Objective: To observe the Compound Wuzhigan Capsules acute toxicity and long-term toxicity. Methods:①Acute toxicity test from 20 NIH mice, male and female in half, the largest drug delivery method using oral administration,7 days after administration of continuous observation, observation of animals recorded during the acute toxic reactions and death.② Long-term toxicity tests, SD rats, 100, 20 in each group, three experimental groups with Compound Wuzhigan Capsules 2.01, 1.02, 0.51 g/kg, the control group received normal saline ig 2 months to observe the general conditions of the measurement index of animal organs, pathological, hematological, and biochemical blood test. Results: The Compound Wuzhigan Capsules was greater than the maximum tolerance 20 g/kg, clinical recommended dosage was equivalent to 370 times;long-term toxicity of Compound Wuzhigan Capsules 2 months continuous oral administration, each dose group were not the targets see exception. Conclusion: Compound Wuzhigan Capsules is a small side effects, not easy to produce accumulation of toxic effects, safe and effective Traditional Chinese Medicine preparation.%目的:观察复方五指柑胶囊的急性毒性和长期毒性.方法:①急性毒性试验,取NIH小白鼠20只,雌雄各半,采用最大给药法灌胃给药,给药后连续观察7 d,观察期间记录动物的毒性反应情况和死亡情况.②长期毒性试验,SD大鼠80只,每组20只,3个试验组用复方五指柑胶囊2.01、1.02、0.51g/kg,对照组给予生理盐水,连续灌胃2个月,观察一般状况测量动物器官指数,进行病理、血液学、血液生化学检查.结果:复方五指柑胶囊的最大耐受量大于20g/kg,相当于临床推荐用量的370倍以上;长期毒性以复方五指柑胶囊连续灌胃给药2个月,各剂量组各项指标均未见异常.结论:复方五指柑胶囊是一种毒副作用小、不易产生蓄积性毒性作用、安全有效的中药制剂.
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