CN101600444B - 口腔护理产品 - Google Patents
口腔护理产品 Download PDFInfo
- Publication number
- CN101600444B CN101600444B CN200780050963.0A CN200780050963A CN101600444B CN 101600444 B CN101600444 B CN 101600444B CN 200780050963 A CN200780050963 A CN 200780050963A CN 101600444 B CN101600444 B CN 101600444B
- Authority
- CN
- China
- Prior art keywords
- oral care
- care product
- tooth
- compositions
- calcium
- 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.)
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- 239000000203 mixture Substances 0.000 claims abstract description 81
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 43
- 239000011159 matrix material Substances 0.000 claims description 29
- 239000002861 polymer material Substances 0.000 claims description 28
- 239000011575 calcium Substances 0.000 claims description 23
- 235000012241 calcium silicate Nutrition 0.000 claims description 23
- 239000012620 biological material Substances 0.000 claims description 22
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- LZZYPRNAOMGNLH-UHFFFAOYSA-M Cetrimonium bromide Chemical group [Br-].CCCCCCCCCCCCCCCC[N+](C)(C)C LZZYPRNAOMGNLH-UHFFFAOYSA-M 0.000 description 6
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- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 6
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- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- 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
- A61K8/24—Phosphorous; Compounds thereof
-
- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/08—Oxides; Hydroxides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/10—Carbonates; Bicarbonates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/42—Phosphorus; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- 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
- A61K8/25—Silicon; Compounds thereof
-
- 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
Abstract
口腔护理产品,所述口腔护理产品包含分散于聚合物材料基质中的中孔硅酸钙生物材料(MCBS)。
Description
本发明涉及包含硅酸钙生物材料的聚合物材料基质、该材料的制剂以及该材料在牙齿表面上形成羟磷灰石膜,以便使牙齿再矿物化和增白的用途。
牙齿由内部的牙本质层和外部的坚硬釉质层组成,釉质层是牙齿的保护层。
由于今天不断地增加酸性饮料和食物消费的生活方式,牙侵蚀变得越来越普遍和常见,其被认为是二十一世纪对牙齿的最大威胁之一。釉质是牙齿的坚硬保护涂层,它保护下面的敏感性牙本质。酸性饮料和食物(例如水果和果汁)可通过酸的侵蚀使牙釉质变软和磨损。如果不干预或进行有效的处理,当表面的釉质被磨损并使内部的牙本质小管暴露时,牙侵蚀能进一步导致牙齿过敏,并伴有严重疼痛。
今天,通常通过依照以下反应流程,加入氟离子,来进行再矿物化:
Ca5(PO4)3OH→Ca5(PO4)3F
氢氧根离子被氟离子取代。产生的氟磷灰石组合物比羟磷灰石组合物坚硬,更能够抵抗酸性侵蚀。由于该原因,大部分口腔护理产品包含氟离子。然而,这种通过氟化物处理的离子取代不能获得损失材料的完全恢复。它仅以阻止侵蚀恶化为目的。因此,该方法基本上是预防性处理,不能积极地将脱矿物质化的牙齿恢复到其最初的化学和机械状态。
牙釉质层的天然颜色为乳浊白或轻微米白色;然而,该釉质层可被染色或变色。牙齿的釉质层由可产生稍微多孔表面的羟磷灰石矿物 结晶组成。相信釉质层这种多孔的性质允许染色剂和脱色物质渗透到釉质并使牙齿脱色。
很多物质可以使人的牙齿染色或降低白度,特别是某些食物、烟草产品以及例如茶和咖啡这样的液体。这些染色和脱色物质经常能够渗透到釉质层。这种问题是经过多年逐渐地发生的,但赋予人牙釉质明显的脱色。
目前很多产品用于牙齿增白。这类产品常常含有过氧化物化合物(单独或与酶组合)。可以条状物的形式使用这类产品。在充分限定的时间之后,这类产品通常必需除去,如果停留时间太长,过氧化物会造成对牙齿和/或齿龈的损害。过氧化物(以及含有擦洗剂的牙膏)的一个特殊问题是它可使牙齿表面变粗糙。
已知,某些现有技术处理导致在牙齿表面上生成羟磷灰石。
US 5,605,675(Enamelon,1997)公开了通过施用两相组合物使牙釉质再矿物化的方法;一相含有水溶性的钙化合物,另一相含有水溶性的无机磷酸盐和水溶性含氟化合物。
US 4,083,955(P&G,1978)公开了通过两种组合物依次施用,使牙釉质再矿物化的方法,第一种含有钙离子,第二种含有磷酸根离子,或者反之亦然。
WO 04/017929(Septodont ou Specialites Sepodont S.A.,2004)公开了一种制剂,该制剂含有:液体水溶液部分;固体部分,该固体部分含有至少一种选自硅酸三钙和硅酸二钙的硅酸盐;氯化钙和减水剂,该制剂用于恢复矿物化的物质,特别是在牙科领域中。
本发明的目的是提供组合物,该组合物使侵蚀的牙齿再矿物化,且同时增白牙齿。该目的不用漂白化学品即可达到,因而避免了上述的缺点。
本发明涉及将中孔硅酸钙释放至牙齿表面,并通过与唾液中存在的和/或从同时或顺序施用源加入到牙齿的磷酸根离子反应,最终原位将该材料转化为羟磷灰石。
羟磷灰石的原位生成导致牙齿的再矿物化,潜在地减少牙蛀的可能性,并改善牙齿的外观,尤其是其白度。结果牙齿也可显得光滑且明亮。因为很多“增白”处理导致牙齿表面的粗糙,因此能够增白而降低表面粗糙度是本发明特别的益处。
本发明释放的益处主要在于靶向釉质;然而,也预期任何暴露的牙本齿也可获得有利的影响。
在本发明的第一个方面中,提供了口腔护理产品,所述口腔护理产品包含分散于聚合物材料基质中的中孔硅酸钙生物材料。
本发明的第二个方面中,提供了将中孔硅酸钙生物材料释放至牙齿的方法,所述方法包括施用聚合物材料基质中的中孔硅酸钙生物材料。
在本发明的第三个方面中,提供了根据本发明第一个方面的产品,该产品用作药物。
在本发明的第四个方面中,提供了中孔硅酸钙生物材料和聚合物材料基质在口腔护理产品制备中的用途,该口腔护理产品用于提高牙齿白度,和/或减少牙蛀,和/或降低敏感性。
本发明的上下文中,MCSB是氧化钙-二氧化硅:CaO-SiO2的不溶性复合材料,所述材料特征在于为中孔状态。所述材料可为无定形态或结晶态。
术语“不溶性”应理解为是指在口腔温度下不溶于水,典型地“不溶性”材料的溶解度在25℃下小于0.01mol/L。
术语“复合材料”应理解为是指包含至少两种不同材料的材料。本发明的氧化钙-二氧化硅复合生物材料包含至少氧化钙和二氧化硅。
术语“生物材料”应理解为是指能够与人和/或动物组织结合的材料,包括活组织(例如骨组织和牙本质)和非活组织(例如牙釉质),也包括软组织和硬组织两者。
术语“孔径大小”应理解为是指孔直径。孔径大小可用本领域技术人员已知的任何合适的方法或手段测量。例如,可用BET氮气吸附法或压汞技术(特别是BET氮气吸附技术)测量孔径大小。
已发现MCSB能够有效的将钙释放至牙齿,至少部分地克服了同与口腔唾液中的磷酸盐过早相互反应有关的问题。
相信MCSB与磷酸根离子反应,形成硅酸钙-磷酸盐粘固粉(CSPC),该材料与牙齿牢固地结合,然后在牙齿表面上逐渐地转化成羟磷灰石。相信CSPC对牙齿表面的高亲和性构成出色的再矿物化和所得增白益处的基础。
如本说明书所示,与非中孔硅酸钙相比,中孔硅酸钙(MCS)以更高的效率释放钙,并且与非中孔硅酸钙相比,MCS以更高的效率刺激羟磷灰石生长。
所述MCSB是二氧化硅基材料。换言之,所述生物材料包含二氧化硅的一级结构。即硅原子与氧原子相互连接。由相互连接的硅原子与氧原子网络形成的特定结构可为任何合适的结构,并且将取决于几个因素,包括用于制备复合生物材料的结构导向剂(structure-directingagent)的特性。例如,当结构导向剂为CTAB时,通常形成六角形多孔结构,当结构导向剂为F127时,通常形成立方体多孔结构。在硅-氧网络中,钙原子与氧原子共价结合,从而形成硅、氧和钙原子的内聚且连续的混合物。所述复合材料一旦成型,通常具有球形形状。
通常,MCSB中的孔具有有序的排列。例如,孔的排序可通过小角度X射线衍射检测,例如以1°-8°的角度(相对于标准晶体所用的10°-80°的角度)。需要小角度X射线衍射,因为孔径大小比原子晶格大。技术人员可认识到,如果孔没有有序排列,则在小角度X射线衍射图中观察不到峰。但是,如果孔具有有序的排列,则在X射线衍射图中会观察到尖峰。
MCSB具有可为1∶10至3∶1的钙与硅的比率(Ca∶Si)。优选Ca∶Si比为1∶5-2∶1,更优选为1∶3-1∶1,最优选为约1∶2。MCSB可包括硅酸单钙、硅酸二钙或硅酸三钙。优选较高的钙与硅(silicate)比率,因 为相信此类比率可增强与牙齿表面的有效结合,并随后转化为羟磷灰石;然而,为了易于得到期望的pH(参见下文),优选较低的比率。
在整个本说明书中,钙与硅的比率(Ca∶Si)应理解为原子比。
在本发明的一个方面,提供了MCSB,该MCSB的平均孔径大小(直径)优选0.4-4nm,更优选0.4-3.5nm,最优选0.4-3nm。
在本发明的另一个方面,提供了MCSB,该MCSB的平均孔径大小(直径)优选2-4nm,更优选2-3.5nm,最优选2-3nm。
在本发明的再一个方面,提供了MCSB,该MCSB的平均孔径大小(直径)优选1-2.7nm,更优选1.35-2.45nm。
可用任何合适的方法或手段测量孔径大小。例如,可用BET氮气吸附法或压汞技术(特别是BET氮气吸附技术)测量孔径大小。
以待施用到牙齿的产品的全部组合物组分计,MCSB的含量通常为0.05-25%,尤其为0.5-15%,特别是为2.5-10%重量。根据它形成其一部分的特定组合物,MCSB通常以0.1-50%,尤其1-30%,特别是5-20%重量存在。
优选,MCSB存在于基本上不含磷酸根离子的组合物中。术语“基本上不含”是指相对于钙离子的重量,磷酸根离子的量低于2.5%,特别是低于1%,更特别是低于0.1%,尤其低于0.01%重量。通过使用高纯度的起始材料,制备含有低于0.005%重量磷酸根离子的氧化钙-二氧化硅是可能的,例如使用由北京中国医药总公司(SINOPHARM)提供的纯度超过99%的氮化钙。
优选,MCSB存在于基本上不含氟离子的组合物中。术语“基本上不含”是指相对于不溶性钙盐中钙的重量,氟离子的量低于2.5%,特别是低于1%,更特别是低于0.1%,尤其低于0.01%重量。
优选,MCSB存在于pH为7-11,更优选为8-10.5,最优选为9-10的组合物中。该组合物优选包含酸性缓冲剂例如柠檬酸。该缓冲剂使组合物能够在期望的pH、特别是期望在较高的Ca∶Si比率,例如1∶1及以上,尤其是2∶1及以上进行配制。
以下制备方法可用于得到优选的MCSB。该方法在我们共同待审的申请PCT/EP2007/057556中进一步描述。
一种制备氧化钙-二氧化硅复合生物材料的方法,所述复合生物材料具有在0.4-4nm范围的平均孔径大小,所述方法包括以下步骤:
(i)在含水溶剂的存在下,在溶液中将钙盐、四(烷基)硅酸盐以及结构导向剂混合,由此发生四(烷基)硅酸盐的水解,导致溶胶形成;
(ii)从所述溶胶中分离固体;和
(iii)将所分离的固体煅烧。
在上述方法的步骤(i)中,四(烷基)硅酸盐水解形成二氧化硅。并不需要将全部的四(烷基)硅酸盐水解。通常,在步骤(i)中,水解至少80%重量的四(烷基)硅酸盐。
上述方法的步骤(i)中可使用任何合适的四(烷基)硅酸盐。合适的四(烷基)硅酸盐包括原硅酸四乙酯[TEOS](优选)和原硅酸四甲酯。较少优选使用原硅酸四甲酯,因为原硅酸四甲酯产生甲醇,甲醇可潜在地干扰溶胶中有序结构的形成,而且有毒性。
上述方法的步骤(i)中可使用任何合适的四(烷基)硅酸盐浓度。合适的浓度包括0.1-1M,特别是0.3-0.6M。
上述方法的步骤(i)中可使用任何合适的钙盐。合适的钙盐包括基本上可溶于pH为8-10的水溶液中的那些。合适的钙盐包括硝酸钙、氟化钙和氯化钙。在一个方面,所述钙盐是硝酸钙。
上述方法的步骤(i)中可使用任何合适的结构导向剂。所述结构导向剂可以是阳离子或非离子表面活性剂,并且性质应为有机的。当所述结构导向剂是该表面活性剂时,所产生的MCSB通常具有约1.7-2.7nm范围的平均孔径大小。
特别合适的阳离子表面活性剂是十六烷基三甲基溴化铵[CTAB]。当所述结构导向剂为CTAB时,所产生的MCSB具有约2.7nm的平均孔径大小。
合适的非离子表面活性剂是十二烷胺。当使用十二烷胺时,所产 生的MCSB具有约2.4nm的平均孔径大小。
更合适的非离子表面活性剂是Pluronic F88(例如ex BASF),其为式EO100PO39EO100的非离子嵌段共聚物,其中EO表示环氧乙烷,PO表示环氧丙烷。当所述结构导向剂为Pluronic F88时,所产生的MCSB具有约3.5nm的平均孔径大小。
更合适的结构导向剂为Tetronic 908(例如ex BASF),其为式(EO113PO22)2N(CH2)2N(PO22EO113)2的非离子星形共聚物表面活性剂。当结构导向剂为Tetronic 908时,所产生的MCSB具有约3.0nm的平均孔径大小。
用于本发明的特别优选的MCSB根据以上方法,使用CTAB、Pluronic F88、Tetronic 908或十二烷胺作为结构导向剂制备。尤其优选CTAB。
聚合物材料基质可以为凝胶、水凝胶以及缠结的聚合物溶液。
关于术语“凝胶”,我们是指胶体系统,其中互联的纳米粒子的多孔网络跨越液体介质的体积。一般而言,凝胶显然为固体、果冻样材料。以重量和体积两者计,凝胶在组成上大多为液态,因此表现出与液体相似的密度;然而,它们具有固体的结构一致性。
关于术语“水凝胶”,我们是指大部分交联的聚合物材料,其吸水并且保持水。代替纯水,水凝胶也可以吸收水溶液,该水溶液另外包含一种或多种与水互溶的其它溶剂(例如液态醇,优选乙醇)和/或包含水溶性化合物。通常,如果水凝胶不仅包含水,其它溶剂和/或化合物的含量不大于10%重量。这表示水含量通常为90-100%重量,并且另外的溶剂和/或化合物的含量为0-10%重量。
关于术语“缠结的聚合物溶液”,我们是指非交联的或轻度交联的聚合物材料,其不保持水。
本发明的聚合物基质通常包含水。聚合物材料基质中的水含量可根据必须提供的组合物的类型而变化。可制备聚合物材料基质,该基质具有高浓度的硅酸钙生物材料,并因此具有较低浓度的水;也可制 备聚合物材料基质,该基质具有低量的硅酸钙生物材料,并因此具有较高浓度的水。水含量可最高达99%重量。优选按聚合物材料基质(不包括硅酸钙生物材料)的总重量计,水含量为75-99%重量,更优选为80-99%重量。按聚合物材料基质(不包括硅酸钙生物材料)的总重量计,聚合物材料基质中的聚合物材料含量优选为1-25%重量,更优选为1-20%重量。
合适的凝胶性质上可为无机或有机的,具有水或水溶液(水凝胶)或非水有机溶剂(有机凝胶)作为液体组分。以下讨论水凝胶。
凝胶在性质上可为胶体或粗的(形成构架的颗粒尺寸),并且可以是刚性的(弹性凝胶剂和触变凝胶)。
合适的有机凝胶可包含如下所述有关水凝胶的聚合物。
水凝胶可由聚乙烯醇、聚丙烯酸钠、具有许多亲水性基团的丙烯酸酯聚合物和共聚物组成。
水凝胶通常包含交联聚合物。
形成水凝胶的优选化合物为多糖、聚丙烯酰胺和聚丙烯酸。多糖(大分子碳水化合物)可为任何种类的多糖,如贮存多糖,如淀粉和糖原,和结构多糖如纤维素和甲壳质。本文所用的术语“多糖”包括天然多糖、合成多糖、多糖衍生物以及修饰的多糖。
合适的多糖可以是贮存多糖,如淀粉或糖原,或结构多糖如纤维素或甲壳质。
合适的多糖可包括选自下列一种或多种的糖单元:异麦芽糖、葡萄糖、果糖、半乳糖、木糖、甘露糖、山梨糖、阿拉伯糖、鼠李糖、岩藻糖、麦芽糖、蔗糖、乳糖、麦芽酮糖、核糖、来苏糖、阿洛糖、阿卓糖、古洛糖、艾杜糖、塔罗糖、海藻糖、黑糖、曲二糖和乳果糖。
优选的水凝胶包含一种或多种多糖,所述多糖选自:罗望子胶、瓜尔胶、刺槐豆胶、塔拉、葫芦巴、芦荟、芡欧鼠尾草、亚麻籽、车前子、桲籽(quince seed)、黄原胶、吉兰糖、文莱胶、鼠李糖、右旋糖苷、凝胶多糖、普鲁兰多糖、小核菌葡聚糖、裂褶多糖、甲壳质、羟 烷基纤维素、阿拉伯聚糖、去支化阿拉伯聚糖、阿拉伯木聚糖、半乳聚糖、果胶半乳聚糖、半乳甘露聚糖、葡苷聚糖、地衣多糖、甘露聚糖、茯苓多糖、鼠李糖半乳糖醛酸聚糖、阿拉伯胶、琼脂、藻酸盐、角叉菜胶、壳聚糖、clavan、透明质酸、肝素、菊粉、纤维糊精、纤维素和纤维素衍生物。
特别优选的水凝胶包含选自以下的多糖:藻酸钠、藻酸羟丙基酯、角叉菜胶、阿拉伯胶(gum grabic)、瓜尔胶、卡拉牙胶、壳聚糖、果胶和淀粉。
其它优选的水凝胶形成组分是卡伯波(Carbopol)聚合物,其可从Noveon购买得到。
聚合物材料基质还可由缠结聚合物材料形成。它可为任何种类的非交联的或仅轻度交联的聚合物。以上公开的聚合物(在其非交联或轻度交联状态下)是合适的,在EP 1,196,137中公开的聚硅氧烷化合物以及在WO 06/071677中描述的系统也是合适的。
所述聚合物基质材料在性质上是固体,即除任何缔合水或在25℃下为液态的其它组分以外,通常以组合物的1-25%重量存在,该基质材料是所述组合物的一部分。
本发明的经口组合物可以为本领域中常见的任何形式,例如凝胶、奶油冻、气溶胶、树胶、锭剂、散剂、软膏剂等,并且还可配制成系统,用于双室型分配器。
除非另外说明,以下段落所描述的组合物中,所有百分比按重量计,并且按照全部组合物的重量计。
根据本发明的优选方面,提供了一种组合物,该组合物包含5-99.9%的聚合物材料基质,和0.1-95%的至少一种MCSB,所述聚合物材料基质包含以聚合物材料基质总重量计为75-99%(优选80-99%)的水,和以聚合物材料基质总重量计为1-25%(优选在1-20%之间)的至少一种聚合物材料。
必须说明的是,对于聚合物材料基质以及硅酸钙基生物材料的浓 度,原则上有两种可能的组合物:
(a)即可使用组合物
即可使用组合物是无需将其稀释,可直接用于牙齿增白和再矿物化的组合物。在该组合物中,硅酸钙基生物材料的含量通常不高于10%。通常该含量为0.1-10%,优选为1-10%,更优选为1-8%。作为其结果,聚合物材料基质的含量通常至少为90%,通常该含量在90-99.9%之间,优选为90-99%,更优选为92-98%。
(b)浓缩组合物。
浓缩组合物是在其可用于置于牙齿上前,需要稀释的组合物。在该浓缩组合物中,硅酸钙基生物材料的含量可高达95%,并且其范围可为10%-95%
因此,根据本发明的另一个方面,提供了浓缩组合物,该浓缩组合物包含5-90%的聚合物材料基质和10-95%的至少一种MCSB,所述聚合物材料基质包含以聚合物材料基质总重量计为75-99%(优选80-99%)的水,和以聚合物材料基质总重量计为1-25%(优选为1-20%)的至少一种聚合物材料。
本发明的组合物通常按照以下方法制备:将MCSB加入水中,并且在第二步中加入聚合物材料(凝胶形成材料、水凝胶形成化合物或缠结的聚合物材料)。
本发明的产品施用后,所述组合物可保留在牙齿上约1分钟-24小时,尽管优选的时间为30分钟-8小时)。可每天进行该过程。
在某些优选的实施方案中,本发明的口腔护理产品包含独立的磷酸根离子源,即磷酸根离子源独立于分散于聚合物材料基质中的MCSB。优选所述离子源是水溶性盐,通常在25℃下,水中溶解度为1%重量或更大。合适的水溶性盐包括磷酸三钠、磷酸氢二钠和磷酸二氢钠。
通常通过使它们包含在独立的组合物中,分散于聚合物材料基质的MCSB以及磷酸根离子源在物理上保持相互分开。这些独立的组合 物释放至牙齿可以是按顺序或同时的。在某些实施方案例如双相牙膏中,优选同时释放组合物。
当采用时,优选磷酸根离子源以1mM-1000mM,更优选5mM-100mM,最优选10mM-50mM的浓度存在于组合物中。
在某些实施方案中,释放工具可涉及带,特别是粘性带,在将条状物置于与牙齿接触之前,将钙离子源和磷酸根离子源施用至所述带上。利用该释放工具,可保持组合物与牙齿表面紧密接触,促进高浓度的钙盐和/或磷酸根离子源接近牙齿表面。使用该释放工具,很少组合物损失到唾液中。
依据本发明使用的组合物可包含本领域常见的其他成分,例如:
·抗微生物剂,例如三氯生、氯己定、铜、锌和亚锡盐如柠檬酸锌、硫酸锌、甘氨酸锌、柠檬酸锌钠和焦磷酸亚锡、血根碱提取物、甲硝唑、季铵盐化合物如氯化十六烷基吡啶鎓;双胍如葡萄糖酸氯己定、海克替啶、奥替尼啶、阿来西定;和卤代双酚化合物,如2,2′-亚甲基双-(4-氯-6-溴苯酚);
·抗炎药如布洛芬、氟比洛芬、阿司匹林、吲哚美辛等;
·防龋剂如三偏磷酸钠和酪蛋白;
·牙菌斑缓冲剂如尿素、乳酸钙、甘油磷酸钙和聚丙烯酸锶;
·维生素如维生素A、C和E;
·植物提取物;
·脱敏剂,例如柠檬酸钾、氯化钾、酒石酸钾、碳酸氢钾、草酸钾、硝酸钾和锶盐;
·抗结石剂,例如碱金属焦磷酸盐、含次磷酸盐聚合物、有机膦酸盐和磷酸柠檬酸盐等;
·生物分子,例如细菌素、抗体、酶等;
·香料,例如薄荷和薄荷油;
·蛋白质材料如胶原蛋白;
·防腐剂;
·遮光剂;
·着色剂;
·pH调节剂;
·甜味剂;
·药学上可接受的载体,例如淀粉、蔗糖、水或水/醇系统等;
·表面活性剂,如阴离子、非离子、阳离子和两性离子或两性表面活性剂;
·颗粒研磨材料如二氧化硅、氧化铝、碳酸钙、磷酸二钙、焦磷酸钙、羟磷灰石、三偏磷酸盐、不溶性六偏磷酸盐等,包括凝聚的颗粒研磨材料,以口腔护理组合物计,用量通常为3-60%重量。
·湿润剂如甘油、山梨醇、丙二醇、木糖醇、乳糖醇等;
·粘合剂和增稠剂如羧甲基纤维素钠、黄原胶、阿拉伯胶等,以及合成聚合物如聚丙烯酸酯和羧基乙烯基聚合物如卡伯波;
·还包括可增强活性成分如抗微生物剂的释放的聚合物。这类聚合物的实例是聚乙烯基甲醚与马来酸酐的共聚物和其它相似的增强释放的聚合物,例如在DE-A-3,942,643(高露洁)中所描述的那些。
·缓冲口腔护理组合物pH和离子强度的缓冲剂和盐;以及
·其它可包括的任选成分是例如漂白剂如过氧化物,例如过二磷酸钾,泡腾系统如碳酸氢钠/柠檬酸系统,颜色变化系统等。
附图概述
图1:(a)处理前,和(b)在含有磷酸盐的唾液中,用MCS-凝胶按照8小时/天循环处理处理两周后,人牙釉质表面形态学的扫描电子显微镜(SEM)图像。
图2:被处理牙齿的横切面的SEM图像。在原始牙釉质(左区)上形成5微米厚度的薄层(右边的亮区)。
图3:穿越图2SEM横切面图像上所示暗线扫描(从左到右)的Ca和P的能散X-射线(EDX)元素分析。所示“距离”是以微米计的距离。
图4:在含磷酸盐组合物存在下,MCS-凝胶处理前和后的牙齿表面的拉曼光谱。
图5a:用磷酸“侵蚀”之前牙齿表面的SEM图像。
图5b:用磷酸侵蚀之后牙齿表面的SEM图像。
图6a:磷酸侵蚀的牙齿表面的拉曼光谱。
图6b:用MCS-凝胶组合物和含磷酸盐组合物处理一周后,磷酸侵蚀的牙齿表面的拉曼光谱。
图7:与磷酸盐缓冲盐水(PBS)一起温育后,MCS的SEM图像。
图8:与PBS一起温育后,非MCS的SEM图像。
下列实施例用于举例说明本发明,而不是将本发明限于它们。如果没有另外的说明,百分比和份以重量计。
实施例
步骤I-包含MCS的凝胶组合物的制备
采用超声处理,以表1中所示的约0.5%至5%的浓度范围,形成细粉MCS(Ca∶Si=1∶2)在蒸馏水中的均匀悬浮液。然后,在剧烈搅拌下加入藻酸钠凝胶颗粒。大约5-15分钟之后,得到均匀的白色凝胶悬浮液。测量凝胶悬浮液的pH,并且也显示在表1中。
表1:MCS组合物
1 | 2 | 3 | 4 | |
MSC粉末(g) | 0.5 | 1.5 | 3 | 5 |
水(g) | 100 | 100 | 100 | 100 |
藻酸钠(g) | 5 | 5 | 5 | 5 |
pH | 9.32 | 9.72 | 9.76 | 10.03 |
如上所述,用按照1g、1.5g和3g提供的藻酸钠,制备其他组合物。所得组合物的粘度发现为藻酸盐水平的函数,在较高的藻酸盐水平下,粘度较高。
步骤II-含有MCS的凝胶组合物的施用
用75%的乙醇清洗拔取的人牙,并用牙膏刷去表面的细菌和残渣。表1中4指示的组合物以每六颗牙齿1.0g的水平,均匀涂覆在牙齿上。然后,于37℃将牙齿浸入人唾液中。8小时之后,用自来水洗去凝胶,于37℃将牙齿再浸入唾液中,持续一天剩余的时间。该处理连续进行两周。
从很多受试者收集所使用的人唾液。其钙浓度从23ppm至60ppm变化,且其磷浓度(以磷酸根离子提供)从124ppm至154ppm变化。
在处理前和后,用SEM研究牙齿的表面形态学。图1(a)代表处理前的外观,图1(b)代表处理后的外观。可以看到在处理前表面是光滑的,处理后某些新的晶体结构从最初光滑的表面长出来。在10,000的放大倍数下,清晰的可见细小晶体结构,测量约为100nm。
为了定量新形成的羟磷灰石的量,在用SEM检查之前,将处理前和处理后的牙齿样品切片和抛光。结果显示在图2中。可以清楚地看到,在初始釉质的上部形成薄的涂层。层的厚度在2-10微米之间变化,但是似乎与牙齿表面的粗糙度正相关。因此,显然处理针对最需要修补的那些牙齿。
通过处理产生的新的结晶物质的化学性质用EDX元素分析(见图3)和拉曼光谱(见图4)研究。图3显示了在新形成的羟磷灰石中钙和磷的含量与在下面初始牙釉质中钙和磷的含量非常相似。图4表明存在于新形成的羟磷灰石中磷酸盐的化学性质基本上与未处理牙齿的相同,因此强烈建议只将“天然的”羟磷灰石加到牙齿中。
使用纳米压痕(nano-indentation)的硬度测试
在该实验中,研究了再生釉质层的机械特性。机械强度对釉质的长期稳定性是至关重要的,并且对于在咬和吃食物期间牙齿的维护是必需的。期望釉质具有高水平的机械硬度。
使用“步骤II”所述相同的操作(参见上文),首先将人牙样品清洁,然后连续两周,每天用组合物5和唾液处理。然而,在该情况下,引入另外的步骤:在将涂覆的牙齿在唾液中浸渍8小时之后,用含有白垩的牙膏刷牙1分钟。然后,按照上述的“步骤II”操作,将它们再浸渍在唾液中。
利用本领域纳米压痕测试设备的说明,测量牙齿表面上羟磷灰石新沉积膜的薄膜硬度。测量了3个处理的牙齿样品,并在每个样品上制备9个压痕。如表3所示,再矿物化层的硬度在5.4至5.7Gpa范围内。这非常接近于初始釉质表面的硬度(也显示在表3中)。另一个重要的机械参数是杨氏模量,其为材料弹性的基础值。该值越高,材料越硬。期望再矿物化层与天然釉质相似。根据表2所示结果,很明显再矿物化膜具有与初始釉质相似的机械特性。
表2:处理前和后牙齿的机械特性
硬度(Gpa) | 杨氏模量(Gpa) | |
处理前(文献值) | 5.0-6.0 | 95-120 |
形成新的釉质层之后 | 5.4-5.7 | 111-121 |
损害牙齿的再生
为了模拟多种类型的酸性果汁对牙齿的脱矿物质化,用37%(wt)的磷酸侵蚀人牙1分钟。用SEM拍摄初始牙齿和磷酸侵蚀的牙齿的图像。图5a代表侵蚀前的牙齿表面,图5b代表侵蚀后的牙齿表面。通过按照上述方法,用组合物5(如下所述)处理,发现可能在一周内治愈由磷酸引起的侵蚀。
组合物5:如上所述,将0.5g MCS粉末加入到10g水中并分散,然后,在剧烈搅拌下加入0.3g藻酸钠。大约10分钟搅拌之后形成均匀的凝胶。
发现处理的样品已经生长出显著厚度的新层。通过拉曼光谱表征新形成的层。图6a是处理前牙齿表面的拉曼光谱,图6b是处理后牙齿表面的拉曼光谱。表3显示了处理前和后的主峰位置。在961.42cm-1 处有峰,该峰对应于主要的磷酸根带。处理后样品给出与处理前样品基本相同的拉曼光谱,包括在961.42cm-1处的磷酸根带的位置。这暗示加入的材料与最初存在的相同,并且是有些令人惊奇的结果。
表3:处理前和处理后人牙釉质的拉曼峰位置
带 | 处理前位置 | 处理后位置 |
v1PO4 3- | 961 | 961 |
v2PO4 3- | 445 | 444 |
v3PO4 3- | 1072 | 1069 |
v4PO4 3- | 579 | 579 |
拉曼谱带v1、v2、v3和v4具有磷灰石晶格的结晶度/完整性特性。
实施例6:双相凝胶产品
制备包含两种凝胶组合物凝胶I和凝胶II的产品。细节在表4中给出。通过在“步骤I”下公开的方法,将以上在“步骤I”下描述的MSC粉末掺入到凝胶I中。通过将藻酸钠加到磷酸盐缓冲剂和氟化钠的溶液中,制备凝胶II。
表4:双相凝胶产品
MCS粉末 (wt%) | 藻酸盐粉末 (wt%) | 磷酸盐(mM) | 氟化物(mM) | |
凝胶I | 5 | 3 | 0 | 0 |
凝胶II | 0 | 3 | 25 | 25 |
通过将相等重量的凝胶I和凝胶II混合,并用棉签(cotton bud)将混合物(总重2g)涂覆在六颗牙齿上,来施用产品。将处理的牙齿于37℃浸渍在人唾液(15ml)中1小时,轻轻搅拌。该时间之后,将牙齿冲洗,并用棉签清洁,除去任何残余的凝胶。然后将它们放进新鲜的唾液中,再保持两小时。每天两次进行该处理,持续两周,总共处理28次。
在进一步的实验中,如上所述,将实施例6(即凝胶I和凝胶II的1∶1重量混合物)施用至粘性塑料带。然后将带环绕各牙齿,并将缠裹的牙齿浸渍在唾液中8小时。使用的剂量是每6颗牙齿2g凝胶I和凝胶II的混合物。该时间之后,用水冲洗牙齿,然后放进新鲜的唾液中。持续两周重复该操作,包括每天刷牙来模拟现实生活的使用。
与涉及刷牙(每天一次)和只用唾液处理的“对照”处理一起,对以上用实施例6处理的关于牙齿增白的效果进行研究。
用Minolta色度仪CR-321(3mm孔径,45/0)定量测量处理前和处理后各牙齿的L*和b*值,来测量增白效果。L*代表从测试表面反射的总的光强度,b*代表来自黄-蓝光的光贡献。牙齿增白通过反射光强度(L*)的增加和“黄色”(b*)的下降指示。结果显示在表5中。两周处理之后的平均颜色变化用ΔL*和Δb*表达。按照本发明的两种处理观察到良好的增白效果。
表5:用实施例6处理后的增白效果
实施例7-9:双相牙膏产品
表6:组合物细节
PEG 1500 | - | - | - | - | 2 |
研磨二氧化硅 | - | - | - | - | 9 |
增稠的二氧化硅 | - | - | - | - | 4.8 |
十二烷基硫酸钠 | 13.5 | 13.5 | 13.5 | 13.5 | - |
羧甲基纤维素钠 | 0.2 | 0.2 | 0.2 | 0.2 | 0.5 |
香料 | 1 | 1 | 1 | 1 | 1 |
糖精 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 |
水和次要组分* | 25 | 25 | 25 | 25 | 4.4 |
*在各“第一种组合物”中为0.25%硝酸钾、0.05%甲醛和0.15%三氯生。
关于表6:
实施例7:第一种组合物7和第二种组合物的1∶1重量混合物;
实施例8:第一种组合物8和第二种组合物的1∶1重量混合物;
实施例9:第一种组合物9和第二种组合物的1∶1重量混合物;
实施例A:第一种组合物A和第二种组合物的1∶1重量混合物;
利用这些实施例来处理抛光的牙釉质块。处理涉及用双相牙膏浆状物在水中(1份牙膏比2份水)刷3分钟,接着于37℃将釉质块在唾液中温育2小时。在4周的时间内,每天两次进行该操作。用常规的“增白”牙膏作对照,同样水也用作对照。
如上所述,用色度仪监测牙釉质块的颜色。最终的结果显示在表7中,ΔL*和ΔW*代表处理之前和之后之间的“亮度”和“白度”的变化。“W”为“白度测量值”,按照以下方程计算:
表7:使用双相牙膏产品后的增白结果
使用的实施例 | ΔL* | ΔW* |
7 | 2.32 | 1.91 |
A | 1.21 | 1.09 |
牙膏对照 | 0.73 | 0.36 |
水对照 | 0.56 | 0.21 |
这些结果显示与对照相比,实施例7给出更优的“明亮”和“增白”效果。
发现使用实施例7时L*值随时间增加。表8中的数字说明了此结果。
表8:处理持续时间的影响
处理(周) | 0 | 1 | 2 | 3 | 4 |
L* | 63.52 | 64.82 | 65.37 | 65.85 | 65.84 |
还研究了处理对抛光牙釉质块硬度的影响。这通过使用HM-122硬度测试仪(来自Mitutoyo,日本),测量努氏硬度进行。每次处理测量10个样品,每个样品制备5个压痕。表9中显示的结果说明实施例8和9导致了釉质硬度的显著增加(p<0.05)。
表9:使用双相牙膏产品后的硬度结果
还研究了处理对抛光牙釉质块粗糙度的影响。这用表面光度仪(日本Mitutoyo的SV2000)进行。每次处理测量10个样品。表10中所显示的结果说明实施例8和9导致了釉质粗糙度的显著下降,即光滑度和亮度显著增加。
表10:处理对釉质粗糙度的影响
所用实施例 | 粗糙度变化(%) |
8 | -10.9 |
9 | -10.2 |
A | +5.2 |
牙膏对照 | +20 |
水对照 | -2.2 |
在独立的研究中,检查了处理对全牙白度的影响。实验操作基本上与关于抛光牙釉质块所描述的(如上所述)相同,唯一的区别是使用全牙。在表11中所显示的结果说明与常规增白牙膏相比,实施例7的功效更优。
表11:对全牙的增白结果
所用的实施例 | ΔL* | Δb* | ΔW* |
7 | 1.76 | -0.77 | 1.88 |
牙膏对照 | 0.20 | -0.28 | 0.26 |
实施例10:双相牙膏产品
表12中详述的两种组合物将以1∶1的重量比使用。这些组合物适用于作为独立组合物/相,从同一管的相同室内挤出,例如第一种组合物形成芯,第二种组合物形成周围的鞘。该实施例中组合物的含水量特别低。
表12:接触挤出的双相牙膏
组分 | 第一种组合物 | 第二种组合物 |
硅酸钙 | 20 | - |
Na2HPO4 | - | 10 |
山梨醇(70%水溶液) | 48 | 61 |
PEG 1500 | 2 | 2 |
研磨二氧化硅 | 9 | 9 |
增稠的二氧化硅 | 8.5 | 7.5 |
十二烷基硫酸钠 | 6.6 | 6.6 |
羧甲基纤维素钠 | 0.6 | 0.6 |
香料 | 1.3 | 1.3 |
糖精 | 0.2 | 0.2 |
水和次要组分* | 3.8 | 1.8 |
*在“第一种组合物”中为2ppm蓝色颜料
实施例11-13:含有不溶性增白颗粒的产品
如前所述,通过加入所示不溶性增白颗粒,制备表13中所示凝胶组合物。在4周时间内,用这些组合物处理羟磷灰石圆盘(n=6-8),每天30分钟。每天30分钟处理后,用磷酸根离子源处理这些圆盘(模拟的口腔液体)。如上所述,使用色度仪监测羟磷灰石圆盘的颜色。最终结果显示在表13的底部。
表13
这些结果表明通过使用本发明,可得到优异的增白益处。
实施例14:双相牙膏产品
表14中详述的两种组合物(“第一种”和“第二种”)将以1∶1的重量比使用。
表14
组分 | 第一种组合物 | 第二种组合物 |
硅酸钙 | 20 | - |
NaH2PO4 | - | 10 |
山梨醇(70%水溶液) | 60 | 60 |
PEG 1500 | 2 | 2 |
研磨二氧化硅 | 2 | 8 |
增稠的二氧化硅 | 8 | 6 |
十二烷基硫酸钠 | 3 | 3 |
羧甲基纤维素钠 | 0.4 | 0.8 |
香料 | 1 | - |
糖精 | 0.1 | 0.1 |
二氧化钛 | - | 5 |
水 | 3.5 | 5.1 |
实施例15:钙离子释放
使用超声,将中孔硅酸钙(0.04g)分散于水(40ml)中,持续5分钟。也制备相同浓度的非中孔硅酸钙(非MCS)的分散体。MCS和非MCS两者具有相同的Ca∶Si比(1∶1)。
上述的分散体样品用水稀释10倍,5分钟后以及20小时后,用原子吸收法测量钙的浓度。结果显示于表15中。显然,MCS比非MCS释放明显更多的钙离子。
表15
实施例16:羟磷灰石生长
在再一个实验中,37℃下,将MSC和非MSC在磷酸盐缓冲盐水(25mM)中独立温育24小时。图7是显示在MSC样品上广泛的羟磷灰石生长的SEM。图8是显示在非MCS样品上无显著羟磷灰石生长的SEM。
Claims (4)
1.一种口腔护理产品,所述口腔护理产品包含分散于聚合物材料基质中的具有直径0.4-4nm的孔的中孔硅酸钙生物材料,其中所述聚合物材料基质为选自以下多糖的水凝胶:藻酸钠、藻酸羟丙基酯、角叉菜胶、阿拉伯胶、瓜尔胶、卡拉牙胶、壳聚糖、果胶和淀粉,其中所述中孔硅酸钙生物材料的Ca∶Si比为1∶3-3∶1,其中基于所施用产品计,所述中孔硅酸钙生物材料以0.5-15%重量存在,其中除任何缔合水以外,所述口腔护理产品包含1-25%重量的聚合物材料基质,所述中孔硅酸钙生物材料的制备方法包括以下步骤:
(i)在含水溶剂的存在下,在溶液中将钙盐、四(烷基)硅酸盐以及结构导向剂混合,由此发生四(烷基)硅酸盐的水解,导致溶胶形成;
(ii)从所述溶胶中分离固体;和
(iii)将所分离的固体煅烧。
2.权利要求1的口腔护理产品,所述口腔护理产品包含具有8.5-10的pH的组合物。
3.权利要求1或2的口腔护理产品,所述口腔护理产品包含独立的磷酸根离子源。
4.权利要求1至3中任一项的产品在制备药物中的用途。
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