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目的:对乌藤镇痛胶囊进行毒理学研究,评价其安全性。方法:参照新药的有关要求进行:(1)ICR小鼠最大耐受量(MTD)试验;(2)SD大鼠慢性毒理学试验。结果:(1)小鼠急性经口最大耐受剂量(MTD)为20 g.kg-1(生药116 g.kg-1),相当于临床日剂量的666倍,无明显急性毒性;(2)大鼠灌胃此药,一般体征、体质量、血液学指标、生化学指标、脏器系数值和病理组织学检测均未见异常,无积蓄毒性。结论:乌藤镇痛胶囊未见明显急性毒性反应和长期毒性反应,在临床剂量下使用是安全的。
OBJECTIVE: To study the toxicology of Wutou Zhuotong Capsule and evaluate its safety. Methods: Refer to the requirements of new drugs: (1) Maximum tolerated dose (MTD) test in ICR mice; (2) Chronic toxicological test in SD rats. Results: (1) The acute oral maximum tolerated dose (MTD) in mice was 20 g.kg-1 (crude drug 116 g.kg-1), equivalent to 666 times of the clinical daily dose, with no obvious acute toxicity. (2) ) Gavage of the drug in rats, the general signs, body mass, hematological indicators, biochemical indicators, organ coefficient values and histopathological examination showed no abnormality, no accumulation of toxicity. Conclusion: Wu Teng analgesic capsules no obvious acute toxicity and long-term toxicity, the use of the drug in the clinical dose is safe.