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目的 :观察生骨胶囊对动物的急性、长期毒性 ,为临床安全用药提供依据。方法 :急性毒性实验用小鼠以口服给药 ,测定其最大耐受量 (MTD) ,并推算出相当临床人用量的倍数。长期毒性实验用大鼠 ,设 8.0 g· kg- 1 ,4.0 g· kg- 1两个剂量组和空白对照组 ,连续给药 180 d,观察动物的饮食、体重。于实验第 90 d,180 d和停药后 15 d,分别处死 1/3动物 ,取血测定血常规及其生化指标 ,并取出主要脏器作组织、病理学检查。结果 :生骨胶囊的 MTD>12 g· kg- 1 ,相当于人临床用量的 90倍。生骨胶囊长期毒性实验 ,大鼠连续给药 180 d,低剂量 4.0 g· kg- 1 和高剂量 8.0 g· kg- 1 组动物饮食、体重正常 ,血液及生化指标均未见异常 ,主要脏器组织、病理学观察 ,心、肝、肾、脑有明显的不同程度充血 ,肝细胞有轻微的可逆性颗粒变性。结论 :生骨胶囊口服给药 ,连续服用较安全
Objective : To observe the acute and long-term toxicity of Shenggu Capsule to animals, and provide basis for clinical safe drug use. METHODS: Acute toxicity test was performed in mice orally, and the maximum tolerated dose (MTD) was determined, and the multiple of the number of clinical people was calculated. Long-term toxicity test rats, set 8.0 g · kg-1, 4.0 g · kg-1 two dose groups and blank control group, continuous administration 180 d, observe the animal’s diet, body weight. At the 90th day of the experiment, 180 days after the withdrawal and 15 days after the withdrawal, 1/3 of the animals were sacrificed. The blood was collected to measure the blood routine and biochemical indicators, and the main organs were removed for histological and pathological examination. Results: The MTD of Shenggu capsule was >12 g·kg-1, which was equivalent to 90 times of the clinical dosage. In the long-term toxicity test of Shenggu capsule, rats in a continuous dose of 180 days, a low dose of 4.0 g.kg-1 and a high dose of 8.0 g.kg-1 were fed with normal diet and weight, and no abnormalities in blood and biochemical indicators were observed. Observations of histopathology and pathology showed that the heart, liver, kidney, and brain had distinct degrees of congestion, and hepatocytes had slight reversible granule degeneration. Conclusion : Shenggu capsules are given orally for continuous administration.