CN113456899A - 一种生物陶瓷复合高效生物降解骨钉的制备方法 - Google Patents
一种生物陶瓷复合高效生物降解骨钉的制备方法 Download PDFInfo
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Abstract
本发明涉及生物材料技术领域,且公开了种生物陶瓷复合高效生物降解骨钉的制备方法,包括以下步骤:S1、将聚乳酸‑羟基乙酸共聚物颗粒溶解到有机溶剂中配制成聚轻基乙酸的油相溶液;S2、将生物活性玻璃粉末加入到油相溶液中,在50‑80℃下反应12‑24小时,形成聚乳酸‑羟基乙酸共聚物/生物活性玻璃的混合乳液。本发明制得的生物降解骨钉生物相容性好、力学强度高、生物利用度高,且生物活性玻璃的加入能中和聚乳酸‑羟基乙酸共聚物降解过程中产生的酸性环境,使聚乳酸‑羟基乙酸共聚物降解液的pH值变化趋于平稳。本发明的制备方法工艺简单,成本低,且生产业更安全。
Description
技术领域
本发明涉及生物材料领域,尤其涉及一种生物陶瓷复合高效生物降解骨钉的制备方法。
背景技术
骨缺损一直是医学上的难题。目前较为理想的方法为自体或同种异体骨移植,自体骨移植被广泛的认为是衡量植骨融合的“金标准”。虽然自体骨移植有诸多的好处,如适应周围骨组织的再生等,但仍存在一些弊端,如自体骨移植供体有限,出现二次创伤,增加手术难度,存在一定的失败率等。异体骨有时会无法刺激成骨,而且常诱发不良的反应,研究新型的骨替代产品成为医务工作者和材料工作者所共同面临的问题。
聚乳酸-聚乙醇酸共聚物[poly(lactic-co-glycolic acid),PLGA]是一种具有良好生物相容性、生物可降解性以及降解速率可调节的有机高分子材料。因其可通过酯键水解降解为乳酸和羟基乙酸,直至最终降解为二氧化碳和水排出体外,对人体不具有毒副作用,成为了为数不多的得到美国食品药品管理局(FDA)批准的高分子材料,被广泛应用于组织工程、药物载体、手术缝合、骨内固定等领域。
然而随着近年来研究的深入,越来越多的报道指出,不管PLGA载体的形态如何,其在体内外的降解、释药过程中,自身的降解产物会对其载有的活性分子,特别是蛋白质多肽类生物分子的活性产生不利影响。其主要原因在于PLGA在降解过程中产生酸性物质,使得蛋白质药物周围微环境的pH值下降,这种酸性环境易导致蛋白质发生降解、聚合而变性,使得在药物缓慢释放的过程中不能很好地保持稳定和活性。
生物活性玻璃是20世纪70年代初由Larry L.Hench教授等人发明的第三代可降解生物材料,Hench研究的生物活性玻璃主要是以SiO2,CaO,P2O5为主体的无机材料。目前,生物活性玻璃材料主要应用在牙科、骨科、骨缺损修复以及软组织损伤愈合等领域,在安全性和临床有效性上已经得到FDA、SFDA的认可。在最近的5年中,生物活性玻璃本身作为一种具有药物负载和传输能力的材料研究也屡见报道。
生物活性玻璃在体液环境中通过钙、镁、钠等离子的溶出而破坏二氧化硅分子网络结构来引发降解,分子级的降解产物可以很容易从人体无害排出,因此给人体新陈代谢系统带来的负担更低。而且生物活性玻璃的降解能力可通过改变组分的不同组成比例来来调节,从而可以控制其在体内的降解和循环时间。这种可调节的生物降解能力使利用生物活性玻璃与PLGA等生物材料形成的复合材料具有可调、可控的生物降解特性,在用于制备药物传输体系具有优势。此外,生物活性玻璃具有很强的惰性,不会引起蛋白多肽类药物失活。但是传统的生物玻璃支架一般具有脆性大,力学强度不高,易引起蛋白多肽类药物失活等缺点。
为解决上述问题,本申请中提出一种生物陶瓷复合高效生物降解骨钉的制备方法。
发明内容
(一)发明目的
为解决背景技术中存在的技术问题,本发明提出一种生物陶瓷复合高效生物降解骨钉的制备方法,本发明制得的生物降解骨钉生物相容性好、力学强度高、生物利用度高,且生物活性玻璃的加入能中和聚乳酸-羟基乙酸共聚物降解过程中产生的酸性环境,使聚乳酸-羟基乙酸共聚物降解液的pH值变化趋于平稳。本发明的制备方法工艺简单,成本低,且生产业更安全。
(二)技术方案
为解决上述问题,本发明提供了一种生物陶瓷复合高效生物降解骨钉的制备方法,包括以下步骤:
S1、将聚乳酸-羟基乙酸共聚物颗粒溶解到有机溶剂中配制成聚轻基乙酸的油相溶液;
S2、将生物活性玻璃粉末加入到油相溶液中,在50-80℃下反应12-24小时,形成聚乳酸-羟基乙酸共聚物/生物活性玻璃的混合乳液;
S3、挥发掉S2制备的混合乳液中的有机溶剂,水洗,烘干,将所得粉体放入放电等离子烧结腔内,在两端分别施加50和70MPa的轴向压力,抽真空,当烧结室压力达到60Pa时开始加热,升温速度为30-70℃/min,待温度升高至720-780℃时开始放电等离子烧结并保持2-10分钟;
S4、烧结完毕,停止加热并卸除压力,随炉冷却至室温,即得聚乳酸-羟基乙酸共聚物/生物活性玻璃复合生物降解骨钉。
优选的,生物玻璃粉体为SiO2-P2O5-CaO生物玻璃粉体。
优选的,SiO2-P2O5-CaO生物玻璃粉体的物质组成质量百分比为:二氧化硅58%,五氧化二磷6%-15%和氧化钙27%-36%。
优选的,在S1中,有机溶剂为二氯甲烷和丙酮的混合溶液,且两者的体积比为9:1。
优选的,聚乳酸-羟基乙酸共聚物的相对分子质量为5000-50000。
本发明的上述技术方案具有如下有益的技术效果:
(1)本发明制备的生物降解骨钉可适应不同部位和形状的骨缺损填充;材料化学组分可调,从而使材料的理化性能及工艺性能可在一定范围调整;制备工艺简单易行,工艺参数易于控制以及产量大等优点;
(2)本发明制备的复合材料生物降解骨钉的外形和内部孔隙结构有利于新生骨组织的长入和骨缺损的修复;
(3)本发明制备的复合材料生物降解骨钉具有良好的力学强度、生物相容性以及一定的生物降解性能。
附图说明
图1为本发明提出的一种生物陶瓷复合高效生物降解骨钉的制备方法的流程图。
图2为本发明的电镜图。
图3为本发明中PLGA(A)和PLGA-BG(B)电镜图。
图4为本发明的模拟人体液中PLGA膜及PLGA-BG复合膜的pH变化图。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明了,下面结合具体实施方式并参照附图1-4,对本发明进一步详细说明。应该理解,这些描述只是示例性的,而并非要限制本发明的范围。此外,在以下说明中,省略了对公知结构和技术的描述,以避免不必要地混淆本发明的概念。
实施例1
S1、采用溶胶-凝胶法制备生物活性玻璃,其中SiO2:P2O5:CaO生物玻璃粉体的物质组成质量百分比为:二氧化硅58%,五氧化二磷6%,氧化钙36%。用纳米研磨机研磨成纳米级生物活性玻璃;
S2、精密称取100mg PLGA颗粒,溶于500μL二氯甲烷和丙酮的混合溶液中(体积比9:1),超声完全溶解后,分别加入BG粉末25mg,分散均匀,在50℃下反应24小时,形成聚乳酸-羟基乙酸共聚物/生物活性玻璃的混合乳液;
S3、在通风橱中挥发掉S2制备的混合乳液中的二氯甲烷和丙酮,水洗,烘干,将所得粉体放入放电等离子烧结腔内,在两端施加50MPa的轴向压力,抽真空,当烧结室压力达到60Pa的时开始加热,升温速度为30℃/min,待温度升高至720℃时开始放电等离子烧结并保持2分钟;
S4、烧结完毕,停止加热并卸除压力,随炉冷却至室温,即得聚轻基乙酸/轻基磷灰石复合生物陶瓷材料,其杨氏模量为68GPa,断裂韧性为3.21MPa·m1/2,致密度为96%。
实施例2
S1、采用溶胶-凝胶法制备生物活性玻璃,其中SiO2:P2O5:CaO生物玻璃粉体的物质组成质量百分比为:二氧化硅58%,五氧化二磷10%,氧化钙32%。用纳米研磨机研磨成纳米级生物活性玻璃;
S2、精密称取100mg PLGA颗粒,溶于500μL二氯甲烷和丙酮的混合溶液中(体积比9:1),超声完全溶解后,分别加入BG粉末25mg,分散均匀,在50℃下反应24小时,形成聚乳酸-羟基乙酸共聚物/生物活性玻璃的混合乳液;
S3、在通风橱中挥发掉S2制备的混合乳液中的二氯甲烷和丙酮,水洗,烘干,将所得粉体放入放电等离子烧结腔内,在两端施加50MPa的轴向压力,抽真空,当烧结室压力达到60Pa的时开始加热,升温速度为30℃/min,待温度升高至720℃时开始放电等离子烧结并保持2分钟,烧结完毕,停止加热并卸除压力,随炉冷却至室温,即得聚轻基乙酸/轻基磷灰石复合生物陶瓷材料,其杨氏模量为68GPa,断裂韧性为3.21MPa·m1/2,致密度为96%。
实施例3
S1、采用溶胶-凝胶法制备生物活性玻璃,其中SiO2:P2O5:CaO生物玻璃粉体的物质组成质量百分比为:二氧化硅58%,五氧化二磷15%,氧化钙27%。用纳米研磨机研磨成纳米级生物活性玻璃;
S2、精密称取100mg PLGA颗粒,溶于500μL二氯甲烷和丙酮的混合溶液中(体积比9:1),超声完全溶解后,分别加入BG粉末25mg,分散均匀,在50℃下反应24小时,形成聚乳酸-羟基乙酸共聚物/生物活性玻璃的混合乳液;
S3、在通风橱中挥发掉S2制备的混合乳液中的二氯甲烷和丙酮,水洗,烘干,将所得粉体放入放电等离子烧结腔内,在两端施加50MPa的轴向压力,抽真空,当烧结室压力达到60Pa的时开始加热,升温速度为30℃/min,待温度升高至720℃时开始放电等离子烧结并保持2分钟,烧结完毕,停止加热并卸除压力,随炉冷却至室温,即得聚轻基乙酸/轻基磷灰石复合生物陶瓷材料,其杨氏模量为68GPa,断裂韧性为3.21MPa·m1/2,致密度为96%。
应当理解的是,本发明的上述具体实施方式仅仅用于示例性说明或解释本发明的原理,而不构成对本发明的限制。因此,在不偏离本发明的精神和范围的情况下所做的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。此外,本发明所附权利要求旨在涵盖落入所附权利要求范围和边界、或者这种范围和边界的等同形式内的全部变化和修改例。
Claims (5)
1.一种生物陶瓷复合高效生物降解骨钉的制备方法,其特征在于,包括以下步骤:
S1、将聚乳酸-羟基乙酸共聚物颗粒溶解到有机溶剂中配制成聚轻基乙酸的油相溶液;
S2、将生物活性玻璃粉末加入到油相溶液中,在50-80℃下反应12-24小时,形成聚乳酸-羟基乙酸共聚物/生物活性玻璃的混合乳液;
S3、挥发掉S2制备的混合乳液中的有机溶剂,水洗,烘干,将所得粉体放入放电等离子烧结腔内,在两端分别施加50和70MPa的轴向压力,抽真空,当烧结室压力达到60Pa时开始加热,升温速度为30-70℃/min,待温度升高至720-780℃时开始放电等离子烧结并保持2-10分钟;
S4、烧结完毕,停止加热并卸除压力,随炉冷却至室温,即得聚乳酸-羟基乙酸共聚物/生物活性玻璃复合生物降解骨钉。
2.根据权利要求1所述的一种生物陶瓷复合高效生物降解骨钉的制备方法,其特征在于,生物玻璃粉体为SiO2-P2O5-CaO生物玻璃粉体。
3.根据权利要求1所述的一种生物陶瓷复合高效生物降解骨钉的制备方法,其特征在于,SiO2-P2O5-CaO生物玻璃粉体的物质组成质量百分比为:二氧化硅58%,五氧化二磷6%-15%和氧化钙27%-36%。
4.根据权利要求1所述的一种生物陶瓷复合高效生物降解骨钉的制备方法,其特征在于,在S1中,有机溶剂为二氯甲烷和丙酮的混合溶液,且两者的体积比为9:1。
5.根据权利要求1所述的一种生物陶瓷复合高效生物降解骨钉的制备方法,其特征在于,聚乳酸-羟基乙酸共聚物的相对分子质量为5000-50000。
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