Article(id=1208491490846815047, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1208491481367687341, articleNumber=null, orderNo=null, doi=10.16438/j.0513-4870.2021-0222, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1612713600000, receivedDateStr=2021-02-08, revisedDate=1616169600000, revisedDateStr=2021-03-20, acceptedDate=null, acceptedDateStr=null, onlineDate=1766056424104, onlineDateStr=2025-12-18, pubDate=1626019200000, pubDateStr=2021-07-12, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1766056424104, onlineIssueDateStr=2025-12-18, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1766056424104, creator=13701087609, updateTime=1766056424104, updator=13701087609, issue=Issue{id=1208491481367687341, tenantId=1146029695717560320, journalId=1189982191388893191, year='2021', volume='56', issue='7', pageStart='1749', pageEnd='2038', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1766056421844, creator=13701087609, updateTime=1766137126496, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1208829981292106015, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1208491481367687341, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1208829981292106016, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1208491481367687341, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1999, endPage=2004, ext={EN=ArticleExt(id=1208491492000248693, articleId=1208491490846815047, tenantId=1146029695717560320, journalId=1189982191388893191, language=EN, title=Preparation and characterization of dissolving microneedles with nano-enhanced mechanical properties, columnId=1190335348761793317, journalTitle=Acta Pharmaceutica Sinica, columnName=Original Articles, runingTitle=null, highlight=null, articleAbstract=
In this paper, the effects of the blend of nanoparticles and microneedle matrix materials on the mechanical properties of dissolving microneedles were studied mainly, so as to construct microneedles with excellent mechanical properties. Different kinds of nanoparticles (calcium carbonate, hydroxyapatite, silica), particle sizes (20, 60, 100 nm) and the proportion of prescription (2%, 6%, 10%) were blended with the matrix material[polyvinyl pyrrolidone (PVP), poly(1-vinylpyrrolidone-co-vinyl acetate)(PVP/VA)] to form dissolving microneedles. The effects of nanoparticles on the elastic modulus and hardness of the microneedles were investigated using a nanoindenter. The results showed that the elastic modulus and hardness of PVP microneedles were significantly improved by nano-calcium carbonate (P < 0.001), and the elastic modulus and hardness of PVP/VA microneedles were significantly improved by nano-hydroxyapatite (P < 0.001). When the particle size of hydroxyapatite was 20 nm, the elastic modulus of PVP/VA microneedles was (10.6±1.0) GPa, and the hardness was (0.47±0.06) GPa. As the size of the nanoparticles increases, the mechanical performance of the microneedles decreases. When the mass proportion of nano-hydroxyapatite increased from 2% to 6%, the elastic modulus and hardness of the microneedles were significantly improved (P < 0.001), but the effect of continue increasing the proportion of nanoparticles on the microneedles was not significant. The nano-enhanced PVP/VA dissolving microneedles has no irritant effect on intact skin and has a slight irritation to damaged skin, but they disappear completely after 72 h. Animal experiments have been approved by the Laboratory Animal Welfare and Ethics Committee of Zhejiang University of Technology. Therefore, the nano-enhanced dissolving microneedles has good biological safety. To sum up, it is necessary to select the appropriate kind of nanoparticle, particle size, and prescription ratio when microneedles constructing with a given matrix material, so as to effectively improve its mechanical performance.
, correspAuthors=Feng-sen MA, authorNote=null, correspAuthorsNote=null, copyrightStatement=Copyright ©2021 Acta Pharmaceutica Sinica. All rights reserved., 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, authorCompany=null, fund=null, authors=null, authorsList=Yang-yang BAO, Zhe LIU, Yong LIU, Feng-sen MA), CN=ArticleExt(id=1208491493690552388, articleId=1208491490846815047, tenantId=1146029695717560320, journalId=1189982191388893191, language=CN, title=纳米增强机械性能的可溶性微针制备与表征, columnId=1190335348896011050, journalTitle=药学学报, columnName=研究论文, runingTitle=null, highlight=null, articleAbstract=
本文主要研究纳米粒对可溶性微针机械性能的影响，从而构建优异机械性能的可溶性微针。采用不同种类的纳米材料(碳酸钙、羟基磷灰石、二氧化硅)、粒径(20、60、100 nm)和处方质量占比(2%、6%、10%)，与微针基质材料[聚乙烯吡咯烷酮(PVP)、乙烯基吡咯烷酮-乙酸乙烯酯共聚物(PVP/VA)]共混形成可溶性微针。通过纳米压痕仪研究纳米粒对微针弹性模量以及硬度的影响。纳米碳酸钙对PVP微针的弹性模量与硬度均有显著性提高(P < 0.001)；纳米羟基磷灰石对PVP/VA微针的弹性模量与硬度均有显著性提高(P < 0.001)。当纳米羟基磷灰石粒径为20 nm时，PVP/VA微针的弹性模量为(10.6±1.0)GPa，硬度为(0.47±0.06)GPa，且随纳米粒粒径增大，微针机械性能降低；当纳米羟基磷灰石质量占比从2%至6%，PVP/VA微针的弹性模量与硬度得到显著性提高(P < 0.001)，但继续提高占比对微针的影响不大。纳米羟基磷灰石增强的PVP/VA可溶性微针对完好皮肤无刺激性影响，对破损皮肤有轻微刺激性，但在72 h后完全消失。动物实验已获得浙江工业大学实验动物福利与伦理委员会批准。因此，纳米羟基磷灰石增强的PVP/VA可溶性微针具有良好的生物安全性。综上可知，根据给定的基质材料构建微针时，需选择合适的纳米粒、粒径以及处方质量占比，才能有效且显著地提升微针机械性能。
, correspAuthors=马凤森, authorNote=null, correspAuthorsNote=
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32: 297-303., articleTitle=Soft regulation of inflammatory immune responses, refAbstract=null)], funds=[Fund(id=1208491503672996737, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, awardId=2013TD15, language=CN, fundingSource=浙江省重点科技创新团队计划资助项目(2013TD15), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1208491493971570794, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, xref=null, ext=[AuthorCompanyExt(id=1208491493975765099, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, companyId=1208491493971570794, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Biologics and Biomaterials Laboratory, College of Pharmacy, Zhejiang University of Technology, Hangzhou 310014, China), AuthorCompanyExt(id=1208491493984153708, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, companyId=1208491493971570794, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=浙江工业大学药学院, 生物制剂与材料实验室, 浙江 杭州 310014)])], figs=[ArticleFig(id=1208491499071844907, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=Jetgg+IHc6fIsIsTFsWqUA==, figureFileBig=hNcujsEzBRlE5Rfp/FfA0g==, tableContent=null), ArticleFig(id=1208491499197674043, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Figure 1, caption=
The appearance (A, B) and morphology (C) of microneedles , figureFileSmall=Jetgg+IHc6fIsIsTFsWqUA==, figureFileBig=hNcujsEzBRlE5Rfp/FfA0g==, tableContent=null), ArticleFig(id=1208491499415777884, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=JHNcGzwrq/cQEmUfQlArIA==, figureFileBig=1+200zLG1OzgCsSH57umDw==, tableContent=null), ArticleFig(id=1208491500678263410, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Figure 2, caption=
Measurement results of elastic modulus and hardness of thin sheets formed by polyvinyl pyrrolidone (PVP) and different nanoparticles. A: Load force <i>versus</i> displacement diagram; B: Hardness test results; C: Elastic modulus measurement results. Hap: Nano-hydroxyapatite; Avg: Average. <i>n</i> = 6, <span class="mag-xml-overline" style="border-top:1px solid black"><i>x</i></span>±<i>s</i>.<sup>***</sup><i>P</i> < 0.001 <i>vs</i> PVP group , figureFileSmall=JHNcGzwrq/cQEmUfQlArIA==, figureFileBig=1+200zLG1OzgCsSH57umDw==, tableContent=null), ArticleFig(id=1208491500879590017, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=jG9RZIXXSS3FHfZLNR/08g==, figureFileBig=zegcVJlbeRZIF9tAcr/Pww==, tableContent=null), ArticleFig(id=1208491501030584969, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Figure 3, caption=
Measurement results of elastic modulus and hardness of thin sheets formed by poly(1-vinylpyrrolidone-<i>co</i>-vinyl acetate) (PVP/VA) and different nanoparticles. A: Load force <i>versus</i> displacement diagram; B: Hardness test results; C: Elastic modulus measurement results. <i>n</i> = 6, <span class="mag-xml-overline" style="border-top:1px solid black"><i>x</i></span>±<i>s</i>.<sup>**</sup><i>P</i> < 0.01, <sup>***</sup><i>P</i> < 0.001 <i>vs</i> PVP/VA group , figureFileSmall=jG9RZIXXSS3FHfZLNR/08g==, figureFileBig=zegcVJlbeRZIF9tAcr/Pww==, tableContent=null), ArticleFig(id=1208491501248688800, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=qFQA5umJGQcKJ2HPg9u6TQ==, figureFileBig=TqM3R84uaoPbuGR4xdPlZw==, tableContent=null), ArticleFig(id=1208491501424849585, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Figure 4, caption=
Measurement results of elastic modulus and hardness of thin slices formed by PVP/VA and Hap of different particle sizes. A: Load force <i>versus</i> displacement diagram; B: Hardness test results; C: Elastic modulus measurement results. <i>n</i> = 6, <span class="mag-xml-overline" style="border-top:1px solid black"><i>x</i></span>±<i>s</i>.<sup>*</sup><i>P</i> < 0.05, <sup>**</sup><i>P</i> < 0.01, <sup>***</sup><i>P</i> < 0.001 <i>vs</i> 100 nm group , figureFileSmall=qFQA5umJGQcKJ2HPg9u6TQ==, figureFileBig=TqM3R84uaoPbuGR4xdPlZw==, tableContent=null), ArticleFig(id=1208491501529707202, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=HFhcPJRh1KbnUoWp+niH0g==, figureFileBig=NF5fHT/ESvwicnwjHr02kA==, tableContent=null), ArticleFig(id=1208491501689090768, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Figure 5, caption=
Elastic modulus and hardness test results of nanoparticles with different proportions. A: Load force <i>versus</i> displacement diagram; B: Hardness test results; C: Elastic modulus measurement results. <i>n</i> = 6, <span class="mag-xml-overline" style="border-top:1px solid black"><i>x</i></span>±<i>s</i>.<sup>*</sup><i>P</i> < 0.05, <sup>**</sup><i>P</i> < 0.01, <sup>***</sup><i>P</i> < 0.001 <i>vs</i> 2% Hap group , figureFileSmall=HFhcPJRh1KbnUoWp+niH0g==, figureFileBig=NF5fHT/ESvwicnwjHr02kA==, tableContent=null), ArticleFig(id=1208491501903000288, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=n+qufD9nCuyMmF74ZGsNFA==, figureFileBig=qfI431KlNNq7OHYRO1WC/g==, tableContent=null), ArticleFig(id=1208491502087549676, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Figure 6, caption=
Results of the investigation of the compressive performance of a single microneedle. <i>n</i> = 6, <span class="mag-xml-overline" style="border-top:1px solid black"><i>x</i></span>±<i>s</i>.<sup>***</sup><i>P</i> < 0.001 <i>vs</i> PVP/VA group , figureFileSmall=n+qufD9nCuyMmF74ZGsNFA==, figureFileBig=qfI431KlNNq7OHYRO1WC/g==, tableContent=null), ArticleFig(id=1208491502318236410, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
| Stimulus response | Point |
| Erythema | |
| No erythema | 0 |
| Mild erythema (barely visible) | 1 |
| Moderate erythema (obviously visible) | 2 |
| Severe erythema | 3 |
| Fuchsia erythema to mild eschar formation | 4 |
| Edema | |
| No edema | 0 |
| Mild edema (barely visible) | 1 |
| Moderate edema (obviously raised) | 2 |
| Severe edema (skin uplift 1 mm, clear contour) | 3 |
| Severe edema (skin swelling over 1 mm and enlarged) | 4 |
| Highest total score | 8 |
), ArticleFig(id=1208491502477619978, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Table 1, caption=
The assessment of skin irritation degree
, figureFileSmall=null, figureFileBig=null, tableContent=
| Stimulus response | Point |
| Erythema | |
| No erythema | 0 |
| Mild erythema (barely visible) | 1 |
| Moderate erythema (obviously visible) | 2 |
| Severe erythema | 3 |
| Fuchsia erythema to mild eschar formation | 4 |
| Edema | |
| No edema | 0 |
| Mild edema (barely visible) | 1 |
| Moderate edema (obviously raised) | 2 |
| Severe edema (skin uplift 1 mm, clear contour) | 3 |
| Severe edema (skin swelling over 1 mm and enlarged) | 4 |
| Highest total score | 8 |
), ArticleFig(id=1208491502632809239, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
| Point | Evaluation |
| 0 - 0.49 | Non-irritation |
| 0.5 - 2.99 | Mild irritation |
| 3.0 - 5.99 | Moderately irritation |
| 6.0 - 8.00 | Severe irritation |
), ArticleFig(id=1208491502767026973, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Table 2, caption=
The evaluation of skin irritation degree
, figureFileSmall=null, figureFileBig=null, tableContent=
| Point | Evaluation |
| 0 - 0.49 | Non-irritation |
| 0.5 - 2.99 | Mild irritation |
| 3.0 - 5.99 | Moderately irritation |
| 6.0 - 8.00 | Severe irritation |
), ArticleFig(id=1208491502934799150, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
| Microneedle type | Penetration depth/μm | Average/μm |
Nano-enhanced dissolving
microneedles | 414.59 | 409.28*** |
| 405.03 |
| 408.22 |
| Dissolving microneedles | 357.19 | 349.75 |
| 344.43 |
| 347.62 |
), ArticleFig(id=1208491503077405506, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Table 3, caption=
Investigation results of microneedle penetration performance. n = 3. ***P < 0.001 vs dissolving microneedles
, figureFileSmall=null, figureFileBig=null, tableContent=
| Microneedle type | Penetration depth/μm | Average/μm |
Nano-enhanced dissolving
microneedles | 414.59 | 409.28*** |
| 405.03 |
| 408.22 |
| Dissolving microneedles | 357.19 | 349.75 |
| 344.43 |
| 347.62 |
), ArticleFig(id=1208491503182263114, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
| Time/h | Test group | | Control group |
| Damaged skin | Complete skin | Damaged skin | Complete skin |
| 1 | 1 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| 24 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 72 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
), ArticleFig(id=1208491503291315031, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Table 4, caption=
The result of skin irritation. n = 4
, figureFileSmall=null, figureFileBig=null, tableContent=
| Time/h | Test group | | Control group |
| Damaged skin | Complete skin | Damaged skin | Complete skin |
| 1 | 1 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| 24 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 72 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
), ArticleFig(id=1208491503412949858, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
| Time/h | Damaged skin nano-enhanced microneedle group | Complete skin nano-enhanced microneedle group | Damaged skin blank microneedle group | Complete skin blank microneedle group |
| 1 | 1.5 | 0 | 0.25 | 0 |
| 24 | 0.5 | 0 | 0 | 0 |
| 72 | 0 | 0 | 0 | 0 |
), ArticleFig(id=1208491503542973295, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1208491490846815047, language=CN, label=Table 5, caption=
The evaluation results of skin irritation. n = 4
, figureFileSmall=null, figureFileBig=null, tableContent=
| Time/h | Damaged skin nano-enhanced microneedle group | Complete skin nano-enhanced microneedle group | Damaged skin blank microneedle group | Complete skin blank microneedle group |
| 1 | 1.5 | 0 | 0.25 | 0 |
| 24 | 0.5 | 0 | 0 | 0 |
| 72 | 0 | 0 | 0 | 0 |
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