生骨胶囊毒理学实验研究

Toxicological Study of Shenggu Capsule

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 。

Objective: The acute and longterm toxicity of Shenggu Capsule were observed to provide the basis for the safety of using this drug in clinical. Methods: Mice were used in acute toxicity experiment. Oral maximal tolerance dose (MTD) were determined, and the times equal to human were calculated accordingly. The longterm toxicity was performed in rats, two treatment groups (8.0 g·kg 1 and 4.0 g·kg 1 ) and control group were divided up. Shenggu Capsule was administered orally for 180 days. The effects of Shenggu Capsule on blood routine examination, biochemical blood test and main organs pathology were investigated. Results: MTD>12 g·kg 1 , equal to 90 times dosage in human. In longterm toxicity experiment, the animals in both low and high doses (4.0 g·kg 1 or 8.0 g·kg 1 ) groups of Shenggu Capsule had normal diets, and no changes were observed in blood routine examination and biochemical blood test after administration for 180 days. Hyperaemia of heart, liver, kidney and brain is obvious and reversible, granular denaturation of liver cell is light in the pathology examination. Conclusion: The present studies show that it is safety to take Shenggu Capusle for oral administration.