CN106267332A - 一种多孔镁合金作为载体在医学上的应用 - Google Patents

一种多孔镁合金作为载体在医学上的应用 Download PDF

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CN106267332A
CN106267332A CN201610753774.0A CN201610753774A CN106267332A CN 106267332 A CN106267332 A CN 106267332A CN 201610753774 A CN201610753774 A CN 201610753774A CN 106267332 A CN106267332 A CN 106267332A
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何国
李秋炎
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Shanghai Jiaotong University
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Abstract

本发明涉及一种多孔镁合金作为载体在医学上的应用，将药物负载在多孔镁合金上，用作血管支架、骨修复或骨支撑材料。通过直接发泡法、腐蚀造孔法、激光打孔法、粉末冶金法、快速成型法、共渗透振动法、3D打印法等方法制备多孔镁合金。然后通过激光熔覆、微弧氧化、阳极氧化、渗透法、包埋法、溶剂挥干法、熔融法、吸附平衡法等方法在多孔镁合金表面或多孔结构中载入药物，起到增加表面活性、促进骨细胞生长和分化、预防感染、针对性给药、局部给药等作用。该制备方法具有操作简单易行，结构可控，载药方便，药物结合牢固，成本低等优点。

Description

一种多孔镁合金作为载体在医学上的应用
技术领域
本发明属于生物医用材料领域，具体涉及一种医用载药多孔镁合金，主要用于心血管支架、骨修复和骨支撑材料方面。
背景技术
镁合金是目前生物医用可降解金属植入材料领域的研究热点。镁合金具有以下优点：1.镁合金具有良好的生物相容性；2.镁是人体内仅次于钙、钠和钾的常量元素之一，能够激活多种酶，参与体内一系列代谢过程，促进钙的沉积，是骨生长的必需元素；3.镁合金具有良好的力学相容性，密度接近自然骨，其弹性模量约41-45GPa，更接近于人骨的弹性模量，可有效缓解应力屏蔽效应，促进骨的生长和愈合并防止发生二次骨折；4.镁可完全降解；5.镁合金成本低。
多孔镁合金作为一种可降解的生物材料，其中的孔可为骨细胞生长提供三维生长空间,并且有利于养料和代谢物的交换运输，其本身具有生物活性，可诱导细胞分化生长和血管长入。在材料降解吸收的过程中，周围的细胞会继续增殖生长，有望形成新的具有原来特定功能和形态的相应组织和器官，以达到修复创伤和重建功能的目。
手术后感染是植入手术后最常见的并发症,这可能会给病人导致重大。传统的预防术后感染的方法为注射抗生素。通过注射抗生素预防术后感染具有注射剂量大，毒性大，副作用大的缺点。
根据需要在多孔镁合金多孔结构或表面载药可以起到增加表面活性、促进骨细胞生长和分化、预防感染、针对性给药、局部给药等作用。例如有针对性的递送一种或多种药物到受损位置，具有较低的剂量和较小的副作用。
发明内容
本发明的目的就是为了克服上述传统给药技术存在的缺陷而提供一种多孔镁合金作为载体在医学上的应用。
本发明的目的可以通过以下技术方案来实现：一种多孔镁合金作为载体在医学上的应用，其特征在于，将药物负载在多孔镁合金上，用作血管支架、骨修复或骨支撑材料。
所述的药物采用激光熔覆、微弧氧化、阳极氧化、渗透法、包埋法、溶剂挥干法、熔融法或吸附平衡法负载到多孔镁合金上，载药量≥1mg/cm3。
所述的药物包括生物相容性好的物质、预防术后感染的药物、促进骨细胞生长的元素，抗肿瘤的药物或生长因子；
所述的生物相容性好的物质包括钽粉、羟基磷灰石、硅酸钙、磷酸钙或硫酸钙；
所述的预防术后感染的药物包括银离子、硫酸庆大霉素或万古霉素；
所述的促进骨细胞生长的元素包括锶、锌、锂或钙。
所述的多孔镁合金包括纯镁以及镁与银、钙、锌、锶、锆的二元或多远合金，其中镁的质量分数为80％-99.9％，优选90％-99.9％。
所述的多孔镁合金的孔隙率为10％-90％，优选45％-85％，孔径大小为0.01-2mm，优选0.1-0.5mm。
所述的多孔镁合金的强度为5-200MPa，优选50-150MPa，弹性模量为0.1-40GPa，优选3-35GPa。
多孔镁合金的孔的形状、大小、分布以及孔隙率可控，主要是通过制备方法控制。
多孔镁合金的力学性能也可控，主要是通过孔的形状、大小、分布以及孔隙率控制。
所述的多孔镁合金的孔通过直接发泡法、腐蚀造孔法、激光打孔法、粉末冶金法、快速成型法、共渗透振动法或3D打印法制备。
本发明的目的是提高医用镁合金的生物活性，并使植入镁合金材料具有预防术后感染和促进骨细胞生长分化等功能。镁合金本身具有多孔结构，有利于骨细胞生长和体液传输。多孔结构的孔的形状、大小和分布可控，孔隙率可控。在多孔结构中或材料表面载入钽粉、羟基磷灰石、磷酸钙、硫酸钙、硅酸钙等生物相容性好的物质，银离子、硫酸庆大霉素、万古霉素等预防术后感染的药物，锶、锌、锂、钙等促进骨细胞生长的元素，抗肿瘤的药物或生长因子。具有增加表面活性、促进骨细胞生长和分化、预防感染、针对性给药、局部给药等作用。该材料可满足心血管支架和骨支撑骨修复材料等植入需要。
与现有技术相比，本发明具有以下优点：
1.具有优良的力学性能，优良的骨传输和骨诱导能力；
2.多孔结构孔的分布、孔径大小、形状和孔隙率可根据需要调节；
3.力学性能可调；
4.材料形状和大小容易控制，可根据植入需要设计；
5.载药方便，药物结合牢固；
6.可以满足大多数心血管支架、骨填充、骨修复、骨移植的需求。
具体实施方式
下面对本发明的实施例作详细说明，本实施例在以本发明技术方案为前提下进行实施，给出了详细的实施方式和具体的操作过程，但本发明的保护范围不限于下述的实施例。
实施例1
利用腐蚀造孔法制备多孔镁，多孔镁孔径大小为100μm，孔隙率为30％，强度为100MPa，弹性模量为20GPa。利用激光熔覆在多孔镁孔内及表面载入钽粉，载药量为1mg/cm3，钽具有优良的生物相容性，可有效提高材料的骨结合能力。该材料可满足骨填充、骨移植、骨修复的需要。
实施例2
利用腐蚀造孔法制备多孔镁，多孔镁孔径大小为300μm，孔隙率为50％，强度为50MPa，弹性模量为11GPa。在孔中载入羟基磷灰石浆体然后固化，羟基磷灰石具有优良的生物相容性，可促进植入体与骨形成牢固的结合。该材料可满足骨填充、骨移植、骨修复的需要。
实施例3
利用腐蚀造孔法制备多孔镁，多孔镁孔径大小为500μm，孔隙率为70％，强度为20MPa，弹性模量为5GPa。在孔中和材料表面载入银离子，载药量为2mg/cm3，银离子具有很好的抑菌作用，可以预防术后感染，降低手术失败的几率。该材料可满足骨填充、骨移植、骨修复的需要。
实施例4
利用腐蚀造孔法制备多孔镁，多孔镁孔径大小为1mm，孔隙率为90％，强度为2MPa，弹性模量为0.5GPa。在孔中利用渗透法载入硫酸庆大霉素，载药量为10mg/cm3，硫酸庆大霉素可有效抑制金黄葡萄球菌和大肠杆菌等，可以预防术后感染，降低植入手术失败的几率。该材料可满足骨填充、骨修复的需要。
实施例5
利用腐蚀造孔法制备多孔镁，多孔镁孔径大小为2mm，孔隙率为50％，强度为50MPa，弹性模量为12GPa。在孔中利用包埋法载入万古霉素，载药量为20mg/cm3，万古霉素是目前临床常用的抗生素，具有抑制葡萄球菌(包括耐青霉素和耐新青霉素株)的作用，可以预防术后感染，降低植入手术失败的几率。该材料可满足骨填充、骨移植、骨修复的需要。
实施例6
利用激光打孔法制备多孔镁，多孔镁孔径大小为50μm，孔隙率为70％，强度为20MPa，弹性模量为5GPa。在孔中利用包埋法载入紫杉醇，载药量为5mg/cm3。该材料可满足心血管支架的需要。
实施例7
利用激光打孔法制备多孔镁锌合金，多孔镁合金孔径大小为25μm，孔隙率为90％，强度为4MPa，弹性模量为0.5GPa。在孔中利用包埋法载入雷帕霉素，载药量为30mg/cm3，雷帕霉素是一种疗效好，低毒，无肾毒性的新型免疫抑制剂。该材料可满足心血管支架的需要。
实施例8
利用激光打孔法制备多孔镁钙合金，多孔镁合金孔径大小为5μm，孔隙率为80％，强度为15MPa，弹性模量为1.5GPa。在孔中利用渗透法载入尼莫地平，载药量为50mg/cm3，尼莫地平用于急性脑血管病恢复期的血液循环改善。各种原因的蛛网膜下腔出血后的脑血管痉挛，及其所致的缺血性神经障碍高血压、偏头痛等。也被用作缺血性神经元保护和血管性痴呆的治疗。该材料可满足心血管支架的需要。
实施例9
利用粉末冶金法制备多孔镁锶合金，多孔镁合金孔径大小为200μm，孔隙率为30％，强度为100MPa，弹性模量为10GPa。在孔中利用吸附平衡法载入布洛芬，载药量为8mg/cm3，布洛芬具有抗炎、镇痛、解热作用。适用于治疗风湿性关节炎、类风湿性关节炎、骨关节炎、强直性脊椎炎和神经炎等。该材料可满足骨填充、骨移植、骨修复的需要。
实施例10
利用3D打印法制备多孔镁锌合金，多孔镁合金孔径大小为400μm，孔隙率为60％，强度为75MPa，弹性模量为8GPa。在孔中利用熔融法载入头孢他啶，载药量为1mg/cm3，头孢他啶适用于敏感革兰氏阴性杆菌所至的败血症、下呼吸系感染、腹腔胆系感染、复杂性尿路感染和严重皮肤软组织感染。对于由多种耐药革兰氏阴性杆菌引起的免疫缺陷者感染、医院内感染以及革兰氏阴性杆菌或绿脓杆菌所致中枢神经系感染尤为适用。该材料可满足心骨填充、骨移植、骨修复的需要。
实施例11
利用3D打印法制备多孔镁锌合金，镁的质量分数为99.9％，多孔镁合金孔径大小为0.01mm，孔隙率为90％，强度为5MPa，弹性模量为0.1GPa。在孔中利用熔融法载入头孢他啶。该材料可满足心骨填充、骨移植、骨修复的需要。
实施例12
利用激光打孔法制备多孔镁钙合金，镁的质量分数为80％，多孔镁合金孔径大小为2mm，孔隙率为10％，强度为200MPa，弹性模量为40GPa。在孔中利用渗透法载入尼莫地平。该材料可满足心血管支架的需要。

Claims (7)

1.一种多孔镁合金作为载体在医学上的应用，其特征在于，将药物负载在多孔镁合金上，用作血管支架、骨修复或骨支撑材料。
2.根据权利要求1所述的多孔镁合金作为载体在医学上的应用，其特征在于，所述的药物采用激光熔覆、微弧氧化、阳极氧化、渗透法、包埋法、溶剂挥干法、熔融法或吸附平衡法负载到多孔镁合金上，载药量≥1mg/cm3。
3.根据权利要求1所述的多孔镁合金作为载体在医学上的应用，其特征在于，所述的药物包括生物相容性好的物质、预防术后感染的药物、促进骨细胞生长的元素，抗肿瘤的药物或生长因子；
所述的生物相容性好的物质包括钽粉、羟基磷灰石、硅酸钙、磷酸钙或硫酸钙；
所述的预防术后感染的药物包括银离子、硫酸庆大霉素或万古霉素；
所述的促进骨细胞生长的元素包括锶、锌、锂或钙。
4.根据权利要求1所述的多孔镁合金作为载体在医学上的应用，其特征在于，所述的多孔镁合金包括纯镁以及镁与银、钙、锌、锶、锆的二元或多远合金，其中镁的质量分数为80％-99.9％，优选90％-99.9％。
5.根据权利要求1所述的多孔镁合金作为载体在医学上的应用，其特征在于，所述的多孔镁合金的孔隙率为10％-90％，优选45％-85％，孔径大小为0.01-2mm，优选0.1-0.5mm。
6.根据权利要求1所述的多孔镁合金作为载体在医学上的应用，其特征在于，所述的多孔镁合金的强度为5-200MPa，优选50-150MPa，弹性模量为0.1-40GPa，优选3-35GPa。
7.根据权利要求1所述的多孔镁合金作为载体在医学上的应用，其特征在于，所述的多孔镁合金的孔通过直接发泡法、腐蚀造孔法、激光打孔法、粉末冶金法、快速成型法、共渗透振动法或3D打印法制备。
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CN106637179A (zh) * 2017-03-06 2017-05-10 浙江工业大学 一种选区激光熔化成型钛合金的表面化学氧化方法
CN107760945A (zh) * 2017-10-26 2018-03-06 中南大学 一种具有高腐蚀抗力和生物活性的镁合金及其制备方法
CN107760945B (zh) * 2017-10-26 2019-06-04 中南大学 一种具有高腐蚀抗力和生物活性的镁合金及其制备方法
CN109402544A (zh) * 2018-11-07 2019-03-01 江苏大学 一种提高镁合金接骨板耐生物腐蚀性的方法
CN112386748A (zh) * 2019-08-12 2021-02-23 湖南早晨纳米机器人有限公司 镁合金纳米机器人及其制备方法
CN110560695A (zh) * 2019-09-03 2019-12-13 西安建筑科技大学 一种表面多孔钛基功能梯度材料及其制备方法
CN110560695B (zh) * 2019-09-03 2021-10-22 西安建筑科技大学 一种表面多孔钛基功能梯度材料及其制备方法
CN110976860A (zh) * 2019-11-27 2020-04-10 东南大学 一种多成分组成的可降解镁合金材料及其制备方法和应用
CN110976860B (zh) * 2019-11-27 2022-03-08 东南大学 一种多成分组成的可降解镁合金材料及其制备方法和应用
CN111407923A (zh) * 2020-04-09 2020-07-14 佳木斯大学 一种控制药物释放镁或镁合金仿生骨及其制备方法
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