Article(id=1322627792295014867, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, 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=1591545600000, acceptedDateStr=2020-06-08, onlineDate=1793268638919, onlineDateStr=2026-10-29, pubDate=1615737600000, pubDateStr=2021-03-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268638919, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268638919, creator=13701087609, updateTime=1793268638919, updator=13701087609, issue=Issue{id=1322627786464936095, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='5', pageStart='385', pageEnd='480', issueExtLink='null', onlineDate='null', pubDate='1615737600000', pubDateStr='2021-03-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268637529, creator='13701087609', updateTime=1793269201588, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322630152530539005, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322630152530539006, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=441, endPage=446, ext={EN=ArticleExt(id=1322627792542478804, articleId=1322627792295014867, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Preparation and calibration of the 5th batch of national standard reference for human menopausal gonadotropin (HMG), columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To prepare and calibrate the 5th batch of national standard reference for human menopausal gonadotropin (HMG).
Methods: Taking WHO 5th batch of international standard 10/286 as reference, the biological potency of the 5th batch of HMG national standard was determined by the method of 1216 follicle stimulating hormone assay and 1217 luteinizing hormone assay in Chinese Pharmacopeia (ChP, Volume Ⅳ, 2015 edition) in 6 laboratories. According to the parallel line measurement method of quantitative response in the biometric method 1431 in ChP (Volume Ⅳ, 2015 edition), BS2000 software was used to calculate the biological potency and conduct the combined calculation.
Results: The biological titer FSH and LH of the 5th batch of HMG national standard products were identified to be 220 IU·ampoule-1 and 203 IU·ampoule-1 after collaborative calibration.
Conclusion: The candidate of HMG can be used as the 5th batch of HMG national standard for biological titer determination of HMG and related preparations.
, authors=Yan-lin WU
1, Yuan ZHANG
1, Long-yan WAN
2, Pei-hua WANG
2, Yan LI
3, Xing-hui XIA
4, Fei YE
4, Li-ming TANG
5, Qiao-xu WANG
5, Chang-hong MENG
6, Yao WANG
6, Hai-ping WU
7, Qing HE
1, Ming-lu ZHANG
1, Ze-an YANG
1, Hua GAO
1, authorsList=Yan-lin WU, Yuan ZHANG, Long-yan WAN, Pei-hua WANG, Yan LI, Xing-hui XIA, Fei YE, Li-ming TANG, Qiao-xu WANG, Chang-hong MENG, Yao WANG, Hai-ping WU, Qing HE, Ming-lu ZHANG, Ze-an YANG, Hua GAO, authorCompany=null, correspAuthors=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=1322627792785748437, articleId=1322627792295014867, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=第5批人绝经尿促性腺素国家标准品的制备与标定, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的: 制备和标定第5批人绝经尿促性腺素(HMG)国家标准品。
方法: 以WHO第5批国际标准品10/286作为标准,选择6个实验室,采用《中华人民共和国药典》2015年版四部1216卵泡刺激素(FSH)测定法和1217黄体生成素(LH)测定法对第5批HMG国家标准品待标品的生物效价进行标定;按照2015年版药典四部通则1431生物统计法中的量反应平行线测定法,采用BS 2000软件计算生物效价,并进行合并计算。
结果: 第5批HMG国家标准品待标品经协作标定,确定其生物效价FSH为220 IU·安瓿-1,LH为203 IU·安瓿-1。
结论: 本批待标品可作为第5批HMG国家标准品供HMG及相关制剂的生物效价测定用。
, authors=吴彦霖
1, 张媛
1, 万龙岩
2, 汪佩华
2, 李严
3, 夏星辉
4, 叶飞
4, 唐黎明
5, 王巧旭
5, 孟长虹
6, 王瑶
6, 吴海苹
7, 贺庆
1, 张铭露
1, 杨泽岸
1, 高华
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