CN117017886B - 可修复皮肤屏障和美白的组合物、敷料及其制造工艺 - Google Patents
可修复皮肤屏障和美白的组合物、敷料及其制造工艺 Download PDFInfo
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- CN117017886B CN117017886B CN202311180826.6A CN202311180826A CN117017886B CN 117017886 B CN117017886 B CN 117017886B CN 202311180826 A CN202311180826 A CN 202311180826A CN 117017886 B CN117017886 B CN 117017886B
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- dressing
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- skin
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- skin barrier
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种可修复皮肤屏障组合物、敷料及其制造工艺；所述可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白1～6％、组合物1～5％、透明质酸钠0.1～0.3％、1，3丙二醇2～5％、苯氧乙醇0.1～0.5％，余量为去离子水。组合物包含以下重量份的原料：紫珠草提取物4～6份、白芨提取物4～6份、白鲜皮提取物4～6份、硫酸化黄芪多糖2～4份。本发明所用原料科学配比，协同发挥作用，不仅可以修复激光治疗后造成的皮肤过敏、还可以创面受损皮肤的皮肤屏障；同时紫珠草提取物、白芨提取物、白鲜皮提取物与硫酸化黄芪多糖复合还具有促进创面愈合的作用。本发明提供的敷料不仅能可修复皮肤屏障促进创面愈合，还具有美白亮肤的作用。
Description
技术领域
本发明涉及皮肤敷料的医药技术领域，特别是一种可修复皮肤屏障组合物、敷料及其制造工艺。
背景技术
外源性的因素(机械损伤、气候干燥、清洁剂的过度使用、辐射和紫外线照射)和内源性的因素(衰老、营养缺乏、特应性皮炎、干燥症)都会影响皮肤的屏障功能。表皮屏障一旦受损，会导致皮肤对外界过敏原和有害刺激的敏感性增加，病原微生物更易通过角质层侵入到皮肤深层，从而使得湿疹、皮炎等皮肤疾病的发病率上升；同时，皮肤老化、湿疹和特应性皮炎等皮肤病的发生本身就伴有表皮屏障功能的受损，如果皮肤的屏障功能得不到及时修复，会使机体处于一种慢性炎症的状态，进而诱导其他疾病的发生。因此，维持和修复表皮屏障功能不仅有助于预防和治疗皮肤疾病，还能够缓解皮肤疾病诱发进一步的感染和慢性炎症。
为了营养皮肤，防止皮肤粗糙和炎症，人们对皮肤屏障修复敷料进行了探索，研究出了多种不同功效的修复敷料。但各种皮肤修复敷料的配方不同，效果也有所差别，研制出更多不同配方的皮肤修复敷料，仍然是人们的期望。
发明内容
本发明的目的在于克服现有技术的不足，提供一种可修复皮肤屏障组合物、敷料及其制造工艺，以解决上述技术背景中提出的问题。
为实现上述目的，本发明通过以下技术方案来实现：
第一方面，本发明提供了一种可修复皮肤屏障组合物，包含以下重量份的原料：紫珠草提取物4～6份、白芨提取物4～6份、白鲜皮提取物4～6份、硫酸化黄芪多糖2～4份。
上述技术方案中，所述可修复皮肤屏障组合物，包含以下重量份的原料：紫珠草提取物5份、白芨提取物5份、白鲜皮提取物5份、硫酸化黄芪多糖3份。
第二方面，本发明还提供了一种可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白1～6％、上述所述的组合物1～5％、透明质酸钠0.1～0.3％、1，3丙二醇2～5％、苯氧乙醇0.1～0.5％，余量为去离子水。
第三方面，本发明还提供了一种可修复皮肤屏障敷料的制造工艺，包括以下制备步骤：
S1、称取配方量鱼胶原蛋白、透明质酸钠、1，3丙二醇、3/5用量的去离子水倒入配料罐内，使用高速搅拌器对物料进行搅拌，使其均匀混合，得到混料A；
S2、称取配方量的紫珠草提取物、白芨提取物、白鲜皮提取物、硫酸化黄芪多糖、2/5用量的去离子水倒入容器内，匀速搅拌加热至80～85℃，保温40～60min，得到混料B；
S3、将步骤二得到的混料B冷却至室温，加入混料A中并搅拌均匀，然后加入苯氧乙醇搅拌均匀，得到敷料原液；
S4、将敷贴基材进行杀菌消毒，并在无菌的环境中将敷贴基材和S3中的敷料原液放入铝箔袋内。
上述技术方案中，所述S4中的敷贴基材为无纺布。
与现有技术相比，本发明的有益效果是：
1、本发明所用原料科学配比，协同发挥作用，不仅可以修复激光治疗后造成的皮肤过敏、还可以创面受损皮肤的皮肤屏障；同时紫珠草提取物、白芨提取物、白鲜皮提取物与硫酸化黄芪多糖复合还具有促进创面愈合的作用。
2、敷料原液中使用植物提取物(紫珠草提取物、白芨提取物、白鲜皮提取物)与硫酸化黄芪多糖在降低酪氨酸酶的活性并减少酪氨酸酶的合成上具有很好的协同作用，而单独使用植物提取物或硫酸化黄芪多糖的敷料原液，其抑制络氨酸酶活力的效果远不如本申请提供的敷料原液。
本发明提供的敷料不仅能可修复皮肤屏障促进创面愈合，还具有美白亮肤的作用。
附图说明
图1为本发明的敷料对酪氨酸酶抑制率的影响的柱状图；
图2为本发明的敷料对各组小鼠皮肤的损伤处TEWL值的影响曲线图；
图3为本发明的敷料对各组小鼠皮肤创口愈合率的影响曲线图。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。需说明的是，在不冲突的情况下，以下实施例及实施例中的特征可以相互组合。
本申请部分原料介绍：
紫珠草提取物，产品规格10:1，购于扶风斯诺特生物科技有限公司；
白芨提取物，产品规格10:1，购于陕西新天域生物科技有限公司；
白鲜皮提取物，纯度95％，购于扶风斯诺特生物科技有限公司；
硫酸化黄芪多糖，参照文献：王筱霏，黄芪多糖及其硫酸化修饰产物体内外抗炎活性研究中硫酸化黄芪多糖(SAPS)中黄芪多糖的硫酸化修饰方法制备得到；
黄芪多糖，CAS号：89250-26-0，有效物质含量99％，购于山东海舟生物工程有限公司。
可修复皮肤屏障组合物
实施例1
本实施例提供了一种可修复皮肤屏障组合物，包含以下重量份的原料：紫珠草提取物4份、白芨提取物6份、白鲜皮提取物4份、硫酸化黄芪多糖4份。
实施例2
本实施例提供了一种可修复皮肤屏障组合物，包含以下重量份的原料：紫珠草提取物5份、白芨提取物5份、白鲜皮提取物5份、硫酸化黄芪多糖3份。
实施例3
本实施例提供了一种可修复皮肤屏障组合物，包含以下重量份的原料：紫珠草提取物6份、白芨提取物4份、白鲜皮提取物6份、硫酸化黄芪多糖2份。
对比例1
本实施例与实施例2相似，区别在于：不含有紫珠草提取物、白芨提取物、白鲜皮提取物。
对比例2
本实施例与实施例2相似，区别在于：不含有紫珠草提取物、白芨提取物。
对比例3
本实施例与实施例2相似，区别在于：不含有紫珠草提取物、白鲜皮提取物。
对比例4
本实施例与实施例2相似，区别在于：不含有白芨提取物、白鲜皮提取物。
对比例5
本实施例与实施例2相似，区别在于：不含有硫酸化黄芪多糖。
对比例6
本实施例与实施例2相似，区别在于：将硫酸化黄芪多糖替换成黄芪多糖。
可修复皮肤屏障敷料
本申请实施例4为一种可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白1％、实施例2所述的组合物5％、透明质酸钠0.3％、1，3丙二醇2％、苯氧乙醇0.1％，余量为去离子水。
本申请实施例5为一种可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白3％、实施例2所述的组合物3％、透明质酸钠0.2％、1，3丙二醇4％、苯氧乙醇0.2％，余量为去离子水。
本申请实施例6为一种可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白6％、实施例2所述的组合物1％、透明质酸钠0.1％、1，3丙二醇5％、苯氧乙醇0.5％，余量为去离子水。
本申请实施例4-6任一项所述可修复皮肤屏障敷料的制造工艺，包含下述步骤：
S1、称取配方量鱼胶原蛋白、透明质酸钠、1，3丙二醇、3/5用量的去离子水倒入配料罐内，使用高速搅拌器对物料进行搅拌，使其均匀混合，得到混料A；
S2、称取配方量的组合物(如实施例4中组合物为紫珠草提取物、白芨提取物、白鲜皮提取物、硫酸化黄芪多糖)、2/5用量的去离子水倒入容器内，匀速搅拌加热至80～85℃，保温40～60min，得到混料B；
S3、将步骤二得到的混料B冷却至室温，加入混料A中并搅拌均匀，然后加入苯氧乙醇搅拌均匀，得到敷料原液；其中，敷贴基材为无纺布；
S4、将敷贴基材进行杀菌消毒，并在无菌的环境中将敷贴基材和S3中的敷料原液放入铝箔袋内。
本申请对比例7为一种可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白3％、对比例1所述的组合物3％、透明质酸钠0.2％、1，3丙二醇4％、苯氧乙醇0.2％，余量为去离子水。
本申请对比例8为一种可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白3％、对比例2所述的组合物3％、透明质酸钠0.2％、1，3丙二醇4％、苯氧乙醇0.2％，余量为去离子水。
本申请对比例9为一种可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白3％、对比例3所述的组合物3％、透明质酸钠0.2％、1，3丙二醇4％、苯氧乙醇0.2％，余量为去离子水。
本申请对比例10为一种可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白3％、对比例4所述的组合物3％、透明质酸钠0.2％、1，3丙二醇4％、苯氧乙醇0.2％，余量为去离子水。
本申请对比例11为一种可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白3％、对比例5所述的组合物3％、透明质酸钠0.2％、1，3丙二醇4％、苯氧乙醇0.2％，余量为去离子水。
本申请对比例12为一种可修复皮肤屏障敷料，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白3％、对比例6所述的组合物3％、透明质酸钠0.2％、1，3丙二醇4％、苯氧乙醇0.2％，余量为去离子水。
本申请对比例13为一种可修复皮肤屏障敷料，与实施例5相似，包含敷料原液和敷贴基材；区别在于：所述敷料原液不包含实施例2所述的组合物。
1、皮肤斑贴安全性试验
参照《化妆品卫生规范》(2007年版)关于人体安全性检验方法中的人体皮肤斑贴试验的实验标准，对本发明的可修复皮肤屏障敷料进行皮肤封闭式斑贴试验，选用本发明实施例5的可修复皮肤屏障敷料的敷料原液作为测试组，对照组为空白组(不置任何物质)进行测试，每组30人，两组之间无统计学差异。根据《化妆品卫生规范》(2007年版)中的规定，30位受试者中出现“±”级(1级)皮肤不良反应的人数多于5位、“+”级(2级)皮肤不良反应的人数多于2位或出现任何1位“++”级(3级)或“++”级(3级)以上皮肤不良反应时，判定受试物对人体有不良反应。相关测试结果如下表所示。
表1皮肤斑贴安全性试验
如表1所示，在去除斑试器0.5，24和48h后，30名受试者中去离子水对照区均未观察到皮肤不良反应，可修复皮肤屏障敷料的敷料原液受试区无1例出现皮肤不良反应反应，该结果表明本发明可修复皮肤屏障敷料的敷料原液的安全性很高，对人体皮肤未引起不良反应。
2、敷料抑制酪氨酸酶试验
本申请人公司通过对敷料原液进行实验发现，敷料原液具有抑制酪氨酸酶活性的功效，具体试验：
2.1待测样品及分组：共设置12试验组，其中第1-10组分别对应为实施例4-6和对比例7-13分别提供的敷料原液，第11组为植物提取物(用磷酸氢二钠-柠檬酸缓冲液溶解，其包含0.83％紫珠草提取物、0.83％白芨提取物、0.83％白鲜皮提取物)、第12组为0.5％硫酸化黄芪多糖(用磷酸氢二钠-柠檬酸缓冲液溶解)、第13组为0.5％黄芪多糖(用磷酸氢二钠-柠檬酸缓冲液溶解)。
磷酸氢二钠-柠檬酸缓冲液：将154.5mL 0.2M Na2HPO4·12H2O加入0.1M一水合柠檬酸45.5mL配成pH6.8的磷酸氢二钠-柠檬酸缓冲液；
100U/mL酪氨酸酶溶液，用pH6.8的磷酸氢二钠-柠檬酸缓冲液配置；
1mg/mL左旋多巴溶液，用pH6.8的磷酸氢二钠-柠檬酸缓冲液配置。
2.2试验方法：构建酪氨酸酶催化反应体系，来评价本申请所得敷料原液对酪氨酸酶的抑制效果。每个试验组别按酪氨酸酶催化反应体系进行实验，每组3个平行实验；酪氨酸酶催化反应体系参照表2分为a、b、c、d(其中，a、不含样品，不加酪氨酸酶溶液；b、不含样品，加酪氨酸酶溶液；c、含样品，不加酪氨酸酶溶液；d、含样品，加酪氨酸酶溶液)四个小组进行加液，在c、d小组中各加入500ul的待测样品，a、b小组则加入500ul磷酸氢二钠-柠檬酸缓冲液；在d和b小组中各加入250ul酪氨酸酶溶液，c和a小组以250ul磷酸氢二钠-柠檬酸缓冲液代替，将样品与酪氨酸酶充分混合，于37℃水浴下恒温反应10min后，依次在各小组中加入1000ul左旋多巴溶液，反应5min后在475nm处测定各小组a、b、c、d吸光值。
酪氨酸酶抑制率(％)＝[1-(d-c)/(b-a)]×100％，计算各实验组的酪氨酸酶抑制率，试验结果见表3和图1所示。
表2
| 反应体系 | a | b | c | d |
| 待测样品(ul) | 0 | 0 | 500 | 500 |
| pH6.8磷酸氢二钠-柠檬酸缓冲液(ul) | 750 | 500 | 250 | - |
| 100U/mL酪氨酸酶溶液(ul) | 0 | 250 | 0 | 250 |
| 1mg/mL左旋多巴溶液(ul) | 1000 | 1000 | 1000 | 1000 |
表3
| 组别 | 酪氨酸酶抑制率(％) |
| 实施例4 | 85.38±0.79a |
| 实施例5 | 91.51±1.24a |
| 实施例6 | 88.09±1.08a |
| 对比例7 | 20.41±0.88 |
| 对比例8 | 35.15±0.40 |
| 对比例9 | 32.45±0.66 |
| 对比例10 | 21.72±1.21 |
| 对比例11 | 37.31±0.69 |
| 对比例12 | 25.78±0.92 |
| 对比例13 | 16.26±0.46 |
| 植物提取物 | 18.84±0.28 |
| 硫酸化黄芪多糖 | 3.81±0.13 |
| 黄芪多糖 | 3.44±0.07 |
由表3和图1可知，实施例4-6的敷料原液中酪氨酸酶抑制率均显著高于对比例7-13提供的敷料原液或植物提取物、硫酸化黄芪多糖、黄芪多糖，说明本申请实施例4-6提供的敷料原液具有更强的抑制酪氨酸酶抑制率，其可能具有更强的抑制体内黑色素沉积的作用，说明敷料原液中使用植物提取物(紫珠草提取物、白芨提取物、白鲜皮提取物)与硫酸化黄芪多糖在降低酪氨酸酶的活性并减少酪氨酸酶的合成上具有很好的协同作用，而单独使用植物提取物或硫酸化黄芪多糖的敷料原液，其抑制络氨酸酶活力的效果远不如本申请提供的敷料原液。
3、敷料对创伤受损的皮肤屏障修复及创面愈合的促进作用
本申请人公司通过小鼠皮肤受损模型实验来证明本发明所得敷料对创伤受损的皮肤屏障修复及创面愈合的促进作用，具体如下：
3.1试验对象及分组：体重25±5g的昆明种小鼠72只(购自南京君科生物科技有限公司)，每组6只，分为12组，其中1组为阴性对照组，1组为阳性对照组，10组为试验组；阴性对照组、阳性对照组和试验组均采用造模小鼠，阴性对照组不做处理；阳性对照组采用凝胶敷料，商品名为清得佳，购于施乐辉医用产品国际贸易(上海)有限公司；10个试验组分别对应采用实施例4-6、对比例7-13所得可修复皮肤屏障敷料。
3.2试验方法
小鼠造模：将昆明种小鼠腹腔注射戊巴比妥钠水溶液，待小鼠进入麻醉状态后，固定小鼠，剪去其背部中央直径3cm左右的圆形区域毛发，剃毛后测量小鼠的TEWL的基础值，之后经聚维酮碘消毒后在脱毛区域剪去直径1.5cm的圆形皮肤组织，建立小鼠皮肤受损模型。
每天早8:00及晚8:00各给药1次，给药21天。每天早上给药前(0，1，2，3...20，21天)测量皮肤水分流水(TEWL)值，g/(h·m2)，给药方式为将敷料直接敷在破损皮肤处。每天(0，1，2，3...20，21天)测量1次小鼠伤口直径，用相机拍摄小鼠皮肤愈合情况。
3.3观察与测量指标
每天肉眼观察小鼠新生皮肤，重点关注其皮肤颜色、透明程度及毛发生长情况等，并使用CK-MPA580多功能无创性皮肤测试仪(德国Courage-Khazaka公司)进行经皮水分散失量(TEWL)的测试，每次测试3次取平均值；0，3，6，9，12，15，18，21天TEWL值见表4和图2所示；在皮肤创口愈合过程中，每3天测量创口面积，计算创口愈合面积，以创口愈合率表示创口愈合效果，创口愈合率＝创口愈合面积/原创口面积×100％，0，3，6，9，12，15，18，21天的创口愈合率见表5和图3所示。
表4各组小鼠损伤处TEWL值
表5各组小鼠皮肤创口愈合率
经皮水分散失量(TEWL)是客观反应皮肤屏障功能的重要指标。正常的皮肤具有保水能力，当皮肤屏障损伤后，保水能力下降，水分蒸发增多，皮肤的经皮水分丢失量上升，因而通过检测TEWL值的变化可以判断皮肤屏障的恢复程度。由表4和图2可知，相较于阴性对照组和对比例7-13，使用实施例4-6的可修复皮肤屏障敷料后，其TEWL值下降明显；实施例5与对比例7、11、12比较可知，实施例5的TEWL值显著下降，在9d后降低到10g/(h·m2)，对比例7、11、12在18d后降低到10g/(h·m2)以下，说明植物提取物(紫珠草提取物、白芨提取物、白鲜皮提取物)与硫酸化黄芪多糖复合能提高敷料的修复创面受损皮肤屏障的能力；实施例5与对比例8-10比较可知，实施例5的TEWL值显著下降，在9d后降低到10g/(h·m2)，对比例8-10在18d后降低到10g/(h·m2)以下，说明植物提取物选用紫珠草提取物、白芨提取物、白鲜皮提取物进行复配达到的修复创面受损皮肤屏障能力最佳。
由表5和图3可知，相较于阴性对照组和对比例7-13，使用实施例4-6的可修复皮肤屏障敷料后，其创口愈合率显著增加；实施例5与对比例7、11、12比较可知，实施例5的创口愈合率在12d达到98％以上，而对比例7、11、12在21d才达到98％以上(对比例7、11、12促进伤口愈合的能力与阴性对照组相当)，说明植物提取物(紫珠草提取物、白芨提取物、白鲜皮提取物)与硫酸化黄芪多糖复合能使得敷料具有促进伤口愈合的能力；实施例5与对比例8-10比较可知，实施例5的创口愈合率在12d达到98％以上，而对比例8-10在18d才达到98％以上(对比例8-10促进伤口愈合的能力与阴性对照组相当)，说明植物提取物选用紫珠草提取物、白芨提取物、白鲜皮提取物进行复配能使得敷料具有促进伤口愈合的能力。
综上，本发明所得的可修复皮肤屏障敷料不仅可以修复创面受损皮肤屏障，还可以促进创面愈合。
以上所述实施例仅表达了本发明的具体实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。
Claims (5)
1.一种可修复皮肤屏障组合物，其特征在于，由以下重量份的原料组成：紫珠草提取物4~6份、白芨提取物4~6份、白鲜皮提取物4~6份、硫酸化黄芪多糖2~4份。
2.根据权利要求1所述的一种可修复皮肤屏障组合物，其特征在于，由以下重量份的原料组成：紫珠草提取物5份、白芨提取物5份、白鲜皮提取物5份、硫酸化黄芪多糖3份。
3.一种可修复皮肤屏障敷料，其特征在于，包含敷料原液和敷贴基材；所述敷料原液按质量百分比包含以下组分：鱼胶原蛋白1~6%、权利要求1-2任一项所述的组合物1~5%、透明质酸钠0.1~0.3%、1，3丙二醇2~5%、苯氧乙醇0.1~0.5%，余量为去离子水。
4.根据权利要求3所述的一种可修复皮肤屏障敷料的制造工艺，其特征在于，包括以下制备步骤：
S1、称取配方量鱼胶原蛋白、透明质酸钠、1，3丙二醇、3/5用量的去离子水倒入配料罐内，使用高速搅拌器对物料进行搅拌，使其均匀混合，得到混料A；
S2、称取配方量的紫珠草提取物、白芨提取物、白鲜皮提取物、硫酸化黄芪多糖、2/5用量的去离子水倒入容器内，匀速搅拌加热至80～85℃，保温40～60min，得到混料B；
S3、将S2中得到的混料B冷却至室温，加入混料A中并搅拌均匀，然后加入苯氧乙醇搅拌均匀，得到敷料原液；
S4、将敷贴基材进行杀菌消毒，并在无菌的环境中将敷贴基材和S3中的敷料原液放入铝箔袋内。
5.根据权利要求4所述的一种可修复皮肤屏障敷料的制造工艺，其特征在于，所述S4中的敷贴基材为无纺布。
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