果糖二磷酸钠注射液的细菌内毒素检查方法探讨 |
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引用本文: | 张显杰,王春艳,闫明寅. 果糖二磷酸钠注射液的细菌内毒素检查方法探讨[J]. 黑龙江医药, 2010, 23(4): 539-540 |
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作者姓名: | 张显杰 王春艳 闫明寅 |
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作者单位: | 哈药集团哈尔滨三精艾富西药业有限公司,150069 |
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摘 要: | 目的:建立果糖二磷酸钠注射液的细菌内毒素检查法。方法:参考中国药典2005年版二部附录XIE,确定果糖二磷酸钠注射液的细菌内毒素限值及进行干扰试验测定最大非干扰浓度。结果:果糖二磷酸钠注射液对细菌内毒素检查有抑制作用,稀释成4mg/mL的供试品溶液后,用0.125EU/mL的鲎试剂对细菌内毒素检查无干扰。结论:果糖二磷酸钠注射液适用于细菌内毒素检查法。
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关 键 词: | 果糖二磷酸钠注射液 细菌内毒素检查 鲎试剂 干扰试验 |
Discussing Fructose Sodium Diphosphate Injection's Endotoxin |
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Affiliation: | Zhang Xianjie,et al( Harbin Sanjing FAC Pharmaceutical Co.,Ltd150069) |
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Abstract: | Objective:To establish the Fructose Sodium Diphosphate Injection Endotoxin test.Methods:refer to the Chinese pharmacopoeia 2005 Edition 2 Appendix of Fructose Sodium Diphosphate Injection bacterial endotoxin text limits and interference measured the concentration of the largest non-interference.Results:Fructose Sodium Diphosphate Injection on the bacterial endotoxin test has inhibited 4mg/ml diluted solution of the tested products of the TAL reagent with 0.125Eu/ml bacterial endotoxin test without interference.Conclusion:Fructose Sodium Diphosphate Injection for Bacterial Endotoxin Test. |
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Keywords: | Fructose Sodium Diphosphate Injection Endotoxin TAL Bacterial Endotoxin Test Intetference Test |
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