CN108478843B - 具有含铜涂层的医用敷料及其制备方法 - Google Patents
具有含铜涂层的医用敷料及其制备方法 Download PDFInfo
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- CN108478843B CN108478843B CN201810118474.4A CN201810118474A CN108478843B CN 108478843 B CN108478843 B CN 108478843B CN 201810118474 A CN201810118474 A CN 201810118474A CN 108478843 B CN108478843 B CN 108478843B
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- copper
- dressing
- coating
- medical dressing
- microspheres
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- 229910052802 copper Inorganic materials 0.000 title claims abstract description 110
- 239000010949 copper Substances 0.000 title claims abstract description 110
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- 238000000034 method Methods 0.000 claims description 21
- JPVYNHNXODAKFH-UHFFFAOYSA-N Cu2+ Chemical compound [Cu+2] JPVYNHNXODAKFH-UHFFFAOYSA-N 0.000 claims description 19
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Abstract
本发明公开了一种具有含铜涂层的医用敷料。将不同浓度的载铜微球通过一定的方式梯度化地固定/分散在医用敷料表面的聚合物载体中,从而可实现医用敷料的生物功能化。其中,功能化载铜微球的固定方式包括化学接枝、物理共混、静电作用等。这种具有生物功能化含铜涂层的敷料贴附于伤口后,可以起到抗细菌增殖,促进伤口愈合,促进新生血管生成及抗组织粘连的作用,从而避免敷料贴附于伤口后发生感染或愈合困难等问题。
Description
技术领域
本发明涉及敷料类医疗器械领域,尤其涉及一种应用于难愈合伤口部位的医用敷料,起隔绝并阻止细菌侵入、繁殖、促进伤口愈合速度、促进新生血管生成并防粘连的含铜医用敷料
背景技术
敷料,即使用于伤口外的覆盖物,在伤口愈合过程中可以替代受损皮肤起到暂时性的保护作用,避免或控制伤口感染,提供受创体表适合的愈合环境。传统敷料,可以起到监督覆盖伤口的作用,不能用于感染性伤口,对伤口愈合没有促进作用,渗液管理能力有限,粘连伤口,对新生上皮组织再损伤和导致出血,病人更换敷料后疼痛。为了提供良好的伤口愈合环境、减少疤痕、并且增进使用者的舒适度,近年来新型医用敷料逐渐地取代仅能提供最简单的隔离保护作用的传统敷料。
随着伤口湿性愈合理论的提出,许多新型敷料不断被研制出来.新型的医用敷料主要包括海藻酸盐类敷料、聚氨酯类敷料、水凝胶类敷料、薄膜类敷料等。虽然敷料种类繁多,但是这些新型的敷料都能为伤口提供一个湿性的环境,可以有效促进伤口愈合。除了为伤口提供湿润环境来促进伤口愈合外,抗菌类敷料还针对伤口愈合过程中可能面临的感染问题而产生。
自从磺胺银Silver sulfadiazine(SSD)开始使用在烧伤伤口后,其中的银离子被缓慢释放出来,起到了抗菌的作用。银离子能在一定的程度上促进伤口的愈合,含银敷料被大量应用于烧烫伤病患及其他一系列出现伤口的病患身上。大量临床结果证实了含银敷料在抗菌方面的有效性,但许多研究证明,纯银离子的抗菌性能比银的复合物强,且复合物较容易产生细胞的毒性,后期发开的纳米银敷料也存在纳米级银微粒可穿透细胞壁进入血液,进入血液循环并沉积在某些器官中,存在威胁人体健康的风险。
因此,本申请提出一种具有生物功能的含铜医用敷料。铜作为人体中必需的一种微量金属元素,在维护心血管的健康方面起着重要的作用。医学研究已发现,铜的缺乏可能会导致一系列心血管疾病的发生,如冠心病、高血压、心律失常等。研究证明,铜能够影响与血管生成有关的生长因子的表达。向现有生物医用材料中适量添加铜后发现,微量铜离子的持续释放能够促进内皮细胞的增殖和迁移,增加内皮细胞中血管生长因子的表达,因而加速伤口的愈合。大量研究已证实了微量铜离子的释放可以具有抗细菌增殖、促进伤口愈合、促进新生血管生成及抗组织粘连的功能。因此,将含铜涂层制备于医用敷料表面或直接添加到敷料本体中,可实现敷料贴敷于伤口后的抗感染、促进伤口愈合、促进新生血管生成及抗组织粘连等多重生物功能,从而降低病患的痛苦及经济负担。
发明内容
本发明的目的是在保证医用敷料基本功能的基础上,在敷料表面添加一种具有生物功能的含铜涂层,实现医用敷料在贴敷于伤口后的抗细菌感染、促进伤口愈合、促进新生血管生成及防组织粘连等多重生物功能。
本发明技术方案如下:
一种具有含铜涂层的医用敷料,其特征在于:在医用敷料表面涂覆有含铜聚合物涂层,该涂层中含有铜元素。
作为优选的技术方案:
所述的具有生物功能的含铜医用敷料,其特征在于,医用敷料的种类包括天然纱布、合成纤维类敷料、多聚膜类敷料、发泡多聚类敷料、水胶体类敷料、藻酸盐敷料等等。
所述具有含铜涂层的医用敷料,其特征在于:所述铜元素通过载铜微球添加,载铜微球为直径在5-500nm的可降解聚合物包衣微球。
所述具有含铜涂层的医用敷料,其特征在于:载铜微球的微球基质材料为具有良好成膜性、生物相容性及可降解性的聚合物,如聚三亚甲基碳酸酯(PTMC)、聚氰基丙烯酸酯(PACA)、聚羟基烷基醇酯(PHAs)、PHB(聚-3-羧基丁酸酯)、聚乙交酯-丙交酯共聚物(PLGA)、聚己内酯(PCL)、聚丙烯酸、纤维素、壳聚糖等之一种或多种,所载含铜物质为纳米级金属铜粉、无机铜离子、含铜有机物之一种或多种。
所述具有含铜涂层的医用敷料,其特征在于:所述纳米级金属铜粉的尺寸在10-200nm的范围内,无机铜离子来自碱式硫酸铜、氧氯化铜、氢氧化铜之一种或多种,含铜有机物为乙酸铜、氨基酸铜、喹啉铜之一种或多种。
所述具有含铜涂层的医用敷料,其特征在于:载铜微球中,基质材料与含铜物质的摩尔比在100:1-2:1的范围内。
所述具有含铜涂层的医用敷料,其特征在于:所述铜元素浓度呈梯度化分布在涂层聚合物中;所述聚合物为壳聚糖及其衍生物、聚氨酯、环糊精、淀粉、纤维素、海藻酸钠、胶原、聚乳酸、聚乙二醇、聚碳酸酯等合成聚合物及天然聚合物。
所述具有含铜涂层的医用敷料,其特征在于:所述含铜聚合物涂层厚度小于等于5μm。
所述医用敷料的制备方法,其特征在于:铜元素在医用敷料表面涂层聚合物中的分布方式为:以载铜微球的形式,通过分层制备法将载铜微球梯度分散在聚合物涂层中。
所述医用敷料的制备方法,其特征在于,包括以下步骤:
步骤一:采用微乳液法制备载铜微球。
步骤二:制备不同配比的载铜微球聚合物溶液,通过浸提或喷涂法逐层制备具有载铜微球的聚合物涂层。
所述医用敷料的制备方法,其特征在于,步骤二中采用微乳液法制备载铜微球包括以下步骤:
(1)配制质量体积浓度为2-120mg/mL的铜盐水溶液;
(2)配制质量体积浓度为2-800mg/mL的微球基质溶液,溶剂为体积比三氯甲烷:丙酮=1:4—4:1;
(3)配制质量体积浓度为1-200mg/mL的PVA水溶液;
(4)将铜盐水溶液加入微球基质溶液中,搅拌均匀后将混合液加入PVA水溶液中;
(5)采用机械搅拌或超声震荡的方法制备不同粒度的微球,其中,搅拌转数在500-5000rpm的范围内,搅拌时间为2-12h;超声功率在50-100W的范围内,超声时间为5-25min;
(6)利用离心或旋转蒸发的方法收集反应制得的微球,其中:
离心法所采取的转数为500-2000rpm,离心后去除上清液,将微球沉淀在蒸馏水中悬浮清洗,干燥;
旋转蒸发法所采取的转速为10-50rpm,将沉降一定时间的溶液,去上清液,将下层反应液加入旋转蒸发仪中,发生温度为30-45℃,时间为30min-2h。
本发明的设计思想:
在医用敷料表面制备具有生物功能的含铜涂层,涂层应均匀分布在敷料的各个位置,以确保医用敷料置入后,发挥抗凝血、抗感染、抗组织粘连等生物功能。将不同浓度的载铜微球,采用物理共混、化学接枝或静电吸附的方法在医用敷料表面逐层制备含铜涂层,使涂层铜含量具有梯度化特点,涂层载体为医用级可降解高分子材料(含铜涂层示意图见附图2)。载铜微球制备时,微球壳体材料应为可生物降解,成膜性良好并具有良好生物相容性的高分子材料。涂层制备过程中,通过调节微球中含铜量或涂层所含微球的量,构建梯度化含铜涂层。涂层制备过程中,对医用敷料结构应不造成破坏,从而实现医用敷料的基本功能,以及抗感染、促进伤口愈合、促进新生血管生成及抗组织粘连等生物功能。
本发明的特点及有益效果在于:
1.本发明提供的一种具有生物功能的含铜涂层医用敷料,使敷料具有抗感染、促进伤口愈合、抗组织粘连等多重生物功能。
2.本发明涉及的具有生物功能的含铜涂层,可替代目前医用敷料所采用的抗生素药物涂层。含铜涂层具有抗感染的特性,可避免因药物涂层引起的细菌耐药性的问题。
3.本发明不但可以作为一种生物功能化“药物涂层”,还具有抗凝血、抗组织粘连的功能,从而减少发生血栓和组织粘连的风险,延长医用敷料的使用周期。
附图说明
图1载铜微球形貌示意图。
图2具有梯度化载铜微球的生物功能化含铜涂层的示意图。
具体实施方式
以下实施例将对本发明予以进一步的说明,但并不因此而限制本发明。
实施例1
逐层化学接枝法在医用敷料上制备具有梯度化载铜微粒的涂层:
采用逐层化学接枝法将具有羟基、羧基等活性官能团的载铜微球固定在具有氨基和羟基的天然可降解壳聚糖聚合物上,每层所载铜的量呈梯度化,通过涂层梯度化释放铜离子,实现含铜涂层的生物功能化可调控。
(1)载铜微球的制备
①称取0.05g、0.2g和0.5gCuCl2,并分别溶解于5mL蒸馏水中配制三种均一溶液;
②再将1.0gPACA溶于三氯甲烷和丙酮的混合溶液中(其中,三氯甲烷:丙酮的体积比为3:2),配制出质量体积浓度为100mg/mL的PACA有机溶液;
③称取PVA1.0g,溶解于蒸馏水中,配制出质量体积浓度为20mg/mL的PVA水溶液,混匀待用;
④将CuCl2水溶液缓慢滴入PACA有机溶液中,混合均匀,再将上述混合液加入PVA水溶液中,磁力搅拌,转数为500rpm,搅拌8小时;超声功率在50-100W的范围内,超声时间为5min;
⑤反应液静置2小时,去上清液,将下层沉淀转入旋转蒸发仪中,在30摄氏度下,旋蒸30分钟,得大量微球粉末。
同法制备不同载铜量的载铜微球,差别在于称取CuCl2的质量分别为0.2g和0.5g,得梯度浓度的微球,微球形貌见附图1。
(2)梯度化载铜聚合物涂层的制备
①配制1%醋酸溶液
取1mL的冰醋酸试剂于100ml容量瓶中,向其中缓慢加入蒸馏水,并定容,混匀待用。
②配制1%壳聚糖溶液
准确称取壳聚糖粉末1g,将100ml配制好的醋酸溶液与粉末混匀,静置24小时,除气泡待用。
③单层载铜涂层的制备
通过浸提法在医用敷料上制备壳聚糖涂层,涂层厚度约0.8μm,待涂层干燥后,在EDC/NHS催化作用下,将低浓度的载铜微球接枝到壳聚糖涂层上。
④具有梯度化载铜微球涂层的制备
重复单层载铜涂层的制备方法,在医用敷料表面逐层制备不同载铜浓度的载铜微球涂层。涂层总厚度控制在5μm以内。
(3)动物实验
将具有梯度化含铜医用敷料贴附于兔子伤口模型上,以无含铜医用敷料作为对照组,15天观察伤口愈合情况及组织粘连程度,对敷料处理后的伤口创面进行观察。实验结果表明,具有含铜医用敷料在使用15天后伤口基本愈合完全,而采用对照组敷料处理的伤口仍表现出红肿、结痂现象;含铜医用敷料与伤口分离时,病患无疼痛感,表面无组织粘连现象发生;而对照组医用敷料表面则与新生纤维组织粘连,敷料与伤口剥离时,病患感到疼痛。因此,本发明具有生物功能的含铜医用敷料表现出抗菌、加速组织愈合、抗组织粘连等特性。
实施例2
逐层静电吸附法在医用敷料上制备具有梯度化载铜微球的涂层:
(1)配制带负电荷的透明质酸钠的水溶液(浓度1-5%),通过浸提法在医用敷料内/外表面制备透明质酸涂层;
(2)载铜微球的制备
①称取0.20g壳聚糖于250mL单口圆底烧瓶中,加入2%(质量分数)醋酸溶液250mL,开启电动搅拌装置缓慢搅拌直至壳聚糖完全溶解。
②边搅拌边加入Span-80 0.4mL和Tween-80 0.6mL,继续搅拌30min使之形成均匀、透明、稳定的微乳液。接着加入0.05g硫酸铜粉末,高速搅拌使之扩散均匀;
③然后,缓慢滴加1mol·L-1的NaOH溶液,同时匀速搅拌,用PHS-3B型精密pH计(中国上海雷磁)在25℃下检测体系pH值的变化,直至微碱性(pH值为7.20);
④NaOH溶液滴加完毕后,中速搅拌并加入0.30g柠檬酸三钠,继续搅拌3h,使乳液中形成的壳聚糖微球交联固化,得到的透明乳液用离心机离心分离;
⑤将下层沉淀转入旋转蒸发仪中,在30摄氏度下,旋蒸30分钟,得大量微球粉末。
同法制备不同载铜量的载铜微球,差别在于称取CuSO4的质量分别为0.2g和0.5g,得梯度浓度的微球。
(3)梯度化载铜聚合物涂层的制备
将带有负电性透明质酸涂层的医用敷料浸入具有正电性低浓度载铜微球的水溶液中,微球将通过静电作用固定于透明质酸涂层上。
重复以上单层涂层的制备方法,构建具有梯度化(含铜量逐层递增模式)载铜微球的聚合物涂层。
(4)亲水性外层的制备
在载有梯度化载铜微球的聚合物涂层外,通过超声雾化喷涂法制备一层<1μm聚乙二醇涂层。
(5)含铜涂层的表征
通过扫描电镜观察带有含铜涂层的医用敷料的表面形貌,表明通过浸提法制备的含铜涂层的表面保持原敷料的原始表面形态。扫描电镜能谱分析结果证实,涂层中有铜的存在。
将带有含铜涂层的医用敷料浸泡在生理盐水(0.9%NaCl)中,1、7、14、28天后分别取浸提液。通过等离子体电感耦合-原子吸收光谱法(ICP-AAS)对浸提液中的铜离子浓度进行测试,结果表明,浸泡过程中,涂层中的铜以离子形式溶出,溶出量在ppb数量级。
本发明具有生物功能的含铜涂层医用敷料可具有良好的生物相容性,并表现出抗菌、促进伤口愈合及抗组织粘连等多重生物功能。
对比例3
将实施例2中制备的具有梯度化载铜微球含铜涂层的制备方法与已申请的发明专利“一种生物可降解含铜涂层纯镁吻合钉及其制备”(专利公开号为:CN 103110977A)中提供的表面涂镀铜离子涂层的方法进行对比,通过对比两种方法制备的涂层在体外的离子溶出性能,以及实际使用情况,评价两种方法制备的含铜涂层的安全性和有效性。
由实施例2可知,本发明具有梯度化载铜微球的含铜涂层,可实现器件植入初期,从涂层中释放足以表达生物功能的铜离子浓度,并通过涂层设计、载铜微球的载铜量的微调来确保铜离子释放量在生物安全范围内;涂层通过初期释放的铜离子来实现避免敷料置入后的细菌感染发生,并促进组织愈合。置入后期,通过微量铜离子的释放抑制纤维蛋白黏附,以实现抗组织粘连的功能。
而根据已申请的专利中提供的涂镀铜离子涂层,则不具有铜离子梯度释放的效果,铜离子的释放量只依赖于涂层载体的性质,如用水溶性或降解速率很快的载体,则植入过程中,涂层中的铜就可能已经释放,当到达目标位置时,已没有足够的铜离子作用于周围组织;如用降解速率慢的载体,则植入后初期没有足够的铜离子释放来实现其多重生物功能性。
将本发明具有梯度化含铜医用敷料贴附于兔子伤口模型上,以已申请的专利制备的不具有铜离子梯度释放的医用敷料作为对照组,15天观察伤口愈合情况及组织粘连程度,对敷料处理后的伤口创面进行观察。实验结果表明,具有梯度化含铜医用敷料在使用15天后伤口基本愈合完全,而对照组敷料处理的伤口仍表现出轻度红肿、结痂现象;含铜医用敷料与伤口分离时,病患无疼痛感,表面无组织粘连现象发生;而对照组医用敷料表面则与新生纤维组织粘连,敷料与伤口剥离时,病患感到疼痛。因此,本发明具有梯度化含铜医用敷料表现出抗菌、加速组织愈合、抗组织粘连等特性,有效由于普通含铜医用敷料。
以上实验结果及分析表明,本发明权利要求中申请保护的具有梯度化载铜微球涂层及其制备方法具有明显的优异效果。
Claims (9)
1.一种具有含铜涂层的医用敷料,其特征在于:在医用敷料表面涂覆有含铜聚合物涂层,该涂层中含有铜元素;所述铜元素通过载铜微球添加;所述铜元素浓度呈梯度化分布在涂层聚合物中,所述聚合物为壳聚糖及其衍生物、聚氨酯、环糊精、淀粉、纤维素、海藻酸钠、胶原、聚乳酸、聚乙二醇、聚碳酸酯之一种或多种。
2.按照权利要求1所述具有含铜涂层的医用敷料,其特征在于,医用敷料的种类为天然纱布、合成纤维类敷料、多聚膜类敷料、发泡多聚类敷料、水胶体类敷料、藻酸盐敷料之一种或多种。
3.按照权利要求1所述具有含铜涂层的医用敷料,其特征在于:载铜微球为直径在5-500nm的可降解聚合物包衣微球。
4.按照权利要求3所述具有含铜涂层的医用敷料,其特征在于:载铜微球的微球基质材料为聚三亚甲基碳酸酯(PTMC)、聚氰基丙烯酸酯(PACA)、聚羟基烷基醇酯(PHAs)、PHB(聚-3-羧基丁酸酯)、聚乙交酯-丙交酯共聚物(PLGA)、聚己内酯(PCL)、聚丙烯酸、纤维素、壳聚糖之一种或多种,所载含铜物质为无机铜离子、含铜有机物之一种或多种,无机铜离子来自碱式硫酸铜、氧氯化铜、氢氧化铜之一种或多种,含铜有机物为乙酸铜、氨基酸铜、喹啉铜之一种或多种。
5.按照权利要求3所述具有含铜涂层的医用敷料,其特征在于:载铜微球中,基质材料与含铜物质的摩尔比在100:1-2:1的范围内。
6.按照权利要求1所述具有含铜涂层的医用敷料,其特征在于:所述含铜聚合物涂层厚度小于等于5μm。
7.一种权利要求1所述医用敷料的制备方法,其特征在于:铜元素在医用敷料表面涂层聚合物中的分布方式为:以载铜微球的形式,通过分层制备法将载铜微球梯度分散在聚合物涂层中。
8.按照权利要求7所述医用敷料的制备方法,其特征在于,包括以下步骤:
步骤一:采用微乳液法制备载铜微球;
步骤二:制备不同配比的载铜微球聚合物溶液,通过浸提或喷涂法逐层制备具有载铜微球的聚合物涂层。
9.按照权利要求8所述医用敷料的制备方法,其特征在于,步骤一中采用微乳液法制备载铜微球包括以下步骤:
(1)配制质量体积浓度为2-120mg/mL的铜盐水溶液;
(2)配制质量体积浓度为2-800mg/mL的微球基质溶液,溶剂为体积比三氯甲烷:丙酮=1:4—4:1;
(3)配制质量体积浓度为1-200mg/mL的PVA水溶液;
(4)将铜盐水溶液加入微球基质溶液中,搅拌均匀后将混合液加入PVA水溶液中;
(5)采用机械搅拌或超声震荡的方法制备不同粒度的微球,其中,搅拌转数在500-5000rpm的范围内,搅拌时间为2-12h;超声功率在50-100W的范围内,超声时间为5-25min;
(6)利用离心或旋转蒸发的方法收集反应制得的微球,其中:
离心法所采取的转数为500-2000rpm,离心后去除上清液,将微球沉淀在蒸馏水中悬浮清洗,干燥;
旋转蒸发法所采取的转速为10-50rpm,将沉降一定时间的溶液,去上清液,将下层反应液加入旋转蒸发仪中,发生温度为30-45℃,时间为30min-2h。
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