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Preparation of the proposed 10th national standard reference for human chorionic gonadotrophin by bioassay
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Yan-lin WU1, Yuan ZHANG1, Long-yan WAN2, Pei-hua WANG2, Li-ming TANG3, Qiao-xu WANG3, Jing RUI4, Xiao-dong HUA4, Juan HOU4, Yuan-yuan GONG4, Xing-hui XIA5, Fei YE5, Yan LI6, Hai-ping WU7, Ming-lu ZHANG1, Qing HE1, Ze-an YANG1, Hua GAO1
Chinese Journal of New Drugs | 2021, 30(20) : 1906 - 1910
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Chinese Journal of New Drugs | 2021, 30(20): 1906-1910
Preparation of the proposed 10th national standard reference for human chorionic gonadotrophin by bioassay
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Yan-lin WU1, Yuan ZHANG1, Long-yan WAN2, Pei-hua WANG2, Li-ming TANG3, Qiao-xu WANG3, Jing RUI4, Xiao-dong HUA4, Juan HOU4, Yuan-yuan GONG4, Xing-hui XIA5, Fei YE5, Yan LI6, Hai-ping WU7, Ming-lu ZHANG1, Qing HE1, Ze-an YANG1, Hua GAO1
Affiliations
  • 1National Institutes for Food and Drug Control, Beijing 102629, China
  • 2Shanghai Li Zhu Pharmacy Co., Ltd., Shanghai 201206, China
  • 3Shanghai Institute for Food and Drug Control, Shanghai 201203, China
  • 4Tianjin Institute for Drug Control, Tianjin 300070, China
  • 5Ningbo Renjian Pharmacy Co., Ltd., Cixi 315300, China
  • 6Shanghai Techwell Biopharmaceutical Co., Ltd., Shanghai 201108, China
  • 7Xiamen Bioendo Technology Co., Ltd., Xiamen 361022, China
Published: 2021-10-30
Outline
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Objective:

To establish the 10th national standard for human chorionic gonadotrophin (HCG).

Methods:

According to Chinese Pharmacopoeia (Volume Ⅳ, 2015 edition) 1209 Chorionic Gonadotrophin bioassay, the 5th batch of international standard 07/364 was taken as reference, six laboratories collaboratively calibrated the biotiter of the 10th HCG nation standard.

Results:

The 10th 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 10th national standard for the determination of the titer of HCG API and preparations.

preparation of standard reference  /  human chorionic gonadotrophin  /  in vivo bioassay  /  potency
吴彦霖, 张媛, 万龙岩, 汪佩华, 唐黎明, 王巧旭, 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, 杨泽岸, 高华. 第10批绒促性素国家标准品的标定. 中国新药杂志, 2021 , 30 (20) : 1906 -1910 .
Yan-lin WU, Yuan ZHANG, Long-yan WAN, Pei-hua WANG, Li-ming TANG, Qiao-xu WANG, Jing RUI, Xiao-dong HUA, Juan HOU, Yuan-yuan GONG, Xing-hui XIA, Fei YE, Yan LI, Hai-ping WU, Ming-lu ZHANG, Qing HE, Ze-an YANG, Hua GAO. Preparation of the proposed 10th national standard reference for human chorionic gonadotrophin by bioassay[J]. Chinese Journal of New Drugs, 2021 , 30 (20) : 1906 -1910 .
Appendix
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Year 2021 volume 30 Issue 20
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Article Info
  • Online Date：2026-10-30
  • Published：2021-10-30
Article Data
Affiliations
History
  • Accepted：2021-07-08
Affiliations
    1National Institutes for Food and Drug Control, Beijing 102629, China
    2Shanghai Li Zhu Pharmacy Co., Ltd., Shanghai 201206, China
    3Shanghai Institute for Food and Drug Control, Shanghai 201203, China
    4Tianjin Institute for Drug Control, Tianjin 300070, China
    5Ningbo Renjian Pharmacy Co., Ltd., Cixi 315300, China
    6Shanghai Techwell Biopharmaceutical Co., Ltd., Shanghai 201108, 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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