CN101613635A - 医疗或食品器械用水性润滑剂乳液及清洗方法 - Google Patents
医疗或食品器械用水性润滑剂乳液及清洗方法 Download PDFInfo
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Abstract
本发明提供了一种医疗或食品器械用水性润滑剂乳液,所述乳液包含:(a)5重量%至30重量%的矿物油;(b)5重量%至30重量%的乳化剂体系,所述乳化剂体系是由失水山梨醇脂肪酸酯和聚氧乙烯山梨醇酐脂肪酸酯组成,或由油醇醚和聚氧乙烯山梨醇酐脂肪酸酯组成,或由失水山梨醇脂肪酸酯和油酸三乙醇胺组成的,其中所述组合中的任何一种的质量比在2∶8至8∶2的范围内;(c)0.5重量%至5重量%的一种或多种助乳化剂,所述一种或多种助乳化剂选自由脂肪醇,长链脂肪酸和琥珀酸二异辛酯磺酸盐组成的组;和(d)余量的水。还描述了一种用于清洗医疗或食品器械的方法,所述方法包括在对医疗和食品器械的清洗步骤之后,使用根据本发明的润滑剂乳液对医疗或食品器械进行处理的步骤。
Description
技术领域
本发明涉及医疗或食品器械用水性润滑剂乳液。本发明还涉及一种医疗或食品器械的清洗方法。
背景技术
在世界各地的医院里,医疗器械每天都在被频繁地使用。同时,器械生锈以及关节失灵的问题长期存在。这些问题增加了医院的运营成本和手术风险。医院通过采用除锈剂对器械进行除锈,这在供应室中需要相当大的劳动量。同时,由于除锈剂通常是强酸体系,因此除锈剂的频繁使用将会影响器械表面上的镀层,这缩短了器械的使用寿命。
为了提高医疗器械清洗后的质量,改善医院的感染风险,降低器械的维护成本,延长器械的使用寿命,并且潜在地降低手术风险,一些医院将清洗后的医疗器械用润滑剂处理。润滑剂在器械表面上形成保护膜,所述保护膜防止空气中的氧气与不锈钢器械接触,但是会被高压水蒸气穿透。
在金属加工行业中,水溶性润滑剂被应用于表面。美国专利US7,273,833涉及一种用于金属切削加工的水溶性润滑剂,其利用分子量1,000~1,000,000的含胺基的聚合物做为润滑成分;中国专利申请CN1138620A提到以土耳其红油,聚乙二醇,酒精,山梨醇,硼酸,三乙醇胺,乙二胺四乙酸和水为原料的一种水基切削液,起到润滑,冷却,清洗和防锈的功效。在美国专利US2,690,426中,矿物油和聚氧乙烯山梨糖醇酐单硬脂酸类化合物的结合得到应用,另外还添加聚氧乙烯十八醇,聚氧乙烯硬脂酸或聚氧乙烯十八醇胺作为润滑成分,得到一种亲水性的,可以在水中分散的油相体系,用于纺织业以及其他工业领域。由于降解性质和/或组分毒性,这些用于金属加工行业的水溶性润滑剂并不能用于处理医疗器械。
在医疗行业中,水性润滑剂被用于导管,插管,穿刺针头的表面润滑。比如在美国专利6,046,143中,一种用于导管的表面处理的水性润滑剂公开了作为润滑成分的改性硅树脂。另外,WO/1999/047187和美国专利5,688,747也都提到了用于导管等医疗器械的表面处理的包含作为润滑成分的有机硅的水基润滑油。然而,所使用的有机硅难以保持像乳液一样稳定。
因此,需要一种用于外科医疗器械清洗之后的处理的稳定的无二氧化硅/有机硅的水性润滑剂。
发明内容
本发明的一个方面是提供一种稳定的医疗和食品器械用水性润滑剂乳液,该润滑剂不含有机硅并且可以长期保持稳定(例如,保质期为2年)。
本发明的另一个方面是提供一种医疗和食品器械的清洗方法,该方法能够提供防锈,润滑的功效,并且对环境友好。
一方面,本发明提供了一种医疗和食品器械用水性润滑剂乳液,以乳液总重量的重量比例计,所述乳液包含:
(a)5重量%至30重量%的矿物油;
(b)5重量%至30重量%的乳化剂体系,所述乳化剂体系是由(i)失水山梨醇脂肪酸酯和聚氧乙烯山梨醇酐脂肪酸酯的组合,或(ii)油醇醚和聚氧乙烯山梨醇酐脂肪酸酯的组合,或(iii)失水山梨醇脂肪酸酯和油酸三乙醇胺的组合组成的,其中所述组合中的任何一种的质量比在2∶8至8∶2的范围内;
(c)0.5重量%至5重量%的一种或多种助乳化剂,所述一种或多种助乳化剂选自由脂肪醇,长链脂肪酸和琥珀酸二异辛酯磺酸盐组成的组;和
(d)余量的水。该组合物还可以含有任选的其它添加剂,例如消泡剂,防锈剂和成膜剂。除非另外规定,全部的重量比都是以基于所述组合物的总重量的重量比计。
本发明提供的医疗和食品器械润滑剂乳液,是一种能够长时间稳定保存(例如保质期可以长达两年)的水包油型乳液,用于外科医疗器械的清洗之后和灭菌之前,具有防锈和润滑的功效从而大大减少或消除了对除锈迹的使用,并且不含有机硅,不含石蜡,所有成分对环境友好,易于降解,使用时方便施用。
另一个方面,本发明提供了一种医疗和食品器械的清洗方法,该方法包括在清洗之后使用本发明的润滑剂乳液对医疗和食品器械进行处理。本发明的方法能够提供防锈,润滑的功效,并且对环境友好,显著减少和/或消除了对于除锈剂的使用,延长了医疗和食品器械的使用寿命。
具体实施方式
本发明涉及一种医疗和食品器械用水性润滑剂,并且具体地,涉及一种用于处理清洗后的外科医疗器械的非-硅胶型水性润滑剂乳液。本发明还涉及一种清洗医疗和食品器械的方法。
本发明中,除非特别指明,术语“医疗和食品器械”包括:
食品加工机械和餐具等,食品加工业和餐饮服务业。本发明可用于医疗器械和医疗工业,并且如在本文中提供的描述也应用于如在食品加工工业和餐饮服务业中使用的食品器械。
除非特别指明,术语“失水山梨醇脂肪酸酯”是失水山梨醇和高级脂肪酸单酯化或三酯化产物,其中脂肪酸优选12~18个碳原子的饱和或非饱和脂肪酸。术语“聚氧乙烯山梨醇酐脂肪酸酯”是指由失水山梨醇脂肪酸酯和环氧乙烷聚合而成的产物,其中,聚氧乙烯的聚合度为20,脂肪酸优选12~18个碳原子的饱和或非饱和脂肪酸。
除非特别指明,术语“轻质白矿物油”是指从加氢处理的基础油通过深度脱蜡和杂质脱除而形成的具有较低密度和粘度的矿物油,例如,在40℃的粘度为10至50mm2/s,优选10至30mm2/s,并且在20℃的密度为0.82至0.86kg/m3,优选0.84~0.86kg/m3的饱和烃类矿物油。
除非特别指明,术语“长链脂肪醇”是指具有双亲性质的脂肪醇类,其脂肪碳链一般为十个碳原子以上,优选10-30个碳原子的直链或支链。
除非特别指明,本发明中所有的百分数,份数,比例等都是以重量计。
本发明提供了一种医疗和食品器械用水性润滑剂乳液,以乳液总重量的重量比例计,所述乳液包含:
(a)5重量%至30重量%的矿物油,优选轻质白矿物油,更优选地,40℃的粘度为10至30mm2/s的轻质白矿物油;
(b)5重量%至30重量%的乳化剂体系,所述乳化剂体系是由(i)失水山梨醇脂肪酸酯和聚氧乙烯山梨醇酐脂肪酸酯的组合,或(ii)油醇醚和聚氧乙烯山梨醇酐脂肪酸酯的组合,或(iii)失水山梨醇脂肪酸酯和油酸三乙醇胺的组合组成的,其中所述组合中的任何一种的质量比在2∶8至8∶2的范围内;
(c)0.5重量%至5重量%的一种或多种助乳化剂,所述一种或多种助乳化剂选自由脂肪醇(优选长链脂肪醇),长链脂肪酸和琥珀酸二异辛酯磺酸盐组成的组;和
(d)余量的水。
根据本发明的某些优选实施方案,本发明的润滑剂乳液中还含有作为一种任选的其它添加剂的防锈剂,其在本发明乳液中的含量,优选为0.1重量%至3重量%。根据进一步优选的某些实施方案,防锈剂选自:磺酸盐,有机羧酸及其盐,有机磷酸盐,酯类,有机胺以及杂环化合物中的一种或几种。
根据本发明的某些优选实施方案,本发明的润滑剂乳液中还含有作为另一种任选的其它添加剂的助剂,所述助剂的例子包括但不限于成膜剂,防腐剂,pH调节剂和消泡剂。
上述成膜剂主要指易溶于水的高分子聚合物,如选自醇解度低,水溶液粘度小的聚乙烯醇,水溶性纤维素及其衍生物,和聚乙烯吡咯烷酮等中的一种或几种;本发明的乳液中的成膜剂的含量优选为0.01重量%至0.5重量%。
上述防腐剂主要指醇类或醛类防腐剂,苯甲酸及其衍生物类,噻唑酮/异噻唑酮类,山梨酸及其盐,乌洛托品,羟甲基甘氨酸钠,十一烯酸及其衍生物等防腐剂其中的一种或几种。本发明的乳液中的防腐剂的含量优选为0.5重量%至2.0重量%。
上述消泡剂主要指聚醚类化合物。本发明的乳液中的消泡剂的含量优选为0.01重量%至1.0重量%。
pH调节剂典型是指有机或无机碱。本发明的乳液中的pH调节剂的含量优选为0.1重量%至1.0重量%。
本发明中的各组分通过加热溶解,并通过强力均质过程,即可得到乳白色水包油乳液。例如,本发明可以通过以下工艺实施:将油相和水相分别在搅拌条件下加热至75~90℃;将油相缓慢转移至水相,继续在该温度条件下搅拌30分钟;和均化混合物并自然冷却至室温得最后产品。
本发明水包油型乳液,可以高倍稀释,稳定性优异,可以给医疗和食品器械提供全面的润滑和防锈保护,所有成分对环境友好,易于降解,使用方便,乳液稳定性可保持至少两年。
实施例:
本发明中,所有含量,百分比都为重量。各实施例的乳液均是通过将表中各组分混合而制备的。
原料 | 供应商 |
轻质白矿油 | 上海新凯润润滑油技术有限公司 |
苯并三氮唑 | 南京润友化工有限公司 |
吐温/司盘系列 | 广州市润华食品添加剂有限公司 |
消泡剂(Dow defax-123或DF1760) | 陶氏化学(上海)有限公司 |
聚乙烯醇 | 上海市安纳化工有限公司 |
尼泊金甲酯 | 昆山市华新日用化学品有限公司 |
尼泊金丙酯 | 昆山市华新日用化学品有限公司 |
三乙醇胺 | 上海祥舜贸易有限公司 |
琥珀酸二异辛酯磺酸钠 | 氰特化学有限公司 |
卡松CG | 上海高维化学有限公司 |
松香胺 | 上海赛福化工发展有限公司 |
十六/十八烷醇 | 上海绿缕商贸有限公司 |
油酸 | |
羟乙基纤维素 |
实施例1:
轻质白矿物油 | 油相 | 15% |
吐温60/司盘80(5.5/4.5) | 乳化剂 | 7.5% |
十六/十八烷醇 | 助乳化剂 | 0.5% |
琥珀酸二异辛酯磺酸钠 | 助乳化剂 | 0.5% |
水 | 至100% |
实施例2:
轻质白矿物油 | 油相 | 20% |
吐温60/司盘80(6.5/3.5) | 乳化剂 | 10% |
十六/十八烷醇 | 助乳化剂 | 1% |
琥珀酸二异辛酯磺酸钠 | 助乳化剂 | 2% |
苯并三氮唑 | 防锈剂 | 1% |
聚乙烯醇 | 成膜剂 | 1% |
消泡剂 | 消泡剂 | 0.5% |
尼泊金甲酯/尼泊金丙酯 | 防腐剂 | 1% |
水 | 至100% |
实施例3:
轻质白矿物油 | 油相 | 10% |
吐温80/司盘20(2.5/7.5) | 乳化剂 | 5% |
十八烷醇 | 助乳化剂 | 2% |
琥珀酸二异辛酯磺酸钠 | 助乳化剂 | 3% |
苯并三氮唑 | 防锈剂 | 2% |
聚乙烯醇 | 成膜剂 | 2% |
消泡剂 | 消泡剂 | 0.5% |
卡松CG | 防腐剂 | 0.2% |
水 | 至100% |
实施例4:
轻质白矿物油 | 油相 | 15% |
吐温80/司盘65(6/4) | 乳化剂 | 7.5% |
十八烷醇 | 助乳化剂 | 1% |
琥珀酸二异辛酯磺酸钠 | 助乳化剂 | 2% |
松香胺 | 防锈剂 | 0.5% |
聚乙烯醇 | 成膜剂 | 2% |
消泡剂 | 消泡剂 | 0.5% |
卡松CG | 防腐剂 | 0.2% |
水 | 至100% |
实施例5:
轻质白矿物油 | 油相 | 15% |
吐温60/司盘80(6.5/3.5) | 乳化剂 | 7.5% |
十六/十八烷醇 | 助乳化剂 | 1% |
琥珀酸二异辛酯磺酸钠 | 助乳化剂 | 1% |
苯并三氮唑 | 防锈剂 | 1% |
聚乙烯醇 | 成膜剂 | 1% |
消泡剂 | 消泡剂 | 1% |
尼泊金甲酯/尼泊金丙酯 | 防腐剂 | 1% |
水 | 至100% |
实施例6
轻质白矿物油 | 油相 | 15% |
吐温20/司盘80(5/5) | 乳化剂 | 7.5% |
十六/十八烷醇 | 助乳化剂 | 1% |
琥珀酸二异辛酯磺酸钠 | 助乳化剂 | 1% |
苯并三氮唑 | 防锈剂 | 1% |
聚乙烯醇 | 成膜剂 | 1% |
消泡剂 | 消泡剂 | 1% |
尼泊金甲酯/尼泊金丙酯 | 防腐剂 | 1% |
水 | 至100% |
实施例7
轻质白矿物油 | 油相 | 15% |
吐温40/司盘40(4.5/5.5) | 乳化剂 | 7.5% |
十六/十八烷醇 | 助乳化剂 | 1% |
琥珀酸二异辛酯磺酸钠 | 助乳化剂 | 1% |
苯并三氮唑 | 防锈剂 | 1% |
聚乙烯醇 | 成膜剂 | 1% |
消泡剂 | 消泡剂 | 1% |
山梨酸钠 | 防腐剂 | 1% |
水 | 至100% |
实施例8
矿物油 | 15% |
司盘80 | 2.7% |
吐温80 | 5.4% |
油酸 | 0.9% |
DF1760 | 0.75% |
苯并三氮唑 | 0.8% |
尼泊金甲酯 | 0.3% |
尼泊金丙酯 | 0.2% |
羟乙基纤维素 | 0.02% |
NaHCO3 | 0.03% |
水 | 至100 |
实施例9:
矿物油(轻质)7# | 20% |
司盘80 | 4.5% |
具有5个EO的油醇醚 | 5.5% |
油酸 | 0.8% |
DF1760 | 0.9% |
苯并三氮唑 | 0.8% |
尼泊金甲酯 | 0.3% |
尼泊金丙酯 | 0.2% |
羟乙基纤维素 | 0.02% |
NaOH | 0.05% |
水 | 至100 |
实施例10:
矿物油(轻质)15# | 10% |
司盘80 | 2.25% |
吐温60 | 5.1% |
油酸 | 0.85% |
DF1760 | 0.75% |
苯并三氮唑 | 0.8% |
尼泊金甲酯 | 0.3% |
尼泊金丙酯 | 0.2% |
羟乙基纤维素 | 0.02% |
三乙醇胺 | 0.05% |
水 | 至100 |
实施例11:
矿物油(轻质)15# | 5% |
油酸三乙醇胺 | 0.9% |
吐温60 | 3.6% |
油酸 | 2.7% |
DF1760 | 0.6% |
苯并三氮唑 | 1.0% |
尼泊金甲酯 | 0.3% |
尼泊金丙酯 | 0.2% |
羟乙基纤维素 | 0.02% |
水 | 至100 |
实施例12:
矿物油(轻质)15# | 30% |
司盘80 | 6% |
吐温60 | 12% |
油酸 | 2% |
DF1760 | 1.0% |
苯并三氮唑 | 1.0% |
尼泊金甲酯 | 0.3% |
尼泊金丙酯 | 0.2% |
羟乙基纤维素 | 0.02% |
三乙醇胺 | 0.1% |
水 | 至100 |
乳液稳定性试验:
对比例:
按照美国专利2,690,426中的实施例1和实施例13的配方,分别在室温搅拌条件下溶解混合均匀得透明油溶液,为水溶性润滑油,室温下稳定。将其进一步分别以1∶10和1∶200的比例,在强烈搅拌的条件下,将油溶液缓慢倾入水中,搅拌20分钟,调制成水性乳液,乳液分别在4天后破乳;
将本发明实施例1-12的配方原液以及其1∶10和1∶200的稀释乳液做对照实验,原液和稀释液4天后依然稳定。关于根据本发明的乳液的性质的各种试验如下所述。
1.离心加速试验:乳液在3500rpm/min条件下离心60分钟后依然保持稳定,乳液无分层,无沉淀;
2.低温0~5℃储存三个月后乳液依然稳定无分层
高温37℃储存三个月后乳液依然稳定无分层
高温54℃储存两个月后乳液依然稳定无分层
3.冻-融试验:样品在-20℃放置12小时后取出置于室温下12小时,然后再置于-20℃,如此循环。经过十个冻融循环后乳液依然稳定无分层
毒理性验证:由上海市疾病控制中心进行毒理试验,试验依据标准为卫生部《消毒技术规范》2002年版2.3.1,2.3.3和2.3.8.4相关章节。结果表明,该配方为无毒级产品,对皮肤无刺激性,无致微核作用。
Claims (12)
1.一种医疗或食品器械用水性润滑剂乳液,所述乳液包含:(a)5重量%至30重量%的矿物油;(b)5重量%至30重量%的乳化剂体系,所述乳化剂体系是由(i)失水山梨醇脂肪酸酯和聚氧乙烯山梨醇酐脂肪酸酯的组合,或(ii)油醇醚和聚氧乙烯山梨醇酐脂肪酸酯的组合,或(iii)失水山梨醇脂肪酸酯和油酸三乙醇胺的组合组成的,其中所述组合中的任何一种的质量比在2∶8至8∶2的范围内;(c)0.5重量%至5重量%的一种或多种助乳化剂,所述一种或多种助乳化剂选自由脂肪醇,长链脂肪酸和琥珀酸二异辛酯磺酸盐组成的组;和(d)余量的水。
2.根据权利要求1的医疗或食品器械用水性润滑剂乳液,所述医疗或食品器械用水性润滑剂乳液还包含添加剂,其中所述添加剂为含量为乳液总重量的0.1重量%至2重量%的防锈剂。
3.根据权利要求2的医疗或食品器械用水性润滑剂乳液,其中所述防锈剂为选自磺酸盐,有机羧酸及其盐,有机磷酸盐,酯类,有机胺以及杂环化合物中的一种或多种。
4.根据权利要求1的医疗或食品器械用水性润滑剂乳液,所述医疗或食品器械用水性润滑剂乳液还包含添加剂,其中所述添加剂为选自成膜剂,防腐剂和消泡剂中一种或多种的助剂。
5.根据权利要求4的医疗或食品器械用水性润滑剂乳液,其中所述成膜剂是选自聚乙烯醇,水溶性纤维素及其衍生物,聚乙烯吡咯烷酮中的一种或多种。
6.根据权利要求4的医疗或食品器械用水性润滑剂乳液,其中所述防腐剂是选自醇类或醛类防腐剂,苯甲酸及其衍生物类,噻唑酮/异噻唑酮类,山梨酸及其盐,乌洛托品,羟甲基甘氨酸钠,十一烯酸及其衍生物中的一种或多种。
7.根据权利要求4的医疗或食品器械用水性润滑剂乳液,其中所述消泡剂为聚醚类化合物。
8.根据权利要求1的医疗或食品器械用水性润滑剂乳液,其中所述矿物油是在40℃的粘度为10至50mm2/s并且在20℃的密度为0.82至0.86kg/m3的饱和烃类矿物油。
9.根据权利要求1的医疗或食品器械用水性润滑剂乳液,其中所述矿物油是在40℃的粘度为10至30mm2/s并且在20℃的密度为0.84至0.86kg/m3的饱和烃类矿物油。
10.根据权利要求1的医疗或食品器械用水性润滑剂乳液,其中所述脂肪醇为脂肪碳链含10-30个碳原子的直链或支链脂肪醇。
11.根据权利要求1的医疗或食品器械用水性润滑剂乳液,其中所述长链脂肪酸为脂肪碳链含10-30个碳原子的饱和或不饱和线型脂肪酸。
12.一种医疗或食品器械的清洗方法,该方法包括清洗医疗或食品器械,然后使用根据权利要求1-11中任一项的水性润滑剂乳液处理所述医疗或食品器械。
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CN200980128527XA Pending CN102099422A (zh) | 2008-06-20 | 2009-06-19 | 用于医学或设备的水性润滑剂乳状液以及洗涤方法 |
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US (1) | US8685904B2 (zh) |
EP (1) | EP2300540A4 (zh) |
JP (1) | JP5744725B2 (zh) |
CN (2) | CN101613635A (zh) |
BR (1) | BRPI0910022A2 (zh) |
CA (1) | CA2728086A1 (zh) |
WO (1) | WO2009155495A1 (zh) |
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- 2009-06-19 BR BRPI0910022A patent/BRPI0910022A2/pt not_active IP Right Cessation
- 2009-06-19 CA CA2728086A patent/CA2728086A1/en not_active Abandoned
- 2009-06-19 US US13/000,224 patent/US8685904B2/en not_active Expired - Fee Related
- 2009-06-19 EP EP09767804A patent/EP2300540A4/en not_active Withdrawn
- 2009-06-19 JP JP2011514832A patent/JP5744725B2/ja not_active Expired - Fee Related
- 2009-06-19 CN CN200910148255A patent/CN101613635A/zh active Pending
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CN102504923A (zh) * | 2011-10-14 | 2012-06-20 | 陕西科技大学 | 一种医疗器械用蓖麻油基水性润滑剂及其制备方法 |
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CN107674746A (zh) * | 2017-11-01 | 2018-02-09 | 南京巨鲨显示科技有限公司 | 一种微乳化医疗器械润滑油及其制备方法 |
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Also Published As
Publication number | Publication date |
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JP5744725B2 (ja) | 2015-07-08 |
BRPI0910022A2 (pt) | 2015-12-29 |
EP2300540A4 (en) | 2012-01-04 |
JP2011525210A (ja) | 2011-09-15 |
CA2728086A1 (en) | 2009-12-23 |
CN102099422A (zh) | 2011-06-15 |
US20110190179A1 (en) | 2011-08-04 |
WO2009155495A1 (en) | 2009-12-23 |
EP2300540A1 (en) | 2011-03-30 |
US8685904B2 (en) | 2014-04-01 |
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