匹多莫德注射液的安全性评价

Safety evaluation of pidotimod injections

目的评价匹多莫德注射液安全性,确定其是否适用于临床静脉给药方式。方法通过对制剂进行刺激性试验、过敏性试验、体外溶血性试验,检验匹多莫德注射液给药后有无血管刺激性、过敏性和溶血反应,评价制剂的安全性。结果家兔静脉给药无血管刺激性;豚鼠静脉给药未见过敏反应;体外溶血试验未见溶血和血球凝集反应;未见大鼠被动皮肤过敏反应。结论匹多莫德注射液安全性好,符合静脉给药要求。

Objective To evaluate safety of pidotimod injections,to determine whether it can be used intravenously in clinic.Methods Rabbit ear vein test,passive cutaneous anaphylaxis,hemolytic test in vitro were performed to assess the vessel irritations,anaphylaxis and haemolytic reaction after intravenous injection of pidotimod injection and therefore to evaluate the safety of preparations.Results The preparation showed no sign of blood vessels irritation after the treatment of rabbit vein;the skin allergic reaction was not seen on guinea pigs in the test;no hemolysis and blood clots response in hemolysis test in vitro was observed;no passive cutaneous anaphylaxis was witnessed in rats.Conclusions Pidotimod injections are safe,conforming to the requirements of injections.