CN110859757A - 含溶菌酶的漱口水泡腾片及其制备方法 - Google Patents
含溶菌酶的漱口水泡腾片及其制备方法 Download PDFInfo
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- CN110859757A CN110859757A CN201911154506.7A CN201911154506A CN110859757A CN 110859757 A CN110859757 A CN 110859757A CN 201911154506 A CN201911154506 A CN 201911154506A CN 110859757 A CN110859757 A CN 110859757A
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Abstract
本发明公开了一种含溶菌酶的漱口水泡腾片,由以下重量份比的各组分组成:泡腾剂:2000~4000份,填充剂:500~2000份,溶菌酶:50~500份,甜味剂:1~15份,润滑剂:50~500份,粘合剂:50~500份,清凉剂:5~400份,香精:5~150份,其他功能性添加剂:5~250份。本发明制成的漱口水不但可以改善人体自身防御功能,增强口腔内有益菌对外界干扰因素的抵抗能力,促进维护口腔自身正常微生态平衡,抑制口腔致病菌的繁殖,减少各种口腔问题;且漱口水泡腾片还便于携带和保存,能够在水中快速崩解制成漱口水,使用方便,能满足频繁出差商旅人员的使用需求。本发明还涉及所述泡腾片的制备方法。
Description
技术领域
本发明涉及一种用于漱口水的泡腾片,尤其是涉及一种含溶菌酶的漱口水泡腾片。本发明还涉及所述泡腾片的制备方法。
背景技术
中国消费者饱受口腔问题困扰,这其中包括了龋齿、牙龈出血、牙龈发炎、牙齿敏感、口臭和牙齿变黄等。2015年第四次全国口腔流行病学调查显示:12岁儿童恒牙龋患率为34.5%,比十年前上升了7.8个百分点。5岁儿童乳牙龋患率为70.9%,比十年前上升了5.8个百分点。中年人的口腔主要集中在牙周健康问题上,牙龈出血检出率高达87.4%。口腔疾病是影响居民健康的常见病、多发病,它不仅影响口腔的咀嚼、发音等生理功能,还与脑卒中、心脏病、糖尿病和消化系统疾病等全身系统疾病密切相关。做好口腔日常保健与护理是增强自我口腔卫生环境最直接最有效的方法。常用的口腔护理产品有牙膏、漱口水、口喷和牙线等。刷牙是必须的,每天早晚刷牙。漱口水也是比较有效的护理方式之一,特别是饭后或是饮食后,漱下口,将牙齿上食物残渣冲走,对口腔牙齿健康更有帮助。目前市面上的漱口水多数采用大瓶装,对常出差旅行的消费者以及中午在外就餐,携带是非常不方便。能有一款便携式的漱口水,可以随时携带,随时使用,将可增大消费者使用漱口水的习惯,更好的呵护牙齿。
人的口腔是一个完整的生态系统,给口腔内各种微生物的生长繁殖和定居提供了非常适宜的环境和条件。在口腔定植的微生物包括种类复杂的细菌、真菌、支原体、原虫和病毒,这些微生物在口腔不同部位共栖竞争和拮抗,构成了口腔微生态系,与宿主口腔的健康和疾病有着密切关系。
众所周知,各种口腔问题主要是由细菌引起的。采用有效的漱口液、牙膏以及口腔疾病的治疗等措施可以明显降低口腔内致病菌的数量和改善甚至消除口腔疾病。漱口水、牙膏等口腔护理产品之所以能实现这些功能是靠产品中活性成分或抑菌成分来实现的,这些抑菌成分以中草药和化学类抑菌剂使用最多。化学类如三氯生、西吡氯铵、洗必泰、抗生素等。但经常使用含有抗菌剂成分的口腔护理产品,容易造成口腔细菌生态失调,或使细菌产生抗药性,不能达到预防口腔疾病的效果,反而引发其他多种口腔疾病。
现有技术还有的不足之处是:
1、液体漱口水存在许多酒精液体;
2、液态不易于携带储存;
3、溶菌酶遇碱失活,酸稳定(溶菌酶在碱性条件下容易失活,在酸性条件下相对稳定)。
发明内容
本发明所要解决的第一个技术问题,就是提供一种含溶菌酶的漱口水泡腾片。
本发明所要解决的第二个技术问题,就是提供一种含溶菌酶的漱口水泡腾片的制备方法。
按本发明的泡腾片配方采用本发明的方法制备出的泡腾片配成的漱口水不但可以改善人体自身防御功能,增强口腔内有益菌对外界干扰因素的抵抗能力,促进维护口腔自身正常微生态平衡,抑制口腔致病菌的繁殖,减少各种口腔问题;且漱口水泡腾片还便于携带和保存,能够在水中快速崩解制成漱口水,使用方便,能满足频繁出差商旅人员的使用需求。
解决上述第一个技术问题,本发明所采用的技术方案如下:
一种含溶菌酶的漱口水泡腾片,其特征是:由且只由以下重量份比的各组分组成:
泡腾剂:2000~4000份,
填充剂:500~2000份,
溶菌酶:50~500份,
甜味剂(甜菊糖苷):1~15份,
润滑剂:50~500份,
粘合剂:50~500份,
清凉剂:5~400份,
香精:5~150份,
其他功能性添加剂:5~250份。
所述的泡腾剂由碱源和酸源组成,其中碱源为碳酸氢钠和碳酸钠中的一种或两种复配;酸源为柠檬酸、酒石酸和苹果酸中的一种或多种复配,其中碱源:酸源为3:1-1:3(1:1/3-3);最优比为3:2(1:2/3)。
所述的填充剂为乳糖、甘露糖、山梨醇粉和麦芽糖精中的一种或多种复配。最优组合为麦芽糖精与山梨醇粉复配。
所述的润滑剂为水溶性聚乙二醇类,如PEG6000或PEG4000。最优选PEG6000。
所述的粘合剂为羟甲基纤维素、羟丙甲基纤维素、羟乙基纤维素、瓜尔胶、海藻酸钠中的一种或多种。最优选羟乙基纤维素。
所述的清凉剂为薄荷脑、WS-3、WS-23和WS-5中的一种或多种。
所述的香精为漱口水用的固体粉末香精。
所述的其他功能性添加剂为维生素类营养添加剂、可溶性锌盐、植物提取物等其中一种或是多种复配;所述的维生素营养添加剂为维生素C、维生素E、维生素A、维生素B类;所述的可溶性锌盐为葡萄酸锌、氯化锌等;所述的植物提取物为水溶性粉末,对口腔细菌有抑制作用,具有消炎、清热的功效的植物提取物,如五倍子提取物、甘草提取物、绿茶提取物等成分。
解决上述第二个技术问题,本发明所采用的方法如下:
一种制备如前所述的泡腾片的制备方法,包括以下步骤:
1)将上述原料除溶菌酶外分别进行研磨,过160~180目筛,并按配比称取各原料,备用;
2)将碱源、50%粘合剂、30%的聚乙二醇(PEG6000用量的30%)加入乙醇溶液,制粒,烘干后粉碎成粉末,过160~180目筛,制得粉末A;
3)将溶菌酶、填充剂、清凉剂、香精、甜菊糖苷、40%的聚乙二醇(PEG6000用量的40%)、其他功能性添加剂均匀混合,加入乙醇溶液,制粒,烘干后粉碎成粉末,过160-180目筛,制得粉末B;
4)将酸源、50%粘合剂、30%的聚乙二醇(PEG6000用量的30%)加入乙醇溶液,制粒烘干粉碎成粉末,过160-180目筛,制得粉末C;
5)将上述粉末A、B、C混合均匀后进行压片,即得。
有益效果:
1.溶菌酶以固体的形式保存在产品中,其活性稳定性得到大大提高。
2.固体的泡腾片携带方便,使用方便简单,节约运输成本。
3.功能成分维生素可以参与机体代谢的调节,增强机体免疫;功能成分中可溶性锌盐可以为人体补充锌离子,改善口腔溃疡等问题;功能成分植物提取物可以抑制口腔致病菌繁殖生长,具有消炎清热的功效。
4.溶菌酶和功能性添加剂复配,能够很好的改善口腔问题,达到标本兼治的效果。
牙菌斑是堆积在牙表面或其他硬的口腔结构上且不能被中度水喷冲去的细菌团块。牙菌斑可引发牙龈炎、牙周炎、龋齿或其他牙周病。各种抗菌剂可延缓细菌生长,减少口腔表面生物膜的形成。本发明所用到的可溶性锌盐提供锌离子通过抑制葡萄糖代谢和/或与细菌细胞壁相互作用,减少口腔内的细菌定植来提供抗菌功效。锌离子可以参与上皮组织分化,能进一步促进伤口愈合。
本发明所涉及的溶菌酶组分是唾液中一种非特异性物质成分,可以抑制微生物生长,与抗生素或其他抑菌形成对比,长期使用,不会出现抗药性。溶菌酶(Lysozyme)是一种能够断裂细菌细胞壁肽聚糖中N-乙酰葡糖胺和N-乙酰胞壁酸之间的β-1,4糖苷键的专性水解酶,属于胞壁质酶。溶菌酶能选择性地溶解目标微生物细胞壁而使其失活,哺乳动物并无细胞壁,因此,其对口腔组织无损伤,而是起保护作用。
口腔黏膜病中的复发性口疮具有复发性和自限性,一般认为发病原因与人体免疫功能异常有关。生物溶菌酶作为机体非特异性免疫因子之一,参与机体的免疫反应,从而保持机体生理平衡。它还可改善和增强巨噬细胞吞噬和消化功能,激活白细胞吞噬功能,从而增强机体的免疫力。溶菌酶还具有激活血小板的功能,可以改善组织局部血液循环,增强局部防御功能。
本发明所涉及含溶菌酶口腔产品,并辅以添加其他对牙齿有作用的功效成分,可以抑制细菌生产,可以改善宿主自身防御功能,增大正常菌群对外界干扰因素的抵抗能力,促进维护口腔自身正常微生态平衡,减少降低各种口腔问题。同时还便于携带和保存,能够在水中快速崩解,服用方便,能满足频繁出差商旅人员的使用需求。
具体实施方式
按表一配方进行配制压片:
表一
配方1-配方8主要研究的是碱源与酸源的比例对泡腾片使用的影响,分别比例为3:1-1:3,其中配方8为对照组;后面的配方9-配方15主要研究的是泡腾剂的含量多少对泡腾片使用的影响,其中配方15是对照组。
制备步骤:
(1)将上述原料除溶菌酶分别进行研磨,过160-180目筛,并按配比称取各原料,备用;
(2)将碳酸氢钠、羟乙基纤维素用量的50%、PEG6000用量的30%加入乙醇溶液,制粒,烘干后粉碎成粉末,过160-180目筛,制得粉末A。
(3)将溶菌酶、山梨糖醇、麦芽糖精、薄荷香精粉、葡萄糖酸锌、维生素C、甜菊糖苷、PEG6000用量的40%均匀混合,加入乙醇溶液,制粒,烘干后粉碎成粉末,160-180目筛,制得粉末B。
(4)将柠檬酸、羟乙基纤维素用量的50%、PEG6000用量的30%加入乙醇溶液,制粒烘干粉碎成粉末,过160-180目筛,制得粉末C。
(5)将上述粉末A、B、C混合均匀后进行压片,即可。
每粒片剂重量约为0.5-1.5g
在上述配方1-8制成的样品中,各取数粒(基本同质量)上述所制备的泡腾片称重,投入50ml的水中,观察其崩解状态,记录崩解时间,测定溶液PH值和计算泡腾剂的溶菌酶含量。表二为各配方测量的平均值。
表二
结论:
碳酸氢钠与柠檬酸质量比为3:1时,泡腾片崩解后,溶液澄清,但ph值为8.61,测量溶菌酶含量为4.62%,明显低于其他实验组,说明配方1溶液可导致部分溶菌酶失活。碳酸氢钠和柠檬酸比2:1-1:2,制备的泡腾片崩解后,溶液基本澄清,基本无杂质,且溶菌酶保持原有活性。在配方3和配方4中,碳酸氢钠与柠檬酸质量比分别为3:2和1:1,泡腾片完全崩解,溶液状态澄清、无杂质,产品外观及崩解后溶液状态都比较理想。
表三
制备步骤:
a)将上述原料除溶菌酶分别进行研磨,过160-180目筛,并按配比称取各原料,备用;
b)将碳酸氢钠、羟乙基纤维素用量的50%、PEG6000用量30%加入乙醇溶液,制粒,烘干后粉碎成粉末,过160-180目筛,制得粉末A。
c)将溶菌酶、山梨糖醇、麦芽糖精、薄荷香精粉、葡萄糖酸锌、维生素C、甜菊糖苷、PEG6000用量的40%均匀混合,加入乙醇溶液,制粒,烘干后粉碎成粉末,160-180目筛,制得粉末B。
d)将柠檬酸、羟乙基纤维素用量50%、PEG6000用量的30%加入乙醇溶液,制粒烘干粉碎成粉末,过160-180目筛,制得粉末C。
e)将上述粉末ABC混合均匀后进行压片,即可。
每粒片剂重量约为0.5-1.5g
在上述配方9-15制成的样品中,各取数粒上述所说的泡腾片称重,投入50ml的水中,观察其崩解状态,记录崩解时间,测定溶液PH值和计算泡腾剂的溶菌酶含量。表四为各配方测量的平均值。
表四
结论:
当崩解剂中碳酸氢钠与柠檬酸为1.5:1,崩解剂总含量逐渐增加,泡腾片崩解时间逐渐减少。通过换算,配方9-15中的崩解剂在泡腾片中占有含量为40%、50%、55%、60%、65%、70%、60%,但在含量50-70%之间崩解时间为1min30s-1min50s,崩解时间比较合理。70%含量,气泡太多崩解,可能会有液体迸溅出杯体。配方12和配方13,泡腾片崩解后过程比较理想,且溶菌酶也有很好的保护。
参照QB 2738-2012日化产品抗菌抑菌效果的评价方法,测定各配方泡腾片崩解溶解液对变异链球菌、牙龈卟啉单胞菌、金黄色葡萄球菌、大肠杆菌的抑制作用。将各配方制备的泡腾片高温45℃放置3个月后,将各配方同质量(1克)的泡腾片投入装有50ml水的烧杯中(0.1%溶菌酶),对其溶液进行抑菌测试。并同步测试配方8、配方15的抑菌效果作为对照组。泡腾片投入水中形成含有0.1%溶菌酶的漱口水溶液,对口腔中细菌具有很好的抑菌功能,测定结果如表五所示。
表五
结果显示,配方1中溶菌酶虽然有部分失活,但对口腔致病菌仍然有很好地抑制作用。配方1-7实验组与配方8对照组对比,碱源与酸源比例在3:1-1:3的范围内,制备的含有溶菌酶制备的泡腾片,崩解后漱口水溶液对口腔中许多致病菌都有较好的抑制作用,抑制率均高于95%。配方9-14实验组与配方15对照组对比,碱源和酸源(崩解剂)总含量在40%-70%范围内,制备的含有溶菌酶制备的泡腾片,崩解后漱口水溶液对口腔中许多致病菌都有较好的抑制作用,抑制率均高于98%。
Claims (10)
1.一种含溶菌酶的漱口水泡腾片,其特征是:由以下重量份比的各组分组成:
泡腾剂:2000~4000份,
填充剂:500~2000份,
溶菌酶:50~500份,
甜味剂(甜菊糖苷):1~15份,
润滑剂:50~500份,
粘合剂:50~500份,
清凉剂:5~400份,
香精:5~150份,
其他功能性添加剂:5~250份。
2.根据权利要求1所述的含溶菌酶的漱口水泡腾片,其特征是:所述的泡腾剂由碱源和酸源组成,所述的碱源为碳酸氢钠和碳酸钠中的一种或两种复配;所述的酸源为柠檬酸、酒石酸和苹果酸中的一种或多种复配;所述的碱源:酸源为3:1-1:3。
3.根据权利要求2所述的含溶菌酶的漱口水泡腾片,其特征是:所述的填充剂为乳糖、甘露糖、山梨醇粉和麦芽糖精中的一种或多种复配。
4.根据权利要求3所述的含溶菌酶的漱口水泡腾片,其特征是:所述的润滑剂为水溶性聚乙二醇类,如PEG6000或PEG4000。
5.根据权利要求4所述的含溶菌酶的漱口水泡腾片,其特征是:所述的粘合剂为羟甲基纤维素、羟丙甲基纤维素、羟乙基纤维素、瓜尔胶和海藻酸钠中的一种或多种。
6.根据权利要求5所述的含溶菌酶的漱口水泡腾片,其特征是:所述的清凉剂为薄荷脑、WS-3、WS-23和WS-5中的一种或多种。
7.根据权利要求6所述的含溶菌酶的漱口水泡腾片,其特征是:所述的香精为漱口水用固体粉末香精。
8.根据权利要求7所述的含溶菌酶的漱口水泡腾片,其特征是:所述的其他功能性添加剂为维生素类营养添加剂、可溶性锌盐和植物提取物其中一种或是多种复配;所述的维生素类营养添加剂为维生素C、维生素E、维生素A或维生素B;所述的可溶性锌盐为葡萄酸锌或氯化锌。
9.根据权利要求8所述的含溶菌酶的漱口水泡腾片,其特征是:由以下重量份比的各组分组成:
碳酸氢钠:1800份;
柠檬酸:1200份;
麦芽糖精:695份;
山梨糖醇:450份;
溶菌酶:250份;
甜菊糖苷:5份;
PEG6000:150份;
羟乙基纤维素:150份;
薄荷脑:100份;
WS-3:50份;
薄荷香精粉:50份;
葡萄糖酸锌:50份;
维生素C:50份。
10.一种如权利要求9所述的含溶菌酶的漱口水泡腾片的制备方法,其特征是包括以下步骤:
(1)将上述原料除溶菌酶外分别进行研磨,过160~180目筛,并按配比称取各原料,备用;
(2)将碱源、50%粘合剂、30%的聚乙二醇(PEG6000用量的30%)加入乙醇溶液,制粒,烘干后粉碎成粉末,过160~180目筛,制得粉末A;
(3)将溶菌酶、填充剂、清凉剂、香精、甜菊糖苷、40%的聚乙二醇(PEG6000用量的40%)、其他功能性添加剂均匀混合,加入乙醇溶液,制粒,烘干后粉碎成粉末,过160-180目筛,制得粉末B;
(4)将酸源、50%粘合剂、30%的聚乙二醇(PEG6000用量的30%)加入乙醇溶液,制粒烘干粉碎成粉末,过160-180目筛,制得粉末C;
(5)将上述粉末A、B、C混合均匀后进行压片,即得。
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