CN1117718A - 用于医用级产品的多层聚合物基薄膜结构 - Google Patents

用于医用级产品的多层聚合物基薄膜结构 Download PDF

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Publication number
CN1117718A
CN1117718A CN94191202A CN94191202A CN1117718A CN 1117718 A CN1117718 A CN 1117718A CN 94191202 A CN94191202 A CN 94191202A CN 94191202 A CN94191202 A CN 94191202A CN 1117718 A CN1117718 A CN 1117718A
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layer
component
sandwich
weight
copolymer
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CN1082889C (zh
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L·A·罗森鲍姆
W·安德森
L·伍
D·劳林
A·L·布安
M·T·K·零
Y-P·S·丁
D·S·海沃德
J·P·霍珀施
G·内布根
S·韦斯特法尔
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Baxter International Inc
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Baxter International Inc
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Abstract

一种多层结构，包括由聚丙烯共聚物与占表层重量0-20％的苯乙烯乙烯-丁烯苯乙烯嵌段共聚物组成的表层，和与表层相粘的射频(“RF”)敏感层。RF层的第一组分为基于丙烯的聚合物，第二组分为非丙烯聚烯烃，第三组分为射频敏感聚合物，及第四组分为聚合物相容剂。

Description

用于医用级产品的多层聚合物基薄膜结构 说明书
技术领域
本发明一般涉及用于生产医用级产品的材料，更具体地讲，涉及可用于生产诸如塑料容器和医用胶管的制品的薄膜产品。
已有背景技术
在医药领域，为将有效试剂进行收集、加工和贮藏于容器中，运输、并最终经胶管通过输注对病人给药以达到治疗效果，用于生产容器的材料必须具有多种性质的极好的组合。例如，为了观察溶液中的细颗粒污染物，容器必须是透光的。为了通过容器壁破裂从容器中注入溶液，而又不将空气引入容器中，形成容器壁的材料必须具有足够的柔软性。这种材料必须在宽温度范围起作用。这种材料还必须在低温下保持其柔软性和韧性的功能。因为有些溶液，例如，某些预混合药液要在如-25至-30℃温度下于容器中贮藏和运输以使药降解减至最小。这种材料在高温下也必须起作用以经受加热消毒，此过程是装货之前大多数医用包装品和营养品必须进行的。消毒过程通常包括将容器暴露于温度通常为121℃及加压下的蒸汽中。因此，这种材料需要承受温度和压力，而无明显形变(“耐热形变”)。
为便于制成可用的制品，需要使用通常为约27.12MHz的射频(“RF”)密封的材料。所以材料必须具有足够的介电损耗性以使RF能量转变成热能。
进一步要求是使由这种材料制备的制品使用后丢弃对环境的影响减至最小，对于那些经淹埋(landfill)处理的制品，需要尽可能少地使用材料同时避免用低分子量可浸出组分制备这类制品。所以，此材料应重量轻并且具有良好的机械强度。要达到的进一步效果是使用可经热塑性再加工用过的制品变成其它可用制品来回收材料来实现的。
对于经焚烧处理的那些容器，使用的材料必须有助于消除对生物的危害性，并尽可能减少或完全消除危害环境、有刺激性和腐蚀性的无机酸的形成，或有害、有刺激性的其它产品或焚烧时产生的有害物的形成。
还要求材料无或具有低含量的低分子量添加剂如增塑剂、稳定剂等，这些添加剂可释放入药物或生物体液或组织中，因而使用这类容器对病人有危险，或污染在这类容器中贮藏或加工的物质。对于贮存输注液的容器，这些污染物会沿着输液路径进入病人体内伤害病人或使病人死亡。
常规柔软聚氯乙烯材料满足上述要求中的大多数，并在某些情况下满足上述要求中的绝大多数。聚氯乙烯(“PVC”)还具有用于制备满足上述要求的容器的大多数昂贵的有效材料之一所具有的独特优点。然而，PVC焚烧时会产生有害量的氯化氢(或当与水接触时产生盐酸)，造成对焚烧炉的腐蚀。PVC有时含有增塑剂，这些增塑剂会渗入与PVC制剂接触的药物或生物液或组织中。所以，已知发明了很多材料用于替代PVC。然而，大多数替代材料太昂贵，不能运用于实际中，并且还不能满足所有上述要求。
已进行了很多研制替代PVC的薄膜材料的尝试。但大多数尝试都因不同原因以失败告终。例如，美国专利US4966795中公开了一种能经受蒸汽消毒的多层薄膜结构物，但不能用射频介电加热熔接，因而不能用这种快速，低廉可靠而实用的方法加工。欧洲申请EP0310143A1公开了一种满足大多数要求的多层薄膜，并可用RF熔接。然而，公开的薄膜组分是用辐射交联的，因而不能用常规的热塑性塑料加工方法回收。此外，由于有辐射步骤，相当量的乙酸释放出来并吸收入材料中。在蒸汽消毒时，这些乙酸转移进包装物中成为污染物，同时通过改变包装物pH值，有可能变成与包装物反应的化学反应试剂或变为使包装物降解的催化剂。
本发明的主要目的是发明一类热塑性材料，这类材料总体上优于我们所知的迄今为止现有技术中已知的或已在工业上使用的或已市售的那些材料。这类材料的性质包括不仅在室温下而且在宽范围的环境温度和冷冻温度下具有柔韧性、延伸性和应变恢复性。此材料应具有足够的目检光学透明性，并可在温度最高达121℃下进行蒸汽消毒。此材料应能经受明显的应变，而不呈现应变发白，此应变发白表明有物理和外观缺陷。本发明的进一步目的是该材料可用RF方法加工。本发明另一个目的是此材料基本不含低分子量可渗出的添加剂，并可经焚烧进行安全处理，而不生成明显量的腐蚀性无机酸。本发明的再一个目的是这种材料使用后可用常规的热塑性加工方法回收。还要求在生产过程中将该材料与回收的经再次研磨的废料掺合以节约材料成本并减少生产中的废弃物。最后，此材料应在成本上作为目前用于医用容器的各种PVC制剂的有效替换物。
当一种以上的聚合物共混形成合金组合物时，要同时实现上述所有目的很困难。例如，在大多数情况下，合金组合物会散射光，所以，这些组合物不能满足光透明性的目的。光散射强度(通过光雾度(haze)测量)取决于在微米(μ)范围的组分尺寸范围和组分的近似折光率。一般情况下，选择可令人满意地加工成非常小的尺寸范围，而又具有最小的折射率不匹配的组分是很困难的任务。
本发明就在于要解决这些问题和其它问题。
本发明的概述
根据本发明，公开了一些多层聚合物基结构。这些薄膜可用于制备医用级制品如贮存药液或血液产品的容器、血袋及其类似制品，或其它由多层结构制成的产品。
本发明的一个目的是制备具有下列物理性质的多层薄膜：(1)根据ASTM D-882测定时机械模量低于40,000psi，更优选低于25,000psi，(2)初始形变20％后，长度恢复大于或等于70％，更优选大于或等于75％，(3)对9密耳厚的结构物按照ASTM D-1003测量时，光雾度小于30％，更优选小于15％，(4)在1Hz及加工温度下测量其损耗角正切值大于1.0，更优选大于2.0，(5)元素卤的含量小于0.1％，更优选小于0.01％，(6)低分子量的水溶性组分低于0.1％，更优选低于0.005％，(7)在1至60MHz之间，温度范围为25-250℃下的最大介电损耗大于或等于0.05，更优选大于或等于0.1，(8)通过在121℃，27psi负载下的样品蠕变测量其耐压热(autoclave resistance)低于或等于60％，更优选低于或等于20％，及(9)在以每分钟约20英寸(50cm)的中等速度拉长约100％进行应变后，无应变发白，并记录应变发白的存在或不存在应变发白。
本发明的多层结构包括优选由聚丙烯共聚物与苯乙烯和烃嵌段共聚物构成的表层，更优选包括由丙烯共聚物与占表层重量0-20％的苯乙烯乙烯—丁烯苯乙烯(“SEBS”)构成的表层。此结构进一步包括粘接到表层上的射频(“RF”)敏感层。此RF层由第一组分—聚丙烯聚合物、第二组分—非丙烯聚烯烃(不含丙烯重复单元)、第三组分—射频敏感聚合物、、和第四组分—聚合物相容剂构成。在另外的实施方案中，将附加层如芯层、废料(scrap)层和阻挡层加到表层和RF层上，使得到的薄膜结构具有附加的或增强的功能。
RF层是同时提交的美国专利申请1417P030(流水号)的主题，此申请这里引入本文作为参考。本发明的多层薄膜结构提供了仅具有RF层的结构物所不具有的附加的特点。此多层薄膜的附加特点包括外表面光泽和薄膜结构外表面的粘性降低。此外，这种多层薄膜结构具有提高了的蒸汽阻挡性，较大的强度和光学透明度，并且较洁净或具有减少了迁移进容器内盛装物中的趋势。
插入表层和RF层之间的芯层由三种组分组成。优选第一组分为聚丙烯，它构成芯层的约40％，第二组分为超低密度聚乙烯(“ULDPE”)，它构成芯层的约50％(重量)，第三组分为苯乙烯-烃嵌段共聚物，更优选为SEBS嵌段共聚物，它构成芯层的约10％(重量)。整个芯层应为4.0密耳厚。
在考虑到其它原因的同时，从经济出发，还需要将在薄膜材料加工过程中回收的再次研磨的废料加入薄膜结构结构物中。这导致使用按整个层结构重量百分比表示的较大量的废料。因而显著降低了薄膜产品的成本。再次研磨的废料既可以作为另一位于表层和RF层之间的单独层加入上述结构中，也可以作为附加组分混入芯层中。对于每种情况，都通过再加工废料而显著节约了原料。
为增加结构的气体屏蔽性，理想的是在表层和RF层之间加入一阻挡层。可使用粘合层将阻挡层粘接到周围层上。阻挡层可选自乙烯乙烯醇如以商品名Evalca(Evalca CO.)出售的乙烯乙烯醇、高玻璃态或结晶聚酰胺如Sclar PA(Dupont Chemical CO.)，腈含量高的丙烯腈共聚物如British Petroleum以商品名Barex出售的丙烯腈共聚物。
已发现具有上述结构和组成的薄膜具有柔韧性、光透明性、无应变发白、及可蒸汽和辐射消毒性。此外，这种薄膜适于医用，因构成薄膜的组分对于与结构物接触的液体和盛装物具有最小的可萃取性。此外，此薄膜对环境安全，即焚烧时不产生有害降解物。并且此薄膜可在成本上作为PVC的有效替换物。
本发明的另外一些特点和优点将由附图和优选实施方案的详细叙述来进行描述，并由此而为显而易见的。
附图的简要描述
图1表示本发明的两层薄膜结构的截面图；
图2表示包括在图1的薄膜上加上芯层的本发明的三层薄膜结构截面图；
图3表示具有溶液接触层的图1的薄膜的截面图；
图4表示在表层和芯层之间有一单独废料层的本发明的四层结构截面图；
图5表示在芯层和RF层之间使用再次研磨的废料作为单独层的薄膜结构截面图；
图6表示用再次研磨的废料作为单独层而将芯层分为两个芯层的薄膜结构截面图；
图7表示包括在芯层和RF层之间的阻挡层及两层粘合层的具有七层的本发明的薄膜结构截面图；
图8表示的结构与图6的结构相同，不同的是阻挡层位于芯层和表层之间；
图9表示具有分裂芯层的阻挡层的薄膜结构截面图；及，
图10表示由本发明的薄膜结构之一制备的容器。
详细描述：
虽然本发明可有许多不同形式的实施方案，并将在这里进行详细描述，但是公开的本发明的优选实施方案应理解为，本发明的公开内容是为举例说明本发明的原理，而不是将本发明的较宽的范围限制于所说明的实施方案。
根据本发明，提供了满足上述要求的多层薄膜结构。
图1表示具有表层12和射频(“RF”)敏感层14的两层薄膜结构10。表层12具有耐热变形和耐磨性，优选为聚丙烯，更优选为与苯乙烯和烃嵌段共聚物共混的聚丙烯共聚物。表层12更优选为与0-20％(重量)的SEBS嵌段共聚物共混的聚丙烯共聚物。表层12应具有的厚度为0.2-3.0密耳。
本发明的RF敏感层14在频率范围为1-60MHz、温度范围为室温至250℃内的介电损耗大于0.05。RF层14优选具有四种组分。RF层14具有RF密封性、柔韧性、耐热变形及与薄膜结构10的相容性。RF层14的第一组分选自聚丙烯共聚物，优选丙烯α-烯烃无规共聚物(“PPE”)。PPE在压热温度为约121℃下具有所需的刚性和耐屈服性。然而，PPE太硬不能满足柔韧性要求，当与某种低模量聚合物结合成合金时，可得到良好的柔韧性。
这些低模量共聚物可包括基于乙烯的共聚物如乙烯-醋酸乙烯酯共聚物(“EVA”)、乙烯-α烯烃共聚物，或所谓的超低密度(通常低于0.90kg/L)聚乙烯类(“ULDPE”)。这些ULDPE包括可市购的以商标TAFMER(Mitsui Petrochemical CO.)、产品牌号A485出售的产品；以商标Exact(Exxon Chemical Company)、产品牌号4023-4024出售的产品，和商标为Insite的技术(technology)聚合物(Dow Chemical Co.)。此外，可接受的共聚物有聚丁烯-1(“PB”)，例如Shell Chemical Company以产品牌号PB-8010、PB-8310出售的产品；基于SEBS嵌段共聚物的热塑性弹性体(Shell Chemical Company)，以产品牌号为Vistanex L-80、L-100、L-120、L-140(Exxon Chemical Company)的聚异丁烯(“PIB”)、乙烯丙烯酸烷基酯，丙烯酸甲酯共聚物(“EMA”)如产品牌号为EMAC 2707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聚物，如PRIMACOR(Dow Chemical Company)和SURYLN(E.I，DuPont deNemours & Company)也可接受。通常，基于乙烯的共聚物的熔点低于约110℃，不适合在压热温度为121℃下运用。此外，仅各种组分的限定比例可同时满足柔韧性和压热性要求。
优选第一组分选自聚丙烯均聚物和与α烯烃的无规共聚物，它构成薄膜重量的约30-60％，更优选35-45％，最优选45％。例如，丙烯与乙烯含量为丙烯重量0-6％，更优选2-6％的乙烯的无规共聚物优选作为第一组分。
RF层14的第二组分使RF层14具有柔韧性和低温延展性，它选自无丙烯重复单元的聚烯烃(“不基于丙烯的聚烯烃”)，包括乙烯共聚物，包括ULDPE，聚丁烯、丁烯乙烯共聚物、乙烯醋酸乙烯酯、醋酸乙烯酯含量为约18-50％的共聚物、丙烯酸甲酯含量为约20-40％的乙烯丙烯酸甲酯共聚物、丙烯酸正丁酯含量为20-40％的乙烯丙烯酸正丁酯共聚物，丙烯酸含量大于约15％的乙烯丙烯酸共聚物。这些产品的例子是那些以商品牌号如Tafmer A-4085(Mitsui)、EMAC DS-1130(Chevron)、Exact 4023、4024和4028(Exxon)出售的产品。第二组分优选是Mitsui PetrochemicalCompany以商品牌号TAFMER A-4085出售的ULDPE，或者是聚丁烯-1、PB 8010和PB8310(Shell Chemical CO.)，它应构成薄膜重量的约25-50％，更优选35-45％，最优选45％。
RF层14的第一和第二组分可用选自熔融温度高和柔韧性好的聚烯烃如Rexene Company以商品牌号FPO出售的那些聚丙烯的单个组分代替。此组分的熔点温度应大于130℃并且模量应小于20,000psi。这种组分应构成RF层重量的30-60％。
为使RF层14具有RF介电损耗，某些已知的介电损耗高的成分可作为薄膜结构10的第三组分包括在薄膜结构中。例如，具有足够高共聚单体含量的EVA和EMA在27MHz时都显现显著的介电损耗性，使结构物可用介电法密封。聚酰胺类物质和乙烯乙烯醇(“EVOH”)共聚物(通常通过水解EVA共聚物制得)，在适当温度下都具有高的介电损耗性。其它的活性材料包括PVC、1，1-二氯乙烯和1，1-二氟乙烯，已知为PHENOXYS(Union Carbide)的双酚-A和表氯醇共聚物。然而，这些含氯和氟的聚合物的含量高时对环境有害，因为焚烧这种材料会产生无机酸。所以，优选RF层14的第三组分选自聚酰胺类物质。
优选本发明的聚酰胺类选自由碳原子数为2-13的二胺的缩聚反应而得的脂肪族聚酰胺、由碳原子数为2-13的二酸的缩聚反应而得的脂肪族聚酰胺，由二聚体脂肪酸的缩聚反应而得的聚酰胺和含酰胺的共聚物(无规、嵌段或接枝)。
聚酰胺如尼龙，因其使薄膜具有耐磨性，广泛用于薄膜材料中。然而，在与药液接触的层中几乎未发现尼龙，因为它们渗入溶液中通常会污染溶液。然而，本发明的申请人已发现由例如HenkelCorporation以产品牌号MACROMELT和VERSAMID出售的各种二聚体脂肪酸聚酰胺不会有这种污染，所以是RF层14最优选的第三组分。第三组分应构成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之间有相容性。第四组分选自苯乙烯-烃嵌段共聚物，优选用马来酸酐、环氧或羧酸酯官能团改性的SEBS嵌段共聚物。最优选的第四组分为马来酸酐官能化的SEBS嵌段共聚物。这种产品是由Shell ChemicalCompany以商品牌号KRATON RP-6509出售的。第四组分应构成RF层14重量的约5-40％，更优选7-13％，最优选10％。
此外还可能理想的是使RF层14包括不用上述官能团改性的SEBS嵌段共聚物第五组分，例如Shell Chemical Company以产品牌号KRATON G-1652出售的产品。这种组分应构成RF层重量的5-40％，更优选7-13％，最优选10％。
优选RF敏感层的厚度为1-9密耳，更优选为5.0密耳-8.0密耳，最优选为5.0密耳。表层的厚度为0.2-3.0密耳，最优选0.5密耳。
图2为本发明在表层12和RF层14之间具有芯层16的另一实施方案。芯层16使薄膜结构10具有耐热变形性和柔韧性，及薄膜结构10的组分之间具有相容性。
优选芯层厚度为0.5-10密耳，更优选为1-4密耳。芯层16包括三个组分。第一组分为聚烯烃，优选为聚丙烯，它构成芯层16重量的20-60％，更优选35-50％，最优选45％。
芯层16的第二组分选自使芯层16具有柔韧性的化合物，包括ULDPE、聚丁烯共聚物。优选芯层的第二组分为ULDPE或聚丁烯-1，它的量以重量计为40％-60％，更优选40-50％，最优选40％。
芯层16的第三组分选自使芯层16各组分之间具有相容性的化合物，包括苯乙烯-烃嵌段共聚物，最优选为SEBS嵌段共聚物。第三组分的量优选为芯层16重量的5-40％，更优选7-15％，最优选15％。
还可以加入在生产容器过程中回收的再次研磨的废料作为芯层16第四组分。废料分散于整个芯层16。废料的加入量优选为芯层16重量的约0-50％。更优选为10-30％，最优选为3-12％。
图3表示包括在表层12背面的RF层一面上粘接一溶液接触层17的图1的薄膜或片材结构。溶液接触层17包括三个组分，它们可选自与上述芯层16相同的前三个组分，和相同的重量百分比。优选溶液接触层17的厚度为0.2-1.0密耳，最优选1.0密耳。
图4表示具有如上所述的表层12，芯层16和RF层14及表层12与芯层16之间的附加的单独废料层20的多层薄膜结构的另一实施方案。图5表示芯层16和RF层20之间的单独废料层20。图6表示废料层20将将芯层16分成第一及第二芯层14a和14b，废料层的厚度优选应为0.5-5.0密耳，最优选1.0密耳。
图7表示具有7层的本发明的另一实施方案，这些层包括上面讨论的表层12、芯层16和RF层14，及处于芯层16和RF层14之间的阻挡层26及用于粘接阻档层的粘接于阻挡层26两相对面上的粘合层28。图8表示阻挡层26位于芯层16和表层12之间。图9表示将芯层14分成两个芯层14a和14b的阻挡层26。阻挡层26增加了薄膜结构10的气体屏蔽性。阻挡层26选自乙烯乙烯醇类例如以商品名Evalca(Evalca Co.)出售的乙烯乙烯醇、高玻璃态或结晶聚酰胺如Sclar PA(Dupont Chemical Co.)、腈含量高的丙烯腈共聚物如British Petroleum以Barex出售的丙烯腈共聚物。阻挡层26优选为乙烯乙烯醇，其厚度为0.3-1.5密耳，最优选为1.0密耳。
粘合层28可选自改性的乙烯和丙烯共聚物，如以产品牌号Prexar(Quantum Chemical Co.)和Bynel(Dupont)出售的改性的乙烯和丙烯共聚物，其厚度应为0.2-1.0密耳，最优选为0.5密耳。
上述各层可用共挤压、共挤压涂布或其它可接受的方法加工。然而，应当明白，生产该薄膜结构的方法不是本发明的一部分。因此本发明的范围不应限制于此。
这些材料可用于生产I.V.治疗袋，如图10所示，通常以30表示。
具有如下实施例所列的上述组分的各种组合及重量百分数的薄膜用下面的方法进行测定。
(1)压热性：
通过在121℃负载27psi下一小时的样品蠕变或样品长度增加测量耐压热性。耐压热性必须低于或等于60％。
(2)低温和环境温度延展性：
(A)低温延展性
在装有以液氮冷却的低温环境腔室的冲击试验仪中，将约7×7英寸(18cm×18cm)的薄膜样品安装在直径约为6英寸(15cm)的圆形样品架上。将带有应力传感器的半球形冲击头以高速(通常大约3m/秒)敲打准备好的薄膜中心。画出应力变化(displacement)曲线，用积分计算出冲击能。在冲击能显著升高时的温度，以及当破碎的样品从脆性变为延展性时的高应变态作为薄膜的低温性能(“L.Temp”)的量度。
(B)机械模量和恢复性：
将具有已知几何形状的压热的薄膜样品安装在具有十字头的伺服水压驱动机械试验机上使样品伸长。在十字头速度为每分钟10英寸(25cm)下，样品伸长至约20％的伸长量。在此点，十字头先向前移动，接着沿原来使样品拉伸的反方向移动。将应力应变行为记录在数字记录仪上。弹性模量(“E(Kpsi)”)以应力-应变曲线的初始斜率表示，恢复以极限(excess)样品尺寸(样品伸长百分数)表示。
(3)RF可加工性
将一约0.25(6.3mm)×4英寸(10cm)的矩形铜模在扁平铜电极的反向连接至Callahan 27.12MHz、2KW Radio Frequency发生仪上。同时电极也与发生仪相连。在于两相对溶液面之间用两片选择的材料将模封闭的同时，将不同振幅和周期(duration)的RF源施于其上。当RF循环结束时，将模打开，对得到的密封体通过用于拉开成两片进行检查。密封强度(可比拟薄膜强度)和失败的方式(剥离、撕裂或粘接失败)用于表示材料的RF敏感性程度。
此外，先将选择的薄膜喷涂100厚的金或钯使其表面导电，将其切成圆形并置于介电容量(capacitance)测量电池的平行电极之间。使用Hewlett Packard 4092自动RF桥，在频率最高达10MHz的不同频率和温度最高达150℃下测量介电常数和介电损耗。可由介电损耗计算RF场下产生的热。通过用RF密封实验进行计算或校正，可得到操作的最小的介电损耗。
若RF密封性能由Callahan密封器获得，则采用下列顺序的等级：
  RF源     RF时间    密封强度    等级
  80％      10      无     0
  80％      10    可剥离     1
  80％      05    可剥离     2
  60％      03      强     3
  50％      03      强     4
  30％      03      强     5
(4)光透明度
将后压热的薄膜样品先切成约2×2英寸(5×5cm)的正方形，并将其装在Hunter Colorimeter上，再根据ASTM D-1003测量其固有雾度。通常要求固有雾度相对于这些厚度，要低于30％，优选低于20％(“Haze％”)。
(5)应变发白：
将压热的薄膜在每分钟约20英寸(50cm)的中等速度下应变至约100％的伸长量(即原长度的两倍)，标记存在应变发白(标记为1)或不存在应变发白(标记为零)(“S，Whitening”)。
(6)对环境的相容性：
环境相容性包括三个重要性质：(a)材料无低分子量增塑剂，此增塑剂会在处理时渗入淹埋物(Landfills)中，(2)材料在完成最初的给药用途后可用热塑性回收方法制成有用的产品，和(3)当用焚烧回收的能量处理时，无明显的危害环境的无机酸释放出。(“Envir.”)。结构物中卤素含量还应低于0.1％(重量)。为了便于熔融法回收，所得的结构物的损耗角正切值在1Hz时于加工温度下测量时，应大于1.0。
(7)溶液相容性
所谓溶液相容性(S.Comp.”)，我们是指用薄膜盛装的溶液不会被构成薄膜结构物的组分污染。结构物的低分子量水溶性组分的S.Comp.应低于0.1％。
对下列薄膜的各种组合用上述测试方法进行测试。
 参考编号 层类型 层组成    模量(psi)    应变恢复y E(kpsi) ％雾度 环境 压热性 介电损耗 低温 S.Comp.
 图1  表层 0.5密耳-100％Amoco PP Copolymer 8410 25 75 10 是 是 3 -35℃ 是
 RF层 8.0密耳-40％Solvay FortilinθTMPPCopolymer 420840％Milsui TafmerTMULDPE10％Shell KratonTMRP-650910％Henkel MacromeltTM6301
 图2  表层 0.5密单-100％Amoco PP Copolymer8410 25 75 12 是 是 4 -40℃ 是
 芯层 4.0密耳-45％Solvay FortilineTMPPCopolymer 420840％Milsui TafmerTMULDPE15％Shell KratonTMG1657
 RF层 5.0密耳-40％ Solvay FortilineTMPPCopolymer 420840％Milsui TalmerTMULDPE10％Shell KralonTMRP-650910％Henkel MacromellTM6301
 图3  表层 0.5密耳-100％Amoco PP Coppolymer 8410 25 70 15 是 是 2 -35℃ 是
 RF层 8.0密耳-40％Solvay FortilineTMPPCopolymer 420840％Milsui TalmerTMULDPE10％Shell KralonTMEP-650910％Henkel MacromellTM6301
 溶液接触表层 1.0密耳-45％Solvay FortilineTMPPCopolymer 420840％Milsul TafmerTMULDPE15％Shell KratonTMG1657
参考编号 层类型 层组成 模量(psi)   应变恢复y E(kpsi) ％雾度 环境 压热性 介电损耗 低温 S.Comp.
    图4 表层 0.5密耳-100％Amoco PP Copolymer 8410 25 75 16 是 是 4 -35℃ 是
重新研磨的废料层 1.0密耳-100％重新研磨的废料层
 芯层 3.0密耳-45％Solvay FortilineTMPPCopotymer 420840％Milsul TafmerTMULDPE15％Shell KratonTMG1657
 RF层 5.0密耳-40％Solvay FortilineTMPPCopolymer 420840％Milsui TafmerTMULDPE10％Shell KratonTMRP650910％Henkel MacromeltllTM6301
    图5  表层 0.5密耳-100％Amoco PP Copolymer8410 25 75 16 是 是 4 35℃ 是
 芯层 3.0密耳-45％Solvay FortilineTMPPCopolymer 420840％Mitsul TafmerTMULDPE15％Shell KratonTMG1657
重新研磨的废料层 1.0密耳-100％重新研磨的废料层
 RF层 5.0密耳-40％Solvay FortilineTMPPCopolymer 420840％Milsul TafmerTMULDPE10％Shell KralonTMRP6509
    参考编号 层类型 层组成   模量(psi)    应变恢复y E(kpsi) ％雾度 环境 压热性 介电损耗 低温 SComp
    图6 表层 0.5密耳-100％Amoco PP共聚物8410 25 75 16 是 是 4 -35℃ 是
芯层 1.5密耳-45％Solvay FortilineTMPPCopolymer 420840％Milsui TalmerTMULDPE15％Shell KratonTMG 1657
重新研磨的废料层 1.0密耳100％重新研磨的废料层
 芯层 1.5密耳45％Solvay FortilineTMPPCopolymer 420840％Mitsul TalmerTMULDPE15％Shell KratonTM1657
 RF层 5.0密耳45％Solvay FortilineTMPPCopolymer 420840％Milsui TafnerTMULDPE15％Shell KretonTMRP650910％Henkel MacromeltTM6301
    图7  表层 0.5密耳-100％Amoco PP Copolymer8410 30 20 20 是 是 4 -20℃ 是
 芯层 2.0密耳-45％Solvay FortilineTMPPCopolymer 420840％Mitsui TafrnerTMULDPE15％Shell KratonTMG1657
粘合层 0.5密耳100％Bynel
阻挡层 1.0密耳100％EVOH
粘合层 0.5密耳100％Bynel
 RF层 5.0密耳40％Sobay FodilineTMPPCopolymer 420840％Mitsul TafmerTMULDPE10％Shell KratonTMRP650910％llenkel MacromeltTM6301
 参考编号 层类型 层组成   模量(psi)    应变恢复y E(kpsi) ％雾度 环境 压热性 介电损耗 低温 S.Comp.
 图8  表层 0.5密耳-100％Amoco PP Copolymer8410 30 70 20 是 是 3 -20℃ 是
粘合层 0.5密耳100％Bynel
阻挡层 1.0密耳100％EVOH
粘合层 0 5密耳100％Bynel
芯层 2.0密耳-45％Solvay FortilineTMPPCopolymer 420840％Milsul TafmerTMULDPE15％Shell KratonTMG 1657
 RF层 5.0密耳40％Solvay FortilineTMPPCopolymer 420840％Milsul TafmerTMULDPE10％Shell KratonTMRP650910％Henkel MacromeltTM6301
 参考编号 层类型 层组成   模量(psi) 应变恢复y E(kpsi) ％雾度 环境 压热性 介电损耗 低温 S.Comp.
 图9  表层 0.5密耳-100％Amoco PP Copolymer8410 30 70 20 是 是 3 -20℃ 是
 芯层 1.0密耳-45％Solvay FortilineTMPPCopolymer 420840％Milsui TafmerTMULDPE15％Shell KratonTMG 1657
粘合层 0.5密耳100％Bynel
阻挡层 1.0密耳100％EVOH
粘合层 0.5密耳100％Bynel
 芯层 1.0密耳-45％Solvay FortilineTMPPCopolymer 420840％Milsul TafmerTMUl DPE15％Shell KratonTMG 1657
 RF层 5.0密耳40％Solvay FortilineTMPPCopolymer 420840％Milsui TafmerTMULDPE10％Shell KralonTMRP650910％Henkel MacromeltTM6301
应明了本发明可用其它具体方式实施而不超出本发明的精神或中心特点。所以应认为本发明的实施例和实施方案都是用于说明的，而不是用于限制的，本发明不受这里给出的细节的限制。

Claims (45)

1.一种多层结构，包括：
一层表层；
粘接在表层上的一层射频(“RF”)敏感层，RF层具有的第一组分为基于丙烯的聚合物，第二组分为非丙烯的聚烯烃，第三组分为射频敏感聚合物，第四组分为聚合物相容剂；
这种结构具有的物理性质为：a＜40,000psi；b＞＝70％；c＜30％；d＞1.0；e＜0.1％；f＜0.1％g＞＝0.05；h＜＝60％i＝0；
其中：
a是根据ASTM D-882测量的结构物的机械模量；
b为20％的初始形变后结构物的长度恢复百分数；
c是根据ASTM D-1003测定的加工成9密耳厚的薄膜结构物的光雾度；
d是在熔融加工温度下测定的1Hz时结构物的损耗角正切值；
e是元素卤含量占结构物重量的百分数；
f是结构物的低分子量水溶性组分；
g是结构物在1至60MHz之间及温度为25至250℃的介电损耗；
h为121℃时对于1英寸长的结构物条负载27psi条件下测量的样品蠕变；和
i表示结构物在以每分钟约20英寸(50cm)的中等速度进行应变，使伸长量为约100％(为原长度的两倍)后无应变发白，记下存在应变发白(标记为1)或无应变发白(标记为0)。
2.一种多层结构，包括：
一层由聚丙烯共聚物与占聚丙烯重量的0-20％的苯乙烯乙烯-丁烯苯乙烯嵌段共聚物组成的表层；
一层粘接到表层上的射频(“RF”)敏感层，RF层具有的第一组分为基于丙烯的聚合物，第二组分为非丙烯聚烯烃，第三组分为射频敏感聚合物，第四组分为聚合物相容剂。
3.权利要求2的结构，其中RF层的非丙烯聚烯烃选自下列乙烯共聚物，包括超低密度聚乙烯、聚丁烯、丁烯乙烯共聚物，醋酸乙烯酯含量为约18-50％的乙烯醋酸乙烯酯共聚物、丙烯酸甲酯含量为约20-40％的乙烯丙烯酸甲酯共聚物、丙烯酸正丁酯含量为20-40％的乙烯丙烯酸正丁酯共聚物、丙烯酸含量大于约15％的乙烯丙烯酸共聚物。
4.权利要求2的结构，其中射频敏感聚合物选自聚酰胺类、醋酸乙烯酯含量为18-50％(重量)的乙烯醋酸乙烯酯、丙烯酸甲酯含量为20％-40％(重量)的乙烯丙烯酸甲酯共聚物、乙烯醇含量为15％-70％的乙烯乙烯醇。经受蒸汽消毒的多层薄膜结构物，但不能用射频介电加热熔接，因而不能用这种快速，低廉可靠而实用的方法加工。欧洲申请EP0310143A1公开了一种满足大多数要求的多层薄膜，并可用RF熔接。然而，公开的薄膜组分是用辐射交联的，因而不能用常规的热塑性塑料加工方法回收。此外，由于有辐射步骤，相当量的乙酸释放出来并吸收入材料中。在蒸汽消毒时，这些乙酸转移进包装物中成为污染物，同时通过改变包装物pH值，有可能变成与包装物反应的化学反应试剂或变为使包装物降解的催化剂。
本发明的主要目的是发明一类热塑性材料，这类材料总体上优于我们所知的迄今为止现有技术中已知的或已在工业上使用的或已市售的那些材料。这类材料的性质包括不仅在室温下而且在宽范围的环境温度和冷冻温度下具有柔韧性、延伸性和应变恢复性。此材料应具有足够的目检光学透明性，并可在温度最高达121℃下进行蒸汽消毒。此材料应能经受明显的应变，而不呈现应变发白，此应变发白表明有物理和外观缺陷。本发明的进一步目的是该材料可用RF方法加工。本发明另一个目的是此材料基本不含低分子量可渗出的添加剂，并可经焚烧进行安全处理，而不生成明显量的腐蚀性无机酸。本发明的再一个目的是这种材料使用后可用常规的热塑性加工方法回收。还要求在生产过程中将该材料与回收的经再次研磨的废料掺合以节约材料成本并减少生产中的废弃物。最后，此材料应在成本上作为目前用于医用容器的各种PVC制剂的有效替换物。
当一种以上的聚合物共混形成合金组合物时，要同时实现上述所有目的很困难。例如，在大多数情况下，合金组合物会散射光，所以，这些组合物不能满足光透明性的目的。光散射强度(通过光雾度(haze)
第二组分：超低密度聚乙烯；和
第三组分：苯乙烯乙烯-丁烯苯乙烯嵌段共聚物。
15.权利要求9的结构，其中第一芯层包括由废料组成的第四组分。
16.权利要求9的结构，它还包括插入第一芯层和表层之间的废料层。
17.权利要求9的结构，它还包括插入第一芯层和射频敏感层之间的废料层。
18.权利要求9的结构，它还包括：
粘接到表层背面的第一芯层上的废料层；和
粘接到芯层背面的废料层上的第二芯层。
19.权利要求9的结构，它还包括阻挡层。
20.权利要求19的结构，其中将阻挡层插入第一芯层和RF层之间。
21.权利要求19的结构，其中将阻挡层插入第一芯层和表层之间。
22.权利要求9的结构，它还包括：
粘接到表层背面的第一芯层上的阻挡层；及
粘接到第一芯层背面的阻挡层上的第二芯层。
23.权利要求22的结构，它还包括两个粘合层，每一个粘合层粘接到阻挡层的相对的各面。
24.权利要求19的结构，其中阻挡层选自乙烯乙烯醇类、和高玻璃态的结晶聚酰胺类。
25.权利要求23的结构，其中粘合层为改性的乙烯和丙烯共聚物。
26.一种多层结构，它包括：
一层由聚丙烯共聚物与占表层重量的0-20％的苯乙烯乙烯-丁烯苯乙烯嵌段共聚物组成的表层；和
一层粘接到表层上的射频(“RF”)敏感层，RF层的第一组分为基于丙烯的聚合物，含量为RF层重量的30-60％；第二组分为非丙烯聚烯烃，含量为RF层重量的0-60％，第三组分为射频敏感聚合物，含量为RF层重量的3-40％，和第四组分为聚合物相容剂，含量为RF层重量的5-40％。
27.权利要求26的结构，其中RF敏感层的第一组分为聚丙烯。
28.权利要求27的结构，其中RF敏感层的第二组分选自超低密度聚乙烯和聚丁烯-1。
29.权利要求28的结构，其中第三组分为脂肪酸聚酰胺。
30.权利要求29的结构，其中第四组分为苯乙烯乙烯-丁烯苯乙烯嵌段共聚物。
31.权利要求30的结构，其中苯乙烯乙烯-丁烯苯乙烯嵌段共聚物是马来酸酐官能化的。
32.权利要求31的结构，其中RF层各组分的用量范围作为RF层的重量百分数表示如下：
第一组分：35-45％；
第二组分：35-45％；
第三组分：7-13％；及
第四组分：7-13％；
33.权利要求32的结构，其中脂肪酸聚酰胺为二聚体脂肪酸聚酰胺。
34.一种多层结构，它包括：
一层由聚丙烯共聚物与占表层重量0-20％的苯乙烯乙烯-丁烯苯乙烯嵌段共聚物组成的表层；
一层具有一面与表层相粘接的芯层；和
一层粘接到表层背面的芯层上的射频(“RF”)敏感层；RF层的组成为第一组分基于丙烯的聚合物，含量占RF层重量的30-60％；第二组分非丙烯聚烯烃，含量占RF层重量的25-50％，第三组分射频敏感聚合物，含量占RF层重量的3-40％，和第四组分聚合物相容剂，含量占RF层重量的5-40％。
35.权利要求34的结构，其中芯层为非射频敏感层。
36.权利要求35的结构，其中RF敏感层的第二组分选自超低密度聚乙烯和聚丁烯-1，射频敏感聚合物为二聚体脂肪酸聚酰胺，RF敏感层的第四组分为SEBS嵌段共聚物，芯层包括：
第一组分：聚烯烃；
第二组分：选自超低密度聚乙烯和聚丁烯共聚物；和，
第三组分：相容剂。
37.权利要求36的结构，其中芯层第一组分的聚烯烃为聚丙烯。
38.权利要求37的结构，其中芯层的第二组分为超低密度聚乙烯。
39.权利要求38的结构，其中芯层第三组分的相容剂为苯乙烯乙烯-丁烯苯乙烯嵌段共聚物。
40.权利要求39的结构，其中芯层还包括废料组分。
41.一种叠层多层结构，它包括：
一层由聚丙烯共聚物与占表层重量0-20％的苯乙烯乙烯-丁烯苯乙烯嵌段共聚物组成的表层；
一层射频(“RF”)敏感层，RF层的组成为：第一组分基于丙烯的聚合物，含量占RF层重量的30-60％；第二组分非丙烯聚烯烃，含量占RF层重量的25-50％；第三组分射频敏感聚合物，含量占RF层重量的3-40％；第四组分聚合物相容剂，含量占RF层重量的5-40％；
一层处于表层和RF层之间的第一芯层；和
一连接到芯层上的废料层。
42.权利要求41的结构，其中表层的一面与芯层粘接，废料层与位于表层背面上的芯层粘接，RF敏感层与位于芯层背面上的废料层粘接。
43.权利要求41的结构，其中表层的一面与废料层粘接，芯层与位于表层背面上的废料层粘接，RF敏感层与废料层背面上的芯层粘接。
44.权利要求43的结构，还包括插入芯层和RF敏感层之间的第二芯层。
45.权利要求41的结构，其中RF敏感层的第二组分选自超低密度聚乙烯和聚丁烯-1，射频敏感聚合物为二聚体脂肪酸聚酰胺，RF敏感层的第四组分为SEBS嵌段共聚物，第一芯层包括：
第一组分：聚烯烃，
第二组分：选自超低密度聚乙烯、和聚丁烯共聚物；及
第三组分：相容剂。
46.一种多层结构，它包括：
一层由聚丙烯共聚物与占表层重量0-20％的苯乙烯乙烯-丁烯苯乙烯嵌段共聚物组成的表层；
一层射频(“RF”)敏感层，RF层的组成为：第一组分基于丙烯的聚合物，含量占RF层重量的30-60％，第二组分非丙烯聚烯烃，含量占RF层重量的25-50％；第三组分射频敏感聚合物，含量占RF层重量的3-40％；和第四组分聚合物相容剂，含量占RF层重量的5-40％；
一层位于表层和RF层之间的第一芯层；
一层与芯层粘接的阻挡层。
47.权利要求46的结构，其中表层的一面与阻挡层粘接，芯层与位于表层背面上的阻挡层粘接，RF敏感层与位于阻挡层背面上的芯层粘接。
48.权利要求41的结构，其中表层的一面与芯层粘接，阻挡层与表层背面上的芯层粘接，RF敏感层与芯层背面上的阻挡层粘接。
49.权利要求47的结构，其中第二芯层插入芯层与RF敏感层之间。
50.权利要求46的结构，其中RF敏感层的第二组分选自超低密度聚乙烯和聚丁烯-1，射频敏感聚合物为二聚体脂肪酸聚酰胺，RF敏感层的第四组分为SEBS嵌段共聚物，其中阻挡层选自乙烯乙烯醇类和高玻璃态的聚酰胺类。
51.权利要求46的结构，它还包括位于阻挡层各面上的两个粘合层。
52.权利要求51的结构，其中粘合层为改性的乙烯和丙烯共聚物。
53.一种多层结构，它包括：
一层由聚丙烯共聚物与占表层重量0-20％的苯乙烯乙烯-丁烯苯乙烯嵌段共聚物组成的表层；
一层具有一面与表层相粘接的芯层，和
一层与位于表层背面上的芯层粘连的射频(“RF”)敏感层，RF层的组成为：高熔点的柔韧的聚丙烯，含量为RF层重量的30-60％；射频敏感聚合物，含量为RF层重量的5-20％；和聚合物相容剂，含量为RF层重量的5-20％。
54.权利要求53的结构，其中RF敏感层的射频敏感聚合物为二聚体脂肪酸聚酰胺，聚合物相容剂为苯乙烯乙烯-丁烯苯乙烯嵌段共聚物。
55.权利要求54的结构，其中芯层包括：
第一组分：聚烯烃；
第二组分：选自超低密度聚乙烯、和聚丁烯共聚物；及
第三组分：相容剂。
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CN100348412C (zh) * 2000-02-07 2007-11-14 巴克斯特国际公司 用于医用级产品的多层聚合物基防渗结构
CN1642736B (zh) * 2002-03-21 2010-12-08 巴克斯特国际公司 医用产品的基于多层聚合物的薄膜结构
CN100434125C (zh) * 2003-10-17 2008-11-19 德国弗雷泽纽斯医疗保健股份有限公司 具有更可靠可剥离性的医用无pvc多层管、及其制造方法和用途
CN102574383A (zh) * 2009-03-24 2012-07-11 巴克斯特医疗保健股份有限公司 具有坚韧核心层的非pvc薄膜
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
CN117603523A (zh) * 2024-01-23 2024-02-27 青州市鲁冠塑料有限公司 一种漫散射树脂组合物及其在散射膜中的应用

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