| 注射用氨磷汀安全性研究 |
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| 引用本文： | 张广伟,徐晓月.注射用氨磷汀安全性研究[J].中国药业,2011,20(12):19-21. |
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| 作者姓名： | 张广伟 徐晓月 |
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| 作者单位： | 河南省食品药品检验所,河南郑州,450003 |
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| 摘 要： | 目的研究注射用氨磷汀的安全性,为临床应用提供依据。方法进行豚鼠全身主动过敏试验(ASA),首先隔日每只豚鼠每次腹腔注射供试品,共3次,再于首次注射后第14日和第21日由耳缘静脉注射供试品,观察动物过敏反应;进行大鼠被动皮肤过敏试验(PCA),大鼠皮内注射抗体血清,静脉注射伊文思蓝,观察蓝色反应斑;进行体外溶血试验,观察供试品在3h内有无溶血和凝聚现象;进行血管刺激试验,家兔连续5 d耳缘静脉注射供试品,观察其对注射局部血管的刺激。结果注射用氨磷汀豚鼠全身主动过敏性试验及大鼠被动皮肤过敏性试验均未见过敏反应;体外溶血试验在3 h内未见溶血和凝聚现象;血管刺激性试验病理组织学检查未见血管刺激性反应。结论注射用氨磷汀安全、可靠。
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| 关 键 词： | 注射用氨磷汀 安全性试验 过敏反应 溶血试验 血管刺激 |
Safety Study of Amifostine for Injection |
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| Zhang Guangwei,Xu Xiaoyue.Safety Study of Amifostine for Injection[J].China Pharmaceuticals,2011,20(12):19-21. |
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| Authors: | Zhang Guangwei Xu Xiaoyue |
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| Institution: | Zhang Guangwei,Xu Xiaoyue(Henan Provincial Institute for Food and Drug Control,Zhengzhou,Henan,China 450003) |
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| Abstract: | Objective To evaluate the safety of Amifostine for Injection to provide the evidence for its clinical application.Methods The active systemic anaphylaxis(ASA) was investigated by guinea pigs,in which each guinea pig was allergized by intraperitoneal injecting Amifostine for Injection every other day,total 3 times.Amifostine for Injection was injected via ear vein for observing the anaphylactic reaction on 14 d and 21 d after the first injection.The rat passive cutaneous anaphylactic reaction was assayed by ... |
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| Keywords: | amifostine for iinjection safety test allergic reaction hemolytic test vessel stimulation |
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