Article(id=1304414708254143412, tenantId=1146029695717560320, journalId=1302319053441957962, issueId=1304414700964443026, articleNumber=null, orderNo=null, doi=10.7501/j.issn.0253-2670.2026.04.006, pmid=null, cstr=null, oa=null, hot=0, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1759161600000, receivedDateStr=2025-09-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1788926301300, onlineDateStr=2026-09-09, pubDate=null, pubDateStr=null, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1788926301300, onlineIssueDateStr=2026-09-09, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1788926301300, creator=13701087609, updateTime=1788926301300, updator=13701087609, issue=Issue{id=1304414700964443026, tenantId=1146029695717560320, journalId=1302319053441957962, year='2026', volume='57', issue='4', pageStart='1209', pageEnd='1596', issueExtLink='null', onlineDate='null', pubDate='1772208000000', pubDateStr='2026-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1788926299563, creator='13701087609', updateTime=1788926573099, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1304415848316297970, tenantId=1146029695717560320, journalId=1302319053441957962, issueId=1304414700964443026, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1304415848316297971, tenantId=1146029695717560320, journalId=1302319053441957962, issueId=1304414700964443026, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1251, endPage=1263, ext={EN=ArticleExt(id=1304414708593882038, articleId=1304414708254143412, tenantId=1146029695717560320, journalId=1302319053441957962, language=EN, title=Effects of soluble excipients on disintegration behavior of traditional Chinese medicine extract tablets, columnId=null, journalTitle=Chinese Traditional and Herbal Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=Objective To systematically evaluate the effects of soluble excipients on the disintegration behavior of Chinese medicine extract tablets prepared by different processes, thereby providing a scientific basis for the formulation design of Chinese medicine tablets. Methods A total of 11 representative Chinese medicine extract powders were selected, and the impacts of three processes (direct compression, dry granulation compression, and wet granulation compression) on tablet disintegration time and dissolution were compared. On this basis, Rougui (Cinnamomi Cortex ) and Quɑnshen (Bistortae Rhizoma ) extract tablets with poor disintegration performance were chosen for a factorial experimental design to investigate the modulating effects of soluble excipient type (sugar alcohols, lactose, and starch and its derivatives), proportion (10%, 20%, and 30%), and preparation process (dry granulation compression and wet granulation compression) on tablet disintegration. Results Except for Kushen (Sophorae Flavescentis Radix ), the granulation process had minimal impact on the disintegration behavior of single Chinese medicine extract tablets, including Hujisheng (Visci Herba ), Dɑnggui (Angelicae Sinensis Radix ), Chuɑnxiong (Chuanxiong Rhizoma ), Wumei (Mume Fructus ), Fuchaocɑngzhu (Atractylodis Rhizoma stir-fried with bran), Zhiheshouwu (Polygoni Multiflori Radix Praeparata ), Bohe (Menthae Haplocalycis Herba ) with a disintegration time ≤ 30 min. However, for single extract tablets with slower disintegration (> 30 min), such as Xixin (Asari Radix et Rhizoma ), Cinnamomi Cortex and Bistortae Rhizoma , granulation prolonged disintegration time and reduced dissolution rate. Under high drug-loading conditions (≥ 70%) sugar alcohols and lactose showed the most significant improvement in disintegration of Cinnamomi Cortex and Bistortae Rhizoma extract tablets, whereas starch and its derivatives exhibited limited effects but enhanced the dissolution of water-soluble components under wet granulation. Wet granulation was more suitable for Cinnamomi Cortex tablets, while dry granulation was preferable for Bistortae Rhizoma tablets. Conclusion In the formulation design of high drug-loading Chinese medicine extract tablets, selecting sugar alcohols or lactose as excipients and optimizing the granulation process based on material properties are effective strategies to enhance disintegration and dissolution. This study provides foundational data for the development of Chinese medicine tablets and related solid dosage forms., authors=ZHAO Shuying, SU Junhui, WANG Yawen, MA Xiao, CHEN Liping, WANG Yidan, JIANG Hui, XU Bing, authorsList=ZHAO Shuying, SU Junhui, WANG Yawen, MA Xiao, CHEN Liping, WANG Yidan, JIANG Hui, XU Bing, 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=1304414708505801653, articleId=1304414708254143412, tenantId=1146029695717560320, journalId=1302319053441957962, language=CN, title=可溶性辅料对中药浸膏片崩解行为的影响研究, columnId=1304140189132149234, journalTitle=中草药, columnName=药剂与工艺, runingTitle=null, highlight=null, articleAbstract=目的 系统评估可溶性辅料对不同制备工艺中药浸膏片崩解行为的影响，为中药片剂处方设计提供依据。方法 选取11种代表性中药浸膏粉，比较了直接压片、干法制粒压片和湿法制粒压片3种工艺对片剂崩解时间和溶出度的影响。在此基础上，选择制粒后崩解性能较差的肉桂和拳参浸膏片作为对象，通过析因实验设计考察可溶性辅料种类（即糖醇类、乳糖类和淀粉及其衍生物类）、辅料添加量（即10%、20%和30%）以及制备工艺（即干法制粒压片和湿法制粒压片）对片剂崩解行为的调控作用。结果 除苦参纯浸膏片外，制粒工艺对崩解时间≤30 min的一元中药纯浸膏片（即槲寄生、当归、川芎、乌梅、麸炒苍术、制何首乌和薄荷）的崩解行为影响较小；而对于崩解时间＞30 min的一元中药纯浸膏片（即细辛、肉桂和拳参），制粒会延长其崩解时间并降低溶出度。在高载药量（≥70%）条件下，糖醇类和乳糖类辅料改善肉桂和拳参浸膏片崩解性能的效果最好；淀粉及其衍生物类辅料的促崩效果不明显，但在湿法制粒下能促进水溶性成分的溶出；肉桂浸膏片更适配湿法制粒压片工艺，而拳参浸膏片更适配干法制粒压片工艺。结论 在高载药量中药浸膏片的处方设计中，优选糖醇类或乳糖类辅料，并结合物料特性选择适宜的制粒工艺，是改善其崩解与溶出性能的有效策略。研究结果对中药片剂及相关固体制剂的研发提供了基础数据参考。, authors=赵殊颖1,2 , 宿军慧3 , 王雅雯1 , 马骁1 , 陈丽萍1 , 王奕丹1 , 江慧1 , 徐冰1,2 , authorsList=赵殊颖, 宿军慧, 王雅雯, 马骁, 陈丽萍, 王奕丹, 江慧, 徐冰, authorCompany=1 北京中医药大学 中药信息学系, 北京 102400; Cinnamomi Cortex ), Keyword(id=1304414709827007430, tenantId=1146029695717560320, journalId=1302319053441957962, articleId=1304414708254143412, language=EN, orderNo=8, keyword=Bistortae Rhizoma )], refs=null, funds=null, companyList=null, figs=null, attaches=null, journal=Journal(id=1302309778002903112, delFlag=0, nameCn=中草药, nameEn=Chinese Traditional and Herbal Drugs, nameHistory1=null, nameHistory2=null, issn=0253-2670, eissn=null, cn=12-1108/R, coden=null, periodic=3, language=CN, oaType=null, ccby=null, superviseOffice=null, ownerOffice=null, pubOffice=null, editorOffice=null, officeType=null, aims=null, clcCode=null, officeProv=null, officeCity=null, officeAddr=null, officeZip=null, officeEmail=null, officePhone=null, editDirector=null, officeDirector=null, officeDirectorPhone=null, officeStaffNum=null, officeEmpNum=null, coverPicUrl=cGpSKCP11AF8PAOcTXYWfg==, journalPrice=null, startedYear=null, abbrevIsoEn=Chinese Traditional and Herbal Drugs, journalRemark=null, publicationField=null, createdTime=1788424446827, updatedTime=1788949289390, createdBy=18614031015, updatedBy=13041195026, firstLetterCn=Z, firstLetterEn=Z, subjectCode=Medical and Pharmaceutical Sciences, subjectName=null, subjectCodeEn=Medical and Pharmaceutical Sciences, subjectNameEn=null, picCn=cGpSKCP11AF8PAOcTXYWfg==, picEn=Xw//kxUC3ON4eHxev0QLhQ==, jcr=null, cjcr=null, exts=[JournalExt(id=1304511127375863983, language=CN, name=中草药, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788949289411, updatedTime=1788949289411, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=https://www.tiprpress.com/zcy/author/login, submissionEditorUrl=https://www.tiprpress.com/zcy/editor/login, submissionReviewUrl=https://www.tiprpress.com/zcy/reviewer/login, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""}), JournalExt(id=1304511127442972848, language=EN, name=Chinese Traditional and Herbal Drugs, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788949289427, updatedTime=1788949289427, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=https://www.tiprpress.com/zcy/author/login, submissionEditorUrl=https://www.tiprpress.com/zcy/editor/login, submissionReviewUrl=https://www.tiprpress.com/zcy/reviewer/login, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""})], databaseList=null, tenantJournalId=1302319053441957962, websiteList=[Website(id=1302319176408912052, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1302319053441957962, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/zcy/CN, language=CN, createTime=1788426687576, createBy=18614031015, updateTime=1788427346252, updateBy=18614031015, name=中草药-中文, tplId=1146099689490845704, title=中草药, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1302322043651904087, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176408912052, code=articleTextType, value=kx, createTime=1788427371180, updateTime=1788427371180, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322043593183828, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176408912052, code=banner, value=null, createTime=1788427371166, updateTime=1788427371166, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322043672875610, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176408912052, code=grayFlag, value=0, createTime=1788427371185, updateTime=1788427371185, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322043584795219, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176408912052, code=logo, value=https://castjournals.cast.org.cn/joweb/zcy/CN/file/pic?fileId=uiD1gpiRqR++OLOz4iKzDg==, createTime=1788427371164, updateTime=1788427371164, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322043689652828, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176408912052, code=minRunFlag, value=0, createTime=1788427371189, updateTime=1788427371189, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322043643515478, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176408912052, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zcy/CN/file/pic, createTime=1788427371178, updateTime=1788427371178, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322043681264219, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176408912052, code=silenceFlag, value=0, createTime=1788427371187, updateTime=1788427371187, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322043601572437, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176408912052, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1788427371168, updateTime=1788427371168, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322043660292696, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176408912052, code=themeColor, value=null, createTime=1788427371182, updateTime=1788427371182, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322043668681305, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176408912052, code=themeStyle, value=null, createTime=1788427371184, updateTime=1788427371184, creator=18614031015, updator=18614031015)]), Website(id=1302319176715096246, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1302319053441957962, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/zcy/EN, language=EN, createTime=1788426687649, createBy=18614031015, updateTime=1788427341161, updateBy=18614031015, name=中草药-英文, tplId=1146101810881728533, title=Chinese Traditional and Herbal Drugs, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1302322015206134340, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176715096246, code=articleTextType, value=kx, createTime=1788427364398, updateTime=1788427364398, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322015185162817, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176715096246, code=banner, value=null, createTime=1788427364393, updateTime=1788427364393, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322015227105863, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176715096246, code=grayFlag, value=0, createTime=1788427364403, updateTime=1788427364403, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322015176774208, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176715096246, code=logo, value=https://castjournals.cast.org.cn/joweb/zcy/EN/file/pic?fileId=uiD1gpiRqR++OLOz4iKzDg==, createTime=1788427364391, updateTime=1788427364391, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322015239688777, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176715096246, code=minRunFlag, value=0, createTime=1788427364406, updateTime=1788427364406, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322015201940035, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176715096246, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zcy/EN/file/pic, createTime=1788427364397, updateTime=1788427364397, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322015235494472, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176715096246, code=silenceFlag, value=0, createTime=1788427364405, updateTime=1788427364405, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322015193551426, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176715096246, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1788427364395, updateTime=1788427364395, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322015214522949, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176715096246, code=themeColor, value=null, createTime=1788427364400, updateTime=1788427364400, creator=18614031015, updator=18614031015), WebsiteProps(id=1302322015218717254, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1302319176715096246, code=themeStyle, value=null, createTime=1788427364401, updateTime=1788427364401, creator=18614031015, updator=18614031015)])], journalTitle=中草药, weixinUrl=null, journalUrl=https://www.tiprpress.com/zcy, iacademicId=null, status=1, seqNo=null, journalTitleEn=Chinese Traditional and Herbal Drugs, journalPhotoCn=cGpSKCP11AF8PAOcTXYWfg==, journalPhotoEn=Xw//kxUC3ON4eHxev0QLhQ==, journalFirstLetter=Z, journalRecommend=null, journalNew=null, journalCollection=null, jcrJf=null, cjcrJf=null, jcrJfStr=null, cjcrJfStr=null, submissionFirstDecision=null, sciSubjectClassification=null, casSubjectClassification=null, citeScore=null, totalCitationFrequency=null, icpCode=null, psCode=null, advertisingLicenseCode=null, copyrightInformation=null, country=null, option=, provinceCode=null, provinceName=null, collectFlag=false, interPubPlatform=, interPubPlatformUrl=null), detailUrlCn=https://castjournals.cast.org.cn/joweb/zcy/CN/10.7501/j.issn.0253-2670.2026.04.006, detailUrlEn=https://castjournals.cast.org.cn/joweb/zcy/EN/10.7501/j.issn.0253-2670.2026.04.006, pdfUrlCn=https://castjournals.cast.org.cn/joweb/zcy/CN/PDF/10.7501/j.issn.0253-2670.2026.04.006, pdfUrlEn=https://castjournals.cast.org.cn/joweb/zcy/EN/PDF/10.7501/j.issn.0253-2670.2026.04.006, aliStartDate=null, aliEndDate=null, collectionFlag=false, citedCount=null, citedUrl=null, previewStatus=0, delFlag=0, hasFullText=0, orderTime=1788926301300, fullTextJson=null, articleText=null, reference=Yang B X, Xu L, Wang Q X, et al . Modulation of the wettability of excipients by surfactant and its impacts on the disintegration and release of tablets [J]. Drug Dev Ind Pharm , 2016, 42(12): 1945-1955.Pharm Acta Helv , 1973, 48(11): 589-609.Polacrilin potassium NF [J]. AAPS PharmSciTech , 2012, 13(1): 24-34.J Pharm Sci , 2016, 105(9): 2545-2555.Pharm Res , 2017, 34(5): 890-917.et al . Exploring the disintegration mechanism of dissolved natural plant products tablets based on pore structure control [J]. Adv Powder Technol , 2024, 35(10): 104586.et al . Investigation of tablet disintegration pathways by the combined use of magnetic resonance imaging, texture analysis and static light scattering [J]. Int J Pharm , 2020, 587: 119719.et al . Advancing the understanding of the tablet disintegration phenomenon-An update on recent studies [J]. Int J Pharm , 2021, 598: 120390.J Pharm Sci , 1987, 76(12): 907-909.et al . A tabletability change classification system in supporting the tablet formulation design via the roll compaction and dry granulation process [J]. Int J Pharm X , 2023, 6: 100204.et al . Sample size requirements of a pharmaceutical material library: A case in predicting direct compression tablet tensile strength by latent variable modeling [J]. Pharmaceutics , 2024, 16(2): 242.et al . A formulation-process-product integrated design method for accelerating pharmaceutical tablet development via the high-shear wet granulation and tableting route [J]. Pharmaceutics , 2025, 17(3): 322.et al . Comparison of spray freeze dried nanozirconia granules using ultrasonication and twin-fluid atomisation [J]. J Eur Ceram Soc , 2014, 34(4): 1001-1008.et al . Co-processed excipients for dispersible tablets-part 1: Manufacturability [J]. AAPS PharmSciTech , 2018, 19(6): 2598-2609.AAPS PharmSciTech , 2021, 23(1): 38.et al . A mathematical approach to consider solid compressibility in the compression of pharmaceutical powders [J]. Pharmaceutics , 2019, 11(3): 121.et al . Using a material library to understand the change of tabletability by high shear wet granulation [J]. Pharmaceutics , 2022, 14(12): 2631.Int J Pharm , 2008, 364(2): 328-343.et al . Influence of moisture content on die filling of pharmaceutical powders [J]. J Drug Deliv Sci Technol , 2022, 78: 103985.et al . A critical review on engineering of d -mannitol crystals: Properties, applications, and polymorphic control [J]. Crystals , 2022, 12(8): 1080.et al . Competing for water: A new approach to understand disintegrant performance [J]. Int J Pharm , 2018, 548(1): 491-499.et al . Modelling the evolution of pore structure during the disintegration of pharmaceutical tablets [J]. Pharmaceutics , 2023, 15(2): 489.et al . Exploring the performance-controlling tablet disintegration mechanisms for direct compression formulations [J]. Int J Pharm , 2021, 599: 120221.Pharmaceutics , 2022, 14(12): 2725.)
中草药
|药剂与工艺
2026
, 57
(4) :
1251
-1263
可溶性辅料对中药浸膏片崩解行为的影响研究
全屏
赵殊颖1,2 , 宿军慧3 , 王雅雯1 , 马骁1 , 陈丽萍1 , 王奕丹1 , 江慧1 , 徐冰1,2
作者信息
1 北京中医药大学 中药信息学系, 北京 102400;
通讯作者:
徐冰
作者简介:
赵殊颖: 赵殊颖，硕士研究生，从事中药固体制剂处方设计研究。E-mail:bucmzsy@163.com
Effects of soluble excipients on disintegration behavior of traditional Chinese medicine extract tablets
ZHAO Shuying, SU Junhui, WANG Yawen, MA Xiao, CHEN Liping, WANG Yidan, JIANG Hui, XU Bing
Affiliations
doi: 10.7501/j.issn.0253-2670.2026.04.006
文章导航
目的 系统评估可溶性辅料对不同制备工艺中药浸膏片崩解行为的影响，为中药片剂处方设计提供依据。方法 选取11种代表性中药浸膏粉，比较了直接压片、干法制粒压片和湿法制粒压片3种工艺对片剂崩解时间和溶出度的影响。在此基础上，选择制粒后崩解性能较差的肉桂和拳参浸膏片作为对象，通过析因实验设计考察可溶性辅料种类（即糖醇类、乳糖类和淀粉及其衍生物类）、辅料添加量（即10%、20%和30%）以及制备工艺（即干法制粒压片和湿法制粒压片）对片剂崩解行为的调控作用。结果 除苦参纯浸膏片外，制粒工艺对崩解时间≤30 min的一元中药纯浸膏片（即槲寄生、当归、川芎、乌梅、麸炒苍术、制何首乌和薄荷）的崩解行为影响较小；而对于崩解时间＞30 min的一元中药纯浸膏片（即细辛、肉桂和拳参），制粒会延长其崩解时间并降低溶出度。在高载药量（≥70%）条件下，糖醇类和乳糖类辅料改善肉桂和拳参浸膏片崩解性能的效果最好；淀粉及其衍生物类辅料的促崩效果不明显，但在湿法制粒下能促进水溶性成分的溶出；肉桂浸膏片更适配湿法制粒压片工艺，而拳参浸膏片更适配干法制粒压片工艺。结论 在高载药量中药浸膏片的处方设计中，优选糖醇类或乳糖类辅料，并结合物料特性选择适宜的制粒工艺，是改善其崩解与溶出性能的有效策略。研究结果对中药片剂及相关固体制剂的研发提供了基础数据参考。
干法制粒压片
/
湿法制粒压片
/
崩解时间
/
崩解过程溶出度
/
可溶性辅料
/
处方设计
/
肉桂
/
拳参
Objective To systematically evaluate the effects of soluble excipients on the disintegration behavior of Chinese medicine extract tablets prepared by different processes, thereby providing a scientific basis for the formulation design of Chinese medicine tablets. Methods A total of 11 representative Chinese medicine extract powders were selected, and the impacts of three processes (direct compression, dry granulation compression, and wet granulation compression) on tablet disintegration time and dissolution were compared. On this basis, Rougui (Cinnamomi Cortex ) and Quɑnshen (Bistortae Rhizoma ) extract tablets with poor disintegration performance were chosen for a factorial experimental design to investigate the modulating effects of soluble excipient type (sugar alcohols, lactose, and starch and its derivatives), proportion (10%, 20%, and 30%), and preparation process (dry granulation compression and wet granulation compression) on tablet disintegration. Results Except for Kushen (Sophorae Flavescentis Radix ), the granulation process had minimal impact on the disintegration behavior of single Chinese medicine extract tablets, including Hujisheng (Visci Herba ), Dɑnggui (Angelicae Sinensis Radix ), Chuɑnxiong (Chuanxiong Rhizoma ), Wumei (Mume Fructus ), Fuchaocɑngzhu (Atractylodis Rhizoma stir-fried with bran), Zhiheshouwu (Polygoni Multiflori Radix Praeparata ), Bohe (Menthae Haplocalycis Herba ) with a disintegration time ≤ 30 min. However, for single extract tablets with slower disintegration (> 30 min), such as Xixin (Asari Radix et Rhizoma ), Cinnamomi Cortex and Bistortae Rhizoma , granulation prolonged disintegration time and reduced dissolution rate. Under high drug-loading conditions (≥ 70%) sugar alcohols and lactose showed the most significant improvement in disintegration of Cinnamomi Cortex and Bistortae Rhizoma extract tablets, whereas starch and its derivatives exhibited limited effects but enhanced the dissolution of water-soluble components under wet granulation. Wet granulation was more suitable for Cinnamomi Cortex tablets, while dry granulation was preferable for Bistortae Rhizoma tablets. Conclusion In the formulation design of high drug-loading Chinese medicine extract tablets, selecting sugar alcohols or lactose as excipients and optimizing the granulation process based on material properties are effective strategies to enhance disintegration and dissolution. This study provides foundational data for the development of Chinese medicine tablets and related solid dosage forms.
dry granulation compression
/
wet granulation compression
/
disintegration time
/
dissolution behavior during disintegration
/
soluble excipients
/
formulation design
/
Cinnamomi Cortex
/
Bistortae Rhizoma
赵殊颖, 宿军慧, 王雅雯, 马骁, 陈丽萍, 王奕丹, 江慧, 徐冰.
可溶性辅料对中药浸膏片崩解行为的影响研究.
中草药,
2026
, 57
(4)
: 1251
-1263
.
DOI: 10.7501/j.issn.0253-2670.2026.04.006
ZHAO Shuying, SU Junhui, WANG Yawen, MA Xiao, CHEN Liping, WANG Yidan, JIANG Hui, XU Bing.
Effects of soluble excipients on disintegration behavior of traditional Chinese medicine extract tablets[J].
Chinese Traditional and Herbal Drugs ,
2026
, 57
(4)
: 1251
-1263
.
DOI: 10.7501/j.issn.0253-2670.2026.04.006
参考文献
引证文献
Yang B X, Xu L, Wang Q X, et al . Modulation of the wettability of excipients by surfactant and its impacts on the disintegration and release of tablets [J]. Drug Dev Ind Pharm , 2016, 42(12): 1945-1955.Pharm Acta Helv , 1973, 48(11): 589-609.Polacrilin potassium NF [J]. AAPS PharmSciTech , 2012, 13(1): 24-34.J Pharm Sci , 2016, 105(9): 2545-2555.Pharm Res , 2017, 34(5): 890-917.et al . Exploring the disintegration mechanism of dissolved natural plant products tablets based on pore structure control [J]. Adv Powder Technol , 2024, 35(10): 104586.et al . Investigation of tablet disintegration pathways by the combined use of magnetic resonance imaging, texture analysis and static light scattering [J]. Int J Pharm , 2020, 587: 119719.et al . Advancing the understanding of the tablet disintegration phenomenon-An update on recent studies [J]. Int J Pharm , 2021, 598: 120390.J Pharm Sci , 1987, 76(12): 907-909.et al . A tabletability change classification system in supporting the tablet formulation design via the roll compaction and dry granulation process [J]. Int J Pharm X , 2023, 6: 100204.et al . Sample size requirements of a pharmaceutical material library: A case in predicting direct compression tablet tensile strength by latent variable modeling [J]. Pharmaceutics , 2024, 16(2): 242.et al . A formulation-process-product integrated design method for accelerating pharmaceutical tablet development via the high-shear wet granulation and tableting route [J]. Pharmaceutics , 2025, 17(3): 322.et al . Comparison of spray freeze dried nanozirconia granules using ultrasonication and twin-fluid atomisation [J]. J Eur Ceram Soc , 2014, 34(4): 1001-1008.et al . Co-processed excipients for dispersible tablets-part 1: Manufacturability [J]. AAPS PharmSciTech , 2018, 19(6): 2598-2609.AAPS PharmSciTech , 2021, 23(1): 38.et al . A mathematical approach to consider solid compressibility in the compression of pharmaceutical powders [J]. Pharmaceutics , 2019, 11(3): 121.et al . Using a material library to understand the change of tabletability by high shear wet granulation [J]. Pharmaceutics , 2022, 14(12): 2631.Int J Pharm , 2008, 364(2): 328-343.et al . Influence of moisture content on die filling of pharmaceutical powders [J]. J Drug Deliv Sci Technol , 2022, 78: 103985.et al . A critical review on engineering of d -mannitol crystals: Properties, applications, and polymorphic control [J]. Crystals , 2022, 12(8): 1080.et al . Competing for water: A new approach to understand disintegrant performance [J]. Int J Pharm , 2018, 548(1): 491-499.et al . Modelling the evolution of pore structure during the disintegration of pharmaceutical tablets [J]. Pharmaceutics , 2023, 15(2): 489.et al . Exploring the performance-controlling tablet disintegration mechanisms for direct compression formulations [J]. Int J Pharm , 2021, 599: 120221.Pharmaceutics , 2022, 14(12): 2725.
2026年第57卷第4期
PDF下载
24
8
引用本文
BibTeX
文章信息
doi: 10.7501/j.issn.0253-2670.2026.04.006
接收时间：2025-09-30
首发时间：2026-09-09
https://castjournals.cast.org.cn/joweb/zcy/CN/10.7501/j.issn.0253-2670.2026.04.006
引用本文
BibTeX
2种不同金属材料的力学参数
科 属数 种数 占总种数比例 属 种数 占总种数比例 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
关闭全屏
BibTeX
EndNote
RefWorks
TxT
PDF下载
全屏
24
8
关闭全屏
北京市海淀区学院南路86号
010-62199257（仅加盟咨询）
qkjq@cast.org.cn
