动态浊度法定量检测清开灵注射液中的内毒素 |
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引用本文: | 房霞,彭向前.动态浊度法定量检测清开灵注射液中的内毒素[J].中国药品标准,2006,7(4):66-68. |
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作者姓名: | 房霞 彭向前 |
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作者单位: | 1. 山东聊城市药品检验所,聊城,252000 2. 山东大学药学院,济南,250012 |
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摘 要: | 目的:对清开灵注射液进行内毒素动态浊度法检查实验,建立定量检测清开灵注射液中内毒素实验方法以代替热原检查法,提高内毒素的检出率,避免临床热原反应的发生。方法:采用《中国药典》2000年版附录检测内毒素的动态比浊法。结果:清开灵注射液经10倍及以上倍数释释后,对鲎试刺反应无干扰作用,内毒素回收率在50%-200%范围内。结论:本方法干扰因素小,检测结果准确,可作为日常检测使用。
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关 键 词: | 清开灵注射液 内毒素 动态浊度法 鲎试剂 |
Quantitative Determination of Endotoxin in Qingkailing Injection by Kinetic Turbidimetric Technique |
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Authors: | Fang Xia and Peng Xiang-qian |
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Institution: | 1Liaocheng Institute for Drug Control of Shandong Province,Liaocheng 252000;2 School of Pharmaceutical Sciences,Shandong University,,Iinan 250012 |
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Abstract: | Objective: To establish the kinetic turbidimetric technique for quality control on endotoxin content in Qingkailing Injection.To set up a reasonable limit of endotoxin for Qingkailing Injection and establish a rapid method for examining endotoxin instead of pyrogen test.Methods: The kinetic turbidimetric technique in Chinese pharmacopoeia 2000 edition was used.Results: Qingkailing Injection did not interfere with limulus test in 1:10 dilution,The endotoxin recovery was more than 50 percent and less than 200 percent.Conclusion: This mehod is slight in interference and accurate in detection result,and can be used in routine assay. |
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Keywords: | Qingkailing Injection endotoxin kinetic turbimetric technique |
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