第二代WHO 重组人胰岛素样生长因子-1(IGF-1) 国际对照品的国际协作标定

International Collaborative Standardization of the 2nd WHO International Standard forRecombinant Human Insulin-like Growth Factor-Ⅰ(IGF-Ⅰ)

英国国家生物制品检定所(NIBSC)组织国际协作标定以建立世界卫生组织(WHO)第二代重组人胰岛素样生长因子-1(IGF-1)的国际对照品。标定分2个阶段,中国食品药品检定研究院参加了第1阶段的标定工作。以初级校准物(PS01)为对照品,采用高效液相色谱法进行试验,以标准曲线法对IGF-1待标品的含量进行计算。结果显示,本实验室系统适用性试验结果均符合要求,平行3次试验结果(分别为每安瓿32.874、33.099及33.042μg)均被采纳,平均值为每安瓿33.005μg,与待标品(19/166)的最终赋值(每安瓿33.0μg)基本一致。目前IGF-1待标品(19/166)已作为第二代IGF-1国际对照品在NIBSC网站进行公布使用。本研究对我国国家对照品的建立与标定有良好的示范及借鉴意义。

To establish the 2nd WHO international standard for recombinant human insulin-like growth factor-Ⅰ(IGF-Ⅰ),an international collaborative standardization was organized by National Institute for Biological Standards and Control(NIBSC).The study was conducted in two phases.Our institute(National Institutes for Food and Drug Control)took part in phase 1.Taking primary calibrant PS01 as reference standard,the content of candidate international standard(IS)was determined by HPLC,using standard curve method.The results of system suitability test met requirements in the protocol,and the data of 3 assays(32.874,33.099 and 33.042μg per ampoule,respectively)submitted by our laboratory had been all adopted.The mean value was 33.005μg per ampoule,which was basically consistent with the assigned content(33.0μg per ampoule)of the candidate IS(19/166).At present,the candidate IS(19/166)has been used as the 2nd WHO international standard for IGF-Ⅰon NIBSC website.This research provided a reference for the establishment and standardization of national reference substance in China.