CN108310452A - 一种温敏性葡聚糖基水凝胶及其制备方法 - Google Patents
一种温敏性葡聚糖基水凝胶及其制备方法 Download PDFInfo
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- CN108310452A CN108310452A CN201810318950.7A CN201810318950A CN108310452A CN 108310452 A CN108310452 A CN 108310452A CN 201810318950 A CN201810318950 A CN 201810318950A CN 108310452 A CN108310452 A CN 108310452A
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- hydrogel
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Landscapes
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Abstract
本发明属于医用功能性敷料技术领域,具体涉及一种温敏性葡聚糖基水凝胶及其制备方法,所述温敏性葡聚糖基水凝胶是以单宁酸为交联剂,由温敏性水凝胶和葡聚糖形成的双网络凝胶。其具有温敏性、抗菌特性,可实现药物可控释放,随着发生炎症部位局部温度变化而灵活控制药物释放,并且能吸附伤口渗出液、生物相容性好、表面润滑性能佳,在临床更换时不易造成伤口的二次伤害,并具有生物可降解性,不会造成环境污染。
Description
技术领域
本发明属于医用敷料领域,具体涉及一种温敏性葡聚糖基水凝胶及其制备方法。
背景技术
传统的伤口敷料如纱布、药棉等容易黏连在伤口部位,在更换或拆除敷料时容易造成伤口肉芽组织的二次损伤。伤口敷料在创面周围应可提供并保持一个潮湿的环境,能够进行气体交换,同时能对外源污染物及微生物等起到阻隔作用。理想的伤口敷料材料应无毒、不黏连,不引起机体过敏反应,具有抗菌性、溶胀吸收性等。
水凝胶是一种高分子网络体系,具有网状交联结构,性质柔软,能保持一定的形状,吸收大量的水并且具有较强的保水能力。而且,水凝胶对水和氧气有很好的透过性能,有良好的生物相容性。水凝胶的密度与生物体器官组织的相似,因而有良好的力学性能和生物相容性。水凝胶材料直接与人体组织接触,可防止体外微生物的感染,控制体液流失,并且能输送氧气到伤口,促进伤口愈合。
然而,普通水凝胶孔隙率低,透气性不好,载药量低,机械性能差,急需一种生物安全的方式来改善现有水凝胶的性能。
生物来源的葡聚糖具有无毒、良好的生物相容性和生物可降解性,抗菌,不会引起生物组织体免疫反应,是一种理想的水凝胶原料。温敏性葡聚糖基水凝胶能随着伤口或炎症部位温度的升高或降低而加快或减慢药物的释放,实现药物的可控释放。
发明内容
针对上述问题,本发明提供一种温敏性葡聚糖基水凝胶敷料,该敷料具有良好的保湿性、透气性、机械性能和缓释性能,在医用敷料领域具有广泛的应用。
为达到上述目的,本发明采用如下技术方案:
一种温敏性葡聚糖基水凝胶,所述温敏性葡聚糖基水凝胶是以单宁酸为交联剂,由温敏性水凝胶和葡聚糖形成的双网络凝胶。
优选的,所述温敏性葡聚糖基水凝胶为多孔温敏性葡聚糖基水凝胶。
优选的,所述温敏性水凝胶为聚N-异丙基丙烯酰胺水凝胶、聚丙烯酸卡必酯水凝胶、聚丙烯酸羟丙酯水凝胶或聚乙烯基吡咯烷酮水凝胶。
优选的,所述温敏性葡聚糖基水凝胶中还含有活性药物成分。
优选的,所述活性药物成分为小分子药物、蛋白质、肽、基因、抗体、麻醉剂、疫苗、多糖合成无机化合物中的一种或几种。
优选的,所述小分子药物为环丙沙星、阿司匹林、左氧氟沙星或诺氟沙星中的一种或几种。
优选的,所述蛋白质为胰岛素。
本发明提供一种上述温敏性葡聚糖基水凝胶的制备方法,包括以下步骤:
(1)配置含温敏性水凝胶单体5~10% wt、N,N-亚甲基丙烯酰胺0.1~1% wt的水溶液并混合均匀,得到混合溶液,之后加入质量分数为3~10%的过硫酸铵水溶液并混合均匀,所述过硫酸铵水溶液与所述混合溶液的体积比为1~7:100;
(2)向步骤(1)得到的溶液中加入四甲基乙二胺,混合均匀后静置,得到温敏性水凝胶;所述四甲基乙二胺与步骤(1)得到的溶液体积比为0.8~6:100;
(3)将所述温敏性水凝胶放入单宁酸和葡聚糖混合水溶液中静置,即得所述温敏性葡聚糖基水凝胶;所述单宁酸和葡聚糖混合水溶液中,单宁酸的质量分数为0.2~4%,葡聚糖的质量分数为1~60%。
优选的,步骤(1)所述温敏性水凝胶单体为N-异丙基丙烯酰胺、丙烯酸卡必酯、丙烯酸羟丙酯或乙烯基吡咯烷酮。
优选的,步骤(1)所述交联剂为N,N-亚甲基丙烯酰胺、N-羟甲基丙烯酰胺、双丙酮丙烯酰胺或聚乙二醇双丙烯酸酯。
优选的,步骤(1)所述引发剂为过硫酸铵或过硫酸钾。
优选的,所述葡聚糖的分子量≤5000。
优选的,步骤(2)所述的静置时间为10~60min;步骤(3)所述的静置时间为10~60min。
优选的,步骤(1)所述的混合溶液还含有0.8~4% wt的NaHCO3,并且步骤(3)完成后,再将所得到温敏性葡聚糖基水凝胶浸泡在温度大于等于50℃的热水中,静置1~10min后再浸泡在冷水中使其恢复原状,所述冷水的温度为10~30℃。所加入的NaHCO3可使得得到的温敏性葡聚糖基水凝胶具有多孔结构。
优选的,步骤(3)完成后,还可以将所得到的温敏性葡聚糖基水凝胶置于-25~-60℃真空冷冻干燥10~60min。同样可以得到多孔结构的温敏性葡聚糖基水凝胶。
优选的,步骤(1)所述的混合溶液还含有0.3~4% wt的聚乙二醇(polyethyleneglycol,PEG),并且在步骤(2)和步骤(3)之间还包括将所述温敏性水凝胶中的聚乙二醇用水置换出的步骤,所述的置换方法为:将所述温敏性水凝胶浸泡于清水中10~30min,之后取出再重新浸泡于清水中,共浸泡2~6次。同样可以得到多孔结构的温敏性葡聚糖基水凝胶。
优选的,步骤(3)所述的单宁酸和葡聚糖混合水溶液还含有0.3~40% wt的活性药物成分。
本发明的有益效果为:
本发明所提供的温敏性葡聚糖基水凝胶敷料,具有抗菌、消炎的功效,能保持伤口出水分,能吸收伤口的渗出液,而且不与伤口粘连,因此换药时不会破坏新生的肉芽或上皮组织,所采用原料安全无毒副作用。
并且,本发明所提供的温敏性葡聚糖基水凝胶敷料以单宁酸为交联剂,添加葡聚糖,形成双网络凝胶,其机械性能也较高,不易损坏。
可实现药物可控释放,随着发生炎症部位局部温度变化而灵活控制药物释放,并且能吸附伤口渗出液、生物相容性好、表面润滑性能佳,具有生物可降解性,不会造成环境污染。
所制备的多孔温敏性葡聚糖基水凝胶敷料,由于其具备多孔结构,透气性能更好,不易滋生细菌,更加有利于伤口的愈合。
附图说明
图1是所述温敏性葡聚糖基水凝胶在热水和冷水中的形状变化对比图,其中,右图为温敏性葡聚糖基水凝胶在冷水中,左图为温敏性葡聚糖基水凝胶在50℃中。
图2是实施例9所测的温度对水凝胶直径大小的影响图。
图3是实施例10所测的水凝胶的受力曲线图,其中曲线1为葡聚糖基水凝胶的受力曲线,曲线2为不含葡聚糖的水凝胶的受力曲线。
图4是实施例1所制备的多孔温敏性葡聚糖基水凝胶的扫描电镜图。
具体实施方式
实施例1 制备多孔温敏性葡聚糖基水凝胶
(1)配置质量分数为5%的过硫酸铵水溶液,然后用4.5ml去离子水配置含质量分数6.6%的N-异丙基丙烯酰胺和0.33%的N,N-亚甲基丙烯酰胺的混合溶液。所得的混合溶液在旋转振荡器上混匀后,迅速加入135μL所配置的过硫酸铵水溶液并迅速在旋转振荡器上混匀,所加入的过硫酸铵溶液与混合溶液的体积比为3:100。
(2)向步骤(1)得到的溶液中加入四甲基乙二胺,四乙基二胺与步骤(1)得到的溶液的体积比为2:100。所得的溶液迅速在旋转振荡器上混匀后,迅速倒入模具中,静置30min,得到温敏性水凝胶。
(3)将成型的水凝胶从模具中取出,放入含单宁酸0.3%wt和葡聚糖10%wt的混合溶液中静置60min,葡聚糖的平均分子量为5000。静置后得到温敏性葡聚糖基水凝胶。
(4)将所得的温敏性葡聚糖基水凝胶置于真空冷冻干燥机中,于-60℃冷冻干燥10min。
实施例2 制备多孔温敏性葡聚糖基水凝胶
(1)配置质量分数为5%的过硫酸铵水溶液,用4.5ml去离子水配置含质量分数6.6%的N-异丙基丙烯酰胺,0.33%的N,N-亚甲基丙烯酰胺和1%的NaHCO3的混合溶液。所得的混合溶液在旋转振荡器上混匀后,迅速加入135μL所配置的过硫酸铵水溶液并迅速在旋转振荡器上混匀,所加入的过硫酸铵溶液与混合溶液的体积比为3:100。
(2)向步骤(1)得到的溶液中加入四甲基乙二胺,四乙基二胺与步骤(1)得到的溶液的体积比为2:100。所得的溶液迅速在旋转振荡器上混匀后,迅速倒入模具中,静置30min,得到温敏性水凝胶。
(3)将成型的水凝胶从模具中取出,放入含单宁酸0.3%wt和葡聚糖3%wt混合溶液中静置60min,葡聚糖的平均分子量小于5000。
(4)将所得的温敏性葡聚糖基水凝胶浸泡在50℃的热水中,静置5min,再将其浸泡在10℃的冷水中使其恢复原状。
实施例3制备多孔温敏性葡聚糖基水凝胶
(1)用0.1ml去离子水配置质量分数为3%的过硫酸钾溶液,用10ml去离子水配置含质量分数5%的丙烯酸卡必酯和0.1%的N-羟甲基丙烯酰胺的混合溶液。所得的混合溶液在旋转振荡器上混匀后,迅速加入所配置的过硫酸钾溶液并迅速在旋转振荡器上混匀。
(2)向步骤(1)得到的溶液中加入四甲基乙二胺,四乙基二胺与步骤(1)得到的溶液的体积比为0.8:100。所得的溶液迅速在旋转振荡器上混匀后,迅速倒入模具中,静置10min,得到温敏性水凝胶。
(3)将成型的水凝胶从模具中取出,放入含单宁酸0.2%wt、葡聚糖1%wt和环丙沙星0.3%wt的混合溶液中静置60min,葡聚糖的平均分子量小于5000。静置后得到温敏性葡聚糖基水凝胶。
(4)将所得的温敏性葡聚糖基水凝胶置于真空冷冻干燥机中,于-25℃冷冻干燥60min。
实施例4制备多孔温敏性葡聚糖基水凝胶
(1)用1ml去离子水配置质量分数为10%的过硫酸钾溶液,用20ml去离子水配置含质量分数10%的丙烯酸羟丙酯,1%的双丙酮丙烯酰胺和0.8%的NaHCO3的混合溶液。所得的混合溶液在旋转振荡器上混匀后,迅速加入所配置的过硫酸钾溶液并迅速在旋转振荡器上混匀。
(2)向步骤(1)得到的溶液中加入四甲基乙二胺,四乙基二胺与步骤(1)得到的溶液的体积比为6:100。所得的溶液迅速在旋转振荡器上混匀后,迅速倒入模具中,静置60min,得到温敏性水凝胶。
(3)将成型的水凝胶从模具中取出,放入含单宁酸4%wt、葡聚糖60%wt和胰岛素2%wt的混合溶液中静置40min,葡聚糖的平均分子量小于5000。
(4)将所得的温敏性葡聚糖基水凝胶浸泡在80℃的热水中,静置1min,再将其浸泡在30℃的冷水中使其恢复原状。
实施例5制备多孔温敏性葡聚糖基水凝
(1)用0.7ml去离子水配置质量分数为7%的过硫酸铵溶液,用10ml去离子水配置含质量分数8%的乙烯基吡咯烷酮,0.6%的聚乙二醇双丙烯酸酯和4%的NaHCO3的混合溶液。所得的混合溶液在旋转振荡器上混匀后,迅速加入所配置的过硫酸铵溶液并迅速在旋转振荡器上混匀。
(2)向步骤(1)得到的溶液中加入四甲基乙二胺,四乙基二胺与步骤(1)得到的溶液的体积比为4:100。所得的溶液迅速在旋转振荡器上混匀后,迅速倒入模具中,静置40min,得到温敏性水凝胶。
(3)将成型的水凝胶从模具中取出,放入含单宁酸1%wt、葡聚糖6%wt和人工干扰素10%wt混合溶液中静置10min,葡聚糖的平均分子量小于5000。
(4)将所得的温敏性葡聚糖基水凝胶浸泡在80℃的热水中,静置10min,再将其浸泡在20℃的冷水中使其恢复原状。
实施例6制备多孔温敏性葡聚糖基水凝
(1)用0.2ml去离子水配置质量分数为4%的过硫酸铵溶液,用10ml去离子水配置含质量分数7%的N-异丙基丙烯酰胺,0.8%的双丙酮丙烯酰胺和0.3%的聚乙二醇的混合溶液。所得的混合溶液在旋转振荡器上混匀后,迅速加入所配置的过硫酸铵溶液并迅速在旋转振荡器上混匀。
(2-1)向步骤(1)得到的溶液中加入四甲基乙二胺,四乙基二胺与步骤(1)得到的溶液的体积比为1:100。所得的溶液迅速在旋转振荡器上混匀后,迅速倒入模具中,静置20min,得到温敏性水凝胶。
(2-2)将成型的水凝胶从模具中取出,然后所述温敏性水凝胶浸泡于清水中10min,之后取出再重新浸泡于清水中,共浸泡6次,将所述温敏性水凝胶中的聚乙二醇用水置换出。
(3)将水凝胶放入含单宁酸0.5%wt、葡聚糖20%wt和麻醉剂40%混合溶液中静置20min,葡聚糖的平均分子量小于5000。
实施例7制备多孔温敏性葡聚糖基水凝
(1)用0.6ml去离子水配置质量分数为6%的过硫酸铵溶液,用10ml去离子水配置含质量分数9%的丙烯酸卡必酯,0.2%的N-羟甲基丙烯酰胺和4%的聚乙二醇的混合溶液。所得的混合溶液在旋转振荡器上混匀后,迅速加入所配置的过硫酸铵溶液并迅速在旋转振荡器上混匀。
(2-1)向步骤(1)得到的溶液中加入四甲基乙二胺,四乙基二胺与步骤(1)得到的溶液的体积比为2:100。所得的溶液迅速在旋转振荡器上混匀后,迅速倒入模具中,静置30min,得到温敏性水凝胶。
(2-2)将成型的水凝胶从模具中取出,然后所述温敏性水凝胶浸泡于清水中30min,之后取出再重新浸泡于清水中,共浸泡2次,将所述温敏性水凝胶中的聚乙二醇用水置换出。
(3)将水凝胶放入含单宁酸2%wt、葡聚糖40%wt和疫苗40%混合溶液中静置50min,葡聚糖的平均分子量小于5000。
实施例8制备温敏性葡聚糖基水凝
(1)配置质量分数为5%的过硫酸铵水溶液,然后用4.5ml去离子水配置含质量分数6.6%的N-异丙基丙烯酰胺和0.33%的N,N-亚甲基丙烯酰胺的混合溶液。所得的混合溶液在旋转振荡器上混匀后,迅速加入135μL所配置的过硫酸铵水溶液并迅速在旋转振荡器上混匀,所加入的过硫酸铵溶液与混合溶液的体积比为3:100。
(2)向步骤(1)得到的溶液中加入四甲基乙二胺,四乙基二胺与步骤(1)得到的溶液的体积比为2:100。所得的溶液迅速在旋转振荡器上混匀后,迅速倒入模具中,静置30min,得到温敏性水凝胶。
(3)将成型的水凝胶从模具中取出,放入含单宁酸0.3%wt和葡聚糖10%wt的混合溶液中静置60min,葡聚糖的平均分子量为5000。静置后得到温敏性葡聚糖基水凝胶。
实施例9
本实施例大致上采用如前述实施例1所述的方法制备温敏性葡聚糖基水凝胶,不同之处在于另外制备一份不含葡聚糖的水凝胶,即去掉步骤(3)和(4)。在水浴锅中调节温度,测两种水凝胶直径随温度的变化。
温敏性葡聚糖基水凝胶在36-37℃的温水中,明显缩小,接近人体温度,达到药物可控释放的效果。
实施例10
本实施例大致上采用如前述实施例1所述的方法制备葡聚糖基水凝胶,不同之处在于另外制备一份不含葡聚糖的水凝胶,即去掉步骤(3)和(4)。
采用万能拉力机测两种水凝胶承受压力的程度。结果显示添加葡聚糖的温敏性水凝胶比普通不含葡聚糖的水凝胶承受大约20N的压力,说明葡聚糖基水凝胶机械性能明显提高。
Claims (10)
1.一种温敏性葡聚糖基水凝胶,其特征在于,所述温敏性葡聚糖基水凝胶是以单宁酸为交联剂,由温敏性水凝胶和葡聚糖形成的双网络凝胶;优选的,所述温敏性葡聚糖基水凝胶为多孔温敏性葡聚糖基水凝胶。
2.根据权利要求1所述的温敏性葡聚糖基水凝胶,其特征在于,所述的温敏性水凝胶为聚N-异丙基丙烯酰胺水凝胶、聚丙烯酸卡必酯水凝胶、聚丙烯酸羟丙酯水凝胶或聚乙烯基吡咯烷酮水凝胶。
3.根据权利要求1所述的温敏性葡聚糖基水凝胶,其特征在于,所述温敏性葡聚糖基水凝胶中还含有活性药物成分;优选的活性药物成分为小分子药物、蛋白质、肽、基因、抗体、麻醉剂、疫苗、多糖或合成无机化合物中的一种或几种;优选的小分子药物为环丙沙星、阿司匹林、左氧氟沙星或诺氟沙星中的一种或几种。
4.一种权利要求1-3任一所述的温敏性葡聚糖基水凝胶的制备方法,包括以下步骤:
(1)配置含温敏性水凝胶单体5~10% wt、交联剂0.1~1% wt的水溶液并混合均匀,得到混合溶液,之后加入质量分数为3~10%的引发剂水溶液并混合均匀,所述引发剂水溶液与所述混合溶液的体积比为1~7:100;优选的所述温敏性水凝胶单体为N-异丙基丙烯酰胺、丙烯酸卡必酯、丙烯酸羟丙酯或乙烯基吡咯烷酮;优选的所述交联剂为N,N-亚甲基丙烯酰胺、N-羟甲基丙烯酰胺、双丙酮丙烯酰胺或聚乙二醇双丙烯酸酯;优选的所述引发剂为过硫酸铵或过硫酸钾。
(2)向步骤(1)得到的溶液中加入四甲基乙二胺,混合均匀后静置,得到温敏性水凝胶;所述四甲基乙二胺与步骤(1)得到的溶液体积比为0.8~6:100;
(3)将所述温敏性水凝胶放入单宁酸和葡聚糖混合水溶液中静置,即得所述温敏性葡聚糖基水凝胶;所述单宁酸和葡聚糖混合水溶液中,单宁酸的质量分数为0.2~4%,葡聚糖的质量分数为1~60%。
5.根据权利要求4所述的方法,其特征在于,所述葡聚糖的分子量≤5000。
6.根据权利要求4所述的方法,其特征在于,步骤(2)所述的静置时间为10~60min;步骤(3)所述的静置时间为10~60min。
7.根据权利要求4所述的方法,其特征在于,步骤(3)所述的单宁酸和葡聚糖混合水溶液还含有0.3~40%wt的活性药物成分。
8.根据权利要求4-7任一所述的方法,其特征在于,步骤(1)所述的混合溶液还含有0.8~4% wt的NaHCO3,并且步骤(3)完成后,再将所得到温敏性葡聚糖基水凝胶浸泡在温度大于等于50℃的热水中,静置1~10min后再浸泡在冷水中使其恢复原状,所述冷水的温度为10~30℃。
9.根据权利要求4-7任一所述的方法,其特征在于,步骤(3)完成后,将所得到的温敏性葡聚糖基水凝胶置于-25~-60℃真空冷冻干燥10~60min。
10.根据权利要求4-7任一所述的方法,其特征在于,步骤(1)所述的混合溶液还含有0.3~4% wt的聚乙二醇,并且在步骤(2)和步骤(3)之间还包括将所述温敏性水凝胶中的聚乙二醇用水置换出的步骤,所述的置换方法为:将所述温敏性水凝胶浸泡于清水中10~30min,之后取出再重新浸泡于清水中,共浸泡2~6次。
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