CN112522020A - 一种微乳液医疗器械润滑剂及其制备方法 - Google Patents
一种微乳液医疗器械润滑剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种微乳液医疗器械润滑剂,其包括如下成分:硬脂酸酰胺0.3‑2%,蓖麻油0.2‑1%,表面活性剂5‑17%,助表面活性剂2‑10%,有机溶剂1‑10%,杀菌剂0.1‑1%,缓蚀剂0.5‑2%,消泡剂0.3‑1.5%,余量为纯化水。本发明还公开了前述微乳液医疗器械润滑剂的制备方法。该微乳液医疗器械润滑剂微粒间分布窄,易控制,通过所选的表面活性剂分子对微粒进行包裹和修饰,使微粒之间不易聚结,从而是液体达到良好的稳定性,本发明的微乳液医疗器械润滑剂无毒无害无污染、绿色环保、高润滑性、水溶性、低泡低残留等优点,既可用于机洗清洗润滑设备,也可手洗操作,同时具有防锈性和高效杀菌性,其制备工艺简单且成本低,易于市场推广及应用。
Description
技术领域
本发明涉及一种微乳液医疗器械润滑剂,此外,本发明还涉及该微乳液医疗器械润滑剂的制备方法。
背景技术
医疗器械大多为铁制器械,表面镀镍铬层,器械在长期频繁的使用过程中,表面的镀镍铬层易发生锈蚀损害,当镍铬层被破坏,不纯的铁暴露于空气中,与氧和水接触时就会发生氧化反应,从而发生锈蚀,缩短器械使用寿命,增加医院成本。因此选择合适的水溶性润滑剂对医疗器械进行保养,能有效降低器械的锈蚀剂损耗率,提高器械灭菌质量,降低医院成本。理想的医用器械润滑剂应符合以下特点:1、水溶性润滑剂,每次使用效果稳定,保证灭菌有效穿透。2、有效润滑器械关节部位,使器械使用更灵活。3、抗锈蚀,延长器械使用寿命。4、辅助添加剂少,减少器械表面添加剂残留和斑点残留。5、产品稳定性好,低泡性,不影响清洗剂正常使用。6、组分能生物降解、环保。
微乳液是目前研究热点,它是利用两种不相溶的溶剂在表明活性剂的条件下形成热力学稳定的、各向同性、外观透明的均匀液体分散体系。目前市场上的医用润滑剂,大都是通过乳化而成,体系不稳定,基础油添加过多,易在器械表面形成油斑等,要全都满足以上特点,且以微乳液的形式存在的,少之又少。譬如,中国专利CN104073323A中基础油添加量在60-80%,同时添加有机硅做润滑剂,润滑性差,且难以生物降解;又譬如,中国专利CN107674746A公开的一种微化医疗器械润滑油及其制备方法其中也提到微乳液,但其基础油添加量在8-20%,在使用时器械表明油斑残留较重,对下一步器械的灭菌造成影响。
发明内容
本发明针对现有医疗器械润滑剂的不足之处,根据本发明的实施例,希望提供一种稳定性好、绿色环保、高润滑性、水溶性、低泡低残留的润滑剂及其制备方法。
根据本发明的实施例,本发明提供的一种微乳液医疗器械润滑剂,其组分和重量百分比为:
硬脂酸酰胺0.3-2%;
蓖麻油0.2-1%;
表面活性剂5-17%;
助表面活性剂2-10%;
有机溶剂1-10%;
杀菌剂0.1-1%;
缓蚀剂0.5-2%;
消泡剂0.3-1.5%;
余量为纯化水。
优选地,本发明微乳液医疗器械润滑剂中,所述的表面活性剂为十三碳异构醇聚氧乙烯醚、月桂醇聚氧乙烯醚或烷基糖苷。
优选地,本发明微乳液医疗器械润滑剂中,所述的助表面活性剂聚乙二醇、丙二醇或丁二醇。
优选地,本发明微乳液医疗器械润滑剂中,所述的有机溶剂为异辛烷、正己烷或环已烷。
优选地,本发明微乳液医疗器械润滑剂中,所述的杀菌剂为2-甲基-4-异噻唑啉酮、壳聚糖或咪唑烷基脲中一种或两种合用。
优选地,本发明微乳液医疗器械润滑剂中,所述的缓蚀剂为苯骈三氮唑、苯甲酸钠中的一种或多种。
优选地,本发明微乳液医疗器械润滑剂中,所述的消泡剂为丙二醇嵌段聚醚系列。
根据本发明的实施例,本发明提供的一种微乳液医疗器械润滑剂的制备方法,包括以下步骤:
(1)按重量百分比称取杀菌剂与水,混匀,得到水相A混合体系;
(2)按重量百分比称取硬脂酸酰胺、蓖麻油、缓蚀剂、消泡剂,混匀,得到油相B混合体系;
(3)按重量百分比称取表面活性剂、助表面活性剂、有机溶剂,混匀,得到C体系,将B体系加入C体系中,在55-65℃条件下搅拌溶解,得D体系;
(4)将A体系加入到D体系中,搅拌均匀,即得到微乳液医疗器械润滑剂。
相对于现有技术,本发明采用微乳液法,利用两种不相溶的溶剂在表明活性剂的条件下形成热力学稳定的、各向同性、外观透明的均匀液体分散体系,与普通的润滑剂采用乳化方法相比,解决了液体稳定性差,易分层,润滑性差等缺点。
本发明选用的润滑剂,少量的添加剂,达到优异的润滑效果,使器械润滑后无油斑残留,完全溶于水,不影响灭菌因子的穿过,同时需用杀菌剂,再次杀灭器械表面残留的细菌,搭配缓蚀剂,防锈性能优异,避免了器械在高温高湿灭菌下生锈,再者选用合适的消泡剂,使产品低泡无残留。
具体实施方式
下面结合具体实施例,进一步阐述本发明。这些实施例应理解为仅用于说明本发明而不用于限制本发明的保护范围。在阅读了本发明记载的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等效变化和修改同样落入本发明权利要求所限定的范围。
实施例1
(1)称取咪唑烷基脲0.8g,与水混匀,得到水相A混合体系。
(2)称取硬脂酸酰胺0.7g、蓖麻油0.6g、苯骈三氮唑0.5g、聚醚L-31 0.9g,混匀,得到油相B混合体系。
(3)称取十三碳异构醇聚氧乙烯醚11g、丙二醇8g、环已烷6g,混匀,得C体系,将B体系加入C体系中,在60℃条件下搅拌溶解,得D体系。
(4)将A体系加入到D体系中,搅拌均匀,得到微乳液医疗器械润滑剂。
实施例2
(1)称取2-甲基-4-异噻唑啉酮0.5g,与水混匀,得到水相A混合体系。
(2)称取硬脂酸酰胺0.5g、蓖麻油0.9g、苯骈三氮唑0.8g、聚醚L-42 0.7g,混匀,得到油相B混合体系。
(3)称取烷基糖苷9g、聚乙二醇5g、正己烷4g,混匀,得C体系,将B体系加入C体系中,在60℃条件下搅拌溶解,得D体系。
(4)将A体系加入到D体系中,搅拌均匀,得到微乳液医疗器械润滑剂。
实施例3
(1)称取壳聚糖0.3g与水,混匀,得到水相A混合体系。
(2)称取硬脂酸酰胺0.7g、蓖麻油0.6g、苯甲酸钠1g、聚醚L-61 0.5g,混匀,得到油相B混合体系。
(3)称取月桂醇聚氧乙烯醚10g、丁二醇8g、异辛烷7g,混匀,得C体系,将B体系加入C体系中,在60℃条件下搅拌溶解,得D体系。
(4)将A体系加入到D体系中,搅拌均匀,得到微乳液医疗器械润滑剂。
实施例4
(1)称取咪唑烷基脲0.6g与水,混匀,得到水相A混合体系。
(2)称取硬脂酸酰胺1.2g、蓖麻油0.3g、苯骈三氮唑0.5g、聚醚L-35 1.0g,混匀,得到油相B混合体系。
(3)称取十三碳异构醇聚氧乙烯醚15g、聚乙二醇9g、正己烷混8g,混匀,得C体系,将B体系加入C体系中,在60℃条件下搅拌溶解,得D体系。
(4)将A体系加入到D体系中,搅拌均匀,得到微乳液医疗器械润滑剂。
试验例
根据中华人民共和国卫生部2002年版《消毒技术规范》对金属腐蚀性的测定试验,取实施例1-4制得的微乳液医疗器械润滑剂,对碳钢、不锈钢进行腐蚀性实验测试。试验结果显示,实施例1-4制得的微乳液医疗器械润滑剂对金属物无腐蚀性。
根据中华人民共和国卫生部2002年版《消毒技术规范》对产品进行稳定性实验测定,取实施例1-4制得的微乳液医疗器械润滑剂原液,放置37度恒温箱内3个月。试验结果显示,实施例1-4制得的微乳液医疗器械润滑剂无颜色变化,无沉淀或悬浮物质产生。
取实施例1-4制得的微乳液医疗器械润滑剂,对其主要性能进行检测,检测结果显示:泡沫量均≤10ml(1:200稀释),对器械润滑前后拉力值下降率均≥90%,对器械润滑后器械表面均无可见油斑。
综合以上所述,本发明提供的微乳液医疗器械润滑剂高润滑性、水溶性、低泡低残留、防锈性好、良好稳定性,完全符合实际临床需求,且制作工艺简单,成本低廉,原料简单,有较好的市场前景和推广应用价值。
Claims (8)
1.一种微乳液医疗器械润滑剂,其特征在于,其组分及其重量百分比为:
硬脂酸酰胺 0.3-2%;
蓖麻油 0.2-1%;
表面活性剂 5-17%;
助表面活性剂 2-10%;
有机溶剂 1-10%;
杀菌剂 0.1-1%;
缓蚀剂 0.5-2%;
消泡剂 0.3-1.5%;
余量为纯化水。
2.根据权利要求1所述的微乳液医疗器械润滑剂,其特征在于,所述的表面活性剂为十三碳异构醇聚氧乙烯醚、月桂醇聚氧乙烯醚或烷基糖苷。
3.根据权利要求1所述的微乳液医疗器械润滑剂,其特征在于,所述的助表面活性剂聚乙二醇、丙二醇或丁二醇。
4.根据权利要求1所述的微乳液医疗器械润滑剂,其特征在于,所述的有机溶剂为异辛烷、正己烷或环已烷。
5.根据权利要求1所述的微乳液医疗器械润滑剂,其特征在于,所述的杀菌剂选自2-甲基-4-异噻唑啉酮、壳聚糖和咪唑烷基脲。
6.根据权利要求1所述的微乳液医疗器械润滑剂,其特征在于,所述的缓蚀剂选自苯骈三氮唑和苯甲酸钠。
7.根据权利要求1所述的微乳液医疗器械润滑剂,其特征在于,所述的消泡剂为丙二醇嵌段聚醚系列。
8.一种微乳液医疗器械润滑剂的制备方法,其特征在于:包括以下步骤:
(1)按重量百分比称取杀菌剂与水,混匀,得到水相A混合体系;
(2)按重量百分比称取硬脂酸酰胺、蓖麻油、缓蚀剂、消泡剂,混匀,得到油相B混合体系;
(3)按重量百分比称取表面活性剂、助表面活性剂、有机溶剂,混匀得到C体系,将B体系加入C体系中,在55-65℃条件下搅拌溶解,得到D体系;
(4)将A体系加入到D体系中,搅拌均匀,即得到微乳液医疗器械润滑剂。
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