人垂体泌乳素第4次国际标准品协作标定  被引量:1

International collaborative study of the proposed 4^(th) International Standard for human pituitary prolactin

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作  者:于婷[1] 曲守方[1] 黄杰[1] 杨振[1] YU Ting Qu Shou-Fang HUANG Jie YANG Zhen(National Institutes for Food and Drug Control, Beijing 100050, China)

机构地区:[1]中国食品药品检定研究院,北京100050

出  处:《药物分析杂志》2017年第10期1776-1781,共6页Chinese Journal of Pharmaceutical Analysis

摘  要:目的:参与标定人垂体泌乳素(PRL)第4次国际候选标准品(批号83/573),为WHO评估其作为国际标准品的适用性提供数据支持。方法:以第3次PRL国际标准品(批号84/500)为标准,采用放射免疫法、磁微粒酶联免疫法、化学发光免疫法和时间分辨免疫荧光法标定PRL第4次国际候选标准品(批号83/573)。结果:本实验室上报数据:PRL第4次国际候选标准品(批号83/573)免疫效价的几何均值为64.7 m IU·安瓿-1,与WHO报告数据相对偏差为-3.6%。全球10个实验室提交了数据。经标定,PRL第4次国际候选标准品(批号:83/573)的免疫效价几何均值为67.2 m IU·安瓿-1,且稳定性和均匀性满足要求。结论:经WHO生物标准专家委员会审核通过,最终确定PRL候选品(批号:83/573)可作为第4次人垂体源PRL国际标准品使用,每安瓿效价定为67 m IU。Objective:To calibrate the proposed 4 th international candidate standard for human pituitary prolactin(PRL),lot No.83/573,which will provide data support for WHO to assess the applicability of candidate asinternational standard.Methods:The assay of the proposed 4 th international candidate standard for PRL,lot No.83/573,were calibrated in terms of the 3 rdIS(PRL,lot No.84/500),by radioimmunoassay,immunoenzymetricassay(magnetic solid phase),time-resolved fluoroimmunometric assay and chemiluminescence immunoassay.Results:The geometric means of immunoreactivity for the proposed 4 thinternational candidate standard for PRL,lot No.83/573,was 64.7 m IU per ampoule by our laboratory,relative standard deviation was-3.6%with corresponding to those data provided in WHO report.Ten laboratories around the world submitted data.The geometric mean of the laboratory estimates of the proposed 4 th international candidate standard for PRL,lot No.83/573,was 67.2 m IU per ampoule,and homogeneity,stability meet the requirements.Conclusion:It is proposed by WHO Expert Committee on Biological Standardization that the candidate preparation in ampoules coded,lot No. 83/573 is established as the 4 th IS for prolactin,human,pituitary for immunoassay with an assigned content of 67.2 m IU per ampoule.

关 键 词:泌乳素 国际标准品 协作标定 放射免疫法 酶联免疫法 化学发光免疫法 时间分辨免疫荧光法 

分 类 号:R914[医药卫生—药物化学]

 

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