| 奥沙利铂脂质微球注射液制剂安全性评价 |
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| 引用本文： | 王三龙,孙立,张颖丽,沈连忠,齐卫红,李欣,王秀文,李保文,李波. 奥沙利铂脂质微球注射液制剂安全性评价[J]. 食品与药品, 2010, 12(5): 174-176 |
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| 作者姓名： | 王三龙 孙立 张颖丽 沈连忠 齐卫红 李欣 王秀文 李保文 李波 |
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| 作者单位： | 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 |
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| 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.
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| 关 键 词： | 奥沙利铂 脂质微球注射液 安全性评价 |
Safety Evaluation of Oxaliplatin Lipid Microsphere Injection |
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| WANG San-long,SUN Li,ZHANG Ying-li,SHEN Lian-zhong,QI Wei-hong,LI Xin,WANG Xiu-wen,LI Bao-wen,LI Bo. Safety Evaluation of Oxaliplatin Lipid Microsphere Injection[J]. Food and Drug, 2010, 12(5): 174-176 |
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| Authors: | WANG San-long SUN Li ZHANG Ying-li SHEN Lian-zhong QI Wei-hong LI Xin WANG Xiu-wen LI Bao-wen LI Bo |
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| Affiliation: | WANG San-long,SUN Li,ZHANG Ying-li,SHEN Lian-zhong,QI Wei-hong,LI Xin,WANG Xiu-wen,LI Bao-wen,LI Bo(National Center for Safety Evaluation of Drugs,National Institute for the Control of Pharmaceutical & Biological Products,Beijing 100176,China) |
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| Abstract: | 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 Oxali... |
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| Keywords: | oxaliplatin lipid microsphere injection safety evaluation |
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