经皮给药压敏胶和水凝胶材料的制备与性能

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1、摘要经皮给药具有诸多优点，是现代给药制剂一大发展方向，但目前我国经皮给药制剂所用辅料严重缺乏，极大限制了该剂型的发展，本论文对适于皮肤用的亲水性非离子聚氨酯压敏胶及两类聚乙烯醇(PVA)凝胶基质进行了研究，期望制得新型经皮给药制剂的适宜基质。非离子聚氨酯压敏胶是由二异氰酸酯与多元醇的混合物进行反应，生成预聚体，再经扩链制得。论文考察了异氰酸酯的种类、反应温度、时间及原料配比等因素的影响，确定了工艺稳定、产品性能优良的亲水性聚氨酯压敏胶的配方及制备工艺。采用斜坡滚球停止法、1800剥离、持粘力测试等方法对一些影响压敏胶力学性能的因素进行了

2、考察。采用Franz扩散池对载药压敏胶贴剂的经皮药物释放行为进行了体外考察。结果表明，该聚氨酯压敏胶贴剂具有良好的力学性能及药物控释能力，适用于经皮给药系统。本论文分别采用硼砂和正硅酸乙酯为交联剂，制备出了I型和II型PVA凝胶。考察了两类凝胶的力学性能与溶胀性能和各影响因素；对两类凝胶进行了透皮释放实验，研究了它们与药物的相容性及经皮给药性能。结果表明，II型PVA凝胶在力学性能(如强度、韧性等方面)和溶胀性能上优于I型PVA凝胶，其药物释放速率略低于I型PVA凝胶。关键词：经皮给药制剂，压敏胶，聚氨酯，凝胶ABSTRACTTrans

3、dermaldrugdeliverysystem(TDDs)hasreceivedmuchattentionindrugreleasebecauseofseveraladvantages．TheseriouslackofpolymermaterialsusedinTDDsisabigboale-neckproblemembarrassingthedevelopmentofTDDs．Inthispapertheskincompatiblehydrophilicpolyurethanepressuresensitiveadhesives(P

4、SAs)andtWOtypesofpolyvinylalcohol(PVA)hydrogelwerestudiedinordertodevelopednewmaterialsforTDDs．ThehydrophilicpolyurethanePSAsweresynthesizedbypolyadditionofpolymerglycol，diisocyanateandextender．Theeffects，suchasthekindsofthediisocyanates，thetemperature，thereactiontimeand

5、theratiosofthematerialsontheproductions，werestudiedcarefullyinthiswork．Themethodsofrollingbollataslope，peelingat1800angleandcohesiontestwereusedtoevaluatethemechanicalpropertiesofPSAs．ThetransdermaldrugdeliverypropertiesofthepreparedPSAswereevaluatedinvitrobyFranzediffus

6、emethod．ThestudyresultsindicatedthatthehydrophilicpolyurethanePSAspreparedinthispapershowgoodmechanicalanddrugdeliveryproperties，whichsuitfortheTDDsapplication．TwotypesofPVAhydrogels，PVA-IandPVA—II，werepreparedbyusingboraxandtetraethoxysilanes(TEeS)ascrosslinkers．Themech

7、anicsandswellingbehaviorofthetwogels，aswellastheirinfluencefactors，wereinvestigated．Thetransdermalreleaseexperimentswerealsoperformedinordertoevaluatethedrugcompatibilityandcontroldrugreleaseproblem．ThestudyresultsshowthatPVA-IIhydrogelpresentsbetterperformanceinmechanic

8、sandswellingpropertiesthanPVA·I，whilePVA-Ishowslightlyhigherdrugreleaserate．KEYWORDS：transdermaldrugdel