药品微生物检查实验中供试液预过滤方法的标准化研究

发布时间：2019-03-13 18:10

【摘要】：目的对药品微生物检查实验中供试液的预过滤方法进行标准化研究,建立药品的微生物检查双层膜过滤方法。方法设计新型微生物检查用双层膜过滤器,筛选不同材料和孔径的滤膜作为预过滤膜。采用形态较大的野生菌株作为实验用菌株,以2010年版《中国药典》方法作为对照方法,进行验证实验,考察预过滤对供试液中微生物的影响情况。结果双层膜过滤方法,各项验证参数与《中国药典》方法无显著性差异(P0.05)。采用标准化的预过滤方法处理供试液,可以有效避免颗粒物堵塞滤膜,利于消除供试液抗菌活性,降低实验过程对样品中微生物造成的损伤或损失。结论双层膜过滤法实验过程符合《中国药典》相关规定,实验结果有效,可用于药品的无菌检查或微生物限度检查实验。
[Abstract]:Objective to establish a two-layer membrane filtration method for microbiological examination of drugs by standardizing the pre-filtration method of the test solution. Methods A new type of double-layer membrane filter for microbiological inspection was designed, and filter membranes with different materials and pore sizes were selected as pre-filtration membranes. Wild strains with larger morphology were used as experimental strains and the 2010 edition of Chinese Pharmacopoeia was used as control. The effects of pre-filtration on microorganisms in the tested solution were investigated. Results there was no significant difference between the method of bilayer membrane filtration and the method of Chinese Pharmacopoeia (P0.05). The standardized pre-filtration method can effectively avoid the particulate matter clogging the filter membrane, eliminate the antibacterial activity of the test solution, and reduce the damage or loss of microorganism in the sample caused by the experiment process. Conclusion the double-layer membrane filtration method accords with the relevant regulations of Chinese Pharmacopoeia. The experimental results are effective and can be used for aseptic examination or microbial limit test of drugs.
【作者单位】：山东省食品药品检验研究院;
【基金】：中国食品药品检定研究院中青年发展研究基金资助项目(2013WA5)
【分类号】：R927.11

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