CN107106477B - 口腔护理组合物和使用方法 - Google Patents
口腔护理组合物和使用方法 Download PDFInfo
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- CN107106477B CN107106477B CN201580069858.6A CN201580069858A CN107106477B CN 107106477 B CN107106477 B CN 107106477B CN 201580069858 A CN201580069858 A CN 201580069858A CN 107106477 B CN107106477 B CN 107106477B
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Abstract
本发明涉及一种用作口腔溃疡性病状例如口腔溃疡和口疮的治疗的口腔护理组合物。所述组合物的主要成分为印度醋栗提取物、甘草提取物和锌源。另外的成分可以包括樟脑以及载体、溶剂和赋形剂。
Description
背景技术
口腔溃疡或口疮由各种原因所致,这些原因包括但不限于药物副作用、化学治疗、机械损伤、刷牙、牙膏、食物过敏、吸烟、烟草、酒精、酸味、睡眠缺乏、细菌/病毒/真菌感染以及牙齿矫正器。存在目前销售用于治疗口腔溃疡各种产品,其包括抗生素诸如多西环素、局部麻醉药诸如利多卡因与抗菌剂诸如西曲溴铵的组合以及收敛剂诸如鞣酸与抗炎剂(诸如水杨酸胆碱)的组合。使用这些制剂通常需要医生开处方,并且频繁使用抗生素可导致抗生素抗性。
使用不含抗生素的产品对于许多消费者而言是期望的。此类产品出于可持续性原因也是期望的。因此,强烈需要用于治疗口腔溃疡的此类产品。
发明内容
本公开提供用于治疗口腔溃疡和口疮的口腔护理组合物。所述组合物包含印度醋栗(Amla)提取物、甘草提取物、锌源以及樟脑。在一些实施方案中,组合物还包含精油提取物诸如丁子香酚。在其他实施方案中,组合物包含增稠剂、溶剂、防腐剂、甜味剂、着色剂和/或另外的赋形剂中的一种或多种。还提供使用所述组合物治疗口腔溃疡性病状的方法。
通过下文中所提供的详细说明,本发明的其他适用领域将变得显而易见。应了解,详细说明和特定实例虽然指示本发明的优选实施方案,但旨在仅用于说明的目的而无意限制本发明的范围。
具体实施方式
以下对于优选实施方案的描述在性质上仅是示例性的,并且决不应限制本发明、其应用或用途。
通篇使用的范围用作描述范围内的每个值的简略表达方式。范围内的任何值可选为范围终点。另外,本文引用的所有参考文献据此全文以引用方式并入。如果本公开中的定义和所引用参考文献的定义发生冲突,则以本公开为准。
除非另外规定,否则本文和本说明书中其他位置处表达的所有百分比和量应理解为是指重量百分比。给定的量是基于材料的有效重量。
本发明人已发现印度醋栗提取物和甘草(或甘草汁)提取物当与锌离子源组合时可以配制成具有与现有口腔护理组合物相当或比其更优异的抗微生物特性的口腔护理组合物。因此,本公开提供用于治疗口腔溃疡性病状诸如口腔溃疡和口疮的口腔护理组合物。在第一实施方案中,本公开提供一种包含在药学上可接受的载体中的印度醋栗提取物、甘草提取物、锌离子源以及任选地樟脑的口腔护理组合物(组合物1);例如:
1.1.组合物1,其中所述组合物为口腔凝胶。
1.2.组合物1或1.1,其中所述印度醋栗提取物以0.5重量%至8重量%,例如1重量%至5重量%,例如1重量%或5重量%的量存在于组合物中;所述甘草提取物以0.1重量%至5重量%,例如1重量%至3重量%,例如1重量%或2.5重量%的量存在于组合物中;所述锌源以足以提供0.1重量%至2重量%,例如0.5重量%至1.2重量%,例如约0.8重量%的量的锌离子的量存在于组合物中。
1.3.任何前述组合物1以及后续组合物,其中所述印度醋栗提取物以0.5重量%至8重量%的量存在于组合物中;所述甘草提取物以0.1重量%至5重量%的量存在于组合物;所述锌源以足以提供0.1重量%至2重量%的量的锌离子的量存在于所述组合物中;并且所述樟脑以0重量%至2重量%的量存在于所述组合物中。
1.4.任何前述组合物1以及后续组合物,其中所述印度醋栗提取物以1重量%至5重量%的量存在于组合物中;所述甘草提取物以1重量%至3重量%的量存在于组合物;并且所述锌源以足以提供0.5重量%至1.2重量%的量的锌离子的量存在于所述组合物中。
1.5.任何前述组合物1以及后续组合物,其中所述锌离子源为乙酸锌、柠檬酸锌、葡糖酸锌、甘氨酸锌、氧化锌、硫酸锌以及柠檬酸锌钠或其中两种或更多种的组合;优选地为氧化锌或硫酸锌或其组合。
1.6.任何前述组合物1以及后续组合物,其中锌离子源为氧化锌或硫酸锌或其组合。
1.7.组合物1.5或1.6,其中氧化锌为微粒形式。
1.8.任何前述组合物1以及后续组合物,其还包含一种或多种调味剂,例如丁子香酚、L-薄荷醇、丁香油、百里酚、芫荽油、桉树油、茴香油、印度楝树油、柠檬油、椰子油和/或罗勒油中的一种或多种。
1.9.任何前述组合物1以及后续组合物,其中丁子香酚以按组合物重量计0.1%至2%,例如0.1%至1%,例如0.6%的量存在;并且L-薄荷醇以0.1%至4%,例如0.1%至2%,例如1%的量存在。
1.10.任何前述组合物1以及后续组合物,其中丁子香酚以按组合物重量计0.1%至2%的量存在;并且L-薄荷醇以0.1%至4%的量存在。
1.11.任何前述组合物1以及后续组合物,其中丁子香酚以按组合物重量计0.1%至1%的量存在;并且L-薄荷醇以0.1%至2%的量存在。
1.12.任何前述组合物1以及后续组合物,其中丁香油以按组合物重量计0.1%至2%,例如0.1%至1%,例如0.6%的量存在;并且L-薄荷醇以0.1%至4%,例如0.1%至2%,例如1%的量存在。
1.13.任何前述组合物1以及后续组合物,其中丁香油以按组合物重量计0.1%至2%的量存在;并且L-薄荷醇以0.1%至4%的量存在。
1.14.任何前述组合物1以及后续组合物,其中丁香油以按组合物重量计0.1%至1%的量存在;并且L-薄荷醇以0.1%至2%的量存在。
1.15.任何前述组合物1以及后续组合物,其中椰子油以按组合物重量计0.1%至5%,例如1%至4%,例如3%的量存在。
1.16.任何前述组合物1以及后续组合物,其中椰子油以按组合物重量计1%至4%的量存在。
1.17.任何前述组合物1以及后续组合物,其还包含按组合物重量计0.1%至4%的量的丁香油。
1.18.任何前述组合物1以及后续组合物,其还包含一种或多种增稠剂。
1.19.组合物1.18,其中所述增稠剂选自改性纤维素例如羟乙基纤维素和羧甲基纤维素、PMC、硅酸铝镁、黄原胶、羟丙基纤维素、甲基纤维素、角叉菜胶、黄芪胶以及其中两种或更多种的组合。
1.20.任何前述组合物1以及后续组合物,其还包含非离子型表面活性剂。
1.21.组合物1.20,其中所述非离子型表面活性剂选自Croduret 40、PEG、PEG600、聚山梨醇酯20(TweenTM 20)、聚山梨醇酯80(TweenTM 80)、PEG 6000、泊洛沙姆以及其中两种或更多种的组合。
1.22.组合物1.20,其中所述非离子型表面活性剂为单独的聚山梨醇酯20(TweenTM20)或者其与另一种非离子型表面活性剂的组合。
1.23.任何前述组合物1以及后续组合物,其还包含一种或多种溶剂。
1.24.组合物1.12,其中所述一种或多种溶剂选自甘油、丙二醇、Croduret 40、PEG、PEG 600、Tween 80、PEG 6000以及泊洛沙姆。
1.25.组合物1.23,其中所述溶剂包括丙二醇。
1.26.任何前述组合物1以及后续组合物,其还包含一种或多种润湿剂,例如甘油。
1.27.任何前述组合物1以及后续组合物,其还包含一种或多种防腐剂。
1.28.组合物1.27,其中所述防腐剂选自苯甲酸钠、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、苯甲醇、乙醇、柠檬酸、山梨酸钾、水杨酸、山梨酸、无机亚硫酸盐、三氯生、调味剂以及其中两种或更多种的组合。
1.29.任何前述组合物1以及后续组合物,其还包含一种或多种选自甜味剂和/或着色剂的另外的成分,例如甜菊、三氯蔗糖、甘草、阿斯巴甜钠、氧化锌、滑石、二氧化钛、颜料、染料以及其中两种或更多种的组合。
本公开还提供一种用于治疗口腔溃疡性病状例如口腔溃疡或口疮的方法(方法1),其包括向有需要的患者施用有效量的组合物1-1.29中任一项所述的组合物。
本公开还提供一种用于制备如以上所述的组合物(例如,组合物1-1.29)的方法(方法2),其包括将印度醋栗提取物、甘草提取物、锌离子源以及樟脑一起组合在药学上可接受的载体中。
本公开还提供印度醋栗提取物、甘草提取物、锌离子源和樟脑的组合在制备用于治疗口腔溃疡性病状例如口腔溃疡和口疮的药物中的用途。
本发明的组合物含有印度醋栗提取物(余甘果),其也称为印度醋栗(IndianGooseberry)。印度醋果提取物含有40%丹宁酸,其提供收敛性。印度醋果已经历初步研究,证实了在体外的抗病毒和抗微生物特性。有体外初步证据表明其提取物诱导细胞凋亡并改变在参与类风湿性关节炎和骨质疏松症的破骨细胞中的基因表达。它可证实具有针对一些癌症的潜在活性。叶子、树皮或果实的实验性制备物已显示针对实验室疾病模型的潜在功效,所述疾病诸如炎症、癌症、年龄相关性肾病以及糖尿病。
印度醋栗还已知具有抗氧化剂特性,并且据报道具有比抗坏血酸更强的抗氧化剂特性。参见Khopde等,Current Science 81(2)2001,所述文献出于所有目的以引用的方式并入本文。尽管印度醋栗被认为富含维生素,并且特别是维生素C,但是维生素含量为微克水平的,并抗氧化剂作用主要是由于较高百分比的单宁酸引起的。尽管不希望限制本发明,但是理论上维生素C由于高百分比的充当抗氧化剂的单宁酸而不会被氧化,从而使得维生素可用于消耗。制备印度醋栗提取物的方法可见于例如Khopde等,同上。
适用于包含在本发明的组合物中的印度醋栗提取物可以通过任何多种多样的程序来制备。适用于包含在本发明的组合物中的印度醋栗提取物优选地并不含有任何溶剂或防腐剂。在一个商业程序中,在小于5℃下将新鲜印度醋栗水果制成浆液以产生印度醋栗浆液,然后使其经历冷压提取以产生印度醋栗果汁,并且过滤以去除任何不溶性物质。在真空下浓缩果汁并且喷雾干燥并例如使用胶体二氧化硅配制。然后研磨并筛选产物。通过此程序制备的适合的印度醋栗提取物可以购自例如Sabinsa Corporation,East Windsor,NJ。
本公开的口腔护理组合物还含有甘草提取物。甘草提取物已广泛地用于其治疗特性。甘草提取物的活性(包括伤口愈合特性)已与不同类型的植物化学物,特别是主要水溶性成分甘草甜素及其分解产物18β-甘草次酸相关联。甘草提取物已用于溃疡治疗的不同产品中。假设甘草次酸具有类似于可的松的结构并且因此提供抗炎特性。
适用于包含在本发明的组合物中的甘草提取物可以通过任何多种多样的程序来制备。适用于包含在本发明的组合物中的甘草提取物优选地并不含有任何溶剂或防腐剂。在一个商业程序中,使用水提取甘草根粉末,将其浓缩并且酸化和过滤。使用水洗涤残余物直到达到中性pH,并且然后干燥,研磨并筛选。通过此程序制备的适合的甘草提取物可以购自例如Sabinsa Corporation,East Windsor,NJ。
本公开的口腔护理组合物也含有例如适用作抗微生物剂、抗牙结石剂或呼吸清新剂的锌离子源。可以存在一种或多种此类锌离子源。合适的锌离子源包括但不限于乙酸锌、柠檬酸锌、葡糖酸锌、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地且说明性地以按组合物重量计0.05%至3%,例如0.1%至1%的总量存在。优选地,锌盐的量被选择来提供0.1重量%至2重量%。例如,0.5重量%至1.2重量%,例如约0.8重量%。例如,以2.2重量%使用的硫酸锌提供约0.8重量%的元素锌(离子),并且以1重量%使用的氧化锌提供约0.8重量%的元素锌(离子)。
在一些优选的实施方案中,组合物包含氧化锌和/或硫酸锌,它们各自已知有收敛性并且已知用于提供抗菌作用。参见Panda,A.等,Natural Product Radiance 5(4)284-288(2006)。
在本发明的一些优选的实施方案中,组合物包含氧化锌和/或硫酸锌。在一些此类实施方案中,氧化锌和/或硫酸锌为微粒形式。根据本发明已发现,虽然将预期锌将以最有效的可溶性状态提供,令人意外的是,在本发明的组合物中掺入具有最小可溶性的氧化锌颗粒提供所需抗菌特性和收敛特性,同时提供避免大部分锌盐的延迟的令人讨论的金属和收敛味道的另外益处。另外,虽然不希望受到特定理论的影响,因为硫酸锌为可溶性的,而氧化锌则不是可溶性的,将预期的是硫酸锌将是更有效的抗微生物剂。然而,申请人已出乎意料地发现,在本发明的组合物中两种盐具有大致等效的抗微生物有效性,如以下实施例所证实的。
在一些实施方案中,本公开的口腔护理组合物也含有一种或多种冷却剂,例如樟脑。多种多样的冷却剂适于本发明。通常,冷却剂以按组合物重量计的0重量%-2重量%;例如0.1重量%-1重量%;例如约0.5重量%的量存在。
在一些实施方案中,本发明的组合物含有适用于例如增强组合物的味道的一种或多种调味剂。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、月桂油、茴香油、桉树油、柑橘油、水果油和水果香精(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(诸如咖啡、可可、可乐果、花生、杏仁)等,吸附的和包封的调味剂等。还涵盖在本文的调味剂之内的是在口中提供芳香和/或其他感官效果(包括凉爽或温热效果)的成分。此类成分说明性包括薄荷醇、三萜醇乙酸酯、乳酸薄荷酯、樟脑、桉树油、桉树脑、茴香脑、丁子香酚、肉桂、羟苯基丁酮、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、桂皮醛甘油缩醛(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重量计0.01%至5%,例如0.1%至2.5%,例如0.1%-1%;例如约0.5%-0.6%的总量存在。优选的调味剂包括例如按组合物重量计0.1%至2%,例如0.1%至1%,例如0.6%的量的丁子香酚;例如按组合物重量计0.1%至4%,例如0.1%至2%,例如1%的量的L-薄荷醇;以及例如按组合物重量计0.1%至4%,例如0.1%至2%,例如0.6%的量的丁香油。其他优选的调味剂包括而不限于百里酚、芫荽油、桉树油、莳萝油、茴香油、印度楝树油、柠檬油以及罗勒油(basil oil);各自通常例如以按组合物重量计0.1%至4%,例如0.1%至2%,例如1%至2%的量存在。
在优选的实施方案中,本公开的组合物含有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。可以使用任何口腔可接受的增稠剂,其包括而不限于也称为羧基乙烯基聚合物的卡波姆、也称为爱尔兰藓并且更具体地为1-角叉菜胶(ι-卡拉胶)的角叉菜胶、纤维素聚合物(诸如羟乙基纤维素、羧甲基纤维素(CMC)及其盐,例如CMC钠)、天然树胶(诸如卡拉胶、黄原胶、阿拉伯树胶和黄蓍胶)、胶体硅酸铝镁、胶体二氧化硅等。一种或多种增稠剂任选地以按组合物重量计0.01%至15%,例如0.1%至10%,或者0.2%-5%或3%-4%的总量存在。在一些优选的实施方案中,组合物包含按组合物重量计3%-4%的组合总量的羟乙基纤维素和羧甲基纤维素,并且羧甲基纤维素与羟乙基纤维素的比率为按重量计1∶1至1∶2,例如1∶1.4至1∶1.8,例如约1∶1.6。
在一些实施方案中,本发明的组合物含有适用于例如增溶组合物的其他组分的至少一种表面活性剂。任何口腔可接受的非离子型表面活性剂为优选的。适合的非离子型表面活性剂包括而不限于泊洛沙姆、聚氧化乙烯脱水山梨醇酯、脂肪醇乙氧化物、烷基酚乙氧化物、叔胺氧化物、叔膦氧化物、二烷基亚砜、聚山梨醇酯等。适合的实例为聚山梨醇酯20(TweenTM 20)。一种或多种表面活性剂通常以按组合物重量计0.01%至10%,例如0.05%至5%或2%至4%,例如3%的总量存在。
在一些实施方案中,本发明的组合物包含适用于例如调节组合物粘度、提供组合物主体并增强甜度的至少一种溶剂和/或润湿剂。可使用任何口腔可接受的润湿剂,包括而不限于多元醇诸如甘油、丙二醇、山梨醇、木糖醇或低分子量PEG。大部分润湿剂也充当甜味剂。一种或多种润湿剂优选地以按组合物重量计1%至70%,例如1%至50%、2%至25%或10%至20%,例如15%的总量存在。在一些优选的实施方案中,组合物包含按组合物重量计10%-20%;例如约15%的组合总量的甘油和丙二醇,并且丙二醇与甘油的比率为按重量计1∶1至1∶3,例如1∶2。
在一些实施方案中,本发明的组合物包含至少一种防腐剂。已知多种多样的适合的防腐剂,包括例如而不限于苯甲酸钠、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、苯甲醇、乙醇、柠檬酸、山梨酸钾、水杨酸、山梨酸、无机亚硫酸盐、三氯生、调味剂以及许多调味剂。
在一些实施方案中,本发明的组合物包含一种或多种另外的成分,诸如甜味剂和着色剂。适合的甜味剂的实例包括例如而不限于糖精钠、甜菊、三氯蔗糖、甘草以及阿斯巴甜钠。着色剂-氧化锌、滑石、二氧化钛、颜料和染料。
在本文中着色剂包括颜料、染料、色淀以及赋予特定光泽或反射率的试剂诸如珠光剂。着色剂可以用于许多功能,包括例如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,包括而不限于滑石、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、红色铁氧化物、黄色铁氧化物、褐色铁氧化物和黑铁氧化物、亚铁氰化铁铵、猛紫、青蓝、钛云母、氯氧化铋、颜料、染料等。一种或多种着色剂任选地以按组合物重量计0.001%至20%,例如0.01%至10%或0.1%至5%的总量存在。
将了解的是本发明的组合物的不同成分可以用于多种目的。例如,樟脑充当疼痛缓解剂并且充当冷却剂。除其调味特性之外,丁香油提供疼痛缓解、麻醉作用、抗微生物特性并且出乎意料地充当樟脑的增溶剂。并且丙二醇可用作溶剂(例如帮助溶解其他组分诸如樟脑)并且用作润湿剂。因此,在化合物列表中包含具有特定功能的给定成分并不旨在将所述成分限定至该特定功能。
实施例
实施例1-提取物对抗引起口疮的口腔病原体的抗菌活性
进行研究以调查口腔细菌和真菌菌株针对以下两种提取物的敏感性:甘草汁和印度醋栗,具有单独的氧化锌和与它组合。印度醋栗提取物和甘草提取物获自SabinsaCorporation,East Windsor,NJ。使用琼脂杯皿法,其中测试样品从杯子扩散穿过陪替氏平皿中的琼脂层至一定程度,使得添加的微生物的生长完全限制于圆形区域或含有抗生素物质溶液的空腔周围的区域。抗微生物活性被表示为以微米计的区域直径,其由一个刻度测量。
生物体:在研究中将金黄色葡萄球菌ATCC 6538用作细菌菌株,并且将白色念珠菌ATCC 10231用作真菌菌株。
制备提取物悬浮液:通过将100mg提取物组合在10ml DMSO稀释液中来制备所有提取物的悬浮液,以产生具有10mg/ml(1%)浓度的测试/储备溶液。由此储备溶液制备其他稀释液以获得1mg/ml(0.1%)和3mg/ml(0.3%)的浓度。
制备测试培养物:由过夜培养物制备测试菌株的接种物并且将悬浮液调节至0.5McFarland标准浊度(对应于细菌的108个CFU/mL和真菌的106个CFU/mL)。
制备琼脂板(表面铺展):通过在20-30ml胰酶解酪蛋白周围倒入豆粉琼脂以获得4mm厚度来获得基础层。然后将其保持用于固化。将无菌拭子浸入到接种管中。然后使用固定压力将拭子抵靠管侧壁(在流体水平之上)旋转,以去除过量流体,使得它未变湿淋淋的。然后通过在整个琼脂表面上用拭子画三次条纹并且每次将半旋转大约60度以确保接种物的均匀分布来接种TSA琼脂板。使盖子微开,然后将板静置在室温下至少3至5分钟,但是不超过15分钟,使琼脂板的表面干燥,之后进行下一个步骤。
实验程序:
使用无菌软木塞钻孔器在每个陪替氏培养皿(Petri dish)的培养基中制备10mm直径的3个杯子。用提取物名称标记陪替氏培养皿并且分别使用2个不同浓度1%和3%标记3个杯子。使用同等浓度的两种提取物制备悬浮液以测试这些提取物组合的功效。然后使用微量加液器将150μl测试悬浮液引入在每个孔中。使用苯甲酸钠作为阳性对照并且使用DMSO作为稀释液对照。将所有板保持在室温下以便测试样品和对照有效扩散。随后将板子37℃±1℃下孵育24小时并进行评价。在任何尺寸的杯子周围的有限区域的存在指示抗菌活性。测量并记录抑制区域的直径。超过8-10mm的区域被视为显著的。
结果显示在以下表1中:
表1
测试的材料 | 在念珠菌属中 | 在金黄色葡萄球菌中 |
1%的印度醋栗 | 21mm | 18mm |
1%的甘草 | 15mm | 13mm |
3%的印度醋栗 | 22mm | 24mm |
3%的甘草 | 18mm | 18mm |
可以看出印度醋栗和甘草二者当针对金黄色葡萄球菌和白色念珠菌进行测试时均显示显著的抑制区域。由于印度醋栗和甘草主要已知分别有收敛性和伤口愈合特性,所以令人吃惊且出乎意料的是印度醋栗和甘草均显示针对金黄色葡萄球菌和白色念珠菌的显著抑制。因此,本发明的组合物具有增加的抗菌和抗真菌功效的益处。
实施例2-短间隔杀灭时间(SIKT)体外测试
使用短间隔杀灭时间(SIKT)测试来确定当在根据本发明的几种制剂中测试时化合物的体外短期抗微生物活性。此测试评定了测试生物体的微生物群体在暴露于体外溃疡凝胶之后的减少。将测试材料与细菌接种物混合,持续所选定的时间间隔,在此之后中和测试系统并已列举存活的细菌。必须稀释洁齿剂或其他粘性或固体样品。将与水相比的细菌减少用作表示活性的基础。
选择金黄色葡萄球菌ATCC 6538和白色念珠菌ATCC 10231作为测试生物体。白色念珠菌为鹅口疮的最常见参与的生物体。口腔和牙齿的正常菌群包括葡萄球菌。这两种生物体为引起继发性感染的机会致病菌。如以下表2所示地制备根据本发明的组合物(A-C)。对这些组合物和以下表3中示出的两种商业组合物进行SIKT分析。
表2
本发明的示例性组合物
表3
商业口腔溃疡凝胶制剂
(在产品上列出的成分)
接种物制备:由过夜培养物制备测试菌株的接种物并且将悬浮液调节至0.5McFarland标准浊度(对应于细菌的108个CFU/mL和真菌的106个CFU/mL)。
样品制备:将9.0g每种测试样品称量到两个无菌容器中的每个容器中。将9.0mL无菌DI水无菌地吸入到无菌容器中以充当测试对照。
样品接种(1:10):用1.0mL制备的接种物接种每个样品和对照。将样品搅拌并混合,并且在所选定的接触时间(即1分钟、2分钟或5分钟)结束时,用无菌搅拌棒取出0.5g并且将其无菌地分配到测试管的4.5mL Difco D/E中和肉汤中。将D/E和产品充分涡旋以确保抗微生物剂的中和。
样品测试:在每个所选定的时间间隔下,使用D/E肉汤(将0.5mL加入到4.5mL D/E)制备每个样品的1:10稀释液(10-1至10-6)。将样品充分混合或涡旋。然后将1.0mL每个稀释液(10-1至10-6)吸入到无菌陪替氏培养皿中。添加15-20mL熔融的改性Letheen琼脂(MLA),并且将板涡旋以完全分散。在使板固化之后,将它们颠倒并在35℃下孵育48-72小时,并且对菌落进行计数。
计算:对每个样品点的两个计数取平均值(A+B/2),以获得平均CFU/g。通过从对照CFU/g中减去平均测试样品CFU/g来计算减少百分比。然后将此结果除以对照CFU x 100。通过从对照CFU/g中减去平均测试样品CFU/g来计算减少百分比。然后将此结果除以对照CFUx 100。
结果:在金黄色葡萄球菌和白色念珠菌中:与从1分钟间隔开始的商业凝胶2相比,表2中列出的所有三种发明组合物A-C具有显著杀灭%。在另一方面,它们的杀灭%相当于商业凝胶1。结果详情附于下表4和表5中:
表4
示例性发明组合物对比商业凝胶使用测试生物体
金黄色葡萄球菌的SIKT结果
表5
示例性发明组合物对比商业凝胶使用测试生物体
白色念珠菌的SIKT结果
结果:可以看出本发明的组合物的抗菌特性将通过防止口腔致病细菌增殖和引起粘膜损害来帮助快速愈合口腔溃疡。它还将防止继发性感染的发生。
实施例3-本发明的其他示例性组合物的短间隔杀灭时间(SIKT)体外测试
还对本发明的组合物D、E和F进行以上所述的SIKT测试,所述组合物具有以下表6所示的组成:
表6
以下表7和表8分别显示针对测试生物体金黄色葡萄球菌和白色念珠菌的结果:
表7
示例性发明组合物对比商业凝胶使用测试生物体
金黄色葡萄球菌的SIKT结果
表8
示例性发明组合物对比商业凝胶使用测试生物体
白色念珠菌的SIKT结果
结果:所有制剂D-F均优于商业凝胶2,并且相当于商业凝胶1。硫酸锌和氧化锌的组合预仅氧化锌相比未显示优异杀灭。另外,令人惊讶并出乎意料的是所有三种制剂D-F均具有大致等同的杀灭特性,无论锌盐的溶解度如何。
本发明已参考说明性实施例进行描述,但是应理解本发明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将做出的改变和修改也处于本发明的范围,所述范围在所附权利要求书中限定。
Claims (27)
1.一种口腔护理组合物,其包含:在药学上可接受的载体中的提取物,锌离子源,以及任选地0重量%至2重量%的量的樟脑,其中
所述提取物包含印度醋栗提取物和甘草提取物;
其中印度醋栗提取物以0.5重量%至8重量%的量存在于所述组合物中;
甘草提取物以0.1重量%至5重量%的量存在于所述组合物中;
锌源为微粒形式的氧化锌或硫酸锌,并且以足以提供0.1重量%至2重量%的量的锌离子的量存在于所述组合物中。
2.如权利要求1所述的口腔护理组合物,其中所述组合物为口腔凝胶。
3.如权利要求1或权利要求2所述的口腔护理组合物,其中:
所述印度醋栗提取物以1重量%至5重量%的量存在于所述组合物中;
所述甘草提取物以1重量%至3重量%的量存在于所述组合物中;并且
所述锌源以足以提供0.5重量%至1.2重量%的量的锌离子的量存在于所述组合物中。
4.如权利要求3所述的口腔护理组合物,其中所述氧化锌为微粒形式。
5.如权利要求1所述的口腔护理组合物,其还包含一种或多种调味剂。
6.如权利要求5所述的口腔护理组合物,其中所述调味剂选自丁子香酚、L-薄荷醇、丁香油、百里酚、芫荽油、桉树油、茴香油、印度楝树油、柠檬油、椰子油和/或罗勒油。
7.如权利要求1所述的口腔护理组合物,其中丁香油以按所述组合物的重量计0.1%至2%的量存在;并且L-薄荷醇以0.1%至4%的量存在。
8.如权利要求7所述的口腔护理组合物,其中丁香油以按所述组合物的重量计0.1%至1%的量存在;并且L-薄荷醇以0.1%至2%的量存在。
9.如权利要求1所述的口腔护理组合物,其中丁子香酚以按所述组合物的重量计0.1%至2%的量存在;并且L-薄荷醇以0.1%至4%的量存在。
10.如权利要求9所述的口腔护理组合物,其中丁子香酚以按所述组合物的重量计0.1%至1%的量存在;并且L-薄荷醇以0.1%至2%的量存在。
11.如权利要求1所述的口腔护理组合物,其中椰子油以按所述组合物的重量计0.1%至5%的量存在。
12.如权利要求11所述的口腔护理组合物,其中椰子油以按所述组合物的重量计1%至4%的量存在。
13.如权利要求1所述的口腔护理组合物,其中所述药学上可接受的载体包含一种或多种增稠剂。
14.如权利要求13所述的口腔护理组合物,其中所述增稠剂选自改性纤维素、羟乙基纤维素、羧甲基纤维素、PMC、硅酸铝镁、黄原胶、羟丙基纤维素、甲基纤维素、角叉菜胶、黄芪胶以及其中两种或更多种的组合。
15.如权利要求1所述的口腔护理组合物,其还包含非离子型表面活性剂。
16.如权利要求15所述的口腔护理组合物,其中所述非离子型表面活性剂选自Croduret 40、PEG、PEG 600、聚山梨醇酯20 (TweenTM 20)、聚山梨醇酯80 (TweenTM 80)、PEG 6000和泊洛沙姆以及其中两种或更多种的组合。
17.如权利要求15所述的口腔护理组合物,其中所述非离子型表面活性剂为单独的聚山梨醇酯20 (TweenTM 20)或者其与另一种非离子型表面活性剂的组合。
18.如权利要求1所述的口腔护理组合物,其还包含一种或多种溶剂。
19.如权利要求18所述的口腔护理组合物,其中所述溶剂为丙二醇。
20.如权利要求1所述的口腔护理组合物,其还包含一种或多种润湿剂。
21.如权利要求1所述的口腔护理组合物,其还包含作为润湿剂的甘油。
22.如权利要求1所述的口腔护理组合物,其还包含一种或多种防腐剂。
23.如权利要求22所述的口腔护理组合物,其中所述防腐剂选自苯甲酸钠、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、苯甲醇、乙醇、柠檬酸、山梨酸钾、水杨酸、山梨酸、无机亚硫酸盐、三氯生、调味剂以及其中两种或更多种的组合。
24.如权利要求1所述的口腔护理组合物,其还包含一种或多种选自甜味剂和着色剂的另外的成分。
25.如权利要求24所述的口腔护理组合物,其中所述甜味剂选自三氯蔗糖、甘草、阿斯巴甜钠以及其中两种或更多种的组合;并且所述着色剂选自氧化锌、滑石、二氧化钛、颜料、染料以及其中两种或更多种的组合。
26.一种用于制备如前述权利要求1-25任一项所述的组合物的方法,其包括将印度醋栗提取物、甘草提取物和锌离子源一起组合在药学上可接受的载体中。
27.印度醋栗提取物、甘草提取物和锌离子源的组合在制备用于治疗口腔溃疡性病状的药物中的用途,所述锌离子源为微粒形式的氧化锌或硫酸锌。
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