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(P ＞0.05)。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 carry out standardization research on pre-filtration method for microbial test solutions of drugs and establish a new double-membrane filtration method in microbial tests.METHODS New filters with double-membranes of different materials or pore-sizes were designed and used as pre-filters for microbial tests. The effects of test solution pre-filtration on several wild-type strains were evaluated and compared with the methods described by Chinese Pharmacopoeia.RESULTS No statistical difference was found between the double-membrane filtration method and the pharmacopoeia method. However, filter-clogging was significantly reduced by using the double-membrane filtration method, and the double-membrane filtration method could also eliminate the antibacterial activity of the samples, thus reducing the damage or loss of microorganisms in special samples.CONCLUSION The double-membrane filtration method meets the requirements of the Chinese Pharmacopoeia; the test results are valid and the method can be used for sterility test and microbial limit test for drug products.
关键词
无菌检查 /
微生物限度检查 /
供试液处理 /
预过滤 /
标准化研究 /
双层膜过滤法
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Key words
sterility test /
microbial limit test /
test solution processing /
pre-filtration /
standardization /
double-membrane filtration method
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中图分类号：
R927
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参考文献
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脚注
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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)
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