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目的考察乙型脑炎减毒活疫苗及稀释剂与其直接接触的包装容器的相容性,评估疫苗及稀释剂现用包装容器的适宜性。方法分别检测已包装的疫苗、稀释剂在加速条件及规定储存条件下,其包装容器的外观、胶塞对疫苗的吸附度,胶塞中抗氧剂2,6-二叔丁基对甲酚(2,6-Di-tert-butyl-4-methylphenol,BHT)和玻璃瓶中有毒有害金属离子As、Sb、Pb、Cd迁移量,玻璃瓶内表面脱片风险等,分析乙型脑炎减毒活疫苗及稀释剂现用包装容器对产品质量的影响程度及包装容器是否被疫苗或稀释剂腐蚀受损。结果 3批乙型脑炎减毒活疫苗在(25±2)℃、相对湿度(RH)(60±5)%放置6个月,(37±2)℃、RH(75±5)%放置4周,2~8℃放置24个月,疫苗及包装材料(容器)外观与0月结果一致,胶塞对疫苗的吸附度低于0.05%,包装容器中抗氧剂BHT及有毒有害金属离子As、Sb、Pb、Cd迁移至疫苗中的量远低于安全限值,玻璃瓶内表面被疫苗腐蚀脱片的风险较低。3批稀释剂在(40±2)℃、RH(75±5)%放置12个月,2~30℃放置至42个月,稀释剂及包装材料(容器)外观与0月结果一致,包装容器中抗氧剂BHT及有毒有害金属离子As、Sb、Pb、Cd迁移至稀释剂中的量远低于安全限值,玻璃瓶内表面被稀释剂腐蚀脱片的风险较低。结论乙型脑炎减毒活疫苗及稀释剂分别与其包装容器发生相互作用的风险可接受,显示了良好的相容性,表明现用包装容器是适宜的。
Objective To investigate the compatibility of attenuated live attenuated B encephalitis (JE) vaccines with their direct contact with packaging containers and to assess the suitability of vaccines and diluents for current packaging containers. Methods The packaged vaccines and diluents were tested respectively under the accelerated conditions and under the specified storage conditions, the appearance of the packaging container, the degree of adsorption of the rubber stopper on the vaccine, the antioxidant 2,6-di-tert-butyl-p-cresol Migration of toxic and harmful metal ions As, Sb, Pb and Cd in glass bottles and the risk of surface delamination in glass bottles were analyzed by using 2,6-Di-tert-butyl-4-methylphenol (BHT) Volatile vaccine and diluent The impact of the current packaging container on product quality and whether the packaging container is corroded by the vaccine or diluent. Results Three batches of live attenuated JE vaccine were placed at (25 ± 2) ℃ and relative humidity (60 ± 5)% for 6 months and placed at 37 ± 2 ℃ and 75 ± 5% RH respectively 4 weeks and 2 ~ 8 ℃ for 24 months. The appearance of vaccine and packaging material (container) was in accordance with the result of 0 month. The adhesiveness of the rubber plug to the vaccine was less than 0.05%. Antioxidant BHT and toxic and harmful metal ions The amount of As, Sb, Pb, Cd migrated into the vaccine is well below the safety limit and the inner surface of the vial is less likely to be eroded by the vaccine. Three batches of diluent were placed at (40 ± 2) ° C, RH (75 ± 5)% for 12 months and at 2 ° C to 30 ° C for 42 months. The thinner and packaging material (container) The amount of migration of the anti-oxidant BHT and toxic and hazardous metal ions As, Sb, Pb, Cd in the container into the diluent is well below the safety limit and the risk of the glass inner surface being denuded by the diluent is low. Conclusion The risk of interaction between live attenuated JE vaccine and diluent respectively with its packaging container is acceptable and shows good compatibility, indicating that the current packaging container is suitable.