CN102725026A - 使用口腔光装置治疗和/或预防由微生物引起的病况的方法 - Google Patents
使用口腔光装置治疗和/或预防由微生物引起的病况的方法 Download PDFInfo
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- 230000002588 toxic effect Effects 0.000 description 1
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- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
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- 210000004881 tumor cell Anatomy 0.000 description 1
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- 230000007923 virulence factor Effects 0.000 description 1
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Abstract
公认安全的(GRAS)染料可用作口腔组合物中的光敏染料,以提供抗菌和抗炎功效。实施方案包括:包含光敏染料的口腔护理组合物、制备所述组合物的方法、使用所述组合物的方法和含有所述组合物和发光装置的药盒。
Description
相关申请的交叉引用
本申请要求于2009年12月21日提交的美国专利临时申请号61/288,377的优先权,其通过引用并入本文。
发明背景
广泛使用洁齿剂组合物以提供口腔健康。已用将为使用者提供许多益处的各种各样活性物质配制呈牙膏、口腔清洗剂、口香糖、可食条(edible strip)、粉末、泡沫等等形式的洁齿剂。这些益处中有抗微生物、抗发炎和抗氧化性质。洁齿剂的这些性质使其成为有益的治疗剂以预防或治疗诸如龋齿、牙龈炎、牙菌斑、牙石、牙周病等许多口腔健康病况。
用于洁齿剂组合物的抗菌剂通常包括化学物或天然提取物。开发适宜的抗菌剂时必须克服的主要问题是将药物摄取进细菌细胞中。革兰氏阴性和革兰氏阳性细菌在其外表面组成不同,对抗微生物剂的反应不同,尤其是在摄取方面。由于革兰氏阴性细菌的高负电荷表面,其相对不渗透中性或阴离子药物,包括最常使用的光敏剂。
众所周知,某些有机化合物(“光敏剂”)可在氧存在下通过吸收光来诱导细胞死亡。细胞毒性效应涉及Ⅰ型和/或Ⅱ型光氧化。所述光敏剂与光一起应用于治疗癌症和其它疾病或感染(光动力学治疗或“PDT”),用于通过光线诱导的微生物破坏来对表面和流体进行灭菌(包括消毒)。同样已知,某些有色吩噻嗪 化合物(例如亚甲基蓝)可参与I型和II型光氧化过程,但迄今为止,证明这类化合物作为光动力学治疗的光敏剂是不合适的或低效的,或表现出低光化学抗微生物活性。为了在PDT中应用,良好的光敏剂必须具有下面性质中的至少一些,优选全部。最重要的是,当暴露在光下时它应该有效导致靶细胞(例如肿瘤细胞或细菌细胞)的破坏。使用光敏剂的PDT治疗应该显示出靶组织和正常组织之间的高度选择性。敏化剂应该具有相对弱的暗毒性,在患者中其应该导致很少的或无皮肤光敏性。敏化剂应该具有短的药物对光的间隔以方便患者和医院,并使治疗费用最小化。
在细菌中研究了许多不同种类的光敏剂。这些包括吩噻嗪化合物、酞菁、二氢卟酚和天然存在的光敏剂。对于革兰氏阴性细菌的摄取,公认阳离子衍生物最有效。吩噻嗪化合物是最大吸收波长在600-700 nm之间的蓝色染料。已研究过吩噻嗪化合物的非光动力学抗菌性质,但除亚甲基蓝和甲苯胺蓝外别的很少进行了光动力学研究。然而,亚甲基蓝和甲苯胺蓝是极其有毒的。因此,需要更安全的备选光敏剂用于口腔护理应用中。
认为各种各样的口腔病症(包括牙菌斑)是由细菌引起的。牙龈炎是牙龈和支撑牙齿的牙槽骨的炎症或感染。通常认为牙龈炎是由口腔中的细菌(特别是促使牙菌斑形成的细菌)和作为细菌副产物形成的毒素引起的。认为毒素在口腔内促使口腔组织炎症。与牙龈炎比较,牙周炎是疾病的渐进恶化状态,其中牙龈发炎,开始从牙齿消退并形成袋,这最终可致使骨和牙周韧带破坏。牙齿支持结构的细菌感染可包括牙龈炎和牙周炎,但也可包括骨感染,例如因手术干预导致的下颌骨的感染。而且,口腔组织炎症可由手术、局部损伤、外伤、坏死、不当口腔卫生或各种全身性起因引起。
通常认为这些疾病和病况牵涉到的细胞组分包括上皮组织、牙龈成纤维细胞和循环白细胞,所有这些有助于宿主对由细菌产生的致病因子的应答。这些口腔感染中牵涉到的最常见的细菌病原体为:链球菌(Streptococci spp.)(例如变形链球菌(S. mutans))、卟啉单胞菌(Porphyromonas spp.)、放线杆菌(Actinobacillus spp.)、拟杆菌(Bacteroides spp.)和葡萄球菌(Staphylococci spp.)、具核梭杆菌(Fusobacterium nucleatum)、小韦荣氏球菌(Veillonella parvula)、内氏放线菌(Actinomyces naeslundii)和牙龈卟啉单胞菌(Porphyromonas gingivalis)。虽然在这些口腔疾病的很多中,细菌感染常常是病原学事件,但疾病的发病机理由宿主应答介导。循环多形核中性白细胞(PMN)是造成在感染位点发现的过兴奋的主要原因。通常PMN和其它炎症细胞介质变得机能亢进并释放毒性化学物,所述毒性化合物一定程度上造成感染病灶周围组织的破坏。
有多种本领域所述用于预防和治疗起因于细菌感染的口腔病症的组合物。具体而言,为了防止源自花生四烯酸途径的炎性介质的积累,已将非甾体抗炎药物(NSAID)成功用于治疗患有由花生四烯酸代谢物引起的牙周病和炎性疾病的患者。实验和临床数据显示,在牙疾病模型中,吲哚美辛、氟比洛芬、酮洛芬、布洛芬、萘普生和甲氯芬那酸对牙槽骨丧失有显著的改善作用并减少前列腺素和白细胞三烯。然而,定期使用NSAID的一个主要缺点是胃灼热(heartburn)、胃溃疡、胃肠出血和毒性的潜在发展。
其它治疗方法包括使用抗微生物治疗剂和抗生素以去除潜在的感染。某些抗生素和其它抗微生物治疗剂可能导致口腔黏膜溃疡、诱导剥脱性龈炎、脱色、长期使用后的可能的抗生素抗性以及因刺激而起的组织炎症恶化。
已建议使用不同波长和强度的光来美白牙齿、治疗牙菌斑和/或附于细菌上并在照射时显露细菌以便使用者可看到牙菌斑集中的区域。已建议仅使用光来处理细菌,或通过使用光敏剂(例如亚甲基蓝或甲苯胺蓝)和光源一起作为抗菌剂来处理细菌。参见例如美国专利号5,611,793、6,616,451、7,090,047、7,354,448和美国专利申请公开号2004/0091834、2006/0281042、2006/0093561和2009/0285766,其全部内容以其整体通过引用并入本文。这些系统中很多使用具有固有危险性的激光,或使用具有对使用者或口腔表面产生非所需热量的波长和强度的光。因此,存在开发安全有效的光敏组合物的需要,所述光敏组合物利用相对低强度的光源,其在使用时不对使用者的手或口腔造成损害。
发明概述
现已发现公认安全的(GRAS)染料,当照常例将其作为着色剂用于口腔护理组合物中时,在可吸收的可见光照射时具有强抗菌活性,且抗菌活性的给予极为迅速,优选少于2分钟。本发明者亦发现在没有照射时,本文所述GARS染料是不活动的,表现出很小或无抗菌活性。然而,在可吸收的可见光存在时其抗菌性质被开启。
根据一个实施方案特征,提供光学透明(optically clear)的口腔组合物,所述组合物包含至少一种光敏染料、氧气发生器(oxygen generator)或氧载体和口腔可接受的光学透明载体。根据另一实施方案,口腔可接受的载体具有与唾液基本相似的折光率,以提供具有与唾液基本相似的折光率的口腔组合物。
本发明亦提供本发明任一方面的光学透明口腔组合物用于制备用于治疗和/或预防受试者中由微生物引起的病况的药物的用途,所述治疗和/或预防包含:a)给予光学透明口腔组合物;和b)用被至少一种光敏染料吸收的波长的光照射给予所述组合物的区域。
所述组合物可用于治疗和/或预防受试者口腔中由微生物引起的病况。例如,所述组合物可用于治疗和/或预防牙周病况、牙龈病况和/或口臭病况。例如,所述病况包括但不限于牙龈炎、牙菌斑形成、牙洞形成、牙周炎、龋齿、根龋、牙根管感染、根尖牙周炎等等。所述组合物亦可用于控制龋齿损害深处的细菌,或去除细菌生物膜。
本发明某些实施方案亦包括治疗和/或预防受试者中由微生物引起的病况的方法,其中所述方法包括用波长为380 nm-780 nm、剂量为1 J/cm2-450 J/cm2和功率密度为约1 mW/cm2-约500 mW/cm2的可见光照射疑似含有微生物的口腔区域达1秒到120分钟的时间。另一实施方案包括将光敏染料给予口腔,然后用光照射给予所述染料的区域。因此,该实施方案包括:a)给予本发明任一方面的光学透明口腔护理组合物;和b)用被所述至少一种光敏染料吸收的波长的光照射给予所述组合物的区域。在一些实施方案中,所述方法包括仅用足以减少炎症和/或减少或去除细菌的波长的光照射发炎组织或含菌组织。
所述方法可用于治疗和/或预防受试者口腔中由微生物引起的病况。例如,所述方法可用于治疗和/或预防牙周病况、牙龈病况和/或口臭病况。例如,所述病况包括但不限于牙龈炎、牙菌斑形成、牙洞形成、牙周炎、龋齿、牙根龋、牙根管感染、根尖牙周炎等等。所述方法亦可用于控制龋齿损害深处的细菌,或去除细菌生物膜。
可以将一定量的所述至少一种光敏染料包括于光学透明口腔护理组合物中。实施照射程序的时间可为120分钟或更短。例如,照射可实施1秒钟至120分钟,在一些情况下,在2秒钟至15分钟之间。实施照射的时间视所用光敏染料的类型和所用光的类型而定。
在一些实施方案中,照射过程所用的光通常具有介于380 nm-1450 nm之间的波长,更优选400 nm-780 nm。步骤(b)中所用光的剂量可介于1 J/cm2-450 J/cm2之间,且功率密度为1-500 mW/cm2。
根据另一实施方案,本发明亦提供用于治疗和/或预防受试者中由微生物引起的病况的药盒,所述药盒包括放置于至少一个适宜的容器中的本发明任一方面的光学透明口腔护理组合物。所述组合物在使用时应该是光学透明的。药盒可进一步包括能够发射适当波长、呈适当剂量和具适当功率的光的发光装置。发光装置可包括于施用器(applicator)中,所述施用器能够将光学透明口腔护理组合物施用到口腔,然后也能够照射给予所述组合物的区域。药盒可用于治疗和/或预防受试者口腔中由微生物引起的病况。例如,药盒可用于治疗和/或预防牙周病况、牙龈病况和/或口臭病况。所述病况包括前面提到的病况,药盒可用于控制龋齿损害深处的细菌,或去除细菌生物膜。
根据本发明实施方案的另一特征,提供了制备本发明任一方面的光学透明口腔护理组合物的方法。所述方法可包括:a)通过让载体组分以充分将所述组分分散以产生光学透明的载体的方式混合,来制备口腔可接受的光学透明的载体;和b)将至少一种光敏染料添加到a)所述混合物中。
所述实施方案提供许多优于已知抗菌治疗的优点。实施方案不使用有毒或不安全的光敏剂。实施方案亦提供使用比激光或其它高能量发光装置更安全的可见光谱中较低能量光的有效抗菌治疗。另外,可将较低浓度活性成分(GRAS染料/光敏剂)用于牙周袋,而不像传统抗微生物剂需要高浓度作用很多小时。这是相对于先前技术的重要区别,先前技术在口腔护理中使用抗微生物剂,其中绝大多数随时间推移而衰竭。所述光敏剂可像催化剂一样重复使用,产生充足的单线态氧或其它有抗微生物益处的自由基种类。这些和其它优势可通过使用本文所述实施方案来获得。
根据下文所提供的详述,本发明实用性的更多方面将变得清楚名明了。应该了解,详述和具体实施例当表明本发明优选实施方案时,仅意在阐明目的,并非意欲限制本发明范围。
详述
在检阅本文所提出的本发明详述时必须考虑以下定义和非限制性指导方针。本文所用标题(例如“背景”和“概述”)和副标题(例如“组合物”和“方法”),仅意在用于本发明公开内容中主题的大体结构,并非意欲限制本发明公开内容或其任一方面。具体而言,“背景”中公开的主题可包括本发明范围内的技术方面,并且可不构成对先前技术的叙述。“概述”中公开的主题不是本发明整个范围或其任一实施方案的详尽或完整公开内容。本说明书章节中将材料归类和讨论为具有特定效用(例如作为“活性”或“载体”成分)仅为方便起见,不应该得出以下推论:当所述材料在任何给定组合物中使用时必须必然地或只能根据其在本文的归类起作用。
本文中参考文献的引用并非承认:所述参考文献是先前技术或与本文所公开的发明的专利性有任何关系。引言中对引用的参考文献内容的任何讨论仅意在提供参考文献作者所作主张的大体概括,并非承认这些参考文献内容的准确性。
详述和具体实施例尽管指明本发明实施方案,但仅意在阐明目的,并非意欲限制本发明范围。此外,叙述许多具有所述特征的实施方案,并非意欲排除具有另外特征的其它实施方案,或合并了所述特征不同组合的其它实施方案。除非另外明确指出,否则提供具体实施例是为了阐明如何制造和使用本发明的组合物和方法的目的,并非意欲表示已经实施过或测试过或未曾实行过或测试过的本发明特定实施方案。
本文所用词语“优选的”和“优选地”,指在某些情形下提供某些益处的本发明实施方案。然而,在相同或其它情形下,亦可能优选其它实施方案。此外,叙述一种或多种优选实施方案并不意味着其它实施方案无用,且并非意欲从本发明范围中排除其它实施方案。此外,所述组合物和方法可包括其中所述要素、基本上由或由其中所述要素组成。
贯穿全文所用的范围被当作描述范围内的各自及每一个数值的速记。可选择范围内的任意值作为范围的边界。此外,本文所引用的所有参考文献都以其整体通过引用并入本文。在本公开内容的定义与被引用参考文献的定义发生冲突时,以本公开内容为准。
除非另外规定,否则本文或本说明书中其它地方表述的所有百分比和量应理解为指重量百分比。给定的量基于材料的有效重量。本文叙述的具体数值,不论是涉及各组分的相应量,还是实施方案的其他特征,意在表示该值加上或减去一定程度的变异性以解释测量误差。例如,给定测量误差程度,10%的量可包括9.5%或10.5%,所述测量误差为本领域普通技术人员所领会和了解。
本文所用“抗菌活性”,在本文中意指通过任何公认的体外或体内抗菌测定或测试所测定的活性。本文“抗炎活性”意指通过任何公认的体外或体内测定或测试所测定的活性,例如抑制前列腺素生成或环加氧酶活性的测定或测试。本文“抗氧化剂活性”意指通过任何公认的体外或体内抗氧化剂测定或测试所测定的活性。
本文“口腔表面”包括口中任何软或硬表面,包括舌表面、硬腭和软腭、颊粘膜、齿龈和牙齿表面。本文“牙齿表面”为天然牙齿表面或人工牙齿的硬表面,包括牙冠、牙帽、牙填充物、牙桥、假牙、牙齿植入物等等。关于口腔组织病况例如炎症的本文术语“抑制”包括预防、压抑病况、降低病况的程度或严重性或改善病况。
本发明口腔护理组合物可采取适于应用到口腔表面的任何形式。在各种阐明性的实施方案中,组合物可以是适于冲洗、漱洗或喷雾的液体溶液剂;洁齿剂,例如粉剂、牙膏或牙凝胶剂;牙周凝胶剂;适于涂抹到牙齿表面的液体(例如液体增白剂);口香糖;可溶、部分可溶或不可溶的膜或条(例如增白条);珠粒(例如明胶包封的组合物);糯米纸囊剂(wafer);锭剂、拭子(wipe)或小毛巾;植入物;口腔清洗剂、泡沫剂、牙线;等等。组合物可含有上述成分之外的活性和/或载体成分。
优选口腔护理组合物包含选自以下的那些:洁齿剂、口腔清洗剂、口腔条(oral strip)、锭剂、珠粒、脂质体、胶团、反胶团、微胶囊化容器或纳米胶囊化容器、酶、蛋白质、细菌靶向肽/小分子、凝胶、溶胶-凝胶、水凝胶、二氧化硅、有机沸石、无机二氧化硅(例如存在于洁齿剂中的那些)、表面涂料(paint-ons)、口腔贴剂、聚合物、喷雾剂、烟雾吸入装置、泡沫、口香糖(来自牙刷头背部或经由牙刷头)、油或用于口腔卫生或益处的其它产品。这些产品亦可包括内源含有或可掺入用于口腔治疗的吸光物质的食料、液体和益生菌(probiotic)。
贯穿本说明中的表述“光学透明的”,意指具有接近或等于清澈或透明材料的澄清度的物质,但所述组合物可能是有颜色的。优选通过测量穿过组合物总厚度的总亮度透射和/或雾度(散射传播的可见光%)来测定澄清度。优选总亮度透射范围为80-100尤其是85-95,雾度范围为<3.5%且特别优选<2.5%。
亦优选本发明光学透明组合物当与穿过透明装置(例如透明膜或玻璃)的光透射比较时不显著降低光密度。例如,当与透射过透明载玻片的光的量相比时,透射过口腔护理组合物的光的量可降低不到40%,优选不到25%,更优选不到10%。当与透射过透明装置的光量相比时,透射过使用光敏染料的洁齿剂浆液的光量可减少不到20%,更优选不到10%,最优选不到8%。在一些情况下,透射过使用光敏染料的洁齿剂浆液的光可增加,而不是减少。
为清晰和方便起见,本文将成分归类为活性剂或载体成分,但不应该得出以下推论:具体的成分在组合物中必然根据其在本文的归类而起作用。此外,具体的成分可有很多种功能,因此,本文作为例示一种功能类别的成分的公开,并不排除其亦可例示另一功能类别的可能性。
本文所述实施方案包括光学透明口腔组合物,所述组合物包含至少一种光敏染料、氧气发生器或氧载体和口腔可接受及光学透明的载体。其它实施方案考虑上述口腔组合物,但口腔可接受的载体具有与唾液基本相似的折光率,以提供具有与唾液基本相似的折光率的口腔组合物。
本文所述口腔护理组合物优选由限制光散射量和程度的成分组成。这将使抗菌或抗牙龈炎功效所需的光剂量最小化,从而减少光密度和口腔光装置中提供光动力必需的总体能量消耗。例如,在一个实施方案中,洁齿剂将是光学透明的;在另一个实施方案中,制剂浆液的折光率将与口腔中唾液的折光率很匹配。因此,可用于折光率匹配的成分将在洁齿剂中尤其有益,例如山梨醇、甘油、聚乙二醇(PEG) 600。应该优选将研磨和遮光成分例如二氧化硅减少到最少(通常少于3%重量),或用其它不透明程度较低的研磨剂例如透明的、研磨水凝胶微球和/或珠粒来取代。洁齿剂优选由在所需光波长下增强光透射和/或不显著减少光透射的成分组成。
口腔护理组合物亦可含有氧气发生器或氧载体。氧气发生器是能产生氧气的化合物,氧载体是能运输氧的化合物,两者都用于增加氧的可利用性并因此增加单线激发态的产率。适宜的氧气发生器或氧载体包括例如氢氟烷、全氟化碳或其混合物。适宜的化合物包括但不限于全氟十氢化萘、全氟萘烷、全氟己烷、八氟丙烷、全氟丁烷、全氟辛烷、全氟癸烷、全氟甲基萘烷、稀次氯酸钠、过氧化氢和其它过氧化物、DMSO、二氧化氯及其混合物。可用于本文所述组合物中的成分亦优选增加光敏染料的三线态寿命,或光敏染料的量子产率。
优选用有助于结合和/或递送光敏染料到所需目的地的成分来制备制剂,所述目的地为含有生物膜的口腔的硬和/或软组织。例如,可用靶向蛋白质、肽和其它分子的细菌来将染料运送到细菌位点。实施方案的这一方面在当细菌存在于口腔中难以到达位点时尤为有用。在一个实施方案中,可将光敏染料并入食物或口香糖中,或可使用富含这类染料的食料。已知含有光敏剂(例如光敏染料)的食料实例包括但不限于欧芹、欧洲防风草、西红柿和胡萝卜。
光敏染料亦可是水溶性,散布于洁齿剂中,或包含于散布在整个洁齿剂的珠粒、条或小容器中。可使用对所用光的波长和光学剂量及对光敏剂稳定的洁齿剂香料成分。该香料优选不被该波长的光吸收。此外,洁齿剂可含有不止一种光敏染料或光敏剂,以便为不同消费者提供可接受的颜色。洁齿剂制剂可含有例如氧化钛,以在仍保持相同浓度GRAS染料时对消费者而言减弱颜色强度。然而,如果使用二氧化钛,其使用量就应该足够低以维持组合物的光学澄清度。
可用于本发明的光敏染料优选具有以下一个或多个特征。优选染料具有高消光系数(>10 L mol-1 cm-1。例如,核黄素的摩尔消光系数为约10,000;β-胡萝卜素为180,000 L mol-1 cm-1)。染料优选对其三线激发能态具有高量子产率(0.05,最大1.0)。此外,染料的三线态能量寿命应足够长,以允许产生高反应性的细胞毒性物质来破坏微生物。最后,优选染料具有高产率的单线态氧1O2、超氧化物O2 -和其它破坏性自由基或非自由基物质。“A compilation of singlet oxygen yields from biologically relevant molecules” (“来自生物学相关分子的单线态氧产率的选编”) Photochemistry & Photobiology, 1999, 70(4), 391-475一文阐述了光敏剂的典型量子产率、单线态氧的系间窜越和形成的速率和产率。
光敏染料的其它有用特征包括以下。染料应仅在光激活作用时有毒,并且应具有最小暗毒性。染料应提供低全身毒性,被靶微生物选择性且迅速地定位和固定,用于重复的光照射周期而无光漂白作用。染料亦应对硬组织或软组织提供很小的或无染色作用,以避免任何不良副作用或不希望的美容染色。染料亦应不会被细胞、口腔中的其它物质吸收或淬灭至任何可觉察程度或在产品配制时被吸收或淬灭至任何可觉察程度。亦优选光敏染料为化学纯并具有已知组成。
任何具有一种或多种上述鉴定特征的光敏染料可用于本发明实施方案中。所述光敏染料为公认安全的或GRAS光敏染料,因而排除通常有毒的染料例如亚甲基蓝或甲苯胺蓝。用于本发明的光敏剂可具有380 nm及以上的最大吸收波长。活性物亦可为荧光性的。可展现磷光的活性物可能特别有益,因为其高的三线态能量寿命将转变为增加其能量转移到基态氧的效率,因此相应提高单线态氧的产率,这将导致光疗法效率的提高。用于本发明的代表性GRAS化合物示于下表1中。
表1
光敏染料(GRAS)
作为一类化合物的总称的花青苷类亦可用于光触发消灭细菌。很多花青苷类用作食品添加剂。事实上,用于软饮料中的色素例如含有很多不同食物染料添加剂的Kool Aid?亦可与光联合使用来消灭细菌。因此,可将富含所述化合物的口腔清洗剂的应用与光联合用于提供有效的口腔卫生。天然食品色素、色淀食品色素、合成食品色素都可用于通过特定使用所需波长的光、光功率和照射时间来辅助消灭细菌。
亦可将细菌中存在的内源生色团加入递送载体中以增强光介导的细菌消灭的功效和效率,而不管递送载体是洁牙剂还是口腔清洗剂。内源生色团例如卟啉类可包括例如八羧基尿卟啉、七羧基卟啉、六羧基卟啉、五羧基卟啉、粪卟啉四羧基卟啉、硬卟啉三羧基卟啉(Herderoporphyrin tricarboxyl porphyrin)、原卟啉二羧基卟啉及其混合物。
在例如以下文献中公开了亦可作为新型抗菌活性物起作用的另外的化合物(但不是所有都必须为GRAS)用于消灭微生物:Photochemistry & Photobiology, 1999, 70(4), 391-475 “A compilation of singlet oxygen yields from biologically relevant molecules” (“来自生物学相关分子的单线态氧产率的选编”)。下表2中列出了可用于本发明的一些已知光敏剂。
表2
光敏剂类型 | 波长范围(nm) |
吖啶 | 400-500 |
吩嗪 | 500-550 |
青色素 | 500-900 |
吩噻嗪 | 590-670 |
卟啉 | 600-690 |
酞菁 | 660-700 |
因此,光敏染料可选自:叶绿酸钠铜盐、酒石黄(FD&C黄5号)、姜黄素、核黄素5'-单磷酸钠盐、诱惑红AC (FD&C红40号)、新胭脂红(CI 16255,食品红7)、铬变素FB (CI 14720,食品红3)、靛胭脂、羊毛罂红二钠盐(FD&C蓝1号)、固绿FCF (FD&C绿3号)、丽丝胺绿B、萘酚绿或酸性绿、胭脂虫红、酸性红偶氮玉红、苋菜红、亮猩红4R、叶绿素和铜络合物、亮黑BN (PN)、巧克力褐HT、β-胡萝卜素、红木素、番茄红素、甜菜苷、核黄素、藻红B钠盐、TiO2锐钛矿P25 Degussa、花青苷类、八羧基尿卟啉、七羧基卟啉、六羧基卟啉、五羧基卟啉、粪卟啉四羧基卟啉、硬卟啉三羧基卟啉、原卟啉二羧基卟啉、吖啶、吩嗪、青色素、吩噻嗪、卟啉、酞菁及其混合物。
优选光敏染料选自叶绿酸钠铜盐、酒石黄(FD&C黄5号)、姜黄素、核黄素5'-单磷酸钠盐、诱惑红AC (FD&C红40号)、新胭脂红(CI 16255,食品红7)、铬变素FB (CI 14720,食品红3)、靛胭脂、羊毛罂红二钠盐(FD&C蓝1号)、固绿FCF (FD&C绿3号)、丽丝胺绿B、萘酚绿或酸性绿、胭脂虫红、酸性红偶氮玉红、苋菜红、亮猩红4R、叶绿素和铜络合物、亮黑BN (PN)、巧克力褐HT、β-胡萝卜素、红木素、番茄红素、甜菜苷、核黄素、藻红B钠盐及其混合物。更优选光敏染料选自酒石黄、姜黄素、诱惑红、固绿FCF及其混合物。
光敏染料可以以在用适当波长的光以适当剂量及功率密度照射适当时间时,有效提供抗菌效应的浓度存在于光学透明口腔护理组合物中。优选染料存在的量的范围为基于组合物总重量的0.0001-2.0%重量。更优选染料存在的量的范围为0.001-1.0%重量,甚至更优选0.05-0.5%重量。
照射程序可使用任何适宜的光。例如,可使用低功率光源或二极管激光光源。可使用任何适宜的的光,例如可见或红外激光。亦可使用高能量不可见光,例如钨卤素或氙弧光源。亦可使用LED光源。使用LED光源的优点是其将降低产生不舒适热的可能性,因此导致降低受试者的不适。可对整个受影响区域实施照射程序。尤其是优选对口腔整个内部实施照射。例如,可对光源进行操作以便照射可达到的内表面。或者,仅照射一些区域。例如,可照射区域的个别牙周袋。光源可能适合于照射口腔的所有区域,包括舌下和肉覆盖的舌、唇、口腔的前后区域各处及咬合表面各处。
优选光源发射380 nm-1450 nm范围内波长的光,更优选400 nm-780 nm (即可见光谱)波长的光。步骤(b)中所用的光剂量可在1 J/cm2-450 J/cm2范围内,且功率密度为1-500 mW/cm2。优选光源为发光二极管(LED)形式,其剂量和功率密度要足以激活光敏染料,但又不能过于强大以致于损害所处理区域。优选LED是因为通过用外部电源改变流过LED的电流,可获得各种波长的光(通常以10 nm变化)和各种光功率输出。
所用光的波长将视光敏染料的最大吸收波长而变化。如果光敏染料具有不止一个明显的吸收谱带,则可在那些波长下单独地或一个吸收波长接着另一个波长序贯地或用多个波长的光同时激活染料。在某些情况下,可能优选脉冲光,尤其是在高剂量的发射光通过以氧消耗快于氧补充的速率生成单态氧而限制了抗菌功效程度的时候,所述抗菌功效来源于单态氧或其它氧依赖性的反应部分。氧气发生器或氧载体的使用优选提高用光进行的抗菌作用。
优选用适当波长的光照射实施方案的组合物达120分钟或更短。例如,照射可实施1秒至120分钟,在某些情况下,为2秒至15分钟。优选用适当波长的光以1-450 J/cm2,更优选1-100 J/cm2,更优选10-50 J/cm2,最优选15-45 J/cm2的能量剂量照射组合物。应优选用具有1-500 mW/cm2光功率密度的适当波长的光照射组合物,所述光功率密度更优选1-400 mW/cm2,甚至更优选1-50 mW/cm2,最优选3-15 mW/cm2。
可使用适于发射如上所述波长、能量剂量和光功率的光的任何装置,包括牙刷、微型牙刷、小铅笔或钢笔型装置。备选光源包括能够立刻照射口腔的大部分的发光治疗装置,例如以下文献中所述的那些装置:美国专利号5,487,662、4,867,682、5,316,473、4,553,936和美国专利申请公开号2006/0093561、2006/0281042、2004/0091834和2009/0285766,其每一个的公开内容通过引用以其整体并入本文。可使用的可手动操作将光递送到口中各个区域的其它发光治疗装置包括:光纤棒、枪或光导管;远光引擎,其利用基于石英卤素、汞氙、氙、金属卤化物、硫磺形式的光产生方式或其它发光二极管技术(LED);由许多单独光纤元件组成的柔韧的光管或液体光管;和含有发光二极管的其它牙印模发射架。虽然可使用各种光装置,但应了解的是所述光装置应该能够递送有效剂量的有效波长光。因此,较高强度的光可与脉冲光递送联合使用,或较低强度的光与连续光递送联合使用。选择由发光治疗装置发射的光的光谱,以使与所用光敏染料的具体吸收曲线匹配。可使用带通滤波器来消除不被光敏剂吸收的波长。
预期优选的发光治疗装置基于LED,且可被制成使患者舒适并对牙医和/或牙科卫生人员而言易于施用的各种形状。预期可自携带包封的散射凝胶(其如本领域所知)的标准牙科口板制得适宜的光装置,当使用该装置时,凝胶被压向齿龈。LED可直接包埋入凝胶中,朝向齿龈组织放置。散射介质应确保光在均一横截面中传送到齿龈组织表面。与LED的电子连接可对口前部之外的牙板进行。或者考虑,光源可呈与LED偶联的光纤或其它光导管形式,所述光纤或其它光导管的末端在散射凝胶内。
本发明某些实施方案包括治疗和/或预防受试者中由微生物引起的病况的方法,其中所述方法包括:a)给予本文所述的光学透明口腔护理组合物;和b)用被至少一种光敏染料吸收的波长的光以适当剂量和光功率密度照射给予所述组合物的区域达有效时间。
所述方法可用于治疗和/或预防受试者口腔中由微生物引起的病况。例如,所述方法可用于治疗和/或预防牙周病况、牙龈病况和/或口臭病况。例如,所述病况包括但不限于牙龈炎、牙菌斑形成、牙洞形成、牙周炎、龋齿、根龋、牙根管感染、根尖牙周炎等等。所述方法亦可用于控制龋齿损害深处的细菌,或清除细菌生物膜。
本文所述实施方案亦设计用于治疗和/或预防受试者中由微生物引起的病况的药盒,所述药盒包括放置于至少一个适宜的容器中的本文所述光学透明口腔护理组合物。药盒可进一步包括能够发射适当波长、呈适当剂量和具适当光功率密度的光的发光装置。发光装置可包括在施用器中,所述施用器能够将光学透明口腔护理组合物施用到口腔,然后也能够照射给予所述组合物的区域。药盒可用于治疗和/或预防受试者口腔中由微生物引起的病况。例如,药盒可用于治疗和/或预防牙周病况、牙龈病况和/或口臭病况。所述病况包括前面提到的病况,药盒可用于控制龋齿损害深处的细菌,或清除细菌生物膜。
本发明另外的特征包括制备光学透明口腔护理组合物的方法,所述方法通过以下步骤来进行:a)通过让载体组分以充分将所述组分分散以产生光学透明的载体的方式混合,来制备口腔可接受的光学透明的载体;和b)将至少一种光敏染料加到a)所述混合物中。
在各种实施方案中,所述光学透明组合物可用传统洁齿剂组分配制,所述洁齿剂组分包括例如至少一种保湿剂、至少一种研磨材料等等。在各种实施方案中,所述光学透明口腔护理组合物不包括另外的抗菌剂,但其使用是任选的。如果使用另外的抗菌剂,所述组合物可进一步包含选自以下的抗菌剂:天然提取物、氯化十六烷基吡啶、多酚、酚类化合物、亚锡离子、锌离子等等。
本文所述的组合物可用任选的其它成分配制,所述其它成分包括但不限于防龋剂、防牙垢剂或牙垢控制剂、阴离子羧酸盐聚合物、粘度调节剂、表面活性剂、食用香料、色素、信号(香味、颜色、光、热、气味和表明组合物有效或有利使用的其它信号)、治疗口干的试剂等。加入任选成分的前提是其加入后组合物仍保持光学透明。即所述成分不应对组合物的光学澄清度产生不利影响。本发明者发现多于6%的量的二氧化硅研磨剂对组合物的光吸光度产生不利影响,因此,优选使用1-6%的二氧化硅研磨剂,更优选1-4%的二氧化硅研磨剂,甚至更优选1-3%的二氧化硅研磨剂,最优选少于2%的二氧化硅研磨剂。
在各种实施方案中,所述组合物包含口腔可接受的氟离子源,其用作防龋剂。可存在一种或多种这样的来源。合适的氟离子源包括氟化物、单氟磷酸盐和氟硅酸盐以及胺氟化物,包括奥拉氟(olaflur)(N'-十八烷基三亚甲基二胺-N,N,N'-三(2-乙醇)-二氢氟化物)。
作为防龋剂,一种或多种释放氟化物的盐任选以提供总共100-20,000 ppm、200-5,000 ppm或500-2,500 ppm氟离子的量存在。当氟化钠是所含有的唯一的释放氟化物的盐时,所述组合物中所含氟化钠的说明性含量可为0.01%重量至5%重量、0.05%重量至1%重量、或0.1%重量至0.5%重量。可使用其它防龋剂,例如精氨酸和精氨酸衍生物(例如乙基月桂酰精氨酸(ELAH))。
本文可用的酚类化合物说明性地包括,进行口腔可接受性测定的,并被Dewhirst (1980), Prostaglandins 20(2), 209-222鉴定为具有抗炎活性的那些,但不限于此。抗菌的酚类化合物的实例包括4-烯丙基儿茶酚、对羟基苯甲酸酯包括对羟基苯甲酸苄酯、对羟基苯甲酸丁酯、对羟基苯甲酸乙酯、对羟基苯甲酸甲酯和对羟基苯甲酸丙酯、2-苄基酚、丁基羟基茴香醚,丁基羟基甲苯、辣椒素、香芹酚、木焦油酚、丁香酚、愈创木酚、卤代双酚类包括六氯酚和溴氯酚(bromochlorophene)、4-己基间苯二酚、8-羟基喹啉及其盐、水杨酸酯包括水杨酸薄荷酯、水杨酸甲酯和水杨酸苯酯、酚、焦儿茶酚、水杨酰苯胺和百里酚。这些酚类化合物通常存在于上述一种或多种天然提取物中。
至少一种酚类化合物任选以0.01%重量至10%重量的总量存在。至少一种酚类化合物在本发明的牙膏或凝胶洁牙剂或口腔清洗剂中的说明性总浓度可以是0.01%至5%、例如0.1%至2%、0.2%至1%、或0.25%至0.5%。
其它适宜的抗菌剂包括但不限于:铜(II)化合物例如氯化铜(II)、氟化铜(II)、硫酸铜(II)和氢氧化铜(II)、锌离子源例如乙酸锌、柠檬酸锌、葡萄糖酸锌、甘氨酸锌、氧化锌、硫酸锌和柠檬酸锌钠、邻苯二甲酸及其盐例如邻苯二甲酸单钾镁、海克替啶、奥替尼啶、血根碱、苯扎氯铵、度米芬、氯化烷基吡啶例如氯化十六烷基吡啶(CPC) (包括CPC与锌和/或酶的组合)、氯化十四烷基吡啶和氯化N-十四烷基-4-乙基吡啶、碘、磺酰胺、双双胍类(bisbiguanides)例如阿来西定、氯己定和葡萄糖酸氯己定、哌啶子基衍生物例如地莫匹醇和辛哌醇、木兰提取物、葡萄籽提取物、薄荷醇、香叶醇、柠檬醛、桉树脑、抗生素例如力百汀、阿莫西林、四环素、多西环素、米诺环素、甲硝唑、新霉素、卡那霉素和氯林肯霉素等。有用抗菌剂的进一步说明性的列表在以下文献中提供:美国专利号5,776,435 (Gaffar等),其通过引用并入本文。如果存在的话,这些额外的抗微生物剂以抗微生物有效总量存在于组合物中,有效总量通常为0.05%重量至10%重量,例如0.1%重量至3%重量。
在另一个实施方案中,所述组合物包含口腔可接受的防牙垢剂。可存在一种或多种这样的试剂。合适的防牙垢剂包括但不限于磷酸酯和多磷酸酯(例如焦磷酸酯)、聚氨基丙磺酸(AMPS)、柠檬酸锌三水合物、多肽例如聚天冬氨酸和聚谷氨酸、聚烯烃磺酸酯、聚烯烃磷酸酯、二膦酸酯例如氮杂环烷-2,2-二膦酸酯(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)和乙烷-1-氨基-1,1-二膦酸、膦酰基链烷羧酸和任何这些试剂的盐,例如它们的碱金属盐和铵盐。有用的无机磷酸盐和多磷酸盐说明性地包括磷酸二氢钠、磷酸氢二钠和磷酸三钠、三聚磷酸钠、四聚磷酸钠、焦磷酸单钠、焦磷酸二钠、焦磷酸三钠、焦磷酸四钠、焦磷酸二氢二钠、三偏磷酸钠、六偏磷酸钠等,其中钠可任选被钾或铵取代。其它有用的防牙垢剂包括阴离子聚羧酸盐聚合物。阴离子聚羧酸盐聚合物在碳骨架上含有羧基并包括丙烯酸、甲基丙烯酸和马来酸酐的聚合物或共聚物。非限制性实例包括聚乙烯甲基醚/马来酸酐(PVME/MA)共聚物,例如可以来自ISP, Wayne, NJ.的Gantrez?牌获得的那些。再其它有用的防牙垢剂包括掩蔽剂包括羟基羧酸例如柠檬酸、富马酸、苹果酸、戊二酸和草酸及其盐和氨基多羧酸例如乙二胺四乙酸(EDTA)。一种或多种防牙垢剂任选以防牙垢有效总量存在于组合物中,所述总量通常为0.01%重量至50%重量、例如0.05%重量至25%重量、或0.1%重量至15%重量。
在各种实施方案中,防牙垢系统包括三聚磷酸钠(STPP)和焦磷酸四钠(TSPP)的混合物。在各种实施方案中,TSPP/STPP的比例范围为1:2至1:4。在一个优选的实施方案中,第一防牙垢活性成分TSPP以1-2.5 %存在,而第二防牙垢活性成分STPP以1-10%存在。
在一个实施方案中,阴离子聚羧酸盐聚合物以0.1%至5%存在。在另一个实施方案中,阴离子聚羧酸盐聚合物以口腔护理组合物的0.5%至1.5%,最优选1%存在。在依照本发明的一个实施方案中,防牙垢系统包括马来酸酐和甲基乙烯醚的共聚物,例如上述Gantrez S-97产品。
在各种实施方案中,TSPP/STPP/合成阴离子聚羧酸盐的比例范围为5:10:1至5:20:10 (或1:4:2)。在一个实施方案中,口腔护理组合物的防牙垢系统包含比例为1:7:1的TSPP、STPP和聚羧酸盐例如马来酸酐和甲基乙烯醚共聚物。在一个非限制性实施方案中,防牙垢系统基本上由以0.5%至2.5%存在的TSPP、以1%至10%存在的STPP和以0.5%至1.5%存在的马来酸酐和甲基乙烯醚共聚物组成。
在另一个实施方案中,所述组合物包含口腔可接受的亚锡离子源,其可用于例如有助于减少牙龈炎、牙菌斑、牙石、龋齿或敏感。可存在一种或多种这样的来源。合适的亚锡离子源包括但不限于氟化亚锡、其它卤化亚锡例如氯化亚锡二水合物、焦磷酸亚锡、有机羧酸亚锡盐例如甲酸亚锡、乙酸亚锡、葡糖酸亚锡、乳酸亚锡、酒石酸亚锡、草酸亚锡、丙二酸亚锡和柠檬酸亚锡、亚乙基果绿定亚锡(stannous ethylene glyoxide)等。一种或多种亚锡离子源任选且说明性地以总量为组合物重量的0.01%至10%、例如0.1%至7%、或1%至5%存在。
在另一个实施方案中,所述组合物包含口腔可接受的锌离子源,其可用作例如抗微生物剂、防牙垢剂或口气清新剂。可存在一种或多种这样的来源。合适的锌离子源包括但不限于乙酸锌、柠檬酸锌、葡萄糖酸锌、甘氨酸锌、氧化锌、硫酸锌、柠檬酸锌钠等。一种或多种锌离子源任选且说明性以总量为组合物重量的0.05%至3%、例如0.1%至1%存在。
在另一个实施方案中,所述组合物包含口腔可接受的口气清新剂。一种或多种这样的试剂可以口气清新有效总量存在。合适的口气清新剂包括但不限于锌盐例如葡萄糖酸锌、柠檬酸锌和亚氯酸锌、α-紫罗兰酮等。
在另一个实施方案中,所述组合物包含口腔可接受的抗菌斑剂,包括菌斑破坏剂。一种或多种这样的试剂可以抗菌斑有效总量存在。合适的抗菌斑剂包括但不限于亚锡盐、铜盐、镁盐和锶盐、二甲基硅氧烷共聚醇例如十六烷基二甲基硅氧烷共聚醇、木瓜蛋白酶、葡糖淀粉酶、葡萄糖氧化酶、尿素、乳酸钙、甘油磷酸钙、聚丙烯酸锶和螯合剂例如柠檬酸和酒石酸及其碱金属盐。
在另一个实施方案中,所述组合物包含不同于上述迷迭香组分的口腔可接受的抗炎剂。一种或多种这样的试剂可以抗炎有效总量存在。合适的抗炎剂包括但不限于甾体类药剂例如肤轻松(flucinolone)和氢化可的松和非甾体类药剂(NSAID)例如酮咯酸、氟比洛芬、布洛芬、奈普生、吲哚美辛、双氯芬酸、依托度酸、吲哚美辛、舒林酸、托美丁、酮洛芬、非诺洛芬、吡罗昔康、萘丁美酮、阿司匹林、二氟尼柳、甲氧芬那酸盐(meclofenamate)、甲芬那酸、羟布宗和保泰松。一种或多种抗炎剂在组合物中任选以抗炎有效量存在。
本发明的组合物任选含有其它成分例如酶、维生素和抗粘连剂。可添加酶例如蛋白酶,用于抗污渍和其它作用。维生素的非限制性实例包括维生素C、维生素E、维生素B5和叶酸。在各种实施方案中,维生素具有抗氧化性能。抗粘连剂包括乙基月桂酰精氨酸(ELAH)、对羟基苯甲酸酯、无花果蛋白酶、硅酮聚合物和衍生物和群体感应(quorum sensing)抑制剂。
本发明组合物中任选包含的有用载体之中有稀释剂、研磨剂、碳酸氢盐、pH调节剂、表面活性剂、泡沫调节剂、增稠剂、粘度调节剂、保湿剂、甜味剂、食用香料和着色剂。可任选存在一种载体材料,或者不止一种同类或不同类的载体材料。应当选择彼此相容并与组合物其它成分相容的载体。
水是优选的稀释剂和在一些组合物例如漱口剂和增白液中通常伴有醇,例如乙醇。漱口剂组合物中水与醇的重量比通常为1:1至20:1,例如3:1至20:1或4:1至10:1。在增白液中,水与醇的重量比可以在以上范围内或低于以上范围,例如1:10至2:1。
在一个实施方案中,本发明的组合物包含至少一种研磨剂,其可用作例如抛光剂。可使用任何口腔可接受的研磨剂,但应当选择研磨剂的种类、细度(粒径)和量,使得在所述组合物的正常使用中牙釉质不被过度磨损。合适的研磨剂包括但不限于二氧化硅(例如以硅胶、水合二氧化硅或沉淀二氧化硅的形式)、氧化铝、不溶性磷酸盐、碳酸钙、树脂研磨剂例如尿素-甲醛缩合产物等。可用作研磨剂的不溶性磷酸盐之中有正磷酸盐、聚偏磷酸盐和焦磷酸盐。说明性实例是正磷酸二钙二水合物、焦磷酸钙、β-焦磷酸钙、磷酸三钙、聚偏磷酸钙和不溶性聚偏磷酸钠。一种或多种研磨剂任选以研磨有效总量存在,所述总量通常为组合物的5%重量至70%重量、例如10%重量至50%重量、或15%重量至30%重量。如果存在的话,研磨剂平均粒径通常为0.1-30 μm,例如1-20 μm或5-15 μm。若用二氧化硅作为研磨剂,优选所用二氧化硅研磨剂的量少于6%重量,更优选少于4%的二氧化硅研磨剂,甚至更优选少于3%的二氧化硅研磨剂,最优选少于2%的二氧化硅研磨剂。
在另一个实施方案中,本发明的组合物包含至少一种碳酸氢盐,其可用于例如因泡腾和释放二氧化碳而赋予牙齿和牙龈“清洁感”。可使用任何口腔可接受的碳酸氢盐,包括但不限于碱金属的碳酸氢盐,例如碳酸氢钠、碳酸氢钾和碳酸氢铵等。一种或多种碳酸氢盐任选以总量为组合物重量的0.1%至50%、例如1%至20%的存在。
在又一个实施方案中,本发明的组合物包含至少一种pH调节剂。这样的试剂包括降低pH的酸化剂,升高pH的碱化剂和控制pH在所需范围之内的缓冲剂。例如,可包含选自酸化剂、碱化剂和缓冲剂的一种或多种化合物,以提供2至10的pH,或在多个说明性实施方案中,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)、碱金属氢氧化物例如氢氧化钠、碳酸盐例如碳酸钠、碳酸氢盐、倍半碳酸盐、硼酸盐、硅酸盐、磷酸盐(例如磷酸单钠、磷酸三钠、焦磷酸盐等)、咪唑等。一种或多种pH调节剂任选以有效维持组合物在口腔可接受的pH范围内的总量存在。
在又一个实施方案中,本发明的组合物包含至少一种表面活性剂,其可用于例如使组合物的其它组分相容并因此提供增强的稳定性,用于通过去垢性而有助于清洁牙表面,和用于在搅拌时(例如在用本发明洁牙剂组合物刷牙期间)提供泡沫。可使用任何口腔可接受的表面活性剂,其大部分都是阴离子表面活性剂、非离子表面活性剂或两性表面活性剂。合适的阴离子表面活性剂包括但不限于C8–20烷基硫酸酯的水溶性盐、C8–20脂肪酸的磺化甘油一酸酯、肌氨酸盐、牛磺酸盐等。这些和其它类别的说明性实例包括月桂基硫酸钠、椰子甘油单酸酯磺酸钠(sodium coconut monoglyceride sulfonate)、月桂基肌氨酸钠、月桂基羟乙基磺酸钠(sodium lauryl isoethionate)、月桂醇聚醚羧酸钠(sodium laureth carboxylate)和十二烷基苯磺酸钠。合适的非离子表面活性剂包括但不限于泊洛沙姆、聚氧乙烯失水山梨糖醇酯、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、二烷基硫氧化物等。合适的两性表面活性剂包括但不限于具有阴离子基团(例如羧酸根、硫酸根、磺酸根、磷酸根或膦酸根)的C8–20脂族的伯胺和叔胺的衍生物。合适实例是椰油酰胺丙基甜菜碱。一种或多种表面活性剂任选以总量为组合物重量的0.01%至10%、例如0.05%至5%、或0.1%至2%存在。
在又一个实施方案中,本发明的组合物包含至少一种泡沫调节剂,其可用于例如增加在搅拌时由组合物产生的泡沫的量、稠度或稳定性。可使用任何口腔可接受的泡沫调节剂,包括但不限于聚乙二醇(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200,000-7,000,000、例如500,000-5,000,000或1,000,000-2,500,000的那些。一种或多种PEG任选以总量为组合物重量的0.1%至10%、例如0.2%至5%、或0.25%至2%存在。
在又一个实施方案中,本发明的组合物包含至少一种增稠剂,其可用于例如赋予组合物所需稠度和/或口感。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(也称为爱尔兰藓,更具体为ι-角叉菜胶(伊奥塔-角叉菜胶))、纤维素聚合物例如羟乙基纤维素、羧甲基纤维素(CMC)及其盐例如CMC钠、天然树胶例如刺梧桐树胶、黄原胶、阿拉伯树胶和西黄蓍胶、胶态硅酸铝镁、胶态二氧化硅等。增稠剂或胶凝剂的优选种类包括丙烯酸与季戊四醇的烷基醚或蔗糖的烷基醚交联的均聚物,或卡波姆。卡波姆可作为Carbopol?系列自B. F. Goodrich市购。特别优选的Carbopol包括Carbopol 934、940、941、956、974P及其混合物。一种或多种增稠剂任选以总量为组合物重量的0.01%-15%,例如0.1%-10%或0.2%-5%存在。
在又一个实施方案中,本发明的组合物包含至少一种粘度调节剂,其可用于例如抑制成分沉降或分离或者用于在搅拌液体组合物时促进再分散。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、凡士林、粘土和有机改性粘土、二氧化硅等。一种或多种粘度调节剂任选以总量为组合物重量的0.01%至10%、例如0.1%至5%存在。
在又一个实施方案中,本发明的组合物包含至少一种保湿剂,其可用于例如防止牙膏在暴露给空气时硬化。可使用任何口腔可接受的保湿剂,包括但不限于多元醇例如甘油、山梨醇、木糖醇或低分子量PEG。大部分保湿剂也可用作甜味剂。一种或多种保湿剂任选以总量为组合物重量的1%至70%、例如1%至50%、2%至25%、或5%至15%存在。
在又一个实施方案中,本发明的组合物包含至少一种甜味剂,其可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人工甜味剂,包括但不限于右旋糖、蔗糖、麦芽糖、糊精、干燥转化糖、甘露糖、木糖、核糖、果糖、左旋糖、半乳糖、玉米糖浆(包括高果糖玉米糖浆和玉米糖浆固体)、部分水解的淀粉、氢化淀粉水解物、山梨醇、甘露醇、木糖醇、麦芽糖醇、异麦芽酮糖醇、阿司帕坦、纽甜、糖精及其盐、基于二肽的强力甜味剂、环己烷氨基磺酸盐等。一种或多种甜味剂任选存在的总量强烈地取决于所选的具体甜味剂,但通常以总量为组合物重量的0.005%至5%存在。
在又一个实施方案中,本发明的组合物包含至少一种食用香料,其可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食用香料,包括但不限于香兰素、鼠尾草、马郁兰、欧芹油、留兰香油、肉桂油、冬青油(水杨酸甲酯)、薄荷油、丁香油、月桂油、茴香油、桉树油、柑橘油、水果油和精油(包括得自柠檬、橙子、酸橙、葡萄柚、杏、香蕉、葡萄、苹果、草莓、樱桃、菠萝等的那些),得自豆类和坚果的香料(例如咖啡、可可、可乐、花生、杏仁等),吸附的食用香料和包囊化的食用香料等。亦包括在本文食用香料内的是在口中提供香味和/或其它感官效果(包括凉爽或温暖效果)的成分。这样的成分说明性地包括薄荷醇、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(cassia)、酮(oxanone)、α-紫罗兰酮、丙烯基愈创木酚(propenyl guaiethol)、百里酚、芳樟醇、苯甲醛、肉桂醛、N-乙基-对-薄荷烷-3-羧胺(carboxamine)、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。一种或多种食用香料任选以总量为组合物重量的0.01%至5%、例如0.1%至2.5%存在。
在再一实施方案中,本发明组合物可包含除光敏染料外的至少一种着色剂,但仅光敏染料也可以用于提供颜色。如果光敏染料不能提供适宜的审美愉快的颜色,可使用另外的着色剂调节颜色。本文的着色剂包括色素、染料、色淀和赋予特定光泽或反射率的试剂例如珠光剂。着色剂可发挥多种功能,包括例如在牙表面提供白色或浅色涂层,作为牙表面上已有效接触组合物的位置的指示剂和/或改善组合物的外观、尤其是颜色和/或不透明性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,包括但不限于滑石粉、云母、碳酸镁、碳酸钙、硅酸镁、硅酸铝镁、二氧化硅、二氧化钛、氧化锌;红色、黄色、褐色和黑色的铁氧化物;亚铁氰化铁铵、锰紫、群青、含钛云母(titaniated mica)、氯氧化铋等。一种或多种着色剂任选以总量为组合物重量的0.001%至20%、例如0.01%至10%、或0.1%至5%存在。
在各种实施方案中,本发明提供口香糖组合物,其包含香糖胶基和有效量的上面所讨论的提取物组合。口香糖制剂通常另外含有一种或多种增塑剂、至少一种甜味剂和至少一种矫味剂。优选用提供光学透明口香糖组合物的光学透明载体来制备口香糖制剂。
香糖胶基材料为本领域所熟知,包括天然或合成香糖胶基或其混合物。代表性的天然树胶或弹性体包括糖胶树胶、天然橡胶、节路顿胶(jielutong)、巴拉塔树胶(balata)、杜仲胶、夹竹桃树胶(lechi caspi)、香豆的果实(sorva)、古塔胶(guttakay)、冠胶(crown gum)和perillo。合成树胶或弹性体包括丁二烯-苯乙烯共聚物、聚异丁烯和异丁烯-异戊二烯共聚物。以10-40%、优选20-35%的浓度将香糖胶基掺入口香糖产品中。
在其它实施方案中,所述口腔组合物包含可食口腔条(edible oral stripe),所述可食口腔条包含一种或多种聚合成膜剂和有效量的上面所讨论的提取物组合。一种或多种聚合成膜剂选自口腔可接受的聚合物,例如支链淀粉、纤维素衍生物和其它可溶聚合物(包括本领域熟知的那些)。此外,聚合物条优选为光学透明的。
在各种实施方案中,所述组合物有效抵抗口腔细菌组合,其如例如在人工口腔抗牙菌斑研究中所示。在各种实施方案中,与不含有抗菌组合物的阴性对照相比,发现牙菌斑发展显著减少。
本发明组合物显示如对各种口腔微生物的最小抑制浓度(MIC)测定所示的抗菌活性。MIC测定为本领域熟知,其程序无需在此赘述。可用于本发明组合物中的光敏染料优选具有范围为0.00001%-10%重量/体积(w/v)、优选0.00005%-5%、甚至更优选0.0001%-1% w/v的MIC。
可用于实施方案中的光敏染料亦具有抗炎作用。使用本文所述的光敏染料可减少促炎细胞因子例如IL-6、IL-8、和TNFα。
参考以下非限制性实例将更加详细描述优选实施方案。
本发明具体实施方案
实施例1
MIC定义为抗微生物剂抑制微生物生长的最低浓度,通常以ppm (μg/mL)表示。用肉汤稀释法测定MIC。为测定MIC,准备一系列培养试管,每一试管含有抗微生物剂浓度逐渐降低的生长培养基(肉汤)。然后用受试生物接种试管,于37℃培养。培养后,肉眼检查试管中由浊度指示的生长。阻止可见生长的最低浓度便是MIC。下面所述光敏染料的MIC通常范围为0.0001% (w/v)-1% (w/v)。
用下表所述的光敏剂或光-触发活性物以低于其最小抑制浓度(MIC)的浓度处理细菌生物膜(24小时龄)。在曝光前预孵育活性物2秒-15分钟,通常少于两分钟;或在曝光生物膜的同时给予活性物。在设定波长下以1-450 J/cm2能量剂量照射细菌2秒-15分钟(通常少于两分钟)。光功率密度通常范围为1-500 mW/cm2。用脉冲光或提供一次连续曝光。对于高光学能量处理,优选脉冲光处理。
在一个实施方案中,仅仅使用LED光以提供位点特异靶向的口腔护理治疗,其中光集中于口腔中特定区域。在另一个实施方案中,使用多种波长的光以提供多种口腔护理益处,例如用蓝光(450 ± 10 nm)同时选择性杀死黑颜色细菌,同时用低水平的红光提供软组织疼痛减轻并抗炎。
与光一起使用的典型口腔护理制剂
表3-洁齿剂配方
成分名称 | 实施例1 |
CMC钠 – 7MF – 食品级 | 0.650 |
聚乙二醇600 (PEG-12) | 3.000 |
山梨醇-无-褐变/非晶体NF-Sol | 56.438 |
FC Brighter FlavorK91-5661 | 1.15 |
糖精钠 | 0.300 |
氟化钠 | 0.243 |
焦磷酸四钠 | 0.500 |
GRAS染料 | 0.400 |
Zeodent 105 – HCS | 20.000 |
Zeodent 165 –合成 –无定形ppt二氧化硅 | 4.25 |
椰油酰胺丙基甜菜碱 | 1.25 |
月桂基硫酸钠 | 1.50 |
软化水 | 10.319 |
材料总量 | 100 |
表4–口腔清洗剂配方
成分名称 | 实施例1 |
甘油 | 8 |
95%乙醇 | 10 |
PEG-40脱水山梨醇二异硬脂酸酯-动物源 | 0.15 |
牙齿乳膏香料 | 0.10 |
糖精 | 0.01 |
酒石黄 | 0.1 |
净化水 | 81.64 |
材料总量 | 100 |
表5a–通过牙刷递送的清洗剂
成分名称 | 实施例1 |
甘油 | 8 |
95%乙醇 | 10 |
PEG-40脱水山梨醇二异硬脂酸酯-动物源 | 40 |
牙齿乳膏香料 | 30 |
糖精 | 2.5 |
酒石黄 | 1.0 |
净化水 | 8.5 |
材料总量 | 100 |
表5b–典型的靶标口腔微生物
评价了光存在时四种“光敏剂”(0.1%浓度)对内氏放线菌(A. naeslundii)生物膜的影响。MIC通常范围为0.0001% (w/v)-1% (w/v)。生物膜减少的百分率列表如下。与只有光比较,核黄素、诱惑红酒石黄、固绿和丽丝胺绿增加生物膜的减少。
表6–生物膜减少的百分率
上表数据显示在该波长、剂量和光密度的单独光有效减少生物膜,从而有效减少口腔中细菌和牙菌斑形成。数据亦显示对于许多光敏染料,与仅使用光相比,染料的存在导致生物膜的减少显著增加。
实施例2
用于本实施例的细胞包括人胚胎腭间质(HEPM)细胞和口腔角化细胞OBA9细胞。实施方案亦可使用其它细胞,例如人牙龈成纤维细胞(HGF)。将细胞接种到24孔板中培养至超过80%汇合。用刺激物例如IL-1β处理汇合阶段的细胞,接着单独光照或光照与GRAS光敏染料联合。细胞在曝光前于光敏染料中预孵育,或在曝光的同时给予光敏染料。如下所述,将细胞在光敏染料中孵育不同的时间,改变光敏染料的浓度,并且每次曝光时光照射细胞的时间不同以及照射一次或多次。照射之后,于37℃孵育细胞。一定时间之后收集细胞培养基用于细胞因子分析。
下表结果显示仅有可见光(不同波长,380-700 nm)和用可见光(不同波长,380-700 nm)照射的光敏染料都具有抗炎作用。下面所示结果显示,在体外细胞培养中,每次(剂量:9 mW/cm2,1.1 J/cm2)于625 nm曝光2分钟,单次曝光或多次曝光都可降低促炎细胞因子IL-6和IL-8浓度。结果进一步显示在体外细胞培养中,1000 ppm的光敏染料固绿与625 nm曝光2分钟(剂量:9 mW/cm2,1.1 J/cm2)联合可降低促炎细胞因子TNFα的浓度。结果示于下表中。
表7
表7中的对照无刺激,因此,无炎症和细胞因子产生。用IL-1β刺激以模拟细胞炎症,因此产生IL-6、IL-8和TNF-α。如上表7所示,625 nm的光可降低IL-1β刺激的口腔角化细胞OBA9细胞的IL-6浓度。每次曝光2分钟,剂量:9 mW/cm2,1.1 J/cm2。表7亦显示625 nm的光可降低由IL-1β刺激的口腔角化细胞OBA9细胞的IL-8浓度。每次曝光2分钟,剂量:9 mW/cm2,1.1 J/cm2。最后,仅用625 nm的光和光与1000 ppm的固绿联合可降低由IL-1β刺激的HEPM细胞的TNFα浓度。曝光2分钟,剂量:9 mW/cm2,1.1 J/cm2。
实施例3
本实施例包括一系列实验以评价在某些波长的LED光下经由牙膏糊剂和牙膏凝胶剂的透射。测定了以下组合物:
表8
含15%孔(Hole)的基础洁齿剂配方
成分名称 | 配方AI (%) |
PEG 600 (PEG-12) NF | 3 |
山梨醇 | 70 |
CMC钠 | 0.6 |
COP Carbopol 974P | 0.9 |
二氧化硅孔 | 0 |
GRAS染料或光敏剂 | 0 |
孔 | 15 |
苯甲酸钠 | 0.5 |
水 | 10 |
如下制备基础洁齿剂。将PEG、山梨醇、CMC钠、COP Carbopol、水和苯甲酸钠按所述顺序加入并混合在一起。首先加入PEG和山梨醇以使CMC和carbopol分散于溶液中。待聚合物分散后,加入水然后加入苯甲酸钠,以帮助该防腐剂在溶液中更快地分散。以上基础组合物的光学澄清度在视觉上相当于保湿剂(山梨醇+水)和含有3-8%的研磨剂或二氧化硅的组合物的光学澄清度。然而,3%的二氧化硅提供最具光学透明的制剂形式。
就典型的洁齿剂粘度来说,CMC和carbopol的联合提供似乎优良的消费者稠度。CMC/Carbopol/苯甲酸盐0.5%亦提供良好的微-稳健性。可用15%的孔来容纳不同成分,例如保湿剂、气味屏蔽成分、抗炎活性物、稳定剂、粘合剂、保湿剂、甜味剂、香料、表面活性剂、氟化物、精氨酸碳酸氢盐、研磨剂、光学流体、条、珠粒、泡沫诱导剂等。
表9–含GRAS染料酒石黄的洁齿剂配方
成分名称 | 配方AI (%) |
基础配方(见表7) | 85 |
二氧化硅 | 3 |
酒石黄 | 0.01 |
水 | 11 |
可以配制0.001%-1%GRAS染料酒石黄,但通常为0.01%。可用的其它GRAS染料包括诱惑红、固绿和姜黄素。在下表15中,除了酒石黄被诱惑红或固绿替代之外,诱惑红和固绿配方与上面的配方一样。
表10–无TiO
2
的洁齿剂
成分名称 | 配方AI (%) |
基料 | 85 |
二氧化硅 | 3 |
酒石黄 | 0.01 |
SLS | 1.17 |
香料 | 1 |
TiO2 | 0 |
水 | 8.799 |
本制剂含有另外的牙膏成分(月桂基硫酸钠(SLS)和香料),并保持其光学透明度,但是当包括二氧化钛时,该洁齿剂变得不透明。有少量或没有二氧化钛的牙膏需要更少的光学剂量来达到抗菌功效。因此,在实施方案中优选使用光学透明的的口腔护理组合物。如下表10所示制备含TiO2的洁齿剂。
表11–含TiO
2
的洁齿剂
成分名称 | 配方AI (%) |
基料 | 85 |
二氧化硅 | 3 |
酒石黄 | 0.01 |
SLS | 1.17 |
香料 | 1 |
TiO2 | 0.3 |
水 | 8.499 |
如下表所示制备其它牙膏制剂。
表12–牙洞防护型
成分名称 | 配方AI (%) |
牙洞防护牙膏 | 99.98 |
酒石黄 | 0.01 |
水 | 0.01 |
制备了类似的牙膏,但没有加入光敏染料。
表13–控垢型
成分名称 | 配方AI (%) |
防牙垢牙膏 | 99.98 |
酒石黄 | 0.01 |
水 | 0.01 |
制备了类似的牙膏,但没有加入光敏染料。
表14–含0.01%姜黄素的洁齿剂配方
成分名称 | 配方AI (%) |
PEG 600 (PEG-12) NF | 3 |
山梨醇 | 70 |
CMC钠 | 0.6 |
Carbopol 974P | 0.9 |
二氧化硅 | 3 |
姜黄素染料 | 0.01 |
孔 | 0 |
苯甲酸钠 | 0.5 |
水 | 21 |
作为例子,提供了不同洁齿剂及其浆液对425 nm光透射的影响。如果洁齿剂或其浆液降低透过透明塑料盖发射的LED的光密度,则该洁齿剂或浆液对光透射有负影响。实施以下实验以测定不同洁齿剂配方对光学澄清度或光透射的影响。
用透明塑料盖盖住425 nm的LED透射光,然后在盖的顶端放置衬板(liner)。衬板的作用在于保证对于所有样品以与样品相等的距离测量光密度。测量光密度以测定无任何口腔组合物(糊剂或浆液或凝胶剂)时LED的光密度。该光密度是与其它读数比较的初始读数。
通过首先横跨透明的盖子放置糊剂或凝胶剂样品,然后用铸棒使糊剂或凝胶剂的深度与透明盖子的深度平衡,来测定各种糊剂对LED光透射的影响。然后按与上述相同的方式测定糊剂或凝胶剂的光密度,用两者之间的差来计算光透射减少的百分率。
如下实施用于评价浆液减少光透射百分率的方法:首先用透明的盖子盖住LED,然后于透明盖子顶端放置显微镜载破片,其直接位于LED之上。按如上所述测定光密度,获得与其它读数比较的初始读数。然后,将(糊剂或凝胶剂)与水重量比为1:2的浆液100 μl加入到透明盖子顶端的每一孔中,然后于浆液的顶端放置显微镜载玻片。再次测量光密度,用两者之间的差来计算光透射减少的百分率(或光透射的增加,视情况而定)。
测定了下列样品:
表15
样品 | 描述 |
初始 | 无糊剂的LED的光密度 |
I | 无染料的基础配方(基础配方–表8) |
A | 含0.01%酒石黄的基础配方对照(表9) |
B | 含0.1%酒石黄的基础配方对照(改进的表9) |
E | 另外的TP成分(无TiO2)-仅SLS和香料(表10) |
F | 另外的TP成分(含TiO2) (表11) |
J | 含0.01%姜黄素的基础配方(表14) |
C | 固绿配方(含替换酒石黄的固绿的表9) |
D | 诱惑红配方(含替换酒石黄的诱惑红的表9) |
K | 无染料的牙洞防护(表12) |
G | 含0.01%酒石黄的牙洞防护(含酒石黄的表12) |
L | 无染料的牙垢控制TP (表13) |
H | 含0.01%酒石黄的牙垢控制TP (含酒石黄的表13) |
于标有十字叉的透明纸上放置每种洁齿剂的条带,以提供对穿过它们的光透射程度的快速评估。样品I (透明-白)、A (黄)和B (黄)提供可清晰看见十字叉的的凝胶剂。样品E (黄)中可看见十字叉,但清晰度不如样品I、A和B。样品F (黄)、K (白)、G (黄)、L (白)和H (黄)都提供不能看见十字叉的凝胶剂。透过样品J (黄)、C (蓝-绿)和D (红)亦可清晰看见十字叉。
测定所有样品A-L作为糊剂或浆液(糊剂与水的重量比为1:2)对光透射的减少。结果示于下表。
表16–光透射
表16的结果显示,无糊剂的LED的光密度和当透过无GRAS染料的牙膏观察时的光强度实质上是一样的。也即是说,相对于无染料的配方,设计并配制的含GRAS染料的洁齿剂对光透射有很小或无负影响。当向牙膏基础配方中加入0.01%的酒石黄时,光密度降低;当染料水平增加到0.1%时,甚至更进一步降低(对比样品A和B之间的透射的减少)。当用绿或红色染料替代黄色GRAS染料时,425 nm下的光密度几乎保持一样。
从表16亦可看出,向基础配方中添加SLS和香料,轻微增加了光密度(比较样品E和I)。向基于Carbopol的配方中添加TiO2,显著降低了光密度和透射。目前市售的Colgate?产品(样品G (牙洞防护型)和H (控垢型))获得与含TiO2的光制剂(样品F)相近的的光密度。
为提高光透射并提供光学透明的口腔护理组合物,所述组合物应优选含有很少或不含TiO2,含有光敏染料例如酒石黄、姜黄素、固绿、诱惑红等,和含有3%或更少的二氧化硅作为研磨剂。
以上参照阐明性实例阐述了本发明,但应了解,本发明并不限于所公开的实施方案。本领域技术人员在阅读本说明书后想到的改变或修改亦在所附权利要求书所限定的本发明范围内。
Claims (20)
1. 一种治疗由微生物引起的病况的方法,所述方法包括用波长380 nm-780 nm、剂量1 J/cm2-450 J/cm2、功率密度约1-约500 mW/cm2的可见光照射疑似含有微生物的口腔区域达1秒到120分钟的时间。
2. 权利要求1的方法,其中所述方法减少生物膜的产生。
3. 权利要求1-2中任一项的方法,其中所述方法治疗炎症。
4. 权利要求1-3中任一项的方法,其中所述方法减少口腔中存在的细菌量。
5. 权利要求1-4中任一项的方法,其中所述光具有400-780 nm的波长。
6. 权利要求1-5中任一项的方法,其中所述时间为2秒到15分钟。
7. 权利要求6的方法,其中照射所述区域达2秒到15分钟的时间,然后再照射所述区域达2秒到15分钟的时间至少一次。
8. 权利要求1-7中任一项的方法,其中以15-45 J/cm2的剂量发射光。
9. 权利要求1-8中任一项的方法,其中以175-250 mW/cm2的功率密度发射光。
10. 一种治疗由微生物引起的病况的方法,所述方法包括:
a)将包含至少一种光敏染料的口腔护理组合物给予疑似含有微生物的口腔区域;和
b)用被至少一种光敏染料吸收的波长的光照射给予了所述组合物的区域。
11. 权利要求10的方法,其中所述光敏染料选自:叶绿酸钠铜盐、酒石黄(FD&C黄5号)、姜黄素、核黄素5'-单磷酸钠盐、诱惑红AC (FD&C红40号)、新胭脂红(CI 16255,食品红7)、铬变素FB (CI 14720,食品红3)、靛胭脂、羊毛罂红二钠盐(FD&C蓝1号)、固绿FCF (FD&C 绿3号)、丽丝胺绿B、萘酚绿或酸性绿、胭脂虫红、酸性红偶氮玉红、苋菜红、亮猩红4R、叶绿素和铜络合物、亮黑BN (PN)、巧克力褐HT、β-胡萝卜素、红木素、番茄红素、甜菜苷、核黄素、藻红B钠盐及其混合物。
12. 权利要求10-11中任一项的方法,其中所述光敏染料选自酒石黄、姜黄素、诱惑红、固绿FCF及其混合物。
13. 权利要求10-12中任一项的方法,其中所述光敏染料以约0.001-约1.0%重量的量存在。
14. 权利要求10-13中任一项的方法,其中所述口腔护理组合物进一步包含全氟十氢化萘。
15. 权利要求10-14中任一项的方法,其中所述组合物呈选自以下的形式:适于冲洗、漱洗或喷雾的液体溶液剂;选自粉剂、牙膏或牙凝胶剂的洁齿剂;牙周凝胶剂;适于涂抹到牙齿表面的液体;口香糖;可溶、部分可溶或不可溶的膜或条;珠粒;糯米纸囊剂;锭剂;拭子或小毛巾;植入物;口腔清洗剂;泡沫剂;和牙线。
16. 权利要求10-15中任一项的方法,其中所述组合物为牙膏、口腔清洗剂或牙凝胶剂。
17. 权利要求10-16中任一项的方法,其中所述光具有400 nm-780 nm的波长。
18. 权利要求10-17中任一项的方法,其中照射所述区域达2秒到15分钟的时间。
19. 权利要求10-18中任一项的方法,其中以15-45 J/cm2的剂量发射光。
20. 权利要求10-19中任一项的方法,其中以175-250 mW/cm2的功率密度发射光。
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PCT/US2010/061332 WO2011079075A1 (en) | 2009-12-21 | 2010-12-20 | Method of treating and/or preventing conditions caused by microorganisms using an oral light device |
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BR112012015726A2 (pt) | 2020-09-29 |
AU2010333751B2 (en) | 2013-10-10 |
RU2012131326A (ru) | 2014-01-27 |
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EP2687257A2 (en) | 2014-01-22 |
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EP2687257A3 (en) | 2014-10-08 |
ZA201204191B (en) | 2014-04-30 |
AU2010333751A1 (en) | 2012-06-07 |
WO2011079075A1 (en) | 2011-06-30 |
TWI464004B (zh) | 2014-12-11 |
EP2516002B1 (en) | 2014-04-23 |
ES2473972T3 (es) | 2014-07-08 |
MX362693B (es) | 2019-02-01 |
EP2516002A1 (en) | 2012-10-31 |
US20120270183A1 (en) | 2012-10-25 |
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CO6481018A2 (es) | 2012-07-16 |
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