CN102762219A - 口腔护理组合物 - Google Patents
口腔护理组合物 Download PDFInfo
- Publication number
- CN102762219A CN102762219A CN201180010909XA CN201180010909A CN102762219A CN 102762219 A CN102762219 A CN 102762219A CN 201180010909X A CN201180010909X A CN 201180010909XA CN 201180010909 A CN201180010909 A CN 201180010909A CN 102762219 A CN102762219 A CN 102762219A
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- CN
- China
- Prior art keywords
- magnolol
- oral cavity
- active component
- compositions
- extract
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Abstract
本文公开了提高木兰提取物中发现的一种或多种活性成分或其合成类似物在口腔组合物中的溶解性和递送的方法。
Description
相关申请的交叉引用
本申请要求2010年2月24日提交的美国临时专利申请号61/307,664的优先权,其通过引用全文并入本文。
背景
在木兰提取物的活性成分(或其合成类似物)和用于配制木兰提取物的传统口腔组合物的递送媒介的组分之间经常有不期望的相互作用,这种相互作用减低这种口腔组合物的有效性能。因此,存在提高木兰提取物的活性成分或它们的合成类似化合物的溶解性和它们与口腔组合物的其它组分之间的积极的相互作用的需要。还存在提高木兰提取物的活性成分或它们的合成类似化合物在口腔组合物中的递送效率的需要,以改进这些活性成分的效率和生物可用性。
概述
本发明的一些实施方案提供提高木兰提取物中发现的活性成分的溶解性的方法,包括将丙二醇和所述活性成分混合。在一些实施方案中,在木兰提取物中发现一种或多种活性成分。在一些实施方案中,在木兰提取物中发现的一种或多种活性成分中的至少一种选自: 木兰酚、和厚朴酚、四氢木兰酚(5,5’-二丙基联苯基-2,2’-二醇)、四氢和厚朴酚(3’,5-二丙基联苯基-2,4’-二醇)、正丁基木兰酚(5,5’-二丁基联苯基-2,2’-二醇)和其两种或更多种的组合。本发明的一些实施方案提供提高木兰提取物中发现的活性成分的合成类似物的溶解性的方法,包括将丙二醇和所述合成类似物混合。在一些实施方案中,所述合成类似物选自异丙基木兰酚、异丁基木兰酚和二氯木兰酚。在一些实施方案中,所述活性成分和丙二醇与口腔可接受的载体混合。
在其它的实施方案中,本发明提供包含在木兰提取物中发现的活性成分或其合成类似物;丙二醇;和口腔可接受的载体的口腔组合物。
进一步的实施方案提供治疗口腔疾病或病症的方法,包括:提供包含以下的组合物:木兰提取物中发现的活性成分或其合成类似物;丙二醇;和口腔可接受的载体;和将该组合物施用到有需要的受试者的口腔。在一些实施方案中,将组合物每天施用到口腔一周时间。在一些实施方案中,将该组合物施用到口腔最多2周。在一些实施方案中,将该组合物施用到口腔持续超过2周时间。
发明详述
本实施方案的方法和组合物通过提供良好增溶、安全和对哺乳动物受试者的细菌感染和/或炎症高度有效的口腔组合物赋予超过现有技术组合物的优点。进一步,本发明的一些实施方案包含木兰提取物的一种或多种活性成分。
本说明书全文所用的表述“载体”或“水性载体”或“口腔可接受的载体”表示任何用于本文的安全和有效的材料。这种材料包括水、溶剂等,其可包含湿润剂例如甘油、山梨醇、木糖醇等。载体或口腔可接受的载体也可包括另外的洁齿剂组分,例如增稠剂、离子活性成分、缓冲剂、防牙垢剂、研磨抛光材料、过氧化物源、碱金属碳酸氢盐、表面活性剂、二氧化钛、着色剂、调味系统、甜味剂、抗微生物剂、草本制剂、脱敏剂、减污剂和其混合物。
除非另有说明,本文所用的所有的百分比和比例都是按照口腔护理组合物的重量计。除非另有说明,所有的测量都在25℃进行。
在此说明书和权利要求书全文中,公开某个数值(例如温度、组分的重量百分比等)意指该数值加或减本领域普通技术人员理解的另外的数值,这取决于一般与该数值有关的变量和测量误差度。例如,给定用于测量温度的仪器,本领域普通技术人员理解给定的温度包括最高10%的变化。
本发明的一些实施方案提供了用于提高木兰提取物中发现的一种或多种活性成分或其合成类似物在口腔组合物中的溶解性的方法。在一些实施方案中,该方法包括混合有效量的丙二醇和木兰提取物中发现的一种或多种活性成分或其合成类似物。在一些实施方案中,木兰提取物中发现的一种或多种活性成分的至少一种选自:木兰酚、和厚朴酚、四氢木兰酚、四氢和厚朴酚(3’,5-二丙基联苯基-2,4’-二醇)、5,5'-二正丁基联苯基-2,2'-二醇、正丁基木兰酚(5,5’-二丁基联苯基-2,2'-二醇)。在一些实施方案中,木兰提取物的活性化合物的合成类似物选自:异丙基木兰酚、异丁基木兰酚和二氯木兰酚。在一些实施方案中,口腔可接受的载体不包含丙二醇作为湿润剂。在其它实施方案中,口腔可接受的载体包含丙二醇。
一些实施方案包括通过混合0.05-10%重量的丙二醇和木兰提取物中发现的一种或多种活性成分的至少一种或其合成类似物;和口腔可接受的载体来制备增溶的口腔组合物的方法。在一些实施方案中,丙二醇构成0.1-5%重量的组合物。在其它实施方案中,木兰提取物中发现的一种或多种活性成分的至少一种或其合成类似物存在的量是组合物的0.05-5%重量,优选组合物的0.1-3%重量。
本发明进一步的实施方案提供口腔组合物,其包含(i)有效量的丙二醇;(ii)木兰提取物中发现的一种或多种活性成分中的至少一种或其合成类似物;和(iii)口腔可接受的载体。在一些实施方案中,口腔组合物为口腔护理组合物。
在一些实施方案中,组合物用于抑制口腔组织中的炎症细胞介质在口腔中由感染、环境毒素或创伤引起的炎症位点的过量产生。在一些实施方案中,有效量的木兰提取物中发现的一种或多种活性成分中的至少一种或其合成类似物充分减少促炎症介质的水平或活性,以减少哺乳动物受试者中的浓度到被治疗的受试者口腔组织中的基础水平,而没有不必要地抑制所有胞间介质的活性。
在一些实施方案中,木兰提取物中发现的一种或多种活性成分中的至少一种或其合成类似物的存在量为给予活性物的人或低等动物受试者中具有期望的治疗或预防效果所需,而没有过度的不良副作用(例如毒性、刺激性或过敏反应),以本发明的方式使用时具有相称的合理的收益/风险比。活性成分的具体的安全和有效量将随以下因素改变,比如:被治疗的具体病症、受试者的健康状况、共同疗法(如有)的特性、所用的具体化合物、具体的剂型、采用的载体和期望的给药方案。本领域技术人员采用本文提供的指引将能够确定用于组合物和方法中的活性成分的安全和有效量。
在高度敏感的组织中,高浓度的木兰可潜在的引起刺激性和加重炎症,而不是减弱它。尽管其它炎症潜在性依赖于个体受试者的体质和对刺激物的反应以及其它和治疗相关的变量,但优选以非刺激性的浓度将木兰提取物中发现的一种或多种活性成分或其合成类似物提供给受试者。“非刺激性”指的是将口腔组合物和哺乳动物受试者的口腔接触不会增加酸痛、疼痛、发红或糙度,也不会使口腔组织的炎症加重或恶化。
此外,木兰提取物中发现的一种或多种活性成分或其合成类似物在口腔组合物中的浓度将依赖递送形式、给药方案、最终益处、病理学和/或对其给药的受试者的个体治疗要求而改变,并且因此预料存在的活性成分的量可改变,如本领域技术人员所认识到的。此外,活性成分的浓度通常依赖于口腔组合物的形式。例如,漱口液通常具有相对低浓度的活性成分,而洁齿剂、凝胶或牙粉根据分散的容易性具有较高的浓度以达到相同的递送剂量。同样,糖果组合物通常具有相对高浓度的活性成分以使当它们溶解或被咀嚼时能充分分散。
本文所用的术语“糖果组合物”包括口香糖和口腔可溶解的片剂、珠和锭剂。唾液溶解锭剂或口香糖产品,且促进和口腔表面的接触延长以便在该产品被使用时,锭剂、片剂、珠或口香糖形式中的活性成分充分递送到目标口腔表面。
本文所指的表述“木兰的提取物”或“木兰提取物”指的是来自木兰科(Magnoliaceae)植物例如凹叶木兰(Magnolia officinalis)(下文称为“木兰”)的干燥的皮层、或树皮的提取物,或这种提取物的合成或半合成等价物或其活性组分。在某些实施方案中,口腔组合物包含从木兰的提取物分离或通过传统合成方法制造的一种或多种活性成分。在其它实施方案中,口腔组合物包含木兰的提取物。优选木兰皮层(凹叶木兰的树皮)的提取物包含以下活性化合物:木兰酚、和厚朴酚、四氢木兰酚(5,5’-二丙基联苯基-2,2’-二醇)和四氢和厚朴酚(3’,5-二丙基联苯基-,2,4’-二醇),它们已经在体外测试中表明对抗代表性口腔细菌(变异链球菌(S.
mutans)、具核梭杆菌(F. nucleatum)、小韦荣球菌(V. parvula)、内氏放线菌(A. naslundii)、牙龈卟啉单胞菌(P. gingivitis))的杀菌特性。应该注意的是木兰科的任何植物都适用于提取用于本实施方案的活性成分。
在一些实施方案中,提取物包含抗微生物有效浓度的化合物,其选自:木兰酚、和厚朴酚、四氢木兰酚、四氢和厚朴酚(3’,5-二丙基联苯基-,2,4’-二醇)、异丙基木兰酚、异丁基木兰酚和正丁基木兰酚(5,5’-二丁基联苯基-2,2’-二醇),和其两种或更多种的组合。在其它实施方案中,口腔组合物包含选自以下的一种或多种活性成分:木兰酚、和厚朴酚、四氢木兰酚、四氢和厚朴酚(3’,5-二丙基联苯基-,2,4’-二醇)、正丁基木兰酚(5,5’-二丁基联苯基-2,2’-二醇)和其两种或更多种的组合,其量有效治疗哺乳动物受试者中与细菌和/或炎症相关的口腔病症。
在一些实施方案中,木兰提取物能通过萃取(extraction)的方式制备。在一个萃取方法中,干燥压碎的木兰树皮的粉末形式依序与乙醇、二氯甲烷和环己烷接触以在各步骤形成浓缩的糊剂,最后的糊剂形式溶于约50℃-60℃的加热的石油醚中,然后真空干燥,最终的提取得到包含约5-约10%重量的和厚朴酚和约15-约25%重量的木兰酚的提取物。
在另一个萃取方法中,从干燥的木兰植物树皮制备木兰提取物,且可以通过采用合适的溶剂萃取树皮而制备。优选的溶剂包括甲醇、乙醇、二氯甲烷、己烷 环己烷、戊烷、石油醚、氯仿、盐酸、二氯乙烷和氢化氟代烷,例如1,1,1,2-四氟乙烷或HFA-13A。通常一份植物组织(干基)用5-50份,优选15份-30份的溶剂采用萃取装置萃取,其中溶剂与树皮接触以获得浓缩的糊剂,然后用不同的溶剂对浓缩的糊剂进行一个或多个额外萃取步骤,以在延长的时间(优选约6小时-约1-2天,更优选约1天)进一步浓缩初始得到的糊剂。在一个简化的萃取方法中,干燥压碎的木兰树皮粉末形式和氢化氟代烷(例如1,1,1,2-四氟乙烷(HFA-13A))接触以形成浓缩的最终提取,得到包含5-50%和厚朴酚和5-50%木兰酚的提取物。
在另一个萃取方法中,木兰提取物通过采用二氧化碳(CO2)通过超临界流体萃取(SPE)分离。超临界流体是具有气体和液体的“正常”相之间性质的气体。压力变化控制超临界流体的特性,依据应用,其可从较气体样性能变为较液体样性能。超临界流体采用容易得到的、不贵的和环境安全的溶剂(CO2和H2O)。二氧化碳没有毒性、没有爆炸性、容易得到且容易从萃取的产物中除去。SFE的过程温度通常是低到中。因此,SFE制备几乎不含溶剂的产物,而且进一步避免任何潜在的变质反应。
此外,在其它提取方法学中有可能存在的天然污染物通常不存在于SFE萃取的产物中。例如,化合物例如马兜铃酸(Aristocholic
acid)和生物碱例如木兰箭毒素(magnocurine)和筒箭毒碱被维持在低浓度(例如通常低于0.0002%)。因此,在通过SFE萃取木兰的实施方案中,提取物基本不含通过加热和水带来的化学改变、溶剂残余物和其它人工制品。
本文所用的固体或液体材料的“提取”或“提取”指的是将材料和合适的材料例如溶剂接触以去除期望从材料中提取的物质。这种提取可以通过本领域技术人员已知的传统手段进行,例如通过采用提取装置例如Soxhlet装置,其将固体材料保留在支持容器中,并允许溶剂流过材料;或通过将溶剂和材料混合在一起,然后通过例如过滤或沉降和倾析来分离液体和固体相或两个不混溶的液体相。
在各种提取方法中,本发明的木兰提取物可包含2-95%的木兰酚。在一些实施方案中,木兰酚以5-50%存在于提取物中。在其它实施方案中,木兰酚可以30-50%存在于提取物中。在某些实施方案中,和厚朴酚可以2-95%存在于提取物中。在进一步的实施方案中,和厚朴酚可以5-50%存在于提取物中。在其它实施方案中,和厚朴酚可以30-50%存在于提取物中。
在某些实施方案中,优选木兰提取物的活性成分包含木兰酚、和厚朴酚或两者。木兰酚与和厚朴酚是非离子性的羟基联苯基化合物,其结构表示如下:
。
此外,四氢木兰酚(5,5’-二丙基联苯基-2,2’-二醇)和四氢和厚朴酚(3’,5-二丙基联苯基-2,4’-二醇)分别是木兰酚与和厚朴酚的氢化类似物,它们通常发现于木兰的提取物中,因此可包括在口腔组合物中。此外,5,5’-二丁基联苯基-2,2’-二醇(木兰酚的同系物)也可以包括在口腔组合物中,且该化合物的合成可通过本领域普通技术人员的传统有机合成方法实现。四氢木兰酚(5,5’-二丙基联苯基-2,2’-二醇)、四氢和厚朴酚(3’,5-二丙基联苯基-2,4’-二醇)和5,5’-二正丁基联苯基-2,2’-二醇(木兰酚的同系物)的结构表示如下:
四氢木兰酚
四氢和厚朴酚
5,5’-二正丁基联苯基-2’2-二醇。
用于本发明的口腔可接受的载体包括用于制备牙膏、牙粉、预防性糊剂(prophylaxis pastes)、漱口液、锭剂、口香糖、珠等的传统和已知的载体,且在下文中更完全描述。优选口腔可接受的载体不引起刺激性、肿胀或疼痛,且通常不会产生过敏或不良反应例如胃不适(gastric
upset)、恶心或眩晕。具体载体组分的选择依赖于期望的产品形式,包括洁齿剂、牙膏、牙粉、预防性糊剂、漱口液、锭剂、口香糖、凝胶、涂布剂、糖果剂等。
本发明的术语“漱口液”指的是性质基本上是液体的口腔组合物,例如漱口水、喷雾剂或润洗剂。在这种制剂中口腔可接受的载体通常具有包含水或水和醇混合物的水性相。此外,在多个实施方案中,口腔载体包括下文介绍的湿润剂和表面活性剂。大体上水和醇的重量比的范围为1:1-20:1,优选3:1-10:1,更优选4:1-6:1的量。这种类型的制剂中的水-醇混合物的总量通常占制剂的70-99.9%的量。在多个实施方案中,醇通常是乙醇或异丙醇。
本领域技术人员认识到,本发明的口腔可接受的载体也可包含本领域技术人员已知的各种其它的传统活性成分,包括抗菌斑制剂、增白剂、抗菌剂、牙垢控制(抗牙垢)剂、抗龋剂、敏感剂等。优选载体不会实质性减弱木兰提取物中发现的抗炎症和抗菌活性成分或其合成类似物的有效性。
本发明的口腔组合物的这种液体和其它制剂的pH通常是4.5-10的量。pH可用酸(例如柠檬酸或苯甲酸)或碱(例如氢氧化钠)控制或(用例如柠檬酸钠、苯甲酸盐、碳酸盐或碳酸氢盐、磷酸氢二钠或磷酸二氢钠)缓冲。
在多个实施方案中,含水口腔组合物(例如漱口液)包含湿润剂。该湿润剂通常是湿润剂例如甘油和山梨醇和多元醇例如己二醇或聚乙二醇的混合物,虽然采用聚乙二醇作为湿润剂和另外将它用于提高活性成分的溶解性是任选的。湿润剂的含量通常在5-40%和优选10-30%的范围内。
适合于本发明组合物的表面活性剂包括阴离子、非离子和两性离子表面活性剂。表面活性剂通常存在于本发明的水性口腔组合物中的量是0.01%-5%,优选0.5-2.5%的量。
根据本发明的口腔组合物可任选包括其它材料,例如,清洁剂、调味剂、甜味剂、粘着剂、表面活性剂、泡沫调节剂、研磨剂、pH改性剂、湿润剂、增湿剂、口感剂、着色剂、研磨剂、防腐剂、氟离子源、唾液刺激剂、润肤剂、粘度改性剂、稀释剂、乳化剂、营养素及其组合。可添加到该口腔组合物的各种组分包括,例如,甜味剂例如糖精或糖精钠、醇例如乙醇、氟离子源例如氟化钠、以及甘油、山梨醇、聚乙二醇、Poloxomer聚合物例如POLOXOMER®407、PLURONIC®
F108(二者在BASF公司有售)、烷基多糖苷(APG)、聚山梨醇酯、PEG40、蓖麻油、薄荷醇等。应理解尽管每一个上述分类的材料的一般属性可以不同,但也可有一些共同的属性,而且在两种或更多种这些分类的材料内的任何给定材料可以起到多个目的。优选选择这种载体材料和木兰提取物中发现的活性成分或其合成类似物以及组合物的其它成分相容。
本文中有用的调味剂包括任何可操作用于增强组合物味道的材料或材料的混合物。可采用任何口腔可接受的天然或合成调味剂,例如调味油、调味醛、酯、醇,类似的材料以及它们的组合。调味剂包括香草醛、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、桂花油、茴香油、桉树油、柠檬油、水果油和精油,包括衍生自柠檬、橙、酸橙、葡萄柚、杏、香蕉、葡萄、苹果、草莓、樱桃、菠萝等的那些,豆和坚果衍生的调味剂例如咖啡、可可、可乐果、花生、杏仁等,吸附和封装的调味剂和其混合物。提供嘴里的香味和/或其它感觉效果,包括冷或暖效果的成分也包含在本文的调味剂中。这种成分包括薄荷醇、醋酸薄荷酯、乳酸薄荷酯、樟脑、桉树油、桉树脑、茴香脑、丁香酚、肉桂、噁烷酮(oxanone)、[α]-紫罗兰酮、丙烯基邻乙氧基苯酚、麝香草酚、芳樟醇、苯甲醛、肉桂醛、N-乙基-对-薄荷基-3-甲酰胺、N,2,3-三甲基-2-异丙基丁酰胺、3-1-薄荷氧基-1,2-丙二醇、肉桂醛甘油乙缩醛(CGA)、薄荷酮甘油乙缩酮(MGA)和其混合物。一种或多种调味剂任选存在的总量是0.01%-5%,在多个实施方案中任选是0.05-2%、0.1%-2.5%和0.1-0.5%。
本文有用的甜味剂包括葡萄糖、聚葡萄糖、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、部分水解的淀粉、氢化淀粉水解产物、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(neotame)、糖精和其盐、三氯蔗糖、基于二肽的强烈甜味剂、环己氨磺酸盐、二氢查耳酮及其混合物。
口感剂包括在组合物的使用中赋予期望的质感或其它感觉的材料。
本文有用的着色剂包括颜料、染料、色淀和赋予特定光泽或反射性的剂例如珠光剂。在多个实施方案中,着色剂可操作用于在牙表面提供白色或淡色的涂层、用于充当牙齿表面上已被组合物有效接触的位点的指示剂、和/或改变组合物的外观,尤其是颜色和/或不透明度以提高对消费者的吸引力。可用任何口腔可接受的着色剂,包括FD&C染料和颜料、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、棕色和黑色的氧化铁、亚铁氰化铁铵、锰紫、群青、钛化云母(titaniated
mica)、氯氧化铋和其混合物。一种或多种着色剂任选存在的总量是0.001%-20%,例如0.01%-10%或0.1%-5%。
在一些实施方案中,本发明的口腔组合物可包含任选的作为例如抛光剂有用的研磨剂。可用任何口腔可接受的研磨剂,但是应该选择研磨剂的类型、细度(粒径)和含量以便在组合物的正常使用中牙釉质不会过度磨损。合适的任选的研磨剂包括二氧化硅(例如沉淀二氧化硅或作为和氧化铝混合的形式)、不溶的磷酸盐、碳酸钙和其混合物。作为研磨剂有用的不溶的磷酸盐是正磷酸盐、聚偏磷酸盐和焦磷酸盐。说明性的实例是正磷酸二钙二水合物、焦磷酸钙、焦磷酸钙、磷酸三钙、聚偏磷酸钙和不溶的聚偏磷酸钠。
在一些实施方案中,本发明的组合物任选包含牙垢控制(防牙垢)剂。本文有用的牙垢控制剂包括任何这些剂的盐,例如它们的碱金属和铵盐:磷酸盐和多磷酸盐(例如焦磷酸盐)、聚氨基丙磺酸(AMPS)、聚烯烃磺酸盐、聚烯烃磷酸盐、二膦酸盐例如氮杂环烷-2,2-二膦酸盐(例如氮杂环庚烷-2,2-二膦酸)、N-甲基氮杂环庚烷-2,3-二膦酸、乙烷-1-羟基-1,1-二膦酸(EHDP)和乙烷-1-氨基-1,1-二膦酸盐、膦酰基链烷羧酸。有用的无机磷酸盐和多磷酸盐包括磷酸二氢钠、磷酸氢二钠和磷酸三钠、三聚磷酸钠、四聚磷酸盐、焦磷酸一、二、三和四钠、三偏磷酸钠、六偏磷酸钠和其混合物。
在其它的实施方案中,本发明的口腔组合物任选包含例如作为抗龋剂有用的氟离子源。可用任何口腔可接受的氟离子源,包括氟化钾、氟化钠和氟化铵和单氟磷酸盐、氟化亚锡、氟化铟、氟化胺例如奥拉氟(N'-十八烷基三甲撑二胺-N,N,N'-三(2-乙醇)-二氢氟酸)和其混合物。一种或多种氟离子源任选存在的量为提供临床有效量的可溶氟离子给口腔组合物。
在进一步的实施方案中,本发明的口腔组合物任选包含有用于例如改善口干的唾液刺激剂。可用任何口腔可接受的唾液刺激剂,包括但不限于食品酸例如柠檬酸、乳酸、苹果酸、琥珀酸、抗坏血酸、己二酸、富马酸和酒石酸及其混合物。一种或多种唾液刺激剂任选以唾液刺激有效的总量存在。
在另外的实施方案中,本发明的口腔组合物任选包含营养素。合适的营养素包括维生素、矿物质、氨基酸和其混合物。维生素包括维生素C和D、硫胺素、核黄素、泛酸钙、尼克酸、叶酸、烟酰胺、吡哆醇、氰钴胺素、对氨基苯甲酸、生物类黄酮和其混合物。营养添加物包括氨基酸(例如L-色氨酸、L-赖氨酸、甲硫氨酸、苏氨酸、左卡尼汀和L-肉毒碱)、亲脂剂(例如胆碱、肌醇、甜菜碱和亚油酸)和其混合物。
在一些实施方案中,本发明提供治疗与口腔细菌的存在相关的病症的方法,包括提供根据任何上述实施方案的口腔组合物和将口腔组合物施用给哺乳动物受试者的口腔。在一些实施方案中,该方法包括重复施用组合物数次直到在受试者达到期望的抗菌和/或抗炎效果。
本文所指的口腔组织的“炎症”一般指的是通过组织损伤或破坏引发的局部保护性反应,其作用于破坏、稀释或隔离有害剂和损伤的组织两者。在急性形式,其特征在于疼痛、灼热、发红、肿胀和失去功能。慢性炎症是缓慢的过程,其主要特征在于形成新的结缔组织。慢性炎症通常是急性炎症的延续或延长的炎症的低度形式(例如与牙周炎或牙龈炎相关的炎症),且通常引起永久的组织损害。组织学上,炎症涉及复杂的系列事件,包括伴随提高的渗透性和血流的小动脉、微血管和小静脉的扩张;体液(包括血浆蛋白)渗出和白细胞迁移进入炎症位点。炎症相应于促炎症细胞介质或从细胞中释放的物质的水平升高,例如作为抗原和抗体相互作用或抗原和敏化淋巴细胞的作用的结果。
在多个实施方案中,采用合适的被覆材料(dressing material)通过润洗、涂覆、刷洗或层化来实现施用或接触。在一些实施方案中,接触也包括在食用或咀嚼时的偶然接触。在多个实施方案中,施用组合物包括采用施用装置,其帮助保持包含木兰提取物的抗炎症活性成分对目标组织的足够的接触时间,以便允许药理学抑制一种或多种炎症介质例如PGE2和TNF-α的产生升高。
在某些实施方案中,口腔组合物不是有意吞服,而是在口腔中保留足够的时间以发挥预期效用。在其它实施方案中,特别是其中口腔组合物提供给动物产品例如宠物食品、宠物食品添加物(例如点心)或咀嚼玩具中的实施方案中,口腔组合物可在对动物无害的低浓度摄入。优选用于本发明的具体材料和组合物是药学或美容可接受的。
一些实施方案提供口腔组合物,该组合物包含:约0.05-约10%重量的丙二醇;约0.05-约5%重量的木兰提取物中发现的一种或多种活性成分或其合成类似物;和口腔可接受的载体。
一些实施方案提供其中一种或多种活性成分中的至少一种是四氢木兰酚的组合物。在一些实施方案中,一种或多种活性成分中的至少一种是四氢和厚朴酚。在其它实施方案中,一种或多种活性成分中的至少一种是5,5'-二正丁基-联苯基-2,2'-二醇。
一些实施方案提供治疗口腔疾病或病症的方法,其包括:提供包含以下的组合物:约0.05-约10%重量的丙二醇,约0.05-约5%重量的木兰提取物中发现的一种或多种活性成分或其合成类似物;和口腔可接受的载体;以及将该组合物施用到有需要的受试者的口腔。
在一些实施方案中,口腔的疾病或病症包括牙齿、口腔粘膜、齿龈或舌头的疾病或病症。这种疾病或病症包括龋齿、牙龈炎、牙周炎和美容病症例如发黄和恶臭。
本发明将以具体实施例的方式更详细地描述。下列实施例为了说明的目的而提供,并不旨在以任何方式限制本发明的范围。本领域技术人员容易意识到各种非关键性的参数可以被改变或修改而得到基本上相同的结果。
实施例
具有列于下表中的成分的口腔组合物可通过以下方法制备。将氟化钠和任何其它盐分散在水中。将湿润剂例如甘油和山梨醇在搅动下在传统混合器中加入混合物。搅动得到的混合物直到形成均一的凝胶相。将颜料例如二氧化钛加入凝胶相中,以及所需的任何酸或碱(例如NaOH)将pH调整到6-7。然后加入有机增稠剂、角叉菜胶和CMC。混合这些成分直到获得均一相。然后将混合物转移到高速真空混合器,往其中加入二氧化硅研磨剂和二氧化硅增稠剂。然后在约20-50
mm汞柱优选约30mm汞柱的真空下将混合物高速混合5-30分钟。称重调味油,然后将木兰提取物或它们的活性成分加入调味油中。将调味油和木兰活性物加入混合物中。最后加入表面活性剂例如十二烷基硫酸钠(SLS)。得到的产物是增溶的,稳定的,有效的,均一的,半固体的可挤出的糊剂或凝胶产品。
实施例
1
表1显示一种增溶和有效的口腔组合物,其含有丙二醇和四氢和厚朴酚(木兰提取物中发现的活性成分之一)。
表1。
成分 | 量 (%) |
净化水 | 29 |
山梨醇 | 19.45 |
甘油 | 20 |
CMC钠-12型USP | 1.1 |
ι角叉菜胶 | 0.4 |
糖精钠-USP | 0.3 |
氟化钠 | 0.24 |
Zeodent-115 | 8.5 |
Zeodent-165 | 3 |
Sylodent XWA650 | 10 |
二氧化钛 | 0.5 |
十二烷基硫酸钠粉末-NF | 1.5 |
调味剂 | 1 |
丙二醇 | 4.5 |
四氢和厚朴酚 | 0.5 |
总计 | 100 |
实施例
2
表2显示一种增溶和有效的口腔组合物,其含有丙二醇和5,5'-二正丁基-联苯基-2,2'-二醇(木兰酚的结构类似物,木兰提取物中发现的活性成分之一)。
表2。
成分 | 量 (%) |
净化水 | 29 |
山梨醇 | 19.45 |
甘油 | 20 |
CMC钠-12型USP | 1.1 |
ι角叉菜胶 | 0.4 |
糖精钠-USP | 0.3 |
氟化钠 | 0.24 |
Zeodent-115 | 8.5 |
Zeodent-165 | 3 |
Sylodent XWA650 | 10 |
二氧化钛 | 0.5 |
十二烷基硫酸钠粉末-NF | 1.5 |
调味剂 | 1 |
丙二醇 | 4.5 |
5,5'-二正丁基-联苯基-2,2'-二醇 | 0.5 |
总计 | 100 |
实施例
3
表3显示一种增溶和有效的口腔组合物,其含有丙二醇和合成和厚朴酚(木兰提取物中发现的活性成分之一)。
表3。
成分 | 量 (%) |
净化水 | 32.51 |
山梨醇 | 19.45 |
甘油 | 20 |
CMC钠-12型USP | 1.1 |
ι角叉菜胶 | 0.4 |
糖精钠-USP | 0.3 |
氟化钠 | 0.24 |
Zeodent-115 | 8.5 |
Zeodent-165 | 3 |
Zeodent-105 | 10 |
二氧化钛 | 0.5 |
十二烷基硫酸钠粉末-NF | 1.5 |
调味剂 | 1 |
丙二醇 | 1 |
合成和厚朴酚 | 0.5 |
总计 | 100 |
实施例
4
表4显示一种增溶和有效的口腔组合物,其含有丙二醇和天然和厚朴酚(木兰提取物中发现的活性成分之一)。
表4。
成分 | 量 (%) |
净化水 | 33.96 |
山梨醇 | 20 |
甘油 | 20 |
CMC钠-12型USP | 1.1 |
ι角叉菜胶 | 0.4 |
糖精钠-USP | 0.3 |
氟化钠 | 0.24 |
Zeodent-115 | 7.5 |
Zeodent-165 | 3 |
Sylodent XWA 650 | 9 |
二氧化钛 | 0.5 |
十二烷基硫酸钠粉末-NF | 1.5 |
调味剂 | 1 |
和厚朴酚 | 0.5 |
丙二醇 | 1 |
总计 | 100 |
实施例
5
下表5描述的数据表明丙二醇对液体制剂中木兰提取物的溶解性的效果。
表5。
成分 | 配方 5A | 配方 5B | 配方 5C | |
水 | 41.04 | 40.95 | 40.07 | |
山梨醇 | 25.80 | 25.42 | 25.42 | |
甘油 | 24.76 | 24.39 | 24.39 | |
氟化钠 | 0.30 | 0.29 | 0.29 | |
硫酸钠 | 0.62 | 0.61 | 0.61 | |
Gantrez共聚物 | 2.80 | 2.75 | 2.75 | |
氢氧化钠 | 0.75 | 0.74 | 0.74 | |
糖精钠 | 0.38 | 0.37 | 0.37 | |
十二烷基硫酸钠 | 1.87 | 1.84 | 1.82 | |
调味剂 | 1.30 | 1.28 | 1.23 | |
木兰提取物(>98%纯度) | 0.39 | 0.38 | 0.37 | |
丙二醇 | 0.98 | 1.94 | ||
总计 | 100 | 100 | 100 | |
制剂外观 | 相分离,奶油状顶层 | 半透明但均一 | 澄清且透明 |
实施例
6
下表6描述的数据表明丙二醇对液体制剂中木兰酚的溶解性的效果。
表6。
成分 | 配方 6A | 配方 6B | 配方 6C | |
水 | 39.10 | 39.11 | 37.43 | |
山梨醇 | 24.04 | 24.04 | 23.73 | |
甘油 | 23.07 | 23.07 | 22.77 | |
氟化钠 | 0.28 | 0.28 | 0.27 | |
硫酸钠 | 0.58 | 0.58 | 0.57 | |
Gantrez共聚物 | 2.60 | 2.60 | 2.56 | |
氢氧化钠 | 0.70 | 0.70 | 0.69 | |
糖精钠 | 0.35 | 0.36 | 0.34 | |
十二烷基硫酸钠 | 2.21 | 1.72 | 1.7 | |
调味剂 | 1.20 | 1.16 | 1.18 | |
木兰酚 | 0.59 | 0.59 | 0.58 | |
丙二醇 | 5.28 | 5.28 | 8.18 | |
Tauranol(另外的表面活性剂) | 0.51 | |||
总计 | 100 | 100 | 100 | |
制剂外观 | 相分离,奶油状顶层 | 相分离,奶油状顶层 | 半透明但均一 |
实施例
7
下表7描述的数据表明丙二醇对液体制剂中丁基木兰酚的溶解性的效果。
表7。
成分 | 配方 7A | 配方 7B | 配方 7C | 配方 7D | |
水 | 40.86 | 40.23 | 39.49 | 38.00 | |
山梨醇 | 25.92 | 25.56 | 25.07 | 24.11 | |
甘油 | 24.88 | 24.53 | 24.06 | 23.14 | |
氟化钠 | 0.30 | 0.29 | 0.29 | 0.28 | |
硫酸钠 | 0.63 | 0.62 | 0.6 | 0.58 | |
Gantrez共聚物 | 2.80 | 2.76 | 2.71 | 2.61 | |
氢氧化钠 | 0.75 | 0.74 | 0.73 | 0.70 | |
糖精钠 | 0.37 | 0.37 | 0.36 | 0.35 | |
十二烷基硫酸钠 | 1.86 | 1.87 | 1.80 | 1.72 | |
调味剂 | 1.26 | 1.21 | 1.18 | 1.15 | |
丁基木兰酚 | 0.38 | 0.37 | 0.37 | 0.37 | |
丙二醇 | 1.46 | 3.34 | 7.00 | ||
总计 | 100 | 100 | 100 | 100 | |
制剂外观 | 非常浑浊 | 非常浑浊 | 浑浊 | 澄清且透明 |
实施例
8
下表8描述的数据表明丙二醇对液体制剂中丙基和厚朴酚的溶解性的效果。
表8。
成分 | 配方 8A | 配方 8B | 配方 8C | 配方 8D | |
水 | 40.86 | 40.26 | 39.46 | 38.00 | |
山梨醇 | 25.92 | 25.54 | 25.05 | 24.12 | |
甘油 | 24.87 | 24.51 | 24.04 | 23.15 | |
氟化钠 | 0.30 | 0.29 | 0.29 | 0.28 | |
硫酸钠 | 0.62 | 0.62 | 0.60 | 0.58 | |
Gantrez共聚物 | 2.80 | 2.76 | 2.71 | 2.61 | |
氢氧化钠 | 0.75 | 0.74 | 0.73 | 0.7 | |
糖精钠 | 0.37 | 0.36 | 0.36 | 0.35 | |
十二烷基硫酸钠 | 1.86 | 1.83 | 1.79 | 1.73 | |
调味剂 | 1.27 | 1.26 | 1.24 | 1.16 | |
丙基和厚朴酚 | 0.38 | 0.37 | 0.38 | 0.35 | |
丙二醇 | 1.46 | 3.35 | 6.97 | ||
总计 | 100 | 100 | 100 | 100 | |
制剂外观 | 非常浑浊 | 澄清且透明 | 澄清且透明 | 澄清且透明 |
在本专利文件中提及的各个专利、专利申请和印刷出版物都特此通过引用全文并入。
本领域技术人员理解,可对本文描述的实施方案进行许多改变和修改,而不会偏离本发明的精神。旨在所有这种变化都落在请求保护的发明的范围内。
Claims (12)
1. 一种口腔组合物,包括:
约0.05-约10%重量的丙二醇;
约0.05-约5%重量的木兰提取物中发现的至少一种或多种活性成分或其合成类似物,其选自木兰酚、和厚朴酚、四氢木兰酚、四氢和厚朴酚、5,5'-二正丁基-联苯基-2,2'-二醇、异丙基木兰酚、异丁基木兰酚;和
口腔可接受的载体。
2. 权力要求1的组合物,其中丙二醇存在的量为组合物的0.1%-5%重量。
3. 权力要求1或权利要求2的组合物,其中一种或多种活性成分中的至少一种存在的量为组合物的0.1%-3%重量。
4. 任一前述权利要求的组合物,其中一种或多种活性成分中的至少一种是木兰酚。
5. 任一前述权利要求的组合物,其中一种或多种活性成分中的至少一种是和厚朴酚。
6. 任一前述权利要求的组合物,其中一种或多种活性成分中的至少一种是四氢木兰酚。
7. 任一前述权利要求的组合物,其中一种或多种活性成分中的至少一种是四氢和厚朴酚。
8. 任一前述权利要求的组合物,其中一种或多种活性成分中的至少一种是5,5'-二正丁基-联苯基-2,2'-二醇。
9. 任一前述权利要求的组合物,其中一种或多种活性成分中的至少一种是异丙基木兰酚。
10. 任一前述权利要求的组合物,其中一种或多种活性成分中的至少一种是异丁基木兰酚。
11. 一种治疗或预防口腔疾病或病症的方法,包括:
提供包含以下的组合物:
约0.05-约10%重量的丙二醇;
约0.05-约5%重量的木兰提取物中发现的一种或多种活性成分或其合成类似物,其选自木兰酚、和厚朴酚、四氢木兰酚、四氢和厚朴酚、异丙基木兰酚、异丁基木兰酚和5,5'-二正丁基-联苯基-2,2'-二醇;和
口腔可接受的载体;和
施用所述组合物到有需要的受试者的口腔。
12. 权利要求11的方法,其中组合物每天施用至少一周时间。
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PCT/US2011/026017 WO2011106492A1 (en) | 2010-02-24 | 2011-02-24 | Oral care compositions |
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AU2011382468B2 (en) * | 2011-12-02 | 2015-06-11 | Colgate-Palmolive Company | Oral care composition comprising isobutyl magnolol |
AU2011382469B2 (en) * | 2011-12-02 | 2015-06-11 | Colgate-Palmolive Company | Oral care compositions comprising n-butyl magnolol and isobutyl magnolol |
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WO2013130104A1 (en) * | 2012-03-02 | 2013-09-06 | Colgate-Palmolive Company | Oral care compositions |
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AR080294A1 (es) | 2012-03-28 |
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ZA201206068B (en) | 2015-04-29 |
CA2788423A1 (en) | 2011-09-01 |
RU2552322C2 (ru) | 2015-06-10 |
BR112012019997A2 (pt) | 2019-09-24 |
JP5665888B2 (ja) | 2015-02-04 |
CO6592076A2 (es) | 2013-01-02 |
RU2015114797A (ru) | 2015-09-20 |
US20120294812A1 (en) | 2012-11-22 |
EP2523676A1 (en) | 2012-11-21 |
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AU2011220789A1 (en) | 2012-08-23 |
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RU2012140474A (ru) | 2014-03-27 |
CN102762219B (zh) | 2016-05-04 |
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