可降解聚己内酯的体外生物学安全性评价

目的：评价可降解聚己内酯的体外生物学安全性。方法：采用可降解PCL的浸出液进行了急性毒性试验，Ames试验、微核试验、肌肉刺激实验、热源试验。结果：PCL浸出液对小鼠的生长及细胞无毒性作用，Ames试验及微核试验结果证明PCL对细胞染色体、DNA水平的遗传物质无损害作用，热源试验及肌肉刺激试验结果证明PCL无免疫原性。结论：CL是一个具有良好的生物相容性、无毒性、无免疫原性的材料。

In Vitro Biological evaluation and degradation of the Compatibility of Polycaprolactone

Objective: To evaluate in vitro the compatibility of polycaprolactone. Methods: Using the extracts of PCL by physiological saline solution. The items of the tests were as follows: A. Systematic injection toxicity in mouse B. Ames test, C. Micronucleus test, D. Muscle stimulation test, E. Pyrogenic test. Results: The extracts of PCL was of no any inhibitive effect on the growth of the mouse and the proliferation of the cultured cells. (3) The two genetic toxic tests suggested that the PCL was not harmful to the genetic substance of cells at the level of chromosome DNA level. (3). Toxicology test, pyrogenic test and muscle stimulation test prove that PCL is safe and antigen free. Conclusion: PCL is to have a good biologic compatibility, no toxin and antigen free material.