第1批尿促卵泡素国家标准品的标定  

Establishment of the proposed 1^(st) national standard reference for human urinary follicle stimulating hormone,urofollitropin,by bioassay

作　　者：吴彦霖[1] 张媛[1] 万龙岩 汪佩华 唐黎明[3] 王巧旭[3] 于德志 扆雪涛 高华[1] WU Yan-lin ZHANG Yuan WAN Long-yan WANG Pei-hua TANG Li-ming WANG Qiao-xu YU De-zhi YI Xue-tao GAO Hua(National Institutes for Food and Drug Control, Beijing 102629, China Shanghai Li Zhu Pharmacy Ltd. Shanghai 201206, China Shanghai Institute for Food and Drug Control, Shanghai 201203, China Qingdao Institute for Food and Drug Control, Qingdao 266071, China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]上海丽珠制药有限公司,上海201206 [3]上海市食品药品检验所,上海201203 [4]青岛市食品药品检验研究院,青岛266071

出　　处：《中国新药杂志》2017年第20期2376-2379,共4页Chinese Journal of New Drugs

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。Objective： To establish the 1^（st） national standard for human urinary follicle stimulating hormone,urofollitropin,by bioassay.Methods： The biological potency of the 1^（st） national standard candidate for human urofollitropin was collaboratively calibrated by 4 laboratories by the method in 1216 in Ch P （Volume Ⅳ,2015 edition）,taking the 1^（st） international standard for urofollitropin （IS 92/512） 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 1^（st） national standard candidate was 213 IU per ampoule,which the purity is 100%.Conclusion： The candidate was established as the 1^（st） national standard for urofollitropin,which can be used for the bioassay of potency of urofollitropin and related products.

关 键 词：尿促卵泡素 促卵泡素 人尿促性素 生物测定 国家标准物质 

分 类 号：R943[医药卫生—药剂学]