CN108283730A - 一种透钙磷石骨水泥的制备方法 - Google Patents
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Abstract
本发明涉及一种透钙磷石骨水泥的制备方法,属于路面养护材料技术领域。本发明利用丝素蛋白作为药物载体,通过丝素蛋白分子链互相缠结,形成三维网络,羟基磷灰石在网络骨架上沉积,从而提高了磷酸钙骨水泥的抗溃散性能,且丝素蛋白通过化学键结合及包裹的方式控制药物释放,有效控制了常见的药物突释效应,从而在骨组织修复治疗中起到维持治疗剂量的局部药物浓度,延长生物材料的药效,使利多卡因能够在体内长久有效发挥其缓解疼痛的疗效,同时以丝素蛋白高分子链网络,提供羟基磷灰石沉积的模板,通过对钙离子的络合作用,延缓固化反应的进行,以达到延长固化时间的作用,使透钙磷石为片状结晶,堆积较为紧密,提升抗压强度。
Description
技术领域
本发明涉及一种透钙磷石骨水泥的制备方法,属于路面养护材料技术领域。
背景技术
骨修复材料广泛应用于骨外科、整形外科以及牙科领域。按来源分类有3种,即自体骨、异体骨和人工合成材料,虽然自体骨是理想的骨修复材料,但供骨来源有限且二次手术给患者带来痛苦,供骨区可能出现形态和功能障碍;异体骨存在免疫排斥反应,有导致传染疾病和肿瘤生成的可能,因此长期以来各国科学家们在不断探索理想的骨缺损修复材料。
透钙磷石骨水泥是一类商业化使用的植骨材料,其在体内可以完全降解,生物相容性好,可适形植入或注入骨缺损部位,利于骨缺损的微创治疗,但是纯透钙磷石骨水泥的固化时间较短,可注射性较差,不利于医生操作,并且不具备抗菌性能。
透钙磷石骨水泥在生物体内具有更好的生物降解能力,但由于固化时间太短(通常为1min以内)、可注射性较差等原因,限制了其在临床上的应用。透钙磷石骨水泥的主要成分是二水合磷酸氢钙(DCPD),是通过两种或两种以上磷酸钙盐在酸性环境中发生酸碱中和反应形成,是一个反应物水解后再成核的过程。柠檬酸溶液是常见的酸性固化液,单一的柠檬酸溶液无法满足骨水泥的综合性能,通常需要向其中加入一种或多种添加剂。
因此,研究一种透钙磷石骨水泥配方,观察骨水泥粉末的微观结构对其理化性能的影响,并通过选用合适的固相粉末及固化液,改善骨水泥的综合性能,满足临床应用的需要。
发明内容
本发明所要解决的技术问题:针对纯透钙磷石骨水泥的固化时间较短,可注射性较差,不利于医生操作,并且不具备抗菌性能的问题,提供了一种透钙磷石骨水泥的制备方法。
为解决上述技术问题,本发明采用的技术方案是:
(1)取二水合磷酸氢钙、碳酸钙,加入超纯水中分散,再装入旋转蒸发仪中减压蒸发至干,将干燥后的产物转入研磨机中研磨,过200目筛,得原料粉;
(2)将原料粉置于马弗炉中煅烧,冷却后以400~500r/min球磨8~10h,再在60~70℃下干燥40~50h,得β-磷酸三钙粉末;
(3)将β-磷酸三钙粉末与磷酸二氢钙按摩尔比1:1混合后装入研钵中研磨,过400目筛,得骨水泥固相粉;
(4)取利多卡因、丹皮酚、丝素蛋白,加入生理盐水中混合均匀,再加入羟丙基甲基纤维素、柠檬酸、壳聚糖加热搅拌30~40min,得骨水泥固化液;
(5)将骨水泥固相粉与骨水泥固化液按质量比1:30混合搅拌30~50s,固化得透钙磷石骨水泥。
步骤(1)所述二水合磷酸氢钙、碳酸钙的重量份为250~300份二水合磷酸氢钙,70~80份碳酸钙。
步骤(2)所述煅烧过程为在1100~1300℃下煅烧10~12h。
步骤(4)所述物料的重量份为1~2份利多卡因,0.1~0.2份丹皮酚,0.2~0.6份丝素蛋白,50~100份生理盐水、0.2~0.6份羟丙基甲基纤维素,5~10份柠檬酸,0.5~1.0份壳聚糖。
步骤(4)所述加热温度为60~70℃。
步骤(4)所述固化过程为注入模具中,并放置于37℃,相对湿度100%的烘箱中固化3~4天。
本发明与其他方法相比,有益技术效果是:
(1)本发明利用与骨骼胶原相似,无明显的抗原性,植入骨骼中不发生排异反应,具有良好的生物相容性,且有利于钙盐沉积的丝素蛋白,作为药物载体,通过丝素蛋白分子链互相缠结,形成三维网络,羟基磷灰石在网络骨架上沉积,从而提高了磷酸钙骨水泥的抗溃散性能,且丝素蛋白通过化学键结合及包裹的方式控制药物释放,有效控制了常见的药物突释效应,从而在骨组织修复治疗中起到维持治疗剂量的局部药物浓度,延长生物材料的药效,有利于骨组织的再生等作用,使利多卡因能够在体内长久有效发挥其缓解疼痛的疗效;
(2)本发明以丝素蛋白高分子链网络,提供羟基磷灰石沉积的模板,通过对钙离子的络合作用,延缓固化反应的进行,以达到延长固化时间的作用,使透钙磷石为片状结晶,堆积较为紧密,提升抗压强度。
具体实施方式
取250~300g二水合磷酸氢钙,70~80g碳酸钙,加入500~600mL超纯水中,以300~400r/min搅拌30~40min,再装入旋转蒸发仪中减压蒸发至干,将干燥后的产物转入研磨机中研磨,过200目筛,得原料粉,将原料粉置于马弗炉中,在1100~1300℃下煅烧10~12h,冷却至室温后将煅烧产物装入球磨机中,以无水乙醇为介质,在400~500r/min球磨8~10h,过滤去除无水乙醇后置于干燥箱中,在60~70℃下干燥40~50h,得β-磷酸三钙粉末,将β-磷酸三钙粉末与磷酸二氢钙按摩尔比1:1混合后装入研钵中研磨,过400目筛,得骨水泥固相粉,取1~2g利多卡因,0.1~0.2g丹皮酚,0.2~0.6g丝素蛋白,加入50~100g生理盐水中,以300~400r/min搅拌20~30min,再加入0.2~0.6g羟丙基甲基纤维素,5~10g柠檬酸,0.5~1.0g壳聚糖,并加热至60~70℃搅拌30~40min,得骨水泥固化液,将骨水泥固相粉与骨水泥固化液按质量比1:30混合搅拌30~50s,再注入模具中,并放置于37℃,相对湿度100%的烘箱中,3~4天后取出得透钙磷石骨水泥。
实例1
取250~300g二水合磷酸氢钙,70~80g碳酸钙,加入500~600mL超纯水中,以300~400r/min搅拌30~40min,再装入旋转蒸发仪中减压蒸发至干,将干燥后的产物转入研磨机中研磨,过200目筛,得原料粉,将原料粉置于马弗炉中,在1100~1300℃下煅烧10~12h,冷却至室温后将煅烧产物装入球磨机中,以无水乙醇为介质,在400~500r/min球磨8~10h,过滤去除无水乙醇后置于干燥箱中,在60~70℃下干燥40~50h,得β-磷酸三钙粉末,将β-磷酸三钙粉末与磷酸二氢钙按摩尔比1:1混合后装入研钵中研磨,过400目筛,得骨水泥固相粉,取1~2g利多卡因,0.1~0.2g丹皮酚,0.2~0.6g丝素蛋白,加入50~100g生理盐水中,以300~400r/min搅拌20~30min,再加入0.2~0.6g羟丙基甲基纤维素,5~10g柠檬酸,0.5~1.0g壳聚糖,并加热至60~70℃搅拌30~40min,得骨水泥固化液,将骨水泥固相粉与骨水泥固化液按质量比1:30混合搅拌30~50s,再注入模具中,并放置于37℃,相对湿度100%的烘箱中,3~4天后取出得透钙磷石骨水泥。
实例2
取250~300g二水合磷酸氢钙,70~80g碳酸钙,加入500~600mL超纯水中,以300~400r/min搅拌30~40min,再装入旋转蒸发仪中减压蒸发至干,将干燥后的产物转入研磨机中研磨,过200目筛,得原料粉,将原料粉置于马弗炉中,在1100~1300℃下煅烧10~12h,冷却至室温后将煅烧产物装入球磨机中,以无水乙醇为介质,在400~500r/min球磨8~10h,过滤去除无水乙醇后置于干燥箱中,在60~70℃下干燥40~50h,得β-磷酸三钙粉末,将β-磷酸三钙粉末与磷酸二氢钙按摩尔比1:1混合后装入研钵中研磨,过400目筛,得骨水泥固相粉,取1~2g利多卡因,0.1~0.2g丹皮酚,0.2~0.6g丝素蛋白,加入50~100g生理盐水中,以300~400r/min搅拌20~30min,再加入0.2~0.6g羟丙基甲基纤维素,5~10g柠檬酸,0.5~1.0g壳聚糖,并加热至60~70℃搅拌30~40min,得骨水泥固化液,将骨水泥固相粉与骨水泥固化液按质量比1:30混合搅拌30~50s,再注入模具中,并放置于37℃,相对湿度100%的烘箱中,3~4天后取出得透钙磷石骨水泥。
实例3
取250~300g二水合磷酸氢钙,70~80g碳酸钙,加入500~600mL超纯水中,以300~400r/min搅拌30~40min,再装入旋转蒸发仪中减压蒸发至干,将干燥后的产物转入研磨机中研磨,过200目筛,得原料粉,将原料粉置于马弗炉中,在1100~1300℃下煅烧10~12h,冷却至室温后将煅烧产物装入球磨机中,以无水乙醇为介质,在400~500r/min球磨8~10h,过滤去除无水乙醇后置于干燥箱中,在60~70℃下干燥40~50h,得β-磷酸三钙粉末,将β-磷酸三钙粉末与磷酸二氢钙按摩尔比1:1混合后装入研钵中研磨,过400目筛,得骨水泥固相粉,取1~2g利多卡因,0.1~0.2g丹皮酚,0.2~0.6g丝素蛋白,加入50~100g生理盐水中,以300~400r/min搅拌20~30min,再加入0.2~0.6g羟丙基甲基纤维素,5~10g柠檬酸,0.5~1.0g壳聚糖,并加热至60~70℃搅拌30~40min,得骨水泥固化液,将骨水泥固相粉与骨水泥固化液按质量比1:30混合搅拌30~50s,再注入模具中,并放置于37℃,相对湿度100%的烘箱中,3~4天后取出得透钙磷石骨水泥。
将本发明制备的透钙磷石骨水泥及上海某公司生产的骨水泥进行检测,具体检测结果如下表表1:
检测方法:
固化时间及可注射性测定:运用类似吉尔摩针压痕法来测定各骨水泥试样的固化时间,实验重复5次;
抗压强度测定:将骨水泥浆体填入Φ10mm×5mm的模具中,0.5h后取出,置于37℃水浴锅中养护72h,利用万能力学试验机进行测试,载荷900N,加压速度为1mm/min,计算抗压强度,各组分骨水泥均采用5个平行样,计算结果取平均值;
骨水泥抗菌性能检测:将骨水泥浆体制成Φ5mm×2mm的圆柱体,购自ATCC的大肠杆菌(35218)和金黄色葡萄球菌(25923)作为菌种,采用平板抑菌圈法测试各试样的抑菌性能,实验重复3次。
表1透钙磷石骨水泥表征
性能表征 | 实例1 | 实例2 | 实例3 | 对比例 |
固化时间/min | 13 | 14 | 15 | 6 |
可注射性系数 | 93 | 94 | 95 | 33 |
抗压强度/MPa | 24 | 26 | 27 | 18 |
抑菌圈直径/mm | 6 | 8 | 10 | 4 |
由表1可知本发明制备的透钙磷石骨水泥,固化时间较长,可注射性好,有利于医生操作,并且抗菌性能优异,具有广阔的市场前景。
Claims (6)
1.一种透钙磷石骨水泥的制备方法,其特征在于,具体步骤为:
(1)取二水合磷酸氢钙、碳酸钙,加入超纯水中分散,再装入旋转蒸发仪中减压蒸发至干,将干燥后的产物转入研磨机中研磨,过200目筛,得原料粉;
(2)将原料粉置于马弗炉中煅烧,冷却后以400~500r/min球磨8~10h,再在60~70℃下干燥40~50h,得β-磷酸三钙粉末;
(3)将β-磷酸三钙粉末与磷酸二氢钙按摩尔比1:1混合后装入研钵中研磨,过400目筛,得骨水泥固相粉;
(4)取利多卡因、丹皮酚、丝素蛋白,加入生理盐水中混合均匀,再加入羟丙基甲基纤维素、柠檬酸、壳聚糖加热搅拌30~40min,得骨水泥固化液;
(5)将骨水泥固相粉与骨水泥固化液按质量比1:30混合搅拌30~50s,固化得透钙磷石骨水泥。
2.如权利要求1所述的一种透钙磷石骨水泥的制备方法,其特征在于,步骤(1)所述二水合磷酸氢钙、碳酸钙的重量份为250~300份二水合磷酸氢钙,70~80份碳酸钙。
3.如权利要求1所述的一种透钙磷石骨水泥的制备方法,其特征在于,步骤(2)所述煅烧过程为在1100~1300℃下煅烧10~12h。
4.如权利要求1所述的一种透钙磷石骨水泥的制备方法,其特征在于,步骤(4)所述物料的重量份为1~2份利多卡因,0.1~0.2份丹皮酚,0.2~0.6份丝素蛋白,50~100份生理盐水、0.2~0.6份羟丙基甲基纤维素,5~10份柠檬酸,0.5~1.0份壳聚糖。
5.如权利要求1所述的一种透钙磷石骨水泥的制备方法,其特征在于,步骤(4)所述加热温度为60~70℃。
6.如权利要求1所述的一种透钙磷石骨水泥的制备方法,其特征在于,步骤(4)所述固化过程为注入模具中,并放置于37℃,相对湿度100%的烘箱中固化3~4天。
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