| 唑来膦酸注射剂细菌内毒素检查的研究 |
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| 引用本文： | 高峰,石峰 有限公司,北京,),魏国义. 唑来膦酸注射剂细菌内毒素检查的研究[J]. 中国医药导报, 2012, 9(9): 43-44,47 |
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| 作者姓名： | 高峰 石峰 有限公司 北京 ) 魏国义 |
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| 作者单位： | 高峰 (首都医科大学附属北京安贞医院,北京,100029) ； 石峰 (保诺科技(北京)有限公司,北京,102206) ； 魏国义 (首都医科大学附属北京安贞医院,北京,100029) ； |
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| 摘 要： | 目的对唑来膦酸注射剂进行凝胶法干扰试验,建立唑来膦酸注射剂细菌内毒素的检查方法。方法按《中国药典》2010年版二部＂细菌内毒素检查法＂,用不同厂家的鲎试剂对不同批号的唑来膦酸制剂分别进行干扰试验。结果注射用唑来膦酸稀释至浓度0.05 mg/mL或以下稀释浓度,唑来膦酸注射液原液稀释14倍后的溶液对细菌内毒素检查法无干扰作用。结论唑来膦酸注射剂统一限度进行内毒素检查是可行的。
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| 关 键 词： | 唑来膦酸 细菌内毒素检查法 干扰试验 鲎试剂 |
Study on the test method of Bacterial endotoxin in Zoledronic Acid Injection |
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| GAO Feng,SHI Feng,WEI Guoyi. Study on the test method of Bacterial endotoxin in Zoledronic Acid Injection[J]. China Medical Herald, 2012, 9(9): 43-44,47 |
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| Authors: | GAO Feng SHI Feng WEI Guoyi |
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| Affiliation: | 1.The Affiliated Beijing Anzhen Hospital to Capital Medical University,Beijing 100029,China;2.Baonuo(Beijing) Inc.LTD,Beijing 102206,China |
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| Abstract: | Objetive To establish a bacterial endotoxin test for Zoledronic acid Olive Oil injection.Methods According to the Bacterial endotoxins test in Chinese Pharmacopoeia(2005,2 edition).Different batches of Zoledronic Acid Injection from different TAL manufacturers were underwent the interference tests.Results There was no interference in the bacterial endotoxins test when the concentration of Zoledronic Acid Injection was less than or equal to the detection limit of 0.05 mg/mL and the concentration of Zoledronic Acid Injection was diluted to 14 times.Conclusion Carrying out the bacterial endotoxin test for Zoledronic Acid Injection is feasible. |
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| Keywords: | Zoledronic acid Bacterial endotoxins test Interference experiment Limulus agent |
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