CN105999361B - 一种具有智能释放抗菌剂能力的医用敷料及其制备方法 - Google Patents
一种具有智能释放抗菌剂能力的医用敷料及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种具有智能释放抗菌剂能力的医用敷料及其制备方法,属于医用敷料材料领域。该医用敷料的材质是无纺布,在无纺布的正面喷涂有防水透湿层,该防水透湿层由聚氨酯纳米纤维膜组成;在防水透湿层的表面涂覆水凝胶层,水凝胶层由水凝胶组成,而水凝胶内部负载有抗菌剂;在无纺布反面也喷涂有防水层。本发明还提供了一种制备方法,首先制备得到复合有聚氨酯纳米纤维膜的无纺布,再在无纺布的反面喷涂聚偏氟乙烯溶液,得到聚偏氟乙烯防水层;再将负载有抗菌剂的水凝胶涂覆在聚氨酯纳米纤维膜的表面,静置,即得具有智能释放抗菌剂的医用敷料。本发明制备方法简单,制备的医用敷料不仅防水透湿效果良好,还能够智能释放抗菌剂,降低细菌耐药性发生。
Description
技术领域
本发明属于医用敷料材料领域,具体地,涉及一种具有智能释放抗菌剂能力的医用敷料及其制备方法。
背景技术
纳米水凝胶是粒径在1~1000nm的水凝胶粒子,能稳定分散在水中形成胶体体系。智能纳米水凝胶是能对外界刺激产生响应的纳米水凝胶,因此又被称为刺激响应性纳米水凝胶。外界刺激通常包括微小的环境温度、分散介质pH和离子强度的变化,以及光、磁场、特定的化学物质或生物物质等。
医用敷料是一类用以覆盖疮、伤口或其他损伤的重要医用材料,它们可替代受损的皮肤起到暂时性屏障作用,避免或控制伤口感染,提供有利于创面愈合的环境。目前可供临床上使用的敷料包括传统敷料(纱布敷料)、生物敷料(尸体皮、羊膜)和水凝胶敷料等。
水凝胶类敷料是将水溶性高分子材料或其单体经特殊加工形成的一种具有三维网状结构且不溶于水的胶状物质,主要成分为70%~90%水及高分子材料。水凝胶敷料具备以下优点:吸水及保水性能良好,可以保持创面湿润,组织相容性好,不会粘合伤口,能减少更换敷料时带来的二次损伤,具有一定的抵抗细菌入侵的功能,防止伤口的感染,低毒甚至没有毒性。与此同时,在制备医用水凝胶敷料的时候可以掺入一定的药物,从而使用时在创口局部缓释以达到局部抗菌功能。
水凝胶的合成主要分为物理交联、化学交联和辐射交联三大类。物理交联主要有共混法、冻融法、纺丝法等,作用机理主要是通过分子间缠结、氢键、离子键、疏水相互作用以及生物特异性识别作用等次价键的作用而形成的凝胶。物理交联水凝胶的最大缺陷是力学性能的不足,使用价值小。化学交联主要有:接枝共聚,作用机理主要是由通过共价键交联形成三维网络聚合物,使用的交联剂有硼酸、醛类、环氧氯丙烷以及可以通过配位络合形成凝胶的重金属盐等,缺陷是其具有一定的细胞毒性。辐射交联是通过高能辐射(如电子辐射、γ射线)引起共价键交联。目前使用的水凝胶基本都是采用化学交联、辐射交联、物理交联中的一种合成方式制作而成,单一方式合成的水凝胶含有大量水分以交联点之间分子链长度分布过宽等因素,致使水凝胶机械强度低,非常易碎,且化学交联不可避免的在合成过程中会引入交联剂、引发剂及有机溶剂等,会使得凝胶体系的毒性增加。
《辐射研究与辐射工艺学报》,2005年,23卷6期,355~358页,报道了题为含药水水凝胶膜的制备及其药物释放规律的研究。该文章研制了PEO(聚氧化乙烯)、PVA(聚乙烯醇)接枝共聚水凝胶膜,并在制作水凝胶过程中掺入了庆大霉素,研究了该含药水凝胶膜的药物体外释放规律。该水凝胶膜抗张强度及溶胀度合适。药物释放平稳,是一种优良的创面敷料。
发明内容
本发明的目的在于,提供一种具有智能释放抗菌剂能力的医用敷料及其制备方法。该医用敷料不仅在细菌感染时,能够定向释放抗菌剂,从而避免细菌的耐药性产生,同时还具有防水透湿等优点,对创面区域形成良好的保护。
本发明公开了一种具有智能释放抗菌剂能力的医用敷料,该医用敷料的材质是无纺布,且在无纺布的正面方向喷涂有防水透湿层,且该防水透湿层由聚氨酯纳米纤维膜组成;在防水透湿层的表面涂覆有水凝胶层,该水凝胶层由水凝胶组成,而水凝胶层内部负载有抗菌剂;同时,在无纺布的反面方向也喷涂有防水层。
具体地,所述水凝胶为聚丙烯酸或聚甲基丙烯酸中的一种与聚甲基丙烯酸-N,N-二甲氨基乙酯通过氢键作用构成,且聚丙烯酸或聚甲基丙烯酸中的一种与聚甲基丙烯酸-N,N-二甲氨基乙酯的质量百分比为41~55:45~59。
具体地,所述无纺布为医用无纺布,所述防水层为聚偏氟乙烯防水层。
更具体地,所述聚丙烯酸或聚甲基丙烯酸的平均分子量均为8~30kDa,聚甲基丙烯酸-N,N-二甲氨基乙酯的平均分子量为5~20kDa。
具体地,所述聚氨酯纳米纤维膜中的纳米纤维的直径为200~700nm,且构成纳米纤维膜的孔径控制在0.2~1.0μm之间。
本发明还设计了一种具有智能释放抗菌剂能力的医用敷料的制备方法,包括如下制备步骤:
1)通过热塑性纳米纤维制备技术,制备出聚氨酯纳米纤维,在分散剪切作用下,得到聚氨酯纳米纤维悬浮液;再将聚氨酯纳米纤维悬浮液均匀的喷淋在无纺布的正面,干燥,制备得到复合有聚氨酯纳米纤维膜的无纺布;
2)在无纺布的反面喷涂聚偏氟乙烯溶液,得到聚偏氟乙烯防水层;
3)将聚丙烯酸或聚甲基丙烯酸溶液中的一种、聚甲基丙烯酸-N,N-二甲氨基乙酯溶液和抗菌剂混合均匀,得到半固态混合物,再将该半固态混合物涂覆在所述步骤1)中制备的聚氨酯纳米纤维膜的表面,静置,即得到具有智能释放抗菌剂的医用敷料。
具体地,所述步骤3)中,聚丙烯酸或聚甲基丙烯酸溶液的质量浓度百分数为20~35%,聚甲基丙烯酸-N,N-二甲氨基乙酯溶液的质量浓度百分数为14~42%,且静置时间为20~40min。
具体地,所述步骤1)中,聚氨酯纳米纤维悬浮液的纳米纤维直径控制在200~700nm之间,且聚氨酯纳米纤维悬浮液的质量浓度百分数为20~35%。
具体地,所述步骤1)中,将聚氨酯纳米纤维悬浮液喷淋在无纺布的正面,然后使用热风烘干干燥,制备得到聚氨酯纳米纤维膜的厚度为0.1~0.3mm。
具体地,所述步骤2)中,聚偏氟乙烯溶液的质量浓度百分数为5~10%,且喷涂时间为3~5s。
为了更好的实现本发明的技术方案,本发明中使用的抗菌剂包括万古霉素、左氧氟沙星、莫匹罗星和硫酸庆大霉素等常见的抗生素。
本发明中使用的热塑性纳米纤维的制备方法为熔融挤出相分离法,其基本原理为:将两种热力学互不相容的聚合物在双螺杆挤出机中充分熔融共混、挤出,共混的聚合物熔体在挤出机和喷丝头内受到剪切和拉伸复合力场的作用下伸长而变形,形成纳米纤维束,最后,去除基质聚合物,获得所需种类的热塑性纳米纤维。
本发明制备的产品的工作原理在于:
本发明制备的医用敷料,由聚氨酯纳米纤维膜作为防水透湿层,不仅对细菌具有良好的阻隔效果,而且具有良好的透气、透湿效果;在聚氨酯纳米纤维膜的表面涂覆有聚丙烯酸或聚甲基丙烯酸中的一种与聚甲基丙烯酸-N,N-二甲氨基乙酯构成的水凝胶层,在水凝胶层里负载有抗菌剂。本发明制备的水凝胶对细菌液敏感,尤其是对细菌液的酸碱性敏感,当周围环境的pH为弱酸性时,水凝胶会膨胀分解,由此,水凝胶里负载的抗菌剂会迅速的释放出来,针对靶标细菌起到定向杀菌的效果。同时该医用敷料还具有聚偏氟乙烯防水层,能起到防水的效果。
本发明制备方法的工作原理在于:
本发明的水凝胶由聚丙烯酸或聚甲基丙烯酸与聚甲基丙烯酸-N,N-二甲氨基乙酯通过氢键作用力构成,同时,在制备水凝胶层的过程中,将抗菌剂混合载入,制备得到负载有抗菌剂的水凝胶层;再将负载有抗菌剂的水凝胶层涂敷在聚氨酯纳米纤维膜的表面,而聚氨酯纳米纤维膜涂覆在无纺布的正面,同时,在无纺布的反面涂覆有偏氟乙烯防水层,最终制备得到既具有防水层,又有防水透湿层,同时还具有负载抗菌剂的水凝胶层的医用敷料。
本发明的有益效果在于:
1、本发明制备的医用敷料具有负载抗菌剂的水凝胶层,针对弱酸性细菌环境能达到智能释放抗菌剂,定向杀菌的目的,从而实现减少抗生素的使用,降低细菌耐药性的发生率。
2、本发明制备的医用敷料具有防水透湿层和防水层,在使用时可以对创面区域形成良好的保护,避免伤口进一步严重化。
3、本发明制备的负载有万古霉素的医用敷料对金黄色葡萄球菌具有快速抑制作用。
4、本发明制备医用敷料的方法简单,成本较低,易于实行。
附图说明
图1为本发明的医用敷料的结构示意图;
图2为图1中水凝胶的扫描电子显微镜图示;
图3为图2中水凝胶在无细菌液中浸泡后的扫描电子显微镜图示;
图4为图2中水凝胶在细菌液中浸泡后的扫描电子显微镜图示;
图5为水凝胶在不同酸碱性环境下质量随时间变化曲线图;
图6为本发明的医用敷料对细菌的抗菌测试结果示意图;
其中,图1中的各标号如下:
1—抗菌剂、2—水凝胶层、3—防水透湿层、4—无纺布、5—防水层;
图5中的各标号如下:
6—曲线6、7—曲线7、8—曲线8。
具体实施例
为了更好地解释本发明,以下结合具体实施例进一步阐明本发明的主要内容,但本发明的内容不仅仅局限于以下实施例。
实施例1
结合图1可知,本实施例公开了一种具有智能释放抗菌剂能力的医用敷料,该医用敷料的材质是无纺布4,该无纺布优选为医用无纺布,且在无纺布4的正面方向喷涂有防水透湿层3,且该防水透湿层3由聚氨酯纳米纤维膜组成。在本实施例中,聚氨酯纳米纤维膜的孔径控制在0.2~1μm之间,因为孔径过大,聚氨酯纳米纤维膜的防水能力和阻隔细菌等微粒的能力下降,而孔径过小,则不利于敷料透湿性的发挥,聚氨酯纳米纤维膜孔径在0.2~1μm之间保证了对细菌良好的阻隔效果,并且具有良好的透气效果。
除此之外,本实施例制备的聚氨酯纳米纤维膜中的纳米纤维的平均直径为300nm(聚氨酯纳米纤维膜中的纳米纤维平均直径控制在200~700nm之间)。与此同时,该实施例中的水凝胶层为聚丙烯酸或聚甲基丙烯酸中的一种与聚甲基丙烯酸-N,N-二甲氨基乙酯通过氢键作用力构成,且聚丙烯酸或聚甲基丙烯酸中的一种与聚甲基丙烯酸-N,N-二甲氨基乙酯的质量百分比控制在41~55:45~59之间,目的是较好的形成水凝胶,本实施中,上述聚丙烯酸或聚甲基丙烯酸中的一种与聚甲基丙烯酸-N,N-二甲氨基乙酯的质量百分比优选为50:50,且选用的聚丙烯酸或聚甲基丙烯酸的平均分子量均为8~30kDa之间,聚甲基丙烯酸-N,N-二甲氨基乙酯的平均分子量控制在5~20kDa之间,本实施例中的聚丙烯酸或聚甲基丙烯酸的平均分子量优选为10~12kDa,聚甲基丙烯酸-N,N-二甲氨基乙酯的平均分子量优选为8~10kDa。聚丙烯酸、聚甲基丙烯酸和聚甲基丙烯酸-N,N-二甲氨基乙酯的平均分子量的选择,原则是为了使两者较好的结合,形成均匀的水凝胶,因为当分子量太小时,水凝胶的形成难度会增加,而分子量过大时,会带来溶液配制的困难,及水凝胶的硬度增加等缺点。
同时,在水凝胶内部还负载有抗菌剂,如万古霉素、左氧氟沙星、莫匹罗星、硫酸庆大霉素等常见的抗生素,本实施例中优选为万古霉素,从而实现水凝胶对抗菌剂的智能释放。
为了提高医用敷料的防水性能,在无纺布4的反面方向也喷涂有防水层5,本实施中优选为聚偏氟乙烯防水层,因为聚偏氟乙烯具有优异的拒水能力,能有效抑制水在医用敷料上的铺展和渗入。
实施例2
本发明还公开了具有智能释放抗菌剂能力的医用敷料的制备方法,且制备步骤如下:
1)通过热塑性纳米纤维制备技术,制备出聚氨酯纳米纤维,在高速分散剪切作用下,得到聚氨酯纳米纤维悬浮液,且聚氨酯纳米纤维悬浮液的纳米纤维平均直径控制在200~700nm之间,聚氨酯纳米纤维悬浮液的质量浓度百分数为20~35%(本实施中制备的聚氨酯纳米纤维悬浮液的纳米纤维直径优选为300~350nm,且制备得到的聚氨酯纳米纤维悬浮液的质量浓度百分数为25%);再将聚氨酯纳米纤维悬浮液均匀的喷淋在医用无纺布的正面,并使用热风烘干干燥,制备得到无纺布上复合有聚氨酯纳米纤维膜,且聚氨酯纳米纤维膜的厚度在0.1~0.3mm之间;
2)在无纺布的反面喷涂聚偏氟乙烯溶液,聚偏氟乙烯溶液的质量浓度百分数控制在5~10%之间,本实施例中采用的聚偏氟乙烯溶液的质量浓度百分数优选为8%,喷涂时间控制在3~5s之间,制备得到聚偏氟乙烯防水层;
3)将平均分子量为10~12kDa之间的聚丙烯酸或聚甲基丙烯酸溶液中的一种,平均分子量为10kDa的聚甲基丙烯酸-N,N-二甲氨基乙酯溶液和抗菌剂(本实施例中的抗菌剂优选为万古霉素)混合均匀,且聚丙烯酸或聚甲基丙烯酸溶液的质量浓度百分数控制在20~35%之间(本实施例优选为25%),聚甲基丙烯酸-N,N-二甲氨基乙酯溶液的质量浓度百分数为14~42%(本实施例优选为20%),得到半固态混合物,再将该半固态混合物涂覆在所述步骤1)中制备的聚氨酯纳米纤维膜的表面,静置时间控制在20~40min之间,即制备得到具有智能释放抗菌剂的医用敷料。
实施例3
将采用实施例2的制备方法,制备得到的具有智能释放抗菌剂的医用敷料的水凝胶在扫描电子显微镜下扫描,得到了图2所示的图示,从图2中可以看出,负载有抗菌剂的水凝胶初始表面结构紧凑;紧接着,将等质量的该医用敷料的水凝胶分别置于相同体积的无细菌溶液和细菌溶液中浸泡相同时间,浸泡30min后,晾干,然后在扫描电子显微镜下扫描,分别得到了图3和图4所示的图示,从图3中可以观察到经过无细菌溶液浸泡的水凝胶层表面出现了溶胀塌缩现象,但是无明显裂解的情况发生;从图4中可以看到,负载有抗菌剂的水凝胶层在细菌溶液中浸泡一段时间后,发生了很明显的裂解。
由此可知,本发明制备的医用敷料,只在与细菌接触时,才会选择释放水凝胶里负载的抗菌剂,实现抗菌的目的,而不会任意的胡乱释放抗菌剂,降低了细菌耐药性的发生。
实施例4
为更好的实现本发明的技术方案,本实施例进一步地探究不同的pH对本发明制备的医用敷料中的水凝胶层的影响:
本实施例中取不同质量的,除此之外完全相同的水凝胶(聚丙烯酸或聚甲基丙烯酸与聚甲基丙烯酸-N,N-二甲氨基乙酯构成的)分别置于不同pH值环境下,监控水凝胶的质量随时间变化曲线,得到了如图5所示的曲线图。结合图5可知,其中,曲线6表示将0.18g水凝胶置于pH=9.18的环境下,水凝胶的质量随时间变化曲线。该曲线表示在0~25min内,水凝胶发生吸水溶胀,质量增加迅速,随着时间的推移,水凝胶的质量变化趋势缓慢,基本上达到了平衡值;曲线7表示,将0.16g水凝胶置于pH=6.86的环境下,水凝胶的质量随时间变化曲线。该曲线表明在0~25min内,水凝胶由于溶胀,质量迅速增加,此后,随着时间的推移,水凝胶的质量变化不明显,和曲线6的走势基本相似;然而,当将0.12g水凝胶置于pH=4.01的环境时,得到了曲线8,从曲线8的变化趋势可以看出,同理,水凝胶先发生吸水溶胀,但是在25min以后,水凝胶的质量迅速减小,究其原因,可能是因为水凝胶在pH=4.01时,选择将内部的抗生素释放出来。由此可知,水凝胶在中性和弱碱性环境下,分解较缓慢,且基本上不会释放内部的抗生素,而在弱酸性环境下,随着时间的推迟,先吸水溶胀,然后逐渐破裂分解,释放出内部的抗生素。
因此,将本发明制备的医用敷料用于抗菌处理,其中,医用敷料中的水凝胶层在没有细菌感染时,水凝胶不会分解,保持了水凝胶中抗生素的完整结构,较少释放,也减少了细菌耐药性的发生。然而,在有细菌存在的时候,水凝胶中的抗生素也不一定会释放出来,必须要保证周围环境的pH为弱酸性时,才会实现水凝胶的逐渐分解和抗生素的缓慢释放,从而,针对于感染部位精准用药,最终实现优异的抗菌效果的同时,也减少了抗生素的使用,增强细菌的耐药性。
实施例5
为了更好的说明本发明的医用敷料的抗菌效果,下面结合具体的医用辅料作进一步地说明。
在载有万古霉素的医用敷料表面接种金黄色葡萄球菌,然后将该细菌置于细菌培养液内培养20h后,得到细菌悬浮液;
测定细菌悬浮液在600nm处的吸光度,得到吸光度随时间变化曲线图,即得到了图6,其中,在600nm处,吸光度强则说明细菌悬浮液中的细菌浓度大,反之,细菌浓度低。
从图6中可以看出,在600nm处,细菌悬浮液的吸光度随着时间的推移,降低的非常迅速,从而可知,细菌悬浮液中的细菌浓度随着时间的推移,也降低的非常迅速,且在400min左右,细菌的浓度降低到最低。由此表明本发明制备的医用敷料可以用来快速的抑制金黄色葡萄球菌的生长,抑菌效果较好。
以上实施例仅为最佳举例,而并非是对本发明的实施方式的限定。除上述实施例外,本发明还有其他实施方式。凡采用等同替换或等效变换形成的技术方案,均落在本发明要求的保护范围。
Claims (7)
1.一种具有智能释放抗菌剂能力的医用敷料的制备方法,其特征在于:包括如下制备步骤:
1)通过热塑性纳米纤维制备技术,制备出聚氨酯纳米纤维,在分散剪切作用下,得到聚氨酯纳米纤维悬浮液;再将聚氨酯纳米纤维悬浮液均匀的喷淋在无纺布的正面,干燥,制备得到复合有聚氨酯纳米纤维膜的无纺布;
2)在无纺布的反面喷涂聚偏氟乙烯溶液,得到聚偏氟乙烯防水层;
3)将聚丙烯酸或聚甲基丙烯酸溶液中的一种、聚甲基丙烯酸-N,N-二甲氨基乙酯溶液和抗菌剂混合均匀,得到半固态混合物,再将该半固态混合物涂覆在所述步骤1)中制备的聚氨酯纳米纤维膜的表面,静置,即得到具有智能释放抗菌剂的医用敷料。
2.根据权利要求1所述的具有智能释放抗菌剂能力的医用敷料的制备方法,其特征在于:所述步骤3)中,聚丙烯酸或聚甲基丙烯酸溶液的质量浓度百分数为20~35%,聚甲基丙烯酸-N,N-二甲氨基乙酯溶液的质量浓度百分数为14~42%,且静置时间为20~40min。
3.根据权利要求1或2所述的具有智能释放抗菌剂能力的医用敷料的制备方法,其特征在于:所述步骤3)中,聚丙烯酸或聚甲基丙烯酸中的一种与聚甲基丙烯酸-N,N-二甲氨基乙酯的质量百分比为41~55:45~59。
4.根据权利要求3所述的具有智能释放抗菌剂能力的医用敷料的制备方法,其特征在于:所述聚丙烯酸或聚甲基丙烯酸的平均分子量均为8~30kDa,聚甲基丙烯酸-N,N-二甲氨基乙酯的平均分子量为5~20kDa。
5.根据权利要求1所述的具有智能释放抗菌剂能力的医用敷料的制备方法,其特征在于:所述步骤1)中,聚氨酯纳米纤维悬浮液的纳米纤维平均直径控制在200~700nm之间,构成聚氨酯纳米纤维膜的孔径控制在0.2~1.0μm之间,且聚氨酯纳米纤维悬浮液的质量浓度百分数为20~35%。
6.根据权利要求1或5所述的具有智能释放抗菌剂能力的医用敷料的制备方法,其特征在于:所述步骤1)中,将聚氨酯纳米纤维悬浮液均匀的喷淋在医用无纺布的正面,然后使用热风烘干干燥,制备得到聚氨酯纳米纤维膜的厚度为0.1~0.3mm。
7.根据权利要求1所述的具有智能释放抗菌剂能力的医用敷料的制备方法,其特征在于:所述步骤2)中,聚偏氟乙烯溶液的质量浓度百分数为5~10%,且喷涂时间为3~5s。
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