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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.“,”Objective:To establish the 1st national standard for human urinary follicle stimulating hormone,urofollitropin,by bioassay.Methods:The biological potency of the 1st national standard candidate for human urofollitropin was collaboratively calibrated by 4 laboratories by the method in 1216 in ChP (Volume Ⅳ,2015 edition),taking the 1 st international standard for urofollitropin (IS 92/5 t2) as reference,which was provided by National Institute for Biological Standard and Control (NIBSC).The concentration of the candidate was determined by HPLC.Results:Relative to the 1 st international standard,the biological potency of the proposed 1st national standard candidate was 213 IU per ampoule,which the purity is 100％.Conclusion:The candidate was established as the 1st national standard for urofollitropin,which can be used for the bioassay of potency of urofollitropin and related products.