| 引用本文: | 许雷鸣,武谷,堵伟锋,李翔,顾倩.米力农原料药细菌内毒素检查方法的建立[J].中国现代应用药学,2014,31(9):1110-1114. |
| XU Leiming,WU Gu,DU Weifeng,LI Xiang,GU Qian.Establishment of Bacterial Endotoxin Test Method for Milrinone Raw Material[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(9):1110-1114. |
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| 摘要: |
| 目的 建立米力农原料药的细菌内毒素检查方法。方法 以DMSO溶解米力农，细菌内毒素检查用水稀释后按中国药典2010年版二部附录细菌内毒素检查法，采用2个不同厂家的鲎试剂进行干扰试验研究。结果 根据临床实际应用情况，确定米力农的内毒素限值L=13 EU·m-1。在本实验条件下，米力农的最大不干扰浓度为0.5 mg·mL-1，可选择市售任意灵敏度的鲎试剂检测米力农中的细菌内毒素。结论 米力农原料药可采用细菌内毒素检查法控制其质量。 |
| 关键词: 米力农 细菌内毒素检查 干扰试验 |
| DOI： |
| 分类号:R927.33 |
| 基金项目:安徽省食品药品监管系统科研项目(0004) |
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| Establishment of Bacterial Endotoxin Test Method for Milrinone Raw Material |
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XU Leiming1, WU Gu1, DU Weifeng1, LI Xiang1, GU Qian2
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1.Anhui Institute for Food and Drug Control, Hefei 230051, China;2.Wannan Medical College, Wuhu 241000, China
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| Abstract: |
| OBJECTIVE To establish bacterial endotoxin test method for milrinone raw material. METHODS Milrinone was dissolved with dimethylsulfoxide and then diluted by water for bacterial endotoxin test. The experiment was carried out according to the bacterial endotoxin test method indexed in the appendix of Ch.P 2010 Vol Ⅱ. Tachypleus amebocyte lysate from two manufacturers were used to for interference test. RESULTS According to the dose of clinical medication, the most suitable limit of bacterial endotoxin for milrinone was 13 EU·mg-1. Under this experimental condition, the maximum noninterference concentration for milrinone was 0.5 mg·mL-1. It was effective that bacterial endotoxin was tested by tachypleus amebocyte lysate with arbitrary sensitivity on the market. CONCLUSION Bacterial endotoxin test can be used to control the quality of milrinone raw material. |
| Key words: milrinone bacterial endotoxin test interference test |
