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目的检定森林脑炎灭活疫苗在2~8℃条件下,储存超过规定有效期12个月后的稳定性。方法利用中华人民共和国药典(2010年版)第三部之中森林脑炎灭活疫苗效价测定方法 ,测定森林脑炎灭活疫苗在2~8℃条件下,储存超过规定有效期12个月后的效价稳定性,测定其他检定项目如;鉴别试验、异常毒性检查等。结果森林脑炎灭活疫苗在2~8℃条件下,储存超过规定有效期12个月后的效价稳定性测定和其它检定项均合格。结论森林脑炎灭活疫苗储存期限应由21个月沿长至33个月。
Objective To determine the stability of inactivated encephalitis vaccine after storage for more than 12 months at 2 ~ 8 ℃. Methods The titer of inactivated forest encephalitis vaccine in the third part of the Pharmacopoeia of the People’s Republic of China (2010 Edition) was measured and the inactivated vaccine of forest encephalitis was stored at 2 ~ 8 ℃ for more than 12 months Potency stability, determination of other test items such as; identification test, abnormal toxicity check. Results The encephalitis inactivated vaccine was qualified at 2 ~ 8 ℃ after storage for more than 12 months after its potency stability test and other test items were qualified. Conclusion The duration of storage of inactivated forest encephalitis vaccine should be increased from 21 months to 33 months.