Article(id=1322181150248906778, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, 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=1610553600000, acceptedDateStr=2021-01-14, onlineDate=1793162151156, onlineDateStr=2026-10-28, pubDate=1627574400000, pubDateStr=2021-07-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793162151156, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793162151156, creator=13701087609, updateTime=1793162151156, updator=13701087609, issue=Issue{id=1322181102488375822, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='14', pageStart='1249', pageEnd='1344', issueExtLink='null', onlineDate='null', pubDate='1627574400000', pubDateStr='2021-07-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793162139770, creator='13701087609', updateTime=1793162209831, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322181396408419308, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322181396408419309, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1334, endPage=1339, ext={EN=ArticleExt(id=1322181150479593499, articleId=1322181150248906778, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Comparison of different polymer detection methods and analysis of polymer impurities of cefathiamidine for injection, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To analyze polymer impurities in cefathiamidine for injection by different methods, and compare the advantages and disadvantages of the specificity of different methods.

Methods:

By using Sephadex G-10 System, high performance gel chromatography and column switching-LC-MSn method, the polymers in cefathiamidine for injection from 11 manufacturers were analyzed.

Results:

No polymer was detected by Sephadex G10 System, high performance gel chromatography could detect polymer impurities, the structure of the components separated by high performance gel chromatography system was confirmed by the column switching-LC-MSn method.

Conclusion:

It was proved that there were some polymer impurities in cefathiamidine for injection, the Sephadex G10 System and high performance gel chromatography had poor specificity, and macromolecular polymers and small molecular impurities could not be separated and qualitatively analyzed. This study laid the foundation to further establish a better specificity method.

, authors=Xiao-meng CHONG, Ye TIAN, Shang-chen YAO, Li-hui YIN, Ying LIU, Ming-zhe XU, authorsList=Xiao-meng CHONG, Ye TIAN, Shang-chen YAO, Li-hui YIN, Ying LIU, Ming-zhe XU, authorCompany=null, correspAuthors=Ying LIU, Ming-zhe XU, 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=1322181150743834652, articleId=1322181150248906778, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=注射用头孢硫脒聚合物检测方法比较及聚合物杂质分析, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的:

本研究采用不同的方法对注射用头孢硫脒中聚合物杂质进行分析,比较不同方法专属性的优劣。

方法:

分别采用葡聚糖凝胶G10系统、高效凝胶色谱系统以及柱切换液质联用系统对11个厂家的注射用头孢硫脒中聚合物进行分析。

结果:

葡聚糖凝胶G10系统并未检出聚合物,高效凝胶色谱系统可检出聚合物,采用柱切换液质联用方法对高效凝胶色谱系统分离的组分进行了结构确认。

结论:

柱切换液质联用方法证明了注射用头孢硫脒中存在多种聚合物杂质,葡聚糖凝胶G10系统以及高效凝胶色谱系统专属性较差,无法将大分子聚合物和小分子杂质进行分离和定性,为进一步建立专属性更好的方法奠定了基础。

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田冶,男,副研究员,主要从事抗生素对照品研究。联系电话:(010)53851533,E-mail:。

崇小萌,女,副主任药师,主要从事抗生素药品质量控制及研究。联系电话:(010)53851538,E-mail:。

, correspAuthorsNote=
刘颖,女,研究员,主要从事抗生素对照品研究。联系电话:(010)53851542, E-mail:。
许明哲,男,主任药师,主要从事化学药品研究。联系电话:(010)53852506, E-mail:。
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崇小萌,女,副主任药师,主要从事抗生素药品质量控制及研究。联系电话:(010)53851538,E-mail:。

"}, bioImg=null, bioContent=

崇小萌,女,副主任药师,主要从事抗生素药品质量控制及研究。联系电话:(010)53851538,E-mail:。

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注射用头孢硫脒聚合物检测方法比较及聚合物杂质分析
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崇小萌 , 田冶 , 姚尚辰 , 尹利辉 , 刘颖 , 许明哲
中国新药杂志 | 实验研究 2021,30(14): 1334-1339
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中国新药杂志 |实验研究 2021 , 30 (14) : 1334 -1339
注射用头孢硫脒聚合物检测方法比较及聚合物杂质分析
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崇小萌,女,副主任药师,主要从事抗生素药品质量控制及研究。联系电话:(010)53851538,E-mail:。

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崇小萌,女,副主任药师,主要从事抗生素药品质量控制及研究。联系电话:(010)53851538,E-mail:。

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崇小萌 , 田冶 , 姚尚辰, 尹利辉, 刘颖 , 许明哲
作者信息
  • 中国食品药品检定研究院,北京 102629
通讯作者:
刘颖,女,研究员,主要从事抗生素对照品研究。联系电话:(010)53851542, E-mail:。
许明哲,男,主任药师,主要从事化学药品研究。联系电话:(010)53852506, E-mail:。
作者简介:

田冶,男,副研究员,主要从事抗生素对照品研究。联系电话:(010)53851533,E-mail:。

崇小萌,女,副主任药师,主要从事抗生素药品质量控制及研究。联系电话:(010)53851538,E-mail:。

Comparison of different polymer detection methods and analysis of polymer impurities of cefathiamidine for injection
Xiao-meng CHONG , Ye TIAN , Shang-chen YAO, Li-hui YIN, Ying LIU , Ming-zhe XU
Affiliations
  • National Institutes for Food and Drug Control, Beijing 102629, China
出版时间: 2021-07-30
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目的:

本研究采用不同的方法对注射用头孢硫脒中聚合物杂质进行分析,比较不同方法专属性的优劣。

方法:

分别采用葡聚糖凝胶G10系统、高效凝胶色谱系统以及柱切换液质联用系统对11个厂家的注射用头孢硫脒中聚合物进行分析。

结果:

葡聚糖凝胶G10系统并未检出聚合物,高效凝胶色谱系统可检出聚合物,采用柱切换液质联用方法对高效凝胶色谱系统分离的组分进行了结构确认。

结论:

柱切换液质联用方法证明了注射用头孢硫脒中存在多种聚合物杂质,葡聚糖凝胶G10系统以及高效凝胶色谱系统专属性较差,无法将大分子聚合物和小分子杂质进行分离和定性,为进一步建立专属性更好的方法奠定了基础。

注射用头孢硫脒  /  聚合物  /  柱切换液质联用
Objective:

To analyze polymer impurities in cefathiamidine for injection by different methods, and compare the advantages and disadvantages of the specificity of different methods.

Methods:

By using Sephadex G-10 System, high performance gel chromatography and column switching-LC-MSn method, the polymers in cefathiamidine for injection from 11 manufacturers were analyzed.

Results:

No polymer was detected by Sephadex G10 System, high performance gel chromatography could detect polymer impurities, the structure of the components separated by high performance gel chromatography system was confirmed by the column switching-LC-MSn method.

Conclusion:

It was proved that there were some polymer impurities in cefathiamidine for injection, the Sephadex G10 System and high performance gel chromatography had poor specificity, and macromolecular polymers and small molecular impurities could not be separated and qualitatively analyzed. This study laid the foundation to further establish a better specificity method.

cefathiamidine for injection  /  polymer  /  the column switching-LC-MSn
崇小萌, 田冶, 姚尚辰, 尹利辉, 刘颖, 许明哲. 注射用头孢硫脒聚合物检测方法比较及聚合物杂质分析. 中国新药杂志, 2021 , 30 (14) : 1334 -1339 .
Xiao-meng CHONG, Ye TIAN, Shang-chen YAO, Li-hui YIN, Ying LIU, Ming-zhe XU. Comparison of different polymer detection methods and analysis of polymer impurities of cefathiamidine for injection[J]. Chinese Journal of New Drugs, 2021 , 30 (14) : 1334 -1339 .

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2021年第30卷第14期
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  • 首发时间:2026-10-28
  • 出版时间:2021-07-30
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  • 录用日期:2021-01-14
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    中国食品药品检定研究院,北京 102629

通讯作者:

刘颖,女,研究员,主要从事抗生素对照品研究。联系电话:(010)53851542, E-mail:。
许明哲,男,主任药师,主要从事化学药品研究。联系电话:(010)53852506, E-mail:。
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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
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