| 氟维司群细菌内毒素检查方法学研究 |
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| 引用本文： | 刘琦,陆益红. 氟维司群细菌内毒素检查方法学研究[J]. 山东医药工业, 2014, 0(12): 696-698 |
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| 作者姓名： | 刘琦 陆益红 |
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| 作者单位： | 江苏省食品药品监督检验研究院,江苏南京210008 |
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| 摘 要： | 目的：建立氟维司群原料药的细菌内毒素检查方法。方法以DMSO溶解氟维司群，再用细菌内毒素检查用水稀释，按《中国药典》2010年版（二部）附录Ⅺ E细菌内毒素检查法进行干扰试验；同时对DMSO溶解氟维司群的步骤进行细菌内毒素回收率试验。结果氟维司群的最大不干扰浓度为0.25 mg·mL-1，DMSO溶解液细菌内毒素回收率在100％~150％之间。结论氟维司群原料药可采用细菌内毒素检查法控制其质量。
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| 关 键 词： | 氟维司群 细菌内毒素 干扰试验 回收率试验 |
Study on the determination method of the bacterial endotoxins in fulvestrant |
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| LIU Qi,LU Yi-hong. Study on the determination method of the bacterial endotoxins in fulvestrant[J]. , 2014, 0(12): 696-698 |
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| Authors: | LIU Qi LU Yi-hong |
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| Affiliation: | ( Jiangsu Institute for Food and Drug Control, Nanjing 210008, China ) |
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| Abstract: | Objective To establish the bacterial endotoxins determination method for fulvestrant. Methods DMSO were added to dissolve fulvestrant,then dilute the solution with pyrogen-free water. The interference test was conducted ac-cording to the appendix Ⅺ E of Chinese Pharmacopoeia 2010 Vol.Ⅱ,the endotoxins recovery test of DMSO solution was conduct. Results Maximum nondisturb concentration of fulvestrant for bacterial endotoxins test was 0. 25 mg·mL-1 ,the endotoxins recovery of DMSO solution was 100% ~150%. Conclusion The established method of endotoxins test was fea-sible for fulvestrant. |
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| Keywords: | Fulvestrant Bacterial endotoxins Interference test Endotoxins recovery test |
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