HMS-01的遗传毒性评价  

Genotoxicity evaluation of HMS-01

作　　者：陈弋 孙青䶮 黎翔 孙旸 刘霞 CHEN Yi;SUN Qingyan;LI Xiang;SUN Yang;LIU Xia(Department of Clinical Pharmacy,School of Pharmacy,Naval Medical University,Shanghai 200433,China;National Key Laboratory of Lead Druggability Research,Shanghai 201203,China)

机构地区：[1]海军军医大学药学系临床药学教研室,上海200433 [2]先导物成药性研究全国重点实验室,上海201203

出　　处：《药学实践与服务》2024年第4期147-150,156,共5页Journal of Pharmaceutical Practice and Service

基　　金：国家自然科学基金项目(82073907,82073842);上海市科委生物医药领域科技支撑项目(20S11902700);上海市2021年度“科技创新行动计划”优秀学术/技术带头人计划项目(21XD1404700)。

摘　　要：目的检测HMS-01的遗传毒性,并对其进行临床前安全评价研究,为后续该药物进入临床试验提供支持。方法采用鼠伤寒沙门氏菌进行细菌回复突变试验(Ames试验)评价HMS-01的遗传毒性。结果HMS-01在20.6、61.7、185.2、555.6、1666.7、5000μg/皿的6个剂量下,无论有无代谢活化条件,对鼠伤寒沙门氏菌均无致突变性。结论在本实验剂量范围内,HMS-01未见致突变性。Objective To provide a toxicological basis for HMS-01 in future clinical trials,through genotoxicity testing of safety evaluation.Methods The genotoxicity of HMS-01 was evaluated by Bacterial Reverse Mutation Assay(Ames test)with Salmonella typhimurium.Results HMS-01 was non-mutagenic against Salmonella typhimurium at six doses of 20.6,61.7,185.2,555.6,1666.7,and 5000μg/dish with(or without)a metabolic activation system.Conclusion HMS-01 was not found to be mutagenic in the dose range of this experiment.

关 键 词：HMS-01 细菌回复突变试验Ames 致突变性 遗传毒性 

分 类 号：R994.3[医药卫生—毒理学]