Article(id=1292135543022834235, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.10.007, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1761753600000, receivedDateStr=2025-10-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998720174, onlineDateStr=2026-08-06, pubDate=1779897600000, pubDateStr=2026-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998720174, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998720174, creator=13701087609, updateTime=1785998720174, updator=13701087609, issue=Issue{id=1292135425250976333, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='10', pageStart='1351', pageEnd='1500', issueExtLink='null', onlineDate='null', pubDate='1779897600000', pubDateStr='2026-05-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998692095, creator='13701087609', updateTime=1786014373634, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201198489202995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201198489202996, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1391, endPage=1396, ext={EN=ArticleExt(id=1292135543463236156, articleId=1292135543022834235, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Determination of cyclosporine A concentration in human whole blood by liquid chromatography tandem mass spectrometry and its clinical application, columnId=1246531413395263850, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Research Method, runingTitle=null, highlight=null, articleAbstract=
Objective

To establish a high-efficiency and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the quantitative analysis of cyclosporine A in human whole blood.

Methods

Protein precipitation with methanol was employed for sample pretreatment, and cyclosporine A-d4 was used as the internal standard. Chromatographic separation was performed on a Kinetex C18 column (3.0 mm×50.0 mm, 2.6 μm, 100 Å) with a mobile phase consisting of 0.1% formic acid in water (phase A) and 0.1% formic acid in methanol (phase B) at a flow rate of 0.55 mL·min-1. The column temperature was maintained at 40 ℃. Quantitative detection was carried out using electrospray ionization in positive ion mode and multiple reaction monitoring (MRM). The method was validated for specificity, calibration curve and lower limit of quantitation (LLOQ), accuracy and precision, matrix effect, and sample stability.

Results

The retention time of cyclosporine A was 1.19 min, with a total run time of 2.0 min per sample. A good linear relationship was observed in the concentration range of 10-1 000 ng·mL-1 (r=0.998 5), and the LLOQ was 10.0 ng·mL-1. The recovery rates ranged from 99.53% to 102.83%, with intra-batch precision ≤3.58% and inter-batch precision ≤3.24%. The sample stability was satisfactory, and the matrix effect was negligible.

Conclusion

The established method features short analysis time, high sensitivity, and low sample volume requirement, making it suitable for therapeutic drug monitoring and accurate quantification of cyclosporine A in human whole blood samples.

, authors=Yu ZHANG, Ya-xin CAO, Yu-xuan CHEN, Wei YANG, authorsList=Yu ZHANG, Ya-xin CAO, Yu-xuan CHEN, Wei YANG, authorCompany=null, correspAuthors=Wei YANG, 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=1292135543916220989, articleId=1292135543022834235, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=液相色谱-串联质谱法测定人全血中环孢霉素A的浓度及临床应用, columnId=1246531413600784769, journalTitle=中国临床药理学杂志, columnName=研究方法, runingTitle=null, highlight=null, articleAbstract=
目的

建立一种高效、灵敏的液相色谱-串联质谱(LC-MS/MS)法用于人全血中环孢霉素A的定量分析。

方法

实验采用甲醇沉淀蛋白的前处理方法,以环孢霉素A-d4为内标,色谱柱为Kinetex C18(3.0 mm×50.0 mm,2.6 μm,100 Å),流动相为0.1%甲酸水溶液(A)-0.1%甲酸甲醇溶液(B);流速为0.55 mL·min-1;柱温为40 ℃。采用电喷雾正离子和多反应监测(MRM)模式进行定量检测。考察该方法的专属性、标准曲线与定量下限、准确度与精密度、基质效应和样本稳定性。

结果

环孢霉素A的保留时间为1.19 min,单个样品分析时间为2.0 min。在10~1 000 ng·mL-1范围内呈现良好线性(r=0.998 5),定量下限为10.0 ng·mL-1。方法回收率为99.53%~102.83%,批内精密度≤3.58%,批间精密度≤3.24%,样本稳定性良好,基质效应可以忽略。

结论

该方法分析时间短,灵敏度较高,全血用量少,适用于全血标本中的环孢霉素A血药浓度监测及准确测定。

, authors=张瑜, 曹雅欣, 陈雨萱, 杨葳, authorsList=张瑜, 曹雅欣, 陈雨萱, 杨葳, authorCompany=null, correspAuthors=杨葳, authorNote=

张瑜(1996-),女,助理工程师,主要从事体外诊断试剂的相关研究

, correspAuthorsNote=
杨葳,高级工程师 MP: 15222288408 E-mail:
, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=JebqpXYW7eEttm/zaC/59A==, magXml=m36f0rTMl7szWGzuDEGNyQ==, pdfUrl=null, pdf=Yoe6KCVGqZvT4zYOVd8lDQ==, pdfFileSize=1920750, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=PsduIfO9VNEKWoEwnhS6yw==, mapNumber=null, fund=null)}, authors=[Author(id=1292135544402760258, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, 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=1292135544474063428, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544402760258, language=EN, stringName=Yu ZHANG, firstName=Yu, middleName=null, lastName=ZHANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135544646029893, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544402760258, language=CN, stringName=张瑜, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=天津市医疗器械审评查验中心,天津 300191, bio={"content":"

张瑜(1996-),女,助理工程师,主要从事体外诊断试剂的相关研究

"}, bioImg=null, bioContent=

张瑜(1996-),女,助理工程师,主要从事体外诊断试剂的相关研究

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135544302096958, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, xref=null, ext=[AuthorCompanyExt(id=1292135544310485567, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China), AuthorCompanyExt(id=1292135544318874176, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=天津市医疗器械审评查验中心,天津 300191)])]), Author(id=1292135544708944455, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, 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=1292135544776053321, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544708944455, language=EN, stringName=Ya-xin CAO, firstName=Ya-xin, middleName=null, lastName=CAO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135544859939402, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544708944455, language=CN, stringName=曹雅欣, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=天津市医疗器械审评查验中心,天津 300191, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135544302096958, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, xref=null, ext=[AuthorCompanyExt(id=1292135544310485567, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China), AuthorCompanyExt(id=1292135544318874176, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=天津市医疗器械审评查验中心,天津 300191)])]), Author(id=1292135544922853964, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, 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=1292135545069654606, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544922853964, language=EN, stringName=Yu-xuan CHEN, firstName=Yu-xuan, middleName=null, lastName=CHEN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135546718016079, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544922853964, language=CN, stringName=陈雨萱, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=天津市医疗器械审评查验中心,天津 300191, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135544302096958, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, xref=null, ext=[AuthorCompanyExt(id=1292135544310485567, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China), AuthorCompanyExt(id=1292135544318874176, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=天津市医疗器械审评查验中心,天津 300191)])]), Author(id=1292135546822873681, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=aiyu11@126.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1292135546906759763, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135546822873681, language=EN, stringName=Wei YANG, firstName=Wei, middleName=null, lastName=YANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135546969674324, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135546822873681, language=CN, stringName=杨葳, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=天津市医疗器械审评查验中心,天津 300191, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135544302096958, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, xref=null, ext=[AuthorCompanyExt(id=1292135544310485567, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China), AuthorCompanyExt(id=1292135544318874176, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=天津市医疗器械审评查验中心,天津 300191)])])], keywords=[Keyword(id=1292135547099697749, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, language=EN, orderNo=1, keyword=cyclosporine A), Keyword(id=1292135547179389526, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, language=EN, orderNo=2, keyword=liquid chromatography tandem mass spectrometry), Keyword(id=1292135547246498391, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, language=EN, orderNo=3, keyword=blood concentration monitoring), Keyword(id=1292135547301024344, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, language=CN, orderNo=1, keyword=环孢霉素A), Keyword(id=1292135547376521817, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, language=CN, orderNo=2, keyword=液相色谱串联质谱), Keyword(id=1292135547447824986, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, language=CN, orderNo=3, keyword=血液浓度监测)], refs=null, funds=null, companyList=[AuthorCompany(id=1292135544302096958, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, xref=null, ext=[AuthorCompanyExt(id=1292135544310485567, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China), AuthorCompanyExt(id=1292135544318874176, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=天津市医疗器械审评查验中心,天津 300191)])], figs=null, attaches=null, journal=Journal(id=1246415058658443328, delFlag=0, nameCn=中国临床药理学杂志, nameEn=Chinese Journal of Clinical Pharmacology, nameHistory1=null, nameHistory2=null, issn=1001-6821, eissn=null, cn=11-2220/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=8cEfS7jvj/ukyhKVOMJePA==, journalPrice=null, startedYear=null, abbrevIsoEn=Chinese Journal of Clinical Pharmacology, journalRemark=null, publicationField=null, createdTime=1775098107259, updatedTime=1788948995538, createdBy=18614031015, updatedBy=13041195026, firstLetterCn=Z, firstLetterEn=Z, subjectCode=Medical and Pharmaceutical Sciences, subjectName=null, subjectCodeEn=Medical and Pharmaceutical Sciences, subjectNameEn=null, picCn=8cEfS7jvj/ukyhKVOMJePA==, picEn=cQ12tu98gbNetbFuefeYGg==, jcr=null, cjcr=null, exts=[JournalExt(id=1304509895005466898, language=CN, name=中国临床药理学杂志, 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=1788948995591, updatedTime=1788948995591, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=https://lcylauthor.cast.org.cn/webm, submissionEditorUrl=https://lcyleditor.cast.org.cn/webm, submissionReviewUrl=https://lcylauthor.cast.org.cn/webm, submissionCeEditorUrl=https://lcyleditor.cast.org.cn/webm, submissionAeEditorUrl=https://lcyleditor.cast.org.cn/webm, option={"copyright":""}), JournalExt(id=1304509895047409939, language=EN, name=Chinese Journal of Clinical Pharmacology, 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=1788948995601, updatedTime=1788948995601, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=https://lcylauthor.cast.org.cn/webm, submissionEditorUrl=https://lcyleditor.cast.org.cn/webm, submissionReviewUrl=https://lcylauthor.cast.org.cn/webm, submissionCeEditorUrl=https://lcyleditor.cast.org.cn/webm, submissionAeEditorUrl=https://lcyleditor.cast.org.cn/webm, option={"copyright":""})], databaseList=null, tenantJournalId=1246415772164075586, websiteList=[Website(id=1246421196657546140, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1246415772164075586, 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/zglcylxzz/CN, language=CN, createTime=1775099570670, createBy=18614031015, updateTime=1775099747371, updateBy=18614031015, name=中国临床药理学杂志-中文, tplId=1146099689490845704, title=中国临床药理学杂志, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1246422027293316008, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=articleTextType, value=kx, createTime=1775099768708, updateTime=1775099768708, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027268150181, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=banner, value=null, createTime=1775099768702, updateTime=1775099768702, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027310093227, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=grayFlag, value=0, createTime=1775099768712, updateTime=1775099768712, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027259761572, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=logo, value=https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/file/pic?fileId=KeUk4pyVjfIIkOq40uZX0Q==, createTime=1775099768700, updateTime=1775099768700, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027322676141, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=minRunFlag, value=0, createTime=1775099768715, updateTime=1775099768715, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027284927399, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/file/pic, createTime=1775099768706, updateTime=1775099768706, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027318481836, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=silenceFlag, value=0, createTime=1775099768714, updateTime=1775099768714, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027276538790, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1775099768704, updateTime=1775099768704, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027297510313, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=themeColor, value=null, createTime=1775099768709, updateTime=1775099768709, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027305898922, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=themeStyle, value=null, createTime=1775099768711, updateTime=1775099768711, creator=18614031015, updator=18614031015)]), Website(id=1246421196871455649, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1246415772164075586, 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/zglcylxzz/EN, language=EN, createTime=1775099570720, createBy=18614031015, updateTime=1775099757298, updateBy=18614031015, name=中国临床药理学杂志-英文, tplId=1146101810881728533, title=Chinese Journal of Clinical Pharmacology, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1246422058998059954, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=articleTextType, value=kx, createTime=1775099776267, updateTime=1775099776267, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422058977088431, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=banner, value=null, createTime=1775099776262, updateTime=1775099776262, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422059014837173, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=grayFlag, value=0, createTime=1775099776271, updateTime=1775099776271, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422058968699822, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=logo, value=https://castjournals.cast.org.cn/joweb/zglcylxzz/EN/file/pic?fileId=KeUk4pyVjfIIkOq40uZX0Q==, createTime=1775099776260, updateTime=1775099776260, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422059031614391, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=minRunFlag, value=0, createTime=1775099776275, updateTime=1775099776275, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422058993865649, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zglcylxzz/EN/file/pic, createTime=1775099776266, updateTime=1775099776266, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422059023225782, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=silenceFlag, value=0, createTime=1775099776273, updateTime=1775099776273, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422058985477040, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1775099776264, updateTime=1775099776264, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422059002254259, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=themeColor, value=null, createTime=1775099776268, updateTime=1775099776268, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422059010642868, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=themeStyle, value=null, createTime=1775099776270, updateTime=1775099776270, creator=18614031015, updator=18614031015)])], journalTitle=中国临床药理学杂志, weixinUrl=null, journalUrl=null, iacademicId=null, status=1, seqNo=null, journalTitleEn=Chinese Journal of Clinical Pharmacology, journalPhotoCn=8cEfS7jvj/ukyhKVOMJePA==, journalPhotoEn=cQ12tu98gbNetbFuefeYGg==, 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/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.10.007, detailUrlEn=https://castjournals.cast.org.cn/joweb/zglcylxzz/EN/10.13699/j.cnki.1001-6821.2026.10.007, pdfUrlCn=https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/PDF/10.13699/j.cnki.1001-6821.2026.10.007, pdfUrlEn=https://castjournals.cast.org.cn/joweb/zglcylxzz/EN/PDF/10.13699/j.cnki.1001-6821.2026.10.007, aliStartDate=0, aliEndDate=0, collectionFlag=false, citedCount=null, citedUrl=null, previewStatus=0, delFlag=0, hasFullText=0, orderTime=1779897600000, fullTextJson=null, articleText=null, reference=null)
收藏切换
液相色谱-串联质谱法测定人全血中环孢霉素A的浓度及临床应用
收藏切换
PDF下载
张瑜 , 曹雅欣 , 陈雨萱 , 杨葳
中国临床药理学杂志 | 研究方法 2026,42(10): 1391-1396
收起
收藏切换
中国临床药理学杂志 |研究方法 2026 , 42 (10) : 1391 -1396
液相色谱-串联质谱法测定人全血中环孢霉素A的浓度及临床应用
全屏
[Author(id=1292135544402760258, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, 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=1292135544474063428, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544402760258, language=EN, stringName=Yu ZHANG, firstName=Yu, middleName=null, lastName=ZHANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135544646029893, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544402760258, language=CN, stringName=张瑜, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=天津市医疗器械审评查验中心,天津 300191, bio={"content":"

张瑜(1996-),女,助理工程师,主要从事体外诊断试剂的相关研究

"}, bioImg=null, bioContent=

张瑜(1996-),女,助理工程师,主要从事体外诊断试剂的相关研究

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135544302096958, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, xref=null, ext=[AuthorCompanyExt(id=1292135544310485567, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China), AuthorCompanyExt(id=1292135544318874176, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=天津市医疗器械审评查验中心,天津 300191)])]), Author(id=1292135544708944455, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, 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=1292135544776053321, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544708944455, language=EN, stringName=Ya-xin CAO, firstName=Ya-xin, middleName=null, lastName=CAO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135544859939402, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544708944455, language=CN, stringName=曹雅欣, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=天津市医疗器械审评查验中心,天津 300191, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135544302096958, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, xref=null, ext=[AuthorCompanyExt(id=1292135544310485567, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China), AuthorCompanyExt(id=1292135544318874176, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=天津市医疗器械审评查验中心,天津 300191)])]), Author(id=1292135544922853964, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, 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=1292135545069654606, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544922853964, language=EN, stringName=Yu-xuan CHEN, firstName=Yu-xuan, middleName=null, lastName=CHEN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135546718016079, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135544922853964, language=CN, stringName=陈雨萱, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=天津市医疗器械审评查验中心,天津 300191, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135544302096958, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, xref=null, ext=[AuthorCompanyExt(id=1292135544310485567, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China), AuthorCompanyExt(id=1292135544318874176, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=天津市医疗器械审评查验中心,天津 300191)])]), Author(id=1292135546822873681, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=aiyu11@126.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1292135546906759763, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135546822873681, language=EN, stringName=Wei YANG, firstName=Wei, middleName=null, lastName=YANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135546969674324, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, authorId=1292135546822873681, language=CN, stringName=杨葳, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=天津市医疗器械审评查验中心,天津 300191, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135544302096958, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, xref=null, ext=[AuthorCompanyExt(id=1292135544310485567, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China), AuthorCompanyExt(id=1292135544318874176, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135543022834235, companyId=1292135544302096958, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=天津市医疗器械审评查验中心,天津 300191)])])]
张瑜, 曹雅欣, 陈雨萱, 杨葳
作者信息
  • 天津市医疗器械审评查验中心,天津 300191
通讯作者:
杨葳,高级工程师 MP: 15222288408 E-mail:
作者简介:

张瑜(1996-),女,助理工程师,主要从事体外诊断试剂的相关研究

Determination of cyclosporine A concentration in human whole blood by liquid chromatography tandem mass spectrometry and its clinical application
Yu ZHANG, Ya-xin CAO, Yu-xuan CHEN, Wei YANG
Affiliations
  • Tianjin Medical Device Evaluation and Inspection Center, Tianjin 300191, China
出版时间: 2026-05-28 doi: 10.13699/j.cnki.1001-6821.2026.10.007
文章导航
收藏切换
目的

建立一种高效、灵敏的液相色谱-串联质谱(LC-MS/MS)法用于人全血中环孢霉素A的定量分析。

方法

实验采用甲醇沉淀蛋白的前处理方法,以环孢霉素A-d4为内标,色谱柱为Kinetex C18(3.0 mm×50.0 mm,2.6 μm,100 Å),流动相为0.1%甲酸水溶液(A)-0.1%甲酸甲醇溶液(B);流速为0.55 mL·min-1;柱温为40 ℃。采用电喷雾正离子和多反应监测(MRM)模式进行定量检测。考察该方法的专属性、标准曲线与定量下限、准确度与精密度、基质效应和样本稳定性。

结果

环孢霉素A的保留时间为1.19 min,单个样品分析时间为2.0 min。在10~1 000 ng·mL-1范围内呈现良好线性(r=0.998 5),定量下限为10.0 ng·mL-1。方法回收率为99.53%~102.83%,批内精密度≤3.58%,批间精密度≤3.24%,样本稳定性良好,基质效应可以忽略。

结论

该方法分析时间短,灵敏度较高,全血用量少,适用于全血标本中的环孢霉素A血药浓度监测及准确测定。

环孢霉素A  /  液相色谱串联质谱  /  血液浓度监测
Objective

To establish a high-efficiency and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the quantitative analysis of cyclosporine A in human whole blood.

Methods

Protein precipitation with methanol was employed for sample pretreatment, and cyclosporine A-d4 was used as the internal standard. Chromatographic separation was performed on a Kinetex C18 column (3.0 mm×50.0 mm, 2.6 μm, 100 Å) with a mobile phase consisting of 0.1% formic acid in water (phase A) and 0.1% formic acid in methanol (phase B) at a flow rate of 0.55 mL·min-1. The column temperature was maintained at 40 ℃. Quantitative detection was carried out using electrospray ionization in positive ion mode and multiple reaction monitoring (MRM). The method was validated for specificity, calibration curve and lower limit of quantitation (LLOQ), accuracy and precision, matrix effect, and sample stability.

Results

The retention time of cyclosporine A was 1.19 min, with a total run time of 2.0 min per sample. A good linear relationship was observed in the concentration range of 10-1 000 ng·mL-1 (r=0.998 5), and the LLOQ was 10.0 ng·mL-1. The recovery rates ranged from 99.53% to 102.83%, with intra-batch precision ≤3.58% and inter-batch precision ≤3.24%. The sample stability was satisfactory, and the matrix effect was negligible.

Conclusion

The established method features short analysis time, high sensitivity, and low sample volume requirement, making it suitable for therapeutic drug monitoring and accurate quantification of cyclosporine A in human whole blood samples.

cyclosporine A  /  liquid chromatography tandem mass spectrometry  /  blood concentration monitoring
张瑜, 曹雅欣, 陈雨萱, 杨葳. 液相色谱-串联质谱法测定人全血中环孢霉素A的浓度及临床应用. 中国临床药理学杂志, 2026 , 42 (10) : 1391 -1396 . DOI: 10.13699/j.cnki.1001-6821.2026.10.007
Yu ZHANG, Ya-xin CAO, Yu-xuan CHEN, Wei YANG. Determination of cyclosporine A concentration in human whole blood by liquid chromatography tandem mass spectrometry and its clinical application[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (10) : 1391 -1396 . DOI: 10.13699/j.cnki.1001-6821.2026.10.007

参考文献 引证文献
排序方式:
2026年第42卷第10期
PDF下载
129
18
引用本文
BibTeX
文章信息
doi: 10.13699/j.cnki.1001-6821.2026.10.007
  • 接收时间:2025-10-30
  • 首发时间:2026-08-06
  • 出版时间:2026-05-28
补充材料
相关文章
文章信息
作者
出版历史
  • 收稿日期:2025-10-30
基金
作者信息
    天津市医疗器械审评查验中心,天津 300191

通讯作者:

杨葳,高级工程师 MP: 15222288408 E-mail:
参考文献
分享链接
https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.10.007
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

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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