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肺靶向红霉素明胶微球的安全性评价
Safety Evaluation of the Lung Targeting Erythromycin Gelatin Microspheres
【摘要】 目的:评价肺靶向红霉素明胶微球(EM-GMS)的安全性。方法:对EM-GMS、注射用乳糖酸红霉素(EM)、空白明胶微球(GMS)进行小鼠急性毒性半数致死量(LD50)实验;以生理盐水为对照进行EM-GMS兔耳缘静脉血管刺激性、豚鼠全身过敏性及体外溶血实验。结果:小鼠尾静脉注射EM-GMS、GMS、EM后LD50分别为173.07、191.01、337.70mg.kg-1;与生理盐水比较,未观察到EM-GMS发生血管刺激性、过敏反应及溶血作用。结论:EM-GMS应用于受试动物安全性较好。
【Abstract】 OBJECTIVE:To evaluate the safety of the lung targeting erythromycin gelatin microspheres(EM-GMS).METHODS:The acute toxicity LD50 test was conducted in mice with EM-GMS,erythromycin(EM) and GMS,respectively;the stimulating test in rabbits’ auricular veins,allergic test and hemolysis test in vitro in guinea pigs were conducted with normal saline used as control.RESULTS:The LD50 in mice after iv of EM-GMS,GMS,and EM were 173.07,191.01,and 337.70 mg·kg-1.As compared with control,neither vascular stimulation,nor allergic response or hemolysis was noted after intervention with EM-GMS.CONCLUSION:The EM-GSM has good safety on test animals.
【Key words】 Erythromycin gelatin microspheres; Acute toxicity; Hemolytic test; Vascular stimulation; Allergic reaction;
- 【文献出处】 中国药房 ,China Pharmacy , 编辑部邮箱 ,2008年04期
- 【分类号】R96
- 【被引频次】12
- 【下载频次】256