CN110721334B - 一种止血创伤敷料及其制备方法 - Google Patents

一种止血创伤敷料及其制备方法 Download PDF

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CN110721334B
CN110721334B CN201911172753.XA CN201911172753A CN110721334B CN 110721334 B CN110721334 B CN 110721334B CN 201911172753 A CN201911172753 A CN 201911172753A CN 110721334 B CN110721334 B CN 110721334B
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hemostatic
tranexamic acid
acid
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熊祥
袁丽琴
韩同
王先成
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Second Xiangya Hospital of Central South University
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Abstract

本发明涉及一种止血创伤敷料及其制备方法，所述止血创伤敷料包含粘性无纺布层、吸水层和药物层，所述吸水层包括微孔淀粉和聚乙烯醇，所述药物层包含氨甲环酸及任选的第二活性成分，具有使用简单，快速止血等优点，添加没食子酸后不仅止血更加迅速，而且可有效减少氨甲环酸的降解，具有显著延长的氨甲环酸储存稳定性，另外没食子酸还具有抗氧化、抗菌和抗炎等活性，有利于促进伤口的愈合。

Description

一种止血创伤敷料及其制备方法
技术领域
本发明属于药物领域，具体涉及一种止血创伤敷料及其制备方法。
背景技术
外伤出血是指机体皮肤因各种原因所导致的伤口出血情况，多见于擦伤、割伤、刺伤、碾压伤、枪弹伤等。根据出血部位及出血量的不同可分为毛细血管出血、静脉出血、动脉出血等，其中动脉出血因压力大，出血表现为喷射状，医学上有动脉出血黄金4分钟的说法，如果动脉出血在4分钟内不能有效止血，则有可能因失血过多而危害患者生命；静脉出血由于压力小，表现为涌血或缓慢出血，而毛细血管出血则无明显的出血点，常常表现为片状渗血。
针对外伤出血目前一般采用指压止血、包扎止血、止血粉止血等，虽然均可以发挥一定的止血效果，但也均存在不同缺点，其中指压止血、包扎止血均需要操作者具有一定的医学知识，而止血粉止血后仍然需要进行包扎。从而导致了其无法广泛的被使用。
氨甲环酸(Tranexamic acid)，又称凝血酸、止血环酸等，因其可以抗纤维蛋白溶解而成为有效的止血剂，其现有的剂型包括注射剂、冻干粉针剂、外用固体制剂等。由于氨甲环酸属于离子敏感型药物，金属离子可明显影响氨甲环酸的储存稳定性，现有技术中有报道在其中加入螯合剂，如EDTA，可以一定程度上缓解氨甲环酸的降解，而EDTA为抗凝剂，加入EDTA会减弱氨甲环酸的止血效果。
没食子酸(Gallic acid)，也称五倍子酸、倍酸等，是一种天然多酚类化合物，具有抗氧化、抗菌、抗炎、止泻、止血等多重药理活性，并且具有一定的金属离子螯合能力。
目前，在创伤的护理过程中，医用敷料已经获得了大面积的应用，具有可以有效的隔离伤口、隔离病原体、促进伤口愈合的效果。并且医用敷料的使用简单，粘贴于伤口上即可。目前尚未发现医用敷料应用于止血，因此，本发明致力于提供一种具有止血效果的医用敷料及其制备方法。
发明内容
本发明的目的是提供一种止血创伤敷料及其制备方法。
一方面，本发明提供一种止血创伤敷料，其特征在于，包含粘性无纺布层、吸水层和药物层，所述药物层包含氨甲环酸和任选的第二活性成分。
优选的，所述止血创伤敷料药物层以氨甲环酸为唯一活性成分；
优选的，所述止血创伤敷料药物层包含第二活性成分。
优选的，所述第二活性成分选自螯合剂、止血剂、止痛剂等；
更优选的，所述第二活性成分选自没食子酸。
优选的，所述氨甲环酸与没食子酸的重量比为5:1-3；更优选的，所述氨甲环酸与没食子酸的重量比为5:2。
优选的，所述吸水层包括微孔淀粉和聚乙烯醇；
更优选的，所述微孔淀粉和聚乙烯醇的重量比为3-7:2-4；
最优选的，所述微孔淀粉和聚乙烯醇的重量比为5:3；
优选的，所述微孔淀粉按照以下方法制备：
(1)马铃薯淀粉用蒸馏水清洗；
(2)清洗后的马铃薯淀粉加入蒸馏水，使用1M NaOH调节pH为9-11，升温至30-50℃，加入浓度为1-5％的三偏磷酸钠，保温条件下搅拌0.5-3h，使用1M盐酸调节溶液pH至5-6，洗涤后喷雾干燥即得所述微孔淀粉。
优选的，所述止血创伤敷料中药物层占吸水层与药物层总重量的5-15％；更优选的，所述止血创伤敷料中药物层占吸水层与药物层总重量的8-14％；最优选的，所述止血创伤敷料中药物层占吸水层与药物层总重量的10％。
另一方面，本发明提供了一种止血创伤敷料的制备方法，其特征在于，包括以下步骤：
(1)备料：按量称取各原料；
(2)固定：将吸水层和药物层依次固定于粘性无纺布层，得敷料；
(3)包装：将步骤(2)所得敷料经灭菌后包装，即得本发明止血创伤敷料。
再一个方面，本发明提供了氨甲环酸与没食子酸的组合在制备止血创伤敷料中的用途，所述止血创伤敷料包含粘性无纺布层、吸水层和药物层；
优选的，所述氨甲环酸与没食子酸的重量比为5:1-3；更优选的，所述氨甲环酸与没食子酸的重量比为5:2。
本发明有益效果
本发明开发了以氨甲环酸为活性成分的止血创伤敷料，具有使用简单，快速止血等优点，另外，本发明开创性的发现了氨甲环酸与没食子酸的组合可有效减少氨甲环酸的降解，具有显著延长的氨甲环酸储存稳定性，并且不具有EDTA减弱氨甲环酸止血效果的弊端，止血更加迅速，而且没食子酸还具有抗氧化、抗菌和抗炎等活性，有利于促进伤口的愈合。
本发明止血创伤敷料在利用药物层止血的同时，吸水层的多孔淀粉可快速吸收伤口出血中的水分，从而在伤口周围富集血小板，加速伤口止血，聚乙烯醇在吸收水分后则快速溶胀，从而给予伤口一定的压力，也有利于加速伤口的止血。
具体实施方式
在下文中更详细地描述了本发明以有助于对本发明的理解。
实施例1：一种止血创伤敷料
氨甲环酸10份、多孔淀粉56份、聚乙烯醇34份、粘性无纺布适量，按照以下方法制备：
(1)备料：按量称取各原料；
(2)固定：将吸水层和药物层依次固定于粘性无纺布层，得敷料；
(3)包装：将步骤(2)所得敷料经灭菌后包装，即得本发明止血创伤敷料。
实施例2：一种止血创伤敷料
氨甲环酸5份、没食子酸2份、多孔淀粉58份、聚乙烯醇35份、粘性无纺布适量，按照实施例1方法制备，即得。
实施例3：一种止血创伤敷料
氨甲环酸5份、没食子酸2份、多孔淀粉51.7份、聚乙烯醇41.3份、粘性无纺布适量，按照实施例1方法制备，即得。
效果例1：本发明止血创伤敷料的止血效果
1.1实验药物：
实施例1-3止血创伤敷料；
对比例1：使用等量没食子酸代替实施例1中的氨甲环酸；
对比例2：氨甲环酸5份、没食子酸2份、多孔淀粉34份、聚乙烯醇58份、粘性无纺布适量，按照实施例1方法制备，即得；
对比例3：使用等量EDTA代替实施例2中的没食子酸。
空白敷料：按照实施例1止血创伤敷料，去掉氨甲环酸后按照实施例1方法制备，即得。
1.2实验方法：
新西兰兔35只，体重为2-3Kg，随机分为7组，具体为：空白敷料组、实施例1-3组和对比例1-3组，新西兰兔麻醉后耳部脱毛，割断耳动脉，3s后擦拭伤口，所述止血创伤敷料中心对折粘着于伤口处，每隔10s观察伤口止血情况，记录止血时间，其中止血是指伤口处无血液渗出。具体实验结果见表1。
1.3实验结果
表1本发明止血创伤敷料的止血效果
样本量 止血时间(秒)
空白敷料 5 80±10.00
实施例1 5 28±8.37
实施例2 5 26±8.94
实施例3 5 30±10.00
对比例1 5 74±11.40
对比例2 5 36±8.94
对比例3 5 56±11.40
表1实验结果显示了，不包含止血药物的空白敷料得益于吸水层快速吸收伤口流出血液中的水分，从而使血小板在伤口部位快速富集，而吸水层溶胀后给予伤口一定的压力，也加速了伤口的止血，因此具有优异的止血效果。本发明实施例1-3的止血敷料通过添加止血药物氨甲环酸、没食子酸后止血时间进一步缩短，其中尤其以实施例2的止血效果最为优异，相对于空白敷料组，止血时间缩短了67.5％。单独的没食子酸虽然止血时间相对于空白敷料组有所缩短，但幅度较小。氨甲环酸与EDTA的组合相对于氨甲环酸与没食子酸的组合止血时间明显延长，其可能的原因为EDTA不仅不具有促凝效果，还具有一定的抗凝活性，从而导致了止血时间的延长。
效果例2：长期贮存后的本发明止血创伤敷料的止血效果
2.1实验药物：
2.1.1新制备的实验药物
实施例1新：实施例1止血创伤敷料；
实施例2新：实施例2止血创伤敷料；
对比例3新：使用等量EDTA代替实施例2中的没食子酸。
2.1.2：长期放置的实验药物
实施例1旧：实施例1止血创伤敷料制备后放置于恒温恒湿的电烘箱内，控制温度为40±2℃、湿度75％±5％，放置六个月；
实施例2旧：实施例2止血创伤敷料制备后放置于恒温恒湿的电烘箱内，控制温度为40±2℃、湿度75％±5％，放置六个月；
对比例3旧：使用等量EDTA代替实施例2中的没食子酸，止血创伤敷料制备后放置于恒温恒湿的电烘箱内，控制温度为40±2℃、湿度75％±5％，放置六个月。
2.2实验方法
同效果例1.
2.3实验结果
表2长期贮存后的本发明止血创伤敷料的止血效果
样本量 止血时间(秒)
实施例1新 5 30±7.07
实施例1旧 5 34±5.48
实施例2新 5 26±5.48
实施例2旧 5 28±4.47
对比例3新 5 58±10.95
对比例3旧 5 60±7.07
表2实验结果显示高温、高湿环境下放置六个月后，实施例1-2和对比例3的止血创伤敷料的止血时间均有所延长，其中不含螯合剂的实施例1组止血时间延长4秒，其可能的原因为药物活性成分氨甲环酸的降解。实施例2和对比例3的止血创伤敷料经高温、高湿环境下放置六个月后止血时间均延长了2秒，短于不含螯合剂的实施例1组，显示了螯合剂的加入有利于缓解活性成分氨甲环酸的降解，而使用没食子酸代替EDTA后具有类似的防止氨甲环酸降解的效果。
以上描述了本发明优选实施方式，然其并非用以限定本发明。本领域技术人员对在此公开的实施方案可进行并不偏离本发明范畴和精神的改进和变化。

Claims (5)

1.一种止血创伤敷料，其特征在于，包含粘性无纺布层、吸水层和药物层，所述药物层包含氨甲环酸和没食子酸；所述氨甲环酸与没食子酸的重量比为5:1-3。
2.根据权利要求1所述的止血创伤敷料，其特征在于，所述氨甲环酸与没食子酸的重量比为5:2。
3.根据权利要求1或2所述的止血创伤敷料，其特征在于，所述吸水层包括微孔淀粉和聚乙烯醇。
4.根据权利要求3所述的止血创伤敷料，其特征在于，所述微孔淀粉和聚乙烯醇的重量比为3-7:2-4。
5.氨甲环酸与没食子酸的组合在制备止血创伤敷料中的用途，所述止血创伤敷料包含粘性无纺布层、吸水层和药物层；所述氨甲环酸与没食子酸的重量比为5:1-3。
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