自固化磷酸钙人工骨的生物学安全性试验研究

EXPERIMENTAL STUDY ON BIOLOGICAL COMPATIBILITY OF CALCIUM PHOSPHATE CEMENT (CPC) ASAN ARTIFICIAL BONE MATERIAL

本文报告了自固化磷酸钙 (CPC)人工骨的遗传毒性试验及动物体内植入实验结果。体外试验采用CPC的浸出液 ,试验项目包括Ames试验、微核试验及UDS试验 ;体内实验包括骨内植入及肌肉内植入实验。结果表明 ,CPC浸出液对体细胞的遗传物质无损害作用 ,无致基因突变的作用。植入体内后 ,只出现一过性的炎症反应 ,无异物反应。CPC与骨形成直接的骨性愈合 ,其溶解形成的钙、磷颗粒经髓腔或哈氏管系统运输。结果是CPC具有良好的生物相容性 。

We presented the results of the inherited toxic tests and implanted experiment in animals on self setting calcium phosphate cement (CPC) as an artificial bone material. In vitro tests were done using CPC extracts from physiological saline, including Ames test, microneuclear test and UDS test. In vivo tests included implanting in bone and muscle. The results showed that there was neither harmful effect on genetic material, nor mutagenesis of cells. After being implanted in rabbits, a directed union was formed between CPC and the host bone. Upon infiltrating in body fluid, solid CPC gradually dissoved into a large number of tiny calcium and phosphorus particles, which were delivered by way of the marrow cavity and the Haversian and Volkmann′s canal. The conclusion was that CPC had a highly biological compatibility, and was qualified as an artificial bone material.