羧甲基壳聚糖的遗传毒性评价

Genotoxicity Experimental Evaluation of Carboxymethyl-Chitosan

目的:通过小鼠骨髓细胞染色体畸变分析试验、小鼠精子畸形试验及小鼠初级精母细胞染色体畸变试验,对治疗骨关节炎的新药羧甲基壳聚糖(CMCTS)进行初步药物遗传毒性的安全性评价,为二期临床试验提供依据。方法:按照国家颁发的毒性试验标准进行小鼠骨髓细胞染色体畸变分析试验、小鼠精子畸形试验及小鼠初级精母细胞染色体畸变试验。结果:各试验中阳性对照组腹腔注射环磷酰胺(CP)可诱发小鼠骨髓细胞染色体畸变率明显增加,与各实验组及阴性对照比较差别具有显著性(P<0.01),各实验组与阴性对照组之间相比较差别无显著性(P>0.05)。结论:在高剂量腹腔注射羧甲基壳聚糖的情况下,不引起小鼠死亡,对小鼠体细胞与生殖细胞染色体未见明显致突作用。

Objective： To study the genotoxicity of Carboxymethyl-chitosan （CMCTS） ,a new agent for the treatment of osteoarthritis,and to provide experimental evidence for secondary clinical test. Methods： The marrow cell chromosome aberration analysis, primary spermatocyte chromosome aberration analysis and spermatozoa aberration test were performed in mice according to the guidebook of Chinese Traditional Medicine Pre-Clinical Trial. Results： In those three tests, giving cyclophosphamide （CP） by intraperitoneal injection increased the rate of marrow cell chromosome aberration obviously（P〈0.01）, and no significant difference was found between the negative control group and the three test groups（P〉0.05）. Conclusion： The results show that even large doses of Carboxymethl-chitosan injection can＇t cause the mice to death, and no significant genotoxicity to the cell of mice was found.