CN111921002A - 一种抗菌促成骨的可吸收骨蜡及其制备方法 - Google Patents
一种抗菌促成骨的可吸收骨蜡及其制备方法 Download PDFInfo
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- calcium sulfate
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Abstract
本发明公开了一种抗菌促成骨的可吸收骨蜡,各组分及其所占重量份数包括:环氧烷共聚物60~90份,塑形剂5~30份,增稠剂2~30份,硫酸钙基修复组分5~30份。本发明所得可吸收骨蜡具有良好的止血性能和降解性能,能够完全被人体吸收,促进骨组织再生,并具有良好的持续抗菌作用,防止伤口感染;且涉及的制备方法简单,临床上操作方便,可满足不同病人的需求,有望得到广泛应用。
Description
技术领域
本发明属于生物医用材料技术领域,具体涉及一种抗菌促成骨的可吸收骨蜡及其制备方法。
背景技术
骨蜡是一类用于控制手术过程中造成的骨质边缘出血的止血材料,将其机械性塞入富含出血的毛细血管的骨腔内,以控制出血。而传统骨蜡的主要成分为蜂蜡,在封堵创面后,因不能降解而残留在创伤区域,会严重阻碍骨愈合。目前,国内还没有能够完全降解的骨蜡产品,对于可降解的骨蜡产品需求日益增加。
从1980年到2000年,文献中报道了许多骨蜡替代物,如脂肪酸盐、纤维蛋白/胶原糊状物、明胶糊状物、乙醇酸或乳酸/甘油低聚物、部分脱乙酰的甲壳素盐酸盐、PEG/微纤维胶原糊剂、聚二氧杂环酮/天然油和PolyArthoester;但这些骨蜡材料难以将传统骨蜡的有益特性与可吸收材料的优点结合起来,未被广泛使用或投放市场。直到21世纪,以环氧共聚物为原材料的可吸收骨蜡才被开发出来,该骨蜡为具备传统骨蜡使用简单,有效止血的优点,同时能够在48小时降解,但是由于水溶性过好,在大出血的情况下,难以有效止血,且功能性单一,仅作为止血材料,虽不会抑制成骨,但是也无法起到促进成骨的作用。因此进一步探索兼具止血、可降解和促进成骨性能的骨蜡材料具有重要的研究和应用意义。
发明内容
本发明的主要目的在于针对现有技术存在的不足,提供一种抗菌促成骨的可吸收骨蜡,它具有优异的生物相容性和延展性,植入体内后可完全降解,并可有效兼顾良好的骨愈合性能和抗菌消炎性能。
为实现上述目的,本发明采用的技术方案为:
一种抗菌促成骨的可吸收骨蜡,各组分及其所占重量份数包括:环氧烷共聚物60~90份,塑形剂5~30份,增稠剂2~30份,硫酸钙基修复组分5~30份。
上述方案中,所述环氧烷共聚物为环氧乙烷-环氧丙烷共聚物,其分子量为5000~15000。
上述方案中,所述塑形剂为分子量为2000~5000的环氧烷共聚物、甘油、维生素E醋酸酯中的一种或几种。
上述方案中,所述增稠剂为壳聚糖、海藻酸钠、羟丙甲纤维素、羧甲基纤维素钠、透明质酸钠中的一种或几种。
上述方案中,所述硫酸钙基修复组分为硫酸钙或硫酸钙复合物,其中硫酸钙复合物通过将硫酸钙与抑菌组分进行研磨、加水制泥,固化、干燥、二次研磨而成。
上述方案中,所述抑菌组分为氯化铜、氯化银或抗生素。
上述方案中,所述硫酸钙与抑菌组分的质量比为(85~99):(1~15);加水制泥采用的固液比为1:0.3~0.5g:ml。
上述方案中,所述硫酸钙复合物的制备方法具体包括如下步骤:
1)将半水硫酸钙与抑菌组分研磨混合均匀,并加水搅拌混合成泥状
2)将所得泥状物在常温下固化1~24h,在70~80℃环境下干燥1.5~2h;
3)将所得干燥粉末进行二次研磨至粉末状,即得所述硫酸钙复合物。
上述方案中,步骤3)中所述研磨步骤为研磨至100~500μm。
上述一种抗菌促成骨的可吸收骨蜡的制备方法,包括如下步骤:
1)按配比称取环氧烷共聚物、塑形剂、增稠剂和硫酸钙基修复组分,将称取的各组分混合,并在70~80℃环境下加热熔融,搅拌10~30min;
2)冷却至室温,挤压成型,直至为面泥状。
与现有技术相比,本发明的有益效果为:
1)具有优异的生物相容性,且植入体内能够完全降解,避免影响骨愈合;
2)首次提出在骨蜡中引入硫酸钙基修复组分,降解过程中可提供钙离子并形成局部微酸环境,发挥促进骨愈合的作用,可兼顾良好的封堵止血功能和骨愈合效果;
3)硫酸钙复合物中,利用硫酸钙预先包裹抗菌成分,降解过程中,抗菌成分持续释放,达到缓释的效果,能够持续抗菌消炎;
4)环氧烷共聚物具有良好的水溶性,会很快溶解,且在常温条件下的塑形性和延展性有限;本发明进一步结合硫酸钙基修复组分、塑形剂和增稠剂可得到兼顾优异骨修复能力、延展性能并可任意塑形的骨蜡材料,尤其引入的钙离子,可进一步交联纤维素盐形成凝胶,进一步有效增强止血能力。
5)生产工艺简单,操作方便,能够实现大规模生产。
附图说明
图1为本发明所述骨蜡的外观形貌,(a)为实施例3骨蜡样品在外观形貌,(b)为实施例4骨蜡样品的外观形貌。
图2为本发明所述骨蜡植入颅骨缺损处,4周后取材的micro-CT图片,左边缺损植入实施例3样品,右边缺损植入实施例1样品。
图3为本发明实施例4所述骨蜡止血动物实验照片,(a)为股骨缺损处渗血照片,(b)为骨蜡封堵缺损后股骨照片。
图4为本发明实施例4所述骨蜡的XRD曲线。
图5为本发明实施例4所述骨蜡的DSC曲线。
具体实施方式
以下对本发明的优选实施例进行说明,应当理解,此处所描述的优选实施例仅用于说明和解释本发明,并不用于限定本发明。
以下实施例中,采用的环氧烷共聚物为泊洛沙姆407,其分子量为10000~15000;
以下实施例中,分子量为2000~4000的环氧烷共聚物泊洛沙姆124。
实施例1
一种抗菌促成骨的可吸收骨蜡,其制备方法包括如下步骤:
1)将95重量份半水硫酸钙和5重量份氯化铜研磨混合均匀,将混合均匀的粉末与水搅拌混合成泥状(固液比为1:0.4g:ml),常温下固化5h,在80℃环境下干燥2h,然后研磨成粉末,得到含氯化铜的硫酸钙复合物;
2)称取分子量为10000~15000的环氧烷共聚物60份、维生素E醋酸酯15份、羟丙甲纤维素15份、硫酸钙复合物10份,在80℃环境下加热熔融,搅拌10min,冷却至室温,挤压成型,直至为面泥状,得到的骨蜡在橡胶手套上不黏连,能够任意塑形。
实施例2
一种抗菌促成骨的可吸收骨蜡,其制备方法包括如下步骤:
1)将90份半水硫酸钙和10份氯化铜研磨混合均匀,将混合均匀的粉末与水搅拌混合成泥状(固液比为1:0.4g:ml),常温下固化12h,在80℃环境下干燥2h,然后研磨成粉末,得到含氯化铜的硫酸钙复合物;
2)称取分子量为8000~10000的环氧烷共聚物80份、分子量为2000~4000的环氧烷共聚物20份、壳聚糖10份、硫酸钙复合物12份,在70℃环境下加热熔融,搅拌15min,冷却至室温,挤压成型,直至为面泥状,得到的骨蜡在橡胶手套上不黏连,能够任意塑形。
实施例3
一种抗菌促成骨的可吸收骨蜡,其制备方法包括如下步骤:称取分子量为10000~15000的环氧烷共聚物90份、维生素E醋酸酯25份、羟丙甲纤维素10份、二水硫酸钙12份,在80℃环境下加热熔融,搅拌20min,冷却至室温,挤压成型,直至为面泥状,得到的骨蜡在橡胶手套上不黏连,能够任意塑形。
实施例4
一种抗菌促成骨的可吸收骨蜡,其制备方法包括如下步骤:
1)将92份半水硫酸钙和8份氯化铜研磨混合均匀,将混合均匀的粉末与水搅拌混合成泥状(固液比为1:0.4g:ml),常温下固化6h,在78℃环境下干燥2h,然后研磨成粉末,得到含氯化铜的硫酸钙复合物;
2)称取分子量为10000~15000的环氧烷共聚物70份、维生素E醋酸酯25份、羧甲基纤维素钠25份、硫酸钙复合物12份,在80℃环境下加热熔融,搅拌10min,冷却至室温,挤压成型,直至为面泥状,得到的骨蜡在橡胶手套上不黏连,能够任意塑形。
图1为本发明实施例3和4所得骨蜡的外观形貌,可以看到骨蜡具有良好的可塑形,能够任意塑形。
图2为本发明实施例3和4所得骨蜡植入颅骨缺损处,4周后取材的micro-CT图片,可以看到骨缺损区域明显减小,骨生长明显,表明该骨蜡具有良好的降解性能(左边的骨缺损中的材料在4周内即可完全降解),未阻碍骨生长,且具有一定的促进成骨的能力。
图3为本发明实施例4所得骨蜡止血动物实验照片,(a)为股骨缺损处渗血照片,(b)为骨蜡封堵缺损后股骨照片。可以看到,在股骨上造孔后,未涂抹骨蜡时,股骨孔隙处渗血明显,涂抹骨蜡后,渗血立即停止,表明骨蜡具有优秀的止血能力。
图4为本发明实施例4所得骨蜡的XRD曲线,可以观察到骨蜡具有明显的二水硫酸钙的特征峰,同时可以观察到当半水硫酸钙与氯化钙预固化形成硫酸钙复合物时,部分半水硫酸钙没有转化成二水硫酸钙,且氯化钙含量越高,半水硫酸钙的特征峰的相对强度更高,说明氯化钙对半水硫酸钙的固化具有一定的抑制作用。
图5为本发明实施例4所得骨蜡的DSC曲线,可以看到熔融峰的区间为45.7~57.8℃,且-20~45.7℃之间没有其他峰,表明在-20~45.7℃之间,骨蜡都可以塑形。
本发明所述骨蜡在常温状态下能够任意塑形,涂抹到渗血部位,能够立即有效的止血,且能够快速降解,不会阻碍新骨愈合,在降解的过程中,其中高分子成分会优先降解,使得硫酸钙暴露在体液环境下,进而使硫酸钙逐渐降解,硫酸钙在降解过程中会形成局部微酸环境,加速诱导因子的释放,同时提供钙源,快速刺激骨生长。同时,在降解过程中释放的铜离子、银离子或抗生素等能够起到消炎杀菌的作用,防止感染。
对比例
一种抗菌促成骨的可吸收骨蜡,其制备方法包括如下步骤:
称取分子量为5000~8000的环氧烷共聚物90份、二水硫酸钙10份,在80℃环境下加热熔融,搅拌10min,冷却至室温,挤压成型,直至为面泥状,得到的骨蜡具有一定的塑形性,但延展性较差,出血量大时,难以有效止血。
显然,上述实施例仅仅是为清楚地说明所作的实例,而并非对实施方式的限制。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而因此所引申的显而易见的变化或变动仍处于本发明创造的保护范围之内。
Claims (9)
1.一种抗菌促成骨的可吸收骨蜡,其特征在于,各组分及其所占重量份数包括:环氧烷共聚物60~90份,塑形剂5~30份,增稠剂2~30份,硫酸钙基修复组分5~30份。
2.根据权利要求1所述的可吸收骨蜡,其特征在于,所述环氧烷共聚物为环氧乙烷-环氧丙烷共聚物,其分子量为5000~15000。
3.根据权利要求1所述的可吸收骨蜡,其特征在于,所述塑形剂为分子量为2000~5000的环氧烷共聚物、甘油、维生素E醋酸酯中的一种或几种。
4.根据权利要求1所述的可吸收骨蜡,其特征在于,所述增稠剂为壳聚糖、海藻酸钠、羟丙甲纤维素、羧甲基纤维素钠、透明质酸钠中的一种或几种。
5.根据权利要求1所述的可吸收骨蜡,其特征在于,所述硫酸钙基修复组分为硫酸钙或硫酸钙复合物,其中硫酸钙复合物通过将硫酸钙与抑菌组分进行混合、研磨、加水制泥,固化、干燥、二次研磨而成。
6.根据权利要求5所述的可吸收骨蜡,其特征在于,所述抑菌组分为氯化铜、氯化银或抗生素。
7.根据权利要求5所述的可吸收骨蜡,其特征在于,所述硫酸钙与抑菌组分的质量比为(85~99):(1~15);加水制泥采用的固液比为1:(0.3~0.5)g:ml。
8.根据权利要求5所述的可吸收骨蜡,其特征在于,所述硫酸钙复合物的制备方法具体包括如下步骤:
1)将半水硫酸钙与抑菌组分研磨混合均匀,并加水搅拌混合成泥状
2)将所得泥状物在常温下固化1~24h,在70~80℃环境下干燥1.5~2h;
3)将所得干燥粉末进行二次研磨至粉末状,即得所述硫酸钙复合物。
9.权利要求1~8所述抗菌促成骨的可吸收骨蜡的制备方法,其特征在于,包括如下步骤:
1)按配比称取环氧烷共聚物、塑形剂、增稠剂和硫酸钙基修复组分,将称取的各组分混合,并在70~80℃环境下加热熔融,搅拌10~30min;
2)冷却至室温,挤压成型,直至为面泥状。
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