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目的针对上市硫普罗宁注射剂存在一定临床反应的反馈,对市售硫普罗宁注射剂进行安全性再评价。方法对硫普罗宁注射剂进行血管刺激性、溶血性、过敏性试验。人与动物剂量换算依照1:20(家兔和豚鼠)。结果硫普罗宁注射剂对家兔耳缘静脉无明显刺激作用;对家兔红细胞无明显溶血及致凝聚作用;对豚鼠无过敏作用。结论上市硫普罗宁注射剂供临床静脉注射用安全性尚好。
Objective To review the safety of tiopronin injection on the market with the feedback of certain clinical reaction. Methods Stimulant, hemolytic and allergic tests were conducted on tiopronin injection. Human and animal dose conversion according to 1:20 (rabbits and guinea pigs). Results Tiopronin injection had no obvious stimulation effect on rabbit ear veins; there was no obvious hemolysis and aggregation on rabbit erythrocytes; and no allergy to guinea pigs. Conclusion The safety of tiopronin injection for clinical intravenous injection is good.