CN113260346A - 抑制嗜中性粒细胞募集到牙龈沟的方法 - Google Patents
抑制嗜中性粒细胞募集到牙龈沟的方法 Download PDFInfo
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- CN113260346A CN113260346A CN201980086022.5A CN201980086022A CN113260346A CN 113260346 A CN113260346 A CN 113260346A CN 201980086022 A CN201980086022 A CN 201980086022A CN 113260346 A CN113260346 A CN 113260346A
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Abstract
公开了在个体的牙龈沟内增加减少与嗜中性粒细胞募集相关的信号的蛋白质,并且减少诱导嗜中性粒细胞募集的蛋白质的方法。所述方法包含向所述个体的口腔施用口腔护理组合物,施用量能有效在个体的牙龈沟内增加减少与嗜中性粒细胞募集相关的信号的蛋白质,并且减少诱导嗜中性粒细胞募集的蛋白质,所述口腔护理组合物包含:磷酸锌、氟化亚锡和任选的有机酸缓冲体系。
Description
背景技术
牙龈(gum/gingiva)是口部软组织衬里的一部分,其围绕牙齿并在牙齿周围提供密封。牙龈缘是龈沟上皮和口腔上皮之间的界面。这一界面存在于牙龈最冠状点处,也称为边缘牙龈的冠部。牙龈沟,也称为龈沟,是位于未附着的牙龈组织的壁与牙釉质和/或牙骨质之间的围绕牙齿的空间。
牙龈疾病是牙龈线发炎,其可进展以影响包围并支撑你的牙齿的骨骼。牙龈疾病的三个阶段从最轻到最重是牙龈炎、牙周炎和晚期牙周炎。
牙龈炎是牙龈疾病的初始阶段。牙龈炎的直接原因是牙菌斑-在牙齿和牙龈上持续形成的细菌的柔软、粘性、无色膜。如果牙菌斑没有通过日常刷牙和用牙线洁牙去除,则随着时间的推移会累积并硬化。这种堆积物中发现的细菌产生可刺激牙龈组织的毒素,从而引起牙龈炎。
牙龈炎是可治疗的。损伤可以逆转,因为将牙齿固持在适当位置的骨骼和结缔组织尚未受到影响。然而,在未经治疗的情况下,牙龈炎可成为牙龈疾病的晚期,即牙周炎,并对牙齿和下颌造成永久损伤。
由牙菌斑产生的细菌刺激牙龈,触发免疫系统产生攻击感染的强大细菌对抗元件。不幸的后果是,这些元件无意中破坏了负责支撑牙齿的骨骼和组织。从本质上说,身体会攻击自己。当组织被分解时,空间开始形成使牙龈与牙齿分离。这些空间变得受感染并加深,进一步破坏了牙龈组织和骨骼。最终,当剩下的骨量不足以支撑牙齿时,牙齿就会开始感到松动并且可能需要去除。
嗜中性粒细胞是一种类型的粒细胞,是形成先天性免疫系统的必需部分的丰富类型的白细胞。在牙龈中炎症的开始阶段,嗜中性粒细胞是朝向炎症部位迁移的炎性细胞的首先响应者之一。嗜中性粒细胞的迁移在称为趋化的过程中由各种化学信号调节。
可减少嗜中性粒细胞募集的蛋白质的实例包括IL-1Ra和sICAM,并且诱导嗜中性粒细胞募集的蛋白质的实例选自由以下组成的组:TNF-a、RANTES、MIF、GCSF、CXCL10和GRO。提高牙龈沟中减少嗜中性粒细胞募集的蛋白质(如IL-1Ra和sICAM)的水平具有减少牙龈炎症的负面后果的抗炎作用。同样,降低牙龈沟中促进嗜中性粒细胞募集的蛋白质(如TNF-a、RANTES、MIF、GCSF、CXCL10和GRO)的水平具有减少牙龈炎症的负面后果的抗炎作用。
通过减少牙龈沟中的嗜中性粒细胞募集来减少牙龈炎症可解决牙龈炎或降低牙龈炎的严重程度,并且在晚期牙龈疾病(如牙周炎和晚期牙周炎)的治疗中起作用。
发明内容
提供控制牙龈炎症并促进健康牙龈和总体良好口腔健康的方法。
提供在个体的牙龈沟内增加减少与嗜中性粒细胞募集相关的信号的蛋白质,并且减少诱导嗜中性粒细胞募集的蛋白质的方法。所述方法包含向所述个体的口腔施用口腔护理组合物,施用量能有效在个体的牙龈沟内增加减少与嗜中性粒细胞募集相关的信号的蛋白质,并且减少诱导嗜中性粒细胞募集的蛋白质,所述口腔护理组合物包含:磷酸锌、氟化亚锡和任选的有机酸缓冲体系。
附图说明
图1是GCM的图示。
图2显示来自实例1中的GCM实验的数据,其比较响应于用牙膏制剂处理的TNFa水平。
图3显示来自实例1中的GCM实验的数据,其比较响应于用牙膏制剂处理的MIF水平。
具体实施方式
将口腔护理组合物施用于个体的口腔可影响个体的牙龈沟中的炎症信号,包括促炎性信号的减少和阻断或减少炎症的信号的上调。减少募集嗜中性粒细胞的信号和促进减少嗜中性粒细胞募集的信号提供了控制炎症和促进健康牙龈和总体良好口腔健康的有效策略。
已设计用于测试口腔健康化合物的生物功效的模型。所述模型在体外细胞培养中采用细胞和细菌生物膜的独特组合,其允许测量预测临床效应的炎性生物标志物。所述模型有助于预测产品功效。
所述模型被称为牙龈沟模型(GCM),包括分层的原代牙龈上皮细胞,如可从MatTek商购获得的组织),与嗜中性粒细胞样细胞偶联,所述嗜中性粒细胞样细胞通过用视黄酸将HL60细胞(ATCC)诱导为嗜中性粒细胞样表型而产生。所述模型模拟在健康的结合牙龈组织内形态上看到的内容。向上皮细胞层添加由唾液捐赠产生且在基材上创建的离体衍生的生物膜,所述基材如HAP盘、聚-D-赖氨酸涂布的基材、胶原涂布的基材、胶原涂布的基材、釉质盘、胶原基质和聚二甲基硅氧烷(PDMS)、琼脂糖、琼脂、聚(乙二醇)、二甲基丙烯酸酯(PEGDMA)和2-甲基丙烯酰氧基乙基磷酸胆碱聚合物(PMPC)水凝胶。为了模拟模型系统内的炎性疾病样状态,可以添加胎牛血清。所述模型允许快速分析口腔护理产品,如牙膏、漱口水等。
GCM适用于测试化合物或制剂预防或解决炎症的能力。GCM还适用于测试化合物或制剂对口腔细菌和生物膜的作用,细菌和生物膜由唾液捐赠和在基材上或在“软”基材上培养产生,基材如HAP、聚-D-赖氨酸、胶原涂布、釉质盘,“软”基材例如由胶原基质,如胶原伤口敷料材料(Impladent Ltd.,纽约牙买加(Jamaica,NY))制成的基材,或由聚二甲基硅氧烷(PDMS)、琼脂糖、琼脂、聚(乙二醇)二甲基丙烯酸酯(PEGDMA)和2-甲基丙烯酰氧基乙基磷酸胆碱聚合物(PMPC)水凝胶制成的基材,以预测健康或疾病状态。所述模型提供预测性临床测量。
使用GCM,测试并分析制剂对趋化因子/细胞因子产生的作用。发现包含口腔可接受的载体、磷酸锌和氟化亚锡的口腔护理组合物实现与嗜中性粒细胞募集相关的信号和减少嗜中性粒细胞募集的促进信号。减少与嗜中性粒细胞募集相关的信号并促进减少嗜中性粒细胞募集的信号的口腔护理组合物适用于控制炎症并促进健康牙龈和总体良好口腔健康。
在一些实施例中,磷酸锌是磷酸锌的预形成的盐。“预形成的盐”在关于磷酸锌使用时意指磷酸锌不是在口腔护理组合物中原位形成,例如通过磷酸和另一锌盐的反应形成。磷酸锌以足以使氟化亚锡解离以在水溶液中提供治疗有效量的亚锡离子的量存在。磷酸锌的量优选相对于口腔护理组合物的重量为0.05重量%至10重量%,优选相对于口腔护理组合物的重量为0.05重量%至5重量%,例如,例如0.1重量%至8重量%或0.1重量%至4重量%,或0.5重量%至5重量%,或0.5重量%至4重量%,或0.5重量%至3重量%,或0.5重量%至2重量%,或0.8重量%至1.5重量%,或0.9重量%至1.1重量%,或约1重量%,或1重量%至4重量%,或1重量%至3重量%,或2重量%至3重量%,或约2重量%,或约2.25重量%,或约2.5重量%。
氟化亚锡的量优选相对于口腔护理组合物的重量为0.01重量%至11重量%,0.01重量%至5重量%,例如相对于口腔护理组合物的重量0.05重量%至4重量%,或0.1重量%至3重量%,0.05重量%至11重量%,例如0.05重量%至7重量%,或0.1重量%至5重量%,或0.2重量%至3重量%,或0.2重量%至2重量%,或0.2重量%至1重量%,或0.2重量%至0.8重量%,或0.3重量%至1重量%,或0.4重量%至0.8重量%,或0.4重量%至0.6重量%,或0.4重量%至0.5重量%,或约0,45重量%>(例如0.454%)。
在一些实施例中,水的量相对于口腔护理组合物的重量为10重量%或更大,或约12重量%或更大,例如10-90%,或10-80%,或10-70%,或10-60%,或10-50%,或10-40%,或10-30%,或15%至85%,或15-30%,或20%至75%,或20-50%或20%至40%或20%至30%,或25%至50%,或30%至40%,或30-35%,例如约35%,或约30%,或约25%或约20%。在一些实施例中,牙膏和口腔凝胶可以包含以组合物的重量计1.0%至99%的水。例如,所述组合物可以包含以组合物的重量计至少10%、15%、20%、25%、30%、35%或40%的水,最多达例如60%、70%、80%、90%、95%或99%的水。如本文所用,水的量是指直接添加到组合物中的水,以及作为成分或组分的一部分添加的水,这些成分或组分作为水溶液而添加。在一些实施例中,组合物包含以组合物的重量计10%至60%的水,或10%至50%的水,或10%至40%的水,或10%至30%的水,或15%至30%的水,或20%至30%的水,或约25%的水。
任选的有机缓冲体系可以包含羧酸和其一种或多种共轭碱盐,例如其碱金属盐(例如柠檬酸和柠檬酸钠)。酸可以选自柠檬酸、乳酸、苹果酸、马来酸、富马酸、乙酸、琥珀酸和酒石酸。一种或多种共轭碱盐可以独立地选自钠盐和钾盐或其组合。一些实施例任选地包含柠檬酸,并且一种或多种共轭碱盐包含柠檬酸单钠(单碱)、柠檬酸二钠(二碱)、柠檬酸三钠(三碱)以及其组合。在一些实施例中,按有机酸和任何共轭碱盐的组合量测量,任选的有机酸缓冲体系的存在量以组合物的重量计为0.1%至5.0%,例如以组合物的重量计为0.5%至4.0%,或1.0%至3.0%,或1.5%至3.0%,或1.0%至2.4%,或1.0%至2.0%,或1.0%至1.5%,或约1.2%。在一些实施例中,任选的有机酸缓冲体系由有机酸和其共轭碱盐组成,例如以组分的重量计,有机酸与其共轭碱盐的比为1∶1至1∶10,例如1∶2至1∶8,或1∶3至1∶6,或1∶4至1∶6,或1∶5至1∶6,或约1∶5。在一些实施例中,任选的有机酸缓冲体系包含柠檬酸和柠檬酸钠盐(例如柠檬酸三钠、柠檬酸二钠或柠檬酸单钠),柠檬酸与柠檬酸钠盐的重量比为1∶3至1∶6,或1∶4至1∶6,或约1∶5(例如约1∶5.7)。
在一些实施例中,口腔护理组合物还包含磨料,例如二氧化硅磨料、钙磨料和如本文所公开的其它磨料,和/或如本文所描述的一种或多种湿润剂和/或一种或多种表面活性剂,和/或有效量的一种或多种碱金属磷酸盐,例如正磷酸盐、焦磷酸盐、三聚磷酸盐、四磷酸盐或更高多磷酸盐。在一些实施例中,碱金属磷酸盐包含焦磷酸四钠或焦磷酸四钾,例如其量为组合物的0.5重量%至5重量%,例如组合物的1重量%至3重量%、或1重量%至2重量%、或约2重量%>、或约2重量%至4重量%、或约3重量%至4重量%、或约4重量%。在一些实施例中,碱金属磷酸盐包含三聚磷酸钠或三聚磷酸钾,例如其量为组合物的0.5重量%至6重量%,例如1重量%至4重量%,或2重量%至3重量%>,或约3重量%>。任何前述组合物,除了磷酸锌外,其还包含增白剂和/或一种或多种锌离子源,例如选自柠檬酸锌、氧化锌、乳酸锌、焦磷酸锌、硫酸锌或氯化锌的锌盐。在一些实施例中,这类组合物是洁齿剂(例如牙膏或口腔凝胶)、粉末(例如牙粉)、锭剂、薄荷糖、乳膏、条或胶(例如口香糖)。
在一些实施例中,组合物包含相对于口腔护理组合物的重量0.5重量%至3重量%的磷酸锌;0.05重量%至11重量%的氟化亚锡;1重量%至8重量%的碱金属磷酸盐,其选自磷酸氢二钠、磷酸氢二钾、磷酸二钙二水合物、焦磷酸四钠、焦磷酸四钾、焦磷酸钙、三聚磷酸钠,和这些中的任何两者或更多者的混合物,以及二氧化硅磨料。所述组合物可以基本上不含卤化二苯醚。所述组合物可以是单相组合物或双相组合物。所述组合物可以不含氧化锌、柠檬酸锌或乳酸锌中的一种或多种。磷酸锌可以是唯一的锌离子源。组合物可以基本上不含六偏磷酸盐(例如六偏磷酸钠)。
制剂可以包括由氟化亚锡提供的亚锡水平,所述亚锡水平范围例如为总组合物中3,000ppm至15,000ppm(质量分数)的亚锡离子。在实施例中,以组合物的总重量计,可溶亚锡含量可以在0.1重量%至0.5重量%或更大,如0.15重量%至0.32重量%的范围内。
所述组合物可以任选地包含适用于口腔护理组合物的另外成分。除了磷酸锌之外,这类成分的实例包括活性剂,如氟化物源和/或磷酸盐源。所述组合物可以在例如包含磨料(例如二氧化硅磨料)、表面活性剂、发泡剂、维生素、聚合物、酶、湿润剂、增稠剂、另外的抗微生物剂、防腐剂、调味剂、着色剂和/或其组合的合适洁齿剂基料中配制。合适的洁齿剂基料的实例在所属领域中是已知的。或者,可以将组合物配制成凝胶(例如在牙托中使用)、口香糖、锭剂或薄荷糖。以下将更详细地讨论可以用于本公开的组合物中的合适的另外成分的实例。
口腔护理组合物包含精氨酸或其盐。在一些实施例中,精氨酸为L-精氨酸或其盐。合适的盐包括所属领域中已知的盐,其是医药学上可接受的盐,通常认为在所提供的量和浓度下是生理学上可接受的。生理学上可接受的盐包括来源于医药学上可接受的无机或有机酸或碱的盐,例如由形成生理学上可接受的阴离子的酸形成的酸加成盐,例如盐酸盐或氢溴酸盐,和由形成生理学上可接受的阳离子的碱形成的碱加成盐,例如来源于碱金属(如钾和钠)或碱土金属(如钙和镁)的碱加成盐。生理学上可接受的盐可以使用所属领域中已知的标准程序获得,例如通过使具有足够碱性的化合物(如胺)与提供生理学上可接受的阴离子的合适的酸反应。在一些实施例中,部分或完全呈盐形式的精氨酸,如精氨酸磷酸盐、精氨酸盐酸盐或精氨酸碳酸氢盐。在一些实施例中,精氨酸以对应于组合物总重量的0.1%至15%,例如0.1重量%至10重量%,例如0.1至5重量%,例如0.5重量%至3重量%,约例如1%、1.5%、2%、3%、4%、5%或8%的量存在,其中精氨酸的重量以游离形式计算。在一些实施例中,精氨酸以对应于组合物总重量的约0.5重量%至约20重量%、组合物总重量的约0.5重量%至约10重量%,例如约1.5重量%、约3.75重量%、约5重量%或约7.5重量%的量存在,其中精氨酸的重量以游离形式计算。在一些实施例中,以组合物的总重量计,精氨酸以0.5重量%至10重量%,或0.5重量%至3重量%或1重量%至2.85重量%,或1.17重量%至2.25重量%,基于或1.4重量%至1.6重量%,或0.75重量%至2.9重量%,或1.3重量%至2重量%,或约1.5重量%的量存在。通常,以口腔护理组合物的总重量计,精氨酸以至多5重量%,进一步任选地0.5重量%至5重量%,再进一步任选地2.5重量%至4.5重量%的量存在。在一些实施例中,精氨酸以0.1重量%至6.0重量%(例如约1.5重量%)或约4.5重量%至8.5重量%(例如5.0%)或3.5重量%至9重量%或8.0重量%的量存在。在一些实施例中,精氨酸以例如约0.5重量%至2重量%存在于洁齿剂中,例如并且在漱口水的情况下以约1%存在。
一种或多种氟离子源任选地以向口腔护理组合物提供临床有效量的可溶性氟离子的量存在。氟离子源适用作例如防龋剂。可使用任何口腔可接受的微粒状氟离子源,包括氟化亚锡、氟化钠、氟化钾、单氟磷酸钾、单氟磷酸钠、单氟磷酸铵、氟硅酸钠、氟硅酸铵、氟化铟、氟化胺(如奥拉氟(N’-十八烷基三甲基二胺-N,N,N’-三(2-乙醇)-二氢氟化物))、氟化铵、氟化钛、六氟硫酸盐和其组合。当存在时,氟化物可以例如约25至约25,000ppm,例如约50至约5000ppm、约750至约2,000ppm对于消费型牙膏(例如1000-1500ppm,例如约1000ppm,例如约1450ppm)产品的水平存在。在一些实施例中,氟化物存在为约100至约1000、约200至约500或约250ppm的氟离子,500至3000ppm。在一些实施例中,氟化物源提供量为50至25,000ppm(例如750-7000ppm,例如1000-5500ppm,例如约500ppm、1000ppm、1100ppm、2800ppm、5000ppm或25000ppm)的氟离子。在一些实施例中,氟化物源为氟化亚锡。在一些实施例中,氟化物源是氟化亚锡,其提供量为750-7000ppm(例如约1000ppm、1100ppm、2800ppm、5000ppm)的氟化物。在一些实施例中,氟化物源是提供量为约5000ppm的氟化物的氟化亚锡。在一些实施例中,氟化物源是提供量为750-2000ppm(例如约1450ppm)的氟化物的氟化钠。在一些实施例中,氟化物源选自氟化钠和单氟磷酸钠,并且其提供量为1000ppm-1500ppm的氟化物。在一些实施例中,氟化物源是氟化钠或单氟磷酸钠,并且其提供量为约1450ppm的氟化物。在一些实施例中,氟化亚锡为唯一的氟化物源。在一些实施例中,氟化物源是氟化亚锡,其提供量为750-7000ppm(例如约1000ppm、1100ppm、2800ppm、5000ppm)的氟化物。在一些实施例中,氟化物源是提供量为约5000ppm的氟化物的氟化亚锡。氟离子源可以约0.001重量%至约10重量%,例如约0.003重量%至约5重量%、0.01重量%至约1重量%或约0.05重量%的水平添加到组合物中。在一些实施例中,氟化亚锡以组合物总重量的0.1重量%至2重量%(0.1重量%至0.6重量%)的量存在。氟离子源可以约0.001重量%至约10重量%,例如约0.003重量%至约5重量%、0.01重量%至约1重量%或约0.05重量%的水平添加到组合物中。然而,应当理解,提供适当水平的氟离子的氟化物盐的重量将显然基于盐中的抗衡离子的重量而变化,并且所属领域技术人员可以容易地确定这样的量。在一些实施例中,氟化物源是以组合物总重量的0.1重量%至2重量%(0.1重量%至0.6重量%)存在的氟化物盐(例如氟化钠(例如约0.32重量%)或单氟磷酸钠)例如0.3-0.4%,例如约0.32%氟化钠。
本文所描述的口腔护理组合物还可以包含一种或多种其它试剂,如通常选自由以下组成的组的试剂:磨料、抗牙菌斑剂、增白剂、抗细菌剂、清洁剂、调味剂、甜味剂、粘合剂、表面活性剂、泡沫调节剂、pH调节剂、湿润剂、口感剂、着色剂、磨料、牙垢控制(抗牙结石)剂、聚合物、唾液刺激剂、营养素、粘度调节剂、抗敏剂、抗氧化剂以及其组合。
在一些实施例中,口腔护理组合物包含一种或多种磨料颗粒,如适用作抛光剂的磨料颗粒。可使用任何口腔可接受的磨料,但应选择磨料的类型、细度(粒度)和量使得牙釉质在组合物的正常使用中不被过度磨损。可以使用的磨料颗粒的实例包括磨料,如碳酸氢钠、不溶性磷酸盐(如正磷酸盐、聚偏磷酸盐和焦磷酸盐,包括正磷酸二钙二水合物、焦磷酸钙、磷酸三钙、聚偏磷酸钙和不溶性聚偏磷酸钠)、磷酸钙(例如磷酸二钙二水合物)、硫酸钙、天然碳酸钙(CC)、沉淀碳酸钙(PCC)、二氧化硅(例如水合二氧化硅或硅胶,或呈沉淀二氧化硅的形式,或与氧化铝掺合的形式)、氧化铁、氧化铝、硅酸铝、煅烧氧化铝、膨润土、其它硅质材料、珍珠岩、塑料颗粒(例如聚乙烯),以及其组合。天然碳酸钙磨料通常为磨细的石灰岩,其可任选地经提炼或部分地提炼以去除杂质。所述材料的平均粒度小于10微米,例如3-7微米,例如约5.5微米。举例来说,小颗粒二氧化硅可具有2.5-4.5微米的平均粒度(D50)。因为天然碳酸钙可含有高比例的未仔细控制的相对大的粒子,这会不可接受地增大研磨性,所以优选地不超过0.01重量%,优选地不超过0.004重量%的粒子将不通过325目筛。所述材料具有强晶体结构,并因此比沉淀碳酸钙硬得多且研磨能力更强。天然碳酸钙的振实密度例如介于1与1.5g/cc之间,例如约1.2,例如约1.19g/cc。天然碳酸钙存在不同的多晶型物,例如方解石、霰石和球霰石,方解石出于本发明的目的是优选的。适用于本发明的市售产品的实例包括得自GMZ的25-11FG。沉淀碳酸钙具有与天然碳酸钙不同的晶体结构。它通常更易碎且更多孔,因此具有较低的研磨性和较高的吸水性。为了用于本发明,颗粒较小,例如具有1-5微米的平均粒度,并且例如不超过0.1重量%,优选地不超过0.05重量%的颗粒将不通过325目筛。所述粒子可例如具有3-6微米,例如3.8-4.9,例如约4.3的D50;1-4微米,例如2.2-2.6微米,例如约2.4微米的D50;和1-2微米,例如1.2-1.4,例如约1.3微米的D10。所述颗粒具有相对高的吸水性,例如至少25g/100g,例如30-70g/100g。适合使用的市售产品的实例包括例如来自Lagos Industria Quimica的15Plus。在一些实施例中,使用另外的含钙磨料,例如磷酸钙磨料,例如磷酸三钙、羟基磷灰石或磷酸二钙二水合物或焦磷酸钙;和/或二氧化硅磨料、偏磷酸钠、偏磷酸钾、硅酸铝、煅烧氧化铝、膨润土或其它硅质材料,或其组合。二氧化硅磨料的实例包括但不限于平均粒度至多约20微米的沉淀或水合二氧化硅(如Zeodent 105和Zeodent 1 14,由J.M.HuberChemicals Division,马里兰州哈弗格雷斯(Havre de Grace,Md.)21078销售);Sylodent783(由W.R.Grace&Company的Davison Chemical Division销售);或Sorbosil AC 43(来自PQ Corporation)。在一些实施例中,二氧化硅磨料的有效量为约10-30%,例如约20%。在一些实施例中,以约2重量%至约35重量%;约3重量%至约20重量%、约3重量%至约15重量%、约10重量%至约15重量%的浓度包括酸性二氧化硅磨料Sylodent。例如,酸性二氧化硅磨料可以选自2重量%、3重量%、4重量%、5重量%、6重量%、7重量%、8重量%、9重量%、10重量%、11重量%、12重量%、13重量%、14重量%、15重量%、16重量%、17重量%、18重量%、19重量%、20重量%的量存在。当在水中以5重量%的浆料测量时,Sylodent 783具有3.4-4.2的pH,并且二氧化硅材料具有小于10微米,例如3-7微米,例如约5.5微米的平均粒度。在一些实施例中,二氧化硅是合成无定形二氧化硅(例如1重量%至28重量%)(例如8重量%至25重量%)。在一些实施例中,二氧化硅磨料为硅胶或沉淀无定形二氧化硅,例如平均粒度在2.5微米至12微米范围内的二氧化硅。一些实施例还包含中值粒度(d50)为1-5微米(例如3-4微米)的小颗粒二氧化硅(例如约5重量%的Sorbosil AC43,得自PQCorporation,英国沃灵顿(Warrington,United Kingdom))。组合物可以含有5重量%至20重量%的小颗粒二氧化硅,或例如10重量%至15重量%,或例如5重量%、10重量%、15重量%或20重量%的小颗粒二氧化硅。在一些实施例中,组合物中总二氧化硅的20重量%至30重量%小颗粒二氧化硅(例如具有3-4微米的中值粒度(d50),并且其中小颗粒二氧化硅是口腔护理组合物的约5重量%。在一些实施例中,二氧化硅用作增稠剂,例如颗粒二氧化硅。在一些实施例中,组合物包含碳酸钙,如高吸收沉淀碳酸钙(例如组合物的20重量%至30重量%,或25%高吸收沉淀碳酸钙),或轻质沉淀碳酸钙(例如约10%轻质沉淀碳酸钙)或约10%天然碳酸钙。
在一些实施例中,口腔护理组合物包含增白剂,例如选自由以下组成的组的增白剂:过氧化物、金属亚氯酸盐、过硼酸盐、过碳酸盐、过氧酸、次氯酸盐、羟基磷灰石和其组合。口腔护理组合物可以包含过氧化氢或过氧化氢源,例如过氧化脲或过氧化物盐或络合物(例如,如过氧磷酸盐、过氧碳酸盐、过硼酸盐、过氧硅酸盐或过硫酸盐;例如过氧磷酸钙、过硼酸钠、过氧碳酸钠、过氧磷酸钠和过硫酸钾或过氧化氢聚合物络合物,如过氧化氢-聚乙烯吡咯烷酮聚合物络合物。
在一些实施例中,口腔护理组合物包含有效量的一种或多种抗细菌剂,例如包含选自以下的抗细菌剂:卤代二苯醚(例如三氯生)、单磷酸三氯生、药草提取物和精油(例如迷迭香提取物、茶叶提取物、木兰提取物、百里酚、薄荷醇、桉树脑、香叶醇、香芹酚、柠檬醛、扁柏醇、厚朴酚、熊果酸、乌尔西克酸、桑色素、儿茶酚、水杨酸甲酯、表没食子儿茶素没食子酸酯、表没食子儿茶素、没食子酸、牙刷树(miswak)提取物、沙棘提取物)、双胍防腐剂(例如氯己定(chlorhexidine)、阿来西定(alexidine)或奥替尼啶(octenidine))、季铵化合物(例如十六烷基氯化吡啶(CPC)、苯扎氯铵、十四烷基氯化吡啶(TPC)、N-十四烷基-4-乙基氯化吡啶(TDEPC))、酚类防腐剂、海克替啶(hexetidine)呋喃酮、细菌素、月桂酰精氨酸乙酯、精胺酸碳酸氢盐、山茶提取物、类黄酮、黄烷、卤化二苯醚、肌酸、血根碱、聚维酮碘、地莫匹醇(delmopinol)、沙利福(salifluor)、金属离子(例如锌盐、亚锡盐、铜盐、铁盐)、蜂胶和氧化剂(例如过氧化氢、缓冲的过氧硼酸钠或过氧碳酸钠)、邻苯二甲酸和其盐、单过氧邻苯二甲酸以及其盐和酯、硬脂酸抗坏血酸酯、油酰肌氨酸、硫酸烷基酯、磺基琥珀酸二辛酯、水杨酰苯胺、溴化度米芬(domiphen bromide)、地莫匹醇(delmopinol)、辛哌醇和其它哌啶基衍生物、乳酸链球菌素制剂、亚氯酸盐;对羟基苯甲酸酯,如对羟基苯甲酸甲酯或对羟基苯甲酸丙酯以及前述中任一种的混合物。一种或多种另外的抗细菌剂或防腐剂可以任选地以按组合物总重量计约0.01重量%至约0.5重量%,任选地约0.05重量%至约0.1重量%或约0.3重量%的量存在于组合物中。
在一些实施例中,口腔护理组合物可以包含至少一种碳酸氢盐,其适用于例如由于泡腾和释放二氧化碳而将“清洁感”赋予牙齿和牙龈。可使用任何口腔可接受的碳酸氢盐,包括但不限于碱金属碳酸氢盐,如碳酸氢钠和碳酸氢钾、碳酸氢铵等。一种或多种另外的碳酸氢盐任选地以按组合物总重量计约0.1重量%至约50重量%,例如约1重量%至20重量%的总量存在。
在一些实施例中,口腔护理组合物还包含至少一种调味剂,其适用于例如增强组合物的味道。可使用任何口腔可接受的天然或合成的调味剂,包括但不限于精油和各种调味醛、酯、醇和类似材料、茶香精、香草醛、鼠尾草、马郁兰、欧芹油、留兰香油、肉桂油、冬青油、薄荷油、丁香油、月桂油、茴香油、桉树油、柑橘油、水果油、檫树和香精(包括源自柠檬、桔子、酸橙、葡萄柚、杏子、香蕉、葡萄、苹果、草莓、樱桃、菠萝等的那些)、源自豆类和坚果的调味剂(如咖啡、可可、可乐果、花生、杏仁等),吸附的和包封的调味剂等。本文中调味剂内还涵盖在口中提供芳香和/或其它感官效果(包括清凉或温热效果)的成分。这类成分说明性包括薄荷醇、香芹酮、乙酸薄荷酯、乳酸薄荷酯、樟脑、桉树油、桉树脑、茴香脑、丁香酚、肉桂、覆盆子酮、α-紫罗兰酮、丙烯基愈创木酚、百里酚、芳樟醇、苯甲醛、肉桂醛、N-乙基-对薄荷烷-3-甲酰胺、N,2,3-三甲基-2-异丙基丁酰胺、3-(1-薄荷氧基)-丙烷-1,2-二醇、肉桂醛甘油缩醛(CGA)、薄荷酮甘油缩醛(MGA)等。一种或多种调味剂任选地以按组合物总重量计约0.01重量%至约5重量%,例如约0.03重量%至约2.5重量%,任选地约0.05重量%至约1.5重量%,另外任选地约0.1重量%至约0.3重量%的总量存在,并且在一些实施例中在各种实施例中约0.01重量%至约1重量%,约0.05重量%至约2重量%,约0.1重量%至约2.5重量%以及约0.1重量%至约0.5重量%的总量存在。
在一些实施例中,口腔护理组合物包含至少一种甜味剂,其适用于例如增强组合物的味道。本文适用的甜味剂包括右旋糖、聚葡萄糖、蔗糖、麦芽糖、糊精、干燥的转化糖、甘露糖、木糖、核糖、果糖、左旋糖、半乳糖、玉米糖浆、部分水解的淀粉、氢化淀粉水解物、乙醇、山梨糖醇、甘露醇、木糖醇、麦芽糖醇、异麦芽酮糖醇、阿斯巴甜、纽甜、糖精和其盐(例如糖精钠)、三氯蔗糖、基于二肽的强力甜味剂、环己基氨基磺酸盐、二氢查耳酮、甘油、丙二醇、聚乙二醇、泊洛昔姆(Poloxomer)聚合物(如POLOXOMER 407、PLURONIC F108(均可从巴斯夫公司(BASF Corporation)获得)),烷基聚糖苷(APG)、聚山梨醇酯、PEG40、蓖麻油、薄荷醇以及其混合物。一种或多种甜味剂任选的存在总量密切取决于选择的特定甜味剂,但是通常为以组合物的总重量计的0.005重量%至5重量%,任选地0.005重量%至0.2重量%,还任选地以组合物的总重量计的0.05重量%至0.1重量%。
在一些实施例中,口腔护理组合物还包含干扰或防止细菌附着的试剂,例如月桂酰精氨酸乙酯(ELA)、尼泊金乙酯(solbrol)或壳聚糖,以及牙菌斑分散剂,如酶(木瓜蛋白酶、葡糖淀粉酶等)。
在一些实施例中,口腔护理组合物还包含至少一种表面活性剂。可使用任何口腔可接受的表面活性剂,其中大部分是阴离子型、阳离子型、两性离子型、非离子型或两性的,以及其混合物。合适的表面活性剂的实例包括高级脂肪酸单甘油酯单硫酸酯的水溶性盐,如氢化椰子油脂肪酸的单硫酸单甘油酯的钠盐;高级烷基硫酸盐,如月桂基硫酸钠、椰子单甘油酯磺酸钠、月桂基肌氨酸钠、月桂基异乙二磺酸钠、月桂醇聚醚羧酸钠和十二烷基苯磺酸钠;烷基芳基磺酸盐,如十二烷基苯磺酸钠;高级烷基磺基乙酸盐,如月桂基磺基乙酸钠;1,2-二羟基丙烷磺酸的高级脂肪酸酯;以及低级脂肪族氨基羧酸化合物的基本上饱和的高级脂肪族酰基酰胺,如在脂肪酸、烷基或酰基中具有12至16个碳的那些;等等。酰胺的实例包括N-月桂基肌氨酸以及N-月桂基、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。阳离子表面活性剂的实例包括具有一条含有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,如氯化月桂基三甲基铵、氯化鲸蜡基吡啶鎓、溴化鲸蜡基三甲基铵、氯化二异丁基苯氧基乙基二甲基苯甲基铵、亚硝酸椰子基烷基三甲基铵、氟化鲸蜡基吡啶鎓以及其混合物。合适的非离子表面活性剂包括但不限于泊洛沙姆(poloxamer)、聚氧乙烯脱水山梨醇酯、脂肪醇乙氧基化物、烷基酚乙氧基化物、叔胺氧化物、叔膦氧化物、二烷基亚砜等。其它实例包括例如非阴离子聚氧乙烯表面活性剂,如泊洛沙姆407、硬脂醇聚醚(Steareth)30、聚山梨醇酯20和蓖麻油;以及两性表面活性剂,如具有阴离子基团(如羧酸根、硫酸根、磺酸根、磷酸根或膦酸根)的脂肪族仲胺和叔胺的衍生物,如椰油酰胺丙基甜菜碱(tegobaine)和椰油酰胺丙基甜菜碱月桂基葡糖苷;氧化乙烯与各种含氢化合物的缩合产物,所述含氢化合物可与氧化乙烯反应并具有长烃链(例如12至20个碳原子的脂肪族链),所述缩合产物(乙沙姆(ethoxamer))含有亲水性聚氧乙烯部分,如聚(氧化乙烯)与脂肪酸、脂肪醇、脂肪酰胺和其它脂肪部分的缩合产物,以及与氧化丙烯和聚氧化丙烯的缩合产物。在一些实施例中,口腔组合物包括表面活性剂体系,其为月桂基硫酸钠(SLS)和椰油酰胺丙基甜菜碱。一种或多种表面活性剂任选以按组合物总重量计约0.01重量%至约10重量%,例如约0.05重量%至约5重量%,或约0.1重量%至约2重量%,例如1.5重量%的总量存在。在一些实施例中,口腔组合物包括阴离子表面活性剂,例如选自月桂基硫酸钠、月桂基乙醚硫酸钠和其混合物的表面活性剂,例如其量为约0.3重量%至约4.5重量%,例如1-2%月桂基硫酸钠(SLS);和/或两性离子表面活性剂,例如甜菜碱表面活性剂,例如椰油酰胺丙基甜菜碱,例如其量为约0.1重量%至约4.5重量%,例如0.5-2%椰油酰胺丙基甜菜碱。一些实施例包含0.5-5%,例如1-2%的量的非离子表面活性剂,其选自泊洛沙姆(泊洛沙姆407)、聚山梨醇酯(例如聚山梨醇酯20)、聚氧乙烯氢化蓖麻油(例如聚氧乙烯40氢化蓖麻油)以及其混合物。在一些实施例中,泊洛沙姆非离子表面活性剂具有的聚氧丙烯分子质量为3000至5000g/mol,并且聚氧乙烯含量为60至80摩尔%,例如泊洛沙姆非离子表面活性剂包含泊洛沙姆407。前述组合物中的任一种还可以包含山梨糖醇,其中所述山梨糖醇的总量为10-40%(例如约23%)。
在一些实施例中,口腔护理组合物包含至少一种泡沫调节剂,其适用于在搅拌时增加由组合物产生的泡沫的量、浓密程度或稳定性。可使用任何口腔可接受的泡沫调节剂,包括例如聚乙二醇(PEG),也称为聚氧乙烯。高分子量PEG是合适的,包括平均分子量为200,000至7,000,000,例如500,000至5,000,000或1,000,000至2,500,000的PEG,一种或多种PEG任选地以按组合物总重量计约0.1重量%至约10重量%,例如约0.2重量%至约5重量%,或约0.25重量%至约2重量%的总量存在。
在一些实施例中,口腔护理组合物包含至少一种pH调节剂。这类试剂包括降低pH的酸化剂、提高pH的碱化剂和将pH控制在所需范围内的缓冲剂。例如,可包括选自酸化剂、碱化剂和缓冲剂的一种或多种化合物以提供2至10或在各说明性实施例中的2至8、3至9、4至8、5至7、6至10、7至9等的pH。可使用任何口腔可接受的pH调节剂,包括但不限于羧酸、磷酸和磺酸;酸式盐(例如柠檬酸单钠、柠檬酸二钠、苹果酸单钠等);碱金属氢氧化物,如氢氧化钠;碳酸盐,如碳酸钠;碳酸氢盐,如碳酸氢钠;倍半碳酸盐;硼酸盐;硅酸盐;硫酸氢盐;磷酸盐(例如磷酸单钠、磷酸三钠、磷酸单钾、磷酸二钾、三代磷酸钠、三聚磷酸钠、磷酸);咪唑;磷酸钠缓冲剂(例如磷酸二氢钠和磷酸二钠);柠檬酸盐(例如柠檬酸、柠檬酸三钠脱水物);焦磷酸盐(钠和钾盐)等以及其组合。一种或多种pH调节剂任选地以能够有效地将组合物维持在口腔可接受的pH范围内的总量存在。组合物可以具有酸性或碱性的pH,例如pH 4至pH 5.5或pH 8至pH 10。在一些实施例中,当组合物溶解于水、漱口液基料或牙膏基料时,缓冲剂的量足以提供约5至约9,优选地约6至约8,且更优选地约7的pH值。以组合物的总重量计,缓冲剂的典型量为约5%至约35%,在一个实施例中约10%至约30%),在另一实施例中约15%至约25%。
在一些实施例中,口腔护理组合物还包含至少一种湿润剂。可使用任何口腔可接受的湿润剂,包括但不限于多元醇,如甘油、山梨糖醇(任选地以70重量%水溶液)、丙二醇、木糖醇或低分子量聚乙二醇(PEG)以及其混合物。大部分湿润剂也充当甜味剂。在一些实施例中,组合物包含15重量%至70重量%或30重量%至65重量%的湿润剂。适合的湿润剂包括可食用的多羟基醇,如甘油、山梨糖醇、木糖醇、丙二醇以及其它多元醇和这些湿润剂的混合物。甘油和山梨糖醇的混合物可在某些实施例用作本文中的组合物组合物的湿润剂组分。一种或多种湿润剂任选地以按组合物总重量计约1重量%至约70重量%,例如约1重量%至约50重量%、约2重量%至约25重量%或约5重量%至约15重量%的总量存在。在一些实施例中,湿润剂(如甘油)以至少20%>,例如20-40%,例如25-35%的量存在。
口感剂包括在组合物的使用期间赋予所需的纹理或其它感觉的材料。在一些实施例中,口腔护理组合物包含适用于例如赋予组合物期望的稠度和/或口感的至少一种增稠剂。可使用任何口腔可接受的增稠剂,包括但不限于卡波姆(carbomer)(也称为羧基乙烯基聚合物)、角叉菜胶(也称为爱尔兰苔藓)并且尤其i-角叉菜胶(ι-角叉菜胶)、纤维素聚合物,如羟乙基纤维素,和纤维素醚的水溶性盐(例如羧甲基纤维素钠和羧甲基羟乙基纤维素钠)、羧甲基纤维素(CMC)和其盐,例如CMC钠,天然胶,如刺梧桐树胶、黄原胶、阿拉伯胶和黄蓍胶、胶体硅酸镁铝、胶体二氧化硅、淀粉、聚乙烯吡咯烷酮、羟乙基丙基纤维素、羟丁基甲基纤维素、羟丙基甲基纤维素和羟乙基纤维素以及无定形二氧化硅等。优选类别的增稠剂或胶凝剂包括与季戊四醇烷基醚或蔗糖烷基醚交联的一类丙烯酸均聚物,或卡波姆。卡波姆可以从B.F.Goodrich以系列商购。特别优选的Carbopol包括Carbopol 934、940、941、956、974P以及其混合物。也可以使用二氧化硅增稠剂,如DT 267(来自PPGIndustries)。一种或多种增稠剂任选地以按组合物总重量计约0.01重量%至15重量%,例如约0.1重量%至约10重量%或约0.2重量%至约5重量%的总量存在。一些实施例包含羧甲基纤维素钠(例如0.5重量%至1.5重量%)。在某些实施例中,使用按总组合物的重量计,约0.5%至约5.0%的量的增稠剂。增稠剂可以1重量%至15重量%、3重量%至10重量%、4重量%至9重量%、5重量%至8重量%,例如5重量%、6重量%、7重量%或8重量%的量存在。
在一些实施例中,口腔护理组合物包含至少一种着色剂。本文中的着色剂包括颜料、染料、色淀和赋予特定光泽或反射率的试剂如珠光剂。在各种实施例中,着色剂可操作以在牙齿表面上提供白色或浅色涂层、充当牙齿表面上已被组合物有效接触的位置的指示和/或修改组合物的外观,特别是颜色和/或不透明度以增强对消费者的吸引力。可使用任何口腔可接受的着色剂,包括FD&C染料和颜料、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、黄色、棕色和黑色氧化铁、亚铁氰化铁铵、锰紫、群青、钛化云母、氯氧化铋以及其混合物。一种或多种着色剂任选地以按组合物的总重量计约0.001%至约20%,例如约0.01%至约10%或约0.1%至约5%的总量存在。
在一些实施例中,口腔护理组合物还包含抗牙结石(牙垢控制)剂。合适的抗牙结石剂包括但不限于:磷酸盐和多磷酸盐、聚氨基丙烷磺酸(AM PS)、聚烯烃磺酸盐、聚烯烃磷酸盐、二膦酸盐如氮杂环烷-2,2-二膦酸盐(例如氮杂环庚烷-2,2-二膦酸)、N-甲基氮杂环戊烷-2,3-二膦酸、乙烷-1-羟基-1,1-二膦酸(EHDP)以及乙烷-1-氨基-1,1-二膦酸盐、磷酰基烷烃羧酸和。适用的无机磷酸盐和多磷酸盐包括磷酸二氢钠、磷酸氢二钠和三代磷酸钠。可溶性焦磷酸盐是适用的抗牙结石剂。焦磷酸盐可以是任何碱金属焦磷酸盐。在某些实施例中,盐包括四碱金属焦磷酸盐、二碱金属二酸焦磷酸盐、三碱金属单酸焦磷酸盐和其混合物,其中碱金属是钠或钾。焦磷酸盐还通过降低水活性来促进组合物的保存,焦磷酸四钠(TSPP)、焦磷酸四钾、三聚磷酸钠、四聚磷酸盐、三偏磷酸钠、六偏磷酸钠以及其混合物。呈水合和未水合形式的盐均为适用的。适用于本发明组合物的焦磷酸盐的有效量通常足以提供至少0.1重量%的焦磷酸根离子,例如0.1重量%至3重量%,例如0.1重量%至2重量%,例如0.1重量%至1重量%,例如0.2重量%至0.5重量%。
其它适用的牙垢控制剂包括聚合物和共聚物。在一些实施例中,口腔护理组合物包括一种或多种聚合物,如聚乙二醇、聚乙烯甲基醚马来酸共聚物、多糖(例如纤维素衍生物,例如羧甲基纤维素,或多糖胶,例如黄原胶或角叉菜胶)。酸性聚合物(例如聚丙烯酸酯凝胶)可以其游离酸或部分或完全中和的水溶性碱金属(例如钾和钠)或铵盐的形式提供。某些实施例包括马来酸酐或马来酸与另一种可聚合烯系不饱和单体,例如甲基乙烯基醚(甲氧基乙烯)的分子量(M.W.)为约30,000至约1,000,000的1∶4至4∶1共聚物,聚乙烯基甲基醚/马来酸酐(PVM/MA)共聚物,如(例如S-97聚合物)。在一些实施例中,PVM/MA共聚物包含甲基乙烯基醚/马来酸酐的共聚物,其中酸酐在共聚作用之后水解,从而得到对应的酸。在一些实施例中,PVM/MA共聚物具有约30,000至约1,000,000,例如约300,000至约800,000的平均分子量(M.W.),例如其中阴离子型聚合物为组合物的重量的约1-5%,例如约2%。在一些实施例中,抗牙结石以按组合物的总重量计0.2重量%至0.8重量%;0.3重量%至0.7重量%;0.4重量%至0.6重量%;或约0.5重量%的量存在于组合物中。共聚物可例如作为GAF化学品公司(GAF Chemicals Corporation)的Gantrez AN 139(M.W.500,000)、AN 1 19(M.W.250,000)以及S-97药物级(M.W.70,000)获得。其它起作用的聚合物包括如马来酸酐与丙烯酸乙酯、甲基丙烯酸羟乙酯、N-乙烯基-2-吡咯酮或乙烯的1∶1共聚物的那些,后者可例如以Monsanto EMA编号1103、M.W.10,000以及EMA等级61获得;以及丙烯酸与甲基丙烯酸甲酯或甲基丙烯酸羟乙酯、丙烯酸甲酯或丙烯酸乙酯、异丁基乙烯醚或N-乙烯基-2-吡咯烷酮的1∶1共聚物。一般来讲,合适的是含有活性碳-碳烯属双键和至少一个羧基的聚合的烯属或烯系不饱和羧酸,即含有因为在相对于羧基的α-β位置中或作为末端亚甲基的一部分存在于单体分子中而容易在聚合中起作用的烯属双键的酸。这类酸的例证为丙烯酸、甲基丙烯酸、乙基丙烯酸、α-氯丙烯酸、巴豆酸、β-丙烯酰氧基丙酸、山梨酸、α-氯代山梨酸、肉桂酸、β-苯乙烯基丙烯酸、粘糠酸、衣康酸(itaconic)、柠康酸、甲基反丁烯二酸、戊烯二酸、乌头酸、α-苯基丙烯酸、2-苄基丙烯酸、2-环己基丙烯酸、当归酸、伞形酸、富马酸、马来酸以及酸酐。可与这类羧酸单体共聚的其它不同的烯属单体包括乙酸乙烯酯、氯乙烯、马来酸二甲酯等。共聚物含有对于水溶性来讲足够的羧酸盐基团。另一类聚合剂包括含有取代丙烯酰胺的均聚物和/或不饱和磺酸及其盐的均聚物的组合物,特别地其中聚合物基于的是选自丙烯酰氨基烷烃磺酸如2-丙烯酰胺2甲基丙烷磺酸的不饱和磺酸,分子量为约1,000至约2,000,000。另一类适用的聚合剂包括聚氨基酸,尤其是含有成比例的阴离子表面活性氨基酸的那些,所述氨基酸如天冬氨酸、谷氨酸和磷酸丝氨酸。
在一些实施例中,口腔护理组合物包含唾液刺激剂,其适用于例如改善口干。可使用任何口腔可接受的唾液刺激剂,包括但不限于食品酸,如柠檬酸、乳酸、苹果酸、琥珀酸、抗坏血酸、己二酸、富马酸和酒石酸以及其混合物。一种或多种唾液刺激剂任选地以有效刺激唾液的总量存在。
在一些实施例中,口腔护理组合物包含营养素。合适的营养素包括维生素、矿物质、氨基酸以及其混合物。维生素包括维生素C和D、硫胺、核黄素、泛酸钙、烟酸、叶酸、烟酰胺、吡哆醇、氰钴胺素、对氨基苯甲酸、生物类黄酮以及其混合物。营养补充剂包括氨基酸(如L-色氨酸、L-赖氨酸、甲硫氨酸、苏氨酸、左卡尼汀和L-肉毒碱)、亲脂物质(如胆碱、肌醇、甜菜碱和亚油酸)以及其混合物。
在一些实施例中,口腔护理组合物包含至少一种粘度调节剂,其适用于例如抑制成分的沉降或分离或者促进液体组合物在搅拌时的再分散性。可使用任何口腔可接受的粘度调节剂,包括但不限于矿物油、石蜡脂、粘土和有机改性的粘土、二氧化硅等。一种或多种粘度调节剂任选地以按组合物总重量计约0.01重量%至约10重量%,例如约0.1重量%至约5重量%的总量存在。
在一些实施例中,口腔护理组合物包含抗敏剂,例如钾盐,如硝酸钾、碳酸氢钾、氯化钾、柠檬酸钾和草酸钾;辣椒素;丁香酚;锶盐;氯盐以及其组合。根据所选试剂,可以按有效量添加这类试剂,例如,以所述组合物的总重量计约1重量%至约20重量%。
在一些实施例中,口腔护理组合物包含抗氧化剂。可使用任何口腔可接受的抗氧化剂,包括丁基化羟基茴香醚(BHA)、丁基化羟基甲苯(BHT)、维生素A、类胡萝卜素、辅酶Q10、PQQ、维生素A、维生素C、维生素E、茴香脑-二硫代硫酮、类黄酮、多酚、抗坏血酸、草本抗氧化剂、叶绿素、褪黑激素以及其混合物。
在一些实施例中,口腔护理组合物包含选自以下的钙和磷酸盐源:(i)钙-玻璃复合物,例如磷硅酸钠钙,和(ii)钙-蛋白质复合物,例如酪蛋白磷酸肽-无定形磷酸钙。前述组合物中的任一种还包含可溶性钙盐,例如选自硫酸钙、氯化钙、硝酸钙、乙酸钙、乳酸钙以及其组合。
在一些实施例中,口腔护理组合物包含选自以下的另外成分:苄醇、甲基异噻唑啉酮(“MIT”)、碳酸氢钠、甲基椰油酰基牛磺酸钠(tauranol)、月桂醇和多磷酸盐。一些实施例包含以0.1重量%至0.8重量%,或0.2重量%至0.7重量%,或0.3重量%至0.6重量%,或0.4重量%至0.5重量%,例如约0.1重量%、约0.2重量%、约0.3重量%、约0.4重量%、约0.5重量%、约0.6重量%、约0.7重量%或约0.8重量%存在的苄醇。
实例
实例1
图1含有牙龈沟模型(GCM)的图示。GCM适用于在紧密模仿牙龈沟的细胞培养模型中评定产品健康益处。牙龈沟是数百种细菌物种以及牙龈上皮细胞和嗜中性粒细胞的家园。可以评价分泌或表达的蛋白质的蛋白质组学、细菌影响和气味,并且将其用于比较各种化合物和组合物的影响。GCM组合了三种组分,即嗜中性粒细胞样细胞、包括口腔细菌的生物膜和口腔上皮组织。
嗜中性粒细胞样细胞:可以通过使HL60细胞与视黄酸接触来诱导HL60细胞(ATCC#CCLO-240)分化成嗜中性粒细胞样细胞类型。将HL60细胞维持在1×105个细胞/毫升(用于HL60的培养基,IMEM ATCC#30-2005)的细胞密度下。通过将视黄酸溶解到ETOH中以产生1mM视黄酸于乙醇中的溶液来制备用于将HL60分化成嗜中性粒细胞样的视黄酸。当通过浓度为1μM(1mM视黄酸溶液的1∶1000稀释液)的视黄酸诱导HL60细胞分化成嗜中性粒细胞样细胞类型时,培养HL60细胞到2×105个细胞/毫升的细胞密度。分化需要6天。分化的细胞,其构成约60-80%的细胞并且在图1中被称为PMN。
生物膜:生物膜如下创建:使用在基材,如HAP盘、聚-D-赖氨酸或胶原涂布的基材上培养的唾液,或在体内使用独立制备的保持器、胶原基质和聚二甲基硅氧烷(PDMS)、琼脂糖、琼脂、聚(乙二醇)二甲基丙烯酸酯(PEGDMA)和2-甲基丙烯酰氧基乙基磷酸胆碱聚合物(PMPC)水凝胶中的釉质。生物膜的培养通常需要2天。用约2mL人唾液接种补充有5μg/ml氯化血红素(最终浓度)和1μg/ml(最终浓度)的McBain培养基。在适当的生长条件下,例如在5%CO2下37℃下,将唾液生物膜在例如HAP盘的基材上培养约16小时。
口腔上皮组织:有两种类型的口腔组织可从MatTek获得:EpiGingivalTM牙龈上皮和EpiOralTM口腔(颊)上皮。MatTek的EpiOral和EpiGingival组织由正常的人源口腔上皮细胞组成。细胞已被培养以形成人颊(EpiOral)和牙龈(EpiGingival)表型的多层、高分化模型。使用无血清培养基在特别制备的细胞培养插入物上培养组织。EpiOral和EpiGingival组织模型表现出均匀且高度可重现的体内样形态和生长特征。对于传统GCM,牙龈上皮是优选的。如果脸颊模型为目标,则使用口腔上皮。
在GCM中组装之前,必须用视黄酸诱导HL60细胞分化成嗜中性粒细胞样表型(PMN),并且必须制备生物膜。PMN和生物膜的制备是协调的,使得PMN和生物膜在从供应商处接收并过夜培育MatTek组织后准备就绪。递送MatTek组织(上皮细胞)置于6孔板中的新鲜培养基中后,使其在培育箱中恢复过夜。
在测试日,GCM的每一种组分的制备是协调的,使得GCM的每一种组分准备好同时进行测试。
当测试牙膏(TP)时,产品制备为浆料。紧接在测试之前,以1∶2稀释度用超纯H2O稀释TP产品。漱口水可以全强度使用。
将MatTek培养基和(FBS)血清温热。组织和生物膜分开处理,并且组装GCM。
在室温下用1∶2(TP∶水)牙膏浆料处理生物膜一次2分钟,同时以约100rpm振荡。在处理之后,以5分钟间隔在无菌去离子水中洗涤生物膜两次,然后转移到新鲜无菌水中,以允许细菌在37℃下恢复约3小时,然后组装GCM,并与经处理的培养的上皮细胞共培育。
为了处理MatTek上皮组织,将MatTek组织从培育箱中移出,并将每个组织取出,以在24孔板中用1∶2(TP∶水)牙膏浆进行处理。在处理之前,去除培养基以供使用基线对照。用牙膏稀释液处理每个组织样品2分钟。
通过在新鲜管中300RPM离心5分钟并再悬浮于对非发炎性病况进行模型化的MatTek培养基中或再悬浮于对发炎性病况进行模型化的MatTek+5%FBS中来制备针对GCM的分化的HL60(2.5×105个细胞/毫升)。
生物膜和上皮组织,各自已用相同类型的牙膏稀释液处理,并且PMN如图1中所示组装并且放置在细菌友好培育箱中过夜。
24小时后,收获来自实验的培养基,并且将HL60/PMN旋转(300RPM,5分钟)并在-20℃下冷冻/存储。使用Millisplex MagPix试剂盒检测并定量细胞因子/趋化因子。可对HAP盘或其它基材上的生物膜进行细菌分析。或者,生物膜可以存储在-80℃中以供稍后分析。
可以回收PMN用于分析。在从细胞中去除上清液后,将细胞在冷PBS中洗涤两次(300RPM,5分钟)。将PMN在200μL固定缓冲液(室温10分钟或在4℃下过夜)中培养,并用所需的抗体染色程序染色。
可在处理后评估MatTek组织。如果存在关于细胞毒性的问题,则应进行MTT分析。如果要评定蛋白质表达的位置,则固定组织以用于组织学分析。如果所关注蛋白未被分泌,则可以对组织进行超声处理并分析以进行细胞因子分析。
GCM用于评估包含氟化亚锡(0.454%SnF2)和磷酸锌(1.0%Zn3(PO4)2)的牙膏组合物,组合物1(Comp1)。来自GCM实验的数据在图2和图3中示出。测量响应于用测试牙膏处理的TNFa(图2)和MIF(图3)水平,并且与来自未处理的对照的结果进行比较。
实例2
包含精氨酸的口腔组合物公开于WO 2017/223292中,其以引用的方式并入本文。在一些实施例中,口腔护理组合物包含口腔可接受的载体、磷酸锌;和氟化亚锡。在一些实施例中,磷酸锌是磷酸锌的预形成的盐。在一些实施例中,磷酸锌以足以使氟化亚锡解离以在水溶液中提供治疗有效量的亚锡离子的量存在。在一些实施例中,相对于口腔护理组合物的重量,磷酸锌的量为0.05重量%至5重量%。在一些实施例中,相对于口腔护理组合物的重量,氟化亚锡的量为0.05重量%至5重量%。在一些实施例中,相对于口腔护理组合物的重量,水的量为约12重量%或更大。在一些实施例中,口腔护理组合物还包含磨料和/或一种或多种湿润剂和/或一种或多种表面活性剂。在一些实施例中,口腔护理组合物还包含有效量的一种或多种碱金属磷酸盐和/或增白剂。在一些实施例中,口腔护理组合物还包含除磷酸锌之外的一种或多种锌离子源。在一些实施例中,口腔护理组合物是洁齿剂、粉末、乳膏、条、胶或凝胶。在一些实施例中,口腔护理组合物包含:相对于口腔护理组合物的重量,0.5重量%至3重量%的磷酸锌;0.05重量%至11重量%的氟化亚锡;1重量%至8重量%的碱金属磷酸盐,其选自磷酸氢二钠、磷酸氢二钾、磷酸二钙二水合物、焦磷酸四钠、焦磷酸四钾、焦磷酸钙、三聚磷酸钠,和这些中的任何两者或更多者的混合物;以及二氧化硅磨料。在一些实施例中,口腔护理组合物具有小于7的pH。
实例3
包含精氨酸的口腔组合物在WO 2017/223311中公开,其以引用的方式并入本文。口腔护理组合物是实例2中阐述的口腔护理组合物,其还包含有机酸缓冲体系。在一些实施例中,相对于口腔护理组合物的重量,口腔护理组合物包含10重量%或更大量的水。在一些实施例中,有机缓冲体系包含羧酸和其一种或多种共轭碱盐,例如其碱金属盐。在一些实施例中,酸选自柠檬酸、乳酸、苹果酸、马来酸、富马酸、乙酸、琥珀酸和酒石酸。在一些实施例中,一种或多种共轭碱盐独立地选自钠盐和钾盐或其组合。在一些实施例中,酸为柠檬酸,并且一种或多种共轭碱盐包含柠檬酸单钠(单碱)、柠檬酸二钠(二碱)、柠檬酸三钠(三碱)以及其组合。在一些实施例中,口腔护理组合物包含以组合物的重量计0.1%至5.0%的量的有机酸缓冲体系,所述量以有机酸和任意共轭碱盐的组合量测量。在一些实施例中,缓冲体系包含呈1∶3至1∶6的比的柠檬酸和柠檬酸钠盐。
实例4
如配方表A-D所示制备包含磷酸锌和氟化亚锡的测试洁齿剂。
配方表A
成分 | |
水 | QS(例如15-40) |
增稠剂 | 0.5-5(例如3.6) |
湿润剂 | 15-55(例如48) |
牙垢控制剂 | 0.5-5(例如2) |
磨料 | 10-30(例如20) |
氟化亚锡 | 0.5-11(例如0.454) |
微量组分(调味剂、着色剂) | 0.5-5(例如2.25) |
表面活性剂 | 0.1-15(例如2.75) |
磷酸锌 | 0.5-5(例如1或2) |
配方表B
成分 | |
水和微量组分(调味剂、着色剂) | 11.74 |
氟化亚锡 | 0.454 |
磷酸锌 | 1.15 |
增稠剂 | 2.9 |
甘油 | 40.79 |
磨料二氧化硅 | 24.00 |
丙二醇 | 4.00 |
柠檬酸三钠三水合物 | 3.00 |
三聚磷酸钠 | 3.00 |
聚乙二醇600 | 3.00 |
焦磷酸四钠 | 2.00 |
阴离子表面活性剂 | 1.75 |
两性离子表面活性剂 | 1.0 |
阴离子聚合物 | 0.61 |
柠檬酸 | 0.60 |
配方表C
配方表D
Claims (24)
1.一种在个体的牙龈沟内增加减少与嗜中性粒细胞募集相关的信号的蛋白质,并且减少诱导嗜中性粒细胞募集的蛋白质的方法,所述方法包含向所述个体的口腔施用口腔护理组合物,施用量能有效在个体的牙龈沟内增加减少与嗜中性粒细胞募集相关的信号的蛋白质,并且减少诱导嗜中性粒细胞募集的蛋白质,所述口腔护理组合物包含:磷酸锌、氟化亚锡和任选的有机酸缓冲体系。
2.根据权利要求1所述的方法,其中所述口腔护理组合物是牙膏。
3.根据权利要求1所述的方法,其中所述磷酸锌是磷酸锌的预形成的盐。
4.根据权利要求1至3中任一项所述的方法,其中磷酸锌以足以使所述氟化亚锡解离以在水溶液中提供治疗有效量的亚锡离子的量存在。
5.根据权利要求1至4中任一项所述的方法,其中相对于所述口腔护理组合物的重量,所述磷酸锌的量为0.05重量%至5重量%。
6.根据权利要求1至5中任一项所述的方法,其中相对于所述口腔护理组合物的重量,所述氟化亚锡的量为0.05重量%至5重量%。
7.根据权利要求1至6中任一项所述的方法,其中相对于所述口腔护理组合物的重量,水的量为约10重量%或更大。
8.根据权利要求1至7中任一项所述的方法,其中相对于所述口腔护理组合物的重量,水的量为约12重量%或更大。
9.根据权利要求1至8中任一项所述的方法,其中所述有机缓冲体系包含羧酸和其一种或多种共轭碱盐,例如其碱金属盐。
10.根据权利要求9所述的方法,其中所述酸选自柠檬酸、乳酸、苹果酸、马来酸、富马酸、乙酸、琥珀酸和酒石酸。
11.根据权利要求9或10所述的方法,其中所述一种或多种共轭碱盐独立地选自钠盐和钾盐或其组合。
12.根据权利要求9至11中任一项所述的方法,其中所述酸为柠檬酸,并且所述一种或多种共轭碱盐包含柠檬酸单钠(单碱)、柠檬酸二钠(二碱)、柠檬酸三钠(三碱)以及其组合。
13.根据权利要求1至13中任一项所述的方法,其中所述组合物包含以所述组合物的重量计0.1%至5.0%的量的所述有机酸缓冲体系,所述量以有机酸和任何共轭碱盐的组合量测量。
14.根据权利要求1至14中任一项所述的方法,其中所述缓冲体系包含呈1∶3至1∶6的比的柠檬酸和柠檬酸钠盐。
15.根据权利要求1至14中任一项所述的方法,其中所述口腔护理组合物还包含磨料。
16.根据权利要求1至15中任一项所述的方法,其中所述口腔护理组合物还包含一种或多种湿润剂。
17.根据权利要求1至16中任一项所述的方法,其中所述口腔护理组合物还包含一种或多种表面活性剂。
18.根据权利要求1至17中任一项所述的方法,其中所述口腔护理组合物还包含有效量的一种或多种碱金属磷酸盐。
19.根据权利要求1至18中任一项所述的方法,其中所述口腔护理组合物还包含增白剂。
20.根据权利要求1至19中任一项所述的方法,其中所述口腔护理组合物还包含除所述磷酸锌之外的一种或多种锌离子源。
21.根据权利要求1至20中任一项所述的方法,其中所述口腔护理组合物是洁齿剂、粉末、乳膏、条、胶或凝胶。
22.根据权利要求1至21中任一项所述的方法,其中所述口腔护理组合物包含:
0.5重量%至3重量%的磷酸锌;
0.05重量%至11重量%的氟化亚锡;
1重量%至8重量%的碱金属磷酸盐,其选自磷酸氢二钠、磷酸氢二钾、磷酸二钙二水合物、焦磷酸四钠、焦磷酸四钾、焦磷酸钙、三聚磷酸钠,和这些中的任何两者或更多者的混合物,所述重量%相对于所述口腔护理组合物的重量;以及
二氧化硅磨料。
23.根据权利要求1至22中任一项所述的方法,其中所述组合物的pH小于7。
24.根据权利要求1至23中任一项所述的方法,其中诱导嗜中性粒细胞募集的所述蛋白质选自由以下组成的组:TNFa和MIF。
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