CN110013569B - 一种人体润滑液及其制备方法 - Google Patents
一种人体润滑液及其制备方法 Download PDFInfo
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- CN110013569B CN110013569B CN201810017325.9A CN201810017325A CN110013569B CN 110013569 B CN110013569 B CN 110013569B CN 201810017325 A CN201810017325 A CN 201810017325A CN 110013569 B CN110013569 B CN 110013569B
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- lubricating fluid
- zwitterionic polymer
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- polymer
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Classifications
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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Abstract
本发明公开了一种人体润滑液及其制备方法，其主要有效成分为两性离子聚合物，提供一种安全，稳定，润滑性能好，易于清洗的润滑液。
Description
技术领域
本发明涉及一种用于人体的润滑液，具体地是可以适用于人体腔道润滑，用于医疗器械或性用产品例如安全套的润滑液。
背景技术
人体润滑液有非常广泛的用途，在医疗手术中，它可以减少摩擦，增加润滑，有助于手术工具和医疗器械的***；在日常生活中，它可以应用在人体腔道或性用产品上，增加生活的情趣。
中国专利1217670C中公开了一种***润滑液，其特征在于它各组分间的重量比为甘油∶珍珠粉∶香料∶纯净水等于30-45∶1.5-2.0∶0.5-1∶50-65，再在上述配方的基础上加入占该配方重量0.5-0.6％的食用碱。
中国专利101700417B公开了一种人体腔道保健润滑液，其特征是由以下数量配比的原料成分组成：蜂蜜8-12g、蜂王浆0.5-1.5g、甘油3-6g、水4-10ml。
中国专利1233426C公开了一种可涂覆于医用导管表面降低摩擦阻力的医用润滑液，以及上述润滑液在医用导管上的使用方法和用上述方法涂覆上述润滑液的医用导管。所述医用润滑液包括分别配制和使用1#溶液，每100体积份有机溶剂中含纤维素酯类1.0-10重量份，粘附性聚合物0-10重量份增塑剂1.0-10重量份；和2#溶液，每100体积份溶剂中含亲水聚合物1.0-20重量份，纤维素酯类0.3-10重量份，将上述溶液分两步涂覆到医用导管上。
中国专利104941010B公开了一种医用***润滑液及其制备方法，由以下原料(重量比)构成：甘油7％～15％，杏仁油7％-16％，山茶油3％-6％，羧甲基纤维素钠1.5％-2.3％，水溶性壳聚糖2.7％-3.2％，纳他霉素0.3％-0.7％，维生素E2％-4.5％，神经酰胺0.15％-0.3％，薄荷油0.4％-0.7％，纯化水余量。
中国专利申请201010171138X公开了一种特制保健润滑液，该润滑液含有基液80-90％、矿物粉体0.1-10％、透皮促进剂0.1-10％及植物提取液或中药0.1-10％组成。所述的基液为酒、水、丙二醇等；所述的矿物粉体包括有远红外粉、电气石粉、负离子粉、磁性粉、泥粉、纳米金粉、纳米银粉、纳米锗粉、或其中几种粉体的混合物等；所述的透皮促进剂包括有月桂氮卓酮、油酸、冰片、香叶醇、亚油酸、柠檬烯、薄荷油、松节油、枫香油、桉油、玫瑰油、香叶天竺葵油等；所述的植物提取液包括有艾叶油、薄荷油、松节油、枫香油、桉油、玫瑰油、香叶天竺葵油，辣椒油等。
中国专利申请201210309855.3公开了一种***保健润滑液及其制备方法，该专利将软化水放入容器中，然后混入丙二醇、羟乙基、甘油、氯化钠、乳酸、透明质酸、洋甘菊提取液和黄原胶，在60±3℃的温度条件下，搅拌混合均匀，待降至常温后密封包装。
中国专利申请201210401536.5公开了一种人体润滑液，按百分比分为2.5％-3.5％大豆蜡，5.5％-6.5％海藻胶，18％-22％甘油，1.5-2.5％乙基纤维素，0.4％-1％磷酸盐，余量为水。
中国专利申请201510210843.9公开了一种用于心血管导丝的水基润滑液的制备方法及其制备的水基润滑液，该方法的步骤如下：1)提取红血球，将富红血球血液放置在体积百分比为2.5％的戊二醛溶液中固定，用离心机将红血球从富红血球血液中分离，并接着干燥红血球；2)将1重量份～2重量份的红血球置于量杯中加入98重量份～99重量份去离子水，均匀搅拌后并超声分散，得到该水基润滑液。
中国专利申请201510211382.7公开了一种丝素水基润滑液的制备方法及其制备的丝素水基润滑液，该方法的步骤如下：1)丝素提取，把生丝切片放置于NaOH溶液中脱胶，用离心机分离得到丝素；2)用去离子水洗涤干净后过滤并烘干，用研磨器将脱胶后的丝素研磨成粉末；3)将1重量份～2重量份的丝素置于量杯中加入98重量份～99重量份去离子水，均匀搅拌后并超声分散，得到该丝素水基润滑液。
中国专利申请201610462349.6公开了一种B超检查用耦合润滑液，所述耦合润滑液按照如下工艺制备而得：步骤1)混合、搅拌以及加热：将丙二醇、甘油以及透明质酸按照25∶10∶2的质量比混合，300转/min搅拌10min，得到混合液；将羟乙基纤维素加入上述混合液中，500转/min搅拌3min，再加热到60℃，保温30min，冷却至室温，得到组分A；其中，羟乙基纤维素和混合液的质量比为1-2∶55-95；步骤2)搅拌均匀：将十二烷基硫酸钠和维生素E依次添加到去离子水中，搅拌均匀，得到组分B；其中，十二烷基硫酸钠、维生素E以及去离子水的质量比为5∶3∶200；步骤3)加热、搅拌：将步骤2)所得组分B加热至50℃，边搅拌边加入碘化钾以及羧甲基壳聚糖，得到组分C；其中，碘化钾、羧甲基壳聚糖以及组分B的质量比为3-7∶2-5∶100-200；步骤4)乙醇提取：将金银花和黑胡椒按照1∶1的质量比混合，添加占混合物两倍重量85％(体积比)的乙醇，回流提取2次，每次1小时，提取液合并，浓缩至密度为1.1g/ml的浸膏，60℃干燥后，粉碎，过100目筛，即得组分D；步骤5)搅拌、分装以及密封：将组分A、组分D依次添加到组分C中，300转/min搅拌15min，分装、密封即得。
中国专利申请201610556398.6公开了一种体腔导入润滑液及其制备方法，体腔导入润滑液按质量份计，组分为杀菌剂0.2-0.6份、润滑剂2-6份、增香剂0.1-0.4份、增稠剂4-8份、蒸馏水余量。
中国专利申请201610660504.5公开了一种水溶性安全套润滑液，按照质量百分比由下述原料配置成：甘油：10％-20％；透明质酸钠：0.1％-1％；柠檬酸钠：3％-10％，甲基氨酸脯氨酸：30％-40％；水：余量。
目前市场在售的人体润滑液各种各样，包括上述的各种专利和专利申请，总共可以分为三类：水基，油基和硅酮基。
水基润滑液的主要成分是甘油，丙二醇，玻璃酸钠，聚乙二醇，聚乙烯吡咯烷酮等可溶于水的材料或亲水水凝胶。甘油(10.8渗摩尔/千克)和丙二醇(13.2渗摩尔/千克)等多种成分其渗透压远高于人体上皮细胞的正常渗透压(0.29渗摩尔/千克)，当使用含此类成分的润滑剂时，会造成上皮细胞严重脱水，由于细胞受损潜在地增加了各种与性相关的疾病例如HIV(艾滋病)的传染风险([1]Gorbach PM，Weiss RE，Fuchs E，Jeffries RA，Hezerah M，Brown S，Voskanian A，Robbie E，Anton P，Cranston RD，“The slipperyslope：lubricant use and rectal sexually transmitted infections：a newlyidentified risk”，Sexually Transmitted Diseases，2012Jan；39(1)：59-64；[2]Dezzutti CS，Brown ER，Moncla B，Russo J，Cost M，Wang L，Uranker K，Kunjara RP，Ayudhya N，Pryke K，Pickett J，LeBlanc MA，Rohan LC，“Is Wetter Better？AnEvaluation of Over-the-Counter Personal Lubricants for Safety and Anti-HIV-1Activity”，PLoS ONE，2012；7(11)：e48328.)玻璃酸钠(透明质酸钠)是一种糖胺聚糖，容易滋生细菌，为此而添加的防腐剂往往会杀灭***的乳酸杆菌，从而破坏菌落平衡，带来新的问题([3]Filoche SK，Soma K，Sissons CH，“Antimicrobial effects of essential oilsin combination with chlorhexidine digluconate”，Oral Microbiology andImmunology，2005；20(4)：221-225.)而聚乙二醇和聚乙烯吡咯烷酮室温下长期保存会氧化或水解，增加溶液中醛类，羟化物和过氧化物的浓度，并会导致pH值的改变([4]WilliamJR，Puvathingal JM，“A simple procedure for removing contaminating aldehydesand peroxides from aqueous solutions of poly(ethylene glycol)s and ofnonionic detergents that are based on the polyoxyethylene linkage”，AnalyticalBiochemistry，1985May；146(2)：307-312)。
油基的润滑液是以植物油，动物油或者矿物油为主要成分，油基的润滑液会使天然乳胶的避孕套膨胀，造成机械性能下降而破裂或脱落，增加性病传播的风险([5]Das SS，Schwerin M，Walsh D，Tack C，Richardson DC，“Changes in viscoelastic propertiesof latex condoms due to personal lubricants”，91IFMBE Proceedings，2010；32：89-90)。油基的润滑液另外一个问题是有异味而且难以清洗。
硅酮基的润滑液对天然乳胶的影响较小，但会破坏以硅酮制成的各种用品。和油基的润滑液一样，硅酮基的润滑液带有异味并难以清洗。
发明内容
为了解决目前市场上使用的润滑液的问题，本发明的一个目的是提供一种安全，稳定，润滑性能好，渗透压低，易于清洗的润滑液。
两性离子聚合物是一类同时带有阴、阳离子基团的聚合物，依据分子结构它主要包括磷酰胆碱型、磺基甜菜碱型、羧基甜菜碱型以及混合型两性离子聚合物等。两性离子聚合物具有极强的亲水性、优良的热和化学稳定性、优异的生物相容性以及良好的抗污染性能等特性。由于两性离子聚合物优良的亲水性，使得其与水结合，能形成一层水膜，具有优异的润滑性能，可以用作人体润滑液的主要成分，解决目前市场上的润滑液存在的问题。
两性离子聚合物的合成大多采用自由基聚合的方法，它与离子型聚合相比具有反应条件温和，单体种类多等优点。自由基聚合过程的例子包括但不限于紫外、热或氧化还原引发的过程。
(i)紫外引发剂
在一种实施方案中，将紫外引发剂与两性离子单体溶解在水溶液中，然后暴露于紫外光中，引发接自由基聚合反应。
紫外自由基引发剂包括但不限于：1-羟基环己基苯基酮、2，2-二乙氧基苯乙酮、2-羟基-2-甲基苯丙酮、2，2-二甲氧基-2-苯基苯乙酮、安息香***、安息香异丁基醚、安息香甲醚、安息香、2-甲基二苯甲酮、3，4-二甲基二苯甲酮、3-羟基二苯甲酮、3-甲基二苯甲酮、4-(二乙氨基)二苯甲酮、4-苯甲酰基二苯基、4-羟基二苯甲酮、4-甲基二苯甲酮、二苯甲酮、苯甲酰基甲酸甲酯、米希勒酮、锍、碘、2-(4-甲氧基苯乙烯基)-4，6-二(三氯甲基)-1，3，5-三嗪、二苯基碘、对甲苯磺酸盐、N-羟基-5-降冰片烯-2，3-二甲酰亚胺全氟代-1-丁烷磺酸酯、N-羟基萘酰亚胺三氟甲磺酸盐、2-叔丁基蒽醌、9，10-菲醌、蒽醌-2-磺酸钠盐单水合物、樟脑醌、二苯基(2，4，6-三甲基苯甲酰基)氧化膦、10-甲基吩噻嗪、噻吨酮。
(ii)热引发剂
在另一种实施方案中，采用热活化的热引发剂替代上述紫外引发剂，通过加热单体水溶液的温度至期望温度而引发，直至聚合反应完成。
适宜的热引发剂包括但不限：过氧苯甲酸叔戊酯、4，4-偶氮二(4-氰基戊酸)、2，2′-偶氮二异丁腈(AIBN)、过氧化苯甲酰、2，2-二(过氧化叔丁基)丁烷、1，1-二(过氧化叔丁基)环己烷、2，5-二(过氧化叔丁基)-2，5-二甲基己烷、2，5-二(过氧化叔丁基)-2，5-二甲基-3-己炔，二(1-(过氧化叔丁基)-1-甲基乙基)苯、1，1-二(过氧化叔丁基)-3，3，5-三甲基环己烷、氢过氧化叔丁基、过乙酸叔丁酯、过氧化叔丁基、过苯甲酸叔丁酯、过氧化叔丁基碳酸异丙酯、氢过氧化枯烯、过氧化环己酮、过氧化二枯基、过氧化月桂酰、过氧化2，4-戊二酮、过乙酸、过硫酸钾。
加热溶液要达到的温度取决于单体和引发剂，聚合反应通过在液氮中快速冷却反应溶液而淬灭。
(iii)氧化还原引发剂
在另一种实施方案中，将氧化还原引发剂体系用于引发两性离子单体的聚合反应。氧化还原引发剂体系通常包括一对引发剂：氧化剂与还原剂。氧化还原引发过程被看作是在温和条件下有效生成自由基的最有效的单电子迁移反应。
适宜的氧化剂包括但不限于：过氧化物、过硫酸盐、过焦硫酸盐、过二磷酸盐、高锰酸盐、金属如Mn(III)、Ce(IV)、V(V)、Co(III)、Cr(VI)和Fe(III)的盐。
适宜的还原剂包括但不限于：诸如Fe(II)、Cr(II)、V(II)、Ti(III)、Cu(II)和Ag(I)的金属盐、硫的含氧酸、羟酸、醇、硫醇、酮、醛、胺和酰胺。
通过直接从氧化还原反应生成的自由基可以引发聚合反应。
具体实施方式
实施例1不含杀菌剂的润滑液
将100克1，3-丙磺酸内酯加入1000毫升无水乙酸乙酯中，再加入80克1-乙烯基咪唑，在25℃反应7天，得到白色的1-乙烯基-3-(3-磺基丙基)咪唑鎓氢氧化物内盐沉淀。用无水乙酸乙酯反复冲洗，并在真空中干燥。
将100克1-乙烯基-3-(3-磺基丙基)咪唑鎓氢氧化物内盐和1.3克4，4’-偶氮双(4-氰基戊酸)混合，加入2000毫升去离子水搅拌溶解，然后倒入一密封容器，通氮气15分钟，在60℃水浴加热24小时，再加入5000毫升1M溴化钾溶液，在去离子水中透析，得到的琥珀色沉淀即可用作人体润滑液，其渗透压和浓度可以通过添加去离子水和氯化钠来调节。
实施例2不含杀菌剂的润滑液
将500克甲基丙烯酸二甲氨乙酯和400克1，4-丁磺酸内酯，2.0克1，3-二硝基苯溶解在5000毫升乙腈中，在60℃回流反应36个小时，得到浅黄色糊状沉淀，在乙酸乙酯中清洗，得到固体沉淀，粉碎并过滤，在乙酸乙酯中洗涤三次，室温在真空中干燥48小时。将值得的粉末200克与500毫克偶氮二异丁腈和500克三氟乙醇混合，氮气保护下55℃恒温反应24小时。反应结束后，用丙酮提纯，真空干燥，粉碎后得到4-[N，N-二甲基-[2-(2-甲基丙-2-烯酰氧基)乙基]铵]丁烷-1-磺酸内盐白色粉末。
配制100克含上述两性离子聚合物的润滑液：
两性离子聚合物10克，氯化钠0.5克，余量为去离子水，60℃下搅拌直到形成均匀分布的粘状液体。
实施例3不含杀菌剂的润滑液
将1000克甲基丙烯酸二乙氨乙酯和400克1，3-丙磺酸内酯，2.0克1，3-二硝基苯溶解在10升乙腈中，在60℃回流反应24个小时，得到浅黄色糊状沉淀，在乙酸乙酯中清洗，得到固体沉淀，粉碎并过滤，在乙酸乙酯中洗涤三次，室温在真空中干燥48小时。将值得的粉末200克与500毫克偶氮二异丁腈和500克三氟乙醇混合，氮气保护下55℃恒温反应24小时。反应结束后，反应结束后，用丙酮提纯，真空干燥，粉碎后得到3-[N，N-二乙基-[2-(2-甲基丙-2-烯酰氧基)乙基]铵]丙烷-1-磺酸内盐白色粉末。
配制100克含上述两性离子聚合物的润滑液：
两性离子聚合物10克，氯化钠0.5克，余量为纯净水，60℃下搅拌直到形成均匀分布的粘状液体。
实施例4
两性离子单体和聚合物的制备过程同实施例1。
配制100克含上述两性离子聚合物的润滑液：
氯化钠0.5克，两性离子聚合物5克，羟乙基纤维素0.5克，透明质酸钠0.2克，聚赖氨酸0.2克，甘油10克，纯净水余量，混合，溶解。
实施例5
两性离子单体和聚合物的制备过程同实施例2。
配制100克含上述两性离子聚合物的润滑液：
氯化钠0.5克，两性离子聚合物5克，羟乙基纤维素0.5克，透明质酸钠0.2克，聚赖氨酸0.2克，甘油10克，纯净水余量，混合，溶解。
实施例6
两性离子单体和聚合物的制备过程同实施例3。
配制100克含上述两性离子聚合物的润滑液：
氯化钠0.5克，两性离子聚合物5克，羟乙基纤维素0.5克，透明质酸钠0.2克，聚赖氨酸0.2克，甘油10克，纯净水余量，混合，溶解。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明技术原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (1)
1.一种人体润滑液，配制100克含4-[N，N-二甲基-[2-(2-甲基丙-2-烯酰氧基)乙基]铵]丁烷-1-磺酸内盐两性离子聚合物的润滑液：
两性离子聚合物10克，氯化钠0.5克，余量为去离子水，60℃下搅拌直到形成均匀分布的粘状液体；
或：配制100克含3-[N，N-二乙基-[2-(2-甲基丙-2-烯酰氧基)乙基]铵]丙烷-1-磺酸内盐两性离子聚合物的润滑液：
两性离子聚合物10克，氯化钠0.5克，余量为纯净水，60℃下搅拌直到形成均匀分布的粘状液体；
或：配制100克含4-[N，N-二甲基-[2-(2-甲基丙-2-烯酰氧基)乙基]铵]丁烷-1-磺酸内盐两性离子聚合物的润滑液：
氯化钠0.5克，两性离子聚合物5克，羟乙基纤维素0.5克，透明质酸钠0.2克，聚赖氨酸0.2克，甘油10克，纯净水余量，混合，溶解；
或：配制100克含3-[N，N-二乙基-[2-(2-甲基丙-2-烯酰氧基)乙基]铵]丙烷-1-磺酸内盐两性离子聚合物的润滑液：
氯化钠0.5克，两性离子聚合物5克，羟乙基纤维素0.5克，透明质酸钠0.2克，聚赖氨酸0.2克，甘油10克，纯净水余量，混合，溶解。
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