CN115006337B - 一种用于皮肤创面修复的双层亲水凝胶贴及其制备方法 - Google Patents
一种用于皮肤创面修复的双层亲水凝胶贴及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于皮肤创面修复的双层亲水凝胶贴及其制备方法,该双层亲水凝胶贴由含药亲水凝胶层和疏水隔离层组成;含药亲水凝胶层由A液倒模凝固后形成;A液是在基质中加入治疗剂量的、具有皮肤创面修复作用的有效成分;所述A液基质由明胶、海藻酸钠和聚乙烯醇组成;疏水隔离层由B液倒模,干燥后,用去离子水清洗至pH值为中性,再次干燥后形成;所述B液由壳聚糖、冰乙酸和去离子水组成。本发明采用亲水性基质材料与有效成分共同制备形成亲水凝胶层,凝胶层直接与皮肤接触,一方面可吸收创面渗出,保持创面湿润状态,另一方面使有效成分稳定持久地发挥皮肤创面修复及抑制瘢痕形成的作用,促进创面愈合。
Description
技术领域
本发明涉及一种用于皮肤创面修复的双层亲水凝胶贴及其制备方法,可应用于化妆品及医药领域。
背景技术
亲水性聚合物在水中通过物理或化学交联的方式形成三维网状结构,形成水凝胶,具有保持湿润环境、吸收渗液、载药量大、生物相容性良好、不容易污染衣服等特点。
白及是一种用于外伤、疮疡的传统中药,含有白及多糖、芪类化合物等成分,具有活血止血、抗菌、促进创伤愈合等作用,现在以其为主药或原料制备的相关制剂及医用材料常被大量用于烫伤、烧伤、压疮或是手术创伤等相关创面的愈合。人参提取液外用可影响人皮肤成纤维细胞增殖和胶原合成,从而促进创面愈合,并能减少瘢痕形成。珍珠具有解毒生肌的功效,常用于治疗皮肤溃疡或炎症、烧烫伤。天花粉在修复创伤时主要发挥其抗炎、抑菌等药理活性。
尽管上述中药在促进创面修复、抑制瘢痕形成方面具有确切的药理作用,但使用传统中药提取物湿敷或清洗等传统用药方式具有以下不足:1.给患者治疗带来不便,容易造成创面二次损伤;2.用药时间短,难以长期维持治疗效果;3.中药提取液成分复杂,容易被污染,增加创面二次感染风险。因此亟需改善中药修复创面的用药方式,以期使治疗更安全、有效、方便。
发明内容
本发明的目的在于提供一种用于皮肤创面修复的双层亲水凝胶贴及其制备方法,本发明采用亲水性凝胶装载有效成分,使含药亲水凝胶具有适宜粘性和吸湿性、皮肤低残留等特点,能够稳定敷贴于创面,保证用药时长,吸收创面渗出液并减少用药对创面的二次损伤;进一步,本发明采用具有抗菌作用的壳聚糖制备多孔膜作为隔离层,保证亲水凝胶层不被污染同时保持透气性,解决亲水性凝胶暴露于日常环境中被微生物附着导致凝胶的污染、霉变问题。在制备方法上,含药凝胶层与不含药隔离层均可采用注液成型法制备成膜,无需涂布设备。
本发明的目的通过下述技术方案实现:
一种双层亲水凝胶贴,由含药亲水凝胶层和疏水隔离层组成;
所述含药亲水凝胶层由A液倒模凝固后形成;
所述A液是在基质中加入治疗剂量的、具有皮肤创面修复作用的有效成分;
所述的有效成分可以是中药单方/复方提取物、化学药或生物药;
所述A液中含有抗菌剂;
所述的抗菌剂优选EDTA-2Na;
所述A液基质由以下重量份的成分组成:
明胶(Gelation,Gel)5-8份;海藻酸钠(Sodium Alginate,SA)0.3-0.6份;聚乙烯醇(Polyving Akohol,PVA)1-4份;
作为一种优选方案,所述的A液基质由以下重量份原料组成:明胶6.5份,海藻酸钠0.4-0.6份,聚乙烯醇2份;
作为一种优选方案,所述的A液基质由以下重量份原料组成:明胶5份,海藻酸钠0.3份,聚乙烯醇1份。
所述A液为pH值中性;优选采用磷酸氢二钠溶液调节pH值至中性。
所述疏水隔离层由B液倒模,干燥后,用去离子水清洗至pH值为中性,再次干燥后形成;
所述B液由以下原料组成:每1.5-3.0g壳聚糖(Chitosan,CS),加入75-150μL冰乙酸和20-40mL去离子水。
与现有的凝胶贴需要无纺布或织物作为背衬层不同,本发明壳聚糖薄膜同时具有作为凝胶背衬和抗菌的作用。
所述的中药复方提取物优选是白及、人参、天花粉和珍珠粉的提取物,特别优选其水提物;
进一步优选地,所述四味药物的配比(重量份)为:白及20~30份、人参10~100份、天花粉10~100份、珍珠粉10~30份;
特别优选的配比为:白及20份、人参10份、天花粉10份、珍珠粉10份;
采用上述中药复方提取物作为有效成分,白及本身含有白及胶,是药辅合一的一个成分,既能发挥药理作用,又能作为辅料构成亲水凝胶。
所述双层亲水凝胶贴包含两种类型:面膜型和普通型;
面模型所用模具为面膜状模具;普通型所用模具为圆形或四边形模具。
所述双层亲水凝胶贴的制备方法,是在制得疏水隔离层后,将A液倒入含有疏水隔离层的模具中,室温下冷却至凝固,在隔离层上附着含药亲水凝胶层,脱模,即得双层亲水凝胶贴。
本发明相对于现有技术具有如下的优点及效果:
1、本发明采用亲水性基质材料与有效成分共同制备形成亲水凝胶层,凝胶层直接与皮肤接触,一方面可吸收创面渗出,保持创面湿润状态,另一方面使有效成分稳定持久地发挥皮肤创面修复及抑制瘢痕形成的作用,促进创面愈合;本发明采用的壳聚糖制备具有纳米级缝隙膜结构的疏水隔离层,与空气面接触,既起透气作用又能隔绝空气污染,降低创面感染的可能性。
2、本发明所用明胶生物相容性较好,溶解于热水再冷却后形成具有黏性、成膜性、弹性的凝胶,明胶还能够有效应用于创伤愈合的促进;聚乙烯醇具有黏合力较强,成膜性好等的性质;海藻酸盐具有止血、透气、吸渗、保湿的功能。在与传统材料的比较中,海藻酸盐敷料能提供潮湿、微酸的环境,可以促血管新生、吸收渗液、减少出血,对促进创面愈合有着重要意义;聚丙烯酸钠在水中形成交联后粘度较高,使凝胶具备高吸水性;壳聚糖为天然碱性多糖,具有非抗原性及较高的生物相容性,吸水性和透气透湿性较好。
附图说明
图1是实施例含药亲水凝胶层使用后的残留情况。
图2是实施例疏水隔离层在显微镜下的放大照片(放大50000×)。
具体实施方式
下面结合实施例及附图对本发明作进一步详细的描述,但本发明的实施方式不限于此。
实施例
一种用于皮肤创面修复的双层亲水凝胶贴的制备,包括以下步骤:
步骤1:按表1所列,分别称取明胶、海藻酸钠、聚乙烯醇,各加入表1所列C液体积的1/3,浸泡,过夜,在65℃加热搅拌至完全溶胀后混合;
表1A液组成
所述C液,是取白及20份、人参10份、天花粉10份、珍珠粉10份、水1000份,于100℃加热回流提取,将提取液浓缩至600份;所述份数为重量份;
步骤2:在步骤1混合液中加入EDTA-2Na 0.12份,搅拌至EDTA-2Na完全溶解,以磷酸氢二钠溶液调整pH值至中性,获得A液;
步骤3:按表2所列,称取原料混合,得到B液,吸取一定量B液注入模具,37℃鼓风干燥1小时形成透明薄膜;加入5mL水润洗,弃去洗液,反复润洗至洗液pH值呈中性,37℃鼓风干燥1小时形成透明薄膜,为疏水隔离层;
表2B液组成
步骤4:将步骤2所得A液超声2h除去气泡,趁热注入步骤3含疏水隔离层的模具,室温下冷却至凝固,在隔离层上形成含药亲水凝胶层,脱模,即得中药双层亲水凝胶贴。
将步骤2所得的A液倒模,凝固后得到含药亲水凝胶层,对其性能评价采用以下评价指标:
1.感官评分:按表3的项目和标准进行评分;
表3感官评分标准
2.初粘力:初粘力测试仪所用球号。
3.吸水性=(吸水后重量-吸水前重量)/吸水前重量×100%。
实施例所得含药亲水凝胶层的性能指标如表4所示:
表4实施例含药亲水凝胶层评价结果
由表4看出,实施例3、7、11所得含药亲水凝胶层气泡少、流动性符合注液成型要求,皮肤追随性好、撕开后凝胶残留少(图1)、粘度适宜、具有理想的吸水性。
实施例3步骤3所制得的疏水隔离层均具有纳米级缝隙(图2,放大倍数50000×),起到透气作用和隔离作用。
对比例1
按表1组别3,称取明胶、海藻酸钠、聚乙烯醇,分别加入1/3的C液,在65℃加热搅拌至完全溶胀,搅拌混合,在混合液中加入EDTA-2Na 0.12份,搅拌至EDTA-2Na完全溶解,以磷酸氢二钠溶液调整pH值至中性,获得A液;另称取聚丙烯酸钠NP-700 0.31g,甘羟铝0.011g,甘油1.9mL充分混合均匀,作为油相;将A液与油相充分混合,超声除泡2h,获得含药亲水凝胶层。
对比例2
按表1组别3,称取明胶、海藻酸钠、聚乙烯醇,分别加入1/3的C液,在65℃加热搅拌至完全溶胀,搅拌混合,在混合液中加入EDTA-2Na 0.12份,搅拌至EDTA-2Na完全溶解,以磷酸氢二钠溶液调整pH值至中性,获得A液;另称取聚丙烯酸钠NP-700 0.55g,甘羟铝0.03g,甘油3.5mL充分混合均匀,作为油相;将A液与油相充分混合,超声除泡2h,获得含药亲水凝胶层。
表5对比例含药亲水凝胶层评价结果
由表5看出,增加NP-700与甘羟铝使A液气泡增加、流动性和吸水性减弱,凝胶残留增加,对其皮肤追随性和初粘力无明显影响,故实施例优于对比例。
上述实施例为本发明较佳的实施方式,但本发明的实施方式并不受上述实施例的限制,其他的任何未背离本发明的精神实质与原理下所作的改变、修饰、替代、组合、简化,均应为等效的置换方式,都包含在本发明的保护范围之内。
Claims (7)
1.一种双层亲水凝胶贴,其特征在于:由含药亲水凝胶层和疏水隔离层组成;
所述含药亲水凝胶层由A液倒模凝固后形成;
所述A液是在基质中加入治疗剂量的、具有皮肤创面修复作用的有效成分;
所述A液基质由以下重量份的成分组成:
明胶6.5份,海藻酸钠0.4-0.6份,聚乙烯醇2份;
或,明胶5份,海藻酸钠0.3份,聚乙烯醇1份;
所述疏水隔离层由B液倒模,干燥后,用去离子水清洗至pH值为中性,再次干燥后形成;
所述B液由以下原料组成:每1.5-3.0g壳聚糖,加入75-150μL冰乙酸和20-40mL去离子水;
所述双层亲水凝胶贴的制备方法包括以下步骤:
在制得疏水隔离层后,将A液倒入含有疏水隔离层的模具中,室温下冷却至凝固,在隔离层上附着含药亲水凝胶层,脱模,即得双层亲水凝胶贴。
2.根据权利要求1所述的双层亲水凝胶贴,其特征在于:所述的有效成分是中药单方/复方提取物、化学药或生物药。
3.根据权利要求1所述的双层亲水凝胶贴,其特征在于:所述A液中含有抗菌剂。
4.根据权利要求1所述的双层亲水凝胶贴,其特征在于:所述A液为pH值中性。
5.根据权利要求2所述的双层亲水凝胶贴,其特征在于:所述的中药复方提取物是白及、人参、天花粉和珍珠粉的提取物。
6.根据权利要求2所述的双层亲水凝胶贴,其特征在于:所述的中药复方提取物是白及、人参、天花粉和珍珠粉的水提物。
7.根据权利要求6所述的双层亲水凝胶贴,其特征在于:四味药物的配比按重量份为:白及20~30份、人参10~100份、天花粉10~100份、珍珠粉10~30份。
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