乙型肝炎人免疫球蛋白的稳定性研究  

Study on the stability of human hepatitis B immunoglobulin

作　　者：郑芳如 温剑飞[2] 戴美兰 欧武强 刘铭 刘栩祥 张剑平 

机构地区：[1]深圳市卫光生物制品股份有限公司,深圳518107 [2]深圳市光明中学,深圳518107

出　　处：《微生物学免疫学进展》2013年第3期15-17,共3页Progress In Microbiology and Immunology

摘　　要：目的考察乙型肝炎人免疫球蛋白的稳定性。方法对乙型肝炎人免疫球蛋白成品进行(25±2)℃条件下为期6个月的加速稳定性试验和(6±2)℃条件下为期4年的长期稳定性试验,对考察的制品按2010版《中国药典》三部进行全面检测,检测其抗-HBs效价、蛋白质含量、纯度、pH值、分子质量大小分布(单体+二聚体)、麦芽糖含量、甘氨酸、无菌检查、异常毒性检查、热稳定性试验、热原检查、外观检查、鉴别试验等质量指标,用t检验分析各质量指标检测数据的变化趋势。结果乙型肝炎人免疫球蛋白制品在进行加速试验后,单体+二聚体、抗-HBs效价值都有下降趋势。在进行长期试验后,除单体+二聚体有所下降趋势之外,其他各项质量指标的变化均无统计学意义。结论乙型肝炎人免疫球蛋白的稳定性良好,在进行6个月的加速破坏性试验和4年的长期稳定性试验后,其质量仍能符合2010版《中国药典》三部的规定要求。Objective To observe the stability of Human hepatitis B immunoglobulin. Methods The accelerate stability test at （25±2） ℃ for 6 months and long term stability test at （6±2） ℃ for 4 years for Human hepatitis B immunoglobulin were carreid out, respectively. We tested all the quality indexs including anti-HBs titer, protein content, purity, pH, mo- lecular size distribution （moner＋polymer） , maltose content, glycine, sterility test, abnormal toxicity, thermal stability test, pyrogen test, appearance, identification test for the stored products, respectively, based on requirements of Chinese Phar- macopoeia （ 2010 edtion Volm ）. Finally t test was adapted to analyse the date trend of the quality indexs. Results After completing accelerate stability test, the data of moner＋polymer and anti-HBs titer showed a downward tendency. After com- pleting long-term stability test, except for the data of moner＋polymer showed a downward tendency, the changes for the rest quality indexs data had no statistical significance. Conclusion Human hepatitis B immunoglobulin has a good stability, all the quality indexs could meet the requirements of Chinese Pharmacopoeia （ 2010 edtion Vol Ⅲ ） after detected by the re- lated tests.

关 键 词：乙型肝炎人免疫球蛋白 稳定性 

分 类 号：R392.1[医药卫生—免疫学]