CN111228040B - 一种可吸收防黏连敷料及其制备方法 - Google Patents
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Abstract
本发明提供一种可吸收防黏连敷料,所述可吸收防黏连敷料从贴近皮肤侧起依次为疏水层、亲水层及保护层,所述疏水层为负载微球的聚己内酯/壳聚糖多孔薄膜,所述亲水层的材料为透明质酸、明胶、海藻酸钠或角蛋白中的一种或多种,所述保护层为蛋壳膜与改性聚氨酯薄膜复合而成,本发明还提供了可吸收防黏连敷料的制备方法,制得的可吸收防黏连敷料可降解吸收,不需频繁更换,保持了利于创口修复的湿润环境,力学性能优,抗菌作用强,可促进药物的单向吸收,提高敷料的利用率,且更换敷料时也不会出现黏连创面的问题,防止了二次损伤。
Description
技术领域
本发明属于生物材料领域,尤其涉及一种可吸收防黏连敷料及其制备方法。
背景技术
皮肤是人体最大的器官,具有保持人体内水分、防止过度散热、透气和防止细菌侵袭的功能。在日常生活中,人体的皮肤表面难免出现创伤、擦伤、皮肤溃烂和烧伤等伤口,这些伤口如不进行有效治疗可能导致更大范围的伤害,如:感染、体液流失,并引起各种并发症等。
如果仅是皮肤的浅层或是小面积受损,新皮肤会自体得以再生,但如果受到严重的创伤,皮肤就不能靠自己修复,通常须附以医用敷料来促进创面愈合。传统的敷料如:脱脂棉纱布、棉垫、凡士林纱布,具有网状编织结构,虽然价格低廉、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,对创面愈合也有一定程度的保护作用,但是不能保持创面湿润,会使创面愈合延迟,敷料渗透后屏障作用差,容易引起外源性感染,止血效果差,并且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,还有时会使渗液通过敷料漏出,粘连衣物及灰尘,使创面感染。
因此,敷料需能满足创面愈合各个阶段的反应,即第一阶段发生炎症反应时产生的渗液及细胞浸润现象,敷料需能吸收渗液,防止创面渗液的积聚;以及第二阶段的组织增生,血管、微脉管的重新构建,敷料应具有保持创面湿润、促进创面愈合的功能;和第三阶段的上皮再生,敷料需能适时降解,以防阻碍新生组织的生长。
发明内容
本发明的目的在于针对现有技术的不足,提供一种可吸收防黏连敷料及其制备方法,本发明的可吸收防黏连敷料是一种体内可降解吸收的多层复合结构敷料,使用时不需频繁更换,可保持创面湿润促进创面愈合,防止渗液外漏,而且即使更换敷料也不会出现黏连问题。
为解决上述技术问题,本发明采用的技术方案是:
一种可吸收防黏连敷料,所述可吸收防黏连敷料从贴近皮肤侧起依次为疏水层、亲水层及保护层;所述疏水层为负载微球的聚己内酯/壳聚糖多孔薄膜,所述微球由海藻酸钠、中药提取物、表皮生长因子、壳聚糖及卵磷脂制成,所述中药提取物为三七、艾叶和积雪草的提取物;所述亲水层的材料为透明质酸、明胶、海藻酸钠或角蛋白中的一种或多种;所述保护层为蛋壳膜与改性聚氨酯薄膜复合而成,所述改性聚氨酯薄膜为羧甲基纤维素钠改性的聚氨酯薄膜。
优选地,所述蛋壳膜为将鸡蛋的蛋清和蛋黄磕出后,将其内膜剥离下来,清洗膜上残留的蛋清液,并浸泡于浓度为1%wt~2%wt的多巴胺溶液中,5h后取出并用去离子水清洗所得;
一种可吸收防黏连敷料的制备方法,具体包括以下步骤:
(1)将聚己内酯、壳聚糖溶于乙酸溶液中,搅拌均匀得到混合液A;将海藻酸钠、中药提取物、表皮生长因子溶于去离子水中,混合均匀得到混合液B;将混合液B分为两份,其中一份加入壳聚糖、卵磷脂及CaCl2溶液,制备含表皮生长因子及中药提取物的微球溶液;将透明质酸、明胶、海藻酸钠或角蛋白中的一种或多种溶于去离子水中,混合均匀得到混合液C;
(2)将蛋壳膜浸泡于混合液B中3h,取出并用去离子水清洗,干燥得到负载表皮生长因子的蛋壳膜,将负载生长因子的蛋壳膜贴附于羧甲基纤维素钠改性的聚氨酯薄膜上,得到保护层;
(3)将步骤一制备的混合液A缓慢浇筑于模具中、流延,静置,真空冷冻干燥,得聚己内酯/壳聚糖多孔薄膜,将多孔薄膜浸泡于步骤一制备的微球溶液中摇床振荡2h,取出并用去离子水清洗薄膜表面溶液,真空冷冻干燥后得负载微球的疏水层薄膜;
(4)将混合液C装入纺丝设备的针管中,通过静电纺丝技术将混合液C产生的亲水性纳米纤维纺丝于负载微球的薄膜上,得疏水层与亲水层组成的多孔双层膜;
(5)将保护层贴附于多孔双层膜之上,以蛋壳膜侧贴附亲水层,用粘合剂使蛋壳膜与亲水层粘合,得到的可吸收防黏连敷料在γ射线下均匀照射杀菌即可。
优选地,步骤(1)中所述聚己内酯、壳聚糖的重量比为5~7:2~3,所述乙酸的质量体积百分浓度为5%~8%,所述混合液A的浓度为20%wt~23%wt;
优选地,步骤(1)中所述海藻酸钠、中药提取物、表皮生长因子的重量比为5~8:0.5~0.8:0.02~0.04,所述混合液B的浓度为7%wt~8%wt;所述壳聚糖、卵磷脂的添加量与海藻酸钠的重量比为5~8:10~12:5~8,所述CaCl2溶液的浓度为0.8~1.5%wt。
优选地,步骤(1)中所述混合液C的浓度为15%wt~18%wt;
优选地,步骤(3)中所述真空冷冻干燥的温度为-15℃~-45℃,温度由低至高,每半小时升温5℃;
优选地,步骤(4)中所述静电纺丝技术的纺丝电压为20kv,纺丝速度为0.8mL/h~1.0mL/h,接收距离为15cm。
优选地,步骤(5)中所述粘合剂为羧甲基纤维素钠、β-环糊精中的一种,所述粘合剂溶液浓度为7%wt~8%wt。
本发明的可吸收防黏连敷料以蛋壳膜与改性聚氨酯作为保护层,蛋壳膜表面由多巴胺通过自我聚合形成聚多巴胺薄膜,与蛋壳膜通过共价键连接,聚多巴胺薄膜具有良好的化学活性,由于其表面含有的酚羟基及醌基等官能团,聚多巴胺薄膜也可以通过席夫碱反应或迈克尔加成反应与生长因子共价偶联,且生长因子对细胞增殖、组织修复和再生都具有重要的促进作,另一方面聚多巴胺薄膜具有很好的生物相容性及粘附性,可以吸附中药提取物中的有效成分,之后持续释放药物,对内有进一步的缓释作用,对外有持续的杀菌作用;蛋壳膜中不仅含有角蛋白、胶原蛋白,同时含有透明质酸、硫酸软骨素等构成细胞外基质的主要成分,起衬垫作用的同时,也具有抗菌、美容的作用,且以具有半透性的蛋壳膜作为敷料的保护层可以更加促进内层可吸收材料及药物成分的单向吸收,提高敷料的利用率,且蛋壳膜价格低廉、易于获取,无毒、无免疫性,具有良好的生物相容性;羧甲基纤维素钠改性的聚氨酯具有良好的降解性及力学性能,与蛋壳膜复合作为保护层一方面增强了保护层的力学性能,另一方面由于蛋壳膜为半透膜,水分子及一些小分子可以透过,与改性聚氨酯结合进一步防止了渗液外漏、外界细菌的感染及与衣物的黏连。
本发明可吸收防黏连敷料采用疏水层、亲水层和保护层三层制成,其中疏水层为贴肤层,且贴皮肤侧为负载海藻酸钠微球的聚己内酯/壳聚糖多孔薄膜,其中聚己内酯作为疏水性材料不会吸收渗液,而壳聚糖为具有良好的生物相容性的天然高分子材料,分子内氨基能吸引带负电荷的血小板和红细胞,加速血小板黏附并刺激血管收缩,具有止血、抗菌作用,还可以促进伤口愈合,且质子化后的壳聚糖能溶于水,可水解,可以防止组织黏连;负载的微球含有表皮生长因子及中药提取物,微球负载于贴肤疏水层,而疏水层不会吸附渗液,渗液从疏水层孔隙达到亲水层的过程中,微球吸收少量渗液并逐渐释放包裹的药物成分,作用于皮肤伤口,三七、艾叶、积雪草共同作用可以消肿止痛,活血化瘀,同时可以止血抗菌,促进皮肤生长,增强免疫功能,表皮生长因子加速创面的愈合,促进皮肤新陈代谢,减少皮肤畸形;同时创面产生的渗液通过疏水层的微孔达亲水层,被亲水层吸收,不仅不会使渗液积聚,也保持创面了的湿润,有助于创面恢复。
与现有技术相比,本发明具有如下优点:
(1)本发明的可吸收防黏连敷料采用疏水层、亲水层及保护层三层结构制备,与创面接触时,能吸收创面中的渗液,防止渗液积聚,并保持利于创口修复的湿润环境,同时不会使渗液漏出,且本发明敷料不会与皮肤黏连,防止了更换敷料带来的二次损伤。
(2)本发明可吸收防黏连敷料以蛋壳膜与改性聚氨酯为保护层,增强了保护层的力学性能,蛋壳膜表面的聚多巴胺薄膜不仅与生长因子共价偶联,还吸附有中药提取物,且蛋壳膜作为半透膜材料可促进药物的单向吸收,提高敷料的利用率,同时防止了渗液外漏、外界细菌的感染及与衣物的黏连。
(3)本发明可吸收防黏连敷料疏水层负载的海藻酸钠微球含有生长因子及中药提取物,中药提取物中三七可以散瘀止血,消肿定痛,艾叶具有抗菌、抗病毒、止血及镇静作用,而积雪草提取物对于皮肤损伤、局部胶原合成代谢具有有效的促进作用,三种中药相辅相成与共同促进创面的修复,且微球负载于疏水层可以减缓微球的溶胀速率,增强缓释性能。
附图说明
图1为本发明可吸收防黏连敷料在10min,30min,1h,2h,5h,10h,20h时的液体吸收率;
图2为本发明可吸收防黏连敷料作用于伤口不同时间后伤口的愈合率。
具体实施方式
下面结合附图和具体实施例对本发明技术方案作进一步的详细描述,以使本领域的技术人员可以更好的理解本发明并能予以实施,但所举实施例不作为对本发明的限定。
实施例1
一种可吸收防黏连敷料,所述可吸收防黏连敷料从贴近皮肤侧起依次为疏水层、亲水层及保护层;所述疏水层为负载微球的聚己内酯/壳聚糖多孔薄膜,所述微球由海藻酸钠、中药提取物、表皮生长因子、壳聚糖及卵磷脂制成,所述中药提取物为三七、艾叶和积雪草的提取物;所述亲水层的材料为透明质酸、明胶、海藻酸钠或角蛋白中的一种或多种;所述保护层为蛋壳膜与改性聚氨酯薄膜复合而成,所述改性聚氨酯薄膜为羧甲基纤维素钠改性的聚氨酯薄膜。
所述蛋壳膜为将鸡蛋的蛋清和蛋黄磕出后,将其内膜剥离下来,清洗膜上残留的蛋清液,并浸泡于浓度为1%wt的多巴胺溶液中,5h后取出并用去离子水清洗所得。
一种可吸收防黏连敷料的制备方法,具体包括以下步骤:
(1)将聚己内酯、壳聚糖以重量比为5:2溶于浓度为5%的乙酸溶液中,搅拌均匀得到浓度20%wt的混合液A;将海藻酸钠、中药提取物、表皮生长因子以重量比为5:0.5:0.03溶于去离子水中,混合均匀得到浓度7%wt的混合液B;将混合液B分为两份,其中一份加入壳聚糖、卵磷脂及浓度为0.8%wtCaCl2溶液,制备含表皮生长因子及中药提取物的微球溶液;将透明质酸、明胶溶于去离子水中,混合均匀得到浓度15%wt的混合液C;
(2)将蛋壳膜浸泡于混合液B中3h,取出并用去离子水清洗,干燥得到负载表皮生长因子的蛋壳膜,将负载生长因子的蛋壳膜贴附于羧甲基纤维素钠改性的聚氨酯薄膜上,得到保护层;
(3)将步骤一制备的混合液A缓慢浇筑于模具中、流延,静置,之后于-15℃~-45℃下真空冷冻干燥,温度由低至高,每半小时升温5℃,得聚己内酯/壳聚糖多孔薄膜,将多孔薄膜浸泡于步骤一制备的微球溶液中摇床振荡2h,取出并用去离子水清洗薄膜表面溶液,再次真空冷冻干燥后得负载微球的疏水层薄膜;
(4)将混合液C装入纺丝设备的针管中,通过静电纺丝技术将混合液C产生的亲水性纳米纤维纺丝于负载微球的薄膜上,得疏水层与亲水层组成的多孔双层膜;
(5)将保护层贴附于多孔双层膜之上,以蛋壳膜侧贴附亲水层,用浓度为7%wt的羧甲基纤维素钠使蛋壳膜与亲水层粘合,得到的可吸收防黏连敷料在γ射线下均匀照射杀菌即可。
步骤(1)所述壳聚糖、卵磷脂的添加量与海藻酸钠的重量比为1:2:1。
步骤(4)中所述静电纺丝技术的纺丝电压为20kv,纺丝速度为0.8mL/h,接收距离为15cm。
实施例2
一种可吸收防黏连敷料,所述可吸收防黏连敷料从贴近皮肤侧起依次为疏水层、亲水层及保护层;所述疏水层为负载微球的聚己内酯/壳聚糖多孔薄膜,所述微球由海藻酸钠、中药提取物、表皮生长因子、壳聚糖及卵磷脂制成,所述中药提取物为三七、艾叶和积雪草的提取物;所述亲水层的材料为透明质酸、明胶、海藻酸钠或角蛋白中的一种或多种;所述保护层为蛋壳膜与改性聚氨酯薄膜复合而成,所述改性聚氨酯薄膜为羧甲基纤维素钠改性的聚氨酯薄膜。
所述蛋壳膜为将鸡蛋的蛋清和蛋黄磕出后,将其内膜剥离下来,清洗膜上残留的蛋清液,并浸泡于浓度为1.5%wt的多巴胺溶液中,5h后取出并用去离子水清洗所得。
一种可吸收防黏连敷料的制备方法,具体包括以下步骤:
(1)将聚己内酯、壳聚糖以重量比为6:2溶于浓度为6%的乙酸溶液中,搅拌均匀得到浓度21%wt的混合液A;将海藻酸钠、中药提取物、表皮生长因子以重量比为6:0.7:0.03溶于去离子水中,混合均匀得到浓度7%wt的混合液B;将混合液B分为两份,其中一份加入壳聚糖、卵磷脂及浓度为1.2%wtCaCl2溶液,制备含表皮生长因子及中药提取物的微球溶液;将透明质酸、明胶溶于去离子水中,混合均匀得到浓度17%wt的混合液C;
(2)将蛋壳膜浸泡于混合液B中3h,取出并用去离子水清洗,干燥得到负载表皮生长因子的蛋壳膜,将负载生长因子的蛋壳膜贴附于羧甲基纤维素钠改性的聚氨酯薄膜上,得到保护层;
(3)将步骤一制备的混合液A缓慢浇筑于模具中、流延,静置,之后于-15℃~-45℃下真空冷冻干燥,温度由低至高,每半小时升温5℃,得聚己内酯/壳聚糖多孔薄膜,将多孔薄膜浸泡于步骤一制备的微球溶液中摇床振荡2h,取出并用去离子水清洗薄膜表面溶液,再次真空冷冻干燥后得负载微球的疏水层薄膜;
(4)将混合液C装入纺丝设备的针管中,通过静电纺丝技术将混合液C产生的亲水性纳米纤维纺丝于负载微球的薄膜上,得疏水层与亲水层组成的多孔双层膜;
(5)将保护层贴附于多孔双层膜之上,以蛋壳膜侧贴附亲水层,用浓度为7%wt的羧甲基纤维素钠使蛋壳膜与亲水层粘合,得到的可吸收防黏连敷料在γ射线下均匀照射杀菌即可。
步骤(1)所述壳聚糖、卵磷脂的添加量与海藻酸钠的重量比为7:11:7。
步骤(4)中所述静电纺丝技术的纺丝电压为20kv,纺丝速度为1.0mL/h,接收距离为15cm。
实施例3
一种可吸收防黏连敷料,所述可吸收防黏连敷料从贴近皮肤侧起依次为疏水层、亲水层及保护层;所述疏水层为负载微球的聚己内酯/壳聚糖多孔薄膜,所述微球由海藻酸钠、中药提取物、表皮生长因子、壳聚糖及卵磷脂制成,所述中药提取物为三七、艾叶和积雪草的提取物;所述亲水层的材料为透明质酸、明胶、海藻酸钠或角蛋白中的一种或多种;所述保护层为蛋壳膜与改性聚氨酯薄膜复合而成,所述改性聚氨酯薄膜为羧甲基纤维素钠改性的聚氨酯薄膜。
所述蛋壳膜为将鸡蛋的蛋清和蛋黄磕出后,将其内膜剥离下来,清洗膜上残留的蛋清液,并浸泡于浓度为2%wt的多巴胺溶液中,5h后取出并用去离子水清洗所得。
一种可吸收防黏连敷料的制备方法,具体包括以下步骤:
1)将聚己内酯、壳聚糖以重量比为7:3溶于浓度为8%的乙酸溶液中,搅拌均匀得到浓度23%wt的混合液A;将海藻酸钠、中药提取物、表皮生长因子以重量比为8:0.8:0.04溶于去离子水中,混合均匀得到浓度8%wt的混合液B;将混合液B分为两份,其中一份加入壳聚糖、卵磷脂及浓度为1.5%wtCaCl2溶液,制备含表皮生长因子及中药提取物的微球溶液;将透明质酸、明胶溶于去离子水中,混合均匀得到浓度18%wt的混合液C;
(2)将蛋壳膜浸泡于混合液B中3h,取出并用去离子水清洗,干燥得到负载表皮生长因子的蛋壳膜,将负载生长因子的蛋壳膜贴附于羧甲基纤维素钠改性的聚氨酯薄膜上,得到保护层;
(3)将步骤一制备的混合液A缓慢浇筑于模具中、流延,静置,之后于-15℃~-45℃下真空冷冻干燥,温度由低至高,每半小时升温5℃,得聚己内酯/壳聚糖多孔薄膜,将多孔薄膜浸泡于步骤一制备的微球溶液中摇床振荡2h,取出并用去离子水清洗薄膜表面溶液,再次真空冷冻干燥后得负载微球的疏水层薄膜;
(4)将混合液C装入纺丝设备的针管中,通过静电纺丝技术将混合液C产生的亲水性纳米纤维纺丝于负载微球的薄膜上,得疏水层与亲水层组成的多孔双层膜;
(5)将保护层贴附于多孔双层膜之上,以蛋壳膜侧贴附亲水层,用浓度为8%wt的β-环糊精使蛋壳膜与亲水层粘合,得到的可吸收防黏连敷料在γ射线下均匀照射杀菌即可。
步骤(1)所述壳聚糖、卵磷脂的添加量与海藻酸钠的重量比为2:3:2。
步骤(4)中所述静电纺丝技术的纺丝电压为20kv,纺丝速度为1.0mL/h,接收距离为15cm。
对比例1
与实施例1相比,对比例1中,敷料的疏水层不含有壳聚糖,其余组成配比及制备方法与实施例1相同。
对比例2
与实施例1相比,对比例2中,敷料的疏水层不含有海藻酸钠微球,其余组成配比及制备方法与实施例1相同。
对比例3
与实施例1相比,对比例3中,敷料的保护层仅由鸡蛋膜组成,不含有改性的聚氨酯薄膜,其余组成配比及制备方法与实施例1相同。
对比例4
与实施例1相比,对比例4中,敷料的设置为从贴皮肤侧起三层膜分别为亲水层、疏水层及保护层,其余组成配比及制备方法与实施例1相同。
大鼠实验:取200g的雄性SD大鼠21只,均分为7组,在大鼠的背部制成二级烧伤,伤口大小为1.0cm×1.0cm,分别贴敷实施例及对比例制成的敷料,实施例1~3分别对应组1~3,对比例1~4分别对应组4~7,分别在第1、3、7、12、18、25天观察伤口情况,若渗液吸满则更换敷料。
液体吸收性能的测定:将实施例1~3以及对比例1~4的敷料剪切成2cm×2cm同样大小的形状,称量重量为W1,然后均放入pH为7.2的PBS缓冲液中,分别在10min,30min,1h,2h,5h,10h,20h取出,擦拭掉表面的液体后再次称量重量为W2,称量后放回PBS缓冲液中,则液体吸收率的计算方法为(W2-W1)/W1×100%。(如表1、图1)
如图1所示,各组敷料浸入PBS缓冲液后迅速吸收液体,10min内的吸收速率为最高,随后液体吸收速率减缓,到20h时,各组敷料的吸收率几乎不再变化。10min时,各组相比发现组7敷料的吸收率最大为220.5%,其次为组1敷料的吸收率为195.5%,但是20h时,组1与组7敷料的吸收率并无明显差异,说明组7敷料的亲水层在外侧更易吸收液体,使刚浸入PBS溶液的敷料迅速洗液,而组1与组7敷料的制备材料并没有变化,因此使组1与组7最终液体吸收量的差异也不明显;而10min时,组4与组6敷料的液体吸收率相对组1明显降低,组5无明显差异,20h时,组4与组6敷料的液体吸收率依然较低,分别为281.7%、316.5%,而组5为370.2%,差异也不明显,说明本发明可吸收防黏连敷料中的壳聚糖对液体吸收率有一定的影响,且改性聚氨酯也明显影响液体吸收率,但是海藻酸钠微球对液体吸收率的影响不大。
如图2所示,各组大鼠的创面愈合率随时间的增长而增长,敷料贴敷的前三天,各组大鼠的创面愈合率无明显的差异,而在第七天开始组1与组4~7大鼠的创面愈合开始有明显的差异,第7天时,组1大鼠的创面愈合率最高,组6次之,组7最低,且在之后一直保持这个状态,18天时,组1大鼠的创面愈合率已达89%,组4~7大鼠的创面愈合率分别为72%、70%、83%、65%,25天时,组1大鼠伤口已完全愈合,组6大鼠伤口愈合率达90%,组4与组5大鼠的伤口愈合率分别为86.2%、82.5%,而组7大鼠的伤口愈合率仅有75%,其伤口完全愈合还需要更长的时间,说明本发明的可吸收防黏连敷料的改性聚氨酯薄膜保护层对创面愈合有明显的促进作用,壳聚糖及海藻酸钠微球对伤口愈合的促进作用更加明显。
表1
(临床上认为创面愈合率达到95%即可认为完全愈合)
由表1数据可知,组1~3大鼠的伤口在25天时均已完全愈合,且伤口均无黏连现象,也没有伤口渗液外漏的现象,说明本发明实施例1~3的敷料在能有效的促进伤口的愈合,且不会与伤口黏连,且可以保证伤口渗液不外漏。
从表1数据还可以看出,组4~7的大鼠在25天时伤口都还没有完全愈合,且有不同程度的黏连现象,其中组4的大鼠伤口黏连程度达15%,伤口愈合率为86.2%,说明对比例1的敷料由于不含壳聚糖,其促伤口愈合的速率降低,且防黏连作用也降低;组5的大鼠黏连程度相比组4降低,但是伤口愈合程度也降低,且在第3~7天发现伤口的红肿现象比较明显,这是由于对比例2敷料组中含有壳聚糖,使黏连度降低,但是没有海藻酸钠微球,其止血消肿的效果下降,促皮肤愈合的作用也降低;组6大鼠的伤口并没有与敷料黏连,但是伤口愈合率较低为80.8%,且敷料表面还有些许渗液漏出,这使敷料易沾染灰尘细菌,再次使伤口感染,说明实施例3制备的除去改性聚氨酯薄膜保护层的敷料易沾染灰尘细菌从而降低伤口愈合速率,且也证明了改性聚氨酯薄膜与鸡蛋膜复合后的防渗漏作用;组7大鼠的伤口黏连度达到35%,且伤口愈合率也降低为75.5%,证明对比例6以亲水层为贴皮肤侧不利于伤口的恢复,创面的恢复需要湿润环境,但是亲水层创面使伤口失水并不利于伤口的恢复,且亲水层易与伤口黏连在一起,造成皮肤的二次损伤。
以上仅为本发明的优选实施例,并非因此限制本发明的专利范围,凡是利用本发明说明书内容所作的等效结构或等效流程变换,或直接或间接运用在其他相关的技术领域,均同理包括在本发明的专利保护范围内。
Claims (3)
1.一种可吸收防黏连敷料,所述可吸收防黏连敷料从贴近皮肤侧起依次为疏水层、亲水层及保护层;所述疏水层为负载微球的聚己内酯/壳聚糖多孔薄膜,所述微球由海藻酸钠、中药提取物、表皮生长因子、壳聚糖及卵磷脂制成,所述中药提取物为三七、艾叶和积雪草的提取物;所述亲水层的材料为透明质酸、明胶、海藻酸钠或角蛋白中的一种或多种;所述保护层为蛋壳膜与改性聚氨酯薄膜复合而成,所述改性聚氨酯薄膜为羧甲基纤维素钠改性的聚氨酯薄膜;所述可吸收防黏连敷料的制备方法,具体包括以下步骤:
(1)将聚己内酯、壳聚糖以重量比为5~7:2~3溶于乙酸溶液中,搅拌均匀得到混合液A;将海藻酸钠、中药提取物、表皮生长因子以重量比为5~8:0.5~0.8:0.02~0.04溶于去离子水中,混合均匀得到混合液B;将混合液B分为两份,其中一份加入壳聚糖、卵磷脂及CaCl2溶液,壳聚糖、卵磷脂的添加量与海藻酸钠的重量比为5~8:10~12:5~8,制备得含表皮生长因子及中药提取物的微球溶液;将透明质酸、明胶、海藻酸钠或角蛋白中的一种或多种溶于去离子水中,混合均匀得到混合液C;其中,所述乙酸的质量体积百分浓度为5%~8%,所述混合液A的浓度为20% wt ~23%wt;所述混合液B的浓度为7%wt ~8%wt;所述CaCl2溶液的浓度为0.8~1.5%wt;所述混合液C的浓度为15% wt ~18% wt;
(2)将蛋壳膜浸泡于混合液B中3h,取出并用去离子水清洗,干燥得到负载表皮生长因子的蛋壳膜,将负载生长因子的蛋壳膜贴附于羧甲基纤维素钠改性的聚氨酯薄膜上,得到保护层;
(3)将步骤一制备的混合液A缓慢浇筑于模具中、流延,静置,真空冷冻干燥,得聚己内酯/壳聚糖多孔薄膜,将多孔薄膜浸泡于步骤一制备的微球溶液中摇床振荡2h,取出并用去离子水清洗薄膜表面溶液,真空冷冻干燥后得负载微球的疏水层薄膜;所述真空冷冻干燥的温度为-15℃~-45℃,温度由低至高,每半小时升温5℃;
(4)将混合液C装入纺丝设备的针管中,通过静电纺丝技术将混合液C产生的亲水性纳米纤维纺丝于负载微球的薄膜上,得疏水层与亲水层组成的多孔双层膜;所述静电纺丝技术的纺丝电压为20kv,纺丝速度为0.8 mL/h ~1.0mL/h,接收距离为15cm;
(5)将保护层贴附于多孔双层膜之上,以蛋壳膜侧贴附亲水层,用粘合剂使蛋壳膜与亲水层粘合,得到的可吸收防黏连敷料在γ射线下均匀照射杀菌即可。
2.根据权利要求1所述的可吸收防黏连敷料,其特征在于,所述蛋壳膜为将鸡蛋的蛋清和蛋黄磕出后,将其内膜剥离下来,清洗膜上残留的蛋清液,并浸泡于浓度为1%wt~2%wt的多巴胺溶液中,5h后取出并用去离子水清洗所得。
3.根据权利要求1所述的可吸收防黏连敷料,其特征在于,步骤(5)中所述粘合剂为羧甲基纤维素钠、β-环糊精中的一种,所述粘合剂溶液浓度为7%wt~8%wt。
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