Article(id=1321425659944091923, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.09.011, 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=1749657600000, acceptedDateStr=2025-06-12, onlineDate=1792982028231, onlineDateStr=2026-10-26, pubDate=1778774400000, pubDateStr=2026-05-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982028231, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982028231, creator=13701087609, updateTime=1792982028231, updator=13701087609, issue=Issue{id=1321425625915707977, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='9', pageStart='897', pageEnd='1008', issueExtLink='null', onlineDate='null', pubDate='1778774400000', pubDateStr='2026-05-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982020119, creator='13701087609', updateTime=1792983090252, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430114441745406, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430114441745407, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=977, endPage=985, ext={EN=ArticleExt(id=1321425660082503956, articleId=1321425659944091923, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Study on impurities in domestic piroxicam gel, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To study the impurities in domestic piroxicam gel.
Methods: An HPLC method was established to study the impurities in piroxican gel. Waters XBridge C18 (250 mm×4.6 mm, 5 μm) column was used with gradient elution of mobile phase consisting of 0.5% of glacial acetic acid in water (adjust with ammonium hydroxide to a pH of 6.2) and acetonitrile. The flow rate was 1.0 mL·min-1, and the UV detection wavelength was 265 nm. Q-TOF technique was used to identify the structures of the main impurities in positive/negative ion modes with ESI as the ion resource.
Results: Piroxicam peak was well separated from each impurity peak. A total of 4 major impurities (≥0.1%) were detected in 17 batches of domestic piroxicam gel: i.e., 2-hydroxy-benzoic acid 2-[bis(2-hydroxyethyl)amino] ethyl ester, 2-hydroxypropyl-4-hydroxybenzoate, 1-hydroxypropyl-2-yl-4-hydroxybenzoate, and 2-methyl-4-methoxy-N-(2-pyridyl)-2H-1,2-benzothiazin-3-formamide-1,1-dioxide, which were for the first time reported in piroxicam gel.
Conclusion: The established HPLC method can be used for impurity detection of piroxicam gel. Impurities in domestic piroxicam gel mainly come from raw materials and excipient ethyl hydroxybenzoate. The production process should be optimized to improve the quality.
, authors=Jie LI
1, Song YUAN
1, Lei-jin ZHU
2, Yang LIU
1, *, authorsList=Jie LI, Song YUAN, Lei-jin ZHU, Yang LIU, authorCompany=null, correspAuthors=Yang LIU, 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=1321425660480962837, articleId=1321425659944091923, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=国产吡罗昔康凝胶的杂质研究, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
方法： 建立HPLC法对吡罗昔康凝胶中的杂质进行考察：采用Waters XBridge C18色谱柱（250 mm×4.6 mm, 5 μm）；以0.5%冰醋酸（氨水调pH 6.2）-乙腈为流动相；梯度洗脱；流速1.0 mL·min-1；检测波长265 nm；联用Q-TOF高分辨质谱对主要杂质结构进行鉴定，采用ESI离子源，正/负离子全扫描模式。
结果： 吡罗昔康峰与各杂质峰分离良好，17批次国产吡罗昔康凝胶中共检出4个主要杂质（≥0.1%）：2-羟基-苯甲酸2-[二（2-羟基乙基）氨基]乙基酯、2-羟丙基4-羟基苯甲酸酯、1-羟丙基-2-基4-羟基苯甲酸酯和2-甲基-4-甲氧基-N-（2-吡啶基）-2H-1,2-苯并噻嗪-3-甲酰胺-1,1-二氧化物，均为吡罗昔康凝胶中首次报道。
结论： 建立的HPLC法可用于吡罗昔康凝胶的杂质检查。国产吡罗昔康凝胶中的杂质主要来源于原料和辅料羟苯乙酯，应优化生产工艺，提高质量。
, authors=李婕
1, 袁松
1, 朱蕾瑾
2, 刘阳
1, *, authorsList=李婕, 袁松, 朱蕾瑾, 刘阳, authorCompany=null, correspAuthors=刘阳, authorNote=
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1中国食品药品检定研究院/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={"content":"
李婕，女，副主任药师，主要从事化学药物的质量控制研究。联系电话：（010）53851577，E-mail: lijie@nifdc.org.cn。
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李婕，女，副主任药师，主要从事化学药物的质量控制研究。联系电话：（010）53851577，E-mail: lijie@nifdc.org.cn。
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1中国食品药品检定研究院/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=1321425661705699624, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425659944091923, 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=1321425661986717994, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425659944091923, authorId=1321425661705699624, language=EN, stringName=Lei-jin ZHU, firstName=Lei-jin, middleName=null, lastName=ZHU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2Yunnan Provincial Institute of Food and Drug Supervision and Inspection, Kunming 650106, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425662091575595, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425659944091923, authorId=1321425661705699624, language=CN, stringName=朱蕾瑾, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2云南省食品药品监督检验研究院，昆明 650106, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1321425660791341337, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425659944091923, xref=2, ext=[AuthorCompanyExt(id=1321425660799729946, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425659944091923, companyId=1321425660791341337, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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