CN113242737A - 包含电解水的愈合用组合物 - Google Patents
包含电解水的愈合用组合物 Download PDFInfo
- Publication number
- CN113242737A CN113242737A CN201980081295.0A CN201980081295A CN113242737A CN 113242737 A CN113242737 A CN 113242737A CN 201980081295 A CN201980081295 A CN 201980081295A CN 113242737 A CN113242737 A CN 113242737A
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- water
- composition
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- natural
- boron
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Abstract
本发明涉及一种用作愈合用药物的包含电解水的组合物。本发明还涉及这种组合物用于治疗皮肤病症的用途。
Description
技术领域
本发明涉及伤口的治疗,更特别涉及包含电解水的愈合用组合物(healingcomposition),其中所述电解水是使水在掺硼金刚石电极的存在下经受电解来获得的。
背景技术
如今,根据待治疗伤口的严重性,将采用不同形式的愈合性治疗。
对于轻微的出血伤,通常使用简单的绷带。市面上存在许多不同的类型,特性也不同。然而,非限制性地,可以提及申请WO2017027386,其目的是提供一种伤口敷料,该伤口敷料包括载体和涂覆所述载体的疏水性弹性体基质,所述基质包括由聚苯乙烯嵌段和聚烯烃嵌段的组合组成的苯乙烯-乙烯-丙烯-苯乙烯嵌段共聚物(styrene-ethylene-propylene-styrene,SEPS)、苯乙烯-乙烯-丁二烯-苯乙烯嵌段共聚物(styrene-ethylene-butylene-styrene,SEBS)或苯乙烯-乙烯-乙烯-丙烯-苯乙烯嵌段共聚物(styrene-ethylene-ethylene-propylene-styrene,SEEPS)类型的弹性体,所述弹性体具有通过凝胶渗透色谱测量,小于或等于290000道尔顿(Dalton)的分子量,弹性体的总比例严格地小于所述弹性体基质总重量的3.0%。
在更严重或致残疾病例如血友病的情况下,简单的伤口敷料是不够的,而是需要使用通常难以提取或昂贵的化学或生物化合物来治疗患者。非穷尽性地,可以提及申请WO2012117203,其涉及包含改性的因子Xa(GDXa)的药物组合物,所述改性的GDXa是非血栓源性的(non-thrombogenic),能够结合组织因子途径抑制物(tissue factor pathwayinhibitor,TFPI)但不能结合磷脂,用于在存在或不存在抑制剂的情况下,预防或治疗患有A型或B型血友病的患者的出血性中风。
当今,一种比血友病更具隐患的疾病正在入侵人体,对患者造成可怕的伤害,长期影响身体有效愈合的能力。这种21世纪的疾病是II型糖尿病,其不仅由于迫使患者注射胰岛素而影响患者的日常生活,而且还影响患者与伤口或切口的日常斗争,导致难以愈合且有时会导致坏疽甚至生命危险。在申请WO2001091696中,该发明的主题是通式(I)的双胍衍生物或其药学上可接受的盐在制备具有愈合效用的药物中的应用,其中,基团R1和R2彼此独立地表示氢原子、C1-C7烷基、环烷基、杂环、C2-C7烯基、芳基、芳烷基,芳氧基烷基或杂芳基,或者R1和R2共同表示其中可含有一个或多个杂原子的C2-C7亚烷基,基团R3表示伯胺、仲胺或叔胺,所述药物为局部用药物形式。
虽然有广泛的治疗手段来治疗伤口并使它们有效地愈合,但使用化学品或生物因子并非没有风险,因为长期使用可能导致对组合物的耐药性。因此,确实需要新的组合物或化合物,该新的组合物或化合物能够有效地愈合伤口,而不需要系统地求助于复杂的化学化合物或生物因子,这些化合物或生物因子有时会但不总是会诱导限制或影响愈合过程的排斥或副作用。
发明内容
因此,本发明的目的是通过提供一种用作愈合用药物的包含电解水的组合物以弥补上述缺点并满足上述需求。
在根据本发明的一个实施方式中,电解水(electrolysed water)是在附着于基底的至少一个硼掺杂金刚石电极的存在下通过电解而获得的。
金刚石电极中硼的浓度在200ppm(3×1019硼原子/cm3)和2000ppm(3.52×1020硼原子/cm3)之间,特别是在200ppm(3×1019硼原子/cm3)和1500ppm(2×1020硼原子/cm3)之间。
用于固定所述金刚石电极的基底选自硅或铌、钽或钨,或它们的混合物,优选为硅或铌,更优选为硅。
根据本发明的一个方面,电解水是通过实施三步法获得的,该方法首先提供自来水或泉水,任选地补充有浓度为0.5g/L至2g/L的氯化钠(NaCl),然后通过电解模块来电解所述水,该电解模块包括附着于硅基底的至少一个硼掺杂金刚石电极,其中硼浓度在200ppm(3×1019硼原子/cm3)和2000ppm(3.52×1020硼原子/cm3)之间,特别是在200ppm(3×1019硼原子/cm3)和1500ppm(2×1020硼原子/cm3)之间,所述模块在电解过程中使水经受的电流的量为每L水15至500mAh(电流密度),更优选每L水40至250mAh,甚至更优选每L水50至200mAh/L,并且电解的持续时间在15分钟至30分钟。
此外,根据本发明的组合物中使用的水是天然水或纯净水,无需要添加任何一种添加剂。
在本发明的另一实施方式中,根据本发明的组合物还可以包含天然或合成的愈合剂。
天然或合成的愈合剂总是以比包含常规或蒸馏的非电解水的等效组合物中更低的浓度存在。
天然或合成愈合剂的浓度比包含常规或蒸馏的非电解水的等效组合物中的浓度低25%至75%。
优选地,天然或合成的愈合剂选自二甲双胍、铜或其衍生物、罂粟碱、地巴唑(bendazole)、金盏花提取物、芦荟、治疗精油、乙酰-丝氨酸-天冬-赖氨酸-脯氨酸(Acetyl-Ser-Asp-Lys-Pro AcSDKP,AcSDKP)四肽、锌或其衍生物、维生素原B5、硫糖铝、白藜芦醇、羊毛脂、维生素A、尿囊素、透明质酸、生育酚或其衍生物、万寿菊、甜杏仁油或荷荷芭油、厚壳或圣约翰草,或它们的混合物。
根据本发明的组合物还包含一种或多种天然或合成的乳化剂和/或赋形剂,选自凡士林、甘油、石蜡、鲸蜡基葡萄糖、蜂蜡或米蜡、大豆卵磷脂、糖酯、硬脂酸甘油酯、橄榄油衍生物或它们的混合物。
在一个实施方式中,根据本发明的组合物包含60重量份至95重量份的电解水、0重量份至10重量份的合成或天然的愈合剂,和1重量份至10重量份的赋形剂和/或乳化剂。
在另一个实施方式中,根据本发明的组合物包含60重量份至95重量份的赋形剂和/或乳化剂、0重量份至10重量份的合成或天然的愈合剂,和10重量份至30重量份的电解水。
根据本发明的组合物也可以是乳膏、凝胶或乳液的形式。
本发明的目的还在于根据本发明的组合物用于治疗产生伤口或愈合缺陷的皮肤病症例如褥疮、丹毒、开放性伤口、静脉曲张性溃疡的用途。
形成本发明组合物基础的电解水可以有利地通过使用电解模块的方法来获得,其中电解模块包括附着于硅基底上的至少一个硼掺杂金刚石电极,其中硼浓度在200ppm(3×1019硼原子/cm3)和2000ppm(3.52×1020硼原子/cm3)之间,特别是在200ppm(3×1019硼原子/cm3)和1500ppm(2×1020硼原子/cm3)之间,所述模块在电解过程中使水经受的电流的量为每L水15至500mAh,更优选每L水40至250mAh,甚至更优选每L水50至200mAh。
电解的持续时间可长可短,通常小于或等于60分钟,特别是1分钟5至60分钟,特别是15分钟至30分钟。通常,5分钟至30分钟的持续时间是合理的。电解可以循环进行,每24小时进行4至12次水处理循环。
本发明的最终目的还在于包含根据本发明的组合物或由本发明获得的组合物用于粘附型应用、伤口敷料、贴片或甚至用于膜片。
本发明的组合物将特别能够用于生产可适用于皮肤或面部的膜片,所述膜片得自于已经向其中添加根据上述方法获得的电解水的粉末例如粘土、去角质剂、粉末状植物提取物或含有活性炭的粘土。
附图说明
图1示出了根据本发明的组合物在伤口愈合过程中的作用,该组合物包含通过硅基底上的硼掺杂金刚石电极A(1200ppm硼)电解水获得的电解水。
图2示出了在愈合过程中,使用常规水处理(对照)和根据本发明的组合物中电解的水处理的对比测试。
图3示出了通过硅基底上的硼掺杂金刚石电极B(2500ppm硼)获得的电解水在伤口愈合过程中的作用。
具体实施方式
将借助于一个或多个实施例更详细地描述本发明,这些实施例不是对本发明的限制。
伤口愈合是一个复杂的机制,涉及许多伤口重建的蛋白质和细胞机制。这个过程可以分为三个阶段:早期血管和炎症阶段,也称为清创期或用于伤口清创的渗出期;称为肉芽阶段的第二阶段,其对应于肉芽组织发育的增殖阶段,肉芽组织由于新血管生成和细胞增殖而使得物质损失能够被新组织填充。肉芽阶段持续直至上皮形成。接下来是一个更长期的阶段,称为疤痕重塑阶段。
市面上存在根据待治疗的伤口的严重性能够使用的若干方案。但是一个简单的擦伤并不需要进行像静脉曲张性溃疡一样的处理。因此,与主要基于使用天然或合成的化合物或伤口敷料的常规治疗方法相比,新的治疗方法是有用的。
本发明的优点是减少或甚至消除药物的使用而实现浅表或更复杂的愈合,并且由于组合物的简单性而易于施用。就其本质而言,所述组合物也可以被“再次激活”。这种再次激活被理解为是指能够对组合物重复施加电解处理,这使得组合物中存在的水,有用产物得以再次被激活。此外,一个显著的优点是,由于其原料,该组合物的成本低于常规组合物的成本。包含在根据本发明的组合物中的主要产品容易获得也是这些优点之一。
根据本发明的用于治疗伤口愈合或相关病症的组合物主要由电解水组成,该电解水通过使用便携式或固定的无膜电解站获得,其中该无膜电解站包括固定在基底上的至少一个硼掺杂金刚石电极,其中基底可由硅、铌、钽、钨或它们的混合物制成。
根据本发明,推荐使用硅或铌基底,硅是优选的基底。
不受理论的约束,硅基底上的硼掺杂金刚石(称为BDD)电极能够实现高电解电势,高于常规用于水电解的铂电极。因此,这些BDD电极能够产生赋予水以尤其在愈合过程中带来治疗潜力的结构改变。
在本发明的优选实施方式中,电极中存在的硼的浓度在200ppm(3×1019硼原子/cm3)和1500ppm(3.52×1020硼原子/cm3)之间,这是获得高质量电解水的最佳值。
较低的硼水平不会产生高质量的电解水,而较高的硼水平会导致电极性能的降低和电极寿命的降低。
基于本发明组合物的电解水是通过使用电解模块的方法获得的,所述电解模块包括如前所述固定在硅基底上的至少一个硼掺杂金刚石电极,所述模块在电解过程中使每水经受的电流的量为每L水15至500mAh,更优选每L水40至250mAh,还更优选每L水50至200mAh。
电解的持续时间可以在5分钟至30分钟之间变动。电解可以循环进行,可以设想每24小时进行4至12次水处理循环。
不受理论的约束,通过上述方法获得的水本身无法进行表征,并且正是通过该方法获得的水才具有根据本发明的愈合特性。例如,通过实施上述方法,使用常规铂电极而不是使用硼掺杂金刚石电极获得的水,并不能获得根据本发明的组合物及其有利效果。
在根据本发明的组合物中,电解水可以在制备所述组合物之前使用,并且有利地,可以在任何时间再次电解,从而在非常长的时间内保持所述组合物的愈合潜力,并且通过相对简单的方法以某种方式再生所述组合物。
所使用的水可以是商业上可获得的已知其治疗特性或优点的纯净水或温泉水。电解的水不需要是蒸馏水。此外,本发明不需要添加任何一种添加剂,例如用于清洁游泳池或水疗中心的电解水制备方法中使用的添加剂,即高浓度的氯或活性氧。
此外,在根据本发明的组合物中使用由BDD型电极电解的水的优点之一是,电解水的存在使得组合物中含有的天然或合成的愈合剂低于在组合物中含有未电解的或蒸馏的天然或自来水的情况下含有的天然或合成的愈合剂。
因此,根据本发明的组合物可以包含这种试剂,天然或合成的愈合剂将总是比包含常规或蒸馏的非电解水的等效组合物中以更低的浓度存在。从长远来看,这样做的好处是减少产品的依赖性或无效性。对于某些疾病,伤口愈合是一个反复出现的问题,长时间或定期暴露可能会导致身体习惯或抵抗这些药物。
在根据本发明的组合物中,天然或合成的愈合剂的浓度将比不包含电解水但包含常规水或蒸馏水的等效市售组合物的浓度低25%至75%。
如上所述,根据本发明的组合物还可以包含天然或合成的愈合剂。应当注意,后者不应理解为本发明框架内的添加剂,因为上文提及的添加剂应理解为用于净化水的盐形式的有机或无机类型的添加剂。
在本发明的框架内,天然或合成的愈合剂被理解为在专利或科学文献中已被认可的,对于愈合产品领域的技术人员来而言是已知的为可能用作愈合剂或用于相关疾病的产品,其中所述相关疾病例如产生伤口或愈合缺陷的皮肤病症,例如褥疮、丹毒、开放性伤口、静脉曲张性溃疡。
非穷尽性地,天然或合成的愈合剂可选自二甲双胍、铜或其衍生物、罂粟碱、地巴唑、金盏花提取物、芦荟、治疗精油、乙酰化-丝氨酰-天冬氨酰-赖氨酰-脯氨酸(AcSDKP)、锌或其衍生物、维生素原B5、硫糖铝、白藜芦醇、羊毛脂、维生素A、尿囊素、透明质酸、生育酚或其衍生物、万寿菊、甜杏仁油或荷荷巴油、红厚壳素(calophyll)或圣约翰草,或它们的混合物。
根据本发明的组合物还可以包含天然或合成的赋形剂和/或乳化剂,与本领域的技术人员已知的旨在将组合物制成乳膏形式的盖伦原理(galenic principles)一致。非穷尽性地,其可以选自凡士林、甘油、石蜡、鲸蜡基葡萄糖、蜂蜡或米蜡、大豆卵磷脂、糖酯、硬脂酸甘油酯、油衍生物(更特别是橄榄油衍生物),或者它们的混合物。
根据需要获得的乳膏的类型及其所需的渗透力,相对于乳化剂,可以向乳膏中添加更高或更低百分比的电解水,反之亦然。在油包水型(也被称为W/O)乳液的情况下,油的量大于水的量。这样得到的乳液能够在皮肤上形成脂质膜而非常有滋养、保湿和防护的作用。它是用于干性皮肤或晚霜的理想选择。
在水包油型(也被称为O/W,法语缩写为H/E)乳液的情况下,水的量大于油的量。这种类型的乳液是滋养的和保湿的。它是用于制作日霜和沐浴乳的理想材料,也可以加入到贴片或绷带型粘合剂中。
根据本发明的组合物的另一种潜在的盖仑形式可以是水基凝胶,也称为水凝胶。水凝胶是一种溶胀剂为水的凝胶。水凝胶的基体通常是不溶于水的聚合物网络,但是在大量水或水性溶液的存在下能够充分溶胀。
因此,根据待治疗患者的需要和待实施的愈合过程的程度,能够对根据本发明的组合物进行若干种配制或成型。它可以是乳膏、凝胶或乳液的形式,甚至可以是绷带型粘合剂或皮肤贴片的形式。
根据所寻求的乳液或组合物的类型,在被称为水包油型(O/W)组合物的情况下,根据本发明的组合物包含60重量份至95重量份的电解水、0重量份至10重量份的合成或天然的愈合剂,以及1重量份至10重量份的赋形剂和/或乳化剂。
在被称为油包水型(W/O,法语缩写为E/H)组合物的情况下,所述组合物包含60重量份至95重量份的赋形剂和/或乳化剂、0重量份至10重量份的合成或天然的愈合剂,以及10重量份至30重量份数的电解水。
将根据本发明的组合物制成各种可能的盖仑剂型以用作愈合药物或用于治疗产生伤口或愈合缺陷的皮肤病症,例如褥疮、丹毒、开放性伤口或静脉曲张性溃疡。
实施例
实施例1:研究电极中硼浓度对伤口愈合效率的影响
研究了成纤维细胞的愈合速率随用于电解培养水的电极中硼含量的变化关系。
本实验中采用的硼掺杂电极(以下,称为BDD/Si电极)A和B具有以下特征:
-BDD/Si电极:硅基底上的硼掺杂金刚石膜;
-基底:单晶硅(100),电阻率100mohm.cm;
-BDD膜:多晶,厚度为2μm至3μm,掺杂1200ppm硼(电极A)或2500ppm硼(电极B),
使用相同的热丝化学气相沉积(Hot Filament Chemical Vapor Deposition,HF-CVD)金刚石膜生长方案来制造电极A和B。它们在各方面都是相同的,只是各自的硼含量不同。
a)将电极施用至培养水的方案如下:
一个2.5L的水箱容纳15℃的城市用水。通过电解模块以200L/h的固定速率泵送这些水,然后使其通过闭合回路返回水箱。电解模块使用两个电极,这两个电极间距为1mm,并且具有70cm2的活性表面积。电解电流为2A,工作周期t=0-1-2-5-10-20-30-40分钟,以实现0至533mAh/L的电解负荷。在测试过程中,使水箱中的水保持在20℃的恒定温度。
在电解模块的出口处取样电解水,然后立即进行无菌过滤(0.2μm多孔膜过滤器),并以1:4的稀释度(=25%浓度)添加到成纤维细胞培养基中。
b)培养方案如下:
成纤维细胞:L-929(小鼠成纤维细胞;ACC 173;DSMZ);内部通道P52-53;(推荐根据EN ISO 10993-5:2009标准)。在包含5%CO2和95%空气的受控封闭环境下,于37℃的培养箱中大量孵育和培养细胞。培养基为含10%生理牛血清、100单位/mL青霉素和100μg/mL链霉素的RPMI 1640。
c)研究细胞再生/愈合的方案如下:
使用硅酮培养插入物(ibidi GmbH,München)。当该插入物置于培养基中时,它形成由厚度为500μm的壁隔开的两个培养罐。使细胞在两个罐中生长,取出硅酮插入物。从而形成两个完美限定的培养斑块,精确地相距500μm。
对于实验,从80重量%至90重量%的悬浮培养物中以500000细胞/mL的密度获得L-929型细胞。将100μL悬浮液引入每个培养插入罐中。使细胞生长24h,以在每个插入物隔开的两个罐中的每一个中获得同质群体。然后,轻轻移除插入物,留下500μm的自由空间来分隔两个培养基。注入电解水直至达到500μL至1500μL(1:4稀释度)的新鲜培养基。使培养基再次生长24h。然后,通过甲醇处理2分钟来固定细胞层,并根据罗曼诺夫斯基(Romanowsky)通过考马斯-吉姆萨(Coomassie-Giemsa)溶液染色。
通过一个27英寸的屏幕拍摄分隔空间,以便在沿着分隔空间的5个点观察两个培养基的接近速度,直到相互连接(图2)。
d)结果
与没有电解的无菌水相比,用BDD电极A(1200ppm掺杂硼B)电解的水的结果显示,从25mAh/L到200mAh/L,愈合率显著加快,直至达到30%以上,然后下降(图1)。
用BDD电极B(约2500ppm B),观察到愈合加速,但远低于用电极A获得的愈合速率(图3)。
实施例2:电解水的硼含量
自来水的电解方案如下:
使用的水是城市用水。
电解方案如下:
将城市用水用电解模块以90L/h的速率来泵送,该电解模块配备有2个如实施例1限定的BDD电极A(1200ppm B),其间隔1mm,活性表面积为12.5cm2。
施加的电流为2.4A。从电解模块的出口直接收集水样(开环回路,废水操作)。
结果如下表所示:
样本1:城市原水
样品2和样品3:用电极A电解的水(1200ppm B)
与原水相比,使用电极A对水进行电解会使得电解水中硼浓度的小幅但明显的增加:施加的电荷约为+101.74μg B/Ah。
测量水中的硼是通过电感耦合等离子体质谱法(ICP-MS)来进行。
Claims (9)
1.一种用作愈合用药物的包含电解水的组合物,其中,所述电解水是使用附着于基底的至少一个硼掺杂金刚石电极通过电解而获得,其中,硼的浓度在200ppm(3×1019硼原子/cm3)和2000ppm(3.52×1020硼原子/cm3)之间,特别是在200ppm(3×1019硼原子/cm3)和1500ppm(2×1020硼原子/cm3)之间。
2.根据权利要求1所述的组合物,其中,所述水是未添加至少一种添加剂的天然水或纯净水。
3.根据前述权利要求中任一项所述的组合物,其中,所述组合物还包含天然或合成的愈合剂。
4.根据权利要求3所述的组合物,其中,所述天然或合成的愈合剂选自:二甲双胍、铜或其衍生物、罂粟碱、地巴唑、金盏花提取物、芦荟、治疗精油、乙酰化-丝氨酰-天冬氨酰-赖氨酰-脯氨酸(AcSDKP)四肽、锌或其衍生物、维生素原B5、硫糖铝、白藜芦醇、羊毛脂、维生素A、尿囊素、透明质酸、生育酚或其衍生物、万寿菊、甜杏仁油、荷荷芭油或圣约翰草,或它们的混合物。
5.根据前述权利要求中任一项所述的组合物,其中,还包含选自以下项的天然或合成的乳化剂和/或赋形剂:凡士林、甘油、石蜡、鲸蜡基葡萄糖、蜂蜡或米蜡、大豆卵磷脂、糖酯、硬脂酸甘油酯、橄榄油衍生物或它们的混合物。
6.根据前述权利要求中任一项所述的组合物,其中,所述组合物包含60重量份至95重量份的电解水、0重量份至10重量份的合成或天然的治愈剂,以及1重量份至10重量份的赋形剂和/或乳化剂。
7.根据前述权利要求中任一项所述的组合物,其中,所述组合物包含60重量份至95重量份的赋形剂和/或乳化剂、0重量份至10重量份的合成或天然的治愈剂,以及10重量份至30重量份的电解水。
8.根据前述权利要求中任一项所述的组合物,用作治疗产生伤口或愈合缺陷的皮肤病症例如褥疮、丹毒、开放性伤口、静脉曲张性溃疡的治愈性药物。
9.一种皮肤敷用面膜,包含根据权利要求1至8中任一项所述的组合物。
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- 2019-11-21 ES ES19813432T patent/ES2938473T3/es active Active
- 2019-11-21 US US17/296,153 patent/US20210338817A1/en active Pending
- 2019-11-21 JP JP2021527861A patent/JP2022508139A/ja active Pending
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Also Published As
Publication number | Publication date |
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CN113242737B (zh) | 2024-01-16 |
WO2020104631A1 (fr) | 2020-05-28 |
JP2022508139A (ja) | 2022-01-19 |
FR3088542A1 (fr) | 2020-05-22 |
FR3088542B1 (fr) | 2021-03-19 |
BR112021009616A2 (pt) | 2021-08-10 |
BR112021009616A8 (pt) | 2023-01-31 |
EP3883583B1 (fr) | 2022-12-28 |
AU2019385694A1 (en) | 2021-06-24 |
IL283296A (en) | 2021-07-29 |
ES2938473T3 (es) | 2023-04-11 |
US20210338817A1 (en) | 2021-11-04 |
EP3883583A1 (fr) | 2021-09-29 |
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