CN107177980B - 一种接触性创面敷料及其制备方法 - Google Patents
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Abstract
本发明涉及医药领域，特别涉及一种接触性创面敷料及其制备方法。一种接触性创面敷料，对非织造布进行羧甲基化，再与水溶性壳聚糖在活化剂作用下交联形成，创面敷料制备方法包括：(1)将非织造布浸渍在10‑30wt％氢氧化钠溶液中进行碱化反应；(2)将步骤(1)处理过的非织造布浸渍于20‑45wt％氯乙酸的乙醇溶液中进行醚化反应，洗涤、干燥；(3)将羧甲基化非织造布与0.1～5wt％水溶性壳聚糖在活化剂作用下进行交联反应，洗涤、干燥得到创面敷料。本发明涉及的创面敷料包含两种成分，适用作有渗出物的创面，具有优异的吸收性和非粘连性，能够促进创面愈合。
Description
技术领域
本发明涉及接触性创面敷料，还涉及该敷料的制备方法。
背景技术
水溶性壳聚糖具有无毒无刺激性，生物相容性优异，促进上皮细胞生长，抑制细菌生长等优异的性能，因此，近年来在创面敷料方面得到了广泛的应用。
羧甲基纤维素能够吸收大量的水分，并在其表面形成凝胶体，该特性在制作具有一定的吸收性和非粘性的创面敷料方面非常有利。专利99807811.5、02817591.3中公开了羧甲基纤维素敷料及其制备方法和抗菌敷料，且专利产品广泛应用于擦伤和裂伤伤口、下肢溃疡、褥疮、糖尿病溃疡、手术伤口、烧伤烫伤创面。
现有的接触性创面敷料虽能提供湿性愈合环境，但抗菌效果较差，生长因子活性较低，导致创面愈合速度减缓。
发明内容
为了解决现有技术的问题，本发明提供了一种接触性创面敷料，用作有渗出物的创面，具有优异的吸收性和非粘连性，促进创面愈合，同时，提供了一种接触性创面敷料的制备方法。
本发明所述技术方案如下：
一种接触性创面敷料，由羧甲基化的非织造布和水溶性壳聚糖在活化剂作用下交联形成。
所述羧甲基化非织造布的的羧甲基取代度为0.15～0.35。
所述活化剂为1-乙基-(3-二甲基氨基丙基)碳二亚胺盐酸盐(EDC)，1-(3-二甲基氨基丙基)-3-乙基碳二亚胺盐甲碘化物(ETC)，环己基-B-(N-甲基吗啉)乙基碳二亚胺盐对甲苯磺酸盐(CMC)，亚苯基乙基碳二亚胺和1.6-环六亚甲基二(碳二亚胺)中的一种。
一种接触性创面敷料的制备方法包括以下步骤：
(1)碱化反应：将非织造布浸渍在10-30wt％氢氧化钠水溶液中，在20-35℃的温度下反应1～3h。
(2)醚化反应：将步骤(1)中处理后的非织造布浸渍在20-45wt％氯乙酸的乙醇的混合溶液中，在60～90℃的温度下反应1-3h，加0.1mol/L盐酸中和，再用75wt％乙醇水溶液洗涤2-4次，最后用95wt％乙醇水溶液洗涤一次，于35～50℃烘箱内烘干备用。
(3)将一定量的活化剂加入到0.1～5wt％水溶性壳聚糖溶液中，充分搅拌均匀，活化剂与水溶性壳聚糖的摩尔比为0～1.5，优选0.5～1。
(4)交联反应：将羧甲基化的非织造布浸于50wt％乙醇中，并与步骤(3)中加入活化剂的水溶性壳聚糖溶液混合，室温下充分搅拌1～4h后，将产物用0.1mol/L盐酸中和，再用75wt％乙醇水溶液洗涤2-4次，最后用95wt％乙醇水溶液洗涤1次，于35～50℃烘箱内烘干，得到接触性创面敷料。
所述的步骤(1)中非织造布可为水刺无纺布、针刺无纺布、湿法无纺布中的一种，非织造布的纤维原料可为棉纤维，粘胶纤维，天丝纤维。
所述的步骤(3)中0.1～5wt％水溶性壳聚糖溶液用0.1mol/L盐酸调节pH至4.2～5.7。
所述的步骤(4)中得到的接触性创面敷料能够吸收其自身重量至少15倍的0.9％(重量)生理盐水溶液，具有足够的非粘性，可从创面完整取下
本发明提供的技术方案带来的有益效果是：
通过结合羧甲基纤维素和水溶性壳聚糖的优势，制备一种接触性创面敷料，可以在为创面提供湿性愈合环境的同时，透气、透水效果好，抗菌灭菌效果理想，具有优异的吸收性和非粘连性，引入水溶性壳聚糖，通过提高生长因子的活性而加快细胞的增殖，使表皮细胞很快地随着聚集于伤口与敷料间的渗出物移动到皮肤表面，使伤口快速愈合。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将结合具体实施方式作进一步地详细描述。
实施例1：
(1)将天丝针刺无纺布(75g/m2)浸渍在10wt％氢氧化钠水溶液中，在25℃的温度下反应，时间为2h，取出无纺布，压干称重。
(2)将步骤(1)中处理后的无纺布浸渍在25wt％氯乙酸的乙醇的混合溶液中，在60℃的温度下反应2h，加0.1mol/L盐酸中和，用75wt％乙醇溶液洗涤3次，再用95wt％乙醇溶液洗涤1次，于40℃烘箱内烘干备用。
(3)将一定量的EDC加入到2wt％水溶性壳聚糖溶液(用0.1mol/L盐酸调节pH至4.2～5.7)中，充分搅拌均匀，活化剂与水溶性壳聚糖的摩尔比为0.5。
(4)将羧甲基化天丝针刺无纺布浸于50wt％乙醇中，并与步骤(3)中加入EDC的水溶性壳聚糖溶液混合，室温下充分搅拌2h后，将产物用0.1mol/L盐酸中和，75wt％乙醇溶液洗涤3次，再用95wt％乙醇溶液洗涤1次，于40℃烘箱内烘干，得到接触性创面敷料。
实施例2：
(1)将粘胶针刺无纺布(90g/m2)在25wt％氢氧化钠水溶液中，在25℃的温度下反应，时间为2h，取出无纺布，压干称重。
(2)将步骤(1)中处理后的无纺布浸渍在40wt％氯乙酸的乙醇的混合溶液中，在60℃的温度下反应2h，加0.1mol/L盐酸中和，用75wt％乙醇溶液洗涤3次，再用95wt％乙醇溶液洗涤一次，于50℃烘箱内烘干备用。
(3)将一定量的EDC加入到0.1wt％水溶性壳聚糖溶液(用0.1mol/L盐酸调节pH至4.2～5.7)中，充分搅拌均匀，EDC与水溶性壳聚糖的摩尔比为0.8。
(4)将羧甲基化粘胶针刺无纺布浸于50wt％乙醇中，并与步骤(3)中加入EDC的水溶性壳聚糖溶液混合，室温下充分搅拌3h后，将产物用0.1mol/L盐酸中和，用75wt％乙醇溶液洗涤3次，再用95wt％乙醇溶液洗涤1次，于50℃烘箱内烘干，得到接触性创面敷料。
实施例3：
(1)将脱脂棉水刺无纺布(50g/m2)在10wt％氢氧化钠水溶液中，在35℃的温度下反应，时间为3h，取出无纺布，压干称重。
(2)将步骤(1)中处理后的无纺布浸渍在25wt％氯乙酸的乙醇的混合溶液中，在70℃的温度下反应2h，加0.1mol/L盐酸中和，用75wt％乙醇溶液洗涤3次，再用95wt％乙醇溶液洗涤1次，于45℃烘箱内烘干备用。
(3)将一定量的EDC加入到5wt％水溶性壳聚糖溶液(用0.1mol/L盐酸调节pH至4.2～5.7)中，充分搅拌均匀，活化剂与水溶性壳聚糖的摩尔比为0.5。
(4)将羧甲基化脱脂棉水刺无纺布浸于50wt％乙醇中，并与步骤(3)中加入EDC的水溶性壳聚糖溶液混合，室温下充分搅拌2h后，将产物用0.1mol/L盐酸中和，75wt％乙醇溶液洗涤3次，再用95wt％乙醇溶液洗涤1次，于45℃烘箱内烘干，得到接触性创面敷料。
上述实施例的技术指标和生物安全性评价如下：
(1)吸收性：称取0.2g样品(W0)，置于已预热至37±1℃的20ml左右0.9％(重量)生理盐水溶液中，10min后取出样品，用镊子夹持样品一角或一端，悬垂30s，精密称重记为W1，计算吸收性V。
结果：实施例1：24.8g/g，实施例2：16.7g/g，实施例3：10.2g/g。
(2)取(1)中经过试验的产品，手工评价凝胶感。
结果：实施例1：形成完整凝胶，基本无粘性；实施例2：形成完整凝胶，粘性较低；实施例3：凝胶不完整，容易脱落片段，有一定的粘性。
(3)无菌试验：将实施例样品按照将实施例样品按照GB/T 14233.2-2005中规定试验方法进行测定。
结果：均未发现微生物。
(4)热原试验：将实施例样品按照GB/T 14233.2-2005中规定试验方法进行测定。
结果：均无热源反应。
(5)体外细胞毒性：将实施例样品按照GB/T16886.5-2003中规定试验方法进行测定。
结果:细胞毒性均在0～1级范围内，细胞形态正常。
(6)刺激与皮肤致敏：将实施例样品按照GB/T16886.10-2005中规定试验方法进行测定。
结果：均无皮内刺激反应，皮肤致敏率均低于1％。
以上所述仅为本发明的较佳实施例，并不用以限制本发明，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 (4)
1.一种接触性创面敷料，其特征在于，由羧甲基化的非织造布和水溶性壳聚糖在活化剂作用下交联形成；
所述羧甲基化的非织造布的羧甲基取代度为0.15～0.35；
所述接触性创面敷料经以下步骤得到：
(1)碱化反应：将非织造布浸渍在10-30wt％氢氧化钠水溶液中，在20-35℃的温度下反应1～3h；
(2)醚化反应：将步骤(1)中处理后的非织造布浸渍在20-45wt％氯乙酸的乙醇的混合溶液中，在60～90℃的温度下反应1-3h，加0.1mol/L盐酸中和，再用75wt％乙醇水溶液洗涤2-4次，最后用95wt％乙醇水溶液洗涤一次，于35～50℃烘箱内烘干备用；
(3)将一定量的活化剂加入到0.1～5wt％水溶性壳聚糖溶液中，充分搅拌均匀，活化剂与水溶性壳聚糖的摩尔比为0.5～1；
(4)交联反应：将羧甲基化的非织造布浸于50wt％乙醇中，并与步骤(3)中加入活化剂的水溶性壳聚糖溶液混合，室温下充分搅拌1～4h后，将产物用0.1mol/L盐酸中和，再用75wt％乙醇水溶液洗涤2-4次，最后用95wt％乙醇水溶液洗涤1次，于35～50℃烘箱内烘干，得到接触性创面敷料；
所述的非织造布为水刺无纺布、针刺无纺布、湿法无纺布中的一种，非织造布的纤维原料为棉纤维，粘胶纤维，天丝纤维。
2.根据权利要求1所述的一种接触性创面敷料，其特征在于，所述的活化剂为1-乙基-(3-二甲基氨基丙基)碳二亚胺盐酸盐(EDC)，1-(3-二甲基氨基丙基)-3-乙基碳二亚胺盐甲碘化物(ETC)，环己基-B-(N-甲基吗啉)乙基碳二亚胺盐对甲苯磺酸盐(CMC)，亚苯基乙基碳二亚胺和1.6-环六亚甲基二(碳二亚胺)中的一种。
3.根据权利要求1所述的接触性创面敷料的制备方法，其特征在于，还包括以下步骤：
(1)碱化反应：将非织造布浸渍在10-30wt％氢氧化钠水溶液中，在20-35℃的温度下反应1～3h；
(2)醚化反应：将步骤(1)中处理后的非织造布浸渍在20-45wt％氯乙酸的乙醇的混合溶液中，在60～90℃的温度下反应1-3h，加0.1mol/L盐酸中和，再用75wt％乙醇水溶液洗涤2-4次，最后用95wt％乙醇水溶液洗涤一次，于35～50℃烘箱内烘干备用；
(3)将一定量的活化剂加入到0.1～5wt％水溶性壳聚糖溶液中，充分搅拌均匀，活化剂与水溶性壳聚糖的摩尔比为0.5～1；
(4)交联反应：将羧甲基化的非织造布浸于50wt％乙醇中，并与步骤(3)中加入活化剂的水溶性壳聚糖溶液混合，室温下充分搅拌1～4h后，将产物用0.1mol/L盐酸中和，再用75wt％乙醇水溶液洗涤2-4次，最后用95wt％乙醇水溶液洗涤1次，于35～50℃烘箱内烘干，得到接触性创面敷料。
4.根据权利要求3所述的接触性创面敷料的制备方法，其特征在于，所述的步骤(4)中得到的接触性创面敷料能够吸收其自身重量至少15倍的0.9％(重量)生理盐水溶液，具有足够的非粘性，从创面完整取下。
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