双抗体夹心法测定注射用重组人白细胞介素-2的含量

ELISA assay of interleukin-2 in recombinant human interleukin-2 for injection

目的:建立用双抗体夹心法(ELISA 法)测定注射用重组人白细胞介素-2的含量。方法:采用酶标仪在450 nm 处测量白细胞介素-2复合物的 A_(450nm)值,并计算重组人白细胞介素-2冻干粉的百分含量。结果:白细胞介素-2浓度在31.25～500 pg·mL^(-1)范围内线性关系良好(r=0.9999);低、中、高3种浓度的回收率分别为97.3%,98.4%,101.4%,RSD 均小于5.0%。质量控制符合要求。精密度在误差许可范围内。注射用重组人白细胞介素-2的含量为49.55μg·mg^(-1)。结论:方法准确、可靠,注射剂辅料对测定无干扰,可用于注射用重组人白细胞介素-2的含量测定。

Objective ：To establish a method to assay recombinant human interleukin -2 （rhlL -2 ）in recombinant human interleukin - 2 for injection. Method： Determined the A450 n,n of the compound recombinant human interleukin - 2 with antibody by ELISA, conversed it to concentration of recombinant human interleukin -2 according to the correlation between them. Results：The linear range was 31.25 -500 pg · mL^-1（ r = 0. 9999）;the recoveries of low, medium and high concentration were 97.3% ,98.4% and 101.4% ,RSD 〈5.0%. Conclusion：This method is optimized to determine recombinant human interleukin -2.