金克痤胶囊浸膏粉对小鼠的急性毒性试验研究

Experimental study on acute toxicity of Jinkecuo capsules extract powder on mice

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 reaction of Jinkecuo capsules extract powder on KM mice.Methods Maximal dosage was adopted and the mice were orally given with Jinkecuo capsules at dose of 40 m L/kg andconcentration of 0.25 g/m L, twice per 24 hours. The dosage was up to 20 g/kg（equivalently 909 times of the formulated adult’sclinical dosage）, then the mice were continuously observed for14 days after administration. The diet, surface, behavior, excreta,toxicosis reaction（include symptom, the degree of severity, initiation time, persistence time, reversible or not and so on）, deathwere observed. Weight of the mice before administration and 7,14 days after administration were measured. After observationthe mice were dissected. Results Weight gains of all mice were fine, no evident toxicosis reaction nor death was found, andno abnormality was observed in gross anatomy.Conclusion After administration of Jinkecuo capsule extract powder in mice,no toxicosis reaction appeared, the maximum tolerated dose exceeded 20 g/kg, equivalent to 909 times of adult’s clinicaldosage.