磺胺多辛乙胺嘧啶片微生物限度检查方法的建立 |
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引用本文: | 潘梅,陆艳.磺胺多辛乙胺嘧啶片微生物限度检查方法的建立[J].生命科学仪器,2008,6(5):45-47. |
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作者姓名: | 潘梅 陆艳 |
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作者单位: | 桂林南药股份有限公司,桂林,541002 |
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摘 要: | 目的:完善磺胺多辛乙胺嘧啶片微生物限度检查方法。方法:采用薄膜过滤并在培养基中加入中和剂(1%的对氨基苯甲酸溶液)的方法,去除磺胺多辛的抗菌活性。结果:本方法满足中国药典2005版验证试验的基本要求。结论:该方法可作为磺胺多辛乙胺嘧啶片的常规微生物限度检查方法。
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关 键 词: | 微生物限度 磺胺多辛乙胺嘧啶片 薄膜过滤 中和剂 |
Estaboishment of method for microbial limit test of Sulfadoxine and pyrimethamine Tablets |
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Abstract: | To establish a method for mixrobial limit test of Sulfadoxine and pyrimethamine Tablets. Method:The filtration method was first used to remove the drug, material and then 1% of 4-Aminobenzoic acid solution as neutralizer was added into the nutrient agar medium to inhibit the residual antimicrobial activity.Result:The method passed the validation test of Chinese pharmacopoeia 2005 version. Conclusion: The method has been used in microbial limit test control for Sulfadoxine andpyrimethamine Tablets oral preparation. |
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Keywords: | mixrobial limit Sulfadoxine and pyrimethamine Tablets membrane-filter neutralizer |
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