CN115569232B - 双层水凝胶敷料及其制备方法和应用 - Google Patents
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Abstract
本发明提供了一种双层水凝胶敷料及其制备方法和应用,该双层水凝胶敷料包括内层和外层,内层包括以下原料:壳聚糖硫酸酯及其衍生物、交联剂和生物活性填充剂;外层包括以下原料:天然多糖、成膜剂和有机溶剂。本发明采用的壳聚糖硫酸酯及其衍生物、交联剂为生物活性高、可生物降解和促进伤口的效果,为伤口的快速修复提供了良好的环境。氧化石墨烯具有良好的抗菌作用,可以有效避免伤口愈合过程中的炎症、脓肿等发生,降低伤口感染的风险。本发明敷料可以实现伤口的快速封闭,为日常和野外伤口处理提供了有效和快捷的处理方式。
Description
技术领域
本发明涉及生物医药领域,具体涉及双层水凝胶敷料及其制备方法和应用。
背景技术
目前,外伤及外伤感染是医院的多发病例,医用敷料可充当保护屏障,用来覆盖伤口,吸收伤口渗出液体,帮助创面愈合。传统医用敷料存在性能单一、吸收能力差、抗菌性能不好等缺点,且在外科手术中,敷料用量大且频繁,传统敷料易粘着创面,更换时会造成二次创伤等。水凝胶由于其良好的柔韧性和生物相容性,其制作的敷料吸收液体性能好,能够为创面创造一个利于组织再生的湿润环境,凝胶滑弹状态可有效地避免了伤口黏连造成的二次伤害,因此成为医用敷料的极佳选择。
目前研究的水凝胶敷料基本是单一的水凝胶组分,虽然其具有良好的保水性能,可以实现伤口的湿润愈合,但是外界细菌对伤口侵染效果无法隔绝,导致伤口容易发生炎症反应,伤口愈合环境更加复杂且难以愈合。
发明内容
本发明提供一种双层水凝胶敷料及其制备方法和应用,采用双层结构的伤口敷料,通过开发具有抗菌和可生物降解性能的水凝胶,抑制伤口炎症反应和促进伤口的快速愈合,同时外层的高分子聚合物膜可以有效隔绝伤口与外界的接触,更加好的保护伤口,可以实现伤口的快速封闭,为日常和野外伤口处理提供了有效和快捷的处理方式。
本发明的技术方案是,一种双层水凝胶敷料,包括内层和外层,内层包括按重量份计的以下原料:壳聚糖硫酸酯及其衍生物:60~80份;交联剂:15~35份;生物活性填充剂:1~3份;外层包括按重量份计的以下原料:天然多糖:2~5份;成膜剂:8~15份;有机溶剂:85~95份。
内层厚度为3~4mm,外层的厚度为0.2~0.4mm。
进一步地,所述壳聚糖硫酸酯及其衍生物为壳聚糖硫酸酯、羧甲基壳聚糖硫酸酯、羟丙基壳聚糖硫酸酯或季铵盐接枝壳聚糖硫酸酯中的一种或几种。
进一步地,所述交联剂为氧化明胶、氧化透明质酸或氧化微晶纤维素的一种或几种。
进一步地,所述生物活性填充剂为氧化石墨烯、纳米羟基磷灰石或纳米氧化锌中的一种或几种。
进一步地,所述天然多糖为透明质酸、透明质酸硫酸酯或羧甲基透明质酸的一种或几种。
进一步地,所述成膜剂为左旋聚乳酸(PLLA)、聚乳酸-羟基乙酸共聚物(PLGA)或聚乙二醇(PEG)中的一种或多种;所述有机溶剂为乙醇、乙酸乙酯、松节油、矿物溶剂、挥发性硅油或石蜡油中的一种或几种。
进一步地,所述聚乳酸-羟基乙酸共聚物中聚乳酸与聚羟基乙酸的质量比为30:70、50:50或40:60;所述聚乙二醇PEG为PEG-800,PEG-2000和PEG-5000中的一种或几种。
本发明还涉及制备所述双层水凝胶敷料的方法,具体步骤为:
S1、将壳聚糖硫酸酯及其衍生物用水溶解,然后加入交联剂和生物活性填充剂,搅拌均匀形成内层水凝胶;
S2、将天然多糖用有机溶剂溶解,超声分散后加入成膜剂混匀,得到外层水凝胶。
本发明还涉及所述双层水凝胶敷料在伤口修复中的应用,具体应用时,先将内层水凝胶涂覆到伤口处,然后涂覆外层水凝胶,待溶剂挥发后对伤口形成保护膜。
本发明具有以下有益效果:
1、本发明采用的壳聚糖硫酸酯及其衍生物、交联剂都为生物活性高、可生物降解和促进伤口的效果,为伤口的快速修复提供了良好的环境。本发明的材料是一种具有高含水量的水凝胶三维高分子网络材料。使用的氧化石墨烯抗菌性能优异,可以有效避免伤口愈合过程中的炎症、脓肿等发生,降低伤口感染的风险。
2、本发明选用的成膜性聚合物皆为高生物活性、成膜性好和疏水的作用,其可以有效的形成聚合物透明膜封闭伤口,同时疏水性膜具有有效隔绝外界水分子进入伤口环境的作用,不会造成伤口发生炎症。
3、本发明选用的溶剂皆为可快速挥发的有机溶剂,对高分子成膜剂的溶解性好,同时可以在环境中快速挥发,伤口形成保护性膜。
4、传统大单层伤口敷料,如果要求具有三维的水凝胶支架结构,那么其对于外界环境的隔离效不佳,受外界环境影响,伤口愈合效果差,如果选用封闭的材料作为敷料,则生物活性不够,创伤处新生细胞粘附和迁移能力差,伤口愈合速度慢。本发明的双层结构可以很好的改善以上的问题,且采用的原材料都为生物相容性好的多糖类材料,通过动态的席夫碱反应交联,可以实现对创面的完全填充,同时加入纳米粒子改善伤口愈合的环境,增加其抗菌、抗炎症的效果。
附图说明
图1为具有抗菌和快速伤口封闭的双层水凝胶敷料产品示意图及其微观表征。
图2大鼠皮肤损伤10天后愈合示意图。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述,但是本领域技术人员将会理解,下列实施例仅用于说明本发明,而不应视为限定本发明的范围。
实施例1:
一种具有抗菌和快速伤口封闭的双层水凝胶敷料制备方法,包括如下步骤:
(1)首先将1.6g壳聚糖硫酸酯溶于25mL超纯水中,然后分别加入0.8g氧化明胶和0.03g氧化石墨烯,常温搅拌20min后形成凝胶,得到水凝胶A份。
(2)将1.0g左旋聚乳酸加入到有10mL乙酸乙酯中,超声分散溶解后得到溶液,然后在溶液中加入0.3g透明质酸,搅拌均匀后得到水凝胶B组分。
实施例2:
一种具有抗菌和快速伤口封闭的双层水凝胶敷料制备方法,包括如下步骤:
(1)首先将1.6g壳聚糖硫酸酯溶于25mL超纯水中,然后分别加入0.5g氧化明胶和0.05g氧化石墨烯,常温搅拌20min后形成凝胶,得到水凝胶A份。
(2)将1.0g左旋聚乳酸加入到有10mL乙酸乙酯中,超声分散溶解后得到溶液,然后在溶液中加入0.3g透明质酸,搅拌均匀后得到水凝胶B组分。
实施例3:
一种具有抗菌和快速伤口封闭的双层水凝胶敷料制备方法,包括如下步骤:
(1)首先将1.6g壳聚糖硫酸酯溶于25mL超纯水中,然后分别加入0.4g氧化明胶和0.03g氧化石墨烯,常温搅拌20min后形成凝胶,得到水凝胶A份。
(2)将1.0g左旋聚乳酸加入到有10mL乙酸乙酯中,超声分散溶解后得到溶液,然后在溶液中加入0.5g透明质酸,搅拌均匀后得到水凝胶B组分。
实施例4:
一种具有抗菌和快速伤口封闭的双层水凝胶敷料制备方法,包括如下步骤:
(1)首先将1.6g羧甲基壳聚糖硫酸酯溶于25mL超纯水中,然后分别加入0.5g氧化明胶和0.03g氧化石墨烯,常温搅拌20min后形成凝胶,得到水凝胶A份。
(2)将1.0g左旋聚乳酸加入到有10mL乙酸乙酯中,超声分散溶解后得到溶液,然后在溶液中加入0.3g透明质酸,搅拌均匀后得到水凝胶B组分。
实施例5:
一种具有抗菌和快速伤口封闭的双层水凝胶敷料制备方法,包括如下步骤:
(1)首先将1.6g壳聚糖硫酸酯溶于25mL超纯水中,然后分别加入0.5g氧化微晶纤维素和0.03g氧化石墨烯,常温搅拌20min后形成凝胶,得到水凝胶A份。
(2)将1.0g左旋聚乳酸加入到有10mL乙酸乙酯中,超声分散溶解后得到溶液,然后在溶液中加入0.3g透明质酸,搅拌均匀后得到水凝胶B组分。
实施例6:
一种具有抗菌和快速伤口封闭的双层水凝胶敷料制备方法,包括如下步骤:
(1)首先将1.6g壳聚糖硫酸酯溶于25mL超纯水中,然后分别加入0.5g氧化明胶和0.03g纳米氧化锌,常温搅拌20min后形成凝胶,得到水凝胶A份。
(2)将1.0g左旋聚乳酸加入到有10mL乙酸乙酯中,超声分散溶解后得到溶液,然后在溶液中加入0.3g透明质酸,搅拌均匀后得到水凝胶B组分。
实施例7:
一种具有抗菌和快速伤口封闭的双层水凝胶敷料制备方法,包括如下步骤:
(1)首先将1.6g壳聚糖硫酸酯溶于25mL超纯水中,然后分别加入0.8g氧化明胶和0.03g氧化石墨烯,常温搅拌20min后形成凝胶,得到水凝胶A份。
(2)将1.0g左旋聚乳酸加入到有10mL乙酸乙酯中,超声分散溶解后得到溶液,然后在溶液中加入0.5g透明质酸,搅拌均匀后得到水凝胶B组分。
实施例8:
一种具有抗菌和快速伤口封闭的双层水凝胶敷料制备方法,包括如下步骤:
(1)首先将1.6g壳聚糖硫酸酯溶于25mL超纯水中,然后分别加入0.5g氧化明胶和0.03g氧化石墨烯,常温搅拌20min后形成凝胶,得到水凝胶A份。
(2)将1.0g聚乳酸-羟基乙酸共聚物(PLGA 50/50)加入到有10mL乙酸乙酯中,超声分散溶解后得到溶液,然后在溶液中加入0.3g透明质酸,搅拌均匀后得到水凝胶B组分。
实施例9:
一种具有抗菌和快速伤口封闭的双层水凝胶敷料制备方法,包括如下步骤:
(1)首先将1.0g壳聚糖硫酸酯0.6g季铵盐接枝壳聚糖硫酸酯溶于25mL超纯水中,然后分别加入0.5g氧化明胶和0.03g氧化石墨烯,常温搅拌20min后形成凝胶,得到水凝胶A份。
(2)将1.0g左旋聚乳酸加入到有10mL可挥发性硅油中,超声分散溶解后得到溶液,然后在溶液中加入0.3g透明质酸,搅拌均匀后得到水凝胶B组分。
实施例10:
一种具有抗菌和快速伤口封闭的双层水凝胶敷料制备方法,包括如下步骤:
(1)首先将1.0g壳聚糖硫酸酯和0.6g季铵盐接枝壳聚糖硫酸酯溶于25mL超纯水中,然后分别加入0.5g氧化明胶和0.03g氧化石墨烯,常温搅拌20min后形成凝胶,得到水凝胶A份。
(2)将0.5g左旋聚乳酸和0.5g PLGA 50/50加入到有10mL乙酸乙酯中,超声分散溶解后得到溶液,然后在溶液中加入0.3g透明质酸硫酸酯,搅拌均匀后得到水凝胶B组分。
动物实验:
选取21只周龄为7~8和体重200-230g的大鼠,首先对大鼠后部脊椎右侧进行消毒和剃毛处理,然后选取背部皮肤缺损伤口模型。
利用手术刀切除直径为10mm的伤口,其中阳性对照组为原皮肤重新缝合,阴性对照为普通纱布处理;实验组则采用实施例1、3、5、7和9制备好的具有抗菌和快速伤口封闭的双层水凝胶敷料进行伤口处理(即先在伤口处涂敷A组分后立即涂敷B组分,30s后溶剂挥发,伤口保护形成)。每组设计3只平行样本,观察10天后伤口愈合情况,结果如下表所示。
序号 | 实验情况 | 第1只大鼠 | 第2只大鼠 | 第3只大鼠 |
1 | 原皮肤重新缝合 | B | B | B |
2 | 实施例1 | A | A | B |
3 | 实施例3 | B | A | A |
4 | 实施例5 | A | A | A |
5 | 实施例7 | A | A | A |
6 | 实施例9 | A | A | A |
7 | 普通纱布处理 | C | D | C |
A表示完全愈合,伤口无感染;B表示伤口完全愈合,有部分感染;C表示伤口完全愈合;D表示伤口未愈合。
上述的实施例仅为本发明的优选技术方案,而不应视为对于本发明的限制,本发明的保护范围应以权利要求记载的技术方案,包括权利要求记载的技术方案中技术特征的等同替换方案为保护范围。即在此范围内的等同替换改进,也在本发明的保护范围之内。
Claims (5)
1.一种双层水凝胶敷料,其特征在于:包括内层和外层,具体应用时,内层水凝胶涂覆到伤口处,然后涂覆外层水凝胶,待溶剂挥发后对伤口形成保护膜,其中内层包括按重量份计的以下原料:壳聚糖硫酸酯及其衍生物:60~80份;交联剂:15~35份;生物活性填充剂:1~3份;外层包括按重量份计的以下原料:天然多糖:2~5份;成膜剂:8~15份;有机溶剂:85~95份;交联剂为氧化明胶、氧化透明质酸或氧化微晶纤维素的一种或几种;生物活性填充剂为氧化石墨烯、纳米羟基磷灰石或纳米氧化锌中的一种或几种;天然多糖为透明质酸、透明质酸硫酸酯或羧甲基透明质酸的一种或几种;成膜剂为左旋聚乳酸(PLLA)、聚乳酸-羟基乙酸共聚物(PLGA)或聚乙二醇(PEG)中的一种或多种;所述有机溶剂为乙醇、乙酸乙酯、松节油、矿物溶剂、挥发性硅油或石蜡油中的一种或几种。
2.根据权利要求1所述的双层水凝胶敷料,其特征在于:内层厚度为3~4mm,外层的厚度为0.2~0.4mm。
3.根据权利要求1所述的双层水凝胶敷料,其特征在于:所述壳聚糖硫酸酯及其衍生物为壳聚糖硫酸酯、羧甲基壳聚糖硫酸酯、羟丙基壳聚糖硫酸酯或季铵盐接枝壳聚糖硫酸酯中的一种或几种。
4.根据权利要求1所述的双层水凝胶敷料,其特征在于:所述聚乳酸-羟基乙酸共聚物中聚乳酸与聚羟基乙酸的质量比为30:70、50:50或40:60;所述聚乙二醇PEG为PEG-800,PEG-2000和PEG-5000中的一种或几种。
5.制备权利要求1~4任意一项所述双层水凝胶敷料的方法,其特征在于,具体步骤为:
S1、将壳聚糖硫酸酯及其衍生物用水溶解,然后加入交联剂和生物活性填充剂,搅拌均匀形成内层水凝胶;
S2、将天然多糖用有机溶剂溶解,超声分散后加入成膜剂混匀,得到外层水凝胶。
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