| 阿莫西林、硫酸黏菌素混悬注射液无菌检查方法研究 |
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| 引用本文： | 赵晖,刘轶秋,王小慈,杨秀玉.阿莫西林、硫酸黏菌素混悬注射液无菌检查方法研究[J].中国动物检疫,2011,28(1):60-61,64. |
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| 作者姓名： | 赵晖 刘轶秋 王小慈 杨秀玉 |
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| 作者单位： | 中国兽医药品监察所,北京,100081 |
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| 基金项目： | "十一五"国家技术支撑计划项目子课题，兽用复方新制剂的研制与应用 |
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| 摘 要： | 目的建立阿莫西林、硫酸黏菌素混悬注射液的无菌检查方法。方法按《中国兽药典》2005年版一部附录进行试验。结果采用薄膜过滤法,每管培养基中加入不少于100万单位的青霉素酶,以1%聚山梨酯80的0.1%蛋白胨水溶液冲洗液,选择冲洗量为300mL,可消除样品对各菌株的抗菌活性。结论阿莫西林、硫酸黏菌素混悬注射液可用该方法进行无菌检查。
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| 关 键 词： | 阿莫西林、硫酸黏菌素混悬注射液 薄膜过滤法 无菌检查 验证 |
Confirmatory Experiment of Sterility Test Method for Amoxicillin and Colistin Sulfate Injectable Suspension |
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| Zhao hui,Liu yiqiu,Wang xiaoci,Yang xiuyu.Confirmatory Experiment of Sterility Test Method for Amoxicillin and Colistin Sulfate Injectable Suspension[J].China Journal Of Animal Quarantine,2011,28(1):60-61,64. |
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| Authors: | Zhao hui Liu yiqiu Wang xiaoci Yang xiuyu |
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| Institution: | (China Institute of Veterinary Drug Control,Beijing,China 100081) |
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| Abstract: | Objective To establish a method of sterility test for amoxicillin and colistin sulfate injectable suspension.Methods The membrane filtration method of sterility test in the appendix to Veterinary Pharmacopoeia of The people’s Republic of China(2005 edition) was used.Results The antibacterial activity of various strains can be eliminated with membrane filtration method needs at least 1 million units penicillinase and 300 mL 1% Tween 80-0.1% peptone sterile solution as flushing fluid.Conclusion The membrane filtration method is suitable for the sterility test of amoxicillin and colistin sulfate injectable suspension. |
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| Keywords: | amoxicillin-colistin sulfate injectable suspension membrane filtration method sterility test verification |
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