归辛胶囊急性毒性实验研究

Acute Toxicity Experiment of Guixin Capsule

目的:进行归辛胶囊急性毒性实验,对小鼠和大鼠可能产生的毒性反应及严重程度,确定无毒反应剂量,为拟定人用安全剂量提供参考。方法:依据《中药、天然药物急性毒性研究技术指导原则》进行急性毒性实验。取小鼠、大鼠各40只,随机分为空白、归辛胶囊低、中、高剂量4个组,每组10只,分别对小鼠、大鼠灌胃给药,给药后连续地观察14天,于给药第1、7、14天称量动物体重,并观察动物饮食、外观、行为、分泌物、排泄物、死亡情况及中毒情况,测定半数致死量(LD50);在药物毒性较低无法测出LD50时测定小鼠、大鼠的最大耐受量(MTD)。取小鼠、大鼠各40只,随机分为空白组和归辛胶囊高剂量组,每组20只,给药后连续观察14天测定最大耐受量(MTD),观察指标同测定LD50。结果:实验动物未出现死亡无法测出LD50,继而测定MTD,小鼠为24.0g/kg,大鼠为16.0 g/kg,各组动物主要脏器均未发现明显病理学改变。结论:归辛胶囊推荐临床日用剂量为0.09 g/kg,按此剂量用药具有安全性。

Objective： To carry out an acute toxicity experiment of Guixin capsule in mice ＆ rat and determine non-toxic reaction for reference safe dose for people. Methods： The experiment was based on （（Chinese natural medicine acute toxicity studies technical guiding principles））, 40 mice ＆ 40 rats were randomly divided into 4 groups with 10 animals in each group, namely blank, Guixin capsule low, middle and hige groups to intragastric administration with different dose, weighed animal weight at 1, 7 and 14 day of administra- tion, observed the animal diet, appearance, behavior, secretions, excretionsand poisoning death case, and then observed 14 days after ad- ministration contiguously to calculate LDs0; we measured maximal tolerance dose（MTD） if LDso of drug with the lower toxicity was unde- tectable. 40 mice ＆40 rats were randomly divided into 2 groups with 20 animals in each group, namely blank and Guixin hige-dose groups. We determined maximal tolerance dose （MTD） after 14 days and observed continuously with LD~ the same indicators. Results： The animals were all survived, therefor, LD50 was not measured, but MTD of Guixin capsule for mice was 24.0 g/kg and it was 16.0 g/kg for rat. Inaddition, pathological damage were not observed in all laboratory animals. Conclusion： Acute toxicity experiment suggests Guixin capsule is safety in clinilal, and the recommended daily dose is 0.09 g/kg.