摘要
目的:为准确分析重组人粒细胞巨噬细胞集落刺激因子(rHuGMCSF)半成品及其制剂的纯度和表达的正确性。方法:用毛细管区带电泳测定了2批rHuGMCSF半成品和3批rHuGMCSF注射液的纯度。用基体辅助激光解吸飞行时间质谱和电喷雾质谱测定了2批rHuGMCSF半成品的分子量。用毛细管等电聚集法测定了rHuGMCSF半成品的等电点。结果:2批半成品中1批含有少量二聚体,且含有4个不同等电点的组分,另1批表达不正确;2批成品均存在大量杂质。结论:发现有些rHuGMCSF样品有生物学活性,但表达不正确,纯度也不高;各分析方法是互补的,不能相互替代。
AIM: To accurately determine the purity and correctness of expression for the bulk samples and preparations of rHuGM CSF with biological activity. METHODS: The purities of two bulk samples and three preparations of rHuGM CSF were determined by capillary zone electrophoresis (CZE), molecular weights of two rHuGM CSF bulk samples by matrix assisted laser desorption ionization time of flight mass spectrometry (MALDI TOF/MS) and electrospray ionization mass spectrometry (ESI/MS), and isoelectric points of rHuGM CSF bulk sample by capillary isoelectric focusing (CIEF). RESULTS: One of the two bulk samples was expressed incorrectly, and the other contained a small amount of dimer, which composed of four components with different isoelectric points. There were large amounts of impurities in the two rHuGM CSF preparations. CONCLUSION: The sample of rHuGM CSF with biologic activity may be expressed incorrectly or contained impurities. The instrumental methods applied in this paper are complementary and we can not use one to replace the other.
出处
《药学学报》
CAS
CSCD
北大核心
1999年第8期621-626,共6页
Acta Pharmaceutica Sinica
基金
国家自然科学基金
国家新药博士基金
关键词
RHUGM-CSF
毛细管电泳法
生物质谱
high performance capillary electrophoresis
matrix assisted laser desorption ionization time of flight mass spectrometry
electrospray ionization mass spectrometry
recombinant human granulocyte macrophage colony stimulating factor
capillary isoelectri