Article(id=1322627827455865652, 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=1609171200000, acceptedDateStr=2020-12-29, onlineDate=1793268647301, onlineDateStr=2026-10-29, pubDate=1615737600000, pubDateStr=2021-03-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268647301, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268647301, creator=13701087609, updateTime=1793268647301, 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=394, endPage=398, ext={EN=ArticleExt(id=1322627827606860597, articleId=1322627827455865652, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Discussion on the container closure integrity of rubber stopper/glass container, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Research on container closure integrity (CCI) is an important part of drug development. This article focuses on the CCI research of the life cycle of the rubber stopper/glass container, including packaging design, production, and stability research, and discusses the MALL establishment of rubber stopper/glass container.
, authors=Jun-wei MA, Di-liang GUO, Juan LIU, Yong-hui LIU, authorsList=Jun-wei MA, Di-liang GUO, Juan LIU, Yong-hui LIU, authorCompany=null, correspAuthors=null, 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=1322627827829158710, articleId=1322627827455865652, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=胶塞/玻璃瓶容器密封完整性研究的探讨, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=
容器密封完整性(container closure integrity,CCI)研究是药物开发的重要组成部分。本文重点论述了胶塞/玻璃瓶容器生命周期的CCI研究,包括包装设计、产品生产、稳定性研究3个方面。对胶塞/玻璃瓶容器最大允许泄漏限度建立进行探讨。
, authors=马骏威, 郭涤亮, 刘涓, 刘永辉, authorsList=马骏威, 郭涤亮, 刘涓, 刘永辉, authorCompany=null, correspAuthors=null, authorNote=
, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=rOAVV9+ge+Js1Bs/QZ5unw==, magXml=4VPgmzO3bqiKgwaq1ECShQ==, pdfUrl=null, pdf=vNOIyE0aGQEVEF66IxYQlg==, pdfFileSize=876728, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=4cxVNi6Nw5hOJcDa+cDPpQ==, mapNumber=null, fund=null)}, authors=[Author(id=1322627828110177083, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=mjw2007@126.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627828189868861, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, authorId=1322627828110177083, language=EN, stringName=Jun-wei MA, firstName=Jun-wei, middleName=null, lastName=MA, 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=1322627828261172030, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, authorId=1322627828110177083, language=CN, stringName=马骏威, 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":"
马骏威,男,主要从事药品审评工作。E-mail:mjw2007@126.com。
"}, bioImg=null, bioContent=
马骏威,男,主要从事药品审评工作。E-mail:mjw2007@126.com。
, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322627828030485303, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, xref=null, ext=[AuthorCompanyExt(id=1322627828038873912, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, companyId=1322627828030485303, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1322627828047262521, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, companyId=1322627828030485303, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心,北京 100022)])]), Author(id=1322627828336669504, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627828407972674, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, authorId=1322627828336669504, language=EN, stringName=Di-liang GUO, firstName=Di-liang, middleName=null, lastName=GUO, 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=1322627828462498627, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, authorId=1322627828336669504, language=CN, stringName=郭涤亮, 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=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322627828030485303, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, xref=null, ext=[AuthorCompanyExt(id=1322627828038873912, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, companyId=1322627828030485303, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1322627828047262521, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, companyId=1322627828030485303, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心,北京 100022)])]), Author(id=1322627828537996101, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627828605104967, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, authorId=1322627828537996101, language=EN, stringName=Juan LIU, firstName=Juan, middleName=null, lastName=LIU, 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=1322627828688991048, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, authorId=1322627828537996101, language=CN, stringName=刘涓, 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=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322627828030485303, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, xref=null, ext=[AuthorCompanyExt(id=1322627828038873912, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, companyId=1322627828030485303, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1322627828047262521, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, companyId=1322627828030485303, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心,北京 100022)])]), Author(id=1322627828764488522, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627828839985996, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, authorId=1322627828764488522, language=EN, stringName=Yong-hui LIU, firstName=Yong-hui, middleName=null, lastName=LIU, 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=1322627828911289165, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, authorId=1322627828764488522, language=CN, stringName=刘永辉, 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=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1322627828030485303, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, xref=null, ext=[AuthorCompanyExt(id=1322627828038873912, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, companyId=1322627828030485303, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1322627828047262521, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, companyId=1322627828030485303, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心,北京 100022)])])], keywords=[Keyword(id=1322627829003563854, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, language=EN, orderNo=1, keyword=rubber stopper/glass container), Keyword(id=1322627829079061327, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, language=EN, orderNo=2, keyword=container closure integrity (CCI)), Keyword(id=1322627829162947408, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, language=EN, orderNo=3, keyword=product life cycle), Keyword(id=1322627829221667665, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, language=EN, orderNo=4, keyword=maximum allowable leakage limit (MALL)), Keyword(id=1322627829292970834, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, language=CN, orderNo=1, keyword=胶塞/玻璃瓶), Keyword(id=1322627829376856915, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, language=CN, orderNo=2, keyword=容器密封完整性), Keyword(id=1322627829443965780, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, language=CN, orderNo=3, keyword=产品生命周期), Keyword(id=1322627829502686037, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, language=CN, orderNo=4, keyword=最大允许泄漏限度)], refs=[Reference(id=1322627829590766422, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=The U.S. Pharmacopeia 43 General Chapter 1207. Sterile Product Packaging-Integrity Evaluation[S].2020., articleTitle=null, refAbstract=null), Reference(id=1322627829683041111, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. FDA Guidance for Industry, Container Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products[S].2008., articleTitle=null, refAbstract=null), Reference(id=1322627829741761368, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=MORTON DK. Container/closure integrity of parenteral vials[J].
J Parenter Sci Technol, 1987, 41(5): 145-158., articleTitle=null, refAbstract=null), Reference(id=1322627829813064537, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=田耀华. 对玻璃瓶轧盖密封性用扭力矩检查方法的探讨[J]. 机电信息, 2014(26): 18-20., articleTitle=null, refAbstract=null), Reference(id=1322627829880173402, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=DEGRAZIO FL. Holistic considerations in optimizing a sterile product package to ensure container closure integrity[J].
PDA J Pharm Sci Technol, 2018, 72(1): 15-34., articleTitle=null, refAbstract=null), Reference(id=1322627829938893659, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=GEHRMANN MR, MCANDREW TP. Long-term study of container closure integrity of rubber-glass vial systems by multiple methods[J].
PDA J Pharm Sci Technol, 2020, 74(1): 147-161., articleTitle=null, refAbstract=null), Reference(id=1322627831604032348, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Question-based Review (QbR) for Sterility Assurance of Terminally Sterilized Products: Frequently Asked Questions[S]. 2011., articleTitle=null, refAbstract=null), Reference(id=1322627831679529821, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=The U.S. Pharmacopeia 43 General Chapter 1207.3. Package Seal Quality Test Technologies[S].2020., articleTitle=null, refAbstract=null), Reference(id=1322627831763415902, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=EWAN S, JIANG M, STEVENSON C,
et al. White paper: container closure integrity control versus integrity testing during routine manufacturing[J].
PDA J Pharm Sci Technol, 2015, 69(3): 461-465., articleTitle=null, refAbstract=null), Reference(id=1322627831834719071, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[10], rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=Freeze-drying/lyophilization of pharmaceutical and biological products[M]. CRC Press, 2016., articleTitle=null, refAbstract=null), Reference(id=1322627831897633632, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[11], rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=NIETO A, ROEHL H, ADLER M,
et al. Evaluation of container closure system integrity for storage of frozen drug products: impact of capping force and transportation[J].
PDA J Pharm Sci Technol, 2018, 72(6): 544-552., articleTitle=null, refAbstract=null), Reference(id=1322627831968936801, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=封二飞. 无菌药品包装完整性研究[J]. 中国医药工业杂志, 2019, 50(11): 1352-1357., articleTitle=null, refAbstract=null), Reference(id=1322627832052822882, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[13], rfOrder=12, authorNames=null, journalName=null, refType=null, unstructuredReference=MATHAES R, MAHLER HC, ROGGO Y,
et al. Impact of vial capping on residual seal force and container closure integrity[J].
PDA J Pharm Sci Technol, 2016, 70(1): 12-29., articleTitle=null, refAbstract=null), Reference(id=1322627832115737443, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=null, journalName=null, refType=null, unstructuredReference=KELLER S, MARCY J, BLAKISTONE B,
et al. Effect of microorganism characteristics on leak size critical to predicting package sterility[J].
J Food Prot, 2003, 66(9): 1716-1719., articleTitle=null, refAbstract=null), Reference(id=1322627832178652004, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=14, authorNames=null, journalName=null, refType=null, unstructuredReference=NIETO A, ROEHL H, BROWN H,
et al. Evaluation of container closure system integrity for frozen storage drug products[J].
PDA J Pharm Sci Technol, 2016, 70(2): 120-133., articleTitle=null, refAbstract=null), Reference(id=1322627832249955173, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[16], rfOrder=15, authorNames=null, journalName=null, refType=null, unstructuredReference=MORRICAL BD, GOVERDE M, GRAUSSE J,
et al. Leak testing in parenteral packaging: establishment of direct correlation between helium leak rate measurements and microbial ingress for two different leak types[J].
PDA J Pharm Sci Technol, 2007, 61(4): 226-236., articleTitle=null, refAbstract=null), Reference(id=1322627832312869734, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[17], rfOrder=16, authorNames=null, journalName=null, refType=null, unstructuredReference=KIRSCH LE, NGUYEN L, MOECKLY CS,
et al. Pharmaceutical container/closure integrity II: The relationship between microbial ingress and helium leak rates in rubber-stoppered glass vials[J].
PDA J Pharm Sci Technol, 1997, 51(5): 195-202., articleTitle=null, refAbstract=null), Reference(id=1322627832379978599, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[18], rfOrder=17, authorNames=null, journalName=null, refType=null, unstructuredReference=ALIASKARISOHI S, HOGREVE M, LANGLOIS C,
et al. Single-use container closure integrity I: using microbial ingress test method to determine the maximum allowable leakage limit (MALL)[J].
PDA J Pharm Sci Technol, 2019, 74(3): 1-20., articleTitle=null, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1322627828030485303, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, xref=null, ext=[AuthorCompanyExt(id=1322627828038873912, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, companyId=1322627828030485303, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1322627828047262521, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627827455865652, companyId=1322627828030485303, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心,北京 100022)])], figs=null, attaches=null, journal=Journal(id=1235980159023624194, delFlag=0, nameCn=中国新药杂志, nameEn=Chinese Journal of New Drugs, nameHistory1=null, nameHistory2=null, issn=1003-3734, eissn=null, cn=11-2850/R, coden=ZXZHA6, periodic=3, language=CN, oaType=null, ccby=null, superviseOffice=null, ownerOffice=null, pubOffice=null, editorOffice=null, officeType=null, aims=null, clcCode=null, officeProv=null, officeCity=null, officeAddr=null, officeZip=null, officeEmail=null, officePhone=null, editDirector=null, officeDirector=null, officeDirectorPhone=null, officeStaffNum=null, officeEmpNum=null, coverPicUrl=ohPEEN//Vz1tDT3ZBNTp4Q==, journalPrice=null, startedYear=null, abbrevIsoEn=Chinese Journal of New Drugs, journalRemark=null, publicationField=null, createdTime=1772610233314, updatedTime=1788948968376, createdBy=18614031015, updatedBy=13041195026, firstLetterCn=Z, firstLetterEn=Z, subjectCode=Medical and Pharmaceutical Sciences, subjectName=null, subjectCodeEn=Medical and Pharmaceutical Sciences, subjectNameEn=null, picCn=ohPEEN//Vz1tDT3ZBNTp4Q==, picEn=f9WK9bvTM4guTmS/iGhOMg==, jcr=null, cjcr=null, exts=[JournalExt(id=1304509780974924039, language=CN, name=中国新药杂志, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788948968404, updatedTime=1788948968404, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=http://draft.newdrug.cn/journalx_zgxy/authorLogOn.action, submissionEditorUrl=http://draft.newdrug.cn/journalx_zgxy/editorLogOn.action, submissionReviewUrl=http://draft.newdrug.cn/journalx_zgxy/expertLogOn.action, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""}), JournalExt(id=1304509781025255688, language=EN, name=Chinese Journal of New Drugs, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788948968416, updatedTime=1788948968416, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=http://draft.newdrug.cn/journalx_zgxy/authorLogOn.action, submissionEditorUrl=http://draft.newdrug.cn/journalx_zgxy/editorLogOn.action, submissionReviewUrl=http://draft.newdrug.cn/journalx_zgxy/expertLogOn.action, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""})], databaseList=null, tenantJournalId=1235980733773295621, websiteList=[Website(id=1235982099191222761, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1235980733773295621, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/zgxyzz/CN, language=CN, createTime=1772610695884, createBy=18614031015, updateTime=1772610860397, updateBy=18614031015, name=中国新药杂志-中文, tplId=1146099689490845704, title=中国新药杂志, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1235983918629966444, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=articleTextType, value=kx, createTime=1772611129672, updateTime=1772611129672, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918604800617, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=banner, value=null, createTime=1772611129666, updateTime=1772611129666, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918655132271, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=grayFlag, value=0, createTime=1772611129678, updateTime=1772611129678, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918596412008, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=logo, value=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/file/pic?fileId=W567vm71kFC7UhK9TSU6xw==, createTime=1772611129664, updateTime=1772611129664, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918667715185, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=minRunFlag, value=0, createTime=1772611129681, updateTime=1772611129681, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918617383531, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/file/pic, createTime=1772611129669, updateTime=1772611129669, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918659326576, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=silenceFlag, value=0, createTime=1772611129679, updateTime=1772611129679, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918613189226, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1772611129668, updateTime=1772611129668, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918634160749, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=themeColor, value=null, createTime=1772611129673, updateTime=1772611129673, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918646743662, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=themeStyle, value=null, createTime=1772611129676, updateTime=1772611129676, creator=18614031015, updator=18614031015)]), Website(id=1235982099270914542, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1235980733773295621, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/zgxyzz/EN, language=EN, createTime=1772610695903, createBy=18614031015, updateTime=1772610875891, updateBy=18614031015, name=中国新药杂志-英文, tplId=1146101810881728533, title=Chinese Journal of New Drugs, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1235983955829248630, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=articleTextType, value=kx, createTime=1772611138541, updateTime=1772611138541, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955804082803, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=banner, value=null, createTime=1772611138535, updateTime=1772611138535, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955854414457, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=grayFlag, value=0, createTime=1772611138547, updateTime=1772611138547, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955795694194, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=logo, value=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/file/pic?fileId=W567vm71kFC7UhK9TSU6xw==, createTime=1772611138533, updateTime=1772611138533, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955866997371, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=minRunFlag, value=0, createTime=1772611138550, updateTime=1772611138550, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955820860021, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/file/pic, createTime=1772611138539, updateTime=1772611138539, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955862803066, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=silenceFlag, value=0, createTime=1772611138549, updateTime=1772611138549, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955812471412, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1772611138537, updateTime=1772611138537, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955837637239, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=themeColor, value=null, createTime=1772611138543, updateTime=1772611138543, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955846025848, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=themeStyle, value=null, createTime=1772611138545, updateTime=1772611138545, creator=18614031015, updator=18614031015)])], journalTitle=中国新药杂志, weixinUrl=null, journalUrl=http://www.newdrug.cn/, iacademicId=null, status=1, seqNo=null, journalTitleEn=Chinese Journal of New Drugs, journalPhotoCn=ohPEEN//Vz1tDT3ZBNTp4Q==, journalPhotoEn=f9WK9bvTM4guTmS/iGhOMg==, journalFirstLetter=Z, journalRecommend=null, journalNew=null, journalCollection=null, jcrJf=null, cjcrJf=null, jcrJfStr=null, cjcrJfStr=null, submissionFirstDecision=null, sciSubjectClassification=null, casSubjectClassification=null, citeScore=null, totalCitationFrequency=null, icpCode=null, psCode=null, advertisingLicenseCode=null, copyrightInformation=null, country=null, option=, provinceCode=null, provinceName=null, collectFlag=false, interPubPlatform=, interPubPlatformUrl=null), detailUrlCn=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/Y2021/V30/I5/394, detailUrlEn=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/Y2021/V30/I5/394, pdfUrlCn=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/PDF/Y2021/V30/I5/394, pdfUrlEn=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/PDF/Y2021/V30/I5/394, aliStartDate=0, aliEndDate=0, collectionFlag=false, citedCount=null, citedUrl=null, previewStatus=0, delFlag=0, hasFullText=0, orderTime=1615737600000, fullTextJson=null, articleText=null, reference=null)