CN116172904A - 一种水包油体系的透明舌苔啫喱及其制备方法 - Google Patents
一种水包油体系的透明舌苔啫喱及其制备方法 Download PDFInfo
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Abstract
一种水包油体系的透明舌苔啫喱,原料按重量份数计包括以下成分:
Description
技术领域
本发明涉及一种水包油体系的透明舌苔啫喱及其制备方法。
背景技术
舌苔中的表面积大且包含一些不规则的结构,比如裂、沟以及乳头下区域等,在大多数人的舌背上可以看见浅的裂纹;而舌苔是附在舌背上的可见的白黄色的层膜,包含了脱屑的上皮细胞、血细胞以及代谢物、营养物和细菌,舌背上的每一个单层上皮细胞都可附着上百个细菌,但是在口腔的其他部位,每一个细胞平均只能附着25个细菌。所以舌苔上的细菌数量以及种类是口腔中的细菌的几倍,现有的舌苔啫喱的抑菌效果根本无法有效抑制舌苔上的细菌。
目前主要通过以下技术手段增强对舌苔上的抑菌作用:
1、通过提高表面活性剂的用量或者选择清洁能力更强的表面活性剂的种类,例如常规的舌苔啫喱一般加入月桂基醚硫酸钠等表面活性剂不仅能达到清洁的功效,而且该类表面活性剂含有的环氧乙烷还可以起到杀菌作用,但是却对人体具有一定的危害。
2、加入清凉剂薄荷醇以及伞花烃、粉末提取物等抑菌剂;在低温稳定性测试中会出现兼容析出的问题。
综上所述,如何研制一款能有效抑制舌苔上的细菌,又能保持体系稳定的舌苔啫喱成为亟待解决的问题。
发明内容
本发明旨在至少解决现有技术中存在的技术问题之一。为此,本发明提出一种水包油体系的透明舌苔啫喱及其制备方法。
本发明的一种实施例解决其技术问题所采用的技术方案是:
一种水包油体系的透明舌苔啫喱,原料按重量份数计包括以下成分:
优选的,所述螯合剂为EDTA-2Na或植酸钠。
优选的,所述保湿剂为山梨(糖)醇、丙二醇、甘油或透明质酸钠中的一种或者几种。
优选的,所述pH调节剂为氢氧化钠或精氨酸。
优选的,所述增稠剂为丙烯酸(酯)类/C10-30烷醇丙烯酸酯交联聚合物和/或卡波姆。
优选的,所述防腐剂为苯甲酸钠、苯氧乙醇、山梨酸钾、羟苯甲酯中的一种或多种。
优选的,制备方法如下:
S1:将80%去离子水、保湿剂、螯合剂、增稠剂加入乳化锅中搅拌加热到80-85℃,均质搅拌溶解完全;
S2:将泊洛沙姆加入20%去离子水搅拌加热到80-85°C并溶解完全后,加入邻伞花烃-5-醇、薄荷醇搅拌溶解完全后开始降温,降温至45℃投入乳化锅中,搅拌均匀;
S3:再加入防腐剂、pH调节剂、癸基葡糖苷搅拌均匀,降温到38℃以下出料。
本发明的有益效果:
1、本申请制备的水包油体系的舌苔啫喱具有更强的抑菌性能,有效地清洁舌苔上裂纹等缝隙的细菌微生物,能更好地抑制舌苔上的细菌。
2、本申请制备的水包油体系的舌苔啫喱不含环氧乙烷、不含甜菜碱、不含硫酸盐、不含硫酸醚;属于低含量的脂肪醇硫酸盐体系的舌苔啫喱;对黏膜友好,属于亲和型的舌苔啫喱。
3、本申请在水包油体系的舌苔啫喱复配邻伞花烃-5-醇、泊洛沙姆、癸基葡糖苷等原料成分,解决了低温稳定性的问题。
具体实施方式
下面结合实施例对本发明做进一步说明,但本发明的保护范围不限于此:
配方及组分(各原料成分质量总和按100g计算)
实施例1的制备方法
(1)将80%去离子水、山梨(糖)醇、丙二醇、甘油、EDTA-2Na、卡波姆加入乳化锅中搅拌加热到80-85℃,均质搅拌溶解完全。
(2)将泊洛沙姆加入20%去离子水搅拌加热到80-85°C并溶解完全后,加入邻伞花烃-5-醇、薄荷醇搅拌溶解完全后开始降温,降温至45℃投入乳化锅中,搅拌均匀。
(3)再加入苯氧乙醇、氢氧化钠、癸基葡糖苷、益生菌、三七根提取物、铁皮石斛茎提取物搅拌均匀,降温到38℃以下出料。
对比例1的制备方法
(1)将80%去离子水、山梨(糖)醇、丙二醇、甘油、EDTA-2Na、卡波姆加入乳化锅中搅拌加热到80-85℃,均质搅拌溶解完全。
(2)将泊洛沙姆加入20%去离子水搅拌加热到80-85°C并溶解完全后,加入邻伞花烃-5-醇、薄荷醇搅拌溶解完全后开始降温,降温至45℃投入乳化锅中,搅拌均匀。
(3)再加入苯氧乙醇、氢氧化钠、益生菌、三七根提取物、铁皮石斛茎提取物搅拌均匀,降温到38℃以下出料。
对比例2的制备方法
(1)将80%去离子水、山梨(糖)醇、丙二醇、甘油、EDTA-2Na、卡波姆加入乳化锅中搅拌加热到80-85℃,均质搅拌溶解完全。
(2)将20%去离子水搅拌加热到80-85℃并溶解完全后,加入邻伞花烃-5-醇、薄荷醇搅拌溶解完全后开始降温,降温至45℃投入乳化锅中,搅拌均匀。
(3)再加入苯氧乙醇、氢氧化钠、益生菌、癸基葡糖苷、三七根提取物、铁皮石斛茎提取物搅拌均匀,降温到38℃以下出料。
实施例1中选用卡波姆作为增稠体系,根据中和增稠的原理,加入氢氧化钠作为中和剂制备成透明的舌苔啫喱。由于卡波不耐离子的特性,实施例1中选取癸基葡糖苷作为表面活性剂,所述癸基葡糖苷由月桂基葡萄糖羧酸钠和月桂基葡糖苷组成;实验中发现其亲油部分的糖苷醚键(-C-O-C-)能在卡波体系中稳定的存在,不会发生水解反应或者与卡波支链上的COO-结合。除此之外,癸基葡糖苷不含环氧乙烷相比月桂基醚硫酸钠、单酸甘油酯类、乙酰化单酸甘油酯、脱水山梨糖醇酯或硬脂基乳酸钠,安全性更高。
舌苔中的表面积大且包含一些不规则的结构,使细菌藏匿深,传统的杀菌药难以渗透至生物膜深处,只能杀死舌苔表面的细菌,舌苔是附在舌背上的可见的白黄色的层膜,该层膜和其他生物膜一样具有“脂质筛”,对癸基葡糖苷、泊洛沙姆等物质的透过性较低,而加入薄荷醇可增加癸基葡糖苷、泊洛沙姆的渗透作用,有利于癸基葡糖苷、泊洛沙姆深入舌苔中的裂纹等深处进行深层杀灭。
由于舌苔上的细菌种类以及数量是比较多的,当舌苔上的金黄色葡萄球菌的数量达到一定程度时,会出现舌苔发黑的现象。本申请的舌苔啫喱可改善上述情况;体系中加入邻伞花烃-5-醇,其也能迅速浸入舌苔中裂纹的金黄色葡萄球菌膜内,有效杀灭舌苔中的金黄色葡萄球菌繁殖体,从而改善舌苔发黑的现象。而在上述方案上复配癸基葡糖苷可形成层状液晶,对邻伞花烃-5-醇具有缓释效果,对舌苔上的微生物环境具有一个持久的杀菌效果。
实验中还发现当体系中只加入癸基葡糖苷(即对比例1)或者仅仅加入泊洛沙姆(即对比例2),在低温稳定实验中均出现了浑浊的现象;而在实施例1在体系中复配泊洛沙姆、癸基葡糖苷,两者在低温稳定性中具有协同增效的作用,可以使实施例1中的体系处于稳定状态。
由于舌苔啫喱主要以水剂为主,而邻伞花烃-5-醇的结构属于疏水性,其在水中的溶解度并不理想。由对比例1实验可得癸基葡糖苷虽然可提升邻伞花烃-5-醇在水中的溶解度,但是无法解决其在低温稳定实验中的浑浊问题,提升邻伞花烃-5-醇在配方中的添加量。
泊洛沙姆在制药领域常用作乳化剂、软膏剂和混选剂的润滑剂、片剂或胶囊的分散剂,其对皮肤刺激性小,例如在眼用制剂中的应用,以泊洛沙姆为温敏型材料制备乳酸环丙沙星眼用凝胶。泊洛沙姆为非离子型的聚氧乙烯-聚氧丙烯共聚物,在药物制剂中主要用作乳化剂和增溶剂,在实施例1中泊洛沙姆在水中形成胶团,以聚氧丙烯链段为内核,以聚氧乙烯链段为栅栏层;根据相似相溶原理,泊洛沙姆能增加邻伞花烃-5-醇的表面溶解度,结合对比例1、对比例2的实验结果表明,泊洛沙姆与癸基葡糖苷在提高邻伞花烃-5-醇水中溶解度具有协同的作用,本申请还发现加入泊洛沙姆制备而成的啫喱,其能增加啫喱表面与舌苔上的黏膜的生物粘附性,从而控制邻伞花烃-5-醇缓慢释放进入舌苔裂纹的缝隙中或者粘附在舌苔的表面相互渗透,从而提高杀菌的效果。
为了改善舌苔上产生的尸胺、腐胺、吲哚等口臭气体,本申请还加入三七根提取物,可控制舌苔上的脱屑的上皮细胞、血细胞代谢,使其恢复正常的代谢功能。
铁皮石斛茎提取物,增强T淋巴细胞的增殖和分化及NK细胞的活性,增强机体免疫力。
山梨(糖)醇,滋润口腔,解决口干口苦。
口腔黏膜刺激试验
一、材料和方法
1.受试物:实施例1制备而成的透明啫喱。
2.动物和饲养环境
SPF级金黄地鼠3只,42天~70天日龄,由北京维通利华实验动物技术有限公司提供,实验动物生产许可证号:SCXK(京)2021一0011,质量合格证号:No.11001122107994826。饲料由北京科澳协力饲料有限公司提供。动物购进后在本院动物房检疫合格后使用,实验动物使用许可证号:SYXK(粤)2018一0137,动物房温度:20℃~26℃,相对湿度:40%~70%。
3.试验方法(多次接触法)
3.1取检疫合格的雄性金黄地鼠3只。用3%戊巴比妥钠按45mg/kg既剂量将动物麻醉,用碘伏清洁消毒动物口腔内外组织。
3.2直接使用材料,记录所用受试物体积,放入金黄地鼠的一侧口腔颊囊内。另一侧口腔颊囊不放置样品作为空白对照。接触时间5min,每小时重复1次,共4次。每次接触后及重复放置前检查颊囊。末次接触后24小时肉眼观察颊囊。
3.3末次接触后24小时无痛处死动物,取试样接触部位的黏膜及其周围组织,10%福尔马林固定,常规石蜡包埋,半连续切片,间隔取片5张,HE染色。
4.结果判定按YY/T0127.13一2018《口腔医疗器械生物学评价第13部分:口腔黏膜刺激试验》中10.1.2表1口腔黏膜反应记分系统、10.2.2表2口腔黏膜组织反应记分系统和11.2表3口腔黏膜组织反应分级进行结果判定。
二、试验结果
给样后,肉眼观察试样放置位置黏膜24小时反应平均评分为O分。金黄地鼠口腔黏膜反应观察结果见表1,口腔黏膜组织反应观察结果见表2。
表1受试物对金黄地鼠末次接触后口腔黏膜肉眼观察反应记分表
表2受试物对金黄地鼠口腔黏膜组织反应记分
注:1.在记分栏,反应记分为每只动物口腔颊囊三个观察部分反应记分之和。
2.平均记分=所有动物反应记分之和/观察总数(动物数X3)。
口腔黏膜刺激指数=0,反应程度:无。
三、结论
在本试验条件下,试验结果为无刺激。
抑菌实验
检验方法:参照GB 15979-2002《一次性使用卫生用品卫生标准》
检验结果:
1.在本试验条件下,实施例1对大肠杆菌的平均抑菌率为>99.9%。
2.在本试验条件下,实施例1对金黄色葡萄球菌的平均抑菌率为>99.9%。
本领域的技术人员容易理解,以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,任何人应得知在本发明的启示下做出的结果变化,凡是与本发明具有相同或相近的技术方案,均落入本发明的保护范围之内。
Claims (7)
2.根据权利要求1所述的一种水包油体系的透明舌苔啫喱,其特征在于,所述螯合剂为EDTA-2Na或植酸钠。
3.根据权利要求2所述的一种水包油体系的透明舌苔啫喱,其特征在于,
所述保湿剂为山梨(糖)醇、丙二醇、甘油或透明质酸钠中的一种或者几种。
4.根据权利要求3所述的一种水包油体系的透明舌苔啫喱,其特征在于,所述pH调节剂为氢氧化钠或精氨酸。
5.根据权利要求1所述的一种水包油体系的透明舌苔啫喱,其特征在于,所述增稠剂为丙烯酸(酯)类/C10-30烷醇丙烯酸酯交联聚合物和/或卡波姆。
6.根据权利要求1所述的一种水包油体系的透明舌苔啫喱,其特征在于,所述防腐剂为苯甲酸钠、苯氧乙醇、山梨酸钾、羟苯甲酯中的一种或多种。
7.制备如权利要求1所述的一种水包油体系的透明舌苔啫喱,其特征在于,制备方法如下:
S1:将80%去离子水、保湿剂、螯合剂、增稠剂加入乳化锅中搅拌加热到80-85℃,均质搅拌溶解完全;
S2:将泊洛沙姆加入20%去离子水搅拌加热到80-85℃并溶解完全后,加入邻伞花烃-5-醇、薄荷醇搅拌溶解完全后开始降温,降温至45℃投入乳化锅中,搅拌均匀;
S3:再加入防腐剂、pH调节剂、癸基葡糖苷搅拌均匀,降温到38℃以下出料。
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