CN113712848B - 一种不含有表面活性剂的可发泡的口腔护理组合物 - Google Patents
一种不含有表面活性剂的可发泡的口腔护理组合物 Download PDFInfo
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- CN113712848B CN113712848B CN202111181422.XA CN202111181422A CN113712848B CN 113712848 B CN113712848 B CN 113712848B CN 202111181422 A CN202111181422 A CN 202111181422A CN 113712848 B CN113712848 B CN 113712848B
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- 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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- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
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Abstract
本发明涉及一种不含有表面活性剂的可发泡的口腔护理组合物,其含有0.5‑10质量%羟丙基甲基纤维素,所述羟丙基甲基纤维素在0.1%质量浓度时,其水溶液的表面张力小于56mN/m,所述口腔护理组合物不含有表面活性剂,并且在刷牙时能够产生泡沫。
Description
本申请为以下申请的分案申请:发明名称为不含有表面活性剂的可发泡的口腔护理组合物,申请号为CN202010950822.1,申请日为2020年9月11日。
技术领域
本申请涉及口腔护理组合物,特别是一种不含有表面活性剂的口腔护理组合物,尤其是不含有表面活性剂的可发泡的牙膏组合物。
背景技术
牙膏是人们的日常必需品。作为每日与口腔密切接触的产品,牙膏的安全性及其对人们健康的影响日益成为人们关注的焦点。牙膏是一种成分复杂的混合物,通常由摩擦剂、保湿剂、表面活性剂、增稠剂、香料香精、甜味剂、着色剂以及杀菌防腐剂等混合而成。
表面活性剂是牙膏产品中必需的组分。例如,US4058595公开了牙膏中常用的表面活性剂,例如烷基芳基磺酸盐、高级烷基磺基乙酸盐、牛磺酸的高级脂肪酸酰胺、山梨醇酐单硬脂酸酯等。但这些合成的表面活性剂及其分解产物可能存在对粘膜的刺激性、皮肤的过敏性、毒性和致癌性,会破坏皮肤口腔生态环境,包括破坏皮肤味觉细胞和口腔细胞,残留的化学成分破坏口腔生态环境,甚至透过口腔黏膜进入血液,带来严重的安全隐患。使得牙膏的安全性受到消费者的广泛关注。
为了降低表面活性剂的潜在安全隐患,还开发出一类温和的牙膏,其使用相对温和的表面活性剂,例如月桂酰肌氨酸钠、烷基葡萄糖苷、椰油酰胺丙基甜菜碱、天然表面活性剂(大豆皂甙)等。但是本研究团队在实验室对一定浓度的牙膏-水溶液进行鱼类急性毒性试验,对含表面活性剂的多种传统牙膏用水稀释500倍的鱼类急性毒性实验。结果显示,含有上述表面活性剂的传统牙膏的水溶液的表面张力较低,测试鱼类都会在1-3个小时内内死亡,表现出很大的毒性。通过绿豆发芽实验显示,含有表面活性剂的牙膏用水稀释20倍后仍然能够导致绿豆不能够发芽。研究表明,表面活性剂的存在降低了牙膏的安全性,具有潜在的安全隐患。
此外,还开发了表面活性剂的替代物用于牙膏组合物。
CN103211716A公开了利用具有表面活性性能蛋白质或蛋白质基表面活性剂作为唯一清洁洗涤成分制造牙膏的方法,其中所述具有表面活性性能蛋白质或蛋白质基表面活性剂是大豆蛋白酸钠、丝蛋白质酸钙、天然丝蛋白乳化剂或酪蛋白酸钠中的一种、两种、三种或四种。
US2006222602A1公开了清洁牙齿的牙膏组合物,该牙膏组合物包含的钙盐成分中包含纳米颗粒和蛋白组分如大豆蛋白、酪蛋白等。该牙膏组合物还包含阴离子表面活性剂、两性离子和两性表面活性剂、非离子表面活性剂、阳离子表面活性剂或这些化合物的混合物。该牙膏组合物兼具柔和处理和清洁的功效。
CN108261343A公开了一种牙膏组合物,其包含基于所述牙膏组合物总重量0.05-5.5%的酪蛋白酸钙,但是该替代表面活性剂成本较高。
为了降低表面活性剂带来的潜在的安全隐患,还开发出一类不含有表面活性剂的牙膏,但是由于不含有表面活性剂的牙膏在刷牙时不能产生的泡沫,导致使用者的体验感较差,使用者接受程度较差。
因此仍然需要开发出一种不含有表面活性剂和防腐剂,但不降低使用体验感的口腔护理组合物,特别是牙膏组合物。
发明内容
纤维素类天然来源的高分子聚合物是牙膏中常用的增稠剂,本发明的研究人员意外的发现,使用特定的羟丙基甲基纤维素作为增稠剂的口腔护理组合物在不使用表面活性剂的情况下仍然能够产生泡沫,在此基础上完成了本发明。
因此,本发明涉及一种可发泡的口腔护理组合物,其含有0.5-10质量%羟丙基甲基纤维素,所述羟丙基甲基纤维素在0.1质量%浓度下,其水溶液的表面张力不大于56mN/m,优选42-55mN/m。
进一步的,本发明涉及口腔护理组合物,其含有:
(a)10-50质量%研磨剂,优选12-40质量%,特别优选15-30质量%,尤其是18-25质量%;
(b)5-50质量%保湿剂,优选10-45质量%,特别优选15-40质量%,尤其是18-30质量%;
(c)0.01-2.0质量%增味剂,优选0.1-1.0质量%,更优选0.5-1.0质量%;
(d)0.01-10质量%功能性添加剂,优选0.1-5质量%,更优选1.0-2.0质量%;
(e)0.5-10质量%羟丙基甲基纤维素,优选1-7质量%,特别优选2-5质量%,尤其是2.5-4.0质量%。
在一个特别的实施方案中,本发明的口腔护理组合物含有:
(a)10-50质量%研磨剂,优选12-40质量%,特别优选15-30质量%,尤其是18-25质量%;
(b)5-50质量%保湿剂,优选10-45质量%,特别优选15-40质量%,尤其是18-30质量%;
(c)2--20质量%纤维素,优选4-16质量%,特别优选6-12质量%,尤其是8-10质量%;
(d)5-30质量%乳酸菌发酵复配物,优选8-26质量%,特别优选12-22质量%,尤其是14-18质量%;
(e)0.5-10质量%羟丙基甲基纤维素,优选1-7质量%,特别优选2-5质量%,尤其是2.5-4.0质量%。
(f)1-12质量%淀粉,优选2-10质量%,特别优选3-8质量%,尤其是4-6.0质量%。
羟丙基甲基纤维素
本发明的口腔护理组合物中,羟丙基甲基纤维素在0.1质量%浓度下,其水溶液的表面张力小于56mN/m,优选为42-56mN/m。
基于所述羟丙基甲基纤维素,其中羟丙氧基的含量为3-12质量%,甲氧基的含量为19-30质量%。
为了获得可接受的泡沫效果,基于口腔护理组合物,本发明的羟丙基甲基纤维素的用量为0.5-10质量%,优选1-7质量%,特别优选2-5质量%,尤其是2.5-4.0质量%。
羟丙基甲基纤维素优选在商业上可购的例如:例如南通金顺(公司)的JS-HPN20,JS-HPN25(食品级),JS-HPN5(医药级);山东一腾公司的YT5,YT15(食品级),YT50(医药级)等。
研磨剂
在本发明的多个实施方案中,在口腔护理组合物的媒介物为固体或糊剂的情况下,该口腔用组合物优选包含牙科可接受的研磨材料或磨光剂,其可用来磨光牙釉质或者提供增白效应。任何口腔可接受的研磨剂都可以使用,但应对研磨剂的类型、精细度(粒度)和量进行选择以使牙釉质在组合物的正常使用中不过度磨损。适宜的研磨剂非限制性地包括二氧化硅,例如硅胶、水合二氧化硅或沉淀二氧化硅形式、氧化铝、难溶性磷酸盐、碳酸钙、树脂研磨剂如脲甲醛缩合物等。用作研磨剂的难溶性磷酸盐包括正磷酸盐、聚偏磷酸盐和焦磷酸盐。示例性的例子是正磷酸二钙二水合物、焦磷酸钙、β-焦磷酸钙、磷酸三钙、聚偏磷酸钙和难溶性聚偏磷酸钠。一种或多种研磨剂任选地以研磨有效的总量存在,典型地为组合物的约10-50质量%、例如12-40质量%或15-30质量%,尤其是18-25质量%;
保湿剂
可用于本发明中的保湿剂包括多元醇如甘油、山梨醇、木糖醇和聚乙二醇。在各种实施方案中,保湿剂可用于防止糊剂或凝胶组合物在暴露于空气时的硬化。在实施方案中保湿剂还起甜味剂的作用。一种或多种保湿剂任选地以5-50质量%,优选10-45质量%,特别优选15-40质量%,尤其是18-30质量%的总量存在。
增稠剂
增稠剂通常用于口腔护理组合物以控制或改变组合物的粘度。在不影响牙膏的泡沫的基础上,本发明的牙膏还可以额外含有不同于羟丙基甲基纤维素的增稠剂选自:多糖或多糖衍生物(例如甲基纤维素、乙基纤维素、羧甲基纤维素、羟乙基纤维素、羟丙基纤维素和其它纤维素衍生物、淀粉)、卡波姆(例如交联聚丙烯酸共聚物或与聚烯基聚醚交联的丙烯酸均聚物和共聚物)、天然和合成树胶(例如角叉菜胶、黄原胶、刺梧桐树胶、瓜尔胶、明胶、藻胶、海藻酸钠、黄芪胶、脱乙酰壳多糖、金合欢树胶等)、丙烯酰胺聚合物、丙烯酸聚合物、乙烯基聚合物(例如聚乙烯醇、聚乙烯吡咯烷酮等)、聚胺、聚季化合物、环氧乙烷聚合物、以及它们的混合物。粘土和有机改性粘土、二氧化硅等的一些无机增稠剂也能够用于本发明。
增味剂
用于本发明中的增味剂包括可操作以增加组合物味道的任何物质或物质的混合物。任何口腔可接受的天然或合成增味剂都可以使用,如调味油、调味醛、酯、醇、类似的物质、及其组合。增味剂包括香草醛、鼠尾草、马郁兰、欧芹油、留兰香油、肉桂油、冬青油、薄菏油、丁香油、月桂油、茴香油、桉叶油、柑桔油、果实油以及包括那些源自柠檬、橙子、酸柚、葡萄柚、杏、香蕉、葡萄、苹果、草莓、樱桃、菠萝等的香精。一种或多种增味剂任选地以0.01-5质量%的总量存在。
用于本发明中的增味剂包括口腔可接受的天然或人造的、营养性或无营养甜味剂。这类甜味剂包括右旋糖,聚右旋糖,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,山梨醇,甘露醇,木糖醇,麦芽糖醇,异麦芽糖醇,阿司帕坦,纽甜,糖精及其盐,三氯蔗糖,及其混合物。一种或多种甜味剂任选地以约0.005-10质量%、任选地约0.01-1质量%的含量存在。
任选的活性物质
本发明的组合物任选地包含一种或多种另外的活性物质,其可用于预防或治疗口腔硬或软组织的病症或障碍、预防或治疗生理失调或病症、或提供化妆益处。在各种实施方案中,活性剂为可治疗或预防障碍或在口腔内(例如,为牙齿、牙龈或口腔的其它硬或软组织)提供化妆益处的“口腔护理活性剂”。可用于本发明中的口腔护理活性剂包括着色剂、缓蚀剂、防龋剂、防牙菌斑剂、抗牙结石剂、消炎剂、除臭剂和/或脱敏剂等。
可用于本发明中的活性剂任选地以安全和有效的量存在于本发明的组合物中。活性剂的“安全有效”量为足以在被施用活性剂的人或低等动物受试者中产生所需治疗或预防效果、而没有不当不良副作用(如毒性、刺激或变态反应)的量,当按本发明的方式应用时具有合理的益处/风险比。活性剂的具体的安全和有效量将随诸如所治疗的具体病症、受试体的身体健康状况、并行治疗(如果有的话)的性质、所用的具体的活性剂、具体的剂型、所用的载体和所需的给药方案的因素而变化。
pH调节剂
可用于本发明中的那些pH调节剂包括降低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,可包含一种或多种选自酸化剂、碱化剂和缓冲剂的化合物以提供约2-约10的pH。任何口腔可接受的pH调节剂都可以使用,包括羧酸,磷酸和磺酸,酸性盐(例如,柠檬酸盐一钠,柠檬酸二钠,苹果酸一钠等),碱金属氢氧化物如氢氧化钠,碳酸盐如碳酸钠,碳酸氢盐,倍半碳酸盐,硼酸盐,硅酸盐,磷酸盐(例如,磷酸一钠,磷酸三钠,多磷酸盐等)。一种或多种pH调节剂任选地以有效维持组合物在口腔可接收的pH范围内的总量存在。
水
在本发明的各种实施方案中,在口腔用组合物中还存在水。优选被除去离子且不含有机杂质。水为除了与其它物质一起引入的水,如与山梨醇一起添加的水以外所添加的游离水。水通常占本发明牙膏组合物的10-50质量%、优选15-35质量%。
表面活性剂
进一步的,本发明的口腔护理组合物优选不含有表面活性剂。本发明的术语“表面活性剂”又称界面活性剂,是一种能降低液体表面张力或两相间界面张力的物质。表面活性剂具有两亲性,含有亲水基团和亲油基团。亲水基团的实例包括但不限于氨基、羧基、磺酸基、羟基等,疏水基团的实例包括但不限于C8及其以上的脂肪族烷烃、烯烃、炔烃及芳香烃等。常用的表面活性剂的实例包括但不限于天然表面活性剂或其衍生物以及合成的表面活性剂。天然表面活性剂或其衍生物的实例有基于蛋白质的表面活性剂。
示意性阴离子表面活性剂,例如高级脂肪酸单甘油酯单硫酸盐的水溶性盐,如氢化椰子油脂肪酸的单硫酸化单甘油酯的钠盐,如N-甲基N-椰油酰基牛磺酸钠、椰油甘油酯硫酸钠;高级烷基硫酸盐,如月桂基硫酸钠;高级烷基醚硫酸盐,例如月桂醇聚醚-2硫酸钠;高级烷基芳基磺酸盐,如十二烷基苯磺酸钠(月桂基苯磺酸钠);高级烷基磺基乙酸盐,如月桂基磺基乙酸钠(十二烷基磺基乙酸钠)、1,2-二羟基丙烷磺酸的高级脂肪酸酯、磺基月桂酸盐和月桂基肌氨酸钠。
本发明所述的阳离子表面活性剂,阳离子表面活性剂可广义地定义为具有一条含有8至18个碳原子的长烷基链的脂族季铵化合物的衍生物,如月桂基三甲基氯化铵、鲸蜡基氯化吡啶、鲸蜡基三甲基溴化铵、二异丁基苯氧基乙基二甲基苄基氯化铵、椰子基烷基三甲基亚硝酸铵、鲸蜡基氟化吡啶及其混合物。
示意性非离子表面活性剂可广义地定义为通过使氧化烯基团与本质上可为脂族或烷基芳族化合物的有机疏水化合物的缩合产生的化合物。适合的非离子表面活性剂的实例包括但不限于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、脂肪族醇的环氧乙烷缩合物、长链叔胺氧化物、长链叔膦氧化物、长链二烷基亚砜以及这类物质的混合物,例如:泊洛沙姆、聚山梨醇酯、聚乙二醇氢化蓖麻油等。
示意性两性表面活性剂包括:甜菜碱(如椰油酰胺丙基甜菜碱);脂肪族仲胺和叔胺的衍生物,其中脂肪族基可为直链或支链的,并且其中脂肪族取代基中的一者含有约8-18个碳原子并且一者含有阴离子水增溶基团(如羧酸根、磺酸根、硫酸根、磷酸根或膦酸根);以及这类材料的混合物。
进一步的,本申请优选不含有防腐剂和抑菌剂。所述防腐剂和抑菌剂选自醇类、甲醛供体和醛类衍生物、苯甲酸及其衍生物以及其他有机化合物。例如苯氧乙醇、苯甲醇。咪唑烷基脲、对羟基苯甲酸酯类、布罗波尔、卡松和季铵盐等。
不受理论约束,本发明通过高含量的保湿剂例如甘油,山梨糖醇和麦芽糖,异麦芽糖醇等水溶性小分子和天然高分子聚合物来控制口腔护理组合物的水活度来抑制微生物生长,本发明的口腔护理组合物的当牙膏水活度小于0.75,优选小于0.65,特别是小于0.6以下。
附图说明
图1:牙膏的发泡能力对比
图2:牙膏的安全性对比
图3:牙膏的安全性对比
具体实施方式
通过阅读下面的实施例可更清楚的理解本发明。这些实施例不是为了限制本发明,而只是本发明方法的优选实施方案。如无特殊说明,下列实施例中组分含量为质量%。
以下列配比制备口腔护理组合物:
实施1#配方:山梨糖醇55(70%),磷酸氢二钙22,甘油5.5,木糖醇5.5,纤维素2.2,淀粉2.2,乳酸菌发酵复合物4.6,HPMC(X1)3.0。
实施2#配方:山梨糖醇52.5(70%),磷酸氢二钙22,甘油8.0,木糖醇5.5,纤维素2.2,淀粉2.2,乳酸菌发酵复合物4.6,HPMC(X2)3.0。
实施3#配方:山梨糖醇50(70%),磷酸氢二钙22,甘油10.5,木糖醇5.5,纤维素2.2,淀粉2.2,乳酸菌发酵复合物4.6,HPMC(X3)3.0。
以下列配比制备口腔护理组合物:
山梨糖醇50(70%),磷酸氢二钙22,甘油10.5,木糖醇5.5,纤维素2.2,淀粉2.2,乳酸菌发酵复合物4.6,HPMC(Xn*)3.0。
注:Xn表示不同型号的HPMC,n为4、5、6……。
表面张力测试方法:
将HPMC制备成0.1质量%的水溶液,通过JYW-200C全自动界面张力仪测定溶液的表面张力。
泡沫测试方法:
牙膏的发泡性采用如下方式测定:挤出一条4cm长牙膏于粗燥的石头表面,粗糙的石头事先润湿,并打湿牙刷,模拟真实的刷牙频率,反复刷1min,观察牙膏表面的起泡性,用0-3的数字评价。作为牙膏使用,发泡性优选为2-3,发泡性为0表示不能发泡。
结果如图1所示,当选用的HPMC在0.1质量%的水溶液的表面张力小于56mN/m时,本发明的牙膏具有与市售的含有表面活性剂的牙膏几乎同等的发泡效果。
稳定性实验
三种牙膏组合物的的水活度Aw
牙膏组合物 | 实施1# | 实施2# | 实施3# |
水活度Aw | 0.67 | 0.65 | 0.61 |
防腐效果挑战实验细菌培养基:卵磷脂吐温80营养琼脂(海博生物):在1000ml锥形瓶中加入24.0g培养基,加热煮沸溶解于500ml蒸馏水中。121℃高压灭菌20分钟,备用。
真菌培养基:马铃薯葡萄糖培养基(PDA),孟加拉红琼脂培养基(北京路桥):在1000ml锥形瓶中加入18.3g培养基,溶于500ml蒸馏水中,加热煮沸至完全溶解,121℃高压灭菌15分钟,备用。
生理盐水:121℃高压灭菌15分钟,备用。
受试菌株:
大肠杆菌(Escherichia Coli),ATCC 8739
绿脓杆菌(Pseudomonas Aeruginosa),ATCC 9027
金黄色葡萄球菌(Staphy Lo Coccus Aureus),ATCC 6538
白色假丝酵母(Candida Albicans),ATCC 10231
黑曲霉(Aspergiblus Niger),ATCC 16404
实验方法:
本实验参考美国药典USP39<51>微生物防腐功效测试方法,即称取各受试样品30g于灭菌的样品瓶中,加入定量的混合菌悬液,样品中的细菌初始加菌浓度为106cfu/g;酵母和霉菌初始加菌浓度为105cfu/g。然后充分混匀,用封口胶封好样品瓶口,置于28℃左右的培养箱中。在接菌的7、14、21和28天取样分析。
评价标准:
细菌总数从初始到第7天的细菌数对数减少值不能小于1.0;细菌总数从初始到第14天的细菌数对数减少值不能小于3.0;并且从14天到28天细菌数不增加。霉菌和酵母菌总数从初始到7天、14天和28天,霉菌和酵母菌总数不增加。
3种实施例牙膏组合的无防腐剂体系的样品进行的微生物挑战试验结果表明:组合物能够通过挑战试验。由此可见,根据本发明中通过控制水活度Aw小于0.7可以达到防腐效果。
安全性实验
鱼类急性毒性测试
测试牙膏样品:
注:M1-M10为市场在售牙膏,-表示不含有表面活性剂
测试方法:
(1)选择体长约5cm的小鱼,在实验条件相似的生活条件下驯养一周,试验前禁食24小时。
(2)纯水稀释牙膏500倍于玻璃鱼缸中,将7条健康小鱼投入其中,观察鱼儿在测试溶液中的生存情况并记录鱼儿的存活时间;自小鱼投入牙膏溶液开始计时,至7条小鱼全部死亡结束。实验结果以分钟(min.)、小时(h.)、天(d.)计。
结果如图2显示,本发明的不含有表面活性剂的牙膏具有更高的安全性。
Claims (11)
1.一种可发泡的口腔护理组合物,其含有羟丙基甲基纤维素,所述羟丙基甲基纤维素在0.1质量%浓度下,其水溶液的表面张力为42-56mN/m,基于组合物总质量,羟丙基甲基纤维素的含量为0.5-10质量%,其不含有表面活性剂,所述表面活性剂包括:阴离子表面活性剂、阳离子表面活性剂、两性表面活性剂或非离子表面活性剂。
2.如权利要求1所述的口腔护理组合物,其含有:
(a)10-50质量%研磨剂;
(b)5-50质量%保湿剂;
(c)0.005-10.0质量%增味剂;
(d)0.01-10质量%功能性添加剂;
(e)0.5-10质量%如权利要求1所述的羟丙基甲基纤维素。
3.如权利要求2所述的口腔护理组合物,其中所述研磨剂选自硅胶、水合二氧化硅或沉淀二氧化硅、氧化铝、难溶性磷酸盐和/或碳酸钙的一种或多种。
4.如权利要求2所述的口腔护理组合物,其中所述保湿剂选自:甘油、山梨醇、木糖醇和/或聚乙二醇的一种或多种。
5.如权利要求2所述的口腔护理组合物,其中所述增味剂选自:香味剂和或甜味剂。
6.如权利要求2所述的口腔护理组合物,其中所述功能性添加剂选自:着色剂、缓蚀剂、防龋剂、防牙菌斑剂、抗牙结石剂、消炎剂、除臭剂和/或脱敏剂。
7.如权利要求1所述的口腔护理组合物,其含有:
(a)10-50质量%研磨剂;
(b)5-50质量%保湿剂;
(c)2--20质量%纤维素;
(d)5-30质量%乳酸菌发酵复配物;
(e)0.5-10质量%羟丙基甲基纤维素;
(f)1-12质量%淀粉。
8.如权利要求1-3任意一项所述的口腔护理组合物,所述口腔护理组合物不含有抑菌剂和防腐剂。
9.如权利要求1-3任意一项所述口腔护理组合物,其中所述口腔护理组合物具有水活度小于0.75。
10.如权利要求9所述口腔护理组合物,其中所述口腔护理组合物具有水活度小于0.65。
11.如权利要求9所述口腔护理组合物,其中所述口腔护理组合物具有水活度小于0.6。
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