文章摘要
赵新霞,杨淑先,王海波,杨飏.聚山梨酯80对药品微生物限度检查的影响[J].中国药品标准,2019,(3):224-230
聚山梨酯80对药品微生物限度检查的影响
Effect of Polysorbate 80 on microbiological examination of drugs
投稿时间:2018-12-06  修订日期:2019-05-22
DOI:
中文关键词: 聚山梨酯80  方法适用性试验  微生物限度检查
英文关键词: polysorbate 80  method suitability tests  microbiological examination
基金项目:
作者单位E-mail
赵新霞 河南省食品药品检验所 zxxybfq@sohu.com 
杨淑先 河南省食品药品检验所 y63388265y@163.com 
王海波 河南省食品药品检验所  
杨飏 河南省食品药品检验所  
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中文摘要:
      目的:分析不同来源、不同浓度的聚山梨酯80对试验菌生长的影响,为聚山梨酯80在药品微生物限度检查中的应用提供参考。方法:取不同生产厂家、不同批号的聚山梨酯80,分别加入pH 7.0无菌氯化钠-蛋白胨缓冲液中,制备成3%、4%、5%、10%、15%、20%浓度(v/v)的溶液,作为供试液。按照中国药典2015年版四部通则1105和1106,进行需氧菌、霉菌和酵母菌计数方法适用性试验。同时进行控制菌大肠埃希菌、金黄色葡萄球菌和铜绿假单胞菌检查的方法适用性试验。结果:不同来源、不同浓度的聚山梨酯80对需氧菌计数和控制菌检查试验结果的影响差别较大,对霉菌和酵母菌计数试验结果影响差别不大。结论:不同来源、不同浓度的聚山梨酯80对试验菌的生长影响不同。药品微生物限度检查中使用聚山梨酯80时,需注意聚山梨酯80的来源不同对试验结果造成的差异。
英文摘要:
      Objective:To analyz the effects of different sources and concentrations of polysorbate 80 on the growth of test organisms, to provide a reference for the application of polysorbate 80 in microbiological examination of drugs. Methods:Polysorbate 80 from different manufacturers and batches were added to pH 7.0 aseptic sodium chloride-peptone buffer solution to prepare a solution of 3%、4%、5%、10%、15%、20% (v / v). According to Chinese Pharmacopoeia 2015 Volume Ⅳ 1105 and 1106, method suitability tests for total aerobic microbial count and total molds and yeasts count were carried out. At the same time, the method suitability tests for Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa were carried out. Results:The effects of different sources and concentrations of polysorbate 80 on total aerobic microbial count and tests for specified microorganisms were quite different, while the effects on total molds and yeasts count were not different. Conclusion:Different sources and different concentrations of polysorbate 80 have different effects on the growth of the test organisms. When using polysorbate 80 in microbiological examination of drugs, attention should be paid to the differences in test results caused by different sources.
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