聚乙二醇化重组人粒细胞刺激因子工作对照品的制备和标定

Preparation and Calibration for Working Reference of Pegylated Recombinant Human Granulocyte Colony-stimulating Factor

目的 制备聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)工作对照品,替换现有的rhG-CSF国家标准品,用于蛋白质含量、理化指标等测定.方法 按2015年版《中国药典》四部有关要求,进行工作对照品的制备、分装、冻干、质量检测、结构表征、活性测定.并采用凯氏定氮法进行蛋白质含量标定.结果 制备的工作对照品各项检测指标均符合标准,结构确证与理论相符,凯氏定氮协作标定结果:蛋白质含量为1.9339 mg/支,标准差为0.02295 mg/支,RSD=1.19%,符合统计学要求.结论 该批PEG-rhG-CSF工作对照品各项指标均符合要求,可用于鉴别、蛋白含量测定、各项纯度检查等日常检验和质量研究.

Objective To prepare the working reference of pegylated recombinant human granulocyte colonystimulating factor(PEG-rhG-CSF)to replace the existing rhG-CSF national standard for the determination of protein content and physical and chemical propertities.Methods According to the requirements listed in Chinese Pharmacopoeia(VolumeⅣ,2015 Edition),the preparation,sub packaging,freeze-drying,quality testing,structural characterization and activity determination of the working reference were carried out.The protein content was determined by Kjeldahl method.Results All the physical and chemical indicators of the prepared working reference met the standards,and the structure was confirmed to be consistent with the theory.The protein content was 1.9339 mg per vial and the standard deviation was 0.02295 mg per vial,with RSD of 1.19%,which met the statistical requirements.Conclusion This batch of PEG-rhG-CSF working reference standard meets the requirements and can be used for daily inspection and quality research such as identification,determination of protein content and purity.