CN116491509A - 一种血透机专用有机酸消毒液及其制备方法 - Google Patents
一种血透机专用有机酸消毒液及其制备方法 Download PDFInfo
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- CN116491509A CN116491509A CN202310336241.2A CN202310336241A CN116491509A CN 116491509 A CN116491509 A CN 116491509A CN 202310336241 A CN202310336241 A CN 202310336241A CN 116491509 A CN116491509 A CN 116491509A
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- organic acid
- hemodialysis machine
- disinfectant
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Classifications
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- A—HUMAN NECESSITIES
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- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
- A01N37/36—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio analogue, or a derivative thereof, and a singly bound oxygen or sulfur atom attached to the same carbon skeleton, this oxygen or sulfur atom not being a member of a carboxylic group or of a thio analogue, or of a derivative thereof, e.g. hydroxy-carboxylic acids
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- A—HUMAN NECESSITIES
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- A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
- A01N37/02—Saturated carboxylic acids or thio analogues thereof; Derivatives thereof
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
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- A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
- A01N59/02—Sulfur; Selenium; Tellurium; Compounds thereof
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01P—BIOCIDAL, PEST REPELLANT, PEST ATTRACTANT OR PLANT GROWTH REGULATORY ACTIVITY OF CHEMICAL COMPOUNDS OR PREPARATIONS
- A01P1/00—Disinfectants; Antimicrobial compounds or mixtures thereof
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11D1/66—Non-ionic compounds
- C11D1/78—Neutral esters of acids of phosphorus
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11D3/201—Monohydric alcohols linear
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11D3/2003—Alcohols; Phenols
- C11D3/2006—Monohydric alcohols
- C11D3/2017—Monohydric alcohols branched
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/16—Organic compounds
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- C11D3/2075—Carboxylic acids-salts thereof
- C11D3/2082—Polycarboxylic acids-salts thereof
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11D3/16—Organic compounds
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Abstract
本发明提供了一种血透机专用有机酸消毒液及其制备方法,制备所述有机酸消毒液的原料及重量份数比为:有机酸20‑55、增效剂4‑8、清洗剂1‑2,消泡剂1‑3、缓蚀剂1‑2,以及水73‑30;其中所述有机酸为柠檬酸。本发明所述的血透机专用有机酸消毒液按照一定比例稀释,液体加温80℃以上可杀灭细菌芽孢,并可灭活病毒、能去除生物膜,且有效期可达24个月。可用于带比例混合系统的能加温至80℃以上血透机内部水路的高水平消毒,适用于医疗卫生机构血透室集中供液系统消毒、血透机消毒。
Description
技术领域
本发明属于消毒液技术领域,特别涉及一种血透机专用有机酸消毒液及其制备方法。
背景技术
目前,终末期肾衰竭患者需要依靠血液透析维持生命。为了不断提高患者的生存率和生活质量,除了采用多元化的治疗方案和不断提高透析用水、透析用浓缩液的品质之外,透析设备的高效消毒无疑也是不容忽视的。在透析治疗中虽然细菌、病毒不能穿透完整的透析膜,但在透析过程中仍有破膜的风险。细菌聚集形成生物膜,产生内毒素,细菌毒性代谢产物内毒素能够通过完整的透析膜进入血液,可引起透析中急性热源反应。如发烧,恶心,抽搐,瘙痒直至休克导致生命危险。少量内毒素进入体内则导致微炎症反应,增加白介素、细胞因子等,对长期透析并发症的产生造成影响。
各国针对透析设备的消毒要求提出了相关规定:美国AAMI标准中制定了透析设备的消毒规范,建议每次治疗结束后消毒透析机,每周消毒水处理系统,每天消毒中心供液系统。
我国发布了《血液净化标准操作规程》(2021版)血液透析室(中心)感染控制标准操作规程,血液透析治疗结束后的消毒要求每次透析结束后,按照透析机使用说明书要求对机器内部管路进行消毒,必须使用经批准的消毒液或具有所在地省级卫生健康行政部门发放的卫生许可证或备案的消毒液商品。采用中心供液自动透析系统、无透析液内部管路的透析机,可自动冲洗后开始下次透析,无需进行机器内部管路消毒;但每日透析结束后应进行透析系统的整体消毒,并做好消毒工作的记录。透析过程中如发生透析器破膜或传感器渗漏,应在透析结束时立即进行透析机消毒,经处理后的透析机方可再次使用。集中供液系统操作规范要求系统使用热消毒,每周1次或更高的消毒频率。(1)热消毒时,应能对消毒的有效温度进行监测。在距离加热器最远的管路末端,温度应不低于85℃,并且持续时间大于20min。(2)热消毒后水温须降至常温方可进行配液。当输送管路发生沉淀或盐积聚时,推荐使用1%~2%醋酸溶液进行清洗。
血透机管路中存在的能够影响透析效果的杂质主要有碳酸钙、碳酸镁、细菌、脂肪、蛋白质和有机物质。在血透系统中,消毒是指去除或减少血透机内透析流路的细菌;脱钙是指去除透析液流路从碳酸氢盐透析液中沉淀下来的碳酸钙或碳酸镁;清理是指去除来自患者体内、主要存在于透析过滤器下游流路的脂肪、蛋白质和有机物质。透析设备力求在尽可能短的时间内达到以上几个目标。并且对设备无损坏,容易冲洗无残留,保证操作者及患者的安全,对环境无害及能够接受的消毒成本。
常用的消毒液有次氯酸钠、过氧乙酸等。但此2款消毒剂消毒效果好,脱钙的作用弱。按照规范的要求,85℃热消毒,并且持续时间大于20min。还需要用醋酸脱钙。时间长,运营成本高,不能满足临床的需求,急需一种消毒加脱钙合二为一的消毒液。
中国专利CN 111418601 A《一种柠檬酸消毒液及其制备和应用》,其添加表面活性剂为非离子表面活性剂,柠檬酸消毒液低温条件达不到杀芽孢的效果,需要加温80℃以上,加温条件下达到了非离子表活的浊点,使体系变浑浊,因此达不到去除有机物的效果。
中国专利CN 111202067 A《一种柠檬酸消毒液及其制备方法和应用》,将柠檬酸、苹果酸、乳酸、柠檬酸钠、甘油和脂肪醇聚氧乙烯醚溶解于纯化的去离子水中,搅拌得到均相溶液;脂肪醇聚氧乙烯醚,有良好的发泡、去污力,浊点78℃,加温造成体系浑浊,清洗过程中丰富的泡沫造成血透机清洗报警。
因此,如何获得一款适于透析设备使用、并兼具消毒/脱钙/去污生物膜三重功效,加温下状态稳定的消毒液,是目前急需解决的问题。
发明内容
本发明的目的在于解决现有透析设备消毒液加温后体系浑浊、有机物去除效果差的问题,提供了一种血透机专用有机酸消毒液及其制备方法。
有机酸消毒液稀释液的杀菌机理为:两个作用方式,一是通过降低细菌环境pH值来实现,另一个作用方式是非解离的有机酸作为一个完整的分子,通过自由扩散方式进入细菌细胞内,加温80℃以上条件加速扩散的速度,然后解离出羧基离子和H+离子。羧基离子有抑制DNA复制、抑制蛋白合成和破坏细菌细胞膜的功能,加温80℃以上条件也有使蛋白质变性的作用,从而抑制细菌产生下一代;而解离出的H+则降低细菌细胞内pH值。细菌必须把多余的H+通过Na-H+-ATP(三磷酸腺苷)泵泵出膜外(主动运输),而这是一个耗能过程。所以细菌消耗能量把H+排出,而失去活性,不能产毒、不能附着。有机酸杀菌能力取决于有多少有机酸能以分子的形式进入细菌细胞内,有机酸过膜是自由扩散过程。现有的有机酸消毒液,由于未添加缓蚀剂和消泡剂,造成长时间使用对透析设备的腐蚀,泡沫多了造成设备报警。因此发明人对此进行了研究,选择低泡的阴离子表面活性剂,同时降低酸性溶液对血透机的腐蚀性,通过添加消泡剂解决清洗过成中的泡沫问题,开发一种有机酸消毒液满足临床血透机的消毒、清洗需求。
为了实现上述目的,本发明的第一方面提供了一种血透机专用有机酸消毒液,制备所述有机酸消毒液的原料包括有机酸、增效剂、清洗剂、消泡剂、缓蚀剂和水,各原料的重量份数比为:
有机酸 20-55
增效剂 4-8
清洗剂 1-2
消泡剂 1-3
缓蚀剂 1-2
水 73-30;
所述有机酸为柠檬酸。
进一步的,所述增效剂为丁二酸、草酸、苹果酸、氨基磺酸、乳酸中的一种或多种的混合物。
进一步的,所述清洗剂为异辛醇磷酸酯、异辛醇聚氧乙烯醚磷酸酯中一种或两者的混合物。
进一步的,所述消泡剂为异辛醇、乙醇、异丙醇、正丙醇中的一种或多种的混合物。
进一步的,所述缓蚀剂为硫脲、1,2,3-苯并三氮唑、溴化十六烷基吡啶中的一种或多种的混合物。
本发明的第二发明提供了一种血透机专用有机酸消毒液的制备方法,包括以下步骤:
S1、用水溶解柠檬酸,搅拌至完全溶解为止,得到第一混合液;
S2、向S1操作步骤得到的第一混合液,加入增效剂并搅拌均匀,得到第二混合液;
S3、向S2操作步骤得到的第二混合液,依次加入清洗剂、消泡剂,并搅拌均匀,得到第三混合液;
S4、向S3操作步骤得到的第三混合液,依次加入缓蚀剂,搅拌均匀,即得到所述血透机专用有机酸消毒液。
在本申请所述的血透机专用有机酸消毒液中,柠檬酸作为主要的杀菌成分,升温到80℃以上,可以杀灭细菌芽孢,柠檬酸脱钙能力好,但是除锈能力差。体系中通过添加增效剂:丁二酸、草酸(铁锈效果好)、苹果酸、氨基磺酸、乳酸一种或几种的混合物,一方面可以增强其脱铁能力,另一方面能提高柠檬酸的杀菌效果,具有双重作用。
体系中所添加的清洗剂是为了彻底清除管路中的有机物(主要指蛋白质),添加清洗剂异辛醇磷酸酯,异辛醇磷酸酯是一种新型阴离子表面活性剂,因其有溶解度高、耐硬水、耐酸、耐高温、乳化分散性强、润湿性好、易生物降解等优点;另外体系中单独添加异辛醇聚氧乙烯醚磷酸酯,或与异辛醇磷酸酯复配添加,可有效去除有机物和生物膜。
体系中所添加消泡剂的作用包括:体系中存在表面活性剂会增加泡沫,在清洗过程中引起血透机器报警,降低清洗脱钙效果,通过添加消泡剂异辛醇、乙醇、异丙醇、正丙醇一种或多种,保证消毒液正常清洗,机器正常运转。
体系中所添加缓蚀剂的作用包括:酸性消毒液长期使用会对金属材质的管路和部件造成腐蚀,为了降低对管路的腐蚀,通过添加酸性相容性的硫脲、1,2,3-苯并三氮唑、溴化十六烷基吡啶一种或多种缓蚀剂降低对血透机管路的腐蚀速率。
本发明相比现有技术的的优点和有益效果是:
1、本发明所述的血透机专用有机酸消毒液,按照一定比例稀释后在加温至80℃以上条件下作用15min,即可杀灭包括细菌芽孢、脊髓灰质炎病毒在内的多种微生物,同时有效去除生物膜,是一种高水平消毒剂,具有脱钙、除蛋白、消毒、除锈等作用,且起效快、高效、无残留、对不锈钢基本无腐蚀性等特点;
2、本发明所述的血透机专用有机酸消毒液,通过急性经口毒性试验,属实际无毒;通过一次完整皮肤刺激试验,属无刺激性;通过小鼠骨髓嗜多染红细胞微核试验,无致突变性。
附图说明
下面结合附图和实施例对本发明作进一步说明。
图1为本发明本实施例1所述血透机专用有机酸消毒液1:25稀释液加温至80℃的状态图;
图2为本发明对比例1所述有机酸消毒液1:25稀释液加温至80℃的状态图。
具体实施方式
在以下实施例中,在没有特别说明的情况下,涉及到的原料和实验仪器均为市售品。
原料,见表1。
实验仪器,见表2
在本文中所披露的范围的端点和任何值都不限于该精确的范围或值,这些范围或值应当理解为包含接近这些范围或值的值。对于数值范围来说,各个范围的端点值之间、各个范围的端点值和单独的点值之间,以及单独的点值之间可以彼此组合而得到一个或多个新的数值范围,这些数值范围应被视为在本文中具体公开。
实施例1:
本实施例提供了一种血透机专用有机酸消毒液,所述消毒液的制备方法包括以下步骤:
S1、按照生产100g称取原料。用纯化水溶解22g柠檬酸,搅拌10min至完全溶解为止,得到第一混合液。
S2、向S1操作步骤得到的第一混合液,加入4.0g丁二酸并搅拌均匀,然后再加入6.0g氨基磺酸,并搅拌10min至均匀,得到第二混合液。
S3、向S2操作步骤得到的第二混合液,依次加入清洗剂——异辛醇磷酸酯1.0g,消泡剂——正丙醇1.0g,并搅拌10min至均匀,得到第三混合液。
S4、向S3操作步骤得到的第三混合液,依次加入缓蚀剂——溴化十六烷基吡啶1.0g,搅拌均匀。
S5、检验合格、包装,即得到所述血透机专用有机酸消毒液。
本实施例所述血透机专用有机酸消毒液经1:25稀释后,加温至80℃的状态如图1所示,消毒液清澈且状态稳定。
实施例2:
本实施例提供了一种血透机专用有机酸消毒液,所述消毒液的制备方法包括以下步骤:
S1、按照生产100g称取原料。用纯化水溶解25g柠檬酸,搅拌10min至完全溶解为止,得到第一混合液。
S2、向S1操作步骤得到的第一混合液,加入4.69g 苹果酸并搅拌均匀,然后再加入6.34g 乳酸,并搅拌10min至均匀,得到第二混合液。
S3、向S2操作步骤得到的第二混合液,依次加入清洗剂——异辛醇磷酸酯1.0g,消泡剂——异辛醇1.0g,并搅拌10min至均匀,得到第三混合液。
S4、向S3操作步骤得到的第三混合液,依次加入缓蚀剂——溴化十六烷基吡啶1.0g,搅拌均匀。
S5、检验合格、包装,即得到所述血透机专用有机酸消毒液。
实施例3:
本实施例提供了一种血透机专用有机酸消毒液,所述消毒液的制备方法包括以下步骤:
S1、按照生产100g称取原料。用纯化水溶解30g柠檬酸,搅拌10min至完全溶解为止,得到第一混合液。
S2、向S1操作步骤得到的第一混合液,加入4.0g 草酸并搅拌均匀,然后再加入6.0g 氨基磺酸,并搅拌10min至均匀,得到第二混合液。
S3、向S2操作步骤得到的第二混合液,依次加入清洗剂——异辛醇磷酸酯1.0g,消泡剂——正丙醇1.0g,并搅拌10min至均匀,得到第三混合液。
S4、向S3操作步骤得到的第三混合液,依次加入缓蚀剂——1,2,3-苯并三氮唑1.0g,搅拌均匀。
S5、检验合格、包装,即得到所述血透机专用有机酸消毒液。
实施例4:
本实施例提供了一种血透机专用有机酸消毒液,所述消毒液的制备方法包括以下步骤:
S1、按照生产100g称取原料。用纯化水溶解40g柠檬酸,搅拌10min至完全溶解为止,得到第一混合液。
S2、向S1操作步骤得到的第一混合液,加入4.0g 丁二酸并搅拌均匀,然后再加入6.0g 草酸,并搅拌10min至均匀,得到第二混合液。
S3、向S2操作步骤得到的第二混合液,依次加入清洗剂——异辛醇聚氧乙烯醚磷酸酯1.0g,消泡剂——乙醇1.0g,并搅拌10min至均匀,得到第三混合液。
S4、向S3操作步骤得到的第三混合液,依次加入缓蚀剂——1,2,3-苯并三氮唑1.0g,搅拌均匀。
S5、检验合格、包装,即得到所述血透机专用有机酸消毒液。
实施例5:
本实施例提供了一种血透机专用有机酸消毒液,所述消毒液的制备方法包括以下步骤:
S1、按照生产100g称取原料。用纯化水溶解50g柠檬酸,搅拌10min至完全溶解为止,得到第一混合液。
S2、向S1操作步骤得到的第一混合液,加入4.63g 苹果酸并搅拌均匀,然后再加入6.32g 乳酸,并搅拌10min至均匀,得到第二混合液。
S3、向S2操作步骤得到的第二混合液,依次加入清洗剂——异辛醇磷酸酯1.0g,消泡剂——乙醇1.0g,并搅拌10min至均匀,得到第三混合液。
S4、向S3操作步骤得到的第三混合液,依次加入缓蚀剂——硫脲1.0g以及,搅拌均匀。
S5、检验合格、包装,即得到所述血透机专用有机酸消毒液。
对比例1:
本实施例提供了一种有机酸消毒液,所述消毒液由柠檬酸消毒液和脂肪醇聚氧乙烯醚组成,制备方法为:
按照生产100g称取原料。用纯化水48g溶解50g柠檬酸,搅拌10min至完全溶解为止,加入脂肪醇聚氧乙烯醚2g搅拌10min溶解完全,即得到所述有机酸消毒液。
本对比例所述有机酸消毒液经1:25稀释后,加温至80℃的状态如图2所示,消毒液体系较为浑浊。
测试例:
分别采用上述检测方法,检测以上实施例和对比例获得的有机酸消毒液的各项性能。具体结果如下:
脱钙能力对比实验
对实施例1-5血透机专用有机酸消毒液与对比例例1所述有机酸消毒液,分别进行脱钙能力测定实验。具体检测方法为:参考《透析管路消毒液》标准附录B取聚四氟乙烯管30支编号,精确称重M1,取0.1ml碳酸钙溶液(20.0%)滴染于载体内壁,涂抹均匀,置120℃干燥箱干燥3h,制成含钙离子载体称重M2。在适配的血液透析机内部管路内选择6处接口(位点尽可能平均分布于透析机内部管路),放置载体,然后按使用说明书的规定启动透析机的消毒程序。待完成一个完整的清洗消毒程序后,取出载体烘干后分别进行称重M3,试验重复5次。以碳酸钙总重量M2减去剩余总重量M3,除以碳酸钙重量(M2-M1),计算除钙率,结果如下表3所示
通过实施例1-5与对比例例1各样品可以看出,同样浓度下添加增效剂和清洗剂后,实施例1~5所述血透机专用有机酸消毒液的钙去除效果,明显强于对比例1。
去除有机物能力,生物膜去除试验
方法依据:参照 T/WSJD 002-2019 医用清洗剂卫生要求标准,用管腔内表面培养法制备铜绿假单胞菌生物膜。对管腔内表面培养法制备的生物膜采用T/WSJD002-2019 中的冲洗消毒方法分别对6个样品(实施例1-5血透机专用有机酸消毒液与对比例例1所述有机酸消毒液)按照1:25稀释,血透机器自动加温80℃以上做生物膜去除试验。结果如下表4所示
与对比例1相比,相同条件下80℃作用、15min后,实施例1-5所述血透机专用有机酸消毒液的去除生物膜对数值>1.00,对管腔内表面培养法制备的铜绿假单胞菌生物膜除菌率>90%,去除效果合格,符合 T/WSJD 002-2019《医用清洗剂卫生要求》。通过对比数据可以看出添加清洗剂成分的被测样品对于去除生物膜有促进效果。
金属腐蚀性试验
对实施例1-5血透机专用有机酸消毒液与对比例例1所述有机酸消毒液,分别进行金属腐蚀性试验。具体检测方法为:按照《消毒技术规范》2002版2.2.4 消毒剂对金属腐蚀性的测定,将3片同种金属片用塑料绳系以标签,记录编号和日期,悬挂浸泡于有600mL 1:24稀释的不同的消毒液样品中(实施例1-5血透机专用有机酸消毒液与对比例例1所述有机酸消毒液),在80℃±1℃条件下连续浸泡72h。浸泡至规定时间后取出金属片先用自来水冲洗,再用毛刷去除腐蚀产物,用粗滤纸吸干水分,置于垫有滤纸的平皿中,放入50℃温箱中干燥1h后称重。同时设不锈钢片浸泡蒸馏水作对照。按照腐蚀速率公式进行计算,结果如下表5所示
80℃恒温作用72h,实施例1-5所述血透机专用有机酸消毒液对不锈钢无腐蚀,对铜和铝中度腐蚀,对不锈钢基本无腐蚀,与对比例1所述消毒液相比,添加缓蚀剂,对金属腐蚀性有明显的缓蚀作用。
载体定量杀菌试验
按照《消毒技术规范》2002版2.1.1.5 中和剂鉴定试验结果:在80℃恒温条件下,所用0.1%吐温磷酸盐缓冲液可有效中和实施例1-5所述血透机专用有机酸消毒液、对比例1所述有机酸消毒液对各种菌的残留作用,且中和剂及其中和产物对芽孢的生长基本无影响。按照《消毒技术规范》2002版2.1.1.7 细菌定量杀灭试验方法,和2.1.1.10 病毒灭活试验1:25稀释液对枯草杆菌黑色变种芽孢在80℃不同作用时间杀灭对数值见下表6所示。
实施例1-5制备的血透机专用有机酸消毒液在80±1℃恒温条件下1:25稀释,脊髓灰质炎灭活实验作用7.5min、15min和22.5min脊髓灰质炎灭活实验,杀灭对数值菌>4.00符合《消毒技术规范》的要求,通过添加增效剂,实验组(实施例1~5)效果明显优于对比例1。
模拟现场消毒实验
对实施例1-5血透机专用有机酸消毒液与对比例例1所述有机酸消毒液,分别模拟现场消毒实验。具体检测方法为:按照《透析管路消毒液》标准附录B取20μL芽孢悬液滴染于载体内壁,涂抹均匀,置37℃培养箱干燥,制成染菌载体。在适配的血液透析机内部管路内选择6处接口(位点尽可能平均分布于透析机内部管路),放置染菌载体,然后按使用说明书的规定启动透析机的消毒程序。待完成一个完整的清洗消毒程序后,取出载体分别投入含10mL中和剂中充分混匀,取其中2~3个稀释度,分别吸取0.5mL,置于两个无菌平皿,用冷至40℃~45℃的胰蛋白胨大豆琼脂培养基作倾注,转动平皿,使其充分均匀,琼脂凝固后翻转平板,于30℃~35℃恒温箱中培养48h,计数菌落数,作为试验组。试验重复5次。以无菌蒸馏水代替消毒液,将3个染菌样本同样条件下处理,然后与试验组样本同法进行活菌培养计数,作为阳性对照组。实验结果见下表7所示
实施例1-5制备的血透机专用有机酸消毒液在80±1℃恒温条件下稀释液,血透机模拟现场消毒实验,作用15min,杀灭对数值菌均>3.00。符合《消毒技术规范》的要求,通过添加杀菌增效剂,实验组(实施例1~5)效果明显优于对比例1,通过添加消泡剂,整个机器循环运转过程中,未出现因泡沫多产生的机器报警情况。
一次完整皮肤刺激试验
按照《消毒技术规范》2002版2.3.3 皮肤刺激试验在试验前24h,用脱毛剂将家兔或豚鼠背部脊柱两侧的毛去掉,不得损伤皮肤。去毛范围,左、右各约3cm×3cm。次日将受试物(浓度一般为消毒应用液的5倍)直接滴于面积为2.5cm×2.5cm 的一侧去毛完整皮肤上,或滴于同样大小的2层~4 层纱布上并敷贴在一侧去毛皮肤表面,然后用一层无刺激塑料膜或油纸覆盖,再用无刺激胶布固定。另一侧去毛皮肤作为空白对照(或溶剂对照)。敷贴时间为 4h。试验结束后,用温水或无刺激性溶剂除去残留受试物。分别于去除受试物后1h、24h和48h观察皮肤局部反应,并按表2-11进行刺激反应评分。实验结果见下表8所示。
实施例1-5制备的血透机专用有机酸消毒液使用液5倍对兔子基本无刺激性,对比例1亦无刺激性。表明实施例1-5配方组分添加增效剂、清洗剂、缓蚀剂、消泡剂没有增加对皮肤的刺激性。
综上所述,本发明筛选有机酸消毒液,添加增效剂、低泡清洗剂、消泡剂、缓蚀剂以合适的配比进行稀释后,适用于可用于带比例混合系统的能加温至80℃以上血透机内部水路的高水平消毒,应用于医疗卫生机构血液透析室。通过脱钙能力实验、生物膜去除实验、金属腐蚀性实验、杀菌实验、一次完整皮肤刺激试验其各项技术指标符合《消毒技术规范》(2002版)的要求,且各项指标优于对照品。
以上详细描述了本发明的优选实施方式,但是,本发明并不限于此。在本发明的技术构思范围内,可以对本发明的技术方案进行多种简单变型,包括各个技术特征以任何其它的合适方式进行组合,这些简单变型和组合同样应当视为本发明所公开的内容,均属于本发明的保护范围。
Claims (6)
1.一种血透机专用有机酸消毒液,其特征在于,制备所述有机酸消毒液的原料包括有机酸、增效剂、清洗剂、消泡剂、缓蚀剂和水,各原料的重量份数比为:
有机酸 20-55
增效剂 4-8
清洗剂 1-2
消泡剂 1-3
缓蚀剂 1-2
水 73-30;
所述有机酸为柠檬酸。
2.根据权利要求1所述的血透机专用有机酸消毒液,其特征在于,所述增效剂为丁二酸、草酸、苹果酸、氨基磺酸、乳酸中的一种或多种的混合物。
3.根据权利要求1所述的血透机专用有机酸消毒液,其特征在于,所述清洗剂为异辛醇磷酸酯、异辛醇聚氧乙烯醚磷酸酯中一种或两者的混合物。
4.根据权利要求1所述的血透机专用有机酸消毒液,其特征在于,所述消泡剂为异辛醇、乙醇、异丙醇、正丙醇中的一种或多种的混合物。
5.根据权利要求1所述的血透机专用有机酸消毒液,其特征在于,所述缓蚀剂为硫脲、1,2,3-苯并三氮唑、溴化十六烷基吡啶中的一种或多种的混合物。
6.一种如权利要求1~5任一项所述血透机专用有机酸消毒液的制备方法,其特征在于,所述制备方法包括以下步骤:
S1、用水溶解柠檬酸,搅拌至完全溶解为止,得到第一混合液;
S2、向S1操作步骤得到的第一混合液,加入增效剂并搅拌均匀,得到第二混合液;
S3、向S2操作步骤得到的第二混合液,依次加入清洗剂、消泡剂,并搅拌均匀,得到第三混合液;
S4、向S3操作步骤得到的第三混合液,依次加入缓蚀剂,搅拌均匀,即得到所述血透机专用有机酸消毒液。
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