目的 观察密蒙花颗粒对小鼠的急性毒性反应及死亡情况,为临床应用安全性提供依据。方法 将30只小鼠分别用不同浓度及最大浓度密蒙花颗粒混悬液灌胃进行预实验,观察7 d未见小鼠死亡,无法测出LD_(50),故进行最大耐受量(MTD)的测定。将40只小鼠随机分为给药组和空白对照组,根据小鼠可承受的最大体积分别用最大混悬浓度的密蒙花颗粒和蒸馏水1 d内灌胃2次,连续观察14 d,每天记录小鼠的一般状况、体质量,14 d后处死动物,测定小鼠的血常规指标,肝、脾、肾等主要脏器指数,观察解剖学及病理组织学改变情况。结果 给药组小鼠无死亡,与空白对照组比较,给药组小鼠的体质量变化无显著差异(P〉0.05),血常规指标与空白对照组亦无显著差异(P〉0.05),小鼠密蒙花颗粒日最大耐受量为114 g/kg。结论 急性毒性结果表明,密蒙花颗粒临床常用量是安全的。
Objective To observe the acute toxic reaction of Flos Buddlejae granules and the situation of mice's death, to provide basis for the clinical safety od medication. Methods Having preliminary experiment on thirty mice with different concentrations of suspension liquid. There was no mice's death in 7 days, LD50 could not been detcted. Therefore, the maximum tolerance (MTD) was measured. Forty mice were randomly divided into the medicated group and the con-trol group. In line with the maximum volume of the mice, the maximal suspension concentration of the Flos Buddle-jae granules and the distilled water were separately given twice daily. Keeping the observation for 14 days, and recording the general condition and body mass in mice every day. After 14 days, the mice were killed. The blood routine indexes, and the major organs indexes of liver, spleen, kidneys and so on, the change of anatomy and pathological histology was observed. Results There was no mice death in medicated group. Compared with the control group, the body weight of mice in medicated group had no significant changes (P〉0.05). The routine blood indexes in the medicated group were not signifi-cantly different (P〉0.05). The maximum tolerance dose of Flos Buddlejae granules in mice was 114 g/kg daily. Conclusion The acute toxicity result shows that the clinical dose of Flos Buddlejae granules is safe.