CN114377186A - 皮肤修复生物活性敷料及其制备方法和制品 - Google Patents
皮肤修复生物活性敷料及其制备方法和制品 Download PDFInfo
- Publication number
- CN114377186A CN114377186A CN202210170283.9A CN202210170283A CN114377186A CN 114377186 A CN114377186 A CN 114377186A CN 202210170283 A CN202210170283 A CN 202210170283A CN 114377186 A CN114377186 A CN 114377186A
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- Prior art keywords
- parts
- woven fabric
- dressing
- skin
- bioactive
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- Medicinal Preparation (AREA)
Abstract
本发明公开了一种用于紫外线致伤的皮肤修复生物活性敷料,涉及生物医用材料技术领域。所述敷料包括10‑20份透明质酸钠,5‑10份霍霍巴籽油,0.1‑3份甘油,0.5‑2份B族维生素,0.01‑0.5份胶原蛋白,0.0002‑0.0016份抗菌剂,0.001‑0.005份纳米材料,55‑80份去离子水以及天然纤维无纺布。本发明敷料通过透明质酸钠、维生素,搭配功能性辅助剂,能够有效修复紫外损伤的皮肤,以改进的功能性天然纤维无纺布作为支撑结构,具有优异的抗菌性能和防紫外线能力,能够有效防止二次伤害。添加的胶原蛋白等物质,增强了修复效果,使得愈后肌肤水润有弹性。
Description
技术领域
本发明涉及生物医用材料技术领域,具体来说是一种生物活性敷料,可以针对性修复紫外线导致的皮肤损伤。
背景技术
皮肤是人体隔绝外来病原体,病毒,细菌等有害物质的重要器官,然而在日常生活中,皮肤不可避免的会遭受到外力损伤,形成创面。紫外损伤是一种常见形式,在强紫外线照射下曝晒一段时间后,皮肤会受到较为严重的伤害,表现为皮肤炎症,发红发热,脱皮等症状。研究表明,紫外线不仅对表皮细胞有伤害,对真皮细胞也会产生损伤,主要的形式是DNA损伤,短期内会引起细胞凋亡,长期的累积则会加速皮肤老化,甚至是癌变。
皮肤产生紫外损伤后,若不及时进行处理或者简单化处理,往往会进一步加剧创伤。因此制备一种可修复紫外创伤,并提供二次保护的敷料十分必要。
发明内容
本发明主要提供了一种针对紫外损伤的皮肤修复生物活性敷料以及制备方法,该敷料不仅可以促进创面修复,并且可以防止皮肤遭受二次伤害。
为达到本发明目的,主要技术路线如下:
皮肤修复生物活性敷料,针对性修复紫外线导致的皮肤损伤、创面,其特征在于包括10-20份透明质酸钠,5-10份霍霍巴籽油,0.1-3份甘油,0.5-2份B族维生素,0.01-0.5份胶原蛋白,0.0002-0.0016份抗菌剂,0.001-0.005份纳米材料,55-80份去离子水,以及天然纤维无纺布。
优选地,透明质酸钠、霍霍巴籽油以及B族维生素含量可以根据皮肤损伤程度进行调节。针对重症,一般重量份的成分为透明质酸钠18份,霍霍巴籽油10份,B族维生素2份。针对轻症,一般重量份的成分为透明质酸钠12份,霍霍巴籽油8份,B族维生素1份。
优选地,除透明质酸钠、霍霍巴籽油以及B族维生素外,其余成分的重量份为2份甘油,0.5份胶原蛋白,70份去离子水。
优选地,所述B族维生素为烟酰胺和泛酸的混合物,质量比为1:1。
优选地,所述胶原蛋白为重组人源胶原蛋白。
优选地,所述纳米材料为氧化锌或者二氧化钛,更为优选地所述纳米材料为二氧化钛。
优选地,配方中所述去离子水电导率应达到18 MΩ·cm。
优选地,所述天然纤维无纺布为海藻酸钠/明胶无纺布或者甲壳素无纺布,更为优选地所述无纺布为甲壳素无纺布。
优选地,所述抗菌剂为硝酸银或硫酸银。
一种针对紫外皮肤损伤的生物活性敷料制备方法,其特征在于步骤包括两大部分:
S1, 功能性无纺布的制备:
S11,在无菌室中,将抗菌剂溶于去离子水,得到质量浓度为0.03g/L的抗菌溶液,放入无纺布进行浸渍,并在40℃条件下干燥,备用;
S12, 将纳米材料与去离子水混合,质量比为1:200,通过高压微射流纳米分散仪制得均匀的悬混液;通过管路将悬混液引入可密封的恒温箱,箱体入口处接有雾化器,箱内置有支架;将上述处理后的无纺布挂于恒温箱中的支架,恒温50℃,处理5h,取出无纺布,在40℃条件下干燥,紫外杀毒后得到功能性无纺布,放入无菌罐备用;
S2, 生物活性敷料的制备:
S21, 在无菌室中,用量筒准确量取去离子水加热至40℃,随即分别依次加入透明质酸钠和霍霍巴籽油,磁力搅拌至混合均匀、溶解充分,得到溶液a,备用;
S22, 在无菌室中,向溶液a中加入甘油、烟酰胺/泛酸混合物,继续搅拌,并升温至80℃,溶液混合均匀、溶解充分后,停止加热,控制冷却至15℃,加入胶原蛋白,磁力搅拌至混合均匀、溶解充分,得到溶液b;
S23, 在无菌室中,对溶液b进行超声消泡,处理完成后自然冷却至常温,随即灌入放有功能性无纺布的无菌罐中,使液体完全浸没无纺布,静置24h;
S24, 在无菌室中,取出充分吸收生物活性敷料液体的无纺布放入阻隔性能优良的包装袋中,并密封灭菌,制得成品。
优选地,包装袋采用内层为PE材质的复合膜袋或者铝箔袋,要求其氧气透过量≤0.5 cm3/(m2·24h·0.1MPa),水蒸气透过量≤0.5 g/(m2·24h)。
一种利用上述生物活性敷料制备的制品,包括防水层、敷料层,所述防水层、所述敷料层上方的四个边之间连接有橡胶板,并且所述敷料层的外壁的下方连接有粘合层,所述敷料层内壁的上方和外壁下方之间贯穿开设有多个出胶口并且所述出胶口位于所述粘合层的空间内,所述敷料层的下方连接有挤压机构并且所述挤压机构位于所述防水层的上方;
所述敷料层的下方连接有两个方便人员撕取的可活动固定条并且所述固定条粘合在所述敷料层的一侧。
优选的,所述挤压机构包括:两个安装在所述敷料层下方的连接柱,所述连接柱的上方连接有挡板并且两个所述挡板之间滑动连接有转辊;
所述挡板包括:第一板体,所述第一板体的垂直方向上弹性配合有第二板体,并且所述转辊滑动配合在两个所述第二板体之间;第一板体的中部开设有直槽,直槽内壁的顶部和第二板体之间连接有弹簧;
所述第二板体的长度方向上开设有燕尾槽,所述转辊的两端均转动连接有滑动配合在所述燕尾槽内的燕尾块。
优选的,所述敷料层的一侧连接有第一魔术贴,所述固定条的上方连接有和所述第一魔术贴粘合的第二魔术贴。
与现有技术相比,本发明的有益效果是:
(1)透明质酸钠和B族维生素协同作用促进表皮细胞的增殖和分化,加速损伤细胞的修复,并且能够消除氧自由基,防止过度氧化,而且透明质酸钠增加了敷料液体黏度,延长敷料在创面作用时间,增强治疗效果;生物油脂能够加速渗透吸收与软化肌肤角质,让肌肤变得柔软有弹性,胶原蛋白深层补水作用能进一步修复肤质;甘油调节湿润度,避免了伤口粘连,增加了用药舒适性,降低二次机械伤害风险;另外采用天然纤维素无纺布作为支撑结构,并负载了银离子和防紫外线纳米材料,保证了敷料的力学性能,同时具有抗菌消炎和屏蔽紫外线的功效;
(2)通过设置的挤压机构,挤压机构可以根据人员需要对防水层进行挤压,使挤压机构挤压橡胶层并使凝胶快速的从出胶口内流出,从而提高了人员对敷料的使用速度;
(3)通过设置的固定条,固定条的设置可以使人员在进行拆除敷料的时候更加方便和快速,并且由于第一魔术贴和第二魔术贴的设置有效的避免人员出现随意碰触固定条的情况发生,从而提高了敷料的实用性;
(4)通过设置的通过转辊,燕尾块和转辊的配合可以使人员推动转辊进行转动,并且可以快速的使凝胶从出胶口内滑出,这样大大的增加了人员在进行使用敷料时候的趣味性。
附图说明
图1为本发明制品的防水层立体结构示意图;
图2为本发明制品的敷料层立体结构示意图;
图3为本发明制品的防水层剖面结构示意图;
图4为本发明制品的挡板剖面结构示意图;
图5为图1中A处结构示意图。
图中:防水层1、敷料层2、橡胶板3、粘合层4、出胶口5、挤压机构6、连接柱7、挡板8、转辊9、第一板体10、第二板体11、直槽12、燕尾槽13、燕尾块14、固定条15、第一魔术贴16、第二魔术贴17。
具体实施方式
以下结合具体实施方式和附图对本发明的技术方案作进一步详细说明。
实施例1:
一种针对紫外皮肤损伤的生物活性敷料制备方法,包括下述步骤,该制备过程均在无菌环境下进行:
1)功能性无纺布的制备:
称取0.0473g硝酸银,溶于去离子水中,转移至1000ml容量瓶中,并定容,得到银离子质量浓度为0.03g/L的抗菌溶液,放入甲壳素无纺布浸渍2h,40℃真空干燥,并紫外杀毒处理4h,得到抗菌无纺布,放入无菌罐中备用;
称取1.0010g与200ml去离子水混合,通过高压微射流纳米分散仪处理10min制得均匀的悬混液;通过管路将悬混液引入可密封的恒温箱,箱体入口处接有雾化器,箱内置有支架;将上述处理后的无纺布挂于恒温箱中的支架,恒温50℃,处理5h,取出无纺布,在40℃条件下干燥,紫外杀毒后得到功能性无纺布,放入无菌罐备用;
2)生物活性敷料的制备:
用量筒量取200ml去离子水于圆底烧瓶中,置于磁力搅拌恒温水浴锅中加热至40℃,分别称取57.14g透明质酸钠、28.57g霍霍巴籽油依次加入水中,然后开始磁力搅拌,直至混合均匀、溶解充分;
向上述溶液中滴加4.5ml甘油,1.425g烟酰胺和1.425g泛酸的混合物,继续搅拌并升温至80℃,混合均匀、溶解充分后停止加热,控制冷却至15℃,加入1.4300g胶原蛋白,磁力搅拌至混合均匀、溶解充分,超声消泡1h,冷却至常温,随即灌入放有功能性无纺布的无菌罐中,使液体完全浸没无纺布,静置24h;
取出充分吸收生物活性敷料液体的无纺布放入阻隔性能优良的包装袋中,并密封灭菌,制得成品。
实施例2:
一种针对紫外皮肤损伤的生物活性敷料制备方法,包括下述步骤,该制备过程均在无菌环境下进行:
1)功能性无纺布的制备:
称取0.0473g硝酸银,溶于去离子水中,转移至1000ml容量瓶中,并定容,得到银离子质量浓度为0.03g/L的抗菌溶液,放入甲壳素无纺布浸渍2h,40℃真空干燥,并紫外杀毒处理4h,得到抗菌无纺布,放入无菌罐中备用;
称取1.0010g与200ml去离子水混合,通过高压微射流纳米分散仪处理10min制得均匀的悬混液;通过管路将悬混液引入可密封的恒温箱,箱体入口处接有雾化器,箱内置有支架;将上述处理后的无纺布挂于恒温箱中的支架,恒温50℃,处理5h,取出无纺布,在40℃条件下干燥,紫外杀毒后得到功能性无纺布,放入无菌罐备用;
2)生物活性敷料的制备:
用量筒量取200ml去离子水于圆底烧瓶中,置于磁力搅拌恒温水浴锅中加热至40℃,分别称取28.57g透明质酸钠、14.29g霍霍巴籽油依次加入水中,然后开始磁力搅拌,直至混合均匀、溶解充分;
向上述溶液中滴加4.5ml甘油,1.425g烟酰胺和1.425g泛酸的混合物,继续搅拌并升温至80℃,混合均匀、溶解充分后停止加热,控制冷却至15℃,加入1.4300g胶原蛋白,磁力搅拌至混合均匀、溶解充分,超声消泡1h,冷却至常温,随即灌入放有功能性无纺布的无菌罐中,使液体完全浸没无纺布,静置24h;
取出充分吸收生物活性敷料液体的无纺布放入阻隔性能优良的包装袋中,并密封灭菌,制得成品。
实施例3:
制备方法同实施例1和实施例2,其中,在本实施例中,称取透明质酸钠51.42g,28.57g霍霍巴籽油,其余成分含量不变。
实施例4:
制备方法和成分含量同实施例3,其中,在本实施例中,选用海藻酸钠/明胶无纺布作为支撑结构。
实施例5:
制备方法和成分含量同实施例3,其中,在本实施例中,选用硫酸银作为抗菌剂。
实施例6:
生物活性敷料,包括透明质酸钠12份,霍霍巴籽油8份,B族维生素1份,2份甘油,0.5份胶原蛋白,70份去离子水,0.003份纳米材料,60份去离子水,以及天然纤维无纺布;
请参阅图1-5,利用上述生物活性敷料2制备的制品,包括防水层1、敷料层2,所述防水层1、所述敷料层2上方的四个边之间连接有橡胶板3,橡胶板3具有拉伸功能,所以橡胶板3可以被挤压机构6所挤压,并且所述敷料层2的外壁的下方连接有粘合层4,所述敷料层2内壁的上方和外壁下方之间贯穿开设有多个出胶口5并且所述出胶口5位于所述粘合层4的空间内,粘合层4起到了密封的作用,并且可以避免了凝胶从人员身体处流出,敷料层2的下方连接有挤压机构6并且挤压机构6位于防水层1的上方,挤压机构6可以更好的对凝胶进行挤压,使凝胶可以更快的从出胶口5处流出。
根据图2所示,具体的,挤压机构6包括:两个安装在敷料层2下方的连接柱7,连接柱7的上方连接有挡板8并且两个挡板8之间滑动连接有转辊9,转辊9可以推动进行推动,使凝胶可以更好的流出。
根据图2所示,具体的,挡板8包括:第一板体10,第一板体10的垂直方向上弹性配合有第二板体11,并且转辊9滑动配合在两个第二板体11之间,第一板体10和第二板体11的设置可以根据凝胶的多少进行控制计量。
根据图4所示,具体的,第一板体10的中部开设有直槽12,直槽12内壁的顶部和第二板体11之间连接有弹簧,通过弹簧的设置便于第二板体11缩入直槽12内。
根据图2所示,具体的,第二板体11的长度方向上开设有燕尾槽13,转辊9的两端均转动连接有滑动配合在燕尾槽13内的燕尾块14,通过燕尾块14和转辊9的配合可以使人员推动转辊进行转动,这样大大的增加了人员在进行使用敷料时候的趣味性。
根据图5所示,具体的,敷料层2的下方连接有两个方便人员撕取的可活动固定条15并且固定条15粘合在敷料层2的一侧,通过设置的固定条15可以更好的使人员进行拉动粘合层4。
根据图5所示,具体的,敷料层2的一侧连接有第一魔术贴16,固定条15的上方连接有和第一魔术贴16粘合的第二魔术贴17,第一魔术贴16和第二魔术贴17的配合可以对固定条15的位置进行固定,方便了人员的使用。
工作原理:在需要使用敷料的时候,先将粘合层4放置到人员的身体上,并使粘合层4贴合人员的身体,然后凝胶会流入人员的身体表面,同时可以凝胶在减少后弹簧会发生弹性形变并使转辊9下降,然后在需要对粘合层4进行更换的时候,人员先推动固定条15,使固定条15一侧连接的第二魔术贴17和第一魔术贴16取消连接关系,然后拉动固定条15,使敷料层2向远离身体的一侧运动,从而完成对凝胶敷料的使用。
对比例1:
制备方法和成分含量同实施例3,其中,在本实施例中,直接使用甲壳素无纺布,不做抗菌溶液浸渍处理。
对比例2:
制备方法同实施例3,其中,在本实施例中,直接使用海藻酸钠/明胶无纺布,不做抗菌溶液浸渍处理。
将实施例1-5和对比例1-2制得的敷料分别进行抗菌性能测试,其中,以金黄色葡萄球菌、大肠杆菌,白念珠菌和伤寒沙门菌作为接种菌种,37℃恒温中牛肉膏蛋白胨培养基培养,剪取培养基同等大小的成品敷料完全覆盖培养基,定时检测有无菌落生长,有菌落生长为阳性,记(+),无菌落生长为阴性,记(-),结果如表1所示。
表1 抗菌性能测试结果
由表1可知,本发明的生物活性敷料具有较好的抗菌性能,能够有效防止伤口感染,对比例1和对比例2分别在48h、24h后发现菌落,说明银离子有效增长了抗菌时间,甲壳素本身具有一定的抗菌性,所以对比例1相对于对比例2抗菌性能更好。
为测试本发明的生物活性敷料的紫外损伤修复性能和二次保护功能等特性,将实施例1-5制得的敷料进行小鼠活体实验,并采用市面上普通敷料进行同样实验作为对比例3。
实验步骤:
随机选取16只小鼠,采用紫外线定点照射的方式在小鼠背部造成大小相同,程度相当的紫外损伤创面,分别采用实施例1-5的敷料进行包扎,其中实施例1-2的敷料分别包扎4只小鼠,并均分为两组,一组放入普通环境,一组继续采用紫外线照射,其余每个实施例或对比例的敷料包扎2只小鼠,作为一组平行样,放入普通环境观察结果。实验结果如表2所示。
表2 小鼠活体实验结果
由表2可知,本发明的生物活性敷料对于紫外损伤有明显的修复功能,增加透明质酸钠或霍霍巴籽油用量能够加速修复速度,并且此敷料对创伤起二次保护作用,这对晒伤后不得已仍要进行户外作业的工作者十分有帮助。另外,本敷料对皮肤具有显著的保养作用,使治愈后的皮肤水润、充满弹性,且与周围皮肤不会产生较大色差。
将实施例1、实施例4和对比例1制得的敷料裁剪为标准的长条形试块,采用电子万能材料试验机测试拉伸强度和断裂伸长率,并选取未浸润过任何溶液的海藻酸钠/明胶无纺布和甲壳素无纺布进行同样的拉伸实验,作对照。实验结果如表3所示。
表3 拉伸实验结果
由表3可知,以甲壳素无纺布作为支撑结构的敷料力学性能优于以海藻酸钠/明胶无纺布作为支撑结构的敷料,浸渍抗菌溶液和负载敷料液体,并不会对无纺布的力学性能产生明显的消极影响,可见本发明提供的生物活性敷料具有优异的力学性能,增加了产品的实用性。
应用实施例1:
选择刚好经历了户外作业后皮肤明显发红发热的使用者,用实施例6制得的敷料进行贴敷,12h后观察治疗效果,使用者的发红发热有明显改善。
本具体实施例仅仅是对本发明的解释,其并不是对本发明的限制,本领域技术人员在阅读完本说明书后可以根据需要对本实施例做出没有创造性贡献的修改,但只要在本发明的权利要求范围内都受到专利法的保护。
Claims (10)
1.皮肤修复生物活性敷料,其特征在于包括10-20份透明质酸钠,5-10份霍霍巴籽油,0.1-3份甘油,0.5-2份B族维生素,0.01-0.5份胶原蛋白,0.0002-0.0016份抗菌剂,0.001-0.005份纳米材料,55-80份去离子水,以及天然纤维无纺布。
2.如权利要求1所述的皮肤修复生物活性敷料,其特征在于,透明质酸钠、霍霍巴籽油以及B族维生素含量可以根据皮肤损伤程度进行调节;针对重症,一般重量份的成分为透明质酸钠18份,霍霍巴籽油10份,B族维生素2份;针对轻症,一般重量份的成分为透明质酸钠12份,霍霍巴籽油8份,B族维生素1份。
3.如权利要求1或2所述的皮肤修复生物活性敷料,其特征在于,除透明质酸钠、霍霍巴籽油以及B族维生素外,其余成分的重量份为2份甘油,0.5份胶原蛋白,70份去离子水。
4.如权利要求1-3任一项所述的皮肤修复生物活性敷料,其特征在于,B族维生素为烟酰胺和泛酸的混合物,质量比为1:1;所述胶原蛋白为重组人源胶原蛋白。
5.根据权利要求4所述的皮肤修复生物活性敷料,其特征在于,所述纳米材料为氧化锌或者二氧化钛,优选地所述纳米材料为二氧化钛。
6. 根据权利要求5所述的生物活性敷料,其特征在于,配方中所采用的去离子水电导率应达到18 MΩ·cm;所述抗菌剂为硝酸银或硫酸银。
7.根据权利要求6所述的皮肤修复生物活性敷料,其特征在于,所述天然纤维无纺布为海藻酸钠/明胶无纺布或者甲壳素无纺布,优选地所述无纺布为甲壳素无纺布。
8.一种根据权利要求1-7任一项所述的皮肤修复生物活性敷料的制备方法,其特征在于包括两部分:
S1,功能性无纺布的制备:
S11,在无菌室中,将抗菌剂溶于去离子水,得到质量浓度为0.03g/L的抗菌溶液,放入无纺布进行浸渍,并在40℃条件下干燥,备用;
S12, 将纳米材料与去离子水混合,质量比为1:200,通过高压微射流纳米分散仪制得均匀的悬混液;通过管路将悬混液引入可密封的恒温箱,箱体入口处接有雾化器,箱内置有支架;将上述处理后的无纺布挂于恒温箱中的支架,恒温50℃,处理5h,取出无纺布,在40℃条件下干燥,紫外杀毒后得到功能性无纺布,放入无菌罐备用;
S2,生物活性敷料的制备:
S21, 在无菌室中,用量筒准确量取去离子水加热至40℃,随即分别依次加入透明质酸钠和霍霍巴籽油,磁力搅拌至混合均匀、溶解充分,得到溶液a,备用;
S22, 在无菌室中,向溶液a中加入甘油、烟酰胺/泛酸混合物,继续搅拌,并升温至80℃,溶液混合均匀、溶解充分后,停止加热,控制冷却至15℃,加入胶原蛋白,磁力搅拌至混合均匀、溶解充分,得到溶液b;
S23, 在无菌室中,对溶液b进行超声消泡,处理完成后自然冷却至常温,随即灌入放有功能性无纺布的无菌罐中,使液体完全浸没无纺布,静置24h;
S24, 在无菌室中,取出充分吸收生物活性敷料液体的无纺布放入阻隔性能优良的包装袋中,并密封灭菌,制得成品。
9.一种根据权利要求1-7任一项所述的皮肤修复生物活性敷料制备的制品,其特征在于,包括:防水层(1)、敷料层(2),所述防水层(1)、所述敷料层(2)上方的四个边之间连接有橡胶板(3),并且所述敷料层(2)的外壁的下方连接有粘合层(4),所述敷料层(2)内壁的上方和外壁下方之间贯穿开设有多个出胶口(5)并且所述出胶口(5)位于所述粘合层(4)的空间内,所述敷料层(2)的下方连接有挤压机构(6)并且所述挤压机构(6)位于所述防水层(1)的上方;
所述敷料层(2)的下方连接有两个方便人员撕取的可活动固定条(15)并且所述固定条(15)粘合在所述敷料层(2)的一侧。
10.一种根据权利要求9所述的生物活性敷料制备的制品,其特征在于,所述挤压机构(6)包括:两个安装在所述敷料层(2)下方的连接柱(7),所述连接柱(7)的上方连接有挡板(8)并且两个所述挡板(8)之间滑动连接有转辊(9);
所述挡板(8)包括:第一板体(10),所述第一板体(10)的垂直方向上弹性配合有第二板体(11),并且所述转辊(9)滑动配合在两个所述第二板体(11)之间;
第一板体(10)的中部开设有直槽(12),直槽(12)内壁的顶部和第二板体(11)之间连接有弹簧;
所述第二板体(11)的长度方向上开设有燕尾槽(13),所述转辊(9)的两端均转动连接有滑动配合在所述燕尾槽(13)内的燕尾块(14)。
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