CN114983874A - 一种中药挥发油组合物漱口液 - Google Patents
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Abstract
本发明公布了一种以抑制口腔细菌、治疗牙周炎为主要功能的中药精油漱口液的制备方法，属于口腔健康技术领域。本发明的中药抑菌精油漱口液由如下原料组成：山苍子(拉丁名：Litsea cubeba)精油、艾叶(拉丁名：Artemisia princeos)精油、仙鹤草(拉丁名：Agrimonia pilosa Ledeb)精油。本发明的中药抑菌精油漱口液全方配伍合理，组分间协同发挥作用，不仅可以有效抑菌清洁口腔，还具有抑制牙龈出血、燥湿化痰的效果。此外，本发明制备工艺简单、适用群体广，孕妇儿童均可使用，无不良反应。
Description
技术领域
本发明公布了一种以抑制口腔细菌为主要功能的中药精油组合物漱口液的组成及制备方法，属于口腔健康技术领域。
背景技术
在中国，口腔健康正受到前所未有的关注。随着经济的发展，生活水平的提高，人们对口腔保健的意识也大大增强。随着市场需求及消费观念的提升和变化，口腔护理产品格局已经由最初的牙膏“一统天下”渐渐升级为牙膏、牙线、牙贴、漱口液、电动牙刷等产品的共同作战。一般而言常规刷牙只能够清除牙面40％～50％的菌斑，邻面只能去30％的菌斑，而对于清除口腔软组织表面的菌斑基本无能为力。菌斑中的致病菌牙龈卟啉单胞菌通过释放毒性产物对牙周组织造成损害，最终形成牙周炎。但漱口液可深入口腔各部位，包括牙刷难接触的牙龈边缘及牙缝间，是一种很好的辅助控制菌斑措施。
金黄色葡萄球菌和牙龈卟啉单胞菌是影响口腔健康的原因之一。金黄色葡萄球菌是革兰氏阳性菌、牙龈卟啉单胞菌是革兰氏阴性菌。
中医理论认为胃火炽热、肾气虚亏和气血不足是导致牙龈问题的主要病因。漱口液在口腔疾病的预防及辅助治疗中起着重要的作用。目前，临床上常用的漱口液中多含有抗生素、碘、乙醇等成分，如洗必泰、含碘新型漱口液等，它们能有效减少牙菌斑中的细菌，减弱细菌产物的毒性，达到控制菌斑，预防牙龈炎、牙周炎等口腔疾病。但长期使用含有广谱抗生素的漱口液容易引起口腔菌群失调，随着使用次数的增多，产生耐药菌及二次感染的风险也越高。洗必泰类漱口液长期使用易造成牙面着色、味觉改变，不宜长时间使用，且因味苦、口感较差、局部刺激较大而不被患者接受，部分患者甚至会产生过敏引起皮疹或口炎。含碘漱口液有效碘含量不稳定，稀释后有效含量降低较快，需现用现配，给患者使用带来不便。因此，寻找天然、副作用少、有效、安全、无酒精、可长期使用的漱口液成为治疗口腔问题的新热点。
天然药物的应用历史悠久且毒副作用小，取材方便，经济实惠，有的还具有杀菌消炎作用，因而广泛用于基础研究及临床实践。中药制剂在口腔中的运用广泛，大量研究表明中药在治疗牙周病、口腔溃疡等疾病上具有良好的疗效。但目前对于该类中药的报道多为某种单一中草药的作用，对中药复方的研究较少，而中药复方更能体现中医辨证论治的特点，充分发挥药物的协同作用及中医药多种有效成分多靶点作用。
艾叶(拉丁名：Artemisia princeos)精油：艾叶精油分子渗透能力极强，易被皮肤迅速渗透吸收，进而调理气血、镇咳化痰、参与代谢，提升免疫力。艾叶辛苦温，具有止血、止痛、去虚火和寒火等功效。人体中的口腔溃疡、口腔炎、咽喉肿痛等病症都是由于体内虚火旺盛或者寒火旺盛导致的，艾叶精油对这些疾病都有很好的缓解作用。
仙鹤草(拉丁名：Agrimonia pilosa Ledeb)精油：仙鹤草精油有收敛止血，止痢杀虫等功效。可用于治疗牙龈出血、口腔发苦等口腔问题。
山苍子(拉丁名：Litsea cubeba)精油：山苍子精油对大部分微生物都具有很好的抗菌作用，对革兰氏阳性菌效果更好，另一方面能促进细胞再生，修护皮肤细胞组织，减轻炎症和肿胀的肌肤问题。
发明内容
本发明的发明目的是提供一种中药抑菌精油组合漱口液的配方及制备方法。本发明的中药抑菌精油漱口液全方配伍合理，组分间协同发挥作用，不仅可以有效抑菌、清洁口腔，还具有抑制牙龈出血、燥湿化痰的效果。此外，本发明制备工艺简单、适用群体广，孕妇儿童均可使用，无不良反应。
本发明提供的技术方案如下：
一种抑制口腔细菌的中药精油漱口液，所述的山苍子精油、艾叶精油和仙鹤草精油的质量比为1-2∶1-2∶1-2。
优选地，所述的山苍子精油、艾叶精油和仙鹤草精油的质量比为1∶1∶1。
本发明还提供了上述抑制口腔细菌的中药精油漱口液的制备方法，包括以下步骤：
将山苍子精油、艾叶精油、仙鹤草精油混合均匀，即制得抑制口腔细菌的中药精油漱口液。
本发明还保护了所述的中药复配精油在抑制口腔细菌、治疗牙周炎的应用，以及保持清洁口腔、抑制牙龈出血、燥湿化痰的应用。
与现有技术相比，本发明具有的有益效果是：
本发明技术方案使用天然的中药抑菌精油漱口液全方配伍合理，组分间协同作用，可显著减少口腔微生物的数量，包括牙龈卟啉单胞菌和金黄色葡萄球菌等，从而降低因牙龈卟啉单胞菌而引发的牙周炎以及因金黄色葡萄球菌、大肠杆菌和白色念球菌等造成的口腔溃疡和口角炎的发病率。本发明具有清洁口腔，抑制牙龈出血、燥湿化痰的效果。此外，本发明的中药复配精油制备工艺简单，有利于产业化的实现，且适用群体广，孕妇儿童均可使用，无不良反应。
附图说明
图1为本发明等量的实施例1-7、对比例1-6制备的中药抑菌精油漱口液(0.5％)、甲硝唑含漱液(0.5％)及蒸馏水对照样品针对金黄色葡萄球菌测得的抑菌环直径对比图。除非特别说明，以上试样标本的含量除标注成分外其余为水。
图2为本发明等量的实施例1-7、对比例1-6制备的中药抑菌精油漱口液(0.5％)、甲硝唑含漱液(0.5％)及蒸馏水对照样品针对牙龈卟啉单胞菌测得的抑菌环直径对比图。
除非特别说明，图1与图2试样标本的含量除标注成分外其余为水。
具体实施方式
实施例及对比例中的K-B纸片扩散体外抑菌法试验(即将含有定量药物的纸片贴在已接种待测菌的琼脂平板的特定区域，药物抑制细菌生长形成透明的抑菌环，来反映待测菌对药物的敏感程度)如下：
(1)将稀释1000倍后的麦氏浓度金黄色葡萄球菌菌液120μL均匀的涂布到备好的琼脂平板上，静置待菌液吸收。
(2)将10片滤纸片置于玻璃平皿中；剧烈摇匀试样，迅速取样10μL滴加至滤纸，然后用无菌镊子将滤纸片贴在涂好菌液的琼脂表面上，轻压纸片，使其与琼脂适当接触，每平板贴三个纸片，平行三个平板，使各纸片间距相等。后于37℃培养箱培养24h后观察抑菌圈，然后用游标卡尺测量每一个抑菌圈直径，取平均值计数。
实施例及对比例中针对牙龈卟啉单胞菌做的抑菌试验：将厌氧血琼脂培养基在装有厌氧培养箱的洁净工作台操作，制备培养皿。在培养基中取牙龈卟啉单胞菌菌液50μL，用无菌涂布棒涂匀，待自然干燥后，用灭菌的打孔器在培养基上打孔，再在孔中分别滴入各实施例及对比例中准备的药液15μL。将培养基置于厌氧培养袋中，置于37℃培养箱中培养16h后观察抑菌圈直径并记录。每组药物平行重复3次，取平均值。
各实施例及对比例中中药抑菌精油漱口液的使用方法如下：取中药抑菌精油漱液0.1g，加清水稀释至20ml，剧烈振荡摇匀，先含3min再漱口。
本发明的甲硝唑含漱液(云中莲甲硝唑含漱液，规格：0.5％)使用方法：含漱，一次20ml，先含3min再漱口。
按重量比称取山苍子精油、艾叶精油和仙鹤草精油，然后混合均匀，即制得抑制口腔细菌的中药精油漱口液。实施例与对比例配方如表1所示：
表1各实施例、对比例配方(重量份)
| 山苍子精油/份 | 艾叶精油/份 | 仙鹤草精油/份 | |
| 实施例1 | 12 | 6 | 6 |
| 实施例2 | 6 | 6 | 12 |
| 实施例3 | 6 | 12 | 6 |
| 实施例4 | 9 | 9 | 6 |
| 实施例5 | 9 | 6 | 9 |
| 实施例6 | 6 | 9 | 9 |
| 实施例7 | 8 | 8 | 8 |
| 对比例1 | 12 | 12 | 0 |
| 对比例2 | 0 | 12 | 12 |
| 对比例3 | 12 | 0 | 12 |
| 对比例4 | 24 | 0 | 0 |
| 对比例5 | 0 | 24 | 0 |
| 对比例6 | 0 | 0 | 24 |
中药抑菌精油漱口液的性能测试
(一)口感及气味测试
选取患有口腔溃疡、牙龈出血等口腔问题的患者60名，男女各半，平均年龄35周岁。以本发明的实施例1-7为测试组，以云中莲甲硝唑含漱液为对照组。结果如表2所示：
表2口感及气味测试结果
| 组别 | 颜色 | 口感 | 气味 |
| 实施例1 | 淡黄色 | 清爽、无刺激 | 清香 |
| 实施例2 | 淡黄色 | 清爽、无刺激 | 清香 |
| 实施例3 | 淡黄色 | 清爽、无刺激 | 清香 |
| 实施例4 | 淡黄色 | 清爽、无刺激 | 清香 |
| 实施例5 | 淡黄色 | 清爽、无刺激 | 清香 |
| 实施例6 | 淡黄色 | 清爽、无刺激 | 清香 |
| 实施例7 | 淡黄色 | 清爽、无刺激 | 清香 |
| 甲硝唑含漱液 | 无色或轻微泛黄 | 刺激性强 | 味道苦 |
表2所示本实施例1-7(山苍子精油、艾叶精油、仙鹤草精油混合均匀制得的中药抑菌精油漱口液)及甲硝唑含漱液针对口感及气味的测试，结果显示本发明的实施例1-7清爽无刺激、气味宜人、顺应性强，而甲硝唑含漱液味道苦，患者难以接受，给治疗造成阻碍。
(二)长期使用效果测试
选取患有口腔溃疡、牙龈出血等口腔问题的患者300名，男女各半，平均年龄35周岁。随机分为15组，每组20人。
患者分别使用等量(20mI)实施例1-7、对比例1-6制备得到的中药抑菌精油漱口液、甲硝唑含漱液、蒸馏水，含漱，先含3min再漱口。一日早中晚饭后漱口三次，连续2星期。
疗效标准：明显改善：口腔问题如口腔溃疡、牙龈出血、口腔异臭明显改善或消失。改善：口腔问题得到一定程度的改善，但不明显。无效：口腔问题未得到改善。恶化：口腔问题进一步恶化。
结果如表3所示：
表3长期使用效果测试结果
表3所示本发明实施例1-7、对比例1-6一日早中晚饭后漱口三次，连续使用2星期的效果测试。比较实施例1-7，结果显示，实施例3的使用效果最好，即当山苍子精油、艾叶精油和仙鹤草精油的质量比为1∶1∶1时口腔问题得到最大程度的改善。比较实施例7和对比例1-6，使用效果的排序为(从优到劣)实施例7＞对比例1＞对比例3＞对比例2＞对比例6＞对比例5＞对比例4，此使用效果排序说明本发明的中药抑菌精油漱口液全方配伍合理，仙鹤草精油、艾叶精油和山苍子精油可发生协同作用，比单独使用某种精油或单独使用任意两种精油效果更好，其疗效也更为显著。此外，从表2也可看出，实施例1-7、对比例1-6的使用效果也都比甲硝唑含漱液更好。
图1所示本发明等量的实施例1-7、对比例1-6制备的中药抑菌精油漱口液(0.5％)、甲硝唑含漱液(0.5％)及蒸馏水对照样品针对金黄色葡萄球菌测得的抑菌环直径对比图。从图1可知，抑菌效果：实施例7＞实施例3＞实施例2＞实施例4＞实施例1＞实施例6＞实施例5＞对比例2＞甲硝唑含漱液＞对比例1＞对比例3＞对比例4＞对比例5＞对比例6＞蒸馏水，说明当山苍子精油、艾叶精油和仙鹤草精油的质量比为1∶1∶1时，对金黄色葡萄球菌的抑菌效果最为显著，且山苍子精油、艾叶精油和仙鹤草精油可协同发挥作用，比单独使用某种精油或单独使用任意两种精油对金黄色葡萄球菌的抑菌效果更好。
图2所示本发明等量的实施例1-7、对比例1-6制备的中药抑菌精油漱口液(0.5％)、甲硝唑含漱液(0.5％)及蒸馏水对照样品针对牙龈卟啉单胞菌测得的抑菌环直径对比图。从图2可知，抑菌效果：实施例7＞实施例5＞实施例6＞实施例2＞实施例1＞实施例3＞甲硝唑含漱液＞对比例1＞对比例3＞对比例4＞对比例2＞对比例5＞对比例6＞蒸馏水，说明当山苍子精油、艾叶精油和仙鹤草精油的质量比为1∶1∶1时，对牙龈卟啉单胞菌的抑菌效果最为显著，且山苍子精油、艾叶精油和仙鹤草精油可协同发挥作用，比单独使用某种精油或单独使用任意两种精油对金黄色葡萄球菌的抑菌效果更好。
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，根据本发明的技术方案及其发明构思加以等同替换或改变，都应涵盖在本发明的保护范围之内。
Claims (4)
1.一种抑制口腔细菌的中药精油漱口液，其特征在于，所述的山苍子(拉丁名：Litseacubeba)精油、艾叶(拉丁名：Artemisia princeos)精油和仙鹤草(拉丁名：Agrimoniapilosa Ledeb)精油的质量比为1-2∶1-2∶1-2，应用于抑制口腔细菌、治疗牙周炎，以及保持清洁口腔、抑制牙龈出血、燥湿化痰。
2.如权利要求1所述的一种抑制口腔细菌的中药精油漱口液，其特征在于，所述的山苍子精油、艾叶精油和仙鹤草精油的质量比为1∶1∶1。
3.如权利要求1任一项所述的一种抑制口腔细菌的中药精油漱口液制备方法，其特征在于，包括如下步骤：
将山苍子精油、艾叶精油、仙鹤草精油混合均匀，即制得抑制口腔细菌的中药精油漱口液。
4.如权利要求1所述的中药复配精油在抑制口腔细菌、治疗牙周炎的应用，以及保持清洁口腔、抑制牙龈出血、燥湿化痰的应用。
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| CN102397176A (zh) * | 2010-09-17 | 2012-04-04 | 南京星银药业集团有限公司 | 一种中药含漱液及其制法 |
| CN103536497A (zh) * | 2013-10-30 | 2014-01-29 | 昆明理工大学 | 一种中药复方漱口液及其制备方法 |
| WO2017206015A1 (zh) * | 2016-05-30 | 2017-12-07 | 江苏奇力康皮肤药业有限公司 | 长效抑菌护齿含漱液 |
| CN113081900A (zh) * | 2021-04-06 | 2021-07-09 | 河北科技大学 | 一种漱口液及其制备方法和应用 |
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| CN102397176A (zh) * | 2010-09-17 | 2012-04-04 | 南京星银药业集团有限公司 | 一种中药含漱液及其制法 |
| CN103536497A (zh) * | 2013-10-30 | 2014-01-29 | 昆明理工大学 | 一种中药复方漱口液及其制备方法 |
| WO2017206015A1 (zh) * | 2016-05-30 | 2017-12-07 | 江苏奇力康皮肤药业有限公司 | 长效抑菌护齿含漱液 |
| CN113081900A (zh) * | 2021-04-06 | 2021-07-09 | 河北科技大学 | 一种漱口液及其制备方法和应用 |
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