门冬胰岛素宿主菌体蛋白残留检测的研究

Study on the determination of residual host cell protein in insulin aspart

目的建立门冬胰岛素酵母菌体蛋白残留量的检测方法,用于门冬胰岛素的质量控制。方法采用S.cerevisiae宿主蛋白含量酶免测定试剂盒,研究适宜的样品配制及测定方法,并从标准曲线、加样回收率、精密度、耐用性、重现性等方面进行方法学验证。结果该法在2～200ng/mL浓度范围内符合四参数回归曲线(r=1.000),精密度和加样回收率均能满足实验测定要求。结论该方法简单,快速,自动化程度高,可用于门冬胰岛素酵母菌体蛋白残留量的检测。

Objective To establish the determination method of residual host cell protein in insulin aspart for its qual- ity control. Methods The preparation of the samples and procedure of the method were studied by using S.cerevisiae host cell protein kit. The method was validated with standard curve, recovery, precision, robust and reproducibility. Results The standard curve of the method accorded to four-parameter regression curve （r = 1.000） in the concentration range of 2-200 ng/mL. The precision and recovery of the method were qualified. Conclusion This method is conve- nient and fast with good automaticality, and it can be used to determine residual host cell protein in insulin aspart.