目的 建立符合《中國(guó)藥典》2015年版要求的氧化鋅滑石粉洗劑的微生物限度檢查方法。方法 采用離心沉淀聯(lián)合薄膜過(guò)濾法進(jìn)行樣品前處理，對(duì)10批次的氧化鋅滑石粉洗劑進(jìn)行微生物計(jì)數(shù)檢查和控制菌檢查。計(jì)數(shù)檢查：需氧菌總數(shù)使用TSA培養(yǎng)基檢查，菌種為：金黃色葡萄球菌、銅綠假單胞菌、枯草芽孢桿菌、白色念珠菌和黑曲霉；霉菌和酵母菌總數(shù)使用SDA培養(yǎng)基檢查，菌種為白色念珠菌和黑曲霉，每種菌株分別制備加菌試驗(yàn)組和菌液對(duì)照組，每種培養(yǎng)基分別制備供試品對(duì)照組和陰性對(duì)照組，進(jìn)行菌落計(jì)數(shù)，計(jì)算回收率。控制菌檢查：應(yīng)用銅綠假單胞菌和金黃色葡萄球菌，設(shè)置菌液驗(yàn)證組、供試品對(duì)照組和陰性對(duì)照組，取各組培養(yǎng)物于相應(yīng)培養(yǎng)基平板上劃線(xiàn)，Microflex LT質(zhì)譜儀進(jìn)行菌種鑒定。結(jié)果 10批次微生物計(jì)數(shù)檢查的5種菌株的回收率均在0.75~1.16；控制菌檢查的菌液驗(yàn)證組均可檢出銅綠假單胞菌和金黃色葡萄球菌，供試品對(duì)照組和陰性對(duì)照組均未見(jiàn)菌生長(zhǎng)，適用性驗(yàn)證合格。結(jié)論 氧化鋅滑石粉洗劑的微生物限度檢查方法經(jīng)驗(yàn)證符合《中國(guó)藥典》2015年版要求。

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.