林可霉素利多卡因凝胶微生物限度检查方法研究

目的:建立林可霉素利多卡因凝胶的微生物限度检查方法。方法:以0.05mol.L-1四硼酸钠溶液(85%磷酸溶液调节pH至7.0)作为稀释剂,采用薄膜过滤法,按《中国药典》2010年版(二部)相关要求进行试验,以枯草芽孢杆菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉为试验菌,铜绿假单胞菌和金黄色葡萄球菌为控制菌对样品进行微生物限度检查的方法学验证。结果:细菌、霉菌和酵母菌计数方法验证试验中,试验菌的回收率均大于70%;控制菌检查结果符合要求。结论:该方法有效可行,可用于林可霉素利多卡因凝胶微生物限度检查。

Study of Microbiological Limit Test for Lincomycin Lidocaine Gel

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.