新型六方介孔硅缓释载体的生物安全性研究  

Biological safety of a novel hexagonal mesoporous silica as controlled-release carrier for bone reconstruction

作　　者：何树[1] 毕龙[1] 刘建[1] 孟国林[1] 魏坤[2] 魏欣苗[2] 张金康[1] 赵轶男[1] 

机构地区：[1]第四军医大学西京医院全军骨科研究所,陕西西安710032 [2]华南理工大学材料科学与工程学院,广州510641

出　　处：《中国矫形外科杂志》2012年第3期251-254,共4页Orthopedic Journal of China

基　　金：国家科学自然基金青年项目(编号:30901532)

摘　　要：[目的]评价一种新型药物缓释载体——六方介孔硅(hexagonal mesoporous silica HMS)的生物安全性,为将HMS作为骨组织工程药物缓释载体的临床应用提供实验依据。[方法]根据国际标准化组织(ISO)颁布的ISO10993系列标准和中国国家医药管理局颁布的GB/T16886.12-2005系列标准,对HMS分别进行急性毒性试验、热原试验、溶血试验、致敏试验和体外细胞毒性试验。[结果]通过尾静脉和腹腔注射两种方法,HMS均未引发小鼠急性毒性反应;热原试验显示家兔体温升高值均低于0.6℃,且本组家兔体温升高总和低于1.4℃,符合热原检测标准规定;致敏试验显示HMS不引发豚鼠过敏反应;溶血试验显示HMS未引起兔红细胞溶血现象;MTT法检测细胞毒性比较,实验组与阴性对照组的吸光度值比较无统计学意义(P>0.05),而与阳性对照组比较有统计学意义(P<0.05),说明HMS对细胞生长无不良影响。[结论]HMS的生物安全性符合国际和国内植入物生物学评价标准,有较高的生物安全性。本研究为HMS作为一种新型骨组织工程药物缓释载体的相关研究提供了实验依据。[ ObjectiveJ To evaluate the biological safety of a novel controlled -release carrier -hexagonal mesoporous sili- ca （HMS） as a biomaterial for bone tissue engineering and provide the experimental evidence for its further clinical practice. [ Methods ] The tests of acute toxicity, pyrogen, hemolysis, sensitization and in vitro cytoxicity were performed for HMS accord- ing to the standard ISO10993 issued by the International Organization for Standardization （ISO） and standards of GB/T16886. 12 - 2005 issued by the State Pharmaceutical Administration of China. [ Results ] The injection of HMS induced no acute toxicity through either tail vein or abdominal cavity. Pyrogen test showed that the body temperature of each tested rabbit had not in- creased, which was in accordance with the standards. No skin irritable reaction occurred in the guinea pig for sensitization test. No evidence of hemolysis was found in the rabbit red blood cell hemolysis test. In the MTT test, there was no significant difference in the OD values of HMS extract and blank control （ P 〉 0. 05 ） , which suggested that HMS had no adverse effect on cell proliferation. [ Conclusion] The biological safety of HMS meets the requirements in line with international and domestic biological evaluation criteria for implant. Therefore, HMS is possible to be used as a new controlled release material for bone tissue en- glneermg.

关 键 词：六方介孔硅 骨组织工程 缓释 生物安全性 

分 类 号：R318.08[医药卫生—生物医学工程]