CN115487338A - 一种甲壳素改性交联透明质酸钠外伤敷料及其制备方法 - Google Patents
一种甲壳素改性交联透明质酸钠外伤敷料及其制备方法 Download PDFInfo
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- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 title claims abstract description 47
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- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 abstract description 9
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- VZSRBBMJRBPUNF-UHFFFAOYSA-N 2-(2,3-dihydro-1H-inden-2-ylamino)-N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]pyrimidine-5-carboxamide Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)C(=O)NCCC(N1CC2=C(CC1)NN=N2)=O VZSRBBMJRBPUNF-UHFFFAOYSA-N 0.000 description 1
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/28—Polysaccharides or their derivatives
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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Abstract
本发明提供了一种甲壳素晶须改性的交联透明质酸钠外伤敷料及其制备方法，所述敷料的组分包括甲壳素晶须和交联透明质酸，将甲壳素晶须超声分散于去离子水中，加入透明质酸钠搅拌均匀，加入含有交联剂的盐酸溶液搅拌均匀，随后用氢氧化钠溶液调pH，将溶胶平铺在冻干盘上，经过风干、冷冻干燥得到交联HA薄膜，再经过剪裁、封装、灭菌得到含甲壳素晶须的交联透明质酸钠外伤敷料。本发明的交联透明质酸钠外伤敷料可以调节交联透明质酸钠膜的机械性能、抑菌能力。
Description
技术领域
本发明属于生物材料领域，具体涉及一种甲壳素晶须改性的交联透明质酸钠外伤敷料及其制备方法。
背景技术
透明质酸(hyaluronic acid，HA)是由葡萄糖醛酸和N-乙酰氨基葡萄糖两种结构单元交替连接而成的一种天然粘多糖，广泛存在于高等动物细胞外基质、结缔组织和生物器官中，因而具有良好的生物相容性和降解性能，是理想的生物材料。未交联的透明质酸钠，水溶性较好，不易于成型，还容易被人体快速吸收。交联的透明质酸钠仍具有较好的生物相容性，并且交联的透明质酸膜具有粘附性，将其贴于出血创面，迅速吸收血液后形成水凝胶，黏附于创面，提高血液中凝血因子浓度，加速止血进程，同时通过堵塞出血部位，从而起到止血效果。此外交联透明质酸钠膜吸水后形成凝胶，能够在组织间形成屏障，起到隔离效果，避免了组织愈合过程中的粘连。
但是，通过交联的透明质酸所制备的敷料，其抑菌能力、力学性能仍然不理想。
发明内容
本发明的目的是为了克服现有技术的不足，提供一种含甲壳素晶须的交联透明质酸钠外伤敷料及其制备方法，增加交联透明质酸钠膜的抑菌能力、力学性能，扩大了交联透明质酸的应用范围。
根据本发明的第一个方面，本发明提供了一种甲壳素晶须改性的交联透明质酸钠外伤敷料，其特征在于，其中的交联透明质酸钠被甲壳素晶须改性。交联透明质酸钠外伤敷料包含甲壳素晶须和交联透明质酸钠。
根据本发明的第二个方面，本发明提供了上述甲壳素晶须改性的交联透明质酸钠外伤敷料的制备方法，其特征在于包含以下步骤：
S1：将甲壳素晶须超声分散于纯化水中，得到甲壳素晶须分散液；
S2：将透明质酸钠加入甲壳素晶须分散液，搅拌均匀；
S3：在步骤S2制备后的分散液中，加入含交联剂的盐酸溶液，搅拌均匀；
S4：调节反应液的pH值至8-9，持续搅拌，得到溶胶；
S5：将所得溶胶用纯化水透析；
S6：将透析液平铺在冻干盘上风干；
S7:冷冻干燥，收集冻干后的薄膜，为含甲壳素晶须的交联透明质酸钠外伤敷料。
步骤S3中所述的交联剂可以为二乙烯基砜、1,4-丁二醇缩水甘油醚、戊二醛中的一种。
在步骤S7后还可进行步骤S8：将剪裁、封装后进行环氧乙烷灭菌，得到可商品销售的含甲壳素晶须的交联透明质酸钠外伤敷料。
其中，在原料用量上，步骤S1的甲壳素晶须和步骤S2的透明质酸钠的比例为0.01:1-1:1。
具体实施方式
为了进一步理解本发明，下面结合实施例对本发明提供的，甲壳素晶须改性的交联透明质酸钠外伤敷料进行具体描述，但本发明并不限于这些实施例，该领域技术人员在本发明核心指导思想下做出的非本质改进和调整，仍然属于本发明的保护范围。
(一)、甲壳素晶须改性交联透明质酸钠外伤敷料制备
实施例1
S1：将0.1g甲壳素晶须，600W超声分散于40mL的纯化水中，得到甲壳素晶须分散液。
S2：将1g透明质酸钠加入甲壳素晶须分散液，搅拌1小时。
S3：在步骤S2制备后的分散液中，加入含0.1g二乙烯基砜的10mL(pH＝4)的盐酸溶液，搅拌3小时。
S4：然后加入1M氢氧化钠溶液，调节pH至8-9，搅拌12小时，得到均一溶胶。
S5：将所得溶胶用纯化水透析3天。
S6：将透析液平铺在冻干盘上，在40℃下风干2小时。
S7：冷冻干燥24小时，收集冻干后的薄膜。
S8：将剪裁、封装后进行环氧乙烷灭菌，得到含甲壳素晶须的交联透明质酸钠外伤敷料。
实施例2
除将甲壳素晶须含量改为0.2g外，其他与实施例1相同。
实施例3
除将甲壳素晶须含量改为0.5g外，其他与实施例1相同。
实施例4
除将甲壳素晶须含量改为透明质酸钠质量的1.0g外，其他与实施例1相同。
对比例：
除不添加甲壳素晶须外，其他与实施例1相同。
(二)、甲壳素晶须改性交联透明质酸钠外伤敷料的机械强度
方法：将实施例1-4和对照组得到的交联透明质酸敷料剪取5cm×1cm的小片，用拉力机测量所得材料的拉伸性能。
结果表明，甲壳素晶须对交联HA膜有填充、增强作用，通过调节甲壳素晶须的含量可以调节膜的机械强度。但是添加过多的甲壳素晶须反而会降低材料强度，这可能是因为过量的甲壳素晶须会发生自聚集导致分散不均，材料强度下降。
表1：实施例1-4和对照组所得甲壳素晶须改性交联透明质酸钠外伤敷料的机械强度
| 组别 | 宽度/cm | 最大剥离力/N |
| 对照组 | 1 | 15.315±2.489 |
| 实施例1 | 1 | 20.313±2.758 |
| 实施例2 | 1 | 24.421±4.129 |
| 实施例3 | 1 | 19.319±3.098 |
| 实施例4 | 1 | 10.778±1.934 |
(三)、甲壳素晶须改性交联透明质酸钠外伤敷料的机械强度的细胞毒性
将将实施例1-4及对照组得到的交联透明质酸敷料分别按以下方法进行细胞毒性试验：
按医疗器械生物学评价:第5部分，体外细胞毒性试验，甲壳素晶须改性交联透明质酸钠外伤敷料剪成碎片，于1mL细胞培养液中加入1g碎片，于37±2℃放置30h，用培养基稀释浸提液，得到一系列浸提稀释液作为供试液。随后，采用MTT法评定交联透明质酸钠外伤敷料材料细胞毒性。
结果表明，甲壳素晶须改性交联透明质酸钠外伤敷料不具有细胞毒性，生物相容性良好。
表2：实施例1-4和对照组所得甲壳素晶须改性交联透明质酸钠外伤敷料的细胞毒性
| 样品编号 | 细胞毒性反应 |
| 对照组 | 0级 |
| 1-1 | 0级 |
| 1-2 | 0级 |
| 1-3 | 0级 |
| 1-4 | 0级 |
(四)、甲壳素晶须改性交联透明质酸钠外伤敷料抑菌性能测试
采用QB/T2591-2003对甲壳素晶须改性交联透明质酸钠外伤敷料的抑菌率进测试。
结果表明，甲壳素晶须改性交联透明质酸钠外伤敷料具有较好的抑菌性能
表3：实施例1-4和对照组所得甲壳素晶须改性交联透明质酸钠外伤敷料的抗菌性能测试
以上结果表明，本发明方法制备的甲壳素晶须改性交联透明质酸钠外伤敷料生物相容性良好，由于甲壳素晶须的加入，膜材的机械性能、抑菌性能明显提高。因此，本发明的交联透明质酸钠外伤敷料是一款具有较大潜力的外伤敷料。
上述实施例仅为说明本发明的原理，而非限制本发明。在本发明权利要求所限定的精神和范围内可对其进行许多改变，修改，但都将在本发明的保护之中。
Claims (3)
1.一种甲壳素改性的交联透明质酸钠外伤敷料，其特征在于，其中的交联透明质酸钠被甲壳素晶须改性。
2.一种甲壳素晶须改性的交联透明质酸钠外伤敷料的制备方法，其特征在于包含以下步骤：
S1：将甲壳素晶须超声分散于纯化水中，得到甲壳素晶须分散液；
S2：将透明质酸钠加入甲壳素晶须分散液，搅拌均匀；
S3：在步骤S2制备后的分散液中，加入含交联剂的盐酸溶液，搅拌均匀；
S4：调节反应液的pH值至8-9，持续搅拌，得到溶胶；
S5：将所得溶胶用纯化水透析；
S6：将透析液平铺在冻干盘上风干；
S7:冷冻干燥，收集冻干后的薄膜，为含甲壳素晶须的交联透明质酸钠外伤敷料。
3.如权利要求2所述的制备方法，其特征在于，步骤S3中所述的交联剂为二乙烯基砜、1,4-丁二醇缩水甘油醚、戊二醛中的一种。
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