第5批人绝经尿促性腺素国家标准品的制备与标定  

Preparation and calibration of the 5th batch of national standard reference for human menopausal gonadotropin (HMG)

作　　者：吴彦霖[1] 张媛[1] 万龙岩 汪佩华 李严 夏星辉 叶飞 唐黎明[5] 王巧旭[5] 孟长虹 王瑶 吴海苹 贺庆[1] 张铭露 杨泽岸 高华[1] WU Yan-lin;ZHANG Yuan;WAN Long-yan;WANG Pei-hua;LI Yan;XIA Xing-hui;YE Fei;TANG Li-ming;WANG Qiao-xu;MENG Chang-hong;WANG Yao;WU Hai-ping;HE Qing;ZHANG Ming-lu;YANG Ze-an;CAO Hua(National Instiues for Food and Drug Control,Beiing 102629,China;Shanghai li Zhu Pharmacy Ltd.,Shanghai 201206,China;Shanghai Techwell Biopharmaceutical Co.,Lud.,Shanghai 201108,China;Ningbo Renjian Pharmacy Ltd.,Cixi 315300,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Jiangsu Institute for Food and Drug Control,Nanjing 210008,China;Xiamen Bioendo Technology Co.,Ltd.,Xiamen 361022,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]上海天伟生物制药有限公司,上海201108 [4]宁波人健药业集团股份有限公司,慈溪315300 [5]上海市食品药品检验所,上海201203 [6]江苏省食品药品监督检定研究院,南京210008 [7]厦门鲎试剂生物科技股份有限公司,厦门361022

出　　处：《中国新药杂志》2021年第5期441-446,共6页Chinese Journal of New Drugs

摘　　要：目的:制备和标定第5批人绝经尿促性腺素(HMG)国家标准品。方法:以WHO第5批国际标准品10/286作为标准,选择6个实验室,采用《中华人民共和国药典》2015年版四部1216卵泡刺激素(FSH)测定法和1217黄体生成素(LH)测定法对第5批HMG国家标准品待标品的生物效价进行标定;按照2015年版药典四部通则1431生物统计法中的量反应平行线测定法,采用BS 2000软件计算生物效价,并进行合并计算。结果:第5批HMG国家标准品待标品经协作标定,确定其生物效价FSH为220 IU·安瓿^(-1),LH为203 IU·安瓿^(-1)。结论:本批待标品可作为第5批HMG国家标准品供HMG及相关制剂的生物效价测定用。Objective: To prepare and calibrate the 5 th batch of national standard reference for human menopausal gonadotropin( HMG). Methods: Taking WHO 5 th batch of international standard 10/286 as reference,the biological potency of the 5 th batch of HMG national standard was determined by the method of 1216 follicle stimulating hormone assay and 1217 luteinizing hormone assay in Chinese Pharmacopeia( ChP,Volume Ⅳ,2015 edition) in 6 laboratories. According to the parallel line measurement method of quantitative response in the biometric method 1431 in ChP( Volume Ⅳ,2015 edition),BS2000 software was used to calculate the biological potency and conduct the combined calculation. Results: The biological titer FSH and LH of the 5 th batch of HMG national standard products were identified to be 220 IU·ampoule^(-1) and 203 IU·ampoule^(-1) after collaborative calibration. Conclusion: The candidate of HMG can be used as the 5 th batch of HMG national standard for biological titer determination of HMG and related preparations.

关 键 词：人绝经尿促性腺素 卵泡生成激素 促黄体生成素 生物测定 效价 标准品制备 

分 类 号：R921.2[医药卫生—药学]