CN1086592C - 抗菌抗凝硅胶导管 - Google Patents
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Abstract
一种抗菌抗凝硅胶导管，主要用于医用输液导管，属医药卫生技术领域，将硅胶导管分别在配置的环丙沙星丙酮液和含洗必泰、肝素季氨酯、聚氨酯树脂的抗菌抗凝溶液中浸泡后烘干，使这种经过处理的医用硅胶导管同时具有抗菌、抗凝的功效，更好地适应临床应用。本发明还可以用于导尿管、创口引流管，体内埋藏管等，具有广泛的发展前途。
Description
一种具有抗菌抗凝作用的硅胶导管，主要用于医用输液导管，属医药卫生技术领域。
在临床上对任何危重病人的抢救与治疗都离不开输液导管，例如对病人的静脉补液或是对胃肠病人的营养补给，输液导管均不可缺少。过去所用的输液导管都是使用聚乙烯或聚氯乙烯等塑料材料制成，管腔容易堵塞、易感染，因此在体内保留的时间很短，这不仅会影响治疗过程的完成，而且还可能引起化脓性静脉炎、化脓性血栓性静脉炎，甚至发展为致命的导管败血症的可能。目前国外许多发达国家已不用塑料输液导管，而以硅胶管取代。但是单独硅胶管本身并无抗菌作用，抗凝作用虽比塑料导管较强，但仍难以满足临床要求。经文献检索，国外有在硅橡胶基质中添加抗菌成份或抗凝成份，使其在体内保留时间更长，但并未见同时兼有两种成份的报告。
本发明的目的在于研究设计一种医用硅胶导管表面处理的新配方和新方法，使这种经过处理的医用硅胶导管同时具有抗菌、抗凝的功效，更好地适应临床应用。
为实现这样的发明目的，本发明的技术解决方案为：配置一种同时具有抗菌抗凝作用的溶液，对硅胶导管进行浸泡表面处理，具体配方和处理方法如下：
1、配置肝素季铵脂溶液
肝素钠12500μ20ml(2ml 1支×10支)
氯化季铵盐(新洁尔灭)原料3-5克
将上述两种药物混合后不断搅拌，使之成胶糊状，待过夜后除去上清液，也可以离心沉淀后除去上清液，然后用蒸馏水洗几遍，主要去除Cl-、Na+，去水后剩下白色胶糊状就是氯化季铵脂；氯化季铵脂加异丙醇5-10ml使基本溶解，再加四氢呋喃适量，使之全部溶解。这一步总量不得超过50ml。
2、配置醋酸洗必泰溶液
醋酸洗必泰1克，加1-2克的聚乙二醇1000(平均分子量900-1100)起增加溶解作用。混合后在100℃水浴上加热10分钟左右，不断搅拌使之成稀糊状，冷却后以2∶1的比例加四氢呋喃和N·N二甲基甲/乙酰胺使溶解。这一步总量不得超过50ml。
3、把1和2配置的肝素季铵脂溶液与醋酸洗必泰溶液混合搅匀，加聚氨酯树脂2·4克，聚异氰酸酯树脂1·9克，再加四氢呋喃稀释使之能流动；把上述组份混合加四氢呋喃至100ml摇匀即得抗菌抗凝溶液。
用以上抗菌抗凝溶液浸泡硅胶导管15分钟后沥干，在55℃-60℃烘干机烘干，即完成对硅胶导管的表面处理。
由于上述制得的抗菌抗凝溶液对G+菌有高效，但对G-菌效果比较差，为增强对G-菌的抗菌作用，故有步骤4。
4、配置环丙沙星丙酮液，抗G-菌作用
环丙沙星0·3克，加聚乙二醇1000 1-2克，适当加聚乙二醇4000，水浴(100℃)上加热10分钟左右，冷却后加丙酮溶解，不断地搅拌使之全部溶解，到100ml。
必须注意，环丙沙星丙酮溶液不能与含洗必泰、肝素季氨酯、聚氨酯树脂的抗菌抗凝溶液混合，否则引起沉淀失效。
因此对硅胶导管的表面处理为：先浸泡环丙沙星丙酮液，取出烘干，再浸泡以上抗菌抗凝溶液15分钟后沥干，在55℃-60℃烘干机烘干。
本发明具有明显的抗菌抗凝效果。用琼脂腔试验法和在营养肉汤中的抑菌活性试验测定导管的抗菌性能，结果表明，本发明的硅胶导管抑菌区大，抗菌效果显著。在10只大鼠急性动静脉短路试验中，将抗菌抗凝药物溶液涂布于用作循环的丝线表面和硅胶管内壁，体外循环30分钟后，线上附着的血栓重量在0·5-5·3mg，而对照线(未涂布抗菌抗凝药物的丝线)所附的血栓重量在29·5-91·7mg。在兔颈外静脉搭桥手术试验中，埋藏抗菌抗凝硅胶管十八天后解剖观察，对照硅胶管内均已完全被血栓堵塞，抗凝硅胶管除少数管内有少量血栓附着外，均基本保持畅通，证明有明显的抗凝血作用。
本发明的抗菌抗凝医用硅胶导管，其用途不限于输液一项，还可以用于导尿管、创口引流管、体内埋藏管等，具有广泛的发展前途。
Claims (2)
1、一种抗菌抗凝硅胶导管，其特征在于硅胶导管的表面处理溶液配方和处理方法按如下步骤进行：
(1)、将肝素钠12500μ20ml与氯化季铵盐原料3-5克混合后搅拌成胶糊状，除去上清液，水洗后成氯化季铵脂，加异丙醇5-10ml和四氢呋喃，使之全部溶解，总量不超过50ml：
(2)、醋酸洗必泰1克，加1-2克聚乙二醇1000，混合后在100℃水浴上加热10分钟左右，搅拌成稀糊状，冷却后以2∶1的比例加四氢呋喃和N·N二甲基甲/乙酰胺使溶解，总量不超过50ml；
(3)、把(1)和(2)配置的肝素季铵脂溶液与醋酸洗必泰溶液混合搅拌，加聚氨酯树脂2·4克，聚异氰酸酯树脂1·9克，加四氢呋喃稀释至100ml摇匀即得抗菌抗凝溶液；
将硅胶导管在以上抗菌抗凝溶液中浸泡15分钟后沥干，在55℃-60℃烘干机烘干。
2、一种如权利要求1所说的抗菌抗凝硅胶导管，其特征还在于硅胶导管的表面处理溶液配方和处理方法增加如下步骤：
配置环丙沙星丙酮液，用环丙沙星0·3克，加聚乙二醇1000 1-2克，加聚乙二醇4000，100℃水浴上加热10分钟左右，冷却后加丙酮溶解，不断搅拌使之全部溶解，到100ml；
将硅胶导管先浸泡环丙沙星丙酮液，取出烘干，再浸泡抗菌抗凝溶液15分钟后沥干，在55℃-60℃烘干机烘干。
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| CN99113477A CN1086592C (zh) | 1999-02-12 | 1999-02-12 | 抗菌抗凝硅胶导管 |
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| CN99113477A CN1086592C (zh) | 1999-02-12 | 1999-02-12 | 抗菌抗凝硅胶导管 |
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| CN1225281A CN1225281A (zh) | 1999-08-11 |
| CN1086592C true CN1086592C (zh) | 2002-06-26 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| KR100564229B1 (ko) * | 2002-06-25 | 2006-03-28 | (주)마이크로 사이언스 테크 | 항균성 또는 항응혈성 의료용품 및 이의 제조방법 |
| US7749529B2 (en) * | 2005-02-08 | 2010-07-06 | Ash Access Technology, Inc. | Catheter lock solution comprising citrate and a paraben |
| CN101987223B (zh) * | 2009-07-29 | 2013-03-27 | 山东百多安医疗器械有限公司 | 具有抗凝抗菌功能的多向瓣膜经外周中心静脉导管及其制备方法 |
| EP2747831A4 (en) * | 2011-09-30 | 2015-08-12 | Sparkmed Res Llc | SYSTEMS, DEVICES AND METHOD FOR INSERTING MEDICAMENTAL MOLECULARS INTO MEDICAL CATHETERS OR HOSES |
| CN110947056A (zh) * | 2019-11-29 | 2020-04-03 | 河南驼人贝斯特医疗器械有限公司 | 一种内外壁抗感染抗凝血留置针软管及其制备方法 |
| CN119868662B (zh) * | 2025-02-05 | 2026-01-27 | 江苏大学附属医院 | 一种导尿管用抗菌涂层及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2220296Y (zh) * | 1995-02-23 | 1996-02-21 | 山东省聊城地区人民医院 | 临床医用一次性吸氧管 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN2220296Y (zh) * | 1995-02-23 | 1996-02-21 | 山东省聊城地区人民医院 | 临床医用一次性吸氧管 |
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