CN1798581A - 感染朊病毒的材料污染表面的清洁和去污染制剂 - Google Patents
感染朊病毒的材料污染表面的清洁和去污染制剂 Download PDFInfo
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- CN1798581A CN1798581A CNA2004800150338A CN200480015033A CN1798581A CN 1798581 A CN1798581 A CN 1798581A CN A2004800150338 A CNA2004800150338 A CN A2004800150338A CN 200480015033 A CN200480015033 A CN 200480015033A CN 1798581 A CN1798581 A CN 1798581A
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Abstract
本发明公开了处理被朊病毒污染的医疗仪器表面的方法,包括将表面与含至少1.5M摩尔浓度过氧化物(等同于大约5%过氧化氢),和优选大约2M过氧化物(大约7%过氧化氢)的过氧化物离子源,例如过氧化氢的组合物接触。该组合物任选采用凝胶的形式。该组合物保持与表面接触约1-2小时直至全部或基本全部除去朊病毒污染。
Description
发明背景
本发明涉及生物去污染领域。本发明发现与清洁和除去和/或破坏来自医疗,牙科,和药用器械的有害生物材料,比如朊病毒(蛋白质传染因子)有关的具体的应用,并通过对其的具体参考而描述。然而应当理解本发明的该方法和系统可以被用于各种设备,器械,及其他被朊病毒感染的材料污染的表面,比如药物制剂设施,食品加工设施,实验动物研究设施包括地板,工作面,器材,笼,发酵罐,流体线等等的生物去污染。
术语“朊病毒“用来描述引起人和/或动物相对类似的脑部疾病蛋白质感染因子,该疾病总是致命的。这些疾病通常称为可传染的海绵状脑病(TSEs)。TSEs包括克罗伊茨费尔特-雅各布氏病(CJD)和人的CJD变体(vCJD),牛海绵状脑病(BSE),又名“疯牛病”,羊瘙痒症,和麇鹿萎缩病。所有的这些疾病攻击动物或易感染该特定疾病的动物的神经器官。它们的特征在于初期的长时间潜伏期,继之以短期神经症状,包括痴呆和机能失调,和最终死亡。
造成这些疾病的传染因子被认为是没有相关核酸的单纯蛋白质。这种朊病毒疾病的发病机理据提议认为涉及初期正常的宿主编码的蛋白。所述蛋白经受构象变化成为异常形式(朊病毒),其具有自我增殖能力。这种改变的确切原因目前是未知的。异常形式的蛋白在体内未被有效地分解,其在某些组织(尤其是神经组织)中累积最终引起组织损伤,比如细胞死亡。一旦已经发生显著的神经组织损伤,则观察到临床征象。
朊病毒疾病可以因此归类为蛋白聚合疾病,其还包括多个其它的致死疾病,比如Alzheimer’s病和淀粉样变性病。就CJD而言,人最普遍的朊病毒疾病(大体上以1∶1,000,000人群比例发生),大约85%的病例被认为偶发的,大约10%被认为是遗传的,和大约5%由医原性引起的。
虽然朊病毒疾病不被认为是高传染性的,但是其可以通过某些高危组织,包括脑,脊髓,大脑脊液,和眼睛而传播。在对朊病毒感染的病人外科手术之后,含有朊病毒的残余物可以遗留在手术器械上,尤其是神经外科和眼科器械上。在长时间潜伏期过程中,极难确定待进行外科手术的病人是否是朊病毒携带者。
现有技术中认可了不同水平的微生物去污染。例如,卫生处理是指通过清洁而除去污物或微生物。消毒需要清洁以破坏有害微生物。灭菌,最高水平的生物污染控制,是指破坏所有活的微生物。
目前已知常规意义上不存活或增殖的某些生物材料,比如朊病毒,毫无疑问能够复制和/或转化成有害的疾病单元。此处使用术语“灭活”包括破坏这种有害生物材料,比如朊病毒,和/或它们的复制或经历构象变化成为有害类型的能力。
液体灭菌系统,比如那些使用过氧乙酸和过氧化氢的系统被广泛地用于微生物去污染。然而朊病毒众所周知耐受性非常强,并显示出对常规的去污染和灭菌方法的抗性。与微生物不同,朊病毒没有待破坏或破裂的DNA或RNA。朊病毒,由于其疏水性,趋向以不溶解的块状聚集在一起。在导致对微生物成功灭菌的许多条件下,朊病毒形成致密的块状,其保护它们自身和其下的朊病毒免于灭菌过程。世界卫生组织(1997)用于朊病毒灭活规程要求将器械在浓氢氧化钠或次氯酸盐中浸泡两个小时,继之以高压灭菌一个小时。其它建议的方法包括延长蒸汽灭菌。这些侵蚀性的处理通常不适合医疗装置,特别是挠性的内窥境及其他具有塑料,铜或铝零件的装置。许多装置因暴露于高温而损坏。化学处理,例如强碱,总的来说对医疗装置材料或表面是有损害的。戊二醛,甲醛,环氧乙烷,液体过氧化氢,大多数酚类,醇类,和比如干热,煮沸,冰冻,UV,电离化,和微波辐射方法通常报道是无效的。例如,3%过氧化氢的水溶液被发现对朊病毒是无效的(Brown,等,J.Infectious Diseases,vol.145,No.5,PP.683-687(1982年5月)。对有效针对朊病毒但是适于表面相容的产品和方法有着明确的需求。
本发明提供了新的和改进的组合物和处理被朊病毒感染的材料污染的表面的方法,其克服上述及其他的问题。
发明概述
根据本发明的一个方面,提供了处理朊病毒污染的表面的方法。所述方法包括将表面与按重量计含有至少5%过氧化氢的水性组合物接触持续足够的时间,以至少基本减少表面上的朊病毒。
根据本发明的另一个方面,提供了一种用于处理被朊病毒污染的装置的方法。所述方法包括用凝胶组合物涂布装置的表面,所述组合物包括摩尔浓度至少为1.5M的过氧化物和湿润剂。凝胶维持和表面接触至少一个小时。
根据本发明的另一个方面,提供了用于处理被朊病毒污染的表面的组合物。所述组合物包括按重量计5-30%的过氧化氢,以足够的量提供700-4000cps粘度的增稠剂,按重量计5-30%的湿润剂,至少按重量计0.1%的腐蚀抑制剂,和过氧化氢稳定剂。
本发明至少一个实施方案的一个优点是对器械是温和的。
本发明至少一个实施方案的另一个优点是迅速并有效地失活朊病毒。
本发明至少一个实施方案的另一个优点是适于多种材料和装置。
本发明至少一个实施方案的另一个优点是可以单个步骤进行清洁和去污染。
本发明至少一个实施方案的另一个优点是在清洗过程中,医疗仪器和清洁设备的交叉污染和对保健工作者的危险性被减少。
本发明更进一步的优点对本领域技术人员而言在阅读和理解以下优选实施方案的详细描述后将更容易理解。
附图简述
本发明可以采取多种组分和组分的安排,和多个步骤以及步骤的安排。附图仅仅为了图示优选的实施方案,不应理解为对本发明的限制。
图1是回肠液体依赖的生物(IFDO)当暴露于本发明的组合物和暴露于对照制剂时,随时间剩余量的图;和,
图2是当暴露于含有按重量计1%到7%过氧化氢的组合物时,IFDO随时间剩余量的图。
优选实施方案详述
被朊病毒污染的表面去污染的方法包括将待处理的表面与包括足够浓度的过氧化氢的组合物接触并且持续足够的时间以从表面除去朊病毒和/或破坏表面上的朊病毒。意外的发现以过氧化氢的含水组合物在比较高的浓度(即,按重量计组合物超过大约5%是过氧化氢或相当摩尔百分比的过氧化物)处理朊病毒,在相当短的时间(大约一个小时,或者更少)内运病毒基本(即大于99%破坏)上得以破坏。在三个小时内,更优选在大约两个小时或更短时间内达到六个数量级的降低(至多保留最初每百万个朊病毒中的一个)。
该处理有效抗人朊病毒(即,能够在人体内复制的朊病毒),以及在其它动物种类,比如牛,羊和小鼠中发现的朊病毒。例如,造成人CJD和vCJD,牛BSE,和羊瘙痒症的朊病毒可被除去。朊病毒通常存在于生物液体和动物组织,比如血液,脑或神经系统组织中。因此,优选用配制成除去生物液体或组织的清洁组合物处理污染的表面,使得残存在表面上的朊病毒很容易被过氧化氢接触到并且失活。
本发明提供了处理物品的组合物,所述物品比如为医疗设备,药用设备,停尸间设备,肉类加工设备,食品加工设备等等。其特别适于用于外科手术的医疗器械及其他医疗装置的处理,诸如解剖刀,剪刀,内窥镜,镊子,尿液管,牵引器,夹具,压舌板等等,并根据具体的参考进行描述。
组合物优选是液体或增稠组合物的形式,比如凝胶或泡沫,其被用于待处理的物品。合适的使用方法包括将组合物喷雾在待去污染的物品上,用供料器(applicator)比如刷子或滚筒施用该组合物,或将物品浸渍或浸没在组合物中。接触可以伴随搅动或洗刷以增加组合物的渗透性并帮助除去生物物质。
对于医疗设备而言,优选的组合物是凝胶或类似增稠的组合物形式。凝胶将组合物保持在设备上延长的时间,因此被朊病毒感染的体液或组织污染的设备在清洗完成以前不干透。如果污染的设备被允许完全干燥,体液硬化并变得难以除去。干燥的残余物使过氧化氢更难渗透并更难破坏残存的朊病毒。含有过氧化氢的增稠组合物在延长的时间内例如两个或更多小时,更优选至少四小时,并直至八小时或更多,即对于待转运到后处理区域的物品并接受进一步的处理而言足够久从而防止设备干透。
凝胶或液体组合物允许所述设备安全地从外科或其它施用该设备的位置转移到进行进一步去污染处理的后处理区域,比如进行进一步的清洁,灭菌,消毒等。
对于较大区域,比如墙壁,工作面,和更大的设备的处理而言,液体组合物是合适的。
除破坏污染的装置上的朊病毒之外,组合物还有效提供对有害病毒比如HIB,HIV,HBV,和MRSA的低水平的消毒。装置上其它的蛋白质也被分解或失活,使得它们更容易从装置除去。
组合物优选是水性的,虽然在组合物中使用其它溶剂比如有机溶剂也被考虑在内。除水之外,组合物包括过氧化物源。过氧化物源优选包括按重量计浓度至少5%的过氧化氢并且可以高达大约30%,更优选,按重量计大约6-8%,并且最优选地,按重量计大约7%的过氧化氢。当考虑更高浓度的过氧化氢时,含有大约7%的组合物被发现在大约两个小时或者更短时间内可有效清除所有痕量的朊病毒(至少减少六个数量级)。大约99%的朊病毒在大约1小时被破坏。
过氧化氢可市售获得的大约3-55%的水溶液,通常在大约35%,其然后被组合物的水及其他组分稀释到所需的水平。
还考虑产生相等摩尔量的过氧化物离子的其它过氧化物源。例如,所述组合物可以包括在混合时形成过氧化物离子的试剂。优选地,组合物中过氧化物的摩尔浓度至少为1.75M(摩尔/升),相当于按重量计5%的过氧化氢浓度,更优选地,至少大约2.18M,相当于按重量计6%的过氧化氢浓度,并且最优选地,大约2.64M(相当于7%的过氧化氢溶液)。
所述组合物任选包括增稠剂以给组合物提供大约500厘泊(cps)或更高的粘度。所述组合物具有足够的粘性使得它涂布所述设备并防止血液和体液的干燥,同时允许通过喷雾,浸渍,涂抹或其它的选择的施用方法来应用凝胶组合物。粘度是影响运输和应用方法的性质。
粘度显示材料的流动性。随着粘度增加,材料显示流动性减少或受限制。具体地,如果所述凝胶组合物具有太高的粘度,它显示潜在地阻碍凝胶的运输或应用的降低的流动性。过高的粘度对其湿润表面的能力和渗透裂隙和零件接触区域的能力具有有害的影响。如果粘度非常低,凝胶从设备流走只留下很薄的涂层。凝胶组合物的粘度优选从大约700到大约4,000厘泊(cps),更优选,从大约1,000到大约3,500cps,并且最优选从大约1,500到3,000cps。粘度超过4,000cps的组合物显示流动性降低,其可以限制某些应用和运输方法。
所需的粘性优选通过增稠剂,比如聚合物系统提供。所述聚合物系统包括聚合物和活化聚合物所需的任意其它组分。在一个实施方案中,聚合物系统包括聚合物和中和剂。例如,在其游离态呈酸式的聚合物显示很少或没有的凝胶稠度。所述中和剂中和酸式聚合物并生产具有胶状性质的聚合物系统。
适合用于聚合物系统的聚合物是形成凝胶的,粘度改性的聚合物,包括但不限于纤维素衍生物,基于丙烯酸的聚合物,树胶,比如瓜耳胶,瓜尔胶衍生物,藻酸盐,藻酸盐衍生物,非离子表面活性剂,非离子聚合物,及其混合物。
合适的纤维素衍生物非限制性的例子包括羧基烷基纤维素聚合物,羟基烷基纤维素聚合物,以及其疏水性改性的衍生物。一些可以市售获得的纤维素衍生物包括NatrosolTM Plus CS Grade 330,疏水性改性的羟乙基纤维素,NatrosolTM 250,羟乙基纤维素,以及KlucelTM,羟丙基纤维素,全部可以从Aqualon获得。
合适的基于丙烯酸的聚合物的例子包括但是不限于以商品名CarbopolTM包括CarbopoTMETD.TM 2001,2020,2050和2623,由B.F.Goodrich出售的那些。其它示例的市售的基于丙烯酸的聚合物包括可以从B.F.Goodrich获得的CarbopoTMAqua 30以及Carbomer系列包括CarbopolTM 934,940,941以及1342。
合适的非离子聚合物包括乙烯酯,乙烯醚,乙烯醇,丙烯酰胺,甲基丙烯酰胺,丙烯酸烷基或芳基酯,甲基丙烯酸烷基或芳基酯,马来酸烷基或芳基酯,丙烯腈,乙烯基吡咯烷酮,聚烯烃,比如苯乙烯,乙烯,或丙烯的聚合物,和多功能酸。非离子聚合物的实例是LaponiteTMXLS和RDSTM,其是合成的硅酸镁钠聚合物,可以从Southern Clay Products获得。
两种或更多合适的聚合物的组合被任选采用以形成凝胶组合物。
例如藻酸盐,优选与其它的聚合物系统组合使用。
中和剂是任何足以中和聚合物形成凝胶的化学品。对于酸性聚合物而言,中和剂通常是碱性的,比如三乙醇胺(TEA),和碱金属氢氧化物,比如氢氧化钾(KOH),氢氧化钠(NaOH),和氢氧化铵(NH4OH)。对于碱性聚合物而言,使用酸性中和剂比如柠檬酸。
例如,就疏水改性的羟基烷基纤维素而言,聚合物首先分散在酸性介质比如pH在大约4的柠檬酸溶液中。一旦分散,所述组合物的pH可以被调解到破坏朊病毒的更优化的pH(pH 4-8)。例如,用碱,比如KOH将pH调解到大约pH 5.0到5.5。
所述聚合物系统的组分以足够高的浓度存在以提供具有所需粘度的凝胶。存在于制剂中最优的聚合物量依赖于凝胶是否是活化的,以及所使用聚合物的类型。对于许多聚合物系统而言,凝胶组合物具有的聚合物浓度从大约0.05%到大约14%,更优选地,大约0.5%到大约3%,并且最优选大约1.0%。所有的百分数,除非另外注明,指重量百分数。
中和剂的浓度依赖于聚合物种类和聚合物的浓度。例如,对具有疏水性改性的羟乙基纤维素,可以使用大约0.022%的45%KOH。
除提供粘性之外,其帮助将制剂保留在被处理的物品上,所述聚合物还帮助增溶和/或防止固定被污染的材料,比如蛋白质,特别是朊病毒蛋白质。
所述组合物优选包括一种或者多种过氧化物稳定剂以延迟过氧化物在酸性溶液中的分解。合适的过氧化氢稳定剂包括描述为螯合剂或自由基抑制剂的无机物或有机物。这种类型的合适的稳定剂包括醇,羧酸比如羟基苯甲酸;膦酸,比如1-羟基亚乙基-1,1-二膦酸(HEDP),氨基(甲基膦酸),或其可溶性盐,比如氨基-三-(甲基膦酸),苯基膦酸或其盐,比如苯膦酸;乙二醇醚,比如乙二醇单甲基醚;以及磺酸,比如p-甲苯磺酸和十二烷基苯磺酸;以及其组合。
用于酸性溶液示例性稳定剂包括1-羟基亚乙基-1,1-二膦酸,其可以从Solutia,Rhodia或Mayo Chemical获得,其是可有效用作过氧化氢稳定剂,尤其是通过螯合过渡金属离子,比如铁。其它的稳定剂包括Oxyrite 100,可以从B.F.Goodrich获得,其作为流变学的稳定剂,以及p-羟基苯甲酸(单独或连同向水性芳基磺酸和/或疏水性烷基芳基磺酸)。
稳定剂以足够的量存在以维持组合物中过氧化氢的稳定性,使得过氧化氢至少按重量计为5%直到组合物被使用,并维持在存在污物的情况下使过氧化氢稳定在足够的浓度以使过氧化氢破坏朊病毒。稳定剂的存在量取决于使用的稳定剂种类和组合物是否将在使用以前立即形成或将存储许多周或月。另外,如果自来水而非去离子水用于组合物中,稍微更高浓度的稳定剂可能是适当的。例如,使用去离子水的稳定的过氧化氢制剂容易使用按重量计0.1-3%的Oxyrite 100,更优选大约0.15%Oxyrite 100以及按重量计0.005到0.02%HEDP,更优选,按重量计大约0.008-0.01%HEDP的组合形成。
在水,血液或腐蚀性液体存在情况下,金属基材趋向开始立即被侵蚀。因此所述组合物,优选包含一种或者多种抗腐蚀剂。抗腐蚀剂根据金属基材的材料的性质来选择。因此优选在组合物中具有一种或者多种抗腐蚀剂,使得组合物可以用于各种金属基材。抗腐蚀剂以足够浓度存在以抑制医疗器械或其它的装置在暴露于组合物期间的腐蚀。
示例的铜和黄铜抗腐蚀剂通常是含氮或含氧的有机化合物,比如胺,硝基化合物,苯甲酸盐,吡咯,咪唑,二唑,三唑,羧酸等等。吡咯比如巯基苯并噻唑,和芳族三唑及其盐,比如苯并三唑,甲苯基三唑和甲苯基三唑钠,特别适合作为铜和黄铜的抗腐蚀剂。基于吡咯的抗腐蚀剂组合物可以例如作为CobratecTM 939从PMC获得。
铜和黄铜腐蚀抗腐蚀剂的浓度优选从大约0.002%到大约1.0%,并且最优选从大约0.1%到大约0.5%。
钢基材合适的抗腐蚀剂包括磷酸盐,膦酸,硫酸盐和硼酸盐。合适的磷酸盐包括碱金属磷酸盐,比如钠盐和钾盐。合适的磷酸盐的其它例子包括磷酸二氢钠,磷酸氢二钠,六偏磷酸钠,和其钾盐等同物。六偏磷酸钠还作为产生水硬盐等等的螯合剂。以商品名DequestTM 2016由Solutia公司出售的羟基次乙基二膦酸是一种示例性的钢抗腐蚀剂。用于钢的抗腐蚀剂,当用于组合物时,优选浓度从大约0.005%到大约1.0%,更优选从大约0.0065%到大约0.1%,并且最优选从大约0.007%到大约0.01%。
示例性的铝抗腐蚀剂包括8-羟基喹啉和邻苯酚。
组合物优选包括湿润剂。当凝胶被用于设备时,这帮助凝胶组合物保持水分。合适的湿润剂包括多羟基化合物,比如山梨糖醇,甘油,葡萄糖醇,聚乙二醇,丙二醇,二丙二醇,1,3-丁二醇,己二醇和其混合物。山梨糖醇可从Roquette Corp.,ADM(Ashland)获得。
所述湿润剂优选按组合物重量计从大约5%到大约30%,更优选,大约10%。
尽管不完全了解其机制,通常认为山梨糖醇,或其它的湿润剂,帮助溶解被污染的材料,比如蛋白质,特别是朊病毒蛋白质,和/或防止被污染的材料固定在被处理的的物品表面上。
所述组合物除过氧化氢之外任选包括活性抗微生物剂,其显示抗微生物功能,比如卫生处理,消毒,或杀菌。卫生处理是指阻止霉菌生长和活跃对抗一些类型的细菌。消毒是指杀死或清除病原微生物。杀菌是指杀死所有的微生物,包括细菌的内孢子,其是对已知的杀菌剂最有抗性的活生物。
组合物中的抗微生物剂不必在接触过程中提供完全的杀菌或消毒。而且,抗微生物剂有助于减少人体在清洁阶段暴露于微生物。合适的抗微生物剂包括,但不限于羟基乙酸,过羟基乙酸,过氧乙酸,二氧化氯,臭氧,及其组合。合适的过氧乙酸包括过乙酸和过甲酸。活性成分的优选组合是过氧化氢和过乙酸。其它可以使用的活性物质包括季铵化合物(其帮助清洁),酚,三氯生TM(TriclosanTM),和葡萄糖酸氯己定(Chlorohexidine Gluconate)。
抗微生物剂以足够量存在实现对设备所需水平的抗微生物处理。例如,更高浓度被用来提供灭菌,而较低的浓度适于消毒或卫生处理。
所述组合物任选包括一种表面能还原剂或润湿剂(“表面活性剂”)以增强渗透进入被处理的物品的缝隙。当对可能在缝隙,接头和内腔中包含微生物污染的复杂的医疗设备进行清洁和除污染时,这是特别重要的。凝胶组合物中的表面活性剂,当涂在所述污染的设备上时,渗透污垢和碎屑的表面并有助于降解和除去所述污物。
示例性的表面活性剂包括阴离子的,阳离子的,非离子,两性的,和/或两性离子表面活性剂。非离子表面活性剂的例子包括脂肪醇聚乙二醇醚,壬基苯氧基聚(乙烯氧基)乙醇,非离子表面活性剂,和乙氧基化聚氧化丙烯,非离子表面活性剂。具体的例子包括Genapol UD-50TM,IgepalTM(壬基苯氧基聚(乙烯氧基)乙醇),FluowetTM,AntaroxTM(乙氧基化聚氧化丙烯),和PegolTM。上述或其它的表面活性剂可以单独使用或彼此组合使用。
如果设备将随后在自动化洗涤器中洗涤,用于组合物的表面活性剂优选是低发泡表面活性剂,比如非离子和两性表面活性剂,例如混合的C8两性羧化物。
表面活性剂优选以浓度从大约0%到大约1.0%存在于凝胶组合物中,更优选从大约0.05%到大约0.5%,和最优选从大约0.08%到大约0.2。
所述组合物还可以包括其它本领域已知的成分,比如水溶性的染料,例如,以使得组合物在设备上更容易看到,芳香剂,和香精,例如,以掩盖与沾污的或污染的设备有关的不良气味,等等。
组合物的余量包括优选在大约50%大约93%范围内的水。优选,去离子水或其它的净化水被用于所述凝胶组合物,但是也可以使用自来水。
对于破坏朊病毒而言,组合物优选具有的pH为大约4-8,更优选,从大约5.0-6.0。PH可以通过例如添加酸或碱到所需的pH进行调节。
示例性的组合物包括:
组分 | 重量% |
过氧化氢 | 5-8% |
疏水性改性的羟乙基纤维素(如,Natrosol Plus CS) | 0.5-3% |
柠檬酸(用于分散Natrosol) | 0.00025到0.0035% |
氢氧化钾 | 调整pH至大约5.0-5.5(约0-0.3%) |
湿润剂(如,山梨糖醇) | 5-30% |
螯合剂/稳定剂(如,HEDP) | 0.008-0.01 |
流体稳定剂(如,Oxyrite 100) | 0.1-0.3 |
吡咯抗腐蚀剂(如,Cobratec 939) | 0.1-1% |
去离子水 | Q.S.(约78-85%) |
特别优选的制剂包括:
组分 | 重量% |
过氧化氢 | 7% |
疏水性改性的羟乙基纤维素(Natrosol Plus CS) | 1% |
柠檬酸 | 0.0003% |
氢氧化钾 | 调整pH至大约5.0-5.5(大约0-0.3%) |
山梨糖醇 | 10% |
HEDP | 0.008% |
流体稳定剂(Oxyrite 100) | 0.15% |
吡咯抗腐蚀剂(Cobratec 939) | 0.2% |
去离子水(如,MilliQ) | Q.S.(约78-85%) |
组合物通过将所需的组分以按照前面确定的量混合而形成。形成之后,组合物可以立即使用或存储以备日后使用。
所述组合物尤其适于医学,牙科,停尸间,或药用设备和/或装置在清洁和去污染前的手术后的处理步骤。所述凝胶组合物提供了使存在于外科手术方法之后沾污的医疗器械上的血液及其他富含蛋白的体液在延长期限内保持湿润以及破坏表面上的朊病毒的方法。
所述凝胶组合物使血液或其它的体液保持湿润几个小时,通常大约三到四小时,并且有时直至八小时,其在大多数情况下足够将设备转运到洗涤系统。凝胶组合物中的水与设备上的液体互相作用以溶解和保持血液及其他生物液体湿润。通过凝胶使液体保持湿润的持续时间取决于施加的凝胶膜的厚度。越厚的膜使得在干燥之前的时间越长。在通常的应用中,凝胶膜暴露的表面首先通常在大约两到大约四小时内开始结皮或干燥,而残存的凝胶保持湿润。优选地,凝胶组合物在完全干燥以前保持八小时以上。
在替换的实施方案中,组合物为液体组合物形式。在此实施例中,装置优选全部浸没在组合物中或用组合物进行喷雾持续所需的暴露时间。
所述组合物通过任何合适的分配液体,凝胶,或泡沫组合物的分配器施用到所述设备上。示例性的分配器包括触发式喷药瓶,泵喷雾容器,加压喷雾罐,压挤瓶,和利用压缩空气泵的喷雾装置。施加所述凝胶组合物到设备的示例性方法包括喷雾。其它的施加方法包括将所述设备浸渍在所述凝胶组合物中或用刷子涂抹所述凝胶组合物或其它的应用。所述方法包括处理手术器械使得存在的朊病毒被失活并且残存在手术后器械上的血液或体液不干透。
例如,朊病毒污染的手术后医疗器械通过施加凝胶形式的组合物到设备,使得所述凝胶保持在设备上足够的时间以破坏设备表面上的基本所有的朊病毒,将涂有施加的凝胶组合物的处理的设备运输到清理站,并对处理的医疗器械进行清洁和优选杀菌进行处理。
优选施加足够量的凝胶组合物使得设备所有的污染区域被充分涂布凝胶组合物以在朊病毒去污染过程中容纳液体并保持其湿润,直到进行清洁。
任选地,在使用组合物之前或之后使用其它的手术后清洗方法。例如,液体清洁剂可用于处理设备的内部通路,或所述设备可以浸泡在液体清洁剂,比如酶清洁剂中。
任选地,如果需要可以施加另外的凝胶于污染的区域。例如,当洗涤器或灭菌器不能对设备进行有效清洁或杀菌时,施加另外的凝胶使得液体不干透,增加在随后的清洁之前经历的时间。
优选地,所述组合物以胶状存在于处理的设备上直到进行清洁和/或微生物去污染过程。在清洁过程中,凝胶和任何污物,血液,或其它液体被从设备表面除去。在其中包含表面活性剂的凝胶组合物特异性促进清洁过程中进行清洁和碎屑的去除。
清洁和灭菌通过任何本领域已知的方法实现。清洁,例如可以在自动洗涤器中使用合适的去污剂完成。灭菌可以在洗涤周期之后通过将设备暴露于杀菌剂,例如液体或蒸汽过乙酸,蒸汽过氧化氢等等而完成。灭菌还可以通过蒸汽灭菌方法合适地完成。
除有效破坏朊病毒之外,此处描述的含有过氧化氢的制剂已经被认为可有效杀死或者可以使各种其它的微生物种类,包括细菌,真菌,和病毒死后以及死后产生的真菌毒素无害。
可以用本发明组合物消毒的典型细菌和细菌芽孢包括芽胞杆菌,例如炭疽芽胞杆菌(Bacillus anthracis),枯草芽胞杆菌(Bacillussubtilis),假单孢菌,如铜绿假单胞菌(Pseudomonas aemginosa),荧光假单胞菌(Pseudomonas fluorescens),沙门菌,如鸡瘟沙门菌(Salmonellapullorum),伤寒沙门氏菌(Salmonella typhosa),肠杆菌,如,泄殖腔肠杆菌(Enterobacter cloacae),肠球菌,如,粪肠球菌(Enterococcusfaecalis),摩拉克氏菌,如卡他摩拉克氏菌(Moraxella catarrhalis),嗜血杆菌,如,流感嗜血杆菌(Haemophilus influenza);克雷伯氏杆菌,如,爱华氏克雷伯氏杆菌(Klebsiella edwardsii),肺炎克雷伯氏菌(Klebsiella pneumoniae),链球菌,如,肺炎链球菌(Streptococcuspneumoniae),坚忍链球菌(Streptococcus durans),粪链球菌(Streptococcus faecium)和化脓性链球菌(Streptococcus pyogenes);葡萄球菌,如,金黄色葡萄球菌(Staphylococcus aureus),化脓葡萄球菌(Staphylococcus pyogenes),埃希氏杆菌,如,大肠杆菌(Escherichiacoli),变形杆菌,如,奇异变形杆菌(Proteus mirabilis),和李斯特菌,如,单核细胞增生李斯特氏菌(Listeria monocytogenes),等等。
可以通过本发明组合物消毒的真菌和真菌孢子包括曲霉,如,烟曲霉(Aspergillus fumigatus),灰绿曲菌(Aspergillus glacus),黑曲霉(Aspergillus niger),镰刀菌,如,茄病镰刀菌(Fusarium solani),青霉,如,变幻青霉(Penicillium variable),葡萄状穗霉,等等。
细菌的和真菌孢子可以被消毒。
可以利用本组合物消毒的病毒包括AIDS病毒,禽源传染性支气管炎病毒,犬冠状病毒,疱疹病毒(传染性牛病毒),鼻气管炎病毒,瘟热病毒,猫疱疹病毒,虹彩病毒(非洲猪瘟),细小病毒,(犬细小病毒),痘病毒假(牛痘),冠状病毒(可传染的胃肠炎病毒),正粘病毒(禽流感病毒),副粘病毒科,细小核糖核酸病毒(猪水泡病毒),口蹄疫病毒,逆转录病毒等等。
并非对本发明的范围进行限制,以下实施例显示了组合物对朊病毒样种类的有效性。
实施例1:过氧化氢对IFDO的作用
制备下表1所示的制剂。制剂1含有7%的过氧化氢。制剂2没有过氧化氢,用作对照。
表1
组分 | 制剂1 | 制剂2 |
去离子水 | 68.6197 | 88.6139 |
柠檬酸 | 0.0003 | 0.0061 |
Natrosol 330 | 1.0 | 1.0 |
KOH | 0.022 | 0.022 |
山梨糖醇 | 10.0 | 10.0 |
HEDP | 0.008 | 0.008 |
Oxyrite | 0.15 | 0.15 |
Cobratec 939 | 0.2 | 0.2 |
过氧化氢(35%溶液) | 20.0 | 0 |
KOH | 按需要调整pH至5.5 | -- |
检验两个制剂对回肠液体依赖的生物(IFDO)的效力。该生物已经显示出可用作人的及其他朊病毒的有效模型,因为它显示当暴露于各种环境,比如消毒和灭菌时对朊病毒相似的行为模式。该生物首先从回肠液体由Burdon提取到(因此得名)(Burdon,J.Med.Micro.,29:145-157(1989))。该生物容易在实验室中培养和检测。例如,该生物培养在改性的支原体基本液体培养基中并通过连续稀释和平皿接种到单纯的琼脂上而进行定量分析。
在本实施例中,通过在室温下的悬浮试验研究两个制剂的功效,其中IFDO的悬浮液被悬浮在洗涤液中,样品按时间间隔取出用于评价。样品通过连续稀释和平皿接种修饰的支原体琼脂上而定量。平皿样品在37℃培养48小时并计数可检测的(为可见的黑斑)的菌落。图表1显示了两个制剂分别以0和5小时间隔检测的剩余的IFDO生物的数量(表示为剩余数目的对数)的图。
从图1可以看出,7%的组合物(制剂1)快速破坏IFDO,在暴露2小时之后没有可观察的菌落。制剂2对IFDO没有可检测的影响。
应当理解该检测是在悬浮液中进行的,因此组合物中其它组分(增稠剂,湿润剂等等)对用于被体液和组织污染的设备的组合物的清洁容量的优点在该检测中不明显。
实施例2:过氧化氢浓度对IFDO的作用
如实施例1的制剂1制备制剂,但是具有不同的过氧化氢浓度(据此调整水的量)。
如实施例1检验不同制剂中IFDO的悬浮液。图2显示了过氧化氢浓度随时间的作用。所述制剂分别地含有按重量计1%,2%,3%和4%的过氧化氢,在暴露3小时之后全部显示可测量水平的IFDO。在5%过氧化氢或更高浓度,在暴露3小时之后制剂显示没有可检测的IFDO。只有7%过氧化氢制剂在2小时检验之后显示没有可检测IFDO。
实施例3:过氧化氢对朊病毒污染的材料的作用
不锈钢丝接种被瘙痒症(羊)朊病毒蛋白质污染的脑部物质。所述金属丝过夜风干。将金属丝组在以下体系中浸泡1小时:去离子水;实施例1的制剂1(包含7%过氧化氢加上表面活性剂,等等);和7%的过氧化氢的去离子水溶液。所述金属丝从液体中取出,在去离子水中漂洗并提取以除去残存的蛋白和生物材料。提取物的样品通过SDEPAGE分离和用抗羊瘙痒症蛋白的抗体进行Western印迹以检测进行处理后羊瘙痒症蛋白是否存在。对照样品,没有经过浸泡,也被提取和检验。结果显示于表2。
表2
处理 | 检测到朊病毒(瘙痒症)的样品的百分比 |
对照(没有处理) | 100% |
水 | 95% |
7%过氧化氢 | 100% |
制剂1 | 0% |
表1显示的结果表明单独的7%过氧化氢在该检测过程中对显示存在朊病毒的样品的百分比没有影响。
制剂1的其它组分显然帮助减少了朊病毒的浓度,例如,通过溶解和/或阻止污染的生物材料固定在被处理的金属丝表面上。
Claims (21)
1.一种处理朊病毒污染的表面的方法,其特征在于:
将表面与含至少1.5M过氧化物的水性组合物接触足够的时间以至少基本上减少表面上的朊病毒。
2.权利要求1的方法,进一步的特征在于:
接触步骤包括:
用凝胶组合物涂布朊病毒污染的装置表面,该凝胶组合物包括摩尔浓度至少为1.5M的过氧化物和湿润剂;以及
将凝胶与表面保持接触至少1小时。
3.权利要求1或2的方法,进一步的特征在于:
所述过氧化物包括过氧化氢。
4.权利要求1-3任一项的方法,进一步的特征在于:
所述过氧化物的浓度为组合物重量的6-8%。
5.权利要求1-4任一项的方法,进一步的特征在于:
所述接触包括将表面与组合物接触至少1小时。
6.权利要求5的方法,进一步的特征在于:
所述接触包括将表面与组合物接触至少2小时。
7.权利要求1-6任一项的方法,进一步的特征在于:
组合物的粘度为至少500cps。
8.权利要求7的方法,进一步的特征在于:
组合物的粘度为700到4000cps。
9.权利要求7和8任一项的方法,进一步的特征在于:
组合物包含选自纤维素衍生物,基于丙烯酸的聚合物,树胶,比如瓜耳胶,瓜尔胶衍生物,藻酸盐,藻酸盐衍生物,非离子表面活性剂,非离子聚合物,及其混合物的增稠剂。
10.权利要求9的方法,进一步的特征在于:
所述增稠剂包括羟乙基纤维素或其疏水性改性的衍生物。
11.权利要求1-10任一项的方法,进一步的特征在于:
所述组合物的pH为约4-8。
12.权利要求11的方法,进一步的特征在于:
所述组合物的pH为5-6。
13.权利要求1-12任一项的方法,进一步的特征在于:
所述组合物还包括保持表面湿润的湿润剂。
14.权利要求13的方法,进一步的特征在于:
所述湿润剂选自山梨糖醇,甘油,葡萄糖醇,聚乙二醇,丙二醇,二丙二醇,1,3-丁二醇,己二醇及其混合物。
15.权利要求14的方法,进一步的特征在于:
所述湿润剂包括山梨糖醇。
16.权利要求14和15任一项的方法,进一步的特征在于:
所述湿润剂的存在量为组合物重量的约5到约30%。
17.权利要求1-16任一项的方法,进一步的特征在于:
所述组合物还包括抗腐蚀剂,过氧化氢稳定剂和表面活性剂中的至少之一。
18.权利要求1-17任一项的方法,进一步的特征在于:所述表面是医疗装置的表面。
19.一种处理朊病毒污染的表面的组合物,其特征在于:
按重量计5-30%的过氧化氢;
足量以提供700-4000cps粘度的增稠剂;
按重量计5-30%的湿润剂;
按重量计至少0.1%的抗腐蚀剂;以及
过氧化氢稳定剂。
20.权利要求19的组合物,进一步的特征在于:
所述组合物的pH为5-6。
21.权利要求19和20任一项的组合物,进一步的特征在于:
过氧化氢的浓度为按重量计6-8%。
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US10/448,910 US7071152B2 (en) | 2003-05-30 | 2003-05-30 | Cleaning and decontamination formula for surfaces contaminated with prion-infected material |
US10/448,910 | 2003-05-30 |
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CNA2004800150338A Pending CN1798581A (zh) | 2003-05-30 | 2004-05-28 | 感染朊病毒的材料污染表面的清洁和去污染制剂 |
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US (3) | US7071152B2 (zh) |
EP (1) | EP1628689B1 (zh) |
JP (2) | JP4490973B2 (zh) |
KR (1) | KR20060023535A (zh) |
CN (1) | CN1798581A (zh) |
AT (1) | ATE370752T1 (zh) |
AU (1) | AU2004245034B2 (zh) |
CA (1) | CA2525751C (zh) |
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CN106184767A (zh) * | 2013-03-15 | 2016-12-07 | 波音公司 | 飞行器舱室的高温去污 |
CN106488976A (zh) * | 2014-05-02 | 2017-03-08 | 凯斯医疗有限公司 | 用于处理潜在的感染性蛋白质污染物的组合物和方法 |
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103096937A (zh) * | 2010-10-19 | 2013-05-08 | Emd密理博公司 | 处理实验室耗材表面上存在的残留核酸的方法 |
CN103096937B (zh) * | 2010-10-19 | 2014-12-10 | Emd密理博公司 | 处理实验室耗材表面上存在的残留核酸的方法 |
CN106184767A (zh) * | 2013-03-15 | 2016-12-07 | 波音公司 | 飞行器舱室的高温去污 |
CN105263533A (zh) * | 2013-03-29 | 2016-01-20 | 原子能和替代能源委员会 | 氧化性碱性生物去污凝胶及用该凝胶的表面生物去污方法 |
CN105263533B (zh) * | 2013-03-29 | 2018-03-27 | 原子能和替代能源委员会 | 氧化性碱性生物去污凝胶及用该凝胶的表面生物去污方法 |
CN106488976A (zh) * | 2014-05-02 | 2017-03-08 | 凯斯医疗有限公司 | 用于处理潜在的感染性蛋白质污染物的组合物和方法 |
Also Published As
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AU2004245034A1 (en) | 2004-12-16 |
AU2004245034B2 (en) | 2009-10-22 |
CA2525751A1 (en) | 2004-12-16 |
DE602004008454D1 (de) | 2007-10-04 |
US20070037723A1 (en) | 2007-02-15 |
ES2293307T3 (es) | 2008-03-16 |
US7071152B2 (en) | 2006-07-04 |
WO2004108170A1 (en) | 2004-12-16 |
ATE370752T1 (de) | 2007-09-15 |
DE602004008454T2 (de) | 2008-05-15 |
EP1628689A1 (en) | 2006-03-01 |
US7393818B2 (en) | 2008-07-01 |
JP2009160445A (ja) | 2009-07-23 |
EP1628689B1 (en) | 2007-08-22 |
US20070289614A1 (en) | 2007-12-20 |
KR20060023535A (ko) | 2006-03-14 |
JP4490973B2 (ja) | 2010-06-30 |
US20060105930A1 (en) | 2006-05-18 |
US7217685B2 (en) | 2007-05-15 |
CA2525751C (en) | 2012-03-27 |
JP2007504927A (ja) | 2007-03-08 |
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