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 (Tg) and median particle size (D50), and associated with supporting attributes including moisture content (H1), bulk density (ρb1), tapped density (ρt1) of the spray-dried powder, ribbon yield, and granule yield. Among these, Tg 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=[Author(id=1307431863845409457, tenantId=1146029695717560320, journalId=null, articleId=1304415532598456476, orderNo=null, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=null, email=null, emailSecond=null, emailThird=null, correspondingAuthor=null, authorType=null, 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程雪丽,张书嘉,高路,等.白芍配方颗粒制备工艺优化的研究[J].化工设计通讯, 2021, 47(11):191-192.
李洁,杜若飞,冯怡,等.中药浸膏粉物理性质与干法制粒工艺的相关性研究[J].中国中药杂志, 2011,36(12):1606-1609.
闫芳,赵娟,郭立新,等.干法制粒技术在中药制剂中的应用[J].中国医药指南, 2013, 11(27):220-221.
汪盛华,秦春娟,安双凤,等.水提干法制粒的中药配方颗粒溶化性与粉体物理属性相关性研究[J].中草药, 2023, 54(5):1439-1448.
中国药典[S].四部. 2025:6.
廖志超,唐雪芳,李焕正,等.基于休止角和流动能的桂枝茯苓胶囊浸膏粉离散元仿真参数标定研究[J].中草药, 2024, 55(21):7279-7287.
潘力,谢泽宇,陈吉生.五味消毒颗粒成型工艺优化[J].中成药, 2024, 46(10):3431-3434.
吕丹,张艳军.中药喷雾干燥技术设备现状及问题研究[J].化工装备技术, 2021, 42(2):8-11.
唐雪.基于粉体学性质的中药固体制剂评价与压缩行为研究[D].南昌:江西中医药大学, 2021.
李更青,吴飞,胡佳亮,等.基于制剂原料物理性质的抗甲方颗粒干法制粒工艺研究[J].中草药, 2018,49(3):575-581.
Khorasani M, Amigo J M, Sonnergaard J, et al.Visualization and prediction of porosity in roller compacted ribbons with near-infrared chemical imaging(NIR-CI)[J]. J Pharm Biomed Anal, 2015, 109:11-17.
Huang Z J, Zhang Y, Li Y, et al. Determining tensile strength of rock by the direct tensile, Brazilian splitting,and three-point bending methods:A comparative study[J].Adv Civ Eng, 2021, 2021(1):5519230.
沈光辉,范涌峰,陈婷.教育研究中的P值使用:问题及对策:兼谈效应量的使用[J].数学教育学报, 2019,28(4):92-98.
Wassertheil S, Cohen J. Statistical power analysis for the behavioral sciences[J]. Biometrics, 1970, 26(3):588.
张希冉,贡磊磊,李轶凡,等. HPLC多指标成分联合PCA、OPLS-DA及灰色关联度法的宫瘤消胶囊综合质量评价[J].中医药导报, 2024, 30(3):43-49.
张侠,杨冰清,王海亭.统计学教学中有关方差分析问题的探讨[J].阜阳师范大学学报:自然科学版, 2023,40(4):111-116.
卢绍浩,谢永恒,许利平,等.基于OPLS-DA模型的雪茄烟叶香气差异分析[J].中国农业科技导报, 2024,26(12):176-186.
刘慧,罗晓健,何雁,等.不同DE值麦芽糊精对五味子喷雾干燥粉性质的影响[J].中国中药杂志, 2016,41(16):3016-3021.
何雁,谢茵,郑龙金,等.空气湿度对中药浸膏喷雾干燥过程的影响及浸膏粉的稳定性预测[J].中国中药杂志, 2015, 40(3):424-429.)
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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
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刘子稀, 孟庆民, 饶小勇, 刘微, 张士威, 滕翀, 罗晓健, 张爱玲
中草药 | 药剂与工艺 2026,57(9): 3343-3352
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中草药 |药剂与工艺 2026 , 57 (9) : 3343 -3352
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
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刘子稀, 孟庆民, 饶小勇, 刘微, 张士威, 滕翀, 罗晓健, 张爱玲
作者信息
通讯作者:
罗晓健
作者简介:
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
Identification and transfer relationship of key attributes in preparation process of Crataegi Fructus formula granules based on QbD principle
LIU Zixi, MENG Qingmin, RAO Xiaoyong, LIU Wei, ZHANG Shiwei, TENG Chong, LUO Xiaojian, ZHANG Ailing
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doi: 10.7501/j.issn.0253-2670.2026.09.008
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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。
山楂配方颗粒  /  关键属性  /  辨析  /  传递  /  玻璃化转变温度
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 (Tg) and median particle size (D50), and associated with supporting attributes including moisture content (H1), bulk density (ρb1), tapped density (ρt1) of the spray-dried powder, ribbon yield, and granule yield. Among these, Tg 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.
Crataegi Fructus formula granules  /  key attributes  /  discrimination  /  transfer  /  glass transition temperature
刘子稀, 孟庆民, 饶小勇, 刘微, 张士威, 滕翀, 罗晓健, 张爱玲. 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. 中草药, 2026 , 57 (9) : 3343 -3352 . DOI: 10.7501/j.issn.0253-2670.2026.09.008
LIU Zixi, MENG Qingmin, RAO Xiaoyong, LIU Wei, ZHANG Shiwei, TENG Chong, LUO Xiaojian, ZHANG Ailing. Identification and transfer relationship of key attributes in preparation process of Crataegi Fructus formula granules based on QbD principle[J]. Chinese Traditional and Herbal Drugs, 2026 , 57 (9) : 3343 -3352 . DOI: 10.7501/j.issn.0253-2670.2026.09.008

    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)

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朱广伟.中药配方颗粒产业路线研究策略[A] //中国商品学会第五届全国中药商品学术大会论文集[C].北京:中国商品学会, 2017:617-646.
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施文婷,刘远俊,张兰兰,等.基于质量源于设计理念和信息熵赋值法优化陈皮配方颗粒喷雾干燥工艺[J].环球中医药, 2023, 16(11):2207-2214.
张兰兰,施文婷,陈伟媚,等.板蓝根配方颗粒喷雾干燥工艺优化研究[J].世界科学技术-中医药现代化,2024, 26(1):202-210.
郭俊林,邵青,吴琳琳,等.山萸肉配方颗粒的制备工艺研究[J].中国现代应用药学, 2019, 36(22):2800-2804.
程雪丽,张书嘉,高路,等.白芍配方颗粒制备工艺优化的研究[J].化工设计通讯, 2021, 47(11):191-192.
李洁,杜若飞,冯怡,等.中药浸膏粉物理性质与干法制粒工艺的相关性研究[J].中国中药杂志, 2011,36(12):1606-1609.
闫芳,赵娟,郭立新,等.干法制粒技术在中药制剂中的应用[J].中国医药指南, 2013, 11(27):220-221.
汪盛华,秦春娟,安双凤,等.水提干法制粒的中药配方颗粒溶化性与粉体物理属性相关性研究[J].中草药, 2023, 54(5):1439-1448.
中国药典[S].四部. 2025:6.
廖志超,唐雪芳,李焕正,等.基于休止角和流动能的桂枝茯苓胶囊浸膏粉离散元仿真参数标定研究[J].中草药, 2024, 55(21):7279-7287.
潘力,谢泽宇,陈吉生.五味消毒颗粒成型工艺优化[J].中成药, 2024, 46(10):3431-3434.
吕丹,张艳军.中药喷雾干燥技术设备现状及问题研究[J].化工装备技术, 2021, 42(2):8-11.
唐雪.基于粉体学性质的中药固体制剂评价与压缩行为研究[D].南昌:江西中医药大学, 2021.
李更青,吴飞,胡佳亮,等.基于制剂原料物理性质的抗甲方颗粒干法制粒工艺研究[J].中草药, 2018,49(3):575-581.
Khorasani M, Amigo J M, Sonnergaard J, et al.Visualization and prediction of porosity in roller compacted ribbons with near-infrared chemical imaging(NIR-CI)[J]. J Pharm Biomed Anal, 2015, 109:11-17.
Huang Z J, Zhang Y, Li Y, et al. Determining tensile strength of rock by the direct tensile, Brazilian splitting,and three-point bending methods:A comparative study[J].Adv Civ Eng, 2021, 2021(1):5519230.
沈光辉,范涌峰,陈婷.教育研究中的P值使用:问题及对策:兼谈效应量的使用[J].数学教育学报, 2019,28(4):92-98.
Wassertheil S, Cohen J. Statistical power analysis for the behavioral sciences[J]. Biometrics, 1970, 26(3):588.
张希冉,贡磊磊,李轶凡,等. HPLC多指标成分联合PCA、OPLS-DA及灰色关联度法的宫瘤消胶囊综合质量评价[J].中医药导报, 2024, 30(3):43-49.
张侠,杨冰清,王海亭.统计学教学中有关方差分析问题的探讨[J].阜阳师范大学学报:自然科学版, 2023,40(4):111-116.
卢绍浩,谢永恒,许利平,等.基于OPLS-DA模型的雪茄烟叶香气差异分析[J].中国农业科技导报, 2024,26(12):176-186.
刘慧,罗晓健,何雁,等.不同DE值麦芽糊精对五味子喷雾干燥粉性质的影响[J].中国中药杂志, 2016,41(16):3016-3021.
何雁,谢茵,郑龙金,等.空气湿度对中药浸膏喷雾干燥过程的影响及浸膏粉的稳定性预测[J].中国中药杂志, 2015, 40(3):424-429.
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doi: 10.7501/j.issn.0253-2670.2026.09.008
  • 接收时间:2025-11-07
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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