| 安丽康,刘沙,王尹潇,等.一种新的阿奇霉素干混悬剂微生物限度检查方法研究[J].安徽医药,2026,30(2):283-286. |
| 一种新的阿奇霉素干混悬剂微生物限度检查方法研究 |
| Study on a new microbiological examination method for azithromycin dry suspension |
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| DOI：10.3969/j.issn.1009-6469.2026.02.013 |
| 中文关键词: 微生物限度检查 阿奇霉素干混悬剂 萃取 薄膜过滤 |
| 英文关键词: Microbiological examination Azithromycin dry suspension Extraction Membrane filtration |
| 基金项目:河北省药品监督管理局科技计划项目( 2025ZC1034) |
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| 摘要点击次数: 379 |
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| 中文摘要: |
| 目的建立一种新的阿奇霉素干混悬剂微生物限度检查方法。方法于 2024年 2―3月分别采用常规法、稀释法、薄膜过滤法、萃取 -薄膜过滤法进行计数方法适用性试验，采用薄膜过滤法、萃取 -薄膜过滤法进行控制菌检查方法适用性试验。结果阿奇霉素干混悬剂对金黄色葡萄球菌、铜绿假单胞菌和枯草芽孢杆菌有较强的抑制作用，需采用萃取 -薄膜过滤法才能使回收率在 0.5~2.0，符合计数方法适用性试验要求；该制剂对霉菌和酵母菌无抑菌性或抑菌性较弱，因此方法适用性试验采用常规法即可达到要求；控制菌检查方法适用性试验也需采用萃取 -薄膜过滤法进行。结论需氧菌总数采用萃取 -薄膜过滤法，霉菌和酵母菌总数采用常规法，控制菌检查采用萃取 -薄膜过滤法，结果符合《中国药典》 2020年版四部通则 1105、1106要求，且操作简单，回收率高。 |
| 英文摘要: |
| Objective To establish a new method for microbiological examination of azithromycin dry suspension. Methods The suitability of the counting method was tested by routine method, dilution method, membrane filtration method, and extraction-mem-brane filtration method from February to March 2024. The suitability of the specified microorganisms was tested by membrane filtrationmethod and extraction-membrane filtration method.Results Since azithromycin dry suspension had a strong inhibitory effect on Staph-ylococcus aureus, Pseudomonas aeruqinosa and Bacillus subtilis, the extraction-membrane filtration method was required to make therecovery rate between 0.5 and 2.0, which met the requirements of suitability of the counting method. This product had no antimicrobialor weak antimicrobial activity for molds and yeasts, so the routine method could meet the requirements of suitability of the countingmethod. The suitability of the specified microorganisms was conducted by extraction-membrane filtration method.Conclusions The to-tal aerobic microbial count is tested by extraction-membrane filtration method, the total yeasts and molds count is tested by routinemethod, and the specified microorganisms is tested by extraction-membrane filtration method. The results meet the requirements of1105 and 1106 of the fourth Rules of Chinese Pharmacopoeia 2020 edition, and the simple operation, high recovery rate. |
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