【摘要】 目的:建立重组人睫神经营养因子的质控方法和质量标准。方法:以TF-1.CN5a1细胞株/MTT比色法测定重组人睫神经营养因子的生物学活性,还原型SDS-PAGE测定相对分子质量,SDS-PAGE和反相高效液相色谱法测定纯度,快速电泳法测定等电点,胰蛋白酶酶切后分析肽图,其余检测项目按中国药典2005年版三部进行。结果:用建立的方法对原液和成品进行了检定,各项指标均符合《人用重组DNA制品质量控制技术指导原则》和中国药典2005年版三部的要求。结论:所建立的质控方法和质量标准可用于重组人睫神经营养因子产品的常规检定。更多还原

【Abstract】 Objective:To develop the methods and standard for quality control of recombinant human ciliary neurotrophic factor(rhCNTF).Methods:Determine the bioactivity of rhCNTF by TF-1·CN5a1/MTT colorimetry molecular mass by reduced SDS-PAGE,the purity by SDS-PAGE and RP-HPLC,the isoelectic point by Phast System and the peptide map by tryptic digestion.The other quality items were tested according to the requirements in ChP 2005(Volume Ⅲ).Results:All the quality indexes of bulk and final product of rhCNTF by the developed methods met the requirements of Guideline for Quality Control of Recombinant DNA Products for Human Use and ChP 2005(Volume Ⅲ).Conclusion:The developed methods and standard are suitable for the routine quality control of rhCNTF.更多还原