摘要
目的:建立风油精微生物限度检查方法。方法:按照《中国药典》2015年版四部要求,根据风油精的理化性质,采用无菌十四烷酸异丙酯作为稀释剂,经稀释法结合薄膜过滤法进行需氧菌总数、霉菌和酵母菌总数的计数方法适用性试验及控制菌金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌的适用性试验。结果:需氧菌总数、霉菌和酵母菌总数计数方法适用性试验各试验组菌落数与菌液对照组菌落数的比值均在0.5~2.0之间,控制菌适用性试验中检出金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌。结论:该方法可用于风油精微生物限度的检查。
Objective:To establish a microbial limit test method for essential balm.Methods:According to Chinese Pharmacopoeia 2015 VolumeⅣ,the sterile isopropyl tetradecanoate was chosen as the diluent based on physical and chemical characteristics of essential balm,and the dilution combined with membrane filtration method was used for the suitability test of the total count of aerobic bacteria,mold and yeast count as well as the suitability test of the control bacteria such as Staphylococcus aureus,Pseudomonas aeruginosa and Escherichia coli.Results:The ratios between CFU of experimental group and CFU of strains group were between 0.5-2.0 for the suitability test of total count of aerobic bacteria,mold and yeast count.Staphylococcus aureus,Pseudomonas aeruginosa and Escherichia coli were detected in the suitability test of the control bacteria.Conclusion:The established method can be used for the microbial limit test of essential balm.
作者
关迪
曹晓云
GUAN Di;CAO Xiaoyun(Tianjin Institute for Drug Control,Tianjin 300070,China)
出处
《中国药品标准》
CAS
2020年第3期239-243,共5页
Drug Standards of China
关键词
风油精
十四烷酸异丙酯
微生物限度检查
稀释法
薄膜过滤法
Essential balm
sterile isopropyl tetradecanoate
microbial limit test
dilution method
membrane filtration method
