第10批绒促性素国家标准品的标定  

Preparation of the proposed 10^(th) national standard reference for human chorionic gonadotrophin 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] 芮菁 华晓东 侯娟 巩媛媛 夏星辉 叶飞 李严 吴海苹 张铭露 贺庆[1] 杨泽岸 高华[1] WU Yan-lin;ZHANG Yuan;WAN Long-yan;WANG Pei-hua;TANG Li-ming;WANG Qiao-xu;RUI Jing;HUA Xiao-dong;HOU Juan;GONG Yuan-yuan;XIA Xing-hui;YE Fei;LI Yan;WU Hai-ping;ZHANG Ming-lu;HE Qing;YANG Ze-an;GAO Hua(National Institutes for Food and Drug Control,Beijing 102629,China;Shanghai Li Zhu Pharmacy Co.,Ltd.,Shanghai 201206,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Tianjin Institute for Drug Control,Tianjin 300070,China;Ningbo Renjian Pharmacy Co.,Ltd.,Cixi 315300,China;Shanghai Techwell Biopharmaceutical Co.,Ltd.,Shanghai 201108,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]上海市食品药品检验所,上海201203 [4]天津市药品检验研究院,天津300070 [5]宁波人健药业集团股份有限公司,慈溪315300 [6]上海天伟生物制药有限公司,上海201108 [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20期1906-1910,共5页Chinese Journal of New Drugs

摘　　要：目的:研制第10批绒促性素(HCG)国家标准品。方法:依据《中华人民共和国药典》2015年版四部1209"绒促性素生物测定法",以第5批国际标准品07/364作为参考,联合6个实验室对HCG国家待标品的生物效价进行协作标定。结果:本批HCG待标品经协作标定和合并计算,生物效价为55 IU·安瓿^(-1)。结论:本品可作为第10批HCG国家标准品,供HCG原料药及制剂的效价测定使用。Objective:To establish the 10^(th) national standard for human chorionic gonadotrophin(HCG).Methods:According to Chinese Pharmacopoeia(Volume Ⅳ,2015 edition)1209 Chorionic Gonadotrophin bioassay,the 5^(th) batch of international standard 07/364 was taken as reference,six laboratories collaboratively calibrated the biotiter of the 10^(th) HCG nation standard.Results:The 10^(th) batch of HCG national standard products was determined to have biological titer of 55 IU·per ampoule after collaborative calibration.Conclusion:The candidate was established as the 10^(th) national standard for the determination of the titer of HCG API and preparations.

关 键 词：标准品研制 绒促性素 生物测定 效价 

分 类 号：R927[医药卫生—药学]