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

目的:针对目前国内药检所微生物实验室用水的实际情况,探索实验室用水微生物分析的可行方法,提出合理的水微生物污染的质控水平。方法:参考国内外药典对药用水的微生物质控方法,采用培养基方法考察了实验用水在储水期、培养基配制过程中的微生物生长情况和运用96孔酶标板法初步考察了水的污染程度对培养基检测性能的影响。结果:水在储水期、培养基配制过程中的微生物生长迅速,在水的微生物污染程度达到104 cfu/m L的时候对培养基的检测性能有影响。结论:本研究为微生物实验室水质影响评估和合理利用实验室用水提供了依据。

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.