| 注射用奥沙利铂细菌内毒素检查法研究 |
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| 引用本文： | 权莹,杨国军. 注射用奥沙利铂细菌内毒素检查法研究[J]. 内江师范学院学报, 2007, 22(2): 57-59 |
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| 作者姓名： | 权莹 杨国军 |
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| 作者单位： | 四川源生生物药业有限公司,四川,成都,610041 |
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| 摘 要： | 目的:建立注射用奥沙利铂细菌内毒素检查法质量标准.方法:参照细菌内毒素检查法和细菌内毒素检查法应用指导原则进行试验.结果:通过干扰试验确证,按拟定标准检验,本法对3批供试品的细菌内毒素检查结果均符合规定.结论:注射用奥沙利铂可用细菌内毒素检查法代替热原检查法.
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| 关 键 词： | 奥沙利铂 细菌内毒素检查法 干扰试验 |
| 文章编号： | 1671-1785（2007）02-0057-03 |
| 收稿时间： | 2006-10-21 |
| 修稿时间： | 2006-10-21 |
Study on the Determination of Oxaliplatin for Injection by Bacterial Endotoxin Test |
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| QUAN Ying,YANG Guo-jun. Study on the Determination of Oxaliplatin for Injection by Bacterial Endotoxin Test[J]. Journal of Neijiang Teachers College, 2007, 22(2): 57-59 |
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| Authors: | QUAN Ying YANG Guo-jun |
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| Abstract: | Objective:To create a quanlity standard of oxaliplatin for injection by determiation of Bacterial Endotoxin.Methods:Referring to the demands of testing methods which are recorded in Chinese Pharmacopoeia(volume 2005).Results:The results of bacterial endotoxin test of three lots are all complied with the quality control of oxaliplatin for injection.Conclusion:The method of bacterial endotoxin test is accurate and reliable which can replace the pyrogen test. |
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| Keywords: | oxaliplatin for injection bacterial endotoxin test interference test |
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