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目的:通过观察利胆软坚方药对小鼠的急性毒性反应,为安全性评价提供理论依据。方法:以最大给药浓度(3 g·m L-1)和最大给药体积(0.04 m L·g-1)的利胆软坚方水煎剂对小鼠灌胃给药,24 h内给药2次,给药后连续观察7 d。详细记录小鼠的存活情况及一般情况。结果:小鼠无一例死亡,也无明显中毒反应,测得利胆软坚方药最大给药量(以含生药量计)为240 g·kg-1,相当于成人临床日用量的160倍。结论:利胆软坚方药比较安全,未在小鼠动物实验中见到明显毒性反应。
OBJECTIVE: To observe the acute toxicity of Lidan Ruanjian Recipe in mice and provide a theoretical basis for its safety evaluation. Methods: Mice were intragastrically administrated with the decoction of Radix Rehmanniae Decoction of the maximum dosing concentration (3 g · m L-1) and the maximum dosing volume (0.04 m L · g-1) Medicine 2 times, continuous observation after 7 days. A detailed record of the survival of mice and the general situation. Results: None of the mice died and no obvious toxic reaction was observed. The maximum dose of Dihuang Ruanjian Recipe (containing crude drug) was 240 g · kg -1, equivalent to 160 times the daily clinical dosage of adult. Conclusion: Dantiao Jiannian medicine is safe, and no obvious toxic reaction has been found in the animal experiments of mice.