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中国药物评价 ›› 2021, Vol. 38 ›› Issue (1): 40-43.

• 药物研究 • 上一篇    下一篇

壮药制剂痛风立安颗粒的小鼠急性毒性试验

赵湘培, 黎丽*, 李运容, 滕红丽   

  1. 广西国际壮医医院, 广西 南宁 530201
  • 收稿日期:2020-11-16 修回日期:2021-02-19 出版日期:2021-02-28 发布日期:2021-02-28
  • 基金资助:

    广西科技重大专项-广西创新驱动发展专项资金项目(桂科AA17202034);

    广西高校中青年教师基础能力提升项目(2108KY0292);

    广西中医药大学自然科学研究项目(2018QN033)

The Acute Toxicity Study on Tongfeng Li′an Granule

  1. Guangxi International Zhuang Medicine Hospital, Guangxi Nanning 530201, China
  • Received:2020-11-16 Revised:2021-02-19 Online:2021-02-28 Published:2021-02-28

摘要: 目的: 观察ICR小鼠经口灌胃给予痛风立安颗粒后出现的急性毒性反应和死亡情况,为其临床用药提供依据。方法:参照经典的小鼠急性毒性试验方法,按40 mL·kg-1经口灌胃给予痛风立安颗粒,在给药后0~4 h内密切仔细观察并记录各组动物的中毒表现和特点、毒性反应出现和恢复时间以及死亡情况等,连续观察14 d。分别于给药当日给药前及给药后第4天、第7天、第10天和第14天对动物进行称重,并记录动物体重变化。结果:痛风立安颗粒各剂量组动物毒性反应与给药剂量呈正相关,主要表现为运动减少、拉稀便、俯卧以及死亡,其中痛风立安颗粒Ⅰ、Ⅱ、Ⅲ、Ⅳ组(103.6 g生药·kg-1、120.4 g生药·kg-1、142.8 g生药·kg-1、168.0 g生药·kg-1)分别出现0/10、0/10、3/10、5/10动物死亡。给药后第2~14天各剂量组存活动物未见明显异常和死亡,对小鼠体重无明显影响,死亡动物和计划解剖动物各器官表面和切面均未见明显异常情况。结论:动物给药后的主要急性毒性反应为拉稀便、运动减少、俯卧以及死亡,提示其可能毒性靶器官为胃肠道等,其最大耐受量(MTD)≤120.4g生药·kg-1,约相当于成人临床拟用剂量的99倍(按公斤体重计算)及13倍(按体表面积计算)。
 

关键词: font-size:medium, ">壮药制剂;痛风立安颗粒;急性毒性试验;最大耐受量

Abstract: Objective: To observe the acute toxicity of the Tong feng li′an Granule and to provide experimental data for safety use in clinical. Methods: According to the classic mouse acute toxicity test method, Tongfeng Li′an Granules are administered by oral gavage at 40 mL·kg-1, and the poisoning performance and characteristics of each group of animals are carefully observed and recorded within 0~4 h after administration. The appearance and recovery time and death, etc., were observed continuously for 14 days. The animals were weighed before and on the 4th, 7th, 10th and 14th days after the administration on the day of administration, and the changes in the body weight of the animals were recorded. Results:The animal toxicity of each dose group of Tongfeng Li′an Granules was positively correlated with the dose administered, mainly manifested as decreased exercise, diarrhea, proneness and death. Among them, the group of Tongfeng Li′an Granules Ⅰ, Ⅱ, Ⅲ and Ⅳ (103.6 g crude drug·kg-1, 120.4 g crude drug·kg-1, 142.8 g crude drug·kg-1, 168.0 g crude drug) 0/10, 0/10, 3/10 and 5/10 animals died respectively. There were no obvious abnormalities and deaths in the surviving animals of each dose group from the afternoon of the next day to the 14th day after the administration, and there was no significant effect on the body weight of the mice. There were no obvious abnormalities on the surfaces and sections of the organs of the dead animals and the planned anatomical animals. Conclusion:The main acute toxicity after animal administration is diarrhea, decreased exercise, proneness, and death, suggesting that the target organ may be the gastrointestinal tract. The maximum tolerated dose (MTD) is ≤120.4 g crude drug·kg-1, which is equivalent to Adult clinical dose 99 times (according to kilogram body weight) and 13 times (according to body surface area).

Key words: font-size:medium, ">Traditional medicine; Tongfeng Li′an Granules; Acute toxicity; Maximum tolerance (MTD)

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