Article(id=1208489274077463193, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1208489265789518263, articleNumber=null, orderNo=null, doi=10.16438/j.0513-4870.2021-1026, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1625846400000, receivedDateStr=2021-07-10, revisedDate=1628784000000, revisedDateStr=2021-08-13, acceptedDate=null, acceptedDateStr=null, onlineDate=1766055895585, onlineDateStr=2025-12-18, pubDate=1636646400000, pubDateStr=2021-11-12, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1766055895585, onlineIssueDateStr=2025-12-18, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1766055895585, creator=13701087609, updateTime=1766055895585, updator=13701087609, issue=Issue{id=1208489265789518263, tenantId=1146029695717560320, journalId=1189982191388893191, year='2021', volume='56', issue='11', pageStart='2881', pageEnd='3202', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1766055893609, creator=13701087609, updateTime=1766137012710, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1208829504026448153, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1208489265789518263, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1208829504026448154, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1208489265789518263, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=3153, endPage=3158, ext={EN=ArticleExt(id=1208489274647888591, articleId=1208489274077463193, tenantId=1146029695717560320, journalId=1189982191388893191, language=EN, title=Preparation, characterization, transformation and solubility of imatinib-oxalate salt polymorphs, columnId=1190335348761793317, journalTitle=Acta Pharmaceutica Sinica, columnName=Original Articles, runingTitle=null, highlight=null, articleAbstract=

The three polymorphs (Ⅰ, Ⅱ, Ⅲ) and one amorphous (Ⅳ) form of imatinib-oxalate new salt were prepared and characterized by powder X-ray diffraction, differential scanning calorimetry, thermogravimetric analysis and infrared spectroscopy, and transformation rules among the four salts were analyzed. The solubility of polymorph Ⅱ was investigated by high performance liquid chromatography. The results show that polymorph Ⅱ was stable but polymorph Ⅰ, Ⅲ and amorphous Ⅳ were unstable at room temperature. Polymorph I transformed into polymorph Ⅱ at room temperature. At relative humidity 90%, polymorph Ⅰ, Ⅱ and amorphous Ⅳ transformed into polymorph Ⅲ, but polymorph Ⅲ transformed into amorphous Ⅳ at 70 ℃. The solubility of imatinib was significantly improved after being salted with oxalic acid, and the equilibrium solubility of polymorph Ⅱ in pH 6.8 buffer solution and pure water was increased by 4.1 and 21.2 fold, respectively, as compared to bulk drug. This research provides guidance for the development and quality control of a new salt form of imatinib.

, correspAuthors=Ning-bo GONG, authorNote=null, correspAuthorsNote=null, copyrightStatement=Copyright ©2021 Acta Pharmaceutica Sinica. All rights reserved., 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=Zheng-yu FANG, Cheng XING, Wen-hui XING, Xue WANG, Ning-bo GONG, Yang LÜ), CN=ArticleExt(id=1208489278334682061, articleId=1208489274077463193, tenantId=1146029695717560320, journalId=1189982191388893191, language=CN, title=伊马替尼草酸盐多晶型的制备、表征、转化规律及溶解性能研究, columnId=1190335348896011050, journalTitle=药学学报, columnName=研究论文, runingTitle=null, highlight=null, articleAbstract=

制备获得伊马替尼-草酸新盐型的3种晶型（Ⅰ、Ⅱ和Ⅲ）和1种无定形（Ⅳ），利用粉末X射线衍射法、差示扫描量热法、热重分析法和红外光谱法对新盐多晶型进行表征，研究4种盐型间的转化规律，使用高效液相色谱法考察晶型Ⅱ的溶解性。结果表明，在室温下晶型Ⅱ稳定而晶型Ⅰ、Ⅲ及无定形Ⅳ不稳定。在室温下晶型Ⅰ可向晶型Ⅱ转化；在相对湿度90%时晶型Ⅰ、Ⅱ及无定形Ⅳ均可转化为晶型Ⅲ，在70 ℃下晶型Ⅲ可转化为无定形Ⅳ。伊马替尼与草酸成盐后可显著提高伊马替尼的溶解度，在pH 6.8缓冲溶液和纯水中晶型Ⅱ的平衡溶解度相较于伊马替尼原料药分别提高4.1和21.2倍。该研究为伊马替尼新盐型的开发和质量控制提供指导。

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