摘要
羟基磷灰石水泥(HAC)是新型的羟基磷灰石类人工骨材料。1991年得到美国食品与药物管理局(FDA)的批准,在临床试用,用于颅骨缺损的填充治疗。华东理工大学最近研制出类似的HAC。我们用它的生理盐水浸出液对其进行了生物学安全性试验,包括细胞培养毒性试验、全身注射毒性试验、Ames试验、微核试验及UDS试验。结果表明HAC的浸出液对培养细胞的生长无抑制作用,对体细胞的遗传物质(染色体、DNA)无致突变作用。上述结果提示我们,HAC用于人体是安全的。
Hydroxyapatite cement (HAC) is a new- type hydroxyapatic artificial bone material. In 1991, HAC was approved by Food and Drug Administration in America for its investigation study in human subjects with cranial defects. A si-miliar product has been produced by the Physicial and Technological Institute of East China recently. Using the extracts of HAC by physiological saline, we carried on a biological safety evaluation of this HAC material. The evaluation tests included cell culture cytotoxicity, systemic injection acute toxicity, Ames test, micronucleus test and UDS( unscheduled DNA synthesis) test. The results showed that the extracts had no inhabitory effect on the growth or the cultured cells, no mutagenic effect on the DNA. These suggeat us that applications of HAC in human subjects may be of safety.
出处
《上海生物医学工程》
1996年第4期8-12,共5页
Shanghai Journal of Biomedical Engineering
基金
上海市科委重点资助项目
