重组人粒细胞集落刺激因子的氨基酸组成分析

Amino Acid Composition of Recombinant Human Granulocyte Colony-stimu-lating Factor

目的分析重组人粒细胞集落刺激因子(rhG-CSF)的氨基酸组成。方法应用氨基酸分析仪,采用离子交换色谱茚三酮柱后衍生法对rhG-CSF进行氨基酸组成分析。样品采用常规酸水解处理后,以氨基酸标准溶液外标法进行测定。结果系统对标准溶液各个氨基酸组分均有良好的分离。3支rhG-CSF样品的9次测定结果除Met外,均较接近,变异系数较小,与理论值基本一致。结论采用氨基酸自动分析仪柱后衍生法分析氨基酸组成重复性好,误差较小,可用于rhG-CSF的质量控制。

Objective To analyze the amino acid composition of recombinant human granulocyte colony-stimulating factor （rhG-CSF）. Methods Three containers of rhG-CSF samples were taken for routine acid hydrolysis, then analyzed for amino acid composition with amino acid analyzer by ninhydrin postcolumn derivative ion exchange chromatography method, using standard amino acid solution as external standard. Results The amino acid composition of standard solution was separated effectively by the system. Each of the 3 containers of samples was tested for 3 times, and the results, except those of Met, were basically consistent with those in theory, of which the variation coefficient was low. Conclusion The analysis of amino acid composition by amino acid analyzer showed good reproducibility and accuracy, which was suitable for the quality control of rhG-CSF.