CN114748683A - 用于制备烧创伤敷料的组合物及其制剂和制备方法 - Google Patents
用于制备烧创伤敷料的组合物及其制剂和制备方法 Download PDFInfo
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- CN114748683A CN114748683A CN202210442357.XA CN202210442357A CN114748683A CN 114748683 A CN114748683 A CN 114748683A CN 202210442357 A CN202210442357 A CN 202210442357A CN 114748683 A CN114748683 A CN 114748683A
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- wound dressing
- burn wound
- silk fibroin
- water
- dressing
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Abstract
本发明属于医用药品技术领域,具体涉及用于制备烧创伤敷料的组合物及其制剂和制备方法。本发明的烧创伤敷料是以丝素蛋白作为抗氧化剂,负载到壳聚糖‑吸水分子的骨架上,制备出多孔非对称的具有抗氧化保湿功能的烧创伤敷料。该烧创伤敷料中丝素蛋白、骨架和辅料按照1:2~10:0.1~5的质量比组成;所述骨架为壳聚糖‑吸水聚合物骨架;所述壳聚糖和吸水聚合物按照1:0.1~5的质量比组成。本发明烧创伤敷料能促进氧化应激微环境下慢性难愈合创面的愈合,是一种集聚高保湿、高强度、透气性、阻隔性以及易揭性等优势的新型复合型敷料。该敷料通过冻干制备完成,制备工艺简单、成本低廉、治疗效果突出、烧创伤安全性好,具有显著的医用价值和产业化潜力。
Description
技术领域
本发明属于烧创伤医药领域,具体涉及用于制备烧创伤敷料的组合物及其制剂和制备方法。
背景技术
烧伤是人类的重大灾难性事件之一,也是全球第四大常见创伤。烧伤后严重的高代谢反应以及抗氧化和细胞防御机制的损伤,局部或者全身氧化应激反应对患者创面恢复具有很重要的影响,会造成烧伤伤口长期处于炎症浸润状态,创面不愈合、瘢痕化,甚至导致多器官衰竭等严重后果。
众所周知氧化应激反应是过量的活性氧(ROS)对伤口部位的DNA、脂质、蛋白质和碳水化合物造成严重破坏。因此,不平衡的ROS改变细胞功能,导致信号传导通路异常,诱发炎症和瘢痕挛缩。目前,已经证明,与其他烧伤创面处理方法相比,抗氧化剂治疗可以最大限度地减少烧伤病理生理学方面的损害,比如组织脂质过氧化,组织坏死,降低死亡率。然而,烧伤引起真皮挛缩/纤维化仍然是临床面临的主要挑战。
在病理条件下,ROS主要由线粒体产生,导致细胞内产生过多的活性氧,从而诱导细胞氧化还原不受调控,导致纤维化。然而,现有的抗氧化策略侧重于细胞外活性氧的淬灭,很少使用烧伤敷料在细胞内/外协同作用调节活性氧。
人们已经清楚地认识到,烧创伤系统中的抗氧化防御能够精确地协同调节来自不同细胞产生的活性氧,例如:1)抗氧化酶(超氧化物歧化酶(SODs)、过氧化氢酶(CAT)、谷胱甘肽过氧化物酶(GSH-Px)和血红素催化酶以及多种金属配位蛋白能使高活性的活性氧分解为惰性分子H2O和O2;2)天然细胞外基质(透明质酸,HA)通过介导主要氧化还原转录因子、核因子NF-E2相关因子(Nrf2)清除细胞内活性氧;3)小分子抗氧化剂如维生素E(VE),可以精确地渗透到膜中,终止阻止脂质过氧化的连锁反应。因此,体内的抗氧化系统可以精确地对抗来自不同细胞的不平衡ROS,以保持体内氧化和抗氧化的平衡。但目前为止,很少有研究探索用于皮肤伤口护理的仿生抗氧化防御敷料。
人工纳米酶材料在抗氧化损伤方面取得了蓬勃发展,例如金纳米材料、氧化铈纳米颗粒、纳米二氧化锰等,它们表现出强大的活性氧清除活性。然而,这些被使用的材料不仅由于其纳米尺寸导致细胞毒性和炎症,而且缺乏护理伤口的活性。
在生理条件下,创伤愈合涉及许多复杂的过程诸如止血、炎症、新的组织形成和皮肤附属器官重塑等。理想的伤口敷料应促进伤口愈合,保持水分,维持电解质平衡和止血,它不仅可以提供类似的细胞外基质(ECM),还可以迅速覆盖伤口,防止细菌和其他病原体入侵伤口。最重要的是,这种烧伤敷料应具有良好的烧创伤安全性,可以通过降低创面氧化应激反应,维持烧伤创面所需的组织微环境,从而促进坏死焦痂组织的自溶清创,防止伤口坏死,促进细胞增殖和迁移,敷料的原材料来源丰富,便于规模化生产。因此,针对上述抗氧化作用的纳米材料进行工业化生产,应用于临床治疗烧伤诱导氧化应激皮肤损伤仍然是一个挑战。
公开号为JP2015165919A的发明专利公开了一种伤口覆盖材料。该发明的目的是提供一种具有一定的生物相容性和保水性以及较高强度的伤口敷料。其利用丝素蛋白多孔体所具有的吸收渗液能力,对皮肤的刺激性小以及透气性的特点解决了伤口组织液渗漏引发的问题,但对于烧创伤诱导的氧化应激反应仍不能有效解决。
发明内容
为解决上述问题,本发明选用具有良好的修复作的丝素蛋白,对其进行研究发现,经过改性后的丝素蛋白具有广谱抗氧化作用,并且发现将改性后的丝素蛋白加热抗氧化作用显著增强。因此,本发明选用丝素蛋白用于降低创面的氧化应激反应,将加热后的丝素蛋白负载到壳聚糖(CTS)-吸水聚合物骨架上,再用硬脂酸(SA)修饰海绵光滑面,制备出具有抗氧化以及保湿功能的烧创伤敷料,将其命名为CTS-GEL/SF/SA。
本发明的目的之一,在于提供一种用于制备烧创伤敷料的组合物。
为实现上述目的,本发明采取以下技术方案:
所述组合物由丝素蛋白和骨架按照1:2~10的质量比组成;所述骨架为壳聚糖-吸水聚合物骨架;所述壳聚糖和吸水聚合物按照1:0.1~5的质量比组成。
进一步,所述丝素蛋白为天然丝素蛋白和/或改性丝素蛋白;所述改性丝素蛋白选自部分去除或完全去除钙的丝素蛋白、加热处理的丝素蛋白及其衍生物、紫外照射的丝素蛋白及其衍生物、有机溶剂处理的丝素蛋白及其衍生物中的任一种或几种。
进一步,所述吸水聚合物选为天然吸水聚合物和/或人工合成吸水聚合物,所述天然吸水聚合物选自胶原、明胶、纤维素及其衍生物,所述人工合成吸水聚合物选自聚乙二醇、聚丙烯酰胺、聚丙烯酸钠或聚乙烯醇。
进一步,所述聚乙二醇优选PEG-400,PEG-600,PEG-1500,PEG-4000,PEG-6000,PEG-20000中的一种或几种。
进一步,所述壳聚糖选自酸溶性壳聚糖、和/或水溶性壳聚糖、和/或酐类改性壳聚糖衍烧创伤、和/或高脱乙酰度壳聚糖、和/或经过酸酐类化合物修饰的壳聚糖。
本发明的目的之二,在于提供一种用于制备烧创伤敷料的制剂组合物。
为实现上述目的,本发明采取以下技术方案:
所述制剂组合物由上述丝素蛋白、骨架和辅料按照1:2~10:0.1~5的质量比组成;所述辅料为增塑剂。
进一步,所述增塑剂选自甘油、丙二醇或山梨醇。
进一步,所述乳化剂选自聚氧乙烯醚、环氧乙烷嵌段共聚物、多元醇脂肪酸酯或聚乙烯醇。
本发明的目的之三,在于提供一种用上述组合物或上述制剂组合物制备烧创伤敷料的方法,该制备烧创伤敷料的方法中间无须分离纯化过程,既节约成本,方便质控,又利于大规模生产。
为实现上述目的,本发明采取以下技术方案:
基于一种制备烧创伤敷料的方法,具体包括以下步骤:
1)制备丝素蛋白溶液;
2)将S1所得物与骨架和辅料混合。
进一步,在S2之后还包括S3将S2所得物用硬脂酸改性。
进一步,所述S1为制备上述改性丝素蛋白,在温度为60℃~120℃,时间为1~12h的条件下进行加热,冷却备用;
进一步,所述S2为将S1所得物与上述骨架和辅料混合,然后搅拌乳化,倒入磨具中,在-4℃冷冻4~24h,-20℃冷冻6~12h,-80℃冷冻6~12h的条件下用冻干,即得。
进一步,所述S3为将S2获得的烧创伤敷料在水中完全溶胀后,用硬脂酸溶液滴在其表面,后用无水乙醇冲洗,-20℃放置2h,-70℃条件下放置6h后再冻干,干燥,即得。
进一步,所述S1在制备过程中加入了钙的螯合剂或能与钙发生螯合作用氨基酸;所述钙的螯合剂为EDTA及其衍生物、EGTA AM及其衍生物、BAPTA及其衍生物;所述能与钙发生螯合作用氨基酸包括谷氨酸、丙氨酸、天冬氨酸、苯丙氨酸、天冬酰胺氨酸、精氨酸、苏氨酸、酪氨酸、色氨酸、甘氨酸、丝氨酸、缬氨酸、组氨酸、异亮氨酸和半胱氨酸及其衍生物中的任一种或几种。
本发明的目的之四,在于提供一种烧创伤敷料,该烧创伤敷料具有广谱抗氧化作用,能促进氧化应激微环境下慢性难愈合创面的愈合,集聚保湿性、高强度、透气性、阻隔性以及易揭性等特点。
为实现上述目的,本发明采取以下技术方案:
用上述制备烧创伤敷料的方法获得的烧创伤敷料。
进一步,所述烧创伤敷料为多孔结构,其孔隙率为55%~80%,其孔径大小为0.5 mm~2 mm。
进一步,所述烧创伤敷料的吸水倍率为1~20倍;其吸水倍率可用如下公式计算:Q=(M2-M1)/ M1;Q为吸水倍率,单位为g/g;M1为吸液前试样质量,单位为g;M2为吸液后试样质量,单位为g。
进一步,所述烧创伤敷料在不同介质中的吸水倍率为:在去离子水中的吸水倍率15~19;在盐水中吸水倍率13~16;在磷酸缓冲液中的吸水倍率11~14;在细胞培养液中的吸水倍率8~13;在血清中的吸水倍率4~9。
进一步,所述烧创伤敷料经过冻干处理、和/或低温处理、和/或高温处理、和/或醇类改性修饰、和/或射线辐照。
本发明的目的之五,在于提供一种吸附液体的方法,该方法为有效吸附液体提供了一种新思路。
为实现上述目的,本发明采取以下技术方案:
所述方法为用上述烧创伤敷料对液体进行吸附,所述液体进入所述烧创伤敷料的孔隙结构,使所述烧创伤敷料孔道壁增厚并凝胶化使管腔变无。
本发明的目的之六,在于提供一种阻隔微生物的方法,该方法为有效阻隔微生物提供了一种新思路。
为实现上述目的,本发明采取以下技术方案:
用含有上述吸附液体的方法的对微生物进行阻隔,用上述吸附液体的方法对上述液体进行吸附,上述烧创伤敷料孔道壁增厚并凝胶化使管腔变无后将微生物隔绝在外。
本发明的有益效果在于:
1)本发明提供的烧创伤敷料能降低创面氧化应激反应,恢复相关细胞的修复功能,加速创面的愈合。
2)本发明提供的烧创伤敷料中适当比例的吸水大分子或聚合物具有一定的吸水锁水作用。当敷料与体液接触时,材料自身溶胀形成凝胶状,可以有效将创面与外界隔绝,同时具有良好的透气性。
3)本发明提供的烧创伤敷料可与创面紧密贴合,封闭创面,阻隔有害微粒接触创面,且不会与创面组织粘连。
4)本发明提供的烧创伤敷料适用于大面积烧伤、大面积创伤或深度烧创伤等情况。
5)本发明提供的烧创伤敷料采用冻干法制备,中间无须分离纯化过程,既节约成本,方便质控,又利于大规模生产。
附图说明
图1为实施例5制备的烧创伤敷料样品电镜照片。
具体实施方式
下面将结合具体的实施例对本发明的技术方案进行更进一步地清楚、完整地描述。显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部实施例。因此,基于本发明中的实施例,本领域技术人员在没有付出创造性劳动前提下所获得的其他所有实施例都属于本发明的保护范围。
如无特殊说明,实施例中的百分数均表示溶剂的质量分数。
实施例1.改性丝素蛋白溶液样品1的制备
1)取丝素纤维10g,加入100mL浓度为的氯化钙三元液(氯化钙:水:乙醇=1:1~5: 1~20),于80℃条件下溶解,透析3天,每天换去离子水3次,得丝素蛋白溶液;
2)取步骤1)得到的丝素蛋白溶液20mL,加入2mL浓度为100mmol/L的EDTA水溶液反应1h,透析3天,每天换去离子水3次,得到低钙或无钙的丝素蛋白溶液样品1。
实施例2.改性丝素蛋白溶液样品2的制备
1)取丝素纤维10g,加入100 mL浓度为10mol/L的溴化锂溶液,于80℃条件下溶解,透析3天,每天换去离子水3次,得丝素蛋白溶液;
2)取步骤1)得到的丝素蛋白溶液20 mL,加入2mL浓度为100mmol/L的EDTA水溶液反应1h,透析3天,每天换去离子水3次,得到低钙或无钙的丝素蛋白溶液样品2。
实施例3.改性丝素蛋白溶液样品3的制备
1)取丝素纤维1g,加入20 ml浓度为100mmol/L的EDTA水溶液反应24h,透析3天,每天换去离子水3次,50℃烘干,得低钙或无钙的丝素纤维;
2)取步骤1)得到的低钙或无钙的丝素纤维10g,加入100mL浓度为10 mol/L的溴化锂溶液,80℃反应24h,透析3天,每天换去离子水3次,得到低钙或无钙的丝素蛋白溶液样品3。
实施例4. 改性丝素蛋白溶液样品的体外广谱抗氧化性能实验
对实施例1-3中制备的低钙或无钙的丝素蛋白溶液样品进行广谱抗氧化性能测试。将实施例1-3中制备的各样品、谷胱甘肽和去离子水分别与超氧阴离子、羟基自由基和H2O2反应,然后用超氧阴离子测试试剂盒、羟基自由基测试试剂盒和过氧化氢定量分析试剂盒检验5组样品各自清除超氧阴离子、羟基自由基和H2O2的能力。
各样品抗氧化作用评价如下表1所示。从表1可以看出,不同制备工艺制备出的丝素蛋白溶液清除超氧阴离子、羟基自由基和H2O2的能力不同,但采用本发明的三种工艺制备出的3组样品均具有良好的抗氧化作用。
表1 抗氧化作用评价
注:“-”表示无抗氧化作用;“+”表示清除率10%~50%;“++”表示清除率50%~90%;“+++”表示清除率>90%。
实施例5.烧创伤敷料样品1的制备
1)取20mL 4%的丝素蛋白溶液在95℃条件下加热处理2h,冷却备用;
2)在步骤1)所得溶液中加入1mL甘油,机械搅拌10min后加入10mL 5%的明胶溶液,再机械搅拌10min形成白色乳液,取10mL 2%的壳聚糖溶液加入上述白色乳液中机械搅拌30min备用;
3)将步骤2)制得的白色乳液倒入100×150mm容器中,4℃放置1h,-20℃放置4h,-70℃放置6h,冻干机冻干后获得CTS-GEL/SF敷料备用;
4)让CTS-GEL/SF敷料充分吸收去离子水,-20℃放置4h,将8mL硬脂酸溶液(40mmol/L乙醇,DCC作为脱水剂)均匀地浇在CTS-GEL/SF敷料的光滑表面上,冷冻2小时,在20℃条件下用无水乙醇冲洗CTS-GEL/SF敷料的光滑表面3次,干燥,得到CTS-GEL/SF/SA敷料,裁切,包装,钴60辐照灭菌,即得。
实施例6.烧创伤敷料样品2的制备
1)取20mL 4%的丝素蛋白溶液在95℃条件下加热处理2h,冷却备用;
2)在步骤1)所得溶液中加入1mL甘油,机械搅拌10min后加入10mL 5%的聚乙二醇(PEG)溶液,再机械搅拌10min形成白色乳液,取10mL 2%的壳聚糖溶液加入上述白色乳液中机械搅拌30min备用;
3) 将步骤2)制得的白色乳液倒入100×150mm容器中,4℃放置1h,-20℃放置4h,-70℃放置6h,冻干机冻干后获得CTS-PEG/SF敷料备用;
4)让CTS-PEG/SF敷料充分吸收去离子水,-20℃放置4h,将8mL硬脂酸溶液(40mmol/L乙醇,DCC作为脱水剂)均匀地浇在CTS-PEG/SF敷料的光滑表面上,冷冻2小时,在20℃条件下用无水乙醇冲洗CTS-PEG/SF敷料的光滑表面3次,干燥,得到CTS-PEG/SF/SA敷料,裁切,包装,钴60辐照灭菌,即得。
实施例7.烧创伤敷料样品3的制备
1)取20mL 4%的丝素蛋白溶液在95℃条件下加热处理2h,冷却备用;
2)在步骤1)所得溶液中加入1mL甘油,机械搅拌10min后加入10mL 5%的聚乙烯醇(PVA)溶液,再机械搅拌10min形成白色乳液,取10mL 2%的壳聚糖溶液加入上述白色乳液中机械搅拌30min备用;
3)将步骤2)制得的白色乳液倒入100×150mm容器中,4℃放置1h,-20℃放置4h,-70℃放置6h,冻干机冻干后获得CTS-PVA/SF敷料备用;
4)让CTS-PVA/SF敷料充分吸收去离子水,-20℃放置4h,将8mL硬脂酸溶液(40mmol/L乙醇,DCC作为脱水剂)均匀地浇在CTS-PVA/SF敷料的光滑表面上,冷冻2小时,在20℃条件下用无水乙醇冲洗CTS-PVA/SF敷料的光滑表面3次,干燥,得到CTS-PVA/SF/SA敷料,裁切,包装,钴60辐照灭菌,即得。
实施例8.烧创伤敷料样品4的制备
1)取20mL 4%的丝素蛋白溶液在95℃条件下加热处理2h,冷却备用;
2)在步骤1)所得溶液中加入1mL甘油,机械搅拌10min后加入10mL 5%的羧甲基纤维素(CMC)溶液,再机械搅拌10min形成白色乳液,取10mL 2%的壳聚糖溶液加入上述白色乳液中机械搅拌30min备用;
3)将步骤2)制得的白色乳液倒入100×150mm容器中,4℃放置1h,-20℃放置4h,-70℃放置6h,冻干机冻干后获得CTS-CMC/SF敷料备用;
4)让CTS-CMC/SF敷料充分吸收去离子水,-20℃放置4h,将8mL硬脂酸溶液(40mmol/L乙醇,DCC作为脱水剂)均匀地浇在CTS-CMC/SF敷料的光滑表面上,冷冻2小时,在20℃条件下用无水乙醇冲洗CTS-CMC/SF敷料的光滑表面3次,干燥,得到CTS-CMC/SF/SA敷料,裁切,包装,钴60辐照灭菌,即得。
实施例9.物理和结构表征
实施例5-8制备的烧创伤敷料样品有弹性,可卷曲,无异味。以实施例5制备的烧创伤敷料样品1为代表,进行大体结构观察,并采用扫描电子显微镜进行微观结构观察。如图1所示,样品皆为相互连通的多孔道结构,孔隙率在55%~80%之间。互相贯穿的孔道结构与体液接触后其孔隙结构迅速将体液吸入孔内,吸水聚合物迅速凝胶化,一方面使得孔道壁吸水后增厚并凝胶化,管腔变无,另一方面可有效阻隔空气微生物伤侵染伤口。
实施例10.物理性能表征
对实施例5-8获得的烧创伤敷料进行保湿性能检测,对照组为普通烧创伤敷料,结果表明实施例5-8获得的烧创伤敷料保湿时间比对照组长,保湿时间均在15小时以上。
对实施例5-8中制备的烧创伤敷料样品的溶胀性能进行测试,分别准确称取实施例5-8中的试样0.1g,将其浸于去离子水(pH=7.0)、生理盐水、磷酸缓冲液、DMEM培养基和血清液中,37oC吸水完全溶胀,吸去表面水分,称取试样吸液后质量,计算样品的吸水倍率。吸水倍率Q计算公式如下:Q=(M2-M1)/ M1,Q为吸水(盐水)倍率,单位为g/g;M1为吸液前试样质量,单位为g;M2为吸液后试样质量,单位为g。
结果如下表2所示,实施例5-8中各样品表现出相近的吸水性。以实施例5制备的敷料样品为例,其在不同介质中的吸水倍率:在去离子水中的吸水倍率为14~16;在盐水中吸水倍率为12~14;在磷酸缓冲液中的吸水倍率为9 ~11;在细胞培养液中的吸水倍率为7 ~10;在血清中的吸水倍率为5 ~7。
表2 不同介质吸水倍率
实施例11.烧创伤敷料样品的体外广谱抗氧化性能实验
对实施例5-8制备的烧创伤敷料样品的广谱抗氧化性能进行测试。将施例5-8中各样品分别与含有超氧阴离子、羟基自由基、和H2O2的溶液反应,用谷胱甘肽和去离子水作为对照。用超氧阴离子测试试剂盒、羟基自由基测试试剂盒和过氧化氢定量分析试剂盒检验6组样品分别清除超氧阴离子、羟基自由基和H2O2的能力。
如下表3所示,实施例5-8中制备的烧创伤敷料样品和谷胱甘肽具有良好的广谱抗氧化性能,其中实施例5制备的烧创伤敷料样品抗氧化效果最好。
表3 广谱抗氧化性能
注:“-”表示无抗氧化作用;“+”表示清除率10%~50%;“++”表示清除率50%~90%;“+++”表示清除率>90%。
实施例12.全层皮肤损伤修复体内评估
深圳湾实验室动物伦理委员会批准体内动物实验。将120只BALB/c小鼠,雄性,每只约重18g±2g,随机分为6组(每组20只小鼠)。腹腔注射戊巴比妥钠(20 mg/kg)麻醉小鼠,脱除皮毛,在每只小鼠背部做成Φ1cm全层皮肤损伤。分别用本发明实施例5-8样品和无菌纱布紧密覆盖创面,每周进行2次更换。通过BALB/c小鼠感染创面修复情况,对本发明的烧创伤敷料进行伤口愈合效应的评价。
实验过程中,5组试样治疗下的创面均有不同程度的结痂,并且创面出现收缩。其中本发明实施例1制备敷料修复的创面收缩较为明显,治疗效果最佳。5组试样的治疗结果如下表4所示,创伤后第3天,本发明实施例5-8样品伤口愈合分别达到51.64±1.45、45.51±2.31、46.11±1.42和43.73±1.71,纱布组仅达到26.12±2.26。实施例5-8样品治疗组创面边缘未见红肿发生,纱布组仍可见部分感染渗出物。通过对小鼠创伤后第7天创面的观察发现,实施例5-8样品治疗组愈合率在69.71±1.31~80.14±1.61。纱布组肉芽生长明显,仍存在部分炎性渗出物。术后第12天,实施例5样品治疗组最佳可以达到99.17±2.42,实施例6-8样品治疗组分别为95.62±2.31、93.56±1.63和94.93±1.75。5组试样愈合率具有显著的统计学差异,实施例5-8样品治疗组最佳,纱布组较差。
表4 创面愈合率
Claims (13)
1.用于制备烧创伤敷料的组合物,其特征在于,所述组合物由丝素蛋白和骨架按照1:2~10的质量比组成;所述骨架为壳聚糖-吸水聚合物骨架;所述壳聚糖和吸水聚合物按照1:0.1~5的质量比组成。
2.根据权利要求1所述的组合物,其特征在于,所述丝素蛋白为天然丝素蛋白和/或改性丝素蛋白;所述的改性丝素蛋白选自部分去除或完全去除钙的丝素蛋白、加热处理的丝素蛋白及其衍生物、紫外照射的丝素蛋白及其衍生物、有机溶剂处理的丝素蛋白及其衍生物中的任一种或几种。
3.根据权利要求1所述的组合物,其特征在于,所述吸水聚合物为天然吸水聚合物和/或人工合成吸水聚合物,所述天然吸水聚合物选自胶原、明胶、纤维素及其衍生物,所述人工合成吸水聚合物选自聚乙二醇、聚丙烯酰胺、聚丙烯酸钠或聚乙烯醇。
4.用于制备烧创伤敷料的制剂组合物,其特征在于,所述的制剂组合物由权利要求1所述的丝素蛋白、骨架和辅料按照1:2~10:0.1~5的质量比组成;所述辅料为增塑剂和/或乳化剂。
5.制备烧创伤敷料的方法,其特征在于,用权利要求1所述的组合物或权利要求4所述的制剂组合物进行制备,具体包括以下步骤:
S1:制备丝素蛋白溶液;
S2:将S1所得物与骨架和辅料混合。
6.根据权利要求5所述的方法,其特征在于,在S2之后还包括S3将S2所得物用硬脂酸改性。
7.根据权利要求5所述的方法,其特征在于,S1在制备过程中加入了钙的螯合剂或能与钙发生螯合作用氨基酸;所述钙的螯合剂为EDTA及其衍生物、EGTA AM及其衍生物、BAPTA及其衍生物;所述能与钙发生螯合作用氨基酸包括谷氨酸、丙氨酸、天冬氨酸、苯丙氨酸、天冬酰胺氨酸、精氨酸、苏氨酸、酪氨酸、色氨酸、甘氨酸、丝氨酸、缬氨酸、组氨酸、异亮氨酸和半胱氨酸及其衍生物中的任一种或几种。
8.用权利要求5-7所述制备生物敷料的方法获得的烧创伤敷料。
9.根据权利要求8所述的烧创伤敷料,其特征在于,所述烧创伤敷料为多孔结构,其孔隙率为55%~80%,其孔径大小为0.5 mm ~2 mm。
10.根据权利要求8所述的烧创伤敷料,其特征在于,所述烧创伤敷料的吸水倍率为15~20倍;其吸水倍率可用如下公式计算:Q=(M2-M1)/ M1;Q为吸水倍率,单位为g/g;M1为吸液前试样质量,单位为g;M2为吸液后试样质量,单位为g。
11.根据权利要求10所述的烧创伤敷料,其特征在于,所述烧创伤敷料在不同介质中的吸水倍率为:在去离子水中的吸水倍率15~19;在盐水中吸水倍率13~16;在磷酸缓冲液中的吸水倍率11~14;在细胞培养液中的吸水倍率8 ~13;在血清中的吸水倍率4~9。
12.用权利要求8-11所述的烧创伤敷料吸附液体的方法,其特征在于,用所述烧创伤敷料对液体进行吸附,所述液体进入所述烧创伤敷料的孔隙结构,使所述烧创伤敷料孔道壁增厚并凝胶化使管腔变无。
13.含有权利要求12所述方法的对微生物进行阻隔的方法,其特征在于,用所述烧创伤敷料对所述流体进行吸附,所述烧创伤敷料孔道壁增厚并凝胶化使管腔变无后将微生物隔绝在外。
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