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第4批人绝经尿促性腺素(HMG)国家标准品的协作标定

Establishment of the proposed 4th national standard reference for human menopausal gonadotropin (HMG)

作者：吴彦霖¹, 张媛¹, 唐黎明², 陆益红³, 芮菁⁴, 汪佩华⁵, 于德志⁶, 夏星辉⁷, 游赣花⁸, 刘倩¹, 贺庆¹, 高华¹

作者(英文)：WU Yan-lin¹, ZHANG Yuan¹, TANG Li-ming², LU Yi-hong³, RUI Jing⁴, WANG Peihua⁵, YU De-zhi⁶, XIA Xing-hui⁷, YOU Gan-hua⁸, LIU Qian¹, HE Qing¹, GAO Hua¹

单位：1. 中国食品药品检定研究院, 北京 100050;
2. 上海市食品药品检验所, 上海 201203;
3. 江苏省食品药品监督检定研究院, 南京 210008;
4. 天津市药品检验所, 天津 300070;
5. 上海丽珠制药有限公司, 上海 201206;
6. 青岛市食品药品检验检测中心, 青岛 266071;
7. 宁波人健药业集团股份有限公司, 慈溪 315300;
8. 贵州食品药品检验所, 贵阳 550004

单位(英文)：1. National Institutes for Food and Drug Control, Beijing 100050, China;
2. Shanghai Institute for Food and Drug Control, Shanghai 201203, China;
3. Jiangsu Institute for Food and Drug Control, Nanjing 210008, China;
4. Tianjin Institute for Drug Control, Tianjin 300070, China;
5. Shanghai Li Zhu Pharmacy Ltd., Shanghai 201206, China;
6. Qingdao Institute for Food and Drug Control, Qingdao 266071, China;
7. Ningbo Ren Jian Pharmacy Ltd., Cixi 315300, China;
8. Guizhou Institute for Food and Drug Control, Guiyang 550004, China

关键词：人绝经尿促性腺素(HMG);卵泡生成激素(FSH);促黄体生成素(LH);生物测定;效价;标准品制备;生物统计分析

关键词(英文)：human menopausal gonadotropin(HMG); follicle stimulating hormone(FSH); luteinizing hormone (LH); in vivo bioassay; potency; standard preparation; biological statistic analysis

分类号：

出版年·卷·期（页码）：2016,36 (8):0-0

DOI: 10.16155/j.0254-1793.2017.01.01

-----摘要：-------------------------------------------------------------------------------------------

目的：制备和标定第4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7个实验室，采用中国药典二部（2010年版）卵泡刺激素（FSH）测定法和黄体生成素（LH）测定法对第4批HMG国家标准品待标品的生物效价进行标定；按照中国药典二部（2010年版）量反应平行线法使用BS 2000对所得数据进行统计计算。结果：第4批HMG国家标准品待标品经协作标定，确定其生物效价为FSH 247 IU·安瓿^-1，LH 202 IU·安瓿^-1。结论：本批待标品可作为第4批HMG国家标准品，以供HMG及相关制剂的生物效价测定用。

-----英文摘要：---------------------------------------------------------------------------------------

Objective: To establish the 4th national standard for human menopausal gonadotropin(HMG) by bioassay.Methods: The biological potency of 4th national standard candidate for HMG was collaboratively calibrated by 7 laboratories using the method collected in Appendix Ⅻ M(FSH bioassay) and N(LH bioassay) in ChP.(Volume Ⅱ,2010 edition) relative to the 5th international standard for human urinary FSH/LH(IS 10/286),which was provided by National Institute for Biological Standard and Control(NIBSC).The calibration of candidate was combined by using BS 2000,according to Appendix Ⅺ V in ChP.(Volume Ⅱ,2010 edition) quantity response parallel line method.Results: Relative to the 5th international standard,the biological potency of proposed 4th national standard for HMG was FSH 247 IU per ampoule and LH 202 IU per ampoule.Conclusion: The established candidate can be used as the 4th national standard for HMG for bioassay.

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第4批人绝经尿促性腺素(HMG)国家标准品的协作标定

Establishment of the proposed 4th national standard reference for human menopausal gonadotropin (HMG)

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