黄芪注射液异常毒性实验研究  

Experimental Study on Abnormal Toxicity of Astragalus Injection

作　　者：郭芯岐 张吟怡 GUO Xin-qi;ZHANG Yin-yi(Changzhou Center for Food and Drug Control,Changzhou 213000,China)

机构地区：[1]常州市食品药品监督检验中心,江苏常州213000

出　　处：《药物生物技术》2020年第6期532-533,共2页Pharmaceutical Biotechnology

摘　　要：评价黄芪注射液异常毒性,观察黄芪注射液是否会对小鼠产生急性毒性反应,为其安全使用提供参考。参照2015年版《中华人民共和国药典》(四部)中"异常毒性检查法",对4个厂家12批次黄芪注射液同时进行小鼠异常毒性试验,每只小鼠分别静脉给予黄芪注射液0.5 m L,在4~5 s内匀速注射完毕,记录48 h内小鼠异常反应症状。给药后48 h内小鼠行动正常;未发生举尾、振颤、痉挛、运动失调、姿态异常等神经系统反应;无眼球突出、流涎、流泪、排尿、下泻、竖毛、皮肤变色等;眼、鼻、口腔无异常分泌物;饮水及食欲正常;无死亡。给予黄芪注射液1 g(原药材量)/20 g(小鼠体重)对小鼠无明显异常毒性,该给药剂量是人临床用药剂量的75倍。To evaluate abnormal toxicity of the astragalus injection and to observe whether astragalus injection had acute toxicity to mice,and to provide reference for its safe drug-usage,based on"inspection method of abnormal toxicity"in Chinese Pharmacopoeia(2015 edition,Vol.IV),4 different enterprises of 12 batches of astragalus injection were simultaneously tested for abnormal toxicity.Each mice was injected 0.5 m L astragalus injection in accordance with tail intravenous injection test in 4 ~ 5 seconds.Symptoms of the mice within 48 hours were recorded.Within 48 hours after administration,the behavior of mice was normal;There was no reaction of the nervous system such as tail,tremor,convulsions,and ataxia,abnormal posture;And no exophthalmos,salivation,tears,urine,collapse,erect hair,skin discoloration,and so on;There were no abnormal secretions of eyes,nose and mouth;The appetite and the water-drinking were normal;No deaths.There was no significant abnormal toxicity in mice when given the astragalus injection at the dose of 1 g(dosage of crude drug)/20 g(mice’s body weight).The dosage in the experiment was 75 times as that in the clinical.

关 键 词：黄芪注射液 异常毒性 急性毒性反应 安全性 检查法 实验研究 

分 类 号：R965.3[医药卫生—药理学]