Home Journals Articles Updates About
CN
image
收藏切换
Determination of biological activity of human insulin by a homogeneous time-resolved fluorescence method
收藏切换
PDF
Lü-yin WANG1, Yan-feng YANG1, 2, Xiao-ming ZHANG1, Ping LÜ1, Hui ZHANG1, Jing LI1, *, Cheng-gang LIANG1
Acta Pharmaceutica Sinica | 2022, 57(10) : 3223 - 3228
Less
收藏切换
Acta Pharmaceutica Sinica | 2022, 57(10): 3223-3228
• Original Articles •
Determination of biological activity of human insulin by a homogeneous time-resolved fluorescence method
Full
Lü-yin WANG1, Yan-feng YANG1, 2, Xiao-ming ZHANG1, Ping LÜ1, Hui ZHANG1, Jing LI1, *, Cheng-gang LIANG1
Affiliations
  • 1. NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, Division of Hormone, National Institutes for Food and Drug Control, Beijing 102629, China
  • 2. China Pharmaceutical University, Nanjing 211198, China
Published: 2022-10-12 doi: 10.16438/j.0513-4870.2022-0641
Outline
收藏切换

We developed an in-vitro bioassay for determining the bioactivity of human insulin by homogeneous time-resolved fluorescence immunoassay. CHO-INSR B1284 transgenic cells were used as target cells. Key assay parameters, including the cell density, the range of working concentrations, and the stimulation time were optimized. The specificity, relative accuracy, intermediate precision, linearity, and range of the method were validated, as well as the passage stability of the CHO-INSR B1284 cell line. The national standard of recombinant human insulin was used as the benchmark to evaluate the relative potency of insulin analogues and drugs. The drugs and the reference human insulin showed a dose-response relationship, R2 > 0.995, which conforms to the four-parameter equation: y = (A - D) / [1 + (x/C)B] + D. Specificity of the method was good. The geometric mean, relative bias, and geometric coefficient of variation (GCV, %) of the five concentrations (n = 8, 64%, 80%, 100%, 125% and 156%) met the requirements of the General Rules of Chinese Pharmacopoeia, 2020 edition, Volume IV (9401). In summary, a bioassay for determining the in vitro bioactivity of human insulin based on a homogeneous time-resolved fluorescence technique was established; the method was simple, time-saving, accurate and precise, and could be used for the evaluation of biological activity and quality.

biological activity  /  human insulin  /  transgenic cell  /  homogeneous time resolved fluorescence  /  method validation
Lü-yin WANG, Yan-feng YANG, Xiao-ming ZHANG, Ping LÜ, Hui ZHANG, Jing LI, Cheng-gang LIANG. Determination of biological activity of human insulin by a homogeneous time-resolved fluorescence method[J]. Acta Pharmaceutica Sinica, 2022 , 57 (10) : 3223 -3228 . DOI: 10.16438/j.0513-4870.2022-0641
Appendix
Less
Year 2022 volume 57 Issue 10
PDF
141
50
Cite this Article
BibTeX
Article Info
doi: 10.16438/j.0513-4870.2022-0641
  • Receive Date：2022-05-25
  • Online Date：2025-12-24
  • Published：2022-10-12
Article Data
Affiliations
History
  • Received：2022-05-25
  • Revised：2022-08-02
Funding
Affiliations
    1. NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, Division of Hormone, National Institutes for Food and Drug Control, Beijing 102629, China
    2. China Pharmaceutical University, Nanjing 211198, China
References
Share
https://castjournals.cast.org.cn/joweb/yxxb/EN/10.16438/j.0513-4870.2022-0641
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
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
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT
Links
Articles
Latest Articles
Most Read
Collections
Updates
Events
News
Multimedia
About
About Us
Contact
No. 86 Xueyuan South Road, Haidian District, Beijing
100081
010-62199257
qkjq@cast.org.cn

Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House