液体细菌截留试验中菌液制备方法的研究  

Study on Preparation Methods of Bacterial Solution in Liquid Bacterial Retention Test

作　　者：李玲 梅享林 王烨婷 刘欢 吴其玉 魏嫣 吴欢 章琳 孔波 LI Ling;MEI Xiang-lin;WANG Ye-ting;LIU Huan;WU Qi-yu;WEI Yan;WU Huan;ZHANG Lin;KONG Bo(Hubei Medical Devices Quality Supervision and Test Institute,Hubei Wuhan 430075;Wuhan W.E.O.Science&Technology Development Co.,Ltd.,Hubei Wuhan 430040)

机构地区：[1]湖北省医疗器械质量监督检验研究院,湖北武汉430075 [2]武汉智迅创源科技发展股份有限公司,湖北武汉430040

出　　处：《中国医疗器械信息》2024年第21期38-40,共3页China Medical Device Information

基　　金：湖北省药品监督管理局药品安全监管科研项目(项目名称:医疗器械用0.22μm除菌级药液过滤器性能评价的研究,项目编号:20220110)。

摘　　要：目的:研究在-70°C保存条件下,不同保存时间点对冻存定量挑战原液中缺陷短波单胞菌活力的影响,探讨冻存定量挑战原液在0.22μm除菌级药液过滤器液体细菌截留试验中的应用效果。方法:为评估冻存定量挑战原液中缺陷短波单胞菌的活力,采用稀释平板计数法对不同保存时间点的冻存定量挑战原液进行定量分析;为评估冻存定量挑战原液能否替代新鲜定量挑战原液进行液体细菌截留试验,同时采用新鲜定量挑战原液与冻存定量挑战原液进行液体细菌截留试验,比较两种不同定量挑战原液试验结果一致性。结果:在-70°C条件下保存至第2、4、6、8、10、12个月的缺陷短波单胞菌冻存挑战原液分别与0个月的菌落计数的对数值相比,结果均无显著性差异(P>0.05)。采用新鲜定量挑战原液与冻存定量挑战原液同时进行液体细菌截留试验,检测结果一致。结论:冻存定量挑战原液在-70°C条件下可稳定保存12个月,且冻存定量挑战原液中缺陷短波单胞菌可保持良好的活力。冻存定量挑战原液可替代新鲜定量挑战原液,应用于0.22μm除菌级药液过滤器的液体细菌截留试验,确保结果准确的前提下提高检测效率。Objective:To study the application effect of frozen quantitative challenge liquid in the test of liquid bacterial retention in 0.22μm debacterialized drug liquid filter,the vitality of frozen quantitative Brevundimonas diminuta solution stored at-70˚C for different time was tested.Methods:In order to evaluate the activity of brevundimonas diminuta in the frozen quantitative challenge solution,the frozen quantitative challenge solution at different storage time points was quantitatively analyzed by dilution plate counting method.The liquid bacteria interception test was conducted.At the same time,the fresh quantitative challenge solution and the frozen counterparts were used for liquid bacteria interception test,and the consistency of the test results of the two different quantitative challenge solutions was compared.Results:There was no significant difference in the results of the frozen challenge liquid Brevundimonas diminuta stored at-70˚C for 2,4,6,8,10 and 12 months,respectively,compared with the logarithmic value of the colony counting at 0 month(P>0.05).The fresh quantitative challenge solution and the frozen counterparts were used for liquid bacterial interception test,and the detection results of the two quantitative challenge solutions were consistent.Conclusion:The frozen quantitative challenge liquid can be stably stored for 12 months at-70˚C,and the frozen quantitative challenge liquid Brevundimonas diminuta can maintain good vitality.The frozen quantitative challenge liquid can replace the fresh one.It can be applied to the test of liquid bacterial retention in 0.22μm debacterialized drug liquid filter,and the detection efficiency can be improved under the premise of ensuring the accuracy of the results.

关 键 词：药液过滤器 缺陷短波单胞菌 液体细菌截留 

分 类 号：R446.5[医药卫生—诊断学]