CN110478349B - 一种伤口护理用敷料及其制备方法 - Google Patents

一种伤口护理用敷料及其制备方法 Download PDF

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CN110478349B
CN110478349B CN201910896902.0A CN201910896902A CN110478349B CN 110478349 B CN110478349 B CN 110478349B CN 201910896902 A CN201910896902 A CN 201910896902A CN 110478349 B CN110478349 B CN 110478349B
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apigenin
dressing
wound
pyrroloquinoline quinone
pharmaceutically acceptable
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CN110478349A (zh
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董晓红
彭玉勃
王悦阳
付琳
王婧姣
张子涵
李庆伟
张正一
杨德芳
李博谦
李晓庆
刘大旭
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Heilongjiang University of Chinese Medicine
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Abstract

本发明涉及一种伤口护理用敷料及其制备方法，所述敷料以吡咯并喹啉醌或其药学上可接受的盐为主要活性成分，并添加抗菌剂，具有优异的促进伤口愈合的效果，通过抗菌剂种类及施用方式的选择，所述伤口护理用敷料可根据伤口感染情况进行针对性抗感染治疗，即有效预防了伤口的感染，也明显降低了细菌耐药及抗菌剂对伤口愈合的干扰。

Description

一种伤口护理用敷料及其制备方法
技术领域
本发明属于药物领域，具体涉及一种伤口护理用敷料及其制备方法。
背景技术
皮肤是一层覆盖于人体表面用于防护的覆盖性器官，通过一些联接组织附着于较深的结构之上。伤口是指正常皮肤(组织)在外界致伤因子(如外科手术、碰撞、摩擦、热、电流、化学物质等)，以及机体内在因素(如局部血液供应障碍等)作用下所导致的损伤。伤口根据愈合时间可分为急性伤口和慢性伤口，其中急性伤口是指愈合时间在两周之内的伤口，而愈合时间超过两周则称为慢性伤口。常见的急性伤口包括了皮肤擦伤、烧伤等；常见的慢性伤口包括压疮、糖尿病足等难愈合伤口。
目前临床在伤口处理中已经广泛使用敷料，常用的敷料种类包括薄膜敷料、泡沫敷料、水凝胶敷料、抗菌敷料等，敷料的使用有利于隔离细菌、为伤口创建和保持适宜的愈合环境，但目前敷料的功能仍然相对单一，往往仅能起到隔离、抗菌、止血等作用中的一种，而影响伤口愈合的因素包括了年龄、营养状况(如维生素缺乏)、药物(如使用糖皮质激素、类固醇等药物)、伤口出血、感染、坏死等，单一功能的敷料已经不能有效满足全面促进伤口愈合的需要。
为了预防和治疗伤口感染，目前多在敷料中加入抗菌药物，而抗菌药物使加入量过小，则抑菌效果有限，不能有效预防和治疗伤口感染，而大量使用抗菌药物则不仅会对伤口造成刺激，干扰伤口的愈合，还会导致细菌耐药的产生。因此，目前敷料中抗菌药物的使用方式也需要改进。
吡咯并喹啉醌(Pyrroloquinoline quinone)，为一种可参与氧化还原反应的辅酶，广泛存在于原核细胞和真核细胞中，虽然已有报道称吡咯并喹啉醌具有促进细胞增殖、促进伤口愈合、抗过敏等多重作用，但由于吡咯并喹啉醌对细菌也同样具有生长促进作用，可加快微生物的生长，将吡咯并喹啉醌局部应用于伤口，会面临增加伤口感染几率的风险，而感染是影响伤口愈合的重要因素之一。因此，目前尚未见到将吡咯并喹啉醌局部应用于伤口，特别是应用于伤口护理用敷料的报道。
芹菜素，又称为芹菜苷元，芹黄素，为一种黄酮类化合物，现有药理学研究表明芹菜素具有抗癌、抗病毒、抗菌以及治疗心脑血管疾病等多重生物活性，尚未见到将芹菜素应用于伤口护理用凝胶，特别是与吡咯并喹啉醌合用于伤口护理用凝胶的报道。
现代病理生理学研究显示，正常皮肤呈现弱酸性，pH通常在5以下，而当伤口出现感染时，会导致伤口渗出液pH的升高，人们利用伤口感染时pH的改变将其用于指示伤口是否存在感染，如CN105803578A即公开了一种具有pH指示功能的海藻酸钙纤维，可用于开发具有pH指示功能的创可贴、敷料等医用纺织品，实现对伤口感染情况的实时监测。现有产品仅能起到伤口是否感染的指示功能，尚不能根据伤口感染情况进行适应性的治疗。
本发明在充分利用吡咯并喹啉醌促进细胞增殖、促进伤口愈合的功效的基础上，通过抗菌药物种类的选择及施用方式的改进，获得了一种可根据伤口感染与否进行针对性治疗的安全有效的伤口护理用敷料。
发明内容
本发明的目的是提供一种伤口护理用敷料及其制备方法。
一方面，本发明提供一种伤口护理用敷料，其特征在于，所述伤口护理用敷料包含吡咯并喹啉醌或其药学上可接受的盐和抗菌剂。
优选的，所述吡咯并喹啉醌或其药学上可接受的盐选自：单钠盐、二钠盐、三钠盐或钙盐。
优选的，所述吡咯并喹啉醌与抗菌剂的质量比为2-8∶1-5，更优选的，所述吡咯并喹啉醌与抗菌剂的质量比为4-6∶2-4；最优选的，所述吡咯并喹啉醌与抗菌剂的质量比为5∶3。
优选的所述抗菌剂经肠溶包衣；更优选的，所述抗菌剂为未包衣抗菌剂与肠溶包衣抗菌剂的混合物；优选的，未包衣抗菌剂与肠溶包衣抗菌剂的质量比为1∶2-6；更优选的，所述未包衣抗菌剂与肠溶包衣抗菌剂的质量比为1∶3-5；最优选的，所述未包衣抗菌剂与肠溶包衣抗菌剂的质量比为1∶4。
优选的，所述抗菌剂选自：纳米银、抗生素、黄连素、大蒜素或芹菜素及其药学上可接受的盐；优选的，所述芹菜素药学上可接受的盐选择：钠盐、钾盐等。
优选的，所述抗菌剂为芹菜素及其药学上可接受的盐；更优选的，所述抗菌剂选自：芹菜素、肠溶包衣的芹菜素、肠溶包衣的芹菜素药学上可接受的盐及其组合；最优选的，所述抗菌剂选自芹菜素、芹菜素与芹菜素药学上可接受的盐的混合物、芹菜素药学上可接受的盐与肠溶包衣的芹菜素药学上可接受盐的混合物。
本发明提供一种伤口护理用敷料，其包含吡咯并喹啉醌或其药学上可接受的盐、芹菜素或其药学上可接受的盐。
本发明提供一种伤口护理用敷料，其包含吡咯并喹啉醌或其药学上可接受的盐、芹菜素药学上可接受的盐、芹菜素；优选的，所述芹菜素药学上可接受的盐与芹菜素的质量比为1∶2-6；更优选的，所述芹菜素药学上可接受的盐与芹菜素的质量比为1∶3-5；最优选的，所述芹菜素药学上可接受的盐与芹菜素的质量比为1∶4。
本发明提供一种伤口护理用敷料，其包含吡咯并喹啉醌或其药学上可接受的盐、芹菜素药学上可接受的盐、肠溶包衣的芹菜素药学上可接受的盐；优选的，所述芹菜素药学上可接受的盐与肠溶包衣的芹菜素药学上可接受的盐的质量比为1∶2-6；更优选的，所述芹菜素与肠溶包衣的芹菜素药学上可接受的盐的质量比为1∶3-5；最优选的，所述芹菜素与肠溶包衣的芹菜素药学上可接受的盐的质量比为1∶5。
优选的，所述敷料选自：水凝胶敷料、海藻酸盐敷料、薄膜敷料等；更优选的，所述敷料为水凝胶敷料；最优选的，所述敷料为壳聚糖水凝胶敷料。
另一方面，本发明提供了一种伤口护理用敷料的制备方法，其特征在于，包括以下步骤：
1)按量称取吡咯并喹啉醌或其药学上可接受的盐和任选的抗菌剂，混合均匀得药效成分；
2)混合：将步骤1)所得药效成分添加于敷料基质中混合均匀后得敷料基质层；
3)制备敷料：将步骤2)所得敷料基质层固定于敷料衬层后，灭菌、分装即得，本发明伤口护理用敷料。
再一个方面，本发明提供吡咯并喹啉醌或其药学上可接受的盐和抗剂的组合在制备伤口护理用敷料中的用途。
优选的，所述吡咯并喹啉醌与抗菌剂的质量比为2-8∶1-5，更优选的，所述吡咯并喹啉醌与抗菌剂的质量比为4-6∶2-4；最优选的，所述吡咯并喹啉醌与抗菌剂的质量比为5∶3。
优选的所述抗菌剂经肠溶包衣；更优选的，所述抗菌剂为未包衣抗菌剂与肠溶包衣抗菌剂的混合物；优选的，未包衣抗菌剂与肠溶包衣抗菌剂的质量比为1∶2-6；更优选的，所述未包衣抗菌剂与肠溶包衣抗菌剂的质量比为1∶3-5；最优选的，所述未包衣抗菌剂与肠溶包衣抗菌剂的质量比为1∶4。
优选的，所述抗菌剂选自：纳米银、抗生素、黄连素、大蒜素或芹菜素及其药学上可接受的盐；优选的，所述芹菜素药学上可接受的盐选择：钠盐、钾盐等。
优选的，所述抗菌剂为芹菜素及其药学上可接受的盐；更优选的，所述抗菌剂选自：芹菜素、肠溶包衣的芹菜素、肠溶包衣的芹菜素药学上可接受的盐及其组合；最优选的，所述抗菌剂选自芹菜素、芹菜素与芹菜素药学上可接受的盐的混合物、芹菜素药学上可接受的盐与肠溶包衣的芹菜素药学上可接受盐的混合物。
本发明的有益效果
本发明首次将吡咯并喹啉醌或其药学上可接受的盐应用于局部伤口护理，获得了一种可有效促进伤口愈合的伤口护理用敷料；
本发明根据伤口的pH变化，根据抗菌药物的种类筛选和施用方式的改进获得了一种可有效降低感染风险的包含吡咯并喹啉醌或其药学上可接受的盐的伤口护理用敷料；
本发明所述敷料中抗菌剂优选为芹菜素、芹菜素药学上可接受的盐或肠溶包衣的芹菜素药学上可接受的盐，其中芹菜素难溶于水，但可溶于碱性溶液，因此，伤口护理用敷料中添加芹菜素后在伤口未感染时由于伤口呈现弱酸性环境，此时芹菜素、肠溶包衣的芹菜素药学上可接受的盐均不会溶解释放至伤口，从而可以有效避免细菌耐药和抗菌剂对伤口愈合的干扰，而当伤口发生感染时，伤口pH升高，芹菜素溶解度增大，肠溶包衣的芹菜素药学上可接受的盐开始溶解释放，从而发挥抑制伤口感染的效果。
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1：一种伤口护理用敷料
吡咯并喹啉醌单钠盐10g、芹菜素钠盐1.2g、芹菜素4.8g、壳聚糖10g，按照以下方法制备：
1)按量称取吡咯并喹啉醌或其药学上可接受的盐和任选的抗菌剂，混合均匀得药效成分；
2)混合：将步骤1)所得药效成分添加于pH3-4的壳聚糖乙酸溶液中，混合均匀后，调整溶液pH为6-7，倒入模具静置成型后按需切割，即得敷料基质层；
3)制备敷料：将步骤2)所得敷料基质层固定于敷料衬层后，灭菌、分装即得，本发明伤口护理用敷料。
实施例2：一种伤口护理用敷料
吡咯并喹啉醌单钠盐10g、芹菜素钠盐2g、芹菜素8g、壳聚糖10g，按照实施例1方法制备即得。
实施例3：一种伤口护理用敷料
吡咯并喹啉醌单钠盐8g、芹菜素钠盐0.2g、芹菜素0.8g、壳聚糖10g，按照实施例1方法制备即得。
实施例4：一种伤口护理用敷料
吡咯并喹啉醌单钠盐10g、芹菜素钠盐2g、芹菜素4g、壳聚糖10g，按照实施例1方法制备即得。
实施例5：一种伤口护理用敷料
吡咯并喹啉醌单钠盐10g、芹菜素钠盐1g、肠溶包衣芹菜素钠盐5g、壳聚糖10g，按照实施例1制备方法制备即得。
实施例6：一种伤口护理用敷料
吡咯并喹啉醌单钠盐10g、芹菜素6g、壳聚糖10g，按照实施例1制备方法制备即得。
对比例1：吡咯并喹啉醌单钠盐16g、壳聚糖10g，按照实施例1方法制备；
对比例2：吡咯并喹啉醌单钠盐10g、大蒜素6g、壳聚糖10g，按照实施例1方法制备；
对比例3吡咯并喹啉醌单钠盐10g、芹菜素钠盐6g、壳聚糖10g，按照实施例1方法制备；
对比例4：空白敷料，按照实施例1方法，其中不包含吡咯并喹啉醌单钠盐、芹菜素钠盐和芹菜素。
效果例1：包含吡咯并喹啉醌单钠盐的伤口用敷料促进伤口愈合的效果
1.1测试药物：实施例1、6、对比例1-4所述敷料，莫比罗星软膏(百多邦，中美天津史克制药有限公司)。
1.2试验方法：
8周龄雄性Wister大鼠35只，体重290-310g，单笼饲养，大鼠麻醉后于背部两侧对称性备皮约2×2cm区域，使用手术刀于备皮区域中间位置剥离1×1cm的皮肤至暴露肌肉层，手术后大鼠随机分为7组，具体为：实施例1组、对比例1-5组和莫比罗星软膏组，每组5只，使用各组对应敷料覆盖伤口，并使用纱布外部固定，其中莫比罗星软膏组为将莫比罗星软膏于纱布上涂敷约1.5×1.5cm区域后覆盖于伤口位置。大鼠正常饲喂，每隔1天更换一次垫料，每隔3天更换一次敷料，同时观察伤口感染情况，更换敷料时使用无菌生理盐水对伤口进行清创清洗。手术后第14d开始，每天观察伤口愈合情况，记录各组大鼠伤口愈合所需时间，其中所述感染是指伤口红肿，有脓性分泌物，所述伤口愈合是指伤口闭合，上皮覆盖，伤口无裂开，无破溃，无出血，具体实验结果见表1。
1.3实验结果
表1包含吡咯并喹啉醌单钠盐的伤口用敷料促进伤口愈合的效果
组别 样本量(只) 伤口数量 感染伤口数量 伤口愈合时间(d)
实施例1 5 10 2 16.30±0.95***
实施例6 5 10 4 18.30±0.95***
对比例1 5 10 10 29.80±3.55*
对比例2 5 10 3 20.60±1.96**
对比例3 5 10 1 19.2±1.03***
对比例4 5 10 8 25.20±3.71
莫比罗星 5 10 5 21.3±2.67*
与对比例5组相比，*，P＜0.05；**，P＜0.01；***，P＜0.001.
表1实验结果显示使用空白敷料的对比例4组大鼠的10处手术伤口在愈合过程中有8处出现了感染，伤口愈合时间平均为25.2天，而莫比罗星组大鼠伤口感染数量明显减少，有5处伤口出现感染，伤口愈合时间也缩短为21.3天；仅包含吡咯并喹啉醌单钠盐的对比例1组大鼠10出伤口均出现了感染情况，相对于对比例4组伤口愈合时间也明显延长，该实验结果显示了虽然现有技术报道了吡咯并喹啉醌单钠盐具有促进伤口愈合的效果，但其并不适合单独局部应用于伤口，吡咯并喹啉醌单钠盐所引起的伤口感染明显延缓了伤口愈合的时间；将吡咯并喹啉醌单钠盐与抗菌剂大蒜素、芹菜素或芹菜素钠盐组合后伤口感染数量明显减少，其中以单独大蒜素、芹菜素钠盐为抗菌剂的对比例2-3组，伤口感染数量明显减少，且以吡咯并喹啉醌单钠盐与芹菜素钠盐的组合伤口感染数量最少，仅1处伤口出现感染情况；而对比例2-3组大鼠伤口愈合时间相对于莫比罗星组大鼠也有所缩短，显示了咯并喹啉醌单钠盐与抗菌剂的组合可以有效发挥促进伤口愈合的效果；以芹菜素为单独抗菌剂的实施例6组大鼠伤口感染数量明显低于仅包含咯并喹啉醌单钠盐的对比例1组，虽然其伤口感染数量多于对比例2-3以及莫比罗星组，但实施例6组大鼠伤口愈合时间明显更短，其原因可能为在未感染伤口芹菜素的溶解度较小，对伤口愈合干扰较小，而在感染伤口，芹菜素溶解度增大，从而可以有效发挥抗感染的效果，有利于加速感染伤口的愈合；以芹菜素与芹菜素钠混合物为抗菌剂的本发明实施例1敷料伤口感染数量明显减少，虽然伤口感染数量仍多于以单独芹菜素钠为抗菌剂的对比例3组，但明显低于单独以芹菜素为抗菌剂的实施例6组，且实施例1组大鼠的伤口愈合时间相对于对比例3组和实施例6组均明显缩短，显示了将吡咯并喹啉醌单钠盐与芹菜素和芹菜素钠组合后不仅可以有效抑制吡咯并喹啉醌单钠盐所引起的伤口感染，还能明显缩短伤口愈合时间，其可能的原因为低含量的芹菜素钠由于溶解度较大因此可以有效发挥预防伤口感染的效果，芹菜素在未感染伤口溶解度较小，对伤口愈合的干扰较小，而在感染伤口，由于芹菜素溶解度增大，从而可以与芹菜素钠组合发挥抗感染的效果，加速感染伤口的愈合。
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 (1)

1.一种伤口护理用敷料，其特征在于，由以下原料制成：吡咯并喹啉醌单钠盐10g、芹菜素钠盐1.2g、芹菜素4.8g、壳聚糖10g；
其中，所述伤口护理用敷料按照以下方法制备：
1)按量称取吡咯并喹啉醌单钠盐、芹菜素钠盐、芹菜素，混合均匀得药效成分；
2)混合：将步骤1)所得药效成分添加于pH3-4的壳聚糖乙酸溶液中，混合均匀后，调整溶液pH为6-7，倒入模具静置成型后按需切割，即得敷料基质层；
3)制备敷料：将步骤2)所得敷料基质层固定于敷料衬层后，灭菌、分装，即得所述伤口护理用敷料。
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