CN102099422A - 用于医学或设备的水性润滑剂乳状液以及洗涤方法 - Google Patents
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Abstract
本发明描述了一种用于医疗或食品设备的水性润滑剂乳状液,所述乳状液包含:(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,所述乳化剂体系由两种选自如下的乳化剂组成:山梨糖醇酐脂肪酸酯、聚氧乙烯山梨糖醇酐脂肪酸酯、油醇醚、油酸三乙醇胺,其中所述两种乳化剂的质量比在2∶8至8∶2范围内;(c)0.5重量%至5重量%的一种或多种助乳化剂,所述助乳化剂选自脂肪醇、长链脂肪酸和琥珀酸二异辛酯磺酸盐;以及(d)余量的水。本发明还描述了一种洗涤医疗或食品设备的方法,所述方法包括在所述医疗或食品设备的洗涤步骤后用根据本发明的润滑剂乳状液处理所述医疗或食品设备的步骤。
Description
相关专利申请的交叉引用
本专利申请要求提交于2008年6月20日的中国专利申请No.200810128864.6和提交于2009年6月19日的中国专利申请No.200910148255.1的优先权。
背景技术
在全世界的医院中,每天都会频繁地使用医疗设备,如外科手术器械。医疗设备的生锈和接头故障是存在已久的问题。这些问题会提高手术成本,并会增加医院手术过程中的医疗风险。医院通过使用除锈剂对设备进行除锈,而这在供应室需要大量的劳动。因为除锈剂通常包含强酸体系,所以频繁使用除锈剂会损坏设备的表面(如使设备上出现镀层,和/或损坏设备上存在的所需镀层),从而缩短设备的使用寿命。
为了提高医疗设备洗涤后的质量、降低医院中的感染风险、降低设备的维护成本、延长设备的使用寿命并潜在地降低手术风险,一些医院用润滑剂处理洗涤后的医疗设备。润滑剂在设备表面上形成保护膜,其防止空气中的氧气接触不锈钢设备,但高压水蒸气能够透过它。
在金属加工行业中,将水溶性润滑剂施用到表面上。美国专利No.7,273,833涉及用于金属切割加工的水溶性润滑剂,其使用分子量为1,000至1,000,000的含氨基聚合物作为润滑成分;CN 1,138,620A公开了一种水基涂层液体,其具有润滑、冷却、洗涤和防腐蚀功能并且使用土耳其红油、聚乙二醇、醇、山梨醇、硼酸、三乙醇胺、乙二胺四乙酸和水作为原材料。在美国专利No.2,690,426中,通过使用矿物油和聚氧乙烯山梨糖醇酐单硬脂酸化合物的组合,并进一步添加聚氧乙烯硬脂醇、聚氧乙烯硬脂酸或聚氧乙烯硬脂醇胺作为润滑成分,从而获得用于纺织工业和其他工业领域的亲水性、水分散性油相体系。不能将金属加工行业中使用的这些水溶性润滑剂用于处理医疗设备,因为其具有劣化性质和/或组分毒性。
在医药工业中,水性润滑剂用于导管、套管或穿刺针的表面润滑。例如,在美国专利No.6,046,143中,公开了用于导管表面润滑的水性润滑剂,其用改性有机硅树脂作为润滑成分。另外,WO/1999/047187和美国专利No.5,688,747还公开了用于导管表面处理的水基润滑油,其包含作为润滑成分的有机硅。然而,使用的有机硅难以在乳状液中保持稳定。
因此,需要稳定的不含二氧化硅/有机硅的水性润滑剂,以用于处理洗涤后的外科手术医疗设备。
发明内容
本发明的一个方面是提供了用于医疗设备的稳定的水性润滑剂乳状液,其基本上不含二氧化硅和/或有机硅,并可以长期保持稳定(例如,储存寿命为2年)。
本发明的另一个方面是提供用于洗涤医疗设备的方法,所述方法可以提供防腐蚀和润滑功能并且是环境友好的。
在一个方面,本发明提供了用于医疗设备的水性润滑剂乳状液,就基于乳状液总重量的重量比而言,该乳状液包含:
(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,该乳化剂体系由两种选自如下的乳化剂组成:山梨糖醇酐脂肪酸酯、聚氧乙烯山梨糖醇酐脂肪酸酯、油醇醚、油酸三乙醇胺,其中这两种乳化剂的质量比在2∶8至8∶2范围内;
(c)0.5重量%至5重量%的一种或多种助乳化剂,其选自脂肪醇、长链脂肪酸和琥珀酸二异辛酯磺酸盐;和
(d)水。该组合物还可包含其他任选的添加剂,例如去沫剂、防锈剂或成膜剂。除非另外指明,否则本文所述的所有重量比均是就基于组合物总重量的重量比而言的。
在另一方面,本发明提供了用于医疗设备的水性润滑剂乳状液,就基于乳状液总重量的重量比而言,该乳状液包含:
(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,该乳化剂体系由如下物质组成:(i)山梨糖醇酐脂肪酸酯与聚氧乙烯山梨糖醇酐脂肪酸酯的组合,或(ii)油醇醚与聚氧乙烯山梨糖醇酐脂肪酸酯的组合,或(iii)山梨糖醇酐脂肪酸酯与油酸三乙醇胺的组合,其中任何组合的质量比均在2∶8至8∶2范围内;
(c)0.5重量%至5重量%的一种或多种助乳化剂,其选自脂肪醇、长链脂肪酸和琥珀酸二异辛酯磺酸盐;和
(d)余量的水。组合物还可包含其他任选的添加剂,例如去沫剂、防锈剂和成膜剂。除非另外指明,否则所有重量比均是就基于组合物总重量的重量比而言的。
本文所述的用于医疗设备的润滑剂乳状液为可长期保持稳定的水包油型乳状液。在大多数实施例中,该乳状液在0至5℃的温度下储存3个月,或在37℃的温度下储存3个月,或在54℃的温度下储存2个月之后是稳定的(如单相乳状液)。
可以在洗涤外科手术医疗设备之后和消毒之前使用润滑剂乳状液。该乳状液具有防腐蚀和润滑功能,因此可以大大减少除锈剂的应用或不用除锈剂。另外,该乳状液基本上不含有机硅或石蜡,并且成分都是环境友好的、易于降解的以及在使用时便于施用。
在另一方面,本发明提供了洗涤医疗设备的方法,该方法使用本文所述的润滑剂乳状液处理洗涤后的医疗设备。本发明的方法可以提供防腐蚀和润滑功能,而且是环境友好的,其可以显著减少除锈剂的使用和/或不使用除锈剂,并可以延长医疗设备的使用寿命。
具体实施方式
本发明涉及用于医疗设备的水性润滑剂,具体地讲,涉及用于处理洗涤后的医疗设备的非硅胶型水性润滑剂乳状液。本发明还涉及洗涤医疗设备的方法。
在本发明中,除非另外指明,否则术语“医疗设备”还包括食品加工机器和盘碟等,例如食品加工行业和食品服务行业中使用的那些。本发明适用于医疗设备和医药行业,而且本文所提供的说明也适用于食品加工行业和食品服务行业中使用的食品设备。
除非另外指明,否则术语“山梨糖醇酐脂肪酸酯”是通使失水山梨醇和高级脂肪酸单酯化或三酯化而获得的产物,其中脂肪酸优选为具有12-18个碳原子的饱和或不饱和脂肪酸。术语“聚氧乙烯山梨糖醇酐脂肪酸酯”意指通过使山梨糖醇酐脂肪酸酯与环氧乙烷聚合形成的产物,其中聚氧乙烯的聚合度为20,脂肪酸优选为具有12-18个碳原子的饱和或不饱和脂肪酸。
除非另外指明,否则术语“轻质石蜡油”意指具有较低密度和粘度的矿物油,其通过必要的严格脱蜡并从加氢处理的基油中去除杂质而形成,例如在40℃下粘度为10至50mm2/s,优选为10至30mm2/s;在20℃下密度为0.82至0.86kg/m3,更优选为0.84至0.86kg/m3的饱和烃类型的矿物油。
除非另外指明,否则术语“长链脂肪醇”意指具有双亲性特性的脂肪醇,其中其脂肪碳链通常具有10个碳原子或更多,具有10-30个碳原子的直链或支链是优选的。
除非另外指明,否则本发明中的所有百分比、份数和比例均是就重量而言的。
在大多数实施例中,提供了用于医疗设备的水性润滑剂乳状液,以基于乳状液总重量的重量比而言,该乳状液包含:
(a)5重量%至30重量%的矿物油,优选轻质石蜡油,并更优选在40℃下粘度为10至30mm2/s的轻质石蜡油;
(b)5重量%至30重量%的乳化剂体系,该乳化剂体系由两种选自如下的乳化剂组成:山梨糖醇酐脂肪酸酯、聚氧乙烯山梨糖醇酐脂肪酸酯、油醇醚和油酸三乙醇胺,其中这两种乳化剂的质量比在2∶8至8∶2范围内;
(c)0.5重量%至5重量%的一种或多种助乳化剂,其选自脂肪醇(优选长链脂肪醇)、长链脂肪酸和琥珀酸二异辛酯磺酸盐;和
(d)水。
在优选的实施例中,乳化剂体系由如下物质组成:(i)山梨糖醇酐脂肪酸酯与聚氧乙烯山梨糖醇酐脂肪酸酯的组合,或(ii)油醇醚与聚氧乙烯山梨糖醇酐脂肪酸酯的组合,或(iii)山梨糖醇酐脂肪酸酯与油酸三乙醇胺的组合,其中任何组合的质量比均在2∶8至8∶2范围内。在优选的实施例中,组合物的余量为水。
根据本发明的一些优选的实施例,本发明的润滑剂乳状液还含有作为一种任选的其他添加剂的防锈剂,其在本发明乳状液中的含量优选为0.1重量%至3重量%。根据本发明的一些另外的优选实施例,防锈剂选自磺酸盐、有机羧酸及其盐、有机磷酸酯、酯类、有机胺和杂环化合物中的一种或多种。
根据本发明的一些优选的实施例,本发明的润滑剂乳状液还含有作为另一种任选的其他添加剂的辅剂。辅剂的例子包括但不限于成膜剂、防腐剂、pH调节剂和消泡剂。
上述成膜剂主要是指水溶性聚合物,例如,选自聚乙烯醇(优选具有较低数量的醇基,并且水溶液的粘度较低)、水溶性纤维素及其衍生物、聚乙烯基吡咯烷酮等中的一种或多种。本发明乳状液中的成膜剂的含量优选为0.01重量%至0.5重量%。
上述防腐剂主要是指一种或多种选自如下的防腐剂:醇型或醛型防腐剂、苯甲酸及其衍生物、噻唑烷酮/异噻唑烷酮、山梨酸及其盐、六次甲基四胺、羟甲基甘氨酸钠、十一烯酸及其衍生物等。本发明乳状液中的防腐剂的含量优选为0.5重量%至2.0重量%。
上述消泡剂主要是指聚醚型化合物。本发明乳状液中的消泡剂的含量优选为0.01重量%至1.0重量%。
pH调节剂通常是指有机或无机碱。本发明乳状液中的pH调节剂的含量优选为0.1重量%至1.0重量%。
可以通过将本发明中的各种组分进行加热溶解或强力均化处理而获得乳白色水包油乳液或油包水乳液。例如,可以通过以下方法形成本文所述的稳定乳状液:分别在搅拌条件下将油相和水相加热至75至90℃;将油相缓慢转移到水相中,并在该温度下将所得的混合物连续搅拌30分钟;以及将混合物进行均化(如以2800RPM的速度匀化120分钟)并使其自然冷却至室温,从而获得产物。在替代方法中,可通过以下方法形成本文所述的稳定乳状液:分别在搅拌条件下将油相和水相加热至50-75℃,更优选55-60℃;将水相缓慢转移到油相中,并在该温度下将所得的混合物连续搅拌30分钟;以及将混合物进行均化(如以2800RPM的速度匀化120分钟),调节混合物的pH,并自然冷却至室温,从而获得产物。在某些实施例中,在乳状液发生相转移(即从油包水至水包油)的温度范围内加热油相和水相。
本发明的水包油型乳状液可以高倍稀释,并具有极好的稳定性,其可为医疗设备提供全面的润滑和防锈保护。它的所有成分都是环境友好、易于降解且便于施用的。乳状液的稳定性可以保持至少2年。
具体例子:
在本发明中,所有含量百分比均以重量计。
实例1:
琥珀酸二异辛酯磺酸钠 | 助乳化剂 | 0.5% |
水 | 加至100% |
实例2:
实例3:
实例4:
消泡剂 | 消泡剂 | 0.5% |
卡松CG | 防腐剂 | 0.2% |
水 | 加至100% |
实例5:
实例6:
实例7:
聚乙烯醇 | 成膜剂 | 1% |
消泡剂 | 消泡剂 | 1% |
山梨酸钠 | 防腐剂 | 1% |
水 | 加至100% |
实例8:
矿物油 | 15% |
司盘80 | 2.7% |
吐温80 | 5.4% |
油酸 | 0.9% |
DF1760 | 0.75% |
苯并三唑 | 0.8% |
对羟基苯甲酸甲酯 | 0.3% |
对羟基苯甲酸丙酯 | 0.2% |
羟乙基纤维素 | 0.02% |
NaHCO3 | 0.03% |
水 | 加至100 |
实例9:
矿物油(轻质)7号 | 20% |
司盘80 | 4.5% |
油醇醚(EO数为5) | 5.5% |
油酸 | 0.8% |
DF1760 | 0.9% |
苯并三唑 | 0.8% |
对羟基苯甲酸甲酯 | 0.3% |
对羟基苯甲酸丙酯 | 0.2% |
羟乙基纤维素 | 0.02% |
NaOH | 0.05% |
水 | 加至100 |
实例10:
矿物油(轻质)15号 | 10% |
司盘80 | 2.25% |
吐温60 | 5.1% |
油酸 | 0.85% |
DF1760 | 0.75% |
苯并三唑 | 0.8% |
对羟基苯甲酸甲酯 | 0.3% |
对羟基苯甲酸丙酯 | 0.2% |
羟乙基纤维素 | 0.02% |
三乙醇胺 | 0.05% |
水 | 加至100 |
实例11:
矿物油(轻质)15号 | 5% |
油酸三乙醇胺 | 0.9% |
吐温60 | 3.6% |
油酸 | 2.7% |
DF1760 | 0.6% |
苯并三唑 | 1.0% |
对羟基苯甲酸甲酯 | 0.3% |
对羟基苯甲酸丙酯 | 0.2% |
羟乙基纤维素 | 0.02% |
水 | 加至100 |
实例12:
矿物油(轻质)15号 | 30% |
司盘80 | 6% |
吐温60 | 12% |
油酸 | 2% |
DF1760 | 1.0% |
苯并三唑 | 1.0% |
对羟基苯甲酸甲酯 | 0.3% |
对羟基苯甲酸丙酯 | 0.2% |
羟乙基纤维素 | 0.02% |
三乙醇胺 | 0.1% |
水 | 加至100 |
乳状液稳定性测试:
比较例:
按照美国专利No.2,690,426中的实例1和实例13的配方,通过在室温搅拌的条件下将其分别溶解并均匀混合而获得透明的油溶液,其中透明的油溶液为水溶性润滑油,并且在室温下稳定。再在强搅拌条件下分别以1∶10和1∶200的比率将油溶液倾注到水中,然后搅拌20分钟以配制成水性乳状液,其在4天后破乳。
对根据本文所述组合物(如实例1-8)的初乳状液及其1∶10和1∶200稀释的乳状液进行相同的测试,以用作比较实验。初乳状液和稀释的乳状液在4天后仍稳定。
下面描述了对根据本发明的乳状液的性能进行的多种测试。
1.离心和加速测试:在3500rpm的条件下离心60分钟后,乳状液保持稳定,没有分层或沉淀;
2.在0-5℃的低温下储存3个月后,乳状液保持稳定,没有分层
在37℃的高温下储存3个月后,乳状液保持稳定,没有分层
在54℃的高温下储存2个月后,乳状液保持稳定,没有分层
3.冻-融测试:将样品保持在-20℃下12小时,然后让样品在室温下融化12小时,然后再将样品暴露于-20℃下,重复该循环。十次冻-融循环后,乳状液保持稳定,没有分层。
毒性验证:毒性测试由上海市疾病预防控制中心进行。该测试是根据中国卫生部2002年消毒技术标准第2.3.1、2.3.3、2.3.8.4章中的相应部分进行的。结果表明,该制剂是无毒产品,不会刺激皮肤或没有微核诱导效应。
Claims (13)
1.一种用于医疗或食品设备的水性润滑剂乳状液,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,其由如下物质组成:(i)山梨糖醇酐脂肪酸酯与聚氧乙烯山梨糖醇酐脂肪酸酯的组合,或(ii)油醇醚与聚氧乙烯山梨糖醇酐脂肪酸酯的组合,或(iii)山梨糖醇酐脂肪酸酯与油酸三乙醇胺的组合,其中所述组合任一者的质量比均在2∶8至8∶2范围内;(c)0.5重量%至5重量%的一种或多种助乳化剂,其选自脂肪醇、长链脂肪酸和琥珀酸二异辛酯磺酸盐;以及(d)余量的水。
2.根据权利要求1所述的用于医疗或食品设备的水性润滑剂乳状液,还包含添加剂,其中所述添加剂是含量为所述乳状液总重量的0.1重量%至2重量%的防锈剂。
3.根据权利要求2所述的用于医疗或食品设备的水性润滑剂乳状液,其中所述防锈剂为选自磺酸盐、有机羧酸及其盐、有机磷酸酯、酯类、有机胺和杂环化合物中的一种或多种。
4.根据权利要求1所述的用于医疗或食品设备的水性润滑剂乳状液,还包含添加剂,其中所述添加剂为辅剂,所述辅剂为选自成膜剂、防腐剂和消泡剂中的一种或多种。
5.根据权利要求4所述的用于医疗或食品设备的水性润滑剂乳状液,其中所述成膜剂为选自聚乙烯醇、水溶性纤维素及其衍生物和聚乙烯吡咯烷酮中的一种或多种。
6.根据权利要求4所述的用于医疗或食品设备的水性润滑剂乳状液,其中所述防腐剂为选自醇型或醛型防腐剂、苯甲酸及其衍生物、噻唑烷酮/异噻唑烷酮、山梨酸及其盐、六亚甲基四胺、羟甲基甘氨酸钠和十一烯酸及其衍生物中的一种或多种。
7.根据权利要求4所述的用于医疗或食品设备的水性润滑剂乳状液,其中所述消泡剂为聚醚型化合物。
8.根据权利要求1所述的用于医疗或食品设备的水性润滑剂乳状液,其中所述矿物油为40℃下粘度为10至50mm2/s且20℃下密度为0.82至0.86kg/m3的饱和烃类矿物油。
9.根据权利要求1所述的用于医疗或食品设备的水性润滑剂乳状液,其中所述矿物油为40℃下粘度为10至30mm2/s且20℃下密度为0.84至0.86kg/m3的饱和烃类矿物油。
10.根据权利要求1所述的用于医疗或食品设备的水性润滑剂乳状液,其中所述脂肪醇为具有含10-30个碳原子的脂肪碳链的直链或支链脂肪醇。
11.根据权利要求1所述的用于医疗或食品设备的水性润滑剂乳状液,其中所述长链脂肪酸为具有含10-30个碳原子的脂肪碳链的饱和或不饱和直链脂肪酸。
12.一种用于医疗或食品设备的水性润滑剂乳状液,所述乳状液包含:
(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,其由两种选自如下的乳化剂组成:山梨糖醇酐脂肪酸酯、聚氧乙烯山梨糖醇酐脂肪酸酯、油醇醚、油酸三乙醇胺,其中这两种乳化剂的质量比在2∶8至8∶2范围内;
(c)0.5重量%至5重量%的一种或多种助乳化剂,其选自脂肪醇、长链脂肪酸和琥珀酸二异辛酯磺酸盐;和
(d)水。
13.一种洗涤医疗或食品设备的方法,包括洗涤所述医疗或食品设备,然后用根据权利要求1-12中任一项所述的水性润滑剂乳状液处理所述医疗或食品设备。
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CN101613635A (zh) | 2009-12-30 |
JP5744725B2 (ja) | 2015-07-08 |
WO2009155495A1 (en) | 2009-12-23 |
EP2300540A4 (en) | 2012-01-04 |
JP2011525210A (ja) | 2011-09-15 |
EP2300540A1 (en) | 2011-03-30 |
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