CN112515987B - 具有粘土和抗菌剂的加合物的口腔护理组合物 - Google Patents
具有粘土和抗菌剂的加合物的口腔护理组合物 Download PDFInfo
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- CN112515987B CN112515987B CN202011429576.1A CN202011429576A CN112515987B CN 112515987 B CN112515987 B CN 112515987B CN 202011429576 A CN202011429576 A CN 202011429576A CN 112515987 B CN112515987 B CN 112515987B
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- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/0241—Containing particulates characterized by their shape and/or structure
- A61K8/0254—Platelets; Flakes
- A61K8/0258—Layered structure
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- A—HUMAN NECESSITIES
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- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
- A61K8/41—Amines
- A61K8/416—Quaternary ammonium compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
- A61K2800/41—Particular ingredients further characterized by their size
- A61K2800/412—Microsized, i.e. having sizes between 0.1 and 100 microns
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
- A61K2800/56—Compounds, absorbed onto or entrapped into a solid carrier, e.g. encapsulated perfumes, inclusion compounds, sustained release forms
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Birds (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cosmetics (AREA)
Abstract
本发明公开了一种口腔护理组合物,其具有:(i)5至60重量%的磨料;(ii)阴离子表面活性剂;和(iii)双极抗微生物颗粒,其前体为包含交替的四面体和八面体片的在一个外表面平面处用四面体片结束和在另一外表面平面处用八面体片结束的不对称的1:1或者2:1:1的粘土颗粒,其具有连接到所述外表面平面之一上的配位阳离子的抗微生物剂,其中所述抗菌剂为季铵材料。所公开的组合物对于控制细菌再生长是非常有效的,以及其对于提供细菌计数的即时控制是同样好的。
Description
本申请是申请号为201380068741.7的中国专利申请的分案申请。
技术领域
本发明涉及具有抗菌活性的口腔护理组合物。
背景技术
大多数口腔护理组合物,例如牙膏通常含有一种或者多种用于口腔卫生的抗菌剂。三氯生(Triclosan)是已被发现广泛接受的抗菌剂。氯化锌、柠檬酸锌和其它的锌盐代表另一类广泛使用的抗菌剂。
三氯生是广谱范围内有效的。目前,其用于多种产品中,但是存在关于其对于人类健康的影响的担忧。据信,在不久的将来可能禁止或者限制三氯生。已建议多种其它的抗微生物剂用于个人护理产品。然而在口腔护理产品的情况中,更为严格的安全性规定限制着可使用的抗菌剂。某些抗菌剂与常用的磨料,例如白垩以及与表面活性剂也是不兼容的。
因此,工业需要更新型的用于口腔护理产品的抗菌剂。
阳离子剂,例如双氯苯双胍己烷(chlorhexidine)和十六烷基氯化吡啶被认为是更实质性的,并且可以被容易地吸收和逐渐地释放。然而,仍未实现将阳离子抗菌剂成功地配制到可销售的牙膏中,并且这至少部分地是由于阳离子抗菌剂与存在于牙膏中的某些常用成分的不兼容性。
不过,在出版的文件中可以找到某些尝试。
WO2007/063506A1(P&G)公开了具有亲水性粘土材料、植酸化合物、口腔护理活性物和极性溶剂载体的洁齿剂组合物,其中该组合物基本上不含磨料材料。该公开内容的新颖性在于使磨料的使用最小化。
WO2003/002056(Church And Dwight Co Inc)公开了口腔组合物,其具有抗菌有效量的十六烷基氯化吡啶和瓜耳胶羟丙基三甲基氯化铵(guarhydroxypropyltrimonium chloride),后者结合到不希望结合到十六烷基氯化吡啶/>的化合物上,由此使十六烷基氯化吡啶/>能够有效地结合到牙齿表面上和执行抗菌功能。
基于双极粘土的抗微生物颗粒已公开于US2012/0177712A1(Unilever)中。该颗粒的前体为包含交替的四面体和八面体片的在一个外表面平面处用四面体片结束和在另一外表面平面处用八面体片结束的不对称的1:1或者2:1:1的粘土颗粒,其具有连接到所述外表面平面之一上的配位阳离子的抗微生物基团(group),其选自包含具有大于或者等于C20的平均链长度的单个烷基或者烯基长链的季铵材料或者季铵材料。
进一步地,公开了所述双极抗微生物颗粒能够用于多种应用中,包括口腔护理组合物。然而,牙膏具有碱性pH。因此,否则在环境条件下是稳定的抗菌剂的络合物、加合物、胶囊(encapsulate)和其它类型的制剂和组合物通常倾向于丧失稳定性和/或功效。持久功效是要求抗菌作用的任何牙膏的重要特征。
JP2004359483A(TOPY IND)公开了改性的氟硅酸盐粉末,其具有增稠和乳化作用,并且其中在热水洗脱测试中被洗脱的氟离子的量减小。该解决方法在于,将用作主体矿物的含氟的可膨胀的层状硅酸盐通过具有疏水性基团的有机铵阳离子改性剂和含有可交换在主体层中的Li或者Na的金属离子的金属离子交换剂来进行改性。合适的是,粉末中的有机铵阳离子大于或者等于10当量%的主体的含氟可膨胀硅酸盐的阳离子交换能力,并且粉末中的金属离子大于或者等于10当量%的主体的含氟可膨胀硅酸盐的阳离子交换能力。
JP 2001 122749 A(KISHO KK)公开了使用蒙皂石作为牙齿磨料以克服传统牙齿磨料的缺陷,该传统牙齿磨料通常给牙齿和牙龈组织造成损伤或者刺激口腔粘膜。
GB710129A(AMM I DENT INC,1954)公开了具有抗生素(例如青霉素)、抛光剂、表面活性剂和亲有机性胶凝剂(organophyllic gelling agent)的牙膏,其中抗生素、抛光剂和洗涤剂分散在赋形剂(vehicle)中。优选的胶凝剂为膨润土及其衍生物,例如所谓的Bentone和硬脂酸铝。
US6569408B(P&G,2003)公开了将口腔护理物质递送到口腔的组合物,其包含有机硅氧烷树脂、能够溶解该有机硅氧烷树脂的挥发性载体、流变改性剂;和至少一种口腔护理物质。
我们如今已确定,含有双极抗微生物颗粒的牙膏提供即时的抗菌活性,其还令人惊奇地比传统组合物持续显著更久,由此提供针对细菌再生长的显著保护,其中细菌再生长为用一些市售的抗菌牙膏通常观察到的现象。
发明概述
根据第一方面公开了口腔护理组合物,其具有:
(i)5至60重量%的磨料,其选自基于钙的磨料或者基于二氧化硅的磨料;
(ii)阴离子表面活性剂;和
(iii)双极抗微生物颗粒,其前体为包含交替的四面体和八面体片的在一个外表面平面处用四面体片结束和在另一外表面平面处用八面体片结束的不对称的1:1或者2:1:1的粘土颗粒,其具有连接到所述外表面平面之一上的配位阳离子的抗微生物剂,其中该抗菌剂为季铵材料。
优选地,该抗菌颗粒的中位数直径(D50)为0.1至10μm。
发明详述
所述口腔护理组合物具有选自基于钙的磨料或者基于二氧化硅的磨料的5至60重量%的磨料、阴离子表面活性剂和双极抗微生物颗粒。该组合物优选为牙膏。
磨料
牙膏通常含有磨料。凝胶通常含有二氧化硅,然而不透明膏剂通常含有基于钙的磨料,尤其是白垩。磨料的量需要一些控制,因为过量磨料造成更多磨耗。此外,不受控的磨料量也将不利地影响膏体粘度。
优选的牙膏组合物具有25至60重量%的磨料,更优选30至50重量%和最优选45至55重量%的磨料,其基于二氧化硅或者基于钙。
当公开的牙膏组合物具有含钙的磨料时,特别优选的磨料为细磨天然白垩(FGNC)。其获自石灰岩或者大理石。FGNC还可以通过在碾磨期间或者之后通过热处理涂覆来进行化学或者物理改性。典型的涂覆材料包括硬脂酸镁和油酸镁。FGNC的形态还可以在碾磨过程中通过使用不同的碾磨技术,例如球磨、气流分级碾磨(air-classifiermilling)或者螺旋喷射碾磨(spiral jet milling)来改性。FGNC可以用作唯一的含钙磨料。然而,FGNC也可以与其它的含钙磨料一起使用,以平衡磨耗。
其它优选的含钙磨料包括磷酸二钙(DCP)、焦磷酸钙和沉淀碳酸钙(PCC)。当使用含钙磨料的组合时,优选的是FGNC为总磨料的35至100%,更优选为75至100%和尤其是95至100%。在此类情况中,余量最优选为PCC。
根据预期的磨耗程度和膏体的组成,还可以使用其它磨料。其包括合成磨料抛光剂,例如无定形的沉淀的二氧化硅和硅胶。其它磨料包括碳酸镁、偏磷酸钠、偏磷酸钾、硅酸锆、偏磷酸钾、正磷酸镁、磷酸三钙、正磷酸镁、磷酸三镁、硅酸铝、硅酸锆和珍珠岩。
表面活性剂
牙膏通常含有表面活性剂,其也通常称为起泡剂。合适的表面活性剂是在整个较宽pH范围内相当稳定并提供泡沫的那些。表面活性剂是阴离子的。本文中有用的阴离子表面活性剂包括在烷基基团中具有8至20个碳原子的烷基硫酸盐的水溶性盐(例如烷基硫酸钠),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。月桂基硫酸钠和椰子单酸甘油酯磺酸钠(sodium coconut monoglyceride sulfonate)是这类阴离子表面活性剂的实例。
优选的组合物含有0.25至12重量%,更优选0.5至8重量%,和最优选1至约6重量%的阴离子表面活性剂。
一些阴离子表面活性剂,特别是月桂基硫酸钠本身具有抗菌效果。此类作用提供某种程度的即时抗菌效果。然而,该效果通常是非常短暂的。因此,通过抗菌剂,例如三氯生提供更可持续的抗菌作用。常规进行以量化抗菌作用的一些测试显示了不一致的结果,因为该程序不区分阴离子表面活性剂的效果和抗菌作用的效果。但是,单物种测定(singlespecies assay)可以提供更精确的结果,因为测试仅专注于抗菌剂的效果。
也可以包括其它表面活性剂,例如非离子、两性或者两性离子表面活性剂。
非离子表面活性剂可以被宽泛地定义为通过环氧烷基团(性质上亲水性)与性质上可为脂族或者烷基芳族的有机疏水性化合物的缩合而产生的化合物。合适的非离子表面活性剂的实例包括泊咯沙姆(以商品名销售)、聚氧乙烯、聚氧乙烯脱水山梨醇酯(以商品名/>销售)、/>40氢化蓖麻油、脂肪醇乙氧基化物、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、脂族醇的环氧乙烷缩合物、长链叔胺氧化物、长链叔膦氧化物、长链二烷基亚砜和此类材料的混合物。
有用的两性表面活性剂可以宽泛地描述为脂族仲胺和叔胺的衍生物,其中脂族基团为直链或者支链的,并且其中脂族取代基中的一个含有约8至约18个碳原子,并且一个含有阴离子的水增溶性基团,例如羧酸根、磺酸根、硫酸根、硫酸根或者膦酸根。其它合适的两性表面活性剂为甜菜碱,特别是椰油酰胺基丙基甜菜碱。也可以使用两性表面活性剂的混合物。
双极抗微生物颗粒
尽管大多数抗菌牙膏提供即时抗菌效果,这在多种情况中通过阴离子表面活性剂来提供;该效果非常快速地消退。当这发生时,残余的细菌细胞繁殖。这也被称作细菌再生长,并且通常通过细菌再生长测定来研究。
虽然在US2012/0177712A1(Unilever)中公开了抗菌颗粒适合于各种应用,我们如今发现,用于口腔护理组合物中的颗粒也提供持续显著更长的功效。
特别优选地,该颗粒的中位数粒度(D50)为0.1至10μm,更优选为0.4至1μm和最优选为0.5至0.8μm。
当这些颗粒具有增大的尺寸时,可用的表面积被认为是较低的。因此,当优选颗粒具有显著较小的尺寸时,据信更大的面积可用于使抗菌剂与其形成加合物。不进一步地受理论约束,据信这更有效地利用了抗菌剂,由此提供充分减小抗菌剂剂量的机会。虽然传统抗菌剂需要0.2至0.5重量%的最佳剂量,以所公开的双极抗菌颗粒的形式递送的抗菌剂看起来甚至在0.01%的(实际)剂量时是高度有效的。
虽然不希望进一步地受理论约束,据信优选的颗粒具有合适的尺寸以适配牙齿表面上的间隙空间内部,这被认为是持久功效的原因。进一步认为,较小尺寸的颗粒很大程度地减小阴离子表面活性剂和抗菌剂之间的任何不利的相互作用,甚至在该颗粒含有例如十六烷基氯化吡啶(其为季铵化合物)时,并且这也被认为是更持久的抗菌益处的原因。
如果需要的话,较小尺寸的颗粒还为增大的抗菌剂装填量提供有效的机制。
粒度分布(D50)也已知为粒度分布的中位数直径和中间值,其为累积分布中的50%处的颗粒直径值。其为表征粒度的重要参数。例如,如果D50=5.8μm,那么样品中50%的颗粒大于5.8μm,并且50%小于5.8μm。D50通常用于表示颗粒组的粒度。D50为将分布以一半超过和一半低于该直径分开的微米尺寸。
具有双极拓扑特异性(topospecific)特性的抗菌颗粒的前体优选为包含交替的四面体和八面体片的在外表面平面处用四面体和八面体片结束的不对称的1:1或者2:1:1的粘土颗粒。1:1粘土的颗粒特别优选地作为前体。优选的1:1粘土包括矿物的高岭石和蛇纹石的亚类。包括在高岭石亚类中的物种包括但是不受限于高岭石、地开石、埃洛石和珍珠陶土。包括在蛇纹石亚类中的物种包括但是不受限于贵橄榄石、利蛇纹石和镁绿泥石。优选的2:1:1粘土包括矿物的绿泥石组。绿泥石包含如同2:1粘土的四面体-八面体-四面体片,在四面体层之间具有额外的弱结合的类似水镁石的层。该四面体片优选地包含硅的配位四面体阳离子。该四面体片还可以包含同晶取代的非硅的配位四面体阳离子。同晶取代的配位四面体阳离子包括但是不受限于铝、铁或者硼的阳离子。
八面体片优选地具有铝的配位八面体阳离子。该八面体片还可以包含同晶取代的非铝的配位八面体阳离子。同晶取代的配位八面体阳离子包括镁或者铁的阳离子。优选抗微生物剂连接到外表面平面之一的外侧上的配位阳离子。因此,抗微生物剂连接到四面体片的外侧上的配位阳离子。可替代地,抗微生物分子连接到八面体片的外侧上的配位阳离子。四面体和八面体表面片中的每一个的外侧上的配位阳离子连接到抗微生物分子,条件是连接到四面体表面片的外侧上的配位阳离子的抗微生物分子不同于连接到八面体表面片的外侧上的配位阳离子的分子。抗微生物剂优选地连接到八面体表面平面的外表面上的配位阳离子,并且不优选地连接到非外部的四面体或者八面体平面的或者表面片的内侧上的配位阳离子。
在以上提及的颗粒抗微生物剂中,粘土:抗微生物剂比率为1:0.001至1:1,更优选为1:0.001至1:0.1。
优选地在所述抗微生物颗粒中,抗菌剂连接到八面体表面平面的外表面上的配位阳离子上。
优选的口腔护理组合物含有0.1至10重量%的双极抗微生物颗粒,更优选0.5至5重量%的颗粒。进一步优选地,此类颗粒含有1%至60%的抗微生物剂装填量。特别优选的抗菌剂为十六烷基氯化吡啶
可以在WO2011/036031A1(Unilever)中找到该颗粒的进一步的细节。
所述抗菌剂是季铵材料。该季铵材料优选地选自包含具有大于或者等于C20的平均链长度的单个烷基或者烯基长链的季铵材料,或者选自十六烷基氯化吡啶(CPC)、十六烷基三甲基氯化铵(CTAC)、十六烷基三甲基溴化铵(CTAB)、苯扎氯铵(BKC)、苄索氯铵、溴棕三甲铵(cetrimide)、季铵盐、四丁基溴化铵、十一烯酰胺基丙基三甲基甲硫酸铵(undecylenamido propyltrimonium methosulphate)、甲苄索氯铵、十六烷基乙基二甲基溴化铵(cetethyldimonium bromide)、十六烷基三甲基甲苯磺酸铵(cetromoniumtosylate)、椰油基三甲基氯化铵、十二烷基苄基三甲基氯化铵、月桂基溴化异喹啉/>氯化月桂基吡啶/>地喹氯铵(dequalinium chloride)、溴化度米芬(domiphen bromide)的季铵材料。
更优选地,该季铵材料选自十六烷基氯化吡啶(CPC)、十六烷基三甲基氯化铵(CTAC)、十六烷基三甲基溴化铵(CTAB)、苯扎氯铵(BKC)、苄索氯铵、溴棕三甲铵或者季铵盐。
十六烷基氯化吡啶(CPC)是特别优选的。其广为人知地作为特别用于抑制牙菌斑的抗菌剂。
不受理论约束,十六烷基氯化吡啶的抗菌活性被认为是与其胺基基团的阳离子电荷相关联。因此,十六烷基氯化吡啶/>连接并结合到微生物的细胞膜或者细胞壁上的带负电的蛋白质基团上和到也通常带负电的牙齿表面上。产生的微生物连接破坏细胞壁结构,并造成细胞内液渗漏,最终杀死相关的微生物。然而,十六烷基氯化吡啶/>由于其倾向于与带负电的组分络合,在多种体系中通常不是有效的。当以该方式结合到粘土上时,十六烷基氯化吡啶/>不可用于与牙齿表面和微生物有效地接触,由此致使该活性剂对于其预期目的失效。
因此,十六烷基氯化吡啶在用于治疗和/或预防牙龈炎、牙菌斑、牙周疾病和/或口臭的常见口腔护理产品中还不是完全有效的。例如,牙膏组合物通常包含阴离子表面活性剂和人造甜味剂。牙膏组合物的这些组分通常结合到十六烷基氯化吡啶/>上,并且由此致使其作为抗菌剂无效或者基本上较不有效。通常在牙膏组合物中存在的其它组分,例如磨料也结合到十六烷基氯化吡啶/>上。因此,在牙膏组合物中使用十六烷基氯化吡啶/>已是有问题的。甚至在含有十六烷基氯化吡啶/>的商业漱口水产品中,十六烷基氯化吡啶/>在牙齿表面处的有效性是非常低的,并且因此其抗菌功效是受限的。
优选成分
除了已描述的成分以外,牙膏还优选地包含一种或多种现在将描述的优选成分。
蒙皂石粘土
优选的组合物包含蒙皂石粘土,其除了粘土以外以抗菌颗粒的方式存在。
蒙皂石构成已知为页硅酸盐或者层状硅酸盐的天然铝硅酸盐矿物种类中的组。优选的蒙皂石粘土选自蒙脱石(膨润土、锂蒙脱石和它们的衍生物);纯化的硅酸铝镁(各种等级作为来自R.T.Vanderbilt Company的是商业可得的);纯化的硅酸钠镁(各种等级作为/>是商业可得的);有机改性的蒙皂石,包括四烷基和/或三烷基铵蒙皂石(有机改性的蒙脱石粘土),例如季铵盐-18膨润土、季铵盐-18锂蒙皂石、司拉氯铵膨润土(stearalkonium bentonite)和司拉氯铵锂蒙脱石/和它们的混合物。硅酸铝镁粘土是特别优选的。实例是/>HV。当暴露于水时,该粘土倾向于膨胀。优选的牙膏组合物含有0.2至3重量%的粘土。更优选的组合物含有0.5至1重量%的粘土。
如认为的,蒙皂石粘土不仅在感官特征(sensory profile)中起作用,其也还在组合物增稠中起作用,这是因为减小了增稠二氧化硅的含量(否则导致具有较低粘度的产品)。
增稠二氧化硅
所公开的组合物含有0至2重量%的增稠二氧化硅,其暗示着组合物可能或者可能不含有增稠二氧化硅,并且特别是在组合物含有蒙皂石粘土时的情况下。每当蒙皂石粘土存在时,其(二氧化硅的)上限为2重量%。传统的凝胶牙膏通常含有最高8.5重量%的增稠二氧化硅,而不透明牙膏通常含有4至10重量%。牙膏组合物可以包含最高2重量%的增稠二氧化硅。优选的组合物具有1.5重量%或者甚至小于1重量%的增稠二氧化硅。最佳组合物具有小于0.5重量%的增稠二氧化硅。高度优选的组合物不含增稠二氧化硅。
当存在时,优选的增稠二氧化硅包括来自Degussa的T系列或者来自Cabot Corporation的/>系列,硅胶,例如来自W.R.Grace&Co的/>或者/>系列,或者沉淀二氧化硅,例如来自J.M.Huber Corporation的/>265。有用的二氧化硅增稠剂还包括/>165、/>163和/或167和/>153、177和/或265二氧化硅,其均从J.M.Huber Corporation可得。其它优选的增稠二氧化硅包括/>-P(来自Madhu Silica)、/>22S和/>200(Ex.Evonik Industries)、来自WR Grace&Company的/>和/>增稠二氧化硅和来自Rhodia的/>43和331,合成的细碎的热解二氧化硅,例如以商品名244、/>266和/>D-200销售的那些。
湿润剂
湿润剂通常包含于用于柔软柔顺口腔感觉的牙膏中。湿润剂还减小牙膏失去水分的趋势。优选的牙膏组合物含有3.5至40重量%的湿润剂。进一步优选的组合物具有10至40重量%,更优选10至20重量%的湿润剂。
特别优选的湿润剂是山梨醇,其通常作为70%的水溶液可得。
其它优选的湿润剂包括丙三醇、麦芽糖醇和木糖醇。为了润滑的口腔感觉,更优选的牙膏含有丙三醇和山梨醇,但是其累积水平不应超过所公开的上限。较低的湿润剂含量提供减小产品成本的有效方式。
粘合剂
优选的牙膏组合物含有粘合剂,其赋予膏体良好的结构。纤维素粘合剂是特别优选的。优选的纤维素粘合剂包括纤维素醚,其包括羟乙基纤维素(HEC)、羟丙基纤维素(HPC)、乙基羟乙基纤维素(EHEC)、羧甲基纤维素(CMC)、羧甲基羟乙基纤维素(CMHEC)、羟丙基羟乙基纤维素(HPHEC)、甲基纤维素(MC)、甲基羟丙基纤维素(MHPC)、甲基羟乙基纤维素(MHEC)、羧甲基甲基纤维素(CMMC)、疏水性改性的羧甲基纤维素(HMCMC)、疏水性改性的羟乙基纤维素(HMHEC)、疏水性改性的羟丙基纤维素(HMHPC)、疏水性改性的乙基羟乙基纤维素(HMEHEC)、疏水性改性的羧甲基羟乙基纤维素(HMCMHEC)、疏水性改性的羟丙基羟乙基纤维素(HMHPHEC)、疏水性改性的甲基纤维素(HMMC)、疏水性改性的甲基羟丙基纤维素(HMMHPC)、疏水性改性的甲基羟乙基纤维素(HMMHEC)和疏水性改性的羧甲基甲基纤维素(HMCMMC)。
其它的纤维素粘合剂包括阳离子羟乙基纤维素(阳离子HEC)、阳离子疏水性改性的羟乙基纤维素(阳离子HMHEC)和微晶纤维素。
高度优选的粘合剂是羧甲基纤维素钠(SCMC)。特别优选的羧甲基纤维素钠包括具有0.6至0.99,优选0.7至0.95的取代度的那些。
除了纤维素粘合剂以外或者作为纤维素粘合剂的代替,可以使用瓜耳胶或者其衍生物,然而,此类粘合剂相比于纤维素的那些是较不优选的。此类衍生物包括羧甲基瓜耳胶(CM瓜耳胶)、羟乙基瓜耳胶(HE瓜耳胶)、羟丙基瓜耳胶(HP瓜耳胶)、羧甲基羟丙基瓜耳胶(CMHP瓜耳胶)、阳离子瓜耳胶、疏水性改性的瓜耳胶(HM瓜耳胶)、疏水性改性的羧甲基瓜耳胶(HMCM瓜耳胶)、疏水性改性的羟乙基瓜耳胶(HMHE瓜耳胶)、疏水性改性的羟丙基瓜耳胶(HMHP瓜耳胶)、阳离子疏水性改性的羟丙基瓜耳胶(阳离子HMHP瓜耳胶)、疏水性改性的羧甲基羟丙基瓜耳胶(HMCMHP瓜耳胶)和疏水性改性的阳离子瓜耳胶(HM阳离子瓜耳胶)。
其它的较不优选的胶包括黄原胶、角叉菜胶及其衍生物,例如爱尔兰藓和viscarin、结冷胶(gellan gum)、菌类植物胶(sclerotium gum)及其衍生物、茁霉多糖(pullulan)、鼠李糖胶、韦兰胶(welan gum)、魔芋胶(konjac)、凝胶多糖、藻胶、藻酸、藻酸盐及其衍生物、磷酸淀粉衍生物、琼脂及其衍生物、阿拉伯树胶及其衍生物、果胶及其衍生物、壳聚糖及其衍生物、刺梧桐胶、槐豆胶(locust bean gum)、纳托胶(natto gum)、黄蓍胶、甲壳质衍生物、明胶、β葡聚糖、糊精、葡聚糖、环糊精和多季铵盐、呋喃泡沫树脂胶(furcellaren gum)、茄替胶、车前籽胶(psyllium gum)、温柏树胶、罗望子胶、落叶松胶和刺云实胶(tara gum)。
在除了蒙皂石粘土以外还具有纤维素粘合剂的优选组合物的情况中,蒙皂石粘土与纤维素粘合剂量的比率为1:0.2至1:0.9。过量的纤维素粘合剂导致在将该组合物分配到牙刷上时显示拖尾效应的组合物,这是使用中不希望的效果。另一方面,大多数纤维素粘合剂和一些其它种类(例如角叉菜胶)是昂贵的成分。因此,尽管对它们的使用可以恢复产品粘度,其不是经济可行的选项。
任选的成分
除了之前描述的成分以外,优选的组合物可以包含一种或者多种如下描述的其它成分。
其它增稠剂
优选的牙膏组合物还可以包含一种或者多种其它的增稠剂,例如羧基乙烯基聚合物,其包括卡波姆(carbomer),其可以从B.F.Goodrich作为系列,包括934、940、941和956商业购得。
其它优选的品种(grade)包括丙烯酸酯/C10-30烷基丙烯酸酯交联聚合物,其可以作为21、/>TR-1和/>TR-2从Noveon Corporation商业购得。优选的组合物可以包含0.05至10重量%,更优选0.1至5重量%,和甚至更优选0.25至约4重量%的其它增稠剂。
脱敏剂
脱敏剂是选自硝酸钾、氯化钾、柠檬酸钾、酒石酸钾和乙酸钾的钾盐,其优选地使用0.5至3重量%,更优选1至2.5重量%和尤其是1.7至2.2重量%。
硅酸盐
优选的牙膏组合物可以具有碱金属硅酸盐。该碱金属为钠或者钾,优选为钠。硅酸钠通常可作为10至40%水溶液使用,最常见为30%溶液。硅酸钠可作为中性硅酸钠或者碱性硅酸钠使用。优选的牙膏具有中性硅酸钠。硅酸钠可以不同比率的Na2O:SiO2使用。
具有Na2O:SiO2比率为3.0至3.8的硅酸钠是优选的,更高度优选的范围为3.25至3.5。优选的牙膏包含0.1至5重量%的硅酸盐(基于干重计)。因此,将30%的硅酸钠溶液以0.3至16重量%的量加入该组合物中。
防龋剂
优选的组合物可以包含一种或者多种防龋剂。此类试剂通常是氟化物。优选地,氟化物的来源为单氟磷酸的碱金属盐,优选为单氟磷酸钠(SMFP)。
当涉及到具有基于钙的磨料,尤其是白垩的牙膏组合物时,SMFP是选择的氟化物来源,因为氟化钠与碳酸钙反应并形成不可溶的具有受限的防龋活性的氟化钙。优选的组合物包含0.01至2重量%,更优选0.15至1重量%和尤其优选0.2至0.5重量%的防龋剂。优选地,维持游离氟化物离子浓度为100至2000ppm,优选900至1500ppm。其它优选的防龋剂包含氟化钠和氟化亚锡、氟化胺(aminefluorides)、三偏磷酸钠和酪蛋白。
其它抗菌剂
虽然不是完全必要,附加的抗菌剂可以存在于组合物中。实例包括三氯生和其它卤化的双酚类化合物,例如2,2'-亚甲基双-(4-氯-6-溴苯酚)。
防腐剂
具有含钙磨料,尤其白垩的牙膏倾向于细菌生长。特定的防腐剂,例如对羟基苯甲酸的甲酯、乙酯、丁酯、丙酯和异丙酯针对细菌生长可能是特别有用的。对羟基苯甲酸的甲酯、乙酯、丁酯和丙酯的混合物是特别优选的。
该混合物的活性可以通过添加苯氧乙醇来增强。甲醛和二甲基乙内酰脲是其它优选的防腐剂。通常包含0.05至0.8重量%的防腐剂。
抗氧化剂
优选的抗氧化剂是与其它组分兼容和对于健康无害的那些。其包括抗坏血酸、抗坏血酸棕榈酸酯、硫代二丙酸、抗坏血酸钙、二硫代丙酸二月桂酯、愈创木脂(gum guaiac)、抗坏血酸钠、丁基化的羟基甲苯、丁基化的羟基苯甲醚和生育酚。可以使用抗氧化剂的混合物。
如果存在,以对于减小或者减轻变色(否则由牙膏组分的氧化造成变色)而言有效的水平添加抗氧化剂。优选的水平为0.01至1重量%。
甜味剂
牙膏还可以含有甜味剂。优选的甜味剂包括糖精钠、天冬甜素、三氯蔗糖、索马甜(thaumatin)、丁磺氨钾、甜菊苷、甜菊提取物、对甲氧基肉桂醛、二氢查耳酮新橙皮苷(neohesperidyl dihydrochalcone)和紫苏糖。常见水平为0.005至5重量%,更优选为0.01至1重量%。
其它成分
优选的牙膏可以包含一种或者多种漂白剂,例如过氧化合物,例如过氧焦磷酸钾,泡腾体系,例如碳酸氢钠/柠檬酸钠体系,变色体系和螯合剂,其为0.001至6重量%,优选为0.5至4重量%,其包括柠檬酸、丙氨酸、甘氨酸和丝氨酸的碱金属盐。
最优选为柠檬酸的碱金属盐,特别是柠檬酸钾,和最优选为柠檬酸三钾。
脂质体可以用于改进一种或者多种活性成分的递送或者稳定性。优选的组合物还可以包含爽口条(breath strip)、发泡剂(sparkle)、大二氧化硅颗粒、颗粒物、珠和风味剂胶囊的一种或者多种,以增强的感觉益处或者视觉感染。
为了不透明性,还可以将二氧化钛加入所述组合物中。通常包含0.25至5重量%的二氧化钛。
优选地,所述组合物含有风味剂。合适的风味剂组分包括冬青油、薄荷油、留兰香油、丁香油、薄荷醇、茴香脑、水杨酸甲酯、桉油精、山扁豆(cassia)、乙酸1-薄荷酯、鼠尾草、丁子香酚、欧芹油、覆盆子酮(oxanone)、α-紫罗兰酮、马郁兰(marjoram)、柠檬、橙子、丙烯基乙基愈创木酚、肉桂、香兰素、乙基香兰素、天芥菜精、4-顺式-庚烯醛、丁二酮、甲基-对-叔丁基苯基乙酸酯和它们的混合物。凉味剂(coolant)也可以是风味剂体系的部分。优选的凉味剂是对薄荷烷甲酰胺试剂,例如N-乙基-对-薄荷烷-3-甲酰胺(商业上已知为)和它们的混合物。该风味剂通常为0.001至5重量%。
现在,将参考以下非限制性的实施例进一步描述本发明。
实施例
实施例-1:制备用于实验的优选牙膏
为了进一步的实验,制备两个优选的组合物。该组合物描述于表1中。
表1
注释*:该颗粒在高岭石上具有1%十六烷基氯化吡啶致使其有效量为基于整个制剂的0.01重量%。该颗粒的D50为0.5μm。
实施例2:用E.cloacae的单物种的再生长测定
单物种的再生长测定是体外测定,实施其以确定细菌的再生长。该测定可以用作预测牙膏中多种活性物之间的抗菌活性的区别的快速方法。检定菌(阴沟肠杆菌)是抗SLS的,并且因此用于评估含SLS的制剂中的活性物的功效。其在用牙膏浆体处理和随后的冲洗之后,涉及监测细菌层的再生长(通过测量630nm下的吸光度)。使用96孔板-读数仪、在630nm下进行每30分钟的动态读数24小时。依此计算用于达到定义的光密度(0.5)的时间。达到该OD的时间越长,抗菌剂越有效。因此,可以将结果直接地与抗菌剂的功效作关联。总之,该步骤涉及用所述产品处理细菌培养物,并且通过研究吸光度(光密度)的变化来监测细菌培养物的生长(再生长)。
更大的吸光度意味着更多的再生长。同时,有效的组合物尽可能多地延迟再生长。
在该特定的测试中,以1比10的稀释来制备牙膏浆体,并且在实施该测试之前充分地混合。用细菌层准备96孔板,并且使用多道移液器来添加该测试溶液,并且在两分钟接触时间之后冲洗孔。重复冲洗步骤两次,并且用封板机(plate sealer)覆盖BHI(脑心浸液)培养基和保持在平板读数仪(plate reader)中37℃下,以评估用于再生长的时间。
数据显示于表2中。
表2
组合物 | 所用时间/小时 |
对照(仅为水) | 8.5 |
对照1(不含所述颗粒的组合物1) | >12.5 |
对照2(不含所述颗粒的组合物2) | >12.0 |
组合物1 | >48 |
组合物2 | >48 |
含有0.3%三氯生的市售的常用牙膏 | >48 |
。
该结果表明,表1的两个优选组合物均提供针对细菌再生长的显著更持久的保护。该保护相对于由含有0.3%三氯生的常用牙膏提供的保护而言是可比较的。然而每个优选组合物,组合物1和组合物2的有效量仅为0.01重量%,而市售组合物具有0.3%的三氯生。
实施例3:悬浮测试
该测试改用自BS EN 1040(用特定接触时间来改进)。以1分钟接触时间来测试CPC-粘土的功效。所用的检定菌为E.cloacae(阴沟肠杆菌)。
通过将冻存物划线到TSA(Tryptic Soy Agar)板上和在37℃下培育24小时来准备测试培养物。然后将少数菌落转移到新鲜TSA板上,并且在37℃下过夜培育。将该菌落再悬浮到0.8%的盐水中,并且调整至620nm下的0.8的OD,这对应于1x108cfu/ml的计数。通过称重测试材料和通过将其按照所需浓度悬浮到MQ水中来制备测试溶液,并且在进行该测试之前充分地漩涡混合。向9ml该测试溶液中加入1ml的测试培养物,并且在特定的接触时间(1分钟)之后,将1ml的该混合物一式两份地在9ml D/E肉汤中立即中和。在对照的情况中,将1ml的测试培养物加入到9ml盐水中并连续地稀释,并且铺板(plate)在TSA上。在凝固之后,在37℃下培育该板48小时,并且对残余菌落计数。
表3
注释:
#制剂的余量与组合物1的一样。仅有的变化是抗菌颗粒的数量。
*这些组合物不含抗菌颗粒。
表3中的数据表明,优选的组合物(3和4)在残余量cfu/ml以及对数降低量方面如何优于其它比较组合物的每一个。
实施例4:唾液沉淀物猝灭(quench)测定
唾液沉淀物猝灭测定涉及人类志愿者,并且该测试在从志愿者处采集的唾液上进行。该测试的目的是查明抗菌剂(在牙膏组合物中)对于存在于汇集的唾液中的细菌混合培养物的即时效果。由于该测定使用人类唾液,其被认为是非常接近体内/临床研究的。
从志愿者处采集唾液,汇集,清洗和标准化至获得唾液沉淀物(2.0OD)。
将唾液沉淀物加入到(1:5稀释的)牙膏浆体(1:1)中。在1分钟的接触时间之后,加入猝灭剂(D/E中和溶液)以停止该测试溶液的活性。连续地稀释产生的悬浮物,铺板和厌氧培育七天。对存活菌落的数量计数。
以存在于样品中的细菌的平均残余量log值的形式来表明该结果。该值越低,产品越好。
表4
组合物 | 残余量log cfu/ml |
对照(水) | 7.8 |
组合物1 | 4.2 |
组合物2 | 4.4 |
含有0.3%三氯生的市售的常见牙膏 | 4.1 |
。
表4中的数据表明,不仅优选的组合物1和2对于控制细菌再生长是高度有效的,而且其提供对于细菌计数的即时控制是同样好的。如在解释表2中数据的情况中,用仅0.01重量%的抗菌剂也看到了技术效果,然而市售组合物具有0.3%的三氯生。
Claims (11)
1.牙膏组合物,其包含:
(i)5至60重量%的磨料,其中所述磨料为含钙磨料;
(ii)阴离子表面活性剂;
(iii)双极抗微生物颗粒,其前体为包含交替的四面体和八面体片的在一个外表面平面处用四面体片结束和在另一外表面平面处用八面体片结束的不对称的1:1或者2:1:1的粘土颗粒,其具有连接到所述外表面平面之一上的配位阳离子的抗菌剂,其中所述抗菌剂为十六烷基氯化吡啶所述抗菌剂的含量为0.01重量%至0.5重量%,所述颗粒的中位数直径D50为0.1至10μm,和
(iv)0.01-2重量%的选自氟化物的防龋剂。
2.如权利要求1中所述的组合物,其中在所述抗微生物颗粒中,所述抗菌剂连接到所述八面体表面平面的外表面上的配位阳离子。
3.如权利要求1或者2中所述的组合物,其中粘土与抗菌剂的比率为1:0.001至1:1。
4.如权利要求1或者2中所述的组合物,其包含0.1至10重量%的双极抗微生物颗粒。
5.如权利要求1或者2中所述的组合物,其中所述颗粒含有1%至60%装填量的所述抗菌剂。
6.如权利要求1或者2中所述的组合物,其包含3.5至40重量%的湿润剂。
7.如权利要求1或者2中所述的组合物,其进一步包含0.2至3重量%的蒙皂石粘土。
8.如权利要求7中所述的组合物,其中所述蒙皂石粘土为硅酸铝镁粘土。
9.如权利要求1或者2中所述的组合物,其包含最高2重量%的增稠二氧化硅。
10.促进口腔卫生的非治疗目的的方法,其包括将有效量的如权利要求1中所述的组合物施用到牙齿上的步骤。
11.如权利要求1中所述的牙膏组合物用于针对存在于口腔中的细菌的持久保护的非治疗目的的用途。
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