CN107213528A - 一种可降解骨植入物的制备方法 - Google Patents

一种可降解骨植入物的制备方法 Download PDF

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CN107213528A
CN107213528A CN201710397413.1A CN201710397413A CN107213528A CN 107213528 A CN107213528 A CN 107213528A CN 201710397413 A CN201710397413 A CN 201710397413A CN 107213528 A CN107213528 A CN 107213528A
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金仲恩
全春兰
张帆
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Suzhou Cosmetic New Materials Co Ltd
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    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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Abstract

本发明公开了一种可降解骨植入物的制备方法,方法包括如下步骤:步骤a.按照重量份称取各组分,将各组分混合搅拌后得到糊状物;步骤b.将糊状物注入模具中,进行加压成型;步骤c.待糊状物固化后脱模,得到骨植入物;步骤d.将骨植入物放置恒温恒湿柜中10‑20h。本发明制得骨植入物具有理想的体内降解性能,且是均匀降解,避免因局部降解过快导,降解速率为3‑10mm/year;同时具备抑菌、耐蚀、无细胞毒性、生物力学性能优良等特点;可以满足医用条件下作为骨钉、骨髓钉或接骨板等多种器件进行使用,综合性能优良。

Description

一种可降解骨植入物的制备方法
技术领域
本发明具体涉及一种可降解骨植入物的制备方法。
背景技术
近年来,随着生物医用植入材料的迅速发展,很多新型的医用植入材料被成功应用到临床中,取得了很好了医疗效果。其中,在骨科医用材料中,传统的钛合金、不锈钢等金属材料虽然已经获得广泛的临床应用,但是也表现出明显的应用局限性。但是不锈钢和钛合金都是生物惰性材料,在体内不可降解,并容易产生可溶性离子,易引起生物毒性、局部过敏或炎症;骨愈合后需要二次手术将植入材料取出,增加了患者的痛苦、心理和经济负担。
因此,研究对象到现在致力于开发新型可降解生物材料,目前临床应用的典型生物体内可降解的医用材料包括高分子材料、无机材料、金属材料和这些材料组成的复合材料。这些材料具有各自的优良特性,但也存在不足之处。高分子材料在可降解生物医用材料中应用最广泛,但是其强度很低,甚至很难达到常规金属材料强度的十分之一,很难在需要承受外力的骨科医用材料中获得使用。无机物有优良的骨组织相容性,但呈现脆性,成形性能差,很难制成临床需要的不同形状、尺寸的骨固定材料。然而,可降解金属的降解速率过快、局部降解不均匀、骨诱导能力不良等问题,目前尚不能满足临床要求。因此,必须开发低降解速率、均匀降解且具有诱导骨细胞生长的可降解骨植入物。
发明内容
本发明的目的在于提供一种可降解骨植入物的制备方法。
为了实现上述目的,本发明提供了一种可降解骨植入物的制备方法,该方法包括如下步骤:
步骤a.按照重量份称取氧化镁56-68份、纳米二氧化硅44-50份、碳化锆15-20份、硅酸三钙4-6份、卵磷脂4-8份、半水硫酸钙10-20份、透明质酸钠6-12份、羧基化细菌纤维素7-14份、淀粉12-18份和蒸馏水150-200份,将各组分混合搅拌后得到糊状物;
步骤b.将糊状物注入模具中,进行加压成型,并保持压力6.4-7.8atm,保压 15-30min;
步骤c.待糊状物固化后脱模,得到骨植入物;
步骤d.将骨植入物放置在温度35-38℃、湿度40-45%的恒温恒湿柜中10-20h。
所述淀粉为玉米淀粉或甘薯淀粉。
所述步骤b,先将可降解的镁合金加工成丝、条、框或网状,并放入模具,然后再将糊状物注入模具中,进行加压成型,并保持压力6.4-7.8atm,保压 15-30min。
所述羧基化细菌纤维素的羧基含量为30-60%。
所述骨植入物为骨螺钉、骨锚、组织U形钉、颅颌面重建板、紧固件、再造的牙科植入物或支架。
有益效果:本发明制得骨植入物具有理想的体内降解性能,且是均匀降解,避免因局部降解过快导,降解速率为3-10mm/year;同时具备抑菌、耐蚀、无细胞毒性、生物力学性能优良等特点;可以满足医用条件下作为骨钉、骨髓钉或接骨板等多种器件进行使用,综合性能优良。
具体实施方式
实施例1
一种可降解骨植入物的制备方法,该方法包括如下步骤:
步骤a.按照重量份称取氧化镁56份、纳米二氧化硅44份、碳化锆15份、硅酸三钙4份、卵磷脂4份、半水硫酸钙10份、透明质酸钠6份、羧基化细菌纤维素7份、淀粉12份和蒸馏水150份,将各组分混合搅拌后得到糊状物;
步骤b.将糊状物注入模具中,进行加压成型,并保持压力6.4atm,保压 30min;
步骤c.待糊状物固化后脱模,得到骨植入物;
步骤d.将骨植入物放置在温度35-38℃、湿度40-45%的恒温恒湿柜中10h。
所述淀粉为玉米淀粉或甘薯淀粉。
所述羧基化细菌纤维素的羧基含量为30%。
所述骨植入物为骨螺钉、骨锚、组织U形钉、颅颌面重建板、紧固件、再造的牙科植入物或支架。
实施例2
一种可降解骨植入物的制备方法,该方法包括如下步骤:
步骤a.按照重量份称取氧化镁68份、纳米二氧化硅50份、碳化锆20份、硅酸三钙6份、卵磷脂8份、半水硫酸钙20份、透明质酸钠12份、羧基化细菌纤维素14份、淀粉18份和蒸馏水200份,将各组分混合搅拌后得到糊状物;
步骤b.先将可降解的镁合金加工成丝、条、框或网状,并放入模具,然后再将糊状物注入模具中,进行加压成型,并保持压力7.8atm,保压 15min;
步骤c.待糊状物固化后脱模,得到骨植入物;
步骤d.将骨植入物放置在温度35-38℃、湿度40-45%的恒温恒湿柜中20h。
所述淀粉为玉米淀粉或甘薯淀粉。
所述羧基化细菌纤维素的羧基含量为60%。
所述骨植入物为骨螺钉、骨锚、组织U形钉、颅颌面重建板、紧固件、再造的牙科植入物或支架。
实施例3
一种可降解骨植入物的制备方法,该方法包括如下步骤:
步骤a.按照重量份称取氧化镁64份、纳米二氧化硅47份、碳化锆17份、硅酸三钙5份、卵磷脂6份、半水硫酸钙15份、透明质酸钠9份、羧基化细菌纤维素10份、淀粉15份和蒸馏水180份,将各组分混合搅拌后得到糊状物;
步骤b.先将可降解的镁合金加工成丝、条、框或网状,并放入模具,然后再将糊状物注入模具中,进行加压成型,并保持压力7.2atm,保压 20min;
步骤c.待糊状物固化后脱模,得到骨植入物;
步骤d.将骨植入物放置在温度35-38℃、湿度40-45%的恒温恒湿柜中15h。
所述淀粉为玉米淀粉或甘薯淀粉。
所述羧基化细菌纤维素的羧基含量为45%。
所述骨植入物为骨螺钉、骨锚、组织U形钉、颅颌面重建板、紧固件、再造的牙科植入物或支架。

Claims (5)

1.一种可降解骨植入物的制备方法,其特征在于该方法包括如下步骤:
步骤a.按照重量份称取氧化镁56-68份、纳米二氧化硅44-50份、碳化锆15-20份、硅酸三钙4-6份、卵磷脂4-8份、半水硫酸钙10-20份、透明质酸钠6-12份、羧基化细菌纤维素7-14份、淀粉12-18份和蒸馏水150-200份,将各组分混合搅拌后得到糊状物;
步骤b.将糊状物注入模具中,进行加压成型,并保持压力6.4-7.8atm,保压 15-30min;
步骤c.待糊状物固化后脱模,得到骨植入物;
步骤d.将骨植入物放置在温度35-38℃、湿度40-45%的恒温恒湿柜中10-20h。
2.根据权利要求1所述的一种可降解骨植入物的制备方法,其特征在于:所述淀粉为玉米淀粉或甘薯淀粉。
3.根据权利要求1所述的一种可降解骨植入物的制备方法,其特征在于:所述步骤b,先将可降解的镁合金加工成丝、条、框或网状,并放入模具,然后再将糊状物注入模具中,进行加压成型,并保持压力6.4-7.8atm,保压 15-30min。
4.根据权利要求1所述的一种可降解骨植入物的制备方法,其特征在于:所述羧基化细菌纤维素的羧基含量为30-60%。
5.根据权利要求1所述的一种可降解骨植入物的制备方法,其特征在于:所述骨植入物为骨螺钉、骨锚、组织U形钉、颅颌面重建板、紧固件、再造的牙科植入物或支架。
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108671265A (zh) * 2018-05-25 2018-10-19 合肥昂诺新材料有限公司 一种医用生物材料组合物及其制备方法
CN114177367A (zh) * 2021-09-30 2022-03-15 中山大学附属口腔医院 一种多功能引导骨再生复合膜及其制备方法和应用

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103044024A (zh) * 2012-12-11 2013-04-17 北京固圣生物科技有限公司 骨植入假体用氧化锆基复合陶瓷及由其制备的骨植入假体
WO2014124496A1 (en) * 2013-02-14 2014-08-21 The University Of Sydney Biocompatible material and uses thereof
CN105536048A (zh) * 2016-01-06 2016-05-04 宁波华科润生物科技有限公司 一种新型可降解骨植入物及其制备方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103044024A (zh) * 2012-12-11 2013-04-17 北京固圣生物科技有限公司 骨植入假体用氧化锆基复合陶瓷及由其制备的骨植入假体
WO2014124496A1 (en) * 2013-02-14 2014-08-21 The University Of Sydney Biocompatible material and uses thereof
CN105536048A (zh) * 2016-01-06 2016-05-04 宁波华科润生物科技有限公司 一种新型可降解骨植入物及其制备方法

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108671265A (zh) * 2018-05-25 2018-10-19 合肥昂诺新材料有限公司 一种医用生物材料组合物及其制备方法
CN114177367A (zh) * 2021-09-30 2022-03-15 中山大学附属口腔医院 一种多功能引导骨再生复合膜及其制备方法和应用

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