重组人促卵泡激素N末端不均一性分析方法研究

发布时间：2018-06-04 09:36

本文选题：重组人促卵泡激素 + N端不均一性　；参考：《药物分析杂志》2017年05期

【摘要】：目的:建立重组人促卵泡激素(rhFSH)N端不均一性的分析方法,并对不同企业样品rh FSH原液的N端不均一性进行比对研究。方法:通过对亚基的还原与烷基化处理方法、糖苷酶切条件及RP-HPLC条件的优化,将完整与N端缺失氨基酸的亚基有效分离,建立了2种rhFSH的N端不均一性分析方法,并利用质谱分别对目的蛋白进行定性鉴别。以国内外企业的rhFSH原液为样品进行N末端不均一性比较。结果:建立的2种RP-HPLC方法均可实现完整与缺失β亚基的有效分离,各样品rhFSH的N端不均一性基本一致。结论:rhFSH国内生物类似药与国外参照药的N端不均一性比较有较高的相似性;本实验建立的2种RP-HPLC方法可评价产品质量,为生物类似药的可比性研究提供技术支持。
[Abstract]:Aim: to establish a method for the analysis of N-terminal heterogeneity of recombinant human follicle stimulating hormone (rhFSH), and to compare the N-terminal heterogeneity of rh FSH samples from different enterprises. Methods: through the reduction and alkylation of subunits, the optimization of the conditions of glucosidase digestion and RP-HPLC, the complete and N-terminal missing amino acid subunits were effectively separated, and two N-terminal heterogeneity analysis methods of rhFSH were established. The target protein was identified qualitatively by mass spectrometry. The N-terminal heterogeneity of rhFSH solution from domestic and foreign enterprises was compared. Results: the complete and missing 尾 subunits were effectively separated by the two RP-HPLC methods, and the N-terminal heterogeneity of rhFSH was basically the same. Conclusion the N-terminal heterogeneity of biological analogues in China is similar to that in foreign countries, and the two RP-HPLC methods established in this experiment can evaluate the product quality and provide technical support for the study of the comparability of biological analogues.
【作者单位】：烟台大学药学院;中国食品药品检定研究院;
【基金】：国家科技重大专项——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平台(课题编号:2014ZX09304311) 中检院学科带头人培养基金课题——重组激素类生物类似药质量可比性研究(课题编号:2013X2)
【分类号】：R917

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