血栓通注射制剂非临床安全性检查

目的：对血栓通注射制剂进行非临床安全性检查.方法：对血栓通注射制剂进行了小鼠半数致死量（LD50）测定,并对三个厂家的血栓通注射制剂进行血管刺激性、溶血性及过敏试验研究.结果：血栓通注射制剂的小鼠LD50为（419.351±22.605） mg·kg^-1;临床使用最大浓度对新西兰兔耳缘静脉无明显刺激作用;溶血试验结果显示三个厂家的溶血率有较大不同;豚鼠全身主动过敏试验显示血栓通注射制剂在该实验条件下静脉注入豚鼠体内会出现类似过敏反应症状;在本实验条件下血栓通注射液和注射用血栓通注入豚鼠体内后,没有引发被动皮肤过敏反应.结论：血栓通注射制剂小鼠LD50为（419.351±22.605） mg·kg-1;血栓通注射制剂临床使用最大浓度对新西兰兔耳缘静脉无明显刺激作用;其不同厂家的溶血率明显不同;可引发豚鼠类似过敏反应的症状.

Test of the Non-Clinical Security of Xueshuantong Injection and Xueshuantong for Injection

Objective： Test of the non - clinical security of xueshuantong injection and xueshuantong for injection. Methods： The lab mice＇s median lethal dose（ LD50 ） of xueshuantong injection was tested, and vascular irritation, hemolysis, allergic reaction of xue-shuantong injection and xueshuantong for injection from 3 different companies were tested. Results：The lab mice＇s LD50 of xueshuan-tong injection was （419. 351 ± 22. 605 ）mg·kg^-1 ; the clinical maximal concentration of xueshuantong injection and xueshuantong for injection had no obvious vascular stimulation on rabbits, and the hemolysis rates of products from the 3 different companies were signifi- cantly different. Active systemic anaphylaxis test in guinea pigs showed that the guinea pigs had developed symptoms of similar anaphy- lactic reaction after injecting xueshuantong injection or xueshuantong for injection. Passive cutaneous anaphylaxis test in guinea pigs showed nnreaction symptoms. Conclusion： Chnical maximal concentration of xueshuantong injection and xueshuantong for injection has no obvious vascular irritation in rabbits. Three different companies have significant differences in their hemolysis rates. Guinea pigs will develope symptoms of similar anaphylactic reaction after injecting xueshuantong injection or xueshuantong for injection.