鱼腥草注射液中细菌内毒素定量检测研究 |
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引用本文: | 苑庆华,唐元泰,孙淑莲,叶志.鱼腥草注射液中细菌内毒素定量检测研究[J].中国药品标准,2002,3(1):48-49,22. |
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作者姓名: | 苑庆华 唐元泰 孙淑莲 叶志 |
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作者单位: | 天津市药品检验所,天津,300070 |
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摘 要: | 目的:对鱼腥草注射液进行添加细菌内毒素干扰回收试验,建立定量检测鱼腥草注射液中污染内毒素试验方法。方法:采用中国药典2000年版附录检测细菌内毒素的动态浊度法,结果:鱼腥草注射液在稀释至12倍时已无干扰因素影响,内毒素回收率均在50%-200%范围内,结论:使用细菌内毒素动态浊度法定量检测鱼腥草注射液的污染内毒素是可行的,可用细菌内毒素定量检查法代替家兔热原检查法。
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关 键 词: | 鱼腥草注射液 细菌内毒素 动态浊度法 干扰试验 定量检测 |
MEASUREMENT OF ENDOTOXIN IN INJECTIO HOUTTUYNIA USING THE KINETIC-TURBIDIMETRIC TECHNIQUE |
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Authors: | Yuan Qinghu Tang Yuantai Sun Shulian and Ye Zhi |
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Institution: | Yuan Qinghua,Tang Yuantai,Sun Shulian,Ye Zhi Tianjin Institute for Drug control,Tianjin 300070 |
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Abstract: | Objective: Establishment of the Kinetic-turbidimetric technique for practical quality controlon endotoxin Content in Houttuynia Injection Methods: using the Kinetic-turbidimetric technique and elimi-nated interfere factors approved by Chinese pharmacopoeia(edition 2000)Result:Endotoxin added to Hout-tuyniae Injection was recovered in a quantitative manner showing neither inhibition nor enhancement in di-luted solution the endotoxin recovery is more than 50 percent and less than 200 percent Conclusion:Theseresults suggest that the Kinetic-turbidimetric technique of TAL-test could be used as an alternativemethod for the rabbit pyrogen test for Houttuyniae |
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Keywords: | Houttuynia injectio kinetic-turbidimetric techniqu Injection bacterial endotoxin interfere factors test |
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