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薄膜过滤法的影响因素分析研究

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目的:探讨薄膜过滤法不同培养方法、混合时间、预过滤对回收率的影响.方法:参考《中国药典》2020版1101无菌检查法,采用薄膜过滤法对不同培养方法、混合时间、预过滤介质的情况进行试验.结果:覆盖培养与常规培养对不同的菌种适用性不同,对于培养过程容易向周围扩展生长的菌种可优先选择覆盖培养法,但对于部分菌种不适用覆盖培养法;总体来看混合时间越长,回收率越低;使用无尘布作为预过滤介质的回收率最高.结论:本研究表明,选用合适的培养方法、混合时间、预过滤介质对薄膜过滤法的回收率有较大影响.
Analysis and research on the influencing factors of membrane filtration method
Objective:To explore the effects of different cultivation methods,mixing time,and pre filtration on the recovery rate of membrane filtration method.Method:Referring to the sterile test method 1101 in the 2020 edition of the Chinese Pharmacopoeia,the membrane filtration method was used to conduct experiments on different cultivation methods,mixing times,and pre filtration media.Result:Coverage culture and conventional culture have different applicability to different bacterial strains.For bacterial strains that are prone to expanding and growing around during the cultivation process,coverage culture method can be preferred,but it is not suitable for some bacterial strains;Overall,the longer the mixing time,the lower the recovery rate;The recovery rate is highest when using dust-free cloth as the pre filtration medium.Conclusion:This study indicates that the selection of appropriate cultivation methods,mixing time,and pre filtration media have a significant impact on the recovery rate of the membrane filtration method.

membrane filtrationinfluencing factorsChinese Pharmacopoeia 2020 Edition

刘立

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北京同仁堂健康药业股份有限公司,北京 102629

薄膜过滤法 影响因素 《中国药典》2020版

2024

北方药学
内蒙古自治区食品药品学会

北方药学

影响因子:0.633
ISSN:1672-8351
年,卷(期):2024.21(4)
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