PDLLA-CPP复合材料的安全性和生物相容性评价

目的　评价新型可吸收性高强度骨折内固定复合材料PDLLA CPP的生物安全性。方法　采用PDLLA CPP复合材料萃出液腹腔注射最大允许剂量的方法,测定该材料最大耐受量,进行小鼠骨髓细胞微核试验、小鼠精子畸变试验、小鼠骨髓细胞染色体畸变试验及致畸试验等毒理学试验,评价其安全性。同时采用该复合材料与体外培养软骨细胞直接接触法,观察其对软骨细胞生长和增殖的影响,评价其生物相容性。结果　最大耐受量的PDLLA CPP复合材料不影响小鼠骨髓细胞微核率、小鼠骨髓细胞染色体畸变率和小鼠精子畸变率,致畸试验阴性,也不影响软骨细胞生长和增殖。结论　PDLLA CPP复合材料是一种安全的可吸收性生物医用材料,有良好的细胞生物相容性。

Evaluation of the security and biocompatibility of bioabsorbable composites PDLLA-CPP

Objective To evaluate the security and biocompatibility of a new kind of absorbable high-strength PDLLA-CPP composite, which is used for internal fracture fixation. Methods According to the national standard of the procedure of appraise in food security and toxicology, micronucleus test of bone marrow cell, spermatic aberration test, chromosomal aberration test, and teratogenic test were measured with IP maximal tolerance dose of maceration extract from PDLLA-CPP composites. Meanwhile, chondrocyte culture with PDLLA-CPP composite was used to evaluate the effect of PDLLA-CPP composite on cartilage cell proliferation. Results Micronucleus test of bone marrow cell, spermatic aberration test, chromosomal aberration test, and teratogenic test were not affected by IP maximal tolerance dose of PDLLA-CPP maceration extract. PDLLA-CPP composite also had no cytotoxicity on cartilage cell proliferation. Conclusion PDLLA-CPP is a new and safe medical material with good biocompatibility and absorbability.