CN115418064B - 一种负压引流胶原/go/pva复合海绵及其制备方法 - Google Patents
一种负压引流胶原/go/pva复合海绵及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种负压引流胶原/GO/PVA复合海绵及其制备方法,本方案使用胶原(COL)对聚乙烯醇(PVA)进行改性,使改性PVA海绵具备良好的生物相容性;本方案中加入的氧化石墨烯(GO)利用微纳粒子对聚合物网络的增强作用提高海绵在水环境下的力学性能,同时利用GO的光热效应为海绵提供近红外光响应抗菌性;本方案创新性地采用低温发泡、液氮定向速冻、冷冻干燥技术组合:采用低温发泡,可防止胶原分子在高温下发生变性;发泡后迅速使用液氮进行定向速冻,不仅使泡沫被迅速固定,避免消泡现象,同时定向速冻对体系中的分子取向有一定的促进作用,可提高力学性能;最后,经冷冻干燥可得到兼具微孔与大孔的多层级结构,增强了海绵内部结构的贯通性。
Description
技术领域
本发明涉及生物医药材料技术领域,尤其涉及一种负压引流胶原/GO/PVA 复合海绵及其制备方法。
背景技术
负压引流技术作为一种重要的物理、非药物、非侵入、安全、有效的伤口愈合技术,其在过去的20年中得到了广泛的应用。研究表明负压引流技术有明显改善创面局部血液循环,促进肉芽组织生长的效果。通常负压封闭引流技术是在引流管外用医用泡沫材料包裹,使泡沫材料成为引流管和被引流腔隙或创面之间的中介,再利用具有生物阀功能的半透性粘贴薄膜封闭被引流区,使之与外界隔绝,接通高负压源,形成一个高效的引流系统,及时地清除被引流区的渗出物。
常用的负压引流敷料多为纯聚乙烯醇海绵和聚氨酯海绵,其内部密布彼此贯通的微孔,具有毛细虹吸作用。然而,聚氨酯海绵疏水性强,临床应用中仅能配合亲肤的隔离垫来使用。聚乙烯醇海绵具有较好的亲水性,但使用过程中也暴露出生物相容性不够理想、缺乏抗菌性等问题。
目前,已有一些针对聚乙烯醇负压引流海绵的技术报道,具有代表性的有:
专利“CN 109646705 B复合海绵及其制备方法和负压引流敷料、装置与医疗设备”,该技术公开了一种以海藻酸酯与聚乙烯醇为主要成分的复合海绵,通过海藻酸酯的加入,该复合海绵具备了较好的保水性。
专利“CN 106916333 B一种聚乙烯醇医用海绵及其制备方法”,该技术提供了一种利用淀粉改性聚乙烯醇医用海绵的方法。该医用海绵具有贯通开孔结构,且孔径均匀,生物相容性好、亲和性能佳、产品孔隙率高、吸液速率快。
专利“CN 107158450 A用于负压封闭引流的氧化石墨烯改性海绵”公开了一种用于负压封闭引流的氧化石墨烯改性海绵及其制备方法。氧化石墨烯改性海绵对大肠杆菌、金黄色葡萄球菌有抑菌效果,海绵中分散的石墨烯基体的表面有较强吸附作用,能吸收血液中的钙离子,从而限制了钙离子过多的流入细胞,破坏了正常的凝血过程,起到抗凝血的作用。
胶原(COL)是细胞外基质的主要结构蛋白,广泛存在于人体及动物体内。作为一种来源广泛的天然高分子材料,胶原具有许多优异的性能,如与细胞的高亲和力、与血小板产生血凝作用、可促进伤口收敛、可生物降解等。因此,使用胶原作为负压引流海绵的组分存在先天优势。
专利“CN109692340 A一种胶原双层结构海绵的制备方法”提及一种以胶原蛋白为原材料的胶原双层结构海绵的制备方法。该法以冷冻干燥方法制备双层胶原海绵。主要解决目前临床使用的负压引流装置不适宜形状不规则的创面,不能与伤口周边组织很好地接触融合的现象。
上述提及的公开技术方案虽然具有诸多优点,但是其依然还存在一定的技术局限性或缺点,例如:
专利“CN 107158450 A用于负压封闭引流的氧化石墨烯改性海绵”中,使用氧化石墨烯的作用主要是抗菌,但众所周知,氧化石墨烯的抗菌是很微弱的。使用氧化石墨烯的另一个目的是抗凝血,但有文献报道称氧化石墨烯具有引起血小板强烈聚集的止血作用,因此,该专利中氧化石墨烯的抗凝血作用没有充分说服力。
专利“CN109692340 A一种胶原双层结构海绵的制备方法”中,该法以冷冻干燥方法而非发泡法制备双层胶原海绵。冷冻干燥法得到的海绵孔径过小,不均匀,海绵力学强度低,变形后的回复性较差,在水环境和负压双重作用下极易坍塌,不能很好地满足负压引流的要求。同时需要指出的是,传统的发泡技术并不适用于胶原体系,这是由于传统的发泡通常在高温下进行,高温会导致胶原发生变性,丧失原有的生物活性。
发明内容
有鉴于此,本发明的目的在于提出一种工艺简单、实施可靠、生物相容性佳和在水环境下材料耐用性强的负压引流胶原/GO/PVA复合海绵及其制备方法。
为了实现上述的技术目的,本发明所采用的技术方案为:
一种胶原/GO/PVA复合海绵,其由预设量的OP-10、碳酸氢钠、甲醛和盐酸依次加入到聚乙烯醇/氧化石墨烯溶液中,且在预设温度下恒温搅拌混合,继而降低混合体系的恒温温度后,再加入胶原溶液继续搅拌混合,最后进行冷冻干燥,制得胶原/GO/PVA复合海绵。
作为一种可能的选择实施方式,进一步,本方案所述聚乙烯醇/氧化石墨烯溶液为聚乙烯醇溶液中混入预设量的氧化石墨烯溶胶制得,且聚乙烯醇/氧化石墨烯混合溶液中氧化石墨烯的浓度为0.03%~0.15%。
作为一种较优的选择实施方式,优选的,本方案所述聚乙烯醇溶液的浓度为50~150mg/mL。
作为一种较优的选择实施方式,优选的,本方案所述胶原溶液为胶原海绵溶解于0.1~0.5mol/L的醋酸溶液中制得,其浓度为20~80mg/mL。
基于上述,本发明还提供一种胶原/GO/PVA复合海绵的制备方法,其包括:将聚乙烯醇溶解于去离子水中,使之质量浓度为50~150mg/mL,制得聚乙烯醇溶液,然后往聚乙烯醇溶液中加入氧化石墨烯溶胶使氧化石墨烯在体系中的质量浓度达到0.03%~0.15%,制得聚乙烯醇/氧化石墨烯溶液,在混合均匀后再依次加入0.5~2mL OP-10作为乳化剂、1.5~5.5mL甲醛、0.75~2g碳酸氢钠,以500~1500r/min的转速进行搅拌溶解,搅拌预设时长后,加入盐酸溶液调节混合体系pH为3.8~5.8,然后继续搅拌至混合体系发泡体积达到预设程度;然后加入20~50mg/mL的胶原溶液至混合体系中,使胶原的质量占比(胶原: 胶原+PVA(w/w))为10%~50%(即,使胶原在胶原与聚乙烯醇混合物中的质量占比为10%~50%,),继续搅拌5~15min,将所制得溶液倒入模具,利用液氮定向冷冻装置速冻10~20min,将样品放入-50~-79℃的低温冰箱中进一步冷冻10~30min,使用冷冻干燥机在-50℃下冷干后,制得胶原/GO/PVA复合海绵。
作为一种较优的选择实施方式,优选的,本方案所述聚乙烯醇溶解于去离子水过程中,还通过油浴对混合体系进行加热至75~90℃,待搅拌至聚乙烯醇完全溶解后将聚乙烯醇溶液温度降至40~60℃。
作为一种较优的选择实施方式,优选的,本方案在加入胶原溶液前,还将混合体系温度快速降至25~35℃。
作为一种较优的选择实施方式,优选的,本方案所述盐酸的浓度为1mol/L。
基于上述,本发明还提供一种负压引流胶原/GO/PVA复合海绵,其由上述所述的制备方法制得。
基于上述,本发明还提供一种医用泡沫材料,其包括上述所述的胶原 /GO/PVA复合海绵。
术语简称说明:
本说明书中所提及的GO为氧化石墨烯的简称;PVA为聚乙烯醇的简称; COL为胶原的简称。
采用上述的技术方案,本发明与现有技术相比,其具有的有益效果为:
1、针对传统聚乙烯醇海绵生物相容性一般的问题,本方案使用胶原对聚乙烯醇进行改性,使改性聚乙烯醇(PVA)海绵具备良好的生物相容性;
2、本方案加入GO作为第二改性剂,但本方案技术中的GO承担的角色与作用机制相比专利“CN 107158450 A用于负压封闭引流的氧化石墨烯改性海绵”而言完全不同,本方案的GO一方面利用微纳粒子对聚合物网络的增强作用提高海绵在水环境下的力学性能,另一方面利用GO的光热效应提供近红外光响应抗菌性;
3、本方案创新性地采用低温发泡、液氮定向速冻、冷冻干燥工序组合;
采用低温发泡,可防止胶原分子在高温下发生变性;发泡后迅速使用液氮进行定向速冻,不仅使泡沫被迅速固定,避免消泡现象,同时定向速冻对体系中的分子取向有一定的促进作用,可提高力学性能;最后,经冷冻干燥可得到兼具微孔与大孔的多层级结构,增强了海绵内部结构的贯通性与力学性能,提高引流能力与水环境下的耐用性。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。
图1是本方案胶原/GO/PVA复合海绵的多层级孔状贯通结构示意图,其中,图a为纵切,图b为横切;
图2是本方案胶原/GO/PVA复合海绵水环境中形变恢复能力示意图,其反映了胶原/GO/PVA复合海绵在水环境中压缩72h后,仍能基本恢复原有高度;
图3是本方案胶原/GO/PVA复合海绵在近红外光照射下的抗菌性能,其反映了胶原/GO/PVA复合海绵在808nm的近红外光照射下,对E.coli具有优异的抑菌效果(抑菌率>90%)。
具体实施方式
下面结合附图和实施例,对本发明作进一步的详细描述。特别指出的是,以下实施例仅用于说明本发明,但不对本发明的范围进行限定。同样的,以下实施例仅为本发明的部分实施例而非全部实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例,都属于本发明保护的范围。
实施例1
本实施例一种胶原/GO/PVA复合海绵的制备方法,其包括:
将PVA溶于去离子水(50mL)中,使之质量浓度为150mg/mL,油浴加热至 90℃,搅拌至完全溶解后将温度降至60℃,加入GO溶胶使GO在体系中的质量浓度达到0.03%,混合均匀后依次加入0.5mL OP-10乳化剂、1.5mL甲醛、 0.75g碳酸氢钠,以500r/min的转速进行搅拌溶解。20min后,加入1moL/L 盐酸溶液调节体系pH为3.8。继续搅拌至体系发泡体积最大。将保温温度快速降至30℃,加入20mg/mL的胶原溶液至混合液中胶原的质量占比为10%,继续搅拌5min。将溶液倒入模具,利用液氮定向冷冻装置速冻20min,将样品放入-60℃的低温冰箱中进一步冷冻20min。使用冷冻干燥机在-50℃下冷干后,可得胶原/GO/PVA复合海绵。
实施例2
本实施例一种胶原/GO/PVA复合海绵的制备方法,其包括:
将PVA溶于去离子水(50mL)中,使之质量浓度为50mg/mL,油浴加热至 80℃,搅拌至完全溶解后将温度降至50℃,混入GO溶胶使GO在体系中的质量浓度达到0.15%,混合均匀后依次加入1mL OP-10乳化剂、3.5mL甲醛、 1.25g碳酸氢钠,以1500r/min的转速进行搅拌。20min后,加入1moL/L盐酸溶液调节体系pH为4.8。继续搅拌至体系发泡体积最大。将保温温度快速降至35℃,加入50mg/mL的胶原溶液至混合液中胶原的质量占比为50%,继续搅拌10min。将溶液倒入模具,利用液氮定向冷冻装置速冻15min,将样品放入-79℃的低温冰箱中进一步冷冻10min。使用冷冻干燥机在-50℃下冷干后,可得胶原/GO/PVA复合海绵。
将本实施例所制得的胶原/GO/PVA复合海绵进行SEM表征、吸水保水能力测试、水环境中形变恢复能力测试以及抗菌测试,其中,所得结果如图1至图3所示,其中,
图1是本方案胶原/GO/PVA复合海绵的多层级孔状贯通结构示意图,其中,图a为纵切,图b为横切;
图2是本方案胶原/GO/PVA复合海绵水环境中形变恢复能力示意图,其反映了胶原/GO/PVA复合海绵在水环境中压缩72h后,仍能基本恢复原有高度;
图3是本方案胶原/GO/PVA复合海绵在近红外光照射下的抗菌性能,其反映了胶原/GO/PVA复合海绵在808nm的近红外光照射下,对E.coli具有优异的抑菌效果(抑菌率>90%)。
由测试结果可以获知,本方案将胶原与氧化石墨烯共同改性聚乙烯醇海绵用作负压引流海绵,其改善了聚乙烯醇海绵生物相容性与力学性能,还赋予了聚乙烯醇海绵光响应抗菌性;采取低温发泡后进行液氮定向速冻固定泡沫,而后进行冷冻干燥的创新工艺,可得到力学强度好,具有多层次孔道结构的海绵产品。
实施例3
本实施例一种胶原/GO/PVA复合海绵的制备方法,其包括:
将PVA溶于去离子水(50mL)中,使之质量浓度为100mg/mL,油浴加热至 75℃,搅拌至完全溶解后将温度降至40℃,混入GO溶胶使GO在体系中的质量浓度达到0.10%,混合均匀后依次加入2mL OP-10乳化剂、5.5mL甲醛、2 g碳酸氢钠,以1000r/min的转速进行搅拌。20min后,加入1moL/L盐酸溶液调节体系pH为5.8。继续搅拌至体系发泡体积最大。将保温温度快速降至 25℃,加入35mg/mL的胶原溶液至混合液中胶原的质量占比为30%,继续搅拌15min。将溶液倒入模具,利用液氮定向冷冻装置速冻5min,将样品放入 -20℃的低温冰箱中进一步冷冻30min。使用冷冻干燥机在-50℃下冷干后,可得胶原/GO/PVA复合海绵。
以上所述仅为本发明的部分实施例,并非因此限制本发明的保护范围,凡是利用本发明说明书及附图内容所作的等效装置或等效流程变换,或直接或间接运用在其他相关的技术领域,均同理包括在本发明的专利保护范围内。
Claims (7)
1.一种胶原/GO/PVA复合海绵,其特征在于,其由预设量的OP-10、碳酸氢钠、甲醛和盐酸依次加入到聚乙烯醇/氧化石墨烯溶液中,且在预设温度下恒温搅拌混合,继而降低混合体系的恒温温度后,再加入胶原溶液继续搅拌混合,最后进行冷冻干燥,制得胶原/GO/PVA复合海绵;
其中,所述聚乙烯醇/氧化石墨烯溶液为聚乙烯醇溶液中混入预设量的氧化石墨烯溶胶制得,且聚乙烯醇/氧化石墨烯混合溶液中氧化石墨烯的浓度为0.03%~0.15%;
所述聚乙烯醇溶液的浓度为50~150 mg/mL;
所述胶原溶液为胶原海绵溶解于0.1~0.5 mol/L的醋酸溶液中制得,其浓度为20~80mg/mL;
所述胶原在胶原与聚乙烯醇混合物中的质量占比为10%~50%。
2.一种胶原/GO/PVA复合海绵的制备方法,其特征在于,其包括:将聚乙烯醇溶解于去离子水中,使之质量浓度为50~150 mg/mL,制得聚乙烯醇溶液,然后往聚乙烯醇溶液中加入氧化石墨烯溶胶使氧化石墨烯在体系中的质量浓度达到0.03%~0.15%,制得聚乙烯醇/氧化石墨烯溶液,在混合均匀后再依次加入0.5~2 mL OP-10作为乳化剂、1.5~5.5 mL甲醛、0.75~2g碳酸氢钠,以500~1500 r/min的转速进行搅拌溶解,搅拌预设时长后,加入盐酸溶液调节混合体系pH为3.8~5.8,然后继续搅拌至混合体系发泡体积达到预设程度;然后加入20~80 mg/mL的胶原溶液至混合体系中,使胶原在胶原与聚乙烯醇混合物中的质量占比为10%~50%,继续搅拌5~15 min,将所制得溶液倒入模具,利用液氮定向冷冻装置速冻10~20 min,将样品放入-50~-79 ℃的低温冰箱中进一步冷冻10~30 min,使用冷冻干燥机在-50 ℃下冷干后,制得胶原/GO/PVA复合海绵。
3.如权利要求2所述的胶原/GO/PVA复合海绵的制备方法,其特征在于,所述聚乙烯醇溶解于去离子水过程中,还通过油浴对混合体系进行加热至75~90 ℃,待搅拌至聚乙烯醇完全溶解后将聚乙烯醇溶液温度降至40~60 ℃。
4.如权利要求3所述的胶原/GO/PVA复合海绵的制备方法,其特征在于,在加入胶原溶液前,还将混合体系温度快速降至25~35 ℃。
5.如权利要求2所述的胶原/GO/PVA复合海绵的制备方法,其特征在于,所述盐酸的浓度为1 mol/L。
6.一种负压引流胶原/GO/PVA复合海绵,其特征在于,其由权利要求2至5之一所述的制备方法制得。
7.一种医用泡沫材料,其特征在于,其包括权利要求6所述的负压引流胶原/GO/PVA复合海绵。
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