Article(id=1322906923498087052, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887411688919265, 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=1619366400000, acceptedDateStr=2021-04-26, onlineDate=1793335188983, onlineDateStr=2026-10-30, pubDate=1636905600000, pubDateStr=2021-11-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335188983, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335188983, creator=13701087609, updateTime=1793335188983, updator=13701087609, issue=Issue{id=1322887411688919265, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='21', pageStart='1921', pageEnd='2016', issueExtLink='null', onlineDate='null', pubDate='1636905600000', pubDateStr='2021-11-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793330537006, creator='13701087609', updateTime=1793337443794, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916380919608076, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887411688919265, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916380919608077, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887411688919265, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1944, endPage=1948, ext={EN=ArticleExt(id=1322906923670053517, articleId=1322906923498087052, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Considerations on the application of antimicrobial preservatives in drugs, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Antimicrobial preservatives, as a kind of common additives in non-solid drug preparations, play an important role in preventing microbial contamination and ensuring drug quality. Due to its toxicity, the application range and level of preservatives should be strictly concerned. Referring to ChP 2020 and EMA related guidelines, this article summarizes the related requirements of preservatives when being used in preparations in ChP and EMA. It is therefore proposed that necessity and level of the application of antimicrobial preservatives should be greatly concerned in developing new drug preparations. The scope of application is also discussed in this article, hoping a helpful reference will be provided for research and development of drugs.

, authors=Zhen TANG, Xiao-xia ZHAO, Hong-feng GUAN, Yong-wen ZHANG, authorsList=Zhen TANG, Xiao-xia ZHAO, Hong-feng GUAN, Yong-wen ZHANG, authorCompany=null, correspAuthors=Yong-wen ZHANG, 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=1322906923980432014, articleId=1322906923498087052, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=关于药物中抑菌剂使用相关问题的思考, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

抑菌剂作为非固体制剂中常见的附加剂，对防止药品微生物污染和保证药品质量具有重要作用。由于抑菌剂具有一定毒性，应严格控制应用范围和用量。通过查阅《中华人民共和国药典》2020年版和欧洲EMA指导原则，本文总结了我国和EMA对药品中使用抑菌剂的相关要求，提出药物研发中使用抑菌剂应关注必要性和用量等问题，对抑菌剂的适用范围进行了思考和探讨，旨在为药品研发提供参考。

, authors=唐溱, 赵晓霞, 关宏峰, 张永文, authorsList=唐溱, 赵晓霞, 关宏峰, 张永文, authorCompany=null, correspAuthors=张永文, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=opSJGtzkpIBlvPihgfqgag==, magXml=+NPHiZIzyJ6+z/BPsKKAOQ==, pdfUrl=null, pdf=t3mw1N66/tMpRiq7xVo2Og==, pdfFileSize=933256, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=kqk/Kn4Bj3h2dH64t4ibXQ==, mapNumber=null, fund=null)}, authors=[Author(id=1322906924261450387, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906923498087052, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=tangqin@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322906924341142165, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906923498087052, authorId=1322906924261450387, language=EN, stringName=Zhen TANG, firstName=Zhen, middleName=null, lastName=TANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322906924408251030, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322906923498087052, authorId=1322906924261450387, language=CN, stringName=唐溱, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京　100022, bio={"content":"

唐溱，女，硕士研究生，主要从事中药、天然药物药学技术审评工作。联系电话：（010）85242884，E-mail：tangqin@cde.org.cn。

"}, bioImg=null, bioContent=

唐溱，女，硕士研究生，主要从事中药、天然药物药学技术审评工作。联系电话：（010）85242884，E-mail：tangqin@cde.org.cn。

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