摘要
目的 观察甲型肝炎(甲肝)灭活疫苗在2℃～8℃保存条件下的稳定性。方法 在2℃～8℃保存条件下,用不同批号的甲肝灭活疫苗免疫动物,检测血清抗体效价,进行效力试验评价;按2 0 0 0年版《中国生物制品规程》测定pH值变化情况,进行异常毒性试验和无菌试验。结果 5批甲肝灭活疫苗在2℃～8℃保存4 2个月半数有效量(ED50 )无明显变化,无菌试验阴性,异常毒性试验合格,pH值变化<0 2 ,不同抗原含量保存在2℃～8℃30个月也无明显变化,批间无明显差异。结论 医学生物学研究所生产的甲肝灭活疫苗2℃～8℃条件下可保存3年,其免疫原性无明显变化,其它理化指标均符合《中国生物制品规程》要求。
Objective To observe the stability of the inactivated hepatitis A vaccine stored at 2℃-8℃MethodsThe vaccines with different batches were stored at 2℃-8℃,and were used to immunize the animal.The serum antibody titer was detected for potency evaluation. The pH values were measured;the abnormal toxicity tests and sterility tests were performed in compliance with the Requirements for Biologics of PRC,version 2000. Results For 5 batches of vaccines stored at 2℃-8℃ for 42 months,the ED50 has no obvious change;the sterility tests are negative;pH values change were less than 0.2.The different antibody contents varied slightly when being stored at 2℃-8℃ for 30 months. No distinct variation was noticed among different batches. Conclusion The inactivated hepatitis A vaccine producd by the Institute of Medical Biology, Chinese Academy of Medical Sciences can be stored at 2℃-8℃ for 3 years without changing its immunogenicity and other physicochemical criteria biologics of PRC.
出处
《中国计划免疫》
2005年第2期127-129,共3页
Chinese Journal of Vaccines and Immunization
基金
"九五"国家医学科技攻关资助课题 (96-90 6-0 3 -0 4)
关键词
甲型肝炎灭活疫苗
稳定性
Inactivated hepatitis A vaccine
Stability
