CN109481148B - 一种吸湿透气型伤口敷料贴 - Google Patents
一种吸湿透气型伤口敷料贴 Download PDFInfo
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Abstract
本发明属于医用材料生产技术领域，具体公开了吸湿透气型伤口敷料贴，本发明的多层吸湿透气型伤口敷料贴，抑菌层由壳聚糖、壳低聚糖、氧化海藻酸钠、明胶和纯化水组成的凝胶制成，具有起效时间短、作用时间长，具有止血、镇痛和促愈等多重作用，吸水层可以吸收皮肤上的液体，保持创口的干燥，其由硅胶和羟基纤维素钠组成，在吸湿的同时具有良好的透气性，而防水层可使水蒸气通透而排放至外部，进一步保持皮肤干燥，适合长时间贴附于人体表面，避免皮肤过敏或不适。本发明的敷料贴具有高吸水性、透气性、透湿性和良好的生物相容性，可广发用于各种创伤的包扎、恢复和治疗中。
Description
技术领域
本发明涉及一种医用敷料贴，具体是吸湿透气型伤口敷料贴。
背景技术
敷料贴因其实用性广、使用效果佳等优点而广泛用于各种伤口的包扎和应急处理，深受广大患者喜爱；较早的敷料产品主要是传统橡皮膏、黑膏药为主，此产品患者贴用后易产生过敏现象，而且当撕除时会有撕拉疼痛感；目前较新的的敷料贴以水溶性高分子材料为基质骨架，富含60％水份，通过所含薄荷脑等有效成份与水凝胶物理作用达到冷敷治疗效果，可以降低关节组织损伤，消除肿胀疼痛减少炎症的并发，虽说解决了老式敷料贴的不利因素，但是结构仍较简单，对于破损性伤口的止血吸湿效果不是很明显，当伤口渗血或体液较厉害时，敷料贴的使用效果将大打折扣。创伤愈合是一个动态过程，所以对创伤敷料的要求会随着痊愈过程有所变化。有效的创伤敷料不仅能使创伤与外界隔离，而且能够除去伤口的渗出液，提供一个促进伤口痊愈的潮湿的微环境，促使组织重建。近年出现了许多以水凝胶为主要成分的创伤辅料，这些材料包括合成聚合物聚氨酯、聚乙烯、聚乳酸、硅酮橡胶等及天然高分子藻酸盐、壳聚糖、明胶等。其中壳聚糖是由甲壳质碱性脱乙酰化得到的聚合物，具有生物相容性、可降解、止血活性、抗感染和加速伤口痊愈的特点。但单纯由壳聚糖制备的水凝胶机械强度差，限制了其在创伤敷料方面的应用。同时，上述材料的透气性较差，不利于伤口的快速愈合。
因此，需要开发一种具有较好的吸湿和透气型伤口敷料贴。
发明内容
本发明的主要目的在于提供一种吸湿透气型伤口敷料贴，其具有四层结构，包括依序贴合的贴敷层、抑菌层、吸水层以及防水层，可直接贴附至人体皮肤，吸收来自皮肤的液体，适合长时间贴附于人体表面，保持皮肤干爽，并能避免皮肤过敏或红肿的不适感或刺激感。
贴敷层具有贴附及固定效果，可直接贴敷并固定于皮肤上，并使皮肤上的液体穿透。抑菌层含有抑菌成分，可以释放抑菌药物，从而达到杀菌消毒的作用，避免伤口二次感染，促进伤口的尽快愈合。吸水层可吸收来自于贴敷层的液体，使伤口保持干燥，避免滋生细菌。防水层可防水膜所构成，可使吸水层所吸收的液体经蒸发后穿透防水层而传送到外部，保持皮肤处在较为干燥的舒爽状态。
贴敷层可由压克力胶、PU胶、硅胶、水凝胶或人工皮而构成，而且贴敷层进一步可具有穿孔、网状或间隙的结构，用以让血液或组织液通过贴敷层而达到抑菌层进而达到吸水层，并由吸水层吸收，此外，抑菌层释放的药物也可以通过穿孔、网状或间隙的结构从而更好的达到伤口，起到抑菌消毒的效果。
抑菌层由壳聚糖、壳低聚糖、氧化海藻酸钠、明胶和纯化水组成的凝胶制成，上述凝胶可以有较为宽泛的配比，优选每100毫升的纯化水内含有0.1克-3克的壳聚糖、0.1克-3克的壳低聚糖、1克-5克的氧化海藻酸钠、0.1克-5克的明胶。更优选每100毫升的纯化水内含有0.5克-2克的壳聚糖、0.5克-2克的壳低聚糖、3克-5克的氧化海藻酸钠、1克-3克的明胶；更进一步优选每100毫升的纯化水内含有1克-1.5克的壳聚糖、1克-1.5克的壳低聚糖、3克-4克的氧化海藻酸钠、2克-3克的明胶。
上述凝胶抑菌层为一种起效时间短、作用时间长，可以的促进烧烫伤、急慢性等伤口愈合，且具有止血、镇痛和促愈三重作用的新型生物水凝胶敷料。使用的不同的分子量梯度的主要原材料即壳聚糖和壳低聚糖以及氧化海藻酸钠，其中壳聚糖的分子量在10万左右，分子量过大，分子间与分子内的氢键使分子链彼此缠绕厉害，溶解度过小，降解较快，不能起到产品有持久作用的效果；壳低聚糖分子量位于2000-10000之间，其中分子量为7000为最佳，既能够直接溶解于水中，又能保证降解发挥作用的时间适中。海藻酸是一类由褐藻提取的多糖，是β-D-甘露糖醛酸(M单元)和α-L-古洛糖醛酸(G单元)的无规嵌段共聚物。氧化海藻酸钠具有很好的生物相容性、低毒性，其分子量在14000以上，具有较好的粘度，能够快速交联并分散药物，具有良好的药物释放性。这三种物质的复配使用以达到被依次逐步吸收而持久发挥作用的目的。
所述凝胶可以采用下述制备方法进行制备，包括以下步骤：
(1)在纯化水内加入壳聚糖进行搅拌直至壳聚糖完全分散在水中；
(2)将明胶加入到步骤(1)得到的溶液中，并置于60℃-70℃的水浴上进行加热，至明胶完全溶解；
(3)在明胶完全溶解的溶液中加入壳低聚糖和氧化海藻酸钠，进行搅拌，使其完全分散在水中形成凝胶，静置消泡后进行灌装、灭菌，再进行无菌试验，合格后即可。
进一步，所述步骤(1)中加入壳聚糖后进行搅拌使其完全分散，搅拌的速度为400-500r/min。
进一步，所述步骤(3)中加入壳低聚糖和氧化海藻酸钠后进行搅拌使其完全分散，搅拌的速度为400-500r/min。
优选的，氧化海藻酸钠采取如下方法制备：取4g海藻酸钠配成质量分数为4％的水溶液，加入1.5g高碘酸钠避光氧化8h后加入2ml乙二醇终止氧化反应30min，加入2.5g NaCl
充分混合后加入70ml乙醇使其沉淀析出，旋蒸，用去离子水溶解产物，用渗析袋截留下分子量大于14000的氧化海藻酸钠，每6h换一次去离子水，渗析24h后，再用乙醇将沉淀析出，抽滤，冷冻干燥即得。使用渗析袋后得到的氧化海藻酸钠分子量较大，产物粘度更大，可以加快交联速率。
吸水层由硅胶和羟基纤维素钠组成，二者可以具有较大范围的质量配比，优选硅胶:羟基纤维素钠在100:10-100:30的范围内，硅胶具有较好的吸湿性，能够吸收伤口处的血液和组织液，但是单纯的硅胶在吸收液体后存在透气性差的缺点，加入一定量羟基纤维素钠后使得吸水层具有一定的孔状，从而改善了在吸湿后的透气性，从而达到能够更好的将吸收后的液体进行蒸发以及保持伤口的干燥。硅胶和羟基纤维素钠可采用机械混合进行挤压成膜进行制备。
防水层可由防水膜所构成，防水膜优选聚乙烯，可以起到防尘、防水、防漏气、防污染的效果。
进一步的，贴敷层、抑菌层和吸水层设置交错的网状或圆孔状通道。
有益效果
本发明的多层吸湿透气型伤口敷料贴，抑菌层由壳聚糖、壳低聚糖、氧化海藻酸钠、明胶和纯化水组成的凝胶制成，具有起效时间短、作用时间长，具有止血、镇痛和促愈等多重作用，吸水层可以吸收皮肤上的液体，保持创口的干燥，其由硅胶和羟基纤维素钠组成，在吸湿的同时具有良好的透气性，而防水层可使水蒸气通透而排放至外部，进一步保持皮肤干燥，适合长时间贴附于人体表面，避免皮肤过敏或不适。本发明的敷料贴具有高吸水性、透气性、透湿性和良好的生物相容性，可广泛用于各种创伤的包扎、恢复和治疗中。
具体实施方式
以下实施方式对本发明的原理和特征进行描述，所举实例只用于解释本发明，并非用于限定本发明的范围。
实施例1：抑菌层凝胶的制备
称取壳聚糖0.5克置搅拌器中，加入100毫升纯化水，搅匀，搅拌速度为450r/min，至完全分散，在该溶液中加入3克明胶，置70℃的水浴锅上加热，至明胶完全溶解，然后再加入1.5克壳低聚糖和5克氧化海藻酸钠搅拌使其完全分散，搅拌速度为400r/min，搅拌至形成凝胶状，最后，静置去泡，分装灭菌，即为成品。
实施例2：抑菌层凝胶的制备
称取壳聚糖2克置搅拌器中，加入100毫升纯化水，搅匀，搅拌速度为500r/min，至完全分散，在该溶液中加入5克明胶，置70℃的水浴锅上加热，至明胶完全溶解，然后再加入2.0克壳低聚糖和3克氧化海藻酸钠搅拌使其完全分散，搅拌速度为450r/min，搅拌至形成凝胶状，最后，静置去泡，分装灭菌，即为成品。
实施例3：抑菌层凝胶的制备
称取壳聚糖3克置搅拌器中，加入100毫升纯化水，搅匀，搅拌速度为500r/min，至完全分散，在该溶液中加入2克明胶，置60℃的水浴锅上加热，至明胶完全溶解，然后再加入1.0克壳低聚糖和4克氧化海藻酸钠搅拌使其完全分散，搅拌速度为500r/min，搅拌至形成凝胶状，最后，静置去泡，分装灭菌，即为成品。
实施例4：多层吸湿透气型伤口敷料贴的制备
在基材无纺布上涂布一层聚乙烯防水层，接着涂布由硅胶和羟基纤维素钠按照质量配比为100:10的比例制备而成的吸水层，然后涂布由实施例1制备得到的抑菌层凝胶，最后涂布PU胶作为贴敷层。上述材料均选用医药材料。最后做无菌处理并进行封装。
实施例5
在基材无纺布上涂布一层聚乙烯防水层，接着涂布由硅胶和羟基纤维素钠按照质量配比为100:20的比例制备而成的吸水层，然后涂布由实施例2制备得到的抑菌层凝胶，最后涂布PU胶作为贴敷层。上述材料均选用医药材料。最后做无菌处理并进行封装。
实施例6
在基材无纺布上涂布一层聚乙烯防水层，接着涂布由硅胶和羟基纤维素钠按照质量配比为100:30的比例制备而成的吸水层，然后涂布由实施例3制备得到的抑菌层凝胶，最后涂布PU胶作为贴敷层。上述材料均选用医药材料。最后做无菌处理并进行封装。
实施例7抗菌测试
将大肠杆菌和金黄色葡萄球菌活化后，将菌种接至斜面上，37℃培养12h，用无菌水洗涤斜面上的菌液，测OD值，以确保每次接种的菌种量相当，取菌种量相当的菌液涂布在培养基平板上，用镊子将直径0.6cm的滤纸片放在平板中，将实施例4-6三种敷料贴，用牛津杯取成相同厚度的小圆柱体水凝胶，放置在滤纸片上，每个梯度做3个平行，37℃恒温培养箱中培养12h,测量抑菌圈的直径。
表1敷料的抗菌性能比较
| 实施例4 | 实施例5 | 实施例6 | |
| 大肠杆菌 | 1.0cm | 1.1cm | 1.1cm |
| 金黄色葡萄球菌 | 0.9cm | 0.9cm | 1.0cm |
从表1中可以看出，这三种敷料均具有良好的抗菌活性。
实施例8测定细胞毒性
采用MTT比色法测定实施例4-6中的3种水凝胶敷料贴的细胞毒性。所选用的细胞为小鼠成纤维细胞(L929)。
表2不同敷料对小鼠成纤维细胞(L929)的细胞毒性
| 实施例 | 相对生长率RGR(％) | 评级 |
| 4 | 107.2 | 0 |
| 5 | 102.1 | 0 |
| 6 | 109.8 | 0 |
从表2中可以看出，实施例4-6制备得到的敷料贴对小鼠成纤维细胞(L929)的细胞毒性较低，细胞的相对生长率达100％以上，评级为0级(最优级)，说明本发明的敷料贴可用作生物医用材料。
Claims (7)
1.一种吸湿透气型伤口敷料贴，特征在于，所述敷料贴具有四层结构，包括依序贴合的贴敷层、抑菌层、吸水层以及防水层；
贴敷层选自压克力胶、PU胶、水凝胶或人工皮；
抑菌层由壳聚糖、壳低聚糖、氧化海藻酸钠、明胶和纯化水组成的凝胶制成；
吸水层由硅胶和羟基纤维素钠组成，硅胶和羟基纤维素钠的质量比为100:10-100:30；
防水层可由防水膜所构成；
抑菌层的凝胶由每100毫升的纯化水内含有0.1克-3克的壳聚糖、0.1克-3克的壳低聚糖、1克-5克的氧化海藻酸钠、0.1克-5克的明胶制备而成；
所述氧化海藻酸钠采取如下方法制备：取4g海藻酸钠配成质量分数为4％的水溶液，加入1.5g高碘酸钠避光氧化8h后加入2ml乙二醇终止氧化反应30min，加入2.5g NaCl充分混合后加入70ml乙醇使其沉淀析出，旋蒸，用去离子水溶解产物，用渗析袋截留下分子量大于14000的氧化海藻酸钠，每6h换一次去离子水，渗析24h后，再用乙醇将沉淀析出，抽滤，冷冻干燥即得。
2.根据权利要求1所述的吸湿透气型伤口敷料贴，其特征在于，抑菌层的凝胶由每100毫升的纯化水内含有0.5克-2克的壳聚糖、0.5克-2克的壳低聚糖、3克-5克的氧化海藻酸钠、1克-3克的明胶制备而成。
3.根据权利要求1所述的吸湿透气型伤口敷料贴，其特征在于，抑菌层的凝胶由每100毫升的纯化水内含有1克-1.5克的壳聚糖、1克-1.5克的壳低聚糖、3克-4克的氧化海藻酸钠、2克-3克的明胶制备而成。
4.根据权利要求1所述的吸湿透气型伤口敷料贴，其特征在于，抑菌层的凝胶采用下述制备方法进行制备，包括以下步骤：
(1)在纯化水内加入壳聚糖进行搅拌直至壳聚糖完全分散在水中；
(2)将明胶加入到步骤(1)得到的溶液中，并置于60℃-70℃的水浴上进行加热，至明胶完全溶解；
(3)在明胶完全溶解的溶液中加入壳低聚糖和氧化海藻酸钠，进行搅拌，使其完全分散在水中形成凝胶，静置消泡后进行灌装、灭菌，再进行无菌试验，合格后即可。
5.根据权利要求4所述的吸湿透气型伤口敷料贴，其特征在于，所述步骤(1)和(3)中搅拌的速度为400-500r/min。
6.根据权利要求1所述的吸湿透气型伤口敷料贴，其特征在于，防水层为聚乙烯膜。
7.根据权利要求1所述的吸湿透气型伤口敷料贴，其特征在于，贴敷层、抑菌层和吸水层设置交错的网状或圆孔状通道。
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| CN113017989A (zh) * | 2021-02-26 | 2021-06-25 | 福建省明辉机械制造有限公司 | 一种超薄透气卫生巾制备方法 |
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