熊胆冻干粉针剂安全性实验报告

The Test Report of the Reliability of Bear Gall Lyophilized Powder for Injection

目的对熊胆冻干粉针剂进行肌肉刺激性、血管刺激性、全身过敏性及溶血性实验,以评价其用药的安全性。方法在肌肉刺激性实验中,主要观察2只家兔注射熊胆冻干粉针剂后48 h的变化。在血管刺激性实验中,主要观察2只家兔分别连续5 d注射熊胆冻干粉针剂及生理盐水的变化。在全身过敏性实验中,6只豚鼠隔日3次腹腔注射熊胆冻干粉针剂,于首次给药后第14日和21日分别静脉注射熊胆冻干粉针剂,观察15 m in内动物的变化。在溶血性实验中,观察本品在4 h内有无溶血和聚集现象。结果熊胆冻干粉针剂对家兔股四头肌无刺激作用,对家兔耳缘静脉无刺激作用,对豚鼠未见过敏反应,家兔无溶血现象。结论熊胆冻干粉针剂的动物实验结果表明其安全可靠。

Objective To evaluate the reliability of bear gall lyophilized powder injection by testing the muscle stimulation, vessel stimulation, hypersensitivity of total boby and haemolytic test. Methods In the muscle stimulation test, two rabbits were observed at 48h after injection bear gall lyophilized powder; In the vessel stimulation, two rabbits were observed on the 5 d after injection bear gall lyophilized powder or saline, respectively; In hypersensitivity of total boby, 6 cavies were injected by bear gall lyophilized powder in abdominal cavity in 3 times, and the last two were 14d and 21d after first medication; In the haemolytic test, hemolysis and coagulation were mainly observed. Results The bear gall lyophilized powder has no stimulation to muscle and ear vein of rabbit, the rabbits have no allergic reaction as contrast and without hemolytic reaction. Conclusion Bear gall lyophilized powder injection is safe and reliable based on the animal experiment.