Article(id=1321426297125974348, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321426285826519296, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.16.013, 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=1765209600000, acceptedDateStr=2025-12-09, onlineDate=1792982180148, onlineDateStr=2026-10-26, pubDate=1788019200000, pubDateStr=2026-08-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982180148, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982180148, creator=13701087609, updateTime=1792982180148, updator=13701087609, issue=Issue{id=1321426285826519296, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='16', pageStart='1681', pageEnd='1792', issueExtLink='null', onlineDate='null', pubDate='1788019200000', pubDateStr='2026-08-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982177454, creator='13701087609', updateTime=1792982881356, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429238297776921, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321426285826519296, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429238297776922, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321426285826519296, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1778, endPage=1784, ext={EN=ArticleExt(id=1321426298979856719, articleId=1321426297125974348, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Development of an
in vitro release method for tazarotene gel and analysis of release behavior differences, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish a flow-through cell method for determining the dissolution of tazarotene gel and analyze the correlation between its in vitro release behavior and microscopic characteristics.
Methods: A closed-loop flow-through cell system was employed to systematically investigate the effects of release medium composition, surfactant concentration, flow rate, filter membrane pore size, and fluid flow pattern on the in vitro release profile of tazarotene, while comparing the release behavior differences between commercial generic and originator products. Additionally, confocal laser micro-Raman imaging was utilized for non-destructive characterization of critical microstructure parameters including API polymorphic form and particle size distribution in both formulations, followed by analysis of key quality attributes contributing to the observed in vitro release performance disparities.
Results: The dissolution curve with a suitable degree of distinction can be obtained by using 0.9% sodium chloride solution containing 0.5% sodium dodecyl sulfate as dissolution medium, at (32±0.5) ℃ with a flow rate of 8 mL·min-1 and a 100 μm filter membrane. Although the polymorphic form of the active pharmaceutical ingredient (API) in generic formulations was consistent with that of the originator product, the undissolved particle counts (54 particles·mm-2) in the generic drugs was significantly higher compared to the originator product (25 particles·mm-2), resulting in statistically significant differences in their in vitro release profiles.
Conclusion: The microstructural characteristics reflect differences in the types of key solubilizing agents used as excipients in the formulation, which may influence the in vitro release properties of the product. It is recommended that domestic manufacturers promptly optimize formulation processes and improve product quality.
, authors=Dan-dan SHEN, authorsList=Dan-dan SHEN, authorCompany=null, correspAuthors=null, 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=1321426299365732688, articleId=1321426297125974348, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=他扎罗汀凝胶体外释放度方法开发和释放行为差异分析, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 建立流通池法测定他扎罗汀凝胶释放度，并分析体外释放行为与微观结构特性的相关性。
方法： 采用流通池闭环系统，分别考察释放介质、表面活性剂浓度、流速、滤膜孔径、液流类型对他扎罗汀体外释放曲线的影响，并比较市售仿制药与原研产品释放行为的差异；采用激光共聚焦显微拉曼成像仪无损表征仿制药与原研产品中活性药物成分（active pharmaceutical ingredient, API）晶型、粒度等微观结构，并分析影响本品体外释放行为差异的关键质量特性。
结果： 以含0.5%十二烷基硫酸钠的0.9%氯化钠溶液为释放介质，温度为（32±0.5） ℃，流速为8 mL·min-1，滤膜孔径为100 μm，可获得既能有效释放又具有一定区分力的释放曲线。国产仿制药中API晶型与原研进口产品一致，但仿制药中未溶解的颗粒数量（54粒·mm-2）明显大于原研产品（颗粒数量为25粒·mm-2），导致两者体外释放曲线存在显著差异。
结论： 微观结构特性反映处方中关键辅料助溶剂种类的不同，可能影响本品体外释放特性，建议国内生产企业尽快优化处方工艺，提升产品质量。
, authors=沈丹丹, authorsList=沈丹丹, authorCompany=null, correspAuthors=null, authorNote=
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沈丹丹，女，硕士，高级工程师，研究方向：药物制剂与药物分析。E-mail: shendandan@cqifdc.org.cn。
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沈丹丹，女，硕士，高级工程师，研究方向：药物制剂与药物分析。E-mail: shendandan@cqifdc.org.cn。
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