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Article(id=1195000464937829096, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195000462479966923, articleNumber=1001-2494(2025)07-0673-07, orderNo=null, doi=10.11669/cpj.2025.07.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1719504000000, receivedDateStr=2024-06-28, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1762839912875, onlineDateStr=2025-11-11, pubDate=1744041600000, pubDateStr=2025-04-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1762839912875, onlineIssueDateStr=2025-11-11, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1762839912875, creator=13701087609, updateTime=1762839912875, updator=13701087609, issue=Issue{id=1195000462479966923, tenantId=1146029695717560320, journalId=1190317699101192196, year='2025', volume='60', issue='7', pageStart='665', pageEnd='776', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1762839912289, creator=13701087609, updateTime=1762840003355, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1195000844501365697, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195000462479966923, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1195000844501365698, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195000462479966923, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=673, endPage=679, ext={EN=ArticleExt(id=1195000465147544303, articleId=1195000464937829096, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Research Progress on SIS Pressure-Sensitive Adhesive: Functionality and Application in Patch Formulation Design, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Styrene-isoprene-styrene block copolymer pressure sensitive adhesive (SIS-PSA) is an ideal commercial adhesive with unique environmental attributes and high processability. As a key excipient for patches, SIS-PSA has a significant impact on the key properties such as drug release and adhesion. Since the performance of SIS-PSA is determined by a combination of different components, a thorough understanding of these components is essential for patch formulation design. This article discusses the impact of each component in SIS-PSA on the key performance of patches, summarizes the composition and application of marketed SIS-PSA patches, and focuses on patch formulation design oriented towards clinical needs, aiming to provide a reference for the research and development of SIS-PSA patches.

, correspAuthors=Jinsong DING, 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, authorCompany=null, fund=null, authors=null, authorsList=Difu SHI, Zhiyuan HOU, Xiangcheng ZHAO, Jinsong DING), CN=ArticleExt(id=1195000743418642474, articleId=1195000464937829096, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=苯乙烯-异戊二烯-苯乙烯嵌段共聚物型压敏胶在贴剂处方设计中的功能与应用研究进展, columnId=1190352408384471863, journalTitle=中国药学杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

苯乙烯-异戊二烯-苯乙烯嵌段共聚物型压敏胶(SIS-PSA)具有独特环保属性和高度可加工性,是一种理想的商业化胶黏剂。作为贴剂的关键辅料,SIS-PSA对药物释放、黏附力等关键性能具有显著影响。由于SIS-PSA的功能是由处方中各种组分共同发挥作用的,因此,深入了解这些组分的性质对于贴剂处方设计至关重要。本文综述SIS-PSA中各组分对贴剂关键性能的影响,并概述已上市的SIS-PSA贴剂组成及其应用,着重讨论以临床需求为导向的贴剂处方设计,旨在为SIS-PSA贴剂的研发提供参考。

, correspAuthors=丁劲松, authorNote=null, correspAuthorsNote=
*丁劲松,男,博士,教授,博士生导师 研究方向:药物新剂型及新技术 Tel:(0731)82650250
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史帝夫,男,硕士研究生 研究方向:经皮给药系统

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史帝夫,男,硕士研究生 研究方向:经皮给药系统

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史帝夫,男,硕士研究生 研究方向:经皮给药系统

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Transdermal patch containing ropinirole: Europe, EP3284465B1[P]. 2019-10-23., articleTitle=Transdermal patch containing ropinirole: Europe, EP3284465B1, refAbstract=null), Reference(id=1195054806113981115, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[43], rfOrder=42, authorNames=HISAMITSU, journalName=null, refType=null, unstructuredReference=HISAMITSU. Ropinirole-containing patch and method for improving skin permeability of ropinirole: Europe, EP4032588A4[P]. 2022-12-21., articleTitle=Ropinirole-containing patch and method for improving skin permeability of ropinirole: Europe, EP4032588A4, refAbstract=null), Reference(id=1195054806176895676, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=2018, volume=90, issue=1, pageStart=5, pageEnd=10, url=null, language=null, rfNumber=[44], rfOrder=43, authorNames=ROMITA P, FOTI C, CALOGIURI G, journalName=Acta Biomed, refType=null, unstructuredReference=ROMITA P, FOTI C, CALOGIURI G, et al. Contact dermatitis due to transdermal therapeutic systems: a clinical update[J]. 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Chin J Pharm(中国医药工业杂志), 2023, 54(2): 191-199., articleTitle=Research progress of transdermal drug delivery systems in treatment of mental disorders, refAbstract=null), Reference(id=1195054806306919102, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/1190700, language=null, rfNumber=[46], rfOrder=45, authorNames=PMDA, journalName=null, refType=null, unstructuredReference=PMDA. (Rivastigmine Exelon® Patch) [EB/OL]. (2023-08-29) [2024-06-27]. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/1190700., articleTitle=(Rivastigmine Exelon® Patch), refAbstract=null), Reference(id=1195054806369833663, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083_exelon_toc.cfm, language=null, rfNumber=[47], rfOrder=46, authorNames=FDA, journalName=null, refType=null, unstructuredReference=FDA. Drug Approval Package: Exelon Patch (rivastigmine transdermal system)[EB/OL]. (2009-05-28) [2024-06-27]. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083_exelon_toc.cfm., articleTitle=Drug Approval Package: Exelon Patch (rivastigmine transdermal system), refAbstract=null), Reference(id=1195054806445331136, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=https://www.ono-pharma.com/sites/default/files/ja/news/press/n19_0314.pdf, language=null, rfNumber=[48], rfOrder=47, authorNames=ONO-PHARMACEUTICAL, journalName=null, refType=null, unstructuredReference=ONO-PHARMACEUTICAL. New base formulations of Rivastigmine® patch and Exelon® patch for the treatment of Alzheimer's disease approved[EB/OL]. (2019-03-14) [2024-06-27]. https://www.ono-pharma.com/sites/default/files/ja/news/press/n19_0314.pdf., articleTitle=New base formulations of Rivastigmine® patch and Exelon® patch for the treatment of Alzheimer's disease approved, refAbstract=null), Reference(id=1195054806516634305, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=2023, volume=103, issue=null, pageStart=adv18428, pageEnd=null, url=null, language=null, rfNumber=[49], rfOrder=48, authorNames=HAMNERIUS N, DAHLIN J, BRUZE M, journalName=Acta Derm Venereol, refType=null, unstructuredReference=HAMNERIUS N, DAHLIN J, BRUZE M, et al. Colophonium-related allergic contact dermatitis caused by medical adhesive tape used to prevent skin lesions in soldiers[J]. Acta Derm Venereol, 2023, 103: adv18428. 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(2023-07-19) [2024-06-27]. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/2649896., articleTitle=Esflurbiprofen (LOQOA® Tapes), refAbstract=null), Reference(id=1195054806856372934, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/2649735, language=null, rfNumber=[54], rfOrder=53, authorNames=PMDA, journalName=null, refType=null, unstructuredReference=PMDA. Loxoprofen sodium (Loxonin® Tape) [EB/OL]. (2023-06-30) [2024-06-27]. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/2649735., articleTitle=Loxoprofen sodium (Loxonin® Tape), refAbstract=null), Reference(id=1195054806923481799, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/2649732, language=null, rfNumber=[55], rfOrder=54, authorNames=PMDA, journalName=null, refType=null, unstructuredReference=PMDA. Flurbiprofen (Yakuban® Tapes) [EB/OL]. (2022-07-01) [2024-06-27]. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/2649732., articleTitle=Flurbiprofen (Yakuban® Tapes), refAbstract=null), Reference(id=1195054806994784968, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/2649719, language=null, rfNumber=[56], rfOrder=55, authorNames=PMDA, journalName=null, refType=null, unstructuredReference=PMDA. Indometacin (Catlep® Tapes) [EB/OL]. (2023-07-28) [2024-06-27]. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/2649719., articleTitle=Indometacin (Catlep® Tapes), refAbstract=null), Reference(id=1195054807066088137, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=https://www.fda.gov/regulatory-information/search-fda-guidance-documents/residual-drug-transdermal-and-related-drug-delivery-systems, language=null, rfNumber=[57], rfOrder=56, authorNames=FDA, journalName=null, refType=null, unstructuredReference=FDA. Residual drug in transdermal and related drug delivery systems[EB/OL]. (2020-04-23) [2024-06-27]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/residual-drug-transdermal-and-related-drug-delivery-systems., articleTitle=Residual drug in transdermal and related drug delivery systems, refAbstract=null), Reference(id=1195054807149974218, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20612.cfm, language=null, rfNumber=[58], rfOrder=57, authorNames=FDA, journalName=null, refType=null, unstructuredReference=FDA. Drug approval package: Lidoderm® (lidocaine) Patch[EB/OL]. (2005-07-05) [2024-06-27]. https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20612.cfm., articleTitle=Drug approval package: Lidoderm® (lidocaine) Patch, refAbstract=null), Reference(id=1195054807225471691, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=2023, volume=27, issue=9, pageStart=307, pageEnd=319, url=null, language=null, rfNumber=[59], rfOrder=58, authorNames=TANG J Y, ZHANG Y C, LIU C X, journalName=Curr Pain Headache Rep, refType=null, unstructuredReference=TANG J Y, ZHANG Y C, LIU C X, et al. Therapeutic strategies for postherpetic neuralgia: mechanisms, treatments, and perspectives[J]. Curr Pain Headache Rep, 2023, 27(9): 307-319., articleTitle=Therapeutic strategies for postherpetic neuralgia: mechanisms, treatments, and perspectives, refAbstract=null), Reference(id=1195054807296774860, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202346, language=null, rfNumber=[60], rfOrder=59, authorNames=FDA, journalName=null, refType=null, unstructuredReference=FDA. FDA-approved drugs: Lidocaine Patch[EB/OL]. (2019-10-02) [2024-06-27]. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202346., articleTitle=FDA-approved drugs: Lidocaine Patch, refAbstract=null), Reference(id=1195054807363883725, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207962Orig1s000TOC.cfm, language=null, rfNumber=[61], rfOrder=60, authorNames=FDA, journalName=null, refType=null, unstructuredReference=FDA. Drug approval package: ZTLIDOTM[EB/OL]. (2019-07-22) [2024-06-27]. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207962Orig1s000TOC.cfm., articleTitle=Drug approval package: ZTLIDOTM, refAbstract=null), Reference(id=1195054807447769806, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=2020, volume=13, issue=null, pageStart=1485, pageEnd=1496, url=null, language=null, rfNumber=[62], rfOrder=61, authorNames=GUDIN J, ARGOFF C, FUDIN J, journalName=J Pain Res, refType=null, unstructuredReference=GUDIN J, ARGOFF C, FUDIN J, et al. A randomized, open-label, bioequivalence study of lidocaine topical system 1.8% and lidocaine patch 5% in healthy subjects[J]. J Pain Res, 2020, 13: 1485-1496., articleTitle=A randomized, open-label, bioequivalence study of lidocaine topical system 1.8% and lidocaine patch 5% in healthy subjects, refAbstract=null), Reference(id=1195054807519072975, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[63], rfOrder=62, authorNames=ITOCHU, journalName=null, refType=null, unstructuredReference=ITOCHU. Non-aqueous patch: U.S., US9925264B2[P]. 2018-03-27., articleTitle=null, refAbstract=null), Reference(id=1195054807590376144, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, doi=null, pmid=null, pmcid=null, year=2024, volume=397, issue=null, pageStart=124052, pageEnd=null, url=null, language=null, rfNumber=[64], rfOrder=63, authorNames=MIR B BAKHTAWAR, NAZ S, journalName=J Mol Liq, refType=null, unstructuredReference=MIR B BAKHTAWAR, NAZ S, et al. Pharmaceutical applications of lidocaine-based ionic liquids-a remarkable innovation in drug delivery[J]. J Mol Liq, 2024, 397: 124052. 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活性成分 商品名 适应证 聚合物 增黏树脂 增塑剂 抗氧剂 批准机构(批准时间)
水杨酸甲酯、薄荷醇 Salonpas® 局部炎症、疼痛 SIS、PIB 脂环族饱和烃树脂 矿物油 N/A2) FDA(2008.02)
酮洛芬 Mohrus®Tapes SIS、PIB 氢化松香甘油酯 LP BHT PMDA(2008.03)
氟比洛芬 Yakuban®Tapes SIS、PIB 松香酯树脂 LP BHT PMDA(2008.03)
洛索洛芬钠 Loxonin®Tape SIS、PIB 氢化松香甘油酯 LP BHT PMDA(2008.03)、NMPA(2014.06)
吲哚美辛 Catlep®Tapes SIS、PIB 脂环族饱和烃树脂 LP BHT PMDA(2010.07)
艾氟洛芬 LOQOA®Tapes SIS、PIB 松香酯树脂HG LP BHT PMDA(2015.09)
双氯芬酸钠 Naboal®Tape SIS、PIB 萜烯树脂 LP BHT PMDA(2008.03)
Voltaren®Tape SIS、PIB 脂环族饱和烃树脂 LP BHT PMDA(2008.03)
Zicthoru®Tapes 癌症相关疼痛(追加) SIS、PIB 氢化松香甘油酯、脂环族饱和烃树脂 LP BHT PMDA(2021.03)
硝酸异山梨酯 EMEC® 心绞痛等缺血性心脏病 SIS、PB 脂肪烃树脂、萜烯树脂 LP N/A PMDA(2008.03)
硝酸甘油 Millistape® SIS 脂环族饱和烃树脂 N/A BHT PMDA(2006.07)
妥洛特罗 Tulobuterol®Tapes 呼吸道阻塞性疾病 SIS、PB 脂环族饱和烃树脂 LP BHT PMDA(2006.03)
利多卡因 Lidocaine®Tapes 穿刺/手术/激光疼痛 SIS 脂环族饱和烃树脂 LP N/A PMDA(2017.02)
ZTlido® 带状疱疹后神经痛 SIS、PIB 萜烯树脂 矿物油 BHT FDA(2018.02)
卡巴拉汀 Exelon®Patch 阿尔茨海默病 SIS、PIB N/A LP N/A PMDA(2011.04)
富马酸依美斯汀 Allesaga®Tapes 过敏性鼻炎 SIS、PIB 脂环族饱和烃树脂 LP BHT PMDA(2018.01)
阿塞那平 Secuado® 精神分裂症 SIS、PIB 脂环族饱和烃树脂 矿物油 BHT FDA(2019.10)
盐酸罗匹尼罗 Haruropi®Tapes 帕金森病 SIS、PIB 脂环族饱和烃树脂 LP N/A PMDA(2019.09)
), ArticleFig(id=1195054802783703696, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195000464937829096, language=CN, label=表1, caption=

部分已上市的苯乙烯-异戊二烯-苯乙烯嵌段共聚物型压敏胶(SIS-PSA)贴剂信息汇总1)

, figureFileSmall=null, figureFileBig=null, tableContent=
活性成分 商品名 适应证 聚合物 增黏树脂 增塑剂 抗氧剂 批准机构(批准时间)
水杨酸甲酯、薄荷醇 Salonpas® 局部炎症、疼痛 SIS、PIB 脂环族饱和烃树脂 矿物油 N/A2) FDA(2008.02)
酮洛芬 Mohrus®Tapes SIS、PIB 氢化松香甘油酯 LP BHT PMDA(2008.03)
氟比洛芬 Yakuban®Tapes SIS、PIB 松香酯树脂 LP BHT PMDA(2008.03)
洛索洛芬钠 Loxonin®Tape SIS、PIB 氢化松香甘油酯 LP BHT PMDA(2008.03)、NMPA(2014.06)
吲哚美辛 Catlep®Tapes SIS、PIB 脂环族饱和烃树脂 LP BHT PMDA(2010.07)
艾氟洛芬 LOQOA®Tapes SIS、PIB 松香酯树脂HG LP BHT PMDA(2015.09)
双氯芬酸钠 Naboal®Tape SIS、PIB 萜烯树脂 LP BHT PMDA(2008.03)
Voltaren®Tape SIS、PIB 脂环族饱和烃树脂 LP BHT PMDA(2008.03)
Zicthoru®Tapes 癌症相关疼痛(追加) SIS、PIB 氢化松香甘油酯、脂环族饱和烃树脂 LP BHT PMDA(2021.03)
硝酸异山梨酯 EMEC® 心绞痛等缺血性心脏病 SIS、PB 脂肪烃树脂、萜烯树脂 LP N/A PMDA(2008.03)
硝酸甘油 Millistape® SIS 脂环族饱和烃树脂 N/A BHT PMDA(2006.07)
妥洛特罗 Tulobuterol®Tapes 呼吸道阻塞性疾病 SIS、PB 脂环族饱和烃树脂 LP BHT PMDA(2006.03)
利多卡因 Lidocaine®Tapes 穿刺/手术/激光疼痛 SIS 脂环族饱和烃树脂 LP N/A PMDA(2017.02)
ZTlido® 带状疱疹后神经痛 SIS、PIB 萜烯树脂 矿物油 BHT FDA(2018.02)
卡巴拉汀 Exelon®Patch 阿尔茨海默病 SIS、PIB N/A LP N/A PMDA(2011.04)
富马酸依美斯汀 Allesaga®Tapes 过敏性鼻炎 SIS、PIB 脂环族饱和烃树脂 LP BHT PMDA(2018.01)
阿塞那平 Secuado® 精神分裂症 SIS、PIB 脂环族饱和烃树脂 矿物油 BHT FDA(2019.10)
盐酸罗匹尼罗 Haruropi®Tapes 帕金森病 SIS、PIB 脂环族饱和烃树脂 LP N/A PMDA(2019.09)
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苯乙烯-异戊二烯-苯乙烯嵌段共聚物型压敏胶在贴剂处方设计中的功能与应用研究进展
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史帝夫 1 , 侯志远 1 , 赵祥程 1 , 丁劲松 1, 2, *
中国药学杂志 | 综述 2025,60(7): 673-679
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中国药学杂志 | 综述 2025, 60(7): 673-679
苯乙烯-异戊二烯-苯乙烯嵌段共聚物型压敏胶在贴剂处方设计中的功能与应用研究进展
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史帝夫1, 侯志远1, 赵祥程1, 丁劲松1, 2, *
作者信息
  • 1 中南大学湘雅药学院, 长沙 410083
  • 2 长沙晶易医药科技股份有限公司, 长沙 410013

    • 史帝夫,男,硕士研究生 研究方向:经皮给药系统

通讯作者:

*丁劲松,男,博士,教授,博士生导师 研究方向:药物新剂型及新技术 Tel:(0731)82650250
Research Progress on SIS Pressure-Sensitive Adhesive: Functionality and Application in Patch Formulation Design
Difu SHI1, Zhiyuan HOU1, Xiangcheng ZHAO1, Jinsong DING1, 2, *
Affiliations
  • 1 Xiangya School of Pharmaceutical Sciences, Central South University, Changsha 410083, China
  • 2 Changsha King-eagle Medical Science and Technology Co., Ltd., Changsha 410013, China
出版时间: 2025-04-08 doi: 10.11669/cpj.2025.07.002
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苯乙烯-异戊二烯-苯乙烯嵌段共聚物型压敏胶(SIS-PSA)具有独特环保属性和高度可加工性,是一种理想的商业化胶黏剂。作为贴剂的关键辅料,SIS-PSA对药物释放、黏附力等关键性能具有显著影响。由于SIS-PSA的功能是由处方中各种组分共同发挥作用的,因此,深入了解这些组分的性质对于贴剂处方设计至关重要。本文综述SIS-PSA中各组分对贴剂关键性能的影响,并概述已上市的SIS-PSA贴剂组成及其应用,着重讨论以临床需求为导向的贴剂处方设计,旨在为SIS-PSA贴剂的研发提供参考。

苯乙烯-异戊二烯-苯乙烯嵌段共聚物  /  压敏胶  /  贴剂  /  黏附性能  /  处方设计

Styrene-isoprene-styrene block copolymer pressure sensitive adhesive (SIS-PSA) is an ideal commercial adhesive with unique environmental attributes and high processability. As a key excipient for patches, SIS-PSA has a significant impact on the key properties such as drug release and adhesion. Since the performance of SIS-PSA is determined by a combination of different components, a thorough understanding of these components is essential for patch formulation design. This article discusses the impact of each component in SIS-PSA on the key performance of patches, summarizes the composition and application of marketed SIS-PSA patches, and focuses on patch formulation design oriented towards clinical needs, aiming to provide a reference for the research and development of SIS-PSA patches.

styrene-isoprene-styrene block copolymer  /  pressure sensitive adhesive  /  patch  /  adhesion property  /  formulation design
史帝夫, 侯志远, 赵祥程, 丁劲松. 苯乙烯-异戊二烯-苯乙烯嵌段共聚物型压敏胶在贴剂处方设计中的功能与应用研究进展. 中国药学杂志, 2025 , 60 (7) : 673 -679 . DOI: 10.11669/cpj.2025.07.002
Difu SHI, Zhiyuan HOU, Xiangcheng ZHAO, Jinsong DING. Research Progress on SIS Pressure-Sensitive Adhesive: Functionality and Application in Patch Formulation Design[J]. Chinese Pharmaceutical Journal, 2025 , 60 (7) : 673 -679 . DOI: 10.11669/cpj.2025.07.002
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经皮给药系统(transdermal/topical drug delivery system,TDDS)旨在透过皮肤表层将活性成分递送至局部组织或全身循环,发挥预期的药理作用[1]。贴剂是TDDS中最常见的剂型,系指原料药物与适宜的材料制成的供贴敷在皮肤上的,可产生局部或全身性作用的一种薄片状柔性制剂[2]。例如,Naboal® Tape 15 mg[3]和Zicthoru® Tapes 75 mg[4]是具有相同面积(70 cm2)、相同用法(1日1次)、不同载药量的双氯芬酸钠贴剂,前者仅用于局部组织的消炎镇痛,而后者还用于癌症的疼痛管理。贴剂在现代医疗中发挥重要作用,尤其是对于患有精神类、慢性疾病的患者而言,它提供了一种可视化、顺应性好的给药方式。
压敏胶(pressure sensitive adhesive,PSA)是一类对压力敏感的非反应性胶黏剂,无需借助溶剂、热量或其他手段,只需与被黏物表面接触后施加轻度的压力即可形成紧密黏合,是贴剂中不可或缺的组件。对于早期的储库型和基质型贴剂,PSA仅发挥皮肤黏附功能。然而,这类贴剂生产工艺复杂、结构稳定性差,且有药物倾泻的安全风险。如今,结构简单、易于生产的骨架型贴剂已逐渐成为市场主流[5],该类型设计中PSA不仅作为皮肤黏合剂,更直接作为载体骨架控制药物的释放[6](图1)。
用于制备贴剂的PSA根据其主体聚合物种类,可大致分为聚丙烯酸酯型PSA、聚异丁烯(polyisobutylene,PIB)型PSA、有机硅型PSA以及苯乙烯-异戊二烯-苯乙烯(styrene-isoprene-styrene,SIS)嵌段共聚物型PSA[7]。其中,SIS-PSA具有独特的环保属性和高度的可加工性,是一种理想的商业化PSA。材料上,SIS-PSA的固含量为100%,不含有机溶剂, 对环境友好。工艺上,SIS-PSA常用于热熔加工,冷却固化后即可直接应用,无需干燥、溶剂回收、废气净化等设备,安全性与自动化程度高,满足大批量高速生产需求。此外,当热熔工艺受限或需要加工对热敏感的物料时,亦可将SIS-PSA溶解或分散于适宜的溶剂(如甲苯、四氯化碳、辛烷等),转化为溶剂型PSA使用[8]。
SIS-PSA作为贴剂的关键辅料,通过控制药物和渗透增强剂释放至皮肤表面的速率,直接影响药物的经皮吸收。而其皮肤黏附性不仅关乎患者的用药顺应性,还决定了贴剂与皮肤的有效接触面积,也是影响药物经皮吸收的关键因素。考虑到SIS-PSA贴剂组分复杂,其功能是由各种组分共同塑造的,深入了解这些组分的性质对于贴剂处方设计至关重要。本文分析了SIS-PSA中各组分对贴剂关键性能的影响,概述了已上市的SIS-PSA贴剂组成与应用情况,通过剖析典型案例着重讨论了以临床需求为导向的SIS-PSA贴剂处方设计,期望对基于SIS-PSA的贴剂研究和开发提供参考。
1 SIS-PSA组分对贴剂关键性能的影响
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SIS-PSA是由SIS这类热塑弹性体作为主体聚合物,并辅以增黏树脂、增塑剂、抗氧剂等制成,这些组分通常相辅相成、缺一不可。为确保贴剂性能符合使用要求,研究者必须立足于SIS-PSA的基本组分,进行全面深入的处方研究。
1.1 SIS
SIS是于1965年首次推向市场的新一代三嵌段热塑弹性体,其分子结构由两端的硬塑性聚苯乙烯(polystyrene,PS)链段和中间的软弹性聚异戊二烯(polyisoprene,PI)链段构成[9]。这两种链段在热力学性质上存在显著差异,导致SIS在微观层面上形成典型的非均相体系——海岛结构,即一定区域内的PS聚集形成球形的物理交联点,分散在PI形成的连续相中。常温状态下,交联的PS相赋予了体系必要的刚性和内聚强度,确保了黏附的持久性;而柔性PI相则提供了良好的弹性和流动性,使其能够贴合于基材表面。当环境温度升高并超过PS的玻璃化转变温度(Tg)约100 ℃时,这些链段将发生滑移和重排,导致原本稳定的物理交联结构出现可逆性改变,这种变化使SIS-PSA在高温下熔融并具有可塑性(图2)[10-11]。
SIS分子结构,如PS/PI嵌段比、相对分子质量等,很大程度上决定了SIS-PSA的微观相分离形态。最近的研究表明,SIS的微观相分离形态(如PS相的形变和破裂、PI相的取向和拉伸)对其宏观力学性能(如应力-应变行为、拉伸强度和韧性等)具有重要影响[12-13],而这些性能正是实现压敏黏附的关键。Cui等[14]研究了SIS的嵌段比和相对分子质量对SIS-PSA的黏附性能影响,并结合透射电子显微镜下嵌段聚合物的聚集态结构对实验结果进行了分析。在SIS的相对分子质量固定为1.2×105的条件下,随着PS/PI嵌段比的增加,SIS-PSA的初黏力逐渐降低,而持黏力则先升后降。初黏力的降低可归因于PI相的减少,导致SIS-PSA的流动性不足,进而影响了其与基材表面的紧密贴合。而持黏力的先升后降则与PS相的增加有关。嵌段比增加初期,物理交联点的增多使得SIS-PSA的内聚力提高;然而,当嵌段比超过25%后,过多的PS相破坏了PI相的连续性,导致SIS-PSA的内聚力和持黏力均有所下降。不仅如此,SIS-PSA的黏附性能还受到SIS相对分子质量的影响。随着SIS相对分子质量的增加,SIS-PSA的持黏力持续升高,而初黏力则先升后降。这是因为随着SIS相对分子质量的增加,分子间范德华力逐渐增强,这有助于SIS的相分离结构更趋于完全状态。此时,PS相的刚性和PI相的弹性均得以较好地体现,并表现为持黏力与初黏力均高。然而,当SIS的相对分子质量超出某一特定范围后,SIS-PSA的流动性将会因内聚力过强而不足,并表现为初黏力的降低。
通常,SIS作为一种非极性高分子聚合物,根据相似相溶原理,更适合负载亲脂性药物。Yu等[15]考察了α-细辛醚等7种药物在SIS-PSA中的释放行为。结果显示,高亲脂性药物与SIS-PSA的相容性更好,药物扩散与释放速率更快。此外,他们的另一项研究指出SIS-PSA的内聚力是影响药物释放的主要因素,内聚力越大,则药物释放速率越慢[16]。这一发现与斯托克斯-爱因斯坦方程的描述一致,该方程表明药物的扩散系数与介质的黏度成反比。在SIS-PSA中,内聚力的大小反映了基质结构的致密程度,这可以类比为介质的黏度。因此,触感软、内聚力小的SIS-PSA往往能更快、更彻底地释放药物。
SIS的非极性特性不仅极大地限制了其对亲水性药物的负载和释放能力,还可能引起由于排汗效果不佳而导致的黏附力下降问题。为克服这些应用上的不足,近年来,许多研究者对SIS-PSA进行了亲水化改性研究,包括物理改性与化学改性。这两种改性策略的主要目的都是通过引入亲水性物质或极性基团,来增强体系的极性。例如,聚乙二醇是一种含有羟基和醚键的亲水性物质,它既可以通过物理共混的方式直接添加到SIS-PSA的配方中[17],也可以作为一种新的链段嵌入SIS原有的分子结构中[18],从而显著提升其亲水性。另一项研究中,Kang等[19]探究了磷酸等5种小分子酸对亲水性药物洛索洛芬钠(logP=-0.19)和疏水性药物氟比洛芬(logP=3.66)在SIS-PSA中的释放影响。结果显示,磷酸等小分子酸显著提高了洛索洛芬钠的释放和渗透速率,且这种增强效果远高于对氟比洛芬的影响。机制研究进一步表明,小分子酸通过向SIS-PSA中引入亲水性基团,提高了体系的亲水性,进而增强了亲水性药物在其中的溶解度、相容性和释放性能。
1.2 增黏树脂
常温条件下,SIS本身并不具备初黏性。为克服这一局限性,需要添加增黏树脂以增强SIS-PSA对基材表面的润湿能力,从而赋予其必要的压敏性与初黏性[20]。同时,具有一定极性的增黏树脂也可适当改善体系的极性[18]。鉴于SIS特殊的两相聚集态结构,在选用增黏树脂时必须考虑其与两相的相容性。通常,仅与PI相容性较好的增黏树脂,如脂环族改性脂肪烃树脂、脂肪烃树脂、萜烯树脂,是适用于SIS-PSA的理想增黏剂[11]。Sasaki等[21]使用透射电子显微镜、脉冲核磁共振和流变学方法研究了4种增黏树脂与PS、PI的相容性及其用量对SIS-PSA微观结构和性能的影响。结果显示,氢化脂环族树脂HC和脂肪烃树脂C5与PS相容性差,与PI良好相容。在低用量时,这两种树脂能够以分子水平均匀分布在PI相中,通过稀释效应削弱PI链段间的作用力,进而提高体系的流动性并减弱其内聚强度。然而,随着用量的增加,这些树脂将逐渐在PI相中析出并形成纳米尺度的树脂团聚体,限制PI链段的运动,并导致体系内聚力重新上升。与之不同,松香酯树脂RE和松香酚醛树脂RP与PS、PI相容性均好,表现出另一种作用模式。它们可以同时分布在PS相和PI相中,通过“溶胀”PS相的交联结构域,减少其对PI链段分子迁移率的限制。然而,随着用量的增加,PS相不断膨胀,最终导致SIS的微观相分离结构消失。进一步地,Sakaguchi等[22]使用摩擦力显微镜研究了两种增黏树脂与SIS的相容性对PSA表面摩擦行为的影响。结果显示,与PI相容的增黏树脂能显著降低PSA表面摩擦力,而与PS相容的增黏树脂则影响较小,这与PSA黏弹性表现一致。
1.3 增塑剂
增塑剂又称软化剂,其作用原理可概括为,通过削弱高分子聚合物的分子间作用力,进而增加链段的活动性。添加增塑剂可以进一步地降低SIS-PSA的熔融黏度、增加初黏性[23]。与增黏树脂类似,适用于SIS-PSA的增塑剂应仅与PI相容,而完全不相容于PS相,以确保必要的内聚强度。此外,理想的增塑剂还应具有低挥发性、低黏度、耐老化以及价格低廉等特点。通常,各种脂肪族矿物油,如液状石蜡(liquid paraffine,LP),以及低相对分子质量液态聚烯烃,如聚丁烯(polybutylene,PB)、PIB能够符合以上要求[11,24]。Wang等[25]以水杨酸甲酯、辣椒素和盐酸苯海拉明为模型药物,使用原子力显微镜和流变学方法研究了增塑剂LP对SIS-PSA微观结构以及药物释放行为的影响。结果显示,对于亲脂性药物水杨酸甲酯和辣椒素来说,LP有助于减少高分子聚合物链之间的相互作用,进而扩大了体系的自由体积,提高了药物的扩散系数。然而,对于亲水性药物盐酸苯海拉明来说,LP在药物释放过程中发挥双重调控作用。一方面,LP通过提高药物在体系中的扩散系数以促进药物释放;另一方面,LP通过竞争作用抑制了水分对基质内部的浸润,进而减少了亲水性药物的释放。最近,来自Kondo团队的两项研究进一步阐述了配方中LP/SIS配比对PSA性能的影响。其中,Terukina等[24]在固定配方中增黏树脂(脂环族饱和树脂)用量为30%的条件下,系统地研究了LP/SIS配比对PSA黏附力和内聚力的影响。流变学和剥离力测试结果表明,随着LP/SIS配比的增加(初始比为1),LP降低了高分子聚合物链之间的相互作用,并竞争性地干扰增黏树脂与PI相的相容性,导致PSA黏附力和内聚力均下降,表现为储能模量(G')、损耗模量(G″)和Tg降低。当LP/SIS>2.5时,SIS无法兼容过量的LP,对应热分析结果中出现新的吸热峰(约-25 ℃);且在100 Hz的高频测试中,PSA黏弹性表现为G″>G',暗示快速剥离时PSA的内聚力难以维持其形态。然而,质构测试结果显示,在慢速剥离条件下,LP/SIS配比并不影响PSA的内聚性能,即便LP/SIS>2.5,也未见内聚破坏现象。不同测试方法引起的结论差异可能源于检测频率或速率的差别,以及检测仪器与PSA直接接触部分的材质不同,如流变仪的不锈钢夹具、质构仪的特氟龙探针、拉力仪的聚对苯二甲酸乙二醇酯板。此外,Osanai等[26]以双氯芬酸钠为模型药物,研究了LP/SIS配比对PSA截面形貌以及药物释放和渗透行为的影响。结果显示,随着LP/SIS配比的增加(初始比为1),PSA与蒸馏水滴的接触角逐渐减小,而药物释放和渗透趋势则先升后降。这是因为适量的LP增加了PSA的自由体积和吸湿性,提高了药物扩散速率;但当扫描电子显微镜观察到PSA形貌变化,提示LP可能过量时,尽管接触角进一步减小,基质表面的LP却阻碍了水分对基质内部的浸润,减少了药物的释放。值得关注的是,虽然Kondo团队阐述了配方中LP/SIS配比对PSA黏附力和药物释放行为的影响,但可能受限于SIS-PSA基质组分与功能的复杂性,他们仍无法建立PSA黏附特性和药物释放之间的普遍相关性。
1.4 抗氧剂及其他组分
SIS的PI链段含有化学性质活泼的烯丙位氢原子,这些活泼氢容易在氧气、高温和紫外线等因素的促进下脱离而生成自由基。这一过程会导致PI链段发生氧化降解,进而引起SIS-PSA黏附、内聚等性能下降。因此,需要根据实际情况采取适当的防氧化措施,如添加抗氧剂或维持氮气环境。SIS-PSA配方中最常使用的是以二丁基羟基甲苯(butylated hydroxytoluene,BHT)为代表的受阻酚类抗氧剂。这类抗氧剂具有优异的抗氧化能力[27]、热稳定性[28],因而特别适合热熔工艺。其抗氧化的热力学机制在气相中由“氢原子转移”主导,而在极性溶剂中则由“质子优先损失电子转移”主导[27]。
除上述提到的几种SIS-PSA配方中的常见组分外,贴剂中的其他组分,如活性成分、透皮促渗剂、抑晶剂,以及由环境向基质中迁移的水分,都可能对贴剂的黏附或释放性能造成影响[29,30]。已有多项研究报道,一些药物对高分子聚合物具有显著的增塑作用,如布洛芬[31]、酮洛芬[32]和马来酸氯苯那敏[33]等。Lin等[34]研究了多种促渗剂以及抑晶剂共聚维酮S-630对PSA黏附性能和流变性能的影响。结果显示,多种促渗剂均能通过稀释效应削弱PSA的内聚力,使初黏力升高、持黏力降低;而共聚维酮则通过增加PSA的固体性质加强PSA的内聚力,使初黏力降低、持黏力升高。共聚维酮具有良好的水溶性和一定的吸湿性[35],因而笔者认为在实际应用中,还需关注皮肤水分的浸润与增塑作用对PSA内聚力的影响。
因此,在进行贴剂处方设计时,研究者应该避免陷入刻板印象,简单地认为某一组分仅代表某种限定的属性,而是应该遵循质量源于设计(quality by design,QbD)原则,全面、综合地评估每一种组分在实际应用中对贴剂性能产生的各种潜在影响。
2 已上市的SIS-PSA贴剂组成与应用概述
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基于SIS-PSA为骨架材料设计的贴剂,最早可追溯至20世纪70年代。1979年,久光制药(久光制药株式会社)在日本申请了一项关于新型贴剂的发明专利[36]。该贴剂的基材由三嵌段热塑弹性体(包括SIS)、增黏树脂、脂肪或高级脂肪酸混熔而成,随后将基材与抗炎类固醇混熔均匀并通过热熔涂布的方式制备为成品。如表1所示,目前,全球范围内已有多个以SIS-PSA为骨架材料的贴剂品种,相继通过美国食品药品监督管理局(Food and Drug Administration,FDA)、国家药品监督管理局(National Medical Products Administration,NMPA)、日本药品和医疗器械管理局(Pharmaceuticals and Medical Devices Agency,PMDA)审批并成功上市。这些贴剂的适应证涉及疼痛管理、心血管系统疾病、呼吸系统疾病以及精神神经系统疾病等多个领域。
根据PMDA和FDA所披露的信息(表1),这些贴剂大都是采用SIS和PIB的物理共混物作为PSA主体聚合物。久光制药的多篇贴剂专利[37-40]均明确指出,由SIS和PIB复配制成的PSA往往具有更加优异的皮肤黏附性能和药物递送效率。这可能是得益于PIB,特别是中、低相对分子质量的PIB,对SIS具有很好的增塑效果,它能通过削弱PI相的分子间作用力,进而提升SIS-PSA的流动性与药物的热力学活性。
理论上,SIS和PIB作为非极性物质,是亲脂性原型药物的理想载体。富马酸依美斯汀和盐酸罗匹尼罗的贴剂专利[41-43]中提到,可以向处方中添加诸如有机胺、长链脂肪酸金属盐等碱性物质将基质中亲水的盐型药物置换为原型药物或亲脂性较强的脂肪酸盐药物。这种一步制备的流程,虽然避免了对原料药进行预先处理的步骤,但也需要额外关注在制备过程中生成的副产物(有机胺盐、无机盐)对体系的影响。
3 以临床需求为导向的SIS-PSA贴剂处方设计
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临床需求是药品研发的出发点。在进行SIS-PSA贴剂处方设计时,研究者必须时刻以患者的实际临床需求为导向,致力于提升患者的用药体验,如减少皮肤副作用、优化黏附性能、提高药物利用率等。
3.1 减少皮肤副作用的设计
皮肤症状是使用贴剂时常见的副作用,并可能由PSA引起[44]。以卡巴拉汀贴剂为例,2007年,卡巴拉汀贴剂Exelon®以“Type 3-新剂型”类型获得FDA批准上市,成为全球首款用于治疗阿尔茨海默病的外用制剂[45]。此后,日本国内的临床试验结果确认了其有效性和安全性,并于2011年获得PMDA生产销售许可[46]。然而,在实际临床应用中,该药频繁引起的皮肤副作用严重影响了患者长期用药的顺应性。Exelon®由聚丙烯酸酯PSA形成的含药基质层和有机硅PSA形成的皮肤黏合层上下覆合而成[47]。为降低皮肤刺激性,提升患者的用药体验,制造商设计了一种基于SIS-PSA的“新处方制剂”,并于2019年获得处方变更许可[48]。新处方采用了不含增黏树脂的SIS-PSA来替换原处方中的两种PSA,并将核心结构由双层简化至单层。通常,增黏树脂为SIS-PSA提供了额外的黏附力,但也可能增加接触性或过敏性皮炎的风险[49]。可能是鉴于卡巴拉汀贴剂的应用时间较短(24 h),尺寸较小(2.5~10 cm2),且贴敷部位多为背、上臂、胸等平整皮肤,对贴剂黏附力的要求相对较低。因此,新处方的SIS-PSA中省略了增黏树脂这一组分,以提高皮肤安全性。新处方已通过人体药动学研究,验证了处方变更前后的生物等效性,并在兔和人的皮肤刺激性研究中显示出更低的皮肤刺激性[46]。
3.2 优化黏附性能的设计
以非甾体抗炎药贴剂为例,在外用非甾体抗炎药(nonsteroidal anti-inflammatory drugs,NSAIDs)剂型中,贴剂和凝胶贴膏因具有向患处持续释放药物的特点,在减少给药频率的同时往往能提供更好的疗效。Zeng等[50]在一项外用NSAIDs治疗骨关节炎的系统评价和网络荟萃分析中,发现双氯芬酸贴剂缓解疼痛的有效性优于双氯芬酸凝胶与溶液剂。相较于凝胶贴膏,贴剂更加轻薄且没有基质失水后黏附力下降的烦恼。基于SIS-PSA设计的NSAIDs贴剂,通常具有更好的持黏性、柔性与弹性,可以更持久地追随关节与皮肤的形变而不易脱落[51]。通常,改变增黏树脂和聚合物的用量,即可灵活调整贴剂的黏附力。例如,艾氟洛芬贴剂LOQOA® Tapes采用SIS-PSA作为骨架材料,具有持久黏附、不易脱落的特点。然而,过强的黏附力也带来了使用后难以剥离的困扰。为进一步提升患者的用药体验,制造商对原处方进行了部分调整。在新处方中,每贴的增黏树脂用量[松香酯树脂(HG)257 mg]减少了20%,同时聚合物用量(SIS+PIB:521 mg)增加了4%。这一改进不仅有效降低了贴剂的剥离力,而且确保了新处方与原处方在药物释放和渗透行为上的一致性,并通过人体药动学研究验证了其生物等效性[52]。这项改进在2020年获得了PMDA的处方变更许可[53]。
在用于治疗慢性肌肉骨骼疼痛的外用NSAIDs制剂的开发中,由凝胶贴膏向SIS-PSA贴剂的“新处方制剂”改进已成为一种趋势。包括洛索洛芬钠[54](Loxonin®)、氟比洛芬[55](Yakuban®)以及吲哚美辛[56](Catlep®)等在内的多种NSAIDs均经历了由凝胶贴膏“Pap”向贴剂“Tape”的产品革新。
3.3 提高药物利用率的设计
从被动扩散的角度考虑,TDDS中需要存在过量的药物,以保证药物在治疗期间的平稳释放。但同样不容忽视的是,制剂中残留的药物还可能带来意外暴露的风险。因此,FDA[57]鼓励在开发TDDS时使用QbD策略,优化药物递送以最大程度地减少药物载量和药物残留,并支持以这种观点进行现有产品的重新设计。
以利多卡因贴剂为例,5%利多卡因凝胶贴膏Lidoderm®,于1999年以“Type 3-新剂型”类型获得FDA批准上市[58]。如今,5%利多卡因凝胶贴膏是国内外公认的治疗带状疱疹后遗神经痛的一线治疗药物[59]。然而,每贴Lidoderm®的含药量高达700 mg,药物的实际利用率仅为(3±2)%,至少95%(即665 mg)的药物残留在制剂中[58]。据报道,利多卡因在pH 7.4时的正辛醇/水分配比为43/1,属于亲脂性药物[58],使用非水体系(非极性)载体材料将更有助于其释放。例如,2015年,基于PIB-PSA开发的Lidocaine Patch 5%(FDA仿制药号:202346)作为Lidoderm®的仿制药,每贴含药量降低至140 mg,而药物的实际利用率提升至(11±4)%[60]。2018年,基于SIS/PIB-PSA开发的1.8%利多卡因贴剂ZTlido®以“Type 5-新处方或新制造商”类型进入美国市场,每贴含药量仅为36 mg,药物的实际利用率高达48%[61]。一项其与Lidoderm®的单剂量、交叉、生物等效性研究[62]显示,ZTlido®在12 h的使用期间具有更好的黏附表现,并提供了与Lidoderm®等效的暴露量。ZTlido®的处方中除常见的SIS-PSA组分外,还包括二丙二醇、异硬脂酸。制造商专利[63]揭示,由有机酸与多元醇混合物构成的非水体系能够有效地溶解利多卡因,并保持稳定的释放速率。这可能是因为利多卡因含有叔胺基团,可与有机酸的羧酸基团产生相互作用(氢键、离子键等),进而改变其原有性质。基于这一原理,已有大量基于利多卡因的离子液体和深共晶溶剂体系被报道[64]。
4 问题与展望
收起
尽管SIS-PSA在TDDS领域的应用潜力已被广泛证实,但当前仍面临一系列亟待解决的问题和挑战。首先,SIS-PSA的组分复杂,不同组分的型号与配比是决定其性能优劣的关键。这要求研究者在开发基于SIS-PSA的TDDS时,需要具备扎实的理论基础与丰富的实践经验。我国在该领域的研发工作尚处早期,仍有较长的路要走。其次,现已借助流变学、体外释放、黏附力检测等手段对SIS-PSA组分、结构与其黏附、药物释放等性能之间的关系有了一定的理解,但仍需进一步结合现代分析技术,如扫描电子/透射电子/原子力显微镜以及质谱/红外/拉曼联用显微成像等,以更全面地揭示SIS-PSA的微观结构如何决定其功能。最后,对于贴剂而言,在体研究是评估SIS-PSA黏附性能的金标准,开发更接近于实际应用场景的体外评价方法,如模拟人皮肤材质的黏附力检测探头,将极大地助力此类产品的研发。
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2025年第60卷第7期
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doi: 10.11669/cpj.2025.07.002
  • 接收时间：2024-06-28
  • 首发时间：2025-11-11
  • 出版时间：2025-04-08
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  • 收稿日期：2024-06-28
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    1 中南大学湘雅药学院, 长沙 410083
    2 长沙晶易医药科技股份有限公司, 长沙 410013

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*丁劲松,男,博士,教授,博士生导师 研究方向:药物新剂型及新技术 Tel:(0731)82650250
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
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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