CN113509317A - 一种创面愈合用抗菌型胶体敷贴及其制备方法 - Google Patents
一种创面愈合用抗菌型胶体敷贴及其制备方法 Download PDFInfo
- Publication number
- CN113509317A CN113509317A CN202110702039.8A CN202110702039A CN113509317A CN 113509317 A CN113509317 A CN 113509317A CN 202110702039 A CN202110702039 A CN 202110702039A CN 113509317 A CN113509317 A CN 113509317A
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- pva
- beta
- antibacterial
- resveratrol
- colloid
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Abstract
本发明属于生物医药技术领域，尤其为一种创面愈合用抗菌型胶体敷贴及其制备方法，包括创面愈合用抗菌型胶体敷贴，创面愈合用抗菌型胶体敷贴包括医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、白藜芦醇‑羟丙基‑β‑环糊精‑富组蛋白‑1缓释微球、薄膜背衬、无纺布、粘合剂和离型纸，创面愈合用抗菌型胶体敷贴为方形结构敷贴，本发明选取医用级聚乙烯醇与氧化葡聚糖作为原材料，采用微波冻融法辅助交联，制备PVA/ODex胶体基质。Res具有抗氧化、促进血管化的能力，His‑1能促进内皮细胞黏附、迁移和血管化，二者通过微球载药体系被负载到PVA/ODex胶体基质中共同发挥作用，用于皮肤急性创面愈合与烧烫伤治疗，创面愈合效果乐观高效。
Description
技术领域
本发明属于生物医药技术领域，具体涉及一种创面愈合用抗菌型胶体敷贴及其制备方法。
背景技术
胶体创面敷料是手术后、急诊以及日常生活中常用医用物品之一，在皮肤组织在遭受损伤后使用，作为支架材料在药物递送与缓释和清创促进愈合方面应用。目前市场上，传统敷料有药纱、乳胶等，但因其具有免疫原性，且操作易造成再次损伤，其替代品的需求量与日俱增，新兴敷料比如藻酸盐、胶原胶体敷料，具有可降解特性，但仍具有免疫原性，且释药环境不稳定，创面愈合效果并不乐观，目前，临床治疗以使用抗生素为主，但长时间使用抗生素药物易使病原体产生耐药性，使原有抗菌作用减弱或活性大大降低，具有较大的毒副作用，且单组分水胶体存在机械强度低、功能单一。
基于此，需要研发一种创面愈合用抗菌型胶体敷贴，从而能够有效的解决上述提出的问题。
发明内容
为解决现有技术中存在的上述问题，本发明提供了一种创面愈合用抗菌型胶体敷贴及其制备方法，具有在应用于皮肤急性创面愈合与烧烫伤治疗时起到高效治疗目的的特点。
为实现上述目的，本发明提供如下技术方案：一种创面愈合用抗菌型胶体敷贴及其制备方法，包括创面愈合用抗菌型胶体敷贴，创面愈合用抗菌型胶体敷贴包括医用级聚乙烯醇/氧化葡聚糖(PVA/ODex) 胶体基质层、白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球、薄膜背衬、无纺布、粘合剂和离型纸，创面愈合用抗菌型胶体敷贴为方形结构敷贴，医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层内设有白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球，薄膜背衬的一侧依次设有医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、离型纸和无纺布，且薄膜背衬、医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、离型纸与无纺布通过粘合剂相连接。
作为本发明的一种创面愈合用抗菌型胶体敷贴优选技术方案，薄膜背衬的材料为聚氨酯，且粘合剂的材料为丙烯酸酯。
作为本发明的一种创面愈合用抗菌型胶体敷贴优选技术方案，白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球中的白藜芦醇和富组蛋白-1的质量比为4：1。
作为本发明的一种创面愈合用抗菌型胶体敷贴优选技术方案，医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层内医用级聚乙烯醇和氧化葡聚糖的质量分数组份分别为6％-15％和10％-25％，且白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球中白藜芦醇和富组蛋白 -1的质量分数组份分别为2％-8％和0.5％-2％。
作为本发明的一种创面愈合用抗菌型胶体敷贴制备方法优选技术方案，具体包括如下步骤：
第一步、首先对医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层进行制备，称取1.5gPVA，置于25mL蒸馏水中，微波30％火力持续1min，水浴95℃加热溶解配置成0.06g/mL的PVA溶液。降温后加入氧化葡聚糖(PVA质量分数为40％)，水浴50℃加热使氧化葡聚糖完全溶剂热。将溶解后的溶液置于平皿中，超声排气30min，— 20℃下冷冻1.5h，微波60％火力融化1min，循环三次。置于加热至 45℃的蒸馏水中洗净单体，50℃真空干燥6h，即可得到PVA/ODex胶体基质，也就是医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层；
第二步、对白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球进行制备，称取一定量白藜芦醇(RES)与羟丙基-β-环糊精(HP- β-CD)，质量比为1：7，先将HP-β-CD溶于适量乙醇中，然后将 RES加入其中搅拌使之溶解，并在室温下挥干乙醇，得到RES-HP-β -CD包合物。再称取一定量富组蛋白-1溶于1％醋酸中，分散加入 RES-HP-β-CD，搅拌，采用喷雾干燥法制备得到RES-HP-β-CD-His-1 缓释微球，也就是白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球；
第三步、将第二步中制得的RES-HP-β-CD-His-1缓释微球在室温下均匀分散在40％的氧化葡聚糖水溶液中，再与第一中配好的 0.06g/mL的PVA溶液按4:1比例，并使用磁力搅拌器搅拌混匀，置于平皿中超声排气30min，后续操作同于第一步的后续处理，即可得到抗菌型医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层；
第四步、将第三步中制得的抗菌型医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层与薄膜背衬、离型纸和无纺布利用粘合剂相连接并压膜成型，再进行模切包装，即可制得方形结构的创面愈合用抗菌型胶体敷贴。
作为本发明的一种创面愈合用抗菌型胶体敷贴制备方法优选技术方案，白藜芦醇的制备方法，具体包括如下步骤：
称取粉碎至60目的虎杖粉末样品5.0g,按固液比1∶20(g/mL) 加入水后,添加1.5mg/g纤维素酶和1.5mg/g阿魏酸酯酶，在温度为 50℃、pH为5.0的条件下酶解3.0h后加入适量甲醇,再恒温加热提取一定时间,减压抽滤、离心后定容至100mL，即可制得白藜芦醇。
作为本发明的一种创面愈合用抗菌型胶体敷贴制备方法优选技术方案，RES/HP-β-CD/His-1的质量比为1：7：0.25，且喷雾干燥法制备得到RES-HP-β-CD-His-1缓释微球的工艺参数为进口温度 130℃，出口温度75℃，进料速度5mL/min，雾化气流速8.8L/min。
与现有技术相比，本发明的有益效果是：
1、本发明在使用时，抑菌活性高，感染率低，通过制备RES-HP- β-CD-His-1缓释微球进行药物负载与输送，相较于普通载药，微球的比表面积较大，可以负载更多的需控释药物，分散性佳，能够自由流动，药物靶向传递更加精准，因而具有更好的释药性能和临床治疗效果；
本发明基于再生医学的理念功能型皮肤组织工程支架结合新型抗菌药物治疗研发出超分子复合胶体敷料，有效治疗急性创面，部分天然材料来源的胶体本身具备一定的抗感染作用，如葡聚糖、海藻酸胶体等，本产品在此基础上将抗菌剂分子固定在高分子载体上形成水不溶性聚合物抗菌剂形成更加优良的抑菌效果。此外，Res具有抗氧化、促进血管的能力，His-1能促进内皮细胞黏附、迁移和血管化，二者被负载到胶体中共同发挥作用，可显著抑制微生物的生长，降低感染风险。
2、本发明在使用时，通过采用复合酶解法提取虎杖中的白藜芦醇，在单因素试验基础上，设计L9(34)正交试验考察提取工艺的酶添加量、酶解温度、pH和时间对白藜芦醇提取率的影响，优选提取工艺的最佳条件为：复合酶添加量为1.5mg/g纤维素酶+1.5mg/g阿魏酸酯酶,温度50℃,pH 5.0,提取时间3.0h，大大提高了虎杖中白藜芦醇的提取率，减少资源浪费，节约生产成本；
本发明抗张强度大，稳定性好，采用微波冻融法将人工有机高分子材料聚乙烯醇与氧化后的天然高分子材料葡聚糖通过化学交联制备出更加理想的胶体基质，综合二者优点，进一步提高保护创面免受机械损伤的能力，且溶胀性能优良，促愈合能力强，本发明通过一种负载白藜芦醇和富组蛋白-1的抗菌型聚乙烯醇-葡聚糖胶体敷贴，用于皮肤急性创面愈合以及烧烫伤。其不溶于水的三维网络状交联聚合物，能够模拟细胞外基质，其良好的溶胀性使其可以吸收伤口渗液，维持湿润的伤口环境。研究表明，湿性环境可促进创面成纤维细胞增殖、表皮细胞迁移和血管增生，更有利于伤口愈合。
具体实施方式
下面将结合本发明实施例，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1
本发明提供以下技术方案：一种创面愈合用抗菌型胶体敷贴及其制备方法，包括创面愈合用抗菌型胶体敷贴，创面愈合用抗菌型胶体敷贴包括医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球、薄膜背衬、无纺布、粘合剂和离型纸；
创面愈合用抗菌型胶体敷贴为方形结构敷贴；
医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层内设有白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球；
薄膜背衬的一侧依次设有医用级聚乙烯醇/氧化葡聚糖 (PVA/ODex)胶体基质层、离型纸和无纺布，且薄膜背衬、医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、离型纸与无纺布通过粘合剂相连接。
薄膜背衬的材料为聚氨酯，且粘合剂的材料为丙烯酸酯。
白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球中的白藜芦醇和富组蛋白-1的质量比为4：1。
医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层内医用级聚乙烯醇和氧化葡聚糖的质量分数组份分别为6％和10％，且白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球中白藜芦醇和富组蛋白-1 的质量分数组份分别为2％和0.5％。
一种创面愈合用抗菌型胶体敷贴制备方法具体包括如下步骤：
第一步、首先对医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层进行制备，称取1.5gPVA，置于25mL蒸馏水中，微波30％火力持续1min，水浴95℃加热溶解配置成0.06g/mL的PVA溶液。降温后加入氧化葡聚糖(PVA质量分数为40％)，水浴50℃加热使氧化葡聚糖完全溶剂热。将溶解后的溶液置于平皿中，超声排气30min，— 20℃下冷冻1.5h，微波60％火力融化1min，循环三次。置于加热至 45℃的蒸馏水中洗净单体，50℃真空干燥6h，即可得到PVA/ODex胶体基质，也就是医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层；
第二步、对白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球进行制备，称取一定量白藜芦醇(RES)与羟丙基-β-环糊精(HP- β-CD)，质量比为1：7，先将HP-β-CD溶于适量乙醇中，然后将 RES加入其中搅拌使之溶解，并在室温下挥干乙醇，得到RES-HP-β -CD包合物。再称取一定量富组蛋白-1溶于1％醋酸中，分散加入 RES-HP-β-CD，搅拌，采用喷雾干燥法制备得到RES-HP-β-CD-His-1 缓释微球，也就是白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球；
第三步、将第二步中制得的RES-HP-β-CD-His-1缓释微球在室温下均匀分散在40％的氧化葡聚糖水溶液中，再与第一中配好的0.06g/mL的PVA溶液按4:1比例，并使用磁力搅拌器搅拌混匀，置于平皿中超声排气30min，后续操作同于第一步的后续处理，即可得到抗菌型医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层；
第四步、将第三步中制得的抗菌型医用级聚乙烯醇/氧化葡聚糖 (PVA/ODex)胶体基质层与薄膜背衬、离型纸和无纺布利用粘合剂相连接并压膜成型，再进行模切包装，即可制得方形结构的创面愈合用抗菌型胶体敷贴。
白藜芦醇的制备方法，具体包括如下步骤：
称取粉碎至60目的虎杖粉末样品5.0g,按固液比1∶20(g/mL) 加入水后,添加1.5mg/g纤维素酶和1.5mg/g阿魏酸酯酶，在温度为50℃、pH为5.0的条件下酶解3.0h后加入适量甲醇,再恒温加热提取一定时间,减压抽滤、离心后定容至100mL，即可制得白藜芦醇。
一种创面愈合用抗菌型胶体敷贴制备方法中RES/HP-β-CD/ His-1的质量比为1：7：0.25，且喷雾干燥法制备得到RES-HP-β-CD- His-1缓释微球的工艺参数为进口温度130℃，出口温度75℃，进料速度5mL/min，雾化气流速8.8L/min。
实施例2
本发明提供以下技术方案：一种创面愈合用抗菌型胶体敷贴及其制备方法，包括创面愈合用抗菌型胶体敷贴，创面愈合用抗菌型胶体敷贴包括医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球、薄膜背衬、无纺布、粘合剂和离型纸；
创面愈合用抗菌型胶体敷贴为方形结构敷贴；
医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层内设有白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球；
薄膜背衬的一侧依次设有医用级聚乙烯醇/氧化葡聚糖 (PVA/ODex)胶体基质层、离型纸和无纺布，且薄膜背衬、医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、离型纸与无纺布通过粘合剂相连接。
薄膜背衬的材料为聚氨酯，且粘合剂的材料为丙烯酸酯。
白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球中的白藜芦醇和富组蛋白-1的质量比为4：1。
医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层内医用级聚乙烯醇和氧化葡聚糖的质量分数组份分别为15％和25％，且白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球中白藜芦醇和富组蛋白 -1的质量分数组份分别为8％和2％。
一种创面愈合用抗菌型胶体敷贴制备方法具体包括如下步骤：
第一步、首先对医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层进行制备，称取1.5gPVA，置于25mL蒸馏水中，微波30％火力持续1min，水浴95℃加热溶解配置成0.06g/mL的PVA溶液。降温后加入氧化葡聚糖(PVA质量分数为40％)，水浴50℃加热使氧化葡聚糖完全溶剂热。将溶解后的溶液置于平皿中，超声排气30min，— 20℃下冷冻1.5h，微波60％火力融化1min，循环三次。置于加热至45℃的蒸馏水中洗净单体，50℃真空干燥6h，即可得到PVA/ODex胶体基质，也就是医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层；
第二步、对白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球进行制备，称取一定量白藜芦醇(RES)与羟丙基-β-环糊精(HP- β-CD)，质量比为1：7，先将HP-β-CD溶于适量乙醇中，然后将 RES加入其中搅拌使之溶解，并在室温下挥干乙醇，得到RES-HP-β -CD包合物。再称取一定量富组蛋白-1溶于1％醋酸中，分散加入 RES-HP-β-CD，搅拌，采用喷雾干燥法制备得到RES-HP-β-CD-His-1 缓释微球，也就是白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球；
第三步、将第二步中制得的RES-HP-β-CD-His-1缓释微球在室温下均匀分散在40％的氧化葡聚糖水溶液中，再与第一中配好的 0.06g/mL的PVA溶液按4:1比例，并使用磁力搅拌器搅拌混匀，置于平皿中超声排气30min，后续操作同于第一步的后续处理，即可得到抗菌型医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层；
第四步、将第三步中制得的抗菌型医用级聚乙烯醇/氧化葡聚糖 (PVA/ODex)胶体基质层与薄膜背衬、离型纸和无纺布利用粘合剂相连接并压膜成型，再进行模切包装，即可制得方形结构的创面愈合用抗菌型胶体敷贴。
白藜芦醇的制备方法，具体包括如下步骤：
称取粉碎至60目的虎杖粉末样品5.0g,按固液比1∶20(g/mL) 加入水后,添加1.5mg/g纤维素酶和1.5mg/g阿魏酸酯酶，在温度为50℃、pH为5.0的条件下酶解3.0h后加入适量甲醇,再恒温加热提取一定时间,减压抽滤、离心后定容至100mL，即可制得白藜芦醇。
一种创面愈合用抗菌型胶体敷贴制备方法中RES/HP-β-CD/ His-1的质量比为1：7：0.25，且喷雾干燥法制备得到RES-HP-β-CD- His-1缓释微球的工艺参数为进口温度130℃，出口温度75℃，进料速度5mL/min，雾化气流速8.8L/min。
实施例3
一种创面愈合用抗菌型胶体敷贴及其制备方法，包括创面愈合用抗菌型胶体敷贴，创面愈合用抗菌型胶体敷贴包括医用级聚乙烯醇/ 氧化葡聚糖(PVA/ODex)胶体基质层、白藜芦醇-羟丙基-β-环糊精- 富组蛋白-1缓释微球、薄膜背衬、无纺布、粘合剂和离型纸；
创面愈合用抗菌型胶体敷贴为方形结构敷贴；
医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层内设有白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球；
薄膜背衬的一侧依次设有医用级聚乙烯醇/氧化葡聚糖 (PVA/ODex)胶体基质层、离型纸和无纺布，且薄膜背衬、医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、离型纸与无纺布通过粘合剂相连接。
薄膜背衬的材料为聚氨酯，且粘合剂的材料为丙烯酸酯。
白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球中的白藜芦醇和富组蛋白-1的质量比为4：1。
医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层内医用级聚乙烯醇和氧化葡聚糖的质量分数组份分别为10％和18％，且白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球中白藜芦醇和富组蛋白 -1的质量分数组份分别为5％和1.3％。
一种创面愈合用抗菌型胶体敷贴制备方法具体包括如下步骤：
第一步、首先对医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层进行制备，称取1.5gPVA，置于25mL蒸馏水中，微波30％火力持续1min，水浴95℃加热溶解配置成0.06g/mL的PVA溶液。降温后加入氧化葡聚糖(PVA质量分数为40％)，水浴50℃加热使氧化葡聚糖完全溶剂热。将溶解后的溶液置于平皿中，超声排气30min，— 20℃下冷冻1.5h，微波60％火力融化1min，循环三次。置于加热至 45℃的蒸馏水中洗净单体，50℃真空干燥6h，即可得到PVA/ODex胶体基质，也就是医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层；
第二步、对白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球进行制备，称取一定量白藜芦醇(RES)与羟丙基-β-环糊精(HP- β-CD)，质量比为1：7，先将HP-β-CD溶于适量乙醇中，然后将 RES加入其中搅拌使之溶解，并在室温下挥干乙醇，得到RES-HP-β -CD包合物。再称取一定量富组蛋白-1溶于1％醋酸中，分散加入 RES-HP-β-CD，搅拌，采用喷雾干燥法制备得到RES-HP-β-CD-His-1 缓释微球，也就是白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球；
第三步、将第二步中制得的RES-HP-β-CD-His-1缓释微球在室温下均匀分散在40％的氧化葡聚糖水溶液中，再与第一中配好的 0.06g/mL的PVA溶液按4:1比例，并使用磁力搅拌器搅拌混匀，置于平皿中超声排气30min，后续操作同于第一步的后续处理，即可得到抗菌型医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层；
第四步、将第三步中制得的抗菌型医用级聚乙烯醇/氧化葡聚糖 (PVA/ODex)胶体基质层与薄膜背衬、离型纸和无纺布利用粘合剂相连接并压膜成型，再进行模切包装，即可制得方形结构的创面愈合用抗菌型胶体敷贴。
白藜芦醇的制备方法，具体包括如下步骤：
称取粉碎至60目的虎杖粉末样品5.0g,按固液比1∶20(g/mL) 加入水后,添加1.5mg/g纤维素酶和1.5mg/g阿魏酸酯酶，在温度为50℃、pH为5.0的条件下酶解3.0h后加入适量甲醇,再恒温加热提取一定时间,减压抽滤、离心后定容至100mL，即可制得白藜芦醇。
一种创面愈合用抗菌型胶体敷贴制备方法中RES/HP-β-CD/ His-1的质量比为1：7：0.25，且喷雾干燥法制备得到RES-HP-β-CD- His-1缓释微球的工艺参数为进口温度130℃，出口温度75℃，进料速度5mL/min，雾化气流速8.8L/min。
本发明中薄膜背衬和粘合剂等所有材料均经过环氧乙烷灭菌，如今对的技术手段中，常使用环氧乙烷做灭菌剂，环氧乙烷是一种广谱灭菌剂，可在常温下杀灭各种微生物，包括芽孢、结核杆菌、细菌、病毒、真菌等，能杀灭所有微生物，包括细菌芽孢，从而达到高效灭菌的效果，为本发明中创面愈合用抗菌型方形胶体敷贴安全高效的使用提供了有利条件。
最后应说明的是：以上所述仅为本发明的优选实施例而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (7)
1.一种创面愈合用抗菌型胶体敷贴，其特征在于：所述创面愈合用抗菌型胶体敷贴包括医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球、薄膜背衬、无纺布、粘合剂和离型纸；
所述创面愈合用抗菌型胶体敷贴为方形结构敷贴；
所述医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层内设有白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球；
所述薄膜背衬的一侧依次设有所述医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、所述离型纸和所述无纺布，且所述薄膜背衬、所述医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层、所述离型纸与所述无纺布通过所述粘合剂相连接。
2.根据权利要求1所述的一种创面愈合用抗菌型胶体敷贴，其特征在于：所述薄膜背衬的材料为聚氨酯，且所述粘合剂的材料为丙烯酸酯。
3.根据权利要求1所述的一种创面愈合用抗菌型胶体敷贴，其特征在于：所述白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球中的白藜芦醇和富组蛋白-1的质量比为4：1。
4.根据权利要求1所述的一种创面愈合用抗菌型胶体敷贴，其特征在于：所述医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层内医用级聚乙烯醇和氧化葡聚糖的质量分数组份分别为6％-15％和10％-25％，且所述白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球中白藜芦醇和富组蛋白-1的质量分数组份分别为2％-8％和0.5％-2％。
5.一种创面愈合用抗菌型胶体敷贴制备方法，其特征在于：具体包括如下步骤：
第一步、首先对医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层进行制备，称取1.5gPVA，置于25mL蒸馏水中，微波30％火力持续1min，水浴95℃加热溶解配置成0.06g/mL的PVA溶液。降温后加入氧化葡聚糖(PVA质量分数为40％)，水浴50℃加热使氧化葡聚糖完全溶剂热。将溶解后的溶液置于平皿中，超声排气30min，—20℃下冷冻1.5h，微波60％火力融化1min，循环三次。置于加热至45℃的蒸馏水中洗净单体，50℃真空干燥6h，即可得到PVA/ODex胶体基质，也就是医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层；
第二步、对白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球进行制备，称取一定量白藜芦醇(RES)与羟丙基-β-环糊精(HP-β-CD)，质量比为1：7，先将HP-β-CD溶于适量乙醇中，然后将RES加入其中搅拌使之溶解，并在室温下挥干乙醇，得到RES-HP-β-CD包合物。再称取一定量富组蛋白-1溶于1％醋酸中，分散加入RES-HP-β-CD，搅拌，采用喷雾干燥法制备得到RES-HP-β-CD-His-1缓释微球，也就是白藜芦醇-羟丙基-β-环糊精-富组蛋白-1缓释微球；
第三步、将第二步中制得的RES-HP-β-CD-His-1缓释微球在室温下均匀分散在40％的氧化葡聚糖水溶液中，再与第一中配好的0.06g/mL的PVA溶液按4:1比例，并使用磁力搅拌器搅拌混匀，置于平皿中超声排气30min，后续操作同于第一步的后续处理，即可得到抗菌型医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层；
第四步、将第三步中制得的抗菌型医用级聚乙烯醇/氧化葡聚糖(PVA/ODex)胶体基质层与薄膜背衬、离型纸和无纺布利用粘合剂相连接并压膜成型，再进行模切包装，即可制得方形结构的创面愈合用抗菌型胶体敷贴。
6.根据权利要求5所述的一种创面愈合用抗菌型胶体敷贴制备方法，其特征在于：所述白藜芦醇的制备方法，具体包括如下步骤：
称取粉碎至60目的虎杖粉末样品5.0g,按固液比1∶20(g/m L)加入水后,添加1.5mg/g纤维素酶和1.5mg/g阿魏酸酯酶，在温度为50℃、pH为5.0的条件下酶解3.0h后加入适量甲醇,再恒温加热提取一定时间,减压抽滤、离心后定容至100mL，即可制得白藜芦醇。
7.根据权利要求5所述的一种创面愈合用抗菌型胶体敷贴制备方法，其特征在于：所述RES/HP-β-CD/His-1的质量比为1：7：0.25，且喷雾干燥法制备得到RES-HP-β-CD-His-1缓释微球的工艺参数为进口温度130℃，出口温度75℃，进料速度5mL/min，雾化气流速8.8L/min。
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| CN115887731B (zh) * | 2022-12-04 | 2024-02-20 | 贵州医科大学 | β乳球蛋白纤维-聚乙烯醇气凝胶的制备方法及其在制备皮肤敷料中的应用 |
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| CN116617191A (zh) * | 2023-05-30 | 2023-08-22 | 南通市优玖医疗用品有限公司 | 一种抗菌、抑制疤痕再生的敷贴及其制备工艺 |
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