可降解材料聚乳酸的生物安全性评价

Evaluation on Biological Safety of Biodegradable Polylactide

对制备的可降解材料聚乳酸进行全面的生物学评价,为医用产品制造和应用提供依据。参照GB/T16886医疗器械生物学评价的要求,对聚乳酸进行热原试验、细胞毒性试验、急性全身毒性试验、溶血试验、皮内反应试验、致敏试验、遗传毒性Ames试验、小鼠淋巴瘤细胞突变试验及染色体畸变试验、植入试验和亚慢性全身毒性试验等系列生物相容性试验研究。结果表明该材料的生物学检测结果均在可接受范围内。该材料具有良好的生物相容性和生物学安全性。

To systematically evaluate the biological safety of biodegradable Polylactide(PLA) to provide some evidence for its manufacture and application for medical products.According to GB/T16886 serial standards for biological evaluation of medical devices,a series of biological tests such as pyrogen test,cytotoxicity test,acute systemic toxicity test,hemolysis test,intradermoreaction test,sensitization test,genotoxicity test including Ames test,lymphoma cell mutation test in mice and chromosome aberration test,local effects test after implantation and subchronic systemic toxicity test were performed for PLA.The results show that the biological test results are all in the acceptable range.The biodegradable PLA has good biocompatibility and biological safety.