本文選題：重組人促卵泡激素 + N端不均一性　； 參考：《藥物分析雜志》2017年05期

【摘要】：目的:建立重組人促卵泡激素(rhFSH)N端不均一性的分析方法,并對(duì)不同企業(yè)樣品rh FSH原液的N端不均一性進(jìn)行比對(duì)研究。方法:通過(guò)對(duì)亞基的還原與烷基化處理方法、糖苷酶切條件及RP-HPLC條件的優(yōu)化,將完整與N端缺失氨基酸的亞基有效分離,建立了2種rhFSH的N端不均一性分析方法,并利用質(zhì)譜分別對(duì)目的蛋白進(jìn)行定性鑒別。以國(guó)內(nèi)外企業(yè)的rhFSH原液為樣品進(jìn)行N末端不均一性比較。結(jié)果:建立的2種RP-HPLC方法均可實(shí)現(xiàn)完整與缺失β亞基的有效分離,各樣品rhFSH的N端不均一性基本一致。結(jié)論:rhFSH國(guó)內(nèi)生物類(lèi)似藥與國(guó)外參照藥的N端不均一性比較有較高的相似性;本實(shí)驗(yàn)建立的2種RP-HPLC方法可評(píng)價(jià)產(chǎn)品質(zhì)量,為生物類(lèi)似藥的可比性研究提供技術(shù)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.
【作者單位】： 煙臺(tái)大學(xué)藥學(xué)院;中國(guó)食品藥品檢定研究院;
【基金】：國(guó)家科技重大專(zhuān)項(xiàng)——抗體類(lèi)生物大分子藥物質(zhì)量屬性分析標(biāo)準(zhǔn)物質(zhì)及評(píng)價(jià)方法研究平臺(tái)(課題編號(hào):2014ZX09304311) 中檢院學(xué)科帶頭人培養(yǎng)基金課題——重組激素類(lèi)生物類(lèi)似藥質(zhì)量可比性研究(課題編號(hào):2013X2)
【分類(lèi)號(hào)】：R917

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