Methodological study on microbial limit test of zinc oxide and talcum powder lotion
10.7501/j.issn.1674-6376.2017.10.013
- VernacularTitle:氧化锌滑石粉洗剂微生物限度检查的方法适用性研究
- Author:
ping Huai TIAN
1
;
Yi DU
;
Chao LI
;
yan Zhi LIN
;
nian Yue TANG
Author Information
1. 上海交通大学医学院附属新华医院
- Keywords:
Zinc oxide and talcum powder lotion;
microbial enumeration test;
microbial limit test;
membrane filtration method
- From:
Drug Evaluation Research
2017;40(10):1432-1435
- CountryChina
- Language:Chinese
-
Abstract:
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.
