盐酸氮卓斯汀滴眼液对实验动物眼部的安全性评价试验  

Safety Evaluation of Azelastine Hydrochloride Eye Drops on the Eyes of Experimental Animals

作　　者：周艳艳 文皓頲 杨倚天 徐丽瑛 郑国安 张俊明 ZHOU Yanyan;WEN Haoting;YANG Yitian;XU Liying;ZHENG Guoan;ZHANG Junming(Jiangxi Medical Device Testing Center,Jiangxi Province Key Laboratory for Safety Evaluation of Drugs,Nanchang Jiangxi 330029,China;Jiangxi University of Traditional Chinese Medicine,Nanchang Jiangxi 330004,China)

机构地区：[1]江西省医疗器械检测中心,江西省药物安全评价重点实验室,江西南昌330029 [2]江西中医药大学,江西南昌330004

出　　处：《药品评价》2022年第21期1305-1308,共4页Drug Evaluation

摘　　要：目的:观察多次给予盐酸氮卓斯汀滴眼液、原研药和赋形剂后实验兔眼及周围组织是否产生刺激症状及症状强弱,客观评价其可能存在的毒性反应及安全性,为临床安全用药提供实验参考。方法:取检疫并符合要求的新西兰兔12只,分为供试品组、赋形剂组和原研药品组,采用左右同体自身对照法,按组别左眼分别给予受试物盐酸氮卓斯汀滴眼液、不含主药成分的赋形剂阴性溶液和原研药品,实验兔右眼均滴入0.9%氯化钠注射液作为对照,每次给药1滴,2次/d,每次间隔6 h,连续给药28 d,给药期间和规定的观察期间用裂隙灯观察实验兔眼球是否存在刺激性及其他损伤。结果:盐酸氮卓斯汀滴眼液、赋形剂阴性溶液、市售的原研盐酸氮卓斯汀滴眼液和0.9%氯化钠注射液均未对兔眼及眼周围产生刺激反应,结膜、虹膜均未见异常反应,评分均为0。结论:盐酸氮卓斯汀滴眼液、赋形剂和原研药品对实验兔眼局部用药均无刺激性反应。Objective:To observe the irritation symptoms and the strength of symptoms in rabbit eyes and surrounding tissues after repeated administration of azelastine hydrochloride eye drops,the original drug and excipient,and to objectively evaluate the possible toxic reactions and safety,so as to provide experimental reference for clinical safe drug use.Rabbit eyes was observed after administering azelastine hydrochloride eye drops,evaluate the irritation and reaction intensity of the experimental rabbit eyes within a specified time,and objectively evaluate the possible toxicity and safety of the drug,which is clinically safe Provide reference for medication.Methods:Twelve New Zealand rabbits that met the quarantine requirements were divided into test group,excipient group and original study drug group.The left and right body self control method was used.The subjects were given azelastine hydrochloride eye drops,excipient negative solution without the main drug component and original study drug respectively in the left eye of each group.0.9%sodium chloride injection was dropped into the right eye of all experimental rabbits as control.One drop per time,twice a day,each time at an interval of 6 h,continuous administration for 28 d.Slit lamp was used to observe whether irritation and other injuries existed in the eyes of experimental rabbits during the administration and the specified observation period.Results:Azelastine hydrochloride eye drops,excipient negative solution,commercially available original azelastine hydrochloride eye drops and 0.9%sodium chloride injection did not produce irritating reactions to the eyes and surrounding eyes of rabbits,and no abnormal reactions were observed in conjunctiva and iris,and the scores were all 0.Conclusion:Azelastine hydrochloride eye drops,excipients and the original drug had no irritant reaction to local administration of experimental rabbit eyes.

关 键 词：药物毒性 药物相关性副作用和不良反应 盐酸氮卓斯汀滴眼液 兔 眼刺激 

分 类 号：R965[医药卫生—药理学]