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OBJECTIVE:To validate the microbial limit tests of Shuanghuanglian oral liquid.METHODS:The recovery rates of 4 kinds of test organisms including E.coli treated by Shuanghuanglian oral liquid were detected by routine method,culture medium dilution method,and membrane-filter procedure respectively.RESULTS:Shuanghuanglian oral liquid was found to be of bacteriostatic action.The contamination of solution couldn't be detected by routine method.The recovery rate of the test organisms detected by membrane-filter procedure was higher than by culture medium dilution method,but the recovery rates in both methods were all up to the requirement.CONCLUSION:Membrane-filter procedure should be considered preferentially in performing microbial limit test for Shuanghuanglian oral liquid.
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OBJECTIVE:To establish the method for sterility test of dexrazoxane for injection. METHODS: The relative procedures were conducted in accordance with the membrane-filter procedure included in sterility test specified in Chinese Pharmacopoeia (2005 edition),with Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Clostridium sporogenes,Candida albicans and Aspergillus niger as test organisms,which were flushed with sodium chloride-peptone buffer solution (150 mL,250 mL,and 350 mL,respectively,pH 7.0) to evaluate the impact of three flushing doses on the results of sterility test. RESULTS: At a flushing dose of 150 mL,there was no growth of bacteria except Bacillus subtilis at 24～72 h;however,at a flushing dose of 250 mL or 350 mL,all bacteria strains had a good growth. CONCLUSION: The established method for sterility test of dexrazoxane for injection is accurate and reliable.
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OBJECTIVE:To establish a microbial limit test method for povidone iodine solution.METHODS:Validation on methodology of the microbial limit test of povidone iodine solution was performed using plating method(Ⅰ),culture agent dilution method(Ⅱ),membrane-filter procedure method(Ⅲ)and sodium thiosulfate neutralization in combination with membrane-filter procedure method(Ⅳ).RESULTS:The recovery rates of all of the test organisms in method Ⅰ and method Ⅱ approached zero,less than 70% in method Ⅲ but above 85% in method Ⅳ.The growth of the control bacteria was abnormal in method Ⅱand method Ⅲ,but normal in method Ⅳ.CONCLUSION:It is advisable to adopt the method Ⅳ for microbial limit test of povidone iodine solution.
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OBJECTIVE:To validate the test condition and test method of the microbil limit test of the Dental ulcer pellicles of Sunset Abelmoschus Flower.METHODS:The methodological validation was carried out in accordance with the standard for microbil limit test stated in the appendix of China Pharmacopoeia(2005 Edition,VolumeⅠ).RESULTS:By membrane-filter procedure,the recovery rates of different test strains in the samples were all over 70%.CONCLUSION:The membrane-filter procedure can more effectively eliminate the bacteriostatic action of Dental ulcer pellicles of Sunset Abelmoschus Flower so as to result in accurate microbil limit test results.