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国产克霉唑乳膏微生物限度检查方法研究及卫生状况评价

蒋受军 刘涛 朱斌 韦涛 黄橘 刘常凯

中国药房2011,Vol.22Issue(33):3126-3128,3.
中国药房2011,Vol.22Issue(33):3126-3128,3.

国产克霉唑乳膏微生物限度检查方法研究及卫生状况评价

Establishment of the Method for Microbial Limit Test and Evaluation of Hygiene Condition of Domestic Clotrimazole Cream

蒋受军 1刘涛 1朱斌 1韦涛 1黄橘 1刘常凯2

作者信息

  • 1. 广西壮族自治区食品药品检验所,南宁市530021
  • 2. 桂林医学院,桂林市541004
  • 折叠

摘要

Abstract

OBJECTIVE:To establish a common suitable method for microbial limit test of Clotrimazole cream, and to evaluate the hygiene condition of domestic Clotrimazole cream with the results of microbial limit test of national-wide products. METHODS: Culture medium dilution, membrane-filter procedure, routine method were used to detect recovery of Escherichia coli, Staphylococcus aureus. Bacillus subtilis, Candida albicans and Aspergillus niger. The validation method was screened and used for the determination of 276 batches of samples from 19 manufacturers. RESULTS: Culture medium dilution was used for bacterial count (0.5 mL in each medium), membrane-filter procedure (300 mL in each washing liquid) was used for mold and saccharomy-cetes count and culture medium dilution was used for Staphylococcus aureus (300 mL in each culture medium). Routine method was used for Pseudomonas aeruginosa count. Candida albicans was the most sensitive strain which can be used as positive control. The acceptability of result of microbial limit test of 276 samples was 99.3%. CONCLUSION: The method is applicable. The hygiene condition of domestic Clotrimazole cream is satisfactory.

关键词

克霉唑乳膏/微生物限度/检查方法/卫生状况/评价

Key words

Clotrimazole cream/ Microbial limit test/ Determination method/ Hygiene condition/ Evaluation

分类

医药卫生

引用本文复制引用

蒋受军,刘涛,朱斌,韦涛,黄橘,刘常凯..国产克霉唑乳膏微生物限度检查方法研究及卫生状况评价[J].中国药房,2011,22(33):3126-3128,3.

中国药房

OACSCDCSTPCD

1001-0408

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