盐酸米托蒽醌氯化钠注射液安全性评价

Security evaluation of mitoxantrone hydrochloride and sodium chloride injection

目的考察盐酸米托蒽醌氯化钠注射液制剂的安全性。方法对盐酸米托蒽醌氯化钠注射液进行了过敏性、溶血性和血管刺激性试验。结果盐酸米托蒽醌氯化钠注射液对豚鼠无致敏作用,对家兔红细胞无溶血及凝聚作用,对家兔耳缘静脉未见刺激性。结论盐酸米托蒽醌氯化钠注射液符合制剂安全性要求。

Objective To study the security of mitoxantrone hydrochloride and sodium chloride injection.Method Carrying out sensitivity test,hemolytic test and blood vessel stimulation test to mitoxantrone hydrochloride and sodium chloride injection.Results It had no hypersensitive to guinea pigs,hemolysis and coacervation were not obvious to red cell of rabbits,and no stimulation to blood vessel.Conclusions Mitoxantrone hydrochloride and sodium chloride injection met the safety requirements.