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鸭嘴花碱经口单次给药安全性评价研究
引用本文:陈桂芳,高娟,谭伟,张祎,孙赟,秦定梅. 鸭嘴花碱经口单次给药安全性评价研究[J]. 中国药事, 2023, 0(8): 919-924
作者姓名:陈桂芳  高娟  谭伟  张祎  孙赟  秦定梅
作者单位:云南医药健康职业学院,昆明 650032;云南中医药大学中药学院,昆明 650500;云南省民族特色养生理论与健康产品工程实验室,昆明 650500 ;省部共建生物资源保护与利用国家重点实验室,昆明 650500;云南中医药大学中药学院,昆明 650500 ;云南省民族特色养生理论与健康产品工程实验室,昆明 650500 ;省部共建生物资源保护与利用国家重点实验室,昆明 650500
基金项目:国家自然科学基金项目(编号 81760741);云南生物资源保护与利用国家重点实验室开放课题(编号 2021KF004);云南医药健康职业学院中药学骨干特色专业建设(编号 2022J1101)
摘    要:目的:通过研究鸭嘴花碱急性毒性,评价鸭嘴花碱的安全性。方法:将120只昆明种小鼠,雌雄各半,随机均等分为6组,每组20只。按40 mL·kg-1小鼠灌胃体积给予相应剂量的药物,密切观察4 h, 记录小鼠毒性反应与死亡率。连续观察14天,记录小鼠一般状态,解剖观察脏器并计算脏器指数,对存活小鼠肝脏、肾脏进行HE染色和生化指标检测。结果:小鼠对鸭嘴花碱最大耐受量(MTD)为153.6 mg·kg-1。观察14天后,与空白组比较,小鼠一般状态、脏器指数无明显变化;病理结果显示无肝肾毒性;血浆中ALT、Cre无显著变化,AST、BUN含量有下降趋势。结论:小鼠对鸭嘴花碱的MTD为153.6 mg·kg-1,该剂量下对小鼠安全性高。

关 键 词:鸭嘴花碱  单次给药  急性毒性  安全性  最大耐受量
收稿时间:2022-12-27

Study on Safety Evaluation of Single Oral Administration of Vasicine
Chen Guifang,Gao Juan,Tan Wei,Zhang Yi,Sun Yun,Qin Dingmei. Study on Safety Evaluation of Single Oral Administration of Vasicine[J]. Chinese Pharmaceutical Affairs, 2023, 0(8): 919-924
Authors:Chen Guifang  Gao Juan  Tan Wei  Zhang Yi  Sun Yun  Qin Dingmei
Abstract:Objective: To evaluate the safety of vasicine by studying its acute toxicity. Methods: A total of 120 Kunming mice were randomly divided into 6 groups with 20 mice in each group. The corresponding dose of the drug was administered at 40 mL·kg-1 mouse intragastric volume. The toxic reaction and mortality of mice were observed closely for 4 h. The mice were observed continuously for 14 days and their general state was recorded. The organs were dissected and the organ index was calculated. HE staining and biochemical indicators on the livers and kidneys of surviving mice were detected. Results: The maximum tolerated dose (MTD) of vasicine in mice was 153.6 mg·kg-1. After 14 days of observation, compared with blank group, the general state and organ index of mice had no significant change. Pathological results showed no hepatorenal toxicity. There were no signifi cant changes in ALT and Cre in plasma, while the contents of AST and BUN decreased. Conclusion: The MTD of mice was 153.6 mg·kg-1, which was safe for mice.
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