CN113993594B - 牙齿用贴片 - Google Patents
牙齿用贴片 Download PDFInfo
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- CN113993594B CN113993594B CN202080042535.9A CN202080042535A CN113993594B CN 113993594 B CN113993594 B CN 113993594B CN 202080042535 A CN202080042535 A CN 202080042535A CN 113993594 B CN113993594 B CN 113993594B
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- oil
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- dental patch
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- 239000012790 adhesive layer Substances 0.000 claims abstract description 69
- 239000010410 layer Substances 0.000 claims abstract description 64
- 239000011241 protective layer Substances 0.000 claims abstract description 62
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims abstract description 39
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 26
- 239000004615 ingredient Substances 0.000 claims abstract description 24
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 20
- 235000011187 glycerol Nutrition 0.000 claims abstract description 14
- 229920003176 water-insoluble polymer Polymers 0.000 claims abstract description 11
- -1 methacryloylethyl betaine Chemical compound 0.000 claims description 74
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 34
- 239000000194 fatty acid Substances 0.000 claims description 34
- 229930195729 fatty acid Natural products 0.000 claims description 34
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 26
- 239000003921 oil Substances 0.000 claims description 24
- 235000019198 oils Nutrition 0.000 claims description 24
- 210000003296 saliva Anatomy 0.000 claims description 23
- 239000000796 flavoring agent Substances 0.000 claims description 11
- 235000019634 flavors Nutrition 0.000 claims description 11
- 239000004359 castor oil Substances 0.000 claims description 10
- 235000019438 castor oil Nutrition 0.000 claims description 10
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 10
- IMQLKJBTEOYOSI-GPIVLXJGSA-N Inositol-hexakisphosphate Chemical compound OP(O)(=O)O[C@H]1[C@H](OP(O)(O)=O)[C@@H](OP(O)(O)=O)[C@H](OP(O)(O)=O)[C@H](OP(O)(O)=O)[C@@H]1OP(O)(O)=O IMQLKJBTEOYOSI-GPIVLXJGSA-N 0.000 claims description 9
- IMQLKJBTEOYOSI-UHFFFAOYSA-N Phytic acid Natural products OP(O)(=O)OC1C(OP(O)(O)=O)C(OP(O)(O)=O)C(OP(O)(O)=O)C(OP(O)(O)=O)C1OP(O)(O)=O IMQLKJBTEOYOSI-UHFFFAOYSA-N 0.000 claims description 9
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- QMVPMAAFGQKVCJ-UHFFFAOYSA-N citronellol Chemical compound OCCC(C)CCC=C(C)C QMVPMAAFGQKVCJ-UHFFFAOYSA-N 0.000 claims description 4
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- LZCLXQDLBQLTDK-UHFFFAOYSA-N ethyl 2-hydroxypropanoate Chemical compound CCOC(=O)C(C)O LZCLXQDLBQLTDK-UHFFFAOYSA-N 0.000 claims description 4
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- JARKCYVAAOWBJS-UHFFFAOYSA-N hexanal Chemical compound CCCCCC=O JARKCYVAAOWBJS-UHFFFAOYSA-N 0.000 claims description 4
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- MLFHJEHSLIIPHL-UHFFFAOYSA-N isoamyl acetate Chemical compound CC(C)CCOC(C)=O MLFHJEHSLIIPHL-UHFFFAOYSA-N 0.000 claims description 4
- 238000010030 laminating Methods 0.000 claims description 4
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- XMGQYMWWDOXHJM-UHFFFAOYSA-N limonene Chemical compound CC(=C)C1CCC(C)=CC1 XMGQYMWWDOXHJM-UHFFFAOYSA-N 0.000 claims description 4
- 239000001525 mentha piperita l. herb oil Substances 0.000 claims description 4
- VAMXMNNIEUEQDV-UHFFFAOYSA-N methyl anthranilate Chemical compound COC(=O)C1=CC=CC=C1N VAMXMNNIEUEQDV-UHFFFAOYSA-N 0.000 claims description 4
- NUJGJRNETVAIRJ-UHFFFAOYSA-N octanal Chemical compound CCCCCCCC=O NUJGJRNETVAIRJ-UHFFFAOYSA-N 0.000 claims description 4
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- 239000004323 potassium nitrate Substances 0.000 claims description 4
- 235000010333 potassium nitrate Nutrition 0.000 claims description 4
- 235000019423 pullulan Nutrition 0.000 claims description 4
- PUZPDOWCWNUUKD-UHFFFAOYSA-M sodium fluoride Chemical compound [F-].[Na+] PUZPDOWCWNUUKD-UHFFFAOYSA-M 0.000 claims description 4
- 239000004094 surface-active agent Substances 0.000 claims description 4
- XOLBLPGZBRYERU-UHFFFAOYSA-N tin dioxide Chemical compound O=[Sn]=O XOLBLPGZBRYERU-UHFFFAOYSA-N 0.000 claims description 4
- RUVINXPYWBROJD-ONEGZZNKSA-N trans-anethole Chemical compound COC1=CC=C(\C=C\C)C=C1 RUVINXPYWBROJD-ONEGZZNKSA-N 0.000 claims description 4
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- NZGWDASTMWDZIW-MRVPVSSYSA-N (+)-pulegone Chemical compound C[C@@H]1CCC(=C(C)C)C(=O)C1 NZGWDASTMWDZIW-MRVPVSSYSA-N 0.000 claims description 3
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- VTAJIXDZFCRWBR-UHFFFAOYSA-N Licoricesaponin B2 Natural products C1C(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2)C(O)=O)C)(C)CC2)(C)C2C(C)(C)CC1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O VTAJIXDZFCRWBR-UHFFFAOYSA-N 0.000 claims description 3
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Abstract
本发明涉及一种牙齿贴片,其具备提高贴附于牙齿或牙齿周边部时的片材的透明性,而能够视觉辨认构成贴附面的最内层的经时变化的两层。即,本发明涉及一种牙齿用贴片,其是将最内贴附层(X)、以及最外保护层(Y)层叠而成的,该最内贴附层(X)具有对牙齿的附着性及对水的溶解性,且含有药用成分(xa);该最外保护层(Y)为对牙齿的附着性及对水的溶解性低于最内贴附层(X)的层,含有水不溶性高分子(ya),且含有选自丙二醇(yb)及甘油(xc)中的1种或2种。
Description
技术领域
本发明涉及一种牙齿用贴片。
背景技术
无论是为了维持健康,也或是就美容上的观点而言,每天对于牙齿或牙龈等牙齿周边部的适当护理不可或缺。如果不进行足够的护理,则牙石或污垢会附着、堆积于牙齿表面而产生不需要的着色或者牙龈退化,而成为牙周病或牙龈炎等的原因,也可能成为牙齿松动或疼痛的发生要素,而且也有可能损害美感。
为了此种与牙齿或牙齿周边部相关的各种症状的预防或治疗、赋予美观,而开发出一种含有所需成分的牙齿用贴片,并尝试通过将其贴附于牙齿或牙齿周边部,而使所需成分发挥作用一定时间。
例如在专利文献1中公开有一种牙齿用贴片,其具有溶解至水中时的pH值显示相互不同的值的层(A)与层(B),且在后者的层中含有植酸等,通过将该牙齿用贴片贴附于牙齿,而对牙齿表面的pH环境赋予经时变化,并且使植酸等有效地发挥作用,而发挥对牙齿的美白效果。
又,在专利文献2中公开有一种牙周病用膜状外用剂,其包含直接贴附于牙齿和/或牙龈侧的最下接着层与最上保护层,且使各层对牙齿和/或牙龈的接着性及对唾液的溶解速度有差异;且做出了以下尝试:以该外用剂整体设为自睡眠开始至睡眠中的至少3小时内对唾液不会完全溶解的溶解速度,由此想要使之长时间滞留于口腔内,而在睡眠时充分地发挥药效成分的效果。
(专利文献1)国际公开第2014/069595号
(专利文献2)日本专利特开2016-84287号公报
发明内容
本发明提供一种牙齿用贴片,其是将最内贴附层(X)、以及最外保护层(Y)层叠而成的,
该最内贴附层(X)具有对牙齿的附着性及对水的溶解性,且含有药用成分(xa);
该最外保护层(Y)为对牙齿的附着性及对水的溶解性低于最内贴附层(X)的层,含有水不溶性高分子(ya),且含有选自丙二醇(yb)及甘油(yc)中的1种或2种,
优选为本发明提供一种牙齿用贴片,其是将最内贴附层(X)、以及最外保护层(Y)层叠而成的,
该最内贴附层(X)具有对牙齿的附着性及对水的溶解性,且含有药用成分(xa);
该最外保护层(Y)为对牙齿的附着性及对水的溶解性低于最内贴附层(X)的层,含有水不溶性高分子(ya),且含有选自丙二醇(yb)及甘油(yc)中的1种或2种,且成分(yb)的含量、与成分(yb)及成分(yc)的合计含量的质量比((yb)/((yb)+(yc)))大于0.5。
上述专利文献中所记载的片材尽管可给牙齿或其周边部带来所需的作用,但任意片材均未充分地确保贴附时的最外层的透明性,从而无法视觉辨认片材的溶解状况或所需成分的扩散情况,又,也难以通过视觉辨认来判断适当的贴附时间。
因此,本发明者进行了各种研究,结果发现,通过设为具备至少两层,即对牙齿的附着性及对水的溶解性显示出差异的最内贴附层及最外保护层的构造,且为了给牙齿或牙齿周边部带来所需效果,而使最内贴附层含有药用成分,并且使最外保护层含有水不溶性高分子以及丙二醇或甘油中的至少一种,可获得具备确保良好的成形性并且显示优异的透明性的最外保护层的牙齿贴片。
即,本发明涉及一种牙齿贴片,其具备提高贴附至牙齿或牙齿周边部时的最外层的透明性而能够视觉辨认构成贴附面的最内层的经时变化的两层。
根据本发明的牙齿用贴片,由于在贴附至牙齿或牙齿周边部时由透明性较高的最外保护层所被覆、保护,因此能够透过最外保护层视觉辨认较最外保护层更内侧的层中的药用成分向牙齿或牙齿周边部的传递、扩散等经时变化,而能够适当地明确需要的贴附时间。又,也能够使本发明的牙齿用贴片与牙齿或牙齿周边部在视觉上同化,而减少异物感。
具体实施方式
以下,对本发明进行详细地进行说明。
本发明的牙齿用贴片由具备最内贴附层(X)与透明性较高的最外保护层(Y)的至少两层的构造构成,且将最内贴附层(X)贴附于牙齿或牙齿周边部来使用。如此,本发明的牙齿用贴片在贴附至牙齿或牙齿周边部时,最内贴附层(X)能够良好地溶解于唾液中,并且能够适当地发挥各自的特定作用。
具体而言,最内贴附层(X)良好地附着于牙齿或牙齿周边部,先于最外保护层(Y)溶解于唾液中,并且使所含有的药用成分(xa)自一面对牙齿或牙齿周边部发挥作用。其间,与最内贴附层(X)相比,最外保护层(Y)不会过度地附着于牙齿或牙齿周边部等口腔内,又,相较于最内贴附层(X),最外保护层(Y)对唾液的溶解延迟,因此最内贴附层(X)对唾液的溶解不会因唾液或舌头而受到不必要的阻碍,可促进药用成分(xa)良好地向牙齿或牙齿周边部传递、扩散,并且透过最外保护层(Y)视觉辨认此种经时变化。
此处,所谓牙齿周边部,是指包含牙龈、所谓牙床的位于牙齿周边的口腔内器官,本发明的牙齿用贴片是仅贴附于牙齿、仅贴附于牙齿周边部、或遍及牙齿及牙齿周边部两者贴附来使用的片材。以下,将“牙齿或牙齿周边部”总称为“牙齿等”。
又,除用于制造本发明的牙齿用贴片的原液以外,关于各质量,设为干燥状态下的质量(干燥质量)。
本发明的牙齿用贴片所具备的最内贴附层(X)是具有对牙齿的附着性及对水的溶解性,且含有药用成分(xa)的层,是具有在使用本发明的牙齿用贴片时供直接贴附于牙齿等的面的层。由此,在将本发明的牙齿用贴片贴附至牙齿等时,最内贴附层(X)可良好地附着于牙齿等并逐渐地溶解于唾液中,从而使药用成分(xa)自最内贴附层(X)内向牙齿等传递、扩散,可给所需部位带来所需的作用。
作为最内贴附层(X)所含有的药用成分(xa),可列举:对预防或治疗牙周病或牙龈炎等有效的成分、对防蛀牙有效的成分、或带来美白作用的成分等。具体而言,可列举:选自植酸、焦磷酸、三聚磷酸、甘草酸、甘草次酸及这些的盐、以及硝酸钾及氟中的1种或2种以上。其中,就期望使药用成分集中地作用于牙齿表面的技术的观点而言,更优选为使用植酸或其盐、硝酸钾、及氟化物。作为优选的氟化物,可列举氟化钠、氟化钾、氟化铵等氟离子供给化合物、及单氟磷酸钠等。尤其是就期望简便地美化牙齿的技术的观点而言,更优选为使用植酸或其盐。
就有效地给牙齿等带来作用的观点而言,药用成分(xa)的含量在最内贴附层(X)100质量%中优选为0.05质量%以上,更优选为0.07质量%以上,进而优选为0.1质量%以上。又,就确保对牙齿等的良好的浸透性的观点而言,药用成分(xa)的含量在最内贴附层(X)100质量%中优选为30质量%以下,更优选为20质量%以下,进而优选为15质量%以下。
更具体而言,就作用于牙齿等而引导至良好的状态的观点而言,药用成分(xa)的含量优选为下述范围。在药用成分(xa)为植酸或其盐的情形时,成分(xa)的含量在最内贴附层(X)100质量%中以酸换算量计优选为1~30质量%,更优选为5~20质量%,进而优选为10~15质量%。
就确保对唾液的良好的溶解性,不仅提高最外保护层(Y)的透明性也提高最内贴附层(X)的透明性,而赋予牙齿用贴片整体较高的透明性,进一步提升成分(xa)向牙齿等的溶解、扩散的可视化的观点而言,最内贴附层(X)优选为进而含有非离子表面活性剂(xb)。作为该非离子表面活性剂(xb),优选为含有聚氧乙烯氢化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2)中的任1种,更优选为含有聚氧乙烯氢化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2)这两者。
作为聚氧乙烯氢化蓖麻油(xb-1),就确保对牙齿的附着性,并且进一步提高最内贴附层(X)的透明性的观点而言,优选为乙烯氧基的平均加成摩尔数为20~60,更优选为40~60。
作为聚甘油脂肪酸酯(xb-2),就确保对唾液的良好的溶解性,并且进一步提高最内贴附层(X)的透明性的观点而言,作为构成其的脂肪酸部分,优选源自碳原子数10~16的脂肪酸,更优选源自碳原子数12~14的脂肪酸。又,就与上述相同的观点而言,甘油的平均缩合度优选为5~12。
就确保对牙齿的附着性及对唾液的溶解性,并且进一步提高最内贴附层(X)的透明性的观点而言,最内贴附层(X)中的聚氧乙烯氢化蓖麻油(xb-1)的含量与聚甘油脂肪酸酯(xb-2)的含量的质量比((xb-1)/(xb-2))优选为0.1以上,更优选为0.5以上,进而优选为1以上,且优选为10以下,更优选为9以下,进而优选为7以下。
最内贴附层(X)也可含有除聚氧乙烯氢化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2)以外的非离子表面活性剂作为非离子表面活性剂(xb)。作为该非离子表面活性剂,可列举选自聚氧乙烯烷基醚、聚氧乙烯聚氧丙烯共聚物、蔗糖脂肪酸酯、山梨醇酐脂肪酸酯、甘油脂肪酸酯、聚氧乙烯山梨醇酐脂肪酸酯、聚氧乙烯山梨糖醇脂肪酸酯、聚氧乙烯甘油脂肪酸酯、聚氧乙烯二醇脂肪酸酯、聚氧乙烯植物甾醇及植物甾烷醇、聚氧乙烯羊毛脂及羊毛醇、聚氧乙烯烷基胺及脂肪酸酰胺、聚氧乙烯烷基苯基甲醛缩合物、聚氧乙烯聚氧丙烯烷基醚、聚氧乙烯烷基苯醚、聚氧乙烯烷基苯醚及脂肪酸乙醇酰胺等中的1种或2种以上。其中,优选为选自蔗糖脂肪酸酯及聚氧乙烯山梨醇酐脂肪酸酯中的1种或2种。
就良好地保持最内贴附层(X)对牙齿的附着性及对唾液的溶解性,并且进一步提高最内贴附层(X)的透明性的观点而言,包含聚氧乙烯氢化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2)的非离子表面活性剂(xb)的总含量在最内贴附层(X)100质量%中优选为0.8质量%以上,优选为2质量%以上,更优选为3质量%以上,进而优选为4质量%以上,且优选为6质量%以下,更优选为5质量%以下,进而优选为4.7质量%以下。
又,就与上述相同的观点而言,聚氧乙烯氢化蓖麻油(xb-1)的含量在最内贴附层(X)100质量%中优选为0.2~5.5质量%,更优选为0.6~4.5质量%,进而优选为1.5~3.5质量%。
进而,就与上述相同的观点而言,聚甘油脂肪酸酯(xb-2)的含量在最内贴附层(X)100质量%中优选为0.1~3质量%,更优选为0.2~2.2质量%,进而优选为0.5~2质量%。
最内贴附层(X)可进而含有香料(xc)。作为该香料(xc),例如可列举:薄荷脑、蒲勒醇(pulegol)、香旱芹酮、大茴香脑、桉树脑、水杨酸甲酯、肉桂醛、丁香酚、3-1-薄荷氧基丙烷-1,2-二醇、瑞香草酚、乙酸香茅酯、芳樟醇、乙酸芳樟酯、香叶醇、乙酸香叶酯、香茅醇、柠檬烯、薄荷酮、乙酸薄荷酯、N-取代-对薄荷烷-3-甲酰胺、蒎烯、辛醛、柠檬醛、蒲勒酮(pulegone)、乙酸香芹酯、乙酸二氢香芹酯、茴香醛、苯甲醛、樟脑、内酯、乙酸乙酯、丁酸乙酯、环己基丙酸烯丙酯、邻氨基苯甲酸甲酯、甲基苯基缩水甘油酸乙酯、香草醛、十一酸内酯、己醛、乙酸丁酯、乙酸异戊酯、己烯醇、二甲基硫醚、甲基环戊烯醇酮(cyclotene)、糠醛、三甲基吡嗪、乳酸乙酯、乳酸甲酯、硫代乙酸乙酯等单品香料成分;草莓香料、苹果香料、香蕉香料、菠萝香料、葡萄香料、芒果香料、黄油香料、牛奶香料、水果混合香料、热带水果香料等调合香料成分;胡椒薄荷油、绿薄荷油、锡兰肉桂油、大茴香油、桉叶油、鹿蹄草油、肉桂油、丁香油、百里香油、鼠尾草油、香紫苏油、肉豆蔻油、茴香油、柠檬油、甜橙油、薄荷油、小豆蔻油、芫荽籽油、罗勒油、红橘油、莱姆油、熏衣草油、迷迭香油、姜油、葡萄柚油、月桂油、黄金菊油、葛缕子油、马郁兰油、香叶油、柠檬草油、香蜂草油、多香果油、玫瑰草油、乳香油、松针油、苦橙叶油、橙花油、玫瑰油、茉莉油等天然香料成分、及将这些天然香料成分进行加工处理所得的香料成分。
就带来良好的风味,并且掩盖成分(xa)的异味而减少贴附时的不舒适感的观点而言,该成分(xc)的含量在最内贴附层(X)100质量%中优选为0.1~3质量%,更优选为0.2~2质量%,进而优选为0.3~1质量%。
就确保最内贴附层(X)本身的良好的成形性的观点、及促进成分(xa)向牙齿等的传递、扩散的观点而言,优选为最内贴附层(X)含有水溶性高分子(xd)。此处,水溶性是指在25℃下在100g水中溶解0.1g以上的成分。
作为该水溶性高分子(xd),具体而言,可列举:选自支链淀粉、羟乙基纤维素、瓜尔胶、羟丙基纤维素、羟丙甲纤维素、明胶及琼脂中的1种或2种以上。其中,就提高最内贴附层(X)的透明性,使成分(xa)向牙齿等的传递、扩散可视化的观点而言,优选为选自支链淀粉、琼脂及羟丙甲纤维素中的1种或2种。
关于水溶性高分子(xd)的含量,就确保最内贴附层(X)本身的良好的成形性的观点、及促进成分(xa)向牙齿等的传递、扩散的观点而言,水溶性高分子(xd)的含量在最内贴附层(X)100质量%中优选为30~70质量%,更优选为40~65质量%,进而优选为45~60质量%。
最内贴附层(X)除上述成分以外,也可在不损害本发明的效果的范围内含有例如氢氧化钠或氢氧化钾等pH值调节剂、丙二醇、甘油等润湿剂、糖精钠或蔗糖素等甜味料、防腐剂、色素等作为上述以外的成分。其中,如果使用氢氧化钾作为pH值调节剂,则也可有助于提高所含有的成分在牙齿用贴片内的溶解性或分散性。
再者,在使用本发明的牙齿用贴片时,就保持良好的附着性或柔软性的观点、及确保所含有的成分在牙齿用贴片内的溶解性或分散性的观点而言,较理想为在经过制造时的干燥工序后的最内贴附层(X)中也保持适度的含水量。该含水量在最内贴附层(X)100质量%中优选为5~16质量%,更优选为6~15质量%,进而优选为7~14质量%。
本发明的牙齿用贴片所具备的最外保护层(Y)为对牙齿的附着性及对水的溶解性低于最内贴附层(X)的层,含有水不溶性高分子(ya),且含有选自丙二醇(yb)及甘油(yc)中的1种或2种。由此,可使对牙齿的附着性及对唾液的溶解性低于最内贴附层(X),并且提高最外保护层(Y)的成形性并赋予优异的透明性。因此,在将本发明的牙齿用贴片贴附至牙齿等时,对唾液的溶解性低于最内贴附层(X)的最外保护层(Y)能够被覆、保护会先溶解于唾液的最内贴附层(X),并且透过该最外保护层(Y)视觉辨认最内贴附层(X)中的药用成分(xa)向牙齿等的传递、扩散等经时变化。又,最外保护层(Y)在药用成分(xa)发挥作用后可利用牙刷的刷洗而容易地去除。
此处,水不溶性是指在25℃下在100g水中溶解的量小于0.1g的成分。
再者,在最外保护层(Y)中,就有效地抑制鱼眼状裂纹(fish eye)等产生、赋予优异的透明性的观点而言,表面活性剂的含量在最外保护层(Y)100质量%中优选为小于0.1质量%,进而优选为小于0.01质量%,特别优选为最外保护层(Y)不含有表面活性剂。
作为该水不溶性高分子(ya),可列举选自乙基纤维素、醋酸羟丙甲纤维素琥珀酸酯、邻苯二甲酸醋酸纤维素、羟丙甲纤维素邻苯二甲酸酯、虫胶、聚乙酸乙烯酯、聚甲基丙烯酸甲酯、甲基丙烯酰基乙基甜菜碱/甲基丙烯酸酯共聚物、甲基丙烯酸共聚物、甲基丙烯酸氨基烷基酯共聚物及琼脂中的1种或2种以上。其中,就防止最外保护层(Y)中的白浊部分出现,赋予优异的透明性的观点而言,优选为选自乙基纤维素及虫胶中的1种或2种,更优选为乙基纤维素。
就有效地抑制最外保护层(Y)中的鱼眼状裂纹等产生、赋予优异的透明性的观点而言,丙二醇(yb)及甘油(yc)的含量、与水不溶性高分子(ya)的含量的质量比(((yb)+(yc))/(ya)),即,成分(yb)及成分(yc)的合计含量、与成分(ya)的含量的质量比(((yb)+(yc))/(ya))优选为0.1以上,更优选为0.25以上,进而优选为0.43以上,优选为9以下,更优选为4以下,进而优选为2.3以下。又,成分(yb)及成分(yc)的合计含量、与成分(ya)的含量的质量比(((yb)+(yc))/(ya))优选为0.1~9,更优选为0.25~4,进而优选为0.43~2.3。又,丙二醇(yb)的含量与水不溶性高分子(ya)的含量的质量比((yb)/(ya))优选为0.1~9,更优选为0.25~4,进而优选为0.43~2.3。
丙二醇(yb)的含量、与丙二醇(yb)及甘油(yc)的合计含量的质量比((yb)/((yb)+(yc)))大于0.5,优选为大于0.7,进而优选为大于0.9。关于质量比(yb)/((yb)+(yc))的上限值,为1以下即可。
就也确保最外保护层(Y)的良好的成形性与由刷洗引起的崩解性的观点而言,选自成分(yb)及(yc)中的1种或2种以上的合计含量在最外保护层(Y)100质量%中优选为7质量%以上,更优选为20质量%以上,进而优选为40质量%以上,且优选为90质量%以下,更优选为80质量%以下,进而优选为70质量%以下。
最外保护层(Y)除上述成分以外,也可在不损害本发明的效果的范围内含有例如防腐剂、色素等作为上述以外的成分。
就有效地防止最内贴附层(X)对唾液的溶解因唾液或舌头而受到不必要的阻碍、促进最内贴附层(X)对唾液的溶解以及药用成分(xa)向牙齿等良好地传递、扩散的观点而言,最外保护层(Y)的厚度优选为0.1μm以上,更优选为0.2μm以上,进而优选为0.3μm以上。又,就确保对最外保护层(Y)赋予较高透明性的观点、及即便在贴附中闭口也不易产生不适感的观点而言,最外保护层(Y)的厚度优选为5μm以下,更优选为3μm以下,进而优选为2.5μm以下。并且,最外保护层(Y)的厚度优选为0.1~5μm,更优选为0.2~3μm,进而优选为0.3~2.5μm。
就在药用成分(xa)向牙齿等良好地传递、扩散的期间被最外保护层(Y)有效地被覆、保护的观点、及在适度的时间内完全溶解于唾液中的观点而言,最内贴附层(X)的厚度优选为9.9~95μm,更优选为19.8~87μm,进而优选为29.7~77.5μm以下。
本发明的牙齿用贴片除上述最内贴附层(X)及最外保护层(Y)以外,也可进而具备在最内贴附层(X)与最外保护层(Y)的层间所形成的中间层(Z)。由此,在使用时最内贴附层(X)溶解于唾液中而将药用成分(xa)释出至口腔内后,继而中间层(Z)溶解于唾液中而药用成分(xa-2)被释出至口腔内。(xa-2)是与最内侧贴附层(X)中所含的药用成分(xa)不同的成分,可列举选自植酸、焦磷酸、三聚磷酸、甘草酸、甘草次酸及这些盐、以及硝酸钾及氟中的1种或2种以上。通过设置中间层(Z),容易赋予阶段性的溶解性,即在使最内贴附层(X)溶解的后继而使中间层(Z)溶解。
作为该中间层(Z)的材质,可列举选自支链淀粉、羟乙基纤维素、瓜尔胶、羟丙基纤维素、羟丙甲纤维素、明胶及琼脂中的1种或2种以上。
就确保适于贴附的柔软性或对牙齿等的追随性的观点、及确保药用成分(xa)作用于牙齿等并引导至良好状态所需要的量的观点而言,本发明的牙齿用贴片的总厚度优选为100~10μm,更优选为90~20μm,进而优选为80~30μm以下。
为了制造本发明的牙齿用贴片,可在分别形成由最内贴附层(X)的单一层构成的片材、由最外保护层(Y)的单一层构成的片材、及由视需要的中间层(Z)的单一层构成的片材后,层叠这些,又,也可在基材之上依序层叠。最内贴附层(X)使用原液(X),最外保护层(Y)使用原液(Y),同样地中间层(Z)也使用原液,继而将这些原液分别制成层状后,经由干燥工序,由此可形成本发明的牙齿用贴片。
再者,用于形成最内贴附层(X)的原液(X)只要将药用成分(xa)以成为上述特定量的方式含有,此外适当含有水等成分而进行制备即可,用于形成最外保护层(Y)的原液(Y)只要将水不溶性高分子(ya)及丙二醇(yb)以成为上述特定的质量比的方式含有,此外适当含有水等成分而进行制备即可。用于形成中间层(Z)的原液也只要以相同的方式进行制备即可。
具体而言,例如在形成由最内贴附层(X)的单一层构成的片材的情形时,在制备含有药用成分(xa)的原液(X)的后,一面考虑厚度,一面在实施过脱模处理等的聚对苯二甲酸乙二酯(PET)膜上涂布原液(X),使其干燥。然后,通过剥离PET膜,可获得各由单一层构成的片材。其中,关于构成供贴附于牙齿等侧的面的片材,也可不剥离PET膜而直接担载。继而,在最下层配置PET膜,在其上依序层叠由构成供贴附于牙齿等侧的面的单一层构成的最内贴附层(X)、其它中间层(Z)、及由相当于最外保护层(Y)的单一层构成的片材后,例如使用加压装置进行压接。再者,此处加压装置也可进行加热。其后,通过剥离最下层的PET膜,可获得本发明的牙齿用贴片。
又,在基材上依序层叠的情形时,在最内贴附层(X)构成供贴附于牙齿等侧的面时,例如首先将PET膜作为基材,涂布原液(X),使其干燥而形成最内贴附层(X)。其次,在最内贴附层(X)上视需要形成中间层(Z)后,涂布原液(Y),使其干燥而形成最外保护层(Y),由此也可获得本发明的牙齿用贴片。
本发明的牙齿用贴片通过贴附于牙齿等,可给被贴附体的牙齿等带来源自药用成分(xa)的所需效果。在将牙齿用贴片贴附至牙齿等时,自刚贴附后至最内贴附层(X)全部溶解于唾液中为止的时间优选为3分钟以上,更优选为5分钟以上,进而优选为7分钟以上,且优选为60分钟以下,更优选为45分钟以下,进而优选为30分钟以下。
本发明的牙齿用贴片是贴附至牙齿等时构成所贴附的面的最内贴附层(X)被透明性较高的最外保护层(Y)所被覆、保护而成。因此,在贴附有片材的部位,可透过最外保护层(Y)视觉辨认配置于较最外保护层(Y)更内侧的层的溶解状况或药用成分(xa)向牙齿等的传递、扩散状况,也可适当地明确适当的贴附时间。又,通过在配置于较最外保护层(Y)更内侧的层施加颜色或花纹,也可容易地透过这种最外保护层(Y)来视觉辨认经时变化。进而,如果也提高最内贴附层(X)的透明性,则也能够使本发明的牙齿用贴片与牙齿或牙齿周边部在视觉上同化,而减少异物感。
[实施例]
以下,基于实施例,对本发明具体地进行说明。再者,表中只要无特别表示,则各成分的含量以质量%表示。
[实施例1~21、比较例1~2]
为了获得表1中所示的最内贴附层(X),使用纯化水作为溶剂并且将含有植酸作为药用成分(xa)的各成分加以混合而制备原液(X)。同样地,为了获得表1中所示的最外保护层(Y),使用乙醇作为溶剂并且将水不溶性高分子(ya)及丙二醇(yb)或甘油(yc)加以混合而制备原液(Y)。
继而,一面考虑厚度,一面将所获得的原液(X)涂布于聚对苯二甲酸乙二酯(PET)膜上,使其干燥而获得最内贴附层(X)。继而,自最内贴附层(X)上涂布原液(Y),使其干燥,获得在最内贴附层(X)60~70μm上层叠最外保护层(Y)1~2μm而成的总厚度为61~72μm的牙齿用贴片。
再者,表1中所示的值是构成干燥后的牙齿用贴片的最内贴附层(X)及最外保护层(Y)的值。
《最外保护层(Y)的透明性及牙齿用贴片整体的透明性的评价》
关于最外保护层(Y)的透明性,将该最外保护层(Y)中有无白浊作为评价的指标。具体而言,将所获得的牙齿用贴片配置于黑纸上,通过目视并以下述5阶段评价来判断有无白浊。
将结果示于表1。
1:完全无白浊部,因此能够立即识别黑色
2:无白浊部(无法识别为白浊部区域),能够识别黑色
3:虽存在少许白浊部(大概1/4以下),但能够识别黑色
4:存在相当的白浊部(大概1/2左右),无法识别一部分黑色
5:白浊部遍及整体存在(大概3/4以上),无法识别黑色
又,关于牙齿用贴片整体的透明性,以透过片材能否识别文字作为评价的指标。具体而言,在距离印有文字的纸一定距离处配置牙齿用贴片,依据下述判定基准来判定能否通过目视透过片材识别文字。
将结果示于表2。
1:由于透明,因此能够立即识别文字
2:虽透明度稍低,但能够充分识别文字
3:透明度多少有些低,但勉强能够识别文字
4:透明度相当欠缺,勉强能够识别文字本身
5:透明度完全欠缺,难以识别文字本身
[表2]
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Claims (29)
1.一种牙齿用贴片,其中,
所述牙齿用贴片是将最内贴附层(X)、以及最外保护层(Y)层叠而成的,
该最内贴附层(X)具有对牙齿的附着性及对水的溶解性,且含有药用成分(xa);
该最外保护层(Y)为对牙齿的附着性及对水的溶解性低于最内贴附层(X)的层,含有水不溶性高分子(ya),且含有选自丙二醇(yb)及甘油(yc)中的1种或2种,并且显示透明性,
成分(ya)为选自乙基纤维素、醋酸羟丙甲纤维素琥珀酸酯、邻苯二甲酸醋酸纤维素、羟丙甲纤维素邻苯二甲酸酯、虫胶、聚乙酸乙烯酯、聚甲基丙烯酸甲酯、甲基丙烯酰基乙基甜菜碱/甲基丙烯酸酯共聚物、甲基丙烯酸共聚物、甲基丙烯酸氨基烷基酯共聚物及琼脂中的1种或2种以上,且
成分(yb)及成分(yc)的合计含量、与成分(ya)的含量的质量比((yb)+(yc))/(ya)为0.1~9,并且
成分(yb)的含量、与成分(yb)及成分(yc)的合计含量的质量比(yb)/((yb)+(yc))大于0.9。
2.如权利要求1所述的牙齿用贴片,其中,
最内贴附层(X)进而含有非离子表面活性剂(xb),且
最内贴附层(X)100质量%中的成分(xb)的含量为2质量%以上6质量%以下。
3.如权利要求2所述的牙齿用贴片,其中,
成分(xb)含有聚氧乙烯氢化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2)中的任1种。
4.如权利要求2所述的牙齿用贴片,其中,
成分(xb)含有聚氧乙烯氢化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2)这两者。
5.如权利要求3所述的牙齿用贴片,其中,
成分(xb-1)的乙烯氧基的平均加成摩尔数为20~60。
6.如权利要求3~5中任一项所述的牙齿用贴片,其中,
成分(xb-2)源自碳原子数10~16的脂肪酸。
7.如权利要求3~5中任一项所述的牙齿用贴片,其中,
成分(xb-2)的甘油的平均缩合度为5~12。
8.如权利要求2~5中任一项所述的牙齿用贴片,其中,
成分(xb)至少含有聚氧乙烯氢化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2),且
最内贴附层(X)中的成分(xb-1)的含量与成分(xb-2)的含量的质量比(xb-1)/(xb-2)为0.1以上10以下。
9.如权利要求1~5中任一项所述的牙齿用贴片,其中,
最内贴附层(X)含有选自支链淀粉、羟乙基纤维素、瓜尔胶、羟丙基纤维素、羟丙甲纤维素、明胶及琼脂中的1种或2种以上的水溶性高分子(xd)。
10.如权利要求1~5中任一项所述的牙齿用贴片,其中,
成分(xa)为选自植酸、焦磷酸、三聚磷酸、甘草酸、甘草次酸及这些的盐、以及硝酸钾、氟化钠、氟化钾、氟化铵、及单氟磷酸钠中的1种或2种以上。
11.如权利要求1~5中任一项所述的牙齿用贴片,其中,
成分(xa)的含量在最内贴附层(X)100质量%中为0.05质量%以上30质量%以下。
12.如权利要求3~5中任一项所述的牙齿用贴片,其中,
最内贴附层(X)含有除成分(xb-1)及成分(xb-2)以外的非离子表面活性剂作为成分(xb)。
13.如权利要求12所述的牙齿用贴片,其中,
除成分(xb-1)及成分(xb-2)以外的非离子表面活性剂为选自聚氧乙烯烷基醚、聚氧乙烯聚氧丙烯共聚物、蔗糖脂肪酸酯、山梨醇酐脂肪酸酯、甘油脂肪酸酯、聚氧乙烯山梨醇酐脂肪酸酯、聚氧乙烯山梨糖醇脂肪酸酯、聚氧乙烯甘油脂肪酸酯、聚氧乙烯二醇脂肪酸酯、聚氧乙烯植物甾醇及植物甾烷醇、聚氧乙烯羊毛脂及羊毛醇、聚氧乙烯烷基胺及脂肪酸酰胺、聚氧乙烯烷基苯基甲醛缩合物、聚氧乙烯聚氧丙烯烷基醚、聚氧乙烯烷基苯醚及脂肪酸乙醇酰胺中的1种或2种以上。
14.如权利要求2~5中任一项所述的牙齿用贴片,其中,
成分(xb)的含量在最内贴附层(X)100质量%中为3质量%以上5质量%以下。
15.如权利要求3~5中任一项所述的牙齿用贴片,其中,
成分(xb-1)的含量在最内贴附层(X)100质量%中为0.2~5.5质量%。
16.如权利要求3~5中任一项所述的牙齿用贴片,其中,
成分(xb-2)的含量在最内贴附层(X)100质量%中为0.1~3质量%。
17.如权利要求1~5中任一项所述的牙齿用贴片,其中,
最内贴附层(X)进而含有香料(xc)。
18.如权利要求17所述的牙齿用贴片,其中,
成分(xc)为选自:薄荷脑、蒲勒醇、香旱芹酮、大茴香脑、桉树脑、水杨酸甲酯、肉桂醛、丁香酚、3-1-薄荷氧基丙烷-1,2-二醇、瑞香草酚、乙酸香茅酯、芳樟醇、乙酸芳樟酯、香叶醇、乙酸香叶酯、香茅醇、柠檬烯、薄荷酮、乙酸薄荷酯、N-取代-对薄荷烷-3-甲酰胺、蒎烯、辛醛、柠檬醛、蒲勒酮、乙酸香芹酯、乙酸二氢香芹酯、茴香醛、苯甲醛、樟脑、乙酸乙酯、丁酸乙酯、环己基丙酸烯丙酯、邻氨基苯甲酸甲酯、甲基苯基缩水甘油酸乙酯、香草醛、十一酸内酯、己醛、乙酸丁酯、乙酸异戊酯、己烯醇、二甲基硫醚、甲基环戊烯醇酮、糠醛、三甲基吡嗪、乳酸乙酯、乳酸甲酯、硫代乙酸乙酯的单品香料成分;草莓香料、苹果香料、香蕉香料、菠萝香料、葡萄香料、芒果香料、黄油香料、牛奶香料、水果混合香料、热带水果香料的调合香料成分;胡椒薄荷油、绿薄荷油、锡兰肉桂油、大茴香油、桉叶油、鹿蹄草油、肉桂油、丁香油、百里香油、鼠尾草油、香紫苏油、肉豆蔻油、茴香油、柠檬油、甜橙油、薄荷油、小豆蔻油、芫荽籽油、罗勒油、红橘油、莱姆油、熏衣草油、迷迭香油、姜油、葡萄柚油、月桂油、黄金菊油、葛缕子油、马郁兰油、香叶油、柠檬草油、香蜂草油、多香果油、玫瑰草油、乳香油、松针油、苦橙叶油、橙花油、玫瑰油、茉莉油的天然香料成分、及将这些天然香料成分进行加工处理所得的香料成分中的1种或2种以上。
19.如权利要求17所述的牙齿用贴片,其中,
成分(xc)的含量在最内贴附层(X)100质量%中为0.1~3质量%。
20.如权利要求1~5中任一项所述的牙齿用贴片,其中,
最内贴附层(X)进而含有水溶性高分子(xd)。
21.如权利要求20所述的牙齿用贴片,其中,
成分(xd)的含量在最内贴附层(X)100质量%中为30~70质量%。
22.如权利要求1~5中任一项所述的牙齿用贴片,其中,
选自成分(yb)及(yc)中的1种或2种以上的合计含量在最外保护层(Y)100质量%中为7质量%以上90质量%以下。
23.如权利要求1~5中任一项所述的牙齿用贴片,其中,
含水量在最内贴附层(X)100质量%中为5~16质量%。
24.如权利要求1~5中任一项所述的牙齿用贴片,其中,
最外保护层(Y)为能够通过利用牙刷的刷洗而去除的层。
25.如权利要求1~5中任一项所述的牙齿用贴片,其中,
在最外保护层(Y)100质量%中表面活性剂的含量小于0.1质量%,或者,最外保护层(Y)不含有表面活性剂。
26.如权利要求1~5中任一项所述的牙齿用贴片,其中,
最外保护层(Y)的厚度为0.1μm以上5μm以下。
27.如权利要求1~5中任一项所述的牙齿用贴片,其中,
最内贴附层(X)的厚度为9.9~95μm。
28.如权利要求1~5中任一项所述的牙齿用贴片,其中,
牙齿用贴片的总厚度为10~100μm。
29.如权利要求1~5中任一项所述的牙齿用贴片,其中,
在将牙齿用贴片贴附至牙齿时,自刚贴附后至最内贴附层(X)全部溶解于唾液中为止的时间为3分钟以上60分钟以下。
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