CN112168739A - 一种含透明质酸的组合物及其在口腔护理产品中的应用 - Google Patents
一种含透明质酸的组合物及其在口腔护理产品中的应用 Download PDFInfo
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- CN112168739A CN112168739A CN202011025853.2A CN202011025853A CN112168739A CN 112168739 A CN112168739 A CN 112168739A CN 202011025853 A CN202011025853 A CN 202011025853A CN 112168739 A CN112168739 A CN 112168739A
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- hyaluronic acid
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- oral care
- molecular weight
- vitamin
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Abstract
本申请公开了一种含透明质酸的组合物及其在口腔护理产品中的应用,原料为:透明质酸、儿茶素、维生素C、维生素E、β‑胡萝卜素、甘油、酒精、焦磷酸钠和蒸馏水;将其应用到口腔护理产品中,产品配方新颖科学,抗牙菌斑,抗牙龈炎,有效杀灭大肠杆菌、白色念珠菌、金黄色葡萄球菌等口腔细菌,保持口腔清洁,无毒、无刺激,维持口气清新,可长期使用。通过高低分子量的透明质酸科学复配儿茶素、维生素等成分,有利于保持成分的活性和稳定性。可应用到漱口水中,避免因氯己定等化学成分的使用可能带来的破坏口腔细菌生态平衡、易染色、易导致味觉改变、牙龈脱屑、超敏反应、刺激口腔粘膜细胞等问题。
Description
技术领域
本发明涉及口腔护理产品技术领域,尤其涉及一种含透明质酸的漱口水及其制备方法与应用。
背景技术
人口腔中有大量的细菌存在,其中有的是机会致病菌,当人体抵抗力降低,咀嚼及舌的动作减少,唾液分泌不足,自洁作用受影响时,细菌就可乘机在温暖湿润的口腔中迅速繁殖,造成口腔炎症、溃疡、牙龈出血等疾患。
口腔护理从广义上讲是对口腔所具有的饮食、咀嚼、吞咽、美容及促进唾液分泌等一切功能的护理,口腔清洁是狭义上的口腔护理。常见的口腔清洁用品主要包括牙膏、漱口水、口腔清洁剂、口腔喷雾剂、牙线等。
虽然使用牙刷和牙线是清洁口腔、去除菌斑的有效措施,但是该方法较难教育掌握,而且乏味、费时,特别对身心残疾的患者难以完成,缺乏动机的人也难采用。对这部分人来说漱口水可能是一种理想的代替方法。
漱口水可以深入口腔各部位,减少引起口臭的细菌、菌斑,改善牙龈健康。实践证明,漱口水使用起来很方便、容易掌握,实际可行、既适合在家中进行日常的口腔护理,又适合外出工作、出差时使用。特别是追求高品质生活的人群,希望用各种手段使口气清新,漱口水可在短时间内达到该效果。漱口水具有杀菌抑菌效能,在刷牙破坏牙菌斑生物膜特性后,效果更佳。
市面上常见的漱口水中通常包含石炭酸、百里酚、桉树脑、苯扎氯铵、氯己定等化学成分。其中氯己定(或称洗必泰)是应用最广、抗菌斑能力最强的双胍类消毒剂,对多数革兰氏阳性菌和革兰氏阴性菌具杀灭作用。但是使用含氯己定的漱口水时,会把对口腔中有益的细菌一并杀死,导致口腔的细菌失去生态平衡,还会引起牙面及舌黏膜着色和味苦,甚至引起味觉障碍。
发明内容
为了解决现有技术中氯己定等化学成分所带来的破坏口腔细菌生态平衡、长时间使用导致牙齿变色、味觉丧失等问题,本发明提供一种含透明质酸的组合物,其配方科学、工艺简单、成本低,以天然活性成分代替氯己定等化学成分,通过与不同分子量透明质酸协同复配,能有效清洁口腔,抗牙菌斑,抗牙龈炎,并能解决现有漱口水存在的破坏口腔细菌生态平衡、易染色、易导致味觉改变、牙龈脱屑、超敏反应、刺激口腔粘膜细胞等问题。
透明质酸由D-葡萄糖醛酸及N-乙酰葡糖胺的双糖单位组成,本身带有负电荷,存在于大部分动物体的软结缔组织中,显示出润滑关节、调节血管壁的通透性、调节蛋白质、水电解质扩散及运转,促进创伤愈合等多种重要的生理功能,尤其是透明质酸特殊的保水作用,广泛应用于医药、化妆品、食品领域。同时透明质酸分子在空间上呈刚性螺旋柱形,柱的内侧由于存在大量的羟基而产生强吸水性,另一方面由于羟基的连续定向排列,又在透明质酸分子链上形成憎水区,使得透明质酸能形成三维网状结构。而且,透明质酸根据其分子量的不同,也表现出不同的理化性质。
本发明将透明质酸用于口腔护理产品中,旨在利用不同分子量的透明质酸形成的特殊网状结构,对儿茶素、维生素C等活性成分进行包裹,有利于活性成分的活性保持和添加产品的稳定性,从而稳定高效发挥产品抑菌、抗牙菌斑、牙龈炎等功效,同时,透明质酸的加入显著改善了漱口水等口腔护理产品中酒精添加带来的灼热感、口干和麻木感,适用范围广,可长期使用。
本发明采用以下技术方案:
一种含透明质酸的组合物,所述含透明质酸的组合物的原料按质量份数配比含有以下成分:透明质酸0.025-0.035份,儿茶素0.01-0.2份,维生素C0.1-2份,维生素E0.1-2份,β-胡萝卜素0.1-1份,壳聚糖0.05-0.3份,焦磷酸钠0.01-0.03份,甘油0.1-2份,酒精0.5-2.5份,蒸馏水5-20份。
进一步的,所述透明质酸包括高分子量透明质酸和水解透明质酸,高分子量透明质酸与水解透明质酸的质量比为(1-5):1,优选为4:1;所述高分子量透明质酸的分子量为2100kDa-3400kDa,所述水解透明质酸的分子量为6kDa-10kDa。
一种含透明质酸的组合物的制备方法,包括以下步骤:
第一步:将儿茶素、维生素C、维生素E、β-胡萝卜素、甘油、酒精搅拌混
合均匀,制得溶液A;
第二步:将透明质酸、焦磷酸钠、壳聚糖溶于蒸馏水中搅拌混合均匀,制得溶液B;
第三步:将溶液A在搅拌下逐滴加入溶液B中,得到含透明质酸的组合物。
本申请还保护一种含透明质酸的组合物在口腔护理产品中的应用,所述口腔护理产品包括漱口水、牙膏、口腔喷剂,优选为漱口水。
进一步的,所述口腔护理产品中,以100重量份计,包括透明质酸0.025-0.035份,儿茶素0.01-0.2份,维生素C0.1-2份,维生素E0.1-2份,β-胡萝卜素0.1-1份,壳聚糖0.05-0.3份,焦磷酸钠0.01-0.03份,甘油0.1-2份,酒精0.5-2.5份,调味剂0.2-0.4份,表面活性剂0.5-1份,稳定剂0.01-0.03份,防腐剂0.3-0.5份,添加剂0.8-4.8份。
进一步的,所述透明质酸包括高分子量透明质酸和水解透明质酸,高分子量透明质酸与水解透明质酸的质量比为(1-5):1,优选为4:1;所述高分子量透明质酸的分子量为2100kDa-3400kDa,所述水解透明质酸的分子量为6kDa-10kDa。
进一步的,所述添加剂采用纤维素胶、聚乙烯醇、聚卡波非、2,4-二氯苄醇、柠檬酸钠中的一种或几种组合物。
进一步的,所述表面活性剂选自PEG40氢化蓖麻油、泊洛沙姆中的一种或两种,其中PEG40氢化蓖麻油:泊洛沙姆的质量比为1:0.5-1。
进一步的,所述稳定剂为乙二胺四乙酸二钠,所述防腐剂为山梨酸钾,所述调味剂为柠檬味调味剂和/或薄荷味调味剂。
本申请还保护一种所述口腔护理产品的制备方法,包括以下步骤:
第一步:将儿茶素、维生素C、维生素E、β-胡萝卜素、甘油、酒精搅拌混合均匀,制得溶液A;
第二步:将透明质酸、焦磷酸钠、壳聚糖溶于蒸馏水中搅拌混合均匀,制得溶液B;
第三步:将溶液A在搅拌下加入溶液B中,得到含透明质酸的组合物;
第四步:将调味剂、表面活性剂、稳定剂、防腐剂、添加剂溶于蒸馏水中搅拌混合均匀,加入第三步的含透明质酸的组合物,继续搅拌混合均匀得口腔护理产品。
有益效果
本发明所述一种含透明质酸的组合物及其在口腔护理产品中的应用,采用以上技术方案与现有技术相比,具有以下技术效果:
1、不同分子量的透明质酸形成的特殊网状结构,可以对儿茶素、维生素C等活性成分进行包裹,有利于活性成分的活性保持和添加产品的稳定性;
2、本发明的组合物,以儿茶素、低分子透明质酸、壳聚糖通过科学配比代替化学抑菌成分,具有较好的抑菌效果,可以有效杀灭大肠杆菌、白色念珠菌、金黄色葡萄球菌等口腔细菌,提高口腔细菌清除率,并能延长杀菌的持续时间,持久保持口腔清洁,维持口气清新;
3、本发明的组合物可以减少口腔中通过氧化反应而产生的氧自由基,缓解对口腔粘膜细胞的刺激,对抗牙龈组织降解和牙周病,防治牙龈炎和牙菌斑,经检测发现能显著降低菌斑指数PLI和出血指数BOP,菌斑指数PLI均在0.4以下,出血指数BOP显著降低至<10%,有效防止了漱口水使用过程中可能出现的牙齿变色问题;
4、该组合物不含氯己定等化学成分,且通过多种分子量透明质酸的复配,显著改善了漱口水等口腔护理产品中酒精添加带来的灼热感、口干和麻木感,适用范围广,适用于不同年龄段,可长期使用。
具体实施方式
以下结合实例对本发明作进一步的描述,实施例仅用于对本发明进行说明,并不构成对权利要求范围的限制,本领域技术人员可以想到的其他替代手段,均在本发明权利要求范围内。
实施例1:
按质量份数配比将0.2份儿茶素,0.1份维生素C,2份维生素E,0.1份β-胡萝卜素,1份甘油,加入2份酒精中搅拌混合均匀,制得溶液A。
将0.02份高分子量透明质酸(2100kDa)、0.005份水解透明质酸(10kDa)、0.3份壳聚糖、0.02份焦磷酸钠溶于10份蒸馏水中,搅拌混合均匀,制得溶液B。
将溶液A在搅拌下加入溶液B中,得到含透明质酸的组合物。
实施例2-5、对比例1-7与实施例1的不同之处是透明质酸分子量及透明质酸、儿茶素、维生素C、维生素E、β-胡萝卜素的含量不同。具体如下表1。
表1
验证例1抑菌效果验证
取保存的金黄色葡萄球菌、大肠杆菌、白色念珠菌菌种,无菌条件下培养18~24h,得到指数生长期菌样本,配置106CFU/mL的菌悬液备用。
取15个灭菌培养皿,在超净工作台上,每个培养皿倒入20mL培养基,凝固后,分别用接种环沾取上述菌悬液各200μL在平板表面均匀涂布,每种菌液涂布5个培养皿。
将滤纸片剪成直径为10mm的圆片,在超净工作台上将灭菌滤纸片用无菌镊子分别放入到装有上述实施例1-实施例5和对比例1-对比例7制备的组合物的灭菌培养皿中浸泡,用无菌镊子夹取含药纸片,将多余药液在内培养皿边上擦掉,贴在含菌平板培养基表面,轻轻按压,使滤片与培养基密切接触,每个培养皿均匀放置5张滤片,滤纸片距离培养皿边缘20mm,每个滤纸片相隔不小于20mm,平行2份,设置无菌生理盐水滤片为对照组。放入37℃恒温培养箱中培养24h,取掉滤纸片,观察是否有抑菌圈,以十字交叉法测定其抑菌直径。结果如表2所示。
表2
本发明实施例制备的组合物可以很好地抑制金黄色葡萄球菌、大肠杆菌、白色念珠菌等口腔常见菌,尤其是实施例3的抑菌效果最好。对比例1-4部分或全部成分不在本发明范围内,抑菌效果要差于本实施例,对比例5、6分别不含低分子透明质酸或高分子透明质酸,其抑菌效果也比实施例差,但是低分子透明质酸对抑菌效果的影响要大于高分子透明质酸,对比例7不含儿茶素,抑菌效果最差。
验证例2
1、含透明质酸漱口水的制备
表3漱口水成分用量表
制备方法:
将表3中除组合物外的其他成分加入蒸馏水中,搅拌混合均匀,加入表1制得的透明质酸组合物,补水至100重量份,继续搅拌混合均匀制得含透明质酸的漱口水,实施例1-5和对比例1-7分别对应应用例1-12。
2、细菌清除率/牙菌斑指数/出血指数评定
所述含透明质酸的漱口水在口腔护理中的应用,通过巴格达大学牙科学院伦理委员会批准,遵循《赫尔辛基和东京宣言》关于人类指南第652/2016号,选择130名患有生物膜诱发性牙龈炎,不吸烟,无吸毒史,有24颗以上天然牙齿,不包括第三磨牙,无牙龈上结石,无牙龈下结石,无正畸治疗,过去4个月未使用过抗生素,不在妊娠期和哺乳期,不对漱口水过敏志愿者,男65人,女65人,年龄段18-23周岁,将130名志愿者随机分成13组,随机使用应用例1-12的漱口水和市售漱口水李施德林。
刷牙后30min后,首先用10mL无菌清水漱口,清除食物残渣,取10ml无菌生理盐水含漱1min,吐入第一管,间隔1min,分别用应用例1-12的漱口水以及市售漱口水含漱1min,吐入第二管,间隔60min,取10ml无菌生理盐水含漱1min,吐入第三管,三管样品静置10min,分别取其适当稀释液,用涂布法接种于肉汤培养基平板,在37℃培养箱中培养48h,计数菌落,计算清除率,结果见表4。清除率1%=(第一管菌落数-第二管菌落数)/第一管菌落数*100%;清除率2%=(第一管菌落数-第三管菌落数)/第一管菌落数*100%;Δ清除率=清除率1%-清除率2%,清除率越高,说明漱口水的杀菌作用越强,Δ清除率越低,说明漱口水的持续杀菌作用越强。
间隔12h,分别用应用例1-12的漱口水以及市售漱口水含漱1min,漱口后30min不喝水不进食,以后每天都在刷牙后30min用应用例1-12的漱口水以及市售漱口水含漱1min,每次间隔12h,分别于第0d、14天、28d测量菌斑指数PLI(表6)和出血指数BOP(表7)。
其中菌斑检测方法:在检测中采用一次性平面口镜,并在电筒辅助照射下进行。先将RED-COTER菌斑显示液按一定比例配制成漱口水,受试者将其在口腔中含漱30s后吐出,然后检查者根据改良Quigley-Hein菌斑指数记录法对各组菌斑进行评价计分,计算每一个受试者的指数均值。菌斑评价标准如下表5。
出血指数BOP采用的是探袋底出血法:用牙周探针沿根面平行探入袋底,探诊后10s-30s记录出血情况,只记录探诊后出血的有或无,最后计算探诊后出血的牙位点与受检牙面之比,即BOP阳性位点占受检位点的百分比。
自行设计口感度调查问卷,内容包括漱口水刺激性程度和口感可接受程度,分为“很刺激不能接受”、“较刺激尚可接受”、“无刺激可接受”3个等级,每位受试者在最后一次复诊时上交调查问卷。结果如表8。
表4细菌清除率
如上表,细菌清除率试验中,清除率1和验证例1的抑菌试验结果一致,市售产品也具有较好的杀菌作用,然而在清除率2的持续杀菌作用考察中,复配透明质酸表现出了对持续抑菌作用较好的增强效果,市售产品持续抑菌率下降明显。
表5菌斑评价标准
得分 | |
无菌斑 | 0 |
龈缘区有薄层菌斑 | 1 |
龈缘区有明显的菌斑,菌斑带小于1mm | 2 |
龈缘区菌斑带大于等于1mm,但不超过牙面的1/3 | 3 |
菌斑达牙面1/3-2/3 | 4 |
菌斑达牙面2/3 | 5 |
表6菌斑指数
从上表可以看出,在使用应用例1-5即本发明实施例制备的漱口水28天后,菌斑指数均在0.4以下,说明本发明范围内的组合物具有很好的抗牙菌斑作用。
表7BOP指数
第0d | 第14d | 第28d | |
应用例1 | 32% | 23% | 9% |
应用例2 | 30% | 23% | 8% |
应用例3 | 31% | 20% | 6% |
应用例4 | 30% | 23% | 7% |
应用例5 | 31% | 23% | 7% |
应用例6 | 30% | 25% | 18% |
应用例7 | 30% | 25% | 16% |
应用例8 | 32% | 26% | 17% |
应用例9 | 30% | 26% | 20% |
应用例10 | 30% | 28% | 25% |
应用例11 | 31% | 27% | 22% |
应用例12 | 31% | 29% | 27% |
市售产品 | 31% | 24% | 12% |
使用应用例1-5即本发明实施例制备的漱口水28天后,出血指数BOP均显著降低至<10%,说明本发明范围内的组合物可以很好的抵抗和治疗牙龈炎。
表8漱口水口感接受度结果,n(%)
本发明范围内制备的组合物用于漱口水中可以很好地缓解酒精等带来的口腔刺激,均对口腔没有刺激性;应用例6-11即对比例1-6制备的漱口水组合物由于复配透明质酸的分子量、含量或比例选择不当,对刺激的缓解能力显著低于实施例,市售产品的口腔刺激最强,这说明复配透明质酸可以很好地缓解酒精等对口腔粘膜的刺激。
验证例3牙齿变色倾向评定
用合并的腮腺唾液在35℃条件下将10mg羟基磷灰石(HAP)粉末培养1h使粉末上产生表膜,得到HAP-表膜模型模拟表膜覆盖的牙齿,离心移除唾液,将HAP-表膜模型分别置于水(阴性对照组)以及应用例1-12的漱口水中搅拌处理1min,离心移除处理液,用唾液洗涤,再实施6个处理循环。7个处理循环后,用盐酸-水溶液将其溶解,读取350-550nm的吸光度,350-550nm之间吸收的AUC(曲线下面积)为染色量度。将空白对照组的数值设为1,采用归一化法得到下表9数据。
表9
本发明应用例1-5即实施例制备的漱口水组合物处理过的HAP-表膜模型染色量度较空白对照几乎没有差异,说明本发明的组合物不会引起牙齿变色或可以很好的对抗漱口水中其他成分引起的牙齿变色。
Claims (10)
1.一种含透明质酸的组合物,其特征在于含有以下成分:透明质酸0.025-0.035份,儿茶素0.01-0.2份,维生素C0.1-2份,维生素E0.1-2份,β-胡萝卜素0.1-1份,壳聚糖0.05-0.3份,焦磷酸钠0.01-0.03份,甘油0.1-2份,酒精0.5-2.5份,蒸馏水5-20份。
2.根据权利要求1所述含透明质酸的组合物,其特征在于:所述透明质酸包括高分子量透明质酸和水解透明质酸,高分子量透明质酸与水解透明质酸的质量比为(1-5):1,优选为4:1;所述高分子量透明质酸的分子量为2100kDa-3400kDa,所述水解透明质酸的分子量为6kDa-10kDa。
3.一种权利要求1所述含透明质酸的组合物的制备方法,其特征在于,包括以下步骤:
第一步:将儿茶素、维生素C、维生素E、β-胡萝卜素、甘油、酒精搅拌混合均匀,制得溶液A;
第二步:将透明质酸、焦磷酸钠、壳聚糖溶于蒸馏水中搅拌混合均匀,制得溶液B;
第三步:将溶液A在搅拌下加入溶液B中,得到含透明质酸的组合物。
4.一种含透明质酸的组合物在口腔护理产品中的应用,其特征在于:所述口腔护理产品包括漱口水、牙膏、口腔喷剂、口香糖,优选为漱口水。
5.根据权利要求4所述的一种含透明质酸的组合物在口腔护理产品中的应用,其特征在于:以100重量份计,包括透明质酸0.025-0.035份,儿茶素0.01-0.2份,维生素C0.1-2份,维生素E0.1-2份,β-胡萝卜素0.1-1份,壳聚糖0.05-0.3份,焦磷酸钠0.01-0.03份,甘油0.1-2份,酒精0.5-2.5份,调味剂0.2-0.4份,表面活性剂0.5-1份,稳定剂0.01-0.03份,防腐剂0.3-0.5份,添加剂0.8-4.8份。
6.根据权利要求5所述的一种含透明质酸的组合物在口腔护理产品中的应用,其特征在于:所述透明质酸包括高分子量透明质酸和水解透明质酸,高分子量透明质酸与水解透明质酸的质量比为(1-5):1,优选为4:1;所述高分子量透明质酸的分子量为2100kDa-3400kDa,所述水解透明质酸的分子量为6kDa-10kDa。
7.根据权利要求5所述的含透明质酸的组合物在口腔护理产品中的应用,其特征在于:所述添加剂采用纤维素胶、聚乙烯醇、聚卡波非、2,4-二氯苄醇、柠檬酸钠中的一种或几种组合物。
8.根据权利要求5所述的一种含透明质酸的组合物在口腔护理产品中的应用,其特征在于:所述表面活性剂选自PEG40氢化蓖麻油、泊洛沙姆中的一种或两种,其中PEG40氢化蓖麻油:泊洛沙姆的质量比为1:0.5-1。
9.根据权利要求5所述的一种含透明质酸的组合物在口腔护理产品中的应用,其特征在于:所述稳定剂为乙二胺四乙酸二钠,所述防腐剂为山梨酸钾,所述调味剂为柠檬味调味剂和/或薄荷味调味剂。
10.一种权利要求4所述的含透明质酸的口腔护理产品的制备方法,其特征在于,包括以下步骤:
第一步:将儿茶素、维生素C、维生素E、β-胡萝卜素、甘油、酒精搅拌混合均匀,制得溶液A;
第二步:将透明质酸、焦磷酸钠、壳聚糖溶于蒸馏水中搅拌混合均匀,制得溶液B;
第三步:将溶液A在搅拌下加入溶液B中,得到含透明质酸的组合物;
第四步:将调味剂、表面活性剂、稳定剂、防腐剂、添加剂溶于蒸馏水中搅拌混合均匀,加入第三步的含透明质酸的组合物,继续搅拌混合均匀得口腔护理产品。
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