CN1314455C - 骨质粉混合物和x射线对比剂及其生产方法 - Google Patents

骨质粉混合物和x射线对比剂及其生产方法 Download PDF

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CN1314455C
CN1314455C CNB031383505A CN03138350A CN1314455C CN 1314455 C CN1314455 C CN 1314455C CN B031383505 A CNB031383505 A CN B031383505A CN 03138350 A CN03138350 A CN 03138350A CN 1314455 C CN1314455 C CN 1314455C
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Abstract

骨质粉混合物由含X射线对比剂的聚合物组分和单体组分组成。X射线对比剂的形成过程为：a)不透X射线的元素以化学结合化合物的聚合物或共聚物形式构成，或b)基本上呈球状的其中分散有不透X射线的大小为3-15纳米无机纳米微粒的聚合物或共聚物颗粒是在纳米微粒存在下，通过聚合作用，最好是悬浮液聚合作用制成，纳米微粒完全或几乎完全被(共)聚合物材料覆盖。

Description

骨质粉混合物和X射线对比剂及其生产方法
技术领域
本发明涉及一种由一种含有X射线对比剂的聚合物组分和一种单体组分组成的骨质粉混合物和一种X射线对比剂组成。本发明还涉及骨质粉混合物和X射线对比剂的生产方法以及X射线对比剂的用途。
背景技术
按照本发明，骨质粉混合物可理解为是一个双组分系统，其中一种组分是粉末状的聚合物组分，第二种是液态的单体组分。两种组分通常在使用前才相互混合。
尤其是那些用于固定人造关节的骨质粉含有用于临床检查的X射线对比剂。这种X射线对比剂可使外科医生对植入物进行可靠的检查，及早诊断可能出现的恶化，如松动。骨质粉是丙烯酸酯基树脂的化学合成材料(如贺利氏古萨两合有限公司的PalacosR)。骨质粉是双组分系统，含有粉末状的混合聚合物和一种液态的单体。在混合聚合物中掺入二氧化锆或硫酸钡作为对比剂。这种X射线对比剂当然不能连在聚合链上，可能造成骨质粉衣显微裂缝。二氧化锆可能在界面上起研磨作用。
EP 41 614介绍了有硫酸钡涂层的粉末用于牙齿填充材料，通过分散和添加聚合物溶液生产。EP 89782介绍了硫酸钡涂层，通过混合PMMA颗粒和含有HEMA的硫酸钡微粒，然后加热生产。JP 06024927涉及聚合物填充剂复合材料，在X射线对比剂存在下由酸单体和不饱和的单体聚合而成。
WO 0057932介绍了由聚合物基质和固体的、液体的或气体的填充剂组成的复合物，“基质韧带的厚度”最好不要超出250纳米，据认为是填充微粒之间的距离。纳米复合材料通过在骨质粉的初始组分(前体)中，在初始组分的搅拌过程中，在引发聚合的预制糊剂、糊状物或液体中加入填充剂制备。填充剂可为不透X射线的氧化锆等。
实施例表明，复合材料具有下列微颗粒：1-3微米硫酸钡，100纳米硫酸钡和60纳米三氧化二铝(丙烯酰基涂层)。
EP644 780：权利要求12涉及一种颗粒状材料或纤维材料，其中填充颗粒(1-15微米大小)至少部分被(共)聚合物基质包围，而聚合物链不裂解。这种材料可通过搅拌和挤压生产。
US6,080,801公开了聚合物球粒(图1)，其中部分或全部球粒含有填充剂微粒。这种球粒不大于300微米，并含有大小为1-250微米，最好是5-15微米的填充颗粒。球粒在填充颗粒的聚合作用过程中形成晶核时生产出来。
发明内容
本发明的任务是提供一种含有改良型X射线对比剂的骨质粉混合物及其生产方法。
本发明的骨质粉混合物，由单体组分和含有X射线对比剂的聚合物组分组成，其特征在于，所述的X射线对比剂含有氧锆基-二-甲基丙烯酸酯和/或其它含锆的甲基丙烯酸酯，在生产过程中将氧锆基-二-甲基丙烯酸酯和/或其它含锆的甲基丙烯酸酯聚合成聚合物或共聚物并添加入聚合物组分。
根据本发明的骨质粉混合物的生产方法，所述骨质粉混合物含有一种聚合物组分和一种单体组分，聚合物组分含有聚合物和/或共聚物，其特征在于，在生产过程中将氧锆基-二-甲基丙烯酸酯和/或其它含锆的甲基丙烯酸酯聚合成聚合物或共聚物并添加入聚合物组分。
X射线对比剂的形成过程为：
a)不透X射线的元素以化学结合化合物的聚合物或共聚物形式构成，或
b)基本上呈球状的其中分散有不透X射线的大小为3-15纳米的无机纳米微粒的聚合物或共聚物颗粒是在纳米微粒存在下，通过聚合作用，最好是悬浮液聚合作用制成，纳米微粒完全或几乎完全被(共)聚合物材料覆盖。
这类含有X射线对比剂的骨质粉混合物含有一种聚合物组分和一种单体组分，聚合物组分含有聚合物和/或共聚物，根据本发明，按下列方式制备：在生产聚合物和/或共聚物时添加含有不透X射线元素的聚合物和/或单体作为原料，或添加不透X射线的大小为3-15纳米的无机纳米微粒。
如果X射线对比剂是通过将氧锆基-二-甲基丙烯酸酯(Zirkonyl-di-methacrylat)和/或其它锆和/或含其它含有不透X射线元素的丙烯酸甲酯聚合到聚合物或共聚物中制成，这样生产出来的X射线对比剂或骨质粉混合物就不含矿物质成分，因为按照发明，X射线对比剂是以聚合物或共聚物的形式构成的。
如果X射线对比剂是用大小为3-15纳米、外有聚合物涂层的无机纳米微粒制成。
X射线对比剂含有锆和/或钡和/或其它不透X射线的元素，尤其是氧锆基-二-甲基丙烯酸酯和/或含其它锆和/或含其它不透X射线元素的丙烯酸甲酯，证明是适宜的。
尤其是使氧锆基-二-甲基丙烯酸酯聚合到聚合物或共聚物中并加入聚合物组分，含钡和/或锆和/或含其它不透X射线元素的聚合物或共聚物按照本发明可以用作骨质粉混合物中的X射线对比剂。
如果在(共)聚合物中加入无机纳米微粒的X射线对比剂，那么适宜的方式是用专业人员熟知的硅烷改变无机纳米微粒的表面。纳米微粒可做成球状、椭圆体状、片状或不规则形状。无机纳米微粒最好主要由二氧化锆组成。
具体实施方式
下面介绍本发明的实施例。
骨质粉的单体组分为普通的单体组分，聚合物组分是用有20％氧锆基-二-甲基丙烯酸酯的共聚物和一种占聚合物组分约1％的引发剂混合制成。
在第二个实施例中，聚合物组分由有40％氧锆基-二-甲基丙烯酸酯的共聚物，聚甲基丙烯酸甲酯聚合物或共聚物和一种引发剂组成，其中含氧锆基-二-甲基丙烯酸酯的共聚物占50％，聚合物占49％，引发剂占全部组分的1％。
第三个实施例的组成与第二个实施例的组成相同，只是共聚物中的氧锆基-二-甲基丙烯酸酯的含量为80％，并占聚合物组分混合物总量的25％，聚合物占74％，引发剂占1％。
也可用其它含锆的丙烯酸酯代替氧锆基-二-甲基丙烯酸酯，材料的不透明性取决于锆(或钡)的含量。
按照本发明，掺有大小为3-15纳米无机纳米微粒的骨质粉混合物可按下列方式获得：采用用作骨质粉的普通单体组分作为单体组分，聚合物组分用其中分散有不透X射线的无机纳米微粒的(共)聚合物颗粒。
在具有涂层或没有涂层的大小为7纳米的二氧化锆微粒存在下对单体进行悬浮液聚合，事先生产出其中分散有不透X射线纳米微粒的(共)聚合物颗粒，得到球状的其中分散有不透X射线的无机纳米微粒的聚合物颗粒或共聚物颗粒。分散在所得的(共)聚合物之中的二氧化锆微粒的数量例如为15％。骨质粉的聚合物组分由以上描述的球状聚合物颗粒或共聚物颗粒和引发剂制成，其中聚合物或共聚物颗粒分散有不透X射线的无机纳米微粒，引发剂数量约占聚合物组分的1％。
在另一实施例中，生产含有大小为3-15纳米的无机纳米微粒的骨质粉混合物，使用骨质粉所需的普通单体组分。聚合物组分由其中分散有不透X射线的无机纳米微粒和不含X射线对比剂的球状聚合物颗粒或共聚物颗粒和一种引发剂组成。
在具有涂层或没有涂层大小为7纳米的二氧化锆微粒存在下对普通单体进行悬浮液聚合，事先生产出其中分散有不透X射线的无机纳米微粒的(共)聚合物颗粒，得到球状的其中分散有不透X射线的无机纳米微粒的聚合物或共聚物颗粒。分散在所得的(共)聚合物之中的二氧化锆微粒的数量例如为30％。骨质粉的聚合物组分由以上描述的50％的球状聚合物颗粒或共聚物颗粒和49％不含X射线对比剂的球状聚合物颗粒或异共聚物颗粒和1％引发剂制成，其聚合物颗粒或共聚物颗粒中分散有不透X射线的无机纳米微粒。
添加透X射线的(共)聚合物来调整骨质粉混合物的X射线不透性，以符合骨质粉聚合物组分中的X射线对比剂的量为5％-45％，最好为8％-16％时X射线不透性的要求。

Claims (2)

1.骨质粉混合物，由单体组分和含有X射线对比剂的聚合物组分组成，其特征在于，所述的X射线对比剂含有氧锆基-二-甲基丙烯酸酯和/或其它含锆的甲基丙烯酸酯，在生产过程中将氧锆基-二-甲基丙烯酸酯和/或其它含锆的甲基丙烯酸酯聚合成聚合物或共聚物并添加入聚合物组分。
2.骨质粉混合物的生产方法，所述骨质粉混合物含有一种聚合物组分和一种单体组分，聚合物组分含有聚合物和/或共聚物，其特征在于，在生产过程中将氧锆基-二-甲基丙烯酸酯和/或其它含锆的甲基丙烯酸酯聚合成聚合物或共聚物并添加入聚合物组分。
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