Article(id=1236408359713304675, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236408356815032449, 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=1663689600000, acceptedDateStr=2022-09-21, onlineDate=1772712324311, onlineDateStr=2026-03-05, pubDate=1676390400000, pubDateStr=2023-02-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772712324311, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772712324311, creator=13701087609, updateTime=1772712324311, updator=13701087609, issue=Issue{id=1236408356815032449, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='3', pageStart='217', pageEnd='328', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1772712323621, creator=13701087609, updateTime=1772712475250, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236408992868659518, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236408356815032449, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236408992868659519, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236408356815032449, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=301, endPage=310, ext={EN=ArticleExt(id=1236408359939797099, articleId=1236408359713304675, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Identification of amino acid sequence of chemically modified insulin analogues by LC-MS/MS, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: Insulin degludec and insulin detemir are the third generation of insulin analogues that are chemically modified on long chain aliphatic acid. It is necessary to establish a specific and sensitive liquid chromatography-tandem mass spectrometry method for the determination of amino acid sequences of chemically modified insulin analogues.
Methods: The separation was achieved by an ACQUITY UPLC peptide BEH C18 column (100 mm×2.1 mm, 1.7 μm,300 Å) with a mobile phase of 0.1% FA/H2O as Solvent A and 0.1% FA/acetonitrile as Solvent B in a gradient mode. The flow rate was set at 0.3 mL·min-1. MSE was used as the detection mode of mass spectrometry, and the collision energy was 30~40 eV.
Results: The coverage rate of insulin degludec and insulin detemir sequences was good as expected, and the fragment ion y1& was detected by chemical modification. RSD% of ionic strength of medium and high strength ions was within 15%. Both insulin sequences can be effectively distinguished it from other unmodified ones.
Conclusion: A liquid mass spectrometry method for amino acid sequences of adipose-side chain modified insulin analogs with good repeatability, specificity and durability was established, providing reference for the research method of sequence structure of this kind of products.
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目的： 德谷胰岛素和地特胰岛素是以长链脂肪酸化学修饰为代表的第3代胰岛素类似物，有必要建立专属性强、灵敏度高的LC-MS/MS法测定化学修饰型胰岛素类似物的氨基酸序列。
方法： 氨基酸序列测定方法的色谱参数为ACQUITY UPLC peptide BEH C18色谱柱（100 mm×2.1 mm，1.7 μm，300 Å），流动相A为0.1%甲酸/水溶液，流动相B为0.1%甲酸/乙腈溶液，梯度洗脱，流速0.3 mL·min-1；质谱参数为MSE采集模式，碰撞能量为30~40 eV。
结果： 德谷胰岛素和地特胰岛素序列覆盖率良好，化学修饰位点的碎片离子y1&可检出，中高强度离子的离子强度RSD在15%之内，可有效区分与其他未修饰胰岛素的序列。
结论： 建立了重复性好、专属性强和耐用性好的脂肪侧链修饰型胰岛素类似物氨基酸序列LC-MS/MS方法，为该类产品序列结构的研究方法提供了借鉴意义。
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, authorsList=胡馨月, 丁晓丽, 孙悦, 秦希月, 张慧, 李晶, 梁成罡)}, authors=[Author(id=1236408360480862350, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=huxinyue@nifdc.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236408360543776915, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, authorId=1236408360480862350, language=EN, stringName=Xin-yue HU, firstName=Xin-yue, middleName=null, lastName=HU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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胡馨月，女，博士，助理研究员，研究方向：激素类药物质量控制。联系电话：(010)53851462，E-mail: huxinyue@nifdc.org.cn。
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胡馨月，女，博士，助理研究员，研究方向：激素类药物质量控制。联系电话：(010)53851462，E-mail: huxinyue@nifdc.org.cn。
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1中国食品药品检定研究院激素室，国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室，国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629)])]), Author(id=1236408361026121908, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, 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=1236408361097425082, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, authorId=1236408361026121908, language=EN, stringName=Yue SUN, firstName=Yue, middleName=null, lastName=SUN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1中国食品药品检定研究院激素室，国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室，国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236408360313090179, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, xref=1, ext=[AuthorCompanyExt(id=1236408360317284484, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, companyId=1236408360313090179, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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1中国食品药品检定研究院激素室，国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室，国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629)])]), Author(id=1236408361240031430, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, 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=1236408361340694735, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, authorId=1236408361240031430, language=EN, stringName=Xi-yue QIN, firstName=Xi-yue, middleName=null, lastName=QIN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1中国食品药品检定研究院激素室，国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室，国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236408360313090179, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, xref=1, ext=[AuthorCompanyExt(id=1236408360317284484, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, companyId=1236408360313090179, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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1中国食品药品检定研究院激素室，国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室，国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629)])]), Author(id=1236408361718182127, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, orderNo=5, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=li_jing@nifdc.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236408361802068212, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, authorId=1236408361718182127, language=EN, stringName=Jing LI, firstName=Jing, middleName=null, lastName=LI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1中国食品药品检定研究院激素室，国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室，国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629)])]), Author(id=1236408361961451772, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, orderNo=6, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=liangchenggang@nifdc.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236408362032754943, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, authorId=1236408361961451772, language=EN, stringName=Cheng-gang LIANG, firstName=Cheng-gang, middleName=null, lastName=LIANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1中国食品药品检定研究院激素室，国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室，国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629)])])], keywords=[Keyword(id=1236408362187944202, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=EN, orderNo=1, keyword=chemically modified insulin analogues), Keyword(id=1236408362246664458, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=EN, orderNo=2, keyword=insulin degludec), Keyword(id=1236408362317967628, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=EN, orderNo=3, keyword=insulin detemir), Keyword(id=1236408362389270804, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=EN, orderNo=4, keyword=LC-MS/MS), Keyword(id=1236408362460573976, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=EN, orderNo=5, keyword=amino acid sequence localization), Keyword(id=1236408362527682842, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=EN, orderNo=6, keyword=enzyme digestion), Keyword(id=1236408362590597405, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=CN, orderNo=1, keyword=脂肪侧链修饰型胰岛素类似物), Keyword(id=1236408362674483489, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=CN, orderNo=2, keyword=德谷胰岛素), Keyword(id=1236408362779341092, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=CN, orderNo=3, keyword=地特胰岛素), Keyword(id=1236408362863227175, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=CN, orderNo=4, keyword=LC-MS/MS法), Keyword(id=1236408362934530347, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=CN, orderNo=5, keyword=氨基酸序列定位), Keyword(id=1236408362993250605, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, language=CN, orderNo=6, keyword=酶切)], refs=null, funds=[Fund(id=1236408363215548720, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, awardId=2022A3, language=CN, fundingSource=中国食品药品检定研究院中青年发展研究基金课题项目(2022A3), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1236408360313090179, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, xref=1, ext=[AuthorCompanyExt(id=1236408360317284484, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, companyId=1236408360313090179, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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1中国食品药品检定研究院激素室，国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室，国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629)]), AuthorCompany(id=1236408360409559176, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, xref=2, ext=[AuthorCompanyExt(id=1236408360413753482, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236408359713304675, companyId=1236408360409559176, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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