CN107674746A - 一种微乳化医疗器械润滑油及其制备方法 - Google Patents
一种微乳化医疗器械润滑油及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种微乳化医疗器械润滑油及其制备方法,所述的微乳化医疗器械润滑油由以下质量百分比的原料组成:8~20%基础油、0.2~1%防锈剂、0.5‑3%润滑剂、0.2‑1.2%杀菌剂、0.2‑2%消泡剂、0.2‑2.0%润滑助剂、5‑15%乳化剂、1‑10%乳化助剂和余量水。制作时先将基础油、防锈剂、润滑剂、消泡剂和润滑助剂混合均匀并加热至50‑60℃,再将乳化剂加入油相中,搅拌30分钟,最后将含有乳化剂和油相的混合物加入混有杀菌剂的水中,继续搅拌30‑40分钟即可。本发明微乳化医疗器械润滑油具有优异的润滑性、防锈性和人体生物相容性,主要用于医疗器械的润滑和保护。
Description
技术领域
本发明涉及一种润滑油,尤其涉及一种微乳化医疗器械润滑油及其制备方法。
背景技术
目前市面上很多厂家提供的医疗器械润滑油外观呈乳白色,主要由表面活性剂、石蜡油和软化水组成,石蜡油与含有表面活性剂的水形成水包油型乳化液,其最大的缺点是乳化体系不稳定,且在临床使用时器械表面的油斑较重,给临床增加额外的工作量。而市面上几家外观透明的水性润滑剂多采用聚烷撑二醇类水溶性基础油,其润滑性较差,且临床使用时也有油斑存在。因此从实际应用出发,有必要提供一种外观稳定、润滑性好和油斑较轻的医疗器械润滑油。
微乳液首先由Schulman等发现并命名,于80年代后作为药物载体受到医药界的重视,而国内对这方面的研究较晚,主要应用在石油工业、制药行业和化妆品行业。由于其不可比拟的稳定性和增溶能力,近几年用在金属加工液方面的研究也逐渐增多。如专利CN103468382A报道的一种无鹏、无氯、无甲醛微乳化切削液及其医用,其主要解决金属加工液普遍使用硼酸、氯化石蜡和甲醛释放剂而导致的不环保问题,由高含量的基础油和一定量的极压剂、润滑剂、耦合剂、混合碱和抗硬水剂等复配而成;专利CN102766510A公开了一种超高极压型微乳化切削液及其制备方法,提供了一种极压更高、使用寿命长、稳定性好的微乳型配方,主要由白油、极压剂、油水平衡剂、润滑剂等复配而成。这些微乳化切削液主要用在工业方面使用,使用的油相大多为工业原料,与人体生物相容性较差;且用到的润滑剂为植物油、脂肪酸酯、妥尔油、石油磺酸钠等,经高倍数稀释后(如1:200),其润滑性较差,很难起到有效润滑器械关节的作用;这些都不能用于医疗器械的润滑。
发明内容
为解决上述问题,本发明的首要目的在于提供一种稳定性好、润滑性优异、生物相容性好、油斑较轻的医疗器械润滑油。
为达到上述目的,本发明采用新技术方案:一种微乳化医疗器械润滑油,由以下质量百分比的原料组成:8~20%基础油、0.2~1%防锈剂、0.5-3%润滑剂、0.2-1.2%杀菌剂、0.2-2%消泡剂、0.2-2.0%润滑助剂、5-15%乳化剂、1-10%乳化助剂和余量水;所述的基础油为C9-C13饱和烷烃。
进一步的,所述的防锈剂为咪唑啉衍生物。
进一步的,所述的润滑剂为N-甲基-N-乙酸基月桂酰胺,N-甲基-N-乙酸基豆蔻酰胺,N-甲基-N-乙酸基油酰胺中的一种或多种。
进一步的,所述的杀菌剂为2-甲基-4-异噻唑啉-3-酮( MI), 2-甲基-5-氯-4-异噻唑啉-3-酮,N,N-双(3-氨丙基)十二烷胺和乳酸的一种或两种。
进一步的,所述的消泡剂为聚醚、有机硅中的一种或他们的混合物。
进一步的,所述的乳化剂为月桂醇,脂肪醇聚氧乙烯醚硫酸钠、异构脂肪醇聚氧乙烯醚、油酸三乙醇胺、月桂酸三乙醇胺、失水山梨醇月桂酸酯中的一种以上;
进一步的,所述的乳化助剂为正丙醇、正戊醇、山梨醇、正己醇中的一种或多种;
本发明还提供了一种所述的微乳化医疗器械润滑油的制备方法,包含如下步骤:
1)将杀菌剂和水在50-60℃条件下混合均匀后,得到澄清透明的水相混合物;
2)将基础油、防锈剂、润滑剂、消泡剂和润滑助剂在50-60℃条件下混合均匀,得到澄清透明的油相混合物;
3)在50-60℃温度和搅拌条件下,将乳化剂和乳化助剂加入油相混合物中搅拌30分钟,得到透明的混合物;
4)将上述3)混合物加入50-60℃水相混合物中,继续搅拌30至40分钟,即得到微乳液。
所述的微乳化医疗器械润滑油的粘度小于1000cps。
本发明优点是:
(1)本发明采用环保高效的润滑剂,即使在1:200-1:400高稀释比例下仍对器械关节具有良好的润滑作用;
(2)本发明采用的原料安全性高,其中油相原料均为医药级或经FDA批准的可用于与食品接触的原料,与人体相容性较好;
(3)稳定性好,高低温下稀释液呈透明状态;
(4)油斑较轻,避免给临床工作者增加额外的工作量;
(5)防锈性能优异,避免器械经高温高湿灭菌条件下发生锈蚀;
(6)生产工艺简单,仅需对原料进行常规加温搅拌即可得到,不需要特殊的加温或搅拌装置。
具体实施方式
下面结合实施例对本发明作进一步详细的描述,但本发明的实施方式不限于此。
实施例1:
一种微乳化医疗器械润滑油,包括以下重量百分比的原料:C9-C13饱和烷烃10%,十七烷基咪唑啉季铵盐0.8%,N-甲基-N-乙酸基油酰胺1.7%,N,N-双(3-氨丙基)十二烷胺0.8%,乳酸0.4%,异构脂肪醇聚氧乙烯醚6%,月桂酸三乙醇胺4%,失水山梨醇月桂酸酯2%,异硬脂酸1.0%、正戊醇6%,有机硅消泡剂(商品牌号:XIAMETER® AFE-1247) 0.5%。
制备方法:
将N,N-双(3-氨丙基)十二烷胺和乳酸加入水中, 50-60℃条件下混合30分钟,得到澄清透明的水相混合物;
将C9-C13饱和烷烃、十七烷基咪唑啉季铵盐、N-甲基-N-乙酸基油酰胺、异硬脂酸和XIAMETER® AFE-1247在50-60℃条件下混合均匀,得到澄清透明的油相混合物;
将异构脂肪醇聚氧乙烯醚、月桂酸三乙醇胺、失水山梨醇月桂酸酯和正戊醇在50-60℃条件下混合均匀,得到混合乳化剂;
在50-60℃温度和搅拌条件下,将混合乳化剂加入油相混合物中搅拌30分钟,后将此混合物加入50-60℃水相中,继续搅拌30-40分钟,即得到微乳液。
实施例2:
一种微乳化医疗器械润滑油,包括以下重量百分比的原料:C9-C13饱和烷烃8%,甲基硫酸十七碳烯基咪唑啉铵0.2%,N-甲基-N-乙酸基月桂酰胺3.0%,甲基异噻唑啉酮(商品牌号:ISOCIL SG1.5)0.5%,月桂酸三乙醇胺0.5%,脂肪醇聚氧乙烯醚硫酸钠2.0%,异构脂肪醇聚氧乙烯醚5%,正丁醇3%,有机硅消泡剂(商品牌号:XIAMETER® AFE-1247)1.5%和月桂酸0.2%。
制备方法:
将ISOCIL SG1.5加入水中, 50-60℃条件下混合10分钟,得到澄清透明的水相混合物;
将C9-C13饱和烷烃、甲基硫酸十七碳烯基咪唑啉铵,N-甲基-N-乙酸基月桂酰胺、月桂酸和XIAMETER® AFE-1247在50-60℃条件下混合均匀,得到澄清透明的油相混合物;
将月桂酸三乙醇胺,脂肪醇聚氧乙烯醚硫酸钠,异构脂肪醇聚氧乙烯醚和正丁醇在50-60℃条件下混合均匀,得到混合乳化剂;
在50-60℃温度和搅拌条件下,将混合乳化剂加入油相混合物中搅拌30分钟,后将此混合物加入50-60℃水相中,继续搅拌30-40分钟,即得到微乳液。
实施例3:
一种微乳化医疗器械润滑油,包括以下重量百分比的原料:C9-C13饱和烷烃20%,甲基硫酸十七碳烯基咪唑啉铵1.0%,N-甲基-N-乙酸基豆蔻酰胺0.5%,甲基异噻唑啉酮(商品牌号:ISOCIL SG1.5)1.0%,月桂酸三乙醇胺3%,油酸三乙醇胺2%、失水山梨醇月桂酸酯3%、,异构脂肪醇聚氧乙烯醚6%,正丁醇8%,有机硅消泡剂(商品牌号:XIAMETER® AFE-1247)1.0%和棕榈酸1.8%。
制备方法:
将ISOCIL SG1.5加入水中, 50-60℃条件下混合10分钟,得到澄清透明的水相混合物;
将C9-C13饱和烷烃、甲基硫酸十七碳烯基咪唑啉铵,N-甲基-N-乙酸基豆蔻酰胺、棕榈酸和XIAMETER® AFE-1247在50-60℃条件下混合均匀,得到澄清透明的油相混合物;
将月桂酸三乙醇胺,油酸三乙醇胺、失水山梨醇月桂酸酯、,异构脂肪醇聚氧乙烯醚和正丁醇在50-60℃条件下混合均匀,得到混合乳化剂;
在50-60℃温度和搅拌条件下,将混合乳化剂加入油相混合物中搅拌30分钟,后将此混合物加入50-60℃水相中,继续搅拌30-40分钟,即得到微乳液。
按照《消毒技术规范》等相关规范对实施例1-3制备得到的润滑油进行性能检测,检测结果如表1所示。
表1 实施例1-3制备得到的微乳化润滑油的性能检测
项目 | 医用润滑油技术要求 | 实施例1 | 实施例2 | 实施例3 |
泡沫(1:200稀释) | 即时泡沫体积不超过20mL | 符合要求 | 符合要求 | 符合要求 |
腐蚀试验(1:200) | 碳钢浸泡72h后无可见锈蚀发生 | 符合要求 | 符合要求 | 符合要求 |
润滑性能 | 医用剪刀润滑前后拉力值下降率达到80%以上 | 符合要求 | 符合要求 | 符合要求 |
表面油斑情况 | 上油后医用剪刀表面无明显可见油斑 | 符合要求 | 符合要求 | 符合要求 |
稳定性 | 原液放置在40℃恒温箱中3个月后无分层、沉淀现象 | 符合要求 | 符合要求 | 符合要求 |
从表1的数据可看出,本实施1-3例制备的微乳化医疗器械润滑油具有优异的低泡性、稳定性、润滑油、防锈性和低油斑性,完全符合临床实际的应用要求。
上述实施例为本发明较佳的实施方式,但本发明的实施方式并不受上述实施例的限制,其他的任何未背离本发明的精神实质与原理下所作的修改、修饰、替代、组合、简化,均应为等效的置换方式,都包含在本发明的保护范围之内。
Claims (10)
1.一种微乳化医疗器械润滑油,其特征在于,包括以下质量百分比的原料:8~20%基础油、0.2~1%防锈剂、0.5-3%润滑剂、0.2-1.2%杀菌剂、0.2-2%消泡剂、0.2-2.0%润滑助剂、3-25%乳化剂、1-10%乳化助剂和余量水;所述的基础油为C9-C13饱和烷烃。
2.根据权利要求1所述的微乳化医疗器械润滑油,其特征在于:所述的防锈剂为咪唑啉衍生物。
3.根据权利要求1所述的微乳化医疗器械润滑油,其特征在于:所述的润滑剂为N-甲基-N-乙酸基月桂酰胺,N-甲基-N-乙酸基豆蔻酰胺,N-甲基-N-乙酸基油酰胺中的一种或多种的混合物。
4.根据权利要求1所述的微乳化医疗器械润滑油,其特征在于:所述的杀菌剂为2-甲基-4-异噻唑啉-3-酮, 2-甲基-5-氯-4-异噻唑啉-3-酮,N,N-双十二烷胺和乳酸的一种或两种的混合物。
5.根据权利要求1所述的一种微乳化医疗器械润滑油,其特征在于:所述的消泡剂为聚醚、有机硅中的一种或两种的混合物。
6.根据权利要求1所述的一种微乳化医疗器械润滑油,其特征在于:所述的乳化剂为月桂醇,脂肪醇聚氧乙烯醚硫酸钠、异构脂肪醇聚氧乙烯醚、油酸三乙醇胺、月桂酸三乙醇胺、失水山梨醇月桂酸酯中的两种或两种以上的混合物。
7.根据权利要求1所述的一种微乳化医疗器械润滑油,其特征在于:所述的乳化助剂为正丙醇、正戊醇、山梨醇、正己醇中的一种或多种。
8.根据权利要求1所述的微乳化医疗器械润滑油的制备方法,其特征在于:包含如下步骤:
S01 将杀菌剂和水混合均匀后,得到澄清透明的水相混合物;
S02 将基础油、防锈剂、润滑剂、消泡剂和润滑助剂下混合均匀,得到澄清透明的油相混合物;
S03 将乳化剂和乳化助剂加入油相混合物中并搅拌,得到透明的混合物;
S04 将S03中透明混合物加入S01中水相混合物中,继续搅拌,即得到微乳液。
9.根据权利要求8所述的制备方法,其特征在于:所述微乳液的粘度小于1000cps。
10.根据权利要求8所述的制备方法,其特征在于:所述S01、S02、S03和S04中混合温度均为50~60℃。
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