注射用银杏达莫(冻干)安全性实验研究

Safety Evaluation of Yinxingdamo(Freeze-dried Powder)

目的对注射用银杏达莫(冻干)进行肌肉刺激性、血管刺激性、豚鼠主动全身过敏反应、大鼠被动皮肤过敏反应及溶血实验,为其临床应用提供安全性实验依据。方法肌肉刺激性实验,观察2只家兔注射用银杏达莫(冻干)后48 h的变化。血管刺激性实验,观察连续用药5 d注射用银杏达莫(冻干)及生理盐水,以及恢复14 d后的注射局部血管和周围组织反应情况。豚鼠主动全身过敏反应,在第1次给药后14 d及21 d,分别从足背静脉注射注射用银杏达莫(冻干)观察注射后15 min动物的过敏症状。大鼠被动皮肤过敏实验,采用0.5%伊文思兰溶液分析法。体外溶血实验,观察该品在3 h内有无溶血和聚集现象。结果注射用银杏达莫(冻干)对家兔股四头肌、耳缘静脉未见明显刺激作用,对豚鼠主动全身过敏反应及大鼠被动皮肤过敏反应均未见明显过敏反应;未见明显体外溶血作用。结论注射用银杏达莫(冻干)的安全性实验结果提示其安全可靠。

Objective To evaluate tbe safety of Yinxingdamo （Freeze -dried Power）. Injected by testing the muscle stimulation, vessel stimulation, active systematic anaphylaxis, passive cutaneous anaphylaxis and haemolytic test. Methods In the muscle stimulation test, two rabbits were observed at 48 h after injection Yinxingdamo （ Freeze - dried Power） ; In the vessel stimulation, four rabbits were observed on the 5 d after injection Yinxingdamo （ Freeze - dried Power） , and the reaction after stopped treatment 14 d. Active systematic anaphylaxis was investigated by male guinea pigs, reaction was observed the 14d and 21d after the first treatment. The rat passive cutaneous anaphylaxis reaction was assayed by Evans blue. In the haemolytic test, hemolysis and coagulation were mainly observed. Results Yinxingdamo （Freeze- dried power） injection had no stimulation to muscle and ear vein of rabbit, the guinea pigs and rats had no allergic reaction as contrast and without hemolytic reaction. Conclusion Yinxingdamo （Freeze- dried Power） injection is safe and reliable based on the animal experiment.