摘要
目的:建立重组人凝血因子Ⅷ中乙二醇残留量的测定方法。方法:采用气相色谱法,三氯乙酸沉淀离心去除蛋白后,使用液体直接进样法,以1,3丁二醇为内标,使用DB-FFAP毛细管柱;以氮气为载气,流速20.0 m L·min^(-1);检测器为氢火焰离子化检测器(FID)。结果:乙二醇在10~600μg·m L^(-1)浓度范围内线性良好(r=0.999 5);精密性良好(RSD为2.1%);回收率在91.2%~108.2%之间;最低检出限为0.49μg·m L^(-1)。结论:该方法快速、准确,可用于检测重组人凝血因子Ⅷ中乙二醇的残留量。
Objective： To establish a method to quantify ethylene glycol residues in recombinant factor Ⅷ.Methods： Ethylene glycol was determined by gas chromatography with liquid direct sampling method. Ttichloroacetic acid was use to precipitating the protein,and 1,3-butanediol was used as internal standard. Separation was performed on a DB-FFAP capillary column with nitrogen as carrier gas at 20. 0 m L·min-（- 1）. Hydrogen flame ionization（ FID） was used as detector. Results： A good linearity was obtained at the concentrations of 10 - 600 μg·m L-（- 1）with a correlation coefficient of 0. 999 5. The precision was good with RSD of 2. 1%. The recovery was 91. 2% -108. 2% and the limit of detection was 0. 49 μg·m L-（- 1）. Conclusion： This method is quick and accurate which could be used to quantify ethylene glycol residues in recombinant factor Ⅷ products.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第8期869-871,共3页
Chinese Journal of New Drugs
基金
国家十二五"重大新药创制"科技重大专项:抗体类生物大分子药物质量属性分析标准物质及评价方法研究(2014ZX09304311-001)
关键词
气相色谱
重组人凝血因子Ⅷ
乙二醇
内标法
血液制品
gas chromatography
recombinant factor Ⅷ
ethylene glycol
internal standard method
blood products
