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目的观察金克痤胶囊浸膏粉对KM小鼠的急性毒性反应情况。方法采用最大给药量法,以最大给药体积40 m L/kg经口给予最大浓度为0.25 g/m L的金克痤胶囊浸膏粉混悬液,24h内给药2次,给药剂量达20 g/kg体重(相当于拟定临床剂量的909倍),给药后连续观察14 d。观察给药后动物饮食、外观、行为、排泄物、中毒反应(症状、严重程度、起始时间、持续时间、是否可逆等)和死亡情况等。称量小鼠给药前、给药后第7、14 d体重。观察期结束对每只小鼠进行大体解剖。结果给药后小鼠体重增加良好,均未见明显中毒反应,无死亡,大体解剖未见异常。结论小鼠经口给予金克痤胶囊浸膏粉后,无毒性反应,其小鼠最大耐受量大于20 g/kg体重(相当于人临床使用剂量的909倍)。
Objective To observe the acute toxicity of Jinke acne capsule extract powder to KM mice. Methods The maximum dose of 40 k L / kg was administered orally to a suspension of Jin Ke Capsule (0.25 g / m L), twice a day for 24 hours The dose of 20 g / kg body weight (equivalent to 909 times the proposed clinical dose), continuous observation after 14 d. The animal diet, appearance, behavior, excretion, poisoning reaction (symptom, severity, starting time, duration, reversibility, etc.) and death were observed after administration. Weighing mice before administration, 7 d after administration of body weight. Each mouse was grossly dissected at the end of the observation period. Results After administration, the body weight of mice increased well, no obvious toxic reaction, no death, no abnormality in general anatomy. Conclusion The mice were given oral Jinke acne capsule extract powder, non-toxic reaction, the maximum tolerated dose of mice greater than 20 g / kg body weight (equivalent to 909 times the clinical dose).