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�й�ҩѧ��־ 2015, Vol. 50 Issue (7) :623-628    DOI: 10.11669/cpj.2015.07.013
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DING Bo, WANG Wei-jian, GONG Li-ping, GUO Ming, SHI Guo-sheng*
Shandong Institute for Food and Drug Control,Jinan 250101,China

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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.
Keywords�� sterility test,   microbial limit test,   test solution processing,   pre-filtration,   standardization,   double-membrane filtration method     
�ո�����: 2014-09-26;
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DING Bo, WANG Wei-Jian, GONG Li-Ping etc .A Standardization Study of Pre-Filtration Method of the Test Solution in Microbial Test for Drug Products[J]  Chinese Pharmaceutical Journal, 2015,V50(7): 623-628
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