四磨汤口服液Beagle犬长毒试验研究

Long-term Toxicological Experiment of SiMoTang Oral Liquid in Beagle Dogs

目的观察Beagle犬灌胃四磨汤口服液的长期毒性反应。方法40只Beagle犬随机分为四磨汤口服液高、中、低3个剂量组和辅料对照组,连续灌胃给药13周、恢复期4周,试验期间进行一般观察、体重、血液学指标、血液生化指标、尿液、组织病理学等检查,并观察停药后各指标的恢复情况。结果四磨汤口服液高、中、低剂量组没有发现明确的毒性作用和毒性靶器官。结论本试验未见明显不良反应剂量为18 g·kg^(-1),表明四磨汤口服液安全性高。

OBJECTIVE To observe the long-term toxic reaction of SiMoTang oral liquid in Beagle dogs.METHODS 40 Beagle dogs were randomly divided into three dosage groups(high,medium and low)and adjuvant control group,Continuous gavage for 13 weeks and recovery period for 4 weeks.Clinical observation,body weight,Hematology Index,blood biochemistry,urine and histopathology were carried out during the trial.The recovery of each index was observed after drug withdrawal.RESULTS No clear toxic effects and toxic target organs were found in the high,middle and low dose groups of SiMoTang oral liquid.CONCLUSION There was no obvious adverse reaction dose of 18 g·kg^(-1)in this experiment,which indicated that the safety of SiMoTang oral liquid was high.