發(fā)布時(shí)間：2018-05-12 02:07

  本文選題：泌乳素 + 國(guó)際標(biāo)準(zhǔn)品��； 參考：《藥物分析雜志》2017年10期

【摘要】：目的:參與標(biāo)定人垂體泌乳素(PRL)第4次國(guó)際候選標(biāo)準(zhǔn)品(批號(hào)83/573),為WHO評(píng)估其作為國(guó)際標(biāo)準(zhǔn)品的適用性提供數(shù)據(jù)支持。方法:以第3次PRL國(guó)際標(biāo)準(zhǔn)品(批號(hào)84/500)為標(biāo)準(zhǔn),采用放射免疫法、磁微粒酶聯(lián)免疫法、化學(xué)發(fā)光免疫法和時(shí)間分辨免疫熒光法標(biāo)定PRL第4次國(guó)際候選標(biāo)準(zhǔn)品(批號(hào)83/573)。結(jié)果:本實(shí)驗(yàn)室上報(bào)數(shù)據(jù):PRL第4次國(guó)際候選標(biāo)準(zhǔn)品(批號(hào)83/573)免疫效價(jià)的幾何均值為64.7 m IU·安瓿-1,與WHO報(bào)告數(shù)據(jù)相對(duì)偏差為-3.6%。全球10個(gè)實(shí)驗(yàn)室提交了數(shù)據(jù)。經(jīng)標(biāo)定,PRL第4次國(guó)際候選標(biāo)準(zhǔn)品(批號(hào):83/573)的免疫效價(jià)幾何均值為67.2 m IU·安瓿-1,且穩(wěn)定性和均勻性滿(mǎn)足要求。結(jié)論:經(jīng)WHO生物標(biāo)準(zhǔn)專(zhuān)家委員會(huì)審核通過(guò),最終確定PRL候選品(批號(hào):83/573)可作為第4次人垂體源PRL國(guó)際標(biāo)準(zhǔn)品使用,每安瓿效價(jià)定為67 m IU。
[Abstract]:Aim: to evaluate the applicability of human pituitary prolactin (PRL) as an international standard for WHO evaluation by participating in the fourth international candidate standard (lot number 83 / 573). Methods: using the 3rd PRL international standard (batch 84 / 500) as the standard, radioimmunoassay, magnetic particle enzyme-linked immunosorbent assay, chemiluminescence immunoassay and time-resolved immunofluorescence method were used to calibrate the fourth international standard of PRL (lot number 83 / 573). Results: the geometric mean of immunological titer of the fourth international candidate standard product (lot number 83 / 573) was 64.7 Miu ampoul -1, and the relative deviation from WHO data was -3.6%. Data were submitted by 10 laboratories around the world. The geometric mean immunoreaction of the fourth international candidate standard for PRL (batch number: 83 / 573) was 67.2 Miu ampoule -1, and the stability and uniformity met the requirements. Conclusion: the candidate of PRL (batch number: 83 / 573) can be used as the fourth international standard for human pituitary PRL by WHO Biological Standards expert Committee. The titer of PRL is 67 m IU per ampoule.
【作者單位】： 中國(guó)食品藥品檢定研究院;
【分類(lèi)號(hào)】：R392-33

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