CN109248320A - 一种稳定的高氧化酸性电位水医用超声耦合剂 - Google Patents
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Abstract
本发明公开了一种稳定的高氧化酸性电位水医用超声耦合剂。所述医用超声耦合剂是用酸性氧化电位水代替去离子水,然后与保湿剂、増稠剂、pH调节剂一起经混合搅拌配制而成。所用稳定的高氧化酸性电位水的特征是:pH为3.0‑6.0,有效氯(Acc)含量为50‑100mg/L,氧化还原电位(ORP)≥1100mV。由于酸性氧化电位水具有广谱杀菌效果,就无需在医用超声耦合剂中再添加尼泊金酯或其他化学防霉剂。使用该医用超声耦合剂还会在接触身体部位起到消毒杀菌效果。该医用超声耦合剂无刺激性、无致敏性,对探头无损伤,使用安全方便,而且会对因细菌引起感染的身体部位起到治疗效果,能有效防止交叉感染。
Description
技术领域
本发明涉及一种稳定的高氧化酸性电位水医用超声耦合剂。是用酸性氧化电位水代替去离子水,然后与保湿剂、增稠剂、pH调节剂一起经混合搅拌配制而成。不含铅、砷、汞等重金属离子有害成分。
医用超声耦合剂主要用于医疗领域。由于此医用超声耦合剂所用的酸性电位水,具有物理、化学两种因素综合作用产生广谱杀菌效果,因而医用超声耦合剂中就无需再添加尼泊金酯或其他化学防霉剂。使用该医用超声耦合剂还会在接触身体部位起到消毒杀菌效果。该医用超声耦合剂无刺激性、无致敏性,对探头无损伤,使用安全方便,而且会对因细菌引起感染的身体部位起到治疗效果,能有效防止交叉感染。
医用超声耦合剂主要应用在超声诊断和超声治疗仪器中,是涂于皮肤粘膜和探头輻射面之间的中介媒质,由于腔内超声检查和治疗的日渐普及,加之粘膜薄弱、易受损伤和感染,最为关注的是临床卫生和交叉感染问题。本发明的一种稳定的高氧化酸性电位水医用超声耦合剂,能为避免交叉感染开辟了新途径。
背景技术
酸性氧化电位水(electrolyzed-oxidizing water,简称EOW),是一种新型绿色环保消毒杀菌剂。其特征是:pH为3.0-6.0,有效氯(Acc)含量为50-100mg/L,而且主要是以次氯酸形式存在电位水中,氧化还原电位(ORP)≥1100mV。研究实践证明:使用时对皮肤粘膜无刺激、不致敏、不致癌,,无残留、无污染,长期使用无毒副作用,细菌不产生耐药性,使用后还原成普通水。
1980年酸性氧化电位水最早在日本应用。当时发现它对MRSA(有″超级细菌″之称的耐甲氧西林的金黄色葡萄球菌)有显著杀菌效果,而用于医药领域。在1993年日用于医疗设备内窥镜消毒,用于手的清洗消毒。1994年EOW作为伤口创面的预防感染消毒剂,获得了世界卫生组织的认可。1998年,美国批准使用酸性氧化电位水。1995年,氧化电位水产品进入中国并开始在医院试用,其杀菌效果和环保特性受到关注。2002年,我国《消毒技术规范》也把该水列入医疗使用范围。2012年公布GB28234——2011酸性氧化电位水生成器安全与卫生标准。酸性氧化电位水已在疾控、防疫、防病和食品安全卫生保障中发挥了特殊作用。
酸性氧化电位水是世界上公认的“绿色环保消毒剂”。但一般情况只能用酸性氧化电位水生成器现制现用。由于不易长期保存而限制了它的应用。山西长治市三明环美生物纤维技术开发有限公司杨黎明在军事医学科学院专家帮助下,解决了酸性氧化电位水保存期短的难题(201110149127.6),为酸性氧化电位水的广泛应用提供了保证。
在医疗领域还提出了无菌型医用超声耦合剂的问题。国外Sonoteth公司最新推出的灭菌型耦合凝胶,并非将现有卡波姆树脂型制剂经灭菌处理而成,而是主要成分不同的全新配方,其主要特点是与活组织生物相容、可生物降解、可生物消除。此外,涉及灭菌环境下和在非完好皮肤、婴儿监护室的婴儿身上进行的超声所有操作,都必须使用灭菌型凝胶。同时也应该考虑,灭菌或抑菌凝胶也是为了在完好粘膜(如食道粘膜、胃粘膜、直肠粘膜、阴道粘膜)上进行的操作而准备的。”而经美国FDA批准注册的Sonoteth产ScanLube牌凝胶,由于具有活组织生物相容性并可生物降解,且润滑特性优异,可涂布于探头内外,从而达到透声、润滑、防交叉传染综合效果。在国外,也有使用是真空环境下生产的达到无菌级的超声凝胶。若是用酸性氧化电位水代替去离子水,生产医用超声耦合剂,在特定条件下即可达到生产无菌级的医用耦合剂要求。
在医疗领域酸性氧化电位水的应用非常广泛。如向患者局部给予治疗有效量的水凝胶配制剂,包括其包含氧化还原电位溶液和胶凝剂,给患者提供了促进患者伤口愈合的方法(CN201080039873.3)。氧化电位水可以进一步用于在牙科操作、口腔手术或颌面手术过程中冲洗和消毒口腔组织和表面,治疗由疾病或手术引起的口腔组织损伤的患者(CN200680019804.X)。通过施用保持稳定至少24小时的氧化还原电位(ORP)水溶液来治疗烧伤,优选2度和3度烧伤的方法(CN200680013725.8)。氧化还原电位水也可用于治疗或预防炎症和相关状态(例如感染,超敏反应,疼痛)的方法(CN101405012B)。这些都表明了酸氧化电位水应用广泛。但酸氧化电位水用于配制医用超声耦合剂还未见报导。
在医用超声耦合剂生产领域,其制造方法基本上是:在纯净水中加入甘油等保湿剂,然后将增稠剂卡波姆分散在水中,再用三乙醇胺等碱中和,直至生成凝胶。为了使医用超声耦合剂在保存和使用中不霉变,保征安全使用,都要在耦合剂中加入化学防腐剂。如一种医用超声耦合剂及其制备方法,加入了阳离子杀菌剂0.1%~3%(CN201610688468.3);一种消毒型医用超声耦合剂及其制备方法,加入了含银抗菌溶液0.5%(CN201610131480.4);一种含三氯生凝胶剂,其显著特征是以三氯生为杀菌成分(CN105193705A);一种消毒型医用超声耦合剂及其生产工艺,其成分包括消毒剂(三氯羟基二苯醚)0.6%-2.2%(CN201510534763.9);一种杀菌消毒型医用超声耦合剂配方及其制造工艺,加入了苯扎氯铵杀菌剂0.3%~1.5%(CN201410263362.X);一种抗菌型医用超声耦合剂及其制备方法,加入了聚乙烯亚胺季铵盐(1~2%)(CN201310374372.6);一种用于治疗性超声诊疗的杀菌型医用超声耦合剂及制备方法,以重量百分比计,加入卤代二苯醚或双胍类杀菌剂0.01-0.5%(CN201110031752.0);一种消毒杀菌型医用超声耦合剂及其制备方法,该耦合剂中含有如下活性成分:聚六亚甲基双胍和氯霉素(CN201110066846.1)。虽然加入这些抗菌成分,但难达到无菌医用超声耦合剂要求。
发明内容
本发明的是一种稳定的高氧化酸性电位水医用超声耦合剂,是用酸性氧化电位水代替去离子水,然后与保湿剂、增稠剂、pH调节剂一起经混合搅拌配制而成。所用稳定的高氧化酸性电位水的特征是:pH为3.0-6.0,有效氯(Acc)含量为50-100mg/L,氧化还原电位(ORP)≥1100mV。所用保湿剂是丙二醇,所用增稠剂是卡波姆,所用pH调节剂是三乙醇胺。由于酸性氧化电位水具有广谱杀菌效果,这就解决了医用超声耦合剂的防腐问题。因此,在医用超声耦合剂中制备中不再添加尼泊金酯或其他化学防霉剂。
在医用超声耦合剂配制中,所用的稳定的高氧化酸性电位水,是山西省长治市三明环美生物纤维技术开发有限公司解决了酸性氧化电位水保存期短的难题(201110149127.6)而生产的,反复试验证实了在技术上是可行的,这就为医用超声耦合剂的生产和广泛应用提供了保证。
具体实施方式
在经过检验达到质量标准的酸性氧化电位水中,慢慢加入2%的丙二醇和0.5%卡波姆细粉,轻轻搅拌,使卡波姆分散到酸性氧化电位水中,並放置一夜。然后将三乙醇胺慢慢滴加到酸性氧化电位水中,同时轻轻搅拌,直至溶液pH值达到7.0-7.5,逐渐形成酸性氧化电位水凝胶,即为本发明的医用超声耦合剂。
尽管本发明通过上述具体实施例,已清楚表明了本发明的精神和范围的条件,凡是在医用超声耦合剂制备中用酸性氧化电位水代替去离子水,均归于本发明权利要求的范围。因此,可以理解本发明不限于所述实施方案,其包括所述每个因素的等同替换。
Claims (5)
1.一种稳定的高氧化酸性电位水医用超声耦合剂,是用酸性氧化电位水代替去离子水,然后与保湿剂、増稠剂、pH调节剂一起经混合搅拌配制而成。
2.根据权利要求1所述,医用超声耦合剂的配制,是用酸性氧化电位水代替去离子水。该稳定的高氧化酸性电位水的特征是:pH为3.0-6.0,有效氯(Acc)含量为50-100mg/L,氧化还原电位(ORP)≥1100mV。
3.根据权利要求1所述,所用保湿剂是丙二醇,所用増稠剂是卡波姆,所用pH调节剂是三乙醇胺。
4.根据权利要求1所述,由于酸性氧化电位水具有广谱杀菌效果,已经解决了医用超声耦合剂的防腐问题,本发明的医用超声耦合剂中,不再添加尼泊金酯或其他化学防霉剂。
5.根据权利要求1所述,由于酸性氧化电位水具有广谱杀菌作用,使用该医用超声耦合剂还会在接触身体部位起到消毒杀菌效果。该医用超声耦合剂无刺激性、无致敏性,对探头无损伤,使用安全方便,而且会对因细菌引起感染的身体部位起到治疗效果,能有效防止交叉感染。
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