文章摘要
于婷,黄杰,曲守方.人重组胰岛素样生长因子-Ⅰ(IGF-Ⅰ)第1次免疫测定用国家标准品的建立[J].中国药事,2018,32(6):764-769
人重组胰岛素样生长因子-Ⅰ(IGF-Ⅰ)第1次免疫测定用国家标准品的建立
Establishment of the First National Standard for the Immunoassay of Human Recombinant Insulin-like Growth Factor-Ⅰ
投稿时间:2018-02-23  
DOI:10.16153/j.1002-7777.2018.06.012
中文关键词: 胰岛素样生长因子-Ⅰ  国家标准品  定量标记免疫分析
英文关键词: Insulin-like Growth Factor-Ⅰ  national standard  quantitative labeling immunoassay
基金项目:
作者单位E-mail
于婷 中国食品药品检定研究院, 北京 100050  
黄杰 中国食品药品检定研究院, 北京 100050  
曲守方 中国食品药品检定研究院, 北京 100050 qushoufang@nifdc.org.cn 
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中文摘要:
      目的:研制并建立了人重组胰岛素样生长因子-Ⅰ(IGF-Ⅰ)第1次免疫测定用国家标准品。方法:取人重组IGF-Ⅰ原料,用含赋形剂的0.01 M PBS缓冲液配制成7000 ng·mL-1溶液,经无菌过滤处理后,分装、冻干制成候选品。以IGF-Ⅰ国际标准品(02/254)为对照品,选择3家实验室进行协作标定。并对IGF-Ⅰ候选品进行瓶间精密度和稳定性分析。结果:候选品IGF-Ⅰ效价为7446 ng·支-1,瓶间精密度为1.9%,37℃放置3个月稳定。结论:候选品瓶间精密度和稳定性符合要求,每安瓿效价定为7400 ng。本标准品的建立将为IGF-Ⅰ免疫测定的标准化提供定量依据。
英文摘要:
      Objective:To do research on and establish the first national standard for the immunoassay of human recombinant Insulin-like Growth Factor-Ⅰ(IGF-Ⅰ) in China. Methods:Raw materials of human recombinant IGF-Ⅰ were used to prepare solution of 7000 ng·mL-1 in 0.01 M PBS buffer containing excipient. The solution was sterilized by filtration, packaged and lyophilized to make the national standard candidate. By using the IGF-Ⅰ International Standard (02/254) as a reference, three laboratories were selected for collaborative calibration. Furthermore, the precision between bottles and stability of the candidate were also analyzed. Results:The titer of candidate was 7446 ng/ampoule. The precision between bottles was 1.9%. The titer of candidate was stable at 37℃ for 12 weeks. Conclusion:The precision between bottles and stability of the candidate are in line with the requirements, and the titer of each ampoule is set at 7400 ng. The establishment of the national standard of IGF-Ⅰ will lay a quantitative basis for the standardization of the immunoassay of IGF-Ⅰ.
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