聚乳酸和乳酸·乙醇酸的致突变性研究

Mutagenicity Study of The Polylactide and Polylactide-Co-Glycolide

生物降解型高分子化合物聚乳酸(PLA)和乳酸·乙醇酸(PLGA)是作为避孕缓释剂的载体,在体内形成释放系统。近年来,国内外已把生物降解长效避孕药作为寻找新一代长效避孕药物的主攻方向。但是激素避孕药对人体的可能不良影响仍是一个有争议的问题,特别是PLA和PLGA作为一种载体,较长时间包埋在人体组织内,其遗传毒性及细胞毒性等的研究是急待解决的问题。据此,本研究对PLA、PLGA经小鼠微核试验、Ames试验及细胞毒性试验,进行突变性及细胞毒性的评价,为提供安全、有效的避孕药物载体提出科学依据。

The evaluate of mutagenicity and cytotoxicity on control release drug-load carrier - biode-gredabale polymer polylactide (PLA) and polylactide-Co-glycolide (PLGA) was determined bymicronucleiy test, Ames test and cytotoxicity test. During 90 days after injecting PLA-or PLGA in mice, the frequencies of micronucleiof peripheral lymphocyte collected at different time in control group and in each dose group ofPLA or PLGA were 0-0.3‰. The frequencies of micronuclear of bone marrow were 0.8-1.2‰.There was no significant difference in these two parameters between control and PLA or PLGA. The results of Ames test showed that the number of colen reversion of stannous octoate indifferent concentrations, a catalyzer in the synthesizing polymer PLA or PLGA, has no signifi-cant difference as compared with their self-reversion. The results of cytotoxicity test Showed that the reaction indexes of PLA or PLGA wereR=0/0. All of parameters tested in present study are negative, and therefore, there were no muta-genicity and cytotoxicity appeared in both PLA and PLGA.