CN1077028C - 多层的、无卤素的、可热压处理的屏障膜 - Google Patents
多层的、无卤素的、可热压处理的屏障膜 Download PDFInfo
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- CN1077028C CN1077028C CN96190822A CN96190822A CN1077028C CN 1077028 C CN1077028 C CN 1077028C CN 96190822 A CN96190822 A CN 96190822A CN 96190822 A CN96190822 A CN 96190822A CN 1077028 C CN1077028 C CN 1077028C
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Abstract
一种多层膜结构,包括表面层,屏障层,射频敏感层,其第一聚烯烃重量为30-60%,第二聚烯烃重量为25-50%,射频敏感聚合物重量为3-40%,苯乙烯和烃嵌段共聚物重量为5-40%,以密封材料层的重量为基础计算。
Description
技术领域
该发明总的说来涉及制造医用产品的材料,更具体地说是与用于制造诸如塑料容器和医用管子的膜材料有关。
背景技术
在医学领域里,有用的药剂收集加工后,储存于容器中,运送到各处,最终通过管子,灌注到病人体内,达到治病的目的。这样,对于制造容器材料的性质,就有一些特殊综合要求。例如,容器必须透明,以便直观地检查溶液中有无颗粒杂质。容器壁的材料必须充分可塑,这样才能在破开容器壁灌注溶液时,不致让空气进入容器中。该材料必须能在广泛的温度范围内使用。它必须能在低温下保持可塑性和柔韧性,因为有些预先混合的药液,为减少其降解,要在-25℃—-30℃的低温下储存和运输。大多数的医药包装和营养品,出厂前要经过高温灭菌。容器在蒸汽中灭菌的典型温度是121℃,并在高压下进行,这就要求容器的材料经得住高温消毒处理,在这样的温度压力下,不致被严重损坏(耐热变性)。
为了使这种材料能容易地制成有用的物品,此材料应能用射频(RF)封接,RF的频率一般约为27.12MHz。因此,该材料应具有充分的介电损耗性质,可将RF能转变以热能。
对此材料的进一步要求,是减少用它制成的物品用后对环境的污染。对于用后丢弃在地面的废物,要求尽量减少材料的用量并避免低分子量的可沥滤的组分掺入此材料中。此材料应较轻,有较好的机械强度。再进一步的要求,是此材料制成物品用后的废弃物,通过热塑重加工,可再循环制成新的有用物品。
对于那些用后焚化的容器,因此,要求采用的材料有助于消除它对生物产生的危害。要减少,或完全杜绝无机酸或其它对自然界有害的、有刺激性和腐蚀性的物质的形成。若无法消除这些有害物质,则焚化办法就不宜采用。此材料中应不含或仅含很少的低分子量添加剂,例如增塑剂,稳定剂及类似物。这些低分子量物质会被释放到药剂中,生物体液里或人体组织内,给病人造成危害;或者污染容器中的物质;或者污染利用此类材料制成的装置中加工的物质。对于输液用的容器,释放的污染物,可能通过输液进入人体,给病人造成损伤,甚至致死。
传统的柔韧聚氯乙烯(“PVC”)材料,能满足上述要求中的一部分,有些情况下,能满足上述要求中的大部分。在制作满足上述要求的装置方面,聚氯乙烯也有其独特的优点,成本最低的材料之一。但聚氯乙烯焚化后会产生有害的氯化氢(遇水即成盐酸)。腐蚀焚化器。聚氯乙烯有时含有增塑剂,它可能通过沥滤而进入与聚氯乙烯材料接触的药物中、生物体液中或人体组织里。至今已设计多种材料来替代聚氯乙烯,但是其中大多数太昂贵,无法实施,并且仍不能满足上述所有的要求。
曾有种种打算,开发一种膜材料来代替聚氯乙烯,但都因某些因素而失败。例如,美国专利4,966,795公开了一种多层膜的组成,这种膜能耐蒸汽消毒的高温,但不能用射频(RF)介电加热来封接,这样就无法用快速、廉价、安全可靠的方法来加工成装置。欧洲专利申请EP0310143A1公开了一种多层膜,它能满足上述绝大部分要求,也能用射频来封接。但该膜的各组分是通过辐射来交联的,因此不能用标准的热塑过程,重新加工利用。此外,由于辐照,释放出相当量的醋酸混入于材料中。在蒸汽消毒时,这些醋酸就会迁移到被包装的材料中,成为污染物;或改变被包装物的pH值,使之成为一种潜在的、与包装物发生反应的化学试剂、也可能成为一种催化剂,加速被包装物的降解。
本发明的主要目标是要创新一种热塑材料,其各项性能要优于到目前为止已知的各种类似材料,包括市场已出售的类似材料。这种材料应在广泛的温度范围内(从环境温度到冷冻室的温度)具有柔韧性、延展性和应变恢复性,而不仅仅是在室温下,才具有这些性质。此材料应充分透明,以便于直观地检查颗粒杂质,同时能耐蒸汽消毒的高温(121℃)。此材料在遭受严重扭歪时,不出现扭曲的白印而影响实质性能和外观。另一个目标是要求此材料可用RF来封接。本发明的另一个目标是,创新的材料实际上不含可沥滤的低分子添加剂,在焚化处理用后的废弃物时,不产生显著量的腐蚀性无机酸。另一个目标是此材料制成的器件使用后,可以用标准的热塑处理方法,再循环利用。还要求此材料在加工过程中产生的碎屑,回收重新粉碎后,合并到新的原料中使用,以减少浪费,降低成本。最后,此材料在价格上,应能与正在使用的聚氯乙烯相接近。
当一种以上的聚合物掺到一起,形成一种合金组合物时,要达到全部上述各项要求是很困难的。例如,在大多数情况下,合金组合物会散射光线,这样它就不会是透明的。光散射强度(浊度法测量)取决于各组分的颗粒度范围(μ量级)和组合物中各组分折光系数接近的程度。一般说来要选择一些组分,它们既能被加工到很细的颗粒度,折光系数又相差很小,这是很困难的。
这种材料用于医药和食品包装时,除了满足上述各项要求外,还希望它能形成一个膜,具有屏障性质,阻止氧气、二氧化碳和水的渗透。对于包装的医药用的溶液,其中的药物或溶质具有所需的浓度,这层膜屏障应能阻止水的渗出,维持浓度一定。在含有缓冲液的溶液里,如常用的碳酸氢纳缓冲液,这层膜屏障应能阻止二氧化碳散失、维持pH值不变。对于含蛋白和氨基酸的医用溶液,这层膜屏障阻止氧气进入,因为氧能氧化蛋白质和氨基酸,使之失效。在食品包装方面,这种膜屏障能保持食品内香味不散失,也不致影响该食品周围其它食品的气味。
这种膜能用来制造容器和其它医用装置,用于储存,加工处理那些易与氧反应的经过肠道或不经肠道服用的溶液。很多这类溶液,要用这种膜制成的容器来储存和运送,溶液装入容器后,进行高温消毒。
目前储存易氧化物质(例如维生素类)的容器是用叠层的、以箔和/或聚偏二氯乙烯(PVDC)为屏障层的膜材料制成。这些叠层膜在价格上与等量的本发明的复合薄膜相比,要高得多。另外,这些叠层膜和PVDC膜对射频能量不敏感,因此不能用射频技术来封接。这些衬箔的容器,即使利用尼龙来提高其韧性,它却仍保留有易碎的结构,容易褶曲破裂,产生针孔,且经不起碰撞。此外,包含PVDC的膜,含有大量可萃出的物质,这些物质来源于制作叠层膜时用的粘合剂。PVDC(聚偏二氯乙烯)也含氯,因此,它的废弃物可能污染环境。
亚乙基乙烯基醇是另一个有效的屏障物质。但它的熔点低,经不起高压灭菌的温度。在需要消毒的场合难以使用。
本发明提供的材料,可以解决上述各种及其他问题。
本发明的描述
本发明公开了多层聚合物结构。这种多层结构聚合物可用于制造医用器件,例如储存医用溶液或血制品的容器,血袋及有关物品,以及其它由多层结构制成的产品。
制备具有下列物理性质的多层膜,是本发明的目的之一:(1)按ASTMD-882测量时,其机械模量应少于2.758×108Pa,少于1.724×108Pa更好,(2)经初始扭曲变形20%以后,其长度恢复大于或等于70%,大于或等于75%更好,(3)按照ASTMD-1003测量0.23mm厚度的材料,其浊度应少于30%,而小于15%则更好,(4)在1Hz和加工温度下测量的耗损角正切值大于1.0,而大于2.0则更好,(5)卤素含量少于0.1%,少于0.01%则更好,(6)低分子量水溶部分应少于0.1%,最好少于0.005%,(7)在25-250℃和1-60 MHz之间,最大介电损耗大于或等于0.05,而最好是大于或等于0.1,(8)在121℃和1.86×105Pa负载下,测量耐热压性,其样品蠕变应少于或等于60%,最好少于或等于20%,(9)在20时/分(50cm/分)速度下拉紧,使伸长100%,观察无应变白印产生。
本发明的多层结构包含着一个表面层,它是由聚丙烯共聚物和苯乙烯与烃嵌段共聚物组成的。这层最好由丙烯和乙烯-丁烯-苯乙烯(SEBS)共聚物构成这个表面层重量的0-20%。有一个射频(RF)敏感层附着在表面层上。射频层包括四个组分,第一个组分是聚丙烯聚合物,第二个组分是非丙烯聚烯烃(即其中不含丙烯的重复单元),第三个组分是射频敏感聚合物,第四个组分是聚合物增容剂。多层结构的另一种形式是,附加层如中心层,碎片层和屏障层被加到表面层和射频层,使整个的膜结构增添提高了性能。
共同提交的美国专利申请No.1417 P030内容主要是关于RF(射频)层,这里我们引为参考。本发明多层膜结构提供附加的特征,即单独的RF层是不提供的。多层膜附加的特征包括光泽的外表面和较薄的外表面厚度。此外,多层膜结构还改进了蒸汽屏障性质,有较大的强度和透明度,且更清洁,减少了溶出物对所包装物品的污染。
中心层***在表面层和RF层之间,由三种组分构成。较好的比例是,第一种组分是聚丙烯,占中心层的40%;第二种组分是超低密度聚乙烯(“ULDPE”),占中心层重量的50%;第三层是苯乙烯-烃嵌段共聚物,若是SEBS嵌段共聚物则更好,占中心层重量的10%。整个中心层厚度是0.10mm。
从经济角度考虑,还应当把加工过程中回收的碎屑重新磨碎掺入到制造膜的原料中去。生产过程中产生的碎屑量是不容忽视的,作为原料使用可降低成本。重新磨碎的碎屑可以作为一个附加的独立层,放在表面层和RF层之间,或作为一种附加的成分掺入中心层中。无论怎么用,碎屑材料的再加工都节省可观的资源,都会降低成本。
为了增加膜结构的气体屏障性质,需要在表面层和RF层之间放一个屏障层。屏障可附于外周层,利用粘着层来粘接。屏障层可自亚乙基乙烯基醇类中来选择,例如市场上销售的Evalca(Evalca Co.),高玻璃化或结晶聚酰胺,如Sclar PA_(Dupont Chemical Co.)高腈含量的丙烯腈共聚物,如英国石油公司(British Petroleum)出售的Barex_(商标名)。具体讲屏障结构将由三层组成:一个由聚丙烯构成的表面层,其厚度为0.013-0.10mm,厚度为0.025-0.076mm更好,厚度为0.025mm最好;一个由亚乙基乙烯基醇构成的屏障层,其厚度范围为0.0076-0.13mm,厚度范围为0.038-0.10mm更好,厚度为0.051mm最好;一个RF敏感层,其厚度范围为0.051-0.20mm,厚度范围为0.076-0.15mm更好,而厚度为0.10mm最好。这种结构的膜能经受高压热消毒,而不致损伤亚乙基乙烯基醇的完整性。
通过连接层的隔离将屏障层分成多层薄屏障层组成的多层次堆叠层,可提高阻止氧、水和二氧化碳的渗透性。一个简单的屏障层,厚度为0.076mm,可分成2-10个屏障层。这10个屏障层,通过连接层分开,每层0.0076mm。这种多层屏障夹芯结构的膜应相似于刚才上面讨论的屏障层膜结构,它有一个由聚丙烯构成的表面层,一个连接层,一个包括1-10个连续的屏障层和连接层的夹芯式的多层屏障,接着是RF活化层或密封层,它由聚烯烃构成,如聚乙烯或聚丙烯。
具有上述组成和结构的膜,有柔韧性,透明,不产生扭曲白印,能耐蒸汽或辐射消毒。且此膜适合于医药应用,因为构成膜的组分最少溶入与之接触的体液或包装物品中。此膜焚化后,不产生危害环境的有害物质。此膜的价格允许其作为PVC(聚氯乙烯)的替代品。
下面通过附图清楚地描述本发明的特点和优点,并详细地介绍由此膜制成的较好的器件。
附图的简要说明
图1是本发明的两层膜结构的断面图;
图2是本发明的三层膜结构的断面图,它比图1多出一个中心层;
图3是比图1多一个溶液接触层的膜的断面图;
图4是本发明的四层膜结构的断面图,它有一个碎屑材料构成的独立层,位于表面层和中心层之间,
图5的膜结构断面图,有一个由重新磨碎的碎屑构成的独立层,在中心层和RF层之间,
图6的膜结构断面图,有一个由重磨碎屑构成的独立层,将中心层劈开成两层,
图7是本发明的7层膜结构的断面图,它包括在中心层与RF层之间的一个屏障层和两个连接层,
图8与图6相同,只是屏障层安排在中心层与表面层之间,
图9的膜结构断面图,其屏障层划分开中心层,
图10是利用本发明的一种结构膜制成的容器,
图11的膜结构断面图有一个表面层,一个屏障层和一个RF层,
图12的膜结构断面图与图11的相比,是在各基本层之间加入了连接层,
图13是多层膜结构图,它有一个聚丙烯层,划分开RF层,以及
图14的多层膜结构图,其屏障层被划分成2-10层。
实施本发明的最佳方案
虽然本发明可以多种形式实施,这里将详细讨论体现本发明的较好的装置,作为解释其基本原理,但本发明不局限应用于这些装置。
按照本发明,提供适合于上述各项要求的多层结构的膜。
图1表明了一个两层膜结构10,它有表面层12和射频敏感层14。表面层12提供耐热变性,和耐磨损性能,一般用聚丙烯,而用聚丙烯共聚物与苯乙烯及烃类嵌段共聚物混合物来构成则更好。最好是表面层12由聚丙烯共聚物与SEBS嵌段共聚物混合构成,占重量百分数为0-20%,表面层12厚度在0.0051-0.076mm之间。
本发明的RF敏感层14,在温度范围为环境温度-250℃、频率范围为1-60MHz时,其介电耗损应大于0.05。RF层14有4个组分。RF层14使本发明的多层膜具有可RF密封性,柔韧性,耐热变性以及同膜结构10的相容性。RF层14的第一个成分是自聚丙烯共聚物中选取,而最好是选自丙烯、α-烯烃无规共聚物(“PPE”)。丙烯α-烯烃无规共聚物具有所需要的刚性、且在121℃高压釜灭菌时不致变形。但PPE本身刚性太强,不适合柔韧性要求,只有把它与某些低模量的聚合物合金化使用,才能获得较好的柔韧性。
这些低模量共聚物包括,以乙烯为基础的共聚物如乙烯与醋酸乙烯酯共聚物(“EVA”),乙烯与α-烯烃共聚物或者所谓的超低密度的聚乙烯(低于0.90kg/L)(“ULDPE”)。这些ULDPE包括市售的TAFMER_(商标,Mitsui石油化学公司),产品编码A485,Exact_(Exxon化学公司),产品编码4023-4024,和Insite_技术聚合物(Dow化学公司)。此外,聚丁烯-1(“PB”)如Shell化学公司以产品编码PB-8010,PB-8310出售的产品;由SEBS嵌段共聚物制成的热塑弹性体(Shell化学公司),聚异丁烯(“PIB”),如以VistanexL-80,L-100,L-120,L-140编码的产品(Exxon化学公司),乙烯丙烯酸烷基酯,丙烯酸甲酯共聚物(“EMA”)如以EMAC 2707,和DS-1130编码的产品(Chevron公司),丙烯酸正丁基酯(“ENBA”)(产品名称,Quantum化学公司)等是可接受的共聚物。乙烯共聚物如丙烯酸和甲基丙烯酸共聚物以及它们的部分中性盐和离子性树脂,如PRIMACOR_(Dow化学公司)和SURYLN_(E、I、DuPontde Nemours & Company)也是可接受的。典型的乙烯为基础的共聚物的熔点低于110℃,不适合121℃下的高温高压消毒。另外,各个组分的重量比例在一定范围内,才能同时满足柔韧性和耐高温高压消毒的要求。
第一个成分是选自聚丙烯类似物与α-烯烃的均聚物和无规共聚物,约占膜重量的30-60%,35-45%更好,而45%最好。例如,丙烯和乙烯无规共聚物作为第一个成分比较合适,其中乙烯含量占丙烯的0-6%,而占2-6%更合适。
RF层14的第二个成分是使基具有柔韧性和低的导热性,这个成分选自不含丙烯重复单元的聚烯烃(非丙烯基的聚烯烃)。这就包括乙烯共聚物(包括超低密度聚乙烯)、聚丁烯、丁烯与乙烯共聚物、乙烯乙酸乙烯酯共聚物(其中乙酸乙烯酯的含量约占18-50%),乙烯丙烯酸甲酯共聚物(其中丙烯酸甲醋约占20-40%)、乙烯丙烯酸正丁酯共聚物(其中丙烯酸正丁酯含量约占20-40%)。乙烯丙烯酸共聚物(其中丙烯酸含量大于或接近15%)。这些产品的例子有TafmerA-4085(Mitsui公司),EMAC DS-1130(Chevron公司),Exact 4023,4024和4028(Exxon公司)。作为第二个成分,上述产品中较好的是ULDPE(超低密度聚乙烯),市售的有TAFMER A-4085(Mitsui石油化学公司)或聚丁烯-1,PB8010和PB8310(Shell化学公司),第二个成分约占膜重的25-50%,35-45%较好,而最好是45%。
上述RF层14的第一和第二个成分可以用单一的成分来代替,这些单一成分选自具有高熔点和柔韧性的烯烃,例如聚丙烯FPO(Rexene公司)。该成分的熔点应高于130℃,机械模量低于1.38×108Pa,此成分应占RF层重量的30-60%。
为了使RF层14有介电耗损,膜结构10包括的第三个成分是一些已知的高介电耗损材料。例如充分的高共聚单体成分EVA和EMA,在27MHz时呈现出显著的介电耗损性质,使膜能用RF封接。聚酰胺一类材料和亚乙基乙烯基乙醇(“EVOH”)共聚物(典型的生产办法是水解EVA共聚物)在适当的温度下都具有高的介电耗损性质。其它活性材料包括PVC(聚氯乙烯),二氯乙烯,氟化物、双酚A和3-氯-1,2-环氧丙烷的共聚物如PHENOXYS_(Umion Carbide)。但是,大量的含有氯和氟的共聚体焚化后产生污染环境的无机酸。因此,RF层14的第三个成分最好自聚酰胺中选取。
本发明用的聚酰胺最好选用由含碳原子数2-13的二胺缩合生成的脂族聚酰胺。由含有碳原子数2-13的二酸缩合反应生成的脂族聚酰胺。由二聚体脂肪酸和含有酰胺的共聚体(无规共聚,嵌段共聚或接枝共聚)缩合生成的脂族聚酰胺。
聚酰胺,例如尼龙,已广泛地应用于膜材料,因为它使膜具有耐磨的性能。但是尼龙很少用于制造与医药溶液接触的层,因为它们沥滤出污染物进入医用溶液中。但是本发明的申请者发现,各种二聚体脂肪酸的聚酰胺,例如MACROMELT和VERSAMID(产品名,Henkel公司)并不导致污染,最适用于RF层14的第三个成分。RF层14的第三个成分占其重量的3-40%,占7-13%较好,而占10%最好。
RF层14的第4个成分是给该层的极性和非极性成分之间增加互溶性。第四个成分选自苯乙烯-烃嵌段共聚物,SEBS嵌段共聚物则更好,SEBS是通过马来酸酐,环氧或羧基官能作用改性的。而最合适的第4个成分是用马来酸酐官能作用改性的SEBS嵌段共聚物。市售的这种产品有KRATON RP-6509(产品名,Shell化学公司)。第四个成分应占RF层14的重量为5-40%,占7-13%更好,而占10%最好。
RF层的第5个成分,是未经上述官能基改性的SEBS嵌段共聚物,例如KRATONG-1652(产品名,Shell化学公司)。此成分占RF层重量的5-40%,占7-13%更好,而占10%最好。
RF敏感层厚度范围为0.0254-0.23mm,0.13-0.20mm更好,0.13mm最好。表面层的厚度为0.0051-0.076mm,最好为0.013mm。
图2是本发明的另一个实例,中心层16插在表面层12和RF层14之间。中心层16给膜结构10提供耐热变性、柔韧性和膜成分之间的相容性。中心层厚度在0.013-0.25mm之间,而厚度在0.025-0.10mm之间更好。中心层16包含三个组分。第一个组分是聚烯烃,最好是聚丙烯,重量为中心层16的20-60%,35-50%更好,45%最好。
中心层16的第二个组分是自能提高中心层16的柔韧性的化合物中选取,包括ULDPE(超低密度聚乙烯),聚丁烯共聚体。中心层的第二个成分最好是ULDPE或聚丁烯-1,重量为中心层的40-60%,40-50%更好,而40%最好。
中心层16的第三个组分是选取那些能提高中心层16各成分相容性的化合物,包括苯乙烯-烃嵌段共聚物,而最好是SEBS嵌段共聚物。第三个成分的含量是中心层16的5-40%,7-15%较好,15%更好。
将加工过程中回收的碎屑材料重新磨细为原料,可给中心层16增加一个第四组分。这些磨细的碎屑分散于整个中心层16。加入的重量为中心层16的0-50%,10-30%较好,而3-12%最好。
图3表示出图1的膜或片状结构,包括一个溶液接触层17,粘附于RF层一侧,相对于表面层12。溶液接触层17包括三个组分,其成分和含量均为中心层16的前三个组分和重量百分数相同。溶液接触层17的厚度在0.0051-0.025mm之间,最好是0.025mm。
图4是多层膜结构的另一个实例,具有表面层12,中心层16和RF(射频)层14,还有一个碎屑组成的独立层20,在表面层12和中心层16之间。图5表示出中心层16和RF层20之间的独立的碎屑层。图6表示碎屑层20将中心层16划分为第一个中心层14a和第二个中心层14b。碎屑重磨构成的层的厚度在0.013-0.13mm之间,最好是0.025mm。
图7表示的是本发明的又一个实例,包括上述表面层12,中心层16,RF层14,屏障层26插在中心层16和RF层14之间,通过连接层28附着到屏障层26的相反的面。图8表示的是屏障层26介于中心层16和表面层12之间。图9表示屏障层26将中心层14划分成中心层14a和14b两部分。屏障层26提高了膜结构10的气体屏障性质。屏障层26选自亚乙基乙烯基乙醇一类化合物,如市售的Evalca(Evalca公司),高玻璃质或结晶聚酰胺,如SclarPA_(Dupont化学公司),英国石油公司(BritishPetroleum)出售的高腈含量的丙烯腈共聚物Barex_。屏障层26最好选取亚乙基乙烯基乙醇,其厚度范围是0.0076-0.038mm,最好是0.025mm。
连接层28可以选用改性的聚烯烃,改性的乙烯和丙烯共聚物,如市售的Admer(产品名Mitsui公司),是通过马来酸酐改性过的聚丙烯,Prexar(产品名,Quantum化学公司)和Bynel(产品名,Dupont公司),其厚度范围为0.0051-0.025mm,最好是0.013mm。
图11表示屏障层结构,有表面层12,屏障层26和RF层14。具表面层可用聚烯烃,包括聚丙烯(改性的和未改性的);聚乙烯,以及聚烯烃同苯乙烯和烃类嵌段共聚物的掺混物,如苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物。图12表明图11的结构加上任意的连接层28,插于主要层之间。表面层12厚度范围是0.013-0.10mm,0.025-0.076mm较好,而0.051mm最好。屏障层26的厚度范围是0.0076-0.13mm,0.038-0.10mm较好,最好是0.051mm。RF层14的厚度范围是0.051-0.20mm,0.076-0.15mm较好,最好是0.10mm。若有连接层,其厚度范围是0.0076-0.025mm,而0.0076-0.013mm更好,示于图11和12的屏障层结构是复合挤压的。
图13表示了另一种屏障结构,有一个聚丙烯层32,将RF层14对称地或不对称地分开。图13所示的结构有一个0.025mm聚丙烯表面层12,0.013mm连接层,0.051mm EVOH屏障层26,0.013mm连接层,0.051mm RF层14,0.025mm聚丙烯,0.051mm RF层14。作为不对称结构的例子,有一个0.025mm RF层14和0.051mm RF层。
图14表示另一个屏障层结构,有一个表面层12,连接层28和屏障夹芯层34,夹芯层34有2-10个亚层单元,包含有屏障层26和连接层28。此结构进一步包含RF层14,附于屏障夹芯层34。屏障夹芯层34与上述单个屏障层26的厚度范围相同。
上面各层,可经过复合挤压,复合挤压涂渍或其它可接受的方法加工。这些材料可用于制造静脉注射袋,如表示在图10上的,一般标明为30的一种。这些结构制造容器30可用通常方法来封接。例如用热模压和板压,接着是冷模压和板压,这在工厂是熟知的。这种结构的封接也可以用导电的或感应的热封接技术,其中包括RF(射频)技术。
上述用各种成分以一定比例结合的各种膜,可用下述方法对其进行检验:
(1)耐高压釜消毒的性能
通过测量样品的潜伸或样品长度的增加,来测定其耐高压釜消毒的性能,条件是在121℃,1.86×105Pa负荷下处理一小时内,样品的潜伸或增加的长度必须小于或等于60%。
(2)低温和环境温度下的延展性
(A)低温下的延展性
在撞击检验器中,安装一个以液氮致冷的低温冷却室,将7时×7时(18cm×18cm)的膜样品装在直径为6时(15cm)的环形样品座上。半球形的碰撞头,带有压力传感器,以高速(3米/秒)冲压予先调节的膜。作出压力-位移曲线,运用积分计算撞击能量。在撞击能量突然升高的温度,当断裂的供试材料由易碎的变成可延展时,高应变形态则作为低温下膜性能的量度(“L.Temp”)。
(B)机械模量和回缩
已知几何形状的高压釜消毒过的膜样品,安装到由液压自动装置驱动的机械检测器上,检测器带有十字头以拉伸样品。当十字头速度以10时/分(25cm/min)移动时,样品被拉伸20%。在这点上,十字头移动,然后反向移动。受力变形现象被记录于数字记录仪上。由受力-变形曲线的起始坡度求出弹性模量(“E(Kpsi)”)从超过样品面积大小,作为样品拉伸的百分率,求出回缩。
(3)RF可加工性
将面积约0.25时×4时(6.3mm×10cm)矩形黄铜模及与其相对放置的黄铜平板电极都接到Callahan 27.12MHz,2KW射频发生器上。当用两片待测材料的膜片于互相面对的溶液侧将模具密接后,施于不同幅度和持续时间的RF能。当RF周期过后,打开模具,通过手工拉开两片膜,检查封接效果,封接的强度(相对于膜的强度)和失败的类型(脱皮,撕裂或粘连)用于额定材料的RF响应程度。
另一个方法是将待测材料首先用阴极真空喷镀,镀上100A厚度的金或钯,使其表面有导电性。将它剪成圆形,装入到介电容量测量池内的两个平行电极之间。利用Hewlett Packard 4092自动RF桥,在不同频率(直到10MHz)和温度(直到150℃)下,测量介电常数和介电耗损。通过RF场产生的热,来计算介电耗损。通过计算或者与RF封接实验联系起来,则可获得操作时的最小介电耗损。
若用Callaha封接器进行RF封接,则下列排列等级被采用。
RF功率 | RF时间 | 封接强度 | 等级 |
80%80%80%60%50%30% | 101005030303 | 无可剥离可剥离强强强 | 012345 |
(4)透明度
将经过高压釜消毒步骤的样品剪成2英寸×2英寸(5cm×5cm)的方块,装到Hunter比色计上,按照ASTM D-1003测量其内部浊度水平,在这样厚度下,浊度水平应小于30%,最好小于20%(“浊度%”)
(5)应变白印
经高压釜消毒的样品,在20英寸/分(50cm/min)中等速度下拉紧,使伸长100%(即达到原长度的两倍),观察应变白印,若有则记为1,若无则记为0。
(b)环境适应性
膜的环境适应性包括三方面重要性质:(1)材料不含会被沥滤到土壤中去的低分子量的增塑剂;(2)能回收利用,性能不变。(3)焚化废弃物回收能量时,不产生显著量的无机酸危害环境(“Envir”)。同时膜的成分中卤素重量应少于0.1%。为便于将用后的膜熔化加工再利用,在加工温度下、1Hz时测量得到的损耗角正切值应大于1.0。
(7)溶液的适应性
溶液的适应性在这里是指包装溶液的膜的成分,不致污染溶液。(“S.Comp.”)膜中水溶性低分子量物质应少于0.1%。
(8)屏障性质
图11所示的屏障膜结构,在另外一个独立的实验室被检验。水蒸汽传输率(WVTR)表达单位是gm/100in2/24h(克/100英寸2/24小时)氧的传输率,分别在50%相对湿度(RH)时和80%相对湿度时表达。氧气和二氧化碳传输率表达单位是cc/100in2/24小时。
采用上述方法,对多层结合膜进行了综合检验,结果列于下表。
参考编号 | 层的类型 | 层的组成 | 模量×105Pa | 拉伸回缩 | %浊度 | 环境适应 | 高压釜消毒 | 介电损耗 | 低温 | 溶液适应 |
图1 | 表面层射频敏感层 | 0.013mm-100%Amoco PP共聚物84100.20mm-40%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE10%Shell KratonTMRP-650910%Henkel MacromeltTM630l | 1.72 | 75 | 10 | 可 | 可 | 3 | -35℃ | 可 |
图2 | 表面层中心层射频敏感层 | 0.013mm-100%Amoco PP共聚物84100.10mm-45%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE15%Shell KratonTMG16570.13mm-40%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE10%Shell KratonTMRP-650910%Henkel MacromeltTM6301 | 1.72 | 75 | 12 | 可 | 可 | 4 | -40℃ | 可 |
图3 | 表面层射频敏感层溶液接触表面层 | 0.013mm-100%Amoco PP共聚物84100.20mm-40%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE10%Shell KratonTMRP-650910%Henkel MacromeltTM63010.025mm-45%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE15%Shell KratonTMG1657 | 1.72 | 70 | 15 | 可 | 可 | 2 | -35℃ | 可 |
参考编号 | 层的类型 | 层的组成 | 模量×105Pa | 拉伸回缩 | %浊度 | 环境适应 | 高压釜消毒 | 介电损耗 | 低温 | 溶液适应 |
图4 | 表面层童磨层中心层射频敏感层 | 0.013mm-100%AmocoPP共聚物84100.025mm-100%重磨0.076mm-45%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE15%Shell KratonTMG16570.13mm-40%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE10%Shell KratonTMRP650910%Henkel MacromeltTM6301 | 4.31 | 75 | 16 | 可 | 可 | 4 | -35℃ | 可 |
图5 | 表面层中心层重磨层射频敏感层 | 0.013mm-100%Amoco PP共聚物84100.076mm-45%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE15%Shell KratonTMG16570.025mm-100%重磨0.13mm-40%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE10%Shell KratonTMRP6509 | 4.31 | 75 | 16 | 可 | 可 | 4 | 35℃ | 可 |
参考编号 | 层的类型 | 层的组成 | 模重×105Pa | 拉伸回缩 | %浊度 | 环境适应 | 高压釜消毒 | 介电损耗 | 低温 | 溶液适应 |
图6 | 表面层中心层重磨层中心层射频敏感层 | 0.0131.mm-100%Amoco PP共聚物84100.038mm-45%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE15%Shell KratonTMG16570.025mm 100%重磨0.038mm 45%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE15%Shell KratonTM16570.13mm 45%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE15%Shell KratonTMRP650910%Henkel MacromeltTM6301 | 1.72 | 75 | 16 | 可 | 可 | 4 | -35℃ | 可 |
图7 | 表面层中心层连接层屏障层连接层射频敏感层 | 0.013mm-100%Amoco PP共聚物84100.051mm-45%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE15%Shell KratonTMG16570.013mm 100%Bynel0.025mm 100%EVOH0.013mm 100%Bynel0.13mm 40%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE10%Shell KratonTMRP650910%Henkel MacromeltTM630l | 2.07 | 20 | 20 | 可 | 可 | 4 | -20℃ | 可 |
参考编号 | 层的类型 | 层的组成 | 模量×105Pa | 拉伸回缩 | %浊度 | 环境适应 | 高压釜消毒 | 介电损耗 | 低温 | 溶液适应 |
图8 | 表面层连接层屏障层连接层中心层射频敏感层 | 0.013mm-100%Amoco PP共聚物84100.013mm 100%Bynel0.025mm 100%EVOH0.013mm 100%Bynel0.051mm-45%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTM ULDPE15%Shell KratonTM G 16570.13mm 40%Solvay FortilineTM PP共聚物420840%Mitsui TafmerTM ULDPE10%Shell KratonTM RP650910%Henkel MacromeltTM 6301 | 2.07 | 70 | 20 | 可 | 可 | 3 | -20℃ | 可 |
参考编号 | 层的类型 | 层的组成 | 模量×105Pa | 拉伸回缩 | %浊度 | 环境适应 | 高压釜消毒 | 介电损耗 | 低温 | 溶液适应 |
图9 | 表面层中心层连接层屏障层连接层中心层射频敏感层 | 0.013mm-100%Amoco PP共聚物84100.025mm-45%Solvay FortilineTMPP共聚物420840%Mitsui afmerTMULDPE15%Shell KratonTMG16570.013mm 100%Bynel0.025mm 100%EVOH0.013mm 100%Bynel0.025mm 45%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTM ULDPE0.13mm 40%Solvay FortilineTMPP共聚物420840%Mitsui TafmerTMULDPE10%Shell KratonTMRP650910%Henkel MacromeltTM6301 | 2.07 | 70 | 20 | 可 | 可 | 3 | -20℃ | 可 |
图11 | 表面层连接层屏障层连接层射频敏感层 | 0.013mm 0.013mm-100%Amoco PP共聚物84100.013mm 0.013mmADMER RQF551A0.076mm 100%EVOH0.013mm ADMERRQF55180.013mm 40%SolvayFortilineTMPP共聚物420840%MitsuiTafmerTM ULDPE10%ShellKratonTMRP650910%HenkelMacromeltTM 6301 | O2传输速率(相对湿度50%)0.0171 | O2传输速率(相对湿度80%)0.0708 | 水蒸汽传输速率0.0409 | Co2传输速率少于0.0645 |
应当了解,不离开本发明的精神和基本特征,实施本发明还可能采取其它形式。现在举的这些例子和方案,仅为阐述本发明的内容,本发明内容不限于这些例子。
Claims (16)
1.一种多层结构,包括:
表面层;
屏障层;和
射频敏感层,该层有第一聚烯烃,以射频敏感层为基计,重量比为30-60%,第二聚烯烃,以射频敏感层为基计,重量比为25-50%,射频敏感聚合物,重量比为3-40%,苯乙烯和烃嵌段共聚物,以射频敏感层为基计,重量比为5-40%。
其特征在于屏障层是具有2-10个单元的屏障层和一个连接层的屏障夹芯层。
2.权利要求1的结构,还在表面层和屏障夹芯层之间包含一个连接层。
3.权利要求1或2的结构,其中屏障层材料选自乙烯乙烯基醇和高玻璃质或结晶聚酰胺。
4.权利要求3的结构,其中表面层包括聚丙烯共聚物,其具有苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物,该共聚物占聚丙烯重量的0-20%。
5.权利要求4的结构,其中,第一聚烯烃是聚丙烯,第二聚烯烃是选自乙烯共聚物,包括超低密度聚乙烯,聚丁烯-1,丁烯乙烯共聚物,乙烯醋酸乙烯酯共聚物,醋酸乙烯酯含量在18-50%,乙烯丙烯酸甲酯共聚物,丙烯酸甲酯含量约为20-40%,乙烯丙烯酸正丁酯共聚物,丙烯酸正丁酯含量为20-40%,乙烯丙烯酸共聚物,丙烯酸含量大于15%。
6.权利要求4的结构,其中,射频敏感聚合物选自下列物质:聚酰胺;乙烯醋酸乙烯酯共聚物,醋酸乙烯酯重量为18-50%;乙烯丙烯酸甲酯共聚物,丙烯酸甲酯重量为20-40%;乙烯乙烯基醇,乙烯基醇重量为15-70%。
7.权利要求6的结构,其中,苯乙烯和烃的嵌段共聚物是苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物。
8.权利要求7的结构,其中,还包括两个连结层,一个是处于表面层和屏障层之间,另一个处于屏障层和射频敏感层之间。
9.以上任一权利要求的结构,其中,每个连接层是选自改性聚烯烃,改性的聚丙烯和聚乙烯共聚物。
10.权利要求8的结构,其中,射频共聚物是二聚体脂肪酸聚酰胺。
11.权利要求8的结构,其中,表面层厚度范围为0.0127-0.1016mm;屏障层厚度范围是0.0076-0.127mm,射频敏感层厚度范围为0.0508-0.2032mm,连接层厚度范围均为0.0076-0.0254mm。
12.根据以上任一权利要求的多层结构,包括:
第一聚丙烯层,其将射频敏感层划分为第一射频敏感层和第二射频敏感层。
13.权利要求12的结构,其中,第一和第二射频敏感层厚度基本上相同。
14.权利要求12的结构,其中,第一和第二射频敏感层具有不同的厚度。
15.权利要求12的结构,其中,各层是按次序连续堆叠的。
16.权利要求12的结构,附属于权利要求5,其中第一聚烯烃是第二聚丙烯。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US48476795A | 1995-06-07 | 1995-06-07 | |
US08/484,767 | 1995-06-07 |
Publications (2)
Publication Number | Publication Date |
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CN1159167A CN1159167A (zh) | 1997-09-10 |
CN1077028C true CN1077028C (zh) | 2002-01-02 |
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CN96190822A Expired - Fee Related CN1077028C (zh) | 1995-06-07 | 1996-04-30 | 多层的、无卤素的、可热压处理的屏障膜 |
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US (1) | US5993949A (zh) |
EP (1) | EP0775052B1 (zh) |
JP (2) | JP3919815B2 (zh) |
CN (1) | CN1077028C (zh) |
CA (1) | CA2195628C (zh) |
DE (1) | DE69615505T2 (zh) |
WO (1) | WO1996040512A1 (zh) |
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- 1996-04-30 DE DE69615505T patent/DE69615505T2/de not_active Expired - Fee Related
- 1996-04-30 CA CA002195628A patent/CA2195628C/en not_active Expired - Fee Related
- 1996-04-30 WO PCT/US1996/005965 patent/WO1996040512A1/en active IP Right Grant
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1997
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Also Published As
Publication number | Publication date |
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JP3919815B2 (ja) | 2007-05-30 |
DE69615505T2 (de) | 2002-05-16 |
CN1159167A (zh) | 1997-09-10 |
WO1996040512A1 (en) | 1996-12-19 |
US5993949A (en) | 1999-11-30 |
DE69615505D1 (de) | 2001-10-31 |
JP2006123556A (ja) | 2006-05-18 |
CA2195628C (en) | 2005-04-19 |
JPH10503982A (ja) | 1998-04-14 |
CA2195628A1 (en) | 1996-12-19 |
EP0775052B1 (en) | 2001-09-26 |
JP4016044B2 (ja) | 2007-12-05 |
EP0775052A1 (en) | 1997-05-28 |
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