硫辛酸注射液局部刺激性与过敏性实验研究  

Experimental Study on Local Irritation and Anaphylaxis of Lipoic Acid Injection

作　　者：周艳艳[1] 张俊明[1] 徐丽瑛[1] 郑国安[1] 丁琦[1] 吴金花[1] ZHOU Yanyan;ZHANG Junming;XU Liying;ZHENG Guoan;DING Qi;WU Jinhua(Jiangxi Medical Device Testing Center,Jiangxi Institute of Materia Medica,Jiangxi Province Key Laboratory for Safety Evaluation of Drugs,Nanchang Jiangxi 330029,China.)

机构地区：[1]江西省医疗器械检测中心,江西省药物研究所安全评价中心,江西省药物研究所安全评价重点实验室,江西南昌330029

出　　处：《药品评价》2024年第7期830-833,共4页Drug Evaluation

摘　　要：目的观察实验动物注射硫辛酸注射液后,产生的刺激和过敏反应及反应强度,客观评价药物可能存在的毒性反应。方法用实验兔血管及肌肉刺激性试验、体外溶血试验、豚鼠主动全身过敏性试验和大鼠被动皮肤过敏实验,考察硫辛酸注射液的安全性。结果硫辛酸注射液对新西兰兔耳缘静脉及股四头肌无刺激性作用;体外溶血试验中,各剂量供试品均未见溶血及红细胞凝集反应;豚鼠全身主动过敏性试验与被动皮肤过敏试验中,豚鼠及大鼠的阳性致敏率均为0。结论本实验条件下,硫辛酸注射液用于静脉注射是安全可靠的。Objective To observe the stimulation,allergic reaction and reaction intensity of experimental animals after injection of lipoic acid,and objectively evaluate the possible toxic reaction of drugs.Methods The safety of lipoic acid injection was evaluated by experimental rabbits vascular and muscle stimulation test,hemolysis test in vitro,guinea pigs active systemic anaphylaxis and rats passive cutaneous anaphylaxis.Results The experimental animals have no stimulation response auricular marginal vein and quadriceps femoris in New Zealand rabbits after injection of lipoic acid injection.The positive sensitization rates of guinea pigs and rats were 0 in both active systemic anaphylaxis and passive cutaneous anaphylaxis.Conclusion Under these experimental conditions,lipoic acid injection was safe and reliable for intravenous use.

关 键 词：硫辛酸注射液 刺激性试验 过敏性试验 溶血性试验 非临床安全性 

分 类 号：R965[医药卫生—药理学]