梨麦消食咀嚼片安全性的毒理学研究  

Study on the Toxicology of Limai Xiaoshi Chewable Tablet

作　　者：兰燕宇[1] 伍萍[1] 宋菲[1] 郑鲁平 李勇军[1] 王永林[1] LAN Yanyu WU Ping SONG Fei ZHENG Luping LI Yongjun WANG Yonglin(College of Pharmacy, Guizhou Medical University, Guiyang 550004, Guizhou, China Guizhou South China Biological Engineering Co. Ltd, Guiyang 550001, Guizhou, China)

机构地区：[1]贵州医科大学药学院,贵州贵阳550004 [2]贵州华南理工生物工程有限公司,贵州贵阳550001

出　　处：《贵州医科大学学报》2016年第11期1274-1278,1284,共6页Journal of Guizhou Medical University

基　　金：贵州省中药现代化[黔科合中药字(2011)5031];贵阳市科学技术计划项目[筑科合同(2012204)13号];贵州省教育厅项目[黔教合协同创新字(2013)04]

摘　　要：目的:探讨梨麦消食咀嚼片的安全性。方法:采用小鼠急性经口毒性试验、遗传毒性试验(Ames试验、小鼠骨髓细胞微核试验和小鼠精子畸形试验)和大鼠30 d喂养试验,评价梨麦消食咀嚼片的安全性。结果:雌、雄性小鼠急性经口最小中毒量(MTD)>15 g/kg,根据急性毒性剂量分级标准,梨麦消食咀嚼片属无毒级;3项遗传毒性试验均为阴性,30 d喂养试验未见大鼠的生长发育、血液学指标、生化指标、脏器/体质量比值比及组织病理学有异常变化。结论:毒性试验未见梨麦消食咀嚼片产生明显毒副作用。Objective：To investigate the safety of Limai Xiaoshi chewable tablet. Method：Adopting acute oral toxicity test,Genotoxicity test（ Ames test,the micronucleus calculation of mouse bone mar-row cells,mice sperm shape abnormality test）and 30 days feeding tests to evaluate safety of Limai Xi-aoshi chewable tablet. Results：For the ICR mice（ female and male）,acute oral toxicity MTD exceed the amount of 15 g/kg;Limai Xiaoshi chewable tablet could be categorized as non-toxic according to the acute toxicity dose classification standard. In the experiment of Ames test,the micronucleus calcu-lation of mouse bone marrow cells and mice sperm shape abnormality test showed negative results. There were no adverse influence on growth and development,haematological indexes,biochemical in-dexes,organ-body ratios and histopathological changes of rats by 30d feeding test. Conclusion：This study demonstrated that Limai Xiaoshi chewable tablet toxicity test did not have obvious poisonous effects.

关 键 词：毒理学 小鼠 急性毒性试验 遗传毒性试验 梨麦消食咀嚼片 

分 类 号：R965.3[医药卫生—药理学]