Article(id=1322125554103468352, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, 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=1620748800000, acceptedDateStr=2021-05-12, onlineDate=1793148896003, onlineDateStr=2026-10-28, pubDate=1638201600000, pubDateStr=2021-11-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793148896003, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793148896003, creator=13701087609, updateTime=1793148896003, updator=13701087609, issue=Issue{id=1322125552731927464, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='22', pageStart='2017', pageEnd='2120', issueExtLink='null', onlineDate='null', pubDate='1638201600000', pubDateStr='2021-11-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793148895675, creator='13701087609', updateTime=1793149501548, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322128094022971944, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322128094022971945, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2024, endPage=2028, ext={EN=ArticleExt(id=1322125554262851905, articleId=1322125554103468352, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Updates and amendments of viral vaccines in the Chinese Pharmacopoeia 2020, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

This article reviews the updates and amendments of viral vaccines in volume Ⅲ of the Chinese Pharmacopoeia (ChP) 2020 edition, including a brief introduction to the newly added, updated and revised monography and general chapter and analysis of the features and reasons, and gives suggestions for the next step work. It is beneficial for better understanding and implementation of the Chinese Pharmacopoeia 2020.

, authors=Li XU1, Zhong-ping GUO2, authorsList=Li XU, Zhong-ping GUO, authorCompany=null, correspAuthors=Zhong-ping GUO, 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=1322125554476761410, articleId=1322125554103468352, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=《中华人民共和国药典》2020年版三部病毒性疫苗制品增修订概况, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

本文介绍了《中华人民共和国药典》2020年版三部中病毒性疫苗制品相关的增修订情况,主要内容包括品种收载情况及新增品种概述、增修订品种及通则情况以及共性增修订内容等。对增修订的特点及原因进行分析,并提出了对下一步工作的建议,便于相关从业人员更好地理解和执行《中华人民共和国药典》2020年版。

, authors=徐莉1, 郭中平2, authorsList=徐莉, 郭中平, authorCompany=null, correspAuthors=郭中平, authorNote=

徐莉,女,助理研究员,主要从事生物制品技术审评工作。联系电话:(010)85242991,E-mail:。

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郭中平,女,研究员,研究方向:生物制品质量标准。联系电话:(010)67079561,E-mail:。
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徐莉,女,助理研究员,主要从事生物制品技术审评工作。联系电话:(010)85242991,E-mail:。

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徐莉,女,助理研究员,主要从事生物制品技术审评工作。联系电话:(010)85242991,E-mail:。

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《中华人民共和国药典》2020年版三部病毒性疫苗制品增修订概况
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徐莉 1 , 郭中平 2
中国新药杂志 | 新药述评与论坛 2021,30(22): 2024-2028
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中国新药杂志 |新药述评与论坛 2021 , 30 (22) : 2024 -2028
《中华人民共和国药典》2020年版三部病毒性疫苗制品增修订概况
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徐莉,女,助理研究员,主要从事生物制品技术审评工作。联系电话:(010)85242991,E-mail:。

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徐莉1 , 郭中平2
作者信息
  • 1国家药品监督管理局药品审评中心,北京 100022
  • 2国家药典委员会,北京 100061
通讯作者:
郭中平,女,研究员,研究方向:生物制品质量标准。联系电话:(010)67079561,E-mail:。
作者简介:

徐莉,女,助理研究员,主要从事生物制品技术审评工作。联系电话:(010)85242991,E-mail:。

Updates and amendments of viral vaccines in the Chinese Pharmacopoeia 2020
Li XU1 , Zhong-ping GUO2
Affiliations
  • 1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
  • 2Chinese Pharmacopoeia Commission, Beijing 100061, China
出版时间: 2021-11-30
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本文介绍了《中华人民共和国药典》2020年版三部中病毒性疫苗制品相关的增修订情况,主要内容包括品种收载情况及新增品种概述、增修订品种及通则情况以及共性增修订内容等。对增修订的特点及原因进行分析,并提出了对下一步工作的建议,便于相关从业人员更好地理解和执行《中华人民共和国药典》2020年版。

中华人民共和国药典  /  病毒疫苗  /  标准  /  黄热疫苗  /  狂犬病疫苗  /  脊髓灰质炎疫苗  /  通则

This article reviews the updates and amendments of viral vaccines in volume Ⅲ of the Chinese Pharmacopoeia (ChP) 2020 edition, including a brief introduction to the newly added, updated and revised monography and general chapter and analysis of the features and reasons, and gives suggestions for the next step work. It is beneficial for better understanding and implementation of the Chinese Pharmacopoeia 2020.

Chinese Pharmacopoeia  /  viral vaccines  /  standard  /  yellow fever vaccine  /  rabies vaccine  /  poliomyelitis vaccine  /  general chapter
徐莉, 郭中平. 《中华人民共和国药典》2020年版三部病毒性疫苗制品增修订概况. 中国新药杂志, 2021 , 30 (22) : 2024 -2028 .
Li XU, Zhong-ping GUO. Updates and amendments of viral vaccines in the Chinese Pharmacopoeia 2020[J]. Chinese Journal of New Drugs, 2021 , 30 (22) : 2024 -2028 .

参考文献 引证文献
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曹琰, 王晓娟, 赵雄, 等. 《中国药典》2020年版(三部)增修订概述[J]. 中国药品标准, 2020, 21(4): 290-294.
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WHO. WHO TRS NO.993, Annex 3: Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated)[EB/OL]. (2020-11-06). https://www.who.int/biologicals/vaccines/Annex_3_POLIO_vaccines_TRS_1024.pdf.
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国家药典委员会. 中华人民共和国药典[S]. 2015年版. 三部. 北京: 中国医药科技出版社, 2015: 3-28.
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王晓娟, 曹琰, 赵雄, 等. 2020年版《中华人民共和国药典》三部人用疫苗总论增修订概况及建议[J]. 中国药学杂志, 2020, 55(19): 1561-1563.
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ICH. Guideline for elemental impurities Q3D(R1)[EB/OL]. (2019) [2020-10-20]. https://database.ich.org/sites/default/files/Q3D-R1EWG_Document_Step4_Guideline_2019_0322.pdf.
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ICH. Quality of biotechnological products: stability testing of biotechnological/biological/biological products Q5C[EB/OL]. (1995) [2020-10-20]. https://database.ich.org/sites/default/files/Q5C%20Guideline.pdf.
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朱凤昌, 崇小萌, 杨青, 等. ICH Q3C残留溶剂指导原则与中国药典残留溶剂控制策略[J]. 中国医药工业杂志, 2021, 52(9): 1259-1262.
2021年第30卷第22期
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  • 首发时间:2026-10-28
  • 出版时间:2021-11-30
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  • 录用日期:2021-05-12
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    1国家药品监督管理局药品审评中心,北京 100022
    2国家药典委员会,北京 100061

通讯作者:

郭中平,女,研究员,研究方向:生物制品质量标准。联系电话:(010)67079561,E-mail:。
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2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
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