CN113058073A - 一种冷敷型医用水凝胶及其制备方法 - Google Patents
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Abstract
本发明属于医用生物材料技术领域,具体涉及一种冷敷型医用水凝胶及其制备方法。本发明所述冷敷型医用水凝胶,以水溶性高分子、琥珀酰化改性淀粉、胶原蛋白、交联剂和去离子水为原料体系,并通过对淀粉的琥珀酰化改性,进一步提高了淀粉凝胶性能、吸水性能及强度性能,进而有效提高了整个水凝胶体系的凝胶含量,以及凝胶强度等力学性能和吸水性能,可以实现水凝胶的降温功效,进一步利用可降温的优势使得所述水凝胶具有了缓解疼痛的作用。
Description
技术领域
本发明属于医用生物材料技术领域,具体涉及一种冷敷型医用水凝胶及其制备方法。
背景技术
水凝胶敷料的兴起得益于20世纪80年代关伤口愈合的重大概念的突破。以往的治疗认为,伤口是需要呼吸的,保持创口的透气性是理想敷料的重要因素,但是新的研究证明无氧的大气环境能促进血管的增生,从而加速伤口的愈合。水凝胶敷料由于具有自动调节伤口的湿润度,有少量吸收渗液的能力,不粘伤口,容易去除的优点,得到广泛的重视。
常规的水凝胶是一种具有三维交联网状结构的高分子材料,水作为液相分散介质填充整个网状结构的空隙。水凝胶的交联网络具有很好的保水性,同时赋予该材料液体与固体的某些性质,例如可以允许小分子物质的渗透和扩散;水凝胶与体液、血液和人体组织接触时能够表现出优良的生物相容性。与其它的合成生物材料相比,水凝胶由于其独特的性质使得它更接近活体组织,与细胞外基质非常类似,吸水后在一定程度上又可以减少对周围组织的摩擦与机械作用,能显著改善材料的生物学性能。因此,水凝胶为发展伤口敷料、药物释放载体、组织工程材料等生物医用材料提供了广阔的空间。而随着医用水凝胶日益广泛的临床应用,对其综合功能性的要求也越来越高。
发明内容
为此,本发明所要解决的技术问题在于提供一种冷敷型医用水凝胶,所述水凝胶在愈合创面的同时具有缓解疼痛的功效;
本发明所要解决的第二个技术问题在于提供上述冷敷型医用水凝胶的制备方法。
为解决上述技术问题,本发明所述的一种冷敷型医用水凝胶,以所述水凝胶的总量计,包括如下原料组分:
具体的,所述琥珀酰化改性淀粉为琥珀酰化改性的小麦淀粉。
具体的,所述水溶性高分子包括明胶、聚乙烯醇和/或聚乙烯吡咯烷酮。
具体的,所述胶原蛋白包括鱼类胶原蛋白。
具体的,所述交联剂包括乙二醇二缩水甘油醚或丙三醇三缩水甘油醚。
本发明还公开了一种制备所述冷敷型医用水凝胶的方法,包括如下步骤:
(1)取选定量的所述水溶性高分子充分溶解于去离子水中,制成水溶性高分子溶液,备用;
(2)取选定量的所述琥珀酰化改性淀粉分散于去离子水中,得到琥珀酰化改性淀粉分散液,备用;
(3)将所得水溶性高分子溶液和所述琥珀酰化改性淀粉分散液混匀,调节体系pH至碱性;
(4)向步骤(3)得到的混合料液中加入选定量的所述交联剂混匀,并倒入模具中成型反应,即得。
具体的,所述步骤(3)中,还包括将所得混合料液于25-40℃进行保温的步骤。
具体的,所述步骤(4)中,控制所述成型步骤的温度为30-40℃。
具体的,所述冷敷型医用水凝胶的制备方法,还包括制备所述琥珀酰化改性淀粉的步骤,具体包括:称取淀粉溶于水配制得到悬浮液并调节pH值碱性,随后加入琥珀酸酐,保持碱性条件下进行琥珀酰化改性反应,即得。
具体的,所述冷敷型医用水凝胶的制备方法:
控制所述淀粉悬浮液的质量浓度为5-8wt%;
控制所述琥珀酸酐的添加量占所述淀粉质量的12-15wt%;
控制所述琥珀酰化改性反应中体系的pH值为9-9.5;
控制所述琥珀酰化改性反应的温度为35-38℃;
控制所述琥珀酰化改性反应的时间为2-3h。
本发明所述冷敷型医用水凝胶,以水溶性高分子、琥珀酰化改性淀粉、胶原蛋白、交联剂和去离子水为原料体系,并通过对淀粉的琥珀酰化改性,进一步提高了淀粉凝胶性能、吸水性能及强度性能,进而有效提高了整个水凝胶体系的凝胶含量,以及凝胶强度等力学性能和吸水性能,可以实现水凝胶的降温功效,进一步利用可降温的优势使得所述水凝胶具有了缓解疼痛的作用。
具体实施方式
制备例
称取小麦淀粉溶于水混匀,配制得到质量浓度为6wt%的悬浮液,并以1mol/L的NaOH溶液调节悬浮液的pH值至9,备用;随后向悬浮液中加入琥珀酸酐(占所述小麦淀粉质量的15wt%)进行琥珀酰化改性反应,并在反应过程中继续以1mol/L的NaOH溶液调节保持反应体系的pH=9,控制反应温度为37℃,保温反应3h;反应完成后,将琥珀酰化的淀粉置于透析袋进行透析48h,以除去小分子及其他杂质,即得。
实施例1
本实施例所述冷敷型医用水凝胶,以所述水凝胶的总量计,包括如下原料组分:
本实施例所述冷敷型医用水凝胶的制备方法,包括如下步骤:
(1)取选定量的所述水溶性高分子充分溶解于部分去离子水中,制成水溶性高分子溶液,备用;
(2)取选定量的所述琥珀酰化改性淀粉分散于去离子水中,得到琥珀酰化改性淀粉分散液,备用;
(3)将所得水溶性高分子溶液和所述琥珀酰化改性淀粉分散液混匀,调节体系pH=9,并于40℃进行保温1h;
(4)向步骤(3)得到的混合料液中加入选定量的所述交联剂混匀,并倒入模具中,于40℃进行保温成型3h,即得。
实施例2
本实施例所述冷敷型医用水凝胶,以所述水凝胶的总量计,包括如下原料组分:
本实施例所述冷敷型医用水凝胶的制备方法同实施例1。
实施例3
本实施例所述冷敷型医用水凝胶,以所述水凝胶的总量计,包括如下原料组分:
本实施例所述冷敷型医用水凝胶的制备方法同实施例1。
对比例1
本对比例所述冷敷型医用水凝胶的原料及制备方法同实施例1,其区别仅在于,以小麦淀粉代替所述琥珀酰化改性淀粉。
对比例2
本对比例所述冷敷型医用水凝胶的原料及制备方法同实施例1,其区别仅在于,以小麦淀粉代替所述琥珀酰化改性淀粉,并以琥珀酰化胶原蛋白代替所述胶原蛋白。
实验例
1、凝胶分数检测
分别对上述实施例1及对比例1-2中制得水凝胶进行凝胶分数的测定:待制得水凝胶干燥后,以去离子水为溶剂,索氏提取器抽提24h,按照如下公式计算相应的凝胶分数:
凝胶分数=(抽提前凝胶干重-抽提后凝胶干重)/抽提前凝胶干重×100%;
测试结果见下表1。
表1凝胶分数测试结果
编号 | 凝胶分数/% |
实施例1 | 95.1 |
对比例1 | 90.4 |
对比例2 | 92.5 |
由上表1结果可见,本发明方案添加的琥珀酰化改性淀粉相比于一般性淀粉而言,琥珀酰化的改性方式有效促进了整体的凝胶性能;而相比于对于胶原蛋白进行琥珀酰化的改性处理,本发明方案选用琥珀酰化淀粉的凝胶含量更高。
2、凝胶强度
使用Lloyd材料试验机,分别测定穿透上述实施例1及对比例1-2中制得水凝胶一定深度所需的力,当凝胶破裂时探头所施加于凝胶的作用力即定义为凝胶强度,测试结果见下表2。
表2凝胶强度测试结果
编号 | 凝胶强度/N |
实施例1 | 7.342 |
对比例1 | 6.849 |
对比例2 | 7.095 |
由上表2结果可见,本发明方案添加的琥珀酰化改性淀粉相比于一般性淀粉而言,琥珀酰化的改性方式有效促进了整个水凝胶体系的凝胶强度性能;而相比于对于胶原蛋白进行琥珀酰化的改性处理,本发明方案选用琥珀酰化淀粉的凝胶强度性能更优。
3、创面愈合实验
实验动物采用雄性Wistar大鼠,观察点分别为伤后3、5、7、10天。大鼠背部用8%硫化钠液脱毛,24h后麻醉,然后用80℃水浴烫15秒造成大鼠背部10%深II度皮肤烫伤,伤后经腹腔给予5mL生理盐水。分别将实施例1及对比例1-2所得的水凝胶敷料覆盖创面位置,并于观察时间点计算创面愈合率,并按照如下公式进行计算:
创面愈合率=(原始创面面积-未愈合创面面积)/原始创面面积;
测试结果见下表3。
表3创面愈合率测试结果/%
编号 | 3d愈合率/% | 5d愈合率/% | 7d愈合率/% | 10d愈合率/% |
实施例1 | 30.3 | 45.7 | 61.5 | 80.2 |
对比例1 | 24.8 | 40.1 | 53.3 | 69.7 |
对比例2 | 27.2 | 42.9 | 57.2 | 75.5 |
由上表3结果可见,本发明方案添加的琥珀酰化改性淀粉相比于一般性淀粉而言,琥珀酰化的改性方式有效促进了整个水凝胶体系促进伤口愈合的性能;而相比于对于胶原蛋白进行琥珀酰化的改性处理,本发明方案选用琥珀酰化淀粉,对于凝胶体系的创面愈合性能更优的愈合效果。
4、降温实验
分别对本发明实施例1及对比例1-2中制备的水凝胶的降温性能进行测试,通过将各水凝胶敷料贴于受试者皮肤上,分别测试受试者皮肤表面的降温情况,记录于下表4。
表4皮肤表面降温测试结果
编号 | 降温幅度/℃ |
实施例1 | 2.8 |
对比例1 | 2.1 |
对比例2 | 2.3 |
由上表4结果可见,本发明方案添加的琥珀酰化改性淀粉有效改善了淀粉的吸水性能,相比于一般性淀粉而言,其吸收环境水分的性能更优,更加有助于冷敷降温,可有效减缓伤口的疼痛;而相比于对于胶原蛋白进行琥珀酰化的改性处理,本发明方案选用琥珀酰化淀粉,对于凝胶体系的降温性能更优。
以上对本发明实施例进行了详细介绍,本文中应用了具体个例对本发明的原理及实施方式进行了阐述,以上实施例的说明只是用于帮助理解本发明的方法及其核心思想;同时,对于本领域的一般技术人员,依据本发明的思想,在具体实施方式及应用范围上均会有改变之处,综上所述,本说明书内容不应理解为对本发明的限制。
Claims (10)
2.根据权利要求1所述冷敷型医用水凝胶,其特征在于,所述琥珀酰化改性淀粉为琥珀酰化改性的小麦淀粉。
3.根据权利要求1或2所述冷敷型医用水凝胶,其特征在于,所述水溶性高分子包括明胶、聚乙烯醇和/或聚乙烯吡咯烷酮。
4.根据权利要求1-3任一项所述冷敷型医用水凝胶,其特征在于,所述胶原蛋白包括鱼类胶原蛋白。
5.根据权利要求1-4任一项所述冷敷型医用水凝胶,其特征在于,所述交联剂包括乙二醇二缩水甘油醚或丙三醇三缩水甘油醚。
6.一种制备权利要求1-5任一项所述冷敷型医用水凝胶的方法,其特征在于,包括如下步骤:
(1)取选定量的所述水溶性高分子充分溶解于去离子水中,制成水溶性高分子溶液,备用;
(2)取选定量的所述琥珀酰化改性淀粉分散于去离子水中,得到琥珀酰化改性淀粉分散液,备用;
(3)将所得水溶性高分子溶液和所述琥珀酰化改性淀粉分散液混匀,调节体系pH至碱性;
(4)向步骤(3)得到的混合料液中加入选定量的所述交联剂混匀,并倒入模具中成型反应,即得。
7.根据权利要求6所述冷敷型医用水凝胶的制备方法,其特征在于,所述步骤(3)中,还包括将所得混合料液于25-40℃进行保温的步骤。
8.根据权利要求6或7所述冷敷型医用水凝胶的制备方法,其特征在于,所述步骤(4)中,控制所述成型步骤的温度为30-40℃。
9.根据权利要求1-8任一项所述冷敷型医用水凝胶的制备方法,其特征在于,还包括制备所述琥珀酰化改性淀粉的步骤,具体包括:称取淀粉溶于水配制得到悬浮液并调节pH值碱性,随后加入琥珀酸酐,保持碱性条件下进行琥珀酰化改性反应,即得。
10.根据权利要求9所述冷敷型医用水凝胶的制备方法,其特征在于:
控制所述淀粉悬浮液的质量浓度为5-8wt%;
控制所述琥珀酸酐的添加量占所述淀粉质量的12-15wt%;
控制所述琥珀酰化改性反应中体系的pH值为9-9.5;
控制所述琥珀酰化改性反应的温度为35-38℃;
控制所述琥珀酰化改性反应的时间为2-3h。
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