格拉司琼透皮贴剂重复给予毒性实验研究  

Study on Long Term Toxicity of Granisetron Patch on Rabbits

作　　者：王丹 林鹏 张鹏[1] 刘芳 袁昕蓉[1] 王冬妍 WANG Dan;LIN Peng;ZHANG Peng;LIU Fang;YUAN Xinrong;WANG Dongyan(Shenyang Institute for Food and Drug Control,Shenyang 110122,China;Liaoning Institute for Drug Control,Shenyang 110036,China)

机构地区：[1]沈阳市食品药品检验所,辽宁沈阳110122 [2]辽宁省药品检验检测院,辽宁沈阳110036

出　　处：《品牌与标准化》2024年第3期1-3,共3页

摘　　要：目的:本文研究了格拉司琼透皮贴剂长期给药对兔产生的毒性反应。方法:实验设3个剂量组和空白对照组,高、中、低3个剂量分别为17.3 cm^(2)/kg、8.6 cm^(2)/kg、4.3 cm^(2)/kg,分别相当于临床使用剂量的20倍、10倍和5倍。结果:在对兔的长期毒性试验中,其体重及体重增重、血液学、血液生化学、血清电解质、脏体比等指标与空白对照组比较,差异无统计学意义(P>0.05)。组织病理学检查中未见与药物毒性相关的明显病变。结论:格拉司琼透皮贴剂长期用药对兔无明显毒性,临床拟用剂量使用较为安全。Objective:The long term toxicity on rabbits were studied.Method:Three sample dose groups and blank control groups were set up in the 4-week long term toxicity test.The high,medium and low doses were 17.3 cm^(2)/kg、8.6 cm^(2)/kg、4.3 cm^(2)/kg,which were 20 times,10 times and 5 times of the human recommended dose.Result:There was no significant difference between the sample groups and the control group in terms of body weight,weight gain,hematological,blood biochemical and serum electrolytes indexes of rats,and visceral body ratio of rabbits(P>0.05).No abnormal phenomenon was observed in the histopathological observation of rabbits.Conclution:No obvious toxic reaction was observed in all indexes during long term toxicity test on rabbits,which infered that the dosageinclinicwas safe.

关 键 词：格拉司琼透皮贴剂 长期毒性 兔 

分 类 号：R965.3[医药卫生—药理学]