CN103785061A - Collagen/hydroxyapatite composite coating joint prosthesis implant and preparation method thereof - Google Patents

Collagen/hydroxyapatite composite coating joint prosthesis implant and preparation method thereof Download PDF

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CN103785061A
CN103785061A CN 201410007905 CN201410007905A CN103785061A CN 103785061 A CN103785061 A CN 103785061A CN 201410007905 CN201410007905 CN 201410007905 CN 201410007905 A CN201410007905 A CN 201410007905A CN 103785061 A CN103785061 A CN 103785061A
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collagen
hydroxyapatite
artificial joint
coating
coated
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CN 201410007905
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CN103785061B (en )
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严伟祺
齐义营
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浙江大学
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Abstract

The invention discloses a collagen/hydroxyapatite composite coating joint prosthesis implant and a preparation method thereof. The surface of a joint prosthesis material is coated with collagen and hydroxyapatite composite sequentially, wherein the thickness of the collagen coating is 10-20 mu m, the porosity of the collagen coating is 90-95 percent, the thickness of the hydroxyapatite coating is 20-50 mu m, and the porosity of the hydroxyapatite coating is 5-15 percent, so that the surface of the joint prosthesis contains a natural bone extracellular matrix ingredient, so that the function of inducing osteogenesis is enhanced, and thus the linkage of bone and an implanted titanium plate is promoted, the joint prosthesis is physiologically fixed, and the difficulty that the joint prosthesis is easy to loosen after being implanted inside in the prior art is effectively solved.

Description

胶原/羟基磷灰石复合涂层人工关节植入体及制备方法 Collagen / hydroxyapatite composite coating of artificial joint implants and preparation method

技术领域 FIELD

[0001] 本发明属于骨外科关节领域,尤其涉及一种胶原/羟基磷灰石复合涂层人工关节植入体及制备方法。 [0001] The present invention is in bone surgery field joint, particularly to a collagen / hydroxyapatite composite coating artificial joint body and a method for preparing implant.

背景技术 Background technique

[0002] 随着人口老龄化的加剧和各种损伤造成的关节损害的增加,往往导致关节结构上发生改变,单纯使用药物治疗只能部分缓解疼痛症状,难以改善关节功能。 [0002] With the increase of increasing aging population and joint damage of all kinds of damage caused, often leads to changes on the joint structure, simple to use drugs only partially relieve pain, it is difficult to improve joint function. 而人工关节置换可以达到缓解疼痛、稳定关节、矫正畸形、改善关节功能等目的。 The artificial joint replacement can achieve pain relief, joint stability, correct deformities, improve joint function purposes. 如类风湿性关节炎引起的疼痛、陈旧性关节脱位等,通过人工关节手术,可以明显矫正关节畸形,使原来僵硬的关节恢复正常功能。 The pain caused by rheumatoid arthritis, old dislocation and the like, by the artificial joint surgery can be significantly corrected joint deformity, so that the original stiff joints restore normal function. 许多疾病所致的关节疼痛和严重功能障碍,都适合采用人工关节置换手术,全世界每年有大约80万人接受人工关节手术,而且有逐年增多的趋势。 Many joint pain and severe functional disorders caused, are suitable for artificial joint replacement surgery, the world has about 80 million people were receiving artificial joint surgery each year, and there is increasing year by year. 人工关节手术是二十世纪医学上取得的一个最成功的手术之一,也是治疗关节疾患的最好方法之一。 Artificial joint surgery is one of the most successful operation made the twentieth century medicine, is one of the best joint disease treatment. 然而它也存在一些问题,假体松动发生率可达2%-24%,究其原因就是材料和人体骨界面不能完好结合,导致置换后骨溶解、关节松动等人工关节问题。 However, it also has some problems, loosening the incidence of up to 2% -24%, the reason is the material and human bone interface is not well combined, leading to the replacement of osteolysis, joint loosening of artificial joint problems.

发明内容 SUMMARY

[0003] 本发明的目的在于针对现有技术的不足,提供了一种胶原/羟基磷灰石复合涂层人工关节植入体及制备方法。 [0003] The object of the present invention is for the deficiencies of the prior art, there is provided a collagen / hydroxyapatite composite coating artificial joint body and a method for preparing implant. 使人工关节植入人体之后使生物活性材料与人体骨之间建立一种骨性结合而实现生物固定,可防止假体松动、下沉,延长人工关节使用年限。 That the artificial joint biologically active material and human bone after implantation of the body between the establishment of a osseointegration is achieved biological fixation prevents prosthesis loosening, subsidence, prolonged artificial joint life.

[0004] 本发明的目的是通过以下技术方案来实现的:一种胶原/羟基磷灰石复合涂层人工关节植入体,人工关节材料表面具有胶原涂层,胶原涂层膜厚度为5~20 μ m、孔隙率为90%~95%,在胶原涂层上具有羟基磷灰石涂层,羟基磷灰石涂层厚度为20~ΙΟΟμπκ孔隙率为5%~15%。 [0004] The object of the present invention is achieved by the following technical solutions: A collagen / hydroxyapatite composite coating of artificial joint implants, artificial material surfaces of the articular having collagen-coated, collagen-coated film thickness of 5 to 20 μ m, a porosity of 90% to 95%, having a hydroxyapatite coating on the collagen-coated hydroxyapatite coating thickness of 20 ~ ΙΟΟμπκ porosity of 5% to 15%.

[0005] 上述胶原/羟基磷灰石复合涂层人工关节植入体的制备方法,包括以下步骤: [0005] The collagen / hydroxyapatite composite coating method for preparing an artificial joint implant body, comprising the steps of:

(1)人工关节植入体经金刚砂纸打磨后,依次置于丙酮、体积百分比为75%的乙醇、双蒸水中超声清洗20、15、20min,再以0.25-0.5mm大颗粒金刚砂磨砂人工关节植入体后,依次以丙酮、体积百分比为75%的乙醇、蒸馏水超声清洗各15 min,得到表面光滑的人工关节植入体; (1) artificial joint implants after emery paper grinding, sequentially disposed acetone volume percentage of 75% ethanol, distilled water, ultrasonic cleaning 20,15,20min, then to 0.25-0.5mm large particles emery frosted artificial joints after the implant, followed by acetone, volume percentage of 75% ethanol, distilled water, ultrasonic cleaning each 15 min, to obtain a smooth surface of the artificial joint implant;

(2)从牛肌腱中提取I型胶原,将I型胶原溶液(5mg/ml)和碳化二亚胺溶液(5mg/ml)等体积混合,得到第一混合溶液,在第一混合溶液中浸入步骤I得到的表面光滑的人工关节植入体,37°C水浴维持18小时,得到胶原涂层的人工关节植入体,将其浸入PBS溶液中超声处理IOmin去除未紧密粘附的胶原; (2) extraction of type I collagen from bovine tendon, Type I collagen solution (5mg / ml) Volume mixing and carbodiimide solution (5mg / ml) and the like, to obtain a first mixed solution was immersed in the first mixed solution step I obtained smooth surface of the artificial joint implants, 37 ° C water bath for 18 hours to obtain a collagen-coated artificial joint implants, immersed in PBS solution was sonicated IOmin removed not closely adhered to collagen;

(3)将20ml尿素酶溶液(1.5mg/ml)与30ml碳化二亚胺溶液(5mg/ml)混合,得到第二混合溶液;将步骤2得到的胶原涂层的人工关节植入体浸入第二混合溶液中,37°C水浴18小时,得到尿素酶修饰的胶原涂层的人工关节植入体,将其置入PBS溶液冲洗; (3) mixing 20ml urease solution (1.5mg / ml) and 30ml carbodiimide solution (5mg / ml), to give a second mixed solution; artificial joint collagen coat layer obtained in Step 2 of the implant immersed into a first two mixed solution, 37 ° C water bath for 18 hours to obtain urease-modified collagen-coated artificial joint implant, which is placed into a PBS solution flushed;

(4)将Ca(N03)2、NH4H2PO4、尿素混合溶解于水中使各自浓度达到10mM、6mM和10禮,用浓度为50mM氨水调节PH值在5.8,配置第三混合溶液,然后将步骤3得到的尿素酶修饰的胶原涂层的人工关节植入体浸入第三混合溶液中,37°C维持I小时,这样胶原涂层的表面被羟基磷灰石涂层,从而得到本发明权利要求1所述胶原/羟基磷灰石混合涂层人工关节植入体。 (4) Ca (N03) 2, NH4H2PO4, urea mixture was dissolved in water so that the respective concentration of 10mM, 6mM and 10 ceremony, a concentration of 50mM ammonia to adjust the PH value of 5.8, the configuration of the third mixed solution, then the resulting Step 3 artificial joints urease modified collagen-coated implant is immersed in the third mixed solution, 37 ° C to maintain I hour, the surface of such collagen-coated hydroxyapatite coating is to obtain the present invention as claimed in claim 1 said collagen / hydroxyapatite hybrid coating of artificial joint implants.

[0006] 本发明的有益效果是,本发明通过对人工关节表面进行胶原和羟基磷灰石复合涂层,使其表面具有天然骨基质的主要成分,促进新骨的长入,从而促进骨与人工关节的链接,防止假体松动的发生。 [0006] Advantageous effects of the present invention, the present invention is by collagen and hydroxyapatite on the artificial articular surface of the composite coating to the surface having the main component of natural bone matrix, promoting new bone ingrowth to promote bone and link artificial joints, prevent loosening occurs. 本发明通过改性植入材料的表面结构,进行胶原和羟基磷灰石混合涂层,使材料和人体骨界面更好结合,将大幅度降低置换并发症,减少置换后骨溶解、关节松动等人工关节问题,延长人工关节使用年限。 The present invention, by the surface structure of the modified implant material, for collagen and hydroxyapatite mixed coating, the material and human bone interface better binding, will be significantly reduced displacement of complications and reduce osteolysis after replacement, joint loosening artificial joint problems, prolonged artificial joint service life.

附图说明 BRIEF DESCRIPTION

[0007]图1为胶原/羟基磷灰石复合涂层的钛板表面电镜结构图。 [0007] FIG. 1 is a collagen / hydroxyapatite surface of the current mirror structure of FIG titanium coating.

[0008] 图2为骨细胞粘附在胶原/羟基磷灰石复合涂层的钛板表面图。 [0008] FIG. 2 is a bone cell adhesion in collagen / apatite composite coating titanium surface in FIG hydroxy.

具体实施方式 Detailed ways

[0009] 下面结合具体实施例对本发明进行进一步描述,但本发明的保护范围并不仅限于此。 [0009] Specific embodiments below in conjunction with the present invention will be further described, but the scope of the present invention is not limited thereto.

[0010] 实施例1: [0010] Example 1:

商用纯钛切割成IOmmX IOmmX Imm正方片,经320#、400#、600#金刚砂纸依次打磨,然 Commercially pure titanium cut IOmmX IOmmX Imm square plate with 320 #, 400 #, 600 # emery paper sequentially polished, then

后依次置于丙酮、体积百分比为75%的乙醇、双蒸水中超声清洗20、15、20min,得到光滑表面钛板。 After sequentially placed in acetone, the volume percentage of 75% ethanol, distilled water, ultrasonic cleaning 20,15,20min, to obtain a smooth surface of a titanium plate. 以0.25-0.5mm大颗粒金刚砂磨砂光滑面钛板,依次以丙酮、体积百分比为75%的乙醇、蒸馏水超声清洗各15 min。 In 0.25-0.5mm large particles emery frosted smooth surface of a titanium plate, followed by acetone, volume percentage of 75% ethanol, distilled water, ultrasonic cleaning each 15 min. 从牛肌腱中提取I型胶原,I型胶原溶液(5mg/ml)和碳化二亚胺溶液(5mg/ml)等体积混合,在混合溶液中浸入钛板,37°C水浴维持18小时,得到胶原涂层的钛板,然后胶原涂层的钛板浸入PBS溶液中超声处理IOmin去除未紧密粘附的胶原;20ml尿素酶溶液(1.5mg/ml)与30ml碳化二亚胺溶液(5mg/ml)混合,尿素酶-碳化二亚胺混合溶液中浸入胶原涂层的钛板,37°C水浴维持18小时,得到尿素酶修饰的胶原涂层的钛板,然后尿素酶修饰的胶原涂层的钛板置入PBS溶液冲洗;最后将Ca(NO3)2、NH4H2PO4,尿素混合溶解于水中使各自浓度达到10mM、6mM和10mM,用50mM氨水调解PH值在5.8,配置混合溶液,然后将尿素酶修饰的胶原涂层的钛板浸入100ml上述混合溶液中,37°C维持I小时,这样在钛板表面被羟基磷灰石涂层,得到图1所示的胶原/羟基磷灰石复合涂层的钛板,对于诱导骨的形成起重要作用。 Extracted from bovine tendon type I collagen, type I collagen solution (5mg / ml) Volume mixing and carbodiimide solution (5mg / ml) and the like, immersed titanium in the mixed solution, 37 ° C water bath for 18 hours to give titanium collagen-coated, and titanium collagen coating layer was immersed in PBS solution was sonicated IOmin removed not closely adhered to collagen; 20ml urease solution (1.5mg / ml) and 30ml carbodiimide solution (5mg / ml ) were mixed, urease - carbodiimide mixed solution was immersed in collagen-coated titanium plate, 37 ° C water bath for 18 hours to give titanium urease modified collagen-coated, and then urease modified collagen-coated titanium plate placed in PBS rinse; Finally, Ca (NO3) 2, NH4H2PO4, urea mixture was dissolved in water so that the respective concentration of 10mM, 6mM and 1OmM, with 50mM ammonia mediation PH value of 5.8, the configuration mixed solution, and then the urease modified titanium collagen-coated was immersed in 100ml of the mixed solution, 37 ° C to maintain I hour, thus hydroxyapatite coatings on titanium surface obtained as shown in FIG. 1 collagen / hydroxyapatite composite coating titanium plates, for the formation of induced bone plays an important role. 胶原涂层厚度为10~20μπι、孔隙率为90%~95%,羟基磷灰石涂层厚度为20~50 μ m、孔隙率为5%~15%。 Collagen coating thickness of 10 ~ 20μπι, a porosity of 90% to 95% hydroxyapatite coating thickness of 20 ~ 50 μ m, a porosity of 5% to 15%.

[0011] 本发明的人工关节种植体可采用纯钛或钛合金制成。 [0011] The artificial joint implant of the present invention may be pure titanium or a titanium alloy.

[0012] 实施例2: [0012] Example 2:

将骨细胞种植到按照实施例1方法所得的微纳米活性钛板上,培养3天后,用扫描电镜观察骨细胞在微纳米化改性的钛板表面的粘附情况,进而评价钛板与骨细胞的生物相容性,结果如图2所示,骨细胞在钛板表面的粘附情况良好。 The cultivation of bone cells to follow the resultant of the method of Example 1 micro-nano active titanium plate, culturing for 3 days, with a scanning electron microscope osteoblasts adhesion was titanium surface of the micro and nano modification further to evaluate the titanium and bone biocompatibility results shown in Figure 2, adhesion was osteoblasts titanium surface of the well.

[0013] 实施例3: [0013] Example 3:

将微纳米活性的人工关节种植体植入到犬股骨近端,行髋关节置换,观察人工关节种植体与周围骨组织的连接情况。 The prosthetic joint implant is implanted into the active micro-nano dogs proximal femur, hip replacement line observed artificial joint implant and bone tissue around the connection. 发现通过对人工关节表面进行胶原和羟基磷灰石复合涂层,使其表面具有天然骨基质的主要成分,促进了新骨的长入,从而促进了骨与人工关节的链接。 Found by artificial articular surface collagen and hydroxyapatite composite coating to the surface having the main component of natural bone matrix, facilitates new bone ingrowth, thereby facilitating links bone and the artificial joint.

Claims (2)

1.一种新型胶原/羟基磷灰石混合涂层人工关节植入体,其特征在于,人工关节材料表面具有胶原涂层,胶原涂层膜厚度为5~20 μ m、孔隙率为90%~95%,在胶原涂层上具有羟基磷灰石涂层,羟基磷灰石涂层厚度为20~100 μ m、孔隙率为5%~15%。 1. A novel collagen / hydroxyapatite hybrid coating of artificial joint implant, characterized in that the artificial joint surface of the material having a collagen-coated, collagen-coated film thickness of 5 ~ 20 μ m, a porosity of 90% ~ 95%, having on collagen-coated hydroxyapatite coating, the hydroxyapatite coating thickness of 20 ~ 100 μ m, a porosity of 5% to 15%.
2.—种权利要求1所述胶原/羟基磷灰石复合涂层人工关节植入体的制备方法,其特征在于,包括以下步骤: (1)人工关节植入体经金刚砂纸打磨后,依次置于丙酮、体积百分比为75%的乙醇、双蒸水中超声清洗20、15、20min,再以0.25-0.5mm大颗粒金刚砂磨砂人工关节植入体后,依次以丙酮、体积百分比为75%的乙醇、蒸馏水超声清洗各15 min,得到表面光滑的人工关节植入体; (2)从牛肌腱中提取I型胶原,将I型胶原溶液(5mg/ml)和碳化二亚胺溶液(5mg/ml)等体积混合,得到第一混合溶液,在第一混合溶液中浸入步骤I得到的表面光滑的人工关节植入体,37°C水浴维持18小时,得到胶原涂层的人工关节植入体,将其浸入PBS溶液中超声处理IOmin去除未紧密粘附的胶原; (3)将20ml尿素酶溶液(1.5mg/ml)与30ml碳化二亚胺溶液(5mg/ml)混合,得到第二混合溶液;将步骤2得到的胶原涂层的人工 1 collagen 2.- kind of claim / hydroxyapatite composite coating prosthetic joint preparation of the implant, characterized by comprising the steps of: (1) artificial joint implants by emery paper grinding, sequentially placed in acetone, the volume percentage of 75% ethanol, distilled water, ultrasonic cleaning 20,15,20min, after then to 0.25-0.5mm large particles emery frosted artificial joint implants, successively with acetone, a volume percentage of 75% ethanol, distilled water, ultrasonic cleaning each 15 min, to obtain a smooth surface of the artificial joint implants; (2) extraction of type I collagen from bovine tendon, type I collagen solution (5mg / ml) and a carbodiimide solution (5mg / ml) mixed in equal volumes, to obtain a first mixed solution was immersed in the first mixed solution in step I to give a smooth surface of the artificial joint implants, 37 ° C water bath for 18 hours to obtain a collagen-coated artificial joint implants , immersed in PBS solution was sonicated IOmin removed not closely adhered to collagen; (3) mixing 20ml urease solution (1.5mg / ml) and 30ml carbodiimide solution (5mg / ml), to give a second mixed solution; collagen coating layer obtained in step 2 artificial 节植入体浸入第二混合溶液中,37°C水浴18小时,得到尿素酶修饰的胶原涂层的人工关节植入体,将其置入PBS溶液冲洗; (4)将Ca(N03)2、NH4H2PO4、尿素混合溶解于水中使各自浓度达到10mM、6mM和10禮,用浓度为50mM氨水调节PH值在5.8,配置第三混合溶液,然后将步骤3得到的尿素酶修饰的胶原涂层的人工关节植入体浸入第三混合溶液中,37°C维持I小时,这样胶原涂层的表面被羟基磷灰石涂层,从而得到本发明权利要求1所述胶原/羟基磷灰石混合涂层人工关节植入体。 Section implant is immersed in the second mixed solution, 37 ° C water bath for 18 hours to obtain the artificial joint urease modified collagen-coated implant, which is placed into a PBS solution rinsed; (4) Ca (N03) 2 , of NH4H2PO4, urea mixture was dissolved in water so that the respective concentration of 10mM, 6mM and 10 ceremony, a concentration of 50mM ammonia to adjust the PH value of 5.8, the configuration of the third mixed solution, and then the step 3 of urease modified collagen-coated prosthetic joint implant is immersed in the third mixed solution, 37 ° C to maintain I hour, the surface of such collagen-coated by hydroxyapatite coating, resulting in the invention of claim 1 collagen / hydroxyapatite mixture applied to layer of artificial joint implants.
CN 201410007905 2014-01-08 2014-01-08 Collagen/hydroxyapatite composite coating joint prosthesis implant and preparation method thereof CN103785061B (en)

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