【摘要】 目的建立重组人白细胞介素-1受体拮抗剂(rhIL-1ra)的质控方法和标准。方法采用黑色素瘤A375.S2细胞杀伤中和试验测定rhIL-1ra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测定纯度,用胰蛋白酶酶切后分析肽图,其余检测项目按《中国药典》三部(2005版)规定进行。结果用建立的质控方法对rhIL-1ra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》三部(2005版)的要求。结论建立的质控方法和标准可保证产品安全有效,可用于rhIL-1ra的检定。更多还原

【Abstract】 Objective To develop the methods and standard for quality control of recombinant human interleukin-1 receptor antagonist(rhIL-1ra).Methods Determine rhIL-1ra for bioactivity by cytotoxicity neutralization assay on melanomatous cell line A375.S2,for relative molecular mass by reduced SDS-PAGE,for purity by SDS-PAGE and RP-HPLC,for peptide map by trypsin digestion with tryptone.Other quality indexes were tested according to the requirements in Chinese Pharmacopoeia(Volume Ⅲ,2005 Edition).Results All the quality indexes of bulk and final product of rhIL-1ra met the requirements in Guiding Principle for Quality Control of Recombinant DNA Products for Human Use and Chinese Pharmacopoeia(Volume Ⅲ,2005 Edition).Conclusion The developed methods and standard assured the safety and efficacy of rhIL-1ra and were suitable for the routine control of rhIL-1ra.更多还原