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Article(id=1322181196193317776, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1604592000000, acceptedDateStr=2020-11-06, onlineDate=1793162162111, onlineDateStr=2026-10-28, pubDate=1627574400000, pubDateStr=2021-07-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793162162111, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793162162111, creator=13701087609, updateTime=1793162162111, updator=13701087609, issue=Issue{id=1322181102488375822, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='14', pageStart='1249', pageEnd='1344', issueExtLink='null', onlineDate='null', pubDate='1627574400000', pubDateStr='2021-07-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793162139770, creator='13701087609', updateTime=1793162209831, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322181396408419308, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322181396408419309, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1316, endPage=1322, ext={EN=ArticleExt(id=1322181197795541905, articleId=1322181196193317776, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Establishment of a bioassay for follicle stimulating hormone titer in vitro based on human ovarian granulosa cells KGN, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To establish a method of stimulating human ovarian granulosa cells KGN to secrete progesterone (PG) by human menopausal gonadotropin (HMG), based on the mechanism of estrogen stimulating the production of progesterone in ovarian granulosa cells in mammalian, to evaluate the titer of follicle-stimulating hormone (FSH), the active component of HMG.

Methods:

KGN cells were stimulated with different concentrations of HMG solution, the content of PG in the secreted supernatant was detected, and the biological activity assay of FSH in vitro was established. According to the 9101 analysis method verification and 9401 biological products bioactivity/potency determination method verification guiding principles in the General Rules of the fourth part of Chinese Pharmacopoeia, the established method was validated in terms of specificity, precision and durability. The national standard of HMG was used as the benchmark to detect the potency of HMG international standard and preparation (qualified and unqualified).

Results:

Different concentrations of HMG displayed effect on KGN cells in a time- and dose-dependent manner.

Conclusion:

The specificity, precision and durability of the method meet the requirements of the General Principles of the fourth part of Chinese Pharmacopoeia. Based on HMG national standard, the titers of HMG international standard and HMG for injection can be effectively determined, with consistent results with the pharmacopoeia method.

, authors=Yan-lin WU1, Ming-lu ZHANG1, Yuan ZHANG1, Long-yan WAN2, Pei-hua WANG2, Tong CAI1, Hua GAO1, authorsList=Yan-lin WU, Ming-lu ZHANG, Yuan ZHANG, Long-yan WAN, Pei-hua WANG, Tong CAI, Hua GAO, authorCompany=null, correspAuthors=Tong CAI, Hua GAO, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322181198059783058, articleId=1322181196193317776, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=基于人卵巢颗粒细胞KGN建立的卵泡刺激素体外生物活性效价测定法, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的：

基于哺乳动物体内激素具有刺激卵巢颗粒细胞产生黄体酮（孕酮）的机理，建立尿促性素（human menopausal gonadotropin，HMG）刺激人卵巢颗粒细胞KGN分泌孕酮（progesterone，PG）法，用于评价HMG中活性成分卵泡刺激素（follicle stimulating hormone，FSH）的效价。

方法：

用不同浓度的HMG溶液刺激KGN细胞，检测分泌上清中的PG含量，建立FSH的体外生物学活性效价测定方法；参照《中华人民共和国药典》2020年版四部通则9101分析方法验证和9401生物制品生物活性/效价测定方法，验证指导原则对所建立的方法进行专属性、精密度、耐用性等方法学研究；以HMG国家标准品作为基准，检测HMG国际标准品和制剂（合格和不合格）的效价。

结果：

不同浓度的HMG作用KGN细胞后具有时间和剂量依赖性。

结论：

本方法的专属性、精密度和耐用性符合《中华人民共和国药典》四部通则的要求；以HMG国家标准品为基准，能有效检测HMG国际标准品和注射用HMG的效价，与药典方法一致。

, authors=吴彦霖1, 张铭露1, 张媛1, 万龙岩2, 汪佩华2, 蔡彤1, 高华1, authorsList=吴彦霖, 张铭露, 张媛, 万龙岩, 汪佩华, 蔡彤, 高华, authorCompany=null, correspAuthors=蔡彤, 高华, authorNote=

吴彦霖，女，博士，副研究员，主要从事药检药理研究。联系电话：（010）53851590，E-mail：。

张铭露，女，硕士研究生，主要从事药检药理研究。E-mail：。

, correspAuthorsNote=
高华，女，博士，研究员，主要从事药检药理研究。联系电话：（010）53851589，E-mail：。
蔡彤，女，硕士，主任药师，主要从事药检药理研究。联系电话：（010）53851592，E-mail：。
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吴彦霖，女，博士，副研究员，主要从事药检药理研究。联系电话：（010）53851590，E-mail：。

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吴彦霖，女，博士，副研究员，主要从事药检药理研究。联系电话：（010）53851590，E-mail：。

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张铭露，女，硕士研究生，主要从事药检药理研究。E-mail：。

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基于人卵巢颗粒细胞KGN建立的卵泡刺激素体外生物活性效价测定法
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吴彦霖 1 , 张铭露 1 , 张媛 1 , 万龙岩 2 , 汪佩华 2 , 蔡彤 1 , 高华 1
中国新药杂志 | 实验研究 2021,30(14): 1316-1322
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中国新药杂志 |实验研究 2021 , 30 (14) : 1316 -1322
基于人卵巢颗粒细胞KGN建立的卵泡刺激素体外生物活性效价测定法
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吴彦霖1 , 张铭露1 , 张媛1, 万龙岩2, 汪佩华2, 蔡彤1 , 高华1
作者信息
  • 1中国食品药品检定研究院，北京　102629
  • 2上海丽珠制药有限公司，上海　201206
通讯作者:
高华，女，博士，研究员，主要从事药检药理研究。联系电话：（010）53851589，E-mail：。
蔡彤，女，硕士，主任药师，主要从事药检药理研究。联系电话：（010）53851592，E-mail：。
作者简介:

吴彦霖，女，博士，副研究员，主要从事药检药理研究。联系电话：（010）53851590，E-mail：。

张铭露，女，硕士研究生，主要从事药检药理研究。E-mail：。

Establishment of a bioassay for follicle stimulating hormone titer in vitro based on human ovarian granulosa cells KGN
Yan-lin WU1 , Ming-lu ZHANG1 , Yuan ZHANG1, Long-yan WAN2, Pei-hua WANG2, Tong CAI1 , Hua GAO1
Affiliations
  • 1National Institutes for Food and Drug Control, Beijing 102629, China
  • 2Shanghai Li Zhu Pharmacy Ltd., Shanghai 201206, China
出版时间: 2021-07-30
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摘要
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目的：

基于哺乳动物体内激素具有刺激卵巢颗粒细胞产生黄体酮（孕酮）的机理，建立尿促性素（human menopausal gonadotropin，HMG）刺激人卵巢颗粒细胞KGN分泌孕酮（progesterone，PG）法，用于评价HMG中活性成分卵泡刺激素（follicle stimulating hormone，FSH）的效价。

方法：

用不同浓度的HMG溶液刺激KGN细胞，检测分泌上清中的PG含量，建立FSH的体外生物学活性效价测定方法；参照《中华人民共和国药典》2020年版四部通则9101分析方法验证和9401生物制品生物活性/效价测定方法，验证指导原则对所建立的方法进行专属性、精密度、耐用性等方法学研究；以HMG国家标准品作为基准，检测HMG国际标准品和制剂（合格和不合格）的效价。

结果：

不同浓度的HMG作用KGN细胞后具有时间和剂量依赖性。

结论：

本方法的专属性、精密度和耐用性符合《中华人民共和国药典》四部通则的要求；以HMG国家标准品为基准，能有效检测HMG国际标准品和注射用HMG的效价，与药典方法一致。

人卵巢颗粒细胞  /  尿促性素  /  卵泡刺激素  /  孕酮  /  方法验证
Objective:

To establish a method of stimulating human ovarian granulosa cells KGN to secrete progesterone (PG) by human menopausal gonadotropin (HMG), based on the mechanism of estrogen stimulating the production of progesterone in ovarian granulosa cells in mammalian, to evaluate the titer of follicle-stimulating hormone (FSH), the active component of HMG.

Methods:

KGN cells were stimulated with different concentrations of HMG solution, the content of PG in the secreted supernatant was detected, and the biological activity assay of FSH in vitro was established. According to the 9101 analysis method verification and 9401 biological products bioactivity/potency determination method verification guiding principles in the General Rules of the fourth part of Chinese Pharmacopoeia, the established method was validated in terms of specificity, precision and durability. The national standard of HMG was used as the benchmark to detect the potency of HMG international standard and preparation (qualified and unqualified).

Results:

Different concentrations of HMG displayed effect on KGN cells in a time- and dose-dependent manner.

Conclusion:

The specificity, precision and durability of the method meet the requirements of the General Principles of the fourth part of Chinese Pharmacopoeia. Based on HMG national standard, the titers of HMG international standard and HMG for injection can be effectively determined, with consistent results with the pharmacopoeia method.

human ovarian granulosa cell  /  human menopausal gonadotropin  /  follicle stimulating hormone  /  progesterone  /  method validation
吴彦霖, 张铭露, 张媛, 万龙岩, 汪佩华, 蔡彤, 高华. 基于人卵巢颗粒细胞KGN建立的卵泡刺激素体外生物活性效价测定法. 中国新药杂志, 2021 , 30 (14) : 1316 -1322 .
Yan-lin WU, Ming-lu ZHANG, Yuan ZHANG, Long-yan WAN, Pei-hua WANG, Tong CAI, Hua GAO. Establishment of a bioassay for follicle stimulating hormone titer in vitro based on human ovarian granulosa cells KGN[J]. Chinese Journal of New Drugs, 2021 , 30 (14) : 1316 -1322 .
基金
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  • 国家药典委员会药品标准提高研究课题资助项目(2020Y06)
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参考文献 引证文献
排序方式：
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TAJIMA K, ORISAKA M, MORI T, et al. Ovarian theca cells in follicular function[J]. Reprod Biomed Online, 2007, 15(5): 591-609.
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2021年第30卷第14期
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  • 首发时间：2026-10-28
  • 出版时间：2021-07-30
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  • 录用日期：2020-11-06
基金
国家药典委员会药品标准提高研究课题资助项目(2020Y06)
作者信息
    1中国食品药品检定研究院，北京　102629
    2上海丽珠制药有限公司，上海　201206

通讯作者:

高华，女，博士，研究员，主要从事药检药理研究。联系电话：（010）53851589，E-mail：。
蔡彤，女，硕士，主任药师，主要从事药检药理研究。联系电话：（010）53851592，E-mail：。
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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
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红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
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