CN1615159A - 用于使伤口愈合并防止绷带粘连伤口的制剂 - Google Patents
用于使伤口愈合并防止绷带粘连伤口的制剂 Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
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- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
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Abstract
本发明公开用于使伤口愈合并防止粘连伤口的制剂,其含有生理上可接受的透明质酸盐、碘及碘化钾。
Description
技术领域
本发明涉及一种以药理学上可接受的透明质酸盐为基础的制剂,该制剂可用于伤口上并能够在防止绷带粘连伤口的同时加速愈合的进程。
背景技术
当前使急性和慢性复杂伤口愈合的现状是以全范围地使用不同原料和技术为基础。当然,理想的解决方式是将伤口清洁后用外科手段处理伤口(缝合、皮肤自体移植等)。然而,上述处理方法只能适用于很少量皮肤损伤,也可应用于外科创伤和急性未受感染的伤口。
多数大型急性伤口被感染并包括坏死部分。可以推测慢性伤口上有细菌感染物,而实际上几乎所有情况下都有一些坏死部分。这些大型亚急性和慢性伤口非常难于处理。
目前,下文所述的方法被用于使大型或慢性伤口愈合。
方法之一是反复更换绷带上的潮湿纱布,从而保证利于伤口愈合的持久湿润环境。纱布使用生理溶液或含有杀菌剂的溶液(优碘(Betadine)、氯胺、雷夫奴儿(rivanol)等)来润湿,由于每隔4-6小时需要频繁地更换绷带,所以上述方法应用困难。这种方法也不能彻底杀灭伤口的细菌,并且不能防止伤口周围的皮肤被浸软。
因为没有定期润湿的绷带常常粘连伤口,所以通常用凡士林浸透它们,这就是所谓的油脂纱布。为了使绷带有抗菌特性,通常将凡士林与碘结合使用。这种用法的缺点是凡士林盖住了伤口和全部的坏死部分,并使感染在伤口下累积。在换绷带过程中,当从较深的伤口处移走凡士林时,问题变得更加严重。
经常使用能够在伤口处保持湿润环境的塑胶绷带来覆盖较小的深伤口,这种绷带含有纤维素衍生物,有时也含有海藻提取物(藻酸盐)。由于这种绷带对于伤口没有杀菌效果,而且它本身不能帮助消除坏死组织,所以该绷带主要起到覆盖功能。市场上通用的是一些使用例如基底中含有胶原酶或木瓜蛋白酶的药膏或乳霜来消除坏死组织的非常复杂和昂贵的方法。主要是用含有活性炭的制剂来除去组织分泌物。
当除去坏死部分并给伤口消毒之后,需使用一些能够提供有利于伤口愈合的湿润环境的制剂。这种情况下主要使用产自海藻的藻酸盐(一种多聚糖)。为了保证愈合所必须的伤口环境的水合作用,一些公司使用羧甲基纤维素钠。在这种情况下该方法的缺点是在应用该物质来促进伤口愈合之前,还需要清洁伤口的单独步骤,此外它不能在没有进一步维护下保持伤口的消毒状态,也不能防止此后感染的发展。
为了增强愈合效果,在一些制剂中应用了不同的增长素和透明质酸的钠盐。在这种情况下该方法的缺点是在应用这些物质来促进伤口愈合之前,还需要清洁伤口的单独步骤。此外,在没有进一步维护下上述制剂不能保持伤口的消毒状态并防止感染的发展。
胶原质和化学改性的纤维素的组合物也被应用于慢性伤口的治疗。如果这种方法不用其它物质来完善,这种方法本身不能确保伤口消毒及除去分泌物等。
此外,一些创造者提出在高压舱中使用氧气治疗法来使慢性伤口愈合(特别适用于糖尿病患者)。然而,考虑到装置的原因,这种治疗是非常苛刻的。
真空治疗是一种在伤口上应用多孔弹性海绵并用不可渗透的薄片来覆盖伤口的治疗方法。其后,从伤口中排出空气,所获得的真空状态可保证伤口的清洁和分泌物的排出。可按固定时间间隔更换海绵。这种方法对装置有极高要求,只适用于高度专门化的工作场所,而且其仅限于选定的诊断中。
发明公开
本发明的目的是提供一种制剂,该制剂应用于伤口上可提供防止伤口感染同时将伤口杀菌的环境。此外,它能排出伤口的分泌物,从而防止伤口及其周围部分浸软,并在组织介质和酶存在下保持伤口内部有良好的水合作用。该制剂也能在伤口中保证肉芽组织形成和其它再生过程所需的理想环境。它能防止伤口与绷带粘连、保护伤口环境及监控伤口的可能变化(尤其是出血的发展)。
依照本发明所述的用于使伤口愈合并防止绷带粘结伤口的制剂解决了本发明背景技术中所述的缺点,实现了上面列出的目的。本发明的主题是一种含有分子量为200000-2500000的生理上可接受的透明质酸盐的凝胶或溶液及碘和碘化钾的制剂。
优选的生理上可接受的透明质酸盐选自:钠盐、钾盐、锂盐、钙盐、镁盐、锌盐、钴盐、锰盐或其组合物。依照本发明所述的制剂优选为粘性水溶液或凝胶的形式。
依照本发明所述的制剂作为具有消毒性能并起到抑制细菌和抑制真菌作用的物质,优选包括按重量计浓度为0.05-10%的生理上可接受的透明质酸盐、按重量计浓度为0.05-2.5%的碘和按重量计浓度为0.05-5%的碘化钾。
本发明的优选实施方案是一种包括按重量计浓度为0.05-10.0%的生理上可接受的透明质酸盐、按重量计浓度为0.075-1%碘和按重量计浓度为0.075-1%的碘化钾的制剂。
将上述物质溶解于消过毒的水中可制得依照本发明所述的制剂。
上述用于使伤口愈合并防止绷带粘连伤口的制剂既可以直接应用于伤口上,也可以按需要量涂在将要置于伤口一面的绷带上。
适宜的透明质酸盐与碘和碘化钾的组合物本身能够满足上述条件。透明质酸盐属于自然界中最有亲水性的分子。上述制剂在应用于纱布和伤口后,能保证组织液的分泌并可提供稳定的湿润环境。当与碘和碘化钾结合时,该制剂可以对伤口进行短时间消毒,从而在伤口处提供洁净的环境。透明质酸盐也有很强的愈合效果,它们在愈合过程的所有阶段都起到积极的作用。所有这些都对肉芽组织的形成和其后的上皮化起到积极作用,从而导致伤口愈合。该制剂的优点还在于绷带监控的可能性,及可仅使伤口本身处于湿润状态而伤口周围的皮肤不会处于潮湿的状态。
与单独使用碘和碘化钾(碘的配合物)及单独使用透明质酸盐相对比,依照本发明所述的制剂能活化角质细胞而产生细胞因子。所产生的细胞因子是在迅速清洁伤口时出现的不同白细胞系的活化剂和趋化剂,其也是用于肉芽组织形成的伤口表面制剂。此外,它们能激活帮助伤口向内生长的角质细胞。如果单独使用本发明制剂的三种组分中的任一种并不能显现出上述的不可预料的效果。一些制剂中使用碘与其它低聚物或聚合物的组合物(如优碘)。在我们的申请中,因为碘在溶液中不能达到所需要的浓度,所以不可能直接应用作为聚合物的透明质酸盐和碘构成的组合物。为此原因,加入碘化钾以形成碘的配合物。碘的配合物能在水中达到需要的溶解度,同时,碘和碘化钾的组合与单独使用碘相比更容易被细胞接受。
发明实施例
实施例1
将0.1g碘溶解于由0.15g碘化钾溶于50ml消过毒的注射用水所形成的溶液中。此外,将1.5g分子量为1000000的透明质酸钠溶于50ml消过毒的注射用水中。溶液分别制备并分别消毒。消毒后在无菌条件下将它们相互混合。所制备的高粘度溶液可以直接应用到其后用绷带覆盖的伤口上,或者应用到其后置于伤口上的绷带上。
实施例2
将1.0g碘溶解于由1.5g碘化钾溶于50ml消过毒的注射用水所形成的溶液中。此外,将1.5g分子量为1500000的透明质酸钠溶于50ml消过毒的注射用水中。溶液分别制备并分别消毒。消毒后在无菌条件下将它们相互混合。所制备的高粘度溶液可以直接应用到其后用绷带覆盖的伤口上,或者应用到其后置于伤口上的绷带上。
实施例3
将0.5g碘溶解于由0.75g碘化钾溶于50ml消过毒的注射用水所形成的溶液中。通过在另一个烧瓶中将2g的透明质酸盐与50ml消过毒的注射用水混合而制得分子量为1500000的透明质酸钾的凝胶。溶液和凝胶分别制备并分别消毒。消毒后在无菌条件下将它们相互混合。可以将所制备的凝胶以薄层形式直接应用于其后用绷带覆盖的伤口上。
Claims (5)
1.用于使伤口愈合并防止粘连伤口的制剂,其特征在于含有分子量为200000-2500000的生理上可接受的透明质酸盐、碘及碘化钾。
2.根据权利要求1所述的制剂,其特征在于所述的生理上可接受的透明质酸盐选自:钠盐、钾盐、锂盐、钙盐、镁盐、锌盐、钴盐、锰盐或其组合物。
3.根据权利要求1所述的制剂,其特征在于所述的生理上可接受的透明质酸盐按重量计其浓度为0.05-10.0%,碘按重量计其浓度为0.05-2.5%,碘化钾按重量计其浓度为0.05-5%。
4.根据权利要求3所述的制剂,其特征在于所述的生理上可接受的透明质酸盐按重量计其浓度为0.05-10.0%,碘按重量计其浓度为0.075-1%,碘化钾按重量计其浓度为0.075-1%。
5.根据权利要求1所述的制剂,其特征在于所述制剂以消过毒的水溶液或凝胶的形式存在。
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CN100355790C (zh) * | 2005-11-04 | 2007-12-19 | 山东福瑞达生物化工有限公司 | 一种透明质酸锌的制备方法 |
CN102258800A (zh) * | 2010-05-25 | 2011-11-30 | 上海建华精细生物制品有限公司 | 一种复方创愈凝胶 |
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Cited By (4)
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CN100355790C (zh) * | 2005-11-04 | 2007-12-19 | 山东福瑞达生物化工有限公司 | 一种透明质酸锌的制备方法 |
CN100348621C (zh) * | 2005-12-02 | 2007-11-14 | 凌沛学 | 透明质酸铋及其制备方法和应用 |
CN102258800A (zh) * | 2010-05-25 | 2011-11-30 | 上海建华精细生物制品有限公司 | 一种复方创愈凝胶 |
CN102258800B (zh) * | 2010-05-25 | 2015-04-08 | 上海建华精细生物制品有限公司 | 一种复方创愈凝胶 |
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US20050181025A1 (en) | 2005-08-18 |
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CA2470639C (en) | 2009-12-22 |
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CZ12015U1 (cs) | 2002-02-25 |
BR0302967A (pt) | 2004-07-06 |
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