CN1396862A - 用于医用级产品的多层聚合物基防渗结构 - Google Patents

用于医用级产品的多层聚合物基防渗结构 Download PDF

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CN1396862A
CN1396862A CN01804141A CN01804141A CN1396862A CN 1396862 A CN1396862 A CN 1396862A CN 01804141 A CN01804141 A CN 01804141A CN 01804141 A CN01804141 A CN 01804141A CN 1396862 A CN1396862 A CN 1396862A
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copolymer
layer
weight
ethylene
radio frequency
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CN100348412C (zh
Inventor
林忠建
吴力弓
罗伯特·沃伊纳罗夫斯基
凯坦·沙阿
格雷格·奈博根
丁原邦
瓦尔沙·卡利安卡
基思·M·K·安德森
莉莲·G·扎卡瑞佳
科琳·克拉默
迈克尔·沙夫
拉里·A·罗森鲍姆
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Baxter International Inc
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Baxter International Inc
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Abstract

本发明提供了一种多层热塑结构物，所述的结构物包括：(1)表层，其选自聚丙烯、密度从约0.930克/立方厘米至约0.960克/立方厘米的乙烯均聚物和混合了密度低于约0.930克/立方厘米的乙烯和α－烯烃共聚物的密度从约0.930克/立方厘米至约0.960克/立方厘米的乙烯均聚物，所述的表层具有高于约3.0mils的厚度；(2)粘附在表层上的射频敏感层，所述的射频敏感层在1－60MHz和环境温度至250℃的温度具有高于0.05的介电损失，并包含：(a)选自聚丙烯和聚丙烯共聚物的第一聚烯烃；(b)选自乙烯共聚物、超低密度聚乙烯、聚丁烯和丁烯乙烯共聚物的第二聚烯烃；(c)射频敏感聚合物，其选自：(i)乙烯共聚物，所述的乙烯共聚物具有50－85％的乙烯含量并且其共聚单体选自下述第一组单体：丙烯酸、甲基丙烯酸、丙烯酸与含有1－10个碳原子的醇所形成的酯衍生物、甲基丙烯酸与含有1－10个碳原子的醇所形成的酯衍生物、乙酸乙烯酯和乙烯醇；(ii)含有至少一段氨基甲酸乙酯、酯、尿素、酰亚胺、砜和酰胺链段的均聚物和共聚物；和(d)苯乙烯和烃共聚物的相容性试剂；其中当将该结构物制成50ml容器时，将该容器在121℃高压蒸煮20分钟并在温度为40℃、相对湿度为15％的环境调节室中储存90天后，该结构物具有低于8％重量的水蒸汽透过率。

Description

用于医用级产品的多层聚合物基防渗结构
相关申请
本申请是1999年6月17日提交的美国专利申请No.09/334,957的部分后续申请，该申请又是1993年11月16日提交的美国专利申请No.08/153,602，目前为美国专利No.5,998,019的继续申请。在此通过引用将上述内容并入本文并作为本文的一部分。
技术领域
本发明总体上涉及制造医用级产品的材料，特别涉及可以用于制造如塑料容器和医疗导管制品的防渗膜产品。
技术背景
在医疗领域，由于在容器中采集、处理和储存有益的试剂，运输，并最终经由导管将此类试剂输注给患者以实现治疗效果，因此，用于制造容器的材料必须具有独特的性能组合。例如，为了在视觉上检查溶液的颗粒污染物，容器必须是光学透明的。为了通过压扁容器壁从容器中输注溶液而不向容器中引入空气，形成壁的材料必须具有足够挠性。此种材料必须能够在大的温度范围发挥功能。此种材料还必须能够在低温下通过维持其挠性和刚性发挥功能，因为有些溶液，如特定的预混合药物溶液需要在例如-25至-30℃的温度下在容器中储存和运输以使药物的降解最小化。该材料还必须能够在高温下发挥功能以承受灭菌的温度；高温灭菌是多数医药包装和营养制品在发货前必须进行的程序。灭菌程序通常包括将容器置于温度通常为121℃并提高压力的蒸气中。因此，该材料需要承受该温度和压力，而不会发生明显的变形(“耐热变形”)。
为便于制成有用的制品，要求该材料通常用约27.12MHz的射频(“RF”)密封该材料。因此，该材料应具有足够的介电损失特性，以将RF能量转换成热能。
进一步的要求是，在实现其预定的用途后，对由该材料所制成的制品的处理对环境的影响最低。对于那些通过垃圾填埋处理的制品，需要使用尽可能少的材料并且在制造该制品中避免加入低分子量的可溶出的组分。因此，该材料应是重量轻的并具有良好的机械强度。将用过的制品再热塑加工成其他有用制品而重复使用材料，从而实现进一步的优点。
对于那些通过焚化进行处理的容器，需要使用有助于排除生物危害危险并且降低或完全排除形成具有环境危害、刺激和腐蚀性的无机酸或其他有害、刺激或者在焚化时产生其他有害产物的材料。
也需要该材料中不含或具有低含量的低分子量添加剂，如增塑剂、稳定剂等。
传统的柔性聚氯乙烯材料满足许多并且在有些情况下满足大多数上述要求。就制造满足上述要求的装置而言，聚氯乙烯(“PVC”)的显著优点是它是最具有成本效率的材料之一。但是，在焚化时，PVC可能产生有害量的氯化氢(或者当与水接触时为盐酸)，导致焚化炉的腐蚀。PVC有时含有增塑剂，增塑剂可能溶出进入与PVC制品接触的药物或生物流体或组织中。因此，已经设计了多种材料以取代PVC。但是，大多数可选择的材料太昂贵，无法应用并且仍然不能满足上述全部要求。
对于某些医疗产品，可能需要提供针对水的渗透的防渗层，以提供低的水蒸气透过率(WVTR)。例如，对于一个与医药的再建装置相关的50ml的柔性稀释液容器，将容器置于其外密封袋或外包装袋12个月期间，要求稀释液含量通过膜蒸发损失不足8％。虽然可以通过增加抗水蒸气渗透层的厚度提高水蒸气渗透的防渗性，但这些防渗材料厚度的增加可能使容器的刚性过大，无法在排空时压扁，或者使容器的刚性过大，无法方便地进行药物的再建程序。
已经作出了许多开发取代PVC膜材料的努力，但多数努力都由于这样或那样的原因而不成功。例如，在美国专利No.4,966,795中，公开了能够耐受蒸气灭菌的多层膜组合物，但该组合物不能通过射频介电加热焊接，因此不能通过此种快速、低成本、可靠和可行的方法进行装配。欧洲申请No.EP 0 310 143 A1公开了满足多数要求并且可被RF焊接的多层膜。但是，所公开的膜的组分在受到辐照时交联并因此不能通过标准的热塑处理方法回收利用。此外，由于辐照步骤，膜释放出可感知量的乙酸并滞留在材料中。在蒸气灭菌时，乙酸作为污染物迁移进入包装内容物中并且通过改变该内容物的pH成为该内容物的潜在的化学反应物或者作为该内容物降解的催化剂。
本发明的主要目的是制造总体上优于我们已经意识到的、迄今为止本领域已知或已经在商业上使用或销售的那些材料的热塑材料。此种材料的性能包括不但在室温下，而且在宽范围的环境和冷冻温度下的挠性、延展性和形变复原性。该材料应该能够在通常为121℃或略高或略低的温度下进行蒸气灭菌。该材料应该能够承受显著的张力，而不会出现张力变白(strain whitening)，张力变白表明物理缺陷和表面缺陷(cosmetic defect)。本发明另一目的是能够通过RF方法装配该材料。另一个目的是该材料基本不含低分子量的可溶出的添加剂并且能够通过焚化被安全地处理，而不产生显著量的腐蚀性无机酸。另一个目的是使用后通过标准的热塑处理方法能够回收该材料。向该材料中加入在制造过程中所回收的重新研磨的碎料以节省材料成本和减少工业废物也是需要的。也需要该材料具有对水蒸气渗透的高防渗性，从而可以将该材料制成不要求使用外密封或外包装材料的液体容器。还需要该材料是无取向的，因为取向膜在受热时可能收缩。最后，该材料应是目前用于医疗装置的各种PVC配方的节省成本的替代品。
本发明提供了对这些和其他问题的解决方案。
本发明概述
根据本发明，公开了特定的多层聚合物基结构膜。该膜可用于制造医疗制品，如用于再建装置的稀释液容器。
本发明的一个目的是制备具有下列物理性质的多层膜：(1)按照ASTMD-882测量的机械模数低于150,000磅/平方英寸(psi)并优选低于120,000psi；(2)卤素元素的含量低于0.1％，优选低于0.01％；(3)低分子量水溶性组分低于0.1％，更优选低于0.005％；(4)在1至60MHz和25-250℃之间的最大介电损失高于或等于0.05并优选高于或等于0.1；(5)通过在121℃，27psi载荷下测量样品蠕变所表达的耐高压釜性低于或等于60％，更优选低于或等于20％；(6)在以约每分钟20英寸的中等速率拉伸并且拉伸约100％后，没有张力变白并且张力变白的存在是可注意到的或者无张力变白现象；(7)在置于外包装外12个月，优选14个月时，充满50ml水的容器的水蒸气透过率低于8重量％、优选低于7重量％，更优选低于6重量％；以及(8)无取向性。
本发明提供了适于制造满足上述物理性质要求的医疗制品的多层热塑结构。该结构具有一个表层和一个射频敏感层。表层选自聚丙烯，密度为0.930g/cc-0.960g/cc的乙烯均聚物，和密度低于约0.930g/cc的乙烯和α-链烯烃的共聚物和乙烯均聚物的混合物。射频敏感层附着在表层上并且在1-60MHz和环境温度至250℃具有高于0.05的介电损失。在本发明的优选形式中，射频敏感层包括一种四组分混合物。第一种组分是选自聚丙烯和聚丙烯共聚物的第一聚烯烃。第二种组分是选自乙烯共聚物、乙烯和α-链烯烃的共聚物、超低密度聚乙烯、聚丁烯和丁烯乙烯共聚物的第二聚烯烃。第三组分是一种选自乙烯共聚物的射频敏感聚合物，该乙烯共聚物具有50-85％的乙烯含量并且其共聚单体选自由丙烯酸、甲基丙烯酸、丙烯酸与1-10个碳原子的醇形成的酯衍生物、甲基丙烯酸与1-10个碳原子的醇形成的酯衍生物、乙酸乙烯酯、一氧化碳和乙烯醇所组成的第一组单体。RF敏感聚合物也可以选自由含有氨基甲酸乙酯、酯、尿素、酰亚胺、砜和酰胺片段的均聚合物和共聚物所组成的第二组单体。这些官能团可以构成RF敏感聚合物的5-100％。射频敏感层的第四种组分是苯乙烯和烃类共聚物的相容试剂。
本发明进一步提供了中间层，以提供额外的物理性质，如增强的低温性能，这将在下文详细说明。此外，本发明还提供了三组分射频敏感层的应用。
本发明的其他特征和优点将在附图和优选实施方案的详细描述中说明，这些特征和优点在附图和详细描述中是显然的。
对附图的简要说明
图1示出了本发明的二层膜结构的截面图；
图2示出了本发明的三层膜结构的截面图，其中包括加入图1所示膜中的核心层；
图3示出了带有溶液接触层的图1的膜的截面图；
图4示出了本发明的四层结构的截面图，其中在表层和核心层之间具有一个碎料(scrap material)的不连续层；
图5示出了使用再研磨的碎料作为核心层和RF层之间的不连续层的膜结构的截面图；
图6示出了使用再研磨的碎料作为将核心层分隔为二个核心层的不连续层的膜结构的截面图；
图7示出了具有七层的本发明膜结构的截面图，其中包括在核心层和RF层之间的防渗层以及二个复合薄膜粘结层；
图8示出了与图6相同的结构，不同之处是将防渗层置于核心层和表层之间；
图9示出了具有分隔核心层的防渗层的膜结构的截面图；
图10示出了由本发明的一种膜结构制成的容器；
图11示出了一种带有稀释液容器和装有待再建粉末状药物的管形瓶的再建装置；
图12示出了本发明的二层的水蒸气防渗膜；
图13是对于本发明的一种膜，为使WVTR处于所需要的范围表层厚度与密封层厚度的关系曲线；
图14示出了本发明的三层水蒸气防渗膜的实施方案；和
图15示出了本发明的四层水蒸气防渗膜的另一个实施方案。
详细描述
虽然本发明允许有多种形式的实施方案，并且将在这里详细描述本发明，但本文公开了本发明的优选实施方案，应当理解的是，本文的公开应被视为本发明原理的示例，该公开并不欲将本发明的广泛方面限制在所示的实施方案之内。
根据本发明，提供了满足上述要求的多层膜结构。
图1示出了一种具有表层12和射频(“RF”)敏感层14的二层膜结构10。表层12使膜具有耐热变形性和耐磨损性并优选是聚丙烯，更优选是混合了苯乙烯和烃的共聚物的聚丙烯共聚物。苯乙烯和烃共聚物可以是嵌段共聚物，包括二嵌段、三嵌段和星形嵌段(star block)，也可以是无规共聚物和本领域技术人员已知的其他类型的苯乙烯和烃的共聚物。在本发明的优选形式中，苯乙烯和烃的共聚物是苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物。更优选表层12是混合了0-20重量％的SEBS嵌段共聚物的聚丙烯共聚物。表层12应具有0.2-3.0密耳(mils)范围的厚度。
本发明的RF敏感层14在1-60MHz的频率范围和环境温度至250℃的温度范围应具有高于0.05的介电损失。优选RF层14具有四种组分。RF层14使膜具有RF可密封性、挠性、耐热变形性和与膜结构10的相容性。RF层14的第一种组分选自聚丙烯共聚物并优选丙烯和α-烯烃的无规共聚物(“PPE”)。PPE具有所要求的刚性以及在约121℃的高压釜温度下的耐变形性。但是，PPE本身的刚性太大，不能满足挠性要求。当通过熔合与特定的低模数聚合物结合时，能够获得良好的挠性。
这些低模数共聚物可以包括乙烯基共聚物，如乙烯-共-乙酸乙烯酯(“EVA”)、乙烯-共-α-烯烃或所谓的超低密度(通常低于0.90Kg/L)聚乙烯(“ULDPE”)。这些ULDPE包括可以购买到的产品，商标为TAFMER(Mitsui Petrochemical Co.)，产品号为A4085的AFFINITYVP8770(Dow Chemical Co.)，产品号为4023-4024的Exact(ExxonChemical Company)和Insite技术聚合物(Dow Chemical Co.)。此外，还发现下列物质是可接受的共聚物：聚丁烯-1(“PB”)，如由Shell Chemical Company所销售的产品号为PB-8010、PB-8310的产品；基于SEBS嵌段共聚物的热塑性弹性体(Shell Chemical Company)；产品号为Vistanex L-80、L-100、L-120、L-140(Exxon ChemicalCompany)的聚异丁烯(‘PIB”)；乙烯和丙烯酸烷基酯，丙烯酸甲酯的共聚物(‘EMA”)，如产品号为EMAC2707和DS-1130(Chevron)的产品和丙烯酸正丁酯(“ENBA”)(Quantum Chemical)。乙烯共聚物，如丙烯酸和甲基丙烯酸共聚物及其部分中和的盐和离子键交联聚合物，如PRIMACOR(Dow Chemical Company)和SURYLN(E.I.DuPontde Nemours & Company)也是可以接受的。通常熔点温度低于约110℃的乙烯基共聚物不适合用于121℃的高压釜中。而且，只有有限比例范围的每种组分允许同时满足挠性和高压釜可用性的要求。
优选第一种组分选自丙烯的均聚物和丙烯与α-烯烃的无规共聚物，该组分占膜重量的约30-60％，更优选35-45％，最优选45％。例如，优选丙烯和乙烯的无规共聚物作为第一种组分，其中乙烯的量在丙烯重量的0-6％范围内，优选在2-6％范围内。除乙烯与乙烯醇共聚物的共聚单体的相对含量以摩尔百分比表示外，在此所述的共聚单体的相对含量为重量百分比。
RF层14的第二种组分使RF层14具有挠性和低温延展性并选自不含丙烯重复单元的聚烯烃(“非丙烯基聚烯烃”)，包括乙烯共聚物，乙烯共聚物包括ULDPE、聚丁烯、丁烯乙烯共聚物、乙酸乙烯酯的含量在约18-50％范围的乙烯乙酸乙烯酯共聚物、丙烯酸甲酯含量在约20-40％范围的乙烯丙烯酸甲酯共聚物、丙烯酸正丁酯含量在20-40％范围的乙烯丙烯酸正丁酯共聚物、丙烯酸含量高于约15％的乙烯丙烯酸共聚物。这些产品的例子是使用产品号为Tafmer A-4085(Mitsui)、EMAC DS-1130(Chevron)、Exact 4023、4024和4028(Exxon)销售的商品。优选第二种组分是由Dow Chemical Co.用商品名AFFINITYVP8770销售、由Mitsui Petrochemical Company用产品号TAFMERA-4085销售的ULDPE，或聚丁烯-1，PB8010、PB83 10和PB8410(Shell Chemical Co.)，并且第二种组分占膜重量的约25-50％，更优选35-45％，最优选45％。
可以用一种单一的组分代替RF层14的第一种和第二种组分，该单一组分选自高熔融温度和挠性的烯烃，如由Huntman Company使用产品号FPO销售的聚丙烯。此种组分的熔点应高于130℃并且模数低于20,000psi。此种组分应占RF层重量的30-60％。
为了使RF层14具有RF介电损失，某种已知的高介电损失的组分作为第三组分包括在膜结构10中。例如，具有足够高共聚单体含量的EVA和EMA在27MHz具有显著的介电损失性质，以允许通过介电处理密封该组合物。作为一类材料的聚酰胺和乙烯与乙烯醇(“EVOH”)共聚物(通常通过水解EVA共聚物制备)在适当的温度均具有高介电损失特性。其他活性物质包括PVC、1，1-二氯乙烯和1，1-二氟乙烯，已知为PHENOXYS(Union Carbide)的双酚-A和表氯醇的共聚物。但是，显著量的这些含氯和含氟的聚合物对环境是不利的，因为在焚化此类物质时将产生无机酸。因此，优选RF层14的第三组分选自聚酰胺类化合物。
优选地，本发明的聚酰胺将选自由2-13个碳原子的二胺通过缩合反应获得的脂肪族聚酰胺、由2-13个碳原子的二酸通过缩合反应获得的脂肪族聚酰胺、由脂肪酸的二聚物通过缩合反应获得的聚酰胺以及含酰胺的共聚物(无规、嵌段或接枝共聚物)。
由于聚酰胺，如尼龙使膜具有抗磨损性，它们广泛用于膜材料中。但是，在与医疗溶液接触的层中通常见不到尼龙，因为在有些情况它们可能通过溶出进入溶液中而污染溶液。但是，本发明的申请人已经发现例如由Henkel Corporation使用产品号MACROMELT和VERSAMID销售的各种二聚物脂肪酸聚酰胺不会导致此种明显的溶出水平，并因此是RF层14最优选的第三组分。第三组分应占RF层14重量的约3-40％，更优选7-13，最优选10％。
RF层14的第四组分使RF层14的极性和非极性组分相容。第四组分选自苯乙烯-烃共聚物并优选苯乙烯-烃嵌段共聚物，如由马来酸酐、环氧或羧酸酯官能团修饰的SEBS共聚物。最优选第四组分是马来酸酐官能化的SEBS嵌段共聚物。此种产品由Shell ChemicalCompany使用产品号KRATON 1901X或1924X销售。第四组分应占RF层14重量的约5-40％，更优选7-13％，最优选10％。
在RF层14中包括无上述官能团修饰的SEBS嵌段共聚物作为第五组分也是可取的，如由Shell Chemical Company使用产品号KRATONG-1652或G-1657销售的产品。此种组分应占RF层重量的5-40％，更优选7-13％，最优选10％。
优选RF敏感层的厚度约为1-9密耳，更优选约5.0密耳-8.0密耳，最优选约5.0密耳。表层的厚度在约0.2-3.0密耳范围，并且最优选约0.5密耳。
图2示出了将核心层16置于表层12和RF层14之间的本发明的另一个实施方案。核心层16使膜结构10具有耐热变形性和挠性并使膜结构10的组分之间相容。优选核心层具有0.5-10密耳的厚度，更优选1-4密耳。核心层16包括三种组分。第一组分是聚烯烃并优选是聚丙烯，该组分的含量占核心层16重量的20-60％，优选35-50％，更优选45％。
核心层16的第二组分选自包括使核心层16具有挠性的化合物组，包括ULDPE、聚丁烯共聚物。优选核心层的第二组分是ULDPE或聚丁烯-1，其含量为40-60重量％，优选40-50重量％，最优选40重量％。
核心层16的第三组分选自使核心层16的组分之间相容的化合物组，并包括苯乙烯-烃嵌段共聚物，最优选SEBS嵌段共聚物。优选第三组分的量为核心层重量的5-40％，更优选7-15％，最优选15％。
也可以向核心层16中加入在制造容器过程中回收的重新研磨的碎屑材料作为第四组分。碎料被分散在整个核心层16中。优选碎料的加入量为核心层16重量的约0-50％，更优选在10-30％范围，最优选在3-12％范围。
图3示出了包括溶液接触层17的图1的膜或片结构，其中层17粘附在与表层12相对的RF层一侧。溶液接触层包括三种组分，该三种组分可以选自与上述核心层16的前三种组分相同的组分以及相同的重量百分比范围。优选溶液接触层17的厚度在约0.2-1.0密耳之间，并最优选约1.0密耳。
图4示出了多层膜结构的另一种实施方案，该膜结构除具有如上文所述的表层12、核心层16和RF层14外，还在表层12和核心层16之间有一个不连续的碎料层20。图5示出了在核心层16和RF层20之间的不连续的碎料层20。图6示出了将核心层16分隔成第一和第二核心层16a和16b的碎料层20。优选重新研磨层的厚度在0.5-5.0密耳范围内，并最优选1.0密耳。
图7示出了具有七层的本发明的另一个实施方案，其中包括上文所述的表层12、核心层16和RF层14，在核心层16和RF层14之间设置防渗层26并在防渗层26相对的两侧粘附复合薄膜粘结层28。图8示出了在核心层16和表层12之间的防渗层26。图9示出了将核心层16分隔成两个核心层16a和16b的防渗层26。防渗层26提高了膜结构10的气体防渗性能。防渗层26选自乙烯乙烯醇，如以Evalca(Evalca Co.)的名字销售的乙烯乙烯醇、高度玻璃质或结晶的聚酰胺，如Sclar PA(Dupont Chemical Co.)和高腈含量的丙烯腈共聚物，如由British Petroleum销售的Barex。优选防渗层26是乙烯乙烯醇，其厚度在0.3-1.5密耳范围，最优选1.0密耳。
复合薄膜粘结层28可以选自改性的乙烯和丙烯共聚物，如以产品名Prexar(Quantum Chemical Co.)和Bynel(Dupont)销售的产品，该层的厚度应在0.2-1.0密耳范围内，最优选0.5密耳。
可以通过复合挤压、共挤贴合或其他可接受的方法加工上述层。但是，应当理解的是制造膜结构的方法不是本发明的一部分，因此，不应将本发明范围限制在该范围。
可以使用这些材料制造静脉注射(I.V.)治疗袋，如在图10所示出并总称为30的治疗袋。
图11示出了药物再建装置50，该装置有一个柔性的稀释液容器52和连接容器52和药瓶的管形瓶进入装置54。稀释液容器52装有水、盐溶液或林格(vingers)乳酸盐溶液或适合再建药物的其他溶液。通常可以获得不同大小的稀释液容器，包括50ml、100ml和250ml。药瓶56装有在给患者使用前必须与稀释液混合的粉末状药物或液体药物。在美国专利申请号08/986,580中更详细地描述了药物再建装置50的操作，在此通过引入该专利申请的全部内容并作为本文的一部分。已经发现上述膜的水蒸气防渗性能不适宜用于制造50ml和100ml体积的稀释液容器52。
可以在不需要额外的外包装或外密封材料的情况下运输和储存容器52是需要的。这要求容器侧壁60由对水分损失具有高防渗性的材料制成。在本发明的一个优选形式中，在121℃对容器进行热压处理约20分钟后或在相对湿度为35％，温度为25℃的环境调节室储存12个月或更长时间以后，50ml容器的侧壁具有低于8重量％的水分损失，更优选低于7重量％，最优选低于6重量％。当将经热压处理的容器置于相对湿度为15％，温度为40℃的环境调节室90天时，50ml的容器也应满足相同的WVTR标准。
图12示出了一种适合制造稀释液容器52的双层防渗膜70。膜70具有一个表层72和一个射频敏感层74。表层72可以选自聚烯烃材料，更优选选自聚丙烯聚合物和共聚物，和乙烯均聚物与乙烯和α-烯烃共聚物的混合物。在本发明的一个优选的形式中，聚丙烯也应是熔体流动速率为0.5-20克/10分钟，更优选1-10克/10分钟，最优选1-5克/10分钟的高分子量聚合物。术语“熔体流动”、“熔体流动速率”和“熔体流动指数”在此用于指在特定的压力和温度下，通过压力使热塑树脂在10分钟内通过指定孔的克数。应按照ASTM D 1238确定该数值。
聚丙烯共聚物可以含有高达共聚物重量的约3重量％的乙烯共聚单体。合适的聚丙烯是由FINA使用产品编号6253和6671销售的，熔体流动分别为1.5克/10分钟和11.0克/10分钟的产品。
图13示出了图12所示出的膜的表层72和射频敏感层74的厚度与获得所需要的WVTR的关系曲线。通过各种表层和密封层(射频敏感层)厚度的组合可以获得所需要的WVTR。如果表层和密封层相对厚度的数据点曲线使数据点位于所绘制曲线上或其上方，则刚刚在上文描述的50毫升容器或100毫升容器将具有所需要的WVTR。对于上述50毫升和100毫升容器，表层厚度应高于3.0mils，优选至少约3.5mils，更优选约3.5mils至约8.0mils。密封层应具有从约3.0mils至约8.0mils的厚度。
如上文所述，表层也可以是任何乙烯均聚物，如密度为约0.930-0.960克/立方厘米的高密度聚乙烯。
在本发明的又一种形式中，表层也可以是HDPE和乙烯与α-烯烃共聚物的混合物，其中，共聚物的密度低于约0.930克/立方厘米，优选约0.900克/立方厘米至约0.930克/立方厘米，并优选是线性低密度聚乙烯。表层混合物应含有20-95重量％的HDPE和5-80重量％的LLDPE，更优选25-45重量％的HDPE和55-75重量％的LLDPE，最优选30重量％HDPE和70重量％LLDPE。
射频敏感层可以选自那些上文所述的三、四和五组分混合物，最优选含有40重量％聚丙烯、40重量％ULDPE、10重量％SEBS和10重量％二聚物脂肪酸聚酰胺的四组分混合物。
图14示出了一种具有表层72、射频敏感层74和中间层76的三层防水蒸气膜。表层72和射频敏感层74可以选自与上文所述用于图12中所示的二层膜的相同的材料。中间层76提高了膜70的低温性能并且在本发明的一个优选形式中，该中间层是聚烯烃材料并且更优选是与弹性体混合的聚丙烯。用于中间层76的适当的聚丙烯是那些熔体流动速率为0.5-20克/10分钟，优选1-10克/10分钟，更优选1-5克/10分钟的材料。适当的弹性体包括苯乙烯和烃共聚物，特别是二嵌段、三嵌段和星形嵌段的共聚物、三元乙烯丙烯橡胶、三元乙烯丙二烯单体、超低密度聚乙烯和极低密度聚乙烯。优选中间层含有约70-约99重量％的聚丙烯和约1-约30重量％弹性体。
在本发明的一个优选形式中，表层的厚度为从约2mils至约4mils，中间层的厚度为从约2mils至约4mils，射频敏感层的厚度为从约3mils至约7mils。
图15示出了一种具有射频敏感层74、表层72和二个中间层76和78的四层防水蒸气膜。表层72可以选自与上文所述用于图12所示二层膜表层的材料相同的材料，并优选是高分子量的聚丙烯。射频敏感层也可以选自与上文所述用于图12所示二层膜的射频敏感层的材料相同的材料。优选第一中间层76是密度从约0.900克/立方厘米至约0.930克/立方厘米的乙烯和α-烯烃的共聚物。第二中间层78是将LLDPE层76粘附到射频敏感层74上的复合薄膜粘结层。在一个优选的形式中，复合薄膜粘结层78是改性的乙烯和丙烯共聚物，如使用产品号Prexar(Quantum Chemical Co.)和Bynel(Dupont)销售的产品，并且其厚度应在0.2-2.0mils范围，最优选0.5mil。
在本发明的一个优选形式中，表层72具有从约1mil至约4mil，更优选从约1mil至约3mils的厚度，第一中间层76具有从约2mils至约4mils，更优选从2mils至约3mils的厚度，复合薄膜粘结层78应具有从0.2-2.0mils，更优选0.5mils的厚度，射频敏感层具有从约3mils至约7mils的厚度。
图11、12、14和15的防渗膜具有足够的挠性以作为用于再建装置的容器。足够的挠性意味着具有低于15,000磅/平方英寸(psi)，更优选低于120,000psi，最优选低于100,000psi的弹性模数。当将50ml的容器置于在25℃具有35％的相对湿度的环境调节室中12个月或更长时间以及当将容器置于在40℃具有15％的相对湿度的环境调节室中90天时，这些防渗膜所具有的WVTR使得容器的损失低于所容纳水分重量的8％，更优选低于7％，最优选低于6％。该防渗膜还具有低于0.1％，更优选低于0.01％的卤素元素含量，低于0.1％，更优选低于0.01％，最优选低于0.005％的低分子量水溶性组分，在1至60MHz和25-250℃之间具有高于或等于0.05，更优选高于或等于0.1的最大介电损失，在27psi载荷，121℃下通过样品蠕变所测量的高压釜耐受性低于或等于60％，更优选低于或等于20％，并且在约每分钟20英寸的中等速率和约100％伸长率下拉伸材料时，该材料不发生张力变白。
按照下列程序测试本发明的防渗膜。(1)高压釜耐受性
通过测量样品在121℃，27psi载荷1小时条件下的蠕变，或样品长度的增加测量高压釜耐受性。高压釜耐受性必须低于或等于60％。(2)RF可加工性
使用由Kiefel销售的工业规模的RF密封设备在12千瓦、约5-6秒的周期内密封50ml容积的容器。容器中充满水并在约121℃高压蒸煮约20分钟。用20psi的压力挤压经高压釜蒸煮的容器约10分钟并检查渗漏。(3)张力变白
将膜切割成约1/2英寸的条带并在Instron机上以20英寸/分钟的速率拉伸至伸长100％，观察拉伸的条带是否存在张力变白现象。(4)环境相容性
环境相容性包括三项重要的性质：(1)材料中不含在处理时可能渗透进入土壤中的低分子量增塑剂；(2)在实现药物输送的首次用途后，可将该材料热塑回收利用成有用的物品；和(3)当通过焚化回收能量进行处理时，不释放显著量的危害环境的无机酸(“Envir”)。该组合物还含有低于0.1重量％的卤素。为了便于通过熔融处理循环利用，所获得的组合物在1Hz应具有在处理温度所测量的高于1.0的损耗角正切值。(5)溶液相容性
溶液相容性是指在膜内容纳的溶液不会受到组成该组合物的组分的污染(“S.Comp.”)。该组合物的低分子量水溶性组分应低于0.1％。(6)防渗性
通过在二组不同的环境条件下测量容器的WVTR测试防渗性。容器为50ml容器并具有9-12mils厚的侧壁。向每个容器中加入约53-55ml水。在121℃下，高压蒸煮每个容器约20分钟。将一个容器置于在25℃具有35％相对湿度的环境调节室中，并在一段时间内监测重量损失。将第二个容器置于在40℃具有15％相对湿度的环境调节室中，并监测重量损失。根据重量损失对时间作图，测量水的重量损失的比例。(7)无取向性
术语“取向的”是指在单一方向或多于一个方向上拉伸处于非熔融态的材料，以在拉伸的方向上排列材料的部分分子的工艺。本发明的膜是通过一种挤压方法制成，在该方法中，在膜从挤压机中挤出并固化后不进行取向步骤。
实施例
制造本发明的二层防渗膜并进行测试以确定容器的WVTR。具体地，二层膜的表层和密封层的厚度如下表1所列。表层由聚丙烯(Fina6253)制成，密封层由聚丙烯、超低密度聚乙烯、二聚脂肪酸聚酰胺和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物的四种成分的混合物制成。通过复合挤压制造该膜。
通过将二片膜对齐并使用射频能量密封以制成具有一个灌装口的容器而将膜制成50ml的容器。该容器具有约为23平方英寸的表面积。然后通过灌装口向每个容器中加入约53ml水。在约121℃，将容器在高压釜中蒸汽灭菌约20分钟。将容器从高压釜中取出并置于相对湿度为15％，温度为40℃的容器中。如表1所示以克/天测量水分损失的速率。根据水分损失对时间的曲线图，计算每个容器损失其6％的水分重量时的时间。这些数据的曲线示于图13中。
表1
  样品编号   密封层厚度    表层厚度 测量的水分损失平均值(克/天) 损失6％重量水分的天数(计算值)
  223-5    5.0mils    5.35mils     0.0285     109天
  223-6    6.0mils    5.30mils     0.0272     114天
  223-7    5.0mils    4.75mils     0.0305     100天
  223-8    5.5mils    5.0mils     0.0286     107天
  223-9    5.4mils    5.15mils     0.029     98天
应当理解的是，可以以其他特定的方式实施本发明，而不会偏离其精神或核心特征。因此，就各方面而言，本文的实施例和实施方案应被理解为示例性而非限制性的，并且不应将本发明限定在在此所给出的细节。

Claims (57)

1.一种多层热塑结构，包括：
(1)表层，其选自聚丙烯、密度从约0.930克/立方厘米至约0.960克/立方厘米的乙烯均聚物、和混合了密度低于约0.930克/立方厘米的乙烯和α-烯烃共聚物的密度从约0.930克/立方厘米至约0.960克/立方厘米的乙烯均聚物，所述的表层具有高于约3.0mils的厚度；
(2)粘附在表层上的射频敏感层，所述的射频敏感层在1-60MHz和环境温度至250℃的温度具有高于0.05的介电损失，所述的射频敏感层包含：
(a)选自聚丙烯和聚丙烯共聚物的第一聚烯烃；
(b)选自乙烯共聚物、超低密度聚乙烯、聚丁烯和丁烯乙烯共聚物的第二聚烯烃；
(c)射频敏感聚合物，其选自：(i)乙烯共聚物，所述的乙烯共聚物具有50-85％的乙烯含量并且其共聚单体选自下述第一组单体：丙烯酸、甲基丙烯酸、丙烯酸与含有1-10个碳原子的醇所形成的酯衍生物、甲基丙烯酸与含有1-10个碳原子的醇所形成的酯衍生物、乙酸乙烯酯和乙烯醇；(ii)含有至少一段氨基甲酸乙酯、酯、尿素、酰亚胺、砜和酰胺链段的均聚物和共聚物；和
(d)苯乙烯和烃共聚物的相容性试剂；
其中当将所述的结构物制成50ml容器时，在将该容器在121℃高压蒸煮20分钟并在温度为40℃、相对湿度为15％的环境调节室中储存90天后，该结构物具有低于8％重量的水蒸气透过率。
2.权利要求1的结构，其中苯乙烯和烃的共聚物是选自二嵌段、三嵌段或星形嵌段共聚物的嵌段共聚物。
3.权利要求2的结构，其中的嵌段共聚物选自第一苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物以及马来酸酐官能化的苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物。
4.权利要求1的结构，其中的表层是熔体流动速率为约0.5至20克/10分钟的聚丙烯。
5.权利要求1的结构，其中的表层是高密度聚乙烯。
6.权利要求1的结构，其中的表层是高密度聚乙烯和线性低密度聚乙烯的混合物。
7.权利要求6的结构，其中的表层含有约25％至约95％表层重量的高密度聚乙烯和从5％至约75％的线性低密度聚乙烯。
8.权利要求7的结构，其中的表层是30重量％的高密度聚乙烯和70重量％的线性低密度聚乙烯。
9.权利要求1的结构，其中的表层具有从约3.5至8.0mils的厚度，射频敏感层具有从约3.0mils至约8.0mils的厚度。
10.权利要求1的结构，其中的结构物是无取向性的。
11.权利要求1的结构，还包括：
置于表层和射频敏感层之间的第一中间层，第一中间层选自：(1)混合了弹性体的聚丙烯；和(2)密度从约0.900克/立方厘米至约0.930克/立方厘米的乙烯和α-烯烃共聚物。
12.权利要求11的结构，其中的弹性体选自苯乙烯和烃的共聚物、三元乙烯丙烯橡胶、三元乙烯丙二烯单体、超低密度聚乙烯和极低密度聚乙烯。
13.权利要求12的结构物，其中的第一中间层含有从约99％至约70％重量的聚丙烯和从约1％至约30％重量的弹性体。
14.权利要求13的结构，其中的第一中间层是75％的聚丙烯和25％的SEBS。
15.权利要求12的结构，其中的第一中间层是线性低密度聚乙烯。
16.权利要求15的结构，其中还包括粘附在第一中间层上的第二中间层。
17.权利要求16的结构，其中的第二中间层是复合薄膜粘结层。
18.权利要求17的结构，其中的复合薄膜粘结层是改性的乙烯和丙烯共聚物。
19.权利要求1的结构，其中当将所述的结构物制成50ml容器时，在将该容器在121℃高压蒸煮30分钟并在温度为40℃、相对湿度为15％的环境调节室中储存90天后，所述的结构物具有低于8％重量的水蒸气透过率。
20.一种适合制造医疗产品的多层热塑结构，所述的结构物包括：
(1)表层，其选自聚丙烯，密度从约0.930克/立方厘米至约0.960克/立方厘米的乙烯均聚物，和混合了密度低于约0.930克/立方厘米的乙烯和α-烯烃共聚物的密度从约0.930克/立方厘米至约0.960克/立方厘米的乙烯均聚物，所述的表层具有高于约3.0mils的厚度；
(2)粘附在表层上的射频敏感层，所述的射频敏感层在1-60MHz和环境温度至250℃的温度具有高于0.05的介电损失，并包含：
(a)其数量在射频敏感层重量的30-60％范围的，选自聚丙烯和聚丙烯共聚物的第一聚烯烃；
(b)其数量在射频敏感层重量的25-50％范围的，选自乙烯共聚物、超低密度聚乙烯、聚丁烯和丁烯乙烯共聚物的第二聚烯烃；
(c)其数量在射频敏感层重量的3-40％范围的射频敏感聚合物，其选自：(i)乙烯共聚物，所述的乙烯共聚物具有50-85％的乙烯含量并且其共聚单体选自下述第一组单体：丙烯酸、甲基丙烯酸、丙烯酸与含有1-10个碳原子的醇所形成的酯衍生物、甲基丙烯酸与含有1-10个碳原子的醇所形成的酯衍生物、乙酸乙烯酯和乙烯醇；(ii)含有至少一段氨基甲酸乙酯、酯、尿素、酰亚胺、砜和酰胺链段的均聚物和共聚物；和
(d)其数量在射频敏感层重量的5-40％范围的苯乙烯和烃共聚物的相容性试剂；
其中当将所述的结构物制成50ml容器时，在将该容器在121℃高压蒸煮20分钟并在温度为40℃、相对湿度为15％的环境调节室中储存90天后，该结构物具有低于8％重量的水蒸气透过率。
21.权利要求20的结构，其中的苯乙烯和烃的共聚物是选自二嵌段、三嵌段或星形嵌段共聚物的嵌段共聚物。
22.权利要求21的结构，其中的嵌段共聚物选自第一苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物，以及马来酸酐官能化的苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物。
23.权利要求20的结构，其中的表层是熔体流动速率为约0.5至20克/10分钟的聚丙烯。
24.权利要求20的结构，其中的表层是高密度聚乙烯。
25.权利要求20的结构，其中的表层是高密度聚乙烯和线性低密度聚乙烯的混合物。
26.权利要求25的结构，其中的表层含有约25％至约95％表层重量的高密度聚乙烯和从5％至约75％的线性低密度聚乙烯。
27.权利要求26的结构，其中的表层是30％重量的高密度聚乙烯和70％重量的线性低密度聚乙烯。
28.权利要求20的结构，其中的表层具有从约3.5至8.0mils的厚度，射频敏感层具有从约3.0mils至约8.0mils的厚度。
29.权利要求20的结构，其中的结构物是无取向性的。
30.权利要求20的结构，其中还包括：
置于表层和射频敏感层之间的第一中间层，第一中间层选自：(1)混合了弹性体的聚丙烯；和(2)密度是从约0.900克/立方厘米至约0.930克/立方厘米的乙烯和α-烯烃共聚物。
31.权利要求30的结构，其中的弹性体选自苯乙烯和烃的共聚物、三元乙烯丙烯橡胶、三元乙烯丙二烯单体、超低密度聚乙烯和极低密度聚乙烯。
32.权利要求31的结构，其中的第一中间层含有从约99％至约70％重量的聚丙烯和从约1％至约30％重量的弹性体。
33.权利要求32的结构，其中的第一中间层是约75％的聚丙烯和约25％的SEBS。
34.权利要求31的结构，其中的第一中间层是线性低密度聚乙烯。
35.权利要求34的结构，其中还包括粘附在第一中间层上的第二中间层。
36.权利要求35的结构，其中的第二中间层是复合薄膜粘结层。
37.权利要求18的结构，其中的复合薄膜粘结层是改性的乙烯和丙烯共聚物。
38.权利要求20的结构，其中当将所述的结构物制成50ml容器时，在将该容器在121℃高压蒸煮20分钟并在温度为40℃、相对湿度为15％的环境调节室中储存90天后，所述的结构物具有低于6％重量的水蒸气透过率。
39.一种适合制造医疗产品的多层热塑结构，所述的结构物包括：
(1)表层，其选自聚丙烯、密度从约0.930克/立方厘米至约0.960克/立方厘米的乙烯均聚物、和混合了密度低于约0.930克/立方厘米的乙烯和α-烯烃共聚物的密度从约0.930克/立方厘米至约0.960克/立方厘米的乙烯均聚物；
(2)粘附在表层上的射频敏感层，所述的射频敏感层包含：
(a)熔点高于130℃并且模数低于20,000psi的聚丙烯，所述的聚丙烯的数量为射频敏感层重量的30-60％范围内；
(b)其数量为射频敏感层重量3-40％范围的射频敏感聚合物，其选自：(i)乙烯共聚物，所述的乙烯共聚物具有50-85％的乙烯含量并且其共聚单体选自下述第一组单体：丙烯酸、甲基丙烯酸、丙烯酸与含有1-10个碳原子的醇所形成的酯衍生物、甲基丙烯酸与含有1-10个碳原子的醇所形成的酯衍生物、乙酸乙烯酯和乙烯醇；(ii)含有至少一段氨基甲酸乙酯、酯、尿素、酰亚胺、砜和酰胺链段的均聚物和共聚物；
(c)其数量在射频敏感层重量的5-20％范围的苯乙烯和烃共聚物的第一相容性试剂；
(d)其中的射频敏感层在1-60MHz和环境温度至250℃的温度具有高于0.05的介电损失。
(3)当将所述的结构制成50ml的容器时，将该容器在121℃高压蒸煮20分钟并在温度为40℃、相对湿度为15％的环境调节室中储存90天后，该结构物具有低于8％重量的水蒸气透过率。
40.权利要求39的结构，其中的苯乙烯和烃的共聚物是选自二嵌段、三嵌段或星形嵌段共聚物的嵌段共聚物。
41.权利要求40的结构，其中的嵌段共聚物选自第一苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物以及马来酸酐官能化的苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物。
42.权利要求39的结构，其中的表层是熔体流动速率约0.5至20克/10分钟的聚丙烯。
43.权利要求39的结构，其中的表层是高密度聚乙烯。
44.权利要求39的结构，其中的表层是高密度聚乙烯和线性低密度聚乙烯的混合物。
45.权利要求44的结构，其中的表层含有约25％至约95％表层重量的高密度聚乙烯和从5％至约75％的线性低密度聚乙烯。
46.权利要求45的结构，其中的表层是30％重量的高密度聚乙烯和70％重量的线性低密度聚乙烯。
47.权利要求39的结构，其中的表层具有从约3.5至8.0mils的厚度，射频敏感层具有从约3.0mils至约8.0mils的厚度。
48.权利要求39的结构，其中的结构物是无取向性的。
49.权利要求39的结构，其中还包括：
置于表层和射频敏感层之间的第一中间层，所述的第一中间层选自：(1)混合了弹性体的聚丙烯；和(2)密度是约0.900克/立方厘米至约0.930克/立方厘米的乙烯和α-烯烃共聚物。
50.权利要求49的结构，其中的弹性体选自苯乙烯和烃的共聚物、三元乙烯丙烯橡胶、三元乙烯丙二烯单体、超低密度聚乙烯和极低密度聚乙烯。
51.权利要求50的结构，其中的第一中间层含有从约99％至约70％重量的聚丙烯和从约1％至约30％重量的弹性体。
52.权利要求51的结构，其中的第一中间层是约75％的聚丙烯和约25％的SEBS。
53.权利要求50的结构，其中的第一中间层是线性低密度聚乙烯。
54.权利要求53的结构，其中还包括粘附在第一中间层上的第二中间层。
55.权利要求54的结构，其中的第二中间层是复合薄膜粘结层。
56.权利要求55的结构，其中的复合薄膜粘结层是改性的乙烯和丙烯共聚物。
57.权利要求39的结构，其中当将所述的结构物制成50ml的容器时，将该容器在121℃高压蒸煮30分钟并在温度为40℃、相对湿度为15％的环境调节室中储存90天后，所述的结构物具有低于6％重量的水蒸气透过率。
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CN103724791A (zh) * 2014-01-02 2014-04-16 苏州艾兴无纺布制品有限公司 超高性能塑料薄膜及其制备方法和复合材料
CN103724791B (zh) * 2014-01-02 2016-08-24 苏州艾兴无纺布制品有限公司 超高性能塑料薄膜及其制备方法和复合材料
CN104403167A (zh) * 2014-11-10 2015-03-11 苏州蔻美新材料有限公司 一种医用耐高温耐酸碱膜及其制备方法
CN109677071A (zh) * 2018-12-29 2019-04-26 石家庄育才药用包装材料股份有限公司 一次性生物反应器专用膜及其制备方法
CN109677071B (zh) * 2018-12-29 2021-04-13 石家庄育才药用包装材料股份有限公司 一次性生物反应器专用膜及其制备方法
CN113795432A (zh) * 2019-05-06 2021-12-14 霍尼韦尔国际公司 具有耐化学性和耐湿性的柔性基底
US11654667B2 (en) 2019-05-06 2023-05-23 Honeywell International Inc. Flexible substrates with chemical and moisture resistance
CN113795432B (zh) * 2019-05-06 2024-03-15 霍尼韦尔国际公司 具有耐化学性和耐湿性的柔性基底
CN114901476A (zh) * 2019-12-16 2022-08-12 Sabic环球技术有限责任公司 用于包装橡胶捆的多层膜

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CN100348412C (zh) 2007-11-14
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US6461696B1 (en) 2002-10-08
EP1259374B1 (en) 2007-07-04
ATE366182T1 (de) 2007-07-15
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KR100650081B1 (ko) 2006-11-27
CA2395063C (en) 2010-06-08
WO2001056783A1 (en) 2001-08-09
AU3675601A (en) 2001-08-14
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CA2395063A1 (en) 2001-08-09
JP4879435B2 (ja) 2012-02-22

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