第2批赖氨酸升压素国家标准品的标定  

Calibration of the proposed 2nd batch of national standard reference for lysine vasopressin

作　　者：吴彦霖[1] 郭龙静 杨泽岸 高华[1] 曹春然 曾亚力 孟长虹 陆益红 唐黎明[5] 航艾[5] 匡荣 蒙宏 朱敏莹 夏星辉 叶飞 张媛[1] WU Yan-lin;GUO Long-jing;YANG Ze-an;GAO Hua;CAO Chun-ran;ZENG Ya-li;MENG Chang-hong;LU Yi-hong;TANG Li-ming;HANG Ai;KUANG Rong;MENG Hong;ZHU Min-ying;XIA Xing-hui;YE Fei;ZHANG Yuan(National Institutes for Food and Drug Control,Bejing 102629,China;Bejing Minhai Biotechnology Co.,Ltd.,Beijing 102609,China;Beijing Institute for Drug Control,Bejing 102206,China;Jiangsu Institute for Food and Drug Control,Nanjing 210008,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Zhejiang Institute for Drug Control,Hangzhou 310052,China;SPH No.1 Biochemical&Pharmaceutical Co.,Ltd.,Shanghai 200240,China;Ningbo Renjian Pharmacy Ltd.,Cixi315300,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]北京民海生物科技有限公司,北京102609 [3]北京市药品检验研究院,北京102206 [4]江苏食品药品监督检验研究院,南京210008 [5]上海市食品药品检验所,上海201203 [6]浙江省食品药品检验研究院,杭州310052 [7]上海上药第一生化药业有限公司,上海200240 [8]宁波人健药业集团股份有限公司,慈溪315300

出　　处：《中国新药杂志》2024年第10期1062-1067,共6页Chinese Journal of New Drugs

基　　金：国家药典委员会国家药品标准制修订研究课题项目(2024Y10)。

摘　　要：目的:制备和标定第2批赖氨酸升压素的国家标准品。方法:参照第1批WHO赖氨酸升压素国际标准品77/512,选择7个实验室,采用《中华人民共和国药典》2020年版四部1205升压素生物测定法和0512HPLC法标定赖氨酸升压素待标品的效价,通过加权平均的方式合并计算2种方法的结果。结果:经标定,待标品的效价为每支安瓿含4 IU的赖氨酸升压素。结论:本批待标品可作为第2批赖氨酸升压素国家标准品,用于赖氨酸升压素的效价测定、鉴别及升压物质检查使用。Objective:To establish the 2nd batch of national standard reference for lysine vasopressin(LVP).Methods:Seven laboratories were selected to calibrate the potency of the 2nd batch of LVP national standard collaboratively according to ChP(Volume IV,2020 edition)1205 Vasopressin bioassay and ChP(Volume IV,2020 edition)0512 HPLC method,using the 1st batch of WHO international standard 77/512 for LVP as the standard.The measured results of the two methods were combined by means of weighted average.Results:The 2nd batch of LVP national standard reference was determined to have the potency of 4 IU per ampoule.Conclusion:The candidate was established as the 2nd batch of LVP national standard for the potency determination,identification,and impurity test of LVP.

关 键 词：赖氨酸升压素 升压素生物测定 效价 标准品 

分 类 号：R927[医药卫生—药学]