CN114466680A - 包含啤酒花β酸和氨基酸的口腔护理组合物 - Google Patents
包含啤酒花β酸和氨基酸的口腔护理组合物 Download PDFInfo
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- CN114466680A CN114466680A CN202080068617.0A CN202080068617A CN114466680A CN 114466680 A CN114466680 A CN 114466680A CN 202080068617 A CN202080068617 A CN 202080068617A CN 114466680 A CN114466680 A CN 114466680A
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- oral care
- care composition
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- fluoride
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Abstract
本发明公开了具有防龋或防蛀牙作用的口腔护理组合物。公开了具有一种或多种啤酒花β酸(诸如来自葎草科物种的提取物)以及一种或多种氨基酸的口腔护理组合物。公开了具有一种或多种氨基酸和来自啤酒花的提取物的口腔护理组合物。公开了使用所公开的组合物破坏需要治疗的患者的口腔中的生物膜的方法。
Description
技术领域
本发明涉及具有改进的防龋和/或抗菌活性的组合物。本发明还涉及包含一种或多种啤酒花β酸诸如来自啤酒花(Humulus lupulus)的提取物和一种或多种氨基酸诸如甘氨酸的组合物。
背景技术
口腔护理组合物(诸如牙膏和/或洁牙剂组合物)可施用于口腔以清洁和/或保持牙齿、牙龈和/或舌头的美观和/或健康。另外,许多口腔护理组合物用于将活性成分直接递送到口腔护理表面。然而,将活性成分递送到生物膜可能具有挑战性。
生物膜是一种或多种类型微生物的集合体,可以在许多不同的表面上生长。生物膜的一个常见示例是牙菌斑,它是在口腔内表面上形成的细菌的积聚。
最初,牙菌斑是无色沉积物,但一旦形成牙垢,就通常呈棕色或淡黄色。牙垢是一种通过矿物质沉淀到生物膜中而形成的硬钙化沉积物,其充当可以容纳附加的生物膜形成的粗糙表面。这被称为牙结石积聚。牙结石的形成与许多临床表现有关,包括口臭、牙龈萎缩和牙龈慢性发炎。刷牙和使用牙线可以去除形成牙结石的牙菌斑;然而,一旦形成,牙结石附着得太牢固,就无法用牙刷去除,因为牙菌斑生物膜群落对外部化学和物理扰动极其顽固。
因此,需要可以穿透生物膜以递送活性剂的口腔护理组合物。
发明内容
本文公开了一种口腔护理组合物,该口腔护理组合物包含:(a)按该组合物的重量计约0.01%至约10%的啤酒花β酸;以及(b)按该组合物的重量计约0.01%至约10%的氨基酸。
本文还公开了一种破坏口腔中具有牙科生物膜的患者口腔中的牙科生物膜的方法,该方法包括将口腔护理组合物施用于牙科生物膜,其中该口腔护理组合物包含:(a)按该组合物的重量计约0.01%至约10%的啤酒花β酸,以及(b)按该组合物的重量计约0.01%至约10%的氨基酸。
附图说明
图1示出了用(从上到下)实施例1、实施例2、实施例3和实施例4处理的原位生物膜的EPS厚度的照片。
图2示出了具有羟基磷灰石盘的口腔夹板。
图3示出了具有凹槽的羟基磷灰石盘。
图4示出了凹槽的剖视图。
具体实施方式
本发明涉及可以穿透、破坏牙科生物膜和/或使牙科生物膜不稳定的口腔护理组合物。另外,本发明涉及包含一种或多种啤酒花β酸和氨基酸的口腔护理组合物。所公开的组合物可导致通过使用氨基酸诸如甘氨酸实现的牙科生物膜结构的破坏和/或不稳定。此外,不稳定的生物膜允许改善成分的渗透率以调节细菌代谢物和毒素,如通过添加甘氨酸增强亚锡渗透率和LPS的中和所见。虽然不希望受理论束缚,但是据信改变生物膜结构的效果可导致生物膜厚度减少,这可减少细菌及其代谢物的量和影响。
定义
为了更清楚地定义本文所用的术语,提供了以下定义。除非另外指明,以下定义均适用于本公开。如果在本公开中使用术语但未在本文中具体定义,则可应用来自IUPACCompendium of Chemical Terminology第2版(1997)的定义,只要该定义不与本文应用的任何其他公开或定义相冲突,或者不使应用该定义的任何权利要求不确定或不能实现。
如本文所用,术语“口腔护理组合物”包括在普通使用过程中不是用于吞咽以用于特定治疗剂的全身给药的目的,而是在口腔中保留足够长的时间以接触牙齿表面或口腔组织的产品。口腔护理组合物的示例包括洁牙剂、牙膏、牙胶、龈下凝胶、漱口水、摩丝、泡沫、口喷剂、锭剂、咀嚼片、口香糖、牙齿美白条、牙线和牙线涂层、口气清新可溶性条、或者义齿护理或粘合剂产品。口腔护理组合物还可掺入条或膜上以用于直接施用或附接到口腔表面。
可用于本文中的“活性成分和其它成分”可根据其美容和/或治疗有益效果或其假定的作用或运行模式来在本文中分类或描述。然而应当理解,在一些情况下,可用于本文的活性物质和其他成分可提供多于一种美容和/或治疗有益效果,或者经由不止一种作用模式起作用或运行。因此,本文的分类只是为了方便起见,而并不旨在将成分限制在所列的具体指定的功能或活性。
术语“口部可接受的载体”包括一种或多种适用于局部口腔给药的相容的固体或液体赋形剂或稀释剂。如本文所用,所谓“相容的”是指组合物的组分能够混合但不相互作用,该相互作用会显著降低组合物的稳定性和/或功效。
如本文所用,术语“基本上不含”是指按此类组合物的总重量计,组合物中存在不超过0.05%、优选地不超过0.01%并且更优选地不超过0.001%的指定材料。
如本文所用,术语“实质上不含”是指所指示的材料不是被有意加入到组合物,或者优选地不以分析可检测的水平存在。这是指包括其中指示的材料仅作为有意加入的其它材料中的一种中的杂质而存在的组合物。
虽然本文以“包括”各种组分或步骤的方式描述组合物和方法,但除非另外指明,该组合物和方法也可“基本上由”或“由”各种组分或步骤组成。
如本文所用,词语“或”当用作两个或更多个元素的连词时,是指包括单独的元素或元素的组合;例如X或Y,是指X或Y或两者。
如本文所用,冠词“一个”和“一种”被理解为受权利要求书保护的或描述的一种或多种材料,例如,“口腔护理组合物”或“漂白剂”。
除非另外指明,否则本文提及的所有测量均在约23℃(即室温)处进行。
一般来讲,使用Chemical and Engineering News,63(5),27,1985中公布的元素周期表的版本中所示的编号方案来指示元素族。在一些情况下,元素族可使用分配到该族的通用名称指示;例如,对于1族的碱金属元素、对于2族的碱土金属元素,诸如此类。
本发明公开了几种类型的范围。当公开或以权利要求书保护任何类型的范围时,其目的在于单独公开或以权利要求书保护此类范围可合理涵盖的每个可能数值,包括该范围的端点以及其中涵盖的任何子范围和子范围的组合。
术语“约”意指数量、尺寸、配方、参数以及其他数量和特性不是且不必是精确的,但可根据需要为近似和/或更大或更小,从而反映公差、转换因子、四舍五入、测量误差等等,以及本领域技术人员已知的其他因素。一般来讲,无论是否进行此类明确表述,数量、尺寸、配方、参数或其他量或特性均为“约”或“近似”。术语“约”还涵盖由于由特定初始混合物产生的对于组合物的不同平衡条件而不同的量。无论是否由术语“约”修饰,权利要求均包括数量的等同量。术语“约”可意指在报告数值10%内的值,优选在报告数值5%内的值。
口腔护理组合物可为任何合适的形式,诸如固体、液体、粉末、糊剂或它们的组合。口腔护理组合物可为洁牙剂、牙胶、龈下凝胶、漱口液、摩丝、泡沫、口喷剂、锭剂、咀嚼片、口香糖、牙齿美白条、牙线和牙线涂层、口气清新可溶性条或者义齿护理或粘合剂产品。可将洁牙剂组合物的组分掺入到膜、条、泡沫或纤维基洁牙剂组合物中。口腔护理组合物可包含多种活性和非活性成分,诸如例如但不限于啤酒花提取物、锡离子源、钙离子源、水、氟离子源、锌离子源、一种或多种多磷酸盐、湿润剂、表面活性剂、其他成分等以及它们的任何组合,如下所述。
下面提供节标题只是仅了组织和方便。节标题并不表示化合物不能在多个节中。实际上,化合物可落入多于一个节内。例如,氯化亚锡既可以是锡离子源又可以是生物膜改性剂,氟化亚锡既可以是锡离子源又可以是氟离子源,甘氨酸可以是氨基酸、缓冲剂和/或生物膜改性剂,以及可以适合多个类别和/或节中的许多其他化合物。
啤酒花
本发明的口腔护理组合物包含式I和/或式IV的至少一种啤酒花化合物。式I和/或式IV的化合物可以由任何合适的来源提供,诸如来自啤酒花或蛇麻花的提取物、啤酒花本身、其合成衍生化合物和/或盐、前药或其他类似物。啤酒花提取物可包含一种或多种啤酒花α酸、一种或多种啤酒花异α酸、一种或多种啤酒花β酸、一种或多种啤酒花油、一种或多种类黄酮、一种或多种溶剂和/或水。合适的啤酒花α酸(一般以式I表示)可以包括葎草酮(式II)、聚葎草酮、类葎草酮、后葎草酮、前葎草酮和/或它们的混合物。合适的啤酒花异α酸可以包括顺式异葎草酮和/或反式异葎草酮。葎草酮异构化为顺式异葎草酮和反式异葎草酮可由式III表示。
式I.啤酒花异α酸A是α位的酸性羟基官能团,B是β位的酸性羟基官能团,并且R是烷基官能团。
式II.葎草酮
式III.葎草酮异构化为异葎草酮。
合适的啤酒花β酸可以包括蛇麻酮、类蛇麻酮、加蛇麻酮和/或它们的混合物。合适的啤酒花β酸可以包括式IV、V、VI和/或VII中描述的化合物。
式IV.啤酒花β酸。B是β位的酸性羟基官能团,并且R是烷基官能团。
式V.蛇麻酮
式VI.加蛇麻酮
式VII.类蛇麻酮
虽然啤酒花α酸可以表现出一些抗菌活性,但是啤酒花α酸也具有苦味。啤酒花α酸提供的苦味可以适用于啤酒,但不适用于口腔护理组合物。相比之下,啤酒花β酸可以与较高的抗菌和/或防龋活性相关,但味道不那么苦。因此,比通常在自然界中发现的具有更高比例的β酸与α酸的啤酒花提取物可以适用于口腔护理组合物,用作抗菌剂和/或防龋剂。
取决于啤酒花的种类,天然啤酒花来源可以包含按啤酒花来源的重量计约2%至约12%的啤酒花β酸。在其他情况下使用的啤酒花提取物,诸如在啤酒的酿造中,可以包含按提取物的重量计约15%至约35%的啤酒花β酸。本文所需的啤酒花提取物可以包含至少约35%、至少约40%、至少约45%、约35%至约95%、约40%至约90%、或约45%至约99%的啤酒花β酸。啤酒花β酸可以呈酸性形式(即,具有连接到羟基官能团的氢原子)或盐形式。
合适的啤酒花提取物在美国专利号7,910,140中有详细描述,该专利全文以引用方式并入本文。所需的啤酒花β酸可以是非氢化的,通过非天然发生的化学反应部分氢化,或通过非天然发生的化学反应氢化。啤酒花β酸可以实质上不含或基本上不含氢化啤酒花β酸和/或啤酒花酸。非天然发生的化学反应是借助啤酒花中不存在的化合物进行的化学反应,诸如在野生啤酒花通常不会经历的高温下和/或金属催化剂中进行的化学加氢反应。
天然啤酒花来源可以包含按啤酒花来源的重量计约2%至约12%的啤酒花α酸。在其他情况下使用的啤酒花提取物,诸如在啤酒的酿造中,可以包含按提取物的重量计约15%至约35%的啤酒花α酸。本文所需的啤酒花提取物可以包含按提取物的重量计小于约10%、小于约5%、小于约1%、或小于约0.5%的啤酒花α酸。
啤酒花油可以包含萜烯烃,诸如月桂烯、葎草烯、石竹烯和/或它们的混合物。本文所需的啤酒花提取物可以包含按提取物的重量计小于5%、小于2.5%、或小于2%的一种或多种啤酒花油。
啤酒花提取物中存在的类黄酮可以包括黄腐酚、8-异戊二烯柚皮素、异黄腐酚和/或它们的混合物。啤酒花提取物可以实质上不含、基本上不含或具有小于250ppm、小于150ppm和/或小于100ppm的一种或多种类黄酮。
如美国专利号5,370,863中所述,先前已将啤酒花酸添加到口腔护理组合物中。然而,美国专利号5,370,863所教导的口腔护理组合物仅包含按口腔护理组合物的重量计至多0.01%。尽管不希望受理论束缚,但据信美国专利号5,370,863仅可掺入少量的啤酒花酸,因为啤酒花α酸具有苦味。具有低含量的啤酒花α酸的啤酒花提取物不具有这一问题。
啤酒花化合物可以与另一种植物诸如木兰属(Magnolia)物种的提取物组合或不含另一种植物的提取物。啤酒花化合物可以与三氯生组合或不含三氯生。
口腔护理组合物可以包含约0.01%至约10%、大于0.01%至约10%、约0.05%,至约10%、约0.1%至约10%、约0.2%至约10%、约0.2%至约10%、约0.2%至约5%、约0.25%至约2%、约0.05%至约2%、或大于0.25%至约2%的啤酒花β酸,如本文所述。啤酒花β酸可以由合适的啤酒花提取物、啤酒花植物本身或合成衍生化合物提供。啤酒花β酸可以作为中性、酸性化合物和/或作为具有合适的抗衡离子诸如钠、钾、氨或任何其他合适的抗衡离子的盐提供。
啤酒花β酸可以由啤酒花提取物提供,诸如来自啤酒花的提取物,其具有按提取物的重量计至少35%的啤酒花β酸和按啤酒花提取物的重量计小于1%的啤酒花α酸。口腔护理组合物可以包含0.01%至约10%、大于0.01%至约10%、约0.05%,至约10%、约0.1%至约10%、约0.2%至约10%、约0.2%至约10%、约O.2%至约5%、约0.25%至约2%、约0.05%至约2%、或大于0.25%至约2%的啤酒花提取物,如本文所述。
氨基酸
口腔护理组合物可包含一种或多种氨基酸。所公开的组合物可导致通过使用氨基酸诸如甘氨酸实现的牙科生物膜结构的破坏和/或不稳定。此外,不稳定的生物膜允许改善成分的渗透率以调节细菌代谢物和毒素,如通过添加甘氨酸增强亚锡渗透率和LPS的中和所见。虽然不希望受理论束缚,但是据信改变生物膜结构的效果可导致生物膜厚度减少,这可减少细菌及其代谢物的量和影响。
氨基酸是含有胺官能团、羧基官能团和每个氨基酸特有的侧链的有机化合物。合适的氨基酸包括例如具有正或负侧链的氨基酸、具有酸性或碱性侧链的氨基酸、具有极性不带电荷侧链的氨基酸、具有疏水侧链的氨基酸和/或它们的组合。合适的氨基酸还包括例如精氨酸、组氨酸、赖氨酸、天冬氨酸、谷氨酸、丝氨酸、苏氨酸、天冬酰胺、谷氨酰胺、半胱氨酸、硒代半胱氨酸、甘氨酸、脯氨酸、丙氨酸、缬氨酸、异亮氨酸、亮氨酸、甲硫氨酸、苯丙氨酸、酪氨酸、色氨酸、瓜氨酸、鸟氨酸、肌酸、二氨基丁酸、二氨基丙酸、它们的盐和/或它们的组合。
合适的氨基酸包括一种或多种碱性氨基酸、一种或多种酸性氨基酸、一种或多种中性氨基酸或它们的组合。
口腔护理组合物可包含按口腔护理组合物的重量计约0.01%至约20%、约0.1%至约10%、约0.5%至约6%或约1%至约10%的氨基酸。
氟离子源
口腔护理组合物可包含氟离子源。氟化合物离子源可包含一种或多种含氟化合物,诸如氟化亚锡、氟化钠、氟化钛、氟化钙、磷酸钙硅酸盐氟化物、氟化钾、氟化胺、单氟磷酸钠、氟化锌和/或它们的混合物。
氟化物离子源和锡离子源可为相同的化合物,例如,氟化亚锡,其可生成锡离子和氟离子。另外,氟化物离子源和锡离子源可为单独的化合物,诸如当锡离子源为氯化亚锡并且氟化物离子源为单氟磷酸钠或氟化钠时。
氟化物离子源和锌离子源可为相同的化合物,例如,氟化锌,其可生成锌离子和氟离子。另外,氟化物离子源和锌离子源可为单独的化合物,诸如当锌离子源为磷酸锌并且氟化物离子源为氟化亚锡时。
氟化物离子源可实质上不含、基本上不含或不含氟化亚锡。因此,口腔护理组合物可包含氟化钠、氟化钾、氟化胺、单氟磷酸钠、氟化锌和/或它们的混合物。
口腔护理组合物可包含能够提供约50ppm至约5000ppm并且优选地约500ppm至约3000ppm的游离氟离子的氟化物离子源。为递送所期望量的氟离子,氟化物离子源可以按口腔护理组合物的重量计约0.0025%至约5%、约0.01%至约10%、约0.2%至约1%、约0.5%至约1.5%、或约0.3%至约0.6%的量存在于口腔护理组合物中。另选地,口腔护理组合物可包含小于0.1%、小于0.01%、实质上不含、基本上不含或不含氟化物离子源。
锡离子源
本发明的口腔护理组合物可包含锡离子源。锡离子源可为任何合适的化合物,当将洁牙剂组合物施用到口腔中时,该化合物可在口腔护理组合物中提供锡离子和/或将锡离子递送到口腔中。锡离子源可包含一种或多种含锡化合物,诸如氟化亚锡、氯化亚锡、溴化亚锡、碘化亚锡、氧化亚锡、草酸亚锡、硫酸亚锡、硫化亚锡、氟化锡、氯化锡、溴化锡、碘化锡、硫化锡和/或它们的混合物。锡离子源可包含氟化亚锡、氯化亚锡和/或它们的混合物。锡离子源也可以是不含氟的锡离子源,诸如氯化亚锡。
口腔护理组合物可包含按该口腔护理组合物的重量计约0.0025%至约5%、约0.01%至约10%、约0.2%至约1%、约0.5%至约1.5%或约0.3%至约0.6%的锡离子源。
Ca离子源
本发明的口腔护理组合物可包含钙离子源。钙离子源可为任何合适的化合物或分子,当将口腔护理组合物施用到口腔中时,该化合物或分子可在口腔护理组合物中提供钙离子和/或将钙离子递送到口腔中。钙离子源可包含钙盐、钙磨料和/或它们的组合。在一些情况下,钙盐也可以被认为是钙磨料,或者钙磨料也可以被认为是钙盐。
钙离子源可包含钙磨料。钙磨料可为任何合适的磨料化合物,当将口腔护理组合物施用到口腔中时,该磨料化合物可在口腔护理组合物中提供钙离子和/或将钙离子递送到口腔中。钙磨料可包含一种或多种钙磨料化合物,诸如碳酸钙、沉淀碳酸钙(PCC)、研磨碳酸钙(GCC)、白垩、磷酸二钙、焦磷酸钙和/或它们的混合物。
钙离子源可包含钙盐,或当将口腔护理组合物施用到口腔中时,可在口腔护理组合物中提供钙离子和/或将钙离子递送到口腔中的不能充当磨料的化合物。钙盐可包括一种或多种钙化合物,诸如氯化钙、硝酸钙、磷酸钙、乳酸钙、草酸钙、氧化钙、葡萄糖酸钙、柠檬酸钙、溴化钙、碘酸钙、碘化钙、羟基磷灰石、氟磷灰石、硫酸钙、甘油磷酸钙和/或它们的组合。
口腔护理组合物可包含约5%至约70%、约10%至约50%、约10%至约60%、约20%至约50%、约25%至约40%或约1%至约50%的钙离子源。
缓冲剂
口腔护理组合物可包含缓冲剂。缓冲剂可以是弱酸或弱碱,它可以在口腔中的选定部位维持特定pH。例如,缓冲剂可以维持牙齿表面的pH,以减轻细菌产生的牙菌斑酸的影响。缓冲剂可包含也存在于口腔护理组合物中的离子的共轭酸。例如,如果钙离子源包含碳酸钙,则缓冲剂可以包含碳酸氢根阴离子(-HCO3 -)。缓冲剂可包含共轭酸/碱对,诸如柠檬酸和柠檬酸钠。
合适的缓冲体系可包含磷酸盐、柠檬酸盐、碳酸盐/碳酸氢盐、三羟甲基氨基甲烷缓冲液、咪唑、脲、硼酸盐和/或它们的组合。合适的缓冲剂包括碳酸氢盐,诸如碳酸氢钠、甘氨酸、正磷酸盐、精氨酸、脲和/或它们的组合。
口腔护理组合物可包含约1%至约30%、约5%至约25%或约10%至约20%的一种或多种缓冲剂。
生物膜改性剂
口腔护理组合物可包含一种或多种生物膜改性剂。生物膜改性剂可包括多元醇、氨生成化合物和/或葡糖基转移酶抑制剂。
多元醇是具有多于一个羟基官能团的有机化合物。多元醇可为在使用前储存口腔护理组合物时可与锡离子弱缔合、相互作用或键合的任何合适的化合物。多元醇可以是糖醇,其是一类可通过具有式(CHOH)nH2的糖化合物的氢化获得的多元醇。多元醇可以是甘油、赤藓醇、木糖醇、山梨醇、甘露糖醇、丁二醇、乳糖醇和/或它们的组合。口腔护理组合物可包含按该口腔护理组合物的重量计0.01%至约70%、约5%至约70%、约5%至约50%、约10%至约60%、约10%至约25%或约20%至约80%的多元醇。
氨生成化合物可以是在递送到口腔时可以生成氨的任何合适的化合物。合适的氨生成化合物包括精氨酸、脲和/或它们的组合。口腔护理组合物可包含约0.01%至约10%、约1%至约5%或约1%至约25%的一种或多种氨生成化合物。
葡糖基转移酶抑制剂可以是可以抑制葡糖基转移酶的任何合适的化合物。葡糖基转移酶是可以建立天然糖苷键的酶。具体地,这些酶将多糖或寡糖部分分解成单糖,用于与龋齿相关的细菌。因此,可以抑制此过程的任何化合物都可以帮助预防龋齿。合适的葡糖基转移酶抑制剂包括油酸、表儿茶素、单宁、单宁酸、门诺霉素、卡泊芬净、乙胺丁醇、氯芬奴隆和/或它们的组合。口腔护理组合物可包含约0.001%至约5%、约0.01%至约2%或约1%的一种或多种葡糖基转移酶抑制剂。
金属离子源
口腔护理组合物可包含金属离子源,该金属离子源包含一种或多种金属离子。如本文所述,金属离子源可包含锡离子源和/或锌离子源或除锡离子源和/或锌离子源之外。合适的金属离子源包括具有金属离子的化合物,诸如但不限于Sn、Zn、Cu、Mn、Mg、Sr、Ti、Fe、Mo、B、Ba、Ce、Al、In和/或它们的混合物。痕量金属源可为具有合适的金属和任何相伴配体和/或阴离子的任何化合物。
可与金属离子源配对的合适配体和/或阴离子包括但不限于乙酸根、硫酸铵、苯甲酸根、溴离子、硼酸根、碳酸根、氯离子、柠檬酸根、葡糖酸根、甘油磷酸根、氢氧根、碘离子、氧化物、丙酸根、D-乳酸根、DL-乳酸根、正磷酸根、焦磷酸根、硫酸根、硝酸根、酒石酸根、和/或它们的混合物。
口腔护理组合物可包含约0.01%至约10%、约1%至约5%或约0.5%至约15%的金属离子源。
抗菌剂
口腔护理组合物可包含一种或多种抗菌剂。合适的抗菌剂包括在口腔中提供抗菌活性的任何分子。合适的抗菌剂包括啤酒花酸、锡离子源、苯甲醇、苯甲酸钠、乙酸薄荷基甘油酯、乳酸薄荷酯、L-薄荷醇、邻新薄荷醇、叶绿酸铜络合物、苯酚、羟喹啉和/或它们的组合。
口腔护理组合物可包含约0.01%至约10%、约1%至约5%或约0.5%至约15%的抗菌剂。
生物活性物质
口腔护理组合物还可包含适于牙齿再矿化的生物活性物质。合适的生物活性物质包括生物活性玻璃、NovaminTM、RecaldentTM、羟基磷灰石、一种或多种氨基酸(例如,精氨酸、瓜氨酸、甘氨酸、赖氨酸或组氨酸)或它们的组合。包含精氨酸的组合物的合适示例可见于美国专利号4,154,813和5,762,911,这两篇专利全文以引用方式并入本文。其他合适的生物活性物质包括任何磷酸钙化合物。其他合适的生物活性物质包括包含钙源和磷酸盐源的化合物。
生物活性玻璃包含钙和/或磷酸盐,其可以类似于羟基磷灰石的比例存在。这些玻璃可粘结到组织并且是生物相容性的。生物活性玻璃可包含磷酸肽、钙源、磷酸盐源、二氧化硅源、钠源和/或它们的组合。
口腔护理组合物可包含按该口腔护理组合物的重量计约0.01%至约20%,约0.1%至约10%或约1%至约10%的生物活性物质。
研磨剂
口腔护理组合物可以包含钙磨料,如本文所述,和/或非钙磨料,诸如膨润土、硅胶(单独的,并且具有任何结构)、沉淀二氧化硅、无定形沉淀二氧化硅(单独的,并且也具有任何结构)、二氧化硅水合物、珍珠岩、二氧化钛、焦磷酸钙、磷酸氢钙二水合物、氧化铝、氧化铝水合物、煅烧氧化铝、硅酸铝、不溶性偏磷酸钠、不溶性偏磷酸钾、不溶性碳酸镁、硅酸锆、微粒热固性树脂和其它合适的磨料材料。可将此类材料引入口腔护理组合物中以定制目标洁牙剂制剂的抛光特性。口腔护理组合物可包含按口腔护理组合物的重量计约5%至约70%、约10%至约50%、约10%至约60%、约20%至约50%、约25%至约40%或约1%至约50%的非钙磨料。
另选地,口腔护理组合物可基本上不含、实质上不含或不含二氧化硅、氧化铝或任何其他非钙磨料。口腔护理组合物可包含少于约5%、少于约1%、少于约0.5%、少于约0.1%或0%的非钙磨料,诸如二氧化硅和/或氧化铝。
水
本发明的口腔护理组合物可为无水制剂、低水制剂或高水制剂。总体而言,口腔护理组合物可包含按组合物的重量计0%至约99%、约5%至约75%、约20%或更多、约30%或更多或者约50%或更多的水。优选地,水为USP水。
在高水口腔护理组合物和/或牙膏制剂中,口腔护理组合物包含按该组合物的重量计约45%至约75%的水。高水口腔护理组合物和/或牙膏制剂可包含按组合物的重量计约45%至约65%、约45%至约55%、或约46%至约54%的水。可将水加入高水制剂中,并且/或者水可因包含其他成分而进入组合物中。
在低水口腔护理组合物和/或牙膏制剂中,口腔护理组合物包含按该组合物的重量计约5%至约45%的水。低水口腔护理组合物可包含按组合物的重量计约5%至约35%、约10%至约25%、或约20%至约25%的水。可将水加入低水制剂中,并且/或者水可因包含其他成分而进入组合物中。
在无水口腔护理组合物和/或牙膏制剂中,口腔护理组合物包含按该组合物的重量计小于约10%的水。无水组合物包含按组合物的重量计小于约5%、小于约1%或0%的水。可将水加入无水制剂中,并且/或者水可因包含其他成分而进入组合物中。
漱口液制剂包含约75%至约99%、约75%至约95%或约80%至约95%的水。
组合物还可包含其他口腔可接受载体材料,诸如醇、湿润剂、聚合物、表面活性剂和接受改善剂(诸如调味剂、甜味剂、着色剂和/或凉爽剂)。
pH
所公开的组合物的pH可以是约4至约10、约7至约10、大于7至约10、大于8至约10、大于7、大于7.5、大于8、大于9或约8.5至约10。
锌离子源
口腔护理组合物可包含锌离子源。锌离子源可包含一种或多种含锌化合物,诸如氟化锌、乳酸锌、氧化锌、磷酸锌、氯化锌、乙酸锌、六氟锆酸锌、硫酸锌、酒石酸锌、葡萄糖酸锌、柠檬酸锌、苹果酸锌、甘氨酸锌、焦磷酸锌、偏磷酸锌、草酸锌和/或碳酸锌。锌离子源可以是不含氟锌离子源,诸如磷酸锌、氧化锌和/或柠檬酸锌。
锌离子源可以按口腔护理组合物的重量计约0.01%至约10%、约0.2%至约1%、约0.5%至约1.5%或约0.3%至约0.6%的量存在于总洁牙剂组合物中。
多磷酸盐
口腔护理组合物可包含多磷酸盐源。多磷酸盐源可包含一个或多个多磷酸盐分子。多磷酸盐是一类通过正磷酸盐脱水和缩合生成不同链长的直链和环状多磷酸盐而获得的物质。因此,多磷酸盐分子通常以多磷酸盐分子的平均数(n)来标识,如下所述。尽管可存在一些环状衍生物,但通常认为多磷酸盐由主要以线性构型排列的两个或更多个磷酸盐分子组成。
优选的多磷酸盐是那些具有平均两个或更多个磷酸基团的多磷酸盐,以使得有效浓度的表面吸附产生足够的未结合的磷酸根官能团,这增强了阴离子表面电荷以及表面的亲水特性。本发明中优选的是具有下式的直链多磷酸盐:XO(XPO3)nX,其中X为钠、钾、铵或任何其他碱金属阳离子,并且n平均为约2至约21。碱土金属阳离子(诸如钙)不是优选的,因为它们趋于由包含氟离子和碱土金属阳离子的水溶液形成不溶性氟化物盐。因此,本文公开的口腔护理组合物可以不含、实质上不含或基本上不含焦磷酸钙。
合适的多磷酸盐分子的一些示例包括例如焦磷酸盐(n=2)、三聚磷酸盐(n=3)、四聚磷酸盐(n=4)、多磷酸钠磷(n=6)、六聚磷酸盐(n=13)、苯多磷酸盐(n=14)、六偏磷酸盐(n=21),其还被称为Glass H.多磷酸盐,可包括由FMC Corporation、ICLPerformance Products和/或Astaris生产的那些多磷酸盐化合物。
口腔护理组合物可包含按该口腔护理组合物的重量计约0.01%至约15%,约0.1%至约10%,约0.5%至约5%,约1%至约20%或约10%或更少的多磷酸盐源。
湿润剂
口腔护理组合物可包含一种或多种湿润剂、具有低含量的湿润剂、实质上不含、基本上不含或不含湿润剂。湿润剂用于增加口腔护理组合物或洁牙剂的稠度或“口感”以及防止洁牙剂变干。合适的湿润剂包括聚乙二醇(具有多种不同的分子量)、丙二醇、甘油(glycerin、glycerol)、赤藓醇、木糖醇、山梨醇、甘露糖醇、丁二醇、乳糖醇、氢化淀粉水解物和/或它们的混合物。口腔护理组合物可包含一种或多种湿润剂,每种湿润剂的含量为按该口腔护理组合物的重量计0%至约70%、约5%至约50%、约10%至约60%或约20%至约80%。
表面活性剂
口腔护理组合物可包含一种或多种表面活性剂。表面活性剂可用于使组合物在美容上更可接受。表面活性剂优选地为赋予组合物去污和发泡性质的去污材料。合适的表面活性剂是安全有效量的阴离子、阳离子、非离子、两性离子、两性和甜菜碱表面活性剂。
合适的阴离子表面活性剂包括例如烷基中具有8至20个碳原子的烷基硫酸的水溶性盐和具有8至20个碳原子的脂肪酸的磺化单酸甘油酯的水溶性盐。这类阴离子表面活性剂的示例是月桂基硫酸钠(SLS)和椰子基单酸甘油酯磺酸钠。其他适宜的阴离子表面活性剂包括肌氨酸盐如月桂酰肌氨酸钠、牛磺酸盐、月桂基磺基乙酸钠、月桂酰羟乙基磺酸钠、月桂基聚氧乙烯醚羧酸钠和十二烷基苯磺酸钠。也可使用阴离子表面活性剂的组合。
另一类合适的阴离子表面活性剂是烷基磷酸盐。这些表面活性有机磷酸酯试剂对釉质表面可具有强亲和力,并且具有充分的表面结合倾向,以使表膜蛋白质解吸,并且保持附连到釉质表面。有机磷酸酯化合物的合适的示例包括由下列通式结构表示的单酯、二酯或三酯,其中Z1、Z2或Z3可相同或不同,其中至少一个为有机部分。Z1、Z2或Z3可选自1至22个碳原子的直链或支链烷基或烯基基团,任选地被一个或多个磷酸酯基团取代;烷氧基化烷基或烯基、(多)糖、多元醇或聚醚基团。
一些其他试剂包括由以下结构表示的烷基或烯基磷酸酯:
其中R1表示具有6至22个碳原子的直链或支链烷基或烯基基团,其任选地被一个或多个磷酸酯基团取代;n和m独立地并且单独地为2至4,并且a和b立地并且单独地为0至20;Z和Z可相同或不同,各自表示氢、碱金属、铵、质子化烷基胺或质子化官能烷基胺,诸如链烷醇胺或R-(OCH2)(OCH)-基团。合适试剂的示例包括烷基磷酸酯和烷基(聚)烷氧基磷酸酯如月桂基磷酸酯;PPGS鲸蜡硬脂基聚氧乙烯醚-10磷酸酯;月桂基聚氧乙烯醚-1磷酸酯;月桂基聚氧乙烯醚-3磷酸酯;月桂基聚氧乙烯醚-9磷酸酯;三月桂基聚氧乙烯醚-4磷酸酯;C12-18 PEG 9磷酸酯:和二月桂基聚氧乙烯醚-10磷酸钠。烷基磷酸盐可以是聚合物的。聚合烷基磷酸酯的示例包括含有重复的烷氧基作为聚合部分的那些,具体地包含3个或更多个乙氧基、丙氧基、异丙氧基或丁氧基的那些。
其他合适的阴离子表面活性剂是肌氨酸盐、羟乙基磺酸盐和牛磺酸盐,尤其是其碱金属盐或铵盐。示例包括:月桂酰肌氨酸盐、肉豆寇酰肌氨酸盐、棕榈酰肌氨酸盐、硬脂酰肌氨酸盐、油酰肌氨酸盐或它们的组合。
其他合适的阴离子表面活性剂包括烷基硫酸钠或烷基硫酸钾,诸如月桂基硫酸钠、酰基羟乙基磺酸盐、酰基甲基羟乙基磺酸盐、烷基醚羧酸盐、酰基丙氨酸盐、酰基谷氨酸盐、酰基甘氨酸盐、酰基肌氨酸盐、甲基酰基牛磺酸钠、月桂基醚磺基琥珀酸钠、α-烯烃磺酸盐、烷基苯磺酸盐、月桂酰基乳酸钠、月桂基葡糖苷羟丙基磺酸钠和/或组合。
可用于本文的两性离子表面活性剂或两性表面活性剂包括脂族季铵、鏻和锍化合物的衍生物,其中脂族基团可以是直链或支链的,并且脂族取代基之一含有8至18个碳原子,并且脂族取代基之一含有阴离子水增溶基团,例如,羧基、磺酸根、硫酸根、磷酸根或膦酸根。合适的甜菜碱表面活性剂公开于美国专利5,180,577中。典型的烷基二甲基甜菜碱包括癸基甜菜碱或2-(N-癸基-N,N-二甲基胺)乙酸酯、椰油基甜菜碱或2-(N-椰油基-N,N-二甲基胺)乙酸酯、十四烷基甜菜碱、棕榈基甜菜碱、月桂基甜菜碱、十六烷基甜菜碱、十六烷基甜菜碱、硬脂基甜菜碱等。酰胺基甜菜碱可由椰油酰胺基乙基甜菜碱、椰油酰胺基丙基甜菜碱(CADB)和月桂酰胺基丙基甜菜碱举例说明。其他合适的两性表面活性剂包括甜菜碱、磺基甜菜碱、月桂基两性乙酸钠、烷基两性二乙酸盐和/或它们的组合。
可用于本发明中的阳离子表面活性剂包括例如具有一条包含8至18个碳原子的长烷基链的季铵化合物衍生物,诸如月桂基三甲基氯化铵;西吡氯铵;十六烷基三甲基溴化铵;十六烷基氟化吡啶鎓或它们的组合。
可用于本发明组合物中的非离子表面活性剂包括例如由环氧烷基团(本身亲水的)与本身可为脂族或烷基芳族的有机疏水化合物缩合而生成的化合物。合适的非离子表面活性剂的示例可包括(即泊洛沙姆)、烷基酚的聚环氧乙烷缩合物、衍生自环氧乙烷与环氧丙烷和乙二胺的反应产物的缩合的产物、脂肪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物质的组合。其他合适的非离子表面活性剂包括烷基葡糖酰胺、烷基葡糖苷和/或它们的组合。
一种或多种表面活性剂还可包括一种或多种天然和/或天然衍生表面活性剂。天然表面活性剂可包括源自天然产物的表面活性剂和/或最小程度加工或未加工的表面活性剂。天然表面活性剂可包括:氢化的、非氢化的或部分氢化的蔬菜油、植物油、西番莲油、小烛树蜡、椰油基辛酸酯、癸酸酯、二辛醚、月桂醇、肉豆蔻酸十四烷基酯、二辛醚、辛酸、辛酯、癸酸辛酯、辛酸辛酯、十一烷、十三烷、油酸癸酯、癸基油酸酯、棕榈酸十六烷基酯、硬脂酸、棕榈酸、硬脂酸甘油酯、氢化的、非氢化的或部分氢化的植物甘油酯、聚甘油-2二多羟基硬脂酸酯、十六/十八醇、蔗糖聚硬脂酸酯、甘油、十八烷醇、水解的、部分水解的或未水解的植物蛋白、水解的、部分水解的或未水解的小麦蛋白水解产物、聚甘油基-3二异硬脂酸酯、油酸甘油酯、肉豆蔻醇、十六烷醇、十六烷硬脂基硫酸钠、十六烷硬脂醇、月桂酸甘油酯、癸酸甘油三酯、椰油基甘油酯、卵磷脂、二辛醚、黄原胶、椰油硫酸钠、十二烷基硫酸铵、椰油基硫酸钠、椰油基谷氨酸钠、多烷基葡糖苷诸如癸基葡糖苷、十六烷硬脂基葡糖苷、十六烷硬脂基多葡糖苷、椰油基葡糖苷和月桂基葡糖苷和/或它们的组合。天然表面活性剂可包括由BASF出售的天然成分中的任一种,例如 和/或它们的组合。
表面活性剂的其他具体示例包括月桂基硫酸钠、月桂基羟乙基磺酸钠、月桂酰甲基羟乙基磺酸钠、椰油基谷氨酸钠、十二烷基苯磺酸钠、月桂酰肌氨酸、肉豆寇酰肌氨酸、棕榈酰肌氨酸、硬脂酰肌氨酸和油酰肌氨酸的碱金属盐或铵盐、聚氧乙烯山梨醇单硬脂酸酯、异硬脂酸酯和月桂酸酯、月桂基磺基乙酸钠、N-月桂酰肌氨酸、N-月桂酰基、N-肉豆蔻酰基或N-棕榈酰基肌氨酸的钠盐、钾盐和乙醇胺盐,烷基酚的聚环氧乙烷缩合物、椰油酰氨基丙基甜菜碱、月桂酰氨基丙基甜菜碱、棕榈基甜菜碱、椰油基谷氨酸钠等。所需的另外的表面活性剂包括谷氨酸的脂肪酸盐、烷基葡糖苷、牛磺酸盐、甜菜碱、辛酸盐和/或它们的混合物。口腔护理组合物也可以不含硫酸盐。
口腔护理组合物可包含一种或多种表面活性剂,每种表面活性剂的含量为按口腔护理组合物的重量计约0.01%至约15%、约0.3%至约10%或约0.3%至约2.5%。
增稠剂
口腔护理组合物可包含一种或多种增稠剂。增稠剂可用于口腔护理组合物中以提供凝胶状结构使洁牙剂和/或牙膏稳定防止相分离。合适的增稠剂包括多糖、聚合物和/或二氧化硅增稠剂。
增稠剂可包含一种或多种多糖。多糖的一些非限制性示例包括淀粉;淀粉甘油;树胶,诸如卡拉牙树胶(刺梧桐树胶)、黄蓍胶、***胶、茄替胶、***树胶、黄原胶、瓜尔胶和纤维素胶;硅酸镁铝(胶体硅酸镁铝);角叉菜胶;藻酸钠;琼脂;果胶;明胶;纤维素化合物,诸如纤维素、微晶纤维素、羧甲基纤维素、羟乙基纤维素、羟丙基纤维素、羟甲基纤维素、羟甲基羧丙基纤维素、甲基纤维素、乙基纤维素和硫酸化纤维素;天然和合成粘土,例如锂蒙脱石粘土;以及它们的混合物。
其他适用于本文的多糖包括角叉菜胶、结冷胶、刺槐豆胶、黄原胶、卡波姆、泊洛沙姆、改性纤维素、以及它们的混合物。角叉菜胶是衍生自海藻的多糖。存在几种类型的角叉菜胶,这些角叉菜胶可通过它们的海藻源和/或通过它们的硫酸化程度和位置来区分。增稠剂可包括κ-角叉菜胶、改性的κ-角叉菜胶、ι-角叉菜胶、改性的ι-角叉菜胶、λ-角叉菜胶、以及它们的混合物。适用于本文的角叉菜胶包括可以系列名称“Viscarin”从FMC公司(FMCCompany)商购获得的那些,包括但不限于Viscarin TP 329、Viscarin TP 388和ViscarinTP 389。
增稠剂可包含一种或多种聚合物。聚合物可为聚乙二醇(PEG)、聚乙烯吡咯烷酮(PVP)、聚丙烯酸、来源于至少一种丙烯酸单体的聚合物、马来酸酐和甲基乙烯基醚的共聚物、交联的聚丙烯酸聚合物,其具有占口腔护理组合物的各种重量百分比以及各种范围的平均分子范围。另选地,口腔护理组合物可以不含、实质上不含或基本上不含马来酸酐和甲基乙烯基醚的共聚物。
增稠剂可包括一种或多种无机增稠剂。合适的无机增稠剂的一些非限制性示例包括胶态硅酸镁铝、二氧化硅增稠剂。可用二氧化硅增稠剂的非限制性示例包括例如无定形沉淀二氧化硅,诸如165二氧化硅。其他非限制性二氧化硅增稠剂包括153、163和167以及177和265二氧化硅产品(均购自赢创公司(Evonik Corporation)),以及热解法二氧化硅。
口腔护理组合物可包含0.01%至约15%、0.1%至约10%、约0.2%至约5%或约0.5%至约2%的一种或多种增稠剂。
异戊二烯化类黄酮
本发明的口腔护理组合物可包含异戊二烯化类黄酮。类黄酮化合物是一组广泛存在于水果、蔬菜、谷物、树皮、根、茎、花、茶和酒中的天然物质。类黄酮对健康状况可具有多种有益效果,诸如抗氧化、抗炎、抗诱变、抗癌和抗菌有益效果。异戊二烯化类黄酮是包括至少一个异戊二烯基官能团(3-甲基丁-2-烯-1-基,如式VIII所示)的类黄酮,其先前已被鉴定为促进与细胞膜的连接。因此,虽然不希望受理论的束缚,但是据信,在类黄酮中添加异戊二烯基基团(即异戊二烯化)可以通过增加母体分子的亲脂性和提高异戊二烯化分子对细菌细胞膜的渗透率来提高原始类黄酮的活性。增加亲脂性以增加对细胞膜的渗透率可能是一把双刃剑,因为异戊二烯化类黄酮在高Log P值(高亲脂性)下会趋于不溶。Log P可以是抗菌功效的重要指标。
因此,术语异戊二烯化类黄酮可包括天然存在的具有一个或多个异戊二烯基官能团的类黄酮、具有合成添加的异戊二烯基官能团的类黄酮和/或具有合成添加的另外的异戊二烯基官能团的异戊二烯化类黄酮。
式VIII.异戊二烯基官能团,R表示分子的其他部分
改善异戊二烯化分子的结构-活性关系(例如,结构-MIC关系)的母体分子的其他合适的官能团包括含有氮或氧、烷基氨基链或取代到母体类黄酮的一个或多个芳环上的烷基链的另外的杂环。
类黄酮可具有具有至少两个苯环和至少一个杂环的15碳主链。一些合适的类黄酮主链可以显示在式IX(黄酮主链)、式X(异黄烷主链)和/或式XI(新黄酮主链)中。
式IX.黄酮主链
式X.异黄酮主链
式XI.新类黄酮主链
其他合适的类黄酮亚组包括花青素、花黄素、黄烷酮、黄烷醇、黄烷、异黄酮、查耳酮和/或它们的组合。
异戊二烯化类黄酮可以包括天然分离的异戊二烯化类黄酮或天然分离的类黄酮,它们通过合成有机化学领域普通技术人员已知的多种合成方法被合成改变以添加一个或多个异戊二烯基官能团。
其他合适的异戊二烯化类黄酮可以包括补骨脂查耳酮、补骨脂二氢黄酮、甲基补骨脂黄酮、Corylifol A、淫羊藿定A、淫羊藿定A1、淫羊藿定B、淫羊藿定C、淫羊藿苷、淫羊藿次苷I、淫羊藿次苷II、淫羊藿素、异补骨脂查尔酮、异黄腐酚、新补骨脂异黄酮、6-异戊二烯柚皮素、8-异戊二烯柚皮素、槐黄烷酮G、(-)-广豆根素、黄腐酚、槲皮素、肉豆蔻木酚素、苦参查耳酮、苦参黄素、桑皮酮G、桑皮酮C、Panduratin A、6-香叶基柚皮素、Australone A、6,8-二异戊二烯圣草酚、dorsmanin C、dorsmanin F、8-异戊二烯山奈酚、7-O-甲基羽扇豆异黄酮、羽扇豆异黄酮、6-异戊二烯染料木黄酮、isowighteone、黄羽扇豆魏特酮和/或它们的组合。其他合适的异戊二烯化类黄酮包括***黄素,诸如***黄素A、***黄素B和/或***黄素C。
优选地,异戊二烯化类黄酮对金黄色葡萄球菌(一种***)具有小于约25ppm的MIC的可能性很高。合适的异戊二烯化类黄酮包括补骨脂二氢黄酮、甲基补骨脂黄酮、Corylifol A、淫羊藿素、异黄腐酚、新补骨脂异黄酮、6-异戊二烯柚皮素、8-异戊二烯柚皮素、槐黄烷酮G、(-)-广豆根素、苦参酮、桑皮酮C、Panduratin A和/或它们的组合。
优选地,异戊二烯化类黄酮对大肠杆菌(一种革兰氏阴性细菌)具有小于约25ppm的MIC的可能性很高。合适的异戊二烯化类黄酮包括甲基补骨脂黄酮、异黄腐酚、8-异戊二烯柚皮素、槐黄烷酮G、苦参酮、Panduratin A和/或它们的组合。
已从植物中鉴定出大约1000种异戊二烯化类黄酮。根据以往报道的异戊二烯化类黄酮的数量,异戊二烯化黄酮是最常见的亚类,并且异戊二烯化黄烷醇是最稀有的亚类。尽管已检测到天然异戊二烯化类黄酮具有多种结构特性,但它们在植物中的分布范围很窄,与母体类黄酮不同,它们几乎存在于所有植物中。大多数异戊二烯化类黄酮存在于以下科中,包括***科(Cannabaceae)、藤黄科(Guttiferae)、豆科(Leguminosae)、桑科(Moraceae)、芸香科(Rutaceae)和伞形科(Umbelliferae)。豆科和桑科,由于它们作为水果和蔬菜食用,是最常被研究的科,并且已经探索了许多新型的异戊二烯化类黄酮。***科的啤酒花包括8-异戊二烯柚皮素和异黄腐酚,它们在啤酒的健康有益效果中发挥着重要作用。
异戊二烯化类黄酮可以通过啤酒花提取物掺入,掺入单独添加的提取物中,或作为本文公开的口腔护理组合物的单独组分添加。
其它成分
口腔护理组合物可包含多种其他成分,诸如调味剂、甜味剂、着色剂、防腐剂、缓冲剂或适用于口腔护理组合物中的其他成分,如下所述。
还可将调味剂添加到口腔护理组合物中。合适的调味剂包括冬青油、胡椒薄荷油、留兰香油、丁香芽油、薄荷醇、对丙烯基茴香醚、水杨酸甲酯、桉油精、肉桂、乙酸1-薄荷酯、鼠尾草、丁子香酚、欧芹油、羟苯基丁酮、α-紫罗兰酮、甘牛至草、柠檬、橙、丙烯基乙基愈创木酚、桂皮、香兰素、乙基香兰素、天芥菜精、4-顺式-庚烯醛、丁二酮、对叔丁基苯乙酸甲酯、以及它们的混合物。冷却剂也可以是风味剂体系的一部分。本发明组合物中优选的冷却剂是对孟烷氨基甲酰试剂,诸如N-乙基-对孟烷-3-甲酰胺(商业上称为“WS-3”)或N-(乙氧羰基甲基)-3-对薄荷烷甲酰胺(商业上称为“WS-5”)以及它们的混合物。风味剂体系通常以按口腔护理组合物的重量计约0.001%至约5%的含量用于组合物中。这些调味剂通常包含醛、酮、酯、酚、酸以及脂族、芳族和其他醇的混合物。
可将甜味剂添加到口腔护理组合物中以赋予产品令人愉悦的味道。合适的甜味剂包括糖精(如糖精钠、糖精钾或糖精钙)、环磺酸盐(如钠盐、钾盐或钙盐)、安赛蜜-K、非洲甜果素、新橙皮苷二氢查耳酮、氨化甘草素、右旋糖、左旋糖、蔗糖、甘露糖、三氯蔗糖、甜菊糖和葡萄糖。
添加着色剂以改善产品的美学外观。合适的着色剂包括但不限于由相应监管机构诸如FDA批准的那些着色剂和欧洲食品和药品指令中列出的那些着色剂,并且包括色素诸如TiO2,以及颜色诸如FD&C和D&C染料。
还可将防腐剂添加到口腔护理组合物中以防止细菌生长。可以安全有效量添加被批准用于口腔组合物中的合适防腐剂,诸如对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、苯甲酸和苯甲酸钠。
二氧化钛也可添加到本发明的组合物中。二氧化钛是能给组合物增加不透明度的白色粉末。二氧化钛通常占按口腔护理组合物的重量计约0.25%至约5%。
口腔护理组合物中可使用其他成分,诸如脱敏剂、康复剂、其他防龋剂、螯合剂/多价螯合剂、维生素、氨基酸、蛋白质、其他抗牙斑/抗牙结石剂、遮光剂、抗生素、抗酶、酶、pH控制剂、氧化剂、抗氧化剂等。
实施例
以下实施例进一步说明了本发明,这些实施例不应以任何方式被理解为对本发明的范围施加限制。在阅读本文的说明书之后,在不脱离本发明的精神或所附权利要求书的范围的下,可向本领域的普通技术人员提出它们自己的各种其他方面、修改和其等同形式。
表1:组合物
用于测量生物膜结构、抗菌剂渗透率和生物膜中内毒素中和率的测定
以下测定用于本发明的发明性口腔护理组合物的原位菌斑生物膜以确定:
1-生物膜EPS基质的不稳定性和牙科生物膜的厚度,通过测量从带标记的EPS生物膜发出的荧光;
2-亚锡离子与细菌的渗透效率,通过测量共定位百分比
3-通过亚锡离子的LPS结合效率改善的抗菌剂在生物膜中的内毒素中和,通过测量与LPS的脂质A结合的荧光染料
测定的细节描述如下。
(a)用于生物膜生长的基质
羟基磷灰石(“HA”)盘用于生物膜的原位生长。HA盘被设计成每个盘中具有三个平行的凹槽(即对于两侧凹槽为200μm宽;200μm深;而对于中间凹槽为500μm宽和500μm深)。将盘附接到受试者的嘴部时,请保持这些凹槽竖直,以模仿牙齿之间的邻间间隙,这是牙斑通常易于积聚的难以清洁的区域。该模型允许从凹槽中收集未受干扰的牙斑。HA盘由中国上海的Shanghai Bei′erkang biomedicine limited company制造。
(b)佩戴夹板
人体受试者佩戴夹板。每个受试者在夹板上至多佩戴12个HA盘,以确保48小时后至少9个HA盘可用。图2中示出了此类夹板和HA盘的非限制性示例。参照图2,装置(1)保持多个HA盘(2a至2d)。在具体示例中,并且参照图3,HA盘(201)具有三个平行的凹槽(203)(两侧的凹槽(203a和203c)为300μm宽和300μm深;而中间凹槽(203b)(在两侧凹槽之间)为500μm宽和500μm深)。中间凹槽被设计成比两侧的凹槽更宽且更深,使得HA盘可更容易地分成两个相同的半盘,以用于头对头比较目的。图4是其中具有生物膜(2005)的凹槽(2003)的示意性剖视图。HA盘的另外细节描述于US2017/0056531(例如段落[0019]至[0020])。
尽管未在图4中示出,但是盘可被定位成使得后退位于牙齿之间的牙间空间中(因为该位置易于牙斑(鉴于清洁困难等)。受试者仅在进餐期间(夹板储存在潮湿条件下的不透明容器中)取出夹板并进行口腔卫生程序。紧接着,夹板再次磨损。要求受试者在饮用时使用吸管。
(c)从HA桌释放原位生物膜
所有HA盘在48小时时通过镊子从夹板移除。使用镊子以保持HA芯片的边缘并将HA盘转移到容纳PBS(磷酸盐缓冲盐水)溶液的2mL离心管中。在每次盘转移之前将镊子彻底清洗(水;75%酒精;以及然后去离子水)。
(d)牙膏上清液的制备
将15克去离子水加入到5克牙膏中(使用实施例1至5中的任一个)。彻底搅拌后,将混合物以12,000RPM离心20分钟。在使用前一天制备上清液并在4℃下储存。
(e)共聚焦激光扫描显微镜检查
从夹板移除HA盘后。使用HA盘以用于通过不同的本发明组合物和比较组合物进行离体处理。用本主题上清液处理并且用微生物荧光探针和亚锡荧光探针标记(诸如描述于US2018/0072944A1;Shi等人中)后,通过共聚焦激光扫描显微镜检查(“CLSM”)(如下所述)测量凹槽中的生物膜。
(f)盘制备
HA盘在PBS溶液中冲洗,并且将每个HA盘通过镊子分成两半。此后,将每个半盘静态置于500μL至1000μL的PBS溶液中1分钟。通过PBS溶液或牙膏上清液处理每个盘两分钟。通过用镊子保持每个盘来清洗每个盘,在1mL的PBS溶液中来回摇动十轮,并且然后重复该洗涤循环。然后将每个盘静态浸入500μL至1000μL PBS溶液中5分钟。
在用PBS和/或口腔护理组合物(例如,牙膏)上清液处理并用特定荧光探针标记后,通过共聚焦激光扫描显微术(CLSM)测量凹槽中的生物膜。
(g)荧光探针染色和显微镜检查
“离子荧光探针”是指特异性结合到一种离子并在一定波长发出荧光的荧光探针。近年来,由于其在生物化学和环境研究中的潜在应用,人们非常重视开发新的高选择性离子荧光探针。已经提出了多种信号机制并用于离子的光学检测,包括光诱导电子/能量转移(PET),分子内电荷转移(ICT),荧光共振能量转移(FRET)等。这些荧光探针中的一些还可以应用于荧光生物成像,其几乎不会造成细胞损伤,并且对活细胞的高速空间分析具有高度敏感性。具体地,在存在和不存在分析物的情况下提供在不同波长下同时记录两种发射强度的FRET成像提供了用于在分子水平上可视化复杂生物过程的简便方法。该技术似乎适用于生物膜和人体中离子的生理功能或发病机理的研究。
通过共定位百分比测量亚锡离子与细菌的亚锡渗透效率。适用于标记生物膜的亚锡荧光探针的非限制性示例可包括以下化合物中的任何一种:(a)(3′,6′-二氨基-3-氧代螺[异吲哚啉-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(b)(3′,6′-双(二甲基氨基)-3-氧代螺[异吲哚啉-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(c)(3′,6′-双(二乙氨基)-3-氧代螺[异吲哚啉-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(d)(3′,6′-双(乙基氨基)-2′,7′-二甲基-3-氧代螺[异吲哚啉-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(e)(3′,6′-二氨基-2′,7′-二甲基-3-氧代螺[异吲哚啉-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(f)(3-氧代-3′,6′--二(吡咯烷-1-基)螺[异吲哚啉-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(g)(3-氧代-3′,6′-双(苯基氨基)螺[异吲哚啉-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(h)(3-氧代-3′,6′-二(哌啶-1-基)螺[异吲哚啉-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(i)(3′,6′-二吗啉基-3-氧代螺[异吲哚啉-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(j)(2′,7′-二丁基-3′,6′-双(二乙氨基)-3-氧代螺[异二氢吲哚-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(k)(2′,7′-二甲基-3-氧代-3′,6′-二(哌啶-1-基)螺[异吲哚啉-1,9′-呫吨]-2-基)氨基甲酸叔丁酯;(1)(3-氧代-1′,2′,3′,4′,10′,11′,12′,13′-八氢螺[异吲哚啉-1,7′-吡喃[2,3-f:6,5-f’]二喹啉]-2-基)氨基甲酸叔丁酯;(m)(3-氧代-1′,2′,3′,4′,8′,9′,10′,11′-八氢螺[异吲哚啉-1,6′-吡喃[3,2-g:5,6-g’]二喹啉]-2-基)氨基甲酸叔丁酯;(n)N-(3′,6′-双(二乙氨基)-3-氧代螺[异二氢吲哚-1,9′-呫吨]-2-基)丙酰胺;(p)N-(3′,6′-双(二乙氨基)-3-氧代螺[异二氢吲哚-1,9′-呫吨]-2-基)丁酰胺;和(q)N-(3′,6′-双(二乙氨基)-3-氧代螺[异二氢吲哚-1,9′-呫吨]-2-基)戊酰胺。优选地,亚锡探针选自:N-(3′,6′-双(二乙氨基)-3-氧代螺[异二氢吲哚-1,9′-呫吨]-2-基)丙酰胺;N-(3′,6′-双(二乙氨基)-3-氧代螺[异二氢吲哚-1,9′-呫吨]-2-基)丁酰胺;和N-(3′,6′-双(二乙氨基)-3-氧代螺[异二氢吲哚-1,9′-呫吨]-2-基)戊酰胺。
通常,这些亚锡荧光探针包含罗丹明B衍生物部分作为荧光团,通过酰胺部分与氨基甲酸酯基团连接。进一步的细节在WO 2015/139577 A1(2015年9月24日)或其美国等同公布中有所描述。优选地,亚锡荧光探针是叔丁氧基-甲酰胺、N-[3′,6′-双(二乙基氨基)-3-氧代螺[1H-异吲哚-1,9′-[9H]氧杂蒽]-H)-基]。
“微生物荧光探针”是指结合生物膜的微生物并在特定波长发出荧光的荧光探针。一类此类探针包括荧光标记的寡核苷酸,优选rRNA定向的寡核苷酸。非限制性示例包括SYTOTM品牌染料。一个具体示例是9绿色荧光核酸染色剂,其中激发是485(DNA)和486(RNA),并且在498(DNA)和501(RNA)处检测到光发射。
在处理和浸没之后,每个半盘用Sn探针与Syto-9探针(包含5μMSyto-9和5μM Sn探针)在黑暗中染色30分钟。SYTO-9/Sn染料染色的样品,使用以下参数:λex=488nm/560nm,λem=500/580nm,20X物镜,并且从表面细菌的底部扫描60μm,其中步长=3μm。
使用BODIPY-TR-尸胺(BC)评估LPS中和效应,其是结合到脂质A从而抑制其荧光的荧光染料。BC被对该脂质具有亲和力的试剂置换。当LPS被其它离子例如亚锡结合时,BC从LPS中释放,并且其荧光与存在的游离(未结合)BC的量成比例。因此,荧光水平指示中和(结合)LPS相对于游离(未结合)LPS的量,以及抗菌剂在降低生物膜毒性方面的功效。结合LPS的量越大,其毒性越低。
在处理和浸没之后,每个半盘用BODIPY-TR-尸胺(BC)探针与Syto-9探针(包含5μMSyto-9和5μM BC探针)在黑暗中染色30分钟。染色后,将每个盘静态浸入500μL至1000μLPBS溶液中2分钟。通过用镊子保持每个盘,在1mL PBS溶液中来回摇动五轮来再次洗涤盘,并重复。对于SYTO-9/BC染料染色的样品,使用以下参数:λex=488nm/589nm,λem=500/616nm,20X物镜,并且从表面细菌的底部扫描60μm,其中步长=3μm。
荧光标记的钙探针是在结合Ca2+时表现出荧光增加的分子。用钙荧光探针标记生物膜。适于标记生物膜的钙荧光探针的示例可以是以下化合物中的任何一者或多者:
(a)Fluo-3TM,AMTM,细胞渗透荧光染色剂;
(b)Fluo-3TM,五磷钾盐,细胞不透性荧光染色剂;
(c)Fluo-4TM,AMTM,细胞渗透荧光染色剂;
(d)Fluo-4TM,五磷钾盐,细胞不透性荧光染色剂;
(e)Fluo-4 DirectTM钙测定试剂盒;
(f)Mag-Fluo-4TM,四钾盐,细胞不透性荧光染色剂;并且
(g)Fluo-5FTM,AMTM,细胞渗透荧光染色剂。
这些探针中的一者或多者可得自ThermoFisher Scientific Company,Waltham,MA。
Fluo-3TM用于对Ca2+信号传导的空间动态进行成像。可通过将溶解的探针直接加入生物膜中,用AMTM酯形式的钙探针处理生物膜。Fluo-3TM、AMTM、细胞渗透性荧光探针用于使用共聚焦显微术、流式细胞术和微板筛选应用来进行细胞内和细胞外钙染色(吸收/发射最大值~506/526nm)。据报道,Concanavalin ATM(Con A),Alexa594缀合物是生物膜的染色EPS的可靠替代形式。Con A的Alexa594缀合物表现出Alexa594染料的明亮的红色荧光(吸收/发射最大值~590/617nm)。Concanavalin ATM、Alexa594缀合物选择性结合到富集于生物膜的EPS部分中的α-吡喃甘露糖苷基残基和α-吡喃葡糖基残基。
一个具体示例为Concanavalin ATM,Fluorescein ConjugateTM,其中激发为494nm,并且在518nm处检测到最大光发射。这些EPS荧光探针以及如何使用它们来定量确定EPS的位置和/或量的程序细节可广泛获得。
适用于标记生物膜的EPS荧光探针的示例可以是以下化合物中的任何一种:
(f)Molecular ProbesTM Concanavalin ATM Fluorescein ConjugateTM;
(h)Molecular ProbesTM Concanavalin ATM tetramethylrhodamineConjugateTM;
这些探针中的一者或多者可得自ThermoFisher Scientific Company(Waltham,MA)
在处理和浸没之后,每种半盘样品用Fluo-3TM、AMTM、细胞渗透性荧光探针连同Concanavalin ATM、Alexa594缀合物探针(包含5uMFluo-3TM+5uM Con-ATM)的染料混合物溶液在暗处染色30分钟。染色后,将每个样品静态浸入500ul至1000ul PBS溶液中并持续2分钟。
通过用镊子保持每个盘,在1mL PBS溶液中来回摇动五轮来再次洗涤盘,并重复。对于Fluo-3TM、AMTM/594共轭染料染色的样品,使用以下参数:λex=506nm/590nm,λem=526/617nm,20X物镜,并且从表面细菌的底部扫描60μm,其中步长=3μm。
(h)共聚焦激光扫描显微镜
使用LeicaTM TCS SP8 AOBS光谱共聚焦显微镜。共聚焦***由LeicaTM DM6000B直立式显微镜和LeicaTM DMIRE2倒置式显微镜组成。直立式支架用于涉及滑动安装样品的应用;而具有37℃温育室和CO2富集附件的竖式支架提供活细胞应用。显微镜共用一个可更换的激光扫描头,并且除了它们自己的电动机驱动平台外,还有一个电流计驱动的高精度Z平台,这有利于在焦平面(Z)中快速成像。除了辐射荧光外,显微镜还支持多种透射光对比度方法,包括明视场、偏振光和微分干涉对比度,并配备有5x、20x、40x、63x(油和干)和100x(油)LeicaTM物镜镜头。
描述了激光扫描和检测***。TCS SP8 AOBS共聚焦***供应有四个激光器(一个二极管、一个氩气和两个氦氖激光器),因此允许激发电磁波谱的UV、可见和远红外范围内的各种荧光染料。激光扫描头的设计(包括声光可调谐滤波器(AOTF)、声光分束器(AOBS)和四棱镜分光光度计探测器)允许同时激发和检测三种荧光染料。直立式显微镜还具有透射光检测器,使得可在荧光记录时覆盖透射光图像。
使用LeicaTM共聚焦软件LAS AF3.3.0。共聚焦经由配备有双监视器和运行LeicaTM共聚焦软件的标准Pentium PC进行控制。Leica共聚焦软件LAS AF3.3.0(购自LeicaLasertechnik GmbH(Heidelberg,Germany))为多维图像系列采集、处理和分析提供界面,包括3D重建和测量、生理记录和分析、延时、荧光染料共定位、光漂白技术诸如FRAP和FRET、光谱混合和多色修复。
(i)图像分析
Sn分析;选择SYTO-9/Sn染料染色的样品以定量红色像素和绿色像素的重叠效率。使用该软件,对“绿色”细菌探针的像素重叠和“红色”亚锡探针的像素重叠进行识别,并且然后将该值除以所有非黑色像素(包括非重叠的亚锡探针)以提供细菌中亚锡的共定位百分比。通常,该共定位百分比越高,口腔护理产品将亚锡递送到细菌中越有效。(参见XiangJ,Li H,Pan B,Chang J,He Y,He T,Strand R,Shi Y,Dong W.(2018)Penetration andBactericidal Efficacy of Two Oral Care Products in an Oral Biofilm Model.Am JDent,Vol.31,Issue 1:53-60)
LPS分析;选择SYTO-9/BC探针染色的样品以定量红色像素和绿色像素的荧光强度。使用该软件,计算结合LPS/细菌细胞的荧光强度比(FIR)。荧光强度比指示每单位细菌的结合(中和)LPS的相对量,以及试剂降低生物膜毒性的功效。荧光强度比越大,LPS内毒素中和功效越高。
Ca:EPS;Fluo-3TM/Con-ATM染色样品,选择两个荧光通道以量化绿色像素(钙)与红色像素(EPS)的荧光强度比,并且选择Con-ATM荧光通道以测量生物膜厚度。由此,评价每个样品的Con-ATM荧光通道的六个选定场。这些场在观察者的一般检查之后被认为是整个样品的代表。距离从生物膜的表面到其底部测量,测量场的厚度,并且随后计算相应样品的生物膜的平均厚度。
表2:LPS中和率、Sn渗透率和EPS厚度
表2示出了添加合适的氨基酸诸如甘氨酸以提高LPS中和率和Sn渗透率的有益效果。如表1所示,实施例1是包含不同氯化物和磷酸盐的对照组合物。实施例1的使用导致最终EPS厚度为28.66μm,Sn渗透率为5.30%,并且LPS中和率为21%。实施例2是一种牙膏组合物,如表1所示,含有啤酒花β助剂、氯化亚锡和碳酸钙。实施例2的使用导致最终EPS厚度为17.57μm,Sn渗透率为75.70%,并且LPS中和率为63%。实施例3是一种牙膏组合物,如表1所示,含有啤酒花β助剂、氯化亚锡、碳酸钙和2重量%的甘氨酸。出乎意料的是,添加2%甘氨酸导致最终EPS厚度为9.43μm,Sn渗透率为86.86%,并且LPS中和率为78%。换句话说,添加2重量%的甘氨酸导致Sn渗透率提高15%,LPS中和率提高25%,并使生物膜EPS基质减少46%。如实施例4中那样,添加4%的甘氨酸导致最终EPS厚度为6.15μm,相对于实施例2中的牙膏(即不含甘氨酸),EPS厚度减少了65%。
合适的口腔护理组合物可具有至少75%、至少80%或至少85%的锡离子渗透率。另外,合适的口腔护理组合物可具有至少50%、至少55%、至少60%、至少65%、至少70%或至少75%的LPS中和率。此外,合适的口腔护理组合物包括相对于不含氨基酸的等效口腔护理组合物可导致生物膜EPS基质厚度减少至少45%、至少50%、至少55%、至少60%或至少65%的那些组合物。
本文所公开的量纲和值不应理解为严格限于所引用的精确数值。相反,除非另外指明,否则每个此类量纲旨在表示该值以及围绕该值功能上等同的范围。例如,公开为“40mm”的量纲旨在表示“约40mm”。
除非明确排除或以其它方式限制,本文中引用的每一篇文献,包括任何交叉引用或相关专利或专利申请以及本申请对其要求优先权或其有益效果的任何专利申请或专利,均据此全文以引用方式并入本文。对任何文献的引用不是对其作为与本发明的任何所公开或本文受权利要求书保护的现有技术的认可,或不是对其自身或与任何一个或多个参考文献的组合提出、建议或公开任何此类发明的认可。此外,当本发明中术语的任何含义或定义与以引用方式并入的文献中相同术语的任何含义或定义矛盾时,应当服从在本发明中赋予该术语的含义或定义。
虽然已举例说明和描述了本发明的具体实施方案,但是对于本领域技术人员来说显而易见的是,在不脱离本发明的实质和范围的情况下可作出各种其它变化和修改。因此,本文旨在于所附权利要求中涵盖属于本发明范围内的所有此类变化和修改。
Claims (8)
1.一种口腔护理组合物,其包含:
(a)按所述组合物的重量计约0.01%至约10%的啤酒花β酸,优选地其中所述啤酒花β酸包括蛇麻酮、类蛇麻酮、加蛇麻酮或它们的组合,更优选地其中所述啤酒花β酸包括啤酒花的提取物,所述提取物包含按所述提取物的重量计小于1%的啤酒花α酸;和
(b)按所述组合物的重量计约0.01%至约10%的氨基酸,优选地其中所述氨基酸包括碱性氨基酸、酸性氨基酸、中性氨基酸或它们的组合,更优选地其中所述氨基酸包括甘氨酸。
2.根据权利要求1所述的口腔护理组合物,其中所述口腔护理组合物包含按所述口腔护理组合物的重量计约0.01%至约10%的氟化物,优选地其中所述氟化物包括氟化钠、氟化亚锡、氟化胺、单氟磷酸钠或它们的组合。
3.根据权利要求1所述的口腔护理组合物,其中所述口腔护理组合物不含氟化物。
4.根据权利要求1至3中任一项所述的口腔护理组合物,其中所述口腔护理组合物包含按所述组合物的重量计约10%至约50%的钙,并且其中所述组合物不含二氧化硅磨料。
5.根据权利要求1至4所述的组合物,其中所述口腔护理组合物包含按所述组合物的重量计约0.01%至约10%的抗菌剂,优选地其中所述抗菌剂包含金属离子源,更优选地其中所述金属离子源包括锡、锌或它们的组合,甚至更优选地其中所述锡包括氯化亚锡、氟化亚锡或它们的组合。
6.一种破坏口腔中具有牙科生物膜的患者的口腔中的牙科生物膜的方法,包括将口腔护理组合物施用于所述牙科生物膜,其中所述口腔护理组合物包含:
(a)按所述组合物的重量计约0.01%至约10%的啤酒花β酸,和
(b)按所述组合物的重量计约0.01%至约10%的氨基酸。
7.根据权利要求6所述的方法,其中所述生物膜具有至少40%、至少50%或至少65%的EPS厚度减少。
8.根据权利要求6或7所述的方法,其中所述口腔护理组合物具有至少75的锡离子渗透率。
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2024
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US20240156715A1 (en) | 2024-05-16 |
EP4037765A1 (en) | 2022-08-10 |
JP7386335B2 (ja) | 2023-11-24 |
US20210121392A1 (en) | 2021-04-29 |
US11918681B2 (en) | 2024-03-05 |
BR112022004397A2 (pt) | 2022-06-14 |
MX2022003758A (es) | 2022-04-18 |
AU2020359944A1 (en) | 2022-03-10 |
WO2021063378A1 (en) | 2021-04-08 |
AU2020359944B2 (en) | 2024-03-07 |
JP2022549843A (ja) | 2022-11-29 |
WO2021062607A1 (en) | 2021-04-08 |
CA3155883A1 (en) | 2021-04-08 |
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