CN1177585C - 贴剂 - Google Patents
贴剂 Download PDFInfo
- Publication number
- CN1177585C CN1177585C CNB008075085A CN00807508A CN1177585C CN 1177585 C CN1177585 C CN 1177585C CN B008075085 A CNB008075085 A CN B008075085A CN 00807508 A CN00807508 A CN 00807508A CN 1177585 C CN1177585 C CN 1177585C
- Authority
- CN
- China
- Prior art keywords
- stripping film
- waveform
- breaking joint
- patch
- mentioned
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Abstract
按照本发明,提供一种具有支持体1、在该支持体的一面层压的粘合层2以及剥离膜4的贴剂,所述剥离膜4附着在该粘合层上,可以剥离,且具有从一侧边缘部分延伸至与其相对的另一侧边缘部分的断缝42,其特征在于,剥离膜的断缝形状为波形,在沿着断缝将剥离膜的一部分剥离,将露出的粘合层的露出面贴付于贴付部位S的状态下,沿着断缝仅将支持体稍微弯曲,即可使残留的剥离膜沿着断缝的边缘部分44从贴付部位和上述粘合层之间迅速突出。
Description
技术领域
本发明涉及硬膏剂或巴布剂等贴剂,更详细地说涉及能够容易地贴付于贴付部位的贴剂。
背景技术
以前,已知图7所示的贴剂。这种贴剂由贴剂本体30和剥离膜40构成,贴剂本体30由无纺布等构成的大致为矩形的支持体10和在其整个面上层压的粘合层20构成,剥离膜40附着在粘合层20上,且可以剥离。剥离膜40在大致中央部位设有波形的断缝50。
使用这种贴剂时,首先将贴剂弯曲,由于剥离膜40的断缝50为波形,如图7所示,沿着断缝50的一部分剥离膜40从粘合层20上翘起。然后,用手指捏住翘起的剥离膜40部分(以下称为“夹捏部分”)60,将剥离膜40的一半剥离。这时,为了容易用手指捏住剥离膜40,以前波形的断缝50的高度H为指尖大小,即15mm±2mm的高度。之后,将露出的粘合层20贴付于患处等贴付部位,最后剥离残留的另一半剥离膜,将粘合层20全部贴付。
另外,作为上述现有贴剂所需要的特性,要求在使用中,对于关节或其周围的肌肉等动作剧烈、皮肤伸缩剧烈的部分,能够避免脱落、剥落这种现象。因此,不断使支持体10具有柔软性、伸缩性,将贴剂本体30改良成较薄且柔软性、伸缩性高的物质。另一方面,为了使具有柔软化趋势的贴剂的操作变容易,同时利用与支持体10的柔软度不同使剥离变容易,剥离膜40使用壁薄但具有适度刚性的物质。
但是,在图7所示的现有贴剂中,如图8(a)和(b)所示,将贴剂的粘合层20贴付于皮肤患处S,将剥离膜40的残留部分剥离时,夹捏部分60夹在皮肤S与粘合层20之间,有时难以用手指捏住。
本发明鉴于上述现有技术中存在的问题,其目的在于提供一种新型贴剂,它具有能够平滑地贴付于皮肤患处等贴付部位的功能。
发明公开
本发明人为了实现上述目的反复进行了悉心的研究,结果发现关于剥离膜40上具有大的波形断缝50的贴剂的上述课题的主要原因在于下述内容。也就是说,如图8(a)所示,如果剥离膜40的波形断缝50的高度H高,则可以充分获得剥离时夹捏部分60的面积,另一方面阻碍剥离的粘合部分70的面积也增大,另外由于将支持体10改为较薄且柔软性、伸缩性高的物质,如图8所示,阻碍剥离的粘合部分70与皮肤S的密合性进一步提高,支持体10的弯曲线R不是靠近波形断缝部分的峰X侧,而是靠近谷Y侧。
而且,本发明人发现为了能够平滑地将贴剂贴付于皮肤患处S,适度减小剥离膜40的波形断缝50的高度H,减小剥离时夹捏部分60的面积是有效的。
本发明的贴剂是基于上述发现获得的贴剂,更详细地说,是具有支持体、在支持体的一面层压的粘合层以及剥离膜的贴剂,所述剥离膜附着在粘合层上,可以剥离,且具有从一侧边缘部分延伸至与其相对的另一侧边缘部分的断缝,其特征在于,剥离膜的断缝形状为波形,在沿着断缝将剥离膜的一部分剥离,将露出的粘合层的露出面贴付于贴付部位的状态下,沿着断缝仅将支持体稍微弯曲,即可使残留的剥离膜沿着断缝的边缘部分迅速突出,而不会夹在贴付部位和粘合层之间。另外,“波形”是指包括正弦波等波形或锯形的波形等在内的概念。
该波形的断缝具体而言优选其波形的高度为4mm~8mm。其中,“波形的高度”是指断缝的形状近似于完全的波时,相当于振幅的值,具体而言在图4或图8中是指“H”表示的高度。
通过使用满足上述条件的剥离膜,将剥离膜的残留部分剥离时,剥离膜的夹捏部分能够容易地用手指夹住,而不会夹在贴付部位和支持体之间。
而且,该剥离膜的波形断缝优选其波形的跨距为6mm~12.5mm。其中,“波形的跨距”是指断缝的形状近似于完全的波时,相当于波长的值,具体而言在图4中是指“P”表示的高度。
通过使用满足上述条件的剥离膜,剥离膜上形成的夹捏部分的面积能够达到适当大小,容易从贴付部位突出,而且容易用手指捏住。
另外,本发明的贴剂也可以具有下述特征,即剥离膜的波形断缝为2条,断缝之间实质上是平行的。
满足上述条件的剥离膜能够在贴付前预先剥离该断缝间的剥离膜,以露出的粘合层面作为粘贴带,预备性地贴付于贴付部位。利用这种功能,贴剂能够固定于贴付部位,例如患处,因此之后能够将残留的剥离膜的端部容易地剥离,同时进行贴付,更平滑地进行一系列的贴付操作。另外,通过预备性的贴付,可有效重贴,能够确实贴付于患处所需的部位。
另外,剥离膜的波形断缝为2条时,断缝之间的间隔为20mm~30mm在发挥上述功能的目的中是有效的。
附图的简单说明
图1是表示本发明贴剂的第1种实施方式的平面图。
图2是表示图1中沿II-II线的部分的放大示意截面图。
图3是表示图1中贴剂的剥离膜单侧剥离后的状态的平面图。
图4是表示图3中IV所示部分的放大示意平面图。
图5A和图5B是表示本发明第1种实施方式中的贴剂贴付于皮肤患处时贴付操作的1个实例的模式截面图。
图6是表示本发明贴剂的第2种实施方式的平面图。
图7是表示现有贴剂弯曲时的状态的斜视图。
图8A是表示现有贴剂的剥离膜单侧剥离后的状态的正面图。图8B是现有贴剂在图8A的状态下贴付于皮肤患处后进一步弯曲时的模式截面图。
发明的最佳实施方式
以下,参照附图详细地说明本发明优选的实施方式。另外,图中对于相同或相应的部分使用同一符号。
图1是表示本发明贴剂的优选实施方式的1个实例的平面图,图2是图1沿II-II线的放大示意截面图。
如图1和图2所示,本实施方式的贴剂由贴剂本体3和剥离膜4构成,贴剂本体3由大致为矩形的支持体1以及在该支持体1的几乎全部表面上层压的粘合层2构成,剥离膜4贴付在粘合层2的几乎全部表面上,使用时剥离。
支持体1的构成材料没有特别的限定,优选使用聚对苯二甲酸乙二醇酯(PET)、乙烯-醋酸乙烯共聚物(EVA)、氯乙烯、聚乙烯、聚丁二烯、以苯乙烯-丁二烯或苯乙烯-异戊二烯为主体的嵌段共聚树脂、丁二烯-苯乙烯-甲基丙烯酸甲酯共聚树脂、尼龙、聚氨酯、烷氧基烷基(甲基)丙烯酸酯共聚物、聚乙烯醋酸酯、聚酰胺、人造丝等合成树脂构成的薄膜、纺布、无纺布或它们的层压体。
另外,支持体1优选具有适度的柔软性和伸缩性。而且,支持体的厚度优选0.01mm~5mm。这是由于支持体1的厚度低于0.01mm则操作性变差,有易于产生皱褶的趋势,另一方面超过5mm则柔软性降低,贴付时产生不适感,另外有易于带来物理刺激的趋势。
粘合层2的主成分为压敏性粘合剂。其构成材料没有特别的限定,优选在常温下能够将药物长时间固定于皮肤表面的具有粘合力的物质,例如丙烯酸类粘合剂、橡胶类粘合剂、硅氧烷类粘合剂等。其中,从粘合性和药物的释放性好这一观点来看,优选使用橡胶类粘合剂,特别优选使用天然橡胶、合成异戊二烯橡胶、聚异丁烯、聚乙烯醚、聚氨酯、聚异戊二烯、聚丁二烯、苯乙烯-丁二烯共聚物、苯乙烯-异戊二烯共聚物、苯乙烯-异戊二烯-苯乙烯嵌段(SIS)共聚物等。而且,使用SIS共聚物时,最优选使用Shell化学公司生产的SIS基质(商品名:CalifurexTR-1107、Califurex TR-1111、Califurex TR-1112、Califurex TR-1117)、日本合成橡胶公司生产的SIS基质(商品名:JSR5000、JSR5002、JSR5100)、日本Zeon公司生产的SIS基质(商品名:Quintack 3570C)等。
粘合层2中必要时也可以添加增粘剂、软化剂、填充剂、老化防止剂、吸收促进剂等添加剂。这种添加剂例如脂环族饱和烃树脂(荒川化学工业公司生产,商品名:Arcon P-100等)、松香酯(荒川化学工业公司生产,商品名:KE-311、KE-100等)、氢化松香酯(Hercules公司生产,商品名:Phoral 105、Phoral 85等)、氢化脂环族烃(Exxon化学公司生产,商品名:Escoretu 5300等)、多萜树脂、石油树脂、酚树脂等增粘剂;液体石蜡、聚丁烯、液态聚异丁烯、动植物油等软化剂;其它填充剂;老化防止剂等。另外,必要时为了提高药物的皮肤透过性,也可以在压敏性粘合剂中含有吸收促进剂,这种吸收促进剂例如肉豆蔻酸异丙酯、癸二酸二乙酯、十八碳烯基磷酸钠、月桂基硫酸钠、辛基苯基醚、月桂基醚、脱水山梨醇单月桂酸酯、月桂酰二乙醇酰胺、月桂酰肌氨酸、油酰肌氨酸、糖酯、卵磷脂、甘草酸、尿素、水杨酸、巯基乙酸钙、乳酸、乳酸酯、橄榄油、角鲨烯、羊毛脂、液体石蜡、甘油等。根据贴剂的目的,也可以在压敏性粘合剂中适当配合其它色素、香料、紫外线吸收剂、表面活性剂、pH调节剂等。
另外,本实施方式的贴剂中保持药物的场合,可以配合到上述压敏性粘合剂中。这种药物例如全身麻醉剂、睡眠·镇痛剂、解热消炎镇痛剂、甾类激素、兴奋·苏醒剂、精神神经用剂、局部麻醉剂、骨骼肌松弛剂、自律神经用剂、抗过敏剂、抗组胺剂、强心剂、心率不齐用剂、利尿剂、降压剂、血管收缩剂、血管扩张剂、钙拮抗剂、抗菌剂、寄生性皮肤疾病用剂、皮肤软化剂、抗生素、解毒剂、镇咳剂、止痒剂、催眠剂、精神活力剂、哮喘剂、激素分泌促进剂、抗溃疡剂、抗癌剂、维生素等。
粘合层2的厚度(涂覆厚)优选10μm~400μm。这是由于粘合层2的厚度超过400μm则有压敏性粘合剂中所含药物的释放性变差的趋势,另一方面,低于10μm则于皮肤的粘合性差,有导致剥落的趋势。
支持体1和粘合层2构成的贴剂本体3优选其角切成圆弧状。贴剂一旦部分撕下、剥落,则皮肤的角质层或灰尘附着在这一部分,难以再次贴付。特别是贴剂的形状为长方形时,存在角容易被衣服等挂住最先撕下、剥落的趋势。因此,优选使贴剂的角成为圆弧状,难以被衣服等挂住,从而存在更充分地防止剥离发生的趋势。而且,使贴剂本体3的角成为圆弧状时,圆弧的曲率半径优选为5mm以上。这是由于该半径低于5mm时,有不能充分实现减少贴付时剥落的趋势。
剥离膜4如图1所示在大致中央部位具有从一侧边缘部分延伸至与其相对的另一侧边缘部分的波形断缝42。而且断缝42的波形的高度(图4中H表示的高度)优选为4mm~8mm,更优选6mm~7mm。另外,该断缝42的波形的跨距(图4中P表示的高度)优选为6mm~12.5mm。关于使该断缝42的波形的高度和波形的跨距达到上述值的理由,是由于能够提高如下所述操作性。
另外,剥离膜4附着于粘合层2的整个面上,可以剥离,在使用时剥离,在使用贴剂本体3之前,可以剥离地贴付于粘合层2的整个面上,具有防止柔软性、伸缩性高的贴剂本体3上出现皱褶的效果以及防止粘合层2中的药效成分和水分逃逸的效果。该剥离膜4的构成材料没有特别的限定,可以适当选择实施了离型处理的厚度为50μm的聚对苯二甲酸乙二醇酯等树脂薄膜、纸等。另外,剥离膜4优选具有适度的刚性。理由如下所述,是由于能够提高剥离膜4的剥离操作的操作性或进行完好的贴付。
其次,按照图3至图5叙述将上述结构的贴剂贴付于贴付部位——患处的皮肤S上的场合。
首先,将贴剂沿剥离膜4的断缝42稍微弯曲,与图7所示的现有贴剂的场合同样,由于剥离膜4的断缝42为波形,沿着断缝42的剥离膜4的边缘部分从粘合层2上翘起。其次,用手指捏住翘起的一部分边缘,即剥离膜4的图4所示夹捏部分44,将通过断缝42分成两份的剥离膜4的一侧剥离,使粘合层2的面露出,呈现图3所示的状态。然后,将该露出的粘合层2的面贴付于皮肤患处的贴付部位S。
然后,如图5所示,用手指捏住贴剂的剥离膜上未剥离一侧的端部,将贴剂向相反侧的端部稍微弯曲,使剥离膜4翘曲,从而使残留剥离膜沿着断缝42的边缘部分从粘合层2上翘起,同时使之从贴付部位,即图5所示皮肤患处S和粘合层2之间迅速突出。
其次,用手指捏住该残留的剥离膜4沿着断缝42的一部分边缘——断缝42的夹捏部分44。
最后,使残留剥离膜4的断缝42的突出边缘部分沿着皮肤患处S的面滑动,牵拉用手指捏住的断缝42的夹捏部分44,缓缓剥下,将贴剂的残留部分没有皱褶地完好地贴付于皮肤患处S上。
另外,在与现有贴剂进行比较的同时详细叙述上述能够平滑进行贴付操作的本实施方式的贴剂的有效性。
如上所述将剥离膜4的一侧剥离,将露出的粘合层2的面贴付于皮肤患处S上之后,剥离残留的另一侧剥离膜,同时贴付全部粘合层时,以前如图8(b)所示,由于使波形断缝50的高度H达到指尖的大小,即15mm+2mm的高度,剥离膜40的夹捏部分容易用手指捏住,另一方面将贴剂的粘合层20贴付于皮肤患处S上剥离残留剥离膜时,夹捏部分60会夹在皮肤S与粘合层20之间,存在难以用手指捏住的问题。
其主要原因是如图8(a)所示,如果剥离膜40的波形断缝50的高度H高,则可以充分获得剥离时夹捏部分60的面积,另一方面阻碍剥离的粘合部分70的面积也增大,另外如图8(b)所示,由于支持体10为较薄且柔软性、伸缩性高的物质,阻碍剥离的粘合部分70于皮肤S的粘合性进一步提高,支持体10的弯曲线R不是靠近波形断缝部分的峰X侧,而是靠近谷Y侧。
与此相对,本实施方式的贴剂在具有适度刚性的剥离膜4上设有的波形断缝42的波形高度H为4mm~8mm,较以前低,而且波形断缝42的波形跨距P为6mm~12.5mm,因而使图4所示的夹捏部分44的面积在能够保持易于夹捏的范围内适度减小,同时阻碍剥离膜剥离的粘合部分22的面积也适度减小。即使支持体1为较薄且柔软性、伸缩性高的物质,也可以使阻碍剥离的粘合部分22和皮肤S的粘合性减小,使支持体1的弯曲线R不靠近波形断缝的谷Y侧,而靠近峰X侧。
结果,如图5(a)和(b)所示,本实施方式的贴剂在将剥离膜4剥离时,剥离膜4不会夹在皮肤S与粘合层2之间,能够容易地突出,用手指捏住,可以防止图8(b)所示的问题,因此与以前相比,贴剂能够平滑的贴付于皮肤患处S。
另外,剥离膜4上设有的波形断缝42的波形高度H如果低于4mm则难以用手指捏住,如果高于8mm则难以缓慢地将剥离膜的夹捏部分44从皮肤S和粘合层2之间拔出。另外,波形断缝42的波形跨距P如果为6mm以下则即使剥离膜的夹捏部分44突出也难以捏住,如果大于12.5mm则难以缓慢地将剥离膜的夹捏部分44从皮肤S和粘合层2之间拔出。
另外,本实施方式的贴剂中,剥离膜4具有适度的刚性从下述两点来看是有效的,如图5(a)所示具有剥离膜容易从皮肤S和粘合层2之间突出的效果,而且从图5(b)所示的状态剥离残留的另一侧剥离膜,同时将粘合层全部贴付于皮肤S上时,通过剥离膜4贴剂能够保持充分的张力,并缓慢地贴付于皮肤S上,因此能够没有皱褶地完好地贴付。
而且,本实施方式的贴剂具有的剥离操作的容易性可以在剥离膜4与粘合层2的接触面的粘合强度比以前大的范围内设定,如以下所述在使用之前的保存时或制造工艺中具有以前所没有的优点,在这一点上是有效的。
第一,以前由于难以将剥离膜4从粘合层2上剥离,有必要将粘合强度减小到某种程度,因此存在使用之前剥离膜4剥离,露出粘合层2,粘合层2中的药效成分或水分逃逸等问题,或贴付后容易从皮肤上剥落等问题,而本发明的贴剂通过将粘合强度设定在较以前大的范围内,可以充分防止这些问题的发生。
第二,以前增大剥离膜4和粘合层2的粘合面的粘合强度时,剥离膜4有必要进行轧纹整理等特殊加工,但是如果剥离操作容易,平滑的薄膜即可。因此,制造过程可以简化,与以前相比可以期待提高大量生产性,并降低成本。
另外,本发明的贴剂也可以如图6所示在剥离膜4上设有2条波形断缝42。
设有2条剥离膜4的波形断缝42时,断缝42之间的结构关系优选实质上是平行的。其中,“实质上平行”是指2条波形断缝近似于完全的波,而且将该波的振幅二等分的波的中心线与剥离膜的大致长方形的短边平行。而且,设有上述2条断缝时,断缝42之间的间隔优选为20mm~30mm。
将设有2条剥离膜4的波形断缝42的贴剂贴付于皮肤患处S的场合,按照图6进行叙述。
首先,以剥离膜4的波形断缝42中任意一方为中心将贴剂稍微弯曲,由于剥离膜4的断缝42为波形,沿着断缝42的剥离膜4的边缘部分从粘合层2上翘起。然后,用手指捏住从粘合层2上翘起的剥离膜的一部分边缘,即图4所示的夹捏部分44,先将剥离膜4的大致中央部分的2条断缝42之间的剥离膜46剥离。其次,将2条断缝42之间剥离膜46剥离后露出的粘合层2的面贴付于患处S所需的部分,预备性地固定贴剂。
然后,按照图5所示的要领,用手指捏住预备性地固定于患处S的贴剂粘贴带两端的剥离膜未剥离部分48的端部,将贴剂稍微弯曲,使剥离膜4翘曲,从而使残留剥离膜沿着断缝42的边缘部分从粘合层2上翘起,同时使之从贴付部位,即图5所示的皮肤患处S和粘合层2之间迅速突出。
然后,用手指捏住该残留剥离膜4沿着断缝42的一部分边缘,即断缝42的夹捏部分44。
最后,使残留剥离膜4的断缝42的突出边缘部分沿着皮肤患处S的面滑动,牵拉用手指捏住的断缝42的夹捏部分44,将剥离膜4的端部48一张或2张同时缓慢剥下,将贴剂的残留部分没有皱褶地完好地贴付于皮肤患处S上。
设置2条剥离膜4的波形断缝42,能够在贴付前预先剥离断缝42之间的剥离膜46,以露出的粘合层2的面作为粘贴带,预备性地贴付于患处,在这一点上是有效的。根据这种功能,可有效重贴,能够确实贴付于患处所需的部位。另外,由于贴付全部贴剂之前,贴剂充分固定于患处S上,之后能够将残留的剥离膜4的端部48容易地剥离,同时进行贴付,能够更平滑地进行一系列贴付操作。
除此之外,设有2条剥离膜4的波形断缝42时,充分确保波形断缝42的间隔为20mm~30mm,能够形成具有适当大小面积的粘贴带,在这一点上是有效的。通过充分确保波形断缝42的间隔,能够将贴剂预先很强的固定于患处,因此将残留的剥离膜端部48剥下时,贴剂不会从患处错位或剥离,以该粘贴带为基点贴剂能够保持充分的张力,因此即使用一只手也能容易地、没有皱褶地、完好地贴付。
其中,作为设置2条上述剥离膜4的波形断缝42的有效性,应当注意到在适当范围内使剥离膜4的波形断缝42的高度比以前低首先发挥出的功能。以前那种大的波形断缝即使设置2条断缝42,以剥离断缝之间的剥离膜46露出的粘合层面作为粘贴带,即使预备性地贴付于皮肤患处S上,将剥离膜的端部48剥下时也会产生难以剥离的问题。另外,由于如上所述剥离膜4与粘合层2的粘合强度不能增大,使用本发明的这种粘贴带将贴剂预备性地固定于皮肤患处S上的效果并不理想。
以上详细说明了本发明优选的实施方式,但是不言而喻本发明并不限于上述实施方式。例如,剥离膜的断缝的波形形状并不限于上述实施方式。具体而言,也可以是锯齿形或矩形。同样,剥离膜的断缝位置也不限于上述实施方式。
在上述实施方式中,对具有含药物的非含水性粘合剂的硬膏剂等贴剂进行了说明,但是本发明的贴剂也可以是所谓巴布剂那样的含有含水性膏体作为粘合剂的贴剂。
含水性膏体没有特别的限定,优选具有常温下能够将药物长时间固定于皮肤表面上的粘合力,除水、增粘剂、润湿剂、填充剂之外,根据需要添加其它交联剂、聚合剂、溶解助剂、吸收促进剂、药物增效剂、稳定剂、抗氧化剂、乳化剂、药物等。
含水性膏体中使用的增粘剂优选能够稳定保持水分30%~80%,而且具有保水性的物质。作为其具体例子,优选使用瓜尔胶、刺槐豆胶、角叉菜胶、海藻酸、海藻酸钠、琼脂、阿拉伯胶、西黄蓍胶、卡拉牙胶、果胶、淀粉等植物类天然高分子,黄原胶、阿拉伯树胶等微生物类天然高分子,明胶、胶原等动物类天然高分子;甲基纤维素、乙基纤维素、羟乙基纤维素、羧甲基纤维素钠等纤维素类,可溶性淀粉、羧甲基淀粉、双醛淀粉等淀粉类等半合成高分子;聚乙烯醇、聚乙烯吡咯烷酮、聚乙烯甲基丙烯酸酯等乙烯基类,其它聚环氧乙烷、甲基乙烯基醚/马来酸酐共聚物等合成高分子;等水溶性高分子。
这种增粘剂从凝胶强度强和保水性优良的角度考虑,特别优选聚丙烯酸,更优选平均聚合度为20000~70000的聚丙烯酸钠。平均聚合度小于20000,则缺乏增粘效果,有不能获得充分的凝胶强度的趋势,另一方面平均聚合度大于70000,则增粘效果过强,有操作性降低的趋势。
含水性膏体中使用的润湿剂例如甘油、丙二醇、山梨醇等多元醇,填充剂例如高岭土、氧化锌、滑石、钛、膨润土、硅酸铝、氧化钛、偏硅酸铝、硫酸钙、磷酸钙等。
另外,在本发明的含水性膏体中也可以添加作为溶解助剂或吸收促进剂的碳酸丙烯酯、克罗它米通、1-薄荷醇、薄荷油、柠檬烯、二异丙基己二酸酯等,或作为药物增效剂的水杨酸甲酯、水杨酸乙二醇酯、1-薄荷醇、百里酚、薄荷油、柠檬烯、壬酸香草酰胺、辣椒提取物等。而且必要时本发明的含水性膏体中也可以添加稳定剂、抗氧化剂或乳化剂等。
此外,必要时在含水性膏体中添加交联剂或聚合剂等,可以加强含水性膏体(粘合剂),同时使之具有保水性。这种交联剂或聚合剂可以根据增粘剂等的种类适当选择。
例如使用聚丙烯酸或聚丙烯酸盐作为增粘剂时,优选使用分子中至少具有2个环氧基的化合物、Ca、Mg、Al等的盐酸盐、硫酸盐、磷酸盐、碳酸盐等无机盐、柠檬酸盐、酒石酸盐、葡萄糖酸盐、硬脂酸盐等有机酸盐、氧化锌、硅酸酐等氧化物、氢氧化铝、氢氧化镁等氢氧化物等多价金属化合物。另外,使用聚乙烯醇作为增粘剂时,优选使用己二酸、巯基乙酸、环氧化合物(表氯醇)、醛类、N-羟甲基化合物、含有Al、Ti、Zr、Sn、V、Cu、B、Cr等的络合物等。另外,使用聚乙烯吡咯烷酮作为增粘剂时,优选使用甲基乙烯基醚/马来酸酐聚合物、多元酸化合物或碱金属盐(聚丙烯酸或鞣酸及其衍生物)等。另外,使用聚环氧乙烷作为增粘剂时,优选使用过氧化物、聚砜叠氮化物等。另外,使用甲基乙烯基醚/马来酸酐共聚物作为增粘剂时,优选使用多官能羟基化合物、聚胺、碘、明胶、聚乙烯吡咯烷酮、铁、汞、铅盐等。另外,使用明胶作为增粘剂时,优选使用甲醛、戊二醛、双醛淀粉等醛类、乙二醛、氧化丁二烯等双环氧化物类、二乙烯基酮等二酮类、二异氰酸酯类。
另外,含水性膏体层中保持有药物时,在含水性膏体层中配合药物即可。这种药物例如全身麻醉剂、睡眠·镇痛剂、解热消炎镇痛剂、甾类激素、兴奋·苏醒剂、精神神经用剂、局部麻醉剂、骨骼肌松弛剂、自律神经用剂、抗过敏剂、抗组胺剂、强心剂、心率不齐用剂、利尿剂、降压剂、血管收缩剂、血管扩张剂、钙拮抗剂、抗菌剂、寄生性皮肤疾病用剂、皮肤软化剂、抗生素、解毒剂、镇咳剂、止痒剂、催眠剂、精神活力剂、哮喘剂、激素分泌促进剂、抗溃疡剂、抗癌剂、维生素或美肤成分等具有美白效果的物质等。
支持体上层压的含水性膏体的厚度(涂覆厚)优选0.1mm~3mm。如果含水性膏体的厚度超过3mm,则有含水性膏体中所含药物的释放性变差的趋势,另一方面如低于0.1mm,则与皮肤的粘合性差,有导致剥落的趋势。
包括支持体和含水性膏体层在内的厚度(巴布剂的厚度)优选0.5mm~5mm。如果巴布剂的厚度超过5mm,则贴付时存在巴布剂的边缘易于被衣服等挂住、剥落的趋势,另一方面如低于0.5mm则巴布剂丧失支持性,有易于引起贴付失误的趋势。
以下,结合实施例和比较例更详细地说明本发明贴剂的内容,但是本发明并不受这些实施例的任何限定。
〔实施例1〕
剥离膜的波形断缝的条数为1条,波形断缝的波形高度为4mm,波形断缝的波形跨距为12.5mm,此外的条件与久光制药株式会社以“拉沙龙帕斯(ら.サロンパス)”的商标出售的贴剂(7cm×10cm)同样,制备图1和图2所示的贴剂。
〔实施例2〕
与实施例1不同的是剥离膜的波形断缝的波形高度为5mm,波形断缝的波形跨距为6mm,其它条件采用与实施例1同样的条件。
〔实施例3〕
与实施例1不同的是剥离膜的波形断缝的波形高度为6mm,波形断缝的波形跨距为8.5mm,其它条件采用与实施例1同样的条件。
〔比较例1〕
与实施例1不同的是剥离膜的波形断缝的波形高度为14mm,波形断缝的波形跨距为36mm,其它条件采用与实施例1同样的条件。另外,该试样相当于现有产品。
〔比较例2〕
与实施例1不同的是剥离膜的波形断缝的波形高度为5mm,波形断缝的波形跨距为20mm,其它条件采用与实施例1同样的条件。
〔比较例3〕
与实施例1不同的是剥离膜的波形断缝的波形高度为12mm,波形断缝的波形跨距为10mm,其它条件采用与实施例1同样的条件。
〔性能比较试验〕
对于上述实施例1~3和比较例1~3的贴剂,进行以下说明的剥离膜的剥离难易程度的性能比较试验。
对于上述贴剂的各个实例,分别使用5张贴剂。而且,分别将剥离膜的一侧剥离,贴付于平滑的丙烯酸酯板上。然后,如图5所示,用手指捏住贴剂另一侧未剥离部分的端部,将贴剂弯曲,使剥离膜翘曲,测定断缝的夹捏部分从粘合层上翘起时的弯曲角度,比较其平均值。
通过比较弯曲角度的大小,能够比较剥离膜断缝的夹捏部分突出的难易程度。该弯曲角度的大小越小,表明剥离膜断缝的夹捏部分越容易迅速突出,而不会夹在假定为皮肤患处的丙烯酸酯板和贴剂本体之间。
另外,通过比较剥离膜断缝的夹捏部分从粘合层上翘起时弯曲角度的大小,能够比较剥离膜断缝的夹捏部分夹捏的难易程度。
总之,通过比较剥离膜断缝的夹捏部分的“突出难易程度”和“夹捏难易程度”,能够比较是否能平滑进行贴付操作的程度。
这些试样的试验结果按照如下所示的剥离膜断缝的夹捏部分的“突出难易程度”和“夹捏难易程度”的评价标准列于表1中。
剥离膜断缝的夹捏部分的“突出难易程度”的评价标准如下,3:夹捏部分非常平滑的突出,2:夹捏部分平滑突出,1:夹捏部分难以突出。
剥离膜断缝的夹捏部分的“夹捏难易程度”的评价标准如下,3:突出的夹捏部分具有相当于指尖大小的足够的大小,容易用手指捏住,2:突出的夹捏部分具有足够的大小,容易用手指捏住,1:突出的夹捏部分小,难以用手指捏住。
〔表1〕
波形断缝的数目 | 波形断缝的波形高度(/mm) | 波形断缝的波形跨距(/mm) | 弯曲角度 | 突出的难易程度 | 夹捏的难易程度 | |
实施例1 | 1 | 4.0 | 12.5 | 85° | 2 | 2 |
实施例2 | 1 | 5.0 | 6.0 | 85° | 3 | 2 |
实施例3 | 1 | 6.0 | 8.5 | 85° | 2 | 3 |
比较例1 | 1 | 14.0 | 36.0 | 150° | 1 | 1 |
比较例2 | 1 | 5.0 | 20.0 | 110° | 1 | 1 |
比较例3 | 1 | 12.0 | 10.0 | 120° | 1 | 1 |
如图5所示,将剥离膜的一侧从波形断缝剥离,将露出的粘合层的面贴付于患处皮肤后,剥离残留的剥离膜,同时将贴剂完全贴付于皮肤患处时,从表1的结果可知,相对于比较例1~3,本发明的实施例1~3在约2分之1的弯曲角度下,波形断缝的夹捏部分突出。
另一方面,比较例1~3在与实施例1相同的弯曲角度下,如图8所示,贴剂的弯曲线不是处于波形断缝部分的峰侧,而是处于谷侧,波形断缝的夹捏部分夹在粘合层和丙烯酸酯板之间,不能突出。而且,增大弯曲角度的同时将捏住的贴剂未贴付部分的端部沿剥离贴付部分的方向,即与捏住的贴剂的端部相对的另一侧端部的方向牵拉,使贴剂的弯曲线由波形断缝的谷侧向峰侧移动,波形剥离膜断缝的夹捏部分稍微突出一点。
关于弯曲时突出的剥离膜波形断缝的夹捏部分的夹捏难易程度,实施例1~3中容易用指尖捏住,与此相对,比较例1中突出的夹捏部分小,难以用指尖捏住。
而且对于实施例1~3,详细讨论了贴剂弯曲时波形断缝的夹捏部分的突出难易程度和该夹捏部分的夹捏难易程度的顺序。波形断缝的夹捏部分的突出难易程度得到了下述结果,实施例1良好,实施例2和3更好。另外,波形断缝的夹捏部分的夹捏难易程度为实施例1和2良好,实施例3更好。总之,实施例1~3中实施例3的贴剂能够最平滑地进行贴付操作。
由此可以确认,象比较例1~3那样波形断缝的波形高度高达14mm,达到指尖程度以上,断缝的夹捏部分难以突出,另一方面降低到4mm,断缝的夹捏部分难以突出一些,另外有难以夹捏的趋势。另外,还确认波形断缝的波形跨距超过12.5mm,则断缝的夹捏部分难以突出。另外,这些数值条件根据使用环境或材料等变化,在不超出本发明主旨的范围内可以适当变更。
工业实用性
如上所述,按照本发明的贴剂,可以提供一种具有能平滑贴付于皮肤患处的功能的新型贴剂。
更详细地说,通过使剥离膜的波形断缝的高度比以前小,在适当的范围内设定,可以提供具有下述优点的新型贴剂。
第一,剥离膜的剥离操作比以前容易。
第二,由于剥离操作容易,可以将剥离膜与粘合层的粘合强度设定为较高。因此,剥离膜没有必要进行轧纹整理等特殊加工,平滑的薄膜即可。在上述方面,可以简化制造工艺,能够期待与以前相比提高大量生产性并降低成本。而且,由于剥离操作容易,能够防止使用之前剥离膜剥离,药效成分和水分从粘合层逃逸。
第三,设有2条剥离膜的波形断缝时,能够以剥离膜的一部分作为粘贴带,使用该部分,能够将贴剂预备性地固定在贴付部位所需的部分。由于可以确实进行这种操作工序,能够更平滑地进行贴付操作。
第四,作为本发明的贴剂中使用的支持体和粘合剂,可以广范围地使用现有构成材料乃至新型构成材料,能够保持与以前同样的柔软性、伸缩性和与皮肤的粘合性。
Claims (3)
1.具有支持体和在上述支持体的一面层压的粘合层以及剥离膜的贴剂,所述剥离膜附着在上述粘合层上,可以剥离,且具有从一侧边缘部分延伸至与其相对的另一侧边缘部分的断缝,
其特征在于,上述剥离膜的断缝形状为波形,
在沿着上述断缝将上述剥离膜的一部分剥离,将露出的上述粘合层的露出面贴付于贴付部位的状态下,沿着上述断缝仅将上述支持体稍微弯曲,即可使残留的剥离膜沿着上述断缝的边缘部分从贴付部位和上述粘合层之间迅速突出,
其中,上述剥离膜的上述波形断缝的波形高度为4mm~8mm,上述剥离膜的上述波形断缝的波形跨距为6mm~12.5mm。
2.如权利要求1所述的贴剂,其中上述剥离膜的上述波形断缝为2条,上述断缝之间实质上是平行的。
3.如权利要求2所述的贴剂,其中上述剥离膜的2条波形断缝之间的间隔为20mm~30mm。
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US (1) | US6841716B1 (zh) |
EP (1) | EP1181930B1 (zh) |
JP (1) | JP5285198B2 (zh) |
KR (1) | KR100663684B1 (zh) |
CN (1) | CN1177585C (zh) |
AT (1) | ATE253355T1 (zh) |
BR (1) | BR0010467B1 (zh) |
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CN101351181B (zh) * | 2005-12-28 | 2012-02-01 | 帝国制药株式会社 | 贴剂及其制备方法 |
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WO2000069422A1 (fr) | 2000-11-23 |
BR0010467B1 (pt) | 2010-11-30 |
KR20020002407A (ko) | 2002-01-09 |
US6841716B1 (en) | 2005-01-11 |
EP1181930A4 (en) | 2002-07-10 |
BR0010467A (pt) | 2002-04-02 |
CN1350451A (zh) | 2002-05-22 |
EP1181930B1 (en) | 2003-11-05 |
KR100663684B1 (ko) | 2007-01-02 |
EP1181930A1 (en) | 2002-02-27 |
DE60006380T2 (de) | 2004-05-13 |
TW532145U (en) | 2003-05-11 |
DE60006380D1 (de) | 2003-12-11 |
JP5285198B2 (ja) | 2013-09-11 |
ATE253355T1 (de) | 2003-11-15 |
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