| 米力农注射液细菌内毒素检查法标准修订 |
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| 引用本文： | 祝清芬,国明,魏霞,李涛.米力农注射液细菌内毒素检查法标准修订[J].中国药事,2012,26(5):456-458. |
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| 作者姓名： | 祝清芬 国明 魏霞 李涛 |
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| 作者单位： | 山东省食品药品检验所,济南,250101 |
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| 基金项目： | 山东省自然科学基金(编号Q2008C06) |
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| 摘 要： | 目的 修订米力农注射液细菌内毒素检查法质量标准.方法 按《中国药典》2010年版二部,修改本品细菌内毒素限值,并研究米力农注射液对细菌内毒素检查试验的干扰情况.结果 本品用1M NaOH调节pH值近中性后对细菌内毒素检查无干扰作用.结论 修订了本品细菌内毒素检查法质量标准,修订后的标准适用于本品细菌内毒素检查.
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| 关 键 词： | 米力农注射液 细菌内毒素检查 干扰试验 |
Revision of the Criterion for Bacterial Endotoxin Test of Milrinone Injection |
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| Zhu Qingfen
,
Guo Ming
,
Wei Xia
,
Li Tao.Revision of the Criterion for Bacterial Endotoxin Test of Milrinone Injection[J].Chinese Pharmaceutical Affairs,2012,26(5):456-458. |
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| Authors: | Zhu Qingfen Guo Ming Wei Xia Li Tao |
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| Affiliation: | *(Shandong Institute for Food and Drug Control,Jinan 250101) |
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| Abstract: | Objective To revise the criterion for bacterial endotoxin test of Milrinone Injection.Methods The limit on the amount of bacterial endotoxin in this product was revised according to CP2010,and the interference of the product in bacterial endotoxin test was studied.Results Milrinone Injection did not interfere in the test when its PH reached almost 7 after adding 1M NaOH.Conclusion The criterion for bacterial endotoxin test of this product was revised.It has been showed that this product is suitable for bacterial endotoxin test. |
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| Keywords: | Milrinone Injection bacterial endotoxin test interference test |
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