CN111714692A - 一种皮肤创面保护组合物及其制备方法 - Google Patents
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- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
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- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/216—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
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Abstract
本发明公开了一种皮肤创面保护组合物及其制备方法。其包含六甲基二硅氧烷溶剂、丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯溶液、抑菌剂。该组合物可在创面患处形成质地柔软、不易脱落、无毒无刺激的皮肤保护膜,该膜具有良好的阻水性、透气性、阻菌性,具有保护创面、促进创面愈合的作用。
Description
技术领域
本发明涉及一种皮肤创面保护组合物及其制备方法,属于生物医药、医疗器械类技术领域。
背景技术
人们日常生活中经常会出现烧伤、烫伤、擦伤、划伤等体表小创面。小创面一般情况下可以自愈,但若在无相应的保护措施下创面也可能造成不同程度的组织坏死和血管断裂出血,出现炎症反应,难以自愈。因此创面保护、促愈合已成为创伤修复领域的一个重要研究课题。
目前用于创面保护的主要有创面敷料及包扎敷料两大类。其中创面敷料主要有含成膜材料、杀菌消毒成分的喷雾型及涂抹型伤口敷料,其使用不受伤口部位及大小的限制,市面上销售的有小林制药的SAKAHAMUKE涂抹型液体创口贴、青岛海氏海诺的涂抹型液体敷料、人福医药的液体伤口敷料美分子、鸿韵医疗的喷尔舒外用离子抗菌敷料等。包扎类敷料主要含无纺布及杀菌消毒成分,有一定抗耐磨性,但使用时受伤口部位及大小的限制,常见的无纺布创可贴即属于此类。
常见的创面敷料含有的成膜材料主要有聚乙烯醇类、硝酸纤维素类、丙烯酸树脂类,此类成膜材料主要需要用乙醇、异丙醇、乙酸乙酯或乙酸丁酯等进行溶解,待溶剂挥发后形成皮肤创面保护膜。这些溶剂对伤口均有较大的刺激性和异味性,尤其不适用于儿童的使用,并且其形成的创面保护膜防水性较差,遇水容易溶解,不易更好的保护创面。包扎类敷料使用中亦出现防水性差及透气性差的问题,易导致创面溃烂。
发明内容
针对现有伤口修复材料的不足,本发明提供了一种皮肤创面保护组合物,该组合物使用丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯作为成膜材料,通过与溶剂的协同搭配,具有无刺激性、无异味性、成膜速度快、透气性好、防水性好等优点。
本发明具体技术方案如下:
一种皮肤创面保护组合物,包括以下重量百分含量的组分:
a.成膜材料:丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯溶液,以有效成分计4-15%;
b.溶剂:70-90%,其中,溶剂为六甲基二硅氧烷,或者为六甲基二硅氧烷与乙二醇二甲醚的混合物;
c.抑菌剂2-5%;
各组分之和为100%。
上述皮肤创面保护组合物中,选择丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯作为成膜材料,选择六甲基二硅氧烷或六甲基二硅氧烷与乙二醇二甲醚的混合物为溶剂,其挥发快速,是一种优良的喷雾载体,且其对伤口基本无刺激,喷于皮肤表面可迅速蒸发,溶剂挥发后,丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯可形成透气、防水的薄膜。
进一步的,市售丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯以溶液的形式存在,其溶液由有效成分丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯和合成溶剂组成,所述合成溶剂包括异辛烷或异构十二烷。一般的,丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯溶液中,丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯的含量为42-67wt%。
进一步的,所述抑菌剂为现有技术中报道的具有杀菌消毒作用的物质。因为本发明组合物为液态,因此在选择抑菌剂时要选择能够与其他组分互溶的、使整个组合物形成均一液态的抑菌剂。例如,抑菌剂可以是有机硅季铵盐、牛至油等成分,抑菌剂可以是一种,也可以是多种。
进一步的,当各组分选择以下重量百分含量时,经试验验证综合性能最佳:
a.成膜材料:丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯溶液,以有效成分计8%;
b.溶剂:84%,其中,溶剂为六甲基二硅氧烷,或者为六甲基二硅氧烷与乙二醇二甲醚混合物;
c.抑菌剂4%;
各组分之和为100%。
本发明还提供了上述皮肤创面保护组合物的制备方法,包括以下步骤:将丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯溶液和溶剂在室温下混合均匀,浸泡1~2h,然后加入抑菌剂,搅拌均匀,即得皮肤创面保护组合物。所得皮肤创面保护组合物为均一的液体状态。
本发明的有益效果如下:
(1)本发明皮肤创面保护组合物可直接涂抹于创面,不受创面大小影响,可在创面患处形成质地柔软,不易脱落的保护膜,具有保护创面、促进创面愈合的作用。
(2)本发明皮肤创面保护组合物形成的保护膜成膜速度快,具有良好的阻水性、透气性、阻菌性,能有效提高伤口愈合的速度。
(3)本发明皮肤创面保护组合物形成的保护膜无毒、无刺激、无异味,适合儿童或敏感性皮肤使用。
具体实施方式
下面结合具体实施例对本发明做进一步说明,下述说明仅是示例性的,并不对本发明保护范围进行限制。
下述实施例中,所用材料、试剂如无特别说明,均为市购产品。
实施例及对比例
一种皮肤创面保护组合物,由成膜材料、溶剂、合成溶剂、抑菌剂等组分组成,所述成膜材料为丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯,所述溶剂为单一的六甲基二硅氧烷,或者为六甲基二硅氧烷与乙二醇二甲醚的混合物,各组分用量如表1所示。
制备方法:将成膜材料、溶剂和合成溶剂加入反应容器中,在室温下混合均匀,浸泡1-2h,然后加入抑菌剂,搅拌均匀,即得皮肤创面保护组合物。
对比例3
一款市售液体创面敷料,成膜剂是硝酸纤维素,溶剂是乙酸乙酯、乙酸丁酯、异丙醇的混合物。
对比例4
一款市售液体创可贴,成膜剂是聚乙烯醇,溶剂是乙醇。
试验例1 水蒸气透过率试验
取120目筛网,裁剪成为33cm2的圆形结构,将其充分浸泡在各实施例和对比例的皮肤创面保护样品溶液中,浸泡后取出,待溶剂挥发后再次进行浸泡,重复三次,作为检测用膜材。
参考YY/T 0471.2-2004检测各膜材的水蒸气透过率。测试方法如下:
1. 仪器:干燥圆筒,圆筒的一端是一个环形的夹板,开孔面积为10cm2,另一端是一直经与凸缘直径相等的金属盖板,并有一密封环以确保与凸缘有效密封,盖板的两端与凸缘夹紧。
2. 步骤:用夹板的凸缘作为模板切割膜材,作为样品;在室温下加入足量的水,使液面与放置后的样品之间的空气间隙为(5±1)mm;将样品精确地盖在试验容器的凸缘上,夹紧样品,使夹板和盖板之间形成水密封;将容器放入干燥箱中,样品向上,温度保持在(37±1)℃;24h后,从干燥箱中取出容器,每个样品平行测定3次,取平均值,测试结果见表2。
3. 计算方法:X=(W1-W2)×1000×24/T
X——水蒸气透过率;
W1——试验前容器、样品和液体的质量;
W2——试验后容器、样品和液体的质量;
T——试验时间。
从实施例1-8与对比例1-2可以看出,水蒸气透过率与成膜材料丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯的含量密切相关,成膜材料含量越高,水蒸气透过率越低,透气性降低。
试验例2 阻水性试验
取120目筛网,裁剪成为33cm2的圆形结构,将其充分浸泡在各实施例和对比例的皮肤创面保护样品溶液中,浸泡后取出,待溶剂挥发后再次进行浸泡,重复三次,作为检测用膜材。
参考YY/T0471.3-2004,用阻水性测试仪(济南众测机电设备有限公司 ZS-01)检测各膜材的阻水性,每个样品平行测定3次,取平均值,测试结果见表3。
从上表结果可以看出,实施例1-8和对比例1-2均具有较好的阻水性,对比例3和4的阻水性较差。而对比例1-2虽然阻水性较优,但透气性较差,不利于皮肤的呼吸,因此综合而言实施例1-8的产品既具有透气性又具有阻水性,性能优异,其中实施例6-8的产品透气性和阻水性综合性能最佳,效果最优。
试验例3 阻菌性试验
取120目筛网,裁剪成为33cm2的圆形结构,将其充分浸泡在各实施例和对比例的皮肤创面保护组合物溶液中,浸泡后取出,待溶剂挥发后再次进行浸泡,重复三次,作为检测用膜材。
参考YY/T 0471.5-2007检测阻菌性。测试方法为:用20℃~25℃的营养肉汤培养粘质沙雷菌24h,获得菌含量约109个/ml,以无菌操作将一个无菌样品移至装有无菌营养琼脂培养基的培养皿上;用无菌吸液管向样品上滴5滴培养菌液,置于20℃~25℃培养24h;培养结束后,用无菌吸液管从样品上将培养菌液吸除,将样品置于20℃~25℃下培养24h,坚持培养皿,观察样品覆盖的表面积内是否有粘质沙雷菌生长,每个样品平行测定3次,3次均未检出视为未检出,有1次检出即为不合格,测试结果见表4。
从上表结果可以看出,实施例1-8均有阻菌性。
试验例4 促进伤口愈合试验
通过ICR小鼠全层皮肤切除模型验证不同实施例和对比例的皮肤创面保护样品对伤口愈合的功效。购买ICR雄性小鼠45只,适应环境7天后,腹腔注射1.5%苯巴比妥溶液,剂量1.0ml/kg,做脱毛处理。24h后,随机分为5组,每组9只,麻醉后,每只小鼠用打孔器制造相同大小的2个创面,右侧创面涂抹实施例及对比例制备的溶液,左侧创面不做任何处理,在制造创面后的4d、10d、16d安乐死,计算创面的面积,根据创面面积计算创面愈合率。
创面愈合率=(初始创面面积-处死时间创面面积)/初始创面面积×100%
试验结果见表5。
从上表可知:实施例的样品在促进伤口愈合方面均优于对比例,其中实施例7的样品效果最优。
试验例5 刺激性试验
参考GB/T16886.10-2011/ISO10993-10:2002动物刺激试验测试实施例3和实施例7样品的刺激性,购买6只健康新西兰兔,不限雌雄,背部脱毛,分为两组,其中一组使用实施例3的样品,一组使用实施例7的样品。将0.5g实施例3和7的样品分别直接涂抹于新西兰兔皮肤表面,用吸水性纱布覆盖接触部位,然后用绷带固定6h,按表6规则进行评分:
将每只新西兰兔的刺激性进行计分,红斑和焦痂形成的计分和水肿形成的计分之和作为该只新西兰兔的总得分,将三只新西兰兔的总得分取平均值,作为最终得分。根据最终得分和下表评价实施例3与实施例7的样品对新西兰兔的刺激性程度。
实施例3的样品对新西兰兔的刺激性结果如下表7所示。
实施例7的样品对新西兰兔的刺激性结果如下表8所示。
综上所述,本发明皮肤创面保护组合物无毒无刺激,所形成的膜具有良好的阻水性、透气性、阻菌性,具有保护创面、促进创面愈合的作用。
Claims (8)
1.一种皮肤创面保护组合物,其特征是包括以下重量百分含量的组分:
a.成膜材料:丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯溶液,以有效成分计4-15%;
b.溶剂:六甲基二硅氧烷或六甲基二硅氧烷与乙二醇二甲醚的混合物70-90%;
c. 抑菌剂2-5%;
各组分之和为100%。
2.根据权利要求1所述的皮肤创面保护组合物,其特征是包括以下重量百分含量的组分:
a.成膜材料:丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯溶液,以有效成分计8%;
b.溶剂:六甲基二硅氧烷或六甲基二硅氧烷与乙二醇二甲醚的混合物84%;
c. 抑菌剂4%;
各组分之和为100%。
3.根据权利要求1或2所述的皮肤创面保护组合物,其特征是:当溶剂是六甲基二硅氧烷与乙二醇二甲醚的混合物时,六甲基二硅氧烷在溶剂中的重量百分含量为30-80%。
4.根据权利要求1或2所述的皮肤创面保护组合物,其特征是:所述丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯溶液由有效成分丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯和合成溶剂组成,所述合成溶剂包括异辛烷或异构十二烷。
5.根据权利要求1、2或3所述的皮肤创面保护组合物,其特征是:所述丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯溶液中,丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯的含量为42-67wt%。
6.根据权利要求1或2所述的皮肤创面保护组合物,其特征是:所述抑菌剂为能够与其他组分互溶的杀菌、消毒物质。
7.根据权利要求1或6所述的皮肤创面保护组合物,其特征是:所述抑菌剂为有机硅季铵盐或/和牛至油。
8.一种权利要求1-7中任一项所述的皮肤创面保护组合物的制备方法,其特征是包括以下步骤:将丙烯酸(酯)类/三(三甲硅氧基)甲硅烷基丙醇甲基丙烯酸酯溶液和溶剂在室温下混合均匀,浸泡1~2h,然后加入抑菌剂,搅拌均匀,即得皮肤创面保护组合物。
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