| 奥沙利铂注射液细菌内毒素检查方法的研究 |
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| 引用本文： | 宋瑜丽,马俊,颜稚宏,余彩玲.奥沙利铂注射液细菌内毒素检查方法的研究[J].中国药业,2005,14(6):38-39. |
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| 作者姓名： | 宋瑜丽 马俊 颜稚宏 余彩玲 |
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| 作者单位： | 深圳市海王英特龙生物技术股份有限公司,广东,深圳,518057 |
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| 摘 要： | 目的:对奥沙利铂注射液进行细菌内毒素检查的干扰试验,并建立其细菌内毒素检查方法.方法:参照2000年版<中国药典(二部)>附录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,本品1个规格共3批供试品的细菌内毒素检查结果均符合规定.结论:本品1 mL含奥沙利铂2 mg的供试品及其稀释液对细菌内毒素检查无干扰.可用鲎试验法代替家兔热原检查法控制奥沙利铂注射液的热原.
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| 关 键 词： | 奥沙利铂注射液 细菌内毒素检查法 干扰试验 |
| 文章编号： | 1006-4931(2005)06-0038-02 |
| 修稿时间： | 2004年9月9日 |
Study on the Determination of Bacterial Endotoxin in Oxaliplatin for Injection Using Tachypleus Amebocyte Lysate |
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| Song Yuli,Ma Jun,Yan Zhihong,Yu Cailing.Study on the Determination of Bacterial Endotoxin in Oxaliplatin for Injection Using Tachypleus Amebocyte Lysate[J].China Pharmaceuticals,2005,14(6):38-39. |
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| Authors: | Song Yuli Ma Jun Yan Zhihong Yu Cailing |
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| Abstract: | Objective:To establish a procedure for determination the bacterial endotoxin in oxaliplatin for injection by tachypleus amebocyte lysate.Methods:Referring to the demands of testing methods which are recorded in Chinese Pharmacopoeia(volume 2000).Results:The results of bacterial endotoxin test of three lots are all complied with the quality control of oxaliplatin for injection.Conclusion:It is available for test of the bacterial endotoxin by diluting the oxaliplatin for injection to 2 mg/mL in tachypleus amebocyte lysate method and it can substitute for the Rabbit Method in quality control. |
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| Keywords: | oxaliplatin for injection:bacterial endotoxin:factors test |
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