注射用重组人血清白蛋白与干扰素α2b融合蛋白稳定性研究  

Stability of Recombinant Human Serum Albumin and Interferon Alpha 2b Fusion Protein for Injection

作　　者：武福军 杜莹莹 张娜 李月 赵洪亮[2] 薛冲[2] 刘志敏[2] WU Fu-jun;DU Ying-ying;ZHANG Na;LI Yue;ZHAO Hong-liang;XUE Chong;LIU Zhi-ming(Shanxi Kangbao Biological Pruduct Co.Ltd,Changzhi 046000,China;Institute of Biotechnology,Academy of Military Medical Scienees,Beijing 100071,China)

机构地区：[1]山西康宝生物制品股份有限公司,山西长治046000 [2]军事医学科学院生物工程研究所,北京100071

出　　处：《中国药学杂志》2018年第15期1309-1312,共4页Chinese Pharmaceutical Journal

基　　金：国家"十一五"863目标导向性课题资助(009AA02Z108)

摘　　要：目的考察制品注射用重组人血清白蛋白与干扰素α2b融合蛋白的稳定性。方法按照《中国药典》2015年三部的方法进行检测,影响因素试验[(42±2)℃高温试验、(4 500±500)Lx强光照射试验、90%高湿试验]、加速试验(37℃加速试验与25℃加速试验)及长期稳定性试验,方法均按照《生物制品稳定性研究技术指导原则》进行。结果影响因素试验、加速试验及长期试验结果显示,温度对于本制品的纯度有一定的影响,随着试验温度越高,制品纯度变化越快,保存时间越短;湿度对制品的水分也有影响,其他指标相对稳定;通过长期稳定性考察发现,制品的试验样品在2~8℃密闭储存条件下保存24个月是相对稳定的,且各项考察指标均符合质量检定标准。结论本制品注射用重组人血清蛋白与干扰素α2b融合蛋白在2~8℃密闭储存条件下保存24个月,各项考察指标保持稳定,且均符合质量检定标准。OBJECTIVE To explore the stability of recombinant human serum albumin and interferon alpha 2b fusion protein for injection. METHODS According to the testing methods of Ch. P, influencing factors test [ high temperature test at （42 ± 2） ℃, strong light test at （4 500 ＋ 500）Ix and humidity test at RH of 90% ], accelerated test （37 and 25 ℃ ）and long-term test were carried out according to the technical guidelines of biological stability study. RESULTS The resuhs of influencing factors test, accelerated test and long-term test showed that temperature had influence on the purity of products. The protein purity decreased with the increase of temperature. Humidity also had influence on the moisture content of products, with little influence on other indicators. Long term stability investigation found that the sample was relatively stable within 24 months and the examined indexes accorded with the quality standard. CONCLUSION This recombinant protein can be stored at 2 - 8 ℃ for 24 months.

关 键 词：重组人血清白蛋白 干扰素α2b融合蛋白 温度 湿度 稳定性 

分 类 号：R917[医药卫生—药物分析学]