促甲状腺素(TSH)免疫测定用国家标准品的研制

  • 摘要: 介绍了促甲状腺素(TSH)第一次免疫测定用国家标准品(批号:0530-9412)的制备过程。选用Sigma公司TSH高纯品,经配制,分装,冷干等一系列标准品制备的常规步骤,制得成品1400支,以WHO2ndIRP80/558为对照品,经协作标定,本标准品免疫活性为520μIU/支。

     

    Abstract: PREPARATION OF TSH NATIONAL STANDARD FOR IMMUNOASSAYHuang Ying Shen Hongzheng Xu Ligen Leng Wei(National Institute for Control of Pharmaceutical and Biological Products, Beijing 100050)ABSTRACTThe first national standard of thyroid stimulating hormone (TSH) for immunoassay is prepared. The highly pure TSH from Sigma Co, are purchased and immuno activity of this material is 7 kIU/g. The batch of ampoules coded 05309412,is prepared according to the procedures used for international biological standard. The ampoule′s potency are calibrated by 8 immunoassay systems including RIA, IRMA and ELISA. The mean potency of the first national standard of TSH for immunoassay is 525 μIU per ampoule.Key words TSH national standard collaborative study

     

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