奥沙利铂脂质微球注射液制剂安全性评价  

Safety Evaluation of Oxaliplatin Lipid Microsphere Injection

作　　者：王三龙[1] 孙立[1] 张颖丽[1] 沈连忠[1] 齐卫红[1] 李欣[1] 王秀文[1] 李保文[1] 李波[1] 

机构地区：[1]中国药品生物制品检定所国家药物安全评价监测中心,北京100176

出　　处：《食品与药品》2010年第5期174-176,共3页Food and Drug

摘　　要：目的评价临床使用奥沙利铂脂质微球注射液的安全性。方法肌肉刺激性实验:主要观察家兔注射奥沙利铂脂质微球后48 h和2周的组织病理变化;溶血性实验:观察本品在3 h内有无溶血和聚集现象;全身过敏性实验:豚鼠隔日3次腹腔注射奥沙利铂脂质微球或牛血清白蛋白V,于末次给药后第10天静脉注射本品,观察3 h内动物的变化。结果奥沙利铂脂质微球注射液对家兔股四头肌无刺激作用,家兔红细胞无溶血现象,豚鼠未见过敏反应。结论实验结果表明奥沙利铂脂质微球注射液安全可靠。Objective To evaluate the preclinical safety of Oxaliplatin Lipid Microsphere Injection. Methods In the muscle stimulation test, the histopathological changes were observed in rabbits at 48 hours and 2 weeks after the administration of Oxaliplatin Lipid Microsphere Injection; in the hemolysis test, the occurrence of any hemolysis and aggregation induced by Oxaliplatin Lipid Microsphere Injection within 3 hours was observed; in the systematic allergy test, guinea pigs were intraperitoneally administered with Oxaliplatin Lipid Microsphere Injection or bovine serum albumin V three times at an interval of two days and further intravenously administered with the same on day 10 after the last administration, and then were observed for three hours. Results Oxaliplatin Lipid Microsphere Injection did not produce stimulation to quadriceps femoris of rabbits. No hemolysis was observed and guinea pigs showed no allergic responses. Conclusion The experiment results show that Oxaliplatin Lipid Microsphere Injection is safe and reliable in animal.

关 键 词：奥沙利铂 脂质微球注射液 安全性评价 

分 类 号：R965.3[医药卫生—药理学]