重组人血清白蛋白与干扰素α-2b融合蛋白中聚乙二醇1500残余量测定方法研究  

Study on the Determination Method of PEG1500 Residue in Recombinant Human Serum Albumin and Interferon Alpha-2b Fusion Protein

作　　者：张娜 杜莹莹 李月 常早荣 薛冲[2] 刘志敏[2] 任飞 Zhang Na;Du Yingying;Li Yue(Laboratory of Biological Preparation Research,Shanxi Kangbao Biological Products Co.,Ltd)

机构地区：[1]山西康宝生物制品股份有限公司生物制剂研究室 [2]军事医学科学院生物工程研究所 [3]长治医学院

出　　处：《长治医学院学报》2019年第5期330-334,共5页Journal of Changzhi Medical College

摘　　要：目的:探讨重组人血清白蛋白与干扰素α-2b融合蛋白中聚乙二醇1500(PEG1500)残留量的检测方法。方法:选择3个不同批次重组人血清白蛋白与干扰素α-2b融合蛋白原液作为供试品,采用聚乙二醇残余量测定法,参照药品质量标准分析方法验证指导原则,分别设计专属性、线性范围、准确性、精密性、定量限实验进行测定。结果:该实验方法专属性、准确性、精密度及5.05~50.50μg/mL范围的线性关系良好,定量限为1.94μg/mL。结论:该实验方法用于人血清白蛋白与干扰素α-2b融合蛋白原液的PEG1500残余量检测,结果准确、可靠。Objective: To explore a method for the determination of polyethylene glycol 1500(PEG1500) residues in recombinant human serum albumin and interferon alpha-2b fusion protein. Methods: Three batches of recombinant human serum albumin and interferon-alpha-2b fusion protein were selected as test samples and the determination method of polyethylene glycol residual amount was used. The specificity, linear range, accuracy, precision and quantitative limit experiments were designed for determination according to the guiding principles of pharmaceutical quality standard analysis method. Results: The specificity, accuracy, precision and the linearity of the range of 5.05~50.50 μg/mL were good. The quantitative limit was 1.94 μg/mL. Conclusion: The method is accurate and reliable for the determination of PEG1500 residues in the original solution of fusion protein of human serum albumin and interferon alpha-2b.

关 键 词：重组人血清白蛋白与干扰素α-2b融合蛋白 聚乙二醇 准确性 精密度 

分 类 号：R917[医药卫生—药物分析学]