CN110478520A - 一种壳聚糖伤口敷料 - Google Patents
一种壳聚糖伤口敷料 Download PDFInfo
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Abstract
本发明涉及一种壳聚糖伤口敷料，所述壳聚糖伤口敷料为包括功能层的层状结构，所述功能层由壳聚糖促愈层和壳聚糖止血层伤口而成。所述伤口敷料通过与血红细胞以及血小板直接接触从而发挥效果，不依赖于体内的止血机制；并且不会引起过敏，不会释放热量，能够在体温过低的情况下发挥作用。本发明所述的壳聚糖伤口敷料适用于妇产科手术、腔镜微创术、普外科手术、骨科开放型伤口、美容整形、门急诊创伤、浅表皮肤溃疡等和各种穿刺、导管、置管的伤口固定、护理和换药，及个人擦伤、挫伤、刀伤和小面积烧伤等创口创面的护理和换药。具有止血、促愈、镇痛、抗菌和抑制疤痕生成的作用。
Description
技术领域：
本发明属于止血材料的技术领域，更具体的说，本发明涉及一种用于促进伤口愈合的壳聚糖伤口敷料。
背景技术：
皮肤是人体的重要器官，它起着控制体温、防止感染、免疫及传感作用。由于创伤、擦伤、皮肤溃烂和烧伤等原因，可能导致皮肤的大范围损伤。皮肤受伤害后易造成细菌感染、体液流失并引起并发症。现有技术中通常采用伤口敷料对伤口进行保护，吸收渗液、防止伤口感染、维持伤口的湿润环境并促进伤口的愈合。而对于伤口敷料有如下要求：1)具有与人体皮肤相近的柔软性能，在湿润时也能保持一定的形态和强度；2)能保持创面的湿润环境，有较好的吸收伤口分泌物的能力，并由一定的透气性；3)敷料无毒，对人体不发生有害的反应和刺激，而且必须能够阻止细菌进入创面以防止造成二次感染，无热源；4)最好有止血、止痛等作用，可促进肉芽生长和皮肤再生，加速愈合，减少疤痕；5)贮存稳定性好，具有可降解性。甲壳素广泛存在于低等动物，特别是节肢动物的外壳中，以及低等动物或植物的细胞壁中，例如可以从虾、蟹等甲壳类动物的外壳以及菌、藻类低等植物的细胞壁中提取出的天然高分子材料，是自然界中仅次于纤维素的第二大生物再生资源。壳聚糖是甲壳素的脱乙酰化产物，是自然界中唯一的碱性多糖。一般来说，甲壳素的N-乙酰基脱去50％以上就可以成为壳聚糖。甲壳素与壳聚糖在自然界中是以共存形式存在的，天然甲壳素中均含有壳聚糖，自然界中天然的壳聚糖也含有甲壳素。
近年来，甲壳素和壳聚糖在生物材料领域的应用日益引起人们的重视，在伤口敷料、可吸收手术缝合线、缓释药物载体、酶固定、凝血剂和抗凝血剂、抗癌药、减肥药等领域的应用都有研究，而甲壳素和壳聚糖由于具有独特而优异的生理活性，在伤口敷料方面的研究逐渐成为其在生物材料应用研究中的一个热点。Allen等发现壳聚糖与伤口接触时能起到清凉而舒服的润肤作用。Azad A K用壳聚糖处理伤口，发现壳聚糖可以加速III胶原蛋白的分泌从而促进肉芽组织和上皮组织的形成。动物实验表明，壳聚糖在伤口处可以抑制I型骨胶原的产生，并促进肉芽组织和上皮组织的形成，减少伤口的收缩程度，从而抑制疤痕的形成。Okamoto等证实壳聚糖有加速止血的作用，对人和动物血液红细胞有聚集作用。壳聚糖分子链中所带正电荷与细胞表面带负电荷的胞壁酸相互吸引而粘附，引起红细胞聚集，从而起到止血作用。Allen等发现，甲壳素和壳聚糖对一般人体表皮存在的细菌如表皮葡萄球菌、大肠杆菌和热带白色念珠菌以及烧伤病人易出现的绿脓杆菌、金黄色葡萄球菌和化脓性金黄色葡萄球菌感染等都有显著的抑制作用。目前，对这类材料确切的抗菌机理还不是很清楚。一般认为：由于壳聚糖分子链中所带正电荷与微生物细胞膜所带负电荷相互吸引，导致细菌的蛋白质和其他成分泄露而产生抗菌作用。虽然甲壳素和壳聚糖具有良好的生理活性，但由于它们所形成的膜较脆，力学性不好，往往需要通过与其它材料共混改善其力学性能。Tanabe等用角蛋白、壳聚糖与甘油共混制膜。用壳聚糖来改善角蛋白膜的强度，用甘油来改善膜的柔韧性。虽然共混能够改善壳聚糖的力学和化学性能，但是也限制了伤口的类型和位置；美国专利US5597581公布将壳聚糖与海藻酸盐通过湿法纺丝共混，值得了具有止血、防霉、抑菌性能并可促愈的敷料，共混敷料吸液量是自身重量的28倍。但是只适用于渗液量大的慢性伤口。
发明内容：
为了解决现有技术中的上述技术问题，本发明的目的在于提供一种壳聚糖复合敷料。本发明所述的壳聚糖伤口敷料，其特征在于：所述伤口敷料为包括功能层的层状结构，所述功能层由壳聚糖促愈层和壳聚糖止血层伤口而成。其中，所述层状结构由无纺布背衬，和依次设置在无纺布背衬上的壳聚糖促愈层、壳聚糖止血层和护页构成。
其中，所述壳聚糖促愈层为壳聚糖无纺布层，选自普通壳聚糖无纺布或膨溶壳聚糖无纺布中的一种或两种。其中，所述壳聚糖无纺布层的厚度为0.3-0.4mm。
其中，所述壳聚糖止血层包括脱乙酰壳聚糖颗粒。
其中，所述壳聚糖止血层为涂覆在所述壳聚糖促愈层上的壳聚糖颗粒涂层，其厚度为0.5-1mm。
其中，所述壳聚糖止血层为壳聚糖颗粒通过胶黏合或涂覆在纱布上形成的纱布层，其中所述壳聚糖颗粒的厚度0.6-0.8mm。
其中，所述无纺布背衬为硅胶无纺布或者丙烯酸压敏胶无纺布，舒适透气，柔韧随体。
其中，所述护页为硅油纸，例如格拉辛硅油纸，揭除方便顺滑。
其中，所述壳聚糖促愈层合壳聚糖止血层的中心与无纺布背衬和护页的中心重合。
本发明所述的壳聚糖伤口敷料，与现有技术相比，具有以下有益效果：本发明所述的壳聚糖伤口敷料适用于各种伤口的止血，伤口位置不受限制，头部、颈部、胸部、腹部等全身各处均可安全使用；对肝素化后的血液有效，作用机理不依赖于血液中的凝血因子，作用时不释放热量，不会产生灼伤，对存储条件没有任何限制。
附图说明：
图1为发明1所述的壳聚糖伤口敷料的结构示意图。图2为发明2所述的壳聚糖伤口敷料的结构示意图。图3为发明3所述的壳聚糖伤口敷料的结构示意图。图4为发明4所述的壳聚糖伤口敷料的结构示意图。
具体实施方式：
以下将结合具体发明和说明书附图对本发明所述的壳聚糖伤口敷料的结构及其性能做进一步的说明，以帮助本领域的技术人员对本发明的发明构思、技术方案有更完整、准确和深入的理解。发明1发明1所述的壳聚糖伤口敷料，其由背衬层10、普通壳聚糖无纺布20、壳聚糖颗粒层30和护页40构成的层状材料。其功能成分为壳聚糖无纺布层和壳聚糖颗粒层，不含有其它功能成分。所述普通壳聚糖无纺布的厚度0.3-0.4mm，克重40-50g/m 2，其不能吸收水分和渗液，其成分是葡萄糖胺聚合物。所述壳聚糖颗粒层，成分是稻黄色脱乙酰壳聚糖颗粒，pH5.0-7.0，含水量＜10％。在制作伤口敷料时壳聚糖颗粒涂层厚度0.5-1mm。所述无纺布背衬为硅胶无纺布或者丙烯酸压敏胶无纺布，舒适透气，柔韧随体。所述护页为格拉辛硅油纸，揭除方便顺滑。在本发明中，所述无纺布背衬和护页的尺寸相同，其范围宽度5-15cm，长度5-25cm，可为正方形、长方形或椭圆形；普通壳聚糖无纺布和壳聚糖颗粒层的宽度尺寸3.5-12cm，长度3.5-22cm；所述普通壳聚糖无纺布和壳聚糖颗粒层的中心与无纺布背衬和护页的中心重合。发明2发明2所述的壳聚糖伤口敷料，其由背衬层10、膨溶壳聚糖无纺布50、壳聚糖颗粒层30和护页40构成的层状材料。其功能成分为壳聚糖无纺布层和壳聚糖颗粒层，不含有其它功能成分。所述膨溶壳聚糖无纺布的厚度为0.3-0.4mm，克重40-50g/m 2，能快速吸收水分和渗液，吸液量是自身重量的10-20倍，其溶液pH5.5-6.5，成分是壳聚糖及其盐酸盐。所述壳聚糖颗粒层，成分是稻黄色脱乙酰壳聚糖颗粒，pH5.0-7.0，含水量＜10％。在制作伤口敷料时壳聚糖颗粒涂层厚度0.5-1mm。所述无纺布背衬为硅胶无纺布或者丙烯酸压敏胶无纺布，舒适透气，柔韧随体。所述护页为格拉辛硅油纸，揭除方便顺滑。在本发明中，所述无纺布背衬和护页的尺寸相同，其范围宽度5-15cm，长度5-25cm，可为正方形、长方形或椭圆形；膨溶壳聚糖无纺布和壳聚糖颗粒层的宽度尺寸3.5-12cm，长度3.5-22cm；所述膨溶壳聚糖无纺布和壳聚糖颗粒层的中心与无纺布背衬和护页的中心重合。施例3所述的壳聚糖伤口敷料，其由背衬层10、普通壳聚糖无纺布20、壳聚糖纱布60和护页40构成的层状材料。所述普通壳聚糖无纺布的厚度0.3-0.4mm，克重40-50g/m 2，其不能吸收水分和渗液，其成分是葡萄糖胺聚合物。壳聚糖纱布是将脱乙酰壳聚糖颗粒通过黏胶粘合在纱布表面，厚度0.6-0.8mm，吸液量不低于自身重力的5倍。从伤口上将止血颗粒清除掉也在临床有了证实，残留物都可以通过清水或盐水冲洗的方式简便的清除。止血颗粒为稻黄色的颗粒，pH5.0-7.0，含水量＜10％，颗粒直径大小0.2-2mm，血液凝结时间300秒内。所述无纺布背衬为硅胶无纺布或者丙烯酸压敏胶无纺布，舒适透气，柔韧随体。所述护页为格拉辛硅油纸，揭除方便顺滑。所述无纺布背衬和护页的尺寸相同，其范围宽度5-15cm，长度5-25cm，可为正方形、长方形或椭圆形；壳聚糖促愈层和壳聚糖止血层的宽度尺寸3.5-12cm，长度3.5-22cm；所述促愈功能层和止血功能层的中心与无纺布背衬和护页的中心重合。发明4所述的壳聚糖伤口敷料，其由背衬层10、普通壳聚糖无纺布20、膨溶壳聚糖无纺布50、壳聚糖纱布60和护页40构成的层状材料。所述普通壳聚糖无纺布的厚度60.3-0.4mm；膨溶壳聚糖无纺布的厚度为0.3-0.4mm。壳聚糖纱布是将脱乙酰壳聚糖颗粒通过黏胶粘合在纱布表面，厚度0.6-0.8mm，吸液量不低于自身重力的5倍。所述无纺布背衬为硅胶无纺布或者丙烯酸压敏胶无纺布，舒适透气，柔韧随体。所述护页为格拉辛硅油纸，揭除方便顺滑。所述无纺布背衬和护页的尺寸相同，其范围宽度5-15cm，长度5-25cm，可为正方形、长方形或椭圆形；壳聚糖促愈层和壳聚糖止血层的宽度尺寸3.5-12cm，长度3.5-22cm；所述促愈功能层和止血功能层的中心与无纺布背衬和护页的中心重合。
本发明所述的壳聚糖伤口敷料通过在所述壳聚糖促愈层上施加所述壳聚糖颗粒，能够通过与血红细胞以及血小板直接接触从而发挥效果，并且形成一种相互交叉的阻碍行凝血，吸收血液后并且能够产生坚韧的凝胶，止血作用不依赖于体内的止血机制；而且其有效成分和功能成分不含壳聚糖以外的其它组分，不会引起过敏，而且在止血和促愈的同时不会释放热量，能够在体温过低(18～25℃)的情况下发挥作用，使用方便。壳聚糖伤口敷料适用于妇产科手术、腔镜微创术、普外科手术、骨科开放型伤口、美容整形、门急诊创伤、浅表皮肤溃疡(含糖尿病溃疡)等和各种穿刺、导管、置管的伤口固定、护理和换药，及个人运动擦伤、挫伤、刀伤和小面积烧伤等创口创面的护理和换药。具有止血、促愈、镇痛、抗菌和抑制疤痕生成的作用。
在本发明中，所述的对于本领域的普通技术人员而言，具体发明只是结合附图对本发明进行了示例性描述，显然本发明具体实现并不受上述方式的限制，只要采用了本发明的方法构思和技术方案进行的各种非实质性的改进，或未经改进将本发明的构思和技术方案直接应用于其它场合的，均在本发明的保护范围之内。
Claims (10)
1.一种壳聚糖伤口敷料，其特征在于：所述伤口敷料为包括功能层的层状结构，所述功能层由壳聚糖促愈层和壳聚糖止血层伤口而成。
2.根据权利要求1所述的壳聚糖伤口敷料，其特征在于：所述层状结构由无纺布背衬，和依次设置在无纺布背衬上的壳聚糖促愈层、壳聚糖止血层和护页组成。
3.根据权利要1或2所述的壳聚糖伤口敷料，其特征在于：所述壳聚糖促愈层为壳聚糖无纺布层，选自普通壳聚糖无纺布或膨溶壳聚糖无纺布中的一种或两种。
4.根据权利要求3所述的壳聚糖伤口敷料，其特征在于：所述壳聚糖无纺布层的厚度为0.3-0.4mm。
5.根据权利要求3所述的壳聚糖伤口敷料，其特征在于：所述壳聚糖止血层包括脱乙酰壳聚糖。
6.根据权利要求5所述的壳聚糖伤口敷料，其特征在于：所述壳聚糖止血层为涂覆在所述壳聚糖促愈层上的壳聚糖颗粒涂层。
7.根据权利要求6所述的壳聚糖伤口敷料，其特征在于：所述壳聚糖颗粒涂层厚度为0.5-1mm。
8.根据权利要求5所述的壳聚糖伤口敷料，其特征在于：所述壳聚糖止血层为壳聚糖颗粒通过胶黏合或涂覆在纱布上形成的壳聚糖纱布层。
9.根据权利要求2所述的壳聚糖伤口敷料，其特征在于：所述无纺布背衬和护页的尺寸相同；所述壳聚糖促愈层和壳聚糖止血层的尺寸相同。
10.根据权利要求9所述的壳聚糖伤口敷料，其特征在于：所述壳聚糖促愈层和壳聚糖止血层的中心与无纺布背衬和护页的中心重合。
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