| 注射用酒石酸吉他霉素细菌内毒素检查方法的研究 |
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| 引用本文： | 孙婷婷,孙丽.注射用酒石酸吉他霉素细菌内毒素检查方法的研究[J].科技通报,2012,28(6):11-12,15. |
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| 作者姓名： | 孙婷婷 孙丽 |
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| 作者单位： | 1. 徐州工业职业技术学院,江苏徐州,221140
2. 宿迁市食品药品检验所,江苏宿迁,223800 |
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| 摘 要： | 目的:研究注射用酒石酸吉他霉素对细菌内毒素检查的干扰情况,建立注射用酒石酸吉他霉素细菌内毒素检查法并进行该药品3批供试品的细菌内毒素检查。方法:依照《中国药典》2010年版(二部)附录细菌内毒素检查法。结果:供试品对鲎试剂与内毒素的反应无干扰作用。结论:采用细菌内毒素凝胶法,用两个厂家的鲎试剂对注射用酒石酸吉他霉素及稀释标准品进行干扰试验,在无干扰影响的情况下进行注射用酒石酸吉他霉素供试品的内毒素检查试验。
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| 关 键 词： | 细菌内毒素检查法 凝胶法 干扰试验 注射用酒石酸吉他霉素 |
Study on Bacterial Endotoxin Test in Kitasamycin Tartrate for Injection |
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| SUN Tingting
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SUN Li.Study on Bacterial Endotoxin Test in Kitasamycin Tartrate for Injection[J].Bulletin of Science and Technology,2012,28(6):11-12,15. |
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| Authors: | SUN Tingting SUN Li |
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| Institution: | 1.Xuzhou College of Industrial Technology,Jiangsu Xuzhou 221140,China; 2.Suqian Institute for food and drug control,Jiangsu Suqian 223800,China) |
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| Abstract: | Objective: To study the interference of Kitasamycin Tartrate for Injection in bacterial endotoxin test,and to establish an method of endotoxin limit test in this drug.Method: according to,the gel-clot method was used to determine the interference of Kitasamycin Tartrate for Injection with tachypleus amebocyte(TAL) made by manufacturers.Result:The samples were no showd interferential efforts on the King Crab reagent.Conclusion:If there was no interference,the bacterial endotoxin limit of chloramphenicol injection can be done. |
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| Keywords: | bacteria endotoxin test gel clot assays interference test Kitasmycin tartrate for injection |
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