中国药房2011,Vol.22Issue(33):3143-3145,3.
林可霉素利多卡因凝胶微生物限度检查方法研究
Study of Microbiological Limit Test for Lincomycin Lidocaine Gel
杨淑先 1赵新霞 1牛坡2
作者信息
- 1. 河南省食品药品检验所,郑州市450003
- 2. 河南省人民医院,郑州市450003
- 折叠
摘要
Abstract
OBJECTIVE: To establish the method for microbiological limit test of Lincomycin lidocaine gel. METHODS: 0.05 mol-L-1 sodium tetraphenyl borate (pH value adjusted to 7.0 using 85% phosphoric acid) was regarded as the diluents. The method of membrane filtration was used for the validation of microbiological test according to the requirements of Chinese Pharmacopeia (2010 edition). Bacillus subtilis, Staphylococcus aureus, Escherichia coli, Candida albicans and Aspergillus niger were used as trial bacterial, and Pseudomonas aeruginosa and Staphylococcus aureus were controlled bacterial. Methodology validation of microbiological test of samples was conducted. RESULTS: In validation tests of bacterial, mold and Saccharomycetes count, recovery rate of trial bacterial were not less than 70%. In the tests of specified microbial species, the results met the standard. CONCLUSION: The method is effective and feasible. It can be used for microbiological limit test of Lincomycin lidocaine gel.关键词
林可霉素利多卡因凝胶/微生物限度检查/四硼酸钠溶液Key words
Lincomycin lidocaine gel/ Microbiological limit test/ Sodium tetraphenyl borate分类
医药卫生引用本文复制引用
杨淑先,赵新霞,牛坡..林可霉素利多卡因凝胶微生物限度检查方法研究[J].中国药房,2011,22(33):3143-3145,3.