低pH孵放病毒灭活处理对马破伤风免疫球蛋白F(ab')_2质量的影响  

The effect to quality of equine anti-tetanus immunoglobulin F(ab')_2 by low pH incubation

作　　者：张玲玲 包正琦 段丽娟 戴于栋 张光磊 高建军 ZHANG Ling-ling;BAO Zheng-qi;DUAN Li-juan;DAI Yu-dong;ZHANG Guang-lei;GAO Jian-jun(Department of Serum, Lanzhou Institute of Biological Products Co., Ltd., Center for Gansu Provincial Vaccine Engineering Research, Lanzhou 730046, Gansu Province,China)

机构地区：[1]兰州生物制品研究所有限责任公司血清室甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《微生物学免疫学进展》2019年第1期40-43,共4页Progress In Microbiology and Immunology

摘　　要：目的考察低pH孵放病毒灭活处理对马破伤风免疫球蛋白F(ab')_2质量的影响。方法取马破伤风免疫球蛋白F(ab')_24份,分别调整pH至3.8、4.1、4.4及6.5,于(25±1)℃条件下放置21 d后取样测定抗体效价、聚合物(二聚体、多聚体)及F(ab')_2含量,评估低pH孵放病毒灭活法对上述质量指标的影响;以1 mL/瓶的规格分装经低pH孵放病毒灭活处理的马破伤风免疫球蛋白F(ab')_2,于(25±1)℃条件下存放6个月,定期取样并进行抗体效价、聚合物(二聚体、多聚体)及F(ab')_2含量检测,评估其稳定性。结果马破伤风免疫球蛋白F(ab')_2经低pH孵放病毒灭活后,其抗体效价、聚合物(二聚体、多聚体)及F(ab')_2含量未发生明显变化;样品于(25±1)℃条件下存放6个月后,抗体效价和F(ab')_2含量均符合《中华人民共和国药典》2015版(三部)的要求。结论低pH孵放病毒灭活法适用于马破伤风免疫球蛋白F(ab')_2病毒的灭活。Objective To investigate effect to quality of equine anti-tetanus immunoglobulin F(ab′) 2 by low pH incubation. Methods The four equal amounts of equine anti-tetanus immunoglobulin F(ab′) 2 were conducted by using different range for pH 3.8, 4.1, 4.4, and 6.5,respectively, after placement at (25±1)℃ for 21 days, the samples were determined for potency test, polymers content(dimer, polymerizer) and F(ab′) 2 content to estimate the influence of low pH incubation on main indexes of tested equine anti-tetanus immunoglobulin F(ab′) 2 . The tested samples were encapsulated at 1 mL per ampoule, after 6 months placement at (25±1)℃, the sampling were performed periodically and detecting in evaluation of stability for the tested samples. Results It was no a significant difference in potency test, polymers content and F(ab′) 2 content before and after treatment by the low pH incubation;after 6 months placement at (25±1)℃,all tested indexes met the requirement of Chinese Pharmacopoeia(Volume Ⅲ, 2015 Edition). Conclusion The low pH incubation was suitable to the virus inactivation of equine anti-tetanus immunoglobulin F(ab′) 2 .

关 键 词：马破伤风免疫球蛋白F(ab′)2 低pH孵放病毒灭活法 抗体效价 F(ab′)2含量 

分 类 号：R392[医药卫生—免疫学]