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Determination of biological activity of luteinizing hormone by a homogeneous time-resolved fluorescence method
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Zhe DENG1, 2, 3, Xiao-ming ZHANG2, Yue SUN2, Jing LI2, Ping LÜ2, Hong-yu XIANG1, *, Cheng-gang LIANG2, *
Acta Pharmaceutica Sinica | 2026, 61(1) : 266 - 272
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Acta Pharmaceutica Sinica | 2026, 61(1): 266-272
• Original Articles •
Determination of biological activity of luteinizing hormone by a homogeneous time-resolved fluorescence method
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Zhe DENG1, 2, 3, Xiao-ming ZHANG2, Yue SUN2, Jing LI2, Ping LÜ2, Hong-yu XIANG1, *, Cheng-gang LIANG2, *
Affiliations
  • 1School of Life Sciences, Jilin University, Changchun 130012, China
  • 2National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Beijing 102629, China
  • 3Heilongjiang Institute for Drug Control, Harbin 150088, China
Published: 2026-01-12 doi: 10.16438/j.0513-4870.2025-0561
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This study employs homogeneous time-resolved fluoroimmunoassay to quantitatively determine the concentration of cyclic adenosine monophosphate (cAMP) within LHCGR(-Ex10)-CRE-luc-HEK293 cells, utilizing a competitive immunoassay method. The research sets forth an in vitro biological activity assessment methodology for luteinizing hormone (LH). Key parameters of the methodology are optimized, and the relative accuracy, intermediate precision, linearity, and range are validated. The optimized experimental conditions are defined as follows: an initial concentration of 200 nmol·mL-1, a seven-fold gradient dilution, a cell density of 24 000 cells·well-1, and a duration of incubation of 30 min. The findings indicate that the method exhibits excellent linearity across a relative potency range of 64% to 156%, high relative accuracy, and satisfactory intermediate precision. The successful establishment and validation of a homogeneous time-resolved fluoroimmunoassay for the evaluation of LH biological activity is reported. This methodology is applicable for the assessment of biological activity and quality control of recombinant LH-like drugs, as well as for the differentiation of recombinant LH.

luteinizing hormone  /  biological activity  /  homogeneous time-resolved fluorescence  /  methodological validation  /  chorionic gonadotropin  /  quality control
邓哲, 张孝明, 孙悦, 李晶, 吕萍, 相宏宇, 梁成罡. 均相时间分辨荧光技术测定促黄体生成素生物学活性. 药学学报, 2026 , 61 (1) : 266 -272 . DOI: 10.16438/j.0513-4870.2025-0561
Zhe DENG, Xiao-ming ZHANG, Yue SUN, Jing LI, Ping LÜ, Hong-yu XIANG, Cheng-gang LIANG. Determination of biological activity of luteinizing hormone by a homogeneous time-resolved fluorescence method[J]. Acta Pharmaceutica Sinica, 2026 , 61 (1) : 266 -272 . DOI: 10.16438/j.0513-4870.2025-0561
Appendix
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Year 2026 volume 61 Issue 1
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Article Info
doi: 10.16438/j.0513-4870.2025-0561
  • Receive Date：2025-05-16
  • Online Date：2026-09-21
  • Published：2026-01-12
Article Data
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History
  • Received：2025-05-16
  • Revised：2025-10-24
Affiliations
    1School of Life Sciences, Jilin University, Changchun 130012, China
    2National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Beijing 102629, China
    3Heilongjiang Institute for Drug Control, Harbin 150088, 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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