| 丹皮酚磺酸钠注射液细菌内毒素检查方法的建立 |
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| 引用本文： | 杨玲,厉青,曹蕾,陈晓玲.丹皮酚磺酸钠注射液细菌内毒素检查方法的建立[J].中国药房,2014(13):1225-1227. |
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| 作者姓名： | 杨玲 厉青 曹蕾 陈晓玲 |
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| 作者单位： | 武警浙江省总队医院,浙江嘉兴314000 |
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| 摘 要： | 目的:建立丹皮酚磺酸钠注射液的细菌内毒素检查方法。方法:按2010年版《中国药典》(二部)附录中细菌内毒素凝胶检查法的要求,通过干扰试验确定样品最大无干扰浓度,并进行方法学验证。结果:丹皮酚磺酸钠注射液稀释至质量浓度≤0.83mg/ml时对鲎试剂未见干扰作用。结论:细菌内毒素法可替代家兔法用于丹皮酚磺酸钠注射液的热原检查。
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| 关 键 词： | 丹皮酚磺酸钠注射液 细菌内毒素 鲎试剂 干扰试验 |
Establishment of Bacterial Endotoxin Test for Paeononlsilatie Sodium Injection |
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| YANG Ling,LI Qing,CAO Lei,CHEN Xiao-ling.Establishment of Bacterial Endotoxin Test for Paeononlsilatie Sodium Injection[J].China Pharmacy,2014(13):1225-1227. |
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| Authors: | YANG Ling LI Qing CAO Lei CHEN Xiao-ling |
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| Institution: | (Zhejiang People＇s Armed Police Corps Hospital, Zhejiang Ji- axing 314000, China) |
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| Abstract: | OBJECTIVE： To establish bacterial endotoxin test for Paeononlsilatie sodium injection. METHODS： The maximum non-interference concentration of samples was determined by interference test according to the requirements of bacterial endotoxin test stated in appendix II of Chinese Pharmacopeia （2010 edition）. And then methodology validation was conducted. RESULTS： The interference of tachypleus amebocyte lysate （TAL） on bacterial endotoxin test can be excluded when Paeononlsilatie sodium in- jection was diluted to below 0.83 mg/ml. CONCLUSIONS： The bacterial endotoxins test can replace the rabbit method for pyrogen test of Paeononlsilatie sodium injection. |
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| Keywords: | Paeononlsilatie sodium injection Bacterial endotoxin Tachypleus amebocyte lysate Interference test |
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