| 氟罗沙星注射液的细菌内毒素检测方法的实验研究 |
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| 引用本文： | 金麟先,王荣. 氟罗沙星注射液的细菌内毒素检测方法的实验研究[J]. 中国药品标准, 2002, 3(3): 37-39 |
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| 作者姓名： | 金麟先 王荣 |
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| 作者单位： | 1. 山东枣庄百科亨迪药业有限公司,枣庄,277000
2. 山东省枣庄市药品检验所,枣庄,277000 |
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| 摘 要： | 目的；建立氟罗沙星注射液的细菌内毒素检查法代替其热原检查法，并制订其细菌内毒素限值（L）。方法：用不同的批号，不同生产帮家的鲎试剂，在严格标准操作的条件下，对4批氟罗沙星注射液按有效浓度范围稀释后，进行干扰试验考察。结果：氟罗沙星注射液（10ml:100mg）经4倍衡释后对细菌内毒素检查法无干扰作用。其细菌内毒素限值可定为2.5Eu/ml。结论：对4批氟罗沙星注射液进行了热原检查及细菌内毒素检查的对比试验，两法符合率为100％。
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| 关 键 词： | 干扰试验 细胞内毒素试验 有效浓度范围 氟罗沙星注射液 |
STUDY ON BACTERIAL ENDOTOXINS TEST FOR FLEROXACIN INJECTION |
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| Jin Linxian and Wang Rong. STUDY ON BACTERIAL ENDOTOXINS TEST FOR FLEROXACIN INJECTION[J]. , 2002, 3(3): 37-39 |
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| Authors: | Jin Linxian and Wang Rong |
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| Affiliation: | Shandong Zao Zhuang Baike Heilen Pharmaceutical Co., Ltd, Zaozhuang, China, 277000;Shandong Zaozhuang Institute for Drug control, Zaozhuang China, 277000 |
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| Abstract: | Objective: The To establish the bacterial endotoxin test of Fleroxacin Injection (10ml:100mg)for instead of pyrogen method and to suppose the limit(L). Methods: The inhibition or enhancement test is carried out on 4 lots of Fleroxacin Injection with different products of tachypleus amebocyte lysate(TAL).Results:The results show that the concentration of Fleroxacin Injection had neither inhibition nor enhancement action.The L was supposed as 2.5EU/ml.Conclutson:The coincidental rate of above comparison test is 100%. |
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| Keywords: | interfering test Bacterial endotoxins test Valid concentration Limit |
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