CN103110536B - 一种洁齿抗菌凝胶配方及其制备方法 - Google Patents

一种洁齿抗菌凝胶配方及其制备方法 Download PDF

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CN103110536B
CN103110536B CN201210556254.2A CN201210556254A CN103110536B CN 103110536 B CN103110536 B CN 103110536B CN 201210556254 A CN201210556254 A CN 201210556254A CN 103110536 B CN103110536 B CN 103110536B
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chitosan
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黄昌平
郑茂鑫
聂开品
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GUIZHOU YANGSHENG MEDICAL INSTRUMENT CO Ltd
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Abstract

本发明公开了一种洁齿抗菌凝胶配方及其制备方法,该凝胶原料有壳聚糖碘,冰醋酸,聚山梨酯-20,丙三醇,碘酸钾,山梨醇,二氧化硅,椰油酰胺丙基甜菜碱,薄荷香精和纯化水。制法为:①称料;②壳聚糖碘中加入冰醋酸、聚山梨酯-20、丙三醇、纯化水搅拌均匀,完全溶解;③取纯化水溶解碘酸钾后加入物料中,搅匀;④再加入山梨醇、二氧化硅、椰油酰胺丙基甜菜碱、薄荷香精,加纯化水,缓慢搅拌,即得成品。本凝胶可杀灭多种病原微生物,抑制和杀灭口腔、咽喉部位的致病菌,有促进创面愈合、止血、消炎作用;还有洁齿除垢功效,能迅速清除齿面菌斑和附作物,且无毒、无口腔黏膜刺激,稳定性好。加工后可用于牙周病等口腔疾患的洁齿抗菌治疗。

Description

一种洁齿抗菌凝胶配方及其制备方法
技术领域
本发明涉及医用敷料,特别涉及含有壳聚糖碘的敷料,具体来说,涉及洁齿抗菌凝胶。
背景技术
碘用于机体消毒已有150年的历史,但由于碘在水中的溶解度很小,在25℃下只有1.315×10-3mol/L,不能配成水性制剂使用;在室温下易升华,含量不稳定;对皮肤粘膜有刺激性等缺点而限制了它的广泛应用。目前,应用广泛的碘伏类消毒剂大多是以有机聚合物或表面活性物质为载体,通过载体分子间形成的网状结构或胶束,以电子和空间的构象效应将碘“束缚”于其中,从而改变碘在一般碘制剂中的游离状态,使其稳定性和杀菌作用增强、刺激性和黄染性降低。但这类以表面活性物质为载体的成品经稀释后原有的胶束力会被破坏,使活性碘的稳定性下降,从而影响其消毒杀菌效果。目前,在我国应用最广泛的碘伏类消毒剂是聚维酮碘络合物。但聚维酮对碘的溶解度较小,而且分子量较大,难被生物降解,长期使用会对环境产生不良影响。另外,聚维酮本身并无杀菌作用,只是作为一种表面活性载体形成胶束,来提高碘分子的稳定性。
壳聚糖(chitosan)是自然界中唯一的带正电荷的支链多糖,具有抗菌,抗肿瘤,增强免疫等功能,具有良好的生物相容性,且无刺激性、无毒副作用,由于2-NH2的存在,壳聚糖具有一定的抑菌功能,但抑菌性能有限,且受到壳聚糖分子量、脱乙酰度等条件的影响。壳聚糖是一种生物性能优异的高分子化合物,吸附碘后,碘的热稳定性大大提高,同其它碘伏一样,壳碘可释放出元素碘,因而具有强的消毒杀菌作用。该成品无毒,稳定性好,无刺激性。有文献报道了壳聚糖碘的灭菌效果(《壳聚糖碘液杀菌效果的实验观察》,衡阳医学院学报(医学版) 2000年05期),其所用壳聚糖原料是水溶性壳聚糖。
牙齿的健康是人体健康的重要部分之一。爱牙就要保护牙齿的洁白与整齐。因此人们研究了许多洁齿的方法和药物。在中国专利数据库中,涉及洁齿的专利申请件多达数十件,例如200480008206.3号《用于牙齿增白的水凝胶组合物》、200610035086.7号《一种弹性凝胶深层增白牙齿贴膜》、200910115132.8号《用于牙齿漂白美白的凝胶》、201110413207.8号《牙科诊室用强效牙齿漂白凝胶》等,但迄今为止,尚无用壳聚糖碘制作洁齿抗菌凝胶制剂的专利申请件。
发明内容
本发明的目的是提供一种稳定性好,杀菌效果佳的洁齿抗菌凝胶配方,使之为人类健康服务。
本发明的又一目的是提供上述洁齿抗菌凝胶的制备方法,使之能够实现临床的实际应用。
发明人提供的洁齿抗菌凝胶,以壳聚糖碘为主要活性成分,其原料质量配方如下:
壳聚糖碘            0.25%~2.0%
        冰醋酸              0.125%~1.0%
        聚山梨酯-20         0.75%~3.0%
        丙三醇              2.5%~7.0%
        碘酸钾              0.025%~0.2%
山梨醇               30%~40%
        二氧化硅             12%~18%
        椰油酰胺丙基甜菜碱   8%~13%
        薄荷香精             0.5%~1.5%
    纯化水               加至100%。
本发明的洁齿抗菌凝胶的原料优选质量配方如下:
壳聚糖碘             0.6%
        冰醋酸               0.3%
        聚山梨酯-20          1.8%
        丙三醇               6.0%
        碘酸钾               0.1%
山梨醇               36%
        二氧化硅             13%
        椰油酰胺丙基甜菜碱   12%
        薄荷香精             1.0%
    纯化水              加至100%。
上述壳聚糖碘系非水溶性壳聚糖与碘经络合反应制备而得。
上述冰醋酸、聚山梨酯-20、丙三醇、碘酸钾、山梨醇、二氧化硅、椰油酰胺丙基甜菜碱、薄荷香精、纯化水均符合《中华人民共和国药典》的要求。
发明人提供的洁齿抗菌凝胶的制备方法,包括以下步骤:
① 按照原料质量配方称料,备用;
② 在壳聚糖碘中加入冰醋酸、聚山梨酯-20、丙三醇、纯化水充分搅拌均匀,使完全溶解,备用;
③ 取少量纯化水溶解碘酸钾,并加入到备用物料中混合,搅拌均匀,得到混合物料; 
④ 按照原料质量配方继续在混合物料中加入山梨醇、二氧化硅、椰油酰胺丙基甜菜碱、薄荷香精,纯化水加至100%,缓慢搅拌使成凝胶,即得。
发明人指出:洁齿抗菌凝胶中的壳聚糖碘起消毒杀菌、促进愈合的作用,冰醋酸用于调节pH值,并起到协同增溶效果,聚山梨酯-20主要起增溶作用,丙三醇起调合保湿及甜味剂作用,碘酸钾起稳定剂作用,山梨醇起保湿赋形及防腐作用,二氧化硅起增加摩擦力的作用,椰油酰胺丙基甜菜碱起到增稠作用,薄荷香精能增加香味,纯化水为稀释剂。洁齿抗菌凝胶主要成分为壳聚糖碘,可非选择性杀灭多种病原微生物,能显著抑制和杀灭口腔、咽喉部位的致病菌,同时具有促进创面愈合、止血、消炎等作用;还具有洁齿除垢功效,能迅速清除牙齿表面的菌斑和附作物,且无毒、无口腔黏膜刺激性,稳定性好。加工后可用于牙周病等口腔疾患的洁齿抗菌治疗。
具体实施方式
通过下列实施例详细说明本发明的具体实施方式:
实施例l   按照下列原料质量配方称量配料:壳聚糖碘0.25g,冰醋酸0.125g,聚山梨酯-20 0.75g,丙三醇2.5g,碘酸钾0.025g,山梨醇30g,二氧化硅12g,椰油酰胺丙基甜菜碱 8g,薄荷香精0.5g,纯化水加至100g。在壳聚糖碘中加入冰醋酸、聚山梨酯-20、丙三醇、部分纯化水充分搅拌均匀,使完全溶解,备用;之后取少量纯化水溶解碘酸钾,并加入到备用物料中混合,搅拌均匀;再按照原料质量配方继续在混合物料中加入山梨醇、二氧化硅、椰油酰胺丙基甜菜碱、薄荷香精,加余下的纯化水至100g,缓慢搅拌使成凝胶,即得洁齿抗菌凝胶成品。
实施例2  按照下列原料质量配方称量配料:壳聚糖碘0.6g,冰醋酸0.3 g,聚山梨酯-20 1.8g,丙三醇6.0g,碘酸钾0.1g,山梨醇36g,二氧化硅13g,椰油酰胺丙基甜菜碱12g,薄荷香精1.0g,纯化水加至100g。制法同实施例1,得到洁齿抗菌凝胶成品。
实施例 3  按照下列原料质量配方称量配料:壳聚糖碘2g,冰醋酸1g,聚山梨酯-20 3g,丙三醇7g,碘酸钾0.2g,山梨醇40g,二氧化硅 18g,椰油酰胺丙基甜菜碱13g,薄荷香精1.5g,纯化水加至100g。制法同实施例1,得到洁齿抗菌凝胶成品。

Claims (4)

1.一种洁齿抗菌凝胶,其特征在于它以壳聚糖碘为主要活性成分,其原料质量配方如下:
壳聚糖碘            0.25%~2.0%
        冰醋酸                0.125%~1.0%
        聚山梨酯-20         0.75%~3.0%
        丙三醇              2.5%~7.0%
        碘酸钾              0.025%~0.2%
山梨醇               30%~40%
        二氧化硅             12%~18%
        椰油酰胺丙基甜菜碱   8%~13%
        薄荷香精             0.5%~1.5%
    纯化水               加至100%。
2. 如权利要求1所述的洁齿抗菌凝胶,其特征在于原料的质量配方如下:
壳聚糖碘             0.6%
        冰醋酸                 0.3%
        聚山梨酯-20          1.8%
        丙三醇               6.0%
        碘酸钾               0.1%
山梨醇               36%
        二氧化硅             13%
        椰油酰胺丙基甜菜碱   12%
        薄荷香精             1.0%
    纯化水              加至100%。
3.如权利要求1或2之一所述洁齿抗菌凝胶,其特征在于所述壳聚糖碘系非水溶性壳聚糖与碘经络合反应制备而得。
4.制备权利要求1或2之一所述洁齿抗菌凝胶的方法,其特征包括以下步骤:
① 按照原料质量配方称料,备用;
② 在壳聚糖碘中加入冰醋酸、聚山梨酯-20、丙三醇、纯化水充分搅拌均匀,使完全溶解,备用;
③ 取少量纯化水溶解碘酸钾,并加入到备用物料中混合,搅拌均匀,得到混合物料; 
④ 按照原料质量配方继续在混合物料中加入山梨醇、二氧化硅、椰油酰胺丙基甜菜碱、薄荷香精,纯化水加至100%,缓慢搅拌使成凝胶,即得。
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CN102144988A (zh) * 2011-03-16 2011-08-10 贵州扬生医用器材有限公司 一种壳聚糖宫颈抗菌膜及其制备方法
CN102764447A (zh) * 2012-07-27 2012-11-07 武汉人福医疗用品有限公司 水凝胶敷料及其制备工艺

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102144988A (zh) * 2011-03-16 2011-08-10 贵州扬生医用器材有限公司 一种壳聚糖宫颈抗菌膜及其制备方法
CN102764447A (zh) * 2012-07-27 2012-11-07 武汉人福医疗用品有限公司 水凝胶敷料及其制备工艺

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