CN105685095A - 一种内镜消毒灭菌剂及其应用 - Google Patents

一种内镜消毒灭菌剂及其应用 Download PDF

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CN105685095A
CN105685095A CN201610165254.8A CN201610165254A CN105685095A CN 105685095 A CN105685095 A CN 105685095A CN 201610165254 A CN201610165254 A CN 201610165254A CN 105685095 A CN105685095 A CN 105685095A
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biocide
sterilizing
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acid
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杜武华
黄显峰
林栋青
丛日楠
宫芳
刁盈盈
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Shandong Weigao Pharmaceutical Co Ltd
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Abstract

本发明提供一种内镜消毒灭菌剂包括18-58重量份的过氧化物，10-33重量份的酰化剂和3-30重量份的缓冲剂；所述1重量份的消毒灭菌剂溶解到20-300重量份的水中后，得到的消毒灭菌溶液中含有过氧酸根离子300-20000mg/L，所述消毒灭菌溶液的水溶液的pH为4-10。本发明内镜消毒灭菌剂杀灭微生物能力强、对内镜腐蚀性小、稳定性好和综合使用成本低，尤其适合内窥镜的消毒灭菌剂。

Description

一种内镜消毒灭菌剂及其应用
技术领域
本发明属于化学消毒剂领域，尤其是涉及一种内镜消毒灭菌剂。
背景技术
内镜诊断与治疗已经普及并广泛应用于临床，仅美国消化内镜学会估计，每年接受消化内镜诊疗者即达1000万人次以上。但由于内镜构造精细，材料特殊，许多部件不耐高温怕腐蚀、造价高、使用周转频繁等原因，给内镜消毒灭菌带来诸多困难，是造成医院交叉感染医源性传播的重要途径。
据报道由内镜引起的医源性感染有：沙门氏菌、绿脓杆菌、分枝杆菌、HBV、HCV、HIV、幽门螺杆菌(HP)、黏质沙雷氏菌、表皮葡萄球菌、肠杆菌、白色毛孢子菌、粪类圆形线虫、单纯疱疹病毒等等。因此加强内镜消毒灭菌管理势在必行。我国部分医院对内镜消毒观念淡薄、清洗消毒不规范、消毒剂使用不当，消毒时间过短，导致消毒后仍存在病原菌污染，有引发医院感染的严重隐患。
过氧乙酸是高效消毒剂，属过氧化物类消毒剂，具有快速、高效、分解后无残留有害物质等优点。应用在皮肤表面、皮肤黏膜、室内物体表面、体温计、污物表面、污水等领域。
近年过氧乙酸还常用于复用血透管路和透析器的消毒处理，为延长需要血液透析病人的生命，降低血液透析治疗费用，减少透析不良反应作出了贡献。用过氧乙酸消毒透析器和管路，血透并发症发生率低于用甲醛消毒，但透析效果并不降低。随着对过氧乙酸认识的深入，其应用范围必将不断扩大，为防病、治病作出贡献。
但传统的过氧乙酸腐蚀性强，有漂白作用，性质不稳定，遇热或有机物、重金属离子、碱等易分解。市售过氧乙酸浓度多在16％-18％，但过氧乙酸本身不稳定，随保存的时间延长以较快速度下降，其下降速度随溶液浓度降低而减慢。浓度在10％以上时下降较快，特别在15％以上时更为显著，在37℃条件下，1天就可能降低25％；10％-15％浓度范围，平均每天可下降6.5％；10％以下，平均每天下降5.1％。
现有技术中，为了克服过氧乙酸的不稳定性，近几年市售产品多为二元包装，即产品分为A、B两液，平时分瓶存放，使用前一天等量混匀，第2天过氧乙酸含量可达16％-18％(24℃，24h)，然后再稀释成所需浓度使用。混合时若温度低于10℃，应适当延长反应时间，否则过氧乙酸浓度将达不到标示浓度。但现有技术制备的二元包装过氧乙酸消毒液反应时间长，不能满足随时使用的要求；与此同时，混合后的过氧乙酸仍然和市售的15％-18％的过氧乙酸一样，性质极其不稳定，且对金属的腐蚀性较强。
申请号：201310667274.1公开了一种过氧乙酸消毒液及其制备方法。包括A剂和B剂，A剂由如下组分组成：过氧乙酸、过氧化氢、乙酸、稳定剂和去离子水；B剂由如下组分组成：磷酸三钠、络合剂、金属抗腐蚀剂、稳定剂和去离子水。该发明改善了传统过氧乙酸不稳定易分解的问题，同时有效的降低了过氧乙酸自身对金属的腐蚀性。使用时A剂和B剂混合使用，混合后的实用液对钼铬合金、不锈钢、PEEK、PPSU等内镜材质基本无腐蚀。
发明内容
本发明的目的是提供杀灭微生物能力强、对内镜腐蚀性小、稳定性好和综合使用成本低的内镜消毒灭菌剂，尤其适合内窥镜的消毒灭菌剂。
本发明的技术方案是：
一种内镜消毒灭菌剂，包括18-58重量份的过氧化物，所述过氧化物为过碳酸盐、过硼酸盐、过磷酸盐、过硅酸盐、过氧化尿素中的一种或几种；10-33重量份的酰化剂，所述酰化剂为乙酰水杨酸、四乙酰乙二胺、四乙酰甘脲、四乙酰戊醛糖、五乙酰葡萄糖、壬酰基苯磺酸钠、N-乙酰己内酰胺中的一种或几种；和3-30重量份的缓冲剂，所述缓冲剂为酒石酸、苹果酸、柠檬酸、苯甲酸、水杨酸、氨基磺酸、邻苯二甲酸、磷酸盐、磷酸氢盐、碳酸盐、碳酸氢盐、硼酸盐、氢氧化钠、铵盐中的一种或几种；所述1重量份的消毒灭菌剂溶解到20-300重量份的水中后，得到的消毒灭菌溶液中含有过氧酸根离子300-20000mg/L，所述消毒灭菌溶液的水溶液的pH为4-10。
现有技术含有过氧酸根离子的灭菌溶液pH值大多为0-3，为强酸性溶液，对内镜等医疗器械的腐蚀性较大。本发明研究人员在研究中发现，采用18-58重量份的过氧化物、10-33重量份的酰化剂和3-30重量份的缓冲剂混合后获得的消毒灭菌剂，溶于水后反应生成的消毒灭菌溶液pH为弱酸性或者弱碱性，对医疗器械腐蚀性较小，尤其是对内镜的腐蚀性小。
内镜通常情况下包括金属、高分子材料，如塑料、硅胶和聚四氟乙烯、橡胶、硅胶、乳胶、和光纤、玻璃等多种材料组成。研究结果表明，当pH＜4或＞10时对上述材料的腐蚀性很大，尤其对塑料类的高分子材料，容易造成高分子材料的加速老化，造成内镜的密封圈、接口等地方漏气或漏水，导致内镜的内部结构发生腐蚀，造成内镜的腐蚀，当pH在4-10的范围内，随着pH越靠近中性，腐蚀性越小。
本发明的内镜消毒灭菌剂杀菌能力强，杀菌时间短，能够5分钟时间内杀死包过大肠杆菌、金黄色葡萄球菌、白色念珠菌和枯草芽孢杆菌黑色变种芽孢在内的所有微生物，大大节省了医疗器械消毒时间，本发明提供的过氧乙酸急性经口毒性小鼠LD50＞5000mg/kg·bw，根据急性毒性分级标准，本发明提供的消毒粉属实际无毒级。同时本发明提供的消毒剂还能有效去除邻苯二甲醛消毒剂在内镜上产生的灰染。
细菌生物膜由依靠胞外产物而吸附于固体表面的微生物集落构成，并能结合有机和无机成分；形成包含复杂的理化过程和生物群落的相互作用。生物膜系统是真核细胞特有的系统，由细胞器膜，细胞膜和核膜构成，这些生物膜的组成成分和结构相似，结构和功能密切相关，表现着协调统一性。能够有效抵御消毒剂的作用，是内镜消毒灭菌失败的最重要的原因。本发明的过氧乙酸能够有效渗透到细菌生内部，将整个生物膜瓦解清除。
所述内镜消毒灭菌剂包括18-58重量份的过氧化物；10-33重量份的酰化剂；和8-25重量份的缓冲剂。
缓冲剂能够起到稳定溶液pH的作用，将溶液的pH控制在弱酸性或弱碱性。缓冲剂控制的pH是过氧化物氧化酰化剂生成过氧酸的重要因素，当pH过低时酰化剂上的酰基基团很难从酰化剂上脱落，无法生成过氧酸根；当pH过高时生成的过氧乙酸会被分解释放出氧气，造成溶液中过氧酸根离子快速下降，无法起到消毒灭菌的效果，同时弱酸性或弱碱性还有利于降低对金属、高分子材料、玻璃等材料的腐蚀性。
所述内镜消毒灭菌剂包括30-40重量份的过氧化物；15-25重量份的酰化剂；和12-22重量份的缓冲剂。
所述消毒灭菌剂还包括0.1-20重量份的阴离子表面活性剂，优选所述消毒灭菌剂还包括2-18重量份的阴离子表面活性剂，更优选所述消毒灭菌剂还包括5-12重量份的阴离子表面活性剂。
所述阴离子表面活性剂为十二烷基硫酸钠、十二烷基苯磺酸钠、二辛基磺化琥珀酸钠、磺基琥珀酸单月桂酯二钠、脂肪酸甲磺酸钠、聚氧乙烯十二烷基醚磷酸酯盐、壬基酚聚氧乙烯醚磺基琥珀酸单酯二钠盐中的一种或几种。
阴离子表面活性剂能够起到促进过氧化物和酰化剂在水中反应的作用，阴离子表面活性剂能够降低酰化剂与水溶液表面的界面张力，增大酰化剂与过氧化物的接触面积，加快反应速度，能够使内镜消毒灭菌剂在短时间内反应生成内镜消毒灭菌溶液，能够将反应时间缩短至5min。
阴离子表面活性剂还具有提高灭菌效果的作用，阴离子表面活性剂还能够细菌表面与水溶液的界面张力，增大过氧酸根与细菌表面的接触面积，增加了过氧酸根对细菌细胞壁、细胞膜的通透性，降低过氧酸根进入细菌内部的阻力，增强过氧酸根的杀菌效果。
阴离子表面活性剂为十二烷基硫酸钠和十二烷基苯磺酸钠按照1:3-5的比例混合。混合后促进反应效果更好，将内镜消毒灭菌剂加入到水中后3min内即可生成灭菌消毒溶液。
一种所述一种内镜消毒灭菌剂所制备的消毒灭菌溶液，所述1重量份的消毒灭菌剂溶解到30-200重量份的水中，所述消毒灭菌溶液中含有过氧酸根离子500-10000mg/L，所述消毒灭菌溶液的pH为5-9。
根据权利要求6所述的内镜消毒灭菌溶液，其特征在于：所述消毒灭菌溶液中含有过氧酸根离子800-3800mg/L，所述消毒灭菌溶液的pH为6-8。
过氧酸根离子浓度过大会造成对医疗器械的腐蚀，导致腐蚀性过大；过氧酸根离子浓度过小会影响灭菌效果，导致作用时间延长，同样会导致腐蚀性增大；综合考虑灭菌效果和腐蚀性的影响，过氧酸根离子在800mg/L-3800mg/L范围内时，能够达到最佳的消毒灭菌效果和最低的极低的腐蚀性。
一种所述的内镜消毒灭菌剂的用途，将1重量份的内镜消毒灭菌剂溶于20-300重量份的水中1-20min获得消毒灭菌溶液，所述消毒灭菌溶液用于内镜消毒和灭菌。
将1重量份的内镜消毒灭菌剂溶于30-200重量份的5-45℃水中搅拌1-15min获得消毒灭菌溶液，获得消毒灭菌溶液用于内镜消毒和灭菌。
水温度越高，反应速度越快，但是过氧乙酸会分解导致产品不稳定，水温越低，反应速度越慢，过氧乙酸的生成速率过慢，无法满足使用的需要。
本发明具有的优点和积极效果是：
本发明的内镜消毒灭菌剂的PH为弱碱性-弱酸性，对医疗器械具腐蚀性小，尤其是是不容易造成内镜的损伤，对内镜的各种组件都具有良好的相容性，包括手柄、手柄连接部、按钮、密封圈、弯曲橡皮、插入管外套、导光缆插入部、塑料管都有良好的材料相容性，不容易造成内镜的腐蚀、漏气、老化等损伤，特别适合于内镜的消毒灭菌。同时还对其他器械材料，例如碳钢、铜、铝、不锈钢、塑料、橡胶、硅胶、乳胶、玻璃等均有良好的材料相容性。
本发明的内镜消毒灭菌剂稳定性良好，在常温下不容易分解，储存周期长达两年，在使用时不会对医护人员产生伤害作用。
本发明的内镜消毒灭菌剂稳定性良好，能够多次重复使用，降低内镜消毒成本，同时本发明的内镜消毒灭菌剂对内镜损伤小，能够延长内镜的使用寿命，提高内镜的使用频率，降低内镜更新购买的费用。
附图说明
图1是本发明实验例3稳定性实验结果
图2是本发明实验例3反应速率实验结果
具体实施方式
实施例
表1实施例1-13的成分
实施例14
将1重量份的本发明实施例1内镜消毒灭菌剂溶于300重量份的45℃水中搅拌5min获得消毒灭菌溶液，获得消毒灭菌溶液用于内镜消毒和灭菌。
实施例15
将1重量份的本发明实施例2内镜消毒灭菌剂溶于40重量份的30℃水中搅拌5min获得消毒灭菌溶液，获得消毒灭菌溶液用于内镜消毒和灭菌。
实施例16
将1重量份的本发明实施例3内镜消毒灭菌剂溶于20重量份的5℃水中搅拌1min获得消毒灭菌溶液，获得消毒灭菌溶液用于内镜消毒和灭菌。
实验例
实验例1杀灭微生物实验
检验依据：卫生部2002年版《消毒技术规范》
实验菌株：大肠杆菌(8099)、金黄色葡萄球菌(ATCC6538)、白色念珠菌(ATCC10231)和枯草芽孢杆菌黑色变种芽孢(ATCC9372)
实验例：实施例13消毒灭菌溶液(过氧酸根2800mg/L，pH为7.2)
对照例：按发明CN102165053实施例1组合物2制备粒状组合物2％重量的水溶液(过氧酸根1600mg/L，pH为9.9)
市售产品1：进口过氧乙酸消毒剂，明泰科消毒剂(过氧酸根1300mg/L，pH为4.2)
市售产品2：进口过氧乙酸消毒剂，派司服医疗器械灭菌粉(过氧酸根2600mg/L，pH为8.5)
实验温度：20℃
杀菌时间：5min
表2杀灭对数值
由表2可以看出，本发明实施例对大肠杆菌(8099)金黄色葡萄球菌(ATCC6538)、对白色念珠菌(ATCC10231)和对枯草芽孢杆菌黑色变种芽孢(ATCC9372)的杀灭对数值为7.14-7.53。对照例的杀灭对数值为4.36-6.23，市售产品1杀灭对数值为5.21-6.24，市售产品2杀灭对数值为5.36-6.84。实验数据表面，本发明内镜消毒灭菌剂的灭菌效果优于对照例和市售产品，尤其是对抗杀菌剂能力最强的枯草芽孢杆菌黑色变种芽孢的杀灭能力明显优于对照例和市售产品。
实验例2腐蚀性实验
实验样本：从内镜上拆下需消毒的部件，包括手柄、手柄连接部、按钮、密封圈、弯曲橡皮、插入管外套、导光缆插入部、塑料管8种样本，处理成约1cm×lcm的实验样品，不可拆的小型部件可整件作为实验样品。其中手柄连接部、按钮、密封圈、弯曲橡皮、插入管外套、导光缆插入部为软质非金属材料，手柄为硬质非金属材料，塑料管为塑料材质。
分析天平(精确度0.0001g)SartoriosBasic编号1115
浸泡容器(带盖玻璃缸，容积为600mL)
实验方法:
1.参照《消毒技术规范》(2002年版)2.2.4项进行实验。
2.样本制备：
使用碱性洗涤剂将样本洗净，用自来水冲洗。然后用超声波清洗器将样本清洗20min，用蒸馏水冲净。使用无水乙醇再次脱脂。置50℃恒温培养箱中干燥1h，待其温度降至室温后称重，每个样本待天平回零后称重3次，精确至0.1mg，取其平均值作为实验前重量。
3.消毒液浸泡：
按照说明书的规定配制实验用消毒液，每一样本需浸泡在200mL消毒液中。
本发明实施例所制备的内镜消毒灭菌剂、对照例、市售产品1和市售产品2消毒液分别对上述8种样本浸泡72h。同时使用蒸馏水对上述8种样本浸泡72h作为对照。
派司服医疗器械灭菌粉每8h换液一次。本发明实施例13所制备的内镜消毒灭菌剂和明泰科消毒剂每24h换液一次。
4.浸泡后样本制备：
浸泡到规定时间后，取出样本，先用自来水冲洗，再用毛刷去除表面腐蚀产物，用蒸馏水冲净。使用无水乙醇脱脂。置50℃恒温培养箱中干燥1h，待其温度降至室温后称重，每个样本待天平回零后称重3次，取其平均值作为实验后重量。
5.失重值计算：
失重值(g)＝实验前重量—实验后重量
实验结果:对内镜软质非金属材料部件浸泡后的失重结果，见表3。
表3对内镜软质非金属材料部件浸泡后的失重结果
对内镜软质非金属材料部件浸泡后的失重结果表明，实施例13产品对手柄连接部、按钮、导光缆密封圈、导光缆插入部、弯曲橡皮、插入管外套等软质非金属材料部件的失重率分别为0.0001-0.0004、0.0003-0.0007、0.0001-0.0008、0.0008-0.0029、0.0003-0.0007、0.0005-0.0014；实施例13对手柄连接部、按钮、导光缆密封圈、导光缆插入部、弯曲橡皮、插入管外套等软质非金属材料部件的腐蚀性与蒸馏水的腐蚀性相当，腐蚀率要明显低于对照例、市售产品1和市售产品2对内镜软质非金属材料部件的腐蚀率。
2.对内镜硬质非金属材料部件浸泡后的失重结果如表4所示。
表4对内镜硬质非金属材料部件浸泡后的失重结果
对内镜硬质非金属材料部件浸泡后的失重结果表明实施例13、对照例、市售产品1、市售产品2和蒸馏水对内镜硬质非金属材料部件的失重量分别为0.0001-0.0003、0.0004-0.0016、0.0008-0.0026、0.0002-0.0007、0.0001-0.0003。本发明的实施例对内镜硬质非金属材料部件的腐蚀率和蒸馏水比较无明显差异，腐蚀率要明显低于对照例、市售产品1和市售产品2对内镜硬质非金属材料部件的腐蚀率。
3.对内镜塑料材质部件浸泡后的失重结果如表5所示。
表5对内镜塑料材质部件浸泡后的失重结果
对内镜塑料材质部件浸泡后的失重结果表明实施例13、对照例、市售产品1、市售产品2和蒸馏水对内镜塑料材质部件的失重量分别为0.0001-0.0002、0.0004-0.0007、0.0002-0.0005、0.0002-0.0004、0-0.0001。本发明的实施例13产品对内镜塑料材质部件的腐蚀率和蒸馏水比较无明显差异，腐蚀率要明显低于对照例、市售产品1和市售产品2对内镜硬质非金属材料部件的腐蚀率。
实验例3稳定性实验
将实施例13、对照例、市售产品1和市售产品2放置24小时，测定溶液中剩余过氧酸根离子与起始时间的过氧酸根的百分比,实验结果如图1所示。
稳定实验结果表明，本发明提供实施例在常温下放置24小时过氧酸根的剩余率为90.6％，而对照例、市售产品1和市售产品2的过氧酸根的剩余率分别为11.8％、85.3％和51.6％。本发明提供的实施例产品的稳定性明显优于对照例、市售产品1和市售产品2。实验例4反应速率实验
将实施例13和市售产品2溶解于20℃水中进行活化反应，测定溶液中过氧酸根离子浓度随时间变化情况,反应速率实验结果见图2。
反应速率实验结果表明，本发明提供实施例在5min的时间内溶液中过氧酸根离子的浓度达到最大值，而市售产品2溶液中过氧酸根离子的浓度达到最大值的反应时间需要20min。本发明提供实施例产品在反应速率上明显优于市售产品2。
以上对本发明的实施例进行了详细说明，但所述内容仅为本发明的较佳实施例，不能被认为用于限定本发明的实施范围。凡依本发明申请范围所作的均等变化与改进等，均应仍归属于本发明的专利涵盖范围之内。

Claims (9)

1.一种内镜消毒灭菌剂，其特征在于：所述内镜消毒灭菌剂包括
18-58重量份的过氧化物，所述过氧化物为过碳酸盐、过硼酸盐、过磷酸盐、过硅酸盐、过氧化尿素中的一种或几种；
10-33重量份的酰化剂，所述酰化剂为乙酰水杨酸、四乙酰乙二胺、四乙酰甘脲、四乙酰戊醛糖、五乙酰葡萄糖、壬酰基苯磺酸钠、N-乙酰己内酰胺中的一种或几种；
和3-30重量份的缓冲剂，所述缓冲剂为酒石酸、苹果酸、柠檬酸、苯甲酸、水杨酸、氨基磺酸、邻苯二甲酸、磷酸盐、磷酸氢盐、碳酸盐、碳酸氢盐、硼酸盐、氢氧化钠、铵盐中的一种或几种；
所述1重量份的消毒灭菌剂溶解到20-300重量份的水中后，得到的消毒灭菌溶液中含有过氧酸根离子300-20000mg/L，所述消毒灭菌溶液的水溶液的pH为4-10。
2.根据权利要求1所述的一种内镜消毒灭菌剂，其特征在于：所述内镜消毒灭菌剂包括18-58重量份的过氧化物；10-33重量份的酰化剂；和8-25重量份的缓冲剂。
3.根据权利要求1所述的一种内镜消毒灭菌剂，其特征在于：所述内镜消毒灭菌剂包括30-40重量份的过氧化物；15-25重量份的酰化剂；和12-22重量份的缓冲剂。
4.根据权利要求1-3所述的一种内镜消毒灭菌剂，其特征在于：所述消毒灭菌剂还包括0.1-20重量份的阴离子表面活性剂，优选所述消毒灭菌剂还包括2-18重量份的阴离子表面活性剂，更优选所述消毒灭菌剂还包括5-12重量份的阴离子表面活性剂。
5.根据权利要求4所述的一种内镜消毒灭菌剂，其特征在于：所述阴离子表面活性剂为直连烷基苯磺酸钠、仲烷基磺酸钠、烷基硫酸钠、二辛基磺化琥珀酸钠、磺基琥珀酸单月桂酯二钠、脂肪酸甲磺酸钠、聚氧乙烯十二烷基醚磷酸酯盐、壬基酚聚氧乙烯醚磺基琥珀酸单酯二钠盐中的一种或几种。
6.一种权利要求1-5任意一项所述一种内镜消毒灭菌剂所制备的消毒灭菌溶液，其特征在于：所述1重量份的消毒灭菌剂溶解到30-200重量份的水中，所述消毒灭菌溶液中含有过氧酸根离子500-10000mg/L，所述消毒灭菌溶液的pH为5-9。
7.根据权利要求6所述的内镜消毒灭菌溶液，其特征在于：所述消毒灭菌溶液中含有过氧酸根离子800-3800mg/L，所述消毒灭菌溶液的pH为6-8。
8.一种权利要求1-5任意一项所述的内镜消毒灭菌剂的用途，其特征在于：将1重量份的内镜消毒灭菌剂溶于20-300重量份的水中1-20min获得消毒灭菌溶液，所述消毒灭菌溶液用于内镜消毒和灭菌。
9.根据权利要求8所述的内镜消毒灭菌剂的用途，其特征在于：将1重量份的内镜消毒灭菌剂溶于30-200重量份的5-45℃水中搅拌1-15min获得消毒灭菌溶液，获得消毒灭菌溶液用于内镜消毒和灭菌。
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