| 注射用奈达铂细菌内毒素检查法的建立 |
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| 引用本文： | 贾瑞波,刘静,耿欣.注射用奈达铂细菌内毒素检查法的建立[J].中国药师,2014(2):332-334. |
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| 作者姓名： | 贾瑞波 刘静 耿欣 |
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| 作者单位： | 大连市食品药品检验所 辽宁大连 116021;大连市食品药品检验所 辽宁大连 116021;大连市食品药品检验所 辽宁大连 116021 |
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| 摘 要： | 目的：建立注射用奈达铂细菌内毒素检查法。方法：按《中国药典》2010年版二部附录XIE进行试验和结果判断。结果：注射用奈达铂对鲎试剂与细菌内毒素的反应不存在干扰。结论：使用细菌内毒素检查法检查注射用奈达铂中的细菌内毒素是可行的，可用细菌内毒素检查法替代家兔热原检查法。
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| 关 键 词： | 注射用奈达铂 细菌内毒素 鲎试剂 干扰试验 |
| 收稿时间： | 7/3/2013 12:00:00 AM |
| 修稿时间： | 2013/10/31 0:00:00 |
Study on Determination Method for Bacterial Endotoxins in Nedaplatin for Injection |
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| Jia Ruibo,Liu Jing and Geng Xin.Study on Determination Method for Bacterial Endotoxins in Nedaplatin for Injection[J].China Pharmacist,2014(2):332-334. |
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| Authors: | Jia Ruibo Liu Jing and Geng Xin |
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| Institution: | (Dalian Institute for Food and Drug Control,Liaoning Dalian 116021, China) |
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| Abstract: | ABSTRACT Objective: To establish a detection method for bacterial endotoxins in nedaplatin for injection. Methods: The experiment was carried out and the result was evaluated according to the appendix XIE of Chinese Pharmacopoeia 2010 Vol. II. Results: There was no interference from nedaplatin for injection to bacterial endotoxin in TAL reaction. Conclusion: The method is feasible to detect bacterial endotoxin in nedaplatin for injection, which can replace the rabbit pyrogen test. |
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| Keywords: | Nedaplatin for injection Bacterial endotoxin TAL Interfere factors test |
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