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作 者:孙虹 沈琳 胡雅静[2] 胡淑毅[2] 许睿 方永奇[3] 李翎[3]
机构地区:[1]国家中药现代化工程技术研究中心,广东珠海519020 [2]丽珠集团利民制药厂,广东韶关512028 [3]广州中医药大学第一附属医院临床实验中心,广东广州510405
出 处:《中国医药导报》2011年第1期50-52,共3页China Medical Herald
摘 要: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、0.51 g/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20 g/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。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.
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