CN106474570A - 一种负载BMPs的可显影生物降解骨钉及其制备方法 - Google Patents
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Abstract
本发明涉及一种负载BMPs的可显影生物降解骨钉及其制备方法,所述骨钉由PCL、纳米羟基磷灰石、BMPs及显影剂组成。制备方法包括:将BMPs溶解在PBS溶液中配置BMPs溶液;将PCL溶解在有机溶剂中,室温下搅拌溶解,然后加入纳米羟基磷灰石、显影剂和BMPs溶液,超声分散,得到混合溶液,将溶剂挥发干净,得到混合材料;将混合材料熔化挤出至模具内,冷却,即得。本发明的可降解骨钉不仅具有高强度,而且具有高的韧性,能承受更大的压力且不易断裂;可用X射线造影,以观察骨钉植入体内后的生物降解情况,便于医师结合分析患者骨折愈合情况及骨钉的降解情况并给予最佳的康复性指导意见。
Description
技术领域
本发明属于医疗器械领域,特别涉及一种负载BMPs的可显影生物降解骨钉及其制备方法。
背景技术
骨钉是医学上常用的骨折内固定器械。传统的采用金属材料或者陶瓷材料制备的骨钉具有高强度高韧性的优点,已广泛用于临床应用中的骨折固定修复,但是这种骨钉不可被机体降解吸收,待患者骨折痊愈后需进行二次手术将其取出,会给患者造成二次伤害,而且骨钉取出后留下的空洞也给患者留下了潜在的骨折风险。目前,国内市场上已有可降解骨钉产品,如成都迪康中科生物医学材料有限公司生产的可吸收骨折内固定螺钉(产品标准号:YZB/国5373-2011),该骨钉由聚乳酸(PDLLA)组成,具有较好的生物相容性、高强度和良好的生物降解性能。但该产品只适用于非承重部位的骨折、截骨术和关节融合术,因为聚乳酸材料韧性较差,容易断裂。而且,组成可降解骨钉的可降解高聚物多数是X线可透性的,在X射线下显影性能不好甚至X射线下不可见,因此难以在术后复查时通过X射线判断骨钉的降解情况,不利于对患者做出最佳的康复性指导意见。
此外,骨钉的使用通常需要人为的在骨骼上钻出空洞以给骨钉制造内固定空间,一定程度上也造成了骨骼的缺损。而可生物降解骨钉在体内会被降解吸收,如若骨钉完全降解后,固定骨钉的空洞部位仍未完全自我修复,势必给患者留下潜在的骨折风险。骨形态发生蛋白(bone morphogenetic proteins,BMPs)家族是一类具有促成骨性能的诱导因子,并具有很强的骨诱导活性,在骨缺损研究中应用广泛,但是目前并没有负载BMPs的可降解骨钉产品或者相关的研究报道。这可能是因为目前常用的可降解骨钉原材料为聚乳酸,该材料的熔点在180℃左右,使得采用熔融铸模工艺制备骨钉的过程中会导致BMPs的失活。因为有报道指出,BMPs在温度高于70℃时即会失活。聚己内酯(PCL)是美国食品药品监督管理局(FDA)批准可用于临床的生物降解聚合物之一,具有良好的生物相容性和极佳的弹性、韧性性能,并且其熔点仅为60℃,易于加工,因此用PCL来负载BMPs具有一定的应用前景,因为在PCL的熔融温度下并不会导致BMPs的失活。
发明内容
本发明所要解决的技术问题是提供一种负载BMPs的可显影生物降解骨钉及其制备方法,该可降解骨钉不仅具有高强度,而且具有高的韧性,能承受更大的压力且不易断裂;不仅进一步提升了骨钉的强度,而且能进一步促进了骨钉内固定空洞部位的成骨修复;可用X射线造影,以观察骨钉植入体内后的生物降解情况,便于医师结合分析患者骨折愈合情况及骨钉的降解情况并给予最佳的康复性指导意见。
本发明的一种负载BMPs的可显影生物降解骨钉,所述骨钉由聚己内酯PCL、纳米羟基磷灰石、生长因子BMPs及显影剂组成;其中,纳米羟基磷灰石的质量占PCL质量的10~80%,显影剂的质量占PCL质量的1~10%,BMPs在骨钉中的含量为100ng/g~1mg/g。
所述BMPs为BMP-2、BMP-7或BMP-4。
所述显影剂为碘海醇。
本发明的一种负载BMPs的可显影生物降解骨钉的制备方法,包括:
(1)将BMPs溶解在PBS溶液中配置BMPs溶液,4~6℃保存备用;
(2)将PCL溶解在有机溶剂中,室温下搅拌溶解,得到浓度为5~20%w/v的均一溶液,然后加入纳米羟基磷灰石、显影剂和步骤(1)中的BMPs溶液,超声分散,得到混合溶液;其中,纳米羟基磷灰石的质量占PCL质量的10~80%,显影剂的质量占PCL质量的1~10%;
(3)将步骤(2)中混合溶液的溶剂挥发干净,得到混合材料;
(4)将步骤(3)得到的混合材料熔化挤出至骨钉模具内,冷却,即得负载BMPs的可显影生物降解骨钉;其中,骨钉中BMPs的含量为100ng/g~1mg/g。
所述步骤(1)中PBS(4℃)溶液的pH为7.4,PBS溶液的温度为4℃。
所述步骤(1)BMPs溶液的浓度为1mg/mL。
所述步骤(2)中有机溶剂为二氯甲烷或三氯甲烷。
所述步骤(2)中超声分散的时间为3-5min。
所述步骤(3)中溶剂挥发的方式为:将混合溶液倒入挥发皿中,在通风橱中吹风处理使大部分溶剂挥发后,置于室外环境挥发1-3d后再放入真空干燥箱1-3d。
所述吹风处理为快速吹风处理。
所述步骤(4)中熔化温度为60~65℃。
所述步骤(4)中熔化挤出为快速熔化挤出。
有益效果
(1)本发明制备的可降解骨钉不仅具有高强度,而且具有高的韧性,能承受更大的压力且不易断裂;
(2)本发明制备的可降解骨钉含有羟基磷灰石和BMPs活性成分,不仅进一步提升了骨钉的强度,而且能进一步促进了骨钉内固定空洞部位的成骨修复;
(3)本发明制备的可降解骨钉可用X射线造影,以观察骨钉植入体内后的生物降解情况,便于医师结合分析患者骨折愈合情况及骨钉的降解情况并给予最佳的康复性指导意见。
附图说明
图1为本发明中负载BMPs的可显影生物降解骨钉的示意图。
图2为本发明实施例1中制备的负载BMPs的可显影生物降解骨钉原材料(步骤(3)中得到的产物)的X光显影图片。
具体实施方式
下面结合具体实施例,进一步阐述本发明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明讲授的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1
(1)将BMP-2溶解在PBS溶液(4℃,pH 7.4)中配置成浓度为1mg/mL的溶液,4℃保存备用;
(2)称取10g PCL溶解在100mL三氯甲烷中室温下搅拌制得浓度为10%(w/v)的均一溶液,向溶液中加入占PCL质量40%(即4g)的纳米羟基磷灰石和占PCL质量5%(即0.5g)的碘海醇,然后向溶液中加入1mL步骤(1)中配制的BMP-2溶液,超声分散5min使纳米羟基磷灰石、碘海醇和BMP-2均匀分散在聚合物溶液中;
(3)将步骤(2)制得的混合溶液倒入挥发皿中,在通风橱中快速吹风处理使大部分溶剂挥发后,置于室外环境挥发3d后再放入真空干燥箱2d,使溶剂充分挥发干净得到干燥的混合材料;
(4)将步骤(3)得到的混合材料在熔融挤出机内快速熔化(60℃)挤出至骨钉模具内,冷却即得负载BMP-2的可显影生物降解骨钉。其中,骨钉中BMP-2的含量约为68.9μg/g。
实施例2
(1)将BMP-7溶解在PBS溶液(4℃,pH 7.4)中配置成浓度为1mg/mL的溶液,4℃保存备用;
(2)称取10g PCL溶解在100mL二氯甲烷中室温下搅拌制得浓度为10%(w/v)的均一溶液,向溶液中加入占PCL质量50%(即5g)的纳米羟基磷灰石和占PCL质量10%(即1g)的碘海醇,然后向溶液中加入0.5mL步骤(1)中配制的BMP-7溶液,超声分散5min使纳米羟基磷灰石、碘海醇和BMP-7均匀分散在聚合物溶液中;
(3)将步骤(2)制得的混合溶液倒入挥发皿中,在通风橱中快速吹风处理使大部分溶剂挥发后,置于室外环境挥发3d后再放入真空干燥箱2d,使溶剂充分挥发干净得到干燥的混合材料;
(4)将步骤(3)得到的混合材料在熔融挤出机内快速熔化(63℃)挤出至骨钉模具内,冷却即得负载BMP-7的可显影生物降解骨钉。其中,骨钉中BMP-7的含量为31.3μg/g。
实施例3
(1)将BMP-4溶解在PBS溶液(4℃,pH 7.4)中配置成浓度为1mg/mL的溶液,4℃保存备用;
(2)称取10g PCL溶解在100mL二氯甲烷中室温下搅拌制得浓度为10%(w/v)的均一溶液,向溶液中加入占PCL质量60%(即6g)的纳米羟基磷灰石和占PCL质量8%(即0.8g)的碘海醇,然后向溶液中加入0.1mL步骤(1)中配制的BMP-4溶液,超声分散5min使纳米羟基磷灰石、碘海醇和BMP-4均匀分散在聚合物溶液中;
(3)将步骤(2)制得的混合溶液倒入挥发皿中,在通风橱中快速吹风处理使大部分溶剂挥发后,置于室外环境挥发3d后再放入真空干燥箱2d,使溶剂充分挥发干净得到干燥的混合材料;
(4)将步骤(3)得到的混合材料在熔融挤出机内快速熔化(65℃)挤出至骨钉模具内,冷却即得负载BMP-4的可显影生物降解骨钉。其中,骨钉中BMP-4的含量为6.0μg/g。
Claims (10)
1.一种负载BMPs的可显影生物降解骨钉,其特征在于,所述骨钉由聚己内酯PCL、纳米羟基磷灰石、生长因子BMPs及显影剂组成;其中,纳米羟基磷灰石的质量占PCL质量的10~80%,显影剂的质量占PCL质量的1~10%,BMPs在骨钉中的含量为100ng/g~1mg/g。
2.根据权利要求1所述的一种负载BMPs的可显影生物降解骨钉,其特征在于,所述BMPs为BMP-2、BMP-7或BMP-4。
3.根据权利要求1所述的一种负载BMPs的可显影生物降解骨钉,其特征在于,所述显影剂为碘海醇。
4.一种负载BMPs的可显影生物降解骨钉的制备方法,包括:
(1)将BMPs溶解在PBS溶液中得到BMPs溶液,4~6℃保存备用;
(2)将PCL溶解在有机溶剂中,室温下搅拌溶解,得到浓度为5~20%w/v的均一溶液,然后加入纳米羟基磷灰石、显影剂和步骤(1)中的BMPs溶液,超声分散,得到混合溶液;其中,纳米羟基磷灰石的质量占PCL质量的10~80%,显影剂的质量占PCL质量的1~10%;
(3)将步骤(2)中混合溶液的溶剂挥发干净,得到混合材料;
(4)将步骤(3)得到的混合材料熔化挤出至骨钉模具内,冷却,即得负载BMPs的可显影生物降解骨钉;其中,骨钉中BMPs的含量为100ng/g~1mg/g。
5.根据权利要求4所述的一种负载BMPs的可显影生物降解骨钉的制备方法,其特征在于,所述步骤(1)中PBS溶液的pH为7.4,PBS溶液的温度为4℃。
6.根据权利要求4所述的一种负载BMPs的可显影生物降解骨钉的制备方法,其特征在于,所述步骤(1)BMPs溶液的浓度为1mg/mL。
7.根据权利要求4所述的一种负载BMPs的可显影生物降解骨钉的制备方法,其特征在于,所述步骤(2)中有机溶剂为二氯甲烷或三氯甲烷。
8.根据权利要求4所述的一种负载BMPs的可显影生物降解骨钉的制备方法,其特征在于,所述步骤(2)中超声分散的时间为3-5min。
9.根据权利要求4所述的一种负载BMPs的可显影生物降解骨钉的制备方法,其特征在于,所述步骤(3)中溶剂挥发的方式为:将混合溶液倒入挥发皿中,在通风橱中吹风处理使大部分溶剂挥发后,置于室外环境挥发1-3d后再放入真空干燥箱1-2d。
10.根据权利要求4所述的一种负载BMPs的可显影生物降解骨钉的制备方法,其特征在于,所述步骤(4)中熔化温度为60~65℃。
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