CN112512468A - 抗微生物泡沫制品及其制备方法 - Google Patents
抗微生物泡沫制品及其制备方法 Download PDFInfo
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- CN112512468A CN112512468A CN201980050926.2A CN201980050926A CN112512468A CN 112512468 A CN112512468 A CN 112512468A CN 201980050926 A CN201980050926 A CN 201980050926A CN 112512468 A CN112512468 A CN 112512468A
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Abstract
本发明提供了一种制品。该制品包括:聚合物泡沫,该聚合物泡沫具有第一主表面和第二主表面;以及治疗组合物的离散域,该离散域被聚合物泡沫至少部分地围绕;其中每个离散域的外表面基本上适形于聚合物泡沫的第一主表面的一部分;其中该制品包括第一主表面和第二主表面;并且其中聚合物泡沫的第一主表面的一部分和离散域的外表面形成制品的第一主表面。
Description
背景技术
慢性伤口通常因微生物感染而推迟愈合。在这些感染中,微生物可定植在伤口上,并且用抗微生物伤口护理产品进行治疗可有助于将慢性伤口转移到愈合的轨道。这些微生物通常生长在被称为生物膜的复杂群落中。生物膜出现在超过80%的慢性伤口中并且被广泛认为会阻碍伤口愈合。
在治疗复杂的慢性伤口时,临床医生通常需要使用可管理伤口渗出物的产品。吸收性泡沫伤口敷料被广泛用于渗出物管理,并且抗微生物泡沫伤口敷料是可商购获得的。许多可商购获得的伤口敷料包含浸渍在整个泡沫中的抗微生物成分。期望有一种更好的制品以将更大量的活性物质直接递送到伤口床。
发明内容
在一个方面,本公开提供了一种制品,该制品包括:聚合物泡沫,该聚合物泡沫具有第一主表面和第二主表面;以及治疗组合物的离散域,该离散域被聚合物泡沫至少部分地围绕;其中每个离散域的外表面基本上适形于聚合物泡沫的第一主表面的一部分;其中该制品包括第一主表面和第二主表面;并且其中聚合物泡沫的第一主表面的一部分和离散域的外表面形成制品的第一主表面。
在另一方面,本公开提供了一种制备伤口敷料的方法,该方法包括:将治疗组合物沉积到衬件的表面上以形成印刷表面;以及将泡沫材料设置在印刷表面上。
在另一方面,本公开提供了一种制备伤口敷料的方法,该方法包括:将第一治疗组合物沉积到第一衬件的表面上以形成第一印刷表面;将第二治疗组合物沉积到第二衬件的表面上以形成第二印刷表面;以及将泡沫材料设置在第一印刷表面与第二印刷表面之间。
已汇总了本公开的示例性实施方案的各个方面和优势。以上发明内容并不旨在描述本公开的每个例示的实施方案或每种实施方式。另外的特征和优点在随后的实施方案中公开。下面的附图和具体实施方式更具体地举例说明了使用本文所公开的原理的某些实施方案。
定义
对于以下给出定义的术语,除非基于以下定义中使用的术语的修改形式的具体引用,在权利要求中或在说明书中的其它地方提供了不同的定义,否则整个说明书、包括权利要求都应该以这些定义为准:
关于数值或形状的术语“约”或“大约”意指数值或性能或特性的+/-5%,但是也明确包括在数值或性能或特性的+/-5%内的任何窄范围以及精确的数值。例如,“约”100℃的温度是指从95℃到105℃的温度,但是也明确包括任何更窄的温度范围或甚至在该范围内的单个温度,包括例如刚好100℃的温度。例如,“约”1Pa-sec的粘度是指从0.95Pa-sec至1.05Pa-sec的粘度,但也明确地包括刚好1Pa-sec的粘度。类似地,“基本上正方形”的周边旨在描述具有四条侧棱的几何形状,其中每条侧棱的长度为任何其他侧棱的长度的95%至105%,但也包括其中每条侧棱刚好具有相同长度的几何形状。
关于特性或特征的术语“基本上”是指该特性或特征表现出的程度大于该特性或特征的相背对面表现出的程度。例如,“基本上”透明的基底是指与不透射(例如,吸收和反射)相比透射更多辐射(例如,可见光)的基底。因此,透射入射在其表面上的可见光多于50%的基底是基本上透明的,但透射入射在其表面上的可见光的50%或更少的基底不是基本上透明的。
术语“一个”、“一种”和“该/所述”包括多个指代物,除非本文内容另外明确指明。因此,例如,提及包含“一种化合物”的材料包括两种或更多种化合物的混合物。
附图说明
结合附图考虑到以下对本公开的各种实施方案的详细说明可以更全面地理解本公开,其中:
图1是制品的一个实施方案的横截面视图。
图2A是制品的横截面的照片。
图2B是制品的俯视图的照片。
虽然可能未按比例绘制的上述附图示出了本公开的各种实施方案,但还可以设想其它实施方案,如在具体实施方式中所指出。在所有情况下,本公开通过示例性实施方案的表示而非通过表达限制来描述当前公开的发明。应当理解,本领域的技术人员可想出许多其它修改和实施方案,这些修改和实施方案落在本公开的范围和实质内。
具体实施方式
在详细解释本公开的任何实施方案之前,应当理解在本申请中本发明不限于在下文描述中提及的部件的使用、构造和布置的细节。本发明容许其它实施方案并且容许以各种方式操作或进行,对于本领域的普通技术人员而言,在阅读本公开时,这些方式将变得显而易见。另外,应当理解,本文中所用的用语和术语均出于说明目的,并且不应被视为限制性的。本文中“包括”、“包含”或“具有”及其变型的使用意指涵盖其后所列举的项目及其等同形式以及附加的项目。应当理解,可利用其它实施方案,并且可在不脱离本公开范围的前提下,作出结构变化或逻辑变化。
如本说明书所使用,通过端点表述的数值范围包括该范围内所包含的所有数值(例如1至5包括1、1.5、2、2.75、3、3.8、4和5等)。
除非另外指明,否则本说明书和实施方案中所使用的表达量或成分、特性测量等的所有数值在所有情况下均应理解成由术语“约”来修饰。因此,除非有相反的说明,否则在上述说明书和所附实施方案列表中示出的数值参数可根据本领域的技术人员利用本公开的教导内容寻求获得的期望特性而变化。最低程度上说,并且在不试图将等同原则的应用限制到受权利要求书保护的实施方案的范围内的情况下,每个数值参数应至少根据所报告的有效位数并通过应用惯常的四舍五入法来解释。
许多可商购获得的伤口敷料包含浸渍在整个泡沫中的抗微生物成分。这种形式使得难以将有效量的抗微生物分子递送到发生细菌定植的伤口床。将更大量的活性物质直接递送到伤口床的一种方式是在泡沫伤口敷料的一个表面上提供大剂量的抗微生物物质。然而,将大量材料涂覆到伤口敷料的一面上可能潜在地阻止泡沫通过涂覆表面吸收水分的能力。本申请提供了一种允许将大量材料掺入泡沫中而不在泡沫上形成形貌特征的制品。
图1是制品100的一个实施方案的示意性侧视图。制品100可包括具有第一主表面112和第二主表面115的聚合物泡沫110以及治疗组合物的离散域120。离散域120可被聚合物泡沫110至少部分地围绕,如图1所示。每个离散域的外表面122可基本上适形于(换句话讲,共面于)聚合物泡沫的第一主表面112的一部分,如图1所示。制品100可具有第一主表面102和第二主表面105。聚合物泡沫110的第一主表面112的一部分和离散域120的外表面122形成制品100的第一主表面102。离散域120的外表面122可覆盖制品100的第一主表面102的介于1%和99%之间、介于5%和95%之间、介于10%和90%之间、介于15%和85%之间、介于20%和80%之间、介于25%和75%之间或介于30%和70%之间。制品100还可包括位于制品100的第一主表面102的顶部上或与制品的第一主表面相邻的衬件150。
在一些实施方案中,制品100可包括被聚合物泡沫110至少部分地围绕的治疗组合物的另外离散域130。在这些实施方案中,每个另外离散域130的外表面132基本上适形于聚合物泡沫110的第二主表面115的一部分。聚合物泡沫110的第二主表面115的一部分和另外离散域130的外表面132形成制品100的第二主表面105。离散域130的外表面132可覆盖制品100的第二主表面105的介于1%和99%之间、介于5%和95%之间、介于10%和90%之间、介于15%和85%之间、介于20%和80%之间、介于25%和75%之间或介于30%和70%之间。制品100还可包括位于制品100的第二主表面105的顶部上或与制品的第二主表面相邻的第二衬件160。
在一些实施方案中,至少在一个平行于制品100的第一主表面102并且位于制品的第一主表面与第二主表面之间的平面处,每个离散域的横截面大于离散域的外表面的横截面。例如,在如图1所示的x平面处,离散域123的横截面125大于离散域123的外表面的横截面126。例如,这样可允许增强治疗组合物域在泡沫内的机械锁定。在一些实施方案中,治疗组合物可保留在离散域中。
在一些实施方案中,离散域可形成图案。该图案可为连续的或不连续的。在连续图案的一些实施方案中,离散域的连续性质不太可能断裂,并且另外,图案的形状可被更精确地控制,因为其不需要在泡沫内芯吸,而芯吸可能是复杂且难以控制的。在一些实施方案中,离散域可形成预定图案,使得它们彼此等距地间隔开并且具有大致均匀的尺寸和形状。在一些实施方案中,离散域可形成随机图案,使得它们可彼此不同地间隔开并且可具有通常不同的尺寸和形状。在一些实施方案中,离散域可散落在整个制品上。在一些实施方案中,离散域的直径可为至少约100微米、至少约200微米、至少约300微米、至少约400微米、至少约500微米、至少约600微米、至少约700微米、至少约800微米、至少约900微米或至少约1000微米。在一些实施方案中,离散域的直径可小于10cm。在一些实施方案中,离散域的直径可在100微米至10cm的范围内。在一些实施方案中,离散域可具有不规则形成的周边。这可意指离散域具有不规则形状(即,无对称线)。它们可具有不平滑的边缘(例如,锯齿状边缘或羽状边缘)。不规则形成的离散域也可具有围绕离散域的聚合物泡沫的多种厚度。
在一些实施方案中,离散域被成形为被泡沫至少部分地围绕的通道。在一些实施方案中,通道具有半圆形或半椭圆形的横截面形状。
在一些实施方案中,离散域被成形为截顶球体或截顶类球体。在一些实施方案中,离散域可为条纹状图案的。条纹状图案可为线性的或弯曲的,例如正弦图案。在一些实施方案中,条纹状图案可以平行或非平行的方式取向。
在一些实施方案中,每个离散域具有周边表面的为弯曲的一部分和周边表面的为平坦的一部分。周边表面的为平坦的至少一部分暴露在制品的表面上。
在一些实施方案中,每个离散域的横截面具有周边的为弯曲的一部分和周边的为线性的一部分。周边的为线性的至少一部分暴露在制品的表面上。
在一些实施方案中,每个离散域的一部分嵌入泡沫中,并且每个离散域具有被泡沫的第一主表面至少部分地围绕的暴露表面。在一些实施方案中,衬件与离散域的暴露表面接触并且还与泡沫的第一主表面接触。在一些实施方案中,衬件具有将其分成两部分的狭缝。
根据本公开的制品是有用的。例如,可将它们施加到皮肤并用作伤口敷料(例如包括封闭敷料和压力敷料)和透皮贴剂。就伤口敷料而言,根据本公开的制品可允许将高载量的活性物质加载到泡沫伤口敷料中,同时保持大表面积的泡沫伤口敷料与伤口接触以便于渗出物管理。在一些实施方案中,本公开的制品可为吸收性泡沫伤口敷料。
制备本公开的伤口敷料制品的方法可包括:将治疗组合物沉积到衬件的表面上以形成印刷表面;以及将泡沫材料设置在印刷表面上。
另选地,制备本公开的伤口敷料制品的方法可包括:将第一治疗组合物沉积到第一衬件的表面上以形成第一印刷表面;将第二治疗组合物沉积到第二衬件的表面上以形成第二印刷表面;以及将泡沫材料设置在第一印刷表面与第二印刷表面之间。第一治疗组合物可与第二治疗组合物相同或不同。
在一些实施方案中,一旦沉积,治疗组合物就在衬件的表面上形成治疗组合物的离散域。泡沫材料可设置在治疗组合物的离散域上。可根据任何图案或图像将治疗组合物沉积到衬件上。图案可包括任何合适的图案,例如包括点、正方形、菱形、线、圆、六边形、三角形及其组合的组合和阵列。
该方法还可包括在约室温至约300℉范围内的温度下固化泡沫材料以在印刷表面上形成泡沫。可能需要较低温度以确保治疗组合物的稳定性。在较低温度下,固化时间较长。固化将花费约10分钟至约15分钟。在较高温度下,当一些治疗组合物保持稳定时,固化时间为例如约4分钟至5分钟。
在一些实施方案中,可在固化步骤之后从泡沫任选地移除衬件。当从泡沫移除衬件时,治疗组合物的离散域随后被嵌入泡沫中,从而形成具有平坦表面的制品。该方法允许将大量治疗组合物掺入泡沫中而不在泡沫上形成形貌特征。先前泡沫产品的明显轮廓形貌特征使得难以处理泡沫产品。
在一些实施方案中,可通过非接触印刷方法诸如喷涂或喷射方法来沉积治疗组合物。在其它实施方案中,可通过溶剂涂覆工艺或热熔融涂覆来沉积治疗组合物。可用的接触印刷方法包括例如柔性版印刷、辊涂、刮涂、刮刀涂覆和凹版辊涂覆。
用于本公开的聚合物泡沫材料可选自亲水性或疏水性聚合物,具体取决于治疗组合物的性质。典型的亲水性聚合物泡沫材料可选自聚氨酯、聚乙酸乙烯酯、聚乙烯醇(PVA)、聚乙烯和医用级有机硅。
在一些实施方案中,治疗组合物可包含活性剂。示例性可用的活性剂(例如,治疗剂)包括:草药、抗炎药、甾族(例如,***龙、曲安西龙)和非甾族(例如,萘普生、吡罗昔康)两者;抗菌剂(例如,青霉素、头孢菌素、红霉素、四环素、庆大霉素、磺胺噻唑、呋喃妥因、三甲氧苄二氨嘧啶和喹诺酮(例如,诺氟沙星、氟甲喹和依巴沙星)、杆菌肽及其盐、新霉素及其盐、多粘菌素B)和防腐剂(例如,氯己定、葡糖酸氯己定、双胍啶、奥替尼啶、抗微生物的季铵表面活性剂诸如苯扎氯铵、西吡氯铵和十六烷基三甲基卤化铵、酚、甲酚、三氯生、抗菌天然油、碘伏、季铵化合物、质子化的叔胺和仲胺化合物、某些金属离子(例如,银和铜)以及它们的盐(例如,葡糖酸银、乳酸银和硫酸银)、双胍、三氯生和聚合物型抗菌剂(例如,聚六亚甲基双胍、具有质子化伯胺、仲胺和/或叔胺的聚合物、以及聚季胺)、抗微生物类脂诸如美国公布专利申请2005/0089539A1(Scholz等人)中描述的那些,其包括甘油和丙二醇的C8-C12烷基单酯和单醚);抗原生动物药(例如,甲硝唑);心血管药物(例如,苯磺酸氨氯地平、三***酯、尼非地平、氯沙坦钾、厄贝沙坦、盐酸地尔硫卓、硫酸氢氯吡格雷、地高辛、阿昔单抗、速尿、盐酸胺碘酮、贝前列素、茶碱、吡布特罗、沙美特罗、异丙去甲肾上腺素和维生素E烟酸酯);钙通道阻滞剂(例如,硝苯啶、硫氮卓酮);酶抑制剂,如胶原酶抑制剂、蛋白酶抑制剂、弹性蛋白酶抑制剂、脂氧合酶抑制剂(例如,A64077)和血管紧张素转化酶抑制剂(例如,卡托普利、赖诺普利);其他抗高血压药(例如,***);白三烯拮抗剂(例如,ICI204、219)抗溃疡药如H2拮抗剂;甾体激素(例如,孕酮、睾酮、***、乙羟基二降孕甾烯炔酮、霉酚酸酯和甲泼尼龙);抗病毒药和/或免疫调节剂(例如,1-异丁基-1H-咪唑[4,5-c]喹啉-4-胺、1-(2-羟基-2-甲基丙基)-1H-咪唑[4,5-c]喹啉-4-胺、阿昔洛韦);强心剂(例如,洋地黄、地高辛);镇咳药(例如,可待因、右美沙芬);抗组胺剂(例如,苯海拉明、扑尔敏、特非那定);剥脱剂(例如,α-羟基酸或β-羟基酸);止痛药(例如,***马多、芬太尼、安乃近、酮洛芬、硫酸***、赖氨酸乙酰水杨酸、对乙酰氨基酚、酮咯酸氨丁三醇、***、洛索洛芬钠和布洛芬);皮肤病学产品(例如,异维A酸和克林霉素磷酸酯);麻醉剂(例如,丙泊酚、盐酸咪唑二氮卓和盐酸利多卡因);偏头痛治疗剂(例如,麦角胺、褪黑激素、舒马曲坦、佐米曲坦和利扎曲坦);镇静剂和催眠药(例如,唑吡坦、酒石酸唑吡坦、***仑和丁溴东莨菪碱);成像组分(例如,碘海醇、锝、TC99M、司他比锝、碘美普尔、钆双胺、碘佛醇和碘普罗胺);肽激素(例如,人或动物生长激素LHRH);强心产品,诸如心房肽;蛋白质产品(例如,胰岛素);酶(例如,抗瘟疫酶、溶菌酶、葡聚糖酶)、抗恶心药(例如,东莨菪碱);抗痉挛药(例如,卡马西平);免疫抑制剂(例如,环孢菌素);精神治疗剂(例如,苯甲二氮卓、盐酸舍曲林、文拉法辛、盐酸安非他酮、奥氮平、盐酸丁螺旋酮、阿普***、盐酸哌甲酯、马来酸氟伏沙明和甲磺酸二氢麦角碱);镇静剂(例如,镇静安眠剂);抗凝剂(例如,肝素);止痛药(例如,对乙酰氨基酚);抗偏头痛剂(例如,麦角胺、褪黑激素、舒马坦);降胆固醇剂(例如,阿托伐他汀、钙、洛伐他汀、苯扎贝特、环丙贝特和吉非贝齐);抗心律失常剂(例如,氟卡胺);止吐剂(例如,甲氧氯普胺、昂丹司琼);血液调节剂(例如,阿法依泊汀、依诺肝素钠和抗血友病因子);抗关节炎组分(例如,塞来考昔、萘丁美酮、米索前列醇和罗非昔布);AIDS和AIDS相关药物(例如,拉米夫定、硫酸茚地那韦和司他夫定);糖尿病和糖尿病相关治疗剂(例如,盐酸二甲双胍、胰岛素、曲格列酮和阿卡波糖);生物制剂(例如,B型肝炎疫苗和A型肝炎疫苗);免疫应答调节剂(例如,嘌呤衍生物、腺嘌呤衍生物和CpGs);抗癌剂(例如,甲氨喋呤、紫杉醇、卡铂、枸橼酸他莫昔芬、多西他赛、盐酸表柔比星、醋酸亮丙瑞林、比卡鲁胺、醋酸戈舍瑞林植入剂、盐酸伊立替康、盐酸吉西他滨和沙格司亭);胃肠产品(例如,兰索拉唑、盐酸雷尼替丁、法莫替丁、盐酸昂丹司琼、盐酸格拉司琼、柳氮磺胺吡啶和英夫利昔单抗);呼吸治疗剂(例如,氯雷他定、盐酸非索非那定、盐酸西替利嗪、丙酸氟替卡松、沙美特罗和布***);免疫抑制剂(例如,环孢菌素);神经剂,诸如抗焦虑药;止血剂;抗肥胖剂;烟碱;杀藻剂;和前述的药学上可接受的盐和酯。
在一些实施方案中,治疗组合物可包含选自以下的活性剂:抗微生物剂、抗生素、抗氧化剂、血小板衍生生长因子、维生素A、维生素C、维生素E、皮质类固醇、磺胺嘧啶银、多粘菌素B硫酸盐、梭链孢酸、吡非尼啶(pirfenedine)、干扰素、治疗油、植物提取物、动物提取物、药物、维生素、激素、抗氧化剂、鸸鹋油、芦荟、薰衣草油、玫瑰果油、磺胺嘧啶银、多粘菌素B、梭链孢酸和吡非尼啶。
活性剂可选自不与泡沫材料和/或活性组合物的其它组分反应的那些,但可使用反应性活性剂。通常基于具体使用中制品将遭遇的微生物的类型来选择抗微生物剂。示例性抗微生物剂可包括青霉素、头孢菌素、红霉素、四环素、庆大霉素、磺胺噻唑、呋喃妥因、三甲氧苄二氨嘧啶、喹诺酮(例如,诺氟沙星、氟甲喹和依巴沙星)、杆菌肽及其盐、新霉素及其盐、多粘菌素B)和防腐剂(例如,氯己定、葡糖酸氯己定、双胍啶、奥替尼啶、抗微生物的季铵表面活性剂诸如苯扎氯铵、西吡氯铵和十六烷基三甲基卤化铵、酚、甲酚、三氯生、抗菌天然油、碘伏、季铵化合物、质子化的叔胺和仲胺化合物、某些金属离子(例如,银和铜)以及它们的盐(例如,葡糖酸银、乳酸银和硫酸银)、双胍、三氯生和聚合物型抗菌剂(例如,聚六亚甲基双胍、具有质子化伯胺、仲胺和/或叔胺的聚合物、以及聚季胺)、以及抗微生物类脂诸如美国公布专利申请2005/0089539 A1(Scholz等人)中描述的那些,其包括甘油和丙二醇的C8-C12烷基单酯和单醚,以及包括螯合剂(例如EDTA和有机酸)的微生物抑制材料。活性剂可以任何量包含在治疗组合物中。在一些实施方案中,基于治疗组合物的总重量计,活性剂可以至少10重量%、20重量%、30重量%、40重量%或甚至至少50重量%的量存在。
在一些实施方案中,治疗组合物可包含载体。载体可包括液体(水性的、溶剂型的或基于溶剂和水的混合物)、凝胶(水凝胶)、霜剂、糊剂或固体。在一些实施方案中,载体在约室温下可为液体。
在另一些实施方案中,载体在约室温下可为固体。在一些实施方案中,载体在约人口腔的温度下(即,在约37℃下)可为液体。在另一些实施方案中,载体在约人口腔的温度下可为固体。示例性液体载体包括水、醇(例如乙醇)、甘油、山梨醇和液体有机硅。示例性固体载体包括结晶或蜡质材料,例如聚乙二醇。
治疗组合物的每种非载体组分可独立地溶解、分散、悬浮或乳化于载体中。在一些实施方案中,治疗组合物的至少一种组分溶解于载体中。在一些实施方案中,治疗组合物的至少一种组分分散于载体中。在一些实施方案中,治疗组合物的至少一种组分悬浮于载体中。在一些实施方案中,治疗组合物的至少一种组分乳化于载体中。在一些实施方案中,活性剂可溶解或分散于水性液体中。在一些实施方案中,活性剂可溶解或分散于凝胶(水凝胶)、霜剂或糊剂中。在一些实施方案中,活性剂可溶解或分散于触变凝胶中。
在一些实施方案中,治疗组合物可包含流变改性剂。流变改性剂可为任何合适的流变改性剂,例如有机或无机材料;可溶或溶胀性聚合物;直链、支链或交联聚合物;天然或合成聚合物等。流变改性剂可用于使治疗组合物的流变特性适用于将组合物沉积在衬件上的期望方法。在一些实施方案中,流变改性剂还可影响包含在治疗组合物中的活性剂的释放动力学。
治疗组合物包含载体。载体可包括液体、固体或两者。在一些实施方案中,载体在约室温下可为液体。在另一些实施方案中,载体在约室温下可为固体。在一些实施方案中,载体在约人口腔的温度下(即,在约37℃下)可为液体。在另一些实施方案中,载体在约人口腔的温度下可为固体。示例性液体载体包括水、醇(例如乙醇)、甘油、山梨醇和液体有机硅。示例性固体载体包括聚合物,诸如天然橡胶、丁基橡胶、聚(异丁烯)、弹性体、苯乙烯-丁二烯橡胶、多糖和蜡(例如蜂蜡)。
治疗组合物的每种非载体组分可独立地溶解、分散、悬浮或乳化于载体中。在一些实施方案中,治疗组合物的至少一种组分溶解于载体中。在一些实施方案中,治疗组合物的至少一种组分分散于载体中。在一些实施方案中,治疗组合物的至少一种组分悬浮于载体中。在一些实施方案中,治疗组合物的至少一种组分乳化于载体中。
适用于本公开的衬件可由牛皮纸、聚乙烯、聚丙烯、聚酯或这些材料中的任何材料的复合物物制成。所述衬件可涂覆有防粘剂,诸如含氟化合物或有机硅。例如,美国专利4,472,480描述了低表面能的全氟化合物衬件,该专利的公开内容据此以引用方式并入。优选的衬件为用有机硅剥离材料涂覆的纸、聚烯烃膜或聚酯膜。可商购获得的有机硅涂覆的剥离纸的示例为购自伊利诺伊州贝德福德公园的詹姆斯河公司H.P.史密斯分部(JamesRiver Co.,H.P.Smith Division(Bedford Park,111.))的POLYSLIKTM有机硅剥离纸和由伊利诺伊州狄克森的道伯特化工公司(Daubert Chemical Co.(Dixon,111.))供应的有机硅剥离纸。最优选的衬件为购自道伯特公司(Daubert)的1-60BKG-157纸衬件,其为具有水基有机硅剥离表面的超级压光牛皮纸。另选地,伤口敷料可为无衬件的并且以诸如美国专利5,803,086中所述的卷形式进行递送。
以下实施方案旨在举例说明本公开而非进行限制。
实施方案
实施方案1是一种制品,所述制品包括:聚合物泡沫,所述聚合物泡沫具有第一主表面和第二主表面;以及治疗组合物的离散域,所述离散域被所述聚合物泡沫至少部分地围绕;其中每个离散域的外表面基本上适形于所述聚合物泡沫的所述第一主表面的一部分;其中所述制品包括第一主表面和第二主表面;并且其中所述聚合物泡沫的所述第一主表面的一部分和离散域的所述外表面形成所述制品的所述第一主表面。
实施方案2是根据实施方案1所述的制品,其中所述制品为伤口敷料。
实施方案3是根据实施方案1至2所述的制品,其中离散域形成图案。
实施方案4是根据实施方案1至3所述的制品,其中至少在一个平行于所述制品的所述第一主表面并且位于所述制品的所述第一主表面与所述第二主表面之间的平面处,每个离散域的横截面大于所述离散域的所述外表面的横截面。
实施方案5是根据实施方案1至4所述的制品,其中离散域的直径为至少约100微米。
实施方案6是根据实施方案1至5所述的制品,其中离散域的所述外表面覆盖所述制品的所述第一主表面的介于1%和99%之间。
实施方案7是根据实施方案1至6所述的制品,所述制品还包括位于所述制品的所述第一主表面的顶部上或与所述制品的所述第一主表面相邻的衬件。
实施方案8是根据实施方案1至7所述的制品,所述制品还包括被所述聚合物泡沫至少部分地围绕的所述治疗组合物的另外离散域。
实施方案9是根据实施方案8所述的制品,其中每个另外离散域的外表面基本上适形于所述聚合物泡沫的所述第二主表面的一部分。
实施方案10是根据实施方案8所述的制品,其中所述聚合物泡沫的所述第二主表面的一部分和另外离散域的所述外表面形成所述制品的所述第二主表面。
实施方案11是根据实施方案1至10所述的制品,所述制品还包括位于所述制品的所述第二主表面的顶部上或与所述制品的所述第二主表面相邻的第二衬件。
实施方案12是根据实施方案1至11所述的制品,其中所述聚合物泡沫包含选自聚氨酯、聚乙酸乙烯酯、聚乙烯醇、聚乙烯和有机硅的材料。
实施方案13是根据实施方案1至12所述的制品,其中所述治疗组合物保留在所述离散域中。
实施方案14是根据实施方案1至13所述的制品,其中所述治疗组合物包含选自以下的活性剂:抗微生物剂、抗生素、抗氧化剂、血小板衍生生长因子、维生素A、维生素C、维生素E、皮质类固醇、磺胺嘧啶银、多粘菌素B硫酸盐、梭链孢酸、吡非尼啶、干扰素、治疗油、植物提取物、动物提取物、药物、维生素、激素、抗氧化剂、鸸鹋油、芦荟、薰衣草油、玫瑰果油、磺胺嘧啶银、多粘菌素B、梭链孢酸和吡非尼啶。
实施方案15是根据实施方案1至14所述的制品,其中所述治疗组合物包含抗微生物剂。
实施方案16是一种制备伤口敷料的方法,所述方法包括:将治疗组合物沉积到衬件的表面上以形成印刷表面;以及将泡沫材料设置在所述印刷表面上。
实施方案17是根据实施方案16所述的方法,所述方法还包括固化所述泡沫材料以在所述印刷表面上形成泡沫。
实施方案18是根据实施方案16至17所述的方法,其中沉积所述治疗组合物包括将所述治疗组合物以一定图案沉积到所述衬件上。
实施方案19是根据实施方案16至18所述的方法,所述方法还包括从所述泡沫移除所述衬件。
实施方案20是一种制备伤口敷料的方法,所述方法包括:将第一治疗组合物沉积到第一衬件的表面上以形成第一印刷表面;将第二治疗组合物沉积到第二衬件的表面上以形成第二印刷表面;以及将泡沫材料设置在所述第一印刷表面与所述第二印刷表面之间。
实施方案21是一种制品,所述制品包括:聚合物膜衬件;聚合物泡沫,所述聚合物泡沫具有第一主表面和第二主表面;以及治疗组合物的多个离散域;其中每个离散域的一部分嵌入所述泡沫中,并且每个离散域具有被所述泡沫的所述第一主表面至少部分地围绕的暴露表面;其中所述衬件与所述离散域的所述暴露表面接触并且还与所述泡沫的所述第一主表面接触。
实施方案22是根据实施方案21所述的制品,其中所述衬件具有将其分成两部分的狭缝。
实施方案23是根据实施方案21至22中任一项所述的制品,其中所述治疗组合物包含抗微生物剂。
实施方案24是根据实施方案15和23所述的制品,其中所述抗微生物剂选自聚六亚甲基双胍(PHMB)、氯己定、苯扎氯铵、苄索氯铵、银盐、新霉素、多粘菌素B、杆菌肽和奥替尼啶。
实施方案25是根据实施方案15、23和24中任一项所述的制品,其中所述抗微生物剂溶解或分散于凝胶、水凝胶、霜剂和糊剂载体中。
实施方案26是根据实施方案1至15和21至25中任一项所述的制品,其中所述制品为吸收性伤口敷料。
以下工作实施例旨在举例说明本公开而非进行限制。
实施例
用于制备聚合物泡沫的材料
SUPRASEC 9634异氰酸酯是改性的亚甲基二苯基二异氰酸酯(MDI),购自德克萨斯州伍德兰兹的亨斯迈化学公司(Huntsman Chemical Company,The Woodlands,TX)。SUPRASEC 9634异氰酸酯被报告为具有以下特性:当量重量为143g/当量,官能度为2.15,并且异氰酸酯含量为29.3%。
CDB-33143聚醚多元醇由甘油、环氧丙烷和环氧乙烷作为共混物制备,购自弗吉尼亚州里士满的卡本特公司(Carpenter Company,Richmond,VA)。根据制造商的报告,CDB-33143聚醚多元醇具有以下特性:羟基数为142,官能度为3,环氧乙烷含量为26%。
CARPOL GP-700聚醚多元醇由甘油和环氧丙烷制备,购自弗吉尼亚州里士满的卡本特公司。根据制造商的报告,CARPOL GP-700聚醚多元醇具有以下特性:平均羟基数为240,官能度为3,环氧乙烷含量为0%。
ARCOL E-434聚醚多元醇是用环氧乙烷改性的聚氧化丙烯三醇,购自弗吉尼亚州匹兹堡的拜耳材料科学公司(Bayer MaterialScience,Pittsburgh,VA)。根据制造商的报告,ARCOL E-434聚醚多元醇具有以下特性:羟基数为33.8至37.2,环氧乙烷含量为15%。
三乙醇胺LFG(低冷冻等级)包含85%的三乙醇胺和15%的水,
购自宾夕法尼亚州康舍霍肯的奎克化学公司(Quaker Chemical Corporation,Conshohocken,PA)。
DABCO 33-LV是三亚乙基二胺(33重量%)在双丙二醇中的溶液,购自宾夕法尼亚州阿伦敦的空气化工产品公司(Air Products Company,Allentown,Pennsylvania,PA)。
DABCO BL-17叔胺催化剂购自空气化工产品公司。
DABCO DC-198有机硅二醇共聚物表面活性剂和DABCO BA-100聚合酸阻断剂购自空气化工产品公司。
用于制备抗微生物凝胶的材料
COSMOCIL PG抗微生物剂[为20%(重量/重量)水溶液形式的聚六亚甲基双胍(PHMB)]购自瑞士巴塞尔的龙沙有限公司(Lonza Limited,Basel,Switzerland)。
聚(乙二醇)4000(PEG4000)购自马萨诸塞州比尔里卡的EMD Millipore公司(EMDMillipore,Billerica,MA)。
聚甘油-3购自比利时布鲁塞尔的苏威公司(Solvay S.A.,Brussels,Belgium)。
单辛酸丙二醇酯(CAPMUL PG8)购自俄亥俄州哥伦布的Abitec公司(AbitecCorporation,Columbus,OH)。
CAB-O-SIL M5热解法二氧化硅购自马萨诸塞州波士顿的卡博特公司(CabotCorporation,Boston,MA)。
PLANTAREN 810UP烷基多葡糖苷表面活性剂购自新泽西州弗洛勒姆公园市的巴斯夫个人护理公司(BASF Personal Care Company,Florham Park,NJ)。
抗微生物凝胶和图案涂覆的剥离衬件的制备
表1报告了用于制备一批抗微生物凝胶的每种组分的总量。
表1:
用外部水浴将双行星式混合机[纽约州哈帕克的查尔斯·罗斯父子公司(CharlesRoss&Son Company,Hauppauge,NY)]的混合容器加热至70℃。将聚甘油-3添加到混合容器中,然后添加PEG4000,并且将混合物以25rpm(转/分钟)的速率共混30分钟。接着,将PHMB、单辛酸丙二醇酯(CAPMUL PG8)和PLANTAREN 810UP烷基多糖苷表面活性剂顺序地添加到混合容器中,并且将混合物以35rpm的速率共混5分钟。然后将CAB-O-SIL M5热解法二氧化硅分三等份添加,在添加每份后以35rpm的速率共混5分钟。将混合容器侧面上的未混合材料刮入批量混合物中,并且将混合物以25rpm的速率再共混10分钟。从混合容器移除所得凝胶,并且在65℃的烘箱中加热一小时。将温热的凝胶加载到带有鲁尔针尖的20mL注射器中。然后将凝胶以非相交线(约10cm长并且间隔约4mm)的图案分配在有机硅涂覆的纸材剥离衬件的剥离表面上。每条线具有约2mm的直径。将图案施加到剥离衬件的10cm×3.5cm部分上。
实施例1.泡沫制品的制备
通过如下方式浇注一层开孔聚氨酯泡沫层:将SUPRASEC 9634异氰酸酯(58.2份)添加到CDB-33143聚醚多元醇(100份)、CARPOL GP-700聚醚多元醇(3.0份)、水(1.0份)、三乙醇胺LFG(3.7份)、DABCO DC-198表面活性剂(2.0份)、ARCOL E-434聚醚多元醇(4.0份)、DABCO 33-LV(0.45份)、DABCO BA-100聚合酸阻断剂(0.12份)和DABCO BL-17叔胺催化剂(0.10份)的混合物中。制剂按比例缩放,使得总反应混合物重40克。使用DAC 150FV高速混合机[南卡罗来纳州兰德拉姆的Flacktek公司(Flacktek,Inc,Landrum,SC)],将组分在塑料杯中以3300rpm的速率混合10秒。然后立即将全部混合物倾倒在先前已施加到有机硅涂覆的剥离纸衬件的凝胶图案上,使得整个凝胶图案被混合物覆盖。被泡沫覆盖的剥离衬件的总面积为约12cm×18cm。将一片聚丙烯涂覆的剥离纸放置在反应性泡沫混合物的暴露表面上。使泡沫在室温下升温并固化。泡沫制品的横截面的图像如图2A所示,并且泡沫制品的俯视图的图像如图2B所示。如图2A和图2B所示,抗微生物凝胶的离散域220被聚合物泡沫210围绕。
比较例A.
遵循与实施例1中报告的相同工序,不同之处在于,在混合之后,将泡沫制剂立即倾倒在没有实施例1的施加的凝胶图案的有机硅涂覆的剥离衬件上。
实施例2.浮游微生物杀灭测定(金黄色葡萄球菌(Staphylococcus
aureus))
将菌株号为6538的金黄色葡萄球菌[购自弗吉尼亚州马纳萨斯的美国典型培养物保藏中心(American Type Culture Collection,Manassas,VA)]的培养物在37℃的胰蛋白酶大豆肉汤[新泽西州富兰克林湖的贝克顿-迪金森公司(Becton,Dickinson andCompany,Franklin Lakes,NJ)]中生长18小时。使用15mL锥形离心管将培养物在无菌磷酸盐缓冲盐水(PBS)[马萨诸塞州沃尔瑟姆的赛默飞世尔科技公司(Thermo FisherScientific Incorporated,Waltham,MA)]中按1:100稀释。
从包含嵌入凝胶的泡沫的区域制备三个实施例1的泡沫制品的圆形冲头(直径为10mm)。在两个剥离衬件均被移除情况下,将10微升等分稀释的金黄色葡萄球菌悬浮液施加到每个泡沫冲头上。将每个等分试样直接施用到包含暴露凝胶的泡沫制品的表面。将接种的冲头样品在室温下温育5分钟,然后置于单独的15mL锥形离心管中,该锥形离心管包含10mL的Dey-Englay(D/E)中和肉汤[新泽西州富兰克林湖市的BD公司(Becton,Dickinsonand Company,Franklin Lakes,NJ)]。使用比较例A的泡沫制品的三个10mm圆形冲头重复该过程。
将每个包含5mL D/E肉汤和泡沫冲头样品的试管在超声处理水浴[Branson 2510型,购自密苏里州圣路易斯的艾默生电气公司(Emerson Electric Company,St.Louis,MO)]中超声处理一分钟,然后用VWR微型涡旋机[宾夕法尼亚州拉德诺的VWR国际公司(VWRInternational,Radnor,PA)]以最大速度涡旋处理一分钟。将中和肉汤逐级稀释(10倍稀释),然后镀覆(1mL)到3M PETRIFILM好氧微生物计数板[明尼苏达州梅普尔伍德的3M公司(3M Corporation,Maplewood,MN)]上。在37℃下将平板温育24至48小时。在温育期结束时,通过目测对每个平板上的菌落进行计数。
基于稀释次数,通过调节观察到的平板计数来计算从泡沫制品(n=3)回收的平均对数(菌落形成单位数/样品)。用学生双尾未配对t检验确定统计显著性,其中P值小于0.05被视为具有统计显著性差异。结果报告于表2中。
实施例3.浮游微生物杀灭测定(铜绿假单胞菌(Pseudomonas
aeruginosa))
遵循与实施例2中报告的相同工序,不同之处在于,使用菌株号为15442的铜绿假单胞菌(购自美国典型培养物保藏中心)代替金黄色葡萄球菌。结果报告于表2中。
表2:从泡沫制品中回收的细菌计数
本文所引用的所有参考文献和公布全文均明确地以引用方式并入本公开。本文讨论了本发明的例示性实施方案,并且引用了本发明范围内可能的变型。例如,结合一个例示性实施方案描绘的特征可与本发明的其它实施方案结合使用。在不脱离本发明范围的前提下,本发明中的这些以及其它变型和修改对本领域内的技术人员将是显而易见的,并且应当理解,本发明并不限于本文阐述的例示性实施方案。因此,本发明仅受以下所提供的权利要求书及其等同物的限定。
Claims (20)
1.一种制品,所述制品包括:
聚合物泡沫,所述聚合物泡沫具有第一主表面和第二主表面;以及
治疗组合物的离散域,所述离散域被所述聚合物泡沫至少部分地围绕;
其中每个离散域的外表面基本上适形于所述聚合物泡沫的所述第一主表面的一部分;
其中所述制品包括第一主表面和第二主表面;并且
其中所述聚合物泡沫的所述第一主表面的一部分和离散域的所述外表面形成所述制品的所述第一主表面。
2.根据权利要求1所述的制品,其中所述制品为伤口敷料。
3.根据权利要求1至2所述的制品,其中离散域形成图案。
4.根据权利要求1至3所述的制品,其中至少在一个平行于所述制品的所述第一主表面并且位于所述制品的所述第一主表面与所述第二主表面之间的平面处,每个离散域的横截面大于所述离散域的所述外表面的横截面。
5.根据权利要求1至4所述的制品,其中离散域的直径为至少约100微米。
6.根据权利要求1至5所述的制品,其中离散域的所述外表面覆盖所述制品的所述第一主表面的介于1%和99%之间。
7.根据权利要求1至6所述的制品,所述制品还包括位于所述制品的所述第一主表面的顶部上或与所述制品的所述第一主表面相邻的衬件。
8.根据权利要求1至7所述的制品,所述制品还包括被所述聚合物泡沫至少部分地围绕的所述治疗组合物的另外离散域。
9.根据权利要求8所述的制品,其中每个另外离散域的外表面基本上适形于所述聚合物泡沫的所述第二主表面的一部分。
10.根据权利要求8所述的制品,其中所述聚合物泡沫的所述第二主表面的一部分和另外离散域的所述外表面形成所述制品的所述第二主表面。
11.根据权利要求1至10所述的制品,所述制品还包括位于所述制品的所述第二主表面的顶部上或与所述制品的所述第二主表面相邻的第二衬件。
12.根据权利要求1至11所述的制品,其中所述聚合物泡沫包含选自聚氨酯、聚乙酸乙烯酯、聚乙烯醇、聚乙烯和有机硅的材料。
13.根据权利要求1至12所述的制品,其中所述治疗组合物保留在所述离散域中。
14.根据权利要求1至13所述的制品,其中所述治疗组合物包含选自以下的活性剂:抗微生物剂、抗生素、抗氧化剂、血小板衍生生长因子、维生素A、维生素C、维生素E、皮质类固醇、磺胺嘧啶银、多粘菌素B硫酸盐、梭链孢酸、吡非尼啶、干扰素、治疗油、植物提取物、动物提取物、药物、维生素、激素、抗氧化剂、鸸鹋油、芦荟、薰衣草油、玫瑰果油、磺胺嘧啶银、多粘菌素B、梭链孢酸和吡非尼啶。
15.根据权利要求1至14所述的制品,其中所述治疗组合物包含抗微生物剂。
16.一种制备伤口敷料的方法,所述方法包括:
将治疗组合物沉积到衬件的表面上以形成印刷表面;以及
将泡沫材料设置在所述印刷表面上。
17.根据权利要求16所述的方法,所述方法还包括固化所述泡沫材料以在所述印刷表面上形成泡沫。
18.根据权利要求16至17所述的方法,其中沉积所述治疗组合物包括将所述治疗组合物以一定图案沉积到所述衬件上。
19.根据权利要求16至18所述的方法,所述方法还包括从所述泡沫移除所述衬件。
20.一种制备伤口敷料的方法,所述方法包括:
将第一治疗组合物沉积到第一衬件的表面上以形成第一印刷表面;
将第二治疗组合物沉积到第二衬件的表面上以形成第二印刷表面;以及
将泡沫材料设置在所述第一印刷表面与所述第二印刷表面之间。
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- 2019-07-19 CN CN201980050926.2A patent/CN112512468A/zh active Pending
- 2019-07-19 US US17/260,616 patent/US20210322227A1/en active Pending
- 2019-07-19 WO PCT/IB2019/056210 patent/WO2020026061A1/en unknown
- 2019-07-19 EP EP19762479.4A patent/EP3829505A1/en active Pending
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US20210322227A1 (en) | 2021-10-21 |
WO2020026061A1 (en) | 2020-02-06 |
EP3829505A1 (en) | 2021-06-09 |
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