CN102015028A - 含有氧化酶的口腔护理组合物 - Google Patents
含有氧化酶的口腔护理组合物 Download PDFInfo
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- CN102015028A CN102015028A CN2009801142685A CN200980114268A CN102015028A CN 102015028 A CN102015028 A CN 102015028A CN 2009801142685 A CN2009801142685 A CN 2009801142685A CN 200980114268 A CN200980114268 A CN 200980114268A CN 102015028 A CN102015028 A CN 102015028A
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- oral care
- care composition
- oxidase
- tooth
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Abstract
本发明描述了包含氧化酶、聚乙烯亚胺和口腔可接受的载体的口腔护理组合物,以及其使用方法。所述口腔护理组合物可应用于牙齿表面以产生过氧化物。
Description
优先权
本申请要求于2008年4月22日提交的序号为61/047,011的美国临时专利申请的优先权,其全部内容引入本文作为参考。
技术领域
本发明的组合物和方法属于口腔护理领域,且涉及包含用于牙齿表面以产生过氧化物的氧化酶和聚乙烯亚胺的组合物的应用。
发明背景
人类牙齿由被称为牙本质的内部软层和保护所述牙本质的被称为釉质的外部硬层构成。牙齿的釉质层在颜色上为半透明的白色或略微的灰白色。在通常情况下,牙齿的釉质表面覆盖了一层被称为表膜的唾液蛋白的薄层。所述釉质、所述表膜或这两者可成为变色的或染色的,呈现不期望的外观。此外,牙齿的釉质层被认为是多孔性质的,允许染色成分和变色物质渗透进入牙结构中,造成难以去除的变色和染色。
除了美容以外,良好的口腔卫生对于保持口腔健康是重要的。有效的口腔卫生需要控制牙菌斑。牙菌斑是细菌、上皮细胞、白细胞、巨噬细胞和其他口腔渗出物的混合基质。牙菌斑的形成是龋齿、牙龈炎、牙周病以及牙缺失的原始来源。
存在为美容及健康原因而改善口腔卫生的组合物和方法的需要。
发明概述
本发明描述的是包含聚乙烯亚胺和非复合的氧化酶的口腔护理组合物及方法。所述组合物可包括口腔可接受的载体。在某些实例中,所述氧化酶可以为葡糖氧化酶,但是也可使用其他氧化酶。在特定实施方案中,所述聚乙烯亚胺和所述非复合的葡糖氧化酶以下述量存在:其足以通过所述聚乙烯亚胺将所述氧化酶结合至牙齿的釉质表面并在所述氧化酶的合适底物存在下产生过氧化物。
所述聚乙烯亚胺可按以重量计0.001%至10%的浓度存在于所述口腔护理组合物中,且所述氧化酶可按以重量计0.0001%至1%的浓度存在于所述口腔护理组合物中。
所述口腔护理组合物可包含下述物质中的至少一种:增稠剂、表面活性剂、润湿剂和研磨剂,以及在一些情况下还包含除所述氧化酶外的第二种酶。在一些情况下,组合物中的氧化酶不与另一种酶复合。
所述口腔护理组合物可被配制为例如流体如牙膏,或固体如粉末或牙线。
所述口腔护理组合物可应用于下述方法中,其包括:在适于将所述氧化酶结合至釉质表面并产生过氧化物的条件下,将所述口腔护理组合物与牙齿的所述釉质表面接触。该方法可用于在牙齿表面产生过氧化物。
所述接触可使用例如牙刷或牙线完成。在特定实例中,所述方法可导致牙齿上的细菌死亡和/或牙齿变白。
本发明还提供了将氧化酶结合至牙齿的方法。在一些实例中,该方法可包括:在提供经由聚乙烯亚胺或山梨醇将氧化酶结合至釉质表面并产生过氧化物的条件下,在所述聚乙烯亚胺或所述山梨醇存在下将具有所述釉质表面的牙齿与所述氧化酶接触。所述接触可使用例如牙刷或牙线完成。
本发明的口腔护理组合物和方法的这些和其他方面以及实施方案在下文中被更详细地描述。
附图简述
图1显示一幅图,其说明了在不同浓度的山梨醇或聚乙烯亚胺存在下,葡糖氧化酶对羟磷灰石的结合。葡糖氧化酶对唾液覆盖的羟磷灰石盘的结合通过使用荧光性的(Amplex Red)辣根过氧化物酶偶联测定法直接从所述盘表面进行测定。相对于无添加剂(以正方形表示),添加剂山梨醇(8、0.8、0.08%,以各自标记的三角形表示)和聚乙烯亚胺(1%,以菱形表示)改善了结合。
发明详述
I.定义
除非另外定义,所有的技术和科学术语应根据它们在本领域中所使用的通常含义。下列术语为了参考的清楚和容易而在下文中定义。其他定义会出现在通篇说明书中。
如本文中所使用,术语“口腔护理组合物”指的是一种产品,其在通常的使用过程中,不是为了特定治疗剂的全身给药而有意地被吞咽,而是为了口腔活性的目的在口腔中保持一段足以接触基本上全部牙齿表面和/或口腔组织的时间。本发明的口腔组合物可为例如牙膏、洁牙剂、牙粉、牙齿凝胶、龈下凝胶、漱口水、假牙产品、口腔喷雾、锭剂、口腔片剂或口香糖的形式。所述口腔组合物也可被掺入用于直接应用或附着于口腔表面的带、薄膜或线中。
如本文中所使用,术语“洁牙剂”指的是膏、凝胶、固体或液体制剂,另有说明除外。洁牙剂组合物可为单相组合物或可为两种或多种单独的洁牙剂组合物的组合。所述洁牙剂组合物可为任何期望的形式,例如深入的带的形式、表面的带的形式、在膏剂周围具有凝胶的多层形式,或者它们的任意组合。在包含两种或多种单独的洁牙剂组合物的洁牙剂中的每种洁牙剂组合物可被包含在分配器的物理上分离的隔室中,并一起被同时或连续分配,例如以并列形式的排布。
如本文中所使用,术语“口腔可接受的载体”指的是用于口腔护理组合物中的任何安全且有效的材料。这样的材料包括氟离子来源、抗牙垢剂、缓冲剂、研磨抛光材料、过氧化物来源、碱金属碳酸氢盐、增稠材料、润湿剂、水、表面活性剂、二氧化钛、矫味系统、甜味剂、木糖醇、着色剂,以及它们的混合物。
如本文中所使用,术语“牙齿”包括天然的牙齿以及义齿或假牙。
如本文中所使用,术语“釉质”指的是牙齿通常可见的部分并且主要由矿物质包括羟磷灰石组成。釉质包括人类和动物的牙齿中天然存在的釉质,以及用于替代损坏或缺失的牙部分的釉质样物质,包括用于这类目的的树脂和瓷。
如本文中所使用,术语“牙石”和“牙垢”可互换使用,指的是矿化的牙菌斑沉积物。
如本文中所使用,术语“聚乙烯亚胺”,缩写为“PEI”,指的是由乙烯亚胺类构成的聚合物。聚乙烯亚胺可以以质子化的或非质子化的形式存在,含有或不含水。聚乙烯亚胺包括支链的和直链的聚胺类,以及它们的盐,包括PEI-盐酸盐、PEI-硫酸盐、PEI-硝酸盐、PEI-乙酸盐、PEI-脂肪酸盐等。PEI具有经验式(C2H5N)n,每个重复单元具有43.07的分子量。
如本文中所使用,术语“复合的”描述了一种酶(其本身可为一种多聚体,如含有两个亚基的二聚体),其通过共价键或非共价键直接或间接地与另一蛋白质连接。
如本文中所使用,术语“非复合的”描述了一种酶(其本身可为一种多聚体,如含有两个亚基的二聚体或者三聚体),其不通过共价键或非共价键直接或间接地与另一蛋白质连接。例如,“非复合的葡糖氧化酶”指的是一种葡糖氧化酶(其可为二聚体或三聚体),其与另一种酶或抗体不发生缀合或连接。
如本文中所使用,术语“基本上有活性的”对于本发明的酶组合物而言表示所述酶具有其最优或最大活性的至少30%、至少50%、至少70%或至少80%。
如本文中所使用的“相容的”表示例如组合物的成分能够被混合在一起,并且不会以一种实质上降低所述组合物的稳定性和/或效能的方式相互影响。
如本文中所使用,术语“锭剂”包括但不限于:薄荷糖、糖锭剂、软锭剂、微胶囊,以及快速溶解的固体形式,包括冷冻干燥形式(糕剂、薄脆饼、薄膜剂、片剂)和压缩片剂。
如本文中所使用,术语“快速溶解的固体形式”表示例如将固体剂型置于口腔或含有假牙的容器中后,所述固体剂型在至少约60秒、至少约15秒或至少约5秒内溶解。
如本文中所使用,术语“个体”、“消费者”或“终端用户”是指其牙齿表面(包括表面或牙植入物)接触所述口腔组合物的个体。所述个体可以是人类或动物。动物包括家庭宠物或其他家畜,或者被圈养的动物。
数值范围包括定义该范围的数值。本文使用的所有的百分数和比值均按特定口腔组合物的重量计,而不是按被递送的全部口腔制剂的重量计算,另有说明除外。
提供标题是为了易于阅读,但不应理解为限制,因为不同标题下的内容可作为一个整体应用于说明书。术语“一种”或“所述”包括复数形式,除非说明书另有清楚指示。
尽管类似或等价于本文所描述那些方法和材料的任何方法和材料可用于实践或测试本发明,但本发明描述的是优选的方法和材料。
本文提到的所有专利和出版物,包括这些专利和出版物中公开的全部关联文献都被明确地引入作为参考。
II.口腔护理组合物
本发明提供了包含聚乙烯亚胺和非复合的氧化酶的口腔护理组合物。在不受限于理论的情况下,认为聚乙烯亚胺促进了所述氧化酶对牙齿表面的羟磷灰石的粘附,从而最大化了所述氧化酶提供清洁益处的效果。所述组合物的成分以及使用它们的示例性方法在下文中被进一步描述。
A.氧化酶
所述氧化酶可以是任何能够在原位(即:在口腔中)产生过氧化物(H2O2)的氧化酶,并且其具有抗微生物的和/或牙齿美白/清洁的活性。代表性的氧化酶包括但不限于:葡糖氧化酶、己糖氧化酶、L-氨基酸氧化酶、木糖醇氧化酶、半乳糖氧化酶、吡喃糖氧化酶和醇氧化酶。所述氧化酶可以从适合的微生物得到或从重组体来源产生。所述葡糖氧化酶可以是野生型酶或变体的重组体形式。许多氧化酶的氨基酸序列是已知的并被存放在NCBI的Genbank数据库中,并可用于选择用于表达或分离的氧化酶。合适的葡糖氧化酶可源自许多微生物,包括曲霉菌属(Aspergillus spp.)例如黑曲霉(Aspergillus niger)菌株或分枝孢子菌属(Cladosporium spp.)例如尖孢支孢霉(Cladosporium oxysporum)。氧化酶还可以从商购供应商购买,例如:AppliChem GmbH(达姆施塔特,德国)、Sigma-Aldrich(圣路易斯,密苏里州,美国)、USB公司(克利夫兰,俄亥俄州,美国)及其他供应商。
在特定实施方案中,所述氧化酶是葡糖氧化酶(EC1.1.3.4/CAS号9001-37-0)。该酶结合至β-D-葡萄糖(六碳糖葡萄糖的一种异构体)并帮助其断裂。在一些实例中,葡糖氧化酶可为二聚蛋白质,其催化β-D-葡萄糖氧化为D-葡糖酸-1,5-内酯,后者接着水解为葡糖酸。所述葡糖氧化酶可利用辅因子例如黄素腺嘌呤二核苷酸(FAD)。在葡糖氧化酶催化的氧化还原反应中,FAD作为最初的电子受体起作用并被还原为FADH2,其接着被最终的电子受体分子氧(O2)氧化。O2接着被还原生成过氧化氢(H2O2)。
在另一实施方案中,所述氧化酶是己糖氧化酶(EC 1.1.3.5),其催化D-葡萄糖和O2之间的反应以生成D-葡糖酸-1,5-内酯和H2O2。所述己糖氧化酶可来自角叉菜属红色海藻(Chondrus crispus)(通常称为爱尔兰藓),其氧化广谱的碳水化合物,例如:D-葡萄糖、D-半乳糖、麦芽糖、纤维二糖、乳糖、D-葡萄糖-6-磷酸酯、D-甘露糖、2-脱氧-D-葡萄糖、2-脱氧-D-半乳糖、D-岩藻糖、D-葡糖醛酸和D-木糖。也可使用红色海藻Iridophrycusflaccidum的己糖氧化酶,其氧化一些不同的单糖和二糖。这些氧化酶可与铜辅因子结合使用。
在另一实施方案中,所述氧化酶为木糖氧化酶(EC 1.1.3.41),其为催化木糖醇和O2之间的反应以生成木糖和H2O2的酶。某些木糖醇氧化酶(参见如JP 80892242)在氧气存在下氧化木糖醇、D-山梨醇、D-半乳糖醇、D-甘露醇和D-阿拉伯糖醇。木糖醇氧化酶可从例如链霉菌属(Streptomycesspp.)的菌株得到。这些酶的最佳pH为7.5,并在pH为5.5至10.5之间和直到65℃的温度下稳定。
在特定实施方案中,所述氧化酶可按约0.0001%至约1%,例如0.001%至0.1%的浓度存在于组合物中。
B.聚乙烯亚胺
聚乙烯亚胺(CAS 9002-98-6,26913-06-4)为阳离子型聚合物,其结合某些蛋白质。它被用于沉淀和纯化酶和脂质并作为免疫学中的标记。聚乙烯亚胺也被称为氮丙啶聚合物、epamine、epomine、乙烯亚胺聚合物及PEI,且可从商业的化学供应公司得到。
在本发明的组合物中,聚乙烯亚胺可按约0.01%至约10%,例如0.1%至5%的浓度存在。
C.载体和制剂
本发明的组合物可包括口腔可接受的载体。通常,本发明的口腔护理组合物配制为使所述氧化酶在活性或无活性的形式中稳定,并当所述口腔护理组合物与牙齿的所述釉质表面接触时保持或变得有活性。在一些实施方案中,当所述组合物与所述牙齿接触后,所述酶在牙齿表面上是有活性的,且所述组合物的剩余部分被冲洗掉,例如在使用牙膏制剂并接着冲洗的情况下。因此,所述氧化酶在口腔里通常的pH条件下,即pH 5.0至9.0之间、pH 6.0至8.5之间、或者甚至pH 6.4至7.5,或者在所述口腔护理组合物中是基本上有活性的。
在一些实施方案中,所述口腔护理组合物包含所述氧化酶的底物如糖或醇,和/或包含对于氧化酶的活性所必需的辅因子如FAD、铜等。在其他实施方案中,针对所述氧化酶的底物可提供在组合物如食品中,该组合物不是所述口腔护理组合物。在一个实施方案中,所述氧化酶可施用于牙齿的所述釉质表面并与其连接,含有针对所述酶的底物的食品(如含糖食品例如糖果、糕点或饮料)可在稍后的时间与牙齿接触。
合适的底物取决于使用的氧化酶。例如,如果所述氧化酶是葡糖氧化酶,葡萄糖可用作底物,以及如果所述氧化酶是己糖氧化酶,那么己糖可用作底物。如果该口腔护理组合物包含底物,其可以按重量计0.1%至5%,例如0.5%至2%的浓度存在,但超出所述范围外的浓度也是可设想的。
所述口腔护理组合物可为例如洁牙剂、牙膏、牙粉、局部口腔凝胶、漱口水、假牙产品、口腔喷雾、锭剂、口腔片剂或口香糖的形式。所述口腔组合物也可被掺入用于直接应用或附着于口腔表面的带、薄膜或线中。
口腔可接受的载体可包含一种或多种相容的固体或液体填充稀释剂或包封物质,其适合于局部口腔给药。所述组合物的所述载体或赋形剂可包括下文中更充分描述的常用及常规成分:洁牙剂(包括非研磨性凝胶和龈下应用的凝胶)、漱口水、口腔喷雾、口香糖及锭剂(包括薄荷糖)。在含水形式中,所述口腔护理组合物可具有约4.0至约10.0范围的pH,例如约5.0至8.0。
在某些实施方案中,基于所述口腔护理组合物被引入口腔的方式来选择所述载体。例如,如果用于牙膏(包括牙齿凝胶等),那么可以选择“牙膏载体”,其包括例如研磨材料、表面活性剂、粘合剂、润湿剂、矫味剂和甜味剂等,如Benedict在美国专利3,988,433中描述的。如果用于漱口水,那么可以选择“漱口水载体”,其包括例如水、矫味剂和甜味剂等,如在同一参考文献中所描述的。类似地,如果用于口腔喷雾,那么可以选择“口腔喷雾载体”,或者如果用于锭剂,那么可以选择“锭剂载体”(如糖果载体)。如果用于口香糖,那么可以选择“口香糖载体”(包括例如香糖胶基、矫味剂和甜味剂)。如果用于小药囊,那么可以选择“小药囊载体”(包括例如小药囊包、矫味剂和甜味剂)。如果用于龈下凝胶(例如为了将活性物质递送至牙周袋或牙周袋周围),那么可以选择“龈下凝胶载体”。其他适于制备本发明组合物的有用载体是本领域熟知的。载体的选择可以根据次要因素考虑,如味道、成本、贮藏稳定性等。
在一些实施方案中,所述组合物可为非研磨性凝胶的形式,如龈下凝胶,其可为含水或无水的。含水凝胶通常包含增稠剂(从约0.1%至约20%)、润湿剂(从约10%至约55%)、矫味剂(从约0.04%至约2%)、甜味剂(从约0.1%至约3%)、着色剂(从约0.01%至约0.5%)以及余量水。所述组合物可包含防龋剂(以氟离子计,从约0.05%至约0.3%)和抗牙垢剂(从约0.1%至约13%)。
在其他实施方案中,所述组合物可为洁牙剂的形式,例如牙膏、牙齿凝胶或牙粉。这样的牙膏和牙齿凝胶的成分可包含一种或多种牙齿研磨剂(从约5%至约50%)、表面活性剂(从约0.5%至约10%)、增稠剂(从约0.1%至约5%)、润湿剂(从约10%至约55%)、矫味剂(从约0.04%至约2%)、甜味剂(从约0.1%至约3%)、着色剂(从约0.01%至约0.5%)和水(从约2%至约45%)。这样的牙膏或牙齿凝胶还可包含一种或多种防龋剂(以氟离子计,从约0.05%至约0.3%)和抗牙垢剂(从约0.1%至约13%)。牙粉可包含基本上所有的非液体成分。
在一些实施方案中,所述组合物为漱口水,包括口腔喷雾。漱口水和口腔喷雾的成分通常包含水(从约45%至约95%)、乙醇(从约0%至约25%)、润湿剂(从约0%至约50%)、表面活性剂(从约0.01%至约7%)、矫味剂(从约0.04%至约2%)、甜味剂(从约0.1%至约3%)和着色剂(从约0.001%至约0.5%)中的一种或多种。漱口水和口腔喷雾还可包含一种或多种防龋剂(以氟离子计,从约0.05%至约0.3%)和抗牙垢剂(从约0.1%至约3%)。
在一些实施方案中,所述组合物为牙用溶液包括灌洗液。牙用溶液的成分通常包含水(从约90%至约99%)、防腐剂(从约0.01%至约0.5%)、增稠剂(从0%至约5%)、矫味剂(从约0.04%至约2%)、甜味剂(从约0.1%至约3%)和表面活性剂(从0%至约5%)中的一种或多种。
在一些实施方案中,所述组合物为口香糖。口香糖组合物通常包含香糖胶基(从约50%至约99%)、矫味剂(从约0.4%至约2%)和甜味剂(从约0.01%至约20%)中的一种或多种。
在一些实施方案中,所述组合物为锭剂。锭剂可包括在矫味基质中包含治疗剂的盘形固体。所述基质可为硬糖果、甘油明胶或者糖与充足的胶浆剂的组合以使基质成型。这些剂型是本领域熟知的。
在一些实施方案中,所述组合物为浸透了所述口腔护理组合物的牙齿填充物的形式。所述牙齿填充物可包括用于与牙齿和口腔中其他组织接触的填充物,该填充物用包含氧化酶和聚乙烯亚胺的组合物浸透。所述牙齿填充物可以是被浸透的纤维类,包括牙线或胶带、薄片、带、薄膜、牙签以及聚合纤维。
下文描述了可存在于口腔可接受的载体中的代表性材料。
1.研磨剂
牙齿研磨剂可包括许多不同的材料。选择的材料应与所述口腔护理组合物中的其他成分相容且不应过于磨损牙本质。合适的研磨剂包括例如硅酸盐如凝胶剂和沉淀物、不溶性的聚偏磷酸钠、氢氧化铝、碳酸钙、磷酸氢钙二水合物、焦磷酸钙、磷酸三钙、聚偏磷酸钙以及树脂状研磨材料如尿素和甲醛的微粒缩合产物。
用于所述组合物的一类研磨剂是微粒热固性聚合树脂。合适的树脂包括例如三聚氰胺、酚醛塑料、尿素、三聚氰胺-尿素、三聚氰胺-甲醛、尿素-甲醛、三聚氰胺-尿素-甲醛、交联的环氧化物和交联的聚酯。
可以选择二氧化硅及许多类型的其他牙齿研磨剂,因为它们具有清洁牙齿和抛光性能而不过度磨损牙釉质或牙本质的益处。二氧化硅研磨抛光材料以及其他研磨剂可具有约0.1至约30微米或约1至约15微米的平均粒度范围。所述研磨剂可为沉淀的二氧化硅或硅胶例如二氧化硅干凝胶。
可以使用研磨剂的混合物。本发明的洁牙剂组合物中研磨剂的总量可在按重量计约6%至约70%的范围。牙膏可含有占所述组合物重量的约10%至约50%的研磨剂。溶液、口腔喷雾、漱口水和非研磨性凝胶组合物可不包含研磨剂
2.表面活性剂
所述口腔护理组合物还可包含表面活性剂,例如:肌氨酸盐表面活性剂、羟乙基磺酸盐表面活性剂或牛磺酸盐表面活性剂。在某些实施方案中,所述组合物可含有这些表面活性剂的碱金属盐或铵盐。所述组合物可含有下述成分的钠或钾盐:月桂酰肌氨酸盐、肉豆蔻酰肌氨酸盐、软脂酰肌氨酸盐、硬脂酰肌氨酸盐和油酰肌氨酸盐。可使用其他适宜的相容的表面活性剂或者与肌氨酸盐或其他表面活性剂联用。
阴离子型表面活性剂包括在烷基中具有10至18个碳原子的烷基硫酸盐的水溶性盐和具有10至18个碳原子的脂肪酸的磺化的单酸甘油酯的水溶性盐。月桂硫酸钠和椰油酸磺酸甘油单酯钠是这类型的阴离子型表面活性剂的实例。也可使用阴离子型表面活性剂的混合物。
阳离子型表面活性剂可被概括地定义为具有一个包含约8至18个碳原子的长烷基链的脂肪族季铵化合物的衍生物,例如月桂基三甲基氯化铵、氯化十六烷基吡啶溴化十六烷基三甲铵、氯化二异丁基苯氧基乙基-二甲基苄铵、椰油酰基烷基三甲基亚硝酸铵、氟化十六烷基吡啶等。在一些实例中,表面活性剂化合物可为具有去污剂性质的季铵盐氟化物。某些阳离子型表面活性剂还可充当所述口腔护理组合物中的杀菌剂。
非离子型表面活性剂可被概括地定义为由环氧烷烃基团(天然亲水的)与有机疏水化合物(其可为天然的脂肪族或烷基芳族)的缩合制备的化合物。合适的非离子型表面活性剂的实例包括普流罗尼类、烷基酚的聚环氧乙烷缩合物、源自环氧乙烷与环氧丙烷和乙二胺的反应产物的缩合产物、脂族醇的环氧乙烷缩合物、长链叔胺氧化物、长链叔膦氧化物、长链二烷基亚砜以及这些材料的混合物。
两性离子型合成表面活性剂可被概括地描述为脂肪族季铵、和锍化合物的衍生物,其中脂族基团可为直链或支链的,且其中脂族取代基之一含有约8至18个碳原子并且有一个含有阴离子型水溶性基团,如:羧基、磺酸根、硫酸根、磷酸根或膦酸根。
甜菜碱型表面活性剂包括癸基甜菜碱或2-(N-癸基-N,N-二甲基铵基)乙酸盐、椰油酰基甜菜碱或2-(N-椰油酰基-N,N-二甲基铵基)乙酸盐、肉豆蔻基甜菜碱、软脂酰基甜菜碱、月桂基甜菜碱、十六烷基甜菜碱、硬脂酰基甜菜碱等。氨基甜菜碱例如椰油酰基氨基乙基甜菜碱、椰油酰基氨基丙基甜菜碱、月桂酰基氨基丙基甜菜碱等。在一些实施方案中,所述甜菜碱为椰油酰基氨基丙基甜菜碱或月桂酰基氨基丙基甜菜碱。
表面活性剂可按总组合物重量的约0.1%至约2.5%、约0.3%至约2.5%、或约0.5%至约2.0%的浓度存在。
3.抗斑剂
所述口腔护理组合物还可包含抗斑剂,例如合成的阴离子型聚合物,如:聚丙烯酸酯或者马来酸酐或马来酸与甲基乙烯基醚的共聚物以及聚氨基丙烷磺酸(AMPS)、柠檬酸锌三水合物、多肽(例如聚门冬氨酸和聚谷氨酸),以及它们的混合物。
4.螯合剂
所述口腔护理组合物可包含螯合剂。螯合剂包括酒石酸及其药学可接受的盐、柠檬酸及碱金属柠檬酸盐及其混合物。螯合剂可络合被发现在细菌细胞壁中的钙。螯合剂还可通过从帮助保持生物量完整的钙桥除去钙来破坏斑。可以不使用可能导致牙齿去矿化的螯合剂。
在特定实施方案中,柠檬酸钠和柠檬酸钾是可用于本发明的组合物的碱金属柠檬酸盐。在一些实例中,螯合剂可包括柠檬酸/碱金属柠檬酸盐组合。在其他实例中,可使用柠檬酸的碱金属盐。其他试剂包括酒石酸二钠、酒石酸二钾、酒石酸钠钾、酒石酸氢钠和酒石酸氢钾。
螯合剂的量可从约0.1%至约2.5%、约0.5%至约2.5%,或者从约1.0%至约2.5%。酒石酸盐螯合剂可单独使用或与其他任选的螯合剂联用。在一些实施方案中,这些螯合剂可具有约101至105的钙结合常数以提供具有减少斑形成的改进的清洁效果。
螯合剂的另一类是阴离子聚合型聚羧酸盐。这样的材料是本领域熟知的,以它们的游离酸、部分或完全中和的水溶性碱金属(如钾和优选钠)盐或铵盐的形式被使用。在一些实例中,组合物可含有1∶4至4∶1的马来酸酐或马来酸与另一种可聚合的乙烯化的不饱和单体的共聚物,后者例如具有约30000至约1000000的平均分子量(AMW)的甲基乙烯基醚(甲氧基乙烯)。
其他有效的聚合型聚羧酸盐包括那些例如马来酸酐与乙基丙烯酸酯、羟乙基异丁烯酸酯、N-乙烯基-2-吡咯烷酮或乙烯按1∶1的共聚物,以及丙烯酸与甲基异丁烯酸酯或羟乙基异丁烯酸酯、甲基丙烯酸酯或乙基丙烯酸酯、异丁基乙烯醚或N-乙烯基-2-吡咯烷酮按1∶1的共聚物。
另外有效的聚合型聚羧酸盐可为马来酸酐与苯乙烯、异丁烯或乙基乙烯基醚、聚丙烯酸、聚衣康酸和聚马来酸、以及AMW低至1000的磺基丙烯酸低聚物的共聚物。
5.氯化物来源
在一些实施方案中,水溶性氟化物化合物可按于25℃在所述组合物中足以提供按重量计从约0.0025%至约5.0%或按重量计约0.005%至约2.0%的氟离子浓度的量被加至所述口腔护理组合物中。许多产生氟离子的材料可用作本发明组合物中的可溶性氟化物的来源。代表性的氟离子来源可包括氟化亚锡、氟化钠、氟化钾、单氟磷酸钠及许多其他来源。在一些实例中,本发明的组合物可含有氟化亚锡和氟化钠,以及它们的混合物。
6.牙齿增白活性物质及牙色修饰物质
牙齿增白剂和/或牙色修饰物质也可存在于所述口腔护理组合物中。这些物质适于修饰牙色。这些物质可包含这样的微粒:当其应用于牙齿表面时,其以吸收或反射光的形式修饰该表面。当含有这样的微粒的薄膜施用在牙齿表面上时,这类微粒可提供外观的益处。
所述口腔护理组合物中的微粒包括化妆品领域中常规使用的色素和着色剂。对于本发明组合物中使用的色素或着色剂没有特别的限制。色素和着色剂可包括无机白色色素、无机有色色素、珠光剂、填充粉末等。具体实例可选自:滑石、云母、碳酸镁、碳酸钙、硅酸镁、硅酸镁铝、二氧化硅、二氧化钛、氧化锌、红色氧化铁、棕色氧化铁、黄色氧化铁、黑色氧化铁、氰亚铁酸铁铵盐、锰紫、群青、尼龙粉末、聚乙烯粉末、异丁烯酸酯粉末、聚苯乙烯粉末、丝粉末、晶态纤维素、淀粉、钛酸盐云母、氧化铁钛酸盐云母、氯化氧铋,以及它们的混合物。在一些实施方案中,本发明组合物含有选自二氧化钛、氯化氧铋、氧化锌以及其混合物的那些物质。
所述色素可用作遮光剂或着色剂。这些色素可以以处理过的颗粒使用或它们本身用作色素原料。对于消费者期望的特定效果可以选择特有的色素浓度。例如,对于特别黑或染色的牙齿,可以使用足量色素使所述牙齿变亮。另一方面,在牙上的单个牙齿或斑比其他牙齿亮时,可使用使该牙齿变暗的色素。使用的色素和着色剂的浓度可在本发明的组合物的约0.05%至约20%、约0.10%至约15%或约0.25%至约10%的范围内。
7.增稠剂
在一些实施方案例如牙膏或凝胶中,可加入增稠材料以提供所述组合物的稠度、使用时有效释放的特性、贮藏及其他稳定性等。增稠剂包括羧基乙烯基聚合物、角叉菜胶、羟乙基纤维素、硅酸镁锂(laponite)及纤维素醚的水溶性盐,例如羟甲基纤维素钠和羧甲基羟乙基纤维素钠。也可使用天然树胶如刺梧桐树胶、黄原胶、阿拉伯胶和西黄蓍胶。胶体硅酸镁铝或精细粉碎的二氧化硅可用作所述增稠剂的一部分来进一步改善质地。
增稠剂或胶凝剂可包含丙烯酸与季戊四醇的烷基醚或蔗糖的烷基醚交联的一类均聚物,或卡波姆,或它们的混合物。
可以在本发明的组合物例如“龈下凝胶”中使用具有从约1000至约120000(数均分子量)范围内的分子量的丙交酯和乙交酯单体的共聚物。
增稠剂可按整个牙膏或凝胶组合物重量的约0.1%至约15%、约2%至约10%、或约4%至约8%的量存在。更高浓度的增稠剂可用于口香糖、锭剂(包括薄荷糖)、小药囊、非研磨性凝胶和龈下凝胶。
8.润湿剂
在一些实施方案中,所述口腔护理组合物包括润湿剂以防止所述组合物暴露于空气后变硬,给予所述组合物对嘴的湿润感,并且对于特定润湿剂而言,用来传递矫味剂中的期望的甜味至例如牙膏组合物。所述润湿剂(基于纯的润湿剂)按本文中组合物的重量计可包含约0%至约70%或约5%至约25%。用于本发明的组合物中的合适的润湿剂包括可食用的多元醇,例如丙三醇、山梨醇、木糖醇、丁二醇、聚乙二醇和丙二醇。在某些实例中,本发明的组合物包含例如山梨醇和丙三醇的润湿剂。
9.矫味剂与甜味剂
所述口腔护理组合物中也可加入矫味剂。合适的矫味剂包括冬青油、薄荷油、留兰香油、丁香芽油、薄荷醇、茴香脑、水杨酸甲酯、桉叶脑、番泻、1-薄荷基乙酸酯、鼠尾草、丁香酚、欧芹油、4-(对羟基苯基)-2-丁酮(oxanone)、α-紫罗兰酮、马郁兰、柠檬、橙、丙烯基乙基愈创木酚、肉桂、香草醛、麝香草酚、芳樟醇、肉桂醛甘油缩醛(称为CGA),以及它们的混合物。矫味剂可按所述组合物的重量的约0.001%至约5%的浓度存在。
合适的甜味剂包括蔗糖、葡萄糖、糖精、右旋糖、左旋糖、乳糖、甘露醇、山梨醇、果糖、麦芽糖、木糖醇、糖精盐、索马汀、阿斯巴甜、D-色氨酸、二氢查耳酮、乙酰舒泛、环己氨基磺酸盐、环己氨基磺酸钠、糖精钠,以及它们的混合物。这些试剂可按全部组合物的重量的约0.1%至约10%或约0.1%至约1%存在。
除了矫味剂和甜味剂,本发明的组合物中还可使用冷却剂、催涎剂、加热剂和致麻剂(numbing agent)作为任选的成分。这些试剂可按所述组合物的重量的约0.001%至约10%或约0.1%至约1%的浓度存在。
所述冷却剂可为任何广泛多样的材料,包括羧酰胺、薄荷醇、缩酮、二醇及它们的混合物。冷却剂包括对薄荷烷羧酰胺试剂,例如N-乙基-p-薄荷烷-3-甲酰胺、N,2,3-三甲基-2-异丙基丁酰胺及它们的混合物。另外的冷却剂可选自薄荷醇、3-1-薄荷氧基丙烷-1,2-二醇、薄荷酮甘油缩醛和薄荷基乳酸酯。术语薄荷醇和薄荷基包括这些化合物的右旋和左旋异构体及其外消旋混合物。
加热剂包括辣椒和烟酸酯例如烟酸苄酯。致麻剂包括苯佐卡因、利多卡因、丁香芽油和乙醇。
10.碱金属碳酸氢盐
所述口腔护理组合物还可包含碱金属碳酸氢盐。除非在水中不稳定,否则碱金属碳酸氢盐可溶解在水中,并可在含水系统中释放二氧化碳。碳酸氢钠,又称为小苏打,可作为碱金属碳酸氢盐存在于本发明的组合物中。在某些实施方案中,本发明的组合物可含有从约0.5%至约30%、约0.5%至约15%或从约0.5%至约5%的碱金属碳酸氢盐。
11.各种载体
在所述口腔护理组合物的制备中应用水可具备低离子含量并免除有机杂质。按含水组合物的重量计,水可占约5%至约70%或约20%至约50%。这些量的水包括直接加入的自由水以及作为其他试剂或载体的一部分被引入的水。
泊洛沙姆可用于所述口腔护理组合物中。泊洛沙姆可被归属为非离子型表面活性剂。它也可用作乳化剂、粘合剂、稳定剂和其他相关功能试剂。泊洛沙姆可为双功能的嵌段聚合物,其封端具有伯醇羟基基团,分子量范围从1000至高于15000。
可用于本发明的组合物的其他乳化剂包括聚合物乳化剂。大部分高分子量的聚丙烯酸聚合物可用作乳化剂。
二氧化钛也可加至所述口腔护理组合物中。二氧化钛为白色粉末,其可以增加所述组合物的不透明性。按本发明的组合物的重量计,二氧化钛可按从约0.25%至约5%的量存在。
本发明组合物的pH优选地基于使用一种或多种缓冲剂进行预选。所述缓冲剂可适于保持组合物的pH在约pH 4.0至约pH 10.0。缓冲剂包括磷酸二氢钠、磷酸三钠、氢氧化钠、碳酸钠、酸式焦磷酸钠、柠檬酸和柠檬酸钠。按所述口腔护理组合物的重量计,缓冲剂可按从约0.5%至约10%的浓度给药。在某些实施方案中,洁牙剂组合物的pH可通过洁牙剂的3∶1的含水浆液测量,如:3份水比1份洁牙剂。
其他可用于本发明组合物的试剂包括选自烷基和烷氧基-二甲聚硅氧烷共聚醇例如C12至C20烷基二甲聚硅氧烷共聚醇及它们的混合物的二甲聚硅氧烷共聚醇。在某些实例中,本发明组合物含有十六烷基二甲聚硅氧烷共聚醇。所述二甲聚硅氧烷共聚醇可按重量计以约0.01%至约25%、约0.1%至约5%或约0.5%至约1.5%的浓度存在。所述二甲聚硅氧烷共聚醇可有助于提供积极的牙齿感觉益处。
12.其他活性剂
本发明的口腔护理组合物还可包括其他活性剂,例如抗菌剂。其中包括水不溶性非阳离子型抗微生物剂例如卤代二苯醚、包括苯酚及其同系物的酚类化合物、单烷基和多烷基的以及芳族卤代苯酚、间苯二酚及其衍生物、双酚类化合物及卤代水杨苯胺、苯甲酸酯和卤代二苯脲。在其他抗微生物剂中,水溶性抗微生物剂可包括季铵盐和bis-biquamide盐。所述季铵试剂可包括那些其中季氮上的取代基中的一个或两个具有约8至约20或约10至约18个碳原子的碳链长度(代表性的为烷基),而剩余的取代基(通常为烷基或苄基)具有较低数目的碳原子,例如从约1个至约7个碳原子,例如甲基或乙基。十二烷基三甲基溴化铵、氯化四癸基吡啶度米芬、N-四癸基-4-乙基氯化吡啶十二烷基二甲基(2-苯氧基乙基)溴化铵、苄基二甲基硬脂酰基氯化铵、氯化十六烷基吡啶季铵化的5-氨基-1,3-双(2-乙基-己基)-5-甲基-六氢嘧啶、苯扎氯铵、苄索氯铵和甲基苄索氯铵是代表性的季铵抗菌剂。其他化合物可为双[4-(R-氨基)-1-吡啶]链烷烃。也可包括其他抗微生物剂如双甘氨酸铜、甘氨酸铜、柠檬酸锌和乳酸锌。
除了变聚糖酶(mutanase),本发明的口腔护理组合物还可包含一种或多种具有碳水化合物水解作用、抗菌或牙齿增白活性的其他酶。这样的酶包括但不限于:脱氨基酶、酯酶、糖苷酶、脂肪酶、氧化酶、过氧化物酶、蛋白酶、脲酶和纤维素酶。
在某些实例中,所述组合物可包含除氧化酶外的酶,如:漆酶、过氧化物酶、葡聚糖酶或变聚糖酶。这些酶可具有抗微生物活性、漂白活性或两者都具有。其他有用的酶包括蛋白酶、裂解酶和菌斑基质抑制物。蛋白酶包括木瓜蛋白酶、胃蛋白酶、胰蛋白酶、无花果蛋白酶、菠萝蛋白酶;细胞壁裂解酶包括溶菌酶;菌斑基质抑制物包括右旋糖苷酶和变聚糖酶。某些酶的作用可通过直接氧化牙齿菌株或经由介体获得。
III.使用方法
本发明还提供了涉及将牙齿的釉质表面与所描述的组合物接触的方法,其在适合于将存在于所述组合物中的所述氧化酶结合至所述釉质表面并在接触步骤期间或在接触步骤后产生过氧化物的条件下进行。相关地,本发明提供了将氧化酶结合至牙齿表面的方法,该方法包括在提供经由聚乙烯亚胺或山梨醇将所述氧化酶结合至釉质表面并产生过氧化物的条件下,在所述聚乙烯亚胺或山梨醇存在下将具有所述釉质表面的牙齿与所述氧化酶接触。所述酶可经由PEI或山梨醇直接或间接地结合至所述釉质表面。
在一些实施方案中,所述方法导致清洁、变白和/或抛光牙齿,减少牙釉质上的染色、菌斑、龈炎和牙垢的发生率,以及它们的组合。
在一些实施方案中,所述方法有效地在所接触的釉质表面上沉积氧化酶。所述沉积可来自水基的制剂如清洁和去垢组合物,或者来自基本上无水的制剂,所述制剂包含聚乙烯亚胺或山梨醇。如图1中所示,当施用于合适的表面时,包含聚乙烯亚胺的示例性口腔组合物增加了葡糖氧化酶在坚硬表面上的保留。
本发明的方法可通过例如刷牙、漱口、咀嚼或其他将所述的组合物引入口腔中来接触牙齿表面的方式进行。接触的方法包括使用局部口腔凝胶、口腔喷雾或其他形式的口腔组合物,例如带、薄膜或线,它们接触牙齿和/或口腔粘膜。所述组合物可通过牙刷、笔形棉棒、鹿脚形棉棒、手指等直接应用至牙齿、牙龈或其他口腔表面。所述方法可完全或部分地由消费者/个体/终端用户进行,例如在家庭环境中,或者由专业的牙科保健人员进行,例如在临床环境中。
实验
提供下述实施例以证明和进一步说明在聚乙烯亚胺或山梨醇存在下,葡糖氧化酶对羟磷灰石的附着是如何增加的。
实施例1
葡糖氧化酶结合至唾液覆盖的羟磷灰石盘
唾液覆盖的羟磷灰石(HAP)盘通常用作牙齿表面的模型。该实施例证明了山梨醇或聚乙烯亚胺的加入提高了葡糖氧化酶以催化活性的构象与唾液覆盖的羟磷灰石的结合。
唾液收集自3-5个供体,通过离心使其澄清,并在遮蔽的塑料托盘中将其加入以覆盖HAP盘(5mm X 2.0mm Clarkson Chromatography)。该盘在室温经唾液温育过夜,伴随轻微摇动。在用于结合测定前,该盘用50mM磷酸盐缓冲液清洗两遍。在山梨醇(0.8-8%)或聚乙烯亚胺(1%)存在下,将不同浓度的葡糖氧化酶(50-650mU/ml)加至唾液覆盖的HAP盘中。按照制造商的建议,在用磷酸盐缓冲盐水连续三次洗涤后,使用荧光性的(Amplex Red,Molecular Probes#A22189)辣根过氧化物酶偶联测定法测定保留在羟磷灰石盘上的葡糖氧化酶的量。
正如实验结果中清楚看到的,至少0.8%山梨醇或1%聚乙烯亚胺的加入增加了在羟磷灰石上检测到的活性葡糖氧化酶的量。
Claims (19)
1.口腔护理组合物,其包含:
a)口腔可接受的载体;
b)聚乙烯亚胺;和
c)非复合的氧化酶。
2.权利要求1的口腔护理组合物,其中所述氧化酶为葡糖氧化酶。
3.权利要求1的组合物,其中所述聚乙烯亚胺和所述非复合的氧化酶以足以使所述氧化酶结合至牙齿的釉质表面并在适合于所述氧化酶的底物存在下产生过氧化物的量存在。
4.权利要求1的口腔护理组合物,其中所述聚乙烯亚胺在所述口腔护理组合物中以按所述组合物的重量计0.001%至10%的浓度存在。
5.权利要求1的口腔护理组合物,其中所述氧化酶在所述口腔护理组合物中以按所述组合物的重量计0.0001%至1%的浓度存在。
6.权利要求1的口腔护理组合物,其中所述口腔护理组合物包含增稠剂、表面活性剂、润湿剂和研磨剂中的至少一种。
7.权利要求1的口腔护理组合物,其中所述口腔护理组合物包含除所述氧化酶外的第二种酶。
8.权利要求7的口腔护理组合物,其中所述氧化酶不与另一种酶复合。
9.权利要求1的口腔护理组合物,其中所述口腔护理组合物为流体。
10.权利要求1的口腔护理组合物,其中所述口腔护理组合物为固体。
11.权利要求9的口腔护理组合物,其中所述口腔护理组合物被配制为牙膏。
12.权利要求10的口腔护理组合物,其中所述口腔护理组合物被配制为牙线。
13.在牙齿表面产生过氧化物的方法,其包括:
在适合于将所述氧化酶结合至釉质表面并产生过氧化物的条件下,将权利要求1的组合物与牙齿的釉质表面接触。
14.权利要求13的方法,其中使用牙刷进行接触。
15.权利要求13的方法,其中使用牙线进行接触。
16.权利要求13的方法,其中所述方法导致所述牙齿上的细菌死亡和/或牙齿变白。
17.将氧化酶结合至牙齿的方法,其包括:
在提供经由所述聚乙烯亚胺或山梨醇将所述氧化酶结合至所述釉质表面并产生过氧化物的条件下,在聚乙烯亚胺或山梨醇存在下将具有釉质表面的牙齿与所述氧化酶接触。
18.权利要求20的方法,其中使用牙刷进行所述接触。
19.权利要求20的方法,其中使用牙线进行所述接触。
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US4701108P | 2008-04-22 | 2008-04-22 | |
US61/047,011 | 2008-04-22 | ||
PCT/US2009/038777 WO2009131799A2 (en) | 2008-04-22 | 2009-03-30 | Oral care composition containing oxidase enzyme |
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CN102015028A true CN102015028A (zh) | 2011-04-13 |
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CN2009801142685A Pending CN102015028A (zh) | 2008-04-22 | 2009-03-30 | 含有氧化酶的口腔护理组合物 |
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US (1) | US20110236859A1 (zh) |
EP (1) | EP2271406A2 (zh) |
CN (1) | CN102015028A (zh) |
WO (1) | WO2009131799A2 (zh) |
Cited By (4)
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CN104546527A (zh) * | 2014-12-29 | 2015-04-29 | 福建省闽东力捷迅药业有限公司 | 一种含七叶皂苷钠的漱口液及其制备方法 |
CN109152705A (zh) * | 2016-03-29 | 2019-01-04 | 安全白股份有限公司 | 用于增白牙齿和牙齿组分的聚电解质牙科粘合剂 |
CN114585418A (zh) * | 2019-05-28 | 2022-06-03 | 联合利华知识产权控股有限公司 | 口腔护理组合物 |
CN115105444A (zh) * | 2022-05-26 | 2022-09-27 | 广州蕴美化妆品有限公司 | 一种美白抗糖化的益生菌漱口水组合物及其制备方法 |
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US10413500B2 (en) | 2016-12-20 | 2019-09-17 | Colgate-Palmolive Company | Oral care compositions and methods for whitening teeth |
CN111050854A (zh) * | 2017-09-08 | 2020-04-21 | 3M创新有限公司 | 口腔护理氟化物水性治疗组合物和方法 |
EP3806686A4 (en) * | 2018-06-12 | 2022-03-23 | Buzzelet Development And Technologies Ltd | DENTAL CANNABIS DELIVERY DEVICE AND USE |
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CN104546527A (zh) * | 2014-12-29 | 2015-04-29 | 福建省闽东力捷迅药业有限公司 | 一种含七叶皂苷钠的漱口液及其制备方法 |
CN109152705A (zh) * | 2016-03-29 | 2019-01-04 | 安全白股份有限公司 | 用于增白牙齿和牙齿组分的聚电解质牙科粘合剂 |
CN114585418A (zh) * | 2019-05-28 | 2022-06-03 | 联合利华知识产权控股有限公司 | 口腔护理组合物 |
CN115105444A (zh) * | 2022-05-26 | 2022-09-27 | 广州蕴美化妆品有限公司 | 一种美白抗糖化的益生菌漱口水组合物及其制备方法 |
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WO2009131799A3 (en) | 2010-12-16 |
US20110236859A1 (en) | 2011-09-29 |
EP2271406A2 (en) | 2011-01-12 |
WO2009131799A2 (en) | 2009-10-29 |
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