论文部分内容阅读
目的建立符合《中国药典》2015年版要求的氧化锌滑石粉洗剂的微生物限度检查方法。方法采用离心沉淀联合薄膜过滤法进行样品前处理,对10批次的氧化锌滑石粉洗剂进行微生物计数检查和控制菌检查。计数检查:需氧菌总数使用TSA培养基检查,菌种为:金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌和黑曲霉;霉菌和酵母菌总数使用SDA培养基检查,菌种为白色念珠菌和黑曲霉,每种菌株分别制备加菌试验组和菌液对照组,每种培养基分别制备供试品对照组和阴性对照组,进行菌落计数,计算回收率。控制菌检查:应用铜绿假单胞菌和金黄色葡萄球菌,设置菌液验证组、供试品对照组和阴性对照组,取各组培养物于相应培养基平板上划线,Microflex LT质谱仪进行菌种鉴定。结果 10批次微生物计数检查的5种菌株的回收率均在0.75~1.16;控制菌检查的菌液验证组均可检出铜绿假单胞菌和金黄色葡萄球菌,供试品对照组和阴性对照组均未见菌生长,适用性验证合格。结论氧化锌滑石粉洗剂的微生物限度检查方法经验证符合《中国药典》2015年版要求。
Objective To establish a microbial limit test method for zinc oxide talc lotion in line with the requirements of the Chinese Pharmacopoeia 2015 edition. Methods Centrifugal sedimentation combined with membrane filtration was used to sample pretreatment. Ten batches of zinc oxide talc lotion were tested for microbial counts and control bacteria. Count test: the total number of aerobic bacteria using TSA medium examination, the strains are: Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans and Aspergillus niger; the total number of mold and yeast using SDA medium examination, The strains were Candida albicans and Aspergillus niger. Each strain was prepared to add bacteria test group and bacterial liquid control group. Each medium was separately prepared for the control group and the negative control group. The colony count and the recovery rate were calculated. Control bacteria test: the application of Pseudomonas aeruginosa and Staphylococcus aureus bacteria set validation group for the test control group and the negative control group, the culture of each group were drawn on the appropriate plate culture medium, Microflex LT mass spectrometer For species identification. Results The recoveries of the five strains tested in 10 batches of microorganisms were all in the range of 0.75 to 1.16. Pseudomonas aeruginosa and Staphylococcus aureus were detected in the bacterial test of control bacteria, No growth of bacteria in the control group, applicability verification. Conclusion The microbial limit test method for zinc oxide talc lotion has been verified to meet the requirements of the 2015 edition of Chinese Pharmacopoeia.