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哌拉西林钠及其注射剂的细菌内毒素检查研究
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
作者姓名:牛慧玲  马辉  陈志英
作者单位:黑龙江省药品检验所,150001
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。

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
Niu Huiling,Ma Hui and Chen Zhiying. Study on Testing The Bacterial Endotoxins of Piperacillin Sodium and Piperacillin Sodium for Injection[J]. , 2006, 7(1): 60-64
Authors:Niu Huiling  Ma Hui  Chen Zhiying
Affiliation:Heilongjiang Provincial InStitute for Drug Control,Harbin 150001
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.
Keywords:Piperacillin Sodium  Piperacillin Sodium for Injection  Bacterial Endotoxin Test   Interfere factors test
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