氧化锌滑石粉洗剂微生物限度检查的方法适用性研究

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。

Methodological study on microbial limit test of zinc oxide and talcum powder lotion

Objective To establish a method for the microbial limit test of zinc oxide and talcum powder lotion in Chinese Pharmacopoeia 2015. Methods Microbial enumeration test and specified microorganisms test with instructions were conducted from Chinese Pharmacopoeia 2015, which involved 10 batches zinc oxide and talcum powder lotion and five species of bacteria in all. The samples were treated by centrifugation and membrane filtration. Microbial enumeration test:the total number of aerobic bacteria using TSA medium to examine, strains were Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, and Aspergillus niger; The total number of molds and yeasts using SDA culture medium to examine, strains were Candida albicans and Aspergillus niger. Each strain was divided into two groups:Adding bacteria test group and bacteria control group. Samplecontrol group and negative control group of each culture medium was prepared respectively. Count the colonies and calculate the rate of recovery. Specified microorganisms test:Pseudomonas aeruginosa and Staphylococcus aureus were applicated and set the bacteria validation group, sample control group, and negative control group. The culture medium of each group was crossed on the corresponding medium plate, and Microflex LT mass spectrometer was used to identify the bacteria. Results The recoveries of all kinds of strains in microbial enumeration test, total yeast and mold count were 0.75-1.16 in all batches. In the validations of Staphylococcus aureus and Pseudomonas aeruginosa, all kinds of strains were respectively detected in bacteria validation group, and there were no bacterial growth in sample control group and negative control group. Conclusion The microbiological examination methods for zinc oxide and talcum powder lotion can meet the requirements of Chinese Pharmacopoeia 2015.