药品微生物检查实验中供试液预过滤方法的标准化研究  

A Standardization Study of Pre-Filtration Method of the Test Solution in Microbial Test for Drug Products

作　　者：丁勃 王维剑 巩丽萍 国明 史国生 

机构地区：[1]山东省食品药品检验研究院,济南250101

出　　处：《中国药学杂志》2015年第7期623-628,共6页Chinese Pharmaceutical Journal

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)

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(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。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 wildtype 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 

分 类 号：R927[医药卫生—药学]