硫辛酸注射液热原反应因素实验研究  

Experimental study on pyrogen reaction factors of Thioctic Acid for Injection

作　　者：田恩圣 潘春芬 田雨阳 戴晓莉 张君茹 TIAN Ensheng;PAN Chunfen;TIAN Yuyang;DAI Xiaoli;ZHANG Junru(Shandong Center for Food and Drug Evaluation&Inspections,Jinan 250014,China;Government Hospital of Zibo municipality,Zibo 255000,China;School of Life Sciences,Hubei University,Wuhan 430000,China;Shandong Academy of Pharmaceutical Sciences,Jinan 250100,China)

机构地区：[1]山东省食品药品审评查验中心,山东济南250014 [2]淄博市市级机关医院,山东淄博255000 [3]湖北大学生命科学学院,湖北武汉430000 [4]山东省药学科学院,山东济南250100

出　　处：《药学研究》2021年第9期571-572,577,共3页Journal of Pharmaceutical Research

摘　　要：目的研究硫辛酸注射液引发热原反应的生物学因素。方法对硫辛酸注射液采用新西兰兔法开展热原试验,并采用鲎试剂检测细菌内毒素,新西兰兔体外和体内溶血法检测溶血反应。结果实验用硫辛酸注射液30 mg·kg^(-1)剂量下兔热原反应为阳性,内毒素检查为阴性,新西兰兔体内外均出现溶血反应。结论实验组硫辛酸注射液30 mg·kg^(-1)注射后可引起兔热原反应阳性,溶血可能是引发热原反应的重要生物学因素。Objective To study the biological factors of pyrogen reaction induced by Thioctic Acid for Injection.Methods The pyrogen test of Thioctic Acid for Injection was carried out in New Zealand rabbits.The bacterial endotoxin was detected by limulus reagent.The hemolysis reaction was detected by in vitro and in vivo hemolysis method in New Zealand rabbits.Results The pyrogen reaction of Thioctic Acid for Injection was positive at the dose of 30 mg·kg^(-1),and the endotoxin test was negative.The hemolysis reaction occurred in New Zealand rabbits both in vivo and in vitro.Conclusion Thioctic Acid for Injection at the dose of 30 mg·kg^(-1) can induce positive pyrogen reaction in rabbits.Hemolysis may be an important biological factor that causes pyrogen reaction.

关 键 词：硫辛酸注射液 热原反应 溶血 内毒素 

分 类 号：R965[医药卫生—药理学]