CN116328020A - 一种生物粘合剂及其制备方法和应用 - Google Patents
一种生物粘合剂及其制备方法和应用 Download PDFInfo
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Abstract
本发明涉及一种生物粘合剂及其制备方法和应用，其含有如下组分：聚丙烯酸酯、N‑羟基琥珀酰亚胺、壳聚糖、醋酸及水。其制备方法包括如下步骤：称量丙烯酸、N‑羟基琥珀酰亚胺，加入去离子水混合均匀，得到溶液A；称量壳聚糖，溶于醋酸溶液中，混合均匀，得到溶液B；在室温下，再将所述溶液A和所述溶液B混合均匀，在紫外光下固化，得到粘合剂样品。本发明可用于制备医用粘合材料。
Description
技术领域
本发明涉及医用材料技术领域，尤其是涉及一种生物粘合剂及其制备方法和应用。
背景技术
根据统计报告，全球每年约有1.14亿例创伤出现，其中仅美国就有3600万例。这些创伤包括皮肤伤口，但也包括实质性器官和中空器官、结缔组织、肌肉、肌腱和膜的任何手术或创伤性导致的破坏，创伤后快速止血和伤口闭合不仅是外科手术过程中的基本操作的核心技术，还是外科手术中必须面对的问题。这些问题不仅会威胁到生命安全，也会带来较大的经济负担。缝合是实现组织伤口愈合的最常用方法，但传统缝合方法往往存在费时、需要麻醉及形成癫痕组织等缺点。并且，缝合方法并不能快速的止血，因此传统的缝合方法不是最佳的伤口闭合和止血的处理方法。
现代医学的理念是最大限度地去减少患者的痛苦，以最快的速度使病人身体康复，并且在最大程度的恢复损坏组织生理功能的同时，并希望创口处的外观也可以完美得到恢复。生物粘合剂由于其操作快速简单，能实现无创闭合，不会造成损伤部位组织周围的伤害，减少缝合时的疼痛，无需二次手术清除粘合剂，还能够避免体液和空气的泄露，不会在粘合处形成疤痕以及用作药物和因子的载体在创伤的局部区域释放等优点，而被广泛用作传统缝合方法的完美替代品。因此，在过去的几十年中，已经开发了各种各样的生物粘合剂，以提供更可靠、更实用和更快速的组织闭合和止血方法，而不损害组织血管形成以及避免泄露风险。
生物粘合剂，又称医用粘合剂，是应用于组织工程中的一类材料。其具有良好的润湿性能和粘接性能，可以通过各种物理或化学作用，使组织之间能够粘合在一起，具有伤口闭合和密封的效果。根据组织部位和应用领域的不同，可以选择相对应功能的生物粘合剂，因此其受到了科研人员的广泛关注和研究，为外科手术中的止血、防止体液和空气的泄露以及软或硬组织的粘合提供了强有力的技术手段。
但是，目前市售的组织粘合剂对被血液覆盖的组织表面只提供微弱或缓慢的粘附力，不能实现快速有效止血，这在很大程度上限制了它们在临床应用中的效用。
公开号为CN104922726A的中国发明专利申请公开了一种可降解软组织粘合剂及其制备方法，该粘合剂由以下质量份的各组分组成：α-氰基丙烯酸正丁酯34-52份、壳聚糖4-13份、乙烯吡咯烷酮5-19份、过氧化苯甲酰2-9份、季戊四醇15-26份、羟乙基纤维素2-8份、甘油7-15份、聚丙烯酸酯5-13份、甲基丙烯酸酯4-11份。
上述粘合剂的组织止血粘附性能依然不足，并且组分过多，制备过程复杂。
发明内容
本发明就是为了解决现有技术中生物粘合剂止血粘附力不足的技术问题，提供一种聚丙烯酸酯/壳聚糖复合生物粘合剂及其制备方法和应用。其可以实现伤口止血密封，由于聚丙烯酸酯具有良好的粘附性，而壳聚糖又是天然多糖，两者复合后具有良好的组织粘合性、优异的止血效果，并且生物毒性低。
为此，本发明提供一种生物粘合剂，其含有如下质量体积比的组分：15％～30％w/v的聚丙烯酸酯、1％～4％w/v的N-羟基琥珀酰亚胺、1％～4％w/v的壳聚糖、0.8～1％w/v的醋酸，余量为水。
优选的，所述组分的质量体积比为：30％w/v的聚丙烯酸酯、4％w/v的N-羟基琥珀酰亚胺、4％w/v的壳聚糖、1％w/v的醋酸，余量为水。
本发明同时提供一种生物粘合剂的制备方法，其包括如下步骤：(1)称取丙烯酸、N-羟基琥珀酰亚胺，加入去离子水混合均匀，得到溶液A；(2)称量壳聚糖，溶于醋酸溶液中，混合均匀，得到溶液B；(3)在室温下，再将所述溶液A和所述溶液B混合均匀，在紫外光下固化，得到粘合剂样品。
优选的，所述步骤(3)中，紫外光波长为365nm。
本发明还提供一种生物粘合剂在制备医用粘合材料中的应用。
本发明具有以下有益效果：
(1)本发明中的聚丙烯酸酯具有良好的粘附性，对各种组织都能有不错的粘合效果；
(2)N-羟基琥珀酰亚胺与丙烯酸发生反应后，与组织表面的胺基能够发生共价交联，进一步加强了组织粘合性；
(3)壳聚糖能够吸附红细胞和血小板，具有良好的止血效果；
(4)聚丙烯酸酯还具有一定的抗菌功能，可以降低粘合剂在使用过程中的染菌风险；
(5)生物粘合剂以凝胶的形式储存，携带简单，容易使用；
(6)聚丙烯酸酯/壳聚糖复合生物粘合剂具有良好的生物相容性，较低的生物毒性；
(7)本发明制备的生物粘合剂的原料有丙烯酸、N-羟基琥珀酰亚胺、醋酸和壳聚糖，原料易得，成本低廉。
附图说明
图1猪皮剪切粘合强度性能测试实验的示意图；
图2不同聚丙烯酸酯含量的生物粘合剂对猪皮剪切粘合强度的结果图；
图3本发明生物粘合剂对大鼠肝脏止血粘合的示意图；
图4本发明生物粘合剂对大鼠心脏止血粘合的示意图。
具体实施方式
本发明提供了一种聚丙烯酸酯/壳聚糖复合生物粘合剂制备方法及其应用。本领域技术人员可以参考本文内容，对相关工艺参数进行适当改进能够得以实现。
本发明采用的原料皆为普通市售品，皆可于市场购得。
下面结合实施例对本发明做进一步描述。
实施例1
制备方法如下：
(1)称量一定含量的丙烯酸、N-羟基琥珀酰亚胺，加入去离子水混合均匀，得到溶液A；
(2)然后称量一定含量的壳聚糖，溶于溶液中，混合均匀，得到溶液B；
(3)在室温下，再将溶液A和B混合均匀，在365nm的紫外光下固化，得到粘合剂样品。
上述方法制备得到生物粘合剂，命名为PANS15，样品中各组分的质量体积比为：15％w/v聚丙烯酸酯、1％w/vN-羟基琥珀酰亚胺、1％w/v壳聚糖、0.8w/v醋酸，余量为水。
实施例2
制备得到生物粘合剂，命名为PANS20，样品中各组分的质量体积比为：20％w/v聚丙烯酸酯、2％w/vN-羟基琥珀酰亚胺、2％w/v壳聚糖、0.9w/v醋酸，余量为水。其余同实施例1。
实施例3
制备得到生物粘合剂，命名为PANS25，样品中各组分的质量体积比为：25％w/v聚丙烯酸酯、3％w/vN-羟基琥珀酰亚胺、3％w/v壳聚糖、1w/v醋酸，余量为水。其余同实施例1。
实施例4
制备得到生物粘合剂，命名为PANS30，样品中各组分的质量体积比为：30％w/v聚丙烯酸酯、4％w/vN-羟基琥珀酰亚胺、4％w/v壳聚糖、1w/v醋酸，余量为水。其余同实施例1。
实施例5
本发明制得的生物粘合剂，也被称为医用粘合剂，可以用于手术中，如肝脏、心脏等组织止血、密封和闭合，可以替代传统的手术方法，如缝合线、缝合钉等。
实施例6为不同聚丙烯酸酯含量的生物粘合剂的剪切粘合强度测试实验
将猪皮表面油脂去除后，按照长宽50mm*25mm切成长条状，并将实施例1-4中制得的生物粘合剂制备成25mm*25mm*1mm状，将二者粘合固定，使用万能力学试验机，分别可以测量其剪切粘合强度，测试图如图1所示，测试结果如图2所示。
由图2的粘合强度测试结果可知，不同羧甲基壳聚糖的生物粘合剂的粘合强度有所不同。其中，PANS30明显强于PANS15(*代表具有统计学差异，p<0.01)。
实施例7为本发明生物粘合剂对大鼠肝脏的止血粘合试验
实验方法：用手术剪对大鼠剪开一个2cm*0.5cm的创口，放血10s后用材料止血，观察止血效果，若不再有血液渗出，说明止血成功。
实施例8为本发明生物粘合剂对大鼠心脏的止血粘合试验
实验方法：用外径1.2mm的针头对大鼠心脏造成一个创口，放血3s后用材料止血，观察止血效果，若不再有血液渗出，说明止血成功。
惟以上所述者，仅为本发明的具体实施例而已，当不能以此限定本发明实施的范围，故其等同组件的置换，或依本发明专利保护范围所作的等同变化与修改，皆应仍属本发明权利要求书涵盖之范畴。
Claims (5)
1.一种生物粘合剂，其特征是，含有如下质量体积比的组分：15％～30％w/v的聚丙烯酸酯、1％～4％w/v的N-羟基琥珀酰亚胺、1％～4％w/v的壳聚糖、0.8～1％w/v的醋酸，余量为水。
2.权利要求1所述的生物粘合剂，其特征在于，所述组分的质量体积比为：30％w/v的聚丙烯酸酯、4％w/v的N-羟基琥珀酰亚胺、4％w/v的壳聚糖、1％w/v的醋酸，余量为水。
3.如权利要求1所述的生物粘合剂的制备方法，其特征是，包括如下步骤：
(1)称取丙烯酸、N-羟基琥珀酰亚胺，加入去离子水混合均匀，得到溶液A；
(2)称量壳聚糖，溶于醋酸溶液中，混合均匀，得到溶液B；
(3)在室温下，再将所述溶液A和所述溶液B混合均匀，在紫外光下固化，得到粘合剂样品。
4.根据权利要求3所述的生物粘合剂的制备方法，其特征在于，所述步骤(3)中，紫外光波长为365nm。
5.如权利要求1所述的生物粘合剂在制备医用粘合材料中的应用。
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