CN114685925A - 一种耐辐照硬质pvc材料及其制备方法与应用 - Google Patents
一种耐辐照硬质pvc材料及其制备方法与应用 Download PDFInfo
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Abstract
本发明公开了一种耐辐照硬质PVC材料及其制备方法与应用。材料包括以下组分：接枝改性PVC粉100phr、稳定剂2～3phr、辅助稳定剂0.5～2phr、加工助剂1～2phr、抗冲改性剂5～10phr、抗氧化剂0.4～1phr、润滑剂0.7～1.5phr、色料0.002～0.008phr。本申请的材料具有良好的耐辐照性能和抗老化性能，解决了硬质PVC材料在18～29kGy剂量辐照灭菌后材料黄变脆化的问题，辐照灭菌后性能满足GB/T 15593标准，从而硬质PVC材料也能应用于辐照灭菌的医疗器械，拓宽了PVC材料在医疗器械领域的应用，对医疗器械的发展具有重要意义。
Description
技术领域
本发明涉及PVC材料技术领域，尤其涉及一种耐辐照硬质PVC材料及其制备方法与应用。
背景技术
医疗器械直接或者间接接触人体，因此，使用前需要进行灭菌处理。灭菌方式主要有环氧乙烷灭菌、辐照灭菌、蒸汽灭菌、过滤灭菌、干热灭菌，目前常见的医疗器械灭菌方式为环氧乙烷灭菌和辐照灭菌。
环氧乙烷灭菌是使用环氧乙烷来杀死微生物的灭菌方式。环氧乙烷是一种环状醚的无色气体，具有刺激性气味及毒性。辐照灭菌是利用电离辐射杀死微生物的灭菌方式，根据辐射源的不同分为电子束灭菌与伽马灭菌。电子束灭菌的辐射源为β射线，伽马灭菌的辐射源为γ射线。环氧乙烷灭菌存在污染环境及残留会危害人体健康的隐患，而辐照灭菌安全可靠。采用辐照进行医疗器械灭菌逐渐趋向主流。
医疗器械所用的材料大多为聚氯乙烯(PVC)，用于医疗器械的PVC材料需满足GB/T15593标准，但辐照灭菌的PVC性能很难满足该标准。并且，PVC材料具有较好的强度，阻燃性优，耐化学性良，易成型，价格低廉，应用广泛，但是聚氯乙烯分子结构中含有不稳定的氯原子，容易脱离。PVC材料添加增塑剂(软质PVC)之后耐辐照性能良好，但是不添加增塑剂的硬质PVC材料经18～29kGy剂量辐照灭菌后，氯原子与氢原子脱离产生HCl气体，形成共轭双键，会导致材料黄变脆化。因此，提高医用PVC材料的耐辐照性能具有重要意义。
发明内容
本发明的首要目的在于克服现有技术的缺点与不足，提供一种耐辐照硬质PVC材料。该耐辐照硬质PVC材料耐辐照，抗老化，同时能满足GB/T 15593标准。
本发明的另一目的在于提供上述耐辐照硬质PVC材料的制备方法。
本发明的再一目的在于提供上述耐辐照硬质PVC材料的应用。
本发明的目的通过下述技术方案实现：一种耐辐照硬质PVC材料，包括以下组分：接枝改性PVC粉100phr、稳定剂2～3phr、辅助稳定剂0.5～2phr、加工助剂1～2phr、抗冲改性剂5～10phr、抗氧化剂0.4～1phr、润滑剂0.7～1.5phr、色料0.002～0.008phr。
优选地，所述接枝改性PVC粉通过将PVC与甲基丙烯酸甲酯(MMA)熔融接枝得到，MMA的添加比例为5～10％。
优选地，所述接枝改性PVC粉的聚合度为780±30。
优选地，所述稳定剂为有机锡稳定剂。
优选地，所述辅助稳定剂为环氧大豆油。
优选地，所述加工助剂为2-甲基丙烯酸甲酯与丙烯酸丁酯的共聚物。
优选地，所述抗冲改性剂为MBS抗冲改性剂和/或抗冲改性剂ACR树脂。
优选地，所述抗氧化剂为受阻酚类抗氧化剂和/或硫代二丙酸双月桂酯(DLTP)；最优选地，所述抗氧化剂为四(3,5-二叔丁基-4-羟基)苯丙酸季戊四醇酯和DLTP按照质量比1：1配比的混合物。
优选地，所述润滑剂为硬脂酸类润滑剂和/或氧化聚乙烯蜡；更优选地，所述润滑剂为硬脂酸类润滑剂和氧化聚乙烯蜡按照质量比2：1配比的混合物。
上述耐辐照硬质PVC材料的制备方法，包括以下步骤：将组分混合均匀，塑化成片，通过压板机压合成片材，或者通过造粒机造粒。
上述耐辐照硬质PVC材料在制备医用器械中的应用。
与现有技术相比，本发明具有以下有益效果：
本发明的耐辐照硬质PVC材料具有良好的耐辐照性能和抗老化性能，解决了硬质PVC材料在18～29kGy剂量辐照灭菌后材料黄变脆化的问题，辐照灭菌后性能满足GB/T15593标准。从而不仅软质PVC材料能应用于辐照灭菌的医疗器械，硬质PVC材料也能应用于辐照灭菌的医疗器械，拓宽了PVC材料在医疗器械领域的应用范围，对未来医疗器械的发展具有重要意义。
附图说明
图1是实施例1-2及对比例1-3的耐辐照硬质PVC材料抗辐照和抗老化性能测试结果图；其中，A为电子束辐照前，B为电子束辐照后，C为加速老化后。
具体实施方式
下面将结合实施例对本发明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他实施例，都属于本发明保护的范围。
实施例中，所使用的实验方法如无特殊说明，均为常规方法，所用的材料、试剂等，如无特殊说明，均可从商业途径得到。
现对实施例及对比例所用原料做如下说明：
PVC粉：台塑宁波，牌号S-60，聚合度为780±30；
接枝改性PVC粉S-60G：将牌号为S-60的PVC与质量占比7％的甲基丙烯酸甲酯(MMA)熔融接枝得到，PVC粉与MMA的混合物加入挤出机料斗中进行熔融挤出，挤出温度为150℃，螺杆转速为40rpm；
稳定剂：甲基硫醇锡；
辅助稳定剂：环氧大豆油，KD-106，东莞市博轩实业投资有限公司；
加工助剂：2-甲基丙烯酸甲酯与丙烯酸丁酯的共聚物，日本钟渊，牌号PA-20；
抗冲改性剂：MBS抗冲改性剂，牌号B-513，广州纺塑化工有限公司；抗冲改性剂ACR树脂，牌号HL-CA81，山东日科化学股份有限公司；
抗氧化剂：四(3,5-二叔丁基-4-羟基)苯丙酸季戊四醇酯，RIANOX 1010，市售；DLTP，市售；
润滑剂：硬脂酸类润滑剂，牌号G78，东莞市巨星塑胶有限公司；氧化聚乙烯蜡，牌号PE-WAX，东莞市巨星塑胶有限公司；
色料：群青，市售。
实施例1-2及对比例1-3
实施例1-2和对比例1-3的耐辐照硬质PVC材料组分及添加量如表1所示。
表1(phr)
性能测试
采用表1中实施例1-2和对比例1-3的组分制备片材，方法如下：将组分混合均匀，经小型开炼机塑化成片，经压板机通过模具压成2mm厚的长条片材。
将实施例1-2和对比例1-3的长条片材进行电子束辐照，辐照剂量为25kGy。将电子束辐照后的长条片材进行加速老化，具体方法为60℃加热30d。
实施例1-2和对比例1-3的长条片材性能测试结果见图1。P1-P3依次为对比例1-3的片材样品，P4和P5依次为实施例1和2的片材样品。
材料的抗辐照性能体现在辐照后材料的黄变程度上，黄变颜色越轻，其抗辐照效果越好。材料的抗老化性能体现在加速老化后材料的的黄变程度上，黄变颜色越重，其力学性能下降越大，即越脆。根据以上评价方法，对比实施例1-2和对比例1-3的长条片材黄变程度，分析如下：
1)PVC粉选择：对比例1、2为普通PVC粉制备的长条片材，辐照、加速老化后长条片材黄变严重，证明了材料抗辐照、抗老化性能不佳；实施例1、2为接枝改性PVC粉制备的长条片材，辐照、加速老化后黄变程度低，证明材料的抗辐照、抗老化性能优良。
2)增韧剂选择：对比实施例1、2，实施例1的长条片材黄变程度比实施例2低，证明采用ACR树脂抗冲改性剂制备的材料抗辐照、抗老化效果优于采用MBS抗冲改性剂制备的材料。
3)抗氧化剂选择，对比对比例2、3，对比例3的长条片材黄变程度比对比例2稍低，证明抗氧化剂1010搭配DLTP可提高材料抗辐照、抗老化效果。1010与1076同为受阻酚类抗氧剂，但1010的有效官能团是1076的四倍，其抗氧化效果更佳，搭配DLTP使用，能发挥协同效应，提高抗氧化效果。
将表1中实施例1-2和对比例1-3的组分经混合机110℃混合，通过造粒机造粒，加工温度为145～155℃，螺杆转速为40rpm。将制备的颗粒按GB/T 15593标准检测物理性能、化学性能及生物性能，实施例1和2的检测结果分别见表2和表3。
表2
表3
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，这些改进和润饰也视为本发明的保护范围。
Claims (10)
1.一种耐辐照硬质PVC材料，其特征在于包括以下组分：接枝改性PVC粉100phr、稳定剂2～3phr、辅助稳定剂0.5～2phr、加工助剂1～2phr、抗冲改性剂5～10phr、抗氧化剂0.4～1phr、润滑剂0.7～1.5phr、色料0.002-0.008phr。
2.根据权利要求1所述耐辐照硬质PVC材料，其特征在于，所述接枝改性PVC粉通过将PVC与MMA熔融接枝得到，MMA的添加量为PVC质量的5～10％。
3.根据权利要求1所述耐辐照硬质PVC材料，其特征在于，所述接枝改性PVC粉的聚合度为780±30。
4.根据权利要求1所述耐辐照硬质PVC材料，其特征在于，
所述稳定剂为有机锡稳定剂；
所述辅助稳定剂为环氧大豆油。
5.根据权利要求1所述耐辐照硬质PVC材料，其特征在于，所述加工助剂为2-甲基丙烯酸甲酯与丙烯酸丁酯的共聚物。
6.根据权利要求1所述耐辐照硬质PVC材料，其特征在于，所述抗冲改性剂为MBS抗冲改性剂和/或抗冲改性剂ACR树脂。
7.根据权利要求1所述耐辐照硬质PVC材料，其特征在于，所述抗氧化剂为受阻酚类抗氧化剂和/或硫代二丙酸双月桂酯；
所述润滑剂为硬脂酸类润滑剂和/或氧化聚乙烯蜡。
8.根据权利要求7所述耐辐照硬质PVC材料，其特征在于，
所述抗氧化剂为四(3,5-二叔丁基-4-羟基)苯丙酸季戊四醇酯和DLTP按照质量比1：1配比的混合物；
所述润滑剂为硬脂酸类润滑剂和氧化聚乙烯蜡按照质量比2：1配比的混合物。
9.权利要求1-8任一项所述耐辐照硬质PVC材料的制备方法，其特征在于，包括以下步骤：将组分混合均匀，塑化成片，通过压板机压合成片材，或者通过造粒机造粒。
10.权利要求1-8任一项所述耐辐照硬质PVC材料在制备医用器械中的应用。
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