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目的:在动物体内验证愈疡胶囊的临床毒副反应及性质。方法:急性毒性试验用小鼠以药物最大浓度和动物的最大胃容纳量24 h内灌服3次,然后连续观察14 d。长期毒性试验将大鼠分4组,分别以3.6、1.8、0.45 g/(kg.d)3个剂量组和等容积生理盐水组连续灌服13周,每周第7天停药1d并称重,分别在第13周和第l5周处死20只和10只大鼠,测大鼠体重、血常规、血液生化学、器官系数各指标,观察脏器组织病理学变化。结果:愈疡胶囊的最大耐受量为42g/kg,按人临床日用量2.7g/60kg计算,相当于成人临床用量的933倍。长期毒性结果显示,高中低剂量分别相当于人临床日用量的80、40和10倍;给药期及恢复期各组大鼠体重增长正常,脏器系数、血液及血生化学指标无显著改变。结论:愈疡胶囊对受试动物未有明显毒性作用,可安全用于临床。
Objective: To verify the clinical toxicity and the nature of Yuyang Capsule in animals. METHODS: Acute toxicity test mice were dosed three times with maximum drug concentration and the maximum stomach capacity of animals within 24 hours, followed by continuous observation for 14 days. Long-term toxicity test rats were divided into 4 groups, respectively, 3.6,1.8,0.45 g / (kg.d) three dose groups and equal volume of saline for continuous administration of 13 weeks, 7 days a week off 1d and said The rats were sacrificed at the 13th and the 15th week, respectively. Twenty and ten rats were sacrificed to measure the body weight, blood routine, blood biochemistry and organ coefficient, and to observe the histopathological changes. Results: The maximum tolerated dose of Yuyang Capsule was 42g / kg, calculated according to the daily clinical dosage of 2.7g / 60kg, which is equivalent to 933 times of the clinical dosage for adults. Long-term toxicity results showed that the high, medium and low doses were equivalent to 80, 40 and 10 times of the daily clinical dosage respectively. There was no significant change in weight, blood and blood biochemical parameters in the rats during the administration and recovery periods . Conclusion: Yuyang capsule has no obvious toxic effect on the test animals and can be safely used in clinic.