CN116370699A - 机械增强型水凝胶伤口敷料及其制备方法 - Google Patents
机械增强型水凝胶伤口敷料及其制备方法 Download PDFInfo
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- CN116370699A CN116370699A CN202310298753.4A CN202310298753A CN116370699A CN 116370699 A CN116370699 A CN 116370699A CN 202310298753 A CN202310298753 A CN 202310298753A CN 116370699 A CN116370699 A CN 116370699A
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- wound dressing
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Abstract
本发明公开了一种机械增强型水凝胶伤口敷料及其制备方法。所述制备方法包括：S1，将多糖聚合物溶于溶剂中，加入高碘酸钠水溶液后在室温及黑暗环境中磁力搅拌，再加入乙二醇，放置至少2小时；向反应混合物中加入乙醇，将沉淀物吸滤后溶于去离子水中，透析、冷冻干燥制得醛基化材料；S2，将含氨基的材料和醛基化材料分别溶PBS缓冲溶液中，将两种溶液混合，得到水凝胶前驱体溶液；S3，向水凝胶前驱体溶液中加入pH变色材料、抗菌药物和机械增强材料，室温下搅拌均匀，静置直至溶胶凝胶化。该伤口敷料能通过颜色变化监测伤口的pH环境变化并具有pH响应释放药物功能，具有抗菌功性且机械性能优异。
Description
技术领域
本发明属于生物医药领域，具体涉及一种机械增强型水凝胶伤口敷料及其制备方法
背景技术
皮肤是覆盖在人体表面、直接接触外界环境的非常重要的器官，具有感受外界刺激和调节体温的作用，能够保护人体免受外界伤害。由于与外界直接接触的特点，皮肤也成为最脆弱的组织之一。伤口的愈合过程包括止血、发炎、增殖和重塑四个连续而协调的过程。然而，伤口愈合的过程一般不能快速并有序地进行，各种因素在任何阶段都可能导致创面愈合异常，由创伤、手术或糖尿病引起的皮肤损伤很容易造成伤口的感染。伤口感染会导致伤口愈合延迟，治疗费用和死亡率增加。此外，感染会导致明显的免疫反应，伴随败血症或感染性休克，导致低血压和多器官衰竭。因此，构建一种可以预防和管理感染的伤口，同时持续监测伤口，并在必要时及时进行响应性动态治疗的伤口敷料是处理无法愈合或慢性感染伤口的重要途径。
目前，传统的伤口敷料包括纱布、海绵、纤维、水凝胶和泡沫等种类，其中水凝胶因其自身的特性而显示出独特的优势，如高含水率和优异的生物相容性。水凝胶是由多孔的三维网络和高含量的水组成的柔性材料，作为一种创新的生物材料在许多领域得到了研究和应用。当用作慢性伤口敷料时，水凝胶可以提供湿润的环境，产生降温效果，允许气体交换，同时吸收伤口区域的渗出物，从而防止脱水并缓解伤口疼痛。然而现有的水凝胶伤口敷料无法实现伤口感染状态的可视化实时监测，需要频繁地揭开敷料进行目视检查，带来二次创伤的风险；在伤口感染后也无法通过响应方式给药予以精准治疗。因此，亟需提供一种能够实时监测伤口状态，通过肉眼检测来判断伤口感染，同时通过智能响应来实现药物的动态释放的伤口敷料。据报道，伤口细菌感染会引起感染部位微环境的pH变化，因此构建一种对pH敏感的水凝胶来快速有效地监测和治疗细菌感染是可能的。
中国发明专利公开号CN106693031A公开了一种可以控制伤口pH值的智能敷料及其制备方法，其存在以下问题：不能实时监测伤口处的pH，无法提供伤口类型的信息，仅能从理论上维持伤口pH在5.5左右，若伤口发生感染，还是需要替换敷料进行常规治疗。
中国发明专利公开号CN114159615A公开了一种用于指示伤口pH和超声响应性药物递送的水凝胶伤口敷料，但存在该伤口敷料只能指示伤口的pH，并且只是有超声响应药物释放的功能，二者没有关联，并不能根据伤口类型有针对性地响应治疗的问题。
因此，研究出一种pH可变色、智能监测并且可以根据伤口类型进行pH响应动态治疗的抗菌的水凝胶伤口敷料具有非常重要的意义。
发明内容
为了解决以上技术问题，本发明的一个目的是提供一种具备伤口环境监测和动态释药功能的机械增强型水凝胶伤口敷料的制备方法，制备的水凝胶伤口敷料能够对伤口愈合过程的可视化进行实时监测，能够更好地判断伤口的愈合状态，并可根据监测结果进行动态智能释药，对伤口部位进行原位治疗，促进慢性伤口愈合。
本发明的另一目的是提供一种上述方法制备的水凝胶伤口敷料。
为此，本发明采用以下技术方案：
一种机械增强型水凝胶伤口敷料的制备方法，其特征在于，包括以下步骤：
S1，制备醛基化材料：
将多糖聚合物按1g：(5-30)mL的比例溶解在溶剂中，然后向得到的溶液中加入浓度为1-20wt％的高碘酸钠水溶液；将得到的混合物在室温及黑暗环境中磁力搅拌6-24h，然后加入乙二醇终止反应，将溶液放置至少2小时；然后向反应混合物中倒入乙醇，乙醇的体积与多糖聚合物的质量比为50mL：1g，以沉淀醛基化材料，将沉淀物用吸滤法收集，收集到的沉淀物溶于去离子水中，用去离子水透析3天，冷冻干燥制得醛基化材料；其中：
所述多糖聚合物为羧甲基纤维素、海藻酸钠、透明质酸、壳聚糖、葡聚糖、魔芋葡甘聚糖中的一种或几种；
所述高碘酸钠水溶液中的高碘酸钠与多糖聚合物单体的摩尔比为0.5：1；
S2，制备水凝胶前驱体：
将含氨基的材料和步骤S1制备的醛基化材料分别溶于pH为7.4的PBS缓冲溶液中，使所述含氨基的材料、醛基化材料的浓度均为1-20wt％；然后将两种溶液混合，得到水凝胶前驱体溶液；其中：
所述含氨基的材料为明胶、支化聚乙烯亚胺、羧甲基壳聚糖、N-羧乙基壳聚糖、聚丙烯酰胺、聚N-异丙基丙烯酰胺中的一种或任意比例的几种；
所述醛基化材料中的醛基和含氨基的材料中氨基的摩尔比为1：(1-2)；
S3，制备水凝胶伤口敷料：向步骤S2得到的水凝胶前驱体溶液中加入pH变色材料、抗菌药物和机械增强材料，在室温下搅拌均匀，静置1min-2h，直至溶胶凝胶化，通过席夫碱反应制得水凝胶伤口敷料，其中：
所述pH变色材料、抗菌药物和机械增强材料的用量与步骤S2中PBS缓冲溶液的体积比分别为(0.01-0.05)g/mL、(0.4-5)g/mL和(0.1-5)g/mL。
其中，步骤S1中所述溶剂为水或乙醇。所述乙二醇与高碘酸钠的摩尔比为(1-10)：1。进行透析时，透析袋截留分子量为3500Da。
优选的是，步骤S3中，所述pH变色材料为石蕊试剂、酚酞试剂、溴百里酚蓝、灿烂黄、茜素、姜黄、荧光素、罗丹明、邻苯二酚紫、酚红的一种或几种。所述抗菌药物为左氧氟沙星、妥布霉素、肝素、抗菌多肽、环丙沙星(CIP)、万古霉素、头孢唑林钠、过氧化氢、阿司匹林中的至少一种。所述机械增强材料包括纤维和微纳米粒子材料中的至少一种，所述纤维为纤维素纤维、羧甲基纤维素纤维、细菌纤维素纤维的一种或几种；所述微纳米粒子为纳米纤维素、明胶纳米粒子、铜纳米粒子、碳化硅纳米粒子的一种或几种。
本发明还提供一种由上述制备方法制备的水凝胶伤口敷料。
本发明的机械增强型水凝胶伤口敷料由具有动态释药功能的水凝胶胶驱体、用于创面环境监测的pH变色材料、抗菌药物和机械增强材料制备而成。其中：
所述水凝胶前驱体为具有动态释药功能的水凝胶，该水凝胶进行动态释药的途径是利用具有pH响应性的动态可逆化学键，如席夫碱键及/或硼酸酯键。
用于创面环境监测的pH变色材料主要为pH变色染料，它可根据伤口pH环境的变化使得水凝胶发生颜色变化，进而监测伤口环境。所述抗菌药物可以对伤口部位进行细菌感染的治疗。所述机械增强材料具有增强水凝胶机械性能的作用。
本发明的水凝胶伤口敷料特别用于：慢性伤口敷料、可穿戴柔性传感器、感染伤口敷料、抗菌伤口敷料、药物释放材料。具体应用如下：
作为慢性伤口敷料，可实现慢性伤口的智能可视化监测和动态治疗；作为可穿戴柔性传感器，可对伤口进行保护，监测其是否感染；作为感染伤口敷料，可对感染的伤口进行监测并进行动态智能释药，对伤口感染部位进行治疗；作为抗菌伤口敷料，对伤口有抗菌作用，免受外界细菌侵袭；作为药物释放材料，可对伤口进行动态可控释药治疗。
与现有技术相比，本发明具有以下有益效果：
1.本发明的水凝胶伤口敷料能随伤口pH的不同而呈现不同的颜色，可对伤口进行可视化监测，并对感染的伤口进行动态释药治疗，促进伤口愈合，具有很好的生物相容性。
2.本发明的原料来源广泛，成本较低，绿色环保，其制备方法简便易行，产品性能稳定。
3.本发明的水凝胶伤口敷料不需要添加任何具有细胞毒性的交联剂、引发剂或促进剂，反应条件温和，并且制备的水凝胶伤口敷料机械性能优异、生物相容性良好，应用范围非常广泛。
4.本发明的水凝胶伤口敷料既克服了物理相互作用交联的结构不稳定、力学性能欠佳等缺点，又解决了单一化学键交联的水凝胶弹性与可塑性差的问题。
5.本发明的水凝胶伤口敷料成胶速度快，具有一定的抗菌性且无细胞毒性。
附图说明
图1为实施例1的水凝胶伤口敷料制备流程示意图；
图2为实施例2的水凝胶伤口敷料的制备方法流程图。
具体实施方式
以下结合附图和实施例对本发明的机械增强型水凝胶伤口敷料的制备方法进行详细说明。
实施例1
参见图1，一种纤维素纳米纤维增强型水凝胶伤口敷料制备方法，包括以下步骤：
S1，制备醛基化海藻酸钠：
将20g海藻酸钠分散在100mL乙醇中，然后向得到的溶液中加入100mL含10.8g高碘酸钠的水溶液。将混合物在25℃的黑暗环境中磁力搅拌6h，然后加入10mL乙二醇，让溶液放置2小时。然后向反应混合物中倒入1.0L乙醇，以沉淀醛基化海藻酸钠，沉淀物用吸滤法收集。将吸滤得到的沉淀物溶于200mL去离子水中，透析(透析袋，截留分子量为3500Da)3天，冷冻干燥制得醛基化海藻酸钠。
S2，制备水凝胶前驱体：
将0.2g支化聚乙烯亚胺(上海碧云天生物技术有限公司，货号C0539)和0.1g步骤S1制备的醛基化海藻酸钠分别溶于1mL pH为7.4的PBS缓冲溶液中，然后将二者混合，得到水凝胶前驱体。
S3，制备水凝胶伤口敷料：向步骤S2的水凝胶前驱体溶液中加入0.1mg溴百里酚蓝(BTB)、15mg左氧氟沙星和50mg纤维素纳米纤维，在室温下搅拌均匀，静置1小时，直至溶胶凝胶化，通过席夫碱反应制得水凝胶伤口敷料。
该实施例制备的伤口敷料的pH监测性能实验如下：
制备不同pH值(pH＝4、5、6、7、8)的PBS缓冲液，将小块滤纸分别在不同pH值的PBS缓冲液中短期浸泡。然后，将滤纸加入24孔板中，然后加入水凝胶伤口敷料(负载pH变色染料为BTB)。在37℃孵育40分钟后，观察水凝胶的颜色变化。
在不同pH值(pH＝4、5、6、7、8)下，水凝胶显示不同的颜色：pH＝4时颜色为黄色，pH＝5和6时颜色为浅绿色，pH＝7时颜色为绿色，pH＝8时颜色为蓝色。
实施例2
参见图2，一种二氧化硅纳米纤维增强型水凝胶伤口敷料制备方法，包括以下步骤：
S1，制备醛基化羧甲基纤维素：
将5g羧甲基纤维素溶解在150mL去离子水中，然后向得到的溶液中加入50mL含2.21g高碘酸钠的水溶液。将混合物在25℃的黑暗环境中磁力搅拌24h，然后加入5mL乙二醇，让溶液放置2小时。然后向反应混合物中倒入250mL乙醇，以沉淀醛基化羧甲基纤维素，沉淀物用吸滤法收集。再溶于50mL去离子水中，然后，用去离子水透析(透析袋，截留分子量为3500Da)3天，冷冻干燥制得醛基化羧甲基纤维素。
S2，制备水凝胶前驱体：
将0.1g羧甲基壳聚糖(润友化学有限公司，货号S30948)和0.1g步骤S1制备的醛基化羧甲基纤维素分别溶于1mLpH为7.4的PBS缓冲溶液中，然后将二者混合制备水凝胶前驱体。
S3，制备水凝胶伤口敷料：向步骤S2的水凝胶前驱体溶液中加入0.1mg姜黄、15mg妥布霉素和50mg二氧化硅纳米纤维，在室温下搅拌均匀，静置1小时，直至溶胶凝胶化，通过席夫碱反应制得水凝胶伤口敷料。
该实施例制备的伤口敷料的pH监测性能实验如下：
制备不同pH值(pH＝7.4、8、9)的PBS缓冲液，将小块滤纸分别在不同pH值的PBS缓冲液中短期浸泡。然后，将滤纸加入24孔板中，然后加入水凝胶伤口敷料(负载pH变色染料为姜黄)。在37℃孵育40分钟后，观察水凝胶的颜色变化。
在不同pH值(pH＝7.4、8、9)下，水凝胶显示不同的颜色：pH＝7.4时颜色为亮黄色，pH＝8时颜色为橘黄色，pH＝9时颜色为红棕色。
Claims (8)
1.一种机械增强型水凝胶伤口敷料的制备方法，其特征在于，包括以下步骤：
S1，制备醛基化材料：
将多糖聚合物按1g：(5-30)mL的比例溶解在溶剂中，然后向得到的溶液中加入浓度为1-20wt％的高碘酸钠水溶液；将得到的混合物在室温及黑暗环境中磁力搅拌6-24h，然后加入乙二醇终止反应，将溶液放置至少2小时；然后向反应混合物中加入乙醇，乙醇的体积与多糖聚合物的质量比为50mL：1g，以沉淀醛基化材料，将沉淀物用吸滤法收集，收集到的沉淀物溶于去离子水中，用去离子水透析3天，冷冻干燥制得醛基化材料；其中：
所述多糖聚合物为羧甲基纤维素、海藻酸钠、透明质酸、壳聚糖、葡聚糖、魔芋葡甘聚糖中的一种或几种；
所述高碘酸钠水溶液中的高碘酸钠与多糖聚合物单体的摩尔比为0.5：1；
S2，制备水凝胶前驱体：
将含氨基的材料和步骤S1制备的醛基化材料分别溶于pH为7.4的PBS缓冲溶液中，使所述含氨基的材料、醛基化材料的浓度均为1-20wt％；然后将两种溶液混合，得到水凝胶前驱体溶液；其中：
所述含氨基的材料为明胶、支化聚乙烯亚胺、羧甲基壳聚糖、N-羧乙基壳聚糖、聚丙烯酰胺、聚N-异丙基丙烯酰胺中的一种或任意比例的几种；
所述醛基化材料中的醛基和含氨基的材料中氨基的摩尔比为1：(1-2)；
S3，制备水凝胶伤口敷料：向步骤S2得到的水凝胶前驱体溶液中加入pH变色材料、抗菌药物和机械增强材料，在室温下搅拌均匀，静置1min-2h，直至溶胶凝胶化，通过席夫碱反应制得水凝胶伤口敷料，其中：
所述pH变色材料、抗菌药物和机械增强材料的用量与步骤S2中PBS缓冲溶液的体积比分别为(0.01-0.05)g/mL、(0.4-5)g/mL和(0.1-5)g/mL。
2.根据权利要求1所述的制备方法，其特征在于：步骤S1中，所述溶剂为水或乙醇。
3.根据权利要求1所述的制备方法，其特征在于：步骤S1中，所述乙二醇与高碘酸钠的摩尔比为(1-10)：1。
4.根据权利要求1所述的制备方法，其特征在于：步骤S1中，使用透析袋进行透析，透析袋截留分子量为3500Da。
5.根据权利要求1所述的制备方法，其特征在于：步骤S3中，所述pH变色材料为石蕊试剂、酚酞试剂、溴百里酚蓝、灿烂黄、茜素、姜黄、荧光素、罗丹明、邻苯二酚紫、酚红的一种或几种。
6.根据权利要求1所述的制备方法，其特征在于：步骤S3中，所述抗菌药物为左氧氟沙星、妥布霉素、肝素、抗菌多肽、环丙沙星(CIP)、万古霉素、头孢唑林钠、过氧化氢、阿司匹林中的至少一种。
7.根据权利要求1所述的制备方法，其特征在于：步骤S3中，所述机械增强材料包括纤维和微纳米粒子材料中的至少一种，所述纤维为纤维素纤维、羧甲基纤维素纤维、细菌纤维素纤维的一种或几种；所述微纳米粒子为纳米纤维素、明胶纳米粒子、铜纳米粒子、碳化硅纳米粒子的一种或几种。
8.一种由权利要求1-7中任一项所述的制备方法制备的水凝胶伤口敷料。
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