第1批尿促卵泡素国家标准品的标定

发布时间：2018-05-24 10:11

  本文选题：尿促卵泡素 + 促卵泡素　； 参考：《中国新药杂志》2017年20期

【摘要】：目的:制备第1批人尿促卵泡素(urofollitropin)国家标准品。方法:以WHO第1批人尿促卵泡素国际标准品92/512作为标准,选择4个实验室,采用《中华人民共和国药典》2015版四部1216卵泡刺激素生物测定法对人尿促卵泡素待标品进行生物效价标定;采用HPLC法对待标品的纯度进行测定。结果:人尿促卵泡素待标品经协作标定,确定其生物效价为每安瓿213 IU,其含量为100%。结论:本批待标品可作为第1批人尿促卵泡素国家标准品,以供尿促卵泡素及相关制剂的生物效价测定用。
[Abstract]:Objective: to prepare the first national standard of human urofollitropin. Methods: the first batch of human urinary follicle stimulating hormone (WHO), 92 / 512, was used as the standard, and four laboratories were selected. The biological titer of human urinary follicle stimulating hormone (FSH) was calibrated by 1216 follicle stimulating hormone bioassay and the purity of the standard product was determined by HPLC method in 2015 edition of the Pharmacopoeia of the people's Republic of China. Results: the biological titer of human urinary follicle stimulating hormone was determined to be 213 IUU per ampoule, and its content was 100. Conclusion: this batch can be used as the first national standard of human follicle stimulating hormone for the determination of the biological titer of urinary follicle stimulating hormone and related preparations.
【作者单位】： 中国食品药品检定研究院;上海丽珠制药有限公司;上海市食品药品检验所;青岛市食品药品检验研究院;
【分类号】：R927
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本文编号：1928677