注射用硫普罗宁细菌内毒素检查法的建立 |
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引用本文: | 李展,周继春.注射用硫普罗宁细菌内毒素检查法的建立[J].中国药品标准,2012,13(3):203-205. |
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作者姓名: | 李展 周继春 |
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作者单位: | 河南省食品药品检验所,郑州,450003 |
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摘 要: | 目的:建立注射用硫普罗宁细菌内毒素检查方法.方法:参照<中国药典>2010年版二部细菌内毒素检查法进行试验.结果:将硫普罗宁稀释至1 mg·mL-1时对细菌内毒素和鲎试剂的反应无干扰作用.结论:该品种可采用细菌内毒素检查法控制药品质量.
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关 键 词: | 注射用硫普罗宁 细菌内毒素检查 干扰试验 |
Bacterial Endotoxin Test for Tiopronin for Injection |
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Authors: | Li Zhan and Zhou Jichun |
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Institution: | ( Henan Institute of Food and Drug Control ,Zhengzhou 450003 ) |
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Abstract: | Objective: To establish a bacterial endotoxin test method for Tiopronin for Injection. Methods : Experiment was carried out according to the test for bacterial endotoxin in appendices XI E of Ch. P. (2010) Volume Ⅱ. Results: At the concentration of 1 mg mL-1 ,Tiopronin has no interferential effects on the gelatin reaction of bacterial endotoxin with Tachypleus Amebocyte Lysate. Conclusion : Endotoxin test method can be adopted on the quality control of Tiopronin for Injection. |
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Keywords: | Tiopronin for Injection bacterial endotoxin test disturbance test |
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