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目的:观察胃肠康定胶囊的急性及长期毒性反应,对其安全性进行评价。方法:以最大浓度(0.35g/ml)最大体积(40ml/kg)一日2次灌胃,观察小鼠的活动及急性毒性反应情况,连续观察两周;每日以三个剂量(制剂量1.75,3.5、7g/kg)灌胃大鼠,每周6次,连续180d,停药恢复30d。观察药物反应,检测动物血液学、血液生化学等指标,并做组织病理学检查。结果:急性毒性未见小鼠出现毒性反应及死亡,最大给药量为临床用药量的280倍。长期毒性:动物耗食量和体重增长正常,恢复期胃肠康定胶囊高剂量组大鼠血清Na+、K+与对照组相比降低,其余各项指标均正常,病理检查一些器官出现病变。结论:胃肠康定制剂量1.75,3.5g/kg是安全剂量。
Objective: To observe the acute and long-term toxic reaction of Weichang Kangding Capsule and evaluate its safety. Methods: Mice were given gavage twice a day (40ml / kg) with maximal concentration (0.35g / ml) to observe the activity and acute toxicity of the mice. The mice were continuously observed for two weeks. Three doses 1.75, 3.5, 7g / kg) were intragastrically administered to rats 6 times a week for 180 consecutive days, stopping withdrawal 30d. Observe the drug response, detection of animal hematology, blood biochemistry and other indicators, and do histopathological examination. Results: There was no acute toxicity and death in mice. The maximum dose was 280 times of the clinical dose. Long-term toxicity: normal animal consumption and body weight gain. In the recovery period, the levels of serum Na + and K + in high-dose and low-dose groups were lower than those in the control group, and the rest of the indexes were normal. Pathological changes of some organs were observed. Conclusion: Gastrointestinal Kangding dose of 1.75, 3.5g / kg is a safe dose.