盐酸阿扎司琼注射液局部安全性实验研究

Local safety evaluation of Azastron Hydrochloride Injections

目的评价盐酸阿扎司琼注射液的安全性,为临床用药提供实验依据。方法家兔耳缘静脉给予盐酸阿扎司琼注射液0.5mg·kg^-1,每天给药1次,连续给药5d,停药96h后对注射部位进行病理组织学检查;家兔股四头肌给予0.25mg·mL^-1盐酸阿扎司琼注射液1mL,给药1次,48h后对注射部位进行病理组织学检查;豚鼠隔日腹腔注射0.5mL盐酸阿扎司琼注射液,连续注射3次,分别于末次致敏后第14天静脉注射1.0mL盐酸阿扎司琼注射液进行激发,观察豚鼠30min内是否出现变态反应;0.1-0.5mL盐酸阿扎司琼注射液在4.5-4.9mL兔红细胞混悬液中放置3h,观察对兔红细胞悬液的溶血及有无红细胞凝聚作用。结果盐酸阿扎司琼注射液无明显血管刺激性;无明显肌肉刺激性;无溶血和凝集反应;豚鼠全身主动过敏性实验为阴性。结论在实验条件下,盐酸阿扎司琼注射液符合注射剂安全要求。

Objective To valuate the safety of Azastron Hydrochloride Injections and provide evidence for clinical medication.Methods Rabbits were administrated with Azastron Hydrochloride Injections（0.5mg·kg^-1,once daily continuously for 5d,iv）,and histopathlogic examination for the injection site was carried out at 96hafter drug withdrawal.The quadriceps femoris of rabbits were administrated with Azastron Hydrochloride Injection（0.25mg·mL^-1,1mL for one time,im）,and histopathlogic examination of injection site was carried out at 48hafter drug withdrawal.Guinea pigs were ip administrated with Azastron Hydrochloride Injections（0.5mL）every other day for three times successively,and on the day 14after the last sensitization 1.0mL of Azastron Hydrochloride Injections was iv administrated to arouse the reaction,and hemolyzation and agglutination of rabbit erythrocyte were observed by incubating Azastron Hydrochloride Injections（0.1-0.5mL）placed in rabbit erythrocyte（4.5-4.9mL）in vitro for 3h.Results Azastron Hydrochloride Injections did not induce obvious vascular and muscle irritative effects and hemolysis reaction,and the active systemic anaphylaxis of Azastron Hydrochloride Injections was negative.Conclusion Azastron Hydrochloride Injections should be safe under the experimental conditions,and it was complianced with the requirement of injection safety.