CN108030953A - 一种医用水胶体敷料及其制备方法 - Google Patents
一种医用水胶体敷料及其制备方法 Download PDFInfo
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- CN108030953A CN108030953A CN201711328950.7A CN201711328950A CN108030953A CN 108030953 A CN108030953 A CN 108030953A CN 201711328950 A CN201711328950 A CN 201711328950A CN 108030953 A CN108030953 A CN 108030953A
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Abstract
本发明提供了一种医用水胶体敷料,包括防水膜;设置在所述防水膜上的水胶体层;设置在所述水胶体层上的隔离层;其中,所述水胶体层包括如下组分:硅凝胶25~40重量份;羧甲基纤维素钠10~30重量份;果胶10~20重量份;明胶5~12重量份;聚丙烯酸钠5~10重量份;有机硅季铵盐1~3重量份。本发明选取防水膜作为基材,具有透明、透气防水、阻隔细菌等特性。本发明的敷料水胶体层由硅凝胶、羧甲基纤维素钠、果胶、明胶和聚丙烯酸钠、有机硅季铵盐特定比例组成,制备得到医用水胶体敷料在使用中不断释放硅油,软化伤口,增加创面防黏连的效果,避免二次损伤。本发明的敷料吸收渗液能力强,为加速创面愈合提供环境。
Description
技术领域
本发明涉及医用敷料技术领域,尤其是涉及一种医用水胶体敷料及其制备方法。
背景技术
水胶体医用敷料是一种具有防水、防粘连、保湿、保温等优点的新型敷料。目前水胶体医用敷料所用的材质和功效区别很大,水胶体敷料所护理的创口也是千姿百态,针对不同的创口,需要安全性好以及具有不同功能的水胶体医用敷料。
现有技术公开的水胶体敷料是把吸水性高分子的颗粒与热熔压敏胶共混后制得的一种医用敷料。这种敷料结合了橡胶材料的黏合性能和吸水性高分子材料的吸水性能。橡胶基材可以使敷料粘贴在伤口上,而水胶体颗粒吸水后溶胀形成凝胶,给伤口提供一个湿润的密闭环境,促进伤口愈合。但是,传统的水胶体敷料一般不能用于渗液比较多的伤口,且无防黏连、抗菌功效,不能达到临床上理想敷料标准。
发明内容
有鉴于此,本发明要解决的技术问题在于提供一种种医用水胶体敷料,本发明提供的医用水胶体敷料具有防黏连效果的同时具有抑菌效果。
本发明提供了一种医用水胶体敷料,包括防水膜;设置在所述防水膜上的水胶体层;设置在所述水胶体层上的隔离层;其中,所述水胶体层包括如下组分:
优选的,所述水胶体层包括如下组分:
优选的,所述有机硅季铵盐为三烷氧基硅烷的季铵盐。
优选的,所述防水膜选自PU膜或硅胶膜的一种或几种;所述隔离层选自离型纸和聚四氟乙烯膜中的一种或几种。
优选的,所述水胶体层厚度为0.5~1.2mm。
本发明提供了一种医用水胶体敷料的制备方法,包括:
A)将硅凝胶、羧甲基纤维素钠、果胶、明胶、聚丙烯酸钠和有机硅季铵盐混合,搅拌,得到反应液;
B)将所述反应液转入内设有防水膜的模具中,固化,得到半成品;
C)将所述半成品与隔离膜粘附得到医用水胶体敷料。
优选的,所述步骤A)具体为将硅凝胶、羧甲基纤维素钠、果胶、明胶和聚丙烯酸钠混合搅拌10~30min,再与有机硅季铵盐混合搅拌10~20min。
优选的,所述搅拌为真空搅拌;所述搅拌温度为25~35℃。
优选的,步骤B)所述转入模具中后还包括25~35℃静置10~15min。
优选的,步骤B)所述固化具体为在烘箱中90~120℃,固化1~5h。
与现有技术相比,本发明提供了一种医用水胶体敷料,包括防水膜;设置在所述防水膜上的水胶体层;设置在所述水胶体层上的隔离层;其中,所述水胶体层包括如下组分:硅凝胶25~40重量份;羧甲基纤维素钠10~30重量份;果胶10~20重量份;明胶5~12重量份;聚丙烯酸钠5~10重量份;有机硅季铵盐1~3重量份。本发明选取防水膜作为基材,具有透明、透气防水、阻隔细菌等特性。本发明的敷料水胶体层由硅凝胶、羧甲基纤维素钠、果胶、明胶和聚丙烯酸钠、有机硅季铵盐特定比例组成,共同制备得到的医用水胶体敷料在使用中不断释放硅油,软化伤口,增加创面防黏连的效果,防止换药时损伤新生组织,避免二次损伤,亦可在创面愈合后期,预防疤痕增生。本发明的敷料吸收渗液能力强,使伤口处形成湿性的闭合环境,为加速创面愈合提供环境,同时还具有止血和杀菌的功效。
具体实施方式
本发明提供了一种医用水胶体敷料,本领域技术人员可以借鉴本文内容,适当改进工艺参数实现。特别需要指出的是,所有类似的替换和改动对本领域技术人员来说是显而易见的,它们都属于本发明保护的范围。本发明的方法及应用已经通过较佳实施例进行了描述,相关人员明显能在不脱离本发明内容、精神和范围内对本文的方法和应用进行改动或适当变更与组合,来实现和应用本发明技术。
本发明提供了一种医用水胶体敷料,包括防水膜;设置在所述防水膜上的水胶体层;设置在所述水胶体层上的隔离层;其中,所述水胶体层包括如下组分:
本发明提供的医用水胶体敷料,包括防水膜。本发明所述防水膜优选选自PU膜或硅胶膜的一种或几种。
本发明对其来源不进行限定,市售即可,所述防水膜的厚度优选为0.3~0.8mm。
本发明提供的医用水胶体敷料,包括设置在所述防水膜上的水胶体层。
其中,所述水胶体层包括如下组分:
本发明提供的水胶体层包括25~40重量份的硅凝胶;优选包括28~38重量份的硅凝胶;更优选包括30~36重量份的硅凝胶。
本发明对于所述硅凝胶不进行限定,本领域技术人员熟知的即可;可以为市售。
本发明选择的硅凝胶为优异的耐候性、耐热性、耐压缩变形性、良好的力学性能的弹性体,在使用中不断释放硅油,软化伤口,增加创面防黏连的效果,防止换药时损伤新生组织,避免二次损伤,亦可在创面愈合后期,预防疤痕增生。
本发明提供的水胶体层包括10~30重量份的羧甲基纤维素钠;优选包括12~28重量份的羧甲基纤维素钠;更优选包括13~25重量份的羧甲基纤维素钠。
本发明对于所述羧甲基纤维素钠的来源不进行限定,市售即可。
本发明所述羧甲基纤维素钠为纤维素羧甲基醚的钠盐,属阴离子型纤维素醚,为白色或乳白色纤维状粉末或颗粒,密度0.5-0.7克/立方厘米,几乎无臭、无味,具吸湿性。是葡萄糖聚合度为100~2000的纤维素衍生物,相对分子质量242.16。
本发明提供的羧甲基纤维素钠为水溶性高分子吸水材料,能吸水溶胀,吸收渗液能力强,吸湿率达1000%以上,能在伤口表面形成凝胶,使伤口处形成湿性的闭合环境,为加速创面愈合提供环境。
本发明提供的水胶体层包括10~20重量份的果胶;优选包括12~18重量份的果胶;更优选包括13~17重量份的果胶。
果胶,英文名称为pectin,英文别名为2,3,4,5-Tetrahydroxypentanal;9000-69-5;pentose,CAS号为9000-69-5,分子式为C5H10O5,为白色至黄褐色粉末,工业生产的果胶的80%~90%用于食品工业,利用其凝胶性生产胶冻、果酱和软糖。还可用在医药方面作止血剂和代血浆,也可用来治疗腹泻和重金属中毒等。果胶是羟基被不同程度甲酯化的线性聚半乳糖醛酸和聚L-鼠李糖半乳糖醛酸。
本发明对于果胶的来源不进行限定,可以为市售。
本发明提供的果胶具有止血的功效,促进伤口愈合。
本发明提供的水胶体层包括5~12重量份明胶;优选包括7~11重量份的明胶;更优选包括8~10重量份的明胶。
明胶(Gelatin),没有固定的结构和相对分子量,由动物皮肤、骨、肌膜、肌魅等结缔组织中的胶原部分降解而成为白色或淡黄色、半透明、微带光泽的薄片或粉粒;是一种无色无味,无挥发性、透明坚硬的非晶体物质,可溶于热水,不溶于冷水,但可以缓慢吸水膨胀软化,明胶可吸收相当于重量5-10倍的水。明胶是是非常重要的天然生物高分子材料之一,已被广泛应用于食品、医药及化工产业。
本发明所述明胶具有止血的功效,促进伤口愈合,防黏连。本发明对于所述明胶的来源不进行限定,市售即可。
本发明提供的水胶体层包括5~10重量份的聚丙烯酸钠;优选包括6~9重量份的聚丙烯酸钠。
本发明所述聚丙烯酸钠(英文:Sodiumpolyacrylate或acrylicsodiumsaltpolymer),简称ASAP,又称super-slurper,是一种分子式为[-CH2-CH(COONa)-]反复的聚合物。本发明对其来源不进行限定,市售即可。
本发明聚丙烯酸钠为水溶性高分子吸水材料,能吸水溶胀,吸收渗液能力强,吸湿率达1000%以上,能在伤口表面形成凝胶,使伤口处形成湿性的闭合环境,为加速创面愈合提供环境。
本发明提供的水胶体层包括1~3重量份的有机硅季铵盐;优选包括1~2重量份的有机硅季铵盐。
本发明所述有机硅季铵盐是一类新型阳离子表面活性剂,除具有有机硅的质地柔软、生理惰性、表面张力低、耐高温及防水透气等特点外,还具有季铵盐的杀菌、抑菌功能。本发明提供的有机硅季铵盐能有效杀灭创面细菌,有效杀菌率大于99.9%。
本发明所述有机硅季铵盐为三烷氧基硅烷的季铵盐。
本发明对其来源不进行限定,可以为市售。
在本发明其中一部分实施例中,所述水胶体层包括如下组分:
按照本发明,所述水胶体层厚度优选为0.5~1.2mm;优选为0.6~1.0mm。
本发明提供的医用水胶体敷料,包括设置在所述水胶体层上的隔离层。
本发明所述隔离层选自离型纸和聚四氟乙烯膜中的一种或几种。
所述隔离层厚度为0.01~0.1mm。
本发明提供了一种医用水胶体敷料,包括防水膜;设置在所述防水膜上的水胶体层;设置在所述水胶体层上的隔离层;其中,所述水胶体层包括如下组分:硅凝胶25~40重量份;羧甲基纤维素钠10~30重量份;果胶10~20重量份;明胶5~12重量份;聚丙烯酸钠5~10重量份;有机硅季铵盐1~3重量份。本发明选取防水膜作为基材,具有透明、透气防水、阻隔细菌等特性。本发明的敷料水胶体层由硅凝胶、羧甲基纤维素钠、果胶、明胶和聚丙烯酸钠、有机硅季铵盐特定比例组成,共同制备得到的医用水胶体敷料在使用中不断释放硅油,软化伤口,增加创面防黏连的效果,防止换药时损伤新生组织,避免二次损伤,亦可在创面愈合后期,预防疤痕增生。本发明的敷料吸收渗液能力强,使伤口处形成湿性的闭合环境,为加速创面愈合提供环境,同时还具有止血和杀菌的功效。
本发明提供了一种医用水胶体敷料的制备方法,包括:
A)将硅凝胶、羧甲基纤维素钠、果胶、明胶、聚丙烯酸钠和有机硅季铵盐混合,搅拌,得到反应液;
B)将所述反应液转入内设有防水膜的模具中,固化,得到半成品;
C)将所述半成品与隔离膜粘附得到医用水胶体敷料。
本发明提供的医用水胶体敷料的制备方法将硅凝胶、羧甲基纤维素钠、果胶、明胶、聚丙烯酸钠和有机硅季铵盐混合,搅拌,得到反应液。
本发明所述硅凝胶为本领域技术人员熟知的,分为硅凝胶A与硅凝胶B,使用时,首先将硅凝胶A与硅凝胶B,按1:0.5~1:1.5质量或者体积混合,搅拌1~5分钟,混合均匀即可。
本发明将硅凝胶、羧甲基纤维素钠、果胶、明胶、聚丙烯酸钠和有机硅季铵盐混合,优选具体为:
本发明首先将硅凝胶A与硅凝胶B,按1:0.5~1:1.5质量或者体积混合,搅拌1~5分钟,混合均匀。而后与、羧甲基纤维素钠、果胶、明胶、聚丙烯酸钠混合,搅拌10~30min;而后与有机硅季铵盐混合继续搅拌10~20min,得到反应液。
本发明上述搅拌在常温真空的条件下进行;所述常温具体为20~35℃;所述真空度优选为20~60Kpa
本发明对于上述硅凝胶、羧甲基纤维素钠、果胶、明胶、聚丙烯酸钠和有机硅季铵盐的配比和来源上述已经有了清楚的描述,在此不再赘述。
得到反应液后,将所述反应液转入内设有防水膜的模具中,固化,得到半成品。
其中,所述内设有防水膜的模具具体为:将硅胶模或PU膜剪裁成模具大小,将其放入成型凹槽模具中,优选的模具上涂有一层厚度为0.1~1.0mm的铁氟龙。
本发明将反应液转入内设有防水膜的模具优选为倒入。倒入模具中后优选为在室温25~35℃下静止10~15min后放入温度为90~120℃的烘箱里,固化放置1~5个小时。所述固化更优选为在95~115℃的烘箱里,固化放置1.5~4.5个小时。
待完全固化后,将半成品取出。
取出后,将所述半成品与隔离膜粘附得到医用水胶体敷料。所述粘附具体为:将所述半成品粘性的一面贴上隔离膜,与样品对齐粘贴。
本发明对于上述贴合的具体操作不进行限定,本领域技术人员熟知的即可。
为了进一步说明本发明,以下结合实施例对本发明提供的一种医用水胶体敷料进行详细描述。
实施例1
一种医用水胶体敷料的制备方法,包括以下步骤
步骤A:将硅胶模剪裁成模具大小,将其放入成型凹槽模具中,其中模具上涂有一层铁氟龙。
步骤B:将硅凝胶15gA与15g硅凝胶B,混合,搅拌5分钟,待混合均匀后按顺序先后加入10g羧甲基纤维素钠、10g果胶、5g明胶、5g聚丙烯酸钠,搅拌20min,最后加入1g有机硅季铵盐,在继续搅拌15min,所有搅拌均在常温真空下进行。
步骤C:将步骤B中的反应液倒入步骤A中的模具中,室温下静止15分钟后放入温度为90的烘箱里,固化放置3个小时,待完全固化后,将样品取出
步骤D:将步骤C中的样品粘性的一面贴上隔离膜,与样品对齐粘贴,得到医用水胶体敷料。
实施例2
步骤A:将PU膜剪裁成模具大小,将其放入成型凹槽模具中,其中模具上涂有一层铁氟龙。
步骤B:将硅凝胶20gA与硅凝胶18gB混合,搅拌3分钟,待混合均匀后按顺序先后加入20g羧甲基纤维素钠、15g果胶、8g明胶、8g聚丙烯酸钠,搅拌15min,最后加入2g有机硅季铵盐,在继续搅拌20min,所有搅拌均在常温真空下进行。
步骤C:将步骤B中的反应液倒入步骤A中的模具中,室温下静止10分钟后放入温度为100℃的烘箱里,固化放置2个小时,待完全固化后,将样品取出
步骤D:将步骤C中的样品粘性的一面贴上隔离膜,与样品对齐粘贴,得到医用水胶体敷料。
实施例3
步骤A:将硅胶模剪裁成模具大小,将其放入成型凹槽模具中,其中模具上涂有一层铁氟龙。
步骤B:将硅凝胶15gA与硅凝胶B16.5g,混合,搅拌2分钟,待混合均匀后按顺序先后加入30g羧甲基纤维素钠、20g果胶、12g明胶、10g聚丙烯酸钠,搅拌15min,最后加入3g有机硅季铵盐,在继续搅拌10min,所有搅拌均在常温真空下进行。
步骤C:将步骤B中的反应液倒入步骤A中的模具中,室温下静止12分钟后放入温度为110℃的烘箱里,固化放置1.5个小时,待完全固化后,将样品取出
步骤D:将步骤C中的样品粘性的一面贴上隔离膜,与样品对齐粘贴,得到医用水胶体敷料。
本发明对各实施例得到的水胶体敷料进行吸湿性能、拉伸性能以及剥离性能试验,测试结果(平均值)如表1所示:
比较例1
一种医用水胶体敷料的制备方法,包括以下步骤
步骤A:将硅胶模剪裁成模具大小,将其放入成型凹槽模具中,其中模具上涂有一层铁氟龙。
步骤B:将30g橡胶与10g羧甲基纤维素钠、10g果胶、5g明胶、5g聚丙烯酸钠混合,搅拌20min,最后加入1g有机硅季铵盐,在继续搅拌15min,所有搅拌均在常温真空下进行。
步骤C:将步骤B中的反应液倒入步骤A中的模具中,室温下静止15分钟后放入温度为90的烘箱里,固化放置3个小时,待完全固化后,将样品取出
步骤D:将步骤C中的样品粘性的一面贴上隔离膜,与样品对齐粘贴,得到医用水胶体敷料。
比较例2
一种医用水胶体敷料的制备方法,包括以下步骤
步骤A:将硅胶模剪裁成模具大小,将其放入成型凹槽模具中,其中模具上涂有一层铁氟龙。
步骤B:将30g聚苯乙烯弹性体与10g羧甲基纤维素钠、10g果胶、5g明胶、5g聚丙烯酸钠混合,搅拌20min,最后加入1g有机硅季铵盐,在继续搅拌15min,所有搅拌均在常温真空下进行。
步骤C:将步骤B中的反应液倒入步骤A中的模具中,室温下静止15分钟后放入温度为90的烘箱里,固化放置3个小时,待完全固化后,将样品取出
步骤D:将步骤C中的样品粘性的一面贴上隔离膜,与样品对齐粘贴,得到医用水胶体敷料。
比较例3
一种医用水胶体敷料的制备方法,包括以下步骤
步骤A:将硅胶模剪裁成模具大小,将其放入成型凹槽模具中,其中模具上涂有一层铁氟龙。
步骤B:将31g聚异丁烯弹性体与10g羧甲基纤维素钠、10g果胶、5g明胶、5g聚丙烯酸钠混合,搅拌20min,在继续搅拌15min,所有搅拌均在常温真空下进行。
步骤C:将步骤B中的反应液倒入步骤A中的模具中,室温下静止15分钟后放入温度为90的烘箱里,固化放置3个小时,待完全固化后,将样品取出
步骤D:将步骤C中的样品粘性的一面贴上隔离膜,与样品对齐粘贴,得到医用水胶体敷料。
表1海藻酸盐敷料测试结果表
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种医用水胶体敷料,其特征在于,包括防水膜;设置在所述防水膜上的水胶体层;设置在所述水胶体层上的隔离层;其中,所述水胶体层包括如下组分:
2.根据权利要求1所述的水胶体敷料,其特征在于,所述水胶体层包括如下组分:
3.根据权利要求1所述的水胶体敷料,其特征在于,所述有机硅季铵盐为三烷氧基硅烷的季铵盐。
4.根据权利要求1所述的水胶体敷料,其特征在于,所述防水膜选自PU膜或硅胶膜的一种或几种;所述隔离层选自离型纸和聚四氟乙烯膜中的一种或几种。
5.根据权利要求1所述的水胶体敷料,其特征在于,所述水胶体层厚度为0.5~1.2mm。
6.一种医用水胶体敷料的制备方法,其特征在于,包括:
A)将硅凝胶、羧甲基纤维素钠、果胶、明胶、聚丙烯酸钠和有机硅季铵盐混合,搅拌,得到反应液;
B)将所述反应液转入内设有防水膜的模具中,固化,得到半成品;
C)将所述半成品与隔离膜粘附得到医用水胶体敷料。
7.根据权利要求6所述的制备方法,其特征在于,所述步骤A)具体为将硅凝胶、羧甲基纤维素钠、果胶、明胶和聚丙烯酸钠混合搅拌10~30min,后再加入有机硅季铵盐混合搅拌10~20min。
8.根据权利要求7所述的制备方法,其特征在于,所述搅拌为真空搅拌;所述搅拌温度为25~35℃。
9.根据权利要求6所述的制备方法,其特征在于,步骤B)所述转入模具中后还包括25~35℃静置10~15min。
10.根据权利要求6所述的制备方法,其特征在于,步骤B)所述固化具体为在烘箱中90~120℃,固化1~5h。
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