CN108186197A - 一种预防和治疗压疮的复合功能敷料及其制备方法 - Google Patents
一种预防和治疗压疮的复合功能敷料及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种预防和治疗压疮的复合功能敷料,一种预防和治疗压疮的复合功能敷料,敷料包括隔离层,隔离层上设有水胶体层,水胶体层上设有泡沫体层,泡沫体层上设有背衬层;水胶体层的原料中含有促润湿吸收剂,促润湿吸收剂包括液体促润湿吸收剂和固体促润湿吸收剂,液体促润湿吸收剂和固体促润湿吸收剂的用量比例为1:0.1‑10。上述敷料能及时吸收伤口渗出液,提高整体吸液量,便于观察,更换方便;本发明还提供了上述敷料的制备方法,包括(1)制备水胶体层;(2)制备泡沫体层;(3)将水胶体层、泡沫体层、背衬层、隔离层复合、灭菌后即为成品;制备方法简单,便于工业化生产。
Description
技术领域
本发明涉及医疗用品技术领域,尤其涉及一种预防和治疗压疮的复合功能敷料及其制备方法。
背景技术
目前,压疮也叫褥疮,是指局部组织长时间受压,血液循环障碍,局部持续缺血、缺氧、营养不良而致的软组织溃烂和坏死。对于危重、昏迷、瘫痪、术后需要长期卧床的患者,由于卧位不舒适,且无法自如挪动,身体局部长期受压,压疮时有发生,给患者身心带来巨大的痛苦,不利于患者的康复。
压疮是临床常见并发症之一,至今仍是护理工作者面临的重大难题。据文献报道,住院患者压疮发生率为1.0%-11.0%,手术患者是院内压疮发生的高危人群,其压疮发生率为4.7%-66.0%,手术当天至手术后第3天为压疮预防的关键时期。压疮一旦发生难以恢复,不仅增加患者痛苦,提高医疗费用,还增加了护理工作量。外部压力作用于皮肤2小时后下面的肌肉会产生缺血改变,相同压力作用于皮肤6小时肌肉完全变性,因此长期受医器械压迫也会产生压疮。故压疮的预防具有非常重要的医学意义,因此采取有效的预防措施非常必要。
临床上,压疮的预防除采用翻身、按摩等方式,也采用气垫圈、烤灯、涂抹凡士林进行压疮的预防,但气垫圈易使局部血循环受阻,造成静脉充血与水肿同时妨碍汗液蒸发而刺激皮肤,特别是水肿和肥胖者更不宜使用;使用烤灯等使皮肤干燥,组织细胞代谢及氧量增加进而造成细胞缺血、甚至坏死;涂抹凡士林等油性剂,无透气性,亦无呼吸功能,水分蒸发量维持在一个较低水平上,远低于正常皮肤的水分蒸发量,导致皮肤浸渍。
某些患者受压部位使用泡沫敷贴等预防压疮的发生。这些方法从一定程度上降低了压疮的发生率,但使用泡沫敷贴的过程中影响护士对患者皮肤情况的观察,而护士又必须观察皮肤或牙床伤口的实际情况,观察局部皮肤时需要撕掉压疮贴,敷贴不能重复使用,这就严重增加了患者经济负担或医疗资源的浪费。
专利CN206587100U中通过设置温湿度传感器、发射器、接收器等来监测压疮伤口情况,虽然降低了敷贴的更换频次,但工艺复杂,操作繁琐。同时增加了生产成本,加重了患者就医费用;专利CN 103212105 A通过水凝胶来预防压疮,但分散缓冲压力小,吸收渗液量差,且需要二次包扎来固定敷料,操作复杂,增加医护人员工作量,且二次包扎也会影响伤口情况观察。
发明内容
为了克服现有技术的不足,本发明的目的之一在于提供一种预防和治疗压疮的复合功能敷料,能及时吸收伤口渗出液,提高整体吸液量,减少更换次数,减少医护人员的工作负荷。
本发明的目的之二在于提供上述防压疮敷料的制备方法,工艺简单,操作方便,便于工业化生产。
本发明的目的之一采用如下技术方案实现:
一种预防和治疗压疮的复合功能敷料,所述敷料包括隔离层,在所述隔离层上设有水胶体层、在所述水胶体层上设有泡沫体层、在所述泡沫体层上设有背衬层;所述水胶体层的原料中含有促润湿吸收剂,所述促润湿吸收剂包括液体促润湿吸收剂和固体促润湿吸收剂,液体促润湿吸收剂和固体促润湿吸收剂的用量比例为1:0.1-10。
使用时取下隔离层,水胶体敷料粘贴后成为闭合环境,形成低氧张力,刺激释放巨噬细胞及白细胞介素,促进局部血液循环。水胶体层配合泡沫体层既能使受压部位保持局部低氧张力,加快毛细血管生成,改善局部组织的微循环,防止皮肤受压后静脉水肿,又能利用泡沫体弹性分散缓冲受压部位皮肤压力,从而更好预防压疮产生。
所述水胶体层由以下重量份的原料制备而成:亲水胶体粒子10-50份,促润湿吸收剂1-15份,SIS热塑性弹性体5-40份,软化油5-40份,增粘树脂5-40份,抗氧化剂0.01-5份,增塑剂0.5-10份,所述促润湿吸收剂包括液体促润湿吸收剂和固体促润湿吸收剂,液体促润湿吸收剂和固体促润湿吸收剂的用量比例为1:0.1-10;通过选择液体促润湿剂与固体促润湿剂相配合,协同发挥作用,既增加亲水胶体粒子湿润性,提高敷料液体吸收速率,提高液体吸收量,有效防止压疮、溃疡等中高渗创面渗液外漏。
进一步地,所述液体促润湿吸收剂选自甘油、丙二醇、聚乙二醇、氮酮、异丙醇、正丁醇中的至少一种;所述固体促润湿吸收剂选自交联羧甲基纤维素接枝丙烯酰胺、淀粉接枝丙烯酸盐类、交联型羟乙基纤维素接枝丙烯酰胺聚合物中的至少一种。
进一步地,所述液体促润湿吸收剂为氮酮和异丙醇的混合物;所述固体促润湿吸收剂为交联羧甲基纤维素接枝丙烯酰胺和交联型羟乙基纤维素接枝丙烯酰胺聚合物的混合物。
进一步地,所述亲水胶体粒子选自羧甲基纤维素钠、交联羧甲基纤维素钠、聚乙烯醇、明胶、果胶、海藻酸钠中的至少一种。
进一步地,所述增粘树脂选自聚异丁烯、石油树脂、松香甘油酯、脂松香、二萜烯聚合物中的至少一种;所述软化油选自液体石蜡、环烷油、植物油、妥儿油中的至少一种;所述抗氧化剂为2,6-二叔丁基甲酚、2,5-二叔丁基喹啉、抗氧化剂1010、抗氧化剂4010、抗氧化剂DLTP、抗氧化剂DSTP、抗氧化剂BHT中的至少一种;所述增塑剂为邻苯二甲酸二辛酯、邻苯二甲酸二丁酯、邻苯二甲酸二异壬酯、己二酸二辛酯中的至少一种。
进一步地,所述泡沫体层由以下重量份的原料制备而成:聚醚多元醇20~40份、二异氰酸酯0.15~0.5份、匀泡剂1~5份、软化剂0.1-2份、催化剂0.5~1.5份、交联剂0.5~1.5份、高吸水性微粒5~30份、纯水3~6份。
进一步地,所述聚醚多元醇选自HSH-330、HSH-303、HSH-305、HSH-230、HSH-240、HSH-215、HSH-220、HSH-390、HSH-360中的至少一种;所述二异氰酸酯选自HDI、IPDI、BDI、HMDI、TDI中的至少一种;所述高吸水性微粒选自羧甲基纤维素钠、海藻酸钠、三乙醇胺、透明质酸钠、聚谷氨酸、聚丙烯酸及其盐、淀粉接枝改性聚丙烯酸盐中的至少一种,通过高吸水性微粒的加入有效改善了泡沫体层的渗液吸收量及吸收速率。
进一步地,所述匀泡剂选自聚氨酯匀泡剂L-580、L-603、L-688、L-5420、SZ-1703、L-6900、Y-7931、L-626、L-5740M、F-68、F-87、F-108中的至少一种;所述软化剂选自C12-14醇聚氧乙烯醚、单烷基磷酸酯钾盐中的一种或两种的组合物;所述催化剂为胺类催化剂和锡类催化剂的组合物,其中胺类催化剂与锡类催化剂比例为1:1-4,所述胺类催化剂选自三乙烯二胺、N,N-二甲基环己胺、双(2-二甲氨基乙基)醚、N,N,N',N'-四甲基亚烷基二胺、三乙胺、N,N-二甲基苄胺中的至少一种;所述锡类催化剂选自有机锡催化剂T9、有机锡催化剂T12、双二甲氨基乙基醚、五甲基二乙烯三胺、二甲基环己胺、二月桂酸二丁基锡、有机铋、三嗪类三聚催化剂中的至少一种。
进一步地,所述背衬层为聚氨酯薄膜;所述隔离层为离型纸、PET薄膜中的一种,采用聚氨酯薄膜作为背衬层防水阻菌,但允许水蒸汽和空气进行交换,从而允许受压部位水分蒸发量维持在正常水平上,另一方面水胶体层和泡沫层能够吸收皮肤蒸发的水分,从而避免皮肤浸渍,从而预防压疮产生。
进一步地,所述水胶体层厚度为0.1-2mm,所述泡沫体层厚度为2-10mm,所述水胶体层表面积大于等于泡沫体层表面积,由于泡沫体层吸收渗液能力优于水胶体层,接触伤口部位水胶体层吸收渗液后垂直传导到泡沫体层,当泡沫体层吸收饱和后,过多渗液横向传导至伤口周边水胶体,致使周边水胶体发白或粘性降低漏液,可提示医护人员更换敷料,避免单独使用泡沫敷料无法及时更换敷料对伤口的伤害,同时降低不断揭除敷料,观察伤口情况造成的浪费。
水胶体层吸收渗液并传导到泡沫体层,改善伤口渗液情况,当伤口与水胶体层接触时,伤口处的氧分压会迅速降低,在低的氧分压情况下,血管形成加速,血管形成后,创面的供血、供氧增加,氧分压增加,从而又促进肉芽组织的行形成,水胶体层的药物作用机制包括:①消除红肿,水胶体具有吸收性能的基础,密闭的半透膜保持局部低氧张力,毛细血管生成快,改善局部组织的微循环,加快渗液的吸收;②减轻疼痛,促进炎性细胞吸收和代谢;③防止坏死,大量输液、药物刺激静脉痉挛可造成持续静脉高压,之后会出现毛细血管渗透性增高,导致纤维蛋白漏入毛细血管周围间隙,并沉积在周围,造成病变血管氧扩散减少,妨碍营养物与代谢废物交换。水胶体还有溶解纤维蛋白的作用,保证了局部组织正常的代谢功能。水胶体层中丰富的促润湿吸收剂和亲水胶体粒子,为创面提供足够的水分,以使创面的坏死组织能充分地水合,从而有利于机体自身自溶性清创过程,同时水胶体层可以吸收过剩的创面渗出物和毒性物质,保持创面合理的湿润状态,促进组织的生长功能,并允许有氧交换并阻挡微生物通过,能够吸收渗出物形成凝胶,保证创面较快愈合。压疮是局部长期受压,导致血液循环不畅产生,可通过泡沫体层有效缓冲压力,配合水胶体层促进血液循环,从而预防压疮产生。压疮一旦发生,压疮伤口会有大量渗出液,不处理易导致皮肤浸渍,伤口扩大或发脓、感染,通过水胶体层快速吸收渗出液,并传导至泡沫体层,保持疮口的清爽,促进疮口的愈合。
本发明的目的之二采用如下技术方案实现:
上述一种预防和治疗压疮的复合功能敷料的制备方法,包括如下步骤:
(1)制备水胶体层:称取上述重量份的各组分,在捏合机中加入SIS热塑性弹性体、软化剂、增粘树脂、抗氧化剂、增塑剂,在加热搅拌的条件下,混合均匀,然后加入亲水胶体颗粒,促润湿吸收剂,混合搅拌后出料,将得到混合均匀的物料均匀涂于隔离纸上,收卷待用;
(2)制备泡沫体层:在混合聚醚多元醇中加入匀泡剂、交联剂、软化剂、催化剂、高吸水性微粒、纯水,搅拌混匀,作为A组分待用,二异氰酸酯作为B组分;将A、B组分加入发泡机中混合,然后将混合均匀物料涂布到离型纸上,在烘道内发泡成型,熟化后,收卷待用;
(3)将水胶体层、泡沫体层、背衬层、隔离层复合,装袋灭菌后即为成品。
进一步地,所述烘道温度为60-100℃,发泡时间为30分钟,熟化时间为24小时。
相比现有技术,本发明的有益效果在于:通过加入液体促润湿吸收剂和固体促润湿吸收剂相互配合来增加水胶体的吸收渗液速度,本发明中限定水胶体层中采用的液体促润湿吸收剂为氮酮和异丙醇的混合物;固体促润湿吸收剂为交联羧甲基纤维素接枝丙烯酰胺和交联型羟乙基纤维素接枝丙烯酰胺聚合物的混合物,各促润湿吸收剂之间发挥协同增效作用,进一步提高敷料吸收渗液的速率,用于压疮创面、溃疡创面时能及时吸收伤口渗出液,并快速传导至泡沫体层;另一方面通过增加泡沫体层来增大产品的吸液速率,提高产品整体的吸液量,使本发明产品吸收渗液后无扩散性能和回渗,使周围组织无浸润,并且减少更换次数,大大减少医护人员的工作负荷。此外,增加泡沫体层后,水胶体接触伤口部位吸收渗液垂直传到到泡沫体层,一方面避免渗液横向传导,浸渍伤口周围皮肤,一方面泡沫体层吸收渗液后膨胀,在伤口处形成微负压,促进伤口愈合。而且使用本发明产品后创面无痂皮形成,避免肉芽组织再次受到机械损伤,保持新鲜肉芽组织的成长迁移,明显缩小创伤面积,缩短愈合时间。水胶体层与聚氨酯背衬层配合使用,能阻碍外界微生物的侵入,防止灰尘等污染创面;同时本发明提供的敷料具有自粘性,无需二次固定,操作方便简单;本发明还提供了上述辅料的制备方法,工艺简单,操作方便,便于工业化生产。
附图说明
图1为本发明实施例1的结构示意图;
图中:1、背衬层;2、泡沫体层;3、水胶体层;4、隔离层。
具体实施方式
下面,结合附图以及具体实施方式,对本发明做进一步描述,需要说明的是,在不相冲突的前提下,以下描述的各实施例之间或各技术特征之间可以任意组合形成新的实施例。
在本发明中,若非特指,所有用量均为重量份,所采用的设备和原料等均可从市场购得或是本领域常用,下述实施例中的方法,如无特别说明,均为本领域的常规方法。
实施例1
实施例1提供一种如图1所示的一种预防和治疗压疮的复合功能敷料,包括隔离层4,在隔离层4上设有水胶体层3,在水胶体层3上设有泡沫体层2,在泡沫体层2上设有背衬层1,上述防压疮辅料经以下步骤制得:
(1)制备水胶体层:将SIS热塑性弹性体40份、液体石蜡25份、松香甘油酯5份、抗氧化剂BHT 5份、增塑剂己二酸二辛酯10份依次加入捏合机中在130℃、45r/min的条件下,混合1h,然后加入丙三醇与交联型羟乙基纤维素接枝丙烯酰胺聚合物共2份(丙三醇和交联型羟乙基纤维素接枝丙烯酰胺聚合物的比例为10:1),羧甲基纤维素钠20份,混合搅拌1h出料;将混合均匀的物料均匀涂于隔离纸上,其涂布厚度为0.2mm,收卷待用;
(2)制备泡沫体层:将HSH-330 20份、纯水6份、L5805份、C12-14醇聚氧乙烯醚0.1份,高吸水性微粒羧甲基纤维素钠1份、三乙醇胺1份、胺催化剂三乙烯二胺0.5份、混合搅拌,静置片刻,加入锡催化剂T9 0.5份,3000rpm,搅拌50-60s,混匀后作为A组分加入发泡机中;将TDI 0.3份作为B组分迅速加入发泡机中,快速混合后将混合均匀物料涂布到离型纸上,在烘道内发泡成型,成型后厚度为2mm,烘道温度60℃,发泡35min,熟化30h后,收卷待用;
(3)将水胶体层、泡沫体层、聚氨酯薄膜、离型纸复合、裁切,装袋灭菌后即为成品。
实施例2
一种预防和治疗压疮的复合功能敷料,经以下步骤制得:
(1)制备水胶体层:将SIS热塑性弹性体30份、液体石蜡25份、环烷油10份、松香甘油酯5份、聚异丁烯10份、抗氧化剂2,6-二叔丁基甲酚2份、2,5-二叔丁基喹啉1份、增塑剂邻苯二甲酸二辛酯4份、邻苯二甲酸二丁酯2份依次加入捏合机中在130℃、45r/min的条件下,混合1h,然后加入氮酮、异丙醇作为液体促润湿吸收剂,交联羧甲基纤维素接枝丙烯酰胺、交联型羟乙基纤维素接枝丙烯酰胺聚合物作为固体促润湿吸收剂共10份(液体促润湿吸收剂和固体促润湿吸收剂的用量比例为1:5),交联羧甲基纤维素钠10份、聚乙烯醇30份,混合搅拌1h出料;将混合均匀的物料均匀涂于隔离纸上,其涂布厚度为0.5mm,收卷待用;
(2)制备泡沫体层:将HSH-305 20份、HSH-230 10份、纯水4份、L-6881份、SZ-17033份、单烷基磷酸酯钾盐0.5份、高吸水性微粒海藻酸钠10份、聚丙烯酸15份、胺催化剂N,N-二甲基环己胺0.5份、混合搅拌,静置片刻,加入锡催化剂双二甲氨基乙基醚1份,3000rpm,搅拌50-60s,混匀后作为A组分加入发泡机中;将HDI 0.15份、BDI0.3份作为B组分迅速加入发泡机中,快速混合后将混合均匀物料涂布到离型纸上,在烘道内发泡成型,成型后厚度为5mm,烘道温度80℃,发泡30分钟,熟化25h后,收卷待用;
(3)将水胶体层、泡沫体层、聚氨酯薄膜、离型纸复合、裁切,装袋灭菌后即为成品。
实施例3
一种预防和治疗压疮的复合功能敷料,经以下步骤制得:
(1)制备水胶体层:将SIS热塑性弹性体40份、液体石蜡10份、植物油20份、妥儿油10份、石油树脂20份、松香甘油酯5份、聚异丁烯10份、抗氧化剂2,6-二叔丁基甲酚1份、2,5-二叔丁基喹啉2份、抗氧化剂1010 2份、己二酸二辛酯4份、邻苯二甲酸二丁酯2份、邻苯二甲酸二异壬酯4份依次加入捏合机中在130℃、45r/min的条件下,混合1h,然后加入氮酮、异丙醇作为液体促润湿吸收剂,交联羧甲基纤维素接枝丙烯酰胺、交联型羟乙基纤维素接枝丙烯酰胺聚合物作为固体促润湿吸收剂共15份(液体促润湿吸收剂和固体促润湿吸收剂的用量比例为1:10),明胶10份、果胶20份、海藻酸钠20份,混合搅拌1h出料;将混合均匀的物料均匀涂于隔离纸上,其涂布厚度为1mm,收卷待用;
(2)制备泡沫体层:将HSH-305 10份、HSH-390 15份、HSH-24025份、纯水6份、Y-7931 1份、L-5740M 1份、F-68 3份、C12-14醇聚氧乙烯醚1份、单烷基磷酸酯钾盐1份,高吸水性微粒羧甲基纤维素钠5份、透明质酸钠10份、三乙醇胺15份、胺催化剂三乙胺0.2份、N,N-二甲基苄胺0.3份、混合搅拌,静置片刻,加入锡催化剂二甲基环己胺0.5份、二月桂酸二丁基锡0.5份,3000rpm,搅拌50-60s,混匀后作为A组分加入发泡机中;将IPDI 0.05份、BDI0.05份、HMDI 0.05份作为B组分迅速加入发泡机中,快速混合后将混合均匀物料涂布到离型纸上,在烘道内发泡成型,成型后厚度为10mm,烘道温度100℃,发泡25分钟,熟化24h后,收卷待用;
(3)将水胶体层、泡沫体层、聚氨酯薄膜、PET薄膜复合,裁切,装袋灭菌后即为成品。
对比例1
对比例1提供一种预防和治疗压疮的复合功能敷料,和实施例3的区别为对比例1未添加促润湿吸收剂。
对比例2
对比例1提供一种预防和治疗压疮的复合功能敷料,和实施例3的区别为对比例2仅添加液体促润湿吸收剂氮酮、异丙醇,液体促润湿吸收剂的用量为15份。
对比例3
对比例1提供一种预防和治疗压疮的复合功能敷料,和实施例3的区别为对比例3仅添加固体促润湿吸收剂交联羧甲基纤维素接枝丙烯酰胺、交联型羟乙基纤维素接枝丙烯酰胺聚合物,固体促润湿吸收剂的用量为15份。
对比例4
对比例4提供一种预防和治疗压疮的复合功能敷料,和实施例3的区别为对比例4中的液体促润湿吸收剂为聚乙二醇、氮酮,其余均和实施例3相同。
对比例5
本对比例敷料与对比例4的不同之处在于省去对比例4中的固体促润湿吸收剂,调整液体促润湿吸收剂的总用量为15份,其他同对比例4。
对比例6
对比例6提供一种预防和治疗压疮的复合功能敷料,和实施例3的区别为对比例6中的液体促润湿吸收剂为甘油、氮酮,其余均和实施例3相同。
对比例7
本对比例敷料与对比例6的不同之处在于省去对比例6中的固体促润湿吸收剂,调整液体促润湿吸收剂的总用量为15份,其他同对比例6。
对比例8
对比例8提供一种预防和治疗压疮的复合功能敷料,和实施例3的区别为对比例8的固体促润湿吸收剂为羧甲基纤维素钠、交联型羟乙基纤维素接枝丙烯酰胺聚合物其余均和实施例3相同。
对比例9
本对比例敷料与对比例8的不同之处在于省去液体促润湿吸收剂,调整固体促润湿吸收剂的总用量为15份,其他同对比例8。
对比例10
对比例10提供一种预防和治疗压疮的复合功能敷料,和实施例3的区别为对比例10的固体促润湿吸收剂为交联羧甲基纤维素接枝丙烯酰胺、接枝丙烯酰胺,其余均和实施例3相同。
对比例11
本对比例敷料与对比例10的不同之处在于省去液体促润湿吸收剂,调整固体促润湿吸收剂的总用量为15份,其他同对比例10。
分别测定实施例1至3和对比例1至11提供的放压疮敷料的吸液速率和吸液量,吸液速率的测定方法:吸取等量液体吸收性试液(氯化钠与二水合氯化钙混合液)分别滴于等量大小和厚度的上述敷料上,记录吸收性试液完全吸收所需时间;参照YY/T0471.1-2004中规定方法测定上述敷料的吸液量,结果如表1所示。
表1
由上表的试验结果可以看出,与对比例1至3相比可知,本发明通过加入液体促润湿吸收剂和固体促润湿吸收剂结合使用吸液速率更快,吸液量更大,通过对比例4至11可以看出,在将本发明提供的液体促润湿吸收剂:氮酮和异丙醇的混合物;固体促润湿吸收剂:交联羧甲基纤维素接枝丙烯酰胺和交联型羟乙基纤维素接枝丙烯酰胺聚合物的混合物中的任一组分替换为其他具有促润湿效果的组分后,其吸液速率缓慢,吸液量减少,进一步说明本发明通过在水胶体层中添加液体促润湿吸收剂:氮酮和异丙醇混合物;固体促润湿吸收剂:交联羧甲基纤维素接枝丙烯酰胺和交联型羟乙基纤维素接枝丙烯酰胺聚合物的混合物,与不添加促润湿吸收剂、单独添加液体促润湿吸收剂或固体促润湿吸收剂,以及调整促润湿吸收剂的成分后,在相同的用量下,本发明提供的促润湿吸收剂组合制得的敷料具有更快的吸液速率和更大的吸液量,上述实验结果说明上述四个组分之间通过相互物配合,相互增益,协同发挥作用,既增加亲水胶体粒子湿润性,提高敷料液体吸收速率,提高液体吸收量,有效防止压疮、溃疡等中高渗创面渗液外漏。
上述实施方式仅为本发明的优选实施方式,不能以此来限定本发明保护的范围,本领域的技术人员在本发明的基础上所做的任何非实质性的变化及替换均属于本发明所要求保护的范围。
Claims (10)
1.一种预防和治疗压疮的复合功能敷料,其特征在于,所述敷料包括隔离层,所述隔离层上设有水胶体层,所述水胶体层上设有泡沫体层,所述泡沫体层上设有背衬层;所述水胶体层的原料中含有促润湿吸收剂,所述促润湿吸收剂包括液体促润湿吸收剂和固体促润湿吸收剂,液体促润湿吸收剂和固体促润湿吸收剂的用量比例为1:0.1-10。
2.根据权利要求1所述一种预防和治疗压疮的复合功能敷料,其特征在于,所述水胶体层由以下重量份的原料制备而成:亲水胶体粒子10-50份、促润湿吸收剂1-15份、SIS热塑性弹性体5-40份、软化油5-40份、增粘树脂5-40份、抗氧化剂0.01-5份、增塑剂0.5-10份。
3.根据权利要求2所述一种预防和治疗压疮的复合功能敷料,其特征在于,所述液体促润湿吸收剂选自丙二醇、氮酮、异丙醇、正丁醇中的至少一种;所述固体促润湿吸收剂选自交联羧甲基纤维素接枝丙烯酰胺、淀粉接枝丙烯酸盐类、交联型羟乙基纤维素接枝丙烯酰胺聚合物中的至少一种。
4.根据权利要求2所述一种预防和治疗压疮的复合功能敷料,其特征在于,所述液体促润湿吸收剂为氮酮和异丙醇的混合物;所述固体促润湿吸收剂为交联羧甲基纤维素接枝丙烯酰胺和交联型羟乙基纤维素接枝丙烯酰胺聚合物的混合物。
5.根据权利要求2所述一种预防和治疗压疮的复合功能敷料,其特征在于,所述亲水胶体粒子选自羧甲基纤维素钠、交联羧甲基纤维素钠、聚乙烯醇、明胶、果胶、海藻酸钠中的至少一种;所述增粘树脂选自聚异丁烯、石油树脂、松香甘油酯、脂松香、二萜烯聚合物中的至少一种;所述软化油选自液体石蜡、环烷油、植物油、妥儿油中的至少一种;所述抗氧化剂为2,6-二叔丁基甲酚、2,5-二叔丁基喹啉、抗氧化剂1010、抗氧化剂4010、抗氧化剂DLTP、抗氧化剂DSTP、抗氧化剂BHT中的至少一种。
6.根据权利要求1所述一种预防和治疗压疮的复合功能敷料,其特征在于,所述泡沫体层由以下重量份的原料制备而成:聚醚多元醇20~40份、二异氰酸酯0.15~0.5份、匀泡剂1~5份、软化剂0.1-2份、催化剂0.5~1.5份、交联剂0.5~1.5份、高吸水性微粒5~30份、纯水3~6份。
7.根据权利要求6所述一种预防和治疗压疮的复合功能敷料,其特征在于,所述聚醚多元醇选自HSH-330、HSH-303、HSH-305、HSH-230、HSH-240、HSH-215、HSH-220、HSH-390、HSH-360中的至少一种;所述二异氰酸酯选自六亚甲基二异氰酸酯、异佛尔酮二异氰酸酯、1,4-丁二异氰酸酯、4,4'-二环己基甲烷二异氰酸酯、甲苯二异氰酸酯中的至少一种;所述高吸水性微粒选自羧甲基纤维素钠、海藻酸钠、三乙醇胺、透明质酸钠、聚谷氨酸、聚丙烯酸及其盐、淀粉接枝改性聚丙烯酸盐中的至少一种;所述匀泡剂选自L-580、L-603、L-688、L-5420、SZ-1703、L-6900、Y-7931、L-626、L-5740M、F-68、F-87、F-108中的至少一种;所述软化剂选自C12-14醇聚氧乙烯醚、单烷基磷酸酯钾盐中的一种或两种的组合物;所述催化剂为胺类催化剂和锡类催化剂的组合物。
8.根据权利要求1所述一种预防和治疗压疮的复合功能敷料,其特征在于,所述背衬层为聚氨酯薄膜;所述隔离层为离型纸、PET薄膜中的一种。
9.根据权利要求1所述一种预防和治疗压疮的复合功能敷料,其特征在于,所述水胶体层厚度为0.1-2mm,所述泡沫体层厚度为2-10mm,所述水胶体层表面积大于等于泡沫体层表面积。
10.一种如权利要求1至9所述预防和治疗压疮的复合功能敷料的制备方法,其特征在于,包括如下步骤:
(1)制备水胶体层:称取上述重量份的各组分,在捏合机中加入SIS热塑性弹性体、软化剂、增粘树脂、抗氧化剂、增塑剂,在加热搅拌的条件下,混合均匀,然后加入亲水胶体颗粒,促润湿吸收剂,混合搅拌后出料,将得到混合均匀的物料均匀涂于隔离纸上,收卷待用;
(2)制备泡沫体层:在混合聚醚多元醇中加入匀泡剂、交联剂、软化剂、催化剂、高吸水性微粒、纯水,搅拌混匀,作为A组分待用,二异氰酸酯作为B组分;将A、B组分加入发泡机中混合,然后将混合均匀物料涂布到离型纸上,在烘道内发泡成型,熟化后,收卷待用;
(3)将水胶体层、泡沫体层、背衬层、隔离层复合,装袋灭菌后即为成品。
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