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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。
Objective: To establish a quality control method and quality standard for recombinant human ciliary neurotrophic factor. Methods: The biological activity of recombinant human CXCRT was assayed by TF-1.CN5a1 cell line / MTT colorimetric assay, and the relative molecular mass was determined by SDS-PAGE. SDS-PAGE and RP-HPLC were used to determine the purity , Rapid electrophoresis method for determination of isoelectric point, tryptic digestion peptide map analysis, the remaining test items according to the Chinese Pharmacopoeia 2005 edition of the three. Results: The original liquid and finished product were tested with the established method. All the indexes were in conformity with the “Technical Guiding Principles for Quality Control of Human Recombinant DNA Products” and the requirements of the third edition of 2005 edition of Chinese Pharmacopoeia. Conclusion: The established quality control methods and quality standards can be used for routine testing of recombinant human CXCRs.