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用小鼠作急性毒性实验，汉丹肝乐的最大灌胃量达２４ｇ／ｋｇ·ｄ，为临床用药量的４００倍，７ｄ观察期内未见明显毒性反应及动物死亡；用大鼠作长期毒性实验，汉丹肝乐口服每天用量为０６ｇ／ｋｇ、１５ｇ／ｋｇ、３０ｇ／ｋｇ，分别为临床用药的１０倍，２５倍和３０倍，２４周观察期内各组动物一般状况良好，血象、肝肾功能均在正常范围内，主要脏器肉眼尸检及组织学镜检未见明显病理反应，观察期内无一动物死亡，表明本品口服安全无毒。
The mice were used for acute toxicity test. The maximum amount of gavage of Handan Gan Le was 24 g/kg·d, which was 400 times of the clinical dosage. No toxic reaction and animal death were observed during the 7-day observation period; Toxicity test: The daily dosage of Handan Gan Le Oral was 06g/kg, 15g/kg, and 30g/kg, which were 10 times, 25 times, and 30 times of the clinical dosage, respectively. Each group in the 24-week observation period Animals were generally in good condition. The blood, liver and kidney functions were all in the normal range. There was no obvious pathological reaction in the gross organ autopsy and histological examination. No animal died during the observation period, indicating that the product was safe and non-toxic.