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

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.