CN112089670A - 一种含天然抑菌成分的儿童防龋牙膏及其制备工艺 - Google Patents
一种含天然抑菌成分的儿童防龋牙膏及其制备工艺 Download PDFInfo
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Abstract
本发明公开了一种含天然抑菌成分的儿童防龋牙膏及其制备工艺。其配方组成以质量百分比计，包括：二氧化硅5～15％，黄原胶0.2～0.9％，卡拉胶0.1～0.8％，山梨醇(70％溶液)30～50％，甘油10～20％，多聚磷酸钠0.5～2.5％，聚乙二醇0.5～2％，十二烷基硫酸钠0.5～2.5％，奥拉氟0.05～0.5％，低聚异麦芽糖0.1～5.0％，木糖醇1.0～6.0％，聚赖氨酸0.001～0.1％，甘氨酸0.001～0.2％，丁香酚0.05～1.5％，凤梨酵素0.06～2.8％，大青叶提取物0.05～2.5％，色素0.001～0.025％，香精0.1～1％，其余为纯化水。本发明的儿童牙膏，不仅能够清洁牙齿，而且可以起到抑菌，抗炎，止血和促进伤口愈合，高效防龋的作用。
Description
技术领域
本发明属于口腔卫生制品技术领域，涉及一种含天然抑菌成分的儿童防龋牙膏及其制备工艺。
背景技术
幼儿初萌牙齿釉质薄，钙化程度低，且由于喂养方式不当及口腔卫生习惯不良导致婴幼儿和儿童是龋病的好发群体，其乳牙可在萌出过程中发生病变，上颌乳切牙和下颌乳磨牙最易受累。乳牙多在婴儿出生后半年萌出到口腔，为微生物定植提供了必要的条件。牙齿是高度钙化的器官，坚硬的釉质表层不同于定期脱落的软组织，致性微生物在牙面形成定植后不易自行清除。龋齿是儿童最常见的口腔问题之一，传统的治疗方法主要有牙钻机械去腐洞后充填和防龋齿牙膏两种方法。前者因许多儿童患者不能耐受钻牙时带来的疼痛不适，更有甚者患上“治牙恐惧”，从而延误治疗或致疗效欠佳。
防龋牙膏指添加防龋功效成分，起到预防治疗龋齿作用的牙膏。龋齿是细菌性疾病，它可以继发牙髓炎和根尖周炎，甚至能引起牙槽骨和颌骨炎症。目前公认的龋病病因学说是四联因素学说，表现为无机质脱矿和有机质的分解，随病程发展而从色泽改变到形成实质性病损的演变过程。是口腔主要的常见病，也是人类最普遍的疾病之一，世界卫生组织已将其与癌肿和心血管疾病并列为人类三大重点防治疾病。
然而市面上在售的防龋齿牙膏，效果好的要求婴幼儿和儿童在使用时要避免吞咽，而部分可吞咽的防龋齿牙膏防龋齿效果却不佳。因此，考虑到儿童群体刷牙容易吞咽，长期使用安全是首要考虑因素，且儿童难以意识到口腔卫生问题的带给自己的危害，给儿童提供一种天然抑菌的牙膏，预防龋齿发生是很有必要的。
发明内容
为了克服上述现有技术的缺点，本发明的目的在于提供一种含天然抑菌成分的儿童防龋牙膏及其制备工艺。
为了达到上述目的，本发明采用以下技术方案予以实现：
本发明公开了一种含天然抑菌成分的儿童防龋牙膏，以质量百分比计，由以下原料组成：
二氧化硅5％～15％，黄原胶0.2％～0.9％，卡拉胶0.1％～0.8％，70％的山梨醇溶液30％～50％，甘油10％～20％，多聚磷酸钠0.5％～2.5％，聚乙二醇0.5％～2％，十二烷基硫酸钠0.5％～2.5％，奥拉氟0.05％～0.5％，低聚异麦芽糖0.1％～5.0％，木糖醇1.0％～6.0％，聚赖氨酸0.001％～0.1％，甘氨酸0.001％～0.2％，丁香酚0.05％～1.5％，凤梨酵素0.06％～2.8％，大青叶提取物0.05％～2.5％，色素0.001％～0.025％，香精0.1％～1％，余量为纯化水。
优选地，所述含天然抑菌成分的儿童防龋牙膏，以质量百分比计，由以下原料组成：
二氧化硅15％，黄原胶0.9％，卡拉胶0.3％，70％的山梨醇溶液50％，甘油10％，多聚磷酸钠2.5％，聚乙二醇2％，十二烷基硫酸钠0.5％，奥拉氟0.1％，低聚异麦芽糖0.1％，木糖醇1.0％，聚赖氨酸0.01％，甘氨酸0.02％，丁香酚0.05％，凤梨酵素0.2％，大青叶提取物0.05％，色素0.001％，香精0.5％，纯化水16.769％。。
本发明还公开了上述含天然抑菌成分的儿童防龋牙膏的制备工艺，包括以下步骤：
1)将黄原胶和卡拉胶分散在甘油中，充分搅拌，使其分散均匀，得到胶体系A；
2)将多聚磷酸钠、聚乙二醇、十二烷基硫酸钠、奥拉氟、低聚异麦芽糖、木糖醇、聚赖氨酸、甘氨酸、丁香酚、凤梨酵素、大青叶提取物和色素溶解于70％的山梨醇溶液和纯化水中，充分搅拌，直至完全溶解，得到溶液体系B；
3)将胶体系A和溶液体系B混合，加热至60℃，充分搅拌使其混合均匀，胶体充分溶解、溶胀，得到凝胶体系C；
4)将二氧化硅加入凝胶体系C中，采用搅拌装置进行分次搅拌，共搅拌5次，每次10分钟，每次搅拌间隔5分钟，在第4次搅拌时加入香精，待分散完成后关闭搅拌装置。
优选地，步骤1)中，充分搅拌时间为5min。
优选地，步骤2)中，充分搅拌时间为10min。
优选地，步骤3)中，充分搅拌时间为15min。
优选地，步骤4)中，搅拌装置的搅拌频率为25Hz，分散频率为40Hz。
与现有技术相比，本发明具有以下有益效果：
本发明公开的含天然抑菌成分的儿童防龋牙膏，不仅能够清洁牙齿，而且可以起到抑菌，抗炎，止血和促进伤口愈合，高效防龋的作用，配方选择的创新优势体现在：
第一，配方中采用了天然抑菌成分聚赖氨酸和甘氨酸，聚赖氨酸是从植物中提取出来的成分，抑菌效果好，无刺激，聚赖氨酸机理主要表现在破坏微生物的细胞膜结构，引起细胞的物质、能量和信息传递中断，最终导致细胞死亡，加入牙膏中，不仅可抑制耐热性较强的G+的微球菌和G-的大肠杆菌、沙门氏菌抑菌、还可抑制保加利亚乳杆菌、嗜热链球菌、酵母菌的生长。甘氨酸的作用机理是破坏微生物的细胞膜结构，引起细胞的物质、能量和信息传递中断，最终导致细胞死亡，两者复配可以增强抑菌的效果，且赖氨酸是人体必需的8种氨基酸之一，甘氨酸也是人体半必需氨基酸，使用起来安全放心，婴孩可用。
第二，使用专效成分“奥拉氟”，奥拉氟与氟化钠的关键区别在于其具有表面活性，有助于保证氟化钙层的均匀分布，附着在牙齿表面区域能够抑制细菌的代谢活性，减少酸性物质的产生，从而抵御蛀牙。临床研究证明奥拉氟防敏感、抗敏功效效果是氟化钠牙膏的3倍，主要是因为奥拉氟它会在牙釉质上形成均匀的氟离子，奥拉氟中的氟离子，可以快速主动的扩散到整个口腔包括刷牙刷不到的缝隙形成有效的防蛀墙，不只停留在表层能更有效的保护氟化钠在牙齿上均匀分布更好地抑制细菌的增长。
第三，使用低聚异麦芽糖和木糖醇，低聚异麦芽糖不仅自身不易被蛀牙病菌链菌发酵腐蚀，无虑龋齿，而且当它与砂糖合并使用时，能强烈抑制砂糖被链球菌合成非水溶性的葡萄糖，并又能强烈抑制由砂糖产生的葡萄糖在牙齿上的附着，从而阻碍形成齿垢，防止牙齿表面珐琅质脱灰。木糖醇的防龋齿特性在所有的甜味剂中效果最好，且不能被口腔中产生龋齿的细菌发酵利用，抑制链球菌生长及酸的产生两者合用不仅可以增加甜味，使得小孩体验口感更佳，而且起到高效防龋和口气清新的作用。
第四，添加了天然植提物，包括丁香酚，凤梨酵素和大青叶提取物。其中丁香酚为有机酚类，其杀菌机理是作用于细菌细胞膜上的脂质和蛋白质，使之发生变性而发挥抗菌作用；凤梨酵素是从菠萝中提取的一组复合的半胱氨酸巯基蛋白水解酶,是可用于临床治疗的植物提取物，研究表明其具有抗水肿、抗炎和抗血栓等功能；大青叶的四种提取物具有较好的体外抗多种病毒(IAV、RSV、Ad7和CVB3)的活性，作用方式主要通过影响病毒穿入细胞后发挥抑制作用。天然植提物的添加不仅可以加强防龋作用，还可以起到抗菌，抗炎，止血和促进伤口愈合的作用
本发明还公开了含天然抑菌成分的儿童防龋牙膏的制备工艺，对配方中的原料先后的加入顺序做了明确的限定，且对于多级、分次搅拌工艺中的搅拌时间也做了明确的要求，分次搅拌一方面是在每次搅拌间隙可观察料体状态，另一方面可避免过度搅拌对料体造成黏度性能损失，过度搅拌容易对胶体的触变性造成不可逆的影响。多级、分次搅拌工艺参数的确定能够保证配方中原料充分分散于混合体系中，从而达到产品的效果。
具体实施方式
为了使本技术领域的人员更好地理解本发明方案，下面将通过实施例对本发明中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分的实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都应当属于本发明保护的范围。
需要说明的是，本发明的说明书和权利要求中术语“包括”和“具有”以及他们的任何变形，意图在于覆盖不排他的包含，例如，包含了一系列步骤或单元的过程、方法、系统、产品或设备不必限于清楚地列出的那些步骤或单元，而是可包括没有清楚地列出的或对于这些过程、方法、产品或设备固有的其它步骤或单元。
下面对本发明做进一步详细描述：
本发明公开的含天然抑菌成分的儿童防龋牙膏，以质量百分比计，由以下原料组成：二氧化硅5％～15％，黄原胶0.2％～0.9％，卡拉胶0.1％～0.8％，70％的山梨醇溶液30％～50％，甘油10％～20％，多聚磷酸钠0.5％～2.5％，聚乙二醇0.5％～2％，十二烷基硫酸钠0.5％～2.5％，奥拉氟0.05％～0.5％，低聚异麦芽糖0.1％～5.0％，木糖醇1.0％～6.0％，聚赖氨酸0.001％～0.1％，甘氨酸0.001％～0.2％，丁香酚0.05％～1.5％，凤梨酵素0.06％～2.8％，大青叶提取物0.05％～2.5％，色素0.001％～0.025％，香精0.1％～1％，余量为纯化水。
本发明所述的大青叶提取物选自宜新生物公司提供的大青叶提取物，产品编号YX-000498；产品成分：靛玉红、菘蓝甙、色氨酮，芥甙、新芥甙、1-磺基芥甙；产品规格98％；是从十字花科植物菘蓝的干燥叶经提取，为棕色粉末状。
本发明所述的凤梨酵素购买自济南圣和化工有限公司，食品级，白色粉末状固体。本发明所述的丁香酚购买自北京市津同乐泰化工产品有限公司。
实施例1
一种含天然抑菌成分的儿童防龋牙膏，以质量百分比计，包括：
二氧化硅18％，黄原胶1.0％，卡拉胶0.2％，山梨醇(70％溶液)48％，甘油12％，多聚磷酸钠2.5％，聚乙二醇2％，十二烷基硫酸钠0.5％，奥拉氟0.1％，低聚异麦芽糖0.1％，木糖醇1.0％，聚赖氨酸0.01％，甘氨酸0.02％，丁香酚0.05％，凤梨酵素0.2％，大青叶提取物0.05％，色素0.001％，香精0.5％，纯化水13.769％。
该配方制备方法是：
1)将称量好的黄原胶和卡拉胶分散在甘油中，充分搅拌，搅拌时间5min，使其分散均匀。
2)将称量好的多聚磷酸钠、聚乙二醇、十二烷基硫酸钠、奥拉氟、低聚异麦芽糖、木糖醇、聚赖氨酸、甘氨酸、丁香酚、凤梨酵素、大青叶提取物、色素溶解于山梨醇溶液(70％)和纯化水中，充分搅拌，搅拌时间10min，直至完全溶解。
3)将完全溶解的水溶液和充分分散的胶体系混合，加热至60℃，搅拌时间15min，充分搅拌，使其混合均匀，胶体充分溶解，溶胀。
4)将二氧化硅加入充分溶解，溶胀的凝胶体系，充分搅拌，搅拌频率25Hz，分散频率为40Hz，共5次，每次10分钟，每次需间隔5分钟，在第4次加入香精，分散期间搅拌不间断，分散完成后关闭主搅拌桨。
实施例2
一种含天然抑菌成分的儿童防龋牙膏，以质量百分比计，包括：
二氧化硅12％，黄原胶0.6％，卡拉胶0.6％，山梨醇(70％溶液)52％，甘油8％，多聚磷酸钠2.5％，聚乙二醇2％，十二烷基硫酸钠0.5％，奥拉氟0.1％，低聚异麦芽糖0.1％，木糖醇1.0％，聚赖氨酸0.01％，甘氨酸0.02％，丁香酚0.05％，凤梨酵素0.2％，大青叶提取物0.05％，色素0.001％，香精0.5％，纯化水19.769％。
该配方制备方法是：
1)将称量好的多聚磷酸钠、聚乙二醇、十二烷基硫酸钠、奥拉氟、低聚异麦芽糖、木糖醇、聚赖氨酸、甘氨酸、丁香酚、凤梨酵素、大青叶提取物、色素、黄原胶和卡拉胶溶解于甘油、山梨醇溶液(70％)和纯化水中，充分搅拌，搅拌时间20min，直至完全溶解，充分溶胀。
2)将二氧化硅加入充分溶解，溶胀的凝胶体系，充分搅拌，搅拌频率25Hz，分散频率为40Hz，共5次，每次10分钟，每次需间隔5分钟，在第4次加入香精，分散期间搅拌不间断，分散完成后关闭主搅拌桨。
实施例3
一种含天然抑菌成分的儿童防龋牙膏，以质量百分比计，包括：
二氧化硅15％，黄原胶0.9％，卡拉胶0.3％，山梨醇(70％溶液)50％，甘油10％，多聚磷酸钠2.5％，聚乙二醇2％，十二烷基硫酸钠0.5％，奥拉氟0.1％，低聚异麦芽糖0.1％，木糖醇1.0％，聚赖氨酸0.01％，甘氨酸0.02％，丁香酚0.05％，凤梨酵素0.2％，大青叶提取物0.05％，色素0.001％，香精0.5％，纯化水16.769％。
该配方制备方法是：
1)将称量好的黄原胶和卡拉胶分散在甘油中，充分搅拌，搅拌时间5min，使其分散均匀。
2)将称量好的多聚磷酸钠、聚乙二醇、十二烷基硫酸钠、奥拉氟、低聚异麦芽糖、木糖醇、聚赖氨酸、甘氨酸、丁香酚、凤梨酵素、大青叶提取物、色素溶解于山梨醇溶液(70％)和纯化水中，充分搅拌，搅拌时间10min，直至完全溶解。
3)将完全溶解的水溶液和充分分散的胶体系混合，加热至60℃，搅拌时间15min，充分搅拌，使其混合均匀，胶体充分溶解，溶胀。
4)将二氧化硅加入充分溶解，溶胀的凝胶体系，充分搅拌，搅拌频率25Hz，分散频率为40Hz，共5次，每次10分钟，每次需间隔5分钟，在第4次加入香精，分散期间搅拌不间断，分散完成后关闭主搅拌桨。
下面通过抑菌实验和经口毒性实验对本发明制备的上述含天然抑菌成分的儿童防龋牙膏进行效果验证。
一、变异链球菌抑菌实验
引起小儿龋齿的主要原因是口腔内变异链球菌与食物残屑混合后黏附在牙齿表面和窝沟中，形成牙菌斑。菌斑中的细菌发酵产酸使牙釉质表面脱矿溶解进行形成龋洞，因此对本发明产品与市售儿童牙膏进行变异链球菌体外抑制试验，以观察产品的抑菌效果。
1、试验菌株：变异链球菌，菌株代数为：第三代
2、检测依据：《消毒技术规范》(2002年版)(2.1.11.3.2)
3、试验结果如下表1所示。
表1抑菌实验结果
注：表1中市售儿童牙膏1为黑人宝贝兔儿童牙膏，其主要成分：山梨(糖)醇、水、水合硅石、草莓味香精、聚乙二醇-12、月桂醇硫酸酯钠、焦磷酸四钠、单氟磷酸钠、皱波角叉菜、苯甲醇、甘油磷酸钙、糖精钠、CL 17200。市售儿童牙膏2为舒克宝贝儿童成长牙膏；其主要成分：山梨(糖)醇、水合硅石、聚乙二醇-8、甘油、月桂醇硫酸酯钠、木糖醇、香精、纤维素胶、焦磷酸四钠、糖精钠、苯甲酸钠、CL15985、CL17200。
4、结论：本发明产品与上述两款市售儿童牙膏原液，作用时间3分钟，试验重复3次，对变异链球菌的抑菌率均＞50％，二者均有抑菌作用，其中本发明产品平均抑菌率为72.82％，市售儿童牙膏1的平均抑菌率为58.6％，市售儿童牙膏2的平均抑菌率为58.14％。可见，本发明产品抑菌率高于上述两种市售产品。
二、急性经口毒性试验
试验过程：选用昆明种小鼠20只，体重18-22g，雌、雄各半。剂量设计：按一次最大限度试验法设20g/kg.Bw为灌胃剂量。样品配制：原样。动物禁食16小时，不禁水，按20.0mL/kg.Bw，一次灌胃。灌胃后连续观察14天内动物的中毒症状及死亡情况，试验开始、第7天及第14天称量小鼠体重，试验结束后处死动物做大体解剖。
试验结果：按一次最大限度试验法，以20g/kg.Bw的剂量给与小鼠灌胃后，小鼠生长良好、行为正常、反应敏捷、体重增加，未见明显中毒症状，观察14天动物无死亡。试验结束解剖动物，大体观察肝、肾、脾、心、肺、肠等主要脏器均未见明显异常。结果表明，本发明产品对小鼠急性经口毒LD50大于20g/kg.Bw。根据《消毒技术规范》中的急性经口毒性分级标准，本发明产品小鼠急性经口毒性属实际无毒级。
表2小鼠急性经口毒性试验结果
以上内容仅为说明本发明的技术思想，不能以此限定本发明的保护范围，凡是按照本发明提出的技术思想，在技术方案基础上所做的任何改动，均落入本发明权利要求书的保护范围之内。
Claims (7)
1.一种含天然抑菌成分的儿童防龋牙膏，其特征在于，以质量百分比计，由以下原料组成：
二氧化硅5％～15％，黄原胶0.2％～0.9％，卡拉胶0.1％～0.8％，70％的山梨醇溶液30％～50％，甘油10％～20％，多聚磷酸钠0.5％～2.5％，聚乙二醇0.5％～2％，十二烷基硫酸钠0.5％～2.5％，奥拉氟0.05％～0.5％，低聚异麦芽糖0.1％～5.0％，木糖醇1.0％～6.0％，聚赖氨酸0.001％～0.1％，甘氨酸0.001％～0.2％，丁香酚0.05％～1.5％，凤梨酵素0.06％～2.8％，大青叶提取物0.05％～2.5％，色素0.001％～0.025％，香精0.1％～1％，余量为纯化水。
2.根据权利要求1所述的含天然抑菌成分的儿童防龋牙膏，其特征在于，以质量百分比计，由以下原料组成：
二氧化硅15％，黄原胶0.9％，卡拉胶0.3％，70％的山梨醇溶液50％，甘油10％，多聚磷酸钠2.5％，聚乙二醇2％，十二烷基硫酸钠0.5％，奥拉氟0.1％，低聚异麦芽糖0.1％，木糖醇1.0％，聚赖氨酸0.01％，甘氨酸0.02％，丁香酚0.05％，凤梨酵素0.2％，大青叶提取物0.05％，色素0.001％，香精0.5％，纯化水16.769％。。
3.权利要求1或2所述的含天然抑菌成分的儿童防龋牙膏的制备工艺，其特征在于，包括以下步骤：
1)将黄原胶和卡拉胶分散在甘油中，充分搅拌，使其分散均匀，得到胶体系A；
2)将多聚磷酸钠、聚乙二醇、十二烷基硫酸钠、奥拉氟、低聚异麦芽糖、木糖醇、聚赖氨酸、甘氨酸、丁香酚、凤梨酵素、大青叶提取物和色素溶解于70％的山梨醇溶液和纯化水中，充分搅拌，直至完全溶解，得到溶液体系B；
3)将胶体系A和溶液体系B混合，加热至60℃，充分搅拌使其混合均匀，胶体充分溶解、溶胀，得到凝胶体系C；
4)将二氧化硅加入凝胶体系C中，采用搅拌装置进行分次搅拌，共搅拌5次，每次10分钟，每次搅拌间隔5分钟，在第4次搅拌时加入香精，待分散完成后关闭搅拌装置。
4.根据权利要求3所述的含天然抑菌成分的儿童防龋牙膏的制备工艺，其特征在于，步骤1)中，充分搅拌时间为5min。
5.根据权利要求3所述的含天然抑菌成分的儿童防龋牙膏的制备工艺，其特征在于，步骤2)中，充分搅拌时间为10min。
6.根据权利要求3所述的含天然抑菌成分的儿童防龋牙膏的制备工艺，其特征在于，步骤3)中，充分搅拌时间为15min。
7.根据权利要求3所述的含天然抑菌成分的儿童防龋牙膏的制备工艺，其特征在于，步骤4)中，搅拌装置的搅拌频率为25Hz，分散频率为40Hz。
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