摘要
Abstract
Objective To establish the microbial limit test of compound sulfamethoxazole tablets. Methods According to the applicability test of microbial limit count method provide by the Chinese Pharmacopoeia (edition 2015,part 4),the plate method,membrane filtration method,membrane filtration adding neutralizing agent method were used to detect the recovery rate of 5 kinds of positive bacteria for exploring the count method of aerobic bacteria and fungi ,and the detection method of control bacterium Escherichia coli. Results In the verification test of aerobic bacterial and fungal total count , the recovery rate of each bacterium reached more than 70.00%,when the recovery rate was 0.50%-2.00%,Escherichia coli could be detected. This method conformed to the requirements of the 2015 edition of the Chinese Pharmacopoeia. Conclusion The established method is suit-able for the microbial limit test under the new edition of the Chinese Pharmacopoeia. The membrane filtration adding neutralizing agent method for detecting aerobic bacterial and fungal total count is adopted to eliminate the bacteriostasis effect of compound sulfamethoxazole tablets,the fungal total count usually adopts the conventional method.关键词
复方合剂/磺胺甲基异恶唑/分析/甲氧苄啶/分析/微生物学技术/药物污染/过滤/方法/中和试验Key words
Drug combinations/Sulfamethoxazole/analysis/Trimethoprim/analysis/Microbiological techniques/Drug contamination/Filtration/methods/Neutralization tests
