CN115869452A - 一种抗菌促凝血的气胸密封贴及其制备方法 - Google Patents
一种抗菌促凝血的气胸密封贴及其制备方法 Download PDFInfo
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- CN115869452A CN115869452A CN202211434594.8A CN202211434594A CN115869452A CN 115869452 A CN115869452 A CN 115869452A CN 202211434594 A CN202211434594 A CN 202211434594A CN 115869452 A CN115869452 A CN 115869452A
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- pneumothorax
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- procoagulant
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Abstract
本发明公开了一种抗菌促凝血的气胸密封贴及其制备方法。所述抗菌促凝血的气胸密封贴由上至下依次包括外保护层、敷料层和密封粘结层;所述敷料层由双醛羧甲基壳聚糖和单宁酸制备复合物,然后在复合物中的双醛羧甲基壳聚糖接枝丙烯酸,再通过交联形成的水凝胶组成。本发明提供的气胸密封贴通过添加单宁酸可以提高气胸密封贴的抗菌和促凝血能力,并且根据水凝胶的结构增强气胸密封贴的止血能力和整体性能。
Description
技术领域
本发明涉及医药用品领域,具体涉及一种抗菌促凝血的气胸密封贴及其制备方法。
背景技术
创伤性气胸多因为肺被肋骨骨折断端刺破,或者因为暴力作用引起的支气管或肺组织挫裂伤,或因气道内压力急剧升高而引起的支气管或肺破裂。锐器伤或火器伤穿通胸壁,伤及肺、支气管和气管或食管,也可以引起气胸,且多为血气胸或脓气胸。在现代战争中,因为碎片、弹片等对人体造成的伤害往往会出现在胸腹部,对胸腹部造成贯通伤或较深的盲管伤,这些伤害容易造成开放性气胸,并伴随创伤性血胸出现,这严重威胁到伤员的生命安全,也是造成战斗减员的重要原因。
临床上一般通过封闭胸腔引流口治疗气胸,现有的方法一般为:先用具有一定密闭性的凡士林纱布覆盖伤口,然后再用纱布或棉垫包扎,最后再用医用胶布或薄膜贴固定。但由于其过程复杂且需要的材料和装置不便携带,操作过程多,因此很难应用于现代战争中。因此,市面上出了便携带使用的气胸密封贴。
气胸密封贴携带方便,使用简单。通过气胸密封贴对伤口封堵来预防气胸,气胸密封贴通常采用聚氨酯复合膜,一面用医用热熔胶进行密封,此类密封贴能够快速封闭伤口,防止气胸形成。但在战场中,医疗环境较差存在大量细菌,并且伤口往往伴随着大量的出血,若不及时止血会导致血液流入胸腔形成血胸,而且伤口愈合缓慢,容易在伤员转移过程中发生破裂导致伤情加重。
综上所述,目前急需一种可以在战场较差的医疗环境中能够及时止血,抵抗细菌感染,并且能够促进伤口愈合的气胸密封贴。
发明内容
发明目的:针对现有技术的缺陷,本发明的目的在于提供一种抗菌促凝血的气胸密封贴及其制备方法,以解决现有技术中难以对伤口止血、易发生细菌感染以及伤口愈合速度慢的问题。
技术方案:
一种抗菌促凝血的气胸密封贴,由上至下依次包括外保护层、敷料层和密封粘结层;
所述敷料层由双醛羧甲基壳聚糖和单宁酸制备复合物,然后在复合物中的双醛羧甲基壳聚糖接枝丙烯酸,再通过交联形成的水凝胶组成。
本发明使用羧甲基壳聚糖,利用其羟基提供接枝位点从而可以进一步改性,同时作为两性聚电解质具有良好的水溶性、成膜性和吸水包水性能,可以作为水凝胶的原料。
单宁酸因为其结构中含有的大量酚羟基可以妨碍细菌对铁、多糖、氨基酸等摄取,破坏细菌细胞壁及细胞膜,抑制生物膜的形成,从而具有很强的抗菌能力,同时单宁酸可以作为一种收敛剂,刺激碱性成纤维细胞生长因子的分泌,加速体内和体外伤口愈合。
本发明通过交联形成的水凝胶具有良好的生物安全性和组织相容性,是优异的止血材料。在双醛羧甲基壳聚糖的羟基位点上接枝丙烯酸,再通过交联剂可以制成三维网格状结构形成水凝胶敷料层。
进一步地,所述外保护层为离型纸外保护层。
进一步地,所述密封粘结层选自具有防渗透的PE、EVA、PEVA、聚氨酯或天然橡胶中的一种。
进一步地,所述双醛羧甲基壳聚糖的制备方法包括以下步骤:
(1)在反应器中加入去离子水后,加入羧甲基壳聚糖搅拌溶解,然后加入氧化剂,调整体系pH至3.5-4;
(2)将步骤(1)的反应器升温至40-45℃,在避光条件下搅拌4-5小时;
(3)向步骤(2)的反应器中加入乙二醇溶液,常温下搅拌0.5-1小时后,将产物离心洗涤,在真空下冷冻干燥20-24小时后,即制得所述双醛羧甲基壳聚糖。
在羧甲基壳聚糖基础上通过选择性氧化生成新的活性基团醛基,可以自身充当部分的交联作用,减少有毒交联剂的使用。
进一步地,所述步骤(1)中氧化剂为高碘酸钠。
进一步地,所述单宁酸为药用单宁酸。符合国家行业标准LY-T 1300、LY-T1640、LY-T1641,纯度高的同时重金属含量低,可用于医药领域。
所述的抗菌促凝血的气胸密封贴的制备方法,包括以下步骤:
(1)在反应器中加入去离子水后,加入双醛羧甲基壳聚糖搅拌溶解,然后加入生物缓冲剂调节体系pH至8-8.5后,加入单宁酸混合均匀,在室温下反应6-8小时;
(2)向步骤(1)的反应器持续通入保护气,然后加入引发剂和丙烯酸搅拌均匀,在室温下反应4-5小时后,静置10-12小时;
(3)向步骤(2)的反应器中加入交联剂,搅拌均匀后密封,然后在室温下静置10-12小时,即可制得所述敷料层;
(4)将步骤(3)的敷料层置于密封粘结层上部,将外保护层覆盖在密封粘结层和敷料层外部,即可制得所述抗菌促凝血的气胸密封贴。
步骤(1)制备双醛羧甲基壳聚糖与单宁酸的复合物。
步骤(2)在双醛羧甲基壳聚糖的羟基位点上接枝丙烯酸。
步骤(3)交联形成水凝胶。
进一步地,所述双醛羧甲基壳聚糖、单宁酸和丙烯酸的质量比为(1-1.5):(3-5):(10-15)。
进一步地,所述步骤(1)中生物缓冲剂选自三羟甲基氨基甲烷、N,N-二羟乙基甘氨酸或4-羟乙基哌嗪乙磺酸中的一种。
本发明所选用的缓冲剂为生物缓冲剂,具有良好的缓冲能力,对生物化学过程的干扰很小并且对细胞没有毒性。
进一步地,所述步骤(2)中引发剂选自偶氮二异丙基咪唑啉盐酸盐或偶氮二异丁酸二甲酯中的一种。
本发明所选用的引发剂选自不含氰基的引发剂,相比其他引发剂,分解产物无毒,对身体危害小,且分解平稳,转化率高。
进一步地,所述步骤(3)中交联剂选自1-乙基-(3-二甲基氨基丙基)碳二亚胺盐酸盐或N-羟基琥珀酰亚胺中的一种。
本发明所选用的交联剂为无毒、生物相容性好的交联剂。与具有一定自交联能力的双醛羧甲基壳聚糖结合使用,在保证足够的交联度的情况下还具有无毒、生物相容性好的特点。
有益效果:
1.本发明提供的气胸密封贴使用双醛羧甲基壳聚糖,壳聚糖是一类天然聚氨基多糖类线性高分子化合物,自身具有广谱抗菌性,生物相容性好,对人体无毒副作用。可以通过红细胞膜的阴极与壳聚糖表面的阳极产生静电反应来止血。
本发明使用羧甲基壳聚糖,利用其羟基提供接枝位点从而可以进一步改性,同时作为两性聚电解质具有良好的水溶性、成膜性和吸水包水性能,可以作为水凝胶的原料。在羧甲基壳聚糖基础上通过选择性氧化生成新的活性基团醛基,可以自身充当部分的交联作用,减少有毒交联剂的使用。
2.本发明提供的气胸密封贴中添加单宁酸,单宁酸具有优异的光谱抗菌活性,同时也具有促进伤口愈合的能力。单宁酸因为其结构中含有的大量酚羟基可以妨碍细菌对铁、多糖、氨基酸等摄取,破坏细菌细胞壁及细胞膜,抑制生物膜的形成,从而具有很强的抗菌能力;单宁酸可以作为一种收敛剂,刺激碱性成纤维细胞生长因子的分泌,加速体内和体外伤口愈合。
3.本发明提供的气胸密封贴使用水凝胶结构,水凝胶是由无限大三维网络与水共同构成的物质,可以与体液进行交换,为细胞和组织的生长提供营养物质,因此具有良好的生物安全性和组织相容性,是优异的止血材料。在双醛羧甲基壳聚糖的羟基位点上接枝丙烯酸,再通过交联剂制成三维网格状结构,网格之间相互连通,使其具有较好的吸水性,接触血液时可以吸收血浆,浓缩血液,有利于血小板聚集,提高止血效能力。
4.本发明提供的气胸密封贴无毒并且具有优良的生物相容性:本发明所选用的缓冲剂为生物缓冲剂,具有良好的缓冲能力,对生物化学过程的干扰很小并且对细胞没有毒性;本发明所选用的引发剂选自不含氰基的引发剂,相比其他引发剂,分解产物无毒,对身体危害小,且分解平稳,转化率高;本发明所选用的交联剂为无毒、生物相容性好的交联剂。与具有一定自交联能力的双醛羧甲基壳聚糖结合使用,在保证足够的交联度的情况下还具有无毒、生物相容性好的特点。
具体实施方式
以下将结合具体实施方案来说明本发明。需要说明的是,下面的实施例为本发明的示例,仅用来说明本发明,而不用来限制本发明。在不偏离本发明主旨或范围的情况下,可进行本发明构思内的其他组合和各种改良。
本申请中使用的羧甲基壳聚糖从山东丰泰生物科技有限公司购买;单宁酸是从张家界九瑞生物科技有限公司购买的药用单宁酸;可吸收止血膜是从北京大清生物技术有限公司购买的大清生物纸;胸腔密封贴是从沈阳鹏悦科技有限公司购买的鹏悦PY191;紧凑型胸封是从美国North American Rescue公司购买的NAR HyFin。其余试剂、设备为本技术领域常规试剂和设备。
双醛羧甲基壳聚糖的制备
(1)按重量份数计,在反应器中加入去离子水后,加入5份羧甲基壳聚糖搅拌溶解,然后加入5份高碘酸钠,调整体系pH至4;
(2)将步骤(1)的反应器升温至45℃,在避光条件下搅拌4小时;
(3)向步骤(2)的反应器中加入乙二醇溶液,常温下搅拌1小时后,将产物用叔丁醇离心洗涤3次,真空冷冻干燥24小时后,即制得所述双醛羧甲基壳聚糖。
实施例1
(1)按重量份数计,在反应器中加入30份去离子水后,加入1份双醛羧甲基壳聚糖搅拌溶解,然后加入三羟甲基氨基甲烷溶液调节体系pH至8.5后,加入3份单宁酸混合均匀,在室温下反应6小时;
(2)向步骤(1)的反应器持续通入氮气,然后加入0.05份偶氮二异丙基咪唑啉盐酸盐和10份丙烯酸搅拌均匀,在室温下反应4小时后,静置12小时;
(3)向步骤(2)的反应器中加入0.05份1-乙基-(3-二甲基氨基丙基)碳二亚胺盐酸盐,搅拌均匀后密封,然后在室温下静置12小时,即可制得敷料层。
(4)将步骤(3)的敷料层置于密封粘结层上部,将外保护层覆盖在密封粘结层和敷料层外部,即可制得所述抗菌促凝血的气胸密封贴。
实施例2
基本同实施例1,所不同的是单宁酸改为5份。
实施例3
基本同实施例1,所不同的是丙烯酸改为15份。
实施例4
基本同实施例1,所不同的是双醛羧甲基壳聚糖改为1.5份。
对比例1
基本同实施例1,所不同的是单宁酸改为等量的透明质酸钠。
对比例2
基本同实施例1,所不同的是丙烯酸改为等量的亚甲基丁二酸。
对比例3
基本同实施例1,所不同的是双醛羧甲基壳聚糖改为等量的羧甲基壳聚糖。
对比例4
可吸收止血膜。
对比例5
胸腔密封贴。
对比例6
紧凑型胸封。
性能测试
1.吸水强度测试:分别将0.5g的实施例1-4和0.5g的对比例1-4的产品置于1000ml的烧杯中,加入500ml蒸馏水,室温静置六小时,吸水达到饱和后滤去蒸馏水,称取质量,计算吸水率。结果如下表。
样品(m/g) | 吸水量(m/g) | 吸水率(g/g) | |
实施例1 | 0.5 | 60 | 120 |
实施例2 | 0.5 | 62 | 124 |
实施例3 | 0.5 | 59 | 118 |
实施例4 | 0.5 | 60 | 120 |
对比例1 | 0.5 | 46 | 92 |
对比例2 | 0.5 | 52 | 104 |
对比例3 | 0.5 | 53 | 106 |
对比例4 | 0.5 | 50 | 100 |
根据实施例1-4与对比例4对比可知,本发明提供的气胸密封贴具有更强的吸水能力,从而具有更强的止血能力。根据实施例1-4与对比例1-3对比可知,单宁酸具有优异的吸水能力,使用丙烯酸接枝改性和使用双醛羧甲基壳聚糖可以使制备出的水凝胶具有更好的吸水能力。
2.止血能力测试:将大耳白兔随机分为11组,将大耳白兔麻醉后固定在手术台上,手术暴露股静脉并横向切断,令其自由喷血10秒后,分别使用实施例1-4和对比例1-6的产品对创口进行止血,使用纱布挤压止血作为空白对照,观察止血时间。
促凝血能力测试:致伤后每2天给大耳白兔伤口拍照,采用Image-Pro PlusVersion 6.0图像分析软件计算白兔的伤口面积,直至伤口愈合。
愈合率=(原始伤口面积-未愈合伤口面积)/原始伤口面积×100%。结果如下表。
根据实施例1-4与对比例4-6以及空白对照对比可知,止血能力方面,本发明提供的气胸密封贴具有止血能力,且较常规止血膜的止血能力更强,可以在更短的时间内完成止血;促凝血能力方面,本发明提供的气胸密封贴在第10天创口基本愈合,较大耳白兔自身愈合能力更强,达到了促进愈合的效果,同时也强于其他气胸密封贴和止血产品的促凝血能力。根据实施例1-4与对比例1-3对比可知,单宁酸相较透明质酸钠具有更优异的止血能力和促凝血能力,并且使用丙烯酸接枝改性和使用双醛羧甲基壳聚糖可以使制备出的水凝胶具有更好的止血和促凝血能力。
3.抗菌能力测试:按照ASTM 21-96合成高分子材料抗真菌性的测定方法,以培养皿法进行产品的防霉性能测试。将实施例1-4和对比例1-4所制样品制成50mm×50mm规格,平放在凝固的无机盐培养基表面。然后准备真菌孢子混合悬液:5种霉菌(黑曲霉、绳状青霉、球毛壳霉、绿粘帚霉、出芽短梗霉),制备的孢子悬浮液应用孢子(1000000±200000)个/mL,可用计数器算出。将菌孢子悬浮液均匀细密地喷在样板整个表面,喷雾器压力应达到110千帕。稍晾干后,盖上培养皿皿盖。盖口注明试样名称、编号和日期,放入培养箱中,保持28℃~30℃温度和不低于85%的相对湿度下培养,试验标准的培养时间为28天,28天后进行防霉等级评价。结果如下表。
防霉等级 | |
实施例1 | 0 |
实施例2 | 0 |
实施例3 | 0 |
实施例4 | 0 |
对比例1 | 2 |
对比例2 | 1 |
对比例3 | 1 |
对比例4 | 3 |
对比例5 | 3 |
对比例6 | 4 |
防霉等级评价标准如下表。
防霉等级 | 防霉等级 |
0 | 无长霉 |
1 | 痕迹生长(小于10%) |
2 | 轻微生长(10-30%) |
3 | 中度生长(30-60%) |
4 | 严重生长(60%-全面覆盖) |
根据实施例1-4与对比例4-6对比可知,本发明提供的气胸密封贴具有很强的抗菌能力,而目前市面上的气胸密封贴和止血产品抗菌能力很差。根据实施例1-4与对比例1-3对比可知,单宁酸具有很强的抗菌能力,并且使用丙烯酸接枝改性和使用双醛羧甲基壳聚糖可以使制备出的水凝胶具有更好的抗菌能力。
以上实施方式只为说明本发明的技术构思及特点,其目的在于让熟悉此项技术的人了解本发明内容并加以实施,并不能以此限制本发明的保护范围,凡根据本发明精神实质所做的等效变化或修饰,都应涵盖在本发明的保护范围内。
Claims (10)
1.一种抗菌促凝血的气胸密封贴,其特征在于,由上至下依次包括外保护层、敷料层和密封粘结层;
所述敷料层由双醛羧甲基壳聚糖和单宁酸制备复合物,然后在复合物中的双醛羧甲基壳聚糖接枝丙烯酸,再通过交联形成的水凝胶组成。
2.根据权利要求1所述的抗菌促凝血的气胸密封贴,其特征在于,所述外保护层为离型纸外保护层。
3.根据权利要求1所述的抗菌促凝血的气胸密封贴,其特征在于,所述密封粘结层选自具有防渗透的PE、EVA、PEVA、聚氨酯或天然橡胶中的一种。
4.根据权利要求1所述的抗菌促凝血的气胸密封贴,其特征在于,所述双醛羧甲基壳聚糖的制备方法包括以下步骤:
(1)在反应器中加入去离子水后,加入羧甲基壳聚糖搅拌溶解,然后加入氧化剂,调整体系pH至3.5-4;
(2)将步骤(1)的反应器升温至40-45℃,在避光条件下搅拌4-5小时;
(3)向步骤(2)的反应器中加入乙二醇溶液,常温下搅拌0.5-1小时后,将产物离心洗涤,在真空下冷冻干燥20-24小时后,即制得所述双醛羧甲基壳聚糖。
5.根据权利要求4所述的抗菌促凝血的气胸密封贴,其特征在于,所述步骤(1)中氧化剂为高碘酸钠。
6.权利要求1-5任意一项所述的抗菌促凝血的气胸密封贴的制备方法,其特征在于,包括以下步骤:
(1)在反应器中加入去离子水后,加入双醛羧甲基壳聚糖搅拌溶解,然后加入生物缓冲剂调节体系pH至8-8.5后,加入单宁酸混合均匀,在室温下反应6-8小时;
(2)向步骤(1)的反应器持续通入保护气,然后加入引发剂和丙烯酸搅拌均匀,在室温下反应4-5小时后,静置10-12小时;
(3)向步骤(2)的反应器中加入交联剂,搅拌均匀后密封,然后在室温下静置10-12小时,即可制得所述敷料层;
(4)将步骤(3)的敷料层置于密封粘结层上部,将外保护层覆盖在密封粘结层和敷料层外部,即可制得所述抗菌促凝血的气胸密封贴。
7.根据权利要求6所述的抗菌促凝血的气胸密封贴的制备方法,其特征在于,所述双醛羧甲基壳聚糖、单宁酸和丙烯酸的质量比为(1-1.5):(3-5):(10-15)。
8.根据权利要求6所述的抗菌促凝血的气胸密封贴的制备方法,其特征在于,所述步骤(1)中生物缓冲剂选自三羟甲基氨基甲烷、N,N-二羟乙基甘氨酸或4-羟乙基哌嗪乙磺酸中的一种。
9.根据权利要求6所述的抗菌促凝血的气胸密封贴的制备方法,其特征在于,所述步骤(2)中引发剂选自偶氮二异丙基咪唑啉盐酸盐或偶氮二异丁酸二甲酯中的一种。
10.根据权利要求6所述的抗菌促凝血的气胸密封贴的制备方法,其特征在于,所述步骤(3)中交联剂选自1-乙基-(3-二甲基氨基丙基)碳二亚胺盐酸盐或N-羟基琥珀酰亚胺中的一种。
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