Article(id=1236331160276619547, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331158678597790, articleNumber=null, orderNo=null, doi=null, 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=1684166400000, acceptedDateStr=2023-05-16, onlineDate=1772693918532, onlineDateStr=2026-03-05, pubDate=1698595200000, pubDateStr=2023-10-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772693918532, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772693918532, creator=13701087609, updateTime=1772693918532, updator=13701087609, issue=Issue{id=1236331158678597790, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='20', pageStart='2009', pageEnd='2120', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772693918151, creator=13701087609, updateTime=1772694963216, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236335542061814375, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331158678597790, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236335542061814376, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331158678597790, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2099, endPage=2105, ext={EN=ArticleExt(id=1236331160540860706, articleId=1236331160276619547, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Preparation and solidification of paeonol nanosuspensions, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To optimize the preparation and solidification process of paeonol nanosuspensions.
Methods: Paeonol nanosuspensions was prepared by solvate-non-solvent precipitation method. With the appearance character, particle size and polymer dispersity index (PDI) as the evaluation indexes, the type of stabilizer, stirring time, stirring speed, drug-auxiliary ratio, organic phase-water ratio and water phase temperature as the influencing factors, the preparation process of nanosuspensions was optimized, and the stability of the prepared nanosuspensions was investigated. The freeze-drying method was used for solidification, and the effect of freeze-drying protectant on solidification was investigated. The drug loading, scanning electron microscopy, differential scanning calorimetry, X-ray diffraction and dissolution in vitro of the solidified nanosuspensions were characterized.
Results: The preparation process of paeonol nanosuspensions was povidone K60 as stabilizer, drug-to-auxiliary ratio 1∶3, organic phase water ratio 1∶10, at 25 ℃, 400 r·min-1 magnetic stirring for 30 min. The prepared nanosuspensions had a particle size of about 40 nm, with narrow distribution and good stability. The lyophilized protectant was determined to be 5% trehalose. The drug loading capacity of solidified nanosuspensions was 21.63%, and the microscopic surface morphology was spherical, and the drug structure changed from crystalline form to amorphous form. The cumulative dissolution rate of the suspension reached 87.12% in 1 h.
Conclusion: The formulation and preparation process of paeonol nanosuspensions are simple, easy to operate, with good formability after solidification and fast dissolution, which lay a foundation for the development of more dosage forms.
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方法： 采用溶剂-非溶剂沉淀法制备丹皮酚纳米混悬剂，以外观性状、粒径及聚合物分散性指数（PDI）为评价指标，考察稳定剂种类、搅拌时间、搅拌速度、药-辅比、有机相水相比例和水相温度对纳米混悬剂制备的影响，并考察其稳定性。采用冷冻干燥法固化，考察冻干保护剂对固化的影响。对固化的纳米混悬剂进行载药量、扫描电镜、差示扫描量热、X射线衍射及体外溶出度表征。
结果： 以聚维酮K60为稳定剂，药-辅比1∶3，有机相水相比例1∶10，于25 ℃，400 r·min-1磁力搅拌30 min，制备得粒径约为40 nm且分布较窄、稳定性较好的丹皮酚纳米混悬剂。固化的冻干保护剂确定为5%的海藻糖。固体纳米混悬剂载药量为21.63%，微观表面形态呈类球形，药物结构由晶型转变为无定形态分散于介质中，1 h累积溶出度可达87.12%。
结论： 所确定的丹皮酚纳米混悬剂的处方与制备工艺简单、易操作，固化后成形性好，溶出速度快，为其更多剂型的开发奠定了基础。
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宗时宇，女，硕士，助理研究员，主要从事中药药效物质基础与新型给药系统研究。联系电话：(029)85395696，E-mail: zongsy114@163.com。
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宗时宇，女，硕士，助理研究员，主要从事中药药效物质基础与新型给药系统研究。联系电话：(029)85395696，E-mail: zongsy114@163.com。
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