哌拉西林钠及其注射剂的细菌内毒素检查研究 |
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引用本文: | 牛慧玲,马辉,陈志英.哌拉西林钠及其注射剂的细菌内毒素检查研究[J].中国药品标准,2006,7(1):60-64. |
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作者姓名: | 牛慧玲 马辉 陈志英 |
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作者单位: | 黑龙江省药品检验所,150001 |
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摘 要: | 目的:建立哌拉西林钠及注射用哌拉西林钠的细菌内毒素检验方法。方法:依据《中国药典》2000年版附录细菌内毒素检查法进行试验。结果;哌拉西林钠及注射用哌拉西林钠在浓度不大于10mg/ml时对TAL试剂检测无干扰因素的影响。结论:该药采用细菌内毒素检查方法可行,可考虑代替热原检查。
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关 键 词: | 哌拉西林钠 注射用哌拉西林钠 细菌内毒素检查法 干扰试验 |
Study on Testing The Bacterial Endotoxins of Piperacillin Sodium and Piperacillin Sodium for Injection |
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Authors: | Niu Huiling Ma Hui and Chen Zhiying |
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Institution: | Heilongjiang Provincial InStitute for Drug Control,Harbin 150001 |
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Abstract: | Objective: To establish a method for testing bacterial endotoxins of Piperacillin Sodium and Piperacillin Sodium for Injection.Methods: According to the Bacterial Endotoxins Test approved by Chinese Pharmacopoeia 2000 edition.Result: Piperacillin Sodium and its Injection did not interfere with bacterial endotoxins test when its concentration is not more than 10mg·ml-1.Conclusion: It is suitable for bacterial endotoxin test of Piperaillin Sodium and Piperacillin Sodium for Injection. And it may take place of test for pyrogens. |
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Keywords: | Piperacillin Sodium Piperacillin Sodium for Injection Bacterial Endotoxin Test Interfere factors test |
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