聚乙二醇化重组人粒细胞集落刺激因子的质量标准和质控方法研究

Study on Methods and Requirments for Quality Control of Pegylated Recombinant Human G-CSF

目的:建立聚乙二醇化重组人粒细胞集落刺激因子的质量标准和质控方法。方法:采用荧光分光光度法测定PEG-rhG-CSF的PEG化率,RP-HPLC方法蒸发光检测器检测游离PEG残留量,胰蛋白酶裂解进行肽图分析,其它指标按照《中国生物制品规程》进行。结果:建立了聚乙二醇化重组人粒细胞集落刺激因子的质控方法和质量标准。绪论:建立的方法和质量标准已用于聚乙二醇化重组人粒细胞集落刺激因子产品的检定。

Objective: To establish methods and requirements for quality control of PEG-rhG-CSF. Methods: Pegylated rate was determined by fluorospectrophotometry. Residual free PEG content was determinde by RP-HPLC detected by evaporative light scattering detector. Peptide map was performed by tryptic digestion. Other items were finished according to National Biological Requirements. Results:The quality control requirements and methods were established and used for quality control of PFG-rhG-CSF. Conclusion: The established control methods and requirements can be used for other pegylated products.