CN116870089A - 一种灵丹草口腔抑菌喷雾剂及其制备方法 - Google Patents
一种灵丹草口腔抑菌喷雾剂及其制备方法 Download PDFInfo
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- CN116870089A CN116870089A CN202310964578.8A CN202310964578A CN116870089A CN 116870089 A CN116870089 A CN 116870089A CN 202310964578 A CN202310964578 A CN 202310964578A CN 116870089 A CN116870089 A CN 116870089A
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Abstract
本发明公开了一种灵丹草口腔抑菌喷雾剂及其制备方法,涉及口腔抑菌技术领域。本发明抑菌喷雾剂含有如下成分:保湿剂、增溶剂、防腐剂、植物提取物混合物和余量的去离子水;植物提取物混合物包括臭灵丹提取物,以及牡丹根提取物、乌拉草提取物、芦荟提取物和神秘果果肉提取物中的至少一种。本发明通过灵丹草提取物和牡丹根提取物二者进行复配时,能提高对大肠杆菌、金黄色葡萄球菌、变异链球菌的抑菌效果,进而提高整体的抑菌效果;同时灵丹草提取物和牡丹根提取物二者进行复配时,抗四款革兰氏阳性菌的MI C有明显的变化,说明臭灵丹提取物复配牡丹根提取物有协同效果和增效。
Description
技术领域
本发明属于口腔抑菌技术领域,特别是涉及一种灵丹草口腔抑菌喷雾剂及其制备方法。
背景技术
口腔作为呼吸道及胃肠道的起点,是机体内环境与外环境直接联系的门户,外环境生态系统中许多细菌可通过呼吸、进食等各种日常生命活动不断进入口腔,并在温暖湿润的口腔中繁殖。链球菌、葡萄球菌和乳酸杆菌等会引发各种口腔疾病,如龋齿、口臭、牙龈炎等。由于口腔内缝隙多且细小,日常刷牙难以对致病菌进行彻底清理,故龋齿和牙龈炎还会进一步加重口臭。另一方面,随着现代人生活节奏加快、工作压力增大,不健康的作息(如熬夜)以及饮食习惯(如不定时进餐,喜食麻、辣、烫等重口味食物)会导致身体内分泌异常,进而引起口腔内酸碱平衡度失调、口腔溃疡,以及牙龈肿痛、出血、萎缩等口腔问题,同样可导致口臭。
由于口臭严重干扰着人们社交和心理健康,所以口臭者多采用含片、袋泡茶、口香糖等进行遮蔽,但是这些方法耗时费力,且仅能短暂起效,并不能从根本上解决口臭问题。含有抗生素成分的口腔喷雾可杀灭或抑制口腔内细菌,但大多具有一定的刺激性,当口腔内有溃疡时,会造成使用者明显刺痛,并且长期使用含抗生素成分的口腔喷雾还可能使口腔内菌群失调,并诱导口腔细菌产生耐药性。
发明内容
针对目前的口腔喷雾具有一定刺激性、可引起口腔内菌群失调并使细菌产生耐药性的问题,本发明的目的在于提供一种灵丹草口腔抑菌喷雾剂。
为解决上述技术问题,本发明是通过以下技术方案实现的:
本发明为一种灵丹草口腔抑菌喷雾剂,以质量百分比计含有如下成分:保湿剂7-20%、增溶剂2-4%、防腐剂0.1-0.2%、植物提取物混合物0.1-1.5%和余量的去离子水;所述植物提取物混合物包括臭灵丹提取物,以及牡丹根提取物、乌拉草提取物、芦荟提取物和神秘果果肉提取物中的至少一种;所述植物提取物混合物中臭灵丹提取物的质量百分比为70-95%。
进一步地,所述植物提取物混合物包括臭灵丹提取物和牡丹根提取物,且植物提取物混合物中牡丹根提取物的质量百分比为5-10%,臭灵丹提取物的质量百分比为90-95%。
进一步地,所述植物提取物混合物包括臭灵丹提取物、牡丹根提取物、乌拉草提取物、芦荟提取物和神秘果果肉提取物;且五者的用量比为70-95:1-7:1-7:1-7:1-7。
进一步地,所述保湿剂包括甘油、山梨(糖)醇和丙二醇,且三者的用量比为1-5:5-10:1-5;所述增溶剂为PEG-40氢化蓖麻油;所述防腐剂为羟苯甲酯。
进一步地,以质量百分比计还含有食用香精0.1-0.5%、尿囊素0.01-0.2%、三氯半乳糖0.01-0.2%、西吡氯铵0.01-0.1%、桃柁酚0.01-0.1%和PH调节剂0.01-0.3%;
其中,所述PH调节剂选用柠檬酸钠、苹果酸、碳酸氢钠和磷酸二氢钠中的一种或两种。
进一步地,所述喷雾剂在40±1℃条件下保温24H后恢复室温、无凝聚物、无分层;所述喷雾剂在-5℃~-10℃条件下保温24H后恢复室温、无凝聚物、无分层、无混浊、无沉淀、不变色。
进一步地,所述喷雾剂细菌总数≦10CFU/ml,霉菌与酵母菌总数≦10CFU/ml。
进一步地,所述喷雾剂在缓解口腔溃疡,牙周炎,牙龈炎,咽喉炎上的应用;所述喷雾剂在扁桃体炎,咽喉炎,腮腺炎上的应用。
一种灵丹草口腔抑菌喷雾剂的制备方法,包括如下步骤:
Stp1、将丙二醇、羟苯甲酯用不锈钢容器加热70±5℃左右溶解混合待用;
Stp2、将PEG-40氢化蓖麻油、食用香精(料)用不锈钢容器加热到45±5℃溶解混合待用;
Stp3、将桃柁酚,丙二醇用不锈钢混合搅拌装置预分散并加热到70±5℃溶解成透明液体,然后添加PEG-40氢化蓖麻油;
Stp4、将水、山梨(糖)醇、甘油、加入乳化锅中,在转速为20-30rmp搅拌并加热升温至80±5℃,保温30分钟消毒,加入预先溶解透明的丙二醇、羟苯甲酯,搅拌均匀,在转速为10-30rmp的条件下搅拌10分钟;
Stp5、降温至45℃,加入预先溶解的PEG-40氢化蓖麻油、食用香精(料),搅拌均匀,在10-20rmp的条件均质5分钟后打开均质器门;
Stp6、加入预先溶解好的桃柁酚、丙二醇、PEG-40氢化蓖麻油,在10-20rmp的条件下均质5分钟后打开均质器门;
Stp7、加入植物提取物混合物在10-20rmp的条件下均质5分钟后打开均质器门;
Stp8、加入EDTA二钠、尿囊素、西吡氯铵、三氯半乳糖,在10-20rmp的条件下搅拌20分钟,用PH调节剂调PH=6.0-7.0;然后用0.22微米滤膜和800目滤布双重过滤,出料;
Stp9、半成品静置24小时后,取样,检测微生物、PH值、外观、口感、功效合格后可以进行罐装。
本发明具有以下有益效果:
1、本发明通过灵丹草提取物和牡丹根提取物二者进行复配时,能提高对大肠杆菌、金黄色葡萄球菌、变异链球菌的抑菌效果,进而提高整体的抑菌效果。
2、本发明中灵丹草提取物和牡丹根提取物二者进行复配时,抗四款革兰氏阳性菌的MIC有明显的变化,说明臭灵丹提取物复配牡丹根提取物有协同效果和增效。
3、本发明提供的抑菌喷雾剂,具备清热,镇静、解毒,消肿,抑菌功效,同时适用于帮助缓解口腔溃疡,扁桃体炎,咽喉炎,腮腺炎的口腔抑菌喷剂,进一步改善口腔其他疾病,如龋齿、牙周炎、牙龈炎症等。
当然,实施本发明的任一产品并不一定需要同时达到以上所述的所有优点。
具体实施方式
下面将结合本发明实施例,对本发明实施例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作出创造性劳动前提下所获得的所有其它实施例,都属于本发明保护的范围。
本发明公开一种灵丹草口腔抑菌喷雾剂的制备方法;包括如下步骤:
Stp1、将丙二醇、羟苯甲酯用不锈钢容器加热70±5℃左右溶解混合待用;
Stp2、将食用香精(料)和4/5用量的PEG-40氢化蓖麻油用不锈钢容器加热到45±5℃溶解混合待用;
Stp3、将桃柁酚,丙二醇用不锈钢混合搅拌装置预分散并加热到70±5℃溶解成透明液体,然后添加剩余的PEG-40氢化蓖麻油;PEG-40氢化蓖麻油作为增溶桃柁酚,避免桃柁酚析出;
Stp4、将水、山梨(糖)醇、甘油、加入乳化锅中,在转速为20-30rmp搅拌并加热升温至80±5℃,保温30分钟消毒,加入预先溶解透明的丙二醇、羟苯甲酯,搅拌均匀,在转速为10-30rmp的条件下搅拌10分钟;
Stp5、降温至45℃,加入预先溶解的PEG-40氢化蓖麻油、食用香精(料),搅拌均匀,在10-20rmp的条件均质5分钟后打开均质器门;
Stp6、加入预先溶解好的桃柁酚、丙二醇、PEG-40氢化蓖麻油,在10-20rmp的条件下均质5分钟后打开均质器门;
Stp7、加入植物提取物混合物在10-20rmp的条件下均质5分钟后打开均质器门;
Stp8、加入EDTA二钠、尿囊素、西吡氯铵、三氯半乳糖,在10-20rmp的条件下搅拌20分钟,用PH调节剂调PH=6.0-7.0;然后用0.22微米滤膜和800目滤布双重过滤,出料,采用双重过滤保证产品清澈度;
Stp9、半成品静置24小时后,取样,检测微生物、PH值、外观、口感、功效合格后可以进行罐装。
实施例2,在上述实施例1的基础上;各原料用量百分比分别为:甘油1.5%、山梨(糖)醇6.5%、丙二醇2%、羟苯甲酯0.15%、PEG-40氢化蓖麻油2.5%、食用香精(料)0.3%、EDTA二钠0.1%、尿囊素0.1%、三氯半乳糖0.1%、西吡氯铵0.05%、桃柁酚0.05%、柠檬酸钠0.1%、牡丹根提取物0.08%、臭灵丹提取物0.7%和余量的去离子水。
实施例3,在上述实施例1的基础上;各组分重量比为:甘油1.5%、山梨(糖)醇6.5%、丙二醇2%、羟苯甲酯0.15%、PEG-40氢化蓖麻油2.5%、食用香精(料)0.3%、EDTA二钠0.07%、尿囊素0.12%、三氯半乳糖0.1%、西吡氯铵0.05%、桃柁酚0.07%、柠檬酸钠0.15%、牡丹根提取物0.08%、臭灵丹提取物0.7%和余量的去离子水。
实施例4,在上述实施例1的基础上;甘油3.5%、山梨(糖)醇8%、丙二醇3.5%、羟苯甲酯0.2%、PEG-40氢化蓖麻油3%、食用香精(料)0.3%、EDTA二钠0.1%、尿囊素0.1%、三氯半乳糖0.1%、西吡氯铵%0.05、桃柁酚0.05%、柠檬酸钠0.1%、牡丹根提取物0.08%、臭灵丹提取物0.7%和余量的去离子水。
实施例5,在上述实施例1的基础上;甘油1.5%、山梨(糖)醇6.5%、丙二醇2%、羟苯甲酯0.15%、PEG-40氢化蓖麻油2.5%、食用香精(料)0.3%、EDTA二钠0.1%、尿囊素0.1%、三氯半乳糖0.1%、西吡氯铵%0.05、桃柁酚0.05%、柠檬酸钠0.1%、乌拉草提取物0.04%、芦荟提取物0.04%、神秘果果肉提取物0.04%、牡丹根提取物0.04%、臭灵丹提取物0.84%和余量的去离子水。
对比例1、在上述实施例1的基础上;各原料用量百分比分别为:甘油1.5%、山梨(糖)醇6.5%、丙二醇2%、羟苯甲酯0.15%、PEG-40氢化蓖麻油2.5%、食用香精(料)0.3%、EDTA二钠0.1%、尿囊素0.1%、三氯半乳糖0.1%、西吡氯铵0.05%、桃柁酚0.05%、柠檬酸钠0.1%、臭灵丹提取物0.78%和余量的去离子水。
对比例2、在上述实施例1的基础上;各原料用量百分比分别为:甘油1.5%、山梨(糖)醇6.5%、丙二醇2%、羟苯甲酯0.15%、PEG-40氢化蓖麻油2.5%、食用香精(料)0.3%、EDTA二钠0.1%、尿囊素0.1%、三氯半乳糖0.1%、西吡氯铵0.05%、桃柁酚0.05%、柠檬酸钠0.1%、牡丹根提取物0.12%、和余量的去离子水。
抑菌测试
实验方法:
将大肠杆菌、金黄色葡萄球菌、变异链球菌在培养液中培养后用于实验;在灭菌后的生理盐水中添加样品,作用5分钟,并接种细菌培养液后在35±1℃中以20rpm做振荡培养;另外再用空实验液体做对比组,在生理盐水中接种细菌培养使用。将对于空实验液体的48小时培养后的菌数与48小时培养后的实验液中菌数来计算减少率。
表一:抑菌测试测试结果
从以上数据,灵丹草提取物具备抑菌喷雾,具有抑菌、抗炎、防龋齿、口气清新的作用,牡丹根提取物具备抑菌喷雾,具有抑菌、抗炎、防龋齿、口气清新的作用;当灵丹草提取物和牡丹根提取物二者进行复配时,能提高对大肠杆菌、金黄色葡萄球菌、变异链球菌的抑菌效果,进而提高整体的抑菌效果。
灵丹草口腔抑菌喷雾功效:
本研究共招募200名患有口腔溃疡、牙周炎、牙龈炎或咽喉炎等的受试者,进行为期14天的随机研究,每天使用灵丹草口腔抑菌喷雾喷口腔3次,志愿者进行了自我评估效果,结果见如下表而所示。
表二:实施例2产品的抑菌喷雾功效测试;
天数 | 有感觉明显的效果(人) | 没有感觉到效果(人) |
3-4天 | 148 | 52 |
6-7天 | 172 | 28 |
9-14天 | 195 | 5 |
从数据可以看出灵丹草口腔抑菌喷雾功效对缓解口腔溃疡,牙周炎,牙龈炎,咽喉炎有比较明显对效果。
同时,招募50名患有口腔溃疡、50名患有牙周炎、50名患有牙龈炎和50名患有咽喉炎的受试者,分成三组,分别用实施例2、对比例1和对比例2的产品进行上述实验,进行为期14天的随机研究,每天使用口腔抑菌喷雾喷口腔3次;志愿者进行了自我评估效果;通过统计每组200名患者使用相应产品后感受到有明显的效果的最短时间,其中超多14天没有感觉到效果不作统计,结果见如下表三所示。
通过表三数据分析可知,灵丹草提取物和牡丹根提取物二者进行复配时,提高对缓解口腔溃疡,牙周炎,牙龈炎,咽喉炎的作用效果和作用速率。
肉汤稀释法测试最低抑制浓度(MIC):
表四:
通过表四分析控制,灵丹草提取物和牡丹根提取物二者进行复配时,抗四款革兰氏阳性菌的MIC有明显的变化,说明臭灵丹提取物复配牡丹根提取物有协同效果和增效。
表五:
通过表四分析控制,灵丹草提取物和牡丹根提取物二者进行复配时,抗四款革兰氏阴性菌的MIC有明显的变化,说明臭灵丹提取物复配牡丹根提取物有协同效果和增效。
同时在本发明提供的实施例5中,通过添加芦荟提取物,利用芦荟提取物中包含蒽醌类化合物、糖类、氨基酸、脂类、矿物质和酶等多种有效成分,整体上提高抗菌、抗炎、抗氧化,尤其适合对患有复发性阿弗他溃疡和扁平苔藓、口腔黏膜下纤维性变、放射性口腔黏膜炎、灼口综合征等患者使用。
同时在本发明提供的实施例5中,利用神秘果果肉提取物改变味觉的神秘特性,将其应用在口腔护理液上,可使得产品有独特的口感效果以及抑菌消炎的作用。
将神秘果洗干净,取其果肉,用压磨机压碎成乳剂,用离心干燥设备将乳剂干燥浓缩形成果肉浆,按照果浆:乙醇1:3加入乙醇,混合均匀,用柠檬酸调至pH值为3.0-3.3,搅拌混合,用120目离心过滤去除滤渣,在-30℃真空冷冻干燥形成粉状。
同时在本发明提供的实施例5中,添加有乌拉草提取物,乌拉草提取物中含多种天然脂肪酸类化合物,此类物质具有较好的抗菌作用,。
乌拉草提取物提取方法取乌拉草药材粉末用甲醇回流提取,过滤,滤液置10mL量瓶中,残渣加适量甲醇洗涤3次,洗涤液滤入量瓶中,用甲醇稀释至刻度即可。
在本说明书的描述中,参考术语“一个实施例”、“示例”、“具体示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中,对上述术语的示意性表述不一定指的是相同的实施例或示例。而且,描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
以上公开的本发明优选实施例只是用于帮助阐述本发明。优选实施例并没有详尽叙述所有的细节,也不限制该发明仅为所述的具体实施方式。显然,根据本说明书的内容,可作很多的修改和变化。本说明书选取并具体描述这些实施例,是为了更好地解释本发明的原理和实际应用,从而使所属技术领域技术人员能很好地理解和利用本发明。本发明仅受权利要求书及其全部范围和等效物的限制。
Claims (10)
1.一种灵丹草口腔抑菌喷雾剂,其特征在于,以质量百分比计含有如下成分:保湿剂7-20%、增溶剂2-4%、防腐剂0.1-0.2%、植物提取物混合物0.1-1.5%和余量的去离子水;
其中,所述植物提取物混合物包括臭灵丹提取物,以及牡丹根提取物、乌拉草提取物、芦荟提取物和神秘果果肉提取物中的至少一种;
所述植物提取物混合物中臭灵丹提取物的质量百分比为70-95%。
2.根据权利要求1所述的一种灵丹草口腔抑菌喷雾剂,其特征在于,所述植物提取物混合物包括臭灵丹提取物和牡丹根提取物,且植物提取物混合物中牡丹根提取物的质量百分比为5-10%,臭灵丹提取物的质量百分比为90-95%。
3.根据权利要求1所述的一种灵丹草口腔抑菌喷雾剂,其特征在于,所述植物提取物混合物包括臭灵丹提取物、牡丹根提取物、乌拉草提取物、芦荟提取物和神秘果果肉提取物;且五者的用量比为70-95:1-7:1-7:1-7:1-7。
4.根据权利要求1所述的一种灵丹草口腔抑菌喷雾剂,其特征在于,所述保湿剂包括甘油、山梨(糖)醇和丙二醇,且三者的用量比为1-5:5-10:1-5;
所述增溶剂为PEG-40氢化蓖麻油;
所述防腐剂为羟苯甲酯。
5.根据权利要求1-4任一项所述的一种灵丹草口腔抑菌喷雾剂,其特征在于,以质量百分比计还含有食用香精0.1-0.5%、尿囊素0.01-0.2%、三氯半乳糖0.01-0.2%、西吡氯铵0.01-0.1%、桃柁酚0.01-0.1%和PH调节剂0.01-0.3%;
其中,所述PH调节剂选用柠檬酸钠、苹果酸、碳酸氢钠和磷酸二氢钠中的一种或两种。
6.根据权利要求5所述的一种灵丹草口腔抑菌喷雾剂,其特征在于,所述喷雾剂在40±1℃条件下保温24H后恢复室温、无凝聚物、无分层;所述喷雾剂在-5℃~-10℃条件下保温24H后恢复室温、无凝聚物、无分层、无混浊、无沉淀、不变色。
7.根据权利要求5所述的一种灵丹草口腔抑菌喷雾剂,其特征在于,所述喷雾剂细菌总数≦10CFU/ml,霉菌与酵母菌总数≦10CFU/ml。
8.如权利要求5所述的一种灵丹草口腔抑菌喷雾剂,其特征在于,所述喷雾剂在缓解口腔溃疡,牙周炎,牙龈炎,咽喉炎上的应用。
9.如据权利要求5所述的一种灵丹草口腔抑菌喷雾剂,其特征在于,所述喷雾剂在扁桃体炎,咽喉炎,腮腺炎上的应用。
10.根据权利要求5所述的一种灵丹草口腔抑菌喷雾剂的制备方法,其特征在于,包括如下步骤:
Stp1、将丙二醇、羟苯甲酯用不锈钢容器加热70±5℃左右溶解混合待用;
Stp2、将PEG-40氢化蓖麻油、食用香精(料)用不锈钢容器加热到45±5℃溶解混合待用;
Stp3、将桃柁酚,丙二醇用不锈钢混合搅拌装置预分散并加热到70±5℃溶解成透明液体,然后添加PEG-40氢化蓖麻油;
Stp4、将水、山梨(糖)醇、甘油、加入乳化锅中,在转速为20-30rmp搅拌并加热升温至80±5℃,保温30分钟消毒,加入预先溶解透明的丙二醇、羟苯甲酯,搅拌均匀,在转速为10-30rmp的条件下搅拌10分钟;
Stp5、降温至45℃,加入预先溶解的PEG-40氢化蓖麻油、食用香精(料),搅拌均匀,在10-20rmp的条件均质5分钟后打开均质器门;
Stp6、加入预先溶解好的桃柁酚、丙二醇、PEG-40氢化蓖麻油,在10-20rmp的条件下均质5分钟后打开均质器门;
Stp7、加入植物提取物混合物在10-20rmp的条件下均质5分钟后打开均质器门;
Stp8、加入EDTA二钠、尿囊素、西吡氯铵、三氯半乳糖,在10-20rmp的条件下搅拌20分钟,用PH调节剂调PH=6.0-7.0;然后用0.22微米滤膜和800目滤布双重过滤,出料;
Stp9、半成品静置24小时后,取样,检测微生物、PH值、外观、口感、功效合格后可以进行罐装。
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