CN116769411B - 一种一次性抗菌手术膜及其制备方法 - Google Patents
一种一次性抗菌手术膜及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种一次性抗菌手术膜及其制备方法，属于医疗器械技术领域，所述手术膜由上到下依次包括聚乙烯膜层、压敏胶层和离型膜，所述聚乙烯膜层包括以下质量份数的原料：低密度聚乙烯80‑95份、乙烯‑辛烯共聚物13‑25份、聚乙烯醇缩丁醛5‑13份、复合抗菌剂3‑6份、碳酸钙42‑45份、硅烷偶联剂1‑3份和助剂3‑7份。本发明的手术膜的抗菌效果好，可以有效地隔离手术部位和周围环境，降低手术感染率，防止交叉感染。本发明的手术膜具有良好的透气性，可以让手术部位保持干燥，防止污染和感染。同时，手术膜具有一定的粘性，可以牢固地贴在手术部位上，不易脱落，手术膜粘贴牢固，可以降低的边缘处菌落数量。
Description
技术领域
本发明属于医疗器械技术领域，具体涉及一种一次性抗菌手术膜及其制备方法。
背景技术
一次性手术膜是一种医用薄膜，用于手术时覆盖在手术部位，主要作用是最大限度地减少洞巾敞口部位外露的皮肤上的不同种类细菌以及病人产生的皮屑向手术创面弥散，同时阻断手术切口组织的附近皮肤深层的微生物向手术切口传播的路径，从而有效的达到降低手术区域污染和感染，保护切口。
手术膜一般是由对人体没有副作用的薄膜当做产品的底基，薄膜上面涂盖上临床用压敏型胶组合而成。手术膜通常由聚氨酯或聚乙烯材料制成，聚氨酯手术膜的弹性和透气性高，但国内大部分聚氨酯材料的手术膜都是进口，成本较高。国内厂家大多采用聚乙烯材料，可以降低成本。但是，聚乙烯材料的手术膜普遍存在缺乏弹性、透气差的问题。因此急需提升传统聚乙烯材料手术膜的性能。
发明内容
本发明的目的是提供一种一次性抗菌手术膜及其制备方法，所述手术膜的抗菌效果好，可以降低手术感染率，同时透气性好、弹性高。
为了实现上述目的，本发明提供了以下技术方案：
一种一次性抗菌手术膜，所述手术膜由上到下依次包括聚乙烯膜层、压敏胶层和离型膜，所述聚乙烯膜层包括以下质量份数的原料：低密度聚乙烯80-95份、乙烯-辛烯共聚物13-25份、聚乙烯醇缩丁醛5-13份、复合抗菌剂3-6份、碳酸钙42-45份、硅烷偶联剂1-3份和助剂3-7份。
进一步地，所述复合抗菌剂选自纳米二氧化钛、烯丙基三苯基氯化膦、Ag-磷酸盐玻璃抗菌剂中的一种或多种。
进一步地，所述复合抗菌剂为质量比1-4：1-6:1的纳米二氧化钛、烯丙基三苯基氯化膦和Ag-磷酸盐玻璃抗菌剂复配。
市售的手术膜对在外科手术过程中的大肠杆菌、金黄色葡萄球菌的抗菌效果较好，但是对绿脓杆菌的抑菌效果并不理想，而绿脓杆菌在外科手术中被感染后，抗生素治疗难度大，病情容易反复，还会导致手术后出现病发症。为了改善这个问题，本发明通过将纳米二氧化钛、烯丙基三苯基氯化膦和Ag-磷酸盐玻璃抗菌剂复配作为抗菌剂添加到原料中，手术膜的整体杀菌能力都有提高，尤其是显著提高了对绿脓杆菌的抑菌性，同时还提升了手术膜的抗菌的广谱性。发明人还意外发现当纳米二氧化钛、烯丙基三苯基氯化膦和Ag-磷酸盐玻璃抗菌剂的质量比为1-4：1-6:1时，手术膜的抗菌时效性得到延长。猜测是在该比例下三种不同的抗菌物质通过复配，协同使发挥抗菌的时间得到了协调配合，延长了抗菌的时间。
更进一步地，所述纳米二氧化钛的晶相为锐钛型，粒径为30nm。购自宁波极微纳新材料科技有限公司。所述Ag-磷酸盐玻璃抗菌剂购自日本石塚硝子IONPURE，型号104。
进一步地，所述低密度聚乙烯、乙烯-辛烯共聚物、聚乙烯醇缩丁醛的质量比为8-10: 1-3: 1。
更进一步地，所述低密度聚乙烯的熔体流动速率0.3g/10min，密度0.923g/cm3，拉伸强度11.9MPa，断裂伸长率670%。购自茂名石化，型号2520D。所述乙烯-辛烯共聚物，CAS：26221-73-8，购自美国陶氏，ENGAGE™ 8180。所述聚乙烯醇缩丁醛，购自默克，P110010。
本发明使用熔体流动速率0.3g/10min、密度0.923g/cm3、拉伸强度11.9MPa和断裂伸长率670%的低密度聚乙烯、乙烯-辛烯共聚物、聚乙烯醇缩丁醛进行复配，提高了手术膜的弹性，在腹部等平坦位置使用效果好。进一步发现当低密度聚乙烯、乙烯-辛烯共聚物、聚乙烯醇缩丁醛的质量比为8-10: 1-3: 1时，手术膜弹性进一步提高，使其可以满足在身体不平坦部位手术使用的要求。而低密度聚乙烯参数的改变会导致长时间手术使用时，手术膜鼓包的现象。猜测是低密度聚乙烯的参数会影响与压敏胶的相容性，长时间因汗液积累导致使用出现脱胶现象，导致气泡产生。
进一步的，所述压敏胶购自潍坊富乐新材料有限公司，型号CF-82。
进一步地，所述碳酸钙包括质量比为的碳酸钙A、碳酸钙B和碳酸钙C；其中，碳酸钙A的平均粒径为2500nm；碳酸钙B的平均粒径为1500nm；碳酸钙C的平均粒径为500nm。均购自江苏沪江汇矿产品有限公司。
在研发过程中，发明人试图通过添加更小粒径如平均粒径为2000nm左右的碳酸钙来提高手术膜的透气性，实验发现得到的抗菌手术膜的透气性有一定的提高。通过大量实验发现，将2500nm、1500nm和500nm三种不同的粒径进行混合添加，可以显著提高了抗菌手术膜的透气性。发明人还意外发现添加不同粒径的碳酸钙同时提高了手术膜的抗菌性。猜测是这三种粒径协同调控了膜的形态和结构，提高了膜的孔隙率，同时该比例下的碳酸钙可以负载纳米TiO2，提高抗菌剂的分散性而提升抗菌作用。但发现手术膜的弹性有一定程度的降低。为了平衡透气性与弹性，且兼顾与抑菌剂的相容性，选择碳酸钙A、碳酸钙B和碳酸钙C的质量比为3-7:1:1-3。
进一步地，所述助剂选自聚乙烯蜡、硬脂酸、硬脂酸钠、硬脂酸锌、异丙苯磺酸钠、癸基硫酸钠、十八烷基硫酸钠中的一种或多种。
进一步地，所述助剂为质量比为3-8:1:1的硬脂酸、异丙苯磺酸钠和癸基硫酸钠复配。
更进一步的，所述硬脂酸，CAS : 57-11-4，购自印尼斯文，1801。异丙苯磺酸钠，CAS : 28348-53-0，购自上海飞歌化学有限公司。癸基硫酸钠，CAS:142-87-0，购自上海飞歌化学有限公司。
在显微条件下观察发现，手术膜中的碳酸钙在部分位置存在团聚现象，进而影响手术膜的力学性能。发明人意外发现当添加质量比为3~8:1:1的硬脂酸、异丙苯磺酸钠和癸基硫酸钠作为助剂，不仅降低碳酸钙的表面张力和空间位阻，提高碳酸钙的分散性，还可以提高手术膜的弹性。还兼顾了手术膜的防水性。猜测是助剂提高了低密度聚乙烯、乙烯-辛烯共聚物、聚乙烯醇缩丁醛的相容性，提高了交联的密度，进而提高了手术膜的防水性。
进一步地，所述助剂的质量占原料量的百分数＞2%。
在大量实验中发现，当助剂的质量占原料量的百分数＞2%时，助剂的使用效果更佳。
进一步地，所述硅烷偶联剂选自硅烷偶联剂KH550、硅烷偶联剂KH560、硅烷偶联剂KH570中的一种或多种。
本发明第二方面提供了所述的一次性抗菌手术膜的制备方法，所述制备方法包括以下步骤：
（1）将低密度聚乙烯、乙烯-辛烯共聚物、聚乙烯醇缩丁醛、复合抗菌剂、碳酸钙、硅烷偶联剂和助剂混合15-30分钟，投入双螺杆造粒机中挤出，造粒、吹塑成膜，制得聚乙烯膜层，厚度为30-80μm；
（2）将聚乙烯膜层上涂布压敏胶，在150-170℃进行熟化处理，得到压敏胶层的厚度为30-40μm；
（3）在压敏胶上覆盖60-70μm的离型膜，得到一次性抗菌手术膜。
与现有技术相比，本发明的优点和有益效果为：
1. 本发明提供了一种一次性抗菌手术膜及其制备方法，所述手术膜的抗菌效果好，可以有效地隔离手术部位和周围环境，降低手术感染率，防止交叉感染。本发明的手术膜具有良好的透气性，可以让手术部位保持干燥，防止污染和感染。 同时，手术膜具有一定的粘性，可以牢固地贴在手术部位上，不易脱落，手术膜粘贴牢固，可以降低的边缘处菌落数量。
2. 本发明使用低密度聚乙烯、乙烯-辛烯共聚物、聚乙烯醇缩丁醛进行复配，提高了手术膜的弹性，手术膜薄而坚韧，不易破裂和撕裂，可以保证手术过程的安全和顺利进行。
3. 本发明通过将纳米二氧化钛、烯丙基三苯基氯化膦和Ag-磷酸盐玻璃抗菌剂复配作为抗菌剂添加到原料中，提高了抗菌性。手术膜的抗菌时效性得到延长。
4. 本发明使用三种不同的粒径进行混合添加，显著提高了抗菌手术膜的透气性。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例，都属于本发明保护的范围。
实施例1
本实施例提供了一种一次性抗菌手术膜，所述手术膜由上到下依次包括聚乙烯膜层、压敏胶层和离型膜，所述聚乙烯膜层包括以下质量份数的原料：低密度聚乙烯90份、乙烯-辛烯共聚物20份、聚乙烯醇缩丁醛10份、复合抗菌剂4份、碳酸钙43份、硅烷偶联剂2份和助剂5份。
所述复合抗菌剂为质量为3：5:1的纳米二氧化钛、烯丙基三苯基氯化膦和Ag-磷酸盐玻璃抗菌剂复配。
所述纳米二氧化钛的晶相为锐钛型，粒径为30nm，购自宁波极微纳新材料科技有限公司。所述烯丙基三苯基氯化膦，CAS:18480-23-4。所述Ag-磷酸盐玻璃抗菌剂购自日本石塚硝子IONPURE，型号104。
所述低密度聚乙烯的熔体流动速率0.3g/10min，密度0.923g/cm3，拉伸强度11.9MPa，断裂伸长率670%。购自茂名石化，型号2520D。所述乙烯-辛烯共聚物，CAS：26221-73-8，购自美国陶氏，ENGAGE™ 8180。所述聚乙烯醇缩丁醛，购自默克，P110010。
所述压敏胶购自潍坊富乐新材料有限公司，型号CF-82。
所述碳酸钙包括质量比为的碳酸钙A、碳酸钙B和碳酸钙C；其中，碳酸钙A的平均粒径为2500nm；碳酸钙B的平均粒径为1500nm；碳酸钙C的平均粒径为500nm。均购自江苏沪江汇矿产品有限公司。
所述助剂为质量比为6:1:1的硬脂酸、异丙苯磺酸钠和癸基硫酸钠复配。
所述硅烷偶联剂为硅烷偶联剂KH550。
所述离型膜层为3M Scotchpak™ 9744。
本实施例提供了所述的一次性抗菌手术膜的制备方法，所述制备方法包括以下步骤：
（1）将低密度聚乙烯、乙烯-辛烯共聚物、聚乙烯醇缩丁醛、复合抗菌剂、碳酸钙、硅烷偶联剂和助剂混合20分钟，投入双螺杆造粒机中挤出，造粒、吹塑成膜，制得聚乙烯膜层，厚度为40μm；
（2）将聚乙烯膜层上涂布压敏胶，在160℃进行熟化处理，得到压敏胶层的厚度为30μm；
（3）在压敏胶上覆盖60μm的离型膜，得到一次性抗菌手术膜。
实施例2
本实施例与实施例1的区别为：一种一次性抗菌手术膜，所述手术膜由上到下依次包括聚乙烯膜层、压敏胶层和离型膜，所述聚乙烯膜层包括以下质量份数的原料：低密度聚乙烯100份、乙烯-辛烯共聚物10份、聚乙烯醇缩丁醛16份、复合抗菌剂5份、碳酸钙60份、硅烷偶联剂1份和助剂4份。
实施例3
本实施例与实施例1的区别为：一种一次性抗菌手术膜，所述手术膜由上到下依次包括聚乙烯膜层、压敏胶层和离型膜，所述聚乙烯膜层包括以下质量份数的原料：低密度聚乙烯90份、聚丙烯20份、聚氯乙烯10份、复合抗菌剂4份、碳酸钙43份、硅烷偶联剂2份和助剂5份。所述低密度聚乙烯，熔体流动速率2g/10min，密度0.9182 g/cm3，拉伸强度15 MPa，断裂伸长率550 %，购自燕山石化。所述聚丙烯，平均Mw-250000，购自默克，427888。所述聚氯乙烯，固有粘度1.40(lit.)，平均Mw为-233000，熔融指数12 g/10 min (230°C/2.16kg)，购自默克，346764。
实施例4
本实施例与实施例1的区别为：一种一次性抗菌手术膜，所述手术膜由上到下依次包括聚乙烯膜层、压敏胶层和离型膜，所述聚乙烯膜层包括以下质量份数的原料：低密度聚乙烯90份、乙烯-辛烯共聚物20份、聚乙烯醇缩丁醛10份、复合抗菌剂4份、碳酸钙30份、硅烷偶联剂2份和助剂1份。
实施例5
本实施例与实施例1的区别为：所述复合抗菌剂为质量为1：1:4的纳米二氧化钛、纳米氧化锌和烯丙基三甲基氯化铵复配。所述纳米二氧化钛为金红石型，粒径为15nm，购自宁波极微纳新材料科技有限公司，WN-R15。
实施例6
本实施例与实施例1的区别为：所述碳酸钙为平均粒径2000nm的碳酸钙，购自江苏沪江汇矿产品有限公司。
实施例7
本实施例与实施例1的区别为：所述助剂为质量比为1:2:4的硬脂酸、硬脂酸钠和十八烷基硫酸钠。购自上海飞歌化学有限公司。
性能测试
1、参照标准YY 0852-2011，对实施例的产品进行性能测定，并购买市面上的一次性抗菌手术膜作为对照组，购自河南迈鼎康医疗科技有限公司，其由聚乙烯膜、压敏胶、离型纸制成。结果见表1。
表1测试结果
通过结果可知，本发明的手术膜的水蒸汽透过性明显高于市售对照组，根据统计，正常人体的水汽挥发为240~1800 g/(m2·24h)，但考虑到手术时人体的水汽挥发偏低，本发明的产品基本可以满足手术中水汽挥发的需求。同时，本发明的手术膜的力学性能也有明显改善。
2、参考YY/T0471.5接触性创面手术膜试验方法第5部分阻菌性潮湿条件下的阻菌性步骤测定抗菌性。检测菌种为外科手术中常见病菌：大肠杆菌、金黄色葡萄球菌、绿脓杆菌、溶血性链球菌、脆弱拟杆菌。结果见表2。
表2抗菌率（%）测定结果
通过结果可知，本发明制备的手术膜的抗菌性更强，并且在实际临床中发现，在长时间外科手术中，本发明的产品的抗菌效果更好，比市面上的产品感染率更低，猜测是本发明产品的抗菌时效更长，但相关数据有待进一步的统计。
以上所述是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明所述原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (5)
1.一种一次性抗菌手术膜，其特征在于，所述手术膜由上到下依次包括聚乙烯膜层、压敏胶层和离型膜，所述聚乙烯膜层包括以下质量份数的原料：低密度聚乙烯80-95份、乙烯-辛烯共聚物13-25份、聚乙烯醇缩丁醛5-13份、复合抗菌剂3-6份、碳酸钙42-45份、硅烷偶联剂1-3份和助剂3-7份；所述复合抗菌剂为质量为3:5:1的纳米二氧化钛、烯丙基三苯基氯化膦和Ag-磷酸盐玻璃抗菌剂复配；所述碳酸钙包括质量比为3-7:1:1-3的碳酸钙A、碳酸钙B和碳酸钙C；其中，碳酸钙A的平均粒径为2500nm；碳酸钙B的平均粒径为1500nm；碳酸钙C的平均粒径为500nm；所述助剂为质量比为3-8:1:1的硬脂酸、异丙苯磺酸钠和癸基硫酸钠复配。
2. 根据权利要求1所述的一次性抗菌手术膜，其特征在于，所述低密度聚乙烯、乙烯-辛烯共聚物、聚乙烯醇缩丁醛的质量比为8-10: 1-3: 1。
3.根据权利要求1所述的一次性抗菌手术膜，其特征在于，所述助剂的质量占原料总量的质量百分数＞2%。
4.根据权利要求1所述的一次性抗菌手术膜，其特征在于，所述硅烷偶联剂选自硅烷偶联剂KH550、硅烷偶联剂KH560、硅烷偶联剂KH570中的一种或多种。
5.权利要求1-4任一项所述的一次性抗菌手术膜的制备方法，其特征在于，所述制备方法包括以下步骤：
（1）将低密度聚乙烯、乙烯-辛烯共聚物、聚乙烯醇缩丁醛、复合抗菌剂、碳酸钙、硅烷偶联剂和助剂混合15-30分钟，投入双螺杆造粒机中挤出，造粒、吹塑成膜，制得聚乙烯膜层，厚度为30-80μm；
（2）将聚乙烯膜层上涂布压敏胶，在150-170℃进行熟化处理，得到压敏胶层，厚度为30-40μm；
（3）在压敏胶层上覆盖60-70μm的离型膜，得到一次性抗菌手术膜。
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