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Comparison of the effect of phthalaldehyde and glutaraldehyde on killing bacterial spores


Release time:

2022-09-27

邻 苯 二 甲醛 (OPA)通 过 美 国食 品与 药品 安 全 管理 局 (FDA)认证高水平消毒剂后,在国外 已用于 内镜 的消毒 【1],国 内近 年来对其十分关注【~ 。为 了解邻苯 二 甲醛 消毒剂 杀灭 芽 孢的能力,我 们选择 了进 口邻 苯二 甲醛 消毒剂和 国产强 化 戊二醛消毒剂进行 比较,采用载体定量杀菌试验,对其实验室 杀灭枯草杆菌黑色变 种芽孢效 果和使 用稳 定性进行 了观 察。 现将结果报告如下 。 1 材 料与方法 1.1 材料 进 口邻苯二甲醛消毒剂(美 国强 生公 司),邻苯二 甲醛标示含量为 0.50%~0.60%;强化戊 二醛 消毒剂为 医院 内镜 消毒使 用产品,戊二醛标示含量 2.0%-2.2%, 1.2 理化指标检测 消毒剂有效成份含量测 定参照《消毒 技 术规范>[4]邻苯二 甲醛消毒剂采用高效液相色谱 法测 定产品 中正一邻苯 二 甲醛的含量 ;强化戊二醛 消毒剂 采用硫 酸滴定 液 测 定产品中戊二醛含量 ;消毒剂 pH值 测定 采用 PHS-25精 密 数显酸 度计。 1.3 载体制备 取枯 草杆 菌黑 色变种 (ATCC 9372)芽孢 悬 液,用胰酪胨 大豆 (TSB)营 养 肉汤配 制染菌 用菌 悬液。取 试 验 菌悬 液 0.02rnl滴染于无菌不锈钢 圆片上 (直径 15mm,厚 0.5ram),置 37℃温箱烘干,制成 菌片备用。 1.4 中和剂鉴定试验 按 《消毒技术规范>规 定设 计 6组,以 枯草杆 菌黑 色变种芽孢为 试验菌 ,采用 载体 定量杀菌 试验 程 度进行 [5]。 1.5 载体浸 泡定 量杀 菌试 验 将 含每 个 菌 片 5ml消毒 液 (阳性对照为磷酸盐缓 冲液 )的无菌平皿置于 (20±1)℃恒 温 水浴中,加入 菌片作用 i定时间,取 出菌片,放 入含 5ml中 和剂 的试管 内,用 电动 混合器 震荡 40S,洗脱 钢 片上的 菌,中 和作 用 10rain;取洗 脱液作 活菌计 数,计算杀灭对数值 。所 有 试验重复 3次。 1.6 连续使 用稳定性试验 分 别取双 份 2000ml的邻苯 二 甲醛、强 化戊二醛 消毒剂原液分 别盛装 于 2个无 菌带盖搪 瓷 盘 中,各放入清洁的 医用镊子 、剪 刀、止 血钳等 医疗器械 达 到 满载要求 ,每 Ft将器械取出 ,用 清水洗涤,沥干 ,再浸泡到消毒 液 中。按每个载 体 10ml取 浸泡 当 日、7,14d搪 瓷盘 中的 消 毒液至无 菌平皿,置于 (20±1)℃ 恒温 水浴 5rain,将试 验 菌 片浸没其 中进行 载体定量 杀菌试验。 2 结 果 2.1 理化 指标测定 邻苯二 甲醛消毒剂为单方制剂 ,经测 定 含正一邻苯二 甲醛 0.53%,pH 值 为 7.45;强 化戊 二醛 消毒 剂 是戊二醛和 阳离子表 面活性剂 的复方 制剂 ,经测 定含戊 二醛 2.18%,活化前 pH值 2.55,活化后 pH值 7.74。 2.2 中和 剂鉴定 试验 用含 3g/L卵 磷脂 、3.0%吐温一8O、 1O L甘氨酸 的磷酸 盐缓 冲液 (PBS)作为 中和 剂,可有效 中 和邻 苯二 甲醛消毒剂原液和强化戊二醛 消毒剂 液对试验菌 残留作用,且中和剂溶液及其中和产物对枯草杆菌黑色变种 芽孢 的生长无明显影响。 2.3 对细菌芽胞的杀灭效果 邻苯二甲醛消毒剂原液作用 3h,对不锈钢 片上 枯 草杆 菌黑色 变 种 芽孢 的 杀灭 对数 值 为 3.21,作用 10h杀灭 对数值 >6.10;强 化戊二 醛消毒剂 原 液 作用 0.5h,对 枯 草 杆 菌黑 色 变 种 芽 孢 的 杀灭 对 数值 达 到 3.43,作用 3h的杀灭对 数值 >6.10(表 1)。 2.4 连 续使 用稳 定性试验 邻苯二 甲醛消毒剂原 液连续 浸 泡 医疗器械 7、14d后,作用 3h,对不锈钢片上枯草 杆菌黑 色 变 种芽孢的平均 杀灭对数值 均 >3.00;强 化戊二 醛消毒 剂原 液连续浸泡 医疗器械 7、14d后,作 用 3h,对芽孢 的杀灭对数 值均 >6.o0(表 2)。 表 1 不 同时间 2种消毒剂对枯草杆菌 黑色 变种 芽孢杀灭 效果比较 注 :阳性对 照组平均菌 数为 1272000cfu/片。结 果为 3次试验 平均值 。 表 2 2种 消毒 剂不 同作 用时 间的平均杀灭对数值 注 :结果为 3次试验平均值。 3 讨 论 本次试 验结 果表 明,0,53%邻苯 二 甲醛 消毒剂 原液 作用 3h可对芽孢达到 消毒效 果,但 与强 化戊 二醛 的 杀芽 孢效果 有一定差距,与黄育 红报道 基本一 致 【6】。本 次邻 苯二 甲醛消 毒剂 杀灭芽孢 的结果 明显 不如 许能 锋等 报道 【3】的 国内邻 苯 二甲醛 消毒 剂,可能与进 口为单方制剂 ,而 国内邻苯二 甲醛 消 毒剂多与醇类、季铵盐类及乳 化剂等复 配,且 pH值在 8.0以 上有关 ;许能锋等 已证实 ,含表面活性剂的碱性邻苯二 甲醛 杀 芽孢效果最 好 。 由于戊二醛在 内镜 消毒 中逐渐 暴露诸 多 问题 ,且 使用 前 要活化、使用浓度相对高等缺 陷,国 内外学者均提 出用邻苯 二 甲醛消毒剂 替代戊 二醛 用于 内镜 消毒 [2, 。本 次研 究证 明, 邻苯二 甲醛 消毒 剂具备高 水平消毒效果 ,且使 用稳定性好,可 连续使用 14d。 实验 中发现邻 苯二 甲醛 消毒 液接 触皮 肤、衣 物后 会有灰 色反应不易洗去;其产品说明中也标注“消毒后务必正确冲洗 干净 ;可能引起过敏反应 ;与 消毒液接 触可能使裸露 的皮肤或 衣服染 色;应避免与眼睛、皮肤 或衣服接 触”,使用中仍应 引起 注意 。
Phthalaldehyde (OPA) approved by the US Food and Drug Safety Administration(FDA) After certification of high-level disinfectant, it has been used for disinfection of endoscopes abroad [1], countryIn recent years, it has been very concerned about 【 ~. To understand the killing of o-phthalaldehyde disinfectantscapacity of spores, we chose imported o-phthalaldehyde disinfectant and domestic fortifiedComparison of glutaraldehyde disinfectant, using carrier quantitative sterilization test, its laboratory.The effect of killing Bacillus subtilis var. niger spores and the stability of use were observed.The results are reported below.
1 Materials and methods
1.1 material
Imported o-phthalaldehyde disinfectant (Johnson & Johnson), o-benzene two.The labeled content of formaldehyde is 0.50%~ 0.60%; the fortified glutaraldehyde disinfectant is hospitalProduct for use in disinfection of endoscopes with 2.0% of the glutaraldehyde label-2.2%,
1.2 physical and chemical indicators to detect the content of the active ingredients of disinfectants refer to the "disinfection technology."Specification> [4]Determination of products by high performance liquid chromatography for o-phthalaldehyde disinfectantsThe content of ortho-phthalaldehyde in the fortified glutaraldehyde disinfectant using sulfuric acid titrationDetermination of glutaraldehyde content in products; pH determination of disinfectant using PHS-25 precisionDigital pH meter.
1.3 carrier preparation
Spore suspension of Bacillus subtilis var. noir (ATCC 9372)liquid, using tryptone soy (TSB) nutrient broth to prepare a bacterial suspension for contamination. TestTest bacteria suspension 0.02rnl drop dye on sterile stainless steel disc (diameter 15mm, thickness
0.5rAm), put in a 37 ℃ incubator for drying, and make bacteria slices for later use.
1.4 neutralizer identification test
Press 《Sterilization Technical Specification> amp; Designs 6 GroupsBacillus subtilis black variant spores as test bacteria, using carrier quantitative sterilization test process.[5].
1.5 carrier immersion quantitative sterilization test will contain 5ml of disinfectant for each bacterial tablet.(positive control is phosphate buffer) sterile plate at (20±1)℃ constant temperatureIn the water bath, add the effect of bacterial tabletsI set the time, take out the bacteria piece and put it into 5mlIn the test tube of the mixture, the bacteria on the steel sheet are eluted by shaking for 40S with an electric mixer.and effect 10rain; Take the eluent for viable count and calculate the killing logarithm. AllThe test was repeated 3 times.
1.6 continuous service stability test
Take two 2000ml of phthalate respectivelyFormaldehyde and enhanced glutaraldehyde disinfectant stock solutions were contained in 2 sterile enamels with covers.Plate, each put clean medical forceps, scissors, hemostatic forceps and other medical equipment to reachFull load requirements, each Ft will be the instrument removed, washed with water, drained, and then soaked to disinfectionIn liquid. According to each carrier 10ml to soak the day, 7,14d enamel plate in the eliminationVenom to sterile plate, placed in (20±1)℃ constant temperature water bath 5rAin, will test bacteriaThe tablets were immersed in the carrier quantitative sterilization test.
2 knotsFruit
Determination of physical and chemical indexes of 2.1
o-phthalaldehyde disinfectant is a unilateral preparation, determinedContaining 0.53% ortho-phthalaldehyde, pH 7.45; enhanced glutaraldehyde disinfectantIs a compound preparation of glutaraldehyde and cationic surfactant, determined to contain glutaraldehyde
2.18, the pH value was 2.55 before activation, and the pH value was 7.74 after activation.
2.2 neutralizer identification test containing 3g/L lecithin, 3.0 Tween 8O,Phosphate buffer solution (PBS) of 1O L glycine as a neutralizing agent can effectivelyand phthalaldehyde disinfectant stock solution and enhanced glutaraldehyde disinfectant solution on the test bacteria.residual effect, and the neutralizer solution and its neutralization products on the black variant of Bacillus subtilis.There was no significant effect on the growth of spores.
Effect of 2.3 on killing bacterial spores Effect of ortho-phthalaldehyde disinfectant stock solution3h, the killing of Bacillus subtilis black variant spores on stainless steel sheet is3.21, the effect of 10h kill value> 6.10; enhanced glutaraldehyde disinfectant stock solutionAfter 0.5h of action, the killing of spores of Bacillus subtilis var.3.43, the killing logarithm value for 3h of action was> 6.10 (Table 1).
2.4 continuous service stability test
Continuous immersion of ortho-phthalaldehyde disinfectant stock solutionAfter soaking the medical device for 7 and 14 days, it acts for 3 hours to black Bacillus subtilis on the stainless steel sheet.The average killing of spores of the variant was> 3.00;After continuous soaking of medical devices for 7 and 14 days, the number of spores killed by the liquid for 3 hoursThe values are all> 6.o0 (Table 2).Table 1 Effects of two disinfectants on Bacillus subtilis var. niger at different timeComparison of spore killing effect
Note: The average number of bacteria in the positive control group was 1272000cfu/tablet. Results for 3 trialsAverage.
Table 2 Average killing logarithmic values of two disinfectants in different action time
Note: The results are the average of 3 tests.
3 to askOn
The test results show that the effect of 0,53% o-phthalaldehyde disinfectant stock solution3h can achieve disinfection effect on spores, but with the enhanced effect of glutaraldehydeThere is a certain gap, which is basically consistent with Huang Yuhong's report [6]]. This o-phthalaldehyde eliminationThe results of killing spores by toxic agents are obviously not as good as those reported by Xu Nengfeng and others.3] of domestic o-benzeneDimethyl aldehyde disinfectant, which may be imported as a unilateral preparation, while domestic o-phthalaldehyde elimination
The poison is mostly compounded with alcohols, quaternary ammonium salts and emulsifiers, and the pH value is above 8.0.On the related; Xu Nengfeng and others have confirmed that the surfactant-containing alkaline phthalic aldehyde kill.Spore effect is best.Because glutaraldehyde gradually exposed many problems in endoscopic disinfection, and before useTo activate, the use of relatively high concentration of defects, domestic and foreign scholars have proposed the use of benzene two.Formaldehyde disinfectant instead of glutaraldehyde for endoscopic disinfection [2,. This study proves that,o-phthalaldehyde disinfectant has a high level of disinfection effect, and the use of good stability, can be14d continuous use.In the experiment, it was found that the o-phthalaldehyde disinfectant would have ash after contacting the skin and clothes.The color reaction is not easy to wash away; The product description also says "Rinse correctly after disinfection."clean; may cause allergic reactions; contact with disinfectant may cause exposed skin orClothes dyeing; should avoid contact with eyes, skin or clothes ", should still causeAttention.

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