香丹注射液安全性实验报告

The Test Report of the Reliability of Xiang Dan for Injection

目的对香丹注射液进行肌肉刺激性、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只家兔注射香丹注射液后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注射香丹注射液及生理盐水的变化。在全身过敏实验中,6只豚鼠隔日3次腹腔注射香丹注射液,于首次给药后第14天和第21天分别静脉注射香丹注射液,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。结果香丹注射液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。结论香丹注射液的动物实验结果表明其安全可靠。

Objective To evaluate the reliability of Xiang Dan 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 48 hours after injection Xiang Dan; in the vessel stimulation, two rabbits were observed at 5 days after injection Xiang Dan or saline, respectively; in hypersensitivity of total boby, 6 guinea pigs were injected by Xiang Dan in abdominal cavity in 3 times, the last two were 14d and 21d after first medication; in the haemolytic test, hemolysis and coagulation were mainly observed. Results The Xiang Dan injection has no stimulation to muscle and ear vein of rabbit, the rabbits have no allergic reaction as contrast and without hemolytic reaction, Conclusion Xiang Dan injection was safety and reliable based on the animal experiment.