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小鼠最大耐受量的黄龙胶囊原药21000mg(相当于生药315000mg)·kg~(-1)”(为临床推荐用量的344倍)灌胃,观察两周,未见死亡和任何中毒症状。长期毒性试验给大鼠(1520、3050、6090mg·kg~(-1)·d~(-1))连续灌胃黄龙胶囊原药30天(相当于生药量22800、45750、91350mg·kg~(-1)·d~(-1)为临床推荐用量的25～100倍)。动物在试验期间的食量与体重呈同步增加,行为活动及大、小便未见异常改变。试验结束对大鼠进行血常规指标;肝、肾功能;血糖;血胆固醇等8项生化指标检查均无明显异常。对其心、肝、肾、脾、肺等9个重要脏器与组织的病理组织学检查未见明显毒性作用,脏器系数计算结果各组间比较无显著性差异。提示该药长期口服基本安全无毒。
The maximum tolerated dose of Huanglong Capsule 21000mg (equivalent to 315000mg of crude drug)·kg -1 (of 344 times the clinically recommended dose) was intragastrically administered and no death or any symptoms of poisoning were observed during the two weeks. Long-term toxicity test for rats (1520,3050,6090 mg·kg -1 ·d -1) continuous gavage Huanglong capsule original drug for 30 days (equivalent to the amount of crude drug 22800, 45750, 91350 mg · kg ~ ( -1)·d~(-1) is 25 to 100 times the clinical recommended dosage.) The animal’s food intake and body weight increased synchronously during the test period, and there was no abnormal change in the behavioral activity or in the large or small urine. Blood biochemical indicators, liver and kidney function, blood glucose, blood cholesterol, and other eight biochemical indicators were all not significantly abnormal, and histopathological examinations of nine important organs and tissues such as heart, liver, kidney, spleen, and lung were not found. There was no significant difference between the groups in terms of obvious toxic effects and organ coefficient calculation results, suggesting that the drug is basically safe and non-toxic for long-term oral administration.