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CN1232241C - 牙齿增白贴片 - Google Patents

牙齿增白贴片 Download PDF

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CN1232241C
CN1232241C CNB018067042A CN01806704A CN1232241C CN 1232241 C CN1232241 C CN 1232241C CN B018067042 A CNB018067042 A CN B018067042A CN 01806704 A CN01806704 A CN 01806704A CN 1232241 C CN1232241 C CN 1232241C
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peroxide
paster
tooth
dry type
teeth whitening
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CN1418085A (zh
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金志荣
金钟昊
张锡胤
尹世荣
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LG H&H Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
    • A61K8/8164—Compositions 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 a carboxyl radical, and containing at least one other carboxyl radical in the molecule, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers, e.g. poly (methyl vinyl ether-co-maleic anhydride)
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K8/817—Compositions 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 a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions or derivatives of such polymers, e.g. vinylimidazol, vinylcaprolactame, allylamines (Polyquaternium 6)
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K8/00—Cosmetics or similar toiletry preparations
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    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
    • A61K8/817—Compositions 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 a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions or derivatives of such polymers, e.g. vinylimidazol, vinylcaprolactame, allylamines (Polyquaternium 6)
    • A61K8/8182—Copolymers of vinyl-pyrrolidones. Compositions of derivatives of such polymers

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Abstract

本发明涉及一种用于牙齿增白的干型贴片，包含基质型粘合层以及背衬层，其中所述粘合层包含作为牙齿增白剂的过氧化物、以及用于该过氧化物的稳定剂和作为基础聚合物的亲水性玻璃聚合物，该粘合层在牙釉质层上被水合时对牙齿产生强的粘合力，并同时释放所述牙齿增白剂。根据本发明的干型贴片与常规的湿型贴片相比使用更简便。另外，其具有优异的粘合力，同时能够长时间地保持贴附牙齿的状态，以确保贴片中的牙齿增白剂与牙齿的污垢之间足够的接触时间，由此产生充分的牙齿增白作用。

Description

牙齿增白贴片
技术领域
本发明涉及仅通过贴附在牙齿上就能够除去牙垢并增白牙齿的干型贴片(patch)。更具体而言，本发明涉及包含亲水性玻璃聚合物作为背衬层上的基质型粘合层以及作为增白剂的过氧化物的干型贴片，其中亲水性玻璃聚合物使得对牙齿具有强的粘性贴附作用，同时在被牙齿上的水分水合时释放牙齿增白剂。本发明的干型贴片具有以下特征：因为是透明的，所以具有不显眼的外观。因此，该贴片在使用时不会干扰任何正常的社会生活。另外，本发明的贴片可非常方便地使用，因为能够确保粘合层中的过氧化物在高温下的经时稳定性。
背景技术
随着人们对牙齿增白之兴趣的增加，市场上已有许多具有牙齿增白效果的牙膏在销售。然而，牙膏中即使包含具有良好性能的牙齿增白剂，仍难以通过牙齿与牙膏1-3分钟的接触时间刷牙而在短时间内达到明显的牙齿增白效果。
近来，为解决上述问题，已有人申请了许多的相关专利申请，而且市场上也出现了各种配方的牙齿增白产品。
在这些产品中，对于专业增白凝胶，患者需要去看牙医一次或两次，以检查其准确的牙齿情况并测量牙齿的大小。牙医则根据检查和测量结果制造与每个患者的牙齿相吻合的牙托。患者在家中按照医师的指示将增白凝胶涂敷在牙托的内壁和槽上，并配戴该牙托过夜或者一天2次或者一周2-4天。典型地，上述治疗在2-4周内完成。然而，该方法的缺点是：患者使用该牙托非常不方便，而且当配戴该牙托时，患者通常有不舒服的感觉。另外，患者不得不付出很多的钱来制造他自己的牙托。再者，牙托中负载的高浓度的过氧化物凝胶有可能流到牙齿上，并与牙龈接触，由此刺激或者损坏牙龈或者口腔
为解决这些问题，转让给Lion Corp.的日本专利10,017,448公开了用于口腔的膏药，其包含牙齿粘合层以及支持层。在该专利中所用的增白剂包括曲酸及其衍生物、抗坏血酸及其衍生物、过氧化脲等，但认为曲酸及其各种盐是特别有效的。但是，因为上述增白剂具有强酸性，有可能因为低pH值导致口腔的刺激作用。此等药剂在高酸性下可提供优异的增白作用。因此，难以得到具有良好增白效果但无刺激作用的膏药。
曲酸广泛用于皮肤护理产品中。然而，尚未证实具有牙齿增白效果，而且从未被用作牙齿增白剂。实际上，当在包含作为粘合剂的玻璃聚合物的贴片剂中分别添加抗坏血酸及其衍生物或者过氧化脲作为增白剂时，会随着时间的流逝而发生变色和发粘的现象。具体而言，当添加过氧化脲时，在40℃下以晶体形式储存产生严重的问题。
另外，该专利中提到的增白剂通常被认为是不稳定的。而且，该专利没有描述如何稳定这些增白剂。上述专利似乎是一项理想的专利，其是通过在使用普通聚合物的膏药中混入曲酸(其是Lion Corp.制造的皮肤增白化妆组合物的典型原料)而形成的，但未进行任何具体的研究。
于1999年3月16日申请并于2000年5月30日公布的日本专利12,281,548公开了一种牙齿增白套盒。权利要求2描述了在与牙齿接触的表面上具有多个凸出的非水溶性带、片、膜、牙托、口腔托盘(mouthtray)、口腔片(mouth piece)、印模填塞物、填塞料、以及咀嚼刷，它们是通过在牙弓上形成而制备的。在阅读该专利的说明书后发现，该发明的特征是在上述器具的支持层上薄薄地涂敷凝胶态的增白组分或者将上述器具的粘合部分浸入包含增白剂的溶液中。也就是说，该专利所要求保护的器具是湿型的。当使用此等类型的器具时，增白剂有可能与手或者身体的其他部分接触，导致刺激作用。
另外，非水溶性带或者片的粘合部分是由纺织布或者无纺布如缧萦、棉花、丝或者纸构成的，而支持层是由非水溶性膜例如聚乙烯、聚丙烯、聚酯等构成。因此，并不认为该发明比第10,017,448号专利有任何改进之处。
同时，该发明使用多磷酸盐替代过氧化物作为增白剂，还包含阴离子表面活性剂以及具有不超过3个碳原子的低分子量醇。该发明描述了添加表面活性剂和低分子量醇以促进缩合磷酸盐渗入牙垢中。但是，尽管能够有效地渗入牙垢中，多磷酸盐不能除去本身具有的牙垢或者严重的外部牙垢。
转让给Procter & Gamble的第5,879,691、5,891,453和5,989,569号美国专利以及WO 98/55044公开了一种用于牙齿增白剂的传送系统，包括其上具有专业增白凝胶等透明的、薄的、柔韧性的聚乙烯带，其中所述专业增白凝胶等在制造步骤预先涂敷或者在将所述带配戴于牙齿上之前直接由使用者涂敷。因为不使用口腔托盘，提高了使用的容易性。另外，因为所述带薄而且透明，配戴该带时不会干扰日常生活。然而，在阅读该发明专利的实施例时，注意到其是湿型的牙齿增白系统，并如下制成：使用增白物质以及以Carbopol商标购自于B.F.GoodrichCompany的作为凝胶剂的优选羧基聚亚甲基、水、pH调节剂和其他载体物质，然后将这些物质涂敷在柔性材料的带上。在处理该类型的系统或者将该系统贴附并配戴于牙齿上时，包含高浓度的过氧化物作为牙齿增白剂的凝胶可粘附并留在手、舌头、牙龈等上。因此，仍有改进处理的余地。另外，因为不能充分地保证配方中的过氧化物的稳定性，当在高温或者长时间储存时减弱了增白效果。
WO 00/54699公开了一种形状优于其母专利的带，使增白剂和带与牙齿更好地贴合接触。该专利最重要的特征在于，所述带的形状覆盖使用者的前四个牙齿以及两个犬齿，同时允许两个犬齿的尖部暴露出来。当该带覆盖两个犬齿的尖部时，使用者很难贴附该带使其与牙齿的轮廓相一致，由此使漂白凝胶与牙齿表面接触足够的时间。然而，在将梯形的带贴附在下边的牙齿上并将其折叠盖住牙齿以将该带贴附在牙齿的后表面上时，舌头有可能触到该带，产生不舒服的感觉。为提高使用该带时的感觉，更希望该系统具有足够的粘合力以及柔韧性，使得该系统更舒服地贴附在牙齿的前表面及后表面，并通过该系统的形状确保接触时间，不必将该系统制成梯形的形状或者未覆盖两个犬齿的尖部的结构。
转让给Colgate-Palmolive Company的第5,310,563和5,639,445号美国专利公开了一种牙科材料，其包含分散在聚硅氧烷聚合物组合物中的活性成分，所述聚硅氧烷聚合物组合物是由Dow Corning Corporation以Dow Corning 3179为商品名售卖的。该材料通过将其压靠在牙齿和牙龈上而贴附在牙齿上，而且可容易地由牙齿上除去，不会被撕成碎片以及粘附在牙齿表面上。然而，由于该材料的结构是活性成分被包胶在聚合物中，活性成分不能容易地释放。因此，为得到牙齿增白效果，需要更长的接触时间。
发明内容
本发明的目的是提供用于牙齿增白的干型贴片，其包含作为粘合层材料的亲水性玻璃聚合物以及作为牙齿增白剂的过氧化物，该贴片能够保证牙齿增白剂与牙齿表面上的污垢之间足够的接触时间。本发明的另一个目的是提供用于牙齿增白的干型贴片，其在使用者用手和手指进行处理或者使用者配戴时是安全的，因为牙齿增白剂不会粘附并残留在使用者的手上，而且不会刺激潮湿的口腔中敏感的皮肤。本发明的再一个目的是提供用于牙齿增白的干型贴片，其使用简便，而且具有舒适的配戴感觉，由此使使用者在配戴该贴片时感觉舒服。
根据本发明用于牙齿增白的干型贴片实现了上述以及其他目的。
本发明提供一种新型的用于牙齿增白的干型贴片，其包括过氧化物作为牙齿增白剂。具体而言，本发明提供一种用于牙齿增白的干型贴片，其中在背衬层上的基质型粘合层中包含过氧化物作为牙齿增白剂，而所述粘合层包含亲水性玻璃聚合物作为其基础聚合物。亲水性玻璃聚合物对牙齿产生强的粘合力，同时在潮湿的口腔中于牙釉质层上被水合时释放分散于其中的牙齿增白剂。
根据本发明的干型贴片与常规的湿型贴片相比使用更简便。另外，其具有优异的粘合力，同时能够长时间地保持贴附牙齿的状态，以确保贴片中的牙齿增白剂与牙齿的污垢之间足够的接触时间，由此产生充分的牙齿增白作用。
对于牙齿增白用干型系统，用作牙齿增白剂的过氧化物的经时稳定性是一个重要的问题。在本发明中，为解决该问题，添加用于过氧化物的稳定剂。另外，通过选择与过氧化物具有良好相容性的玻璃聚合物以及适当控制溶剂合物的比例，即使不添加稳定剂也可解决与过氧化物的稳定性相关的问题。因此，根据本发明，提供一种新型的牙齿增白用干型贴片，其包括作为贴片的粘合层的亲水性玻璃聚合物以及分散于该粘合层中作为牙齿增白剂的过氧化物，而且通过使用过氧化物的稳定剂或者选择与过氧化物具有良好相容性的玻璃聚合物以及适当控制溶剂合物的比例，该贴片可实现良好的过氧化物稳定性。
根据本发明，多磷酸盐也可与过氧化物一起加入作为牙齿增白剂，以增强牙齿增白作用。
通常情况下，用于医疗目的的贴片分为两类：湿型和干型。湿型贴片例如有水凝胶制剂，或者通过将凝胶施用在粘合层上或将粘合层浸入溶液中而形成的制剂。该类型的贴片具有以下特征：制剂的初始状态是湿润的，因为制剂中的水含量或者湿润剂含量高。同时，干型贴片具有以下特征：制剂的初始状态是干燥的，因为制剂中的水含量或者湿润剂含量低。为向干燥的皮肤传送增湿剂或者其他药物成分，优选使用湿型贴片，这是因为该类型的贴片具有良好的柔韧性和水性质。然而，湿型贴片剂通常缺乏粘合强度。另外，因为当使用者处理该类型的贴片时，其初始状态是粘的，使得当将其粘附于所希望的位置时，药物成分有可能粘在手上。再者，在某些情况下，取决于制剂，药物成分或者包含牙齿增白剂的凝胶有可能由支持层透过，渗入相反的方向。特别是对于包含高浓度的过氧化物并以包含大量湿润剂的凝胶形式施用的贴片剂，当使用者试图将该贴片贴附于牙齿的轮廓时，过氧化物有可能粘在非所希望的部位，如手、唇、舌头等，产生刺激作用。另外，湿润剂通常没有味道。因此，如果湿润剂残留在舌头上，使用者有可能有异样的感觉。
因此，本发明采用干型的贴片剂。根据本发明的干型贴片具有以下优点：在潮湿的口腔中具有足够的粘结强度，并同时可避免牙齿增白剂粘附在手或者其他部位以及口腔中的牙龈及舌头上，降低异样感觉。
为制造此等干型贴片，必须选择能够在被所希望的贴附位置处的少量水水合时获得粘结性或者增强其粘结性的聚合物，同时该聚合物在干燥状态时几乎或者根本没有粘性。该聚合物还应通过水合作用开始释放牙齿增白剂。本发明的发明者发现亲水性玻璃聚合物具有此等性质，并由此通过使用亲水性玻璃聚合物作为基质型贴片的粘合层中基础聚合物而完成了本发明。
根据本发明，作为背衬层，可使用通过使用非水溶性以及非水透过性的聚合物作为膜形成物而形成的片材。背衬层具有防止粘合层粘附在牙龈或者舌头以及防止贴片变形或者由于唾液而由牙齿上脱落的作用。
牙齿增白作用可通过调节贴片的厚度或者通过改变牙齿增白剂来控制。因为本发明的贴片是透明，使用者在配戴该贴片时可观察到过氧化物漂白牙齿或者除去牙垢时产生的氧气泡，并由此可肉眼识别增白效果。另外，因为根据本发明之透明材料的贴片在配戴时不是非常显眼，使用者的日常生活不会受到干扰。
本发明的基质型贴片不是用于贴附在皮肤或者粘膜上，而是贴附在牙齿的釉质层上，以对牙齿表面提供足够时间的牙齿增白剂。
以下将描述贴片可粘附在牙齿上而且在牙齿表面上释放包含于基质中的增白剂的原理。
在药物传送系统中，已有人提出在透皮制剂中使用由皮肤排出的水分，使得具有时间延迟的透皮给药系统在贴附后经过预定的时间释放药物。更具体而言，在透皮制剂中，不透过药物的屏障层设置在储药层和皮肤粘结表面之间。当所述制剂粘附在皮肤上时，屏障层逐渐被皮肤排出的水分水合，其渗透性由此增加。在此情况下，亲水性玻璃聚合物可用作屏障层的材料。
基于上述想法，本发明是通过在基质型贴片的粘合层中使用亲水性玻璃聚合物而完成的，使得在用手处理该贴片以将其贴附于牙齿上时增白剂在干燥状态下不会释放，但是当聚合物被牙齿上的水分水合时则释放增白剂。在水合时，大多数的此等玻璃聚合物可提供足够的粘结强度，保持与牙齿表面的接触状态。因此，根据本发明，不需要使用额外的手段或者特征以将贴片固定在牙齿上(如待折叠在牙齿的背面上的边缘粘合层)，在增白剂和牙齿之间实现足够的接触时间。本发明的贴片在直接与牙龈或者口腔中的皮肤相接触时，对牙龈或者口腔中的皮肤不产生明显的刺激作用。另外，本发明的贴片可仅贴附在牙齿上，使得增白剂不会被释放在牙龈上。因此，本发明的第一个特征是在干型贴片的粘合层中使用亲水性玻璃聚合物。
为上述目的，可用于本发明之贴片粘合层中的聚合物包括聚烷基乙烯基醚-马来酸共聚物(PVM/MA共聚物)，如Gantrez AN 119、AN 139和S-97，聚乙烯醇，聚丙烯酸，泊洛沙姆407(Pluronic)，聚乙烯吡咯烷酮-乙酸乙烯酯共聚物(PVP/VA共聚物)，如Luviskol VA和PlasdoneS PVP/VA，聚乙烯吡咯烷酮(PVP，K-15至K-120)，聚季铵-11(Gafquat755N)，聚季铵-39(Merquat plus 3330)，卡波姆(Carbopol)，羟丙基甲基纤维素，羟乙基纤维素，羟丙基纤维素，明胶以及藻酸盐如藻酸钠。上述聚合物可单独或者以混合物的形式使用。这些聚合物所用的溶剂包括水、乙醇或者它们的混合物。
待贴附于牙齿上的贴片应具有足够的柔韧性，使其可以变形以符合牙齿的轮廓线。取决于它们的类别，一些聚合物具有差的柔韧性。在此情况下，可添加合适的增塑剂。虽然此等增塑剂可根据所用聚合物的类别和制剂进行变化，但丙二醇、甘油和聚乙二醇通常是合适的。
包含在牙齿釉质粘合层中的牙齿增白剂可由以下组中选择：过氧化氢、过氧化脲、过氧化钙、过碳酸钠、过硼酸钠、过氧化焦磷酸四钠以及它们的混合物。过氧化焦磷酸四钠(TSPP-H2O2)是焦磷酸四钠与过氧化氢的加成化合物，在水溶液或者晶体状态下，其具有焦磷酸四钠本身的性质，而且还具有过氧化氢的性质。通常，焦磷酸四钠稳定过氧化氢，但不会改变过氧化氢的内在性质。换言之，其防止了在单独使用过氧化氢时产生的问题。金属过氧化氢酶、UV射线、氧化酶、热处理等可促进过氧化氢的分解，而过氧化焦磷酸四钠对于以上物质和处理是稳定的，并具有过氧化氢的内在性质及功能。实际上，与单独使用过氧化物相比，使用液相、凝胶相或者糊相的过氧化焦磷酸四钠在40℃下表现良好的经时稳定性。然而，即使使用过氧化焦磷酸四钠，过氧化氢在贴片中的稳定性也不能轻易地实现。
通常情况下，过氧化物已知由于其非常高的反应活性而在产品中几乎难以稳定。另外，其与聚合物的相容性非常差。产品中过氧化氢的稳定性涉及产品的类型或者制备方法。对于产品中过氧化物的稳定性，已有许多专利涉及普通凝胶、糊或者溶液相的过氧化物的稳定，而且发现它们中的一些可在一定程度上确保过氧化物在高温下的稳定性。但是，尚没有人提示对薄涂层凝胶或者贴片中的过氧化物的稳定。在进行一些研究后，本发明的发明者同样发现此等问题不能通过已知的过氧化物稳定剂来解决。现在，在筛选用于贴片之过氧化物的稳定剂时，本发明的发明者发现可在本发明的范围中使用但对本发明贴片的基本性质没有损害的稳定剂，该稳定剂可提高贴片中过氧化物在高温时的经时稳定性。
因此，根据另一个方面，本发明涉及与过氧化物一起使用过氧化物的稳定剂作为牙齿增白剂。
与过氧化物具有良好相容性的稳定剂包括一种或者多种选自于以下组中的物质：烷基芳基磺酸盐，烷基硫酸盐，烷基羧酸盐，烷基二苯基氧化物二磺酸盐，Span系列如Span 60(脱水山梨醇硬脂酸酯)、Span 80(脱水山梨醇单油酸酯)、Span 85(脱水山梨醇三油酸酯)以及它们的混合物。以下将更为详细地予以解释。
根据本发明，在贴片中使用过氧化物作为主要的牙齿增白剂。但是，对于仅包括增白剂的贴片，当在40℃的温度下储存贴片时，贴片中过氧化物的含量会随着时间而降低。在体外检查贴片的增白效果时，发现与初始期相比，增白效果减弱。对于凝胶型制剂，即使使用过量的聚合物作为膜形成剂而且不添加用于过氧化物的特殊稳定剂，过氧化物随时间丢失较少。即使制剂包括缺乏稳定性的过氧化物，通过使用少量已知作为过氧化物稳定剂的螯合剂如EDTA或者柠檬酸钠，仍可得到所希望的作用。但是，在本发明中，凝胶的溶剂被蒸发，形成片状贴片，是不同的物质。如果在组合物中不使用稳定剂，虽然组成与以上所述相同，但贴片中过氧化物的经时稳定性比在溶液相时得到的稳定性受到更大的损害。另外，在添加螯合剂时，观察到贴片中过氧化物的稳定性与其添加之前相比降低。再者，即使使用Dequest磷酸盐类的稳定剂(对于溶液中的过氧化物具有非常优异的稳定性)，仍不能得到令人满意的稳定作用效果。
如上所述，贴片中过氧化物的经时稳定性根据剂型如凝胶、液体或者片而不同的原因有多种不同的解释。根据第4,320,102号美国专利，过氧化物的特征在于通过组合物中存在的最小量的金属的催化反应而非常灵敏地分解。有报道的数据表明，每1L的5％过氧化物水溶液中，0.1mg的铁、0.2mg的铜、0.1mg的镁或者0.02mg的铬，都可使过氧化物分解。本发明涉及的是通过由溶液或者凝胶相中蒸发溶剂而形成的片型贴片，在非常小厚度的贴片中包含高含量的金属。另外，片状贴片具有宽的表面积，这使得在表面上具有高的反应速率。实际上，发现凝胶非常薄地涂敷在表面上，产生宽的表面积，降低过氧化物随时间的残留，而包含相同组分但包含在容器中的凝胶在相对较高的温度下是稳定的。由于这些原因，诸如本发明的贴片需要一些处理或者添加剂以稳定过氧化物。
在本发明中，贴片中所用的过氧化物的稳定剂主要由表面活性剂或者乳化剂组成，它们在片材的表面上形成胶束，对过氧化物的稳定产生积极的作用。但是，可用于本发明中的一些亲水性玻璃聚合物与过氧化物具有良好的相容性，使得过氧化物可通过调节溶剂比例但不添加某些过氧化物用稳定剂而充分地被稳定。因此，本发明并不仅限于基本包含过氧化物用稳定剂。
现更为详细地描述。
亲水性玻璃聚合物如聚乙烯吡咯烷酮(PVP，K-15至K-120)、polyquaternium-11、polyquaternium-39、聚乙烯吡咯烷酮-乙酸乙烯酯共聚物(PVP/VA共聚物)与过氧化物具有良好的相容性，而且在水和乙醇中具有良好的溶解性。因此，通过在贴片中使用这些聚合物，仅通过调节水与乙醇的比例为9∶1-0∶10，就可稳定过氧化物，无需过氧化物的稳定剂。据信，过氧化物变得相容性，并由此通过氢键形成聚乙烯吡咯烷酮与过氧化物的复合物而被稳定。还发现过氧化物与具有季铵结构的聚合物如polyquaternium具有相容性。
根据本发明，使用水和乙醇的混合物作为溶剂。通常与过氧化物具有良好相容性的玻璃聚合物具有非常高的亲水性，使得它们不能均匀地涂敷释放衬里或者其他片材的表面。使用水和乙醇的溶剂混合物可解决上述问题，得到均匀的片材相。
因此，本发明的第三个方面涉及用于牙齿增白的贴片，其包含作为牙齿增白剂的过氧化物、与该过氧化物具有良好相容性的玻璃聚合物，其中该贴片在高温下通过调节水与乙醇的比例而不是添加过氧化物稳定剂来稳定。
本发明的贴片还包含增塑剂，以使贴片具有足够柔韧性。合适的增塑剂包含丙二醇、甘油和聚乙二醇，但其根据所用聚合物的类型及贴片的组分而变化。
另外，除作为主要增白剂的过氧化物外，为增强增白效果，本发明可包括多磷酸盐作为增白助剂。
例如，根据本发明可使用的多磷酸盐包含一种或者多种选自于以下组中的物质：焦磷酸四钠(TSPP)、酸式焦磷酸钠(SAPP)、六偏磷酸钠(SHMP)、三聚磷酸钠(STP)、三聚磷酸钠钾(SKTP)、焦磷酸四钾(TKPP)、超磷酸盐(ultraphosphates)如酸性偏多磷酸钠和酸性多磷酸钠。通常情况下，已知多磷酸盐可有效地在牙膏中用作牙垢控制剂，以抑制牙垢的形成或者除去牙垢。还已知多磷酸盐可用于增强牙齿增白效果，这是因为多磷酸盐可有效地除去形成于牙齿表面上的牙垢，特别是那些由食物或者工作环境中的金属如铁、钙、镁等形成的牙垢。多磷酸盐可用作上述金属的螯合剂。因此，根据本发明还期望多磷酸盐与过氧化物一起使用可长时间地抑制牙垢的形成并除去牙垢。实际上，已观察到在向牙齿上贴附根据本发明的贴片时，牙齿的表面或者牙齿之间的缝隙得到清洁。
可在根据本发明的基质型贴片的背衬层中使用的聚合物包括例如聚乙酸乙烯酯，乙基纤维素，聚甲基丙烯酸甲酯，甲基丙烯酸共聚物如由Mitsubishi以Yukaformer为商品名出售的甲基丙烯酰基乙基甜菜碱/甲基丙烯酸酯共聚物，甲基丙烯酸共聚物如Eudragit L100、Eudragit L12，5、Eudragit L100-5、Eudragit L 30D-55，氨基烷基甲基丙烯酸酯共聚物，如Eudragit E 100、Eudragit E 12，5、Eudragit RL100、Eudragit RL 30D，乙酸邻苯二甲酸纤维素，紫胶或者它们的混合物。另外，在口腔中pH 6-8的环境下不溶解的肠溶包衣聚合物也可用作背衬层中的聚合物。
根据本发明，出于与粘合层中相同的原因，可在背衬层中使用任意的增塑剂。在此情况下，根据所用的溶剂，可使用丙二醇、甘油和聚乙二醇以外的其他物质。例如，可包括蓖麻油、氢化蓖麻油。
另外，为使牙齿看起来更白，可在背衬层中使用任意的白色颜料。例如，可单独或者混合使用二氧化钛、滑石、羟基磷灰石、氧化锌等。如果这些颜料与粘合层中的增白剂不相容时，可使用经表面处理的二氧化钛。另外，根据个体的情况可使用珍珠材料或者各种颜色的颜料。
根据本发明，可单独或者混合使用在常规牙膏中由于经时稳定的问题而不被使用的物质如酶，特别是葡聚糖酶、葡萄糖氧化酶。还可添加已知具有牙齿增白作用的木瓜蛋白酶。另外，当使用本发明的贴片用于治疗口腔疾病时，可添加有效抑制口臭的三氯生、氯己定、维生素E或其衍生物(特别是维生素乙酸酯)、氧化剂、叶绿素或其衍生物。
具体实施方式
制备实施例
实施例1-10以及对比例1-5
按照以下描述的组成，分别制备实施例1-10和对比例1-5的贴片。以下所用的缩写的含意如下：
TKPP：焦磷酸四钾
SAPP：酸式焦磷酸钠
TSPP：焦磷酸四钠
实施例1
粘合剂溶液
聚乙烯醇                    10％
聚乙烯吡咯烷酮              3％
过氧化焦磷酸四钠            5％
烷基硫酸盐(SLS)             2％
甘油                        3％
水                          至100％
背衬层溶液
乙基纤维素                  8％
Eudragit                    5％
蓖麻油                      4％
乙醇                        至100％
实施例2
粘合剂溶液
聚乙烯吡咯烷酮                10％
过氧化氢                      5％
甘油                          10％
乙醇                          30％
水                            至100％
背衬层溶液
聚乙酸乙烯酯                  5％
Yukaformer(Mitsubishi)        5％
甘油                          6％
乙醇                          至100％
实施例3
粘合剂溶液
Polyquaternium-39             10％
过氧化脲                      10％
乙醇                          50％
水                            至100％
背衬层溶液
乙酸邻苯二甲酸纤维素          30％
蓖麻油                        4％
丙酮和乙醇的混合物            至100％
(丙酮∶乙醇＝4∶1)
实施例4
粘合剂溶液
聚烷基乙烯基醚-马来酸共聚物(Gantrez S 97)        12％
过氧化焦磷酸四钠                                 6％
Span 85                                          2％
EDTA2Na                                          0.2％
水                                               至100％
背衬层溶液
乙基纤维素                    10％
蓖麻油                        6％
乙醇                          至100％
实施例5
粘合剂溶液
聚烷基乙烯基醚-马来酸共聚物(Gantrez S 97)        12％
过氧化焦磷酸四钠                                 6％
烷基硫酸盐(SLS)                                  10％
NaOH                                             合适(pH
                                                 最高为7)
水                                               至100％
背衬层溶液
乙基纤维素                                       10％
蓖麻油                                           6％
乙醇                                             至100％
实施例6
粘合剂溶液
聚烷基乙烯基醚-马来酸共聚物(Gantrez S 97)        11％
聚乙烯吡烷酮                                     3％
过氧化氢                                         3％
SAPP                                             4％
烷基芳基磺酸盐                                   2％
NaOH                                             合适(pH
                                                 最高为7)
水                                               至100％
背衬层溶液
聚甲基丙烯酸甲酯                                 8％
丙酮                                             至100％
实施例7
粘合剂溶液
Polyquaternium-11                                20％
过碳酸钠(PC)                                     4％
TKPP                                             4％
烷基二苯基过氧化物二磺酸盐                       2％
水                                               至100％
背衬层溶液
Eudragit                                         15％
丙二醇                                           5％
乙醇                                             至100％
实施例8
粘合剂溶液
聚乙烯吡咯烷酮                            10％
过氧化氢                                  1.5％
SAPP                                      2％
烷基二苯基过氧化物二磺酸盐                1％
甘油                                      5％
水                                        至100％
背衬层溶液
乙基纤维素                                12％
蓖麻油                                    6％
乙醇                                      至100％
实施例9
粘合剂溶液
聚乙烯醇                                  12％
过氧化氢                                  1.5％
TSPP                                      3.4％
Span 60                                   5％
丙二醇                                    3％
水                                        至100％
背衬层溶液
乙基纤维素                                8％
乙酸邻苯二甲酸纤维素            2％
丙酮和乙醇的混合物              至100％
(丙酮∶乙醇＝4∶1)
实施例10
粘合剂溶液
聚乙烯吡咯烷酮                  18％
过氧化氢                        1.5％
乙醇                            至100％
背衬层溶液
乙基纤维素                      10％
Eudragit                        2％
蓖麻油                          5％
乙醇                            至100％
对比例1
粘合剂溶液
聚乙烯醇                        10％
PEG-抗坏血酸                    6％
丙二醇                          3.1％
水                              至100％
背衬层溶液
乙基纤维素                      10％
丙二醇                          4％
乙醇                        至100％
对比例2
粘合剂溶液
聚烷基乙烯基醚-马来酸共聚物(Gantrez S 97)        12％
过氧化焦磷酸四钠                                 6％
Dequest                                          0.1％
水                                               至100％
背衬层溶液
聚乙酸乙烯酯                                     5％
Yukaformer                                       5％
甘油                                             6％
乙醇                                             至100％
对比例3
粘合剂溶液
聚烷基乙烯基醚-马来酸共聚物(Gantrez S 97)        12％
过氧化焦磷酸四钠                                 6％
EDTA                                             0.15％
NaOH                                             合适(pH
                                                 最高为7)
水                                               至100％
背衬层溶液
乙基纤维素                                       10％
蓖麻油                        6％
乙醇                          至100％
对比例4
粘合剂溶液
Carbopol                      12％
过氧化氢                      4.5％
SAPP                          0.48％
甘油                          80％
水                            至100％
背衬层
聚乙烯条
对比例5
粘合剂溶液
聚乙烯醇                      10％
抗坏血酸                      2％
丙二醇                        2％
水                            至100％
背衬层溶液
乙基纤维素                    10％
蓖麻油                        6％
乙醇                          至100％
测试实施例
测试实施例1
在40℃下储存所制备的具有如上所述组成的贴片1周，并测量贴片以观察表面情况的变化。它们按照以下标准分级：○，粘性增加或者变色；×，粘性没有增加也没有变色。
                表1
  粘性   变色
  实施例1   ×   ×
  实施例2   ×   ×
  实施例3   ×   ×
  实施例5   ×   ×
  实施例7   ×   ×
  实施例8   ×   ×
  实施例9   ×   ×
  实施例10   ×   ×
  对比例1   ○   ○
  对比例5   ○   ○
由表1可以看出，其中根据本发明使用亲水性玻璃聚合物的实施例，在初始状态或者在40℃的温度下储存一周后都没有表现粘性增加及表面情况的变化。但是，其中在粘合层中使用聚乙烯醇作为亲水性玻璃聚合物、而且使用抗坏血酸或其衍生物如PEG-抗坏血酸替代过氧化物的对比例1和5，显示出随时间的流逝浓度增加，而且有严重的变色。
测试实施例2
根据以下方法检测贴片的牙齿增白效果。
(1)制备受污染的羟基磷灰石(HAP)片样品
通过IR压片机将羟基磷灰石粉末形成片。所得的片在1000℃下烧结，用环氧树脂成模，然后用强酸蚀刻。将样品浸入含有茶、咖啡、铁、粘蛋白的TSB(trypticase豆汤)溶液中，然后干燥，由此对片样品进行污染。该过程重复多次，并持续一周。污染后，用流水和小刷子轻轻地刷洗该样品，以除去可溶解在水中或者容易用水清除的轻微污染。最后，在室温下干燥样品。
(2)牙齿增白效果的评估
用色度计(chroma meter)测量各样品的初始亮度值L(100表示白色，而0表示黑色)。将按照上述制备实施例和对比例制得的牙齿增白用贴片贴附在潮湿的样品上。在其上贴附有贴片的样品在温度为37℃、湿度为95％的thermohygrostat中储存。经过预定的时间后，由样品上除去贴片。用流水刷洗已除去贴片的样品，然后在室温下干燥。测定各样品的L值。对于各贴片，计算贴附贴片之前与之后的L值差——ΔL。结果示于以下表2中。
                       表2
  ΔL(1小时)   ΔL(3小时)
  实施例1   33.45±3.25   38.95±5.31
  实施例6   34.55±4.55   39.23±3.77
  实施例8   32.38±3.44   40.00±3.88
  实施例9   37.10±3.44   38.00±3.88
  实施例10   14.73±4.11   32.25±3.33
  对比例1   7.05±1.71   15.26±2.37
  对比例4   14.55±2.41   30.35±3.24
  对比例5   17.98±3.05   20.05±2.99
由表2可以看出，包含过氧化物作为增白剂的贴片与包含抗坏血酸或其衍生物的贴片相比具有优异的牙齿增白效果。同样还注意到，包含过氧化物和多磷酸盐组合或者添加过氧化物及焦磷酸盐作为牙齿增白剂的贴片与仅包含过氧化物的贴片相比具有更高的牙齿增白效果。
测试实施例3
根据以上制备实施例所述的组成制得的牙齿增白用贴片，用以下方法评估在40℃下的经时稳定性。
(1)评估贴片中的过氧化物含量
能够溶解贴片之背衬层和粘合层的溶剂混合物放入Erlenmeyer烧瓶中。精确称量合适量的各测试贴片，并将它们放入所述烧瓶中，然后完全溶解在溶剂混合物中。在烧瓶中添加5ml的6N盐酸，然后将约2g的碘化钾溶解在所述溶剂中。将该烧瓶放置在凉爽、黑暗的地方1小时。接着，用50mM的硫代硫酸钠溶液滴定，由此对各贴片中的过氧化物含量进行定量。所得结果示于以下表3中。
                                   表3
  残留过氧化物  实施例3  实施例4  实施例5   实施例10  对比例2  对比例3  对比例4
  1周   96％   100％   96％   100％   80％   86％   96％
  2周   89％   100％   93％   100％   65％   70％   91％
  4周   85％   95％   91％   100％   50％   61％   84％
  6周   85％   91％   88％   94％   42％   50％   71％
  8周   80％   90％   86％   90％   16％   30％   65％
表3中实施例4和5以及对比例2和3的结果表明，当其他组分相同时，添加过氧化物的稳定剂对于经时稳定性是有利的。但是，在不包括过氧化物稳定剂的实施例3和对比例10中，因为所用的玻璃聚合物和过氧化物能够相互非常良好地相容，高温下过氧化物的经时稳定性通过调节制备过程中粘合层水与乙醇的比例也可以是非常好的。对比例4是用于评估由Procter and Gamble制造的新型湿型增白剂——CrestWhitestrips。可观察到，贴片中的残留过氧化物含量在4周后快速降低。
由以上描述可以明显看出，根据本发明的牙齿增白用贴片具有优异的牙齿增白效果。另外，本发明的贴片是在粘合层中使用亲水性玻璃聚合物的干型贴片。因此，在将贴片贴附于牙齿上时，玻璃聚合物发生水合，形成粘结力，并同时释放增白剂。由此，在短时间使用时，该贴片是安全并且有效的。另外，本发明的贴片在高温下具有良好的过氧化物稳定性。

Claims (10)

1、一种用于牙齿增白的干型贴片，包含基质型粘合层以及背衬层，其中所述粘合层包含作为牙齿增白剂的过氧化物、以及用于该过氧化物的稳定剂和作为基础聚合物的亲水性玻璃态聚合物，该粘合层在牙釉质层上被水合时对牙齿产生强的粘合力，并同时释放所述牙齿增白剂；
所述过氧化物是一种或者多种选自于以下组中的物质：过氧化氢、过氧化脲、过氧化钙、过碳酸钠、过硼酸钠和过氧化焦磷酸四钠；
用于过氧化物的稳定剂为一种或者多种选自于以下组中的物质：烷基芳基磺酸盐、烷基硫酸盐、烷基羧酸盐、烷基二苯基氧化物二磺酸盐、脱水山梨醇硬脂酸酯、脱水山梨醇单油酸酯和脱水山梨醇三油酸酯；以及
粘合层中所用的亲水性玻璃态聚合物为一种或多种选自于以下组中的物质：聚烷基乙烯基醚—马来酸共聚物、聚乙烯醇、聚丙烯酸、泊洛沙姆407、聚乙烯吡咯烷酮—乙酸乙烯酯共聚物、聚乙烯吡咯烷酮、聚季铵-11、聚季铵-39、卡波姆、羟丙基甲基纤维素、羟乙基纤维素、羟丙基纤维素、明胶以及藻酸钠。
2、如权利要求1所述的用于牙齿增白的干型贴片，其中该贴片还包括用于增强增白效果的多磷酸盐。
3、如权利要求2所述的用于牙齿增白的干型贴片，其中所述多磷酸盐为一种或者多种选自于以下组中的物质：焦磷酸四钠、酸式焦磷酸钠、六偏磷酸钠、三聚磷酸钠、三聚磷酸钠钾、焦磷酸四钾和酸性偏多磷酸钠。
4、如权利要求1所述的用于牙齿增白的干型贴片，其中所述背衬层包含一种或多种选自于以下组中的物质：乙酸邻苯二甲酸纤维素、紫胶、聚乙酸乙烯酯、乙基纤维素、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。
5、如权利要求4所述的用于牙齿增白的干型贴片，其中所述背衬层中还包括白色颜料或者珍珠材料或各种颜色的颜料，其中白色颜料选自二氧化钛、经表面处理的二氧化钛、氧化锌、羟基磷灰石、滑石中的一种或多种。
6、一种用于牙齿增白的干型贴片，包含基质型粘合层以及背衬层，其中所述粘合层包含作为牙齿增白剂的过氧化物、以及作为基础聚合物的亲水性玻璃态聚合物，所述过氧化物是一种或者多种选自于以下组中的物质：过氧化氢、过氧化脲、过氧化钙、过碳酸钠、过硼酸钠和过氧化焦磷酸四钠，而所述亲水性玻璃态聚合物为一种或多种选自于以下组中的与所述过氧化物具有良好相容性的物质：聚乙烯吡咯烷酮—乙酸乙烯酯共聚物、聚乙烯吡咯烷酮、聚季铵-11、聚季铵-39，通过调节水与乙醇的比例为6∶4-0∶10，在不添加用于过氧化物的稳定剂的情况下也能够实现过氧化物的经时稳定性，而且该粘合层在牙釉质层上被水合时对牙齿产生强的粘合力，并同时释放所述牙齿增白剂。
7、如权利要求6所述的用于牙齿增白的干型贴片，其中该贴片还包括用于增强增白效果的多磷酸盐。
8、如权利要求7所述的用于牙齿增白的干型贴片，其中所述多磷酸盐为一种或者多种选自于以下组中的物质：焦磷酸四钠、酸式焦磷酸钠、六偏磷酸钠、三聚磷酸钠、三聚磷酸钠钾、焦磷酸四钾和酸性偏多磷酸钠。
9、如权利要求6所述的用于牙齿增白的干型贴片，其中所述背衬层包含一种或多种选自于以下组中的物质：乙酸邻苯二甲酸纤维素、紫胶、聚乙酸乙烯酯、乙基纤维素、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。
10、如权利要求9所述的用于牙齿增白的干型贴片，其中所述背衬层中还包括白色颜料或者珍珠材料或各种颜色的颜料，其中白色颜料选自二氧化钛、经表面处理的二氧化钛、氧化锌、羟基磷灰石、滑石中的一种或多种。
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US20030198606A1 (en) 2003-10-23
US6682721B2 (en) 2004-01-27
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US20060193794A1 (en) 2006-08-31
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