Lowry法测定重组人血清白蛋白-白细胞介素2融合蛋白含量的方法验证

The study on Methodology Validation of Recombinant Human Serum Albumin Interleukin 2 Fusion Protein by Lowry Method

试验验证了Lowry法测定重组人血清白蛋白-白细胞介素2融合蛋白含量的方法,为后续试验提供重组人血清白蛋白-白细胞介素2融合蛋白含量的检测方法。以蛋白含量测定国家标准品为标准品,在100~0μg/m L浓度范围内建立标准曲线,线性关系良好,相关系数(R^2)大于0.99。标准曲线上至少6点(包含两端)满足准确度介于95.2%~111.67%,标准曲线下限准确度介于95.98%~103.6%。高、中、低质量浓度(80,40,20μg/m L)质控样本批内精密度均介于1.51%~4.41%,批间精密度均介于3.83%~6.36%。综合上述信息,Lowry法测定重组人血清白蛋白-白细胞介素2融合蛋白含量的方法稳定,可重现。重组人血清白蛋白-白细胞介素2在200~10μg/m L质量浓度范围内均一。

This test verifies the Lowry method which determines the content of recombinant fusion protein human serum albumin-interleukin 2,and provides a method that can determine the content of recombinant fusion protein human serum albumin-interleukin 2 for the following experiment. Methods： In the experiment of determination of protein content,national standard protein was measured as the standard,in the concentration range of 100~0 μg/m L we create a standard curve with good linear correlation and the coefficient（R^2） is greater than 0.99. Results： The standard curve contains six points（both ends inclusive） at least and it can satisfy the accuracy ranged from 95.2%~111.67%,and the accuracy of the lower limit of the standard curve is between 95.98%~103.6%. The precisions of protein concentration（high,middle,low） of samples were between 1.51%~4.41%. The precisions between three batches were 3.83%~6.36%. The Lowry method for protein concentration of human serum albumin-interleukin 2 fusion is stable and repeatable. The data of protein concentration between 200~10 μg/m L were stable.