CN1376082A - 用于除去可提取物的溶剂的净化和重新使用方法 - Google Patents

用于除去可提取物的溶剂的净化和重新使用方法 Download PDF

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CN1376082A
CN1376082A CN00813297A CN00813297A CN1376082A CN 1376082 A CN1376082 A CN 1376082A CN 00813297 A CN00813297 A CN 00813297A CN 00813297 A CN00813297 A CN 00813297A CN 1376082 A CN1376082 A CN 1376082A
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马杜·阿亚加尔吉
埃里克·M·因德拉
马亨德拉·P·南杜
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Abstract

一种处理生物医学设备、特别是接触镜片的方法,包括:将含有可提取物的聚合物设备与一溶剂接触,该溶剂溶解并由此从设备中除去可提取物,处理该溶剂从而从溶剂中除去可提取物,由此将所述溶剂净化,并使用净化过的溶剂除去聚合物生物医学设备上的其它可提取物。

Description

用于除去可提取物的溶剂的净化和重新使用方法
                      发明领域
本发明涉及一种用于从聚合物生物医学设备、特别是眼用设备包括接触镜片、人工晶状体和眼植入物中除去可提取物的溶剂的净化和重新使用的方法。
                      发明背景
水凝胶代表了一类生产各种生物医学设备、包括接触镜片的理想材料。水凝胶是一种含有平衡状态的水的水合交联聚合体系。水凝胶镜片提供了相对高的氧渗透性以及理想的生物相容性和舒适感。
在生产水凝胶聚合接触镜片的常规方法中，将含有稀释剂和合适单体的组合物倒入一模具中并固化。模制的镜片可以经过机械操作如车床切削、擦光和抛光，并进一步经过提取、水合和灭菌步骤。
通常，在生产接触镜片时，一部分单体混合物组分未完全聚合。来自聚合过程的未完全聚合的材料可能影响光学透明度或对眼镜有害。残余物料，可能为亲水或者亲油的，包括溶剂、未反应的单体、或者低分子量低聚物。亲水残余物料能够用水提取；疏水残余组分，本文称之为“可提取物”，通常是用水混溶性有机溶剂提取，具体地说，是用例如异丙醇的醇类除去的。在醇提过程之后，镜片需要用水处理进行水合，然后通过例如在缓冲盐水中高压灭菌进行灭菌。典型的提取步骤描述在US 5,260,000的实施例和US 5,789,461的实施例B-11中，其中接触镜片是从成型模具中取出并用异丙醇提取的。作为另一种提取方法，US 5,607,518和PCT公布WO 95/20476和WO98/07554公开了一种将接触镜片与二氧化碳接触的方法，所述二氧化碳可与异丙醇混合，从而从接触镜片中提取残余物质。
用工业规模生产用的异丙醇提取的缺点是可能有相当大量的废溶剂需要替换和处理，这在经济和环境方面都是不理想的。本发明使生产生物医学设备的废提取溶剂的量降低。
                     发明概述
本发明提供了一种生物医学设备、特别是眼用生物医学设备的改进的生产方法，其中将含有可提取物的聚合物设备与能够溶解来自所述设备的可提取物的溶剂接触，由此将设备净化；并使用净化过的溶剂除去其它可提取物。可以使用净化过的溶剂从其它聚合物设备中除去可提取物，或者可以将净化过的溶剂用于相同聚合物设备的随后的间歇处理中，从而从其中除去其它可提取物。
                     附图简述
图1和2是分别使用填充床柱和流化床柱的本发明方法的示意图。
图3是在间歇方法中使用吸附剂悬液的本发明方法的示意图。
图4和5是分别以平行和串联排列使用两个柱的本发明方法的示意图。
              优选实施方式的详细说明
本发明提供了一种从生物医学设备，特别是眼用生物医学设备中除去可提取物的方法。术语“生物医学设备”意思是打算直接与活组织接触的设备。术语“眼用生物医学设备”意思是打算直接与眼组织接触的设备，包括接触镜片、人工晶状体和眼植入物。在以下说明中，本发明是根据水凝胶接触镜片进行讨论的，它是本发明的特别优选的实施方式。
水凝胶镜片通常由至少一种亲水单体和交联单体的共聚物形成。亲水性是由于存在亲水基团如羟基、羧酸、酰胺和磺酸。通过使水进入亲水聚合物的渗透驱动力与聚合物链施加的阻止膨胀的力之间的平衡达到膨胀平衡状态。这类镜片通常是由至少一种亲水单体和交联单体的共聚物形成的。亲水单体包括：不饱和羧酸如甲基丙烯酸和丙烯酸；(甲基)丙烯酸取代的醇或二醇如甲基丙烯酸2-羟基乙酯、丙烯酸2-羟基乙酯和甲基丙烯酸甘油酯；乙烯基内酰胺类如N-乙烯基-2-吡咯烷酮；和丙烯酰胺类如甲基丙烯酰胺和N，N-二甲基丙烯酰胺。而且这些亲水单体的例子可以在US 4,153,641、4,740,533、5,034,461和5,070,215找到。
交联单体可以是具有多个可聚合官能团、优选乙烯基官能团的物质。代表性的交联单体包括：二乙烯基苯、甲基丙烯酸烯丙酯、二甲基丙烯酸乙二酯、二甲基丙烯酸四乙二酯、聚乙二醇二甲基丙烯酸酯和二醇二甲基丙烯酸酯类的乙烯基碳酸酯衍生物。当为聚硅氧烷水凝胶接触镜片时，共聚合物料还包括至少一种含聚硅氧烷的单体。
有机稀释剂包含在最初单体混合物中。正如本文所用的，术语“有机稀释剂”包含使组分在最初单体混合物中的不相容性最小化并且基本上不与最初混合物中的组分反应的有机化合物。此外，有机稀释剂用于使单体混合物聚合所产生的聚合产物的相分离最小化。同样，有机稀释剂通常使反应聚合混合物的玻璃化温度降低，这样允许有一更充分的固化过程并最终获得更均匀的聚合产物。最初单体混合物和聚合产物的均匀性是聚硅氧烷水凝胶特别关注的，这主要是由于含有含聚硅氧烷的单体。
期望的有机稀释剂包括：一元醇，特别优选C6-C10直链脂族一元醇；二元醇如乙二醇；多元醇如甘油；醚类如二乙二醇一乙醚；酮类如甲基乙基酮；酯类如庚酸甲酯；和烃类如甲苯。优选有机稀释剂在大气压或其附近通过蒸发充分挥发以便将其从固化物品中除去。
在生产接触镜片时已知有各种方法将单体混合物固化，包括旋转浇铸和静态浇铸。旋转浇铸法公开在US 3,408,429和3,660,545中，静态浇铸法公开在US 4,113,224和4,197,266中，将它们公开的内容通过引用加入本文。可以通过机械操作来进行单体混合物的固化，以便提供具有所需最终构型的接触镜片。
按照生产接触镜片的几种已知技术，浇铸法可以获得具有所需的镜片后表面和前表面的成型物品。例如，在静态浇铸法中，可以将单体混合物倒入包括第一模具段和第二模具段的模具中，所述第一模具段具有形成所需镜片前表面用的表面，所述第二模具段具有形成所需镜片后表面用的表面。在旋转浇铸法中，可以将单体混合物倒入具有形成所需镜片前表面用的表面的开口模具中，并且所需镜片后表面是由模具旋转形成的。然而，在物品固化之后可能仍然需要机械操作以提供更适合放置在眼睛上的接触镜片。这些机械操作包括车床切削镜片以获得所需镜片边缘、将镜片边缘擦光或将镜片边缘或表面抛光。
在其它已知的加工技术中，浇铸法可以获得不具有所需镜片前表面和/或后表面的成型制品。因此，浇铸法之后进行机械操作以形成所需镜片表面。作为一个例子，US 4,555,732(将其公开的内容通过引用加入本文)描述了一种通过在模具中旋转浇铸使过量单体混合物弯曲以形成具有镜片前表面且厚度相当大的成型物品的方法；接着将固化的旋转浇铸物品的后面经过车床切削以提供具有所需厚度和镜片后表面的接触镜片。在车床切削镜片表面之后可以进行例如前面所述的边缘抛光操作的其它机械操作。
典型地通过将镜片与提取溶剂接触足够时间以确保基本上完全除去这些可提取物组分而从聚合物接触镜片除去可提取组分。例如，将一批接触镜片浸泡在异丙醇池中并保持几个小时，以便从眼镜中除去例如单体和低聚物的可提取物。将这些眼镜取出，并将一批新的浸泡在该池中。保持几个小时之后，取出这一批，并重复该过程。因此，异丙醇重新使用，在用新鲜溶剂替换之前用给定量的异丙醇提取几千个接触镜片。
在该异丙醇池中，可提取物的浓度随镜片提取的进行而增加并使得从镜片中除去可提取物的效率降低。因此，既使通过一批异丙醇提取的所有镜片都可能满足抛光产品规格，但是在溶剂池寿命终点附近经过提取的镜片趋于比在溶剂池寿命早期处理的那些镜片含有更多的残余可提取物。在溶剂池寿命期间保持均匀提取效率是理想的，并且显然可以通过减少给定量溶剂所处理的镜片量来实现，但是从经济和环境的角度这是不理想的。另外，可以通过连续地补充溶剂来保持提取效率；然而，这种方案可能导致产生大量的需要处理的污染溶剂。
本发明的方法提供了一种延长用于从聚合物接触镜片除去可提取物的溶剂池的使用寿命的理想方式。因此，所需处理的废溶剂的体积大大降低。
图1图示了通过吸附剂，例如活性炭的填充床柱12的废溶剂11的再生，废溶剂11例如是来自通过溶剂11的镜片提取步骤中的异丙醇，所述废溶剂含有从聚合物接触镜片除去的可提取物(未显示)。所述吸附剂从溶剂11除去可提取物，从而获得净化过的溶剂13，它可有效地用于提取其它量的接触镜片(未显示)，或者用于从相同聚合物接触镜片中提取其它可提取物。
图2是与图1相似的示意图，但是描述了将废溶剂21转变成净化过的溶剂23的吸附剂的流化床柱22。流化床22与填充床12相比的优点是压降降低。
图3是在配备有搅拌器34的容器33中通过将满载可提取物的废溶剂31与悬浮吸附剂32接触而将其净化的间歇技术示意图。使用过滤器35从净化过的溶剂36中除去吸附剂32。
分别用于图1和2的柱12和22、或者悬浮于图3的容器33中的合适吸附剂包括活性炭、疏水分子筛、活性炭分子筛、二氧化硅和氧化铝。如果需要的话，可以将吸附剂混合物用于这些柱中。
根据本发明，活性炭为优选的吸附剂。Fillipova的US 5,370,891(将其内容通过引用加入本文)描述了将乙醇混合物通过增加表面活性的三层活性炭吸附剂来净化用于伏特加酒的乙醇。据说在吸附剂使用之后通过将加热干气流流过活性炭层可以恢复吸附剂的活性。
Naujokas的US 5,770,778(将其公开的内容通过引用加入本文)描述了一种从碎聚酯回收的乙二醇的净化方法，它是以任意顺序将所回收的二醇与对极性污染物具有高亲和力的第一吸附剂和对非极性污染物具有高亲和力的第二吸附剂接触。对极性污染物具有高亲和力的吸附剂的例子包括氧化铝和二氧化硅；其中对非极性污染物具有高亲和力的吸附剂是活性炭和疏水的活性炭分子筛。
图4图示了将污染溶剂41通过以平行构型排列的两个吸附柱42a和42b来将污染溶剂41净化为净化过的溶剂43。该排列可用于增加溶剂净化步骤中的通过量。用于柱42a和42b的吸附剂可以是单一物质或者是吸附剂的混合物。可以使用阀42a和42b来调节溶剂通过柱42a和42b的流速。
图5显示了使用串联排列的两个吸附剂柱52a和52b将污染溶剂51净化为净化过的溶剂53的类似步骤。该排列可以有益地提高可提取物从废溶剂中除去的完全性。在柱52a中所含的吸附剂可以与柱52b中所用的相同或者不同。同样，可以使用阀54a和54b控制液体流速。
通过以下实施例描述本发明的方法，在每种情况下使用从55加仑异丙醇中取出的小量样品，所述异丙醇已用于提取了约6000个聚合物接触镜片：
(A)将100-mL所述废异丙醇样品通过直径为1英寸高度为2英尺且填充有约10g的100目炭的柱。在样品通过填充炭柱之前和之后使用气相色谱(GC)和尺寸排阻色谱(SEC)测定两种主要组分：镜片聚合物的单体前体和相对低分子量的化合物的除去。所述处理除去了所有两种被监控的可提取组分中的93.45％。
(B)将25-mL废异丙醇于室温下与约5 g的100目活性炭一起搅拌约16小时，然后过滤分离吸附剂。该处理使得从溶剂中除去了所有两种被监控的可提取组分中的93.20％。
尽管如此描述了本发明的优选实施方式，但是本领域技术人员显然可以在不背离下面权利要求中所述的本发明精神和范围的情况下对其进行各种改进、添加和改变。

Claims (14)

1.一种聚合物生物医学设备的生产方法，包括：
将含有可提取物的所述设备与一溶剂接触，该溶剂能够有效地溶解所述可提取物，由此从所述设备中除去所述可提取物；
在有效地从溶剂中除去可提取物的条件下处理含有所述可提取物的溶剂，由此将所述溶剂净化；和
使用净化过的溶剂除去聚合物生物医学设备的其它可提取物。
2.权利要求1的方法，其中含有可提取物的溶剂的处理包括将所述溶剂与有效地吸附所述可提取物的吸附剂接触。
3.权利要求2的方法，其中所述吸附剂被包含在至少一个柱中，并且含有可提取物的溶剂流过所述柱。
4.权利要求3的方法，其中所述柱为填充床柱或流化床柱。
5.权利要求2的方法，其中所述吸附剂被包含在平行或串联排列放置的多个柱中。
6.权利要求2的方法，其中所述吸附剂悬浮于含可提取物的溶剂中。
7.权利要求6的方法，其中所述吸附剂和所述含有可提取物的溶剂被装在配备有用于搅拌所述吸附剂和所述溶剂的搅拌器、以及从所述溶剂中分离所述吸附剂的过滤器的容器中。
8.权利要求2的方法，其中所述溶剂包括异丙醇。
9.权利要求2的方法，其中所述吸附剂选自：活性炭、疏水分子筛、活性炭分子筛、二氧化硅和氧化铝。
10.权利要求9的方法，其中所述吸附剂是活性炭。
11.权利要求1的方法，其中所述生物医学设备是眼用生物医学设备。
12.权利要求11的方法，其中所述生物医学设备是接触镜片。
13.权利要求12的方法，其中使用所述净化过的溶剂从所述接触镜片中除去其它可提取物。
14.权利要求1的方法，其中使用所述净化过的溶剂从其它接触镜片中除去可提取物。
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