本文選題：尿促卵泡素 + 促卵泡素　； 參考：《中國(guó)新藥雜志》2017年20期

【摘要】：目的:制備第1批人尿促卵泡素(urofollitropin)國(guó)家標(biāo)準(zhǔn)品。方法:以WHO第1批人尿促卵泡素國(guó)際標(biāo)準(zhǔn)品92/512作為標(biāo)準(zhǔn),選擇4個(gè)實(shí)驗(yàn)室,采用《中華人民共和國(guó)藥典》2015版四部1216卵泡刺激素生物測(cè)定法對(duì)人尿促卵泡素待標(biāo)品進(jìn)行生物效價(jià)標(biāo)定;采用HPLC法對(duì)待標(biāo)品的純度進(jìn)行測(cè)定。結(jié)果:人尿促卵泡素待標(biāo)品經(jīng)協(xié)作標(biāo)定,確定其生物效價(jià)為每安瓿213 IU,其含量為100%。結(jié)論:本批待標(biāo)品可作為第1批人尿促卵泡素國(guó)家標(biāo)準(zhǔn)品,以供尿促卵泡素及相關(guān)制劑的生物效價(jià)測(cè)定用。
[Abstract]:Objective: to prepare the first national standard of human urofollitropin. Methods: the first batch of human urinary follicle stimulating hormone (WHO), 92 / 512, was used as the standard, and four laboratories were selected. The biological titer of human urinary follicle stimulating hormone (FSH) was calibrated by 1216 follicle stimulating hormone bioassay and the purity of the standard product was determined by HPLC method in 2015 edition of the Pharmacopoeia of the people's Republic of China. Results: the biological titer of human urinary follicle stimulating hormone was determined to be 213 IUU per ampoule, and its content was 100. Conclusion: this batch can be used as the first national standard of human follicle stimulating hormone for the determination of the biological titer of urinary follicle stimulating hormone and related preparations.
【作者單位】： 中國(guó)食品藥品檢定研究院;上海麗珠制藥有限公司;上海市食品藥品檢驗(yàn)所;青島市食品藥品檢驗(yàn)研究院;
【分類(lèi)號(hào)】：R927
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本文編號(hào)：1928677