Article(id=1322906855403565350, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, 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=1625673600000, acceptedDateStr=2021-07-08, onlineDate=1793335172748, onlineDateStr=2026-10-30, pubDate=1635523200000, pubDateStr=2021-10-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335172748, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335172748, creator=13701087609, updateTime=1793335172748, updator=13701087609, issue=Issue{id=1322906824709648449, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='20', pageStart='1825', pageEnd='1920', issueExtLink='null', onlineDate='null', pubDate='1635523200000', pubDateStr='2021-10-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793335165428, creator='13701087609', updateTime=1793337419278, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916278284976934, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916278284976935, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1906, endPage=1910, ext={EN=ArticleExt(id=1322906855592309031, articleId=1322906855403565350, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Preparation of the proposed 10
th national standard reference for human chorionic gonadotrophin by bioassay, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish the 10th national standard for human chorionic gonadotrophin (HCG).
Methods: According to Chinese Pharmacopoeia (Volume Ⅳ, 2015 edition) 1209 Chorionic Gonadotrophin bioassay, the 5th batch of international standard 07/364 was taken as reference, six laboratories collaboratively calibrated the biotiter of the 10th HCG nation standard.
Results: The 10th batch of HCG national standard products was determined to have biological titer of 55 IU·per ampoule after collaborative calibration.
Conclusion: The candidate was established as the 10th national standard for the determination of the titer of HCG API and preparations.
, authors=Yan-lin WU
1, Yuan ZHANG
1, Long-yan WAN
2, Pei-hua WANG
2, Li-ming TANG
3, Qiao-xu WANG
3, Jing RUI
4, Xiao-dong HUA
4, Juan HOU
4, Yuan-yuan GONG
4, Xing-hui XIA
5, Fei YE
5, Yan LI
6, Hai-ping WU
7, Ming-lu ZHANG
1, Qing HE
1, Ze-an YANG
1, Hua GAO
1, authorsList=Yan-lin WU, Yuan ZHANG, Long-yan WAN, Pei-hua WANG, Li-ming TANG, Qiao-xu WANG, Jing RUI, Xiao-dong HUA, Juan HOU, Yuan-yuan GONG, Xing-hui XIA, Fei YE, Yan LI, Hai-ping WU, Ming-lu ZHANG, Qing HE, 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=1322906855860744488, articleId=1322906855403565350, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=第10批绒促性素国家标准品的标定, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的: 研制第10批绒促性素(HCG)国家标准品。
方法: 依据《中华人民共和国药典》2015年版四部1209“绒促性素生物测定法”,以第5批国际标准品07/364作为参考,联合6个实验室对HCG国家待标品的生物效价进行协作标定。
结果: 本批HCG待标品经协作标定和合并计算,生物效价为55 IU·安瓿-1。
结论: 本品可作为第10批HCG国家标准品,供HCG原料药及制剂的效价测定使用。
, authors=吴彦霖
1, 张媛
1, 万龙岩
2, 汪佩华
2, 唐黎明
3, 王巧旭
3, 芮菁
4, 华晓东
4, 侯娟
4, 巩媛媛
4, 夏星辉
5, 叶飞
5, 李严
6, 吴海苹
7, 张铭露
1, 贺庆
1, 杨泽岸
1, 高华
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