重组促胰岛素分泌素生物学活性测定方法的研究

Study methods for biological activity determination of recombinant human extendin-4

目的:建立重组促胰岛素分泌素生物活性测定方法,并对工作参考品进行效价标定。方法:体外细胞测定法—酶标法。结果:经统计学验证,回归方程的相关系数 r 的检验结果具有显著性意义,FL(AU·mL^(-1))为3546～4576;实验重现性较好,符合生物制品质量控制分析技术的要求;重组促胰岛素分泌素生物活性工作参考品效价为4000 AU·mL^(-1),待检样品成品效价为标示量的102.5%;原液效价为3.9×10~5AU·mL^(-1)。结论:该标定结果可靠,方法简单快捷、安全,可作为常规重组促胰岛素分泌素生物学活性测定的方法。

Objective： Establishing the methods for detection of recombinant human extendin -4 biological activity. The biological activity of bulk product and product were then detected by the method. Method ：In vitro culture - immunoassay. Results： By statistical analysis, the potency of the reference substance for rh - extendin - 4 were con- formed to be 4000 AU ·mL^-1 ; the potency of the bulk product and product showed 3.9 ×10^5 AU·mL^-1 and 102.5% compared to their labeled potency respectively. Conclusion：The method possesses simple, rapid, sensitive, safe, and can be used as standards method for the biological activity control of rh - extendin -4.