| 氟康唑氯化钠注射液细菌内毒素检查法的可行性研究 |
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| 引用本文： | 陈金凤,钱生稳,黄新兰,李竟梅,易翠英.氟康唑氯化钠注射液细菌内毒素检查法的可行性研究[J].中国药业,2007,16(18):30-31. |
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| 作者姓名： | 陈金凤 钱生稳 黄新兰 李竟梅 易翠英 |
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| 作者单位： | 扬子江药业集团有限公司,江苏,泰州,225321 |
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| 摘 要： | 目的建立氟康唑氯化钠注射液的细菌内毒素检查法。方法用不同厂家的鲎试剂（TAL）对不同批号的产品分别进行干扰试验，考察确立氟康唑氯化钠注射液的细菌内毒素检查法。结果氟康唑氯化钠注射液稀释2倍以下时可消除干扰作用，结果准确可靠。结论对于氟康唑氯化钠注射液，可用细菌内毒素检查法代替热原检查法.
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| 关 键 词： | 氟康唑氯化钠注射液 细菌内毒素检查法 干扰试验 |
| 文章编号： | 1006-4931（2007）18-0030-02 |
| 修稿时间： | 2006-12-072007-04-02 |
Feasible Study on Bacterial Endotoxins Test for Fluconazole and Sodium Chloride Injection |
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| Chen Jinfeng,Qian Shengwen,Huang Xinlan,Li Jingmei,Yi Cuiying.Feasible Study on Bacterial Endotoxins Test for Fluconazole and Sodium Chloride Injection[J].China Pharmaceuticals,2007,16(18):30-31. |
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| Authors: | Chen Jinfeng Qian Shengwen Huang Xinlan Li Jingmei Yi Cuiying |
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| Institution: | Yangtze River Pharmaceutical Group Co. Ltd., Taizhou, Jiangsu, China 225321 |
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| Abstract: | Objective To establish a method of bacteria endotoxins test for Fluconazole and Sodium Chloride Injection.Methods Tachypleus arnebocyte lysate(TAL)from different manufacturers was used to conduct the interferential test of products with different batch number.The method of bacteria endotoxins test for Fluconazole and Sodium Chloride Injection was investigated.Results Less than two-fold diluted solution of Fluconazole and Sodium Chloride Injection did not interfere with bacteria endotoxins test.Conclusion It is feasible for bacterial endotoxins test of Fluconazole and Sodium Chloride Injection to substitute pyrogen test. |
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| Keywords: | Fluconazole and Sodium Chloride Injection bacterial endotoxins test interferential test |
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