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药品质控实验室用水的微生物分析

顾珉 杨美琴 马仕洪 顾炳仁

中国执业药师Issue(10):14-17,56,5.
中国执业药师Issue(10):14-17,56,5.DOI:10.3969/j.issn.1672-5433.2015.10.004

药品质控实验室用水的微生物分析

Microbiological Analysis of Water Used in Laboratory of Quality Control of Pharmaceuticals

顾珉 1杨美琴 2马仕洪 2顾炳仁1

作者信息

  • 1. 苏州市食品药品检验所,江苏 苏州 215002
  • 2. 中国食品药品检定研究院,北京 100050
  • 折叠

摘要

Abstract

Objective: In view of the actual situation of the water used in microbiological laboratories in domestic institutes for drug control, feasible methods for microbiological analysis of water for laboratory use were explored and the reasonable standards were put forward for the quality control of water at different microbial contamination levels. Methods: Referring to the methods set forth in domestic and foreign pharmacopoeias for quality control of microorganism in the water for pharmaceutical use, an investigation was conducted, using culture medium method, of the microbial growth in water for laboratory use during the period of water storage and the process of culture medium preparation, and the impact on the detection performance of culture medium by water microbial contamination was detected using 96-well enzyme labeling plate method. Results: During the water storage period and the process of culture medium preparation, microbial growth was fast and the detection performance of culture medium was impacted when microbial contamination level of water reached to 104 cfu/mL. Conclusion: A basis was provided for the assessment of water quality and the reasonable utilization of water for the microbiological laboratories.

关键词

实验室用水/微生物分析/培养基法/96 孔酶标板法

Key words

Water for Laboratory Use/Microbiological Analysis/Culture Medium Method/96-well Enzyme Labeling Plate Method

引用本文复制引用

顾珉,杨美琴,马仕洪,顾炳仁..药品质控实验室用水的微生物分析[J].中国执业药师,2015,(10):14-17,56,5.

中国执业药师

2096-3327

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