舒洛地特注射液非临床安全性评价  

Non-Clinical Safety Evaluation of Sulodexide Injection

作　　者：张娟 冷佳蔚 李水仙 赵岩 祝清芬 ZHANG Juan;LENG Jiawei;LI Shuixian;ZHAO Yan;ZHU Qingfen(Shandong Institute for Food and Drug Control·NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Jinan,Shangong,China 255101)

机构地区：[1]山东省食品药品检验研究院·仿制药研究与评价重点实验室,山东济南250101

出　　处：《中国药业》2021年第6期28-31,共4页China Pharmaceuticals

摘　　要：目的评价舒洛地特注射液的安全性。方法采用血管刺激性试验、肌肉刺激性试验、溶血性试验观察舒洛地特注射液对家兔试验部位及溶血的影响,采用主动全身过敏性试验和被动皮肤过敏性试验观察舒洛地特注射液对豚鼠过敏反应的影响。结果舒洛地特注射液未见血管刺激性反应,给药结束24 h后家兔肌肉刺激性反应与上市药物对照一致,均为轻度刺激,14 d恢复期结束后均未出现刺激性反应及溶血和红细胞凝聚现象;豚鼠过敏性试验结果为阴性。结论试验动物注射舒洛地特注射液后未发生刺激性反应、溶血性反应及过敏反应。Objective To evaluate the safety of Sulodexide Injection.Methods The blood vessel stimulation test,muscle stimulation test and hemolytic test were used to observe the effect of Sulodexide Injection on the experimental site and hemolysis in rabbits.Active systemic anaphylaxis and passive cutaneous anaphylaxis were used to observe the effect of Sulodexide Injection on allergic reaction in guinea pigs.Results Sulodexide Injection had no vascular stimulation reaction.The muscle stimulation reaction of rabbits after the last administration for24 h was consistent with that of the marketed drug control,which was mild stimulation,and no stimulation reaction,hemolysis or erythrocyte aggregation occurred after 14 d of the recovery period.The result of the allergy test in guinea pigs was negative.Conclusion The experimental animals have no stimulation response,haemolyticus and allergic reaction after injection of Sulodexide Injection.

关 键 词：舒洛地特注射液 安全性评价 刺激性试验 溶血性试验 过敏反应 非临床安全性 

分 类 号：R965.2[医药卫生—药理学] R973.2[医药卫生—药学]