Article(id=1321425570370539756, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.07.005, 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=1755014400000, acceptedDateStr=2025-08-13, onlineDate=1792982006876, onlineDateStr=2026-10-26, pubDate=1776182400000, pubDateStr=2026-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982006876, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982006876, creator=13701087609, updateTime=1792982006876, updator=13701087609, issue=Issue{id=1321425569611362746, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='7', pageStart='673', pageEnd='784', issueExtLink='null', onlineDate='null', pubDate='1776182400000', pubDateStr='2026-04-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982006695, creator='13701087609', updateTime=1792983136833, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430309837587328, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430309837587329, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=701, endPage=709, ext={EN=ArticleExt(id=1321425570576060653, articleId=1321425570370539756, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Research advances in key technologies and real-time quality control for quality by design-driven micrometer-scale tablet formulations, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Micron-scale tablets (1 000~3 000 μm), driven by the dual forces of Pharmaceutical Industry 4.0 and precision medicine, have emerged as a core carrier for pediatric and personalized treatment due to their exceptional dose flexibility and multi-unit delivery advantages. The quality by design (QbD) concept provides a systematic framework to overcome key industrialization bottlenecks-such as poor flowability at high drug loads, challenges in achieving blend uniformity for ultra-low-dose formulations, and stringent sensitivity requirements for miniaturized quality control-facilitating the successful establishment of a multidimensional "structure-process-quality" correlation model in the field. Research advances demonstrate that the integration of multimodal spectral imaging (HSI-FT-NIR coupling) with neural network fusion technology enables real-time tracking of content uniformity and release profiles at the millimeter level, facilitating the formation of a full-chain quality control closed-loop from process analysis to dynamic release. The integrated application of innovative technologies such as hot melt extrusion-based microfluidic 3D printing offers new pathways for constructing complex functional dosage forms like colon-targeted and gastric-floating tablets. This review further examines the challenges and breakthrough directions for intelligent upgrades in continuous manufacturing under the QbD framework and outlines interdisciplinary pathways and future prospects for the efficient clinical translation of micron-scale tablet technologies.

, authors=Lei WU¹, Peng-fei REN¹, Zhou-bo YU¹, Zhen-bo LI¹, Yu-xin HE¹, Yi-han LIU¹, Jing YANG², Rui WANG^{1, *}, authorsList=Lei WU, Peng-fei REN, Zhou-bo YU, Zhen-bo LI, Yu-xin HE, Yi-han LIU, Jing YANG, Rui WANG, authorCompany=null, correspAuthors=Rui WANG, 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=1321425570848690414, articleId=1321425570370539756, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=质量源于设计驱动的微米级片制剂关键技术及实时质量控制研究进展, columnId=1236330553964810454, journalTitle=中国新药杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

微米级片剂（1 000~3 000 μm）凭借其卓越的剂量灵活性与多单元递送优势，在制药工业4.0与精准医疗双重驱动下，已成为儿科及个体化治疗的核心载体。质量源于设计（quality by design, QbD）理念为克服其产业化瓶颈（如高载药流动性差、超低剂量混合均匀性控制难、微型化质控灵敏度要求高）提供了系统框架，领域内已成功构建“结构-工艺-质量”多维度关联模型。研究进展表明，多模态光谱成像（HSI-FT-NIR联用）与神经网络融合技术，可实现含量均匀性与释放曲线的毫米级实时追踪，推动形成了从过程分析到动态放行的全链条质控闭环。热熔挤出-微流体3D打印等创新技术的集成应用，为构建结肠靶向、胃漂浮等复杂功能剂型提供了新途径。综述进一步探讨了QbD框架下连续制造智能化升级面临的挑战与突破方向，并展望了微片技术从实验室向临床高效转化的跨学科路径与前景。

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吴磊，男，硕士研究生，主要从事新药及新剂型研究。E-mail: 2048972176@qq.com。

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吴磊，男，硕士研究生，主要从事新药及新剂型研究。E-mail: 2048972176@qq.com。

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