed purified pertussis vaccine was studied. There was no significant difference in toxicity test units during 0.5, 1 ,2, and 3 years stored ar 4-8℃,0.5 year at 18-22℃ or 40 days at 37℃. Also there was no significant difference in potency test units (P＞n0．05) during 7 months or 2 years stored at 4-8℃.