摘要
目的分析鉴定国产重组人粒细胞巨噬细胞集落刺激因子原液中的相关蛋白。方法采用液质联用技术,对产品的相关蛋白进行相对分子量测定及肽图分析,分别从分子量及肽段水平进行鉴定。结果对两家生产企业的原液进行检测,相对分子量测定结果显示:样品中存在的相关蛋白有氧化形式、乙酰化形式。肽图分析结果显示:在第1位、第79位或第80位甲硫氨酸上发生了氧化修饰,在第64位或/和第73位赖氨酸上发生了乙酰化修饰。结论为重组人粒细胞巨噬细胞集落刺激因子的质量研究提供了依据。
OBJECTIVE To identify the related proteins in the bulk of recombinant human granulocyte-macrophage colony stimulating factor(rhGM-CSF)produced in China.METHODS Mass spectrometry combined with ultra-performance liquid chromatography was used for the identification at the intact protein and peptide mapping respectively.RESULTS Bulk products from two manufacturers were analyzed.Results of relative molecular weights showed that the most common related proteins included oxidatine and acetylated forms.Peptide mapping results showed that the oxidized form was at the 1st,79^(th) or 80^(th) position of methionine,and the acetylation modification was at the 64^(th) or 73^(rd) position of lysine.CONCLUSION Our study provides ideas for the quality study of recombinant human granulocyte-macrophage colony stimulating factor.
作者
刘冰
LIU Bing(Chongqing Institute for Food and Drug Control,Chongqing,401121 P.R.China)
出处
《华西药学杂志》
CAS
CSCD
2023年第2期172-175,共4页
West China Journal of Pharmaceutical Sciences
关键词
人粒细胞巨噬细胞集落刺激因子
相关蛋白
原液
液质联用
重组蛋白
肽图
分子量
质量控制
Human granulocyte-macrophage colony stimulating factor
Related proteins
Bulk
LC-MS/MS
Recombinant protein
Peptide mapping
Molecular weight
Quality control