CN117064794A - 一种口腔护理用组合物及其应用 - Google Patents
一种口腔护理用组合物及其应用 Download PDFInfo
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- CN117064794A CN117064794A CN202311271141.2A CN202311271141A CN117064794A CN 117064794 A CN117064794 A CN 117064794A CN 202311271141 A CN202311271141 A CN 202311271141A CN 117064794 A CN117064794 A CN 117064794A
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- hyaluronate
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Abstract
本申请涉及一种口腔护理用组合物及其应用,属于口腔护理技术领域。本申请中的口腔护理用组合物,包括a)透明质酸盐;b)凝胶质,选自羟丁基壳聚糖、胶原蛋白、卡拉胶、卡波姆或它们的混合物;c)生理学上可接受的辅料或其他活性成分。本发明提供的口腔护理用组合物在缩短成膜时间提高成膜性能的同时,还能够进一步提高对口腔黏膜的修复能力,其中成分不仅可以形成保护膜,进行抗炎修复,还能抑菌以避免病毒、细菌影响黏膜创伤处,为黏膜的修复提供良好环境,从而进一步促进患者口腔粘膜的修复。
Description
技术领域
本申请涉及一种口腔护理用组合物及其应用,属于口腔护理技术领域。
背景技术
卡波姆(carbomer),是以季戊四醇等与丙烯酸交联得到的丙烯酸交联树脂,是一类比较重要的流变调节剂,中和后的卡波姆是非常优秀的凝胶基质,有增稠、悬浮等重要用途,工艺简单,稳定性好,被广泛应用于乳液、膏霜、凝胶之中。
透明质酸(简称HA,全称Hyaluronic acid)是一种天然存在的非硫酸化糖胺聚糖,是由葡糖醛酸和氨基葡糖的双糖重复单位所组成的多糖。它是构成细胞外基质和细胞间质的主要成分之一,在眼玻璃体、脐带、软骨、关节滑液、皮肤等身体的器官和组织的细胞外基质中广泛存在。
含漱液是一种黏膜粘附性的液体制剂,其在口腔黏膜表面形成一层保护膜的同时,通过黏膜给药而发挥局部治疗作用,从而缓解因口腔溃疡、口腔炎症、磕碰造成的微小创口所带来的疼痛。卡波姆是含漱液中常用的成膜剂,它具有良好的生物粘附性,可与黏膜蛋白相互作用,形成物理性缠结,之后与糖蛋白寡糖链上的糖形成氢键,形成较强的粘液胶状结构,从而牢固的粘附于黏膜上,形成一层屏障,同时也是功效物的良好载体。
现有技术中CN105997862A公开了一种口腔溃疡含漱液及其制备方法,所述口腔溃疡含漱液包括如下组分混合而成:麦芽糖糊精、羧甲基纤维素钠、卡波姆、柠檬酸三钠、糖精钠、氯化钠、氢氧化钾和纯化水。该含漱液为一种水凝胶类液体,可以在口腔溃疡表面形成保护膜,从而隔绝创口。然而该凝胶的成膜时间较长,不能快速的起到隔绝的作用,同时其不含有消炎、抑菌等成分,治疗或护理效果也有待提高。
发明内容
为了解决上述问题,提供了一种口腔护理用组合物及其应用,本发明提供的口腔护理用组合物在缩短成膜时间提高成膜性能的同时,还能够进一步提高对口腔黏膜的修复能力,其中成分不仅可以快速形成保护膜持续进行抗炎修复,还能抑菌以避免病毒、细菌影响黏膜创伤处,为黏膜的修复提供良好环境,从而进一步促进患者口腔粘膜的修复。
根据本申请的一个方面,提供了一种口腔护理用组合物,所述组合物包括
a)透明质酸盐;
b)凝胶质,选自羟丁基壳聚糖、胶原蛋白、卡拉胶、卡波姆或它们的混合物;
可选的,所述凝胶质与透明质酸盐的质量比为1:2~7,优选的,为1:3~5。
可选的,所述凝胶质与透明质酸盐的质量比可以为1:2、1:3、1:4、1:5、1:6、1:7以及之间任一比值,优选的,可以为1:3、1:4、1:5以及之间任一比值。
可选的,所述透明质酸盐为透明质酸锌,和/或,
所述凝胶质为卡波姆。
可选的,所述透明质酸锌的分子量为10~1000kDa,优选的,为30kDa-200kDa。
可选的,所述透明质酸锌的分子量为10kDa、20kDa、30kDa、40kDa、50kDa、60kDa、70kDa、80kDa、90kDa、100kDa、150kDa、200kDa、250kDa、300kDa、350kDa、400kDa、450kDa、500kDa、550kDa、600kDa、650kDa、700kDa、750kDa、800kDa、850kDa、900kDa、950kDa、1000kDa以及之间任一分子量。
可选的,所述透明质酸盐和凝胶质的质量之和占所述组合物总质量的0.2~0.8wt%;
可选的,所述透明质酸盐和凝胶质的质量之和占所述组合物总质量的0.2wt%、0.3wt%、0.4wt%、0.5wt%、0.6wt%、0.7wt%、0.8wt%以及之间任一比值。
可选的,所述组合物还包括生理学上可接受的辅料或其他活性成分;
可选的,所述辅料可以是适当的溶剂、抛射剂、增溶剂、助溶剂、乳化剂、着色剂、黏合剂、崩解剂、填充剂、润滑剂、润湿剂、渗透压调节剂、稳定剂、助流剂、矫味剂、防腐剂、助悬剂、包衣材料、芳香剂、抗黏合剂、整合剂、渗透促进剂、pH值调节剂、缓冲剂、增塑剂、表面活性剂、发泡剂、消泡剂、增稠剂、包合剂、保湿剂、吸收剂、稀释剂、絮凝剂与反絮凝剂、助滤剂、释放阻滞剂等。
需要指出的是,本申请的组合物可以通过通用方法来制备,其中可加入一种或多种稀释剂或载体,例如,呈口服形式,例如丸剂、片剂、胶囊剂、颗粒剂、散剂、锭剂、糖浆剂、乳剂、混悬剂等。
可选的,所述组合物还包括甘油、氢氧化物、无机酸、甜味剂、含苯基的脂肪醇、聚山梨酯或它们的混合物;
优选的,所述组合物包括甘油、氢氧化钾、磷酸、糖精钠、柠檬酸钠、苯甲醇、吐温60或它们的混合物。
根据本申请的又一个方面,提供了任一上述的口腔护理用组合物在制备化妆品、药品中的用途。
根据本申请的再一个方面,提供了任一上述的口腔护理用组合物在制备具有高效成膜修复作用的口腔护理产品中的用途。
可选的,所述口腔护理产品包括牙膏、牙贴、口腔凝胶、口腔含漱液或漱口水。
根据本申请的还一个方面,提供了一种口腔含漱液,包括任一上述的口腔护理用组合物。
根据本申请的最后一个方面,提供了一种漱口水,包括任一上述的口腔护理用组合物。
本申请的有益效果包括但不限于:
1.本申请提供的的口腔护理用组合物,具有良好的生物粘附性,可以快速在口腔黏膜上形成一层保护屏障同时持久发挥抗炎抑菌修复作用,以此阻挡病原性微生物入侵,从而维持口腔健康。
2.本申请提供的口腔护理用组合物,具有优异的护龈功效,和口腔黏膜屏障修复的效果,还具有抑制口腔细菌的作用,可以调节口腔微生态,对口腔起到优异的护理功效。
具体实施方式
下面结合实施例详述本申请,但本申请并不局限于这些实施例。
本申请对试验中所用到的材料以及试验方法进行一般性和/或具体的描述,在下面的实施例中,如果无其他特别的说明,%表示wt%,即重量百分数。所用试剂或仪器未注明生产厂商者,均为可以通过市购获得的常规试剂产品。其中下面试验中使用到的卡波姆(型号:卡波姆980)购自路博润公司;透明质酸锌(简写为HA-Zn,分子量179kDa,37kDa,745kDa),购自华熙生物,下面使用到的EGF为表皮细胞生长因子(Epidermal GrowthFactor),LPS为脂多糖(Lipopolysaccharide)。
针对背景技术部分提出的问题,为此本发明方案中给出了一种口腔护理用组合物成分,其中包括卡波姆和透明质酸锌,发明人通过实验和研究后发现,当卡波姆与透明质酸锌以特定的比例进行组合配伍使用时,相比于单用卡波姆或是单用透明质酸,或是以其他比例混合搭配卡波姆与透明质酸锌时,能够大幅降低口腔含漱液的成膜时间,成膜性能得到明显改善,从而可以提高该口腔护理用组合物发挥作用的功效。
发明人通过实验研究发现,透明质酸锌(HA-Zn)作为透明质酸的锌盐,除了兼有透明质酸钠的优良性能外还具有抗炎、修复、抑菌的作用,还具有较高的粘弹性,在组织表面成膜后能够减少病毒和细菌渗入组织,为口腔粘膜的修复提供良好的环境。而通过实验研究发现,卡波姆对于口腔黏膜的修复能力具有抑制作用。
然而发明人发现卡波姆与透明质酸锌以上述比例配合使用时,却能够起到非常好的协同增效作用,口腔黏膜的修复能力得到大幅度提升,本发明提供的口腔护理用组合物在缩短成膜时间提高成膜性能的同时,还能够进一步提高对口腔黏膜的修复能力,两者配合使用不仅可以形成保护膜,进行抗炎修复,还能抑菌以避免病毒、细菌影响黏膜创伤处,为黏膜的修复提供良好环境,进一步促进患者口腔粘膜的修复。
下面通过具体实施例对本申请方案以及其效果进行具体说明。
实施例1
本实施例中的口腔含漱液配方如表1所示:
表1口腔含漱液配方
本实施例中的口腔含漱液的制备方法包括以下步骤:
(1)在烧杯中称取0.083%的卡波姆980加入到去离子水中,快速分散均匀,加入甘油,边加边搅拌,随后加入0.167%的透明质酸锌,得澄清凝胶A;
(2)取处方量的磷酸0.5%,加入处方量的柠檬酸钠、糖精钠和氢氧化钾溶液10%,搅拌至完全溶解,得澄清溶液B;
(3)将溶液B加入凝胶A中,得澄清凝胶;
(4)取处方量的苯甲醇、吐温60,加热混合均匀,得油相C;
(5)将油相C加入到澄清凝胶中,边加边搅拌,得澄清凝胶;
(6)调节凝胶的pH值至7-8,继续搅拌30min至混合均匀,得口腔含漱液S1。
实施例2
本实施例中口腔含漱液的制备方法同实施例1,区别仅在于含漱液配方的口腔护理用组合物中,卡波姆的用量为0.0625%,透明质酸锌的用量为0.1875%,得口腔含漱液S2。
实施例3
本实施例中口腔含漱液的制备方法同实施例1,区别仅在于含漱液配方的口腔护理用组合物中,卡波姆的用量为0.05%,透明质酸锌的用量为0.2%,得口腔含漱液S3。
实施例4
本实施例中口腔含漱液的制备方法同实施例1,区别仅在于含漱液配方的口腔护理用组合物中,卡波姆的用量为0.0417%,透明质酸锌的用量为0.2083%,得口腔含漱液S4。
实施例5
本实施例中口腔含漱液的制备方法同实施例1,区别仅在于含漱液配方的口腔护理用组合物中,卡波姆的用量为0.031%,透明质酸锌的用量为0.219%,得口腔含漱液S5。
实施例6
本实施例中口腔含漱液的制备方法同实施例1,区别仅在于含漱液配方的口腔护理用组合物中,卡波姆的用量为0.0417%,透明质酸锌的用量为0.2083%,且分子量为37kDa,得口腔含漱液S6。
实施例7
本实施例中口腔含漱液的制备方法同实施例1,区别仅在于含漱液配方的口腔护理用组合物中,卡波姆的用量为0.0417%,透明质酸锌的用量为0.2083%,且分子量为745kDa,得口腔含漱液S7。
对比例1
本对比例中口腔含漱液的制备方法同实施例1,区别仅在于含漱液配方的口腔护理用组合物中,不加入透明质酸锌,且卡波姆的用量为0.25%,得口腔含漱液D1。
对比例2
本对比例中口腔含漱液的制备方法同实施例1,区别仅在于含漱液配方的口腔护理用组合物中,不加入卡波姆,且透明质酸锌的用量为0.25%,得口腔含漱液D2。
对比例3
本实施例中口腔含漱液的制备方法同实施例1,区别仅在于含漱液配方的口腔护理用组合物中,卡波姆的用量为0.125%,透明质酸锌的用量为0.125%,得口腔含漱液D3。
对比例4
本对比例中口腔含漱液的制备方法同对比例2,区别仅在于含漱液配方的口腔护理用组合物中,透明质酸锌的分子量为37kDa,得口腔含漱液D4。
对比例5
本对比例中口腔含漱液的制备方法同对比例2,区别仅在于含漱液配方的口腔护理用组合物中,透明质酸锌的分子量为749kDa,得口腔含漱液D5。
实验例1成膜性能评估
为了验证口腔含漱液产品的成膜性,将实施例和对比例的含漱液,分别用棉签涂抹在表面皿上,涂抹后立即放入37℃烘箱中,每隔30s取出,将表面皿90°垂直放置,观察是否完全成膜,并记录成膜时间,重复此操作8次,结果取平均值。成膜时间结果见表2,表2中S1~S7分别对应实施例1~7,D1~D5分别对应对比例1~5,空白组为无卡波姆和HA-Zn添加。
表2成膜性结果
表2注:与0.25%卡波姆980相比,显著性以*表示,P-value<0.05表示为*,P-value<0.01表示为**;与0.25% HA-Zn组相比,显著性以#表示,P-value<0.01表示为##。
根据表2中的实验结果可有如下实验结论:对于成膜时间,其中含0.083%卡波姆与0.167%HA-Zn组合物(S1)的含漱液成膜时间为184秒,含0.0625%卡波姆与0.1875%HA-Zn组合物(S2)的含漱液成膜时间为173秒,含0.05%卡波姆与0.2%HA-Zn组合物(S3)的含漱液成膜时间为176秒,含0.0417%卡波姆与0.2083%HA-Zn组合物(S4)的含漱液成膜时间为176秒,含0.031%卡波姆与0.219%HA-Zn组合物(S5)的含漱液成膜时间为191秒,仅含0.25%卡波姆(D1)和仅含0.25%HA-Zn(D2)的含漱液成膜时间分别为210秒和233秒。由上述几组对比结果可知,含卡波姆、HA-Zn组合物的含漱液成膜更迅速,成膜能力比单一物质更强,并且有显著差异。其中,组合物中卡波姆、HA-Zn的质量比为1:3~5时,成膜时间最短为158~176秒。此外,不同分子量的透明质酸锌与卡波姆组合后,组合物的成膜能力均好于单一物质。
实验例2修复能力评估
本实验以3D口腔模型EpiOriis为研究模型,靶向口腔黏膜屏障修复,待测物处理后,通过检测屏障指数进行漱口水在体外口腔黏膜的修复功效评估。
表3口腔修复测试条件
具体包括以下步骤:
1)根据上表3中的测试分组,将模型转移到6孔板中(提前加入小模具),在6孔板上标注测试组编号;
2)刺激:除空白对照组外,其他各组连续四天(Day1-Day4)均加入3.7mL含10μg/mLLPS刺激物的模型培养液,空白对照组加入3.7mL正常模型培养液;
3)给药:模型接收当天为Day1,在Day1、Day3按照测试分组进行给药,给药方式为表面给药,空白对照组不给药,每天仅更换培养液;
4)ET50测试:在Day5进行ET50测试,0.3% TritonX-100的孵育时间点设置为0min、15min。采用移液器吸取80μL0.3%TritonX-100进行给药(0min即不进行TritonX-100刺激),每个时间点设置3个重复。每个时间点最后一个模型给药结束后,将所有的6孔板转移到CO2培养箱中(37℃、5%CO2)按暴露时间设置进行孵育。孵育结束前预备24孔板,并在每孔中加入300μL 1mg/mL的MTT工作液;
5)清洗:孵育结束后,用PBS的洗瓶清洗模型,保持PBS稳速不间断的流出,充满培养小室后倒掉,重复此操作10次。清洗结束后,用无菌棉签轻轻吸去水分;
6)MTT孵育:将清洗后的模型,放入含有1mg/mL MTT工作液的24孔板中,随后将24孔板转移到CO2培养箱中(37℃、5%CO2)孵育3h;
7)异丙醇浸提:MTT孵育结束后,取出模型,用吸水纸擦拭底面残留的MTT液体后,转移到新的24孔板中,加入2mL异丙醇,用封口膜密封24孔板,4℃静置过夜;
8)检测:浸提结束后,用200μL移液器枪头刺穿模型,使异丙醇浸提液从模型中流出到24孔板中,丢弃被刺穿的模型,将每孔内的异丙醇浸提液吹打3次,充分混匀,混匀后,从每孔中吸取2份200μL异丙醇浸提液,分别加入96孔板的对应孔中,做好标记。酶标仪570nm波长读取吸光度值;
9)结果统计分析:应用GraphPad Prism作图,结果表示为Mean±SD,各组间比较采用t-test统计分析,统计分析均为双尾,P<0.05认为具有显著差异,P<0.01认为具有极显著差异。
实验结果如下表4所示:
表4修复能力评估结果
表4注:用BC组0min组织活力计为100%归一。用t-test方法进行统计分析时,与BC组相比,显著性以#表示,P-value<0.05表示为#,P-value<0.01表示为##;与NC组相比,显著性以*表示,P-value<0.05表示为*,P-value<0.01表示为**。
表4结果显示:0.1%卡波姆的细胞活性为90.52%,0.5%HA-Zn和0.1%卡波姆+0.5%HA-Zn的细胞活性为94.49%和98.72%,若以阴性对照为基准,0.1%卡波姆的修复提升为-0.5%。0.5%HA-Zn和0.1%卡波姆+0.5%HA-Zn相对于阴性对照,细胞活性都有不同程度的修复,0.5%HA-Zn的修复提升为3.8%,0.1%卡波姆+0.5%HA-Zn修复提升为8.5%。
根据表4结果可有以下实验结论:与阴性对照组相比,含卡波姆和透明质酸锌组合物的含漱液在LPS刺激4天后(0min)以及TritonX-100刺激15min后的组织活力显著提升,而卡波姆含漱液和透明质酸锌含漱液在LPS刺激4天后(0min)以及TritonX-100刺激15min后的组织活力均无显著变化。在LPS刺激4天后(0min),阴性对照的细胞活性为90.99%,0.1%卡波姆的细胞活性为90.52%,低于阴性对照,说明0.1%的卡波姆没有修复作用,甚至会使得组织进一步受损,0.5%HA-Zn的细胞活性为94.49%,两者的组合物细胞活性为98.72%,均高于阴性对照,说明其具有一定的修复作用,且组合物的细胞活性要高于单一0.5%HA-Zn,与阴性对照组比具有显著性差异,说明组合物与单一成分相比在组织修复作用上具有增效协同性。
进一步,再根据回归方程计算组织活力为50%的时间,即为屏障指数(ET50),ET50越高代表组织活力下降至50%的时间越长。对于表4结果中屏障指数的大小,有如下规律:含漱液(卡波姆+透明质酸锌)>含淑液(透明质酸锌)>含漱液(阴性对照)>含淑液(卡波姆),由此进一步印证了如下结论:含卡波姆与HA-Zn的组合物可以增加含漱液对口腔黏膜的屏障修复能力,而单用卡波姆具有抑制作用,单用透明质酸锌虽然具有一定的促进作用,但卡波姆与HA-Zn两者复用时能够取得显著的协同增效效果,能够获得更好的口腔黏膜修复效果。
以上所述,仅为本申请的实施例而已,本申请的保护范围并不受这些具体实施例的限制,而是由本申请的权利要求书来确定。对于本领域技术人员来说,本申请可以有各种更改和变化。凡在本申请的技术思想和原理之内所作的任何修改、等同替换、改进等,均应包含在本申请的保护范围之内。
Claims (9)
1.一种组合物,其特征在于,所述组合物包括
a)透明质酸盐;
b)凝胶质,选自羟丁基壳聚糖、胶原蛋白、卡拉胶、卡波姆或它们的混合物;
其中,所述凝胶质与透明质酸盐的质量比为1:2~7。
2.根据权利要求1所述的组合物,其特征在于,所述凝胶质与透明质酸盐的质量比为1:3~5。
3.根据权利要求1或2所述的组合物,其特征在于,所述透明质酸盐为透明质酸锌,和/或,
所述凝胶质为卡波姆。
4.根据权利要求1-3任一所述的组合物,其特征在于,所述透明质酸盐和凝胶质的质量之和占所述组合物总质量的0.2~0.8wt%。
5.根据权利要求1-5任一所述的组合物,其特征在于,所述组合物还包括生理学上可接受的辅料或其他活性成分。
6.如权利要求1~6中任一项所述的组合物在制备化妆品、药品中的用途。
7.如权利要求1~6中任一项所述的组合物在制备具有高效成膜修复作用的口腔护理产品中的用途。
8.一种口腔含漱液,其特征在于,包括权利要求1~6任一项所述的组合物。
9.一种漱口水,其特征在于,包括权利要求1~6任一项所述的组合物。
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