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作 者:李志坤 刘瑞 赵艳霞 李水仙 祝清芬 郭毅 吕志涛 LI Zhikun;LIU Rui;ZHAO Yanxia;LI Shuixian;ZHU Qingfen;GUO Yi;LYU Zhitao(Shandong Institute for Food and Drug Control·NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Jinan,Shandong,China 250101;Xi'an Libang Chengchuang Pharmaceutical Technology Co.,Ltd.,Xi'an,Shaanxi,China 710075;Shandong Chengchuang Blue Sea Pharmaceutical Technology Co.,Ltd.,Jinan,Shandong,China 250013)
机构地区:[1]山东省食品药品检验研究院·国家药品监督管理局仿制药研究与评价重点实验室,山东济南250101 [2]西安力邦诚创医药科技有限公司,陕西西安710075 [3]山东诚创蓝海医药科技有限公司,山东济南250013
出 处:《中国药业》2024年第12期42-44,共3页China Pharmaceuticals
基 金:国家药典委员会课题[2018Y007]。
摘 要:目的建立舒更葡糖钠异常毒性及降压物质的检查方法。方法取SPF级小鼠40只,随机分为5组,各8只,每组小鼠均予舒更葡糖钠尾静脉注射,给药剂量分别为4600,4370,4152,3944,3747 mg/kg,给药后72 h内观察小鼠死亡情况;计算半数致死量(LD50)及其95%置信区间(CI),以其95%CI下限的1/4剂量进行异常毒性检查。取实验猫1只,股静脉注射40,20,10 mg/kg舒更葡糖钠,以0.1µg/kg组胺作对照;记录给药前后实验猫的颈动脉血压,计算下降值,确定药品降压物质检查限值并验证。结果舒更葡糖钠的LD50为4182.8 mg/kg,95%CI为3988.1~4409.4 mg/kg;1000 mg/kg剂量下,3组小鼠(各5只)48 h内均未死亡。降压物质检查限值为10 mg/kg,实验猫在此剂量下血压下降值均未超过组胺所致血压下降值的50%;3批样品检查结果均符合规定。结论该方法可用于舒更葡糖钠异常毒性及降压物质的检查。Objective To establish methods for abnormal toxicity and depressor substance tests of sugammadex sodium.Methods Forty SPF mice were selected and randomly divided into five groups,with eight mice in each group.The mice in each group were injected 4600,4370,4152,3944,3747 mg/kg sugammadex sodium via tail vein,and the mortality of the mice was observed within 72 h after administration.The median lethal dose(LD50)and its 95%confidence interval(CI)were calculated,the quarter dosage of the lower limit of 95%CI was selected for the abnormal toxicity test.One experimental cat was taken and injected 40,20,10 mg/kg sugammadex sodium via femoral vein,with 0.1µg/kg histamine as the control.The carotid blood pressure of the experimental cat before and after administration was recorded,the reduction value was calculated,the limit of depressor substance test for sugammadex sodium was determined and verified.Results The LD50 of sugammadex sodium was 4182.8 mg/kg,and the 95%CI was in the range of 3988.1 to 4409.4 mg/kg.All mice in three groups(five in each group)did not die within 48 h at the dosage of 1000 mg/kg.The limit of depressor substance test was 10 mg/kg,the reduction value of blood pressure in experimental cat was not over 50%of that induced by histamine at this dosage,and the results of tests in three batches of samples were all in compliance with regulations.Conclusion The established methods can be used for the abnormal toxicity and depressor substance tests of sugammadex sodium.
分 类 号:R917[医药卫生—药物分析学]
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