药品包装材料与b型流感嗜血杆菌结合疫苗相容性研究  

Study on compatibility in between packaging materials and Haemophilus influenzae type b conjugate vaccine

作　　者：钱秋娟[1] 赵小洁[1] 马庆华[1] 蒋井明[1] 魏然[1] 陈刚[1] 傅林锋[1] 

机构地区：[1]兰州生物制品研究所有限责任公司,兰州730046

出　　处：《微生物学免疫学进展》2012年第5期42-46,共5页Progress In Microbiology and Immunology

摘　　要：目的考察不同组合的内包装材料对Hib结合疫苗的影响,选出最适合的包装材料。方法对所选药品包装材料按照生产厂家的不同来搭配,共得到12种组合,根据相容性试验设计,将样品置于25±2℃环境下,分别在1、2、3、6个月时取样,进行pH值、内毒素、不溶性微粒3个项目的检测。结果对pH值、内毒素含量、不溶性微粒检测数据进行分析,选出了对Hib结合疫苗影响最小的包装材料组合C+Y组。结论一个适宜的包装内环境对产品的稳定性十分重要。QIAN Qiu-juan, ZHAO Xiao-jie, MA Qing-hua, JIANG Jing-ming, WEI Ran, CHEN Gang, FU Lin-feng （ Lanzhou Institute of Biological Products Co. Ltd , Lanzhou 730046, China） Abstract： Objective To study the effects in between the combinations for different packaging materials（ groups ） and Haemophilus influenzae type b conjugate vaccine （ Hib vaccine ） , select the optimal packaging materials in packaging of the vaccine. Methods 12 combination groups were selected based on materials from different manufacturers, the samples were kept at 25 ＋2 ~C , sampling tests were performed after samples stored for 1, 2, 3, 6 months, respectively, and the pH, endotoxin and insolable particles were determinated. Results The group C＋Y was selected, which had the smallest influence upon packaged Hib vaccine according to analysis of the determinations. Conclusion A suitable inner environment for packaging is crucial to the stability for Hib vaccine.

关 键 词：相容性试验 包装材料 B型流感嗜血杆菌结合疫苗 

分 类 号：R95[医药卫生—药学]