注射用黄芪冻干粉的安全性试验和急性毒性试验

Study on safety tests and acute toxicological test of lyophilized powder of Astragalus for injection

目的考察注射用黄芪冻干粉的安全性和急性毒性反应。方法采用不同的动物,进行注射用黄芪冻干粉的溶血试验、肌肉刺激试验、静脉血管刺激试验、全身过敏试验、热原试验及急性毒性试验。结果注射用黄芪冻干粉的制剂安全;急性毒性试验未测出LD50,静脉注射最大耐受量为200 g/kg,相当于临床日用量(0.57 g/kg)的350倍;腹腔注射最大耐受量为400 g/kg,相当于临床日用量的700倍。结论在本实验条件下,黄芪冻干粉是安全的,为其长期毒性试验和临床研究提供了实验依据。

Objective To study the safety and acute toxicological reaction of lyophilized powder of Astragalus for injection （LPA）. Methods We experimented with animals for hemolytic test, muscular and venous stimulative test, allergic test, pyrogen test and acute toxicological test. Results The preparation of LPA was reliable and safe; with no LD50 detected during acute toxicological test. The maximum tolerance dose was 200 g/kg iv, an equivalent of 350 times clinical daily dose （0.57 g/kg）, and 400 g/kg ip, equivalent of 700 times of clinical daily dose. Conclusion LPA was proved to be safe in our experiment, which provides theoretical basis for long - term toxicological test and clinical research.