CN105536030B - 一种止血促修复敷料芯片及其制备方法 - Google Patents
一种止血促修复敷料芯片及其制备方法 Download PDFInfo
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- OKHHGHGGPDJQHR-YMOPUZKJSA-L calcium;(2s,3s,4s,5s,6r)-6-[(2r,3s,4r,5s,6r)-2-carboxy-6-[(2r,3s,4r,5s,6r)-2-carboxylato-4,5,6-trihydroxyoxan-3-yl]oxy-4,5-dihydroxyoxan-3-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylate Chemical compound [Ca+2].O[C@@H]1[C@H](O)[C@H](O)O[C@@H](C([O-])=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](O)[C@H](O2)C([O-])=O)O)[C@H](C(O)=O)O1 OKHHGHGGPDJQHR-YMOPUZKJSA-L 0.000 claims abstract description 40
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Abstract
本发明涉及止血促修复敷料芯片及其制备方法;芯片由海藻酸盐层和附着层连接在一起构成,海藻酸盐层和附着层都为纤网层,附着层的材质为吸水纤维或抗菌纤维,海藻酸盐层由海藻酸钙纤维以及吸水颗粒组成。吸水颗粒为多孔藻酸钙微球。以D‑泛酸钙作为海藻酸盐敷料制备的交联剂,当海藻酸盐敷料吸收创面积液后,会有D‑泛酸钙游离出,经皮渗透,促进皮肤修复;利用海藻酸钙多孔微球进一步帮助吸收多余积液,保持创面清洁;提供了一种高吸收性、持续清创、能快速止血、能维持湿润的伤口环境、并促进创面愈合的止血促修复敷料芯片。
Description
技术领域
本发明属于医用敷料材料领域,特别涉及一种止血促修复敷料芯片及其制备方法。
背景技术
皮肤是人体的重要器官,对人体起保护作用。皮肤损伤会引起机体一系列的问题,比如细菌感染、新陈代谢加剧、水分和蛋白质过度流失、内分泌及免疫系统功能失调等,严重的可能危及生命。因此,皮肤损伤后,通常需要采用医用敷料来保护伤口,防止创面感染和严重脱水,提供有利于伤口愈合的湿润环境,促进创面愈合。
理想医用伤口敷料应具备以下条件:(1)吸收血液和过量渗出液,且不会造成敷料与创面之间的积液,减轻疼痛;(2)提供或维持湿润的伤口环境;(3)保持、促进肉芽和上皮组织正常生长,促使创面愈合,不留疤痕;(4)快速止血作用;(5)透气、透水汽,生物相容性好;(6)保护伤口,避免细菌侵染;(7)去除或控制伤口产生气味;(8)低粘附,易更换,不会带来二次损伤;(9)敷料应有一定的机械强度,柔软,不产生变形;(10)减少医用敷料用量,护理时间短。
目前传统敷料如医用脱脂棉纱布、棉垫和凡士林纱布等,是临床上皮肤创伤应用最广的敷料。传统敷料具有网状编织结构,其价格低廉、制作工艺相对简单、原料来源广泛、质地柔软,有较强的吸收能力,能防止创面渗液积聚,对创面愈合有一定程度的保护作用,至今仍在皮肤创伤中广泛应用。但是传统敷料也有很明显的缺点,比如不能保持创面湿润,延迟创面愈合;创面肉芽组织容易长入敷料的网眼中,更换敷料时易与创面伤口粘连,损伤新生的肉芽组织并引起疼痛;敷料渗透后屏障作用差,容易引起外源性感染,止血效果差等。为了解决传统敷料的这些问题,人们采用了物理或化学的方法来提高传统敷料的作用效果,如在医用脱脂棉纱布中加入油脂,或在湿润纱布中加入抗生素等方法用以预防外源性感染等,临床应用效果不是十分理想。
海藻酸盐是一类主要从褐藻中提取的天然线性多糖,无毒,可生物降解,生物相容性高,海藻酸盐的高吸湿性和凝胶性,使其在现代伤口敷料方面得到了广泛应用。海藻酸钙纤维是海藻酸与钙离子结合后形成的盐,在与伤口渗出液中的钠离子接触后,随着离子交换的进行,海藻酸钙被转换成海藻酸钠,大量的水分进入纤维的结构而使纤维吸湿膨胀,形成一种纤维状的水凝胶。这种独特的成胶性能赋予了海藻酸钙医用敷料一系列特殊的护理性能,与棉纱布等传统伤口护理产品相比具有更好的疗效。在吸收伤口上产生的渗出液时,海藻酸钙纤维把液体吸收在纤维的结构中,一方面由于纤维的膨胀而具有很高的吸湿容量;另一方面,纤维的膨胀使纤维与纤维之间的孔隙堵塞,阻断了液体的横向扩散,产生凝胶阻断效果。这种凝胶阻断作用在避免伤口周边健康皮肤受浸渍的同时,通过纤维所吸收的水分使创面保持在一个湿润的愈合环境中,有利于加速伤口的愈合。但是,当积液过多时,普通海藻酸盐敷料容易被浸透,从而失去阻菌功能,而且随着皮肤运动易剥落、溃散。一般临床使用时,会增加海藻酸盐敷料的使用量以及更换次数来解决积液过多的问题,但是这不但增加了材料成本,还增加了人工成本,不利于伤口快捷有效的处理。
海藻酸钙纤维是海藻酸与钙离子结合后形成的盐,与伤口渗出液中的钠离子接触后会发生离子交换,海藻酸钙被转换成海藻酸钠,钙离子游离出。D-泛酸钙又称维生素B5,是在人体和动物体内辅酶A的成分之一,作为海藻酸钙纤维中钙离子来源,不仅可以杀菌止血,外用还可以加强正常皮肤的水合作用,促进皮肤正常角质化,改善皮肤耐受力,具有制造抗体功能,对皮肤、毛发和黏膜功能的正常化必不可少。
发明内容
本发明目的在于针对现有的海藻酸盐敷料不能大量吸液保湿、更换敷料周期短、敷料易渗透后屏障作用差、不能主动促进皮肤修复等问题,提供一种高吸收性、持续清创、能快速止血、能维持湿润的伤口环境、并促进创面愈合的止血促修复敷料芯片。敷料芯片可以任意裁剪,作为创面敷料或填充式敷料使用,也可以与非织造布结合作为黏贴式敷料使用,特别适用于渗出液较多的伤口上。
根据本发明的研究,具体技术方案如下:
一种止血促修复敷料芯片,由海藻酸盐层和附着层连接在一起构成,海藻酸盐层和附着层都为纤网层,附着层的材质为吸水纤维或抗菌纤维,海藻酸盐层由海藻酸钙纤维以及吸水颗粒组成。
吸水颗粒为多孔藻酸钙微球。
一种止血促修复敷料芯片的制备方法,包括以下步骤:
a)配制海藻酸钠溶液,喷雾干燥法制备海藻酸钠微球,浸入D-泛酸钙溶液中交联5-25min,冷冻干燥;所得微球依次浸入海藻酸钠溶液、D-泛酸钙溶液,冷冻干燥;反复“浸入海藻酸钠溶液-D-泛酸钙溶液-冷冻干燥”这个过程3-5次,得到多孔藻酸钙微球。
b)多孔藻酸钙微球悬浮于海藻酸钠溶液内,悬浮液纺丝制备海藻酸钠纤维层,后浸于D-泛酸钙溶液5-25min,冷冻干燥,即可得到海藻酸层。
c)纺丝制备附着层,将海藻酸层与附着层结合在一起。
上述步骤中所涉及的海藻酸钠溶液2wt%-12.5wt%,D-泛酸钙溶液浓度0.5wt%-2wt%。
所制备的多孔藻酸钙微球尺寸0.2mm-0.7mm。
制备过程中悬浮液中多孔海藻酸钙微球含量为海藻酸钠溶液的5wt%-60wt%。
依次浸入海藻酸钠溶液时间优选为3-15min、浸入D-泛酸钙溶液时间优选5-25min。
敷料芯片可以任意裁剪,作为创面敷料或填充式敷料使用,也可以与非织造布结合作为黏贴式敷料使用,特别适用于有渗出液的伤口上。
与现有的伤口敷料相比,本发明突出优点在于:以D-泛酸钙作为海藻酸盐敷料制备的交联剂,当海藻酸盐敷料吸收创面积液后,会有D-泛酸钙游离出,经皮渗透,促进皮肤修复;利用海藻酸钙多孔微球进一步帮助吸收多余积液,保持创面清洁;提供了一种高吸收性、持续清创、能快速止血、能维持湿润的伤口环境、并促进创面愈合的止血促修复敷料芯片。厚度1mm时,敷料芯片水蒸气透过率在2400-3000g.m-2.d-1之间,符合理想创面敷料的应用要求;厚度1mm时,每100cm2的平均吸水量在6-11g,与同类已临床应用辅料比较,已达到新型敷料对大量液体吸收量的要求,又不会引起创面过分干燥。结果显示,所制备的敷料芯片具有良好的透气率和吸液量,优于纯海藻酸盐敷料。
附图说明
图1:为所制备的止血促修复敷料芯片示意图:敷料芯片包括连接在一起的海藻酸层2和附着层1,海藻酸层由藻酸钙纤维以及吸水颗粒3组成。
图2:为多孔海藻酸钙微球形貌图:微球具有均匀的多孔结构,且多为连通孔。
图3:为敷料芯片的水蒸气透过率:制备厚度1mm样品,以g.m-2.d-1表示。
图4:为敷料芯片的吸液量:制备厚度1mm样品,每100cm2的平均吸水量,以g表示。
具体实施方式
制备海藻酸钠微球,浸入D-泛酸钙溶液中交联,冷冻干燥,所得微球依次浸入海藻酸钠溶液3-15min、D-泛酸钙溶液5-25min、冷冻干燥;反复浸入海藻酸钠溶液-D-泛酸钙溶液-冷冻干燥过程3-5次,得到多孔藻酸钙微球。
多孔藻酸钙微球悬浮于海藻酸钠的悬浮液,纺丝制备海藻酸钠纤维层,后浸于D-泛酸钙溶液交联,冷冻干燥,即可得到海藻酸层。
纺丝制备附着层,利用针刺工艺将海藻酸层与附着层结合在一起,最终所得敷料芯片结构如图1所示;敷料芯片包括连接在一起的海藻酸层2和附着层1,海藻酸层由藻酸钙纤维以及吸水颗粒3组成。
下面结合实施例对本发明的内容作进一步的详细说明,但本发明的实施方式不限于此。
实施例1
以上述方法制备敷料芯片,2.0wt%浓度海藻酸钠溶液制备微球,浸入0.5wt%浓度D-泛酸钙溶液交联0.5h,冷冻干燥,反复“浸入海藻酸钠溶液3min、D-泛酸钙溶液5min、冷冻干燥”5次,得到尺寸0.3-0.4mm的多孔藻酸钙微球,结构如图2所示,微球多孔结构均匀,微孔尺寸在10-20um,且为连通孔,有利于液体的吸收的保存。
向2.5wt%浓度海藻酸钠溶液中加入45wt%海藻酸钙微球制备悬浮液,纺丝制备海藻酸钠纤维层,后浸入1.0wt%的D-泛酸钙溶液交联10min,冷冻干燥,得到海藻酸层。
纺丝制备羧甲基纤维素钠附着层,利用针刺工艺将海藻酸层与附着层结合在一起。
依国标测试水蒸气透过率和液体吸收性,结果分别如图3和图4,敷料芯片水蒸气透过率达到2552g.m-2.d-1,平均吸水量达9.08g,符合新型敷料要求。
实施例2
以上述方法制备敷料芯片,6.0wt%浓度海藻酸钠溶液制备微球,浸入1.0%浓度D-泛酸钙溶液交联0.5h,冷冻干燥,反复“浸入海藻酸钠溶液5min、D-泛酸钙溶液10min、冷冻干燥”5次,得到尺寸0.4-0.6的多孔藻酸钙微球。
向6.0wt%浓度海藻酸钠溶液中加入18wt%海藻酸钙微球制备悬浮液,纺丝制备海藻酸钠纤维层,后浸入1.0wt%的D-泛酸钙溶液交联10min,冷冻干燥,得到海藻酸层。
纺丝制备附着层,利用针刺工艺将海藻酸层与附着层结合在一起。
敷料芯片水蒸气透过率在2400-3000g.m-2.d-1之间,平均吸水量在6-11g,符合新型敷料要求。
实施例3
以上述方法制备敷料芯片,8wt%浓度海藻酸钠溶液制备微球,浸入0.5%浓度D-泛酸钙溶液交联1h,冷冻干燥,反复“浸入海藻酸钠溶液3min、D-泛酸钙溶液10min、冷冻干燥”4次,得到尺寸0.3-0.5mm的多孔藻酸钙微球。
向8wt%浓度海藻酸钠溶液中加入5wt%海藻酸钙微球制备悬浮液,纺丝制备海藻酸钠纤维层,后浸入2.0wt%的D-泛酸钙溶液交联5min,冷冻干燥,得到海藻酸层。
纺丝制备羧甲基纤维素钠附着层,利用针刺工艺将海藻酸层与附着层结合在一起。
敷料芯片水蒸气透过率在2400-3000g.m-2.d-1之间,平均吸水量在6-11g,符合新型敷料要求。
实施例4
以上述方法制备敷料芯片,10wt%浓度海藻酸钠溶液制备微球,浸入1.0%浓度D-泛酸钙溶液交联1h,冷冻干燥,反复“浸入海藻酸钠溶液10min、D-泛酸钙溶液20min、冷冻干燥”3次,得到尺寸0.2-0.4的多孔藻酸钙微球。
向10wt%浓度海藻酸钠溶液中加入8wt%海藻酸钙微球制备悬浮液,纺丝制备海藻酸钠纤维层,后浸入1.0wt%的D-泛酸钙溶液交联10min,冷冻干燥,得到海藻酸层。
纺丝制备羧甲基纤维素钠附着层,利用针刺工艺将海藻酸层与附着层结合在一起。
敷料芯片水蒸气透过率在2400-3000g.m-2.d-1之间,平均吸水量在6-11g,符合新型敷料要求。
实施例5
以上述方法制备敷料芯片,12.5wt%浓度海藻酸钠溶液制备微球,浸入1.5%浓度D-泛酸钙溶液交联1.5h,冷冻干燥,反复“浸入海藻酸钠溶液15min、D-泛酸钙溶液25min、冷冻干燥”3次,得到尺寸0.6-0.7mm的多孔藻酸钙微球。
向5.0wt%浓度海藻酸钠溶液中加入50wt%海藻酸钙微球制备悬浮液,纺丝制备海藻酸钠纤维层,后浸入2.0wt%的D-泛酸钙溶液交联5min,冷冻干燥,得到海藻酸层。
纺丝制备羧甲基纤维素钠附着层,利用针刺工艺将海藻酸层与附着层结合在一起。
敷料芯片水蒸气透过率在2400-3000g.m-2.d-1之间,平均吸水量在6-11g,符合新型敷料要求。
实施例6
以上述方法制备敷料芯片,8wt%浓度海藻酸钠溶液制备微球,浸入2.0%浓度D-泛酸钙溶液交联2h,冷冻干燥,反复“浸入海藻酸钠溶液15min、D-泛酸钙溶液15min、冷冻干燥”3次,得到尺寸0.2-0.3mm的多孔藻酸钙微球。
向12.5wt%浓度海藻酸钠溶液中加入5wt%海藻酸钙微球制备悬浮液,纺丝制备海藻酸钠纤维层,后浸入0.5wt%的D-泛酸钙溶液交联5min,冷冻干燥,得到海藻酸层。
纺丝制备羧甲基纤维素钠附着层,利用针刺工艺将海藻酸层与附着层结合在一起。
敷料芯片水蒸气透过率在2400-3000g.m-2.d-1之间,平均吸水量在6-11g,符合新型敷料要求。
实施例7
以上述方法制备敷料芯片,2.0wt%浓度海藻酸钠溶液制备微球,浸入2.0%浓度D-泛酸钙溶液交联2h,冷冻干燥,反复“浸入海藻酸钠溶液15min、D-泛酸钙溶液20min、冷冻干燥”3次,得到尺寸0.2-0.3mm的多孔藻酸钙微球。
向2.0wt%浓度海藻酸钠溶液中加入60wt%海藻酸钙微球制备悬浮液,纺丝制备海藻酸钠纤维层,后浸入2.0wt%的D-泛酸钙溶液交联30min,冷冻干燥,得到海藻酸层。
纺丝制备羧甲基纤维素钠附着层,利用针刺工艺将海藻酸层与附着层结合在一起。
敷料芯片水蒸气透过率在2400-3000g.m-2.d-1之间,平均吸水量在6-11g,符合新型敷料要求。
Claims (5)
1.一种止血促修复敷料芯片的制备方法,其特征在于,包括以下步骤:
a)配制海藻酸钠溶液,喷雾干燥制备海藻酸钠微球,浸入D-泛酸钙溶液中交联0.5-2h,冷冻干燥,所得微球依次浸入海藻酸钠溶液3-15min、D-泛酸钙溶液5-25min、冷冻干燥;反复“浸入海藻酸钠溶液-D-泛酸钙溶液-冷冻干燥”这个过程3-5次,得到多孔藻酸钙微球;
b)多孔藻酸钙微球悬浮于海藻酸钠溶液内,悬浮液纺丝制备海藻酸钠纤维层,后浸于D-泛酸钙溶液5-30min,冷冻干燥,即可得到海藻酸盐层;
c)纺丝制备附着层,利用针刺工艺将海藻酸盐层与附着层结合在一起。
2.如权利要求1所述的方法,其特征在于,所涉及的海藻酸钠溶液浓度2wt%-12.5wt%,D-泛酸钙溶液浓度0.5wt%-2wt%。
3.如权利要求1所述的方法,其特征在于,多孔藻酸钙微球尺寸0.2mm-0.7mm。
4.如权利要求3所述的方法,其特征在于,悬浮液中多孔藻酸钙微球含量为海藻酸钠溶液的5wt%-60wt%。
5.如权利要求1的一种止血促修复敷料芯片的制备方法,其特征在于,由海藻酸盐层和附着层连接在一起构成,海藻酸盐层和附着层都为纤网层,附着层的材质为吸水纤维或抗菌纤维,海藻酸盐层由海藻酸钙纤维以及吸水颗粒组成,海藻酸盐层的吸水颗粒为多孔藻酸钙微球。
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