| 奥扎格雷钠注射液细菌内毒素检查法的研究 |
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| 引用本文： | 符成龙,殷栋二.奥扎格雷钠注射液细菌内毒素检查法的研究[J].海南医学院学报,2004,10(6):381-383. |
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| 作者姓名： | 符成龙 殷栋二 |
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| 作者单位： | 海南碧凯药业有限公司,海口,570216 |
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| 摘 要： | 目的:研究奥扎格雷钠注射液的细菌内毒素检查方法。方法:参照中国药典2000年版收载的细菌内毒素检查法及指导原则进行干扰试验。结果:奥扎格雷钠注射液在稀释至0.5 mg/mL时,对鲎试剂的凝集反应无干扰作用,采用灵敏度为0.5 Eu/mL的鲎试剂可进行细菌内毒素检查。结论:可用细菌内毒素检查法控制奥扎格雷钠注射液的质量,本品细菌内毒素限值为1.0 EU/mg。
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| 关 键 词： | 奥扎格雷钠注射液 鲎 指示剂和试剂 细菌 毒素类 |
| 文章编号： | 1007-1237(2004)06-0381-03 |
| 修稿时间： | 2004年10月22 |
STUDY ON THE EXAMINATION OF BACTERIAL ENDOTOXIN IN OZAGREL SODIUM INJECTION |
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| FU Cheng-long,YIN Dong-er.STUDY ON THE EXAMINATION OF BACTERIAL ENDOTOXIN IN OZAGREL SODIUM INJECTION[J].Journal of Hainan Medical College,2004,10(6):381-383. |
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| Authors: | FU Cheng-long YIN Dong-er |
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| Abstract: | Objective: To study the method of testing bacterial endotoxin in the ozagrel sodium injection. Methods: The interference test was performed according to the assigned method and guiding principle for bacterial endotoxin test in Chinese Pharmacopoeia 2000. Results: When the proper sensitivity of limulus test agent for bacterial endotoxin test was 0.5 EU/mL, Ozagrel sodium injection does not interfere the agglutination response with limulus reagent, whose concentration was diluted to 0.5 mg/mL . Conclusion: Bacterial endotoxin test can be used for quality control of ozagrel sodium injection. |
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| Keywords: | Ozagrel sodium injection Limulus Indictor and reagent Bacteria Endotoxin |
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