CN105833347B - 具有优异生物相容性的制备人工关节用材料及其制备方法 - Google Patents

具有优异生物相容性的制备人工关节用材料及其制备方法 Download PDF

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CN105833347B
CN105833347B CN201610259376.3A CN201610259376A CN105833347B CN 105833347 B CN105833347 B CN 105833347B CN 201610259376 A CN201610259376 A CN 201610259376A CN 105833347 B CN105833347 B CN 105833347B
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庄玉春
李彬
赵琨
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Abstract

本发明提供一种具有优异生物相容性的制备人工关节用材料及其制备方法，该材料包括按照质量份数计的如下原料：硅橡胶40~60份，胶原蛋白10~20份，乙烯基硅油1.5~4份，气相法白炭黑20~32份，氢氧化钙0.8~3份。本发明提供的材料具有优异的生物活性、生物相容性和骨传导性，均优于医用钛及硅橡胶，并且其强度高、机械性能好。

Description

具有优异生物相容性的制备人工关节用材料及其制备方法
技术领域
本发明涉及医学用品领域，尤其涉及一种制备人工关节用材料及其制备方法。
背景技术
人工关节是人们为挽救已失去功能的关节而设计的一种人工器官，它在人工器官中属于疗效最好的一种。一般来说，其使用年限可达20年以上。随着科技进步，人工关节手术已经是一种十分成功和有把握的手术：它可以即刻消除关节疼痛、恢复关节的正常活动功能，使长期受关节病痛折磨的人们再次获得新生，手术后可以像正常人那样，行走、爬楼、外出旅行、外出工作、购物和体育锻炼等。
人工关节的金属部件曾采用不锈钢来制做，后来又发展了钴合金材料，钴合金的耐腐蚀性、耐磨性和机械性能都较好。近来又发展了钛及钛合金材料，含钛材料不但耐腐蚀，而且比重小，更易与人自体的骨长在一起，是理想的材料。人工关节金属部件之间一般都垫有高密度超高分子量聚乙烯塑料。
多年来人们就采用各种人工关节治疗关节强直、关节畸形和各种破坏性骨关节疾病，力图将这些有病的关节矫正，并恢复功能，使之成为稳定的、不疼的，并有一定的功能的关节。为此许多学者做出了巨大的努力。迄今已研制出膝、髋、肘、肩、指、趾关节假体，用于临床。
我国每年20万例的人工关节置换手术。近20年来，我国关节疾病的发病人数不断攀升，其中老年性骨关节炎是发病最多的一种关节疾病。目前我国60岁以上老人中，有55%的人患有骨关节炎，全国约有1.2亿人患有此病。关节置换数量每年以超过30%的速度增加。我国有骨性关节炎的人数占总人口的3%、类风湿患者占0.3%、强直患者约占0.3%，这几千万人虽然不一定都要做手术，但需要做手术的人数最少是实施手术人数的10倍以上。也就是需要做人工关节的人数在200万以上，按每例人工关节材料费4-6万计算，市场理想需求在800亿以上，但是目前需要做手术并且实施手术的比例大约占10%-20%。也就是目前市场规模大约是80亿到160亿，随着生活提高和医改深入，医疗条件改善，目前我国人工关节置换手术增速是30%。
目前市场上现有的制备人工关节用材料本身脆度高、抗折强度低，并且不具有良好的生物活性和生物相容性。
发明内容
解决的技术问题：针对现有的制备人工关节用材料存在的缺点，本发明提供一种制备人工关节用材料及其制备方法，该材料具有优异的生物活性、生物相容性和骨传导性，并且其强度高、机械性能好。
技术方案：一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶40～60份，胶原蛋白10～20份，乙烯基硅油1.5～4份，气相法白炭黑20～32份，氢氧化钙0.8～3份。
上述所述的一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶45～55份，胶原蛋白12～18份，乙烯基硅油2～3份，气相法白炭黑24～30份，氢氧化钙1.3～2.3份。
上述所述的一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶48份，胶原蛋白14份，乙烯基硅油2.2份，气相法白炭黑25份，氢氧化钙1.5份。
上述所述的一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶50份，胶原蛋白15份，乙烯基硅油2.5份，气相法白炭黑27份，氢氧化钙1.8份。
上述所述的一种制备人工关节用材料的制备方法，包括如下步骤：将硅橡胶、胶原蛋白、乙烯基硅油、气相法白炭黑和氢氧化钙加入挤出机中熔融共混10～20min，在温度为180～200℃下挤出，即得制备人工关节用材料。
上述所述的熔融共混15min，在温度为190℃下挤出。
有益效果：与现有技术相比，本发明提供的一种制备人工关节用材料及其制备方法，该材料具有优异的生物活性、生物相容性和骨传导性，均优于医用钛及硅橡胶，并且其强度高、机械性能好。
具体实施方式
实施例1
一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶40份，胶原蛋白10份，乙烯基硅油1.5份，气相法白炭黑20份，氢氧化钙0.8份。
一种制备人工关节用材料的制备方法，包括如下步骤：将硅橡胶、胶原蛋白、乙烯基硅油、气相法白炭黑和氢氧化钙加入挤出机中熔融共混10min，在温度为180℃下挤出，即得制备人工关节用材料。
实施例2
一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶60份，胶原蛋白20份，乙烯基硅油4份，气相法白炭黑32份，氢氧化钙3份。
一种制备人工关节用材料的制备方法，包括如下步骤：将硅橡胶、胶原蛋白、乙烯基硅油、气相法白炭黑和氢氧化钙加入挤出机中熔融共混20min，在温度为200℃下挤出，即得制备人工关节用材料。
实施例3
一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶45份，胶原蛋白12份，乙烯基硅油2份，气相法白炭黑24份，氢氧化钙1.3份。
一种制备人工关节用材料的制备方法，包括如下步骤：将硅橡胶、胶原蛋白、乙烯基硅油、气相法白炭黑和氢氧化钙加入挤出机中熔融共混10min，在温度为180℃下挤出，即得制备人工关节用材料。
实施例4
一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶55份，胶原蛋白18份，乙烯基硅油3份，气相法白炭黑30份，氢氧化钙2.3份。
一种制备人工关节用材料的制备方法，包括如下步骤：将硅橡胶、胶原蛋白、乙烯基硅油、气相法白炭黑和氢氧化钙加入挤出机中熔融共混20min，在温度为200℃下挤出，即得制备人工关节用材料。
实施例5
一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶52份，胶原蛋白17份，乙烯基硅油2.8份，气相法白炭黑28份，氢氧化钙2份。
一种制备人工关节用材料的制备方法，包括如下步骤：将硅橡胶、胶原蛋白、乙烯基硅油、气相法白炭黑和氢氧化钙加入挤出机中熔融共混20min，在温度为200℃下挤出，即得制备人工关节用材料。
实施例6
一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶48份，胶原蛋白14份，乙烯基硅油2.2份，气相法白炭黑25份，氢氧化钙1.5份。
一种制备人工关节用材料的制备方法，包括如下步骤：将硅橡胶、胶原蛋白、乙烯基硅油、气相法白炭黑和氢氧化钙加入挤出机中熔融共混15min，在温度为190℃下挤出，即得制备人工关节用材料。
实施例7
一种制备人工关节用材料，包括按照质量份数计的如下原料：硅橡胶50份，胶原蛋白15份，乙烯基硅油2.5份，气相法白炭黑27份，氢氧化钙1.8份。
一种制备人工关节用材料的制备方法，包括如下步骤：将硅橡胶、胶原蛋白、乙烯基硅油、气相法白炭黑和氢氧化钙加入挤出机中熔融共混15min，在温度为190℃下挤出，即得制备人工关节用材料。
性能测试
对本发明实施例1~7产品的性能进行测试，测试结果见表1。
表1产品性能测试数据
以上对本发明进行了详细介绍，对于本领域的一般技术人员，依据本发明实施例的思想，在具体实施方式及应用范围上均会有改变之处，综上所述，本说明书内容不应理解为对本发明的限制。

Claims (1)

1.一种制备人工关节用材料的制备方法，其特征在于，所述制备人工关节用材料包括按照质量份数计的如下原料：硅橡胶48份，胶原蛋白14份，乙烯基硅油2.2份，气相法白炭黑25份，氢氧化钙1.5份；
所述的制备方法，包括如下步骤：将硅橡胶、胶原蛋白、乙烯基硅油、气相法白炭黑和氢氧化钙加入挤出机中熔融共混10～20min，在温度为180～200℃下挤出，即得制备人工关节用材料。
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