首页 期刊 论文 学科刊群 资讯 加盟 关于
EN
image
Article(id=1195687994960163177, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195707415279747621, articleNumber=1001-2494(2024)03-0281-04, orderNo=null, doi=10.11669/cpj.2024.03.013, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1658246400000, receivedDateStr=2022-07-20, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1763003832806, onlineDateStr=2025-11-13, pubDate=1707321600000, pubDateStr=2024-02-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1763008464265, onlineIssueDateStr=2025-11-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=1763003832806, onlineFirstDateStr=2025-11-13, sourceXml=null, magXml=null, createTime=1763003832806, creator=13701087609, updateTime=1763003832806, updator=13701087609, issue=Issue{id=1195707415279747621, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='3', pageStart='193', pageEnd='284', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1763008462972, creator=13701087609, updateTime=1763009150406, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1195710298666611616, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195707415279747621, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1195710298670805921, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195707415279747621, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=281, endPage=284, ext={EN=ArticleExt(id=1195687995203432816, articleId=1195687994960163177, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Application and Practical Exploration of Media Fill Test in Pharmacy Intravenous Admixture Services, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To explore an evaluation method of sterile operation in pharmacy intravenous admixture services(PIVAS). OBJECTIVE The US intravenous quality assurance(IVQA) media fill test kit was used to verify the aseptic operation of the mixed dispensing personnel in our hospital, and the feasibility of applying the media fill test in the PIVAS was preliminarily explored. RESULTS The media fill test was easy to operate without harsh culture conditions and testing equipment. The test results were different under two different mixing conditions, which can verify the operation of personnel. CONCLUSION The media fill test is applicable to the quality control of personnel in sterile dispensing operations.

, correspAuthors=ZHAO Bin, 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, authorCompany=null, fund=null, authors=null, authorsList=ZHANG Fan, LU Boyu, BAI Xue, ZOU Yuzhen, ZHANG Xinyue, ZHAO Bin, MEI Dan), CN=ArticleExt(id=1195688079068541443, articleId=1195687994960163177, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=培养基灌装试验在静脉用药集中调配中心的应用及实践探索, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 针对静脉用药集中调配的无菌操作,我国当前缺少行之有效的人员验证措施,亟需探索无菌操作评估方法。方法 使用美国静脉质量保障(intravenous quality assurance,IVQA)培养基灌装试验套件对我院混合调配人员进行无菌操作验证,初步探索培养基灌装试验在国内静脉用药集中调配中心应用的可行性。结果 培养基灌装试验操作简便,无需苛刻培养条件与检测设备,在2种不同混合调配条件下试验结果不同,可验证人员操作。结论 培养基灌装试验适用于无菌调配操作的人员质控。

, correspAuthors=赵彬, authorNote=null, correspAuthorsNote=
*赵彬,男,副主任药师 研究方向:医院药学和营养支持 Tel:(010)69156513
, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=yy20h5JPXsOsf4F7hiWqCg==, magXml=ZiOYjO7tC+8N6nBZRyWkKQ==, pdfUrl=null, pdf=LKo3Sr5K3tD3Iuow2nXBng==, pdfFileSize=3755215, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=wHztFZun9wK4JUTyFXBoLQ==, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=qzZSD8u0FrKrHvjz1MgezA==, mapNumber=null, authorCompany=null, fund=null, authors=

张凡,女,主管药师 研究方向:医院药学和营养支持

, authorsList=张凡, 陆泊宇, 白雪, 邹羽真, 张鑫悦, 赵彬, 梅丹)}, authors=[Author(id=1197101180900917652, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, orderNo=0, 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=1197101180972220822, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101180900917652, language=EN, stringName=ZHANG Fan, firstName=ZHANG, middleName=null, lastName=Fan, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1197101181030941079, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101180900917652, language=CN, stringName=张凡, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730, bio={"content":"

张凡,女,主管药师 研究方向:医院药学和营养支持

"}, bioImg=null, bioContent=

张凡,女,主管药师 研究方向:医院药学和营养支持

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1197101180749922700, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, xref=1, ext=[AuthorCompanyExt(id=1197101180754117005, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China), AuthorCompanyExt(id=1197101180762505614, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730)])]), Author(id=1197101181093855641, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, 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=1197101181198713243, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101181093855641, language=EN, stringName=LU Boyu, firstName=LU, middleName=null, lastName=Boyu, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1197101181253239196, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101181093855641, language=CN, stringName=陆泊宇, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1197101180749922700, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, xref=1, ext=[AuthorCompanyExt(id=1197101180754117005, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China), AuthorCompanyExt(id=1197101180762505614, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730)])]), Author(id=1197101181316153758, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, 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=1197101181400039840, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101181316153758, language=EN, stringName=BAI Xue, firstName=BAI, middleName=null, lastName=Xue, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1197101181454565793, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101181316153758, language=CN, stringName=白雪, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1197101180749922700, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, xref=1, ext=[AuthorCompanyExt(id=1197101180754117005, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China), AuthorCompanyExt(id=1197101180762505614, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730)])]), Author(id=1197101181525868963, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, 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=1197101181626532261, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101181525868963, language=EN, stringName=ZOU Yuzhen, firstName=ZOU, middleName=null, lastName=Yuzhen, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1197101181685252518, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101181525868963, language=CN, stringName=邹羽真, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1197101180749922700, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, xref=1, ext=[AuthorCompanyExt(id=1197101180754117005, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China), AuthorCompanyExt(id=1197101180762505614, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730)])]), Author(id=1197101181748167080, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, orderNo=4, 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=1197101181811081642, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101181748167080, language=EN, stringName=ZHANG Xinyue, firstName=ZHANG, middleName=null, lastName=Xinyue, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2 Department of Pharmacology and Pharmacy,LKS Faculty of Medicine, The University of Hong Kong, Hong Kong 999077, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1197101181890773419, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101181748167080, language=CN, stringName=张鑫悦, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2 香港大学李嘉诚医学院药理及药剂学系, 中国香港 999077, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1197101180821225871, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, xref=2, ext=[AuthorCompanyExt(id=1197101180833808784, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180821225871, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 Department of Pharmacology and Pharmacy,LKS Faculty of Medicine, The University of Hong Kong, Hong Kong 999077, China), AuthorCompanyExt(id=1197101180842197393, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180821225871, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 香港大学李嘉诚医学院药理及药剂学系, 中国香港 999077)])]), Author(id=1197101181953687981, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, orderNo=5, 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=1, authorType=1, ext={EN=AuthorExt(id=1197101182016602543, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101181953687981, language=EN, stringName=ZHAO Bin, firstName=ZHAO, middleName=null, lastName=Bin, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, *, address=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1197101182079517104, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101181953687981, language=CN, stringName=赵彬, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, *, address=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1197101180749922700, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, xref=1, ext=[AuthorCompanyExt(id=1197101180754117005, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China), AuthorCompanyExt(id=1197101180762505614, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730)])]), Author(id=1197101182138237362, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, orderNo=6, 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=1197101182209540532, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101182138237362, language=EN, stringName=MEI Dan, firstName=MEI, middleName=null, lastName=Dan, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1197101182272455093, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, authorId=1197101182138237362, language=CN, stringName=梅丹, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1197101180749922700, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, xref=1, ext=[AuthorCompanyExt(id=1197101180754117005, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China), AuthorCompanyExt(id=1197101180762505614, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730)])])], keywords=[Keyword(id=1197101182402478518, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=EN, orderNo=1, keyword=media fill test), Keyword(id=1197101182494753207, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=EN, orderNo=2, keyword=sterile operation), Keyword(id=1197101182549279160, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=EN, orderNo=3, keyword=quality control), Keyword(id=1197101182616388025, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=EN, orderNo=4, keyword=pharmacy intravenous admixture services(PIVAS)), Keyword(id=1197101182708662714, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=CN, orderNo=1, keyword=培养基灌装试验), Keyword(id=1197101182800937403, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=CN, orderNo=2, keyword=无菌操作), Keyword(id=1197101182872240572, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=CN, orderNo=3, keyword=质量控制), Keyword(id=1197101182939349437, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=CN, orderNo=4, keyword=静脉用药集中调配中心)], refs=[Reference(id=1197101183723684290, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, doi=null, pmid=null, pmcid=null, year=2008, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=State Food and Drug Administration Center for Certification of Drug, journalName=European Union Guidelines of Good Manufacturing Practice of Medical Products(欧盟药品GMP指南), refType=null, unstructuredReference=State Food and Drug Administration Center for Certification of Drug. European Union Guidelines of Good Manufacturing Practice of Medical Products(欧盟药品GMP指南)[M]. Beijing: The Medicine Science and Technology Press of China, 2008:appendix 1:105., articleTitle=null, refAbstract=null), Reference(id=1197101183782404547, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=4, pageEnd=5, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=USP 42-NF 37(2019) Chapter 797, refType=null, unstructuredReference=USP 42-NF 37(2019) Chapter 797[S].2019 :4-5., articleTitle=null, refAbstract=null), Reference(id=1197101183841124804, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, doi=null, pmid=null, pmcid=null, year=2020, volume=18, issue=11, pageStart=40, pageEnd=44, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=ZHANG X Y, WANG L, HUANG L H, journalName=Clin Med J(临床药物治疗杂志), refType=null, unstructuredReference=ZHANG X Y, WANG L, HUANG L H, et al. Bibliometric analysis on hospital media fill test[J]. Clin Med J(临床药物治疗杂志), 2020, 18(11): 40-44., articleTitle=Bibliometric analysis on hospital media fill test, refAbstract=null), Reference(id=1197101183895650757, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, 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=Ch.P(2020)Vol Ⅳ(中国药典2020年版.四部), refType=null, unstructuredReference=Ch.P(2020)Vol Ⅳ(中国药典2020年版.四部)[S]. 2020: 156., articleTitle=null, refAbstract=null), Reference(id=1197101183954371014, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, doi=null, pmid=null, pmcid=null, year=2009, volume=66, issue=22, pageStart=2032, pageEnd=2036, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=STUCKI C, SAUTTER A, FAVET J, journalName=Am J Health Syst Pharm, refType=null, unstructuredReference=STUCKI C, SAUTTER A, FAVET J, et al. Microbial contamination of syringes during preparation:the direct influence of environmental cleanliness and risk manipulations on end-product quality[J]. Am J Health Syst Pharm, 2009, 66(22):2032-2036., articleTitle=Microbial contamination of syringes during preparation:the direct influence of environmental cleanliness and risk manipulations on end-product quality, refAbstract=null), Reference(id=1197101184055034311, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, doi=null, pmid=null, pmcid=null, year=2014, volume=59, issue=1, pageStart=1, pageEnd=8, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=GUPTA N, HOCEVAR S N, MOULTON-MEISSNER H A, journalName=Clin Infect Dis, refType=null, unstructuredReference=GUPTA N, HOCEVAR S N, MOULTON-MEISSNER H A, et al. Outbreak of serratia marcescens bloodstream infections in patients receiving parenteral nutrition prepared by a compounding pharmacy[J]. Clin Infect Dis, 2014, 59(1):1-8., articleTitle=Outbreak of serratia marcescens bloodstream infections in patients receiving parenteral nutrition prepared by a compounding pharmacy, refAbstract=null), Reference(id=1197101184109560264, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, doi=null, pmid=null, pmcid=null, year=2021, volume=21, issue=1, pageStart=235, pageEnd=242, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=GARZA-GONZÁLEZ E, BOCANEGRA-LBARIAS P, RODRÍGUEZ-NORIEGA E, journalName=BMC Infect Dis, refType=null, unstructuredReference=GARZA-GONZÁLEZ E, BOCANEGRA-LBARIAS P, RODRÍGUEZ-NORIEGA E, et al. Molecular investigation of an outbreak associated with total parenteral nutrition contaminated with NDM-producing Leclercia adecarboxylata[J]. BMC Infect Dis, 2021, 21(1): 235-242., articleTitle=Molecular investigation of an outbreak associated with total parenteral nutrition contaminated with NDM-producing Leclercia adecarboxylata, refAbstract=null), Reference(id=1197101184168280521, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, doi=null, pmid=null, pmcid=null, year=2013, volume=83, issue=2, pageStart=160, pageEnd=163, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=AUSTIN P, ELIA M, journalName=J Hosp Infect, refType=null, unstructuredReference=AUSTIN P, ELIA M. Improved aseptic technique can reduce variable contamination rates of ward-prepared parenteral doses[J]. J Hosp Infect, 2013, 83(2):160-163., articleTitle=Improved aseptic technique can reduce variable contamination rates of ward-prepared parenteral doses, refAbstract=null), Reference(id=1197101184252166602, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, doi=null, pmid=null, pmcid=null, year=2012, volume=69, issue=15, pageStart=1197, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=KASTANGO E S, journalName=Am J Health Syst Pharm, refType=null, unstructuredReference=KASTANGO E S. Challenging our aseptic skills using more-rigorous media-fill tests[J]. Am J Health Syst Pharm, 2012, 69(15):1197., articleTitle=Challenging our aseptic skills using more-rigorous media-fill tests, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1197101180749922700, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, xref=1, ext=[AuthorCompanyExt(id=1197101180754117005, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China), AuthorCompanyExt(id=1197101180762505614, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180749922700, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 中国医学科学院北京协和医学院北京协和医院, 北京 100730)]), AuthorCompany(id=1197101180821225871, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, xref=2, ext=[AuthorCompanyExt(id=1197101180833808784, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180821225871, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 Department of Pharmacology and Pharmacy,LKS Faculty of Medicine, The University of Hong Kong, Hong Kong 999077, China), AuthorCompanyExt(id=1197101180842197393, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, companyId=1197101180821225871, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 香港大学李嘉诚医学院药理及药剂学系, 中国香港 999077)])], figs=[ArticleFig(id=1197101183195201982, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=EN, label=null, caption=null, figureFileSmall=W019muOQKmIMOqJIcsrJmg==, figureFileBig=ZrOZs44eugqZHhrENORfhw==, tableContent=null), ArticleFig(id=1197101183312642495, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=CN, label=图1, caption=培养基灌装试验在不同操作环境下制备对照组第7、14天结果

A-条件A对照组第7天,右1样本浑浊;B-条件A对照组第14天,右1样本浑浊;C-条件B对照组第7天,样本无浑浊;D-条件B对照组第14天,右1样本浑浊。

, figureFileSmall=W019muOQKmIMOqJIcsrJmg==, figureFileBig=ZrOZs44eugqZHhrENORfhw==, tableContent=null), ArticleFig(id=1197101183455248832, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=EN, label=null, caption=null, figureFileSmall=Pd2hnObCy8NOasSBjI8zSw==, figureFileBig=uTFjAGkQRv08bmYN72KyjA==, tableContent=null), ArticleFig(id=1197101183530746305, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195687994960163177, language=CN, label=图2, caption=培养基灌装试验在不同操作环境下制备实验组第7、14天结果

A-条件A实验组第7天,样本无浑浊;B-条件A实验组第14天,样本无浑浊;C-条件B实验组第7天,样本无浑浊;D-条件B实验组第14天,样本无浑浊。

, figureFileSmall=Pd2hnObCy8NOasSBjI8zSw==, figureFileBig=uTFjAGkQRv08bmYN72KyjA==, tableContent=null)], attaches=null, journal=Journal(id=1190317596361715715, delFlag=0, nameCn=中国药学杂志, nameEn=Chinese Pharmaceutical Journal, nameHistory1=null, nameHistory2=null, issn=1001-2494, eissn=null, cn=11-2162/R, coden=null, 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=hRN1R6HnoNwYkve/JRn0DA==, journalPrice=null, startedYear=null, abbrevIsoEn=null, journalRemark=null, publicationField=null, createdTime=1761723430007, updatedTime=1761735858241, createdBy=18614031015, updatedBy=13701087609, firstLetterCn=C, firstLetterEn=C, subjectCode=Life Sciences, subjectName=Life Sciences, subjectCodeEn=Life Sciences, subjectNameEn=null, picCn=hRN1R6HnoNwYkve/JRn0DA==, picEn=xSRntM4yOh2wVIE2w+OjYg==, jcr=null, cjcr=null, exts=[JournalExt(id=1190369724262355196, language=CN, name=中国药学杂志, 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=1761735858264, updatedTime=1761735858264, createdBy=13701087609, updatedBy=13701087609, submissionGuidelinesUrl=, submissionAuthorUrl=https://zgyxzzauthor.manuscriptcloud.com/login, submissionEditorUrl=https://zgyxzzeditor.manuscriptcloud.com/login, submissionReviewUrl=https://zgyxzzauthor.manuscriptcloud.com/login, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""}), JournalExt(id=1190369724358824189, language=EN, name=Chinese Pharmaceutical Journal, 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=1761735858287, updatedTime=1761735858287, createdBy=13701087609, updatedBy=13701087609, submissionGuidelinesUrl=, submissionAuthorUrl=https://zgyxzzauthor.manuscriptcloud.com/login, submissionEditorUrl=https://zgyxzzeditor.manuscriptcloud.com/login, submissionReviewUrl=https://zgyxzzauthor.manuscriptcloud.com/login, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""})], databaseList=null, tenantJournalId=1190317699101192196, websiteList=[Website(id=1190317834875011552, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1190317699101192196, 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/zgyxzz/CN, language=CN, createTime=1761723486870, createBy=18614031015, updateTime=1761723510130, updateBy=18614031015, name=中国药学杂志-中文, tplId=1146099689490845704, title=中国药学杂志, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1190318144041353703, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834875011552, code=articleTextType, value=kx, createTime=1761723560581, updateTime=1761723560581, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318144016187876, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834875011552, code=banner, value=null, createTime=1761723560575, updateTime=1761723560575, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318144062325226, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834875011552, code=grayFlag, value=0, createTime=1761723560586, updateTime=1761723560586, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318144007799267, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834875011552, code=logo, value=https://castjournals.cast.org.cn/joweb/zgyxzz/CN/file/pic?fileId=puyAm9wIHqZks7K8hj8APQ==, createTime=1761723560573, updateTime=1761723560573, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318144074908140, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834875011552, code=minRunFlag, value=0, createTime=1761723560589, updateTime=1761723560589, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318144032965094, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834875011552, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zgyxzz/CN/file/pic, createTime=1761723560579, updateTime=1761723560579, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318144070713835, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834875011552, code=silenceFlag, value=0, createTime=1761723560588, updateTime=1761723560588, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318144024576485, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834875011552, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1761723560577, updateTime=1761723560577, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318144049742312, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834875011552, code=themeColor, value=null, createTime=1761723560583, updateTime=1761723560583, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318144053936617, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834875011552, code=themeStyle, value=null, createTime=1761723560584, updateTime=1761723560584, creator=18614031015, updator=18614031015)]), Website(id=1190317834937926113, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1190317699101192196, 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/zgyxzz/EN, language=EN, createTime=1761723486885, createBy=18614031015, updateTime=1761723527689, updateBy=18614031015, name=中国药学杂志-英文, tplId=1146101810881728533, title=Chinese Pharmaceutical Journal, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1190318170478051825, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834937926113, code=articleTextType, value=kx, createTime=1761723566884, updateTime=1761723566884, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318170461274606, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834937926113, code=banner, value=null, createTime=1761723566880, updateTime=1761723566880, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318170494829044, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834937926113, code=grayFlag, value=0, createTime=1761723566888, updateTime=1761723566888, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318170452885997, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834937926113, code=logo, value=https://castjournals.cast.org.cn/joweb/zgyxzz/EN/file/pic?fileId=puyAm9wIHqZks7K8hj8APQ==, createTime=1761723566878, updateTime=1761723566878, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318170507411958, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834937926113, code=minRunFlag, value=0, createTime=1761723566891, updateTime=1761723566891, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318170473857520, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834937926113, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zgyxzz/EN/file/pic, createTime=1761723566883, updateTime=1761723566883, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318170503217653, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834937926113, code=silenceFlag, value=0, createTime=1761723566890, updateTime=1761723566890, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318170465468911, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834937926113, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1761723566881, updateTime=1761723566881, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318170482246130, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834937926113, code=themeColor, value=null, createTime=1761723566885, updateTime=1761723566885, creator=18614031015, updator=18614031015), WebsiteProps(id=1190318170486440435, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1190317834937926113, code=themeStyle, value=null, createTime=1761723566886, updateTime=1761723566886, creator=18614031015, updator=18614031015)])], journalTitle=中国药学杂志, weixinUrl=null, journalUrl=http://www.zgyxzz.com.cn/, iacademicId=null, status=1, seqNo=null, journalTitleEn=Chinese Pharmaceutical Journal, journalPhotoCn=hRN1R6HnoNwYkve/JRn0DA==, journalPhotoEn=xSRntM4yOh2wVIE2w+OjYg==, journalFirstLetter=C, 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), detailUrlCn=https://castjournals.cast.org.cn/joweb/zgyxzz/CN/10.11669/cpj.2024.03.013, detailUrlEn=https://castjournals.cast.org.cn/joweb/zgyxzz/EN/10.11669/cpj.2024.03.013, pdfUrlCn=https://castjournals.cast.org.cn/joweb/zgyxzz/CN/PDF/10.11669/cpj.2024.03.013, pdfUrlEn=https://castjournals.cast.org.cn/joweb/zgyxzz/EN/PDF/10.11669/cpj.2024.03.013, aliStartDate=null, aliEndDate=null, collectionFlag=false, citedCount=null, citedUrl=null, reference=null)
收藏切换
培养基灌装试验在静脉用药集中调配中心的应用及实践探索
收藏切换
PDF下载
张凡 1 , 陆泊宇 1 , 白雪 1 , 邹羽真 1 , 张鑫悦 2 , 赵彬 1, * , 梅丹 1
中国药学杂志 | 论著 2024,59(3): 281-284
收起
收藏切换
中国药学杂志 | 论著 2024, 59(3): 281-284
培养基灌装试验在静脉用药集中调配中心的应用及实践探索
全屏
张凡1, 陆泊宇1, 白雪1, 邹羽真1, 张鑫悦2, 赵彬1, *, 梅丹1
作者信息
  • 1 中国医学科学院北京协和医学院北京协和医院, 北京 100730
  • 2 香港大学李嘉诚医学院药理及药剂学系, 中国香港 999077

    • 张凡,女,主管药师 研究方向:医院药学和营养支持

通讯作者:

*赵彬,男,副主任药师 研究方向:医院药学和营养支持 Tel:(010)69156513
Application and Practical Exploration of Media Fill Test in Pharmacy Intravenous Admixture Services
ZHANG Fan1, LU Boyu1, BAI Xue1, ZOU Yuzhen1, ZHANG Xinyue2, ZHAO Bin1, *, MEI Dan1
Affiliations
  • 1 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
  • 2 Department of Pharmacology and Pharmacy,LKS Faculty of Medicine, The University of Hong Kong, Hong Kong 999077, China
出版时间: 2024-02-08 doi: 10.11669/cpj.2024.03.013
文章导航
收藏切换
摘要
收起

目的 针对静脉用药集中调配的无菌操作,我国当前缺少行之有效的人员验证措施,亟需探索无菌操作评估方法。方法 使用美国静脉质量保障(intravenous quality assurance,IVQA)培养基灌装试验套件对我院混合调配人员进行无菌操作验证,初步探索培养基灌装试验在国内静脉用药集中调配中心应用的可行性。结果 培养基灌装试验操作简便,无需苛刻培养条件与检测设备,在2种不同混合调配条件下试验结果不同,可验证人员操作。结论 培养基灌装试验适用于无菌调配操作的人员质控。

培养基灌装试验  /  无菌操作  /  质量控制  /  静脉用药集中调配中心

OBJECTIVE To explore an evaluation method of sterile operation in pharmacy intravenous admixture services(PIVAS). OBJECTIVE The US intravenous quality assurance(IVQA) media fill test kit was used to verify the aseptic operation of the mixed dispensing personnel in our hospital, and the feasibility of applying the media fill test in the PIVAS was preliminarily explored. RESULTS The media fill test was easy to operate without harsh culture conditions and testing equipment. The test results were different under two different mixing conditions, which can verify the operation of personnel. CONCLUSION The media fill test is applicable to the quality control of personnel in sterile dispensing operations.

media fill test  /  sterile operation  /  quality control  /  pharmacy intravenous admixture services(PIVAS)
张凡, 陆泊宇, 白雪, 邹羽真, 张鑫悦, 赵彬, 梅丹. 培养基灌装试验在静脉用药集中调配中心的应用及实践探索. 中国药学杂志, 2024 , 59 (3) : 281 -284 . DOI: 10.11669/cpj.2024.03.013
ZHANG Fan, LU Boyu, BAI Xue, ZOU Yuzhen, ZHANG Xinyue, ZHAO Bin, MEI Dan. Application and Practical Exploration of Media Fill Test in Pharmacy Intravenous Admixture Services[J]. Chinese Pharmaceutical Journal, 2024 , 59 (3) : 281 -284 . DOI: 10.11669/cpj.2024.03.013
正文
收起
我国静脉用药集中调配中心(pharmacy intravenous admixture service,PIVAS)承担静脉药物在院内的混合调配工作,调配过程中存在引入微生物污染的风险,从而引发患者用药安全事件。调配人员是否具备无菌操作能力以及无菌操作的准确性是控制成品输液污染的关键。然而,我国目前对于医疗机构内药物混合调配工作人员全流程操作技能的无菌验证尚无官方要求或指南建议,也缺乏行之有效的验证方法。
培养基灌装试验(media fill test,MFT),又称无菌工艺模拟(aseptic process simulation,APS),是一种评价整体无菌工艺流程有效性与可靠性的验证方法,根据工艺阶段可能引入的微生物污染选用适宜培养基,通过模拟常规无菌生产工艺、样本培养、污染情况观察,验证人员、环境、物料、流程等全要素是否满足无菌要求[1],广泛用于药品生产领域。原国家卫生部2010年发布的《药品生产质量管理规范》(Good Manufacturing Practice of Medical Products,GMP)要求药品生产企业在流程首次验证以及空气净化系统、设备、生产工艺及人员产生重大变更后均需要进行MFT,以零污染为目标,每半年需重复验证。此外,MFT还可用于医院领域。《美国药典》第797章(无菌药品)建议院内承担无菌药品(coumpounded sterile preparations, CSPs)调配的工作人员在上岗前应经过适当培训并通过培养基灌装试验进行无菌操作技能评估,意大利、法国、德国、瑞士均有相关文献发表[2-3]。这些方法尽可能模拟了日常无菌生产工艺中较为复杂的操作,文件记录应包括:被评估人姓名、评估日期/时间、培养基生产企业生产批号与有效期、培养日期、判定结果、检测人员、核对人员。
实施培养基灌装试验可使用培养基、密封容器等自行开展,也可直接购买试验套件。使用商业无菌微生物生长培养基应在确保有效期的前提下验证该批次培养基的促微生物生长能力。如可选用胰酪大豆胨液体培养基(TSB),适合真菌和需氧菌的培养[4]。本研究以IVQA培养基灌装试验套件为例,探索该方法在静脉用药集中调配中心对调配人员的无菌操作技能进行验证。
1 材料与方法
收起
1.1 材料
美国IVQA高危型培养基灌装试验套件(Media Fill Test Kit),批次#170906、#190103,各1套。试验套件包括100 mL非无菌容器(含3 g培养基)1个和10 mL无菌西林瓶9个。
自备材料:灭菌注射用水(华仁药业股份有限公司,规格500 mL/袋)、一次性使用无菌注射器(上海康德莱企业发展集团股份有限公司,规格30 mL 带针)、Acrodsc® Syringe Fiter一次性针头式滤器(Pall Corporation,型号25 mm w/0.2 μm)、一次性使用无菌注射针(Becton Dickinson Medical,型号Needle 18G 1 1/2)、医用输液瓶口贴(江阴汇诚医疗科技有限公司,规格28×16)。
1.2 方法
由我院PIVAS 1名经验丰富的混合调配人员,在两种无菌条件下(条件A和条件B),按试验套件说明实施培养基灌装试验,并观测两组结果差异。条件A使用#190103批次,在非无菌条件下制备非无菌培养基溶液和对照组样本;条件B使用#170906批次,在ISO Class5级条件下制备非无菌培养基溶液和对照组样本。
1.2.1 实验步骤
①制备非无菌培养基溶液:条件A在非无菌环境中操作、条件B在ISO5级洁净环境中操作。将100 mL灭菌注射用水加入含3 g培养基的非无菌容器内,制成0.03 kg·L-1的非无菌培养基溶液。
②制备对照组样本:条件A在非无菌环境中操作、条件B在ISO Class5级洁净环境中操作。抽取25 mL培养基溶液并转移5 mL至无菌西林瓶中,重复上述操作2次。条件A、B各得到3份阳性对照组样本(如被微生物污染则培养时可见浑浊)。
③制备实验组样本:条件A和条件B均在ISO5级洁净环境中操作,严格使用无菌技术。为无菌注射器安装针头式过滤器并更换无菌注射针,向2个无菌西林瓶中各转移10 mL培养基溶液,并在西林瓶顶部加封瓶口贴,重复上述操2次。条件A、B各得到6份试验组样本。
④样本培养:将18份样本放置于25~37 ℃条件,培养14 d。
1.2.2 结果判定
在培养第7天和第14天,由2名药师裸眼观察样本浑浊情况以判断是否有微生物生长。如2人判断结果不同,则请上级药师协助判断,并记录结果。
对照组样本发生浑浊,证明3%浓度TSB培养基具备支持细菌生长的能力,阳性对照有效,否则试验失败。实验组样本发生浑浊,证明混合调配人员在操作过程中引入细菌污染,无菌操作考核失败;试验组样本全部为阴性,证明该混合调配人员本次无菌操作考核合格。
2 结果
收起
2.1 对照组微生物污染情况
非无菌环境中制备的对照组样本(条件A)在第7天出现1例浑浊(图1),无菌环境中制备的对照组样本(条件B)在第14天出现1例浑浊,证实培养基在2种环境下操作均具备促微生物生长能力,阳性对照有效。
2.2 实验组微生物污染情况
2种条件下实验组样本全部均未出现浑浊,表明该调配人员的无菌操作符合标准要求,见图2。
3 讨论
收起
3.1 培养基灌装试验在PIVAS应用的必要性
市售药品剂型通常无法满足所有患者的用药需求,需要改变药品性状或药物浓度实现个体化药物调配。静脉用药集中调配应在无菌环境中使用无菌操作(又称无菌技术,aseptic technique)进行混合调配,这一过程称为无菌调配(sterile compounding),是一项具有技术含量与价值的服务。我国成立静脉用药集中调配中心的医疗机构已接近2 000家,通常承担危害药品与肠外营养液的混合调配,选择性承担电解质输液和抗菌药物类输液的混合调配。对静脉输液实行集中调配与供应,更有利于提高患者用药安全,有文献表明在不同环境下调配无菌药品,手术室操作污染率约6%、病房开放式操作污染率约16%,而在ISO Class7级洁净室内ISO Class5级层流洁净台进行调剂操作的污染率为零[5]。
与药品生产过程相比,静脉用药集中调配流程只能依靠质量保证(quality assurance)规范混合调配流程,缺乏质量控制检测,成品输液缺少临床安全性或有效性评估,也缺乏人员无菌操作验证。无菌调配污染导致用药安全不良事件的案例曾多次发生,如2011年美国阿拉巴马州6家医院因调配的肠外营养液污染导致19名患者感染黏质沙雷菌,最终9人死亡;2021年墨西哥3家医院因使用受污染肠外营养液致25名患者感染碳青霉烯类耐药的非脱羧勒克菌[6-7]。
调配人员是否具备无菌操作能力以及无菌操作的准确性是影响成品制剂污染的关键步骤。在洁净环境中,操作人员是否经过培训、调配经验是否丰富都会影响成品质量,无菌注射器的操作是最易发生污染的环节,例如接触未灭菌物品或不戴手套操作注射器等[5,8]。对于承担无菌药品调配的工作人员来说,无菌操作是核心能力,熟练具备规范的无菌操作技能是底线要求。本研究表明,培养基灌装试验可有效验证人员无菌操作的规范性与操作流程的可靠性,作为医院药学质量控制环节,评估员工是否具备无菌工作实践的能力与工作胜任力。
3.2 培养基灌装试验在医院药学领域应用的可行性
培养基灌装试验用于无菌调配技能验证的可行性考虑有以下几点:①相对于无菌药品生产,医疗机构内药物混合调配属于药品调剂流程,不需要预处理原料辅料、调剂流程简单、无菌操作步骤少、单药调剂用时短,不需要考虑物料剂型、灭菌工艺、干预措施设计等诸多事项,因此培养基灌装试验的流程设计相对简洁,操作简便;②IVQA试验套件单价为63美元且国内较难获得,后期可参考试验套件的流程设计,单独购买TSB培养基与密封容器等自行开展可极大降低成本,或可寻找国内替代产品;③样本培养条件为25~37℃,通常PIVAS室温即可满足,不需要苛刻的培养条件;④观测方法为目测,不需要特殊检测设备。PIVAS常规工作条件即可满足培养基灌装试验的完成要求,整体执行成本较低。
3.3 培养基灌装试验的局限性与进一步探索方向
MFT是目前PIVS对人员无菌操作的验证最佳的方式,通过本次对试验流程的摸索,一些细节问题仍有待进一步完善与验证。首先,对照组样本浑浊作为判定培养基具备促微生物生长能力的依据,但其浑浊程度及无菌操作缺陷没有明确等级划分,也有研究人员对该测试的敏感性表示担忧[9];其次,样本阳性的判定仅靠裸眼判断缺乏精确标准,本研究采用2位药师判断加第三位药师仲裁的方法,以减少判断差异;再次,如实验组样本出现阳性则调配人员未通过考核,仅证实流程中出现不规范操作,但无法明确疏漏出现在哪个步骤,仍需要人工判断,如分析调配过程的监控视频;最后,调配人员通过本次无菌操作考核只能证明该员工在该时间点具备参与调配无菌药品的能力,考核应定期举行并通过其他途径完善质量保证流程。
4 结论
收起
综上所述,培养基灌装试验是已成熟用于药品生产领域的有效方法,是GMP要求强制进行的项目之一,具备可靠性,但用于医院内药物调配无菌操作验证在我国还未得到推广。该方法操作简便,结果观测便捷,无需苛刻培养条件与检测设备,适用于PIVAS员工无菌调配标准化评价与人员质控,也可作为治疗室、床旁等护理环节无菌操作验证的手段之一。
文献
收起
参考文献 引证文献
排序方式：
[1]
State Food and Drug Administration Center for Certification of Drug. European Union Guidelines of Good Manufacturing Practice of Medical Products(欧盟药品GMP指南)[M]. Beijing: The Medicine Science and Technology Press of China, 2008:appendix 1:105.
[2]
USP 42-NF 37(2019) Chapter 797[S].2019 :4-5.
[3]
ZHANG X Y, WANG L, HUANG L H, et al. Bibliometric analysis on hospital media fill test[J]. Clin Med J(临床药物治疗杂志), 2020, 18(11): 40-44.
[4]
Ch.P(2020)Vol Ⅳ(中国药典2020年版.四部)[S]. 2020: 156.
[5]
STUCKI C, SAUTTER A, FAVET J, et al. Microbial contamination of syringes during preparation:the direct influence of environmental cleanliness and risk manipulations on end-product quality[J]. Am J Health Syst Pharm, 2009, 66(22):2032-2036.
[6]
GUPTA N, HOCEVAR S N, MOULTON-MEISSNER H A, et al. Outbreak of serratia marcescens bloodstream infections in patients receiving parenteral nutrition prepared by a compounding pharmacy[J]. Clin Infect Dis, 2014, 59(1):1-8.
[7]
GARZA-GONZÁLEZ E, BOCANEGRA-LBARIAS P, RODRÍGUEZ-NORIEGA E, et al. Molecular investigation of an outbreak associated with total parenteral nutrition contaminated with NDM-producing Leclercia adecarboxylata[J]. BMC Infect Dis, 2021, 21(1): 235-242.
[8]
AUSTIN P, ELIA M. Improved aseptic technique can reduce variable contamination rates of ward-prepared parenteral doses[J]. J Hosp Infect, 2013, 83(2):160-163.
[9]
KASTANGO E S. Challenging our aseptic skills using more-rigorous media-fill tests[J]. Am J Health Syst Pharm, 2012, 69(15):1197.
2024年第59卷第3期
PDF下载
171
80
引用本文
BibTeX
文章信息
doi: 10.11669/cpj.2024.03.013
  • 接收时间：2022-07-20
  • 首发时间：2025-11-13
  • 出版时间：2024-02-08
补充材料
相关文章
文章信息
作者
出版历史
  • 收稿日期：2022-07-20
基金
作者信息
    1 中国医学科学院北京协和医学院北京协和医院, 北京 100730
    2 香港大学李嘉诚医学院药理及药剂学系, 中国香港 999077

通讯作者:

*赵彬,男,副主任药师 研究方向:医院药学和营养支持 Tel:(010)69156513
参考文献
分享链接
https://castjournals.cast.org.cn/joweb/zgyxzz/CN/10.11669/cpj.2024.03.013
分享至
全文二维码

扫描看全文

引用本文
BibTeX
本文的引用情况
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
关闭全屏
相关链接
论文
最新文章
热读文章
热点专题
内参
蓝皮书
产业发展报告
传播力报告
期刊分级目录
资讯
学术新闻
行业新闻
学术会议
行业会议
关于
关于我们
联系我们
北京市海淀区学院南路86号
100081
010-62199257
qkjq@cast.org.cn

中国科学技术协会版权所有 京ICP 备10216604号-4 海淀分局备案 1101084647
科技导报社主办 中国科协信息中心技术支持