摘要
目的:对艾迪注射液进行豚鼠主动全身过敏反应试验、大鼠被动皮肤过敏反应试验、溶血试验、肌肉刺激性及血管刺激性试验,为其临床应用提供安全性依据。方法:豚鼠主动全身过敏反应,在第1次给药后14d及21d,分别从足背静脉注射艾迪注射液观察注射后30min动物的过敏症状;大鼠被动皮肤过敏试验,采用伊文思蓝溶液分析法;体外溶血试验,观察本品在3h内有无溶血和聚集现象;肌肉刺激性试验,观察2只家兔注射艾迪注射液后48h的变化;血管刺激性试验,观察连续用药5d艾迪注射液及生理盐水,以及恢复14d后的注射局部血管和周围组织反应情况。结果:艾迪注射液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;对家兔股四头肌、耳缘静脉未见明显刺激作用。结论:艾迪注射液的安全性试验结果提示其安全可靠。
OBJECTIVE To evaluate the reliability of Aidi injection by testing the muscle stimulation,vessel stimulation,ac-tive systemic anaphylaxis,passive cutaneous anaphylaxis and haemolytic test. METHODS In the muscle stimulation test, two rabbits were observed for 48 h after injecting Aidi injection; In the vessel stimulation, four rabbits were observed for 5 d after injecting Aidi injection, and the reaction after stopping treatment for 14 d; Active systemic anaphylaxis was investigated by male guinea pigs, reaction was observed when had injected Aidi injection on 14 d and 21 d 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 There were no stimulation to muscle and ear vein of rabbits, and no allergic reaction as contrast and without hemolytic reaction to the guinea pigs and rats. CONCLUSION Aidi injection is safe and reliable based on the animal experi ments.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2008年第21期1850-1853,共4页
Chinese Journal of Hospital Pharmacy
作者简介
彭佼，女，硕士，电话：0851-8974161，E-mail：pengjiao@163．com
[通讯作者]沈祥春，男，博士，教授，电话：0851-6908108，E-mail：shenxiangchun@126．com
