磷酸钙与聚甲基丙烯酸甲酯制备复合型骨水泥的生物安全性研究  

Preparation of composite bone cement(CPC/PMMA) and its biological safety

作　　者：郭新辉[1] 吕扬阳[2] 范积平[1] 蔡伟斌[1] 陈大军[1] 凌龙[1] 郝健[1] 张卫民[1] 库建斌[1] 宋飞[1] 黄季萌[1] 杨俊[1] 

机构地区：[1]解放军第421医院骨科,广东广州510318 [2]广州军区疾病预防控制中心

出　　处：《中国骨与关节损伤杂志》2016年第5期506-510,共5页Chinese Journal of Bone and Joint Injury

基　　金：广东省医学科学技术研究基金(A2013460)

摘　　要：目的探讨磷酸钙(CPC)和聚甲基丙烯酸甲酯(PMMA)按不同比例混合而制备复合型骨水泥(CPC/PMMA)的方法及评价其生物安全性。方法制备CPC/PMMA复合型骨水泥试件并分组,共分为CPC(100%)组、CPC/PMMA(75%、67%、50%、33%、16.7%、9.1%、6.25%、4.8%)组、PMMA(100%)组;通过急性毒性实验、全身亚急性毒性实验、热源实验、致敏实验、溶血实验检测CPC/PMMA复合型骨水泥的生物安全性。结果 CPC(100%)组、CPC/PMMA(75%)组、CPC/PMMA(67%)组、CPC/PMMA(50%)组OD值两两比较差异无统计学意义(P>0.05),细胞毒分级为1级,无细胞毒性。CPC/PMMA(50%)组与对照组、CPC(100%)组、PMMA(100%)组小鼠的血常规检、生化检查、脏器湿重、体重变化差异无统计学意义(P>0.05)。实验组的组织病理学检查、热源实验、致敏实验、溶血实验未出现异常。结论复合型骨水泥CPC/PMMA制备过程简便可靠,具有良好的生物安全性、血液与组织相容性,无毒性及致敏性。Objective To investigate the method of preparing composite bone cement （CPC/PMMA） with calcium phosphate （CPC） and poly methyl methaerylate （PMMA） in different proportions and evaluate its biological safety. Methods The CPC/ PMMA composite bone cement specimen and packet were prepared, and then they were divided into the CPC group （100%） and CPC/ PMMA （75%, 67%, 50%, 33%, 16.7%, 9.1%, 6.25%, 4.8%） group, PMMA （100%） group. The CPC/PMMA composite bone cement biological safety was detected through aeute toxicity experiment, systemic subacute toxicity experiment, pyrogen test, sensitivity test, hemolysis test. Results There were no statistically significant difference in the CPC group（100%）, CPC/PMMA（75%） group, CPC/PMMA（67%） group, CPC/PMMA（50%） of the group with OD pairwise comparison （P 〉0.05）. Cytotoxieity grade was grade 1, there was no cell toxicity. Among CPC/PMMA （50%） group and control group, CPC group （100%）, PMMA （100%） there were no significant differenees in mice blood routine examination and bioehemieal examination, organ wet weight and weight ehange（P 〉0.05）. In the experimental group, the histopathologieal examination, heat source experiment, sensitized test, hemolysis test did not appear abnormal. Conclusion The preparation process of compound bone cement CPC/PMMA is simple and reliable, and has good biologieal safety, blood and tissue compatibility, without toxicity and aUergenieity.

关 键 词：磷酸钙 聚甲基丙烯酸甲酯 骨水泥 生物安全性 实验研究 

分 类 号：R318[医药卫生—生物医学工程]