阿尔道醇高水平消毒剂。

Aldahol high-level disinfectant.

机构信息

MicroChem Laboratory, Inc., 1107-C South Airport Circle, Euless, TX 76040, USA.

出版信息

Am J Infect Control. 2010 Apr;38(3):205-11. doi: 10.1016/j.ajic.2009.08.009. Epub 2009 Nov 8.

DOI:10.1016/j.ajic.2009.08.009

PMID:19900736

Abstract

BACKGROUND

Glutaraldehyde and ortho-phthalaldehyde (OPA) are widely used as the active ingredients of high level disinfectants for heat-sensitive, semicritical medical instruments. However, both of these chemicals have limitations in their spectrum of antimicrobial activity. Glutaraldehyde disinfectants are poorly mycobactericidal, and require impractically long exposure times to kill spore-forming bacteria. OPA disinfectants kill many types of mycobacteria in practical exposure times, but require 32 hours to pass the Association of Official Analytical Chemists (AOAC) sporicidal test, and do not claim to be sterilants. These could be serious limitations that contribute to the formation of biofilms in endoscopes, after which the endoscopes are difficult to disinfect. The objective of our research was to discover a disinfectant formulation, based on aldehydes, that killed mycobacteria and spore-forming bacteria in a practical exposure time and temperature.

METHODS

Solutions of glutaraldehyde or OPA were prepared with various concentrations of alcohols, sodium and potassium salts, chelating agents, and detergents at alkaline pH values, and tested against cultures of mycobacteria and spore-forming bacteria to find a formulation that would kill these bacteria in practical exposure times at 20 degrees C or 25 degrees C.

RESULTS

Concentrations of < or =20% w/w isopropanol and < or =8% potassium acetate in combination with < or =3.5% w/w glutaraldehyde at alkaline pH values killed 6 log(10) of mycobacteria within 10 minutes at 20 degrees C. Similar combinations killed 6 log(10) of Bacillus subtilis in suspension within 30 minutes at 25 degrees C, and B subtilis within 60 minutes at 20 degrees C. The sporicidal activity of OPA was not increased by combination with isopropanol and potassium acetate salts.

CONCLUSIONS

Aldahol high-level disinfectant (US FDA K041360), a formulation of 3.5% glutaraldehyde in combination with 20% w/w isopropanol and 8% potassium acetate, kills mycobacteria within 10 minutes at 20 degrees C and kills 6 log(10) of cultures of the spore-forming bacteria B subtilis within 60 minutes at 20 degrees C.

摘要

背景

戊二醛和邻苯二甲醛（OPA）被广泛用作热敏感、半关键医疗器械的高水平消毒剂的有效成分。然而，这两种化学物质在其抗菌活性谱方面都存在局限性。戊二醛消毒剂对分枝杆菌的杀菌效果较差，需要不切实际的长时间暴露才能杀死形成孢子的细菌。OPA 消毒剂在实际暴露时间内可以杀死许多类型的分枝杆菌，但需要 32 小时才能通过美国分析化学家协会（AOAC）的孢子杀灭试验，并且不声称是灭菌剂。这些可能是导致内窥镜中生物膜形成的严重限制因素，此后内窥镜难以消毒。我们研究的目的是发现一种基于醛的消毒剂配方，该配方可以在实际暴露时间和温度下杀死分枝杆菌和形成孢子的细菌。

方法

在碱性 pH 值下，将戊二醛或 OPA 与各种浓度的醇、钠和钾盐、螯合剂和洗涤剂混合制成溶液，并对分枝杆菌和形成孢子的细菌进行培养，以找到一种在 20°C 或 25°C 的实际暴露时间内能够杀死这些细菌的配方。

结果

浓度为<或=20%w/w 的异丙醇和<或=8%的乙酸钾与碱性 pH 值下的<或=3.5%w/w 的戊二醛结合使用，可在 20°C 下 10 分钟内杀死 6 对数（10）的分枝杆菌。类似的组合在 25°C 下 30 分钟内杀死悬浮液中的枯草芽孢杆菌 6 对数（10），在 20°C 下 60 分钟内杀死枯草芽孢杆菌。OPA 的杀菌活性并未因与异丙醇和乙酸钾盐的组合而增强。