CN106937941A - 一种医用皮肤伤口消炎凝胶及其制备方法 - Google Patents
一种医用皮肤伤口消炎凝胶及其制备方法 Download PDFInfo
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- CN106937941A CN106937941A CN201710202831.0A CN201710202831A CN106937941A CN 106937941 A CN106937941 A CN 106937941A CN 201710202831 A CN201710202831 A CN 201710202831A CN 106937941 A CN106937941 A CN 106937941A
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Abstract
本发明涉及一种医用皮肤伤口消炎凝胶及其制备方法,该消炎凝胶是由氧化海藻酸盐与二胺或二肼类物质发生交联反应构成凝胶基体,再复配以下重量份的组分构成:卡波姆5~10份;低聚麦芽糖10~20份;消炎剂0.1~5份;透皮吸收促进剂5‑20份;保湿剂5~20份;纯化水40~70份。本发明藻酸盐经特定工艺的过碘酸钠部分氧化后,可激活海藻酸中的羧基活性基团,加速交联反应的发生,提高凝胶的生产效率。所形成的复合藻酸盐凝胶具有有较高的内聚能,可以适用于任何部位的伤口,主要用于干燥结痂或有腐烂组织的伤口,并且能抑制体内有害菌的繁殖和有毒腐败物质的产生,发挥其消炎、止血、抗菌、清创的功效,加速伤口的愈合。
Description
技术领域
本发明涉及医用耗材技术领域,具体包含一种医用皮肤伤口消炎凝胶。
背景技术
皮肤及粘膜损伤时应选择合适的敷料覆盖在伤口上,它可发挥保持伤口湿润环境、吸收分泌物、缓解疼痛并控制出血的作用,从而促进伤口快速愈合。有研究证明,在湿性环境下,伤口愈合速度是干性环境下的两倍,使得人们对伤口愈合的过程有了新的认识。炎症因子是影响伤口使命的关键因素之一,伤口渗出液里含有的大量炎症因子、蛋白酶和自由基都会减缓伤口的愈合速度。新型复合镇痛功能材料的研发对治疗炎症伤口有重要意义,是创面敷料发展的新趋势。
藻酸盐(alginate),也称为褐藻胶(algin)、海藻酸(alginic acid),是一种在褐藻细胞壁广泛分布的阴离子多糖,通过与水结合形成粘性胶体。藻酸盐敷料的主要成份是藻酸钙,是一种不溶于水的物质。当其遇到富含钠离子的液体(如渗液和血液等)时,钙钠离子会发生交换,钙离子被释放出来,而钠离子则与海藻酸结合,形成了亲水的凝胶状物质,帮助伤口维持湿性环境和加强自溶性清创,以及促进肉芽组织的生长。藻酸盐具有很强的液体吸收能力,可以吸收达到其自身重量20倍的液体。因此,藻酸盐敷料可以用于中至重度渗出的伤口,对于有坏死组织的伤口还可以加速清创,甚至感染伤口也可以使用。
随着技术的发展,人们对敷料的性能有了更高的要求。一般凝胶敷料需满足一定强度、控制和吸收渗出物、保湿、阻菌、镇痛、无毒无害无刺激等性能要求,然而现有医用凝胶,尤其是藻酸盐凝胶难以同时满足这些要求。
发明内容
为了解决现有技术中存在的各种问题,本发明的目的是提供一种强度高,生产效率高,具有预防和控制感染并能保湿、清创、消炎以及物理隔离作用的医用皮肤消炎凝胶。
为解决上述技术难题,本发明提供的技术方案为:
一种医用皮肤伤口消炎凝胶,由氧化海藻酸盐与二胺或二肼类物质发生交联反应构成凝胶基体,再复配以下重量份的A液组成:卡波姆5~10份、低聚麦芽糖10~20份、消炎剂0.1~5份、透皮吸收促进剂5-20份、保湿剂5~20份、纯化水40~70份。
优选地,所述的氧化海藻酸盐由海藻酸盐制备而来,所述的海藻酸盐为海藻酸钠、海藻酸钾、海藻酸铵中的任意一种。
优选地,所述的二胺类物质为乙二胺、丙二胺、已二胺等当中的任意一种组成,所述的二肼类物质为己二酰二肼、联硫二丙酰二肼两者当中的任意一种组成。
优选地,所述的消炎剂为环丙沙星、利福霉素、甲硝唑当中的任意一种组成;所述的透皮吸收促进剂为合成龙脑、聚乙二醇、二甲基亚砜、丙二醇、丁香油等当中的任意一种组成;所述的保湿剂为甘油、丙二醇、甘露醇、丁二醇和山梨醇中的任意一种组成。
优选地,所述的凝胶为无定形凝胶,其包括如下的制备步骤:
S1:氧化海藻酸盐的制备:取重量份为1~10份的海藻酸盐并配成质量分数为1~5%的水溶液,用1~5份的0.2~0.3mol/L过碘酸钠溶液避光氧化24~48h后加入0.1~1份乙二醇终止氧化反应,加入0.1~0.5份NaCl充分混合后加入50~100份乙醇其沉淀析出即可;
S2:A液的制备:按重量称取卡波姆、低聚麦芽糖、消炎剂、透皮吸收促进剂、保湿剂,加入纯化水至所需计量,于室温下搅拌至完全润湿,热滤去除不溶物,得A液;
S3:交联:取步骤S1制得的重量份为0.1~0.5份的氧化海藻酸盐,加入5~15份的2-(N-吗啡啉)乙磺酸缓冲液,40~50℃恒温搅拌至完全溶解,然后加入0.2~0.6份的二胺或二肼类物质继续于40~50℃下恒温搅拌40~80min后,加入A液至反应完全;
S4:将上述S3得到的混合物静置、真空脱泡、灌装、灭菌即得无定形凝胶。
更优选地,所述的凝胶为固体片状凝胶,其包括如下的制备步骤:
S1:氧化海藻酸盐的制备:取重量份为1~10份的海藻酸盐并配成质量分数为1~5%的水溶液,用1~5份的0.2~0.3mol/L过碘酸钠溶液避光氧化24~48h后加入0.1~1份乙二醇终止氧化反应,加入0.1~0.5份NaCl充分混合后加入50~100份乙醇其沉淀析出即可;
S2:A液的制备:按重量称取卡波姆、低聚麦芽糖、消炎剂、透皮吸收促进剂、保湿剂,加入纯化水至所需计量,于室温下搅拌至完全润湿,热滤去除不溶物,得A液;
S3:交联:取步骤S1制得的重量份为0.1~0.5份的氧化海藻酸盐,加入5~15份的2-(N-吗啡啉)乙磺酸缓冲液,40~50℃恒温搅拌至完全溶解,然后加入0.2~0.6份的二胺或二肼类物质继续于40~50℃下恒温搅拌40~80min后,加入A液至反应完全;
S4:将上述S3得到的混合物静置、真空脱泡,并将热凝胶灌装在推托盘内,封装于-20℃下极冷,37-60℃解冻20-30min,重复3~6次,后在25-30kGy辐射剂量下辐照灭菌即得固体片状凝胶。
由于海藻酸盐上有羧基活性基团,可以同二胺,二肼类物质发生交联反应,通过-NH2和COO-的脱水缩合反应形成酰胺键,从而得到强度稳定的海藻酸钠共价交联水凝胶。这种凝胶无色透明、清创保湿、柔软,经冷冻干燥后呈层状结构,吸水后变得透明。然而,由于反应需要较长时间,工业化生产效率一般不高。一般可通过采用活化体系(诸如EDC/NHS体系)来提高交联速率,使凝胶速率加快。本发明中,通过过碘酸钠氧化,海藻酸盐顺式邻二醇结构中的C-C键断裂,部分糖醛酸单元的羟基转变成反应活性高于羧基的醛基基团,从而使海藻酸盐以更快的速率与二胺、多胺类物质发生席夫碱交联反应,进而可加快水凝胶的生产效率。
本发明的有益效果为:(1)藻酸盐经本发明特定工艺的过碘酸钠氧化后,可激活海藻酸中的羧基活性基团,加速交联反应的发生,提高凝胶的生产效率;(2)所形成的复合藻酸盐凝胶具有有较高的内聚能,强度高,不会在伤口上残留、脱落,可以适用于任何部位的伤口,主要用于干燥结痂或有腐烂组织的伤口;(3)凝胶中含有透皮吸收促进剂,可促进低聚麦芽糖、消炎剂等功能药物的透皮吸收,从而能更好地抑制体内有害菌的繁殖和有毒腐败物质的产生,发挥其消炎、止血、抗菌、清创的功效,加速伤口的愈合;(4)加入保湿剂和增稠剂,除了增强凝胶的保湿作用外,还有较好的增塑作用,使得凝胶涂布于伤口上之后的肤感更加柔软,并且在凝胶水分蒸发之后不会产生伤口的紧绷感,舒适性好。
具体实施例
下面结合实施例对本发明做进一步描述;以下实施例仅用于更加清楚地说明本发明的目的、技术方案及优点,并不能以此来限制本发明的保护范围。
实施例1:
无定形凝胶的制备:
(1)氧化海藻酸盐的制备:取重量份为5份的海藻酸钠并配成质量分数为1%的水溶液,用3份的0.28mol/L过碘酸钠溶液避光氧化36h后加入0.8份乙二醇终止氧化反应,加入0.1份NaCl充分混合后加入75份乙醇,待沉淀析出即可;
(2)A液制备:按重量份数称取卡波姆8份、低聚麦芽糖12份、环丙沙星0.1份、合成龙脑5份、甘油20份,加入纯化水50份后于室温下搅拌至完全润湿,热滤去不溶物,得A液;
(3)交联反应:取上述制备的重量份为0.5份的氧化海藻酸盐,加入10份的2-(N-吗啡啉)乙磺酸缓冲液,45℃恒温搅拌至完全溶解,然后加入0.2份的二胺联硫二丙酰二肼继续于40℃下恒温搅拌40min后,加入A液继续搅拌至反应完全;
(4)无定形凝胶:将上述(3)得到的混合物静置、真空脱泡、灌装、灭菌即得无定形凝胶敷料。
实施例2:
无定形凝胶的制备:
(1)氧化海藻酸盐的制备:取重量份为7份的海藻酸钾并配成质量分数为4%的水溶液,用4份的0.25mol/L过碘酸钠溶液避光氧化24h后加入1份乙二醇终止氧化反应,加入0.3份NaCl充分混合后加入100份乙醇,待沉淀析出即可;
(2)A液制备:按重量份数称取卡波姆6份、低聚麦芽糖10份、消炎剂利福霉素5份、聚乙二醇20份、保湿剂丙二醇5份,加入纯化水40份后于室温下搅拌至完全润湿,热滤去不溶物,得A液;
(3)交联反应:取上述制备的重量份为0.4份的氧化海藻酸盐,加入5份的2-(N-吗啡啉)乙磺酸缓冲液,50℃恒温搅拌至完全溶解,然后加入0.4份的二胺丙二胺继续于50℃下恒温搅拌80min后,加入A液继续搅拌至反应完全;
(4)无定形凝胶:将上述(3)得到的混合物静置、真空脱泡、灌装、灭菌即得无定形凝胶敷料。
实施例3:
固体片状凝胶的制备:
(1)氧化海藻酸盐的制备:取重量份为10份的海藻酸铵并配成质量分数为5%的水溶液,用1份的0.3mol/L过碘酸钠溶液避光氧化48h后加入0.1份乙二醇终止氧化反应,加入0.5份NaCl充分混合后加入60份乙醇,待沉淀析出即可;
(2)A液制备:按重量份数称取卡波姆10份、低聚麦芽糖15份、甲硝唑3份、透皮吸收促进剂丙二醇10份、二甲基亚砜10份、保湿剂甘露醇10份,加入纯化水60份后于室温下搅拌至完全润湿,热滤去不溶物,得A液;
(3)交联反应:取上述制备的重量份为0.3份的氧化海藻酸盐,加入15份的2-(N-吗啡啉)乙磺酸缓冲液,40℃恒温搅拌至完全溶解,然后加入0.5份的己二酰二肼继续于45℃下恒温搅拌30min后,加入A液继续搅拌至反应完全;
(4)固体片状凝胶:将上述(3)得到的混合物静置、真空脱泡,并将热凝胶灌装在推托盘内,封装于-20℃下极冷,37℃解冻30min,重复6次,后在25kGy辐射剂量下辐照灭菌即得固体片状凝胶。
实施例4:
固体片状凝胶的制备:
(1)氧化海藻酸盐的制备:取重量份为1份的海藻酸钠并配成质量分数为3%的水溶液,用5份的0.2 mol/L过碘酸钠溶液避光氧化36h后加入0.5份乙二醇终止氧化反应,加入0.4份NaCl充分混合后加入50份乙醇,待沉淀析出即可;
(2)A液制备:按重量份数称取卡波姆5份、低聚麦芽糖20份、环丙沙星0.8份、透皮吸收促进剂丁香油15份、保湿剂山梨醇15份,加入纯化水70份后于室温下搅拌至完全润湿,热滤去不溶物,得A液;
(3)交联反应:取上述制备的重量份为0.1份的氧化海藻酸盐,加入12份的2-(N-吗啡啉)乙磺酸缓冲液,45℃恒温搅拌至完全溶解,然后加入0.6份的乙二胺继续于45℃下恒温搅拌20min后,加入A液继续搅拌至反应完全;
(4)固体片状凝胶:将上述(3)得到的混合物静置、真空脱泡,并将热凝胶灌装在推托盘内,封装于-20℃下极冷, 60℃解冻20min,重复3次,后在30kGy辐射剂量下辐照灭菌即得固体片状凝胶。
实施例5:内聚能密度的测试
以普通藻酸盐水凝胶为对照组,将实施例1~4得到的凝胶样与对照组样品进行聚合物最大溶比法测试各自的内聚能密度,其结果如下表所示:
内聚能是指1mol凝聚态克服分子间相互作用力变为气态所需的能量,内聚能密度是单位体积的内聚能,是对物质分子间相互作用力大小的度量。从上述表述的实验数据可以看出,本发明的凝胶样品其内聚能密度显著高于普通水凝胶,这主要是因为海藻酸盐上有羧基活性基团,可以同二胺,二肼类物质发生交联反应,通过-NH2和COO-的脱水缩合反应形成酰胺键,从而得到强度稳定的海藻酸钠共价交联水凝胶。
实施例6:动物实验
取雄性新西兰兔,72只,每只2~3kg,随机分为六组,每组12只。各兔子均按照临床动物实验烧伤标准模型制备方法均造成30%TBSA浅II度烧伤,其中A组兔子不使用任何敷料,B组兔子敷用一般凝胶样品,C、D、E、F组敷用本发明实施例1~4的皮肤消炎凝胶,每天更换两次,直到C、D、E、F组的创面愈合便结束本次动物实验。
从动物实验的结果上看,C~F组兔子创面敷用各自的敷料后,创面均无感染现象、无红肿发生。而从愈合时间上看,C~F组兔子创面的愈合时间明显少于B组,时间差异具有显著意义,见表2:
表2 各组动物创面感染及愈合情况(%)
从六组实验的整体结果上看,一般凝胶样品和本发明制备的敷料对创面的愈合能起到加速的作用,而C~F组敷料因为含抑菌、消炎及透皮吸收剂等功能成分,在保湿剂的作用下有效护理伤口,显著改善了创面局部的微环境,促进创面愈合并缩短愈合时间。
显然,本发明的上述实施例仅仅是为清楚地说明本发明所作的举例,而并非是对本发明的实施方式的限定;对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动,这里无需也无法对所有的实施方式予以穷举;凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明权利要求的保护范围之内。
Claims (6)
1.一种医用皮肤消炎凝胶,其特征在于,由氧化海藻酸盐与二胺或二肼类物质发生交联反应构成凝胶基体,再复配以下重量份的A液组成:卡波姆5~10份、低聚麦芽糖10~20份、消炎剂0.1~5份、透皮吸收促进剂5~20份、保湿剂5~20份、
纯化水40~70份;所述的氧化海藻酸盐重量份为0.1~0.5份;所述的二胺或二肼类物质重量份为0.2~0.6份。
2.根据权利要求1所述的一种医用皮肤消炎凝胶,其特征在于,所述的氧化海藻酸盐由海藻酸盐制备而来,所述的海藻酸盐为海藻酸钠、海藻酸钾、海藻酸铵中的任意一种。
3.根据权利要求1所述的一种医用皮肤消炎凝胶,其特征在于,所述的二胺类物质为乙二胺、丙二胺、已二胺中的任意一种,所述的二肼类物质为己二酰二肼、联硫二丙酰二肼两者中的任意一种。
4.根据权利要求1所述的一种医用皮肤消炎凝胶,其特征在于,所述的消炎剂为环丙沙星、利福霉素、甲硝唑中的任意一种;所述的透皮吸收促进剂为合成龙脑、聚乙二醇、二甲基亚砜、丙二醇、丁香油中的任意一种;所述的保湿剂为甘油、丙二醇、甘露醇、丁二醇和山梨醇中的任意一种。
5.一种如权利要求1-4所述的医用皮肤消炎凝胶的制备方法,其特征在于,所述制备方法具体工艺步骤如下: S1:氧化海藻酸盐的制备:取重量份为1~10份的海藻酸盐并配成质量分数为1~5%的水溶液,用1~5份的0.2~0.3mol/L过碘酸钠溶液避光氧化24~48h后加入0.1~1份乙二醇终止氧化反应,加入0.1~0.5份NaCl充分混合后加入50~100份乙醇其沉淀析出即可; S2:A液的制备:按重量称取卡波姆、低聚麦芽糖、消炎剂、透皮吸收促进剂、保湿剂,加入纯化水至所需计量,于室温下搅拌至完全润湿,热滤去除不溶物,得A液; S3:交联:取步骤S1制得的重量份为0.1~0.5份的氧化海藻酸盐,加入5~15份的2-(N-吗啡啉)乙磺酸缓冲液,40~50℃恒温搅拌至完全溶解,然后加入0.2~0.6份的二胺或二肼类物质继续于40~50℃下恒温搅拌40~80min后,加入A液至反应完全; S4:将上述S3得到的混合物静置、真空脱泡、灌装、灭菌即得无定形凝胶。
6.根据权利要求5所述的一种医用皮肤消炎凝胶的制备方法,其特征在于, S1:氧化海藻酸盐的制备:取重量份为1~10份的海藻酸盐并配成质量分数为1~5%的水溶液,用1~5份的0.2~0.3mol/L过碘酸钠溶液避光氧化24~48h后加入0.1~1份乙二醇终止氧化反应,加入0.1~0.5份NaCl充分混合后加入50~100份乙醇其沉淀析出即可; S2:A液的制备:按重量称取卡波姆、低聚麦芽糖、消炎剂、透皮吸收促进剂、保湿剂,加入纯化水至所需计量,于室温下搅拌至完全润湿,热滤去除不溶物,得A液; S3:交联:取步骤S1制得的重量份为0.1~0.5份的氧化海藻酸盐,加入5~15份的2-(N-吗啡啉)乙磺酸缓冲液,40~50℃恒温搅拌至完全溶解,然后加入0.2~0.6份的二胺或二肼类物质继续于40~50℃下恒温搅拌20~40min后,加入A液至反应完全; S4:将上述S3得到的混合物静置、真空脱泡、灌装在推托盘内,封装于-20℃下极冷,37-60℃解冻20-30min,重复3~6次,后在25-30kGy辐射剂量下辐照灭菌即得固体片状凝胶。
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