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Preparation and calibration of the 5th batch of national standard reference for human menopausal gonadotropin (HMG)
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Yan-lin WU1, Yuan ZHANG1, Long-yan WAN2, Pei-hua WANG2, Yan LI3, Xing-hui XIA4, Fei YE4, Li-ming TANG5, Qiao-xu WANG5, Chang-hong MENG6, Yao WANG6, Hai-ping WU7, Qing HE1, Ming-lu ZHANG1, Ze-an YANG1, Hua GAO1
Chinese Journal of New Drugs | 2021, 30(5) : 441 - 446
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Chinese Journal of New Drugs | 2021, 30(5): 441-446
Preparation and calibration of the 5th batch of national standard reference for human menopausal gonadotropin (HMG)
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Yan-lin WU1, Yuan ZHANG1, Long-yan WAN2, Pei-hua WANG2, Yan LI3, Xing-hui XIA4, Fei YE4, Li-ming TANG5, Qiao-xu WANG5, Chang-hong MENG6, Yao WANG6, Hai-ping WU7, Qing HE1, Ming-lu ZHANG1, Ze-an YANG1, Hua GAO1
Affiliations
  • 1National Institutes for Food and Drug Control, Beijing 102629, China
  • 2Shanghai Li Zhu Pharmacy Ltd., Shanghai 201206, China
  • 3Shanghai Techwell Biopharmaceutical Co., Ltd., Shanghai 201108, China
  • 4Ningbo Renjian Pharmacy Ltd., Cixi 315300, China
  • 5Shanghai Institute for Food and Drug Control, Shanghai 201203, China
  • 6Jiangsu Institute for Food and Drug Control, Nanjing 210008, China
  • 7Xiamen Bioendo Technology Co., Ltd., Xiamen 361022, China
Published: 2021-03-15
Outline
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Objective:

To prepare and calibrate the 5th batch of national standard reference for human menopausal gonadotropin (HMG).

Methods:

Taking WHO 5th batch of international standard 10/286 as reference, the biological potency of the 5th 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 5th 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 5th batch of HMG national standard for biological titer determination of HMG and related preparations.

human menopausal gonadotropin (HMG)  /  follicle stimulating hormone (FSH)  /  luteinizing hormone (LH)  /  in vivo bioassay  /  potency  /  preparation of standard reference
吴彦霖, 张媛, 万龙岩, 汪佩华, 李严, 夏星辉, 叶飞, 唐黎明, 王巧旭, 孟长虹, 王瑶, 吴海苹, 贺庆, 张铭露, 杨泽岸, 高华. 第5批人绝经尿促性腺素国家标准品的制备与标定. 中国新药杂志, 2021 , 30 (5) : 441 -446 .
Yan-lin WU, Yuan ZHANG, Long-yan WAN, Pei-hua WANG, Yan LI, Xing-hui XIA, Fei YE, Li-ming TANG, Qiao-xu WANG, Chang-hong MENG, Yao WANG, Hai-ping WU, Qing HE, Ming-lu ZHANG, Ze-an YANG, Hua GAO. Preparation and calibration of the 5th batch of national standard reference for human menopausal gonadotropin (HMG)[J]. Chinese Journal of New Drugs, 2021 , 30 (5) : 441 -446 .
Appendix
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Year 2021 volume 30 Issue 5
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  • Online Date：2026-10-29
  • Published：2021-03-15
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History
  • Accepted：2020-06-08
Affiliations
    1National Institutes for Food and Drug Control, Beijing 102629, China
    2Shanghai Li Zhu Pharmacy Ltd., Shanghai 201206, China
    3Shanghai Techwell Biopharmaceutical Co., Ltd., Shanghai 201108, China
    4Ningbo Renjian Pharmacy Ltd., Cixi 315300, China
    5Shanghai Institute for Food and Drug Control, Shanghai 201203, China
    6Jiangsu Institute for Food and Drug Control, Nanjing 210008, China
    7Xiamen Bioendo Technology Co., Ltd., Xiamen 361022, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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