CN112166163A - 皮肤用层叠粘合性片材 - Google Patents

皮肤用层叠粘合性片材 Download PDF

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CN112166163A
CN112166163A CN201980035631.8A CN201980035631A CN112166163A CN 112166163 A CN112166163 A CN 112166163A CN 201980035631 A CN201980035631 A CN 201980035631A CN 112166163 A CN112166163 A CN 112166163A
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adhesive
skin
adhesive sheet
adhesive layer
sheet according
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CN112166163B (zh
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权英淑
长谷川纯也
天河崇
神山文男
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CosMED Pharmaceutical Co Ltd
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CosMED Pharmaceutical Co Ltd
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    • C09J7/00Adhesives in the form of films or foils
    • C09J7/30Adhesives in the form of films or foils characterised by the adhesive composition
    • C09J7/38Pressure-sensitive adhesives [PSA]
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    • A61K8/8141Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
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    • A61K9/7053Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7069Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
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Abstract

提供对皮肤的亲和性高,封闭敷料疗法(ODT)效果和伸缩性优异的局部皮肤应用片材。涉及依次层叠皮肤粘合层、保护粘合层和高伸缩支撑体而成的皮肤用层叠粘合性片材以及依次层叠皮肤粘合层、中间层、保护粘合层和高伸缩支撑体而成的皮肤用层叠粘合性片材。

Description

皮肤用层叠粘合性片材
技术领域
本发明涉及医疗用、化妆用的皮肤应用片材,详细而言,涉及层叠有粘合剂和膜的粘合片材。
背景技术
应用于皮肤的各种粘合性片材根据其目的开发并使用了具有各种性质的片材。一方面,提高了水蒸气透过性的产品的开发得以推行(专利文献1),另一方面,为了提高经皮吸收,还研发了封闭敷料疗法(Occlusive dressing therapy;ODT)。ODT中通过将软膏涂布于患部,用聚乙烯制、聚偏二氯乙烯制等的薄膜覆盖该部分,用创可贴固定并密封,从而提高了药物的经皮吸收,能够在短时间内治愈病变。为了这个目的,水蒸气透过性低的材料是有用的。
近年来,正在开发以下的技术:通过使用微小的针、即微针对角质层进行穿孔,由此与涂布法相比,可以显著提高药物透过效率。将多个这种微针聚集于基板上而成的就是微针阵列。另外,在微针阵列上附加用于使微针阵列附着于皮肤的粘合胶带或用于在使用前维持无菌状态的覆盖片材等,制成易于使用的产品,将其称为微针贴片。
若以糖质等在体内溶解并因代谢而消失的物质作为原材料来制作微针,则即使针折断并残留于皮肤内,也不会发生事故。不仅如此,若在糖质中含有药物,则通过所刺入的微针在体内溶解,能够容易地将药物向皮内、皮下给药(专利文献2)。
特别是,若将由透明质酸、胶原蛋白等生物体可溶性高分子物质构成的微针刺入皮肤,则皮肤内水分扩散到微针,插入到皮肤的针部溶胀,然后溶解。其结果是,透明质酸、胶原蛋白扩散到皮肤内而表现出抗皱作用,或者预先溶解于针部的药物、有用物质扩散到皮肤内(专利文献3、4)。
为了使微针在皮肤内溶胀并溶解,其间需要将微针阵列稳定地保持于皮肤表面。通常,将面积比微针阵列大的粘合性保护胶带覆盖在微针阵列上并按压到皮肤表面,通过该保护胶带的粘合性而进行密合保持。
然而,该粘合性保护胶带对微针在皮肤内的溶解性产生较大影响。若使用水蒸气透过性高的保护粘合胶带,则从皮肤进入到微针阵列的水分蒸发,微针不充分溶胀,药物向皮肤内扩散的速度降低。因此,胶带抑制水分从皮肤蒸发是很重要的。
如上所述,皮肤用粘合片材或微针用保护粘合片材降低水蒸气透过性是重要的。为了实现这一点,若使用水蒸气透过性低的支撑体,则会产生如下缺点:片材整体的刚性增加,贴附时无法跟随皮肤的活动,容易成为皮肤刺激的原因。
现有技术文献
专利文献
专利文献1:日本特表2012-532903号公报
专利文献2:日本特开2003-238347号公报
专利文献3:日本特开2009-273872号公报
专利文献4:日本特开2010-029634号公报
发明内容
发明要解决的课题
对于局部皮肤应用片材,要求在一定期间内用于将其固定于皮肤的粘合效果,并且兼具ODT效果和片材的伸缩性的特性。本发明的目的在于提供对皮肤的亲和性高、ODT效果和伸缩性优异的局部皮肤应用片材。
用于解决课题的手段
本发明人等确认了,3层片材实现了ODT效果和伸缩性的兼顾,从而完成了本发明,所述3层片材使用像丙烯酸系粘合剂那样与皮肤的亲和性高、长期贴附优异但透湿性高、不易发挥ODT效果的粘合层,透湿性低且ODT优异的橡胶系粘合剂,以及作为层叠支撑体的像氨基甲酸酯膜那样伸缩性高的膜。橡胶系粘合剂和丙烯酸系粘合剂的粘接性未必良好,有时也会发生剥离,因此为了进一步改良物性,通过在橡胶系粘合剂层与丙烯酸系粘合剂层之间夹设聚氨基甲酸酯片材,从而成功制造出层叠化得到改善、伸缩性和皮肤亲和性优异、ODT效果优异的粘合性片材,从而完成了本发明。
本发明如下所示。
〔1〕一种皮肤用层叠粘合性片材,是依次层叠皮肤粘合层、保护粘合层和高伸缩支撑体而成。
〔2〕一种皮肤用层叠粘合性片材,是依次层叠皮肤粘合层、中间层、保护粘合层和高伸缩支撑体而成。
〔3〕根据〔1〕或〔2〕中记载的粘合性片材,其中,上述皮肤粘合层包含丙烯酸系粘合剂或氨基甲酸酯系粘合剂。
〔4〕根据〔1〕~〔3〕中任一项记载的粘合性片材,其中,上述高伸缩支撑体由聚氨基甲酸酯膜或乙烯乙酸乙烯酯膜或氨基甲酸酯无纺布或聚酯无纺布构成。
〔5〕根据〔1〕~〔4〕中任一项记载的粘合性片材,其中,上述保护粘合层包含橡胶系粘合剂。
〔6〕根据〔2〕~〔5〕中任一项记载的粘合性片材,其中,上述中间层由聚氨基甲酸酯膜或乙烯乙酸乙烯酯膜构成。
〔7〕根据〔1〕~〔6〕中任一项记载的粘合性片材,其中,拉伸弹性模量为30N以下。
〔8〕根据〔1〕~〔7〕中任一项记载的粘合性片材,其中,水蒸气透过度为200g/m2·24h以下。
〔9〕根据〔1〕~〔8〕中任一项记载的粘合性片材,其中,上述皮肤粘合层的厚度为20μm~80μm。
〔10〕根据〔1〕~〔9〕中任一项记载的粘合性片材,其中,上述高伸缩支撑体的厚度为5μm~60μm。
〔11〕根据〔1〕~〔10〕中任一项记载的粘合性片材,其中,在上述皮肤粘合层的表面具有脱模片。
〔12〕根据〔1〕~〔11〕中任一项记载的粘合性片材,其中,上述皮肤粘合层包含药物或有用物质。
〔13〕根据〔12〕中记载的粘合性片材,其中,上述药物选自由以下组成的组:解热消炎镇痛剂、抗癫痫剂、抗精神病剂、抗抑郁剂、抗焦虑剂、抗帕金森病剂、抗瘙痒剂、抗痴呆症剂、催眠剂、镇静剂、解痉剂、肌肉松弛剂、自主神经作用剂、脑循环改善剂、脑代谢改善剂、强心剂、抗心绞痛剂、高血压用剂、心律失常用剂、血管扩张剂、降血压剂、加压剂、利尿剂、呼吸促进剂、镇咳祛痰剂、支气管扩张剂、哮喘治疗剂、鼻变态反应治疗剂、呼吸器用剂、感冒用剂、止吐剂、抗酸剂和抗溃疡剂。
〔14〕根据〔12〕中记载的粘合性片材,其中,上述有用物质选自由以下组成的组:美白成分、抗皱成分、抗炎症成分、血液循环促进成分、抗菌成分、抗瘙痒成分、各种维生素及其衍生物、抗氧化成分、抗变态反应成分和香料。
〔15〕一种粘合性片材,包括橡胶系粘合剂与
丙烯酸系粘合剂或氨基甲酸酯系粘合剂或有机硅系粘合剂的层叠粘合剂。
〔16〕一种粘合性片材,是将橡胶系粘合剂和
伸缩性支撑体和
丙烯酸系粘合剂或氨基甲酸酯系粘合剂或有机硅系粘合剂层叠而成。
发明的效果
本发明的粘合性片材是由以下的3层或优选4层结构构成的皮肤用粘合性片材。数字小的一方是接近皮肤的层。
1.由于为高透湿性而皮肤亲和性高的粘合剂层(皮肤粘合层)
优选丙烯酸系粘合剂、氨基甲酸酯粘合剂、有机硅粘合剂等。通过将片材作为皮肤接触表面贴附于皮肤,从而使其具有对皮肤的长期粘接性优异的性质。
2.低透湿性的粘合剂层(保护粘合层)
通过低透湿性、不释放来自皮肤的水分、密合性优异的特性,可以促进微针阵列的溶胀或溶解,另外,在贴附型医药品、化妆品中,提高皮肤对有用成分的吸收效果。优选使用橡胶系粘合剂。
3.具有伸缩性的支撑体膜(高伸缩支撑体)
优选氨基甲酸酯膜、EVA膜等。具有高伸缩性且与保护粘合层的粘接性良好的膜。
本发明涉及由以上这3层构成的皮肤用粘合性片材。
4.具有伸缩性的中间层膜(中间层)
皮肤粘合层的极性与保护粘合层的极性不同,在改良相互的粘接性而制成更良好的皮肤用粘合性片材的情况下,在上述两层之间层叠具有伸缩性的中间层膜(中间层)是有效的。该实施方式也是本发明的完成形式。即,将中间层夹在皮肤粘合层与保护粘合层之间。
优选氨基甲酸酯膜、EVA膜等。具有高伸缩性、与皮肤粘合层和保护粘合层的粘接性良好的膜。厚度优选为5μm~100μm。
附图说明
图1是表示本发明的粘合性片材的结构的截面图。本图为4层,但也存在没有中间层的情况。
附图标记说明
1:皮肤粘合层
2:保护粘合层
3:高伸缩支撑体
4:中间层
具体实施方式
1.皮肤粘合层
构成本发明的粘合性片材的皮肤粘合层为高透湿性且与皮肤接触的面,根据需要含有药物或有用物质。
皮肤粘合层中所含的粘合剂为高透湿性粘合剂,例如可举出丙烯酸系粘合剂、氨基甲酸酯系粘合剂、有机硅系粘合剂。其中,优选丙烯酸系粘合剂和氨基甲酸酯系粘合剂,最优选丙烯酸系粘合剂。
作为丙烯酸系粘合剂,可例示由碳数1~18,特别优选4~18的脂肪族醇和(甲基)丙烯酸得到的(甲基)丙烯酸烷基酯的均聚物、共聚物以及(甲基)丙烯酸烷基酯与其他官能性单体的共聚物。
作为官能性单体的实例,有具有羟基的单体、具有羧基的单体、具有酰胺基的单体、具有氨基的单体等,另外,作为共聚性单体,例如也可以使用乙酸乙烯酯、苯乙烯、α-甲基苯乙烯、氯乙烯、丙烯腈、乙烯、丙烯、丁二烯等。粘合剂中优选含有50质量%以上的(甲基)丙烯酸烷基酯作为(共)聚合成分。
氨基甲酸酯系粘合剂是具有氨基甲酸酯基(-NCHCOO-)的粘合剂,是通过使聚酯多元醇或聚醚多元醇与多价异氰酸酯类反应而制造,或者由聚氨基甲酸酯多元醇构成。优选由聚氨基甲酸酯多元醇构成的氨基甲酸酯系粘合剂。氨基甲酸酯系粘合剂也与丙烯酸系粘合剂同样地通过混和增塑剂并进一步使其交联,能够制成对肌肤温和且无残胶的粘合剂。
有机硅系粘合剂是由在主骨架具有硅氧烷键的聚合物构成的粘合剂。粘合物性良好,但价格昂贵。
上述粘合剂中可以根据需要添加增塑剂、填充剂、防老化剂等配合剂。
另外,上述粘合剂中可以根据需要含有药物或有用物质。
为了制备丙烯酸系粘合剂,通常在聚合引发剂的存在下进行所需单体的溶液聚合。但是,聚合方式不限于此。另外,聚合反应条件主要根据单体的种类来适当选择。
氨基甲酸酯系粘合剂的制备可以依据日本特开2016-65238号的记载来进行。
皮肤粘合层是具有水蒸气透过度为500g/m2·24h以上的性质的粘合层,需要吸收来自皮肤的水分的性能。水蒸气透过度测定法将在后文进行叙述。皮肤粘合层的厚度优选为20μm~80μm。
4.具有伸缩性的中间层膜(中间层)
中间层用于增强皮肤粘合层与保护粘合层之间的粘接。需要是具有高伸缩性,且与皮肤粘合层和保护粘合层的粘接性良好的膜。可以优选使用氨基甲酸酯膜、EVA膜、氨基甲酸酯无纺布、聚酯无纺布等。中间层膜需要在较弱的力下伸长而不断裂。作为与其对应的力学参数,优选中间层的拉伸弹性模量为0.1以下,断裂伸长率为100%以上。拉伸弹性模量的单位为104kg/cm2。拉伸弹性模量、断裂伸长率等膜的机械性质的测定法依据ASTM D638。具体而言,将总长65mm、窄的平行部长度57mm的哑铃形状的膜放置于拉伸试验机(岛津制作所),以5mm/min的速度进行拉伸,求出应力-应变曲线。根据初始倾斜的切线计算拉伸弹性模量,根据断裂时的伸长率测量断裂伸长率。
2.低透湿性的粘合剂层(保护粘合层)
构成本发明的粘合性片材的保护粘合层具有通过与皮肤粘合层层叠而对粘合性片材赋予防水(低透湿性)功能的作用。可以优选使用橡胶系粘合剂。作为橡胶系粘合剂,可例示通过向天然橡胶、苯乙烯-异戊二烯-苯乙烯嵌段共聚物、苯乙烯-丁二烯-苯乙烯嵌段共聚物、苯乙烯-烯烃-苯乙烯嵌段共聚物、聚异戊二烯、聚丁烯、聚异丁烯、乙烯-乙酸乙烯酯共聚物等橡胶弹性体100质量份中添加例如松香系树脂、聚萜烯树脂、香豆酮-茚树脂、石油系树脂、萜烯-酚树脂等粘合性赋予剂20质量份~200质量份以及根据需要添加适量液态聚丁烯、矿物油、羊毛脂、液态聚异戊二烯、液态聚丙烯酸酯等软化剂、氧化钛等填充剂、丁基羟基甲苯等防老化剂等而成的粘合剂。
上述粘合剂中可以根据需要添加增塑剂、填充剂、防老化剂等配合剂。例如,众所周知,苯乙烯-异戊二烯-苯乙烯嵌段共聚物并不是仅通过其自身而成为粘合剂,而是通过与增粘剂、油成分等混和而成为粘合剂。作为油成分,通常为液体石蜡,但也可以使用橄榄油、霍霍巴油、角鲨烷等。
保护粘合层的厚度优选5μm~200μm。
3.高伸缩支撑体
对高伸缩支撑体所要求的性质与对中间层膜所要求的性质相同,可以将与中间层膜相同的膜用于高伸缩支撑体。具体而言,可以使用氨基甲酸酯膜、EVA膜、氨基甲酸酯无纺布、聚酯无纺布等。通过调整保护粘合层成分,能够使粘合性极少,通过使用这样的保护粘合层,能够使其具有高伸缩支撑体的作用。
从柔软性的观点考虑,高伸缩支撑体的厚度通常为3μm~100μm,优选为5μm~60μm。
由以上的3层或4层构成的皮肤用层叠粘合性片材((皮肤粘合层、(中间层)、保护粘合层和高伸缩支撑体))的水蒸气透过度具有300g/cm2·24h以下、优选200g/cm2·24h以下、进一步优选100g/cm2·24h以下的值。另外,优选皮肤用层叠粘合性片材的拉伸弹性模量为30N以下。
脱模片
为了保护皮肤粘合层的表面的粘合力,本发明的粘合性片材可以在皮肤粘合层的表面具有脱模片。脱模片在应用于皮肤之前从粘合性片材取下。作为脱模片,可以没有限定地使用粘合制剂中通常使用的脱模片,例如可举出有机硅树脂涂布聚酯膜等。
药物和有用物质
作为上述皮肤粘合层中所含的药物和有用物质,只要是能够经皮透过生物体膜即可。
作为药物的实例,例如可例示解热消炎镇痛剂、抗癫痫剂、抗精神病剂、抗抑郁剂、抗焦虑剂、抗帕金森病剂、抗瘙痒剂、抗痴呆症剂、催眠剂、镇静剂、解痉剂、肌肉松弛剂、自主神经作用剂、脑循环改善剂、脑代谢改善剂、强心剂、抗心绞痛剂、高血压用剂、心律失常用剂、血管扩张剂、降血压剂、加压剂、利尿剂、呼吸促进剂、镇咳祛痰剂、支气管扩张剂、哮喘治疗剂、鼻变态反应治疗剂、呼吸器用剂、感冒用剂、止吐剂、抗酸剂、抗溃疡剂等。
本发明产品对皮肤的弯曲部的亲和性高,因此,作为包含解热消炎镇痛剂且适合应用于肘等弯曲部位的药物,可例示吲哚美辛、水杨酸、水杨酸乙二醇酯、阿司匹林、对乙酰氨基酚、双氯芬酸钠、布洛芬、舒林达克(Sulindac)、萘普生、酮洛芬等。
作为可作为化妆品的有用物质而配合的成分的实例,可举出美白成分、抗皱成分、抗炎症成分、血液循环促进成分、抗菌成分、抗瘙痒成分、各种维生素及其衍生物、抗氧化成分、抗变态反应成分、香料等。
作为美白成分,没有特别限定,例如可举出抗坏血酸磷酸酯镁盐、抗坏血酸葡糖苷及其盐类和酰化衍生物、抗坏血酸乙酯、抗坏血酸棕榈酸酯等维生素C衍生物、α-熊果苷、β-熊果苷、曲酸、胎盘提取物、半胱氨酸、谷胱甘肽、鞣花酸、噜忻喏(Rucinol(ルシノール))、氨甲环酸、黄芩黄素、腺苷及其磷酸钠盐、虾青素、鹿角灵芝、油溶性甘草、薰衣草、香姜(ルムプヤン)、地榆、白藜芦醇、灵芝和它们的提取物、虾青素、酊剂或它们中所含的成分等。
作为抗皱成分,没有特别限定,例如可举出视黄醇、视黄酸、视黄醇乙酸酯、视黄醇棕榈酸酯等类视黄醇、柠檬酸、水果酸、乙醇酸、乳酸等α-羟基酸、α-羟基酸胆固醇、芸香苷衍生物、N-甲基丝氨酸、弹性蛋白、胶原蛋白、丝胶蛋白、积雪草提取物、黄金提取物等。
作为抗炎症成分,没有特别限定、例如可举出甘草次酸、甘草次酸2K、尿囊素(Allantoin)、ε-氨基己酸、薁(Azulene)、紫草根、氨甲环酸和黄连、甘草、榄仁树(Terminalia)、蓍、紫根、聚合草、芦荟、假叶树(Butcher's Broom(ブッチャーブルーム))、欧洲七叶树(Marronnier(マロニエ))、桃叶、枇杷叶和它们的提取物、酊剂或它们中所含的成分等。
作为血液循环促进成分,没有特别限定,例如可举出维生素E类、烟酸、烟酸酰胺、烟酸苄酯、尼可莫尔、咖啡因、辣椒素、壬酸香草酰胺、姜烯酚(ショウガオール)、姜酚等。
作为抗菌成分,没有特别限定,例如可举出异丙基甲基苯酚、三氯生、三氯二苯脲、三氯羟基苯酚、卤卡班、苯扎氯铵、苄索氯铵等阳离子表面活性剂、感光素、氧化锌、氧化钛、几丁质、壳聚糖、扁柏酚和茴香等。
作为抗瘙痒成分,没有特别限定,例如可举出盐酸苯海拉明、马来酸氯苯那敏、克罗米通、甘草酸类、薄荷醇、樟脑、迷迭香油、辣椒素、壬酸香草酰胺、地布卡因等。
作为维生素类及其衍生物,没有特别限定,例如,作为油溶性维生素类,可举出维生素A油、肝油、视黄醇乙酸酯、视黄醇棕榈酸酯、视黄醇、脱氢视黄醇、维生素A3、视黄酸、维生素D、维生素D2(麦角钙化醇)、维生素D3(胆钙化醇)、维生素衍生物、维生素E(生育酚)、dl-α-生育酚乙酸酯、dl-α-生育酚、生育酚丁酸酯、生育酚烟酸酯、烟酸苄酯、天然维生素E、维生素K、维生素U等。作为水溶性维生素类,可举出维生素B1(硫胺素)、维生素B2(核黄素丁酸酯)、维生素B6(二辛酸吡哆醇酯、二棕榈酸吡哆醇酯等脂肪酸酯)、维生素B12(钴胺素)、维生素B13、维生素B14、维生素B15(泛氨酸)等。
作为抗氧化成分,没有特别限定,例如可举出花青素、儿茶素、绿茶多酚、苹果多酚等多酚类、抗坏血酸、抗坏血酸钠、抗坏血酸硫酸酯钠、β-胡萝卜素、虾青素等类胡萝卜素、生育酚类、生育酚乙酸酯、天然维生素E、生育单烯醇、生育三烯醇、姜黄素等β-二酮、芝麻素、芝麻林素等木脂素、丁子香酚等酚等。
作为抗变态反应成分,没有特别限定,例如可举出甘草次酸、甘草次酸2K等甘草次酸衍生物、甘草、小球藻、聚合草、牡丹皮、心叶椴(Tilia cordata(フユボダイジュ))、延命草、鼠尾草、紫苏、艾草和它们的提取物、酊剂或它们中所含的成分等。
作为香料,可举出麝香、灵猫香(シペット)、百里香油、肉桂皮油等。
粘合性片材的制造方法
本发明的粘合性片材的制造法的一个实例是将丙烯酸系粘合剂的乙酸乙酯溶液涂布于脱模PET上并干燥而形成皮肤粘合层后,层压于中间层的单侧。中间层使用约5μm厚度的氨基甲酸酯膜。保护粘合层是将橡胶系粘合剂溶液涂布于脱模PET上并干燥而形成,进一步将其层压在与中间层所使用的相同的氨基甲酸酯膜上,由此形成具有内衬的高伸缩支撑体。其后,将剥离脱模PET而得到的保护粘合层面层压于上述中间层的相反侧,制成产品。其他构成的粘合性片材也可以按照同样的顺序制造。
水蒸气透过度
水蒸气透过度的测定依据JIS Z 0208[防湿包装材料的透湿度试验方法(杯法)]进行。
拉伸弹性模量
使用岛津制作所制拉伸试验机(小型台式试验机EZ Test EZ-SX)。试样使用宽度10mm长度50mm的两端加宽的哑铃片。以拉伸速度10mm/min进行拉伸,根据应力-应变曲线的直线部的斜率求出弹性模量。本发明中的弹性模量为应变10mm时的应力(N)的值。
实施例
以下,例示实施例来说明本发明,但本发明不限于实施例。
实施例1
将HiPAS粘合剂(丙烯酸系粘合剂,COSMED制药株式会社制)的乙酸乙酯溶液涂布于PET脱模膜上并使其干燥,得到厚度50μm的膜(皮肤粘合层)。将得到的粘合剂膜层压于氨基甲酸酯片材(共和工业株式会社制造品,厚度50μm)(中间层)。另外,使100质量份的苯乙烯/异戊二烯、三嵌段共聚物(SIS)(苯乙烯含量30质量%,株式会社Kraton Polymer Japan制)、100质量份的液体石蜡溶解于甲苯,涂布于PET脱模膜上并使其干燥,得到厚度80μm膜(保护粘合层)。将得到的粘合剂膜层压于氨基甲酸酯片材(厚度7μm)(高伸缩支撑体)。将保护粘合层面与中间层面进行层压而制成4层的层叠粘合片材。
实施例2
在实施例1中,不使用氨基甲酸酯片材作为中间层,除此以外,与实施例1同样地操作,制造3层的层叠粘合片材。
实施例3
在实施例1中,在皮肤粘合层中添加相对于HiPAS粘合剂为20质量%的乳酸辛基十二烷基酯,并且使支撑体的氨基甲酸酯片材的厚度为10μm,除此以外,与实施例1同样地操作,制造4层的层叠粘合片材。
实施例4
在实施例1中,使用EVA(乙烯-乙酸乙烯酯共聚树脂)膜作为中间层,并且使支撑体的氨基甲酸酯片材的厚度为10μm,除此以外,与实施例1同样地操作,制造4层的层叠粘合片材。
实施例5
在实施例1中,在皮肤粘合层中添加相对于HiPAS粘合剂为20质量%的乳酸辛基十二烷基酯和1.0质量%的抗坏血酸棕榈酸酯(理研维他命株式会社),在保护粘合层中添加霍霍巴油(NIKKOL霍霍巴油S,日光Chemicals株式会社)来代替液体石蜡,除此以外,与实施例1同样地操作,制造4层的层叠粘合片材。
实施例6
在实施例1中,使用氨基甲酸酯无纺布作为中间层,并且使支撑体的氨基甲酸酯片材的厚度为50μm,除此以外,与实施例1同样地操作,制造4层的层叠粘合片材。
实施例7
在实施例1中,将保护粘合层设为聚异丁烯(PIB)+液体石蜡,除此以外,与实施例1同样地操作,制造4层的层叠粘合片材。
比较例1
在实施例1中,使用PET膜作为中间层,除此以外,与实施例1同样地操作,制造4层的层叠粘合片材。
比较例2
在实施例1中,使用HiPAS粘合剂代替SIS粘合剂作为保护粘合层,使保护粘合层的厚度为50μm,除此以外,与实施例1同样地操作,制造4层的层叠粘合片材。
[表1]
Figure BDA0002801001530000131
表1中示出所制造的层叠粘合剂片材的特征。对所得到的层叠粘合剂片材的水蒸气透过度、拉伸弹性模量和断裂伸长率进行测定。
水蒸气透过度依据JIS Z 0208[防湿包装材料的透湿度试验方法(杯法)]进行测定。
关于拉伸弹性模量,将层叠粘合剂片材切断成宽度10mm、长度50mm的两端变宽的哑铃形状,置于拉伸试验机(岛津制作所制,小型台式试验机EZ Test EZ-SX),以10mm/min的速度拉伸,求出应力-应变曲线。根据初始的直线部的斜率计算拉伸弹性模量。
将测定结果(单次测定)示于表2。
[表2]
Figure BDA0002801001530000141

Claims (16)

1.一种皮肤用层叠粘合性片材,其特征在于,依次层叠皮肤粘合层、保护粘合层和高伸缩支撑体而成。
2.一种皮肤用层叠粘合性片材,其特征在于,依次层叠皮肤粘合层、中间层、保护粘合层和高伸缩支撑体而成。
3.根据权利要求1或2所述的粘合性片材,其中,所述皮肤粘合层包含丙烯酸系粘合剂或氨基甲酸酯系粘合剂。
4.根据权利要求1~3中任一项所述的粘合性片材,其中,所述高伸缩支撑体由聚氨基甲酸酯膜或乙烯乙酸乙烯酯膜或氨基甲酸酯无纺布或聚酯无纺布构成。
5.根据权利要求1~4中任一项所述的粘合性片材,其中,所述保护粘合层包含橡胶系粘合剂。
6.根据权利要求2~5中任一项所述的粘合性片材,其中,所述中间层由聚氨基甲酸酯膜或乙烯乙酸乙烯酯膜构成。
7.根据权利要求1~6中任一项所述的粘合性片材,其中,拉伸弹性模量为30N以下。
8.根据权利要求1~7中任一项所述的粘合性片材,其中,水蒸气透过度为200g/m2·24h以下。
9.根据权利要求1~8中任一项所述的粘合性片材,其中,所述皮肤粘合层的厚度为20μm~80μm。
10.根据权利要求1~9中任一项所述的粘合性片材,其中,所述高伸缩支撑体的厚度为5μm~60μm。
11.根据权利要求1~10中任一项所述的粘合性片材,其中,在所述皮肤粘合层的表面具有脱模片。
12.根据权利要求1~11中任一项所述的粘合性片材,其中,所述皮肤粘合层包含药物或有用物质。
13.根据权利要求12所述的粘合性片材,其中,所述药物选自由以下组成的组:解热消炎镇痛剂、抗癫痫剂、抗精神病剂、抗抑郁剂、抗焦虑剂、抗帕金森病剂、抗瘙痒剂、抗痴呆症剂、催眠剂、镇静剂、解痉剂、肌肉松弛剂、自主神经作用剂、脑循环改善剂、脑代谢改善剂、强心剂、抗心绞痛剂、高血压用剂、心律失常用剂、血管扩张剂、降血压剂、加压剂、利尿剂、呼吸促进剂、镇咳祛痰剂、支气管扩张剂、哮喘治疗剂、鼻变态反应治疗剂、呼吸器用剂、感冒用剂、止吐剂、抗酸剂和抗溃疡剂。
14.根据权利要求12所述的粘合性片材,其中,所述有用物质选自由以下组成的组:美白成分、抗皱成分、抗炎症成分、血液循环促进成分、抗菌成分、抗瘙痒成分、各种维生素及其衍生物、抗氧化成分、抗变态反应成分和香料。
15.一种粘合性片材,其特征在于,包括橡胶系粘合剂与
丙烯酸系粘合剂或氨基甲酸酯系粘合剂或有机硅系粘合剂的层叠粘合剂。
16.一种粘合性片材,其特征在于,将橡胶系粘合剂和
伸缩性支撑体和
丙烯酸系粘合剂或氨基甲酸酯系粘合剂或有机硅系粘合剂层叠而成。
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