摘要
目的:考察水痘减毒活疫苗的稳定性。方法:疫苗在2～8℃放置30～36个月,检测病毒滴度、水分、牛血清蛋白残留量、无菌、外观等主要技术指标,并进行25℃6个月加速试验和37℃4周热稳定性试验。结果:各项检测结果均符合《中华人民共和国药典》及《水痘减毒活疫苗注册标准》要求。结论:本品质量稳定,可将有效期延长至2～8℃贮存24个月。
Objective： To investigate the stability of live attenuated varicella vaccine. Methods： The virus titer, moisture, bovine serum albumin residue, sterility and appearance of vaccine were tested after storage for 30 36 months under 2 -8 ℃. Then acceleration test under 37 ℃ for 4 weeks. Results： All of the test was conducted under 25 ℃ for 6 months, and heat stability test results consisted with the requirements of Chinese Pharmacopeia and Live Attenuated Varicella Vaccine Registration Standard. Conclusion： The quality of the vaccine is very stable The validity period can be prolonged to 24 months under 2 - 8 ℃ storage condition.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2012年第10期1182-1185,共4页
Chinese Journal of New Drugs
关键词
水痘减毒活疫苗
稳定性
病毒滴度
有效期
live attenuated varicella vaccine
stability
virus titer
validity period
