中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2015年
2期
91-95
,共5页
自动化检测设备%微生物%鉴定
自動化檢測設備%微生物%鑒定
자동화검측설비%미생물%감정
automatically detected equipment%microorganism%identification
目的：探讨不同原理自动化检测设备对药品中污染微生物进行鉴定。方法：采用传统的生理生化鉴定方法和分子生物学技术这两种原理的设备对不同菌株进行对比鉴定试验。结果：快筛设备A对特定细菌鉴定准确，但检测范围窄、费用偏高，适合应急快检；微生物全自动生化鉴定仪B对绝大多数的革兰阳性菌和革兰阴性菌都能准确鉴定到种，费用适中，但对芽孢杆菌和酵母菌的鉴定效果不十分理想，仅能鉴定到属且结果不稳定；基因测序仪C对细菌和真菌鉴定准确率高，可鉴定到亚种水平，但费用高。结论：三类鉴定设备均具有各自的优势，在检验工作中应根据实际情况和需要，合理利用设备。
目的：探討不同原理自動化檢測設備對藥品中汙染微生物進行鑒定。方法：採用傳統的生理生化鑒定方法和分子生物學技術這兩種原理的設備對不同菌株進行對比鑒定試驗。結果：快篩設備A對特定細菌鑒定準確，但檢測範圍窄、費用偏高，適閤應急快檢；微生物全自動生化鑒定儀B對絕大多數的革蘭暘性菌和革蘭陰性菌都能準確鑒定到種，費用適中，但對芽孢桿菌和酵母菌的鑒定效果不十分理想，僅能鑒定到屬且結果不穩定；基因測序儀C對細菌和真菌鑒定準確率高，可鑒定到亞種水平，但費用高。結論：三類鑒定設備均具有各自的優勢，在檢驗工作中應根據實際情況和需要，閤理利用設備。
목적：탐토불동원리자동화검측설비대약품중오염미생물진행감정。방법：채용전통적생리생화감정방법화분자생물학기술저량충원리적설비대불동균주진행대비감정시험。결과：쾌사설비A대특정세균감정준학，단검측범위착、비용편고，괄합응급쾌검；미생물전자동생화감정의B대절대다수적혁란양성균화혁란음성균도능준학감정도충，비용괄중，단대아포간균화효모균적감정효과불십분이상，부능감정도속차결과불은정；기인측서의C대세균화진균감정준학솔고，가감정도아충수평，단비용고。결론：삼류감정설비균구유각자적우세，재검험공작중응근거실제정황화수요，합리이용설비。
Objective:To study the identification of contamination microorganisms in drugs using automatical instruments of different detection mechanisms.Methods:Instruments with traditional physiological and biochemical reaction or molecular biological technology were compared for identification of different bacteria .Results:For several special bacteria the results were correct with quick screening equipment A indicated that was suitable for fast test , but the scope of detection was narrow and the expense was high .Instrument B was capable of detecting most of gram positive and gram negative bacteria at the species -level and the expense was appropriate , but it′s not satisfied for identification of bacillus and yeast at the genus-level and with concerns of unstable .Gene sequencing instrument C was the best for bacteria and fungi with high detection precision to subspecies-level, but the expense was too high.Conclusion: Each of the three types of automatical detection instruments have their respective advantages and limitations , which can be reasonably used accord-ing to the practical condition and requirement in detection work .
