Article(id=1304415532598456476, tenantId=1146029695717560320, journalId=1302319053441957962, issueId=1304415531491152712, articleNumber=null, orderNo=null, doi=10.7501/j.issn.0253-2670.2026.09.008, pmid=null, cstr=null, oa=null, hot=0, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1762444800000, receivedDateStr=2025-11-07, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1788926497840, onlineDateStr=2026-09-09, pubDate=null, pubDateStr=null, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1788926497840, onlineIssueDateStr=2026-09-09, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1788926497840, creator=13701087609, updateTime=1788926497840, updator=13701087609, issue=Issue{id=1304415531491152712, tenantId=1146029695717560320, journalId=1302319053441957962, year='2026', volume='57', issue='9', pageStart='3261', pageEnd='3684', issueExtLink='null', onlineDate='null', pubDate='1778515200000', pubDateStr='2026-05-12', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1788926497576, creator='13701087609', updateTime=1788926796984, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1304416787358049066, tenantId=1146029695717560320, journalId=1302319053441957962, issueId=1304415531491152712, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1304416787358049067, tenantId=1146029695717560320, journalId=1302319053441957962, issueId=1304415531491152712, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3343, endPage=3352, ext={EN=ArticleExt(id=1304415532892057758, articleId=1304415532598456476, tenantId=1146029695717560320, journalId=1302319053441957962, language=EN, title=Identification and transfer relationship of key attributes in preparation process of Crataegi Fructus formula granules based on QbD principle, columnId=null, journalTitle=Chinese Traditional and Herbal Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=Objective This study applied the quality by design (QbD) principle to identify key attributes and elucidate their transfer relationships along the “spray-dried powder-ribbon-granule” manufacturing chain of Shanzha (Crataegi Fructus) formula granules. Methods A fractional factorial design was implemented to investigate seven major factors affecting the properties of the spray-dried powder, ribbons, and granules. The relevant properties of these intermediates were measured. Modeling and attribute identification were performed using analysis of variance, multiple linear regression, and orthogonal partial least squares-discriminant analysis (OPLS-DA). Results Excipient amount, inlet air temperature, and roller pressure were identified as critical process parameters. A key attribute transfer relationship was established, centered on glass transition temperature (T_g) and median particle size (D₅₀), and associated with supporting attributes including moisture content (H₁), bulk density (ρ_b1), tapped density (ρ_t1) of the spray-dried powder, ribbon yield, and granule yield. Among these, T_g served as a representative key indicator with both discriminative and transfer functions. Conclusion This research clarifies the identification and transfer relationships of key attributes in the dry granulation process of Crataegi Fructus formula granules, providing a basis for developing effective quality control strategies and supporting the high-quality development of the formula granules industry., authors=LIU Zixi, MENG Qingmin, RAO Xiaoyong, LIU Wei, ZHANG Shiwei, TENG Chong, LUO Xiaojian, ZHANG Ailing, authorsList=LIU Zixi, MENG Qingmin, RAO Xiaoyong, LIU Wei, ZHANG Shiwei, TENG Chong, LUO Xiaojian, ZHANG Ailing, 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=1304415532824948893, articleId=1304415532598456476, tenantId=1146029695717560320, journalId=1302319053441957962, language=CN, title=基于QbD理念的山楂配方颗粒制备工艺关键属性的辨析和传递关系研究, columnId=1304140189132149234, journalTitle=中草药, columnName=药剂与工艺, runingTitle=null, highlight=null, articleAbstract=目的 基于质量源于设计（quality by design，QbD）理念，以山楂配方颗粒为研究对象，辨析山楂配方颗粒“喷干粉-条带-颗粒”关键属性及传递关系。方法 对影响山楂喷干粉、条带和颗粒性质的7个主要因素，进行部分因子试验，测定喷干粉、条带和颗粒的相关性质，经方差分析、多元线性回归以及正交偏最小二乘-判别分析（orthogonal partial least squares-discriminant analysis，OPLS-DA）进行建模与属性辨识。结果 辅料用量、进风温度和辊轮压力为山楂配方颗粒制备工艺的关键参数；试验辨析出以玻璃化转变温度（glass transition temperature，Tg）、粒径D₅₀为核心，与喷干粉含水量（H₁）、喷干粉堆密度（ρb₁）和振实密度（ρt₁）、条带得率和颗粒得率为辅的关键属性传递关系；其中Tg为代表性的、具有辨析和传递性的关键指标。结论 明确了山楂配方颗粒干法制粒过程中关键属性的辨析与传递关系，为质量控制策略及推动配方颗粒产业的高质量发展提供了依据。, authors=刘子稀¹, 孟庆民², 饶小勇^1,3, 刘微^1,3, 张士威⁴, 滕翀¹, 罗晓健^1,3, 张爱玲³, authorsList=刘子稀, 孟庆民, 饶小勇, 刘微, 张士威, 滕翀, 罗晓健, 张爱玲, authorCompany=1 江西中医药大学, 江西 南昌 330004;
2 北京燕京中发生物技术有限公司, 北京 101300;
3 中药固体制剂制造技术国家工程研究中心, 江西 南昌 330004;
4 翰林航宇(天津)实业有限公司, 北京 101300, correspAuthors=罗晓健, authorNote=刘子稀: 刘子稀,硕士研究生,研究方向为中药制剂研究工作。E-mail:3497516004@qq.com, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=TukbXlgRyEkqY2ZRffXCnA==, pdfFileSize=1863827, 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=国家自然科学基金青年项目(82204656);博士后科学基金特别资助(2024T170534);山东省中医药科技项目(M20241725);山东中医药大学青年创新团队支持计划(22202105))}, authors=null, keywords=[Keyword(id=1304415533009498271, tenantId=1146029695717560320, journalId=1302319053441957962, articleId=1304415532598456476, language=CN, orderNo=1, keyword=山楂配方颗粒), Keyword(id=1304415533068218528, tenantId=1146029695717560320, journalId=1302319053441957962, articleId=1304415532598456476, language=CN, orderNo=2, keyword=关键属性), 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