| 注射用氨磷汀细菌内毒素检查方法的建立 |
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| 引用本文： | 李龙健,陆金花.注射用氨磷汀细菌内毒素检查方法的建立[J].中国药房,2014(1):76-77. |
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| 作者姓名： | 李龙健 陆金花 |
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| 作者单位： | 武警浙江总队医院,浙江嘉兴314000 |
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| 摘 要： | 目的:建立注射用氨磷汀细菌内毒素的检查方法。方法:按2010年版《中国药典》附录细菌内毒素凝胶检查法的要求,通过预干扰和干扰试验确定样品最大无干扰浓度,并进行方法学验证。结果:样品稀释至5.00 mg/ml时对细菌内毒素检查法无干扰作用。结论:建立的方法用于检查注射用氨磷汀的细菌内毒素可行。
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| 关 键 词： | 注射用氨磷汀 细菌内毒素检查 凝胶法 干扰试验 |
Establishment of Bacterial Endotoxin Test of Amifostine for Injection |
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| LI Long-jian,LU Jin-hua.Establishment of Bacterial Endotoxin Test of Amifostine for Injection[J].China Pharmacy,2014(1):76-77. |
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| Authors: | LI Long-jian LU Jin-hua |
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| Institution: | (Zhejiang Armed Police Corps Hospital, Zhejiang Jiaxing 314000, China) |
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| Abstract: | OBJECTIVE： To establish a method for bacterial endotoxin test of Amifostine for injection. METHODS： Maximal non-interference concentrations of samples were determined by pre-interferenee test and interference test according to the appendix of Chinese Pharmacopiea （2010 edition）. And then methodology validation was conducted. RESULTS： The interference on bacteri- al endotoxin test can be excluded when the sample was diluted to below 5.00 mg/ml. CONCLUSIONS： The established method is feasible to detect the bacterial endotoxin of Amifostine for injection. |
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| Keywords: | Amifostine for injection Bacterial endotoxin test Gel-clot Interference test |
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