CN101631572B - 含银泡沫结构 - Google Patents
含银泡沫结构 Download PDFInfo
- Publication number
- CN101631572B CN101631572B CN2008800066529A CN200880006652A CN101631572B CN 101631572 B CN101631572 B CN 101631572B CN 2008800066529 A CN2008800066529 A CN 2008800066529A CN 200880006652 A CN200880006652 A CN 200880006652A CN 101631572 B CN101631572 B CN 101631572B
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- Prior art keywords
- silver
- hours
- foaming structure
- gel
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Abstract
本发明涉及制造含银盐的亲水性聚氨酯泡沫结构的方法,所述银盐选自硫酸银、柠檬酸银、乙酸银、碳酸银、乳酸银和磷酸银或者这些盐的混合物。所述方法包括以下步骤:(a)提供包含表面活性剂和至少一种银盐的水相,其中所述至少一种银盐分散在所述水相中;(b)提供具有超过2个官能度的端异氰酸酯聚醚;(c)混合所述水相和所述端异氰酸酯聚醚,立即转移所得混合物至模具,从而获得泡沫结构;和(d)干燥所述泡沫结构直至其湿含量为最多10%(wt)。本发明还提供一种由所述方法制造的亲水性聚氨酯泡沫结构以及包含所述泡沫结构的创伤敷料。
Description
技术领域
本发明涉及抗菌和亲水性的聚氨酯泡沫结构。更具体地,该抗菌和亲水性的泡沫结构在聚合物基质中和泡孔内均含有增量的银。此外,本发明还提供制造该抗菌和亲水性的泡沫结构的方法。
背景技术
WO97/42985公开了包含泡沫材料吸收剂层的创伤敷料,该泡沫材料吸收剂层包括空穴图案。空穴开向在该泡沫材料的在敷用该敷料时邻近敷用者皮肤的侧面,并且所述泡沫材料层涂有一层粘附皮肤的疏水性凝胶,其中当敷用该敷料时邻近敷用者皮肤的泡沫材料中的空穴壁的那些末端部位携带凝胶。该文献没有公开有关在该敷料中包含特定的抗微生物或抗菌化合物的内容。
US5,662,913描述了使用通过与无环聚醚聚合物形成复合物来稳定的银盐。此外,银盐的阴离子相对于银离子过量。US5,662,913中的稳定银盐复合物可包含在泡沫结构中。该专利公开的发明目的是提供用于预防传染的、光稳定的、非污染的抗微生物金属组合物,并使聚氨酯基泡沫体能够抗微生物。该文献没有公开有关控制从聚氨酯结构中释放银的内容。
WO2004/007595公开了在控释银组分存在下制备的柔性多孔聚氨酯泡沫产品。通常银从结构中缓慢地释放,这在一些应用中是有利的,但在其他应用中可能有不足。
EP-A1-1486523和US4,937,273二者均涉及聚氨酯泡沫,该聚氨酯泡沫包含结合于沸石颗粒的抗微生物的银。通常银从该结构中缓慢地释放,这在一些应用中是有利的,但在其他应用中可能有不足。
WO2002/062403公开了创伤敷料的制造,该创伤敷料具有与元素周期表第IV族金属形成的可释放的银复合物,特别是银锆盐。该文献并未公开有关本发明权利要求1中的银盐。
EP-A1-0059049涉及包含磺胺嘧啶银的创伤敷料。该文献并未公开有关本发明权利要求1中的银盐。
不同的创伤需要诸如银的抗微生物剂的不同释放模式。然而,对于已感染的创伤和可变得易感染的创伤,期望使用初始既能释放大量抗微生物的银并且能够保持这种释放持续一段时间的敷料。
发明内容
本发明提供一种制造可用作创伤敷料的抗菌和亲水性的聚氨酯泡沫结构的方法。所述方法包括以下步骤:
a)提供包含表面活性剂的水相;
b)提供具有超过2个官能度的端异氰酸酯聚醚;
c)将所述水相和所述端异氰酸酯聚醚混合,立即转移所得混合物至模具或连续网,从而获得泡沫结构;和
d)干燥所述泡沫结构直至其湿含量为最多10%(wt),优选最多8%(wt),并且更优选最多5%(wt)。
所述方法的基本特征是在步骤a)中的所述水相还包含银盐。一部分所述银盐分散于所述水相中。该方法的优点是抗微生物的银离子在延长的时间段内以有利的方式从泡沫释放。上述银盐选自硫酸银、柠檬酸银、乙酸银、碳酸银、乳酸银和磷酸银或这些盐的混合物。
此外,优选在步骤c)中加入混合物之前,在所述模或连续网上衬有浇铸纸。在干燥步骤d)之前移除所述浇铸纸。
在存在催化剂的情况下,还优选在步骤d)之后获得的泡沫结构的一个表面增加一个或多个形成凝胶的硅氧烷组分,该组分通过固化形成交联硅氧烷凝胶。所述催化剂优选是铂络合物。
最后,本发明提供一种孔尺寸为30~1000μm的抗菌和亲水性的聚氨酯泡沫结构,其中所述结构可通过上述公开的方法制造。优选地,48小时后每平方厘米泡沫结构累积释放的银总计为超过0.2mg/cm2,更优选超过0.25mg/cm2,最优选超过0.30mg/cm2。此外,72小时后每平方厘米泡沫结 构累积释放的银总计超过0.3mg/cm2,更优选超过0.35mg/cm2,最优选超过0.40mg/cm2。优选地,在48小时后,更优选96小时后,最优选120小时后,累积释放的银总计为最多0.80mg/cm2。
优选地,所述泡沫结构的抗菌特性使得:根据参考方法ASTM E2149,在35℃+/-2℃的温度下,当所述泡沫的直径为20mm和厚度为5mm的圆形样品暴露于10ml包含细菌的模拟创伤流体(1∶1的小牛血清和蛋白胨水(包含0.9%(wt)NaCl和0.5%(wt)蛋白胨的水溶液)的溶液)时,能够在72小时内将活的铜绿假单胞菌细胞的量从106减小至小于102,并在120小时内将活的金黄色葡萄球菌细胞的量从106减小至小于102。
本发明还提供包含所述释放银的泡沫结构的创伤敷料。
发明详述
因此,本发明提供一种制造具有改善的抗菌银离子随时间释放特征的抗菌和亲水性的泡沫结构的方法。
本发明的亲水性泡沫结构主要是亲水性聚氨酯泡沫。适合的亲水性聚氨酯泡沫包括那些Hypol(商标)泡沫。Hypol泡沫可由Dow Chemicals销售的Hypol亲水性预聚物制成。
将具有超过两个官能度的端异氰酸酯聚醚与表面活性剂和水一起混合并浇铸该混合物到表面上可制成适合的亲水性聚氨酯泡沫。
优选的端异氰酸酯聚醚包括Dow Chemicals销售的Hypol FHP 2000、2001、3000、3001、2002和2000HD。在W.R.Grace and Co.出版的册子“Hypol:foamable hydrophilic polymers--laboratory procedures and foamformulations”中记载了Hypol。编号为1429711和1507232的英国专利说明书公开了它们的制备和使用方法。
用于形成一致的亲水性聚合物泡沫的合适表面活性剂包括非离子型表面活性剂。适合的非离子型表面活性剂是BASF Wyandotte销售的称为Pluronic(商标)的环氧丙烷-环氧乙烷嵌段共聚物。优选的Pluronic表面活性剂包括L65、F87、P38、P75和L62。
适合的银源是在水中具有中等溶解度的银盐。同样重要的是所述银盐在灭菌条件下稳定以及它们可以药用。在本发明的一个实施方案中,在水 中具有中等溶解度的银盐与具有低水溶性的银盐混合。在制造过程中,必须有一部分银盐分散于水性反应混合物中。根据本发明可使用的银盐的实例包括:硫酸银、柠檬酸银、乙酸银、碳酸银、乳酸银和磷酸银或这些盐的混合物。
在典型泡沫的制备中,将100重量份的Hypol FHP 2000、2001、3000、3001、2002或2000HD与0.3~7重量份的表面活性剂或表面活性剂的混合物、2~9重量份诸如硫酸银的银盐和30~300重量份的水混合,并将该发泡混合物浇铸到表面上。典型的发泡混合物的乳白时间(cream time)为约20~30s,起发时间为约60~250s,固化时间为约400~800s。此外,适合的泡孔尺寸可以在30~1000μm之间变化。
如上所述,通过施加一种或多种形成凝胶的硅氧烷组分并且固化所施加的硅氧烷以形成交联的凝胶,可在本发明抗菌和亲水性的聚氨酯泡沫结构的一侧涂敷硅氧烷凝胶。用作本发明的抗菌和亲水性的聚氨酯泡沫的涂层的交联硅氧烷凝胶的适宜特征在于其拉伸强度、渗透性和剥离强度。如本文中使用的“拉伸强度”表示可施加(利用标准英斯特朗试验仪)至5cm宽、3mm厚的所述交联的硅氧烷凝胶条的最大拉伸载荷。
本领域中已知交联的硅氧烷凝胶可由各种形成凝胶的硅氧烷组分和混合物所形成,例如可由具有活性基团的线性硅氧烷所形成。优选地,在诸如铂催化剂的合适催化剂存在下,通过乙烯基取代的硅氧烷组分和包含氢化物的硅氧烷组分之间的反应形成所述凝胶。
所用的形成凝胶的硅氧烷组分的粘度可为100~10000mPas,数均分子量为350~40000,并且可具有例如每克0.004~0.4毫摩尔的反应基团。
当通过交联两种或更多种硅氧烷组分的混合物形成所述硅氧烷凝胶时,各种组分的分子量和/或它们被反应性基团取代的程度可以是不同的。这样,仅仅通过改变组分的比例即可形成具有不同物理性能的多种凝胶。
用于本发明的抗菌和亲水性的聚氨酯泡沫结构的、形成合适的交联硅氧烷的组分可以是从Wacker获得的Wacker Silgel 612。
如上所述,在泡沫材料片上涂敷一种或多种非交联的硅氧烷组分然后使其交联形成本发明的结构。在由一个组分的乙烯基与另一个组分的氢化基反应形成凝胶的情况下,一般会在浓度为5~15ppm的诸如铂络合物的催化剂的存在下实施这种固化。在这种情况下,室温下固化数天可形成所述凝胶,但是优选使用升高的温度。例如,在40~120℃的温度下,优选在80~100℃的温度下固化可形成所述硅氧烷凝胶。在80℃的温度下,一般固化10秒钟至10分钟,例如1~5分钟。在50℃的温度下,一般固化10分钟至2小时,例如15分钟至1小时。
在化学上适合形成凝胶(聚二甲基硅氧烷凝胶)的硅氧烷组分的一个实例是铂催化的双组分加成硬化室温硫化(RTV)硅氧烷,例如来自德国Burghausen的瓦克化学有限公司(Wacker-Chemie GmbH)的SiIGeI 612和来自美国Carpinteria的诺稀尔公司(NuSiI Technology)的MED-6340。
因此,本发明提供敷料,其特征在于:吸收性、包含银离子的抗菌和亲水性的聚氨酯泡沫材料层,所述泡沫材料层包括开向在该泡沫材料的使用时邻近敷用者皮肤的侧面的空穴的图案。优选地,泡沫材料具有粘附所述皮肤的亲水性交联硅氧烷凝胶涂层,其中泡沫材料中的空穴壁涂有凝胶,所述凝胶位于在使用敷料时邻近敷用者皮肤的所述壁的那些末端部。
在意图用于仅流出微量或者正常量流体的创伤的第一优选实施方案中,所述泡沫结构具有由抗菌泡沫材料中的孔组成的空穴图案。在应用交联硅氧烷凝胶的情况下,所述凝胶还稍微延伸进入邻接凝胶层的所述泡沫材料的开孔中,而没有封闭全部的孔。
优选地,所述泡沫材料在使用时远离敷用者皮肤的侧面上涂有一层不透液体的材料。
包含所述抗菌泡沫结构并在意图朝向敷用者皮肤的侧面上具有硅氧烷凝胶涂层的敷料的皮肤粘合力F1为0.1~2.0N,合适地为0.2~1.3N,优选为0.2~0.7N。
在第一实施方案中,硅氧烷凝胶层的厚度为0.05~1.0mm。
在第二实施方案中,在所述泡沫材料置于形成凝胶的硅氧烷组分混合物层上之前,在所述泡沫材料中产生空穴图案。
现在参考附图以便更详细地描述本发明,其中:
图1是根据一个实施方案的一片本发明敷料的示意性透视图;
图1A是图1的一个特征的放大图;
图2示意地说明用于施加一种或多种形成凝胶的硅氧烷组分至泡沫结构以获得根据本发明的硅氧烷凝胶涂层的设备;
图3示意地说明如何测量从含银结构释放的银;
图4示出呈现于此的材料(样品A)与两个可商业获得的银泡沫(WO2002/062403中描述的样品B和US5,681,575和US5,837,275中描述的样品C)相比的银释放的图。图4A示出在具体时间点释放的银的量,而图4B示出累积的银释放。
图5示出呈现于此的发明(样品A)与两种其它市售银泡沫产品(WO2002/062403中描述的样品B以及US5,681,575和US5,837,275中描述的样品C)相比保持抗微生物效果的图。图5A显示对金黄色葡萄球菌的效果,图5B示出对铜绿假单胞菌的效果。对于两种细菌类型,由呈现于此的发明获得的抗菌泡沫表现出比参考样品更高的抗微生物效能,即抗菌效能。
图6概括了包含根据本发明结构的敷料的制造。示出的是银泡沫的制造。水相包含水、例如硫酸银的银盐和表面活性剂。
图6描述了制造过程。在分散和混合设备中将聚氨酯预聚物与包含表面活性剂和已分散和溶解的银盐的水相混合。随后将反应混合物转移至已经衬有浇铸纸的模具或连续网。聚合反应终止后,从浇铸物移除所述浇铸纸并将获得的泡沫干燥至湿含量为最多10%(wt),优选最多8%(wt),最优选最多5%(wt)。然后将所述泡沫卷在塑料芯上(泡沫层间有纸)并且包装。
图1说明根据本发明一个实施方案的敷料片。敷料由吸收性泡沫材料2组成,在所述泡沫材料2的在使用该敷料时邻近敷用者创伤或皮肤的侧面上涂有凝胶层3。图1A示意地说明,凝胶层3的布置使得甚至泡沫材料中开向其凝胶涂敷侧的部分开孔或孔4的壁上也涂有凝胶。因为凝胶层3没有封闭而是仅仅覆盖了面对创伤的泡沫材料的孔的末端部中的壁的一部分,所以过量的创伤流体可被引入泡沫材料2并由此得到吸收。凝胶层还形成有防止泡沫材料与敷用者创伤或皮肤直接接触的间隔层。整个凝胶层的厚度(即包括穿入泡沫材料的孔的深度)为0.1-2.0mm。凝胶层封闭了一些面向创伤的泡沫材料中的孔。
为了提供具有干外表面的敷料,所述敷料在与凝胶层3相反的侧面上具有不透液层5。该不透液层5可适当地包括薄的不透液体、但可透蒸汽的塑料膜,例如聚氨酯膜。
示于图1的敷料旨在用于流出微量至正常量流体的创伤。泡沫层的厚度为1-10mm,优选为2-6mm。如上所述,泡沫材料用作吸收剂和凝胶载体,因此敷料总体上将是非常软的和易弯的。因为凝胶粘在创伤周围的皮肤上,所以敷料被保持在该处同时凝胶还提供密封功能并防止浸软,即防止创伤流体流到健康皮肤上并软化和最后损伤表皮。凝胶层和泡沫材料的开孔结构还使皮肤能够呼吸。用于本发明的粘附凝胶的性质与通常用于固定敷料的胶,例如目前为此目的而使用的丙烯酸酯胶或热熔胶的性质全然不同。这些胶与根据本发明使用的凝胶之间的显著差异是凝胶比所述胶显著更软并具有更好的“润湿能力”。这使所述凝胶可以具有更低的比粘着性(specific adhesiveness),即单位接触表面面积的更低的附着力,相比之下,为了实现与所述凝胶提供的等效的总体粘着性,较硬的胶则必须具有更高的比粘着性。
图2高度示意性地示出了用于施加一种或多种形成凝胶的硅氧烷组分层至根据本发明的结构的设备。示出的设备包括将塑料膜8在图2中从左至右进行输送的输送机(未显示)。未固化凝胶混合物层9位于膜8上。凝胶混合物意指固化之后形成凝胶的那些组分的混合物,包括可彼此反应以形成交联结构的聚合物。借助于辊11将吸收性泡沫材料层10施加于未固化凝胶混合物层9,然后将层9和10输送到烘箱12中。凝胶混合物在其通过烘箱12时固化并在泡沫材料的下侧面上形成凝胶层。
已经发现:通过合适地选择一种或多种形成凝胶的组分和混合物及其比例、压力F、凝胶混合物的量、施加泡沫材料和加热所述层之间的时间、固化温度等,可以在泡沫材料上形成不连续的凝胶涂层。这是因为毛细管作用将凝胶混合物引入泡沫材料中开向邻近凝胶混合物的泡沫材料侧面的那些孔或空穴。当形成凝胶的涂层施加至缺乏空穴而不缺孔的空穴的泡沫材料时,凝胶混合物必须以薄层施加,以确保凝胶涂层不会将过多的开向泡沫材料下侧面的孔阻塞或堵塞。凝胶混合物的粘度和泡沫材料中孔的尺寸还影响混合物渗入所述孔中的趋势。已经发现凝胶混合物层应该优选以0.05~1.00mm的厚度施加。更大部分的凝胶混合物层被吸入泡沫,以此包括空气和泡沫的总体凝胶层的厚度可为0.10~2.00mm。
在上述方法用于在抗菌聚氨酯泡沫片下侧面涂敷硅氧烷凝胶的第一应用中,使用密度为80~150kg/m3、厚度为5mm的开孔型、软的亲水性聚氨酯泡沫板。
利用从Wacker获得的SilGel 612制备硅氧烷混合物,A组分和B组分的混合比为1.0∶0.9。未固化混合物的粘度为约1000mPa。
将聚氨酯片置于厚度为0.2mm的硅氧烷混合物上,不从辊11施加压力F,换言之硅氧烷混合物仅承受该泡沫片的重量。将泡沫材料10和下垫的硅氧烷混合物9从辊11输送至烘箱12花费的时间为1分钟并且固化温度为130℃。硅氧烷在烘箱中的数分钟停留时间内固化。然后将具有高透气性和厚度为0.025mm的聚氨酯膜牢固地胶合至泡沫的与凝胶涂层相反的侧面上。在该混合比例下,硅氧烷凝胶的针入度值为16mm,经测量敷料的皮肤粘合力为0.42N。在这些条件下,已经发现凝胶混合物层可优选具有至少0.1mm的厚度,以便在泡沫材料上获得适合的不连续凝胶涂层。
当凝胶混合物层的厚度大于0.4mm时,将堵塞泡沫材料中过高百分比的孔,导致凝胶涂层的渗透性不足。
上述内容明显表明,当参考图2实施上述方法时,成品质量取决于许多因素。因此,不可能为这些因素提供一般的极限值,并且这些极限值必须根据使用的凝胶混合物和泡沫材料根据经验确定。
参考图1所示类型的敷料因此能根据所述方法非常容易地制造。该方法还非常灵活并且大体上能够通过相同的方法并借助于相同设备来制造吸收性互不相同的敷料。
所述敷料当然可通过诸如环氧乙烷灭菌或蒸汽灭菌来进行灭菌,并意图以不同尺寸交付并用于不同类型创伤,可以灭菌包装也可以非灭菌包装。由于它们很软,所以它们适于和压迫绷带一起使用并可有益地用于水疱、下肢溃疡等创伤。高柔性还使它们适用于关节疮上,例如膝疮和肘疮上,甚至用于疮愈合过程的晚期。该敷料也可切割为适合于所述疮或创伤的尺寸。
应当理解,在本发明范围内,上述示例性实施方案,特别是在所述材料和所用工艺参数方面是可以改变的。
本发明将在所附实施例中进一步描述。
实施例1:泡沫结构的制备
通过溶解/分散非离子型表面活性剂Pluronic F87、硫酸银和活性碳制备了用于泡沫制造方法的水相。水相中这些组分的最后浓度为0.5%(wt) 的Pluronic F87和2.2%(wt)的硫酸银。溶解的硫酸银的浓度为0.8%(wt),其余的硫酸银分散于水相中。
同时,准备衬有浇铸纸的模具。模具具有足够的深度以便产生厚度为5mm的形成片的泡沫浇铸料。
室温下,在分配和混合设备中将预聚合物Hypol 2001(端异氰酸酯聚醚)以40%(wt)的量加入水相。立即将所得混合物转移至铸模。发泡30秒,然后固化该泡沫10分钟。固化后,移除浇铸纸并在120℃下将泡沫干燥至湿含量为最多10%(wt)(参见图1和图2)。
实施例2:泡沫材料的吸收
将样品:实施例1中生产的泡沫产品样品A和两种商业可得产品,即WO 2002062403中描述的样品B以及US5681575(A)和US 5837275(A)中描述的样品C,切成6×6cm的试片并称重。随后,将该试片浸泡于过量自来水中。三个小时之后,再次称重该片。获得的结果示于表1:
表1
干重(g) | 湿重(g) | 吸收 (g/36cm2) | 吸收 (g/cm2) | |
样品A | 2.82 | 35.5 | 32.7 | 0.91 |
样品B | 3.52 | 28.5 | 25.0 | 0.69 |
样品C | 3.31 | 33.0 | 29.7 | 0.82 |
结果显示实施例1的产品(样品A)具有和商业可得产品一样良好或者稍微更好的吸收能力。
实施例3:银释放
将根据实施例1制造的材料(此处称为样品A)和两种商业可得产品(WO2002062403描述的样品B,以及US 568157(A)和US 5837275(A)描述的样品C)冲制成直径20mm的圆形样品。图3示出用于测量银释放的一些设备,即均来自Becton Dickinson Labware的Falcon TM 6孔多孔单元(Falcon TM 6 well Multiwell unit)(2)和相应的细胞培养插件(4)(将细胞培养插件(4)底部的扩散膜移除并用防水聚酰胺膜替换)。在底部膜冲制直径12mm的开口(6)。在开口(6)顶部的细胞培养插件(4)中放入干样品(10)。在样品(10)的顶部安置直径20mm、重量15g的不锈钢 砝码(12),以便将所述样品压缩并固定在底部膜。
根据以下方案(见表2),将限定量的0.15M NaNO3水溶液(从现在起称为试液(8))加入Multiwell TM单元(2):
表2
0h | 6h | 24h | 48h | 72h | 96h | 120h | 144h | 168h |
3.5ml | 1.5ml | 1.5ml | 1.5ml | 1.5ml | 1.5ml | 1.5ml | 1.5ml | 0ml |
将细胞培养插件(4)置于Multiwell TM单元(2)中,由此使试液(8)与样品(10)接触。采用二室模型的盖(lid of the two-comportment model)。在每次取样时收集未被样品(10)吸收的试液。每次取样后,在清洁Multiwell TM单元中加入新鲜试液,将仍然载有相同样品(10)的细胞培养插件(4)放置其中。在整个试验期间,全部6个样品进行三次重复测试。在每次取样时,采用银离子电极评估银的释放量。
样品 | 0h mg Ag/cm2 | 0h累积 mg Ag/cm2 | 6h mg Ag/cm2 | 6h累积 mg Ag/cm2 |
A | 0 | 0 | 0.006 | 0.006 |
B | 0 | 0 | 0.005 | 0.005 |
C | 0 | 0 | 0.002 | 0.002 |
样品 | 24h mg Ag/cm2 | 24h 累积 mg Ag/cm2 | 48h mg Ag/cm2 | 48h 累积 mg Ag/cm2 | 72h mg Ag/cm2 | 72h 累积 mg Ag/cm2 |
A | 0.134 | 0.14 | 0.18 | 0.32 | 0.15 | 0.47 |
B | 0.010 | 0.015 | 0.002 | 0.017 | 0.010 | 0.027 |
C | 0.005 | 0.007 | 0.010 | 0.017 | 0.020 | 0.037 |
样品 | 96h mg Ag/cm2 | 96h 累积 mg Ag/cm2 | 120h mg Ag/cm2 | 120h 累积 mg Ag/cm2 | 144h mg Ag/cm2 | 144h 累积 mg Ag/cm2 | 168h mg Ag/cm2 | 168h 累积 mg Ag/cm2 |
A | 0.13 | 0.60 | 0.09 | 0.69 | 0.07 | 0.76 | 0.07 | 0.83 |
B | 0.010 | 0.037 | 0.014 | 0.051 | 0.010 | 0.061 | 0.010 | 0.071 |
C | 0.014 | 0.051 | 0.014 | 0.065 | 0.010 | 0.075 | 0.08 | 0.083 |
获得的结果见图4A和4B。在一周的测试期间,实施例1的产品释放 其约70%的银含量。约48小时后达到最高释放速率。
实施例4:抗菌活性
基于参照方法ASTM E2149的方法测量抗菌活性。在具有细菌(金黄色葡萄球菌或铜绿假单胞菌)和10ml模拟创伤流体(SWF)(即小牛血清和蛋白胨水(具有0.5%蛋白胨的0.9%的NaCl)的1∶1溶液)的烧瓶中,放入实施例1中获得的银泡沫样品(直径20mm)(样品A)和对比材料(WO2002062403描述的样品B,US 5681575(A)和US 5837275(A)描述的样品C以及对照样品;如实施例1所述但没有任何银含量的泡沫)。振荡该烧瓶约10秒钟,然后将该烧瓶在35+/-2℃下保温。为了测量产品的抗微生物效果,每24小时后取出样品,直至8天。使用标准平板计数法确定样品中活细胞的数目。
实验结果显示:与其它测试产品相比,此处的银泡沫更多地减少了金黄色葡萄球菌的活菌数(见图5A)。与其它测试产品相比,Mepilex Ag也更多地减少了铜绿假单胞菌的活菌数(见图5B)。结果也见于表4A和4B。
表4A:对金黄色葡萄球菌的持续抗微生物效果
样品 | 0h log CFU/ml | 24h log CFU/ml | 48h log CFU/ml | 72h log CFU/ml | 96h log CFU/ml | 120h log CFU/ml | 144h log CFU/ml | 168h log CFU/ml |
参比 | 6.3 | 8.6 | 8.6 | 8.3 | 8.3 | 8.2 | 8.1 | 8.1 |
样品A | 6.3 | 5.1 | 4.6 | 3.2 | 2.4 | 2.0 | 2.1 | 2.0 |
样品B | 6.3 | 6.6 | 5.5 | 4.1 | 3.5 | 2.7 | 2.6 | 2.3 |
样品C | 6.3 | 6.2 | 5.1 | 4.5 | 4.3 | 4.3 | 4.2 | 4.6 |
表4B:对铜绿假单胞菌的持续抗微生物效果
样品 | 0h log CFU/ml | 24h log CFU/ml | 48h log CFU/ml | 72h log CFU/ml | 96h log CFU/ml | 120h log CFU/ml | 144h log CFU/ml | 168h log CFU/ml |
参比 | 6.52 | 9.95 | 9.48 | 8.75 | 8.55 | 9.00 | 9.13 | 9.15 |
样品A | 6.51 | 3.58 | 2.26 | 2.00 | 2.00 | 2.00 | 2.00 | 2.00 |
样品B | 6.38 | 6.55 | 3.20 | 2.95 | 2.59 | 2.00 | 2.00 | 2.00 |
样品C | 6.35 | 5.89 | 5.90 | 5.55 | 6.03 | 4.90 | 5.49 | 4.59 |
检测限是2.00logCFU/ml。
Claims (18)
1.一种制造抗菌和亲水性的聚氨酯泡沫结构的方法,包括以下步骤:
a)提供包含表面活性剂的水相;
b)提供具有超过2个官能度的端异氰酸酯聚醚;
c)混合所述水相和所述端异氰酸酯聚醚,立即转移所得混合物至模具,从而获得泡沫结构;和
d)干燥所述泡沫结构直至其湿含量为最多10%(wt);
特征在于在步骤a)中的所述水相还包含银盐,所述银盐选自硫酸银、柠檬酸银、乙酸银、碳酸银、乳酸银和磷酸银或这些盐的混合物,并且一部分所述银盐溶于所述水相中而另一部分所述银盐分散于所述水相中。
2.根据权利要求1的方法,其中在步骤d)中干燥所述泡沫结构直至其湿含量为最多8%(wt)。
3.根据权利要求1的方法,其中在步骤d)中干燥所述泡沫结构直至其湿含量为最多5%(wt)。
4.根据权利要求1的方法,其中在步骤c)中加入所述混合物之前所述模具衬有浇铸纸,并且在所述干燥步骤d)之前将所述浇铸纸移除。
5.根据权利要求1-4中任何一项的方法,其中在催化剂的存在下将一种或多种形成凝胶的硅氧烷组分添加至步骤d)之后获得的所述泡沫结构的一个表面,随后通过固化使得所述形成凝胶的硅氧烷组分形成交联的硅氧烷凝胶。
6.根据权利要求5的方法,其中所述催化剂是铂络合物。
7.一种抗菌和亲水性的聚氨酯泡沫结构,其具有30~1000μm的孔尺寸并且包含至少一种银盐,其中所述结构通过根据权利要求1-6中任何一项的方法来制造。
8.根据权利要求7的泡沫结构,其中48小时后每平方厘米所述结构累积释放的银总计为至少0.2mg/cm2。
9.根据权利要求7的泡沫结构,其中48小时后每平方厘米所述结构累积释放的银总计为至少0.25mg/cm2。
10.根据权利要求7的泡沫结构,其中48小时后每平方厘米所述结构累积释放的银总计为至少0.30mg/cm2。
11.根据权利要求8的泡沫结构,其中72小时后每平方厘米所述结构累积释放的银总计为至少0.3mg/cm2。
12.根据权利要求8的泡沫结构,其中72小时后每平方厘米所述结构累积释放的银总计为至少0.35mg/cm2。
13.根据权利要求8的泡沫结构,其中72小时后每平方厘米所述结构累积释放的银总计为至少0.40mg/cm2。
14.根据权利要求8-13中任何一项的泡沫结构,其中48小时后,所述累积释放的银总计为最多0.80mg/cm2。
15.根据权利要求8-13中任何一项的泡沫结构,其中96小时后,所述累积释放的银总计为最多0.80mg/cm2。
16.根据权利要求8-13中任何一项的泡沫结构,其中120小时后,所述累积释放的银总计为最多0.80mg/cm2。
17.根据权利要求7的泡沫结构,其中根据参考方法ASTM E2149,在35℃+/-2℃的温度下,当所述泡沫的直径为20mm和厚度为5mm的圆形样品暴露于10ml包含细菌的模拟创伤流体时,能够在72小时内将活的铜绿假单胞菌细胞的量从106减小至小于102,并在120小时内将活的金黄色葡萄球菌细胞的的量从106减小至小于102,其中所述模拟创伤流体由1∶1的小牛血清和蛋白胨水的溶液组成,所述蛋白胨水是含有0.9%(wt)NaCl和0.5%(wt)蛋白胨的水溶液。
18.一种创伤敷料,包括根据权利要求7~17中任意一项的泡沫结构。
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PL1964580T3 (pl) | 2011-05-31 |
CN101631572A (zh) | 2010-01-20 |
WO2008104276A8 (en) | 2009-03-26 |
MX2009008893A (es) | 2009-08-28 |
ATE493156T1 (de) | 2011-01-15 |
BRPI0808549B8 (pt) | 2021-06-22 |
BRPI0808549B1 (pt) | 2018-06-05 |
BRPI0808549A2 (pt) | 2014-08-19 |
AU2008221041B2 (en) | 2012-12-20 |
WO2008104276A1 (en) | 2008-09-04 |
EP1964580B1 (en) | 2010-12-29 |
DE602007011564D1 (de) | 2011-02-10 |
CA2678034A1 (en) | 2008-09-04 |
AU2008221041A1 (en) | 2008-09-04 |
ES2358684T3 (es) | 2011-05-12 |
KR101433058B1 (ko) | 2014-08-22 |
US8263100B2 (en) | 2012-09-11 |
JP5283636B2 (ja) | 2013-09-04 |
KR20090117772A (ko) | 2009-11-12 |
JP2010520313A (ja) | 2010-06-10 |
US20100196501A1 (en) | 2010-08-05 |
EP1964580A1 (en) | 2008-09-03 |
CA2678034C (en) | 2014-10-28 |
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