CN110960722A - 一种抗菌藻酸盐创口贴及其制备方法 - Google Patents
一种抗菌藻酸盐创口贴及其制备方法 Download PDFInfo
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- alginate
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Abstract
本发明涉及医疗护理用品,具体涉及一种抗菌藻酸盐创口贴及其制备方法,该创口贴包括粘贴层、敷心层和离型纸层;所述敷心层包括椭圆形藻酸盐泡沫敷料和分布在藻酸盐泡沫敷料周围的藻酸盐无纺布;所述椭圆形藻酸盐泡沫敷料通过冻干工艺制备,无需添加交联剂,pH 5.0~6.0;所述椭圆形藻酸盐泡沫敷料与创口贴合面表面层含溶菌酶;本发明提供的藻酸盐创口贴,使用方便、防水透气、为创面提供湿性愈合环境,敷心层藻酸盐泡沫敷料与伤口接触面含溶菌酶,具有抑菌消炎作用,可对伤口形成一定的压力,加快止血,敷心层藻酸盐泡沫敷料不添加交联剂,成分简单,安全性好。
Description
技术领域
本发明涉及医疗护理用品,具体涉及一种抗菌藻酸盐创口贴及其制备方法。
背景技术
传统的伤口护理创口贴产品主要是由纱布和棉花制成的,只注重对渗液的吸收,干型传统敷料可以起到监督覆盖伤口的作用,但不能用于感染性伤口,对伤口愈合没有促进作用,大量吸附伤口水分,渗液管理能力有限,容易导致伤口组织脱水,限制肉芽组织生长和结缔组织再生,粘连伤口,对新生上皮组织造成再损伤和导致出血,病人更换敷料后疼痛。随着湿性愈合理论的发展和成熟,开发出一系列的新型敷料,不仅能吸收伤口创面过多的渗出物,还可以保持湿性环境,促进肉芽组织生长和预防细菌感染,是治疗高渗性伤口创面的首选敷料,目前吸收型敷料主要有:泡沫类敷料、海绵类敷料、藻酸盐类敷料、水胶体类敷料及亲水纤维敷料等。
防感染是伤口护理的重点之一,目前,存在一些壳聚糖等自身抗菌敷料,但其抑菌作用存在很大的局限性,必须负载抗菌剂。纳米银型抗菌水凝胶敷料在抗菌修复上有良好的抗菌效果,但过多的纳米银使用易对表皮细胞和成纤维细胞等宿主细胞产生细胞毒性,并且在治疗过程中使用纳米银或银基敷料可能会产生不良影响。开发一种更加安全有效的抗菌敷料产品是非常有必要的。
溶菌酶是一种天然蛋白质,具有溶菌作用,对革兰阳性菌、好氧性孢子形成菌、枯草杆菌、地衣型芽孢杆菌等都有抗菌作用,而对没有细胞壁的人体细胞不会产生不利影响,具有良好的生物安全性,适用于伤口防护。
海藻酸钠是从褐藻类的海带或马尾藻中提取的一种天然高分子多糖,在自然界中广泛存在,具有良好的生物相容性及安全性。海藻酸盐在与组织渗出液接触后,形成了强亲水性凝胶,从而表现出强吸收能力,降低了水积和细菌感染。一些科学研究己经报告了海藻酸盐对角质细胞迁移的抑制作用,海藻酸盐通过激活巨噬细胞来产生引发炎症信号的TNF-a,从而加快伤口愈合。一旦将海藻酸盐敷料应用在伤口上,存在于海藻酸盐中的离子将会与血液发生交换,从而形成保护膜。
发明内容
本发明的目的在于提供一种使用便捷、功能多样、疗效更优的抗菌海藻酸盐创口贴,以应用于皮表伤口防护,能快速止血,更加安全有效地预防感染,促进伤口愈合。
为了解决上述技术问题,本发明提供如下技术方案:一种抗菌海藻酸钠创口贴,包括粘贴层、敷心层和离型纸层,所述敷心层包括椭圆形藻酸盐泡沫敷料和分布在所述藻酸盐泡沫敷料周围的藻酸盐无纺布,所述椭圆形藻酸盐泡沫敷料的表面层含有溶菌酶。
进一步地,所述一种抗菌藻酸盐创口贴的制备方法,包括如下步骤:
S1:采用冻干工艺制备单面含溶菌酶的藻酸盐泡沫敷料,裁切成椭圆形备用;
S2:将藻酸盐纤维用梳理机梳理得到有条理的藻酸盐纤维,进行开松、梳理、铺网、针刺、分切,得到长方形且中间椭圆形挖空的藻酸盐无纺布敷心;
S3:将医用丙烯酸胶水层均匀涂在弹力布上,涂胶后将带胶水的弹力布放入到烘道烘干胶水,面料涂胶面覆盖一层隔离纸,收大卷,按照创口贴尺寸规格纵向分切得到创口贴基材;
S4:剥离创口贴基材上的隔离纸,在中心部位复合敷心,在胶水和敷心一面复合上离型纸,最后粘合创口贴包装,得到抗菌藻酸盐创口贴。
进一步的,所述单面含溶菌酶的藻酸盐泡沫敷料的制备方法具体包括以下步骤:
S1:先用甘油分散海藻酸钠,再加入100 mL去离子水,常温下搅拌至完全溶解,滴加1%的醋酸溶液调节pH至5.0~6.0,倒入模具中,-20℃下预冻4~8h,冻干机冻干,脱模,制得藻酸盐泡沫敷料;
S2:配制0.1~1%溶菌酶水溶液,按0.1ml/cm²模具面积加入模具中,将S1制得的藻酸盐泡沫敷料放入模具吸收加入的溶菌酶溶液,-20℃下预冻1h,冻干机冻干,脱模,得到具有一定弹性的单面含溶菌酶藻酸盐泡沫敷料。
优选的,所述海藻酸钠为2~5g,所述甘油为8~12 mL。
本发明的有益效果为:
(1)将创口贴敷心层分为中心区椭圆形藻酸盐泡沫敷料和周围的藻酸盐无纺布,使用时对伤口形成一定的压力,加快止血。
(2)将藻酸盐泡沫敷料和溶菌酶复合冻干,制备的椭圆形藻酸盐泡沫敷心与创面接触的表面含有溶菌酶,对伤口具有抗菌消炎,预防感染的作用,抑菌性和生物安全性好。
(3)敷心层椭圆形藻酸盐泡沫敷料是通过醋酸调节适宜的pH范围以增进海藻酸钠的亲水性,再通过冻干工艺制得,无需添加交联剂既可制得有较好弹性、强度和柔韧性得藻酸盐泡沫敷料,工艺、成份简单,安全性好。
附图说明
图1为本发明一种抗菌藻酸盐创口贴的结构示意图。
具体实施方式
实施例一:
如图1所示,一种抗菌藻酸盐创口贴,由粘贴层3、敷心层和覆盖在粘贴层和敷心层之上的离型纸层组成;所述敷心层包括椭圆形藻酸盐泡沫敷料1和分布在藻酸盐泡沫敷料1周围的藻酸盐无纺布2,所述藻酸盐无纺布2呈长方形分布,藻酸盐泡沫敷料1与藻酸盐无纺布2在同一水平上;椭圆形藻酸盐泡沫敷料1与创口贴表面层含溶菌酶。粘贴层3为涂医用丙烯酸胶水层的弹力布胶带;离型纸层为格拉锌硅油纸;覆盖在粘贴层和敷心层之上,使用时揭开离型纸层,将敷心椭圆形藻酸盐泡沫敷料对准伤口,轻抚粘结层固定于伤口周围完好皮肤上。
所述一种抗菌藻酸盐创口贴的制备方法包括如下步骤:
S1:采用冻干工艺制备单面含溶菌酶的藻酸盐泡沫敷料,裁切成椭圆形备用;
S2:将藻酸盐纤维用梳理机梳理得到有条理的藻酸盐纤维,进行开松、梳理、铺网、针刺、分切,得到长方形且中间椭圆形挖空的藻酸盐无纺布敷心;
S3:将医用丙烯酸胶水层均匀涂在弹力布上,涂胶后将带胶水的弹力布放入到烘道烘干胶水,面料涂胶面覆盖一层隔离纸,收大卷,按照创口贴尺寸规格纵向分切得到创口贴基材;
S4:剥离创口贴基材上的隔离纸,在中心部位复合敷心,在胶水和敷心一面复合上离型纸,最后粘合创口贴包装,得到抗菌藻酸盐创口贴。
所述单面含溶菌酶的藻酸盐泡沫敷料的制备方法具体包括以下步骤:
S1:在3g海藻酸钠中加入8 mL甘油分散,再加入100 mL去离子水,搅拌至溶解均匀,滴加1%的醋酸溶液调节pH至5.3,倒入模具中,-20℃下预冻4~8h,冻干机冻干,脱模;
S2:配制0.1%溶菌酶水溶液,按0.1ml/cm²模具面积加入模具中,将S1制得的藻酸盐泡沫敷料放入,-20℃下预冻1h,冻干机冻干,脱模,得到具有一定弹性的单面含溶菌酶藻酸盐泡沫敷料,裁切成椭圆形敷心。
实施例二:
如图1所示,一种抗菌藻酸盐创口贴,由粘贴层3、敷心层和覆盖在粘贴层和敷心层之上的离型纸层组成;所述敷心层包括椭圆形藻酸盐泡沫敷料1和分布在藻酸盐泡沫敷料1周围的藻酸盐无纺布2,所述藻酸盐无纺布2呈长方形分布,藻酸盐泡沫敷料1与藻酸盐无纺布2在同一水平上;椭圆形藻酸盐泡沫敷料1与创口贴表面层含溶菌酶。粘贴层3为涂医用丙烯酸胶水层的弹力布胶带;离型纸层为格拉锌硅油纸;覆盖在粘贴层和敷心层之上,使用时揭开离型纸层,将敷心椭圆形藻酸盐泡沫敷料对准伤口,轻抚粘结层固定于伤口周围完好皮肤上。
所述一种抗菌藻酸盐创口贴的制备方法包括如下步骤:
S1:采用冻干工艺制备单面含溶菌酶的藻酸盐泡沫敷料,裁切成椭圆形备用;
S2:将藻酸盐纤维用梳理机梳理得到有条理的藻酸盐纤维,进行开松、梳理、铺网、针刺、分切,得到长方形且中间椭圆形挖空的藻酸盐无纺布敷心;
S3:将医用丙烯酸胶水层均匀涂在弹力布上,涂胶后将带胶水的弹力布放入到烘道烘干胶水,面料涂胶面覆盖一层隔离纸,收大卷,按照创口贴尺寸规格纵向分切得到创口贴基材;
S4:剥离创口贴基材上的隔离纸,在中心部位复合敷心,在胶水和敷心一面复合上离型纸,最后粘合创口贴包装,得到抗菌藻酸盐创口贴。
所述单面含溶菌酶的藻酸盐泡沫敷料的制备方法具体包括以下步骤:
S1:在4g海藻酸钠中加入10 mL甘油分散,再加入100 mL去离子水,搅拌至溶解均匀,滴加1%的醋酸溶液调节pH至5.3,倒入模具中,-20℃下预冻4~8h,冻干机冻干,脱模。
S2:配制0.1%溶菌酶水溶液,按0.1ml/cm²模具面积加入模具中,将S1制得的藻酸盐泡沫敷料放入,-20℃下预冻1h,冻干机冻干,脱模,得到具有一定弹性的单面含溶菌酶藻酸盐泡沫敷料,裁切成椭圆形敷心。
实施例三:
将本发明制备的单面含溶菌酶藻酸盐泡沫敷料进行抗菌性能检测。
从保存菌中取一株在营养琼脂中划线,37℃培养24小时,取一株接种于20mL营养肉汤中,37℃ 130r/min震荡培养18小时,用PBS缓冲液(0.03 mol/L)稀释至活菌数目为1×109CFU/mL~5×109CFU/mL,制得菌悬液备用。称取1g样品,剪成碎片放入烧瓶中,加入95mLPBS缓冲液(0.03 mol/L)搅拌均匀,另设一空白对照。取菌悬液5mL加入烧瓶中,恒温震荡均匀,马上取1mL用PBS进行四次10倍梯度稀释。取第四次稀释菌悬液200微升涂布在培养基上,37℃恒温倒扣培养48h,观察医用水凝胶与菌悬液0时接触后的抑菌效率;烧瓶中剩余溶液在37℃ 130r/min继续震荡培养2、6小时,用PBS进行四次10倍梯度稀释。取第四次稀释菌悬液200微升涂布在培养基上,37℃恒温倒扣培养48h,观察医用水凝胶与菌悬液接触后的抑菌效率。
实验结果如表1所示:
表1 抗菌实验结果
接触时间 | 大肠杆菌 | 金色葡萄球菌 |
0h | 20.2% | 30.6% |
2h | 79.2% | 85.0% |
6h | 85.6% | 89.2% |
由表1可见,本发明涉及的一种抗菌藻酸盐创口贴敷心层对大肠杆菌8099、金黄色葡萄球菌ATCC 6538均具有很好的抗菌效果,6h接触抑菌效率在80%以上。
实施例四:
参照GB/T 16886.5-2017 医疗器械生物学评价 第五部分:体外细胞毒性试验方法进行。
细胞系:小鼠成纤维细胞L929
阴性对照组:2%胎牛血清培养基
阳性对照组:10%DMSO溶液
试验组:按样品质量0.1g/ml的比例加入2%胎牛血清培养基浸提液,37℃恒温震荡24±1h。
将培养48h-72h生长旺盛的细胞消化制备成密度为1.5×104个/ml的细胞悬液,接种于96孔板3块,每孔加入100µL,置于5%CO2培养箱37℃培养24h。
弃掉原培养液,分别加入200µL阴性对照液、阳性对照液、供试品液,各组5孔,置于5%CO2培养箱37℃分别培养24h、48h、72h。每个时间点取出一块96孔板,加入15µLMTT溶液,5%CO2培养箱37℃培养4h,弃去培养液,分别加入150µLDMSO,震荡10min,酶标仪上检测490nm处吸光度,计算增值率,按照表2进行体外细胞毒性反应分级。试验结果如表3所示。
表2 体外细胞毒性反应分级
毒性级别(级) | 0 | 1 | 2 | 3 | 4 |
相对增殖率(%) | ≥100 | 80-99 | 50-79 | 30-49 | 0-29 |
表3 第1、2、3天体外细胞毒性反应分级
由表3可见,将藻酸盐无纺布和单面含溶菌酶藻酸盐泡沫敷料的浸提液分别培养细胞1-3天,细胞毒性反应分级在0-1级之间,说明本发明涉及的一种抗菌藻酸盐创口贴敷心层包括藻酸盐无纺布和单面含溶菌酶藻酸盐泡沫敷料均具有良好的生物相容性。
以上对本发明的特定实施例进行了说明,但本发明的保护内容不仅仅限定于以上实施例,在本发明的所属技术领域中,只要掌握通常知识,就可以在其技术要旨范围内进行多种多样的变更。
Claims (4)
1.一种抗菌藻酸盐创口贴,其特征在于,包括粘贴层、敷心层和离型纸层,所述敷心层包括椭圆形藻酸盐泡沫敷料和分布在所述藻酸盐泡沫敷料周围的藻酸盐无纺布,所述椭圆形藻酸盐泡沫敷料的表面层含有溶菌酶。
2.权利要求1所述一种抗菌藻酸盐创口贴的制备方法,其特征在于,包括如下步骤:
S1:采用冻干工艺制备单面含溶菌酶的藻酸盐泡沫敷料,裁切成椭圆形备用;
S2:将藻酸盐纤维用梳理机梳理得到有条理的藻酸盐纤维,进行开松、梳理、铺网、针刺、分切,得到长方形且中间椭圆形挖空的藻酸盐无纺布敷心;
S3:将医用丙烯酸胶水层均匀涂在弹力布上,涂胶后将带胶水的弹力布放入到烘道烘干胶水,面料涂胶面覆盖一层隔离纸,收大卷,按照创口贴尺寸规格纵向分切得到创口贴基材;
S4:剥离创口贴基材上的隔离纸,在中心部位复合敷心,在胶水和敷心一面复合上离型纸,最后粘合创口贴包装,得到抗菌藻酸盐创口贴。
3.根据权利要求2所述一种抗菌藻酸盐创口贴的制备方法,其特征在于,所述单面含溶菌酶的藻酸盐泡沫敷料的制备方法具体包括以下步骤:
S1:先用甘油分散海藻酸钠,再加入100 mL去离子水,常温下搅拌至完全溶解,滴加1%的醋酸溶液调节pH至5.0~6.0,倒入模具中,-20℃下预冻4~8h,冻干机冻干,脱模,制得藻酸盐泡沫敷料;
S2:配制0.1~1%溶菌酶水溶液,按0.1ml/cm²模具面积加入模具中,将S1制得的藻酸盐泡沫敷料放入模具吸收加入的溶菌酶溶液,-20℃下预冻1h,冻干机冻干,脱模,得到具有一定弹性的单面含溶菌酶藻酸盐泡沫敷料。
4.根据权利要求2所述一种抗菌藻酸盐创口贴的制备方法,其特征在于,所述海藻酸钠为2~5g,所述甘油为8~12 mL。
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