| 潘震宇,汤茜,李瑞莲.硝酸布康唑栓微生物限度检查方法适用性试验研究[J].中国药事,2017,(1):43-48 |
| 硝酸布康唑栓微生物限度检查方法适用性试验研究 |
| Methodological Study on Microbial Limit Test of Butoconazole Nitrate Suppositories |
| 投稿时间：2015-12-25 |
| DOI：10.16153/j.1002-7777.2017.01.009 |
| 中文关键词: 硝酸布康唑栓 微生物限度 薄膜过滤法 中和法 金黄色葡萄球菌 铜绿假单胞菌 白色念珠菌 |
| 英文关键词: Butoconazole Nitrate Suppositories microbial limits membrane filtration method neutralization method Staphylococcus aureus Pseudomonas aeruginosa Candida albicans |
| 基金项目:湖南省自然科学基金（编号2015JJ6053） |
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| 中文摘要: |
| 目的：建立硝酸布康唑栓微生物限度检查方法。方法：按照《中国药典》2015年版四部通则进行硝酸布康唑栓微生物限度检查方法适用性试验，对中和剂的种类、薄膜过滤冲洗液体积、菌液加入时间等进行考察，通过试验菌株的回收试验，确立需氧菌总数、霉菌和酵母菌总数计数方法，并确立金黄色葡萄球菌、铜绿假单胞菌和白色念珠菌的检查方法。结果：试验样品硝酸布康唑栓对细菌和真菌均具有较强的抑菌性。采用薄膜过滤法和中和法联用的方法可有效去除其抑菌性。结论：建立的硝酸布康唑栓微生物限度检查方法符合《中国药典》2015年版要求，可用于常规的药品质量控制检验工作。 |
| 英文摘要: |
| Objective: To establish testing methods of microbial limits for Butoconazole Nitrate Suppositories. Methods: Applicability tests were conducted according to the general principles of Chinese Pharmacopoeia (2015 edition), Experiments were made on the varieties of neutralizing agent, the volume of rinsing solution and the addition time of bacteria suspension. The count methods were established by the recovery tests with tested strains. The methods for the examination of Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans were also established. Results: Butoconazole Nitrate Suppositories had strong antimicrobial activities both on bacteria and fungi. The antimicrobial activities could be effectively eliminated with the membrane filtration method combined with the neutralization method. Conclusion: The method meets the requirements of Chinese Pharmacopoeia (2015 edition), and can be used in routine microbial limits test for Butoconazole Nitrate Suppositories. |
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