CN111202870A - 负载雷奈酸锶的hap/pla复合材料骨修复支架的制备方法 - Google Patents
负载雷奈酸锶的hap/pla复合材料骨修复支架的制备方法 Download PDFInfo
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Abstract
本发明公开了医用骨科材料技术领域内的一种负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,其将纳米级羟基磷灰石粉末、医用级PLA塑料颗粒及雷奈酸锶粉末充分混合得到混合原料;再经螺杆挤出机熔融挤出成丝,得到可供3D打印的掺杂雷奈酸锶的HAP/PLA线材,线材再在FDM熔融型打印机上打印,获得掺杂雷奈酸锶的HAP/PLA的骨修复支架。获得的骨修复支架具有高强度、高硬度和高抗冲击强度,并且具有良好的抗菌性和良好的生物相容性,其可以被人体降解且吸收,可降低了骨缺损处发生炎症的概率,是植入体材料的良好选择,负载的雷奈酸锶药物的“双重性”,促进骨生成的同时又能抑制骨吸收,从而加快骨缺损处的修复。
Description
技术领域
本发明属于医用骨科材料技术领域,特别涉及一种3D打印的骨修复支架材料的制备方法。
背景技术
骨质疏松是由于骨量的日益减少和骨组织微结构的破坏从而导致骨头脆性增加和骨折危险性增加,常常在老年人和绝经后妇女中发病。该病通常会直接影响到人全身的骨骼,其中骨折是骨质疏松的最常见的并发症,往往会引起腕、脊椎和髓骨的骨折。随着我国人日老龄化的日益恶化,骨质疏松病人的数量也逐渐增多。因此,使用安全有效的预防和治疗骨质疏松的药物是很有必要的。雷奈酸锶(Strontium ranelate)化学名为5-[二(羧甲基)氨基]-3-羧甲基-4-氰基-2-噻吩羧酸二锶盐,是法国的一家制药公司研制开发出的具有重要意义的新一代抗骨质疏松药,其对骨质疏松引起的骨折风险、增加骨强度和骨密度都有非常良好的疗效。该药已于2004年底经欧盟药物评审委员会(EMEA)审批通过并获准上市。雷奈酸锶是由微量元素锶和大分子有机酸雷奈酸形成的大分子络合物。其中锶是骨骼的重要的组成部分,它能促进骨骼的发育和类骨质的形成,井有调节钙代谢的作用。在许多治疗骨质疏松的药物中,雷奈酸锶是唯一一种既能刺激成骨细胞形成,又能抑制破骨细胞吸收功能的治疗骨质疏松的药物,由于该药物有很好的生物利用性和耐受性,雷奈酸锶的临床应用和进一步研究对骨质疏松症的预防和治疗将会有重要意义。
现有技术中,FDM 是一种采用热融型喷头,能够使热塑性材料熔化后从喷头内按一定速率挤出,并熔融沉积于我们所需打印位置后凝固成型的 3D 打印技术。FDM 成型技术的优点是成型精度较高、成型物件的力学性能较好、可以多色打印;缺点是成型物件的表面还需要进一步的加工处理。从打印仪器和材料成本来说,FDM操作更简便、可靠性更高,且成本较低,特别是对于小型公司和家庭用户更加实用,因此,FDM 技术是目前应用最为广泛的3D打印技术。
目前用于FDM 3D打印的聚合物线材主要是ABS和聚乳酸塑料(PLA)。因为PLA材料的来源广泛、可再生、可完全生物降解、力学性能优异以及生物相容性好,因而与ABS相比,PLA线材展现出更大的应用前景。例如,以PLA为线材通过FDM 3D打印制造完整的微流体装置,或在低温等离子体中使用PLA线材打印出了骨组织支架,或利用PLA线材打印了冷冻生物装置。然而,尽管PLA线材已经成功地应用于FDM过程,有关详细地挤出PLA线材的报道却少见报道。特别是随着当前个性化3D打印技术的发展,对多品类、每次耗用量少的新型聚合物线材的需求越来越强劲。
发明内容
本发明的目的是提供一种负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,所获得的骨修复支架具有促进骨生成和抑制骨吸收效果。
本发明的目的是这样实现的:一种负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,包括如下步骤:
1)将纳米级羟基磷灰石粉末、医用级PLA塑料颗粒充分混合及雷奈酸锶粉末充分混合得到混合原料;
2)经螺杆挤出机熔融挤出成丝,得到可供3D打印的掺杂雷奈酸锶的HAP/PLA线材,线材直径控制在1.70~1.80mm;
3)在FDM熔融型打印机上,导入设计好的骨修复支架三维模型后,以步骤2)获得的线材进行打印,获得掺杂雷奈酸锶的HAP/PLA的骨修复支架。
进一步地,为了使我们的骨修复支架的强度达到承受人体重量的标准,在所述混合原料中,纳米级羟基磷灰石粉末、医用级PLA塑料、雷奈酸锶粉末的质量比为(9~11):(88~92):1。
进一步地,为了使材料之间更好的紧密粘结形成复合材料,所述纳米级羟基磷灰石粉末及雷奈酸锶粉末混合前都是分别过200目筛。
所述医用级PLA颗粒优选为左旋聚乳酸颗粒(左旋聚乳酸的降解物对人体无害)。
本发明的步骤2)中,可采用单螺杆挤出机挤出成型,单螺杆挤出机的熔融温度为170~190℃。该温度下可保证羟基磷灰石粉末、医用级PLA塑料颗粒及雷奈酸锶能更好地混合,且不会发生分解。
进一步地,步骤3)中控制打印喷头温度为190~195℃,打印底板温度为30~50℃,打印速度为20~40mm/s,冷却风扇转速为1500~2000rpm,填充密度为40~60%,3D打印时的优选填充密度为50%,所选用打印喷头直径为0.2mm。
与现有技术相比,本发明有益效果在于,步骤2)中获得的线材可方便地进行3D打印,步骤3)获得的复合材料骨修复支架具有高强度、高硬度和高抗冲击强度,并且具有良好的抗菌性和良好的生物相容性,其可以被人体降解且吸收,可降低了骨缺损处发生炎症的概率,是植入体材料的良好选择,由于材料自身的高抗冲击性和硬度,能够满足人体骨缺损处的支撑。由于负载的雷奈酸锶药物的“双重性”,促进骨生成的同时又能抑制骨吸收,从而加快骨缺损处的修复。
附图说明
图1为实施例1制得负载雷奈酸锶的HAP/PLA复合材料的电镜扫描图。
图2为实施例1制得负载雷奈酸锶的HAP/PLA复合材料的能谱图。
图3为MC3T3细胞在材料组、纯PLA组和空白组的活死染色荧光图。
图4为MC3T3细胞在材料组、纯PLA组和空白组的CCK8检测数据图。
具体实施方式
下面结合实施例和附图对本发明作进一步详述。
以下实例中使用的医用级PLA塑料为进口医用级材料,购自Nature Works公司,已获得FDA认证。
实施例1
一种负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,按如下步骤进行:
1)将纳米级羟基磷灰石粉末、医用级PLA塑料颗粒及雷奈酸锶粉末充分混合得到混合原料;混合原料中,纳米级羟基磷灰石粉末、医用级PLA塑料、雷奈酸锶粉末的质量比为10:90:1;纳米级羟基磷灰石粉末及雷奈酸锶粉末混合前分别过200目筛。医用级PLA颗粒优选为左旋聚乳酸颗粒。原料加入密炼机在200℃混合15min。
2)将混合后的原料经单螺杆挤出机熔融挤出成丝,得到可供3D打印的掺杂雷奈酸锶的HAP/PLA线材,线材直径控制在1.75mm;单螺杆挤出机的熔融温度为170~175℃。
3)在FDM熔融型打印机上,导入设计好的骨修复支架三维模型后,以步骤2)获得的线材进行打印,获得掺杂雷奈酸锶的HAP/PLA的骨修复支架。
打印时,控制打印喷头温度为190~195℃,打印底板温度为30~50℃,打印速度为20~40mm/s,冷却风扇转速为1500~2000rpm,填充密度为50%,所选用打印喷头直径为0.2mm。
实施例2
一种负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,按如下步骤进行:
1)将纳米级羟基磷灰石粉末、医用级PLA塑料颗粒及雷奈酸锶粉末充分混合得到混合原料;混合原料中,纳米级羟基磷灰石粉末、医用级PLA塑料、雷奈酸锶粉末的质量比为9:92:1;纳米级羟基磷灰石粉末及雷奈酸锶粉末混合前分别过200目筛。
2)经单螺杆挤出机熔融挤出成丝,得到可供3D打印的掺杂雷奈酸锶的HAP/PLA线材,线材直径控制在1.70~1.80mm;单螺杆挤出机的熔融温度为180~190℃。
3)在FDM熔融型打印机上,导入设计好的骨修复支架三维模型后,以步骤2)获得的线材进行打印,获得掺杂雷奈酸锶的HAP/PLA的骨修复支架。
打印时,控制打印喷头温度为190~195℃,打印底板温度为45~50℃,打印速度为35~40mm/s,冷却风扇转速为1500~1600rpm,填充密度为40%,所选用打印喷头直径为0.2mm。
实施例3
一种负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,按如下步骤进行:
1)将纳米级羟基磷灰石粉末、医用级PLA塑料颗粒及雷奈酸锶粉末充分混合得到混合原料;混合原料中,纳米级羟基磷灰石粉末、医用级PLA塑料、雷奈酸锶粉末的质量比为11:88:1;纳米级羟基磷灰石粉末及雷奈酸锶粉末混合前分别过200目筛。
2)经单螺杆挤出机熔融挤出成丝,得到可供3D打印的掺杂雷奈酸锶的HAP/PLA线材,线材直径控制在1.70~1.75mm;单螺杆挤出机的熔融温度为180℃。
3)在FDM熔融型打印机上,导入设计好的骨修复支架三维模型后,以步骤2)获得的线材进行打印,获得掺杂雷奈酸锶的HAP/PLA的骨修复支架。
打印时,控制打印喷头温度为180~185℃,打印底板温度为30~35℃,打印速度为20~25mm/s,冷却风扇转速为1800~2000rpm,填充密度为60%,所选用打印喷头直径为0.2mm。
以下为上述实施例1的实验数据,实施例2和3与之具有基本的相同的效果。
图1和图2为负载雷奈酸锶的HAP/PLA的复合材料的电镜扫描和能谱图。从电镜扫描图中可以看出复合材料表面光滑,呈一根根棒状粘结在一起,这样非常利于后续的3D打印。从对应的能谱图也可以看出, Sr元素也是在材料中均匀分布。
图3为材料组、纯PLA组和空白组在第一天和第三天的对MC3T3细胞的活死染色荧光图。a和d为掺药的材料组,b和e为纯PLA的对照组,c和f为空白组。通过三者的对比可以明显看出第三天的细胞数量多于第一天的细胞数量,说明我们的材料可以促进MC3T3细胞的生长。同时掺锶的PLA的材料组与未掺锶的纯PLA组相比,其细胞数量更多,说明锶成功的掺入到了PLA中,且掺锶后有助于细胞生长,且与空白组相比,没有明显的差别,说明制备的材料具有良好的生物相容性,可进行进一步的应用。
图4为材料组、纯PLA组和空白组对MC3T3细胞的CCK8的检测结果。从图中可以看出掺锶的PLA与未掺锶的相比其细胞数量更多,说明药物被成功的掺杂在PLA中,且掺锶后有助于细胞生长,且与空白组相比,没有明显的差别,说明制备的材料具有良好的生物相容性,这一结果同时也佐证了活死染色荧光数据的可信度。
本发明并不局限于上述实施例,在本发明公开的技术方案的基础上,本领域的技术人员根据所公开的技术内容,不需要创造性的劳动就可以对其中的一些技术特征作出一些替换和变形,这些替换和变形均在本发明的保护范围内。
Claims (7)
1.一种负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,其特征在于,包括如下步骤:
1)将纳米级羟基磷灰石粉末、医用级PLA塑料颗粒及雷奈酸锶粉末充分混合得到混合原料;
2)经螺杆挤出机熔融挤出成丝,得到可供3D打印的掺杂雷奈酸锶的HAP/PLA线材,线材直径控制在1.70~1.80mm;
3)在FDM熔融型打印机上,导入设计好的骨修复支架三维模型后,以步骤2)获得的线材进行打印,获得掺杂雷奈酸锶的HAP/PLA的骨修复支架。
2.根据权利要求1所述的负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,其特征在于,所述混合原料中,纳米级羟基磷灰石粉末、医用级PLA塑料、雷奈酸锶粉末的质量比为(9~11):(88~92):1。
3.根据权利要求1或2所述的负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,其特征在于,纳米级羟基磷灰石粉末及雷奈酸锶粉末混合前分别过200目筛。
4.根据权利要求1或2所述的负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,其特征在于,所述医用级PLA颗粒为左旋聚乳酸颗粒。
5.根据权利要求1或2所述的负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,其特征在于,步骤2)中,采用单螺杆挤出机挤出成型,单螺杆挤出机的熔融温度为170~190℃。
6.根据权利要求1或2所述的负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,其特征在于,步骤3)中控制打印喷头温度为190~195℃,打印底板温度为30~50℃,打印速度为20~40mm/s,冷却风扇转速为1500~2000rpm,填充密度为40~60%,所选用打印喷头直径为0.2mm。
7.根据权利要求6所述的负载雷奈酸锶的HAP/PLA复合材料骨修复支架的制备方法,其特征在于,3D打印时的填充密度为50%。
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