CN115181208B - 一种具有碘缓释作用的医用压敏胶、压敏胶带及其制备方法 - Google Patents

一种具有碘缓释作用的医用压敏胶、压敏胶带及其制备方法 Download PDF

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CN115181208B
CN115181208B CN202210718832.1A CN202210718832A CN115181208B CN 115181208 B CN115181208 B CN 115181208B CN 202210718832 A CN202210718832 A CN 202210718832A CN 115181208 B CN115181208 B CN 115181208B
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张国亮
沈冲
孟琴
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Zhejiang University of Technology ZJUT
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Abstract

本发明公开了一种具有碘缓释作用的医用压敏胶、压敏胶带及其制备方法；本发明将能络合碘的N‑乙烯吡咯烷酮、聚乙二醇二丙烯酸酯与丙烯酸酯单体共聚，制备成溶剂型压敏胶，由于其组分中含有聚乙烯吡咯烷酮、聚乙二醇二丙烯酸酯链段，从而能以络合物的方式负载碘，形成载碘的压敏胶；将该压敏胶涂覆在背衬上制成压敏胶带，贴合于皮肤表面后，所负载的碘可缓慢从压敏胶中释放，渗透到皮肤结构中，从而杀死皮肤中的细菌；本发明载碘压敏胶大大增强了碘和压敏胶之间的作用力，因此载碘量高，且具有长效缓释碘的作用，可作为长效抗菌敷料用于伤口包扎、手术贴膜、留置针固定和造口防感染等医学实践中。

Description

一种具有碘缓释作用的医用压敏胶、压敏胶带及其制备方法
技术领域
本发明属于胶黏剂技术领域，涉及一种医用抗菌压敏胶、压敏胶带及其制备方法。
背景技术
压敏胶是一种粘弹性体，只需轻度压力就能粘接到大多数干表面和部分湿表面，而且撕下时胶粘剂不易残留在被粘表面上。由于压敏胶具有使用方便、稳定性好、制备简便等诸多优点，其在外科手术包扎、皮肤伤口处理、粘接生物医学装置、透皮药物释放贴片、医用标签和胶带等医疗卫生领域中得到了广泛的应用。
丙烯酸酯是合成医用压敏胶的主要材料，其具有两大优势：1.制备丙烯酸酯类压敏胶不需要添加额外组分，通过乳液或溶液聚合制得后即可直接使用，无需分离纯化，因此具有极大的成本优势，且避免了潜在的安全问题；2.调节丙烯酸酯单体的含量和种类，可得到不同性能的压敏胶，因此在产品多样性和灵活性上也具有优势。
由于压敏胶常用于皮肤伤口的覆盖性保护，赋予其抗菌性是十分必要的，可以防止伤口感染，利于伤口愈合。碘是一种常见的医用杀菌剂，通常配置成碘酒或碘伏溶液使用。将碘伏颗粒溶解在溶剂型丙烯酸酯压敏胶中，可制得含碘的压敏胶，并已被制作成碘伏手术巾(CN100563596)。然而，由于碘伏在压敏胶溶液中的溶解度十分有限，导致载碘量不高；且碘伏与压敏胶之间没有化学/配位键等相互作用，因此粘贴在皮肤上后碘伏会快速释放，不能起到缓释碘的作用，从而无法满足长效抗菌的要求。
因此，需要一种载碘量高、能缓慢释放碘的压敏胶，赋予丙烯酸酯压敏胶长效抗菌的独特功能，拓展其在医药卫生领域的应用。
发明内容
本发明提供了一种新型的碘缓释型医用压敏胶、压敏胶带及其制备方法。
本发明的技术原理在于：将能络合碘的N-乙烯吡咯烷酮、聚乙二醇二丙烯酸酯与丙烯酸酯单体共聚，制备成溶剂型压敏胶。由于其组分中含有聚乙烯吡咯烷酮、聚乙二醇二丙烯酸酯链段，从而能以络合物的方式负载碘，形成载碘的压敏胶；将该压敏胶涂覆在背衬上制成压敏胶带，贴合于皮肤表面后，所负载的碘可缓慢从压敏胶中释放，渗透到皮肤结构中，从而杀死皮肤中的细菌。
本发明的技术方案如下：
一种具有碘缓释作用的医用压敏胶，由如下质量百分比的原料制成：
10-20％硬单体、40-50％软单体、5-10％载碘化合物、0.1-0.5％引发剂、0.01-2％交联剂、0.01-6％碘、溶剂余量；
所述硬单体为短链丙烯酸酯单体，结构式CH2＝CHCOOR1，R1为C1-C4烷基；优选丙烯酸甲酯或丙烯酸丁酯；
所述软单体为长链丙烯酸酯单体，结构式CH2＝CHCOOR2，R2为C6-C14烷基；优选丙烯酸异辛酯或丙烯酸月桂酯；
所述载碘化合物为N-乙烯基吡咯烷酮、聚乙二醇二丙烯酸酯中的一种或两种任意比例的混合；
所述引发剂为过氧化二苯甲酰或偶氮二异丁腈；
所述交联剂为二异氰酸酯；优选1,6-己二异氰酸酯或异佛尔酮二异氰酸酯；
所述溶剂为乙酸乙酯。
本发明所述的具有碘缓释作用的医用压敏胶的制备方法为：
(1)压敏胶共聚和交联
将软单体、硬单体、载碘化合物和引发剂依次加入溶剂乙酸乙酯中，搅拌均匀，通氮气(60分钟)后，加热至70～90℃(优选80℃)进行聚合反应20～30h(优选24h)，之后滴加交联剂，保温反应3～5h(优选4h)后降温至室温，得到溶剂型压敏胶；
(2)载碘压敏胶制备
将步骤(1)制得的溶剂型压敏胶与碘单质混合，加热至50～70℃(优选60℃)并充分搅拌混匀，制得所述具有碘缓释作用的医用压敏胶；
所得压敏胶为透明的棕黄色均相溶液，最大载碘量为60mg/g压敏胶(含溶剂)。
将本发明所述的具有碘缓释作用的医用压敏胶涂覆在背衬上，烘干后即可制备成具有碘缓释效果的压敏胶带；所述背衬为聚氨酯薄膜、聚丙烯薄膜或无纺布。
该压敏胶带在干性皮肤上的180°剥离粘性为80-120gf/cm，在湿性皮肤上为40-70gf/cm。在干性皮肤上，12-36h内释放90％的碘，在湿性皮肤上，8-32h内释放90％的碘。
该压敏胶带可作为抗菌敷料用于伤口包扎、手术贴膜、留置针固定和造口防感染。
本发明的有益效果在于：
与将碘伏和压敏胶直接混合的已有技术方案相比，本发明所述的载碘压敏胶具有显著的创新性和性能优势：其大大增强了碘和压敏胶之间的作用力，因此载碘量高，且具有长效缓释碘的作用，可作为长效抗菌敷料用于伤口包扎、手术贴膜、留置针固定和造口防感染等。而已有技术方案由于缺乏碘和压敏胶之间的相互作用，碘负载量无法提高，且使用中碘会快速释放，不能起到长效抗菌的效果。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述，但是本领域技术人员将会理解，下列实施仅用于说明本发明，而不应视为限制本发明的范围。实施例中未注明具体条件者，按照常规条件或者制造商建议的条件进行。所用试剂或者仪器未注明生产厂商者，均为可以通过市售购买获得的常规产品。
实施例1：载碘压敏胶的制备
根据下表的配比合成载碘压敏胶。将软单体、硬单体、载碘化合物以及引发剂按配比依次加入乙酸乙酯中，并定容至100ml，在三口烧瓶中搅拌均匀，接好冷凝管，通氮气60分钟后，加热至80℃进行聚合反应。保温回流24h后，缓慢滴加交联剂，保温反应4h后降温至室温，得到溶剂型丙烯酸压敏胶。
将碘单质磨碎，按比例加入上述溶液中，加热至60℃并充分搅拌直至形成透明的棕黄色均相溶液，冷却，即制得载碘压敏胶。
表1载碘压敏胶配方(余量为乙酸乙酯)
实施例2：载碘压敏胶带的制备
将实施例1中制备的7种压敏胶按0.2g/cm2的量涂覆在A4离型纸上，将离型纸置于60℃烘箱2h后，在压敏胶表面覆盖聚氨酯薄膜，放置过夜。7种压敏胶制得的胶带分别标记为1-7#。
实施例3：载碘压敏胶带的粘性评价
采用万能试验机，依据GB/T2792-1998测试实施例2制备的7种压敏胶带的粘性(180°剥离实验)，并以市售的美国3M公司碘伏手术薄膜(Ioban 2 6640)为对照组。结果如下表所示。可见，所制备的7种载碘压敏胶带均具有良好的粘性，且略高于对照组。此外，在撕去胶带的时候均没有胶残留，说明其可去除性较好。
表2压敏胶带的粘性测试结果
实施例4：载碘压敏胶带的碘缓释特性
将实施例2所制备的2-7#载碘压敏胶带裁剪成30mm×30mm的小片，并贴在皮肤表面，4h后每1h撕去胶带，采用硫代硫酸钠滴定法测定压敏胶中残留的碘含量，计算碘的释放率，至释放率>90％时停止实验并记录时间。而1#压敏胶带由于载碘量过小(0.01％)，因此未包括在本实施例中。
结果如表3所示。可见，在干性皮肤上，2-7#压敏胶带在14-36h内释放90％的碘，在湿性皮肤上，10-30h内释放90％的碘，其释放速度远小于对照组(3M碘伏手术薄膜)，说明其有显著的缓释效果。而3M碘伏手术薄膜将碘伏直接掺入压敏胶中制备而成，碘伏与压敏胶之间缺乏键合作用，因此在6h内碘已经几乎完全释放。碘的快速释放使其抗菌性无法长期保持，从而在伤口敷料和留置针固定等需要长期抗菌的应用上存在局限性。
表3压敏胶带释放碘的效果比较
实施例5：载碘压敏胶的长效抗菌性评价
将实施例2所制备的2-7#载碘压敏胶带裁剪成直径25mm的圆片，根据GB/T20944.1-2007所述方法测定对金黄葡萄球菌和大肠杆菌的抑菌圈；1#压敏胶带由于载碘量过小(0.01％)，因此未包括在本实施例中。将培养皿在37℃培养箱中温育24h后，测定抑菌圈直径。结果如表4所示。可见，3-5#压敏胶带的抑菌效果均高于对照组，这一方面因为其载碘量高于对照组，另一方面则与其缓释效果有关。而2#和6-7#压敏胶的载碘量仅3-5#的2/3(因为添加的碘较少，未到其最大负载量)，因此其抑菌效果不如3-5#压敏胶带。
表4压敏胶的抑菌效果测试

Claims (8)

1.一种具有碘缓释作用的医用压敏胶，其特征在于，由如下质量百分比的原料制成：
10-20％硬单体、40-50％软单体、5-10％载碘化合物、0.1-0.5％引发剂、0.01-2％交联剂、0.01-6％碘、溶剂余量；
所述硬单体结构式CH2＝CHCOOR1，R1为C1-C4烷基；
所述软单体结构式CH2＝CHCOOR2，R2为C6-C14烷基；
所述载碘化合物为聚乙二醇二丙烯酸酯；
所述引发剂为过氧化二苯甲酰或偶氮二异丁腈；
所述交联剂为二异氰酸酯；
所述溶剂为乙酸乙酯。
2.如权利要求1所述的具有碘缓释作用的医用压敏胶，其特征在于，所述硬单体为丙烯酸甲酯或丙烯酸丁酯。
3.如权利要求1所述的具有碘缓释作用的医用压敏胶，其特征在于，所述软单体为丙烯酸异辛酯或丙烯酸月桂酯。
4.如权利要求1所述的具有碘缓释作用的医用压敏胶，其特征在于，所述交联剂为1,6-己二异氰酸酯或异佛尔酮二异氰酸酯。
5.如权利要求1所述的具有碘缓释作用的医用压敏胶的制备方法，其特征在于，所述制备方法为：
(1)压敏胶共聚和交联
将软单体、硬单体、载碘化合物和引发剂依次加入溶剂乙酸乙酯中，搅拌均匀，通氮气后，加热至70～90℃进行聚合反应20～30h，之后滴加交联剂，保温反应3～5h后降温至室温，得到溶剂型压敏胶；
(2)载碘压敏胶制备
将步骤(1)制得的溶剂型压敏胶与碘单质混合，加热至50～70℃并充分搅拌混匀，制得所述具有碘缓释作用的医用压敏胶。
6.一种具有碘缓释效果的压敏胶带，其特征在于，所述压敏胶带由权利要求1所述的医用压敏胶涂覆在背衬上，烘干后制得。
7.如权利要求6所述的具有碘缓释效果的压敏胶带，其特征在于，所述背衬为聚氨酯薄膜、聚丙烯薄膜或无纺布。
8.如权利要求6所述的具有碘缓释效果的压敏胶带在伤口包扎、手术贴膜、留置针固定和造口防感染中的应用。
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