CN116212122A - 一种抗凝血涂层及其应用和制备方法 - Google Patents
一种抗凝血涂层及其应用和制备方法 Download PDFInfo
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- CN116212122A CN116212122A CN202310512495.5A CN202310512495A CN116212122A CN 116212122 A CN116212122 A CN 116212122A CN 202310512495 A CN202310512495 A CN 202310512495A CN 116212122 A CN116212122 A CN 116212122A
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Abstract
本发明属于医疗新材料技术领域,公开了一种抗凝血涂层及其应用和制备方法,主要针对未经表面处理的血管导管容易出现凝血和生物相容性差的问题,采用甲基苯基乙烯基硅油、乙烯基硅树脂、含氢硅油、抑制剂、铂络合物、偶联剂和溶剂为原料,制得基础涂层后,经磺化试剂和碱性试剂处理即可制备得到具有抗凝血涂层的导管,可使血液与导管管路接触时不易发生凝血反应,且具有良好生物相容性能,有助于减少因凝血而引发的并发症。
Description
技术领域
本发明属于医疗新材料技术领域,具体的说,是一种抗凝血涂层及其应用和制备方法。
背景技术
血管内管路是一类应用于临床的植/介入医疗器械,在临床上具有诊断、治疗等作用。其中,血液接触植/介入医疗器械及体外血液循环设备在临床应用中一直面临着术后感染和血栓栓塞等并发症,这些并发症不仅会影响器械寿命,更为严重的是还会对患者造成极大的伤害。
每天有成千上万的病人使用血液接触类器械,如血液透析循环管路、中心静脉导管、心脏支架、血管移植物、心脏瓣膜等。该类器械直接与血液接触时会发生一系列反应,首先,血浆蛋白会快速在材料表面吸附,引发血小板的黏附激活,继而引发凝血级联及补体激活等过程,并释放凝血因子,激活后的血小板、凝血因子与纤维蛋白原共同作用最终形成血栓。临床上,通常需要口服抗血小板药物或抗凝剂来抑制器械表面血栓形成,但同时会增加出血的风险。因此,在材料/器械表面设计及构建安全和有效的抗凝血表面至关重要。
材料的血液相容性主要由材料表面决定,抗凝血材料的制备主要是在材料上制备出具有血液相容性的表面,因此对材料表面进行改性是一种非常有效的方法,其中化学处理是一种简单而高效的处理方法。目前临床上使用最广泛的抗凝血药物肝素是一种含磺酸基、磺胺基和羧基的天然阴离子多糖,可以通过催化血液中凝血因子和抗凝因子的复合而有效的阻抗凝血过程,但是在导管上使用肝素存在药物用量大、长期介入后抗凝血性能不稳定、易导致自体出血、血小板减少、皮下组织坏死等缺点。
发明内容
本发明针对未经表面处理的血管导管容易出现凝血和生物相容性差的问题,提供了一种抗凝血涂层以及使用该涂层制备的导管及其制备方法,可以获得具有抗凝血涂层的血管导管,可使血液与导管管路接触时不易发生凝血反应,且具有良好生物相容性能,有助于减少因凝血而引发的并发症。
本发明通过下述技术方案实现:一种抗凝血涂层,由固化后的基础涂层经过磺化试剂和碱性试剂处理制得,所述基础涂层包括以下重量组分的原料制备而成:
甲基苯基乙烯基硅油:5~40份;
乙烯基硅树脂:1~20份;
含氢硅油:0.1~10份;
抑制剂:0.001~0.5份;
铂络合物:0.01~0.5份;
偶联剂:0.5~5份;
溶剂:20~95份。
所述溶剂为庚烷、正己烷、石油醚、异辛烷中的一种或多种。
所述甲基苯基乙烯基硅油的粘度为100~100000 mPas,其结构如下式(1)所示:
式(1)中,R为甲基、乙基、苯基、丙基或三氟丙基中的一种,m∶n=1∶1~99。
所述乙烯基硅树脂中乙烯基含量为0.5~5wt%。
所述含氢硅油中每个分子至少含有两个活性氢,含氢量为0.1~1.5wt%。
一种抗凝血涂层导管的制备方法,按上述原料的重量比,将甲基苯基乙烯基硅油、乙烯基硅树脂、含氢硅油、抑制剂、铂络合物、偶联剂和溶剂混合均匀后,涂覆于导管上形成基础涂层,将基础涂层固化后,再经磺化、中和反应后,即得抗凝血涂层导管。
所述固化的温度为40~100℃。
所述磺化是将具有基础涂层的导管浸入磺化试剂中进行的磺化反应,磺化反应温度为20~120℃,反应时间为2~12h。
所述中和反应是将磺化后的导管浸入碱性试剂进行处理的过程,中和反应温度为20~50℃,反应时间为1~3h。
采用上述方法制备得到的抗凝血涂层导管。
所述抗凝血涂层导管具有抗凝血涂层,该抗凝血涂层的结构如下式(2)所示:
本发明与现有技术相比,具有以下优点及有益效果:
(1)本发明通过对基础涂层进行改性而获得抗凝血涂层,并由此而制备医用导管,具有抗凝血性能显著,且无细胞毒性的特点。
(2)本发明在基础涂层中采用(甲基)丙烯酰氧基硅烷偶联剂和含氢硅油的搭配使用,可以显著提升抗凝血涂层固化后与导管的粘接力,使抗凝血涂层可以长久附着在管路材料上,提高医用导管的使用寿命。
附图说明
图1为实施例1中抗凝血涂层导管1的静态凝血测试图;
图2为实施例2中抗凝血涂层导管2的静态凝血测试图;
图3为实施例3中抗凝血涂层导管3的静态凝血测试图;
图4为对比例1中基础涂层导管7的静态凝血测试图;
图5为对照组TPU片血小板粘附SEM图;
图6为实施例1TPU片血小板粘附SEM图;
图7为实施例2TPU片血小板粘附SEM图;
图8为实施例3TPU片血小板粘附SEM图;
图9为实施例4TPU片血小板粘附SEM图;
图10为实施例5TPU片血小板粘附SEM图;
图11为实施例6TPU片血小板粘附SEM图。
具体实施方式
下面将本发明的发明目的、技术方案和有益效果作进一步详细的说明。
应该指出,以下详细说明都是示例性的,旨在对所要求的本发明提供进一步的说明,除非另有说明,本文使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同含义。
本发明旨在保护一种抗凝血涂层以及使用该涂层制备的导管及其制备方法,提供了一种以有机硅为基础涂层,经过磺化反应和中和反应后制备的抗凝血涂层导管,不仅可以保证涂层与导管基材的粘结性能,还能显著改善导管的抗凝血性能,且制备方法简单,成本低廉。
以下是对本发明技术方案的进一步概况:
首先,制备基础涂层,包括但不限于以下重量组分的原料:
甲基苯基乙烯基硅油:5~40份,乙烯基硅树脂:1~20份,含氢硅油:0.1~10份,抑制剂:0.001~0.5份,铂络合物:0.01~0.5份,偶联剂:0.5~5份,溶剂:20~95份。
本发明中,甲基苯基乙烯基硅油作为聚合物的基础树脂,可为后续反应提供所需基团,具体的,可选择的甲基苯基乙烯基硅油的粘度为100~100000 mPas,其结构如下式(1)所示:
式(1)中,R为甲基、乙基、苯基、丙基或三氟丙基中的一种,m∶n=1∶1~99。可选择的乙烯基硅树脂中乙烯基含量为0.5~5wt%。乙烯基硅树脂用于与含氢硅油反应,增加基础涂层的强度 ,具体的,含氢硅油中每个分子至少含有两个活性氢,含氢量为0.1~1.5wt%。
进一步的,可选择的抑制剂包括四甲基四乙烯基环四硅氧烷、四甲基二乙烯基二硅氧烷、乙炔基环己醇、丁炔醇、四甲基乙二胺、马来酸二烯丙酯、3-甲基-1-丁炔-3 醇、3-苯基-1-丁炔-3醇、3-丙基-1-丁炔-3醇、三苯基膦中的至少一种,抑制剂能够抑制基础涂层反应活性,使其有较长的操作时间。可选择的铂络合物如二乙烯基四甲基二硅氧烷和氯铂酸络合物,铂含量为500~5000ppm,能够催化甲基苯基乙烯基硅油、乙烯基硅树脂和含氢硅油的反应。可选择的偶联剂(甲基)丙烯酰氧基硅烷偶联剂,其包括γ-甲基丙烯酰氧基丙基三甲氧基硅烷、丙烯酰氧基丙基三甲氧基硅烷、γ-甲基丙烯酰氧丙基三乙氧基硅烷、丙烯酰氧基丙基三乙氧基硅烷中的至少一种,采用偶联剂和含氢硅油搭配使用,可以显著提升涂层与导管的粘接性能,使涂层能够在使用过程中长期附着于导管上,延长导管的使用性能。可选择的磺化试剂包括发烟硫酸、氯磺酸中的至少一种,可通过磺化反应在抗凝血涂层中引入磺酸基团或磺酰基团。可选择的碱性试剂包括碳酸钠、碳酸氢钠、氢氧化钠中的至少一种,可用于中和体系中过多的磺化试剂,将磺酸基反应为磺酸钠,使导管涂层具有抗凝血的功能结构。
制备时,按上述重量比,先将甲基苯基乙烯基硅油、乙烯基硅树脂、含氢硅油、抑制剂、铂络合物、偶联剂和溶剂混合均匀后,涂覆于导管上形成基础涂层,再于40~100℃下固化,然后将导管浸入磺化试剂中,在20~ 120℃下进行磺化反应2~12h,再将导管取出并浸入碱性试剂进行中和反应,在20~50℃下反应1~3h后,即得抗凝血涂层导管,抗凝血导管的抗凝血涂层为具体如下式(2)所示:
下面以几个典型实施例来列举说明本发明的具体实施方式,当然,本发明的保护范围并不局限于以下实施例。
实施例1:
向配料釜中加入30份(重量份,下同)粘度为 2000mPas(25℃,下同)的二甲基苯基乙烯基硅油(m∶n=1∶60),20份乙烯基含量1.0wt%的乙烯基硅树脂,10份含氢量0.1wt%的含氢硅油,0.001份四甲基乙二胺,0.5份γ-甲基丙烯酰氧基丙基三甲氧基硅烷和29.5份正己烷,搅拌均匀后,再加入0.2份铂含量为1000ppm的铂络合物,搅拌均匀,得到抗凝血涂层的基础涂层1。将基础涂层1浸涂在PVC管上,70℃加热固化,将固化后的导管放入发烟硫酸中,于70℃下磺化反应10h,再置于1.0wt%碳酸钠水溶液中,于30℃下处理3小时,得到抗凝血涂层导管1。
实施例2:
向配料釜中加入30份粘度为2000mPas的二甲基苯基乙烯基硅油(m∶n=1∶80),10份粘度为1000mPas的甲基乙基苯基乙烯基硅油(m∶n=1∶60),20份乙烯基含量0.5wt%的乙烯基硅树脂,5份含氢量0.5wt%的含氢硅油,0.001份乙炔基环己醇,5份丙烯酰氧基丙基三甲氧基硅烷和35份庚烷,搅拌均匀后,再加入0.3份铂含量为3000ppm的铂络合物,搅拌均匀,得到抗凝血涂层的基础涂层2。将基础涂层2喷涂在硅胶管上,80℃加热固化,将固化后的导管放入发烟硫酸中,于80℃下磺化反应8h,再置于3.0wt%碳酸氢钠水溶液中,于40℃下处理3小时,得到抗凝血涂层导管2。
实施例3:
向配料釜中加入10份粘度为10000mPas的甲基乙基苯基乙烯基硅油(m∶n=1∶30),3份乙烯基含量2wt%的乙烯基硅树脂,1份含氢量1.0wt%的含氢硅油,0.004份四甲基二乙烯基二硅氧烷,1份丙烯酰氧基丙基三甲氧基硅烷和89份异辛烷,搅拌均匀后,再加入0.01份铂含量为500ppm的铂络合物,搅拌均匀,得到抗凝血涂层的基础涂层3。将基础涂层3浸涂在TPU管上,90℃加热固化,将固化后的导管放入氯磺酸中,于30℃下磺化反应6h,再置于4.0wt%碳酸钠水溶液中,于50℃下处理2小时,得到抗凝血涂层导管3。
实施例4:
向配料釜中加入4份粘度为100000mPas的甲基丙基苯基乙烯基硅油(m∶n=1∶2),2份粘度为5000mPas的甲基乙基苯基乙烯基硅油(m∶n=1∶10),2份乙烯基含量1.5wt%的乙烯基硅树脂,0.1份含氢量1.5wt%的含氢硅油,0.5份四甲基乙二胺,1份丙烯酰氧基丙基三乙氧基硅烷和95份石油醚,搅拌均匀后,再加入0.02份铂含量为2000ppm的铂络合物,搅拌均匀,得到抗凝血涂层的基础涂层4。将基础涂层4浸涂在嵌段聚醚酰胺(PEBAX)管上,85℃加热固化,将固化后的导管放入氯磺酸中,于35℃下磺化反应5h,再置于2.0wt%碳酸钠水溶液中,于35℃下处理2小时,得到抗凝血涂层导管4。
实施例5:
向配料釜中加入10份粘度为5000mPas的甲基苯基三氟丙基乙烯基硅油(m∶n=1∶50),1份粘度为1000mPas的二甲基苯基乙烯基硅油(m∶n=1∶70),4份乙烯基含量1.0wt%的乙烯基硅树脂,0.5份含氢量0.8wt%的含氢硅油,0.01份马来酸二烯丙酯,2份γ-甲基丙烯酰氧基丙基三乙氧基硅烷和78份异辛烷,搅拌均匀后,再加入0.05份铂含量为3000ppm的铂络合物,搅拌均匀,得到抗凝血涂层的基础涂层5。将基础涂层5浸涂在聚乙烯(PE)管上,65℃加热固化,将固化后的导管放入发烟硫酸中,于90℃下磺化反应8h,再置于5.0wt%碳酸钠水溶液中,于45℃下处理2小时,得到抗凝血涂层导管5。
实施例6:
向配料釜中加入15份粘度为9000mPas的甲基乙基苯基乙烯基硅油(m∶n=1∶40),2份粘度为2000mPas的甲基二苯基乙烯基硅油(m∶n=1∶80),3份乙烯基含量1.2wt%的乙烯基硅树脂,0.3份含氢量1.0wt%的含氢硅油,0.02份四甲基四乙烯基环四硅氧烷,3份丙烯酰氧基丙基三甲氧基硅烷和87份正己烷,搅拌均匀后,再加入0.02份铂含量为2000ppm的铂络合物,搅拌均匀,得到抗凝血涂层的基础涂层6。将基础涂层6喷涂在聚丙烯(PP)管上,85℃加热固化,将固化后的导管放入氯磺酸中,于40℃下磺化反应7h,再置于6.0wt%碳酸氢钠水溶液中,于50℃下处理3小时,得到抗凝血涂层导管6。
对比例1:
向配料釜中加入30份(重量份,下同)粘度为 2000mPas(25℃,下同)的二甲基苯基乙烯基硅油(m∶n=1∶60),20份乙烯基含量1.0wt%的乙烯基硅树脂,10份含氢量0.1wt%的含氢硅油,0.001份四甲基乙二胺,0.5份γ-甲基丙烯酰氧基丙基三甲氧基硅烷和29.5份正己烷,搅拌均匀后,再加入0.2份铂含量为1000ppm的铂络合物,搅拌均匀,得到基础涂层。将基础涂层浸涂在PVC管上,70℃加热固化,得到基础涂层导管7。
实验部分:
(1)MTT细胞毒性测试:
将实施例1~6的抗凝血涂层导管1~6切成1cm的小段,使用细胞培养基浸提24h后,在相同条件下使用浸提培养基培养24h后,观察不同浸提培养基培养下细胞的存活率均大于85%,表明本发明所述涂层抗凝导管均无细胞毒性。
(2)静态凝血测试:
任意选取实施例1~3的抗凝血涂层导管1~3,以及对比例1的基础涂层导管7,分别放置于37℃的复钙枸橼酸血液中培育4小时。结果如图1至图4所示,抗凝血涂层导管1~3取出后,导管管壁均无残留的血栓附着,具体参见图1至图3;基础涂层导管7取出后,导管管壁有少量血细胞粘附,具体参见图4。
由此可见,本发明通过基础涂层改性而得到的抗凝血涂层导管,静态凝血效果得到提升。
(3)血小板粘附测试:
按实施例1~6的方法,将抗凝血涂层涂覆于TPU片上,将未涂覆抗凝血涂层的TPU片作为对照组。将TPU片剪成5cm×5cm的正方形,将新鲜血液离心收集富血小板血浆,接种于涂覆了抗凝血涂层的TPU片上,孵育固定脱水后,通过扫描电子显微镜观察血小板粘附情况,结果如图5至图11所示,可见,含抗凝血涂层的TPU片较未涂覆抗凝血涂层的TPU片而言,对血小板有明显的抗黏附和抗激活作用。
以上所述,仅是本发明的较佳实施例,并非对本发明做任何形式上的限制,凡是依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化,均落入本发明的保护范围之内。
Claims (10)
1.一种抗凝血涂层,其特征在于:由固化后的基础涂层经过磺化试剂和碱性试剂处理制得,所述基础涂层包括以下重量组分的原料制备而成:
甲基苯基乙烯基硅油:5~40份;
乙烯基硅树脂:1~20份;
含氢硅油:0.1~10份;
抑制剂:0.001~0.5份;
铂络合物:0.01~0.5份;
偶联剂:0.5~5份;
溶剂:20~95份。
3.根据权利要求1所述的抗凝血涂层,其特征在于:所述乙烯基硅树脂中乙烯基含量为0.5~5wt%。
4.根据权利要求1所述的抗凝血涂层,其特征在于:所述含氢硅油中每个分子至少含有两个活性氢,含氢量为0.1~1.5wt%。
5.一种抗凝血涂层导管的制备方法,其特征在于:按权利要求1所述原料的重量比,将甲基苯基乙烯基硅油、乙烯基硅树脂、含氢硅油、抑制剂、铂络合物、偶联剂和溶剂混合均匀后,涂覆于导管上形成基础涂层,将基础涂层固化后,再经磺化、中和反应后,制得抗凝血涂层导管。
6.根据权利要求5所述的制备方法,其特征在于:所述固化的温度为40~100℃。
7.根据权利要求5所述的制备方法,其特征在于:所述磺化是将具有基础涂层的导管浸入磺化试剂中进行的磺化反应,磺化反应温度为20~120℃,反应时间为2~12h。
8.根据权利要求5所述的制备方法,其特征在于:所述中和反应是将磺化后的导管浸入碱性试剂进行处理的过程,中和反应温度为20~50℃,反应时间为1~3h。
9.采用权利要求5所述方法制备得到的抗凝血涂层导管。
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