中文摘要：

目的：研究生物可降解材料聚丁二酸丁二醇酯[poly（butylene succinate）,PBS]浸提液对人外周血单核细胞（peripheral blood mononuclear cells,PBMCs）的体外遗传毒性。方法：参照GB/T16886-2005标准制备PBS浸提液。采用MTT试验评价不同浓度（200、100、50、25、12.5、6.25、3.125mg/mL）PBS浸提液对PBMCs的细胞毒性;并进行染色体畸变试验和微核试验评价其体外遗传毒性。同时设溶剂RPMI-1640和医用级左旋聚乳酸（L-polylactide,L-PLA）对照组。结果：PBS浸提液对PBMCs的细胞毒性与溶剂对照和L-PLA比较差异均无统计学意义（P〉0.05）;200mg/mLPBS浸提液在代谢活化和非代谢活化条件下与PBMCs共培养48h后染色体畸变均为阴性;200mg/mLPBS浸提液诱发的微核细胞数与溶剂对照组和L-PLA组相比差异均无统计学意义（P〉0.05）。结论：在本试验条件下,生物可降解材料PBS浸提液在体外对PBMCs无遗传毒性,其影响与医用级L-PLA相当。

英文摘要：

OBJECTIVE： To evaluate the in vitro genotoxicity of PBS [poly（butylene succinate）] in human peripheral blood mononuclear cells. METHODS：The cytotoxicity in PBMCs of PBS including different concentrations （200,100,50,25,12.5,6.25,3.125 mg/mL） was assessed by MTT and the genotoxicity of extracts was evaluated by chromosomal aberration test and micronucleus test. Meanwhile RPMI-1640 and medical biodegradable L-PLA （L-polylactide） were used as control groups. RESULTS：There was little toxicity in the extracts of PBS and no IC50 was valued. There were no cells with chromosomal aberration after co-culture with 200 mg/mL PBS for 48 h under metabolic and non-metabolic activation. The results of micronucleus test compared with the RPMI-1640 and L-PLA groups were not significantly different （P0.05）. CONCLUSION：PBS showed less genotoxicity in peripheral blood mononuclear cells under this experimental condition. It may be a promising medical biodegradable polymer because of excellent biocompatibility.