| 氨茶碱注射液细菌内毒素检查方法的建立 |
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| 引用本文： | 周继春. 氨茶碱注射液细菌内毒素检查方法的建立[J]. 中国药品标准, 2013, 14(1): 38-40 |
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| 作者姓名： | 周继春 |
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| 作者单位： | 河南省食品药品检验所 |
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| 摘 要： | 目的:建立氨茶碱注射液细菌内毒素检查方法。方法:按《中国药典》2005年版二部附录细菌内毒素检查法,对不同批号的样品进行了干扰试验和细菌内毒素检查。结果:高浓度氨茶碱注射液溶液对TAL与细菌内毒素的凝集反应有干扰作用,经稀释后可排除干扰。结论:本品不干扰浓度为7.81 mg.mg-1,可采用细菌内毒素检查法进行质量控制。
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| 关 键 词： | 氨茶碱注射液 细菌内毒素 鲎试剂 干扰试验 |
| 收稿时间： | 2012-03-12 |
Establishment of Bacterial Endotoxin Test for Amophylline Injection |
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| Zhou Jichun. Establishment of Bacterial Endotoxin Test for Amophylline Injection[J]. , 2013, 14(1): 38-40 |
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| Authors: | Zhou Jichun |
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| Affiliation: | Zhou Jichun(Henan Institute for Food and Drug Control,Zhengzhou 450003) |
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| Abstract: | Objective： To establish a method for bacterial endotoxin test of Amophylline Injection. Method： According to ChP. 2005 edition Vol Ⅱ Appendix Ⅺ E, the interference test and bacterial endotoxin test of different batches of samples were carried out. Result： There was interference in the agglutinate reaction between the sample and the relative TAL with the high concentration of Amophylline Injection , and the interference was eliminated after diluted. Conclusion：The noninterference concentration of Amophylline Injection is 7.81 mg· mL-1. The bacterial endotoxin test can be used for the quality control of Amophylline Injection. |
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| Keywords: | AmophyUine Injection bacterial endotoxin TAL interference test |
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