CN117085164A - 一种具有治疗疤痕的医用硅酮功能性敷料及其制备方法 - Google Patents
一种具有治疗疤痕的医用硅酮功能性敷料及其制备方法 Download PDFInfo
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- CN117085164A CN117085164A CN202311119875.9A CN202311119875A CN117085164A CN 117085164 A CN117085164 A CN 117085164A CN 202311119875 A CN202311119875 A CN 202311119875A CN 117085164 A CN117085164 A CN 117085164A
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Abstract
本发明提供一种具有治疗疤痕的医用硅酮功能性敷料及其制备方法，所述的功能性敷料由无纺纱布、凝胶层、保护液三部分组成，凝胶层紧贴无纺纱布的一侧，保护液则均匀浸透于无纺纱布和凝胶层中。凝胶层由高粘度二甲基硅氧烷、低粘度聚二甲基硅氧烷、卡波姆、甘露聚糖、β‑葡聚糖纯化水组成，保护液由三乙醇胺、甘油、羟苯甲酯钠、玻璃酸钠、谷胱甘肽和纯化水组成。本发明具有促进伤口愈合、减小疤痕形成、修复增生性疤痕的作用。
Description
技术领域
本发明涉及预防、治疗疤痕敷料技术领域，特别涉及一种具有治疗疤痕，促进改善皮肤美容美观的医用硅酮功能性敷料及其制备方法。
背景技术
人体皮肤是直接暴露在外界环境的器官，经常因为各种疾病或机械创伤而导致皮肤组织的破坏和缺损，当皮肤软组织受到严重损伤而不能完全自行正常修复时，纤维组织将替代其修复留下的既影响外观又影响功能的局部症状，这些由纤维组织修复后的局部症状即为疤痕。疤痕给患者带来的是巨大的肉体痛苦和精神痛苦，而疤痕的增生期几乎让患者苦不堪言，使患者受到极大的身、心双重障碍。
目前疤痕的主要改善或是治疗方式有疤痕内药物注射、冷冻治疗、基因治疗、口服防疤痕药物、压力疗法、激光治疗、硅凝胶膜类产品等，各种治疗方式的治疗效果也不尽相同。
目前的去疤痕产品均存在作用机制单一问题，有的渗透性差很难透过角质层从而不能进入真皮层从而导致抗炎效果不佳、有的不能阻止疤痕表面水分的挥发从而导致修复速度慢、有的不能隔离外界环境的有害生物从而导致二次感染。且这些产品的主要关注点都只在保护伤口环境、促进伤口愈合、预防伤口感染的环节上，虽然在伤口治疗上起到了较好的作用，但均未涉及预防和减少疤痕形成，而疤痕的形成不但影响美观，而且会产生排汗不畅、严重瘙痒等症状，给患者造成极大的痛苦。
发明内容
鉴于此，本发明提出一种具有预防和治疗疤痕的医用硅酮功能性敷料及其制备方法，解决上述问题。
本发明的技术方案是这样实现的：一种具有预防和治疗疤痕的医用硅酮功能性敷料，所述的功能性敷料由无纺纱布、凝胶层、保护液三部分组成，凝胶层紧贴无纺纱布的一侧，保护液则均匀浸透于无纺纱布和凝胶层中；
所述凝胶层的组分和含量为：高粘度聚二甲基硅氧烷5-8份、低粘度聚二甲基硅氧烷8-10份、卡波姆4-8份、甘露聚糖5-10份、β-葡聚糖5-10份、纯化水60-80份；
所述保护液的组分和含量为：三乙醇胺1-5份、甘油8-10份、羟苯甲酯钠1-3份、纯化水35-65份。
进一步说明，所述保护液中还含有玻璃酸钠3-8份、谷胱甘肽5-9份。
进一步说明，所述凝胶层的组分和含量为：高粘度聚二甲基硅氧烷7份、低粘度聚二甲基硅氧烷9份、卡波姆6份、甘露聚糖5份、β-葡聚糖5份、纯化水70份；所述保护液的组分和含量为：三乙醇胺3份、甘油9份、羟苯甲酯钠2份、纯化水50份、玻璃酸钠5份、谷胱甘肽7份。
进一步说明，所述高粘度聚二甲基硅氧烷运动粘度为1200-1400Pa·s，低粘度聚二甲基硅氧烷运动粘度为200-400Pa·s。
进一步说明，所述无纺纱布由可降解的纤维制成，其无纺纱布平方米质量为10-25g/m2。
本发明还提供一种具有预防和治疗疤痕的医用硅酮功能性敷料的制备方法，包括以下步骤：
(1)凝胶层的制备：将卡波姆用纯化水溶胀，得到卡波姆凝胶；向油相反应釜中加入高粘度聚二甲基硅烷、低粘度聚二甲基硅氧烷、纯化水加热搅拌均匀，降温至室温，然后边加入甘露聚糖、β-葡聚糖边搅拌，最后加入卡波姆凝胶高速分散搅拌，得到凝胶层；
(2)保护液的制备：将甘油、三乙醇胺、纯化水混合搅拌，再加入羟苯甲酯钠、玻璃酸钠、谷胱甘肽，低速搅拌得到浑液状保护液。
(3)将凝胶层紧贴无纺纱布，然后使保护液均匀浸透于无纺纱布和凝胶层，得到医用硅酮功能性敷料。
进一步说明，所述步骤(1)中，卡波姆与纯化水的质量比为4-8:30-50。
进一步说明，所述步骤(1)中，加热的温度为70-90℃，高速分散搅拌的速度为4000-8000rpm，时间为15-30min。
进一步说明，所述步骤(2)中，低速搅拌的速度为400-600rpm，时间为30-50min。
进一步说明，所述敷料的尺寸为：(1)圆形敷料半径为2-10cm；(2)方形敷料的面积为60-80cm2。
与现有技术相比，本发明的有益效果是：
(1)本发明的具有预防和治疗疤痕的医用硅酮功能性敷料不仅能促进伤口愈合、减小伤疤形成，而且对增生性疤痕具有修复作用。
(2)本发明的敷料分成三层结构，保护液中将三乙醇胺与甘油、谷胱甘肽、玻璃酸钠等复配，形成稳定的结构，可以为疤痕创造理想的环境，降低表面张力和阻止水分挥发。凝胶层通过不同粘度的聚二甲基硅氧烷复配，能有效降低类黄酮的自然降解速率，在此基础上再与甘露聚糖、β-葡聚糖、卡波姆复配，各组分相互协作，使得制备的敷料具有优异的增稠和保湿等性能，同时也可以起到与上皮角质层相同的作用，提高创伤后疤痕恢复内环境的稳定性，减轻毛细血管充血和纤维增生，从而防止增生性疤痕的形成达到改善皮肤损伤表面的张力，降低对抗张力的胶原纤维的合成，更好的抑制疤痕的生成。
(3)本发明的敷料肤感清爽舒适、不油腻，且适合于体表各个部位，不受体表凹凸、关节和皮肤褶皱的影响。
具体实施方式
为了更好理解本发明技术内容，下面提供具体实施例，对本发明做进一步的说明。
本发明实施例所用的实验方法如无特殊说明，均为常规方法。
本发明实施例所用的材料、试剂等，如无特殊说明，均可从商业途径得到。
实施例
一种具有治疗疤痕，促进改善皮肤美容美观的医用硅酮功能性敷料，根据下述敷料的制备方法，分别取如下组分的不同配比进行复配，制备敷料：
所述高粘度聚二甲基硅氧烷的粘度为1350Pa·s，低粘度聚二甲基硅氧烷的粘度为350Pa·s。
敷料的制备方法包括如下步骤：
(1)凝胶层的制备：将称取重量的卡波姆用纯化水溶胀，得到卡波姆凝胶；向油相反应釜中加入高粘度聚二甲基硅烷、低粘度聚二甲基硅氧烷、纯化水加热至70-90℃(本例优选75℃)搅拌均匀，降温至27±2℃，然后边加入甘露聚糖、β-葡聚糖边搅拌，最后加入卡波姆凝胶高速分散搅拌，高速分散搅拌速度为4000-8000rpm(本利优选6500rpm)，时间为15-30min(本例优选20min)，得到凝胶层；
其中，实施例1-4中用于溶胀卡波姆的纯化水的用量分别为：30g、40g、35g、50g；
(2)保护液的制备：将甘油、三乙醇胺、纯化水混合搅拌，再加入羟苯甲酯钠、玻璃酸钠、谷胱甘肽，低速搅拌得到浑液状保护液，低速搅拌的速度为400-600rpm(本例优选500rpm)，时间为30-50mim(本例优选40min)。
(3)将凝胶层紧贴无纺纱布，然后将凝胶层和无纺纱布放在保护液中浸泡2h，使保护液均匀浸透于无纺纱布和凝胶层，得到医用硅酮功能性敷料。
实施例5
本实施例与实施例1的区别在于，高粘度聚二甲基硅氧烷的粘度为1200Pa·s，低粘度聚二甲基硅氧烷的粘度为200Pa·s，其余配方及制备方法均与实施例1一致。
实施例6
本实施例与实施例1的区别在于，高粘度聚二甲基硅氧烷的粘度为1400Pa·s，低粘度聚二甲基硅氧烷的粘度为400Pa·s，其余配方及制备方法均与实施例1一致。
实施例7
本实施例与实施例1的区别在于，组分的重量不同，具体为：
凝胶层的组分和含量为：高粘度聚二甲基硅氧烷10份、低粘度聚二甲基硅氧烷15份、卡波姆8份、甘露聚糖7份、β-葡聚糖7份、纯化水50份；
保护液的组分和含量为：三乙醇胺7份、甘油8份、羟苯甲酯钠4份、纯化水60份、玻璃酸钠1份、谷胱甘肽10份，其余参数及制备方法均与实施例1一致。
对比例1
本对比例与实施例1的区别在于，将高粘度聚二甲基硅烷、低粘度聚二甲基硅氧烷统一替换成粘度为600Pa·s的聚二甲基硅氧烷，其余均与实施例1一致。
对比例2
本对比例与实施例1的区别在于，保护液中未添加谷胱甘肽，其余均与实施例1一致。具体为：
一种具有预防和治疗疤痕的医用硅酮功能性敷料，所述的功能性敷料由无纺纱布、凝胶层、保护液三部分组成，凝胶层紧贴无纺纱布的一侧，保护液则均匀浸透于无纺纱布和凝胶层中；
所述凝胶层的组分和重量份为：所述高粘度聚二甲基硅氧烷7g、低粘度聚二甲基硅氧烷8g、卡波姆6g、甘露聚糖5g、β-葡聚糖5g、纯化水70g；
所述保护液的组分和重量份为：三乙醇胺3g、甘油9g、羟苯甲酯钠2g、玻璃酸钠5g、纯化水50g；
所述高粘度聚二甲基硅氧烷的粘度为1350Pa·s，低粘度聚二甲基硅氧烷的粘度为350Pa·s。
敷料的制备方法包括如下步骤：
(1)凝胶层的制备：将称取重量的卡波姆用纯化水溶胀，得到卡波姆凝胶；向油相反应釜中加入高粘度聚二甲基硅烷、低粘度聚二甲基硅氧烷、纯化水，加热至75℃，搅拌均匀，降温至27±2℃，然后边加入甘露聚糖、β-葡聚糖边搅拌，最后加入卡波姆凝胶高速分散搅拌，高速分散搅拌速度为6500rpm，时间为20min，得到凝胶层；
其中，用于溶胀卡波姆的纯化水的用量分别为：30g、40g、35g、50g；
(2)保护液的制备：将甘油、三乙醇胺、纯化水混合搅拌，再加入羟苯甲酯钠、玻璃酸钠，低速搅拌得到浑液状保护液，低速搅拌的速度为500rpm，时间为40min。
(3)将凝胶层紧贴无纺纱布，然后将凝胶层和无纺纱布放在保护液中浸泡2h，使保护液均匀浸透于无纺纱布和凝胶层，得到医用硅酮功能性敷料。
对比例3
本对比例与实施例1的区别在于，保护液中未添加玻璃酸钠。具体为：
一种具有预防和治疗疤痕的医用硅酮功能性敷料，所述的功能性敷料由无纺纱布、凝胶层、保护液三部分组成，凝胶层紧贴无纺纱布的一侧，保护液则均匀浸透于无纺纱布和凝胶层中；
所述凝胶层的组分和重量份为：所述高粘度聚二甲基硅氧烷7g、低粘度聚二甲基硅氧烷8g、卡波姆6g、甘露聚糖5g、β-葡聚糖5g、纯化水70g；
所述保护液的组分和重量份为：三乙醇胺3g、甘油9g、羟苯甲酯钠2g、谷胱甘肽7g、纯化水50g；
所述高粘度聚二甲基硅氧烷的粘度为1350Pa·s，低粘度聚二甲基硅氧烷的粘度为350Pa·s。
敷料的制备方法包括如下步骤：
(1)凝胶层的制备：将称取重量的卡波姆用纯化水溶胀，得到卡波姆凝胶；向油相反应釜中加入高粘度聚二甲基硅烷、低粘度聚二甲基硅氧烷、纯化水，加热至75℃，搅拌均匀，降温至27±2℃，然后边加入甘露聚糖、β-葡聚糖边搅拌，最后加入卡波姆凝胶高速分散搅拌，高速分散搅拌速度为6500rpm，时间为20min，得到凝胶层；
其中，用于溶胀卡波姆的纯化水的用量分别为：30g、40g、35g、50g；
(2)保护液的制备：将甘油、三乙醇胺、纯化水混合搅拌，再加入羟苯甲酯钠、谷胱甘肽，低速搅拌得到浑液状保护液，低速搅拌的速度为500rpm，时间为40min。
(3)将凝胶层紧贴无纺纱布，然后将凝胶层和无纺纱布放在保护液中浸泡2h，使保护液均匀浸透于无纺纱布和凝胶层，得到医用硅酮功能性敷料。
对比例4
本对比例与实施例1的区别在于，敷料的制备方法不同，其余组分及含量均与实施例1一致。具体为：
敷料的制备方法包括如下步骤：
(1)凝胶层的制备：将称取重量的卡波姆用纯化水溶胀，得到卡波姆凝胶；向油相反应釜中加入高粘度聚二甲基硅烷、低粘度聚二甲基硅氧烷、甘油、三乙醇胺、羟苯甲酯钠、纯化水加热至75℃搅拌均匀，降温至27±2℃，然后边加入甘露聚糖、β-葡聚糖边搅拌，最后加入卡波姆凝胶高速分散搅拌，高速分散搅拌速度为6500rpm，时间为20min，得到凝胶层；
其中，实施例1-4中用于溶胀卡波姆的纯化水的用量分别为：30g、40g、35g、50g；
(2)保护液的制备：将甘油、三乙醇胺、纯化水混合搅拌，再加入羟苯甲酯钠、玻璃酸钠、谷胱甘肽，低速搅拌得到浑液状保护液，低速搅拌的速度为500rpm，时间为40min。
(3)先将无纺纱布置于保护液当中浸泡2h，再使凝胶层紧贴无纺纱布的一侧，得到敷料。
一、药性检测
1、促进伤口愈合、减小疤痕形成药效检测
(1)实验模型的建立：
挑选雌雄SD大鼠各55只，体重(250-275g)。在大鼠的背部造成一个半径1cm的圆形创面，全层皮肤缺损，至肌筋膜深层。空白处理对照组为局部脱毛后不做其他处理。
按随机分组法，分为市售去疤膏组(对照组)、本发明敷料组(实验组)，每组各10只大鼠，各组按照以下用药方法进行给药：对照组将膏药涂覆创面或待治疗的疤痕处，实验组则裁剪尺寸稍大于创面面积的敷料，然后将其敷于创面表面(完全覆盖)，各组每天涂覆两次。
(2)检测方法
造模后第28天，用涤纶投影薄膜覆盖于创面，标记并计算创面面积，作为愈后疤痕面积；记录各组造模后至创面愈合所需时间，作为创面愈合时间。
上皮组织生长宽度的测量：用显微测微尺(nm)在显微镜下测量组织HE染色切片第7天、第14天上皮组织的宽度。各组检测结果取平均值。
检测结果如下：
结果显示，实验组创面愈合时间均短于对照组，其中实施例1组效果最好，与对照组相差最大，而对比例1-3组效果则一般，与对照组无显著差别。由此可说明，本发明的敷料具有促进创面愈合的作用。对于疤痕面积：实验组疤痕面积均明显小于对照组，其中实施例1-3组与对照组有明显的差值，而对比例1组效果最差，疤痕面积大至36.67mm2。试验中还发现，实施例1-3组疤痕皮色接近于正常肤色，无发红现象，且弹性接近正常皮肤。可见，本发明的敷料具有减少疤痕形成的作用。对于上皮生长宽度：无论是第7天还是第14天，本发明实施例1-3组的上皮生长宽度均达到较好的效果，说明本发明敷料具有良好的促进上皮生长的作用。
2、修复增生性疤痕药效检测
(1)实验模型的建立：
挑选体重为1.5-2.0kg的健康雌雄成年新西兰大白兔各40只，饲养1周。
常规术前准备：首先对大白兔注射2％利多卡因进行局部麻醉，严格无菌操作技术下，在大白兔兔耳腹侧进行全层皮肤切除手术，并刮去软骨膜，造成4-6个1cm2-1.5cm2大小的创面，创面间相距1cm，于手术后7天除去创面痂皮，第21天创面上皮化，待痂皮自行脱落，形成早期增生性疤痕动物模型。将造模成功后的大白兔随机分成7个实验组和一个对照组，每组十只。
实验组处理：在创面上皮化后开始采用由实施例1、6、7及对比例1-4制备的敷料按尺寸大小进行表面覆盖敷疗，每只大白兔使用相应的敷料7周。
对照组处理：采用市售去疤敷料进行治疗，具体方法与实验组一致。
(2)检测方法
疤痕厚度：同一测定人在相同条件下采用彩色超声诊断仪测定各组创面形成疤痕的厚度。
疤痕硬度：采用疤痕硬度测量仪测定疤痕硬度，将硬度计垂直放置在待测的疤痕和皮肤上，依靠硬度计本身重量作用于测定部位，根据测定不同疤痕和皮肤硬度不同，仪表上即显示不同的测量结果。将读书换算成硬度值，单位为N/mm2，每只大白兔平行测定3次，并计算平均值。
疤痕增生指数(Hypertrophic Index，HI)：根据公式HI＝a/b，计算疤痕增生指数，a为疤痕最高处至耳软骨表面的垂直厚度，b为疤痕周边正常皮肤至耳软骨表面的垂直厚度。
检测结果如下：
治疗前，大白兔的兔耳腹侧创面的愈合具有增生疤痕的特点，上皮化时出现硬块，而硬块不断高于皮面，呈现鲜红色，增生块的厚度通常为耳腹侧面正常肤色的2-3倍。实验组治疗5周后，疤痕组织开始出现软化表现，增生块逐渐呈现淡红色，疤痕明显软化，颜色和质地接近正常皮肤。由表中数据可知，实施例1的疤痕硬度、疤痕厚度及疤痕增生指数均最小，且与对比例组和对照组有明显的差距。
由以上试验证明，本发明的敷料能促进伤口愈合、减小疤痕形成，对增生性疤痕具有修复作用。且与对照组相比，有较佳的效果。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (10)
1.一种具有预防和治疗疤痕的医用硅酮功能性敷料，其特征在于，所述的功能性敷料由无纺纱布、凝胶层、保护液三部分组成，凝胶层紧贴无纺纱布的一侧，保护液则均匀浸透于无纺纱布和凝胶层中；
所述凝胶层的组分和重量份为：高粘度聚二甲基硅氧烷5-8份、低粘度聚二甲基硅氧烷8-10份、卡波姆4-8份、甘露聚糖5-10份、β-葡聚糖5-10份、纯化水60-80份；
所述保护液的组分和重量份为：三乙醇胺1-5份、甘油8-10份、羟苯甲酯钠1-3份、纯化水35-65份。
2.如权利要求1所述的一种具有预防和治疗疤痕的医用硅酮功能性敷料，其特征在于，所述保护液中还含有玻璃酸钠3-8份、谷胱甘肽5-9份。
3.如权利要求1所述的一种具有预防和治疗疤痕的医用硅酮功能性敷料，其特征在于，所述凝胶层的组分和含量为：高粘度聚二甲基硅氧烷7份、低粘度聚二甲基硅氧烷9份、卡波姆6份、甘露聚糖5份、β-葡聚糖5份、纯化水70份；
所述保护液的组分和含量为：三乙醇胺3份、甘油9份、羟苯甲酯钠2份、纯化水50份、玻璃酸钠5份、谷胱甘肽7份。
4.如权利要求1所述的一种具有预防和治疗疤痕的医用硅酮功能性敷料，其特征在于，所述高粘度聚二甲基硅氧烷运动粘度为1200-1400Pa·s，低粘度聚二甲基硅氧烷运动粘度为200-400Pa·s。
5.如权利要求1所述的一种具有预防和治疗疤痕的医用硅酮功能性敷料，所述无纺纱布由可降解的纤维制成，其平方米质量为10-25g/m2。
6.权利要求1-5所述的一种具有预防和治疗疤痕的医用硅酮功能性敷料的制备方法，其特征在于，包括以下步骤：
(1)凝胶层的制备：将卡波姆用纯化水溶胀，得到卡波姆凝胶；向油相反应釜中加入高粘度聚二甲基硅烷、低粘度聚二甲基硅氧烷、纯化水加热搅拌均匀，降温至室温，然后边加入甘露聚糖、β-葡聚糖边搅拌，最后加入卡波姆凝胶高速分散搅拌，得到凝胶层；
(2)保护液的制备：将甘油、三乙醇胺、纯化水混合搅拌，再加入羟苯甲酯钠、玻璃酸钠、谷胱甘肽，低速搅拌得到浑液状保护液。
(3)将凝胶层紧贴无纺纱布，然后使保护液均匀浸透于无纺纱布和凝胶层，得到医用硅酮功能性敷料。
7.如权利要求6所述的一种具有预防和治疗疤痕的医用硅酮功能性敷料的制备方法，其特征在于，所述步骤(1)中，卡波姆与纯化水的质量比为4-8:30-50。
8.如权利要求6所述的一种具有预防和治疗疤痕的医用硅酮功能性敷料的制备方法，其特征在于，所述步骤(1)中，加热的温度为70-90℃，高速分散搅拌的速度为4000-8000rpm，时间为15-30min。
9.如权利要求6所述的一种具有预防和治疗疤痕的医用硅酮功能性敷料的制备方法，其特征在于，所述步骤(2)中，低速搅拌的速度为400-600rpm，时间为30-50min。
10.如权利要求1所述的一种具有预防和治疗疤痕的医用硅酮功能性敷料的制备方法，其特征在于，所述敷料的尺寸为：(1)圆形敷料半径为2-10cm；(2)方形敷料的面积为60-80cm2。
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