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第九批绒促性素国家标准品的建立
引用本文:钱德明,刘群丽,张媛,邵燕,杨赟昀,孙圆媛,华晓东,张月玲,芮菁,朱社敏,匡荣. 第九批绒促性素国家标准品的建立[J]. 中国药事, 2007, 21(10): 816-818
作者姓名:钱德明  刘群丽  张媛  邵燕  杨赟昀  孙圆媛  华晓东  张月玲  芮菁  朱社敏  匡荣
作者单位:1. 中国药品生物制品检定所,北京,100050
2. 北京市药品检验所
3. 天津市药品检验所
4. 浙江省药品检验所
摘    要:制备、标定第九批绒促性素(Human Chorionic Gondotrophin,HCG)国家标准品。以第四批绒促性素国际标准品(NIBSC Code:75/589)为标准,全国有4个实验室参加,用幼龄小鼠子宫增重法进行协作标定。采用4个实验室共18个标定结果,经合并计算,测得本批待标品每支含生物效价为60个国际单位。本批待标品可以作为绒促性素第九批国家标准品使用,其批号为150513-200409。2007年6月份正式分发使用。

关 键 词:绒促性素  标准品  生物效价
文章编号:1002-7777(2007)10-0816-03

Establish the 9th National Standard for Human Chorionic Gonadotrophin
Qian Deming,Liu Qunli,Zheng Yuan,Shao Yan,Yang Binyun,Sun Yuanyuan,Hua Xiaodong,Zhang Yueling,Rui Jing,Zhu Shemin,Kuang Rong. Establish the 9th National Standard for Human Chorionic Gonadotrophin[J]. Chinese Pharmaceutical Affairs, 2007, 21(10): 816-818
Authors:Qian Deming  Liu Qunli  Zheng Yuan  Shao Yan  Yang Binyun  Sun Yuanyuan  Hua Xiaodong  Zhang Yueling  Rui Jing  Zhu Shemin  Kuang Rong
Affiliation:National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050; 1 Beijing Institute for Drug Control; 2 Tianjin Institute for Drug Control; 3Zheiiang Institute for Drug Control
Abstract:To prepared and determine the 9th national standard of Human Chorionic Gonadotrophin(HCG).Determine the 9th national standard of HCG by young female mice uterus weight assay,which regarded the 4th the international standard of HCG(NIBSC Code:75/589).The potencies of the 9th national standard of HCG was 60 units per ampoule,which was combinative calculated 18 results from 4 laboratories.The 9th national standard of HCG was established successfully,whose lot was 150513-200409,and was distributed in June 2007.
Keywords:Human Chorionic Gonadotrophin(HCG)  standard  potency
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