CN112755179A - 一种预防及治疗口腔中的幽门螺杆菌的组合物及其应用 - Google Patents
一种预防及治疗口腔中的幽门螺杆菌的组合物及其应用 Download PDFInfo
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- CN112755179A CN112755179A CN202110143206.XA CN202110143206A CN112755179A CN 112755179 A CN112755179 A CN 112755179A CN 202110143206 A CN202110143206 A CN 202110143206A CN 112755179 A CN112755179 A CN 112755179A
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Abstract
本发明涉及医药领域,具体涉及一种预防及治疗口腔中的幽门螺杆菌的组合物及其应用。本发明公开了一种预防及治疗口腔中幽门螺杆菌的组合物,包括乳铁蛋白、赖氨酸、溶菌酶和奥替尼啶。本发明提供了一种预防及治疗口腔中幽门螺杆菌的组合物及其在制剂中的应用,能够有效预防及减少口腔中感染幽门螺杆菌的问题,长期使用可以改善口腔中幽门螺杆菌引起的口臭、口腔溃疡、慢性咽炎等问题,从而解决幽门螺杆菌可能会引起的胃溃疡及胃癌等问题,适用范围广,且不易发生不良反应。
Description
技术领域
本发明涉及医药领域,具体涉及一种预防及治疗口腔中的幽门螺杆菌的组合物及其应用。
背景技术
幽门螺杆菌是包含犬幽门螺杆菌、胃螺杆菌、黑氏螺杆菌、拉普尼螺杆菌和萨洛莫尼螺杆菌等螺旋形微厌氧,是目前所知能够在猕猴、大鼠、猪、犬等动物胃中生存的对生长条件要求十分苛刻的细菌。口腔幽门螺旋杆菌是一种革兰氏阴性菌,主要分布在唾液、牙菌斑、龈沟液中,90%口臭、56.9%口腔溃疡、77.63%慢性咽炎是由口腔幽门螺旋杆菌引起的。口腔幽门螺旋杆菌在世界不同种族、不同地区的人群和宠物中均有感染,总的趋势是:口腔幽门螺旋杆菌感染率随年龄增加而上升。我国20岁-40岁感染率为45.4%-63.6%,70岁以上高达78.9%。以此同时,幽门螺杆菌能够通过咀嚼、吞咽等行为到达胃部引起胃部感染,首先会引起慢性胃炎,之后会导致胃溃疡和胃萎缩,严重者则发展为胃癌。
口腔幽门螺旋杆菌感染性强,传播广,耐药性强,且具有独特的“生物膜”结构,药物难以到达而发挥作用,所以口腔幽门螺旋杆菌不易根除。而幽门螺旋杆菌在口腔内定植,是幽门螺旋杆菌根除失败、复发或再感染的重要原因。预防方法主要有:避免群集性感染;保持口腔健康;不吃生食;餐具器皿应定期消毒,如消毒柜高温就达到125℃能够杀死大部分病菌;非抗生素预防。
因此,一种能够有效治疗口腔幽门螺杆菌的组合物或制剂是非常迫切的。基于上述研究发现,本发明提供了一种用于治疗口腔幽门螺杆菌的组合物,该组合物从根源口腔来预防及治疗幽门螺杆菌,能够有效解决上述幽门螺杆菌会带来的口臭、慢性咽炎、胃溃疡及胃癌等问题。
发明内容
为了解决上述问题,本发明的第一方面提供了一种预防及治疗口腔中幽门螺杆菌的组合物,包括乳铁蛋白、赖氨酸、溶菌酶和奥替尼啶。
作为一种优选的技术方案,所述的预防及治疗口腔中幽门螺杆菌的组合物,包括如下重量百分比的组分:0.5%-5%乳铁蛋白,0.3%-5%赖氨酸,0.1%-1%溶菌酶,0.01%-1%奥替尼啶,余量为水。
作为一种优选的技术方案,所述的预防及治疗口腔中幽门螺杆菌的组合物,包括如下重量百分比的组分:1%-3%乳铁蛋白,1%-3%赖氨酸,0.2%-0.8%溶菌酶,0.05%-0.5%奥替尼啶,余量为水。
作为一种优选的技术方案,所述的预防及治疗口腔中幽门螺杆菌的组合物,包括如下重量百分比的组分:2%乳铁蛋白,2%赖氨酸,0.5%溶菌酶,0.1%-0.3%奥替尼啶,余量为水。
作为一种优选的技术方案,所述的预防及治疗口腔中幽门螺杆菌的组合物,还包括如下重量百分比的组分:0.01%-0.5%薄荷脑,1%-8%木糖醇。
作为一种优选的技术方案,所述的预防及治疗口腔中幽门螺杆菌的组合物,包括如下重量百分比的组分:0.1%薄荷脑,3%木糖醇。
作为一种优选的技术方案,所述的预防及治疗口腔中幽门螺杆菌的组合物,还包括如下重量百分比的组分:0.1%-2%吐温80,0.1%-0.5%卡波姆940。
作为一种优选的技术方案,所述的预防及治疗口腔中幽门螺杆菌的组合物,包括如下重量百分比的组分:0.8%吐温80,0.3%卡波姆940。
本发明的第二方面提供了该预防及治疗口腔中幽门螺杆菌的组合物在制剂中的应用,所述制剂为喷剂。
本发明的第三方面提供了该预防及治疗口腔中幽门螺杆菌的组合物在制剂中的应用,所述喷剂的规格为10mL、15mL、20mL、25mL、30mL、35mL、40mL、50mL、60mL、65mL、70mL、80mL中任一种。
有益效果
本发明提供了一种预防及治疗口腔中幽门螺杆菌的组合物及其在制剂中的应用,能够有效预防及减少口腔中感染幽门螺杆菌的问题,长期使用可以改善口腔中幽门螺杆菌引起的口臭、口腔溃疡、慢性咽炎等问题,从而解决幽门螺杆菌可能会引起的胃溃疡及胃癌等问题,适用范围广,且不易发生不良反应。
具体实施方式
结合以下本发明的优选实施方法的详述以及包括的实施例可进一步地理解本发明的内容。除非另有说明,本文中使用的所有技术及科学术语均具有与本申请所属领域普通技术人员的通常理解相同的含义。如果现有技术中披露的具体术语的定义与本申请中提供的任何定义不一致,则以本申请中提供的术语定义为准。
在本文中使用的,除非上下文中明确地另有指示,否则没有限定单复数形式的特征也意在包括复数形式的特征。还应理解的是,如本文所用术语“由…制备”与“包含”同义,“包括”、“包括有”、“具有”、“包含”和/或“包含有”,当在本说明书中使用时表示所陈述的组合物、步骤、方法、制品或装置,但不排除存在或添加一个或多个其它组合物、步骤、方法、制品或装置。此外,当描述本申请的实施方式时,使用“优选的”、“优选地”、“更优选的”等是指,在某些情况下可提供某些有益效果的本发明实施方案。然而,在相同的情况下或其他情况下,其他实施方案也可能是优选的。除此之外,对一个或多个优选实施方案的表述并不暗示其他实施方案不可用,也并非旨在将其他实施方案排除在本发明的范围之外。
为了解决上述问题,本发明的第一方面提供了一种预防及治疗口腔中幽门螺杆菌的组合物,包括乳铁蛋白、赖氨酸、溶菌酶和奥替尼啶。
乳铁蛋白是一个80kDa的铁结合糖蛋白,属于转铁蛋白家族。乳铁蛋白不仅参与铁的转运,而且具有广谱抗菌,例如:对多种细菌、真菌、酵母、病毒和寄生虫表现出强大的抗菌活性、抗氧化、抗癌、调节免疫系统等强大生物功能,被认为是一种新型抗菌、抗癌药物和极具开发潜力的食品和饲料添加剂。乳铁蛋白可以响应各种生理和环境的变化,因此它被认为是先天防御系统的关键组成成分。
赖氨酸是人类和哺乳动物的必需氨基酸之一,机体不能自身合成,必须从食物中补充。赖氨酸主要存在于动物性食物和豆类中,谷类食物中赖氨酸含量很低。赖氨酸在促进人体生长发育、增强机体免疫力、抗病毒、促进脂肪氧化、缓解焦虑情绪等方面都具有积极的营养学意义,同时也能促进某些营养素的吸收,能与一些营养素协同作用,更好的发挥各种营养素的生理功能。
溶菌酶又称胞壁质酶或N-乙酰胞壁质聚糖水解酶,是一种能水解细菌中黏多糖的碱性酶。溶菌酶主要通过破坏细胞壁中的N-乙酰胞壁酸和N-乙酰氨基葡萄糖之间的β-1,4糖苷键,使细胞壁不溶性黏多糖分解成可溶性糖肽,导致细胞壁破裂内容物逸出而使细菌溶解。溶菌酶还可与带负电荷的病毒蛋白直接结合,与DNA、RNA、脱辅基蛋白形成复合体,使病毒失活。溶菌酶可作为一种具有杀菌作用的天然抗感染物质,有抗菌、抗病毒、止血、消肿止痛及加快组织恢复功能等作用。溶菌酶含片用于急慢性咽炎、口腔溃疡等。
奥替尼啶是一种抗微生物剂,用于皮肤、粘膜和伤口的特殊净化剂。奥替尼啶对抗革兰氏阳性、阴性菌和真菌显示出一种广谱抗菌效力。这种效力不会受干扰物如血液、粘液等的影响。奥替尼啶在皮肤有很强的残存效应,应用24小时后仍可以观察出来。由于奥替尼啶有极好的的抗微生物效力和组织相容性,奥替尼啶可用于不同的局部快速应用和发挥必需的长效作用。有着高效作用和光谱活性的奥替尼啶,在局部治疗微生物感染方面有突出和理想的效果。
在一些优选的实施方式中,所述的预防及治疗口腔中幽门螺杆菌的组合物,包括如下重量百分比的组分:0.5%-5%乳铁蛋白,0.3%-5%赖氨酸,0.1%-1%溶菌酶,0.01%-1%奥替尼啶,余量为水。
在一些优选的实施方式中,所述的预防及治疗口腔中幽门螺杆菌的组合物,包括如下重量百分比的组分:1%-3%乳铁蛋白,1%-3%赖氨酸,0.2%-0.8%溶菌酶,0.05%-0.5%奥替尼啶,余量为水。
在一些优选的实施方式中,所述的预防及治疗口腔中幽门螺杆菌的组合物,包括如下重量百分比的组分:2%乳铁蛋白,2%赖氨酸,0.5%溶菌酶,0.1%-0.3%奥替尼啶,余量为水。
在一些优选的实施方式中,所述的预防及治疗口腔中幽门螺杆菌的组合物,还包括如下重量百分比的组分:0.01%-0.5%薄荷脑,1%-8%木糖醇。
薄荷脑也叫薄荷醇,是一种有机化合物。薄荷脑系由薄荷的叶和茎中所提取,白色晶体,为薄荷和欧薄荷精油中的主要成分。薄荷醇一般有两种异构体(D型和L型),天然的薄荷醇主要为左旋异构体(L-薄荷醇),这里的薄荷脑一般指消旋的薄荷醇(DL-薄荷醇)。薄荷脑可用作牙膏、香水、饮料和糖果等的赋香剂;在医药上用作刺激药,作用于皮肤或粘膜,有清凉止痒作用;内服可作为驱风药,用于头痛及鼻、咽、喉炎症等;有杀菌和防腐作用。
木糖醇是一种有机化合物,原产于芬兰,是从白桦树、橡树、玉米芯、甘蔗渣等植物原料中提取出来的一种天然甜味剂。在自然界中,木糖醇广泛存在于各种水果、蔬菜、谷类之中,但含量很低。对于人体来说,木糖醇也不是一种“舶来品”,它本就是人们身体正常糖类代谢的中间体。木糖醇入口后往往伴有微微的清凉感,这是因为它易溶于水,并在溶解时会吸收一定热量。有改善肝功能、防龋齿、稳定激素等作用。
在一些优选的实施方式中,所述的预防及治疗口腔中幽门螺杆菌的组合物,包括如下重量百分比的组分:0.1%薄荷脑,3%木糖醇。
在一些优选的实施方式中,所述的预防及治疗口腔中幽门螺杆菌的组合物,还包括如下重量百分比的组分:0.1%-2%吐温80,0.1%-0.5%卡波姆940。
吐温80,即聚氧乙烯脱水山梨醇单油酸酯,简称聚山梨酯-80,是一种有机化合物。易溶于水,溶于乙醇、植物油、乙酸乙酯、甲醇、甲苯,不溶于矿物油。低温时成胶状,受热后复原。常作为表面活性剂,为非离子型表面活性剂。有乳化作用,可作混悬剂的润湿剂。也可用作油类的助溶剂。
卡波姆940是以季戊四醇等与丙烯酸交联得到的丙烯酸交联树脂,是一类非常重要的流变调节剂,中和后的卡波姆是优秀的凝胶基质,有增稠悬浮等重要用途,工艺简单,稳定性好,广泛应用于乳液、膏霜、凝胶中。
在一些优选的实施方式中,所述的预防及治疗口腔中幽门螺杆菌的组合物,包括如下重量百分比的组分:0.8%吐温80,0.3%卡波姆940。
本发明的第二方面提供了该预防及治疗口腔中幽门螺杆菌的组合物在制剂中的应用,所述制剂为喷剂。
本发明的第三方面提供了该预防及治疗口腔中幽门螺杆菌的组合物在制剂中的应用,所述喷剂的规格为10mL、15mL、20mL、25mL、30mL、35mL、40mL、50mL、60mL、65mL、70mL、80mL中任一种。
实施例
以下通过实施例对本发明技术方案进行详细说明,但是本发明的保护范围不局限于所述实施例。如无特殊说明,本发明中的原料均为市售。
实施例1
实施例1提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:2%乳铁蛋白,2%赖氨酸,0.5%溶菌酶,0.2%奥替尼啶,0.1%薄荷脑,3%木糖醇,0.8%吐温80,0.3%卡波姆940,余量为水。
实施例2
实施例2提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:5%乳铁蛋白,5%赖氨酸,1%溶菌酶,1%奥替尼啶,0.5%薄荷脑,8%木糖醇,2%吐温80,0.5%卡波姆940,余量为水。
实施例3
实施例3提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:0.5%乳铁蛋白,0.3%赖氨酸,0.1%溶菌酶,0.01%奥替尼啶,0.01%薄荷脑,1%木糖醇,0.1%吐温80,0.1%卡波姆940,余量为水。
实施例4
实施例4提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:3%乳铁蛋白,3%赖氨酸,0.8%溶菌酶,0.5%奥替尼啶,0.1%薄荷脑,3%木糖醇,0.8%吐温80,0.3%卡波姆940,余量为水。
实施例5
实施例5提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:1%乳铁蛋白,1%赖氨酸,0.2%溶菌酶,0.05%奥替尼啶,0.1%薄荷脑,3%木糖醇,0.8%吐温80,0.3%卡波姆940,余量为水。
实施例6
实施例6提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:2%乳铁蛋白,2%赖氨酸,0.5%溶菌酶,0.2%奥替尼啶,0.5%薄荷脑,8%木糖醇,2%吐温80,0.5%卡波姆940,余量为水。
对比例1
对比例1提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:2%赖氨酸,0.5%溶菌酶,0.2%奥替尼啶,0.1%薄荷脑,3%木糖醇,0.8%吐温80,0.3%卡波姆940,余量为水。
对比例2
对比例2提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:2%乳铁蛋白,0.5%溶菌酶,0.2%奥替尼啶,0.1%薄荷脑,3%木糖醇,0.8%吐温80,0.3%卡波姆940,余量为水。
对比例3
对比例3提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:2%乳铁蛋白,2%赖氨酸,0.2%奥替尼啶,0.1%薄荷脑,3%木糖醇,0.8%吐温80,0.3%卡波姆940,余量为水。
对比例4
对比例4提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:2%乳铁蛋白,2%赖氨酸,0.5%溶菌酶,0.1%薄荷脑,3%木糖醇,0.3%卡波姆940,余量为水。
对比例5
对比例5提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:2%乳铁蛋白,2%赖氨酸,0.5%溶菌酶,0.2%奥替尼啶,3%木糖醇,0.8%吐温80,余量为水。
对比例6
对比例6提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:2%乳铁蛋白,2%赖氨酸,0.5%溶菌酶,0.2%奥替尼啶,0.8%吐温80,0.3%卡波姆940,余量为水。
对比例7
对比例7提供了预防及治疗口腔中幽门螺杆菌的组合物,包含如下重量百分比的各组分:2%乳铁蛋白,2%赖氨酸,0.5%溶菌酶,0.2%奥替尼啶,0.1%薄荷脑,3%木糖醇,余量为水。
根据上述实施例和对比例的组成,制备相对应的喷剂,用于其性能评价。
性能评价
1.体外抑菌试验
用于测定抗菌药物体外抑制细菌生长效力的试验称为抑菌试验。通过抑菌实验,可以测定一个药物的最低抑菌浓度,用以评价该药物的抑菌性能,这是抗菌药物的最基本的药效学数据。
本实验主要通过培养口腔中的幽门螺杆菌,来评价本申请的幽门螺杆菌制剂对于抑制口腔中的幽门螺杆菌的效果。具体实验操作如下:将幽门螺杆菌培养在肉汤培养基中,然后取培养液5mL,13份,分别加入0.1mL的由上述实施例或者对比例配制得到的制剂。然后在37℃下培养。用稀释平板法测定前后培养液中各种菌的数目。然后利用下式计算抑菌率。
抑菌率=(培养前菌数-培养后菌数)/培养前菌数×100%
其中,在10分钟、30分钟、1小时、4小时、12小时及24小时时,分别对培养液进行取样监测,并计算抑菌率,具体见下表。
表1.具体实施方式在体外实验中的抑菌率
从表1中的抑菌率,我们可以看出:本申请中的各组分之间是协同作用,联合使用对于口腔中的幽门螺杆菌的抑制能力较好。经过24小时的体外培养,我们可以看出,当喷剂中缺少其中一种或多种成分时,其抑菌效果会大幅降低。当喷剂中缺少乳铁蛋白或赖氨酸时,其抑菌效果会大大降低。这说明乳铁蛋白和赖氨酸共同使用,在抑制口腔中幽门螺杆菌的效果较好。同时,当制剂中缺少溶菌酶、奥替尼啶、薄荷脑和木糖醇、吐温80和卡波姆940时,其抑菌效果也会有所降低,这说明本申请中的各组分是协同作用,联合使用效果较佳。
2.治疗口腔幽门螺杆菌的功效测试
本次实验共选择390名幽门螺杆菌感染患者参加,平均每组30名。经C13吹气法测定为阳性(测定数值为4.5-7.0,标准值为小于4),记录该数值。然后让所有参加者每天在特定时间以口腔喷雾给药,每天3次,每次3喷,喷完后30分钟不得饮水或进餐,连续使用30天。然后再经C13吹气法检测,检测结果为阴性的有310人,占79.5%,仍为阳性的有80人,占20.5%。具体结果如下表:
表2.治疗口腔幽门螺杆菌的效果情况
从表2的治疗口腔幽门螺杆菌的效果情况中,我们可以得出本申请中各组分是协同作用,共同使用对于口腔幽门螺杆菌的治疗效果较好,经过30天的使用,我们可以看出,当缺少其中一种或多种组分时,其治疗口腔幽门螺杆菌效果会有大幅的降低。当喷剂中缺少乳铁蛋白或赖氨酸时,其治疗口腔幽门螺杆菌效果会大大降低。这说明乳铁蛋白和赖氨酸共同使用,在治疗口腔幽门螺杆菌的效果较好。同时,当制剂中缺少溶菌酶、奥替尼啶、薄荷脑和木糖醇、吐温80和卡波姆940时,其治疗口腔幽门螺杆菌效果也会有所降低,这说明本申请中的各组分是协同作用,联合使用效果较佳。
最后指出,上述实施例仅为本发明较佳的实施方式,但本发明的实施方式并不受上述实施例的限制,其他的任何未背离本发明的精神实质与原理下所作的改变、修饰、替代、组合、简化,均应为等效的置换方式,都包含在本发明的保护范围之内。
Claims (10)
1.一种预防及治疗口腔中幽门螺杆菌的组合物,包括乳铁蛋白、赖氨酸、溶菌酶,其特征在于,还包括奥替尼啶。
2.根据权利要求1所述的预防及治疗口腔中幽门螺杆菌的组合物,其特征在于,包括如下重量百分比的组分:0.5%-5%乳铁蛋白,0.3%-5%赖氨酸,0.1%-1%溶菌酶,0.01%-1%奥替尼啶,余量为水。
3.根据权利要求2所述的预防及治疗口腔中幽门螺杆菌的组合物,其特征在于,包括如下重量百分比的组分:1%-3%乳铁蛋白,1%-3%赖氨酸,0.2%-0.8%溶菌酶,0.05%-0.5%奥替尼啶,余量为水。
4.根据权利要求3所述的预防及治疗口腔中幽门螺杆菌的组合物,其特征在于,包括如下重量百分比的组分:2%乳铁蛋白,2%赖氨酸,0.5%溶菌酶,0.1%-0.3%奥替尼啶,余量为水。
5.根据权利要求4所述的预防及治疗口腔中幽门螺杆菌的组合物,其特征在于,还包括如下重量百分比的组分:0.01%-0.5%薄荷脑,1%-8%木糖醇。
6.根据权利要求5所述的预防及治疗口腔中幽门螺杆菌的组合物,其特征在于,包括如下重量百分比的组分:0.1%薄荷脑,3%木糖醇。
7.根据权利要求6所述的预防及治疗口腔中幽门螺杆菌的组合物,其特征在于,还包括如下重量百分比的组分:0.1%-2%吐温80,0.1%-0.5%卡波姆940。
8.根据权利要求7所述的预防及治疗口腔中幽门螺杆菌的组合物,其特征在于,包括如下重量百分比的组分:0.8%吐温80,0.3%卡波姆940。
9.权利要求1-8中任一项所述的预防及治疗口腔中幽门螺杆菌的组合物在制剂中的应用,其特征在于,所述制剂为喷剂。
10.权利要求9所述的预防及治疗口腔中幽门螺杆菌的组合物在制剂中的应用,其特征在于,所述喷剂的规格为10mL、15mL、20mL、25mL、30mL、35mL、40mL、50mL、60mL、65mL、70mL、80mL中任一种。
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