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CN1118367C - 多层膜及容器 - Google Patents

多层膜及容器 Download PDF

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Publication number
CN1118367C
CN1118367C CN99814444A CN99814444A CN1118367C CN 1118367 C CN1118367 C CN 1118367C CN 99814444 A CN99814444 A CN 99814444A CN 99814444 A CN99814444 A CN 99814444A CN 1118367 C CN1118367 C CN 1118367C
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CN
China
Prior art keywords
layer
density
weight
multilayer film
ethylene
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CN99814444A
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English (en)
Other versions
CN1330588A (zh
Inventor
片冈完
传宝孝之
须崎元晶
田中达也
樫山薰明
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Otsuka Pharmaceutical Factory Inc
Original Assignee
Otsuka Pharmaceutical Factory Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Otsuka Pharmaceutical Factory Inc filed Critical Otsuka Pharmaceutical Factory Inc
Publication of CN1330588A publication Critical patent/CN1330588A/zh
Application granted granted Critical
Publication of CN1118367C publication Critical patent/CN1118367C/zh
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/04—Homopolymers or copolymers of ethene
    • C08L23/08—Copolymers of ethene
    • C08L23/0807—Copolymers of ethene with unsaturated hydrocarbons only containing more than three carbon atoms
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29C66/73—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/731—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the intensive physical properties of the material of the parts to be joined
    • B29C66/7313—Density
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    • B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Laminated Bodies (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Bag Frames (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Tubes (AREA)
  • Wrappers (AREA)
  • Thermally Insulated Containers For Foods (AREA)
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Abstract

本发明提供第1、第3以及第5层为密度0.930～0.950g/cm3的乙烯·α-烯烃共聚物，第2层及第4层为35～55重量%的密度0.900～0.930g/cm3聚丙烯、40～60重量%的密度为0.860～0.900g/cm3的乙烯·α-烯烃系弹性体以及2～8重量%的密度0.955～0.970g/cm3的高密度聚乙烯组成的混合树脂组成的多层膜以及由该膜成形的容器(输液袋等)。所述多层膜以及容器可用于医疗用。

Description

多层膜及容器
技术领域
本发明涉及多层膜和使用该膜而成形的容器，更详细地说，涉及在医疗领域中特别作为药液及血液等的收容用材料使用的多层膜及其容器。
背景技术
输液袋等医疗用挠性塑料制的容器为了提高其性质，人们正在尝试使用多层膜作为原料。已有的医疗用多层容器例如可以由以下的聚乙烯系树脂制成。1)特开昭62-64363号公报
由直链状低密度聚乙烯制成，是内外层的密度为0.920g/cm3以上、中间层的密度小于0.920g/cm3的3层袋。2)特开昭63-286333号公报
由直链状低密度聚乙烯构成的3层，内外层的密度为0.910～0.940g/cm3、中间层的密度为0.880～0.905g/cm、两者的密度差为0.01g/cm3以上的容器。3)特开昭63-277365号公报
外层为密度0.920g/cm3以上的直链状低密度聚乙烯、中间层为密度0.915g/cm3以下的直链状低密度聚乙烯、内层为密度0.918g/cm3以上的支链状低密度聚乙烯的3层袋。4)特开平4-266759号公报
由内外层为密度0.930g/cm3以下的长链支链状低密度聚乙烯中混合5～40％的密度0.945g/cm3以上的高密度聚乙烯，中间层为密度0.920g/cm3以下的直链状低密度聚乙烯中混合15％以下的上述高密度的树脂组成的3层以上的袋。
所述已有的医疗用多层容器具有如下的几个缺点。
(i)由于膜的内外层由低密度的聚乙烯树脂构成，所以耐热性不够，通过高压蒸汽灭菌及热水灭菌等的高温条件下的灭菌，密封强度及坠落强度降低。
(ii)所述高温条件灭菌后易引起粘连(耐粘连性差)
(iii)由于膜的强度低，需要加大壁厚。
(iv)由于膜的拉伸强度不充分，所以不能提高制袋速度。
(v) 热封时不能提高加热的温度，所以不能在短时间内密封(密封性差)。
(vi)灭菌后等膜的透明性及柔软性低下。
另外，制造如图1所示的医疗用容器(输液袋)10的情况，将膜22的2片重合，使开口部件(开口)20插入2片膜22中间，在该状态下对膜22的周边进行热封。
但是，如图2所示，在入口部件20的邻接部，膜22有大的弯曲，所以使用现有的多层膜进行热封时，在弯曲部24膜延伸，膜厚变薄，有可能产生针孔。
因此，本发明的目的在于提供耐热性、耐粘连性、强度、密封性、透明性以及柔软性优良，而且在热封时可以防止在弯曲部发生针孔的多层膜以及容器。
发明的概述
本发明者为了解决上述问题，反复进行研究，将中间层做成3层结构，而且对各层配的树脂或混合树脂和多层膜整体的层的组合进行了各种研究，结果发现不损害透明性、柔软性等的基本性质，可以提高耐热性的全新的树脂组成和其配置的组合，直至完成本发明。
即，本发明是由5层组成的多层膜，其特征在于，第1层及第5层是密度为0.930～0.950g/cm3的乙烯·α-烯烃共聚物，第2层为(B)密度0.910～0.930g/cm3的乙烯·α-烯烃共聚物30～60重量％、密度0.860～0.900g/cm3的乙烯·α-烯烃系弹性体35～65重量％、密度0.955～0.970g/cm3的高密度聚乙烯1～10重量％组成的混合树脂、或(C)密度0.900～0.930g/cm3的聚丙烯35～55重量％、密度0.860～0.900g/cm3的乙烯·α-烯烃系弹性体40～60重量％以及密度0.955～0.970g/cm3的高密度聚乙烯2～8重量％组成的混合树脂；第3层为所述(A)的乙烯·α-烯烃共聚物、或(D)密度0.900～0.930g/cm3的聚丙烯40～60重量％和密度0.860～0.900g/cm3的乙烯·α-烯烃系弹性体40～60重量％组成的混合树脂，而且第4层为所述(C)的混合树脂。
根据所述本发明的多层膜，在制造所述的医疗用容器(输液袋)10等时，可以充分地防止发生针孔。特别是由于可以在比较高的温度进行孔20的热熔接，而且在弯曲部24没有膜过延伸，所以可以确实地防止该弯曲部24上的针孔发生。
附图的简单说明
图1为显示本发明的容器的第1实施例的正面图。
图2为图1的A-A部分剖面图。
符号说明
  10容器
  20开口部件
实施发明的最佳方案
本发明的多层膜，在上述之中第2层为所述(C)的混合树脂，并且第3层为所述(A)的乙烯·α-烯烃共聚物混合树脂，考虑保持足够的耐热性，同时降低制造成本而优选。
另外，在本发明的多层膜中，所述(C)或(D)的混合树脂中使用的聚丙烯其熔体流动指数(MFR)为1～40g/10分(230)、其熔点为140～170℃者，考虑和其他的树脂的亲和性而优选。
本发明的多层膜中的各层厚度的比例，相对膜整体的厚度优选：第1层为5～15％、第2层为25～45％、第3层为2～15％、第4层为25～45％并且第5层为7～20％的范围；更优选：第1层为5～10％、第2层为30～45％、第3层为2～10％、第4层为30～45％并且第5层为7～15％的范围。
本发明的容器特征在于，使用所述的多层膜中的任何一种，将该多层膜的第1层作为外层，第5层作为内层而成形。
本发明的容器由于使用本发明的多层膜而成形，所以其耐热性好、耐粘连性、强度、密封性、柔软性及透明性良好，可以有效地防止针孔的发生。
下面对本发明的多层膜以及容器中使用的各层树脂和本发明的多层膜以及容器的制造方法进行详细说明。
另外，本发明中规定的物性值都是基于美国材料与试验协会(TheAmerican Society for Testing and Materials(ASTM))的规定进行测定的，密度基于ASTM D1505、熔体流动指数(MFR)基于ASTMD1238、熔点基于ASTM D2117进行测定。
首先，对本发明的多层膜中使用的树脂、共聚物以及弹性体进行说明。
[乙烯·α-烯烃共聚物以及乙烯·α-烯烃系弹性体]
在标题共聚物或弹性体中的α-烯烃例如有：丙烯、1-丁烯、1-戊烯、1-己烯、4-甲基-1-戊烯、1-庚烯、1-辛烯、1-壬烯、1-癸烯、1-十一烯、1-十二烯等碳3～12的α-烯烃。
标题共聚物或弹性体更适合使用由中低压法制造的、支链为单链的物质。
[高密度聚乙烯]
标题高密度聚乙烯除乙烯的均聚物之外，也可以是和α-烯烃的共聚物。作为α-烯烃例举所述例示的3～12个碳的α-烯烃。另外，含有α-烯烃的比例没有特别限定，通常设定为0.1～5摩尔％的范围。
本发明使用的高密度聚乙烯密度为0.955～0.970g/cm3的范围，其中MFR为1～30g/10分(190℃)的物质更适合。
[聚丙烯]
标题聚丙烯除丙烯的均聚物之外，也可以是含有少量乙烯及α-烯烃的共聚物。作为α-烯烃例如所述例示的1-丁烯等所述例示的α-烯烃中4～12个碳左右的α-烯烃。另外，含有α-烯烃的比例通常设定为10重量％以下的范围。
本发明使用的聚丙烯密度为0.900～0.930g/cm3的范围，其中更适合的是MFR为1～40g/10分(230℃)、熔点为140～170℃的范围的等规聚丙烯。
下面对构成本发明的多层膜的混合树脂进行说明。
[由30～60重量％的密度为0.910～0.930g/cm3的乙烯·α-烯烃共聚物、35～65重量％的密度为0.860～0.900g/cm3的乙烯·α-烯烃系弹性体以及1～10重量％的密度为0.955～0.970g/cm3的高密度聚乙烯组成的混合树脂(混合树脂(B))]
构成标题混合树脂(B)的乙烯·α-烯烃共聚物、乙烯·α-烯烃系弹性体以及高密度聚乙烯例如可以使用所述例示中其密度在标题范围内的物质。
所述乙烯·α-烯烃共聚物在标题范围中特别优选密度为0.915～0.925g/cm3，MFR优选1.0～5.0g/10分(190℃)、熔点优选115～125℃的范围的物质。
构成所述乙烯·α-烯烃系弹性体在标题范围中特别优选密度为0.870～0.890g/cm3，MFR优选0.1～2.0g/10分(190℃)的物质。
所述高密度聚乙烯优选MFR为1～30g/10分(190℃)物质。
构成标题混合树脂(B)的乙烯·α-烯烃共聚物、乙烯·α-烯烃系弹性体以及高密度聚乙烯的混合在标题范围内依次优选35～55重量％、40～60重量％以及3～8重量％。
构成标题混合树脂(B)的各树脂等的比率超出以上范围，则发生或者柔软性及耐热性降低、或者成形性变差、或者耐针孔性降低等的问题。
[由35～55重量％的密度为0.900～0.930g/cm3的聚丙烯、40～60重量％的密度为0.860～0.900g/cm3的乙烯·α-烯烃系弹性体以及2～8重量％的密度为0.955～0.970g/cm3的高密度聚乙烯组成的混合树脂(混合树脂(C))]
构成标题混合树脂(C)的聚丙烯、乙烯·α-烯烃系弹性体以及高密度聚乙烯例如可以使用所述例示中其密度在标题范围内的物质。
所述聚丙烯为其密度在标题范围中的物质，特别优选如前所述的MFR为1～40g/10分(230℃)、熔点为140～170℃的范围的等规聚丙烯。
乙烯·α-烯烃系弹性体以及高密度聚乙烯的密度、MFR或熔点的优选范围和所述相同。
构成标题混合树脂(C)的聚丙烯、乙烯·α-烯烃系弹性体以及高密度聚乙烯的混合比例在标题范围内依次优选40～50重量％、45～55重量％以及3～7重量％。
构成标题混合树脂(C)的各树脂等的比例超出以上范围，则产生或者柔软性及耐热性降低、或者成形性变差、或者耐针孔性降低等的问题。
特别是高密度聚乙烯的混合比例超过所述范围，则成形困难，不能得到膜。相反，低于所述范围，使用多层膜形成容器时，产生多个折痕等外观上的问题。
[由40～60重量％的密度为0.900～0.930g/cm3的聚丙烯、40～60重量％的密度为0.860～0.900g/cm3的乙烯·α-烯烃系弹性体组成的混合树脂  (混合树脂(D))]
构成标题混合树脂(D)的聚丙烯和乙烯·α-烯烃系弹性体使用所述例示中密度为在标题范围中的物质。
聚丙烯以及乙烯·α-烯烃系弹性体的密度MFR或熔点的使用范围如前所述。
构成标题混合树脂(D)的聚丙烯以及乙烯·α-烯烃系弹性体的混合比例在标题范围内依次优选40～50重量％以及50～60重量％。
构成标题混合树脂(D)的树脂等的比率超出以上范围，则产生或是强度降低、或是耐热性降低等的问题。
下面对本发明的多层膜的各层进行说明。
[第1层及第5层]
本发明的多层膜的第1层及第5层分别是形成医疗用容器的外层以及内层的层，第1层(外层)要求机械强度(特别是拉伸强度)及耐热性，第5层(内层)要求密封性及耐粘连性。
第1层以及第5层上作为兼备上述性质的树脂可使用密度0.930～0.950g/cm3的乙烯·α-烯烃系共聚物。
所述共聚物中特别是密度为0.935～0.945g/cm3，MFR为1～5.0g/10分(190℃)、熔点为120～130℃的范围的物质具有更优良的性质，更适合使用。
第1层(外层)的厚度的比例相对膜整体的厚度优选5～15％，更优选5～10％。第1层的厚度的比例低于所述范围，多层膜及医疗用容器的机械强度及耐热性恐怕不够。相反即使超过所述范围加厚，机械强度及耐热性也没有大的变化，反而有多层膜的柔软性低下之虞。
一方面，第5层(内层)的厚度的比例相对膜整体的厚度优选7～20％，更优选7～15％。第5层的厚度的比例低于所述范围，担心多层膜的密封性低下，容器的外观有劣化的危险。反之，即使超过所述范围加厚，密封性及耐粘连性也没有大的变化，反而有多层膜的柔软性低下之虞。
[第2层]
本发明的多层膜的第2层为由3层组成的中间层中的一层，为了不损害多层膜的耐热性并赋予柔软性，可使用所述混合树脂(B)或(C)。
第2层的厚度的比例相对膜整体的厚度优选25～45％，更优选30～45％。厚度的比例超过所述范围，要么会担心多层膜及容器的柔软性不够，要么有耐热性及耐针孔性低下的危险。
[第3层]
本发明的多层膜的第3层为第3层组成的中间层中处于最中间位置的层，为了保持多层膜的强度，可以使用第1层及第5层使用的乙烯·α-烯烃系共聚物(A)、或混合树脂(D)。
第3层的厚度的比例相对膜整体的厚度优选2～15％。厚度的比例超过所述范围，担心多层膜及容器的柔软性不够或即使能维持强度柔软性也受到损害。
[第4层]
本发明的多层膜的第4层为由3层组成的中间层之一，为了在保持多层膜的柔软性的同时赋予耐热性，可以使用所述混合树脂(C)。
第4层的厚度的比例相对膜整体的厚度优选25～45％、更优30～45％。厚度的比例超过所述范围，有和所述第2层的情况相同的担心。
根据本发明的多层膜，设定如前所述的层构成、特别时中间层(第2～4层)的构成，这样可以在维持膜整体的柔软性(弹性)的同时，保持膜整体的强度，而且提高耐热性。
所以，可以提供能够充分忍受在苛刻的条件下的针孔试验及坠落试验的、安全的容器。
下面对本发明的多层膜的制造方法进行说明。
为了制造本发明的多层膜，可以使用水冷式或空冷式共挤吹胀法、共挤压T型模法、干层压法、挤出层压法等。考虑性能特别是透明性、经济性及卫生性等方面，优选水冷式共挤吹胀法、共挤压T型模法。
对于任意一种方法，需要在各层的树脂熔融的温度下进行，但当温度过高，树脂的一部分则产生热劣化，担心产生劣化物引起的性能低下。所以，制造本发明的多层膜时的温度条件通常为150～250℃、优选170～200℃。
利用上述制造的发明膜的厚度一般为100～350μm、优选200～300μm，可以根据使用的目的适当增减，在250μm程度的厚度也保持足够的强度。
下面对本发明的容器，参照第1实施方案所示的图1进行说明。
图1为显示医疗用容器(输液袋)的一个例子的正面图。
医疗用容器10利用通常的方法截断2片按所述得到的片状的多层膜，分别将第5层作为内层相互重合，将容器10的周边进行热封，再利用热封等方法安装口部部件20，制成所定的形状及尺寸的容器10。另外，将多层膜的第5层设定为内层制成内管状，再利用热封成形容器10也可。这里作为膜热封的条件可以采用130～200℃的温度范围，例如具有250μm左右的厚度的膜的情况，在所述的温度范围，利用0.5～6秒这样短的时间进行密封。
在口部部件20上，优选使用由和本发明的多层膜上的第5层熔接性好的树脂、例如聚乙烯成形得到的物质。作为口部材料20假设为熔点约120～130℃的聚乙烯制的情况下的热封的条件，可以预先加热数秒钟口部材料，而且在约140～170℃、大约0.5～5秒的范围进行加热。
实施例
下面利用实施例、比较例以及试验例说明本发明的多层膜及容器。
构成实施例以及比较例中使用的混合树脂的成分如下所示。
[乙烯·α-烯烃共聚物]
(1)乙烯·1-丁烯共聚物[三井化学(株)制、密度＝0.920g/cm3、MFR＝2.1g/10分(190℃)]
[乙烯·α-烯烃系弹性体]
(2)乙烯·1-丁烯共聚物弹性体[三井化学(株)制、密度＝0.885g/cm3、MFR＝0.5g/10分(190℃)]
[高密度聚乙烯]
(3)乙烯·1-丁烯共聚物[三井化学(株)制、密度＝0.962g/cm3、MFR＝15g/10分(190℃)]
[聚丙烯]
(4)等规聚丙烯(乙烯含量：5重量％以下)[三井化学(株)制、密度＝0.910g/cm3、MFR＝1.6g/10分(230℃)]
表1所示的树脂分别如下。
[所述(A)的乙烯·α-烯烃共聚物]
A-1：乙烯·1-丁烯共聚物[三井化学(株)制、密度＝0.940g/cm3、MFR＝2.1g/10分(190℃)]
[所述(B)的混合树脂]
B-1：45重量％的所述(1)的共聚物、50重量％的所述(2)的弹性体以及5重量％的所述(3)的高密度聚乙烯组成的混合树脂(混合树脂的密度＝0.906g/cm3)
[所述(C)的混合树脂]
C-1：45重量％的所述(4)的聚丙烯共聚物、50重量％的所述(2)的弹性体以及5重量％的所述(3)的高密度聚乙烯组成的混合树脂
C-2：41.5重量％的所述(4)的聚丙烯共聚物、53.5重量％的所述(2)的弹性体以及5重量％的所述(3)的高密度聚乙烯组成的混合树脂
C-3：30重量％的所述(4)的聚丙烯共聚物、65重量％的所述(2)的弹性体以及5重量％的所述(3)的高密度聚乙烯组成的混合树脂
C-4：45重量％的所述(4)的聚丙烯共聚物、45重量％的所述(2)的弹性体以及10重量％的所述(3)的高密度聚乙烯组成的混合树脂
[所述(D)的混合树脂]
D-1：45重量％的所述(4)的聚丙烯共聚物、55重量％的所述(2)的弹性体组成的混合树脂
实施例1～5、比较例1～4
(多层膜的制造)
使用所述A-1，B-1，C-1～C-4和D-1的树脂(混合树脂)，利用水冷共挤吹胀法成形下述的表1所示的层构成的膜。
另外，比较例2的多层膜为没有相当于第3层的4层膜。
比较例4中，中间层第2以及第4层使用的混合树脂(C)的组成脱离本发明的范围，成形困难不能得到膜。
表[1]
                        上段：数字种类，下段：厚度
       第1层    第2层    第3层    第4层    第5层实施例1     A-1      B-1      A-1      C-1      A-1
        20μm    100μm   10μm    100μm   30μm实施例2     A-1      C-1      A-1      C-1      A-1
        20μm    100μm   10μm    100μm   30μm实施例3     A-1      B-1      D-1      C-1      A-1
        20μm    95μm    20μm    100μm   30μm实施例4     A-1      C-2      A-1      C-1      A-1
        20μm    100μm   10μm    100μm   30μm实施例5     A-1      C-1      D-1      C-1      A-1
        20μm    95μm    20μm    100μm   30μm比较例1     A-1      D-1      A-1      D-1      A-1
        20μm    100μm   10μm    100μm   30μm比较例2     A-1      B-1       -       C-1      A-1
        20μm    100μm            100μm   30μm比较例3     A-1      C-3      A-1      C-3      A-1
        20μm    100μm   10μm    100μm   30μm比较例4     A-1      C-4      D-1      C-4      A-1
        20μm    95μm    10μm    95μm    30μm
(容器的制造)
下面使用所述实施例1～5、比较例1～4的膜，制造图1所示的内容量为500ml的医疗用容器(输液袋)10。成形该医疗用容器10时的周边部的热封是在155℃、进行4.5秒，口部材料20的密封是在140～150℃、进行3秒。
(性能试验)
利用下述的方法，对所述实施例1～5的多层膜得到的医疗用容器(输液袋)10，进行各种特性的评价试验。
·耐热性：在容器中加入蒸馏水，在110℃、40分钟的高压蒸汽灭菌处理之后，目测观察该容器的变形、破袋、密封泄漏的状态。
·坠落试验：在约4℃冷藏之后，沿3个方向将容器分别各5次，从1m的高度落下，之后目测观察破袋及密封泄漏的状态。
·柔软性：利用目测观察内溶液的自然排出性。
·透明性：在容器中加入蒸馏水，和所述同样进行高压蒸汽灭菌处理之后，目测观察，再测定450nm的透光率。
·外观：目测观察，调查折皱、粘连、变形及破袋的状况。
下述耐热性、落下试验、柔软性、透明性以及外观的评价，◎非常好、○表示良好(适于使用)、△稍不好(不适合使用)、×不好。
以上的试验结果示于表2。
表2
        实施例1  实施例2  实施例3   实施例4   实施例5耐热性        ◎       ◎       ◎         ◎        ◎坠落试验      ◎       ◎       ◎         ◎        ◎柔软性        ◎       ◎       ◎         ◎        ◎透明性目测          ◎       ◎       ◎         ◎        ◎透过率％      83.2     83.4     85.3       85.7      88.0外观          ◎       ◎       ◎         ◎        ◎
从表2的而结果可知，本发明的容器从耐热性、坠落试验、柔软性、透明性以及外观的任何一个项目上都得到非常好的结果。
试验例2
使用上述实施例1～5以及比较例1～3的多层膜得到的医疗用容器(输液袋)10中加入生理食盐液，利用橡胶塞密闭，在110℃进行40分钟的高压蒸汽灭菌处理。处理后，使用简易型静电容量式针孔测试仪[电测精工(株)制的针孔测试仪H型]，检查有无针孔。
对于在140℃、145℃以及150℃的3个条件下进行的口部材料20的密封的容器，分别在负荷电压15KV、20KV、25KV3个条件下进行各10袋的检查。总共进行合计90袋的检查。
另外，所述试验和医疗用容器的通常的制造条件相比是非常严酷的条件。所以，只要是在所需的条件下发生针孔的物体的比例为小于5％(90个中小于5个)，即可认定耐针孔性为良好。
表3中表示针孔检出的物体的数和其比例(％)。
表3
              实施例                 比较例
      1    2     3     4    5     1    2     3检体数    4    1     4     3    4     0    9     15比例(％)  4.4  1.1   4.4   3.3  4.4   0    10.0  16.7
从表3的结果可知，实施例1～5的容器发生针孔的物体的比例均小于5％，耐针孔性好。
与此相对，4层的多层膜的比较例2和中间层的第2层以及第4层中使用的混合树脂(C)的组成超过本发明的范围的比较例3相比，针孔发生物体的比率大，耐针孔性在使用上不够。
另外，比较例1中，中间层的第2层以及第4层使用的混合树脂都不含有高密度聚乙烯，针孔的发生物体的比率为0％，耐针孔性极好。但是，灭菌处理后确认多个折皱，外观极不好，作为医疗用容器不适合。
本发明中，和实施例1～5同样，可以成形下述的表4所示的层结构的膜。这些膜也具有和上述一样的优良的性质。
[表4]
      第1层    第2层    第3层    第4层    第5层实施例6    A-1      B-1      A-1      C-2      A-1
       20μm    100μm   10μm    100μm   30μm实施例7    A-1      B-1      D-1      C-2      A-1
       20μm    100μm   10μm    100μm   30μm实施例8    A-1      C-1      A-1      C-2      A-1
       20μm    100μm   20μm    100μm   30μm实施例9    A-1      C-1      D-1      C-2      A-1
       20μm    100μm   10μm    100μm   30μm实施例10   A-1      C-2      A-1      C-1      A-1
       20μm    100μm   20μm    100μm   30μm实施例11   A-1      C-2      D-1      C-1      A-1
       20μm    100μm   10μm    100μm   30μm实施例12   A-1      C-2      D-1      C-2      A-1
       20μm    100μm   10μm    100μm   30μm工业实用性
本发明得到的多层膜以及容器具有优良的耐热性、耐粘连性、强度、密封性、透明性、柔软性、以及外观，同时，还具有热封时在弯曲部不发生针孔的优点，可用作输液袋、血液袋等医疗用容器。

Claims (8)

1、一种多层膜，是由5层组成的多层膜，其特征在于，第1层以及第5层为(A)密度0.930～0.950g/cm3的乙烯·α-烯烃共聚物，
第2层为(B)混合树脂或(c)混合树脂，其中(B)混合树脂为30～60重量％的密度0.910～0.930g/cm3的乙烯·α-烯烃共聚物、35～65重量％的密度0.860～0.900g/cm3的乙烯·α-烯烃系弹性体和1～10重量％的密度0.955～0.970g/cm3的高密度聚乙烯组成的混合树脂；(C)为35～55重量％的密度为0.900～0.930g/cm3的聚丙烯、40～60重量％的密度为0.860～0.900g/cm3的乙烯·α-烯烃系弹性体以及2～8重量％的密度0.955～0.970g/cm3的高密度聚乙烯组成的混合树脂、
第3层为所述的(A)乙烯·α-烯烃共聚物、或(D)密度为0.900～0.930g/cm3的聚丙烯40～60重量％以及密度为0.860～0.900g/cm3的乙烯·α-烯烃系弹性体40～60重量％组成的混合树脂，而且第4层为所述(C)的混合树脂。
2、如权利要求1所述的多层膜，第2层为所述(C)的混合树脂，而且第3层为乙烯·α-烯烃共聚物。
3、如权利要求1或2所述的多层膜，其中所述聚丙烯为熔体流动指数MFR为1～40g/10分(230℃)、熔点为140～170℃的等规聚丙烯。
4、如权利要求1所述的多层膜，其中，相对膜整体的厚度，各层的厚度的比例为第1层：5～15％、第2层：25～45％、第3层：2～15％、第4层：25～45％、第5层：7～20％的范围。
5、如权利要求4所述的多层膜，其中，相对膜整体的厚度，各层的厚度的比例为第1层：5～10％、第2层：30～45％、第3层：2～10％、第4层：30～45％、第5层：7～15％的范围。
6、如权利要求4所述的多层膜，其中，膜整体的厚度为200～300μm。
7、一种容器，其特征在于，使用权利要求1～6的任何一项所述的多层膜，以该多层膜的第1层为外层，第5层为内层而成形。
8、如权利要求7所述的容器，聚乙烯制口部材料夹于膜的中间，熔接而成。
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