《中华人民共和国药典》（2025年版）卵泡刺激素生物活性测定法修订研究

doi:10.19803/j.1672-8629.20250537

中国药物警戒 ›› 2025, Vol. 22 ›› Issue (10): 1132-1136.
DOI: 10.19803/j.1672-8629.20250537

《中华人民共和国药典》（2025年版）卵泡刺激素生物活性测定法修订研究

吴彦霖¹, 温苗^1,2△, 杨泽岸¹, 张媛^1#, 贺庆^1,*

¹中国食品药品检定研究院药理室,北京 102629;
²中国药科大学药学院药物分析系,江苏南京 210009

收稿日期:2025-08-11 出版日期:2025-10-15 发布日期:2025-10-20
通讯作者: ^*贺庆,男,博士,研究员,药检药理。E-mail: a1heqing@163.com;^#为共同通信作者。
作者简介:吴彦霖,女,博士,副研究员,药检药理。^△为并列第一作者。
基金资助:
国家重点研发计划（2024YFA1107301）

Interpretations of Revised Bioassay of Follicle-Stimulating Hormone in Chinese Pharmacopoeia 2025

WU Yanlin¹, WEN Miao^1,2△, YANG Ze'an¹, ZHANG Yuan^1#, HE Qing^1*

¹National Institutes for Food and Drug Control, Beijing 102629, China;
²Department of Pharmaceutical Analysis, School of Pharmacy, China Pharmaceutical University, Nanjing Jiangsu 210009, China

Received:2025-08-11 Online:2025-10-15 Published:2025-10-20

摘要/Abstract

摘要： 目的基于《中华人民共和国药典》（以下简称《中国药典》）（2025年版）新增、修订的卵泡刺激素生物活性测定法,对方法细化和标准化进行比对研究,以便于标准的理解和实施。方法介绍卵泡刺激素生物活性测定法修订概况,对方法的增修订进行说明,明确新增方法的必要性和可行性。结果《中国药典》（2025年版）1216卵泡刺激素生物活性测定法-第二法和3536人促卵泡激素生物活性测定法的新增订方法均为细胞反应法,具有灵敏度高、特异性好、准确性高,且与现行标准有较好的一致性。结论本次新增方法在卵泡刺激素活性测定方面属国内外首创,有助于提高卵泡刺激素产品的质量控制水平。

关键词: 《中国药典》（2025年版）, 卵泡刺激素, 生物活性测定法, 效价, 颗粒细胞, 体外测定法

Abstract: Objective To interpret the newly added and revised bioassay methods for the determination of bioactivity of follicle-stimulating hormone (FSH) in the Chinese Pharmacopoeia (2025 edition), and to conduct a comparative study on the refinement and standardization of these methods so as to facilitate the understanding and implementation of these standards. Methods An overview of the revisions of and additions to FSH bioassay methods was given. By elaborating on the process of drafting the additions of and revisions to the methods, the necessity and feasibility of the newly added methods were explained. Results The newly added methods in the Chinese Pharmacopoeia (2025 Edition), namely Method Two of 1216 FSH Biological Activity Determination and Method 3536 for Human FSH Biological Activity Determination, were both cell response methods. They were characterized by a high sensitivity, good specificity, high accuracy, and good consistency with the current standards. Conclusion The newly added methods for the determination of the FSH biological activity in the Chinese Pharmacopoeia (2025 Edition) is the first of its kind globally in the field of FSH activity determination. The progress in methods for FSH biological activity determination will help improve quality control of FSH products.

Key words: 2025 Edition of the Chinese Pharmacopoeia, Follicle Stimulating Hormone, Biological Activity Determination Method, Potency, Granulosa Cell, in vitro Assay Method

中图分类号:

R927.1

吴彦霖, 温苗, 杨泽岸, 张媛, 贺庆. 《中华人民共和国药典》（2025年版）卵泡刺激素生物活性测定法修订研究[J]. 中国药物警戒, 2025, 22(10): 1132-1136.

WU Yanlin, WEN Miao, YANG Ze'an, ZHANG Yuan, HE Qing. Interpretations of Revised Bioassay of Follicle-Stimulating Hormone in Chinese Pharmacopoeia 2025[J]. Chinese Journal of Pharmacovigilance, 2025, 22(10): 1132-1136.

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参考文献

[1] LUNDIN K, SEPPONEN K, VÄYRYNEN P, et al. Human Pluripotent Stem Cell-Derived Cells Endogenously Expressing Follicle-Stimulating Hormone Receptors: Modeling the Function of an Inactivating Receptor Mutation[J]. Molecular Human Reproduction, 2022, 28(5): 1-13.
[2] YE J, YAN X, ZHANG W, et al.Integrative Proteomic and Phosphoproteomic Analysis in the Female Goat Hypothalamus to Study the Onset of Puberty[J]. BMC Genomics, 2023, 24(1): 621-632.
[3] SHENG S, LIU W, XUE Y, et al.Follicle-Stimulating Hormone Promotes the Development of Endometrial Cancer in vitro and in vivo[J]. International Journal of Environmental Research and Public Health, 2022, 19(22): 15344-15354.
[4] ROSE MP, GAINES DAS RE, BALEN AH.Definition and Measurement of Follicle Stimulating Hormone[J]. Endocrine Reviews, 2000, 21(1): 5-22.
[5] LI ZJ, LI XX, LIANG CG.Comparison of the Methods for in vivo FSH Bioassay in Pharmacopoeia of Various Countries[J]. J. Pharm. Anal(药物分析杂志), 2014, 34(4): 727-732.
[6] ELVERS LH, LOEBER JG.Comparison of Six Radioimmunoassay Kits for Human Follitropin in Serum[J]. J Clin Chem Clin Biochem, 1983, 21(10): 615-620.
[7] WU DZ, LIN GC.Detection of Serum LH and FSH with Enzyme-linking Immunoassay[J]. J Mod Lab Med(现代检验医学杂志), 2002, 17(2): 15-16.
[8] ZENG HQ, WANG LJ, ZHANG GJ.Establishment and Preliminary Application of ELISA Joint Detection[J]. Lab Med Clin(检验医学与临床), 2016, 13(9): 1179-1183.
[9] ZENG ZH, ZENG QH, LI MF, et al.Analysis of the Value of Chemiluminescence Immunoassay in Detection of Serum Basic Gonadal Hormones in Female[J]. Chin Community Doctors(中国社区医师), 2020, 36(19): 118-119.
[10] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China, Volume IV(中华人民共和国药典四部)[M]. Beijing: China Medical Science Press, 2020.
[11] ZHANG Y, WU YL, ZHANG ML, et al.Research Progress on Follicle Stimulating Hormone and Its Measurement Methods[J]. Chin J New Drugs(中国新药杂志), 2022, 31(6): 573-578.
[12] DE LEEUW R, MULDERS J, VOORTMAN G, et al.Structure-Function Relationship of Recombinant Follicle Stimulating Hormone (Puregon)[J]. Molecular Human Reproduction, 1996, 2(5): 361-369.
[13] COSS D.Commentary on the Recent FSH Collection: Known Knowns and Known Unknowns[J]. Endocrinology, 2020, 161(1): 1-6.
[14] ALLEN LA, ACHERMANN JC, PAKARINEN P, et al.A Novel Loss of Function Mutation in Exon 10 of the FSH Receptor Gene Causing Hypergonadotrophic Hypogonadism: Clinical and Molecular Characteristics[J]. Human Reproduction, 2003, 18(2): 251-256.
[15] SKLIUTĖ G, VAIGAUSKAITĖ-MAŽEIKIENĖ B, KAUPINIS A, et al. The Effects of the Follicle-Stimulating Hormone on Human Follicular Fluid-Derived Stromal Cells[J]. International Journal of Molecular Sciences, 2023, 24(3): 2450-2463.
[16] JOHAM AE, PILTONEN T, LUJAN ME, et al.Challenges in Diagnosis and Understanding of Natural History of Polycystic Ovary Syndrome[J]. Clinical Endocrinology, 2022, 97(2): 165-173.
[17] SALEHPOUR S, ALEYASIN A, MOINI A, et al.Luteinizing Hormone Supplementation in Controlled Ovarian Stimulation: the Iran Delphi Consensus[J]. Frontiers in Reproductive Health, 2024, 6: 1-9.
[18] HUANG C, SHEN X, MEI J, et al.Effect of Recombinant LH Supplementation Timing on Clinical Pregnancy Outcome in Long-Acting GnRHa Downregulated Cycles[J]. BMC Pregnancy and Childbirth, 2022, 22(1): 632-639.
[19] World Health Organization Infertility Prevalence Estimates, 1990-2021[M]. Geneva: WHO, 2023.
[20] NEVELLI F, PALMESE A, GLEIXNER R, et al.Biological Assay to Determine Gonadotropin Potency: From in vivo to in vitro Sustainable Method[J]. International Journal of Molecular Sciences, 2023, 24(9): 8040-8068.
[21] WANG LY, LYU P, ZHANG H, et al.Collaborative Study to Evaluate a Reporter Gene Assay for Recombinant Human Follicle-Stimulating Hormone Bioactivity[J]. Acta Pharm Sin(药学学报), 2023, 58(3): 760-766.
[22] DUAN XH, WANG MR, LING J, et al.Normalized Application of Four-Parameter Logistic Model in Bioassay Based on Microsoft Excel[J]. Chin J Biol(中国生物制品学杂志), 2021, 34(2): 202-206, 212.
[23] CUMBERLAND W N, FONG Y, YU X, et al.Nonlinear Calibration Model Choice between the Four and Five-Parameter Logistic Models[J]. Journal of Biopharmaceutical Statistics, 2015, 25(5): 972-983.
[24] MAYER BT, DECAMP AC, HUANG Y, et al.Optimizing Clinical Dosing of Combination Broadly Neutralizing Antibodies for HIV Prevention[J]. PLoS Computational Biology, 2022, 18(4): 1-20.
[25] BUTNEV VY, MAY JV, BROWN AR, et al.Human FSH Glycoform α-Subunit Asparagine52 Glycans: Major Glycan Structural Consistency, Minor Glycan Variation in Abundance[J]. Frontiers in Endocrinology, 2022, 13(1): 1-24.
[26] WIDE L, ERIKSSON K, SLUSS P M, et al.Determination of Half-lives of Circulating FSH and LH Glycoforms in Women During GnRH Receptor Blockade[J]. The Journal of Clinical Endocrinology and Metabolism, 2022, 107(10): e4058-e4062.
[27] MASTRANGELI R, SATWEKAR A, BIERAU H.Innovative Metrics for Reporting and Comparing the Glycan Structural Profile in Biotherapeutics[J]. Molecules, 2023, 28(8): 3304-3339.

《中华人民共和国药典》（2025年版）卵泡刺激素生物活性测定法修订研究

Interpretations of Revised Bioassay of Follicle-Stimulating Hormone in Chinese Pharmacopoeia 2025

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