| 张红霞,李亚东,赵小芳.莫匹罗星软膏微生物限度检查方法的建立[J].中国药品标准,2017,18(3):211-215 |
| 莫匹罗星软膏微生物限度检查方法的建立 |
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| 投稿时间：2017-04-01 修订日期：2017-04-13 |
| DOI： |
| 中文关键词: 莫匹罗星软膏 微生物限度检查 薄膜过滤法 |
| 英文关键词: |
| 基金项目: |
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| 摘要点击次数: 802 |
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| 中文摘要: |
| 目的: 对莫匹罗星软膏微生物限度检查方法进行方法验证/适用性试验。方法: 根据中国药典 2010 年版和 2015 年版方法，分别进行试验。结果: 按中国药典 2010 年版方法，细菌计数和金黄色葡萄球菌的检查采用薄膜过滤法（1:10供试液 100ml/次，300 ml/膜），霉菌和酵母菌计数采用平皿法，铜绿假单胞菌的检查采用常规法; 按中国药典 2015 年版方法，需氧菌计数和金黄色葡萄球菌的检查采用薄膜过滤法（1:10供试液 100ml/次，500 ml/膜），霉菌和酵母菌计数采用薄膜过滤法（1:10供试液100ml/次，300 ml/膜），铜绿假单胞菌的检查采用常规法。结论: 建立了莫匹罗星软膏的微生物限度检查方法。 |
| 英文摘要: |
| ABSTRACT Objective: To establish a method for the microbial limit test of mupirocin ointment. Methods: According to the methods in the 2010 edition and 2015 edition of Chinese Pharmacopoeia，the test was performed respectively. Results: The bacteria count and staphylococcus aureus could be carried out by the membrane filtration method(1:10 sample 100 ml/second, 300 ml/film) in the 2010 edition, the total combined molds and yeasts count could be performed by the plate count method, pseudomonas aeruginosa could be tested with the routine method. The bacteria count and staphylococcus aureus could be carried out by the membrane filtration method(1:10 sample 100 ml/second, 500 ml/film) in the 2015 edition, the total combined molds and yeasts count could be performed by the membrane filtration method(1:10 sample 100 ml/second, 300 ml/film) and pseudomonas aeruginosa could be tested with the routine method. Conclusion: The above methods can be used for the microbial limit test of mupirocin ointment．
KEYWORDS mupirocin Ointment; Microbial limit test; Membrane filtration method |
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