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为了建立适合匹伐他汀钙片微生物限度检查方法,消除匹伐他汀钙片在微生物限度检查法中的抑菌作用,采用稀释液加入增溶剂和促微生物生长物质后,用常规法及培养基稀释法(0.2 mL/皿和0.5 mL/皿)进行方法验证,结果表明细菌和大肠埃希菌可采用常规法,真菌可经过稀释液(2)稀释后,采用培养基稀释法(0.2 mL/皿),白色念珠菌和黑曲霉对匹伐他汀钙片非常敏感,可作为匹伐他汀钙片微生物限度检查方法的质控菌株。
In order to establish a method suitable for the determination of pitavastatin calcium microbial limit and to eliminate the inhibitory effect of pitavastatin calcium tablet in the limit test of microorganisms, a diluent is added to the solubilizer and the microorganism growth substance and then diluted by a conventional method and a medium Method (0.2 mL / dish and 0.5 mL / dish), the results showed that the bacteria and Escherichia coli can be used conventional method, the fungus can be diluted by dilution (2), the use of medium dilution method (0.2 mL / dish Candida albicans and Aspergillus niger are very sensitive to pitavastatin calcium tablets and can be used as quality control strains for the screening method of pitavastatin calcium microbes.