CN101044021B - 医疗用阻气薄膜及使用它的医疗用袋 - Google Patents
医疗用阻气薄膜及使用它的医疗用袋 Download PDFInfo
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- CN101044021B CN101044021B CN2005800357130A CN200580035713A CN101044021B CN 101044021 B CN101044021 B CN 101044021B CN 2005800357130 A CN2005800357130 A CN 2005800357130A CN 200580035713 A CN200580035713 A CN 200580035713A CN 101044021 B CN101044021 B CN 101044021B
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Abstract
本发明的目的在于,提供一种适于医疗用途的阻气薄膜及使用它的医疗用袋,所述阻气薄膜即使在加热灭菌处理后等中,其气体·水蒸汽阻挡性也优良,可以抑制来自粘结剂的成分等的溶出。本发明的医疗用阻气薄膜具有多层阻气薄膜(10)和多层基材薄膜(22),其中,所述多层阻气薄膜(10)具有在一侧表面具有无机氧化物的蒸镀层(13)的蒸镀拉伸聚酯层(11)、粘接于蒸镀层(13)表面的拉伸聚酰胺层(15)、粘接于拉伸聚酰胺层(15)的与粘接面(15a)的相反一侧表面的聚乙烯层(17);所述多层基材薄膜(22)具有聚环状烯烃层(25)、弹性体层(24、26)及热封层(23);多层基材薄膜(22)粘接于蒸镀拉伸聚酯薄膜层(11)的蒸镀层的相反一侧的表面(11b)上,以使热封层(23)成为最外层。
Description
技术领域
本发明涉及一种适合于医疗用途的阻气薄膜及使用它的医疗用袋,所述阻气薄膜不影响薄膜的柔软性、透明性及耐冲击性,即使在实施了加热灭菌处理后及经过长期保存后,也可以维持优良的气体·水蒸汽阻挡性,抑制薄膜的配合成分及来自粘结剂的成分的溶出。
背景技术
输液袋等塑料制袋具有操作性良好、使用后的废弃处理简单等优点。目前,在医疗用容器领域普及的塑料制袋中,通常采用安全性高的聚乙烯。
但是,由于聚乙烯是气体透过性高的塑料,因此,可以采用如下处置:例如,在收容氨基酸等之类的易氧化药品时,通常将医疗用袋与脱氧剂一起收容于具有阻气性的塑料制的外层袋中。
另一方面,近几年,为了降低外装袋的成本,要求对医疗用袋本身赋予阻气性,对除柔软性、透明性、耐冲击性等特性之外还具有阻气性的塑料材料正在进行各种研究。
专利文献1所述的塑料材料是多层薄膜,其具有具有热封性树脂层、无机氧化物的蒸镀层的双向拉伸聚酯系树脂薄膜、和双向拉伸聚酰胺树脂薄膜及表面保护层,其特征在于,上述双向拉伸聚酯系树脂薄膜的蒸镀层和上述热封性树脂层粘接,上述双向拉伸聚酯系树脂薄膜的蒸镀面的反面与上述双向拉伸聚酰胺树脂薄膜的一个表面粘接,并且,在上述双向拉伸聚酰胺树脂薄膜的另一侧表面上配置有上述表面保护层。
专利文献2所述的塑料材料是多层薄膜,其具有形成有热熔合密封部的聚乙烯层、聚环状烯烃层及具有无机氧化物的蒸镀层的聚对苯二甲酸乙二醇酯层,其特征在于,在上述聚乙烯层上粘接上述聚环状烯烃层的一个表面,在上述聚环状烯烃层的另一侧表面粘接上述聚对苯二甲酸乙二醇酯层的蒸镀层。
另外,专利文献3所述的塑料材料是多层薄膜,其具有热熔合层(乙烯系聚合物)、具有无机氧化物蒸镀层的双向拉伸薄膜(双向拉伸聚酯)基材及保护层(双向拉伸聚酰胺薄膜),其特征在于,上述双向拉伸薄膜基材的与无机氧化物蒸镀层的相反侧的表面粘接上述热蒸镀层,在上述双向拉伸薄膜基材的无机氧化物蒸镀层侧的表面粘接上述保护层。
专利文献1:日本专利申请公开第2004-58336号公报
专利文献2:日本专利申请公开第2001-157705号公报
专利文献3:日本专利申请公开第2004-148681号公报
发明内容
发明要解决的课题
但是,就医疗用袋而言,在要求现有的塑料制袋所要求的柔软性、透明性、耐冲击性等特性的同时,要求例如能耐受加热灭菌处理的耐热性、相对被收容的药剂的安全性(特别是树脂薄膜的配合成分及来自粘结剂的成分的溶出性低)等,目前的现状为:还无法得到完全满足这些特性的塑料材料。
另外,上述专利文献1~3所述的多层薄膜都存在如下问题,薄膜的柔软性欠缺,在形成输液袋等时容易产生折痕及条纹。
而且,在上述专利文献1和2所述的多层薄膜中存在如下问题,在成为其基材的聚酯(聚对苯二甲酸乙二醇酯)薄膜中,由于上述蒸镀层配置在使用有上述多层薄膜的包装体的内表面侧,因此其气体·水蒸汽阻挡性容易经时降低。在专利文献1及3所述的多层薄膜中,有可能存在用于层间粘接的粘接剂溶出的问题,在专利文献2及3所述的多层薄膜中,由于从使用有上述多层薄膜的包装体的外表面至上述蒸镀层之间的厚度薄,故其气体·水蒸汽阻挡性有可能经时地降低。
因此,本发明的目的在于,提供一种适合于医疗用途的阻气薄膜及使用其的医疗用袋,所述阻气薄膜一方面维持薄膜的柔软性、透明性及耐冲击性,另一方面即使在实施加热灭菌处理后及长期保存后,也可以发挥优良的气体·水蒸汽阻挡性,可以抑制薄膜的配合成分及来自粘结剂的成分的溶出。
解决课题的方法
为了解决上述课题,本发明提供:
(1)一种医疗用阻气薄膜,其特征在于,其具有多层阻气薄膜和粘接于该多层阻气薄膜上的多层基材薄膜,上述多层阻气薄膜具有在一侧表面具有无机氧化物的蒸镀层的蒸镀拉伸聚酯层、粘接于上述蒸镀拉伸聚酯层的上述蒸镀层侧的表面的拉伸聚酰胺层、粘接于上述拉伸聚酰胺层的与上述蒸镀层的粘接面的相反一侧表面的聚乙烯层,上述多层基材薄膜具有聚环状烯烃层、弹性体层和热封层,并且粘接于上述蒸镀拉伸聚酯层的另一侧表面,上述热封层配置在上述多层基材薄膜的与上述蒸镀拉伸聚酯层的粘接面的相反一侧的表面。
(2)如上述(1)所述的医疗用阻气薄膜,其特征在于,上述多层基材薄膜具有聚环状烯烃层、粘接于上述聚环状烯烃层的一侧表面的第1弹性体层、粘接于上述第1弹性体层的与上述聚环状烯烃层的粘接面的相反一侧表面的热封层、粘接于上述聚环状烯烃层的另一侧表面的第2弹性体层、粘接于上述第2弹性体层的与上述聚环状烯烃层的粘接面的相反一侧的表面的聚乙烯层。
(3)如上述(2)所述的医疗用阻气薄膜,其特征在于,上述第1弹性体层和上述第2弹性体层的总厚度为上述多层基材薄膜的厚度的55~80%。
(4)如上述(1)所述的医疗用阻气薄膜,其特征在于,上述多层阻气薄膜的聚乙烯层的厚度,相对于上述蒸镀拉伸聚酯层和上述拉伸聚酰胺层的总厚度为1~2倍。
(5)如上述(1)所述的医疗用阻气薄膜,其特征在于,上述多层阻气薄膜的聚乙烯层是由密度0.910~0.930g/cm3的直链聚乙烯薄膜和粘接于上述直链聚乙烯的两侧表面的密度0.950~0.970g/cm3的高密度聚乙烯薄膜构成的3层薄膜,并且,各上述高密度聚乙烯薄膜的厚度为上述直链聚乙烯薄膜厚度的0.2~0.3倍。
(6)如上述(1)所述的医疗用阻气薄膜,其特征在于,上述无机氧化物是氧化铝。
(7)如上述(1)所述的医疗用阻气薄膜,其特征在于,上述多层基材薄膜是利用吹塑成型形成的筒状薄膜,并且,该筒状薄膜的最内层是上述热封层。
(8)一种医疗用袋,其特征在于,由医疗用阻气薄膜与上述热封层相向地熔敷而成,上述医疗用阻气薄膜具有多层阻气薄膜和粘接于该多层阻气薄膜上的多层基材薄膜,上述多层阻气薄膜具有在一侧表面具有无机氧化物的蒸镀层的蒸镀拉伸聚酯层、粘接于上述蒸镀拉伸聚酯层的上述蒸镀层侧的表面的拉伸聚酰胺层、粘接于上述拉伸聚酰胺层的与上述蒸镀层的粘接面的相反一侧表面的聚乙烯层,上述多层基材薄膜具有聚环状烯烃层、弹性体层和热封层,并且粘接于上述蒸镀拉伸聚酯层的另一侧表面,上述热封层配置在上述多层基材薄膜的与上述蒸镀拉伸聚酯层的粘接面的相反一侧的表面。
(9)一种医疗用袋,其特征在于,其将医疗用阻气薄膜中的多层基材薄膜的开口端熔敷而成,上述医疗用阻气薄膜具有多层阻气薄膜和粘接于该多层阻气薄膜上的多层基材薄膜,上述多层阻气薄膜具有在一侧表面具有无机氧化物的蒸镀层的蒸镀拉伸聚酯层、粘接于上述蒸镀拉伸聚酯层的上述蒸镀层侧的表面的拉伸聚酰胺层、粘接于上述拉伸聚酰胺层的与上述蒸镀层的粘接面的相反一侧表面的聚乙烯层,上述多层基材薄膜是利用吹塑成型形成的筒状薄膜,具有聚环状烯烃层、弹性体层和热封层,并且粘接于上述蒸镀拉伸聚酯层的另一侧表面,上述热封层配置在上述多层基材薄膜的与上述蒸镀拉伸聚酯层的粘接面的相反一侧的表面,上述筒状的多层基材薄膜的最内层是上述热封层。
(10)如上述(8)所述的医疗用袋,其特征在于,对其填充药液并密封后,整体实施加热灭菌。
(11)如上述(9)所述的医疗用袋,其特征在于,对其填充药液并密封后,整体实施加热灭菌。
发明效果
依据本发明的医疗用阻气薄膜,一方面维持薄膜的柔软性、透明性及耐冲击性,一方面可使其气体·水蒸汽阻挡性优良,并且,可以抑制加热灭菌处理及长期保存造成的气体·水蒸汽阻挡性的经时降低,而且,可以抑制薄膜的配合成分及来自粘结剂的成分的溶出。
附图说明
图1是表示医疗用阻气薄膜的一个实施方式的层构成的概略剖面图。
图2是表示医疗用袋的一个实施方式的正面图。
图3是表示医疗用袋的其它实施方式的正面图。
符号说明
10多层阻气薄膜
11蒸镀拉伸聚酯层
15拉伸聚酰胺层
17聚乙烯层
22多层基材薄膜
23热封层
24第1弹性体层
25聚环状烯烃层
26第2弹性体层
30医疗用袋
具体实施方式
本发明的医疗用阻气薄膜的特征在于,其具有:
(i)多层阻气薄膜,其具有:在一个表面具有无机氧化物的蒸镀层的蒸镀拉伸聚酯层、粘接于上述蒸镀层表面的拉伸聚酰胺层、粘接于上述拉伸聚酰胺层的与上述蒸镀层的粘接面的相反一侧的表面的聚乙烯层;
(ii)多层基材薄膜,其具有聚环状烯烃层、弹性体层和热封层。
上述(ii)的多层基材薄膜粘接于上述(i)的多层阻气薄膜中的蒸镀拉伸聚酯层的另一侧表面,
上述(ii)的多层基材薄膜中的热封层配置在与上述蒸镀拉伸聚酯层的粘接面相反侧的表面。
如上所述,多层阻气薄膜具有如下3层:由在一个表面具有无机氧化物的蒸镀层的拉伸聚酯薄膜构成的层(下面,称为“蒸镀拉伸聚酯层”)、粘接于上述蒸镀拉伸聚酯层的上述蒸镀层侧的表面的拉伸聚酰胺层、粘接于上述拉伸聚酰胺层的与上述蒸镀层的粘接面的相反一侧的表面的聚乙烯层。
蒸镀拉伸聚酯层是例如为了对医疗用阻气薄膜整体赋予阻气性而设置的层,是使用在实施了拉伸处理的聚酯薄膜的表面形成有无机氧化物的蒸镀层而成的。
拉伸聚酯薄膜的聚酯例如可举出:聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丁二醇酯(PBT)、聚萘二甲酸乙二醇酯(PEN)、聚萘二甲酸丁二醇酯(PBN)等。
聚酯薄膜的拉伸处理可以是单向拉伸,也可以是双向拉伸。另外,双向拉伸处理的具体方法例如可举出:管法双向拉伸、拉幅法双向拉伸等。通过对聚酯薄膜实施拉伸处理,可以提高薄膜的耐针孔性、强度、蒸镀处理时的耐热性、表面平滑性等。
形成蒸镀层的无机氧化物例如可举出:氧化铝(铝的氧化物)、二氧化硅(硅氧化物)、氧化镁、氧化钛等。其中,从蒸镀层的透明性的观点来考虑,优选为氧化铝。
蒸镀层为氧化铝的蒸镀拉伸聚酯薄膜(下面,称为“氧化铝蒸镀拉伸聚酯薄膜”)的具体例,例如可举出:凸版印刷(株)制的透明阻挡薄膜(商品名:“GLフアミリ一”、“GL-AEH”(基材:PET)、“GL-AU(基材:PET)、“GL-AE(基材:PET)等)、东丽薄膜加工(株)制的透明阻挡薄膜(商品名为“バリアロツクス”系列、“1011RG”、“1011HG”、“1031HG等)。
蒸镀拉伸聚酯层的厚度的比例,相对于多层阻气薄膜的厚度,优选为15~35%,更优选为10~30%,相对于医疗用阻气薄膜整体的厚度,优选为3~10%,更优选为5~7%。另外,蒸镀拉伸聚酯层的厚度优选为7~20μm,更优选为9~15μm。
拉伸聚酰胺层是例如为了保护蒸镀拉伸聚酯层的蒸镀层而设置的层,是使用实施了拉伸处理的聚酰胺薄膜而形成的。
拉伸聚酰胺薄膜的聚酰胺例如可举出:尼龙-6、尼龙-6,6、尼龙-6,10、尼龙-6,12、尼龙-11、尼龙-12等。
聚酰胺薄膜的拉伸处理可以是单向拉伸,也可以是双向拉伸,双向拉伸处理的具体方法例如可举出:管法双向拉伸、拉幅法双向拉伸等。通过对聚酰胺薄膜实施拉伸处理,可以提高薄膜的耐针孔性、强度、蒸镀处理时的耐热性、表面平滑性等。
作为聚酰胺薄膜的具体例,例如可举出:Unitika(株)制的双向拉伸尼龙薄膜(商品名“エンブレム(注册商标)”系列;“エンブレムONMB”等)。
拉伸聚酰胺层的厚度的比例,相对于多层阻气薄膜的厚度,优选为15~35%,更优选为20~30%,相对于医疗用阻气薄膜整体的厚度,优选为3~10%,更优选为5~10%。另外,拉伸聚酰胺层的厚度优选为7~20μm,更优选为10~15μm。
多层阻气薄膜中的聚乙烯层是在使用本发明的医疗用阻气薄膜形成医疗用袋时形成医疗用袋的最外层的层,是例如为了保护医疗用阻气薄膜的表面、且对医疗用阻气薄膜赋予柔软的手感而设置的层。
形成上述聚乙烯层的聚乙烯薄膜例如可举出:高密度、低密度等密度范围;直链状等分子结构;不限于高压法、低压法等制造方法的各种聚乙烯薄膜。
另外,聚乙烯薄膜可以是1种聚乙烯构成的薄膜,也可以是由2种以上的混合物构成的薄膜。
而且,上述聚乙烯薄膜也可以是2种以上的聚乙烯的层压薄膜。所述层压薄膜的具体例例如可举出:在密度0.910~0.930g/cm3的直链聚乙烯薄膜的两面配置有密度0.950~0.970g/cm3的高密度聚乙烯而成的3层薄膜等。
在使用上述3层薄膜作为形成上述聚乙烯层的聚乙烯薄膜时,可以进一步提高本发明的医疗用阻气薄膜的成型性、强度等特性。另外,上述3层薄膜中的各上述高密度聚乙烯的厚度的比例,相对于直链聚乙烯的厚度,优选为0.2~0.3倍,更优选为0.22~0.28倍。
上述聚乙烯层的厚度相对于上述氧化铝蒸镀拉伸聚酯层和上述拉伸聚酰胺层的总厚度,优选为1~2倍,更优选为1.2~1.8倍。另外,上述聚乙烯层的厚度优选为5~30μm左右。
多层阻气薄膜可以如下制作:在分别成型的上述氧化铝蒸镀拉伸聚酯层、拉伸聚酰胺层及聚乙烯层的3种薄膜上,用层压法进行层压。
层压方法可以采用各种方法,其中,优选为使用有粘结剂的干式层压法。
多层阻气薄膜整体的厚度没有特别限定,例如,优选为30~80μm左右。
用于上述干式层压法的粘结剂可以使用用于制造多层薄膜的各种粘结剂。例如可举出:三井武田化学(株)制的商品名“タケラツク”系列(“タケラツクA315”等)、同公司制的商品名“タケネ一ト”系列等。
另外,上述粘结剂优选为从多层阻气薄膜中溶出的成分越少越好。所述粘结剂例如为至少由主剂和固化剂构成的干式层压用粘结剂,可以例举由下述主剂和固化剂组合而成的粘结剂(参照日本专利申请公开第2000-309770号公报、日本专利申请公开第2000-351953号公报及日本专利申请公开第2002-155260号公报)。
主剂:将由聚醚和二醇类及/或胺类构成的树脂用二异氰酸酯类增长而成的聚醚-聚氨酯类树脂;选自芳香族羧酸、脂环式羧酸、脂肪族羧酸及不饱和羧酸中的至少1种酸类、由其酯或内酯和至少1种二醇类构成的聚酯树脂;将上述聚酯树脂用二异氰酸酯增长而成的聚酯-尿烷-二醇树脂;由选自二聚物脂肪酸类及其酯中的至少1种和至少1种二醇类(选自芳香族二羧酸类及其酯化合物中的至少1种二醇类)构成的聚酯树脂;将上述聚酯树脂用二异氰酸酯增长而成的聚酯-尿烷-二醇树脂;将由选自二聚物脂肪酸类及其加氢物及酯中的至少1种和至少1种二醇类构成的聚酯二醇树脂用二异氰酸酯增长而成的聚酯-尿烷-二醇树脂。
固化剂:三羟甲基丙烷的异氰酸酯类加成物、二异氰酸酯类的缩二脲物或三聚物。
另外,在上述多层阻气薄膜的制作中,可以取代上述干式层压法,采用挤出层压法。此时,取代上述粘结剂,使用粘结性树脂即可,另外,采用公知的挤出层压法的成型条件即可。
粘结性树脂优选为例如可举出:使聚乙烯等聚烯烃和例如马来酸、富马酸、四氢邻苯二甲酸、衣康酸、柠康酸、巴豆酸、异巴豆酸、降冰片烯二酸、丙烯酸、甲基丙烯酸等不饱和羧酸或它们的酐进行接枝共聚得到的改性聚烯烃。
如上所述,多层基材薄膜设置在上述多层阻气薄膜中的蒸镀拉伸聚酯层的另一侧表面(具有蒸镀层的面的相反一侧的表面),是具有聚环状烯烃层、弹性体层和热封层的层压体。
聚环状烯烃层是例如为了防止由于从上述多层阻气薄膜中来自粘结剂的物质渗出及水分渗透而给上述蒸镀拉伸聚酯薄膜的蒸镀层带来剥离等不良影响而设置的层。
形成聚环状烯烃层的聚环状烯烃例如可举出:乙烯和二环戊二烯类化合物的共聚物、乙烯和降冰片烯类化合物的共聚物、环戊二烯类化合物的开环聚合物、由2种以上的环戊二烯类化合物构成的开环共聚物、它们的加氢物等。
在上述例示的聚环状烯烃中,特别是作为饱和聚合物的上述加氢物,由于其水蒸汽阻挡性及阻气性更优良,在防止药物的吸收附着(吸收、吸附)的效果、耐热性、透明性、稳定性等方面都优良,故适合作为本发明中的聚环状烯烃层的形成材料。
在上述例示的聚环状烯烃中,特别优选为:乙烯和降冰片烯类化合物的共聚物的加氢物、1或2种以上的环戊二烯衍生物的开环(共)聚合物的加氢物。
上述聚环状烯烃的具体例例如可举出:具有下述通式(1)表示的重复单元和下述通式(1’)表示的重复单元的聚合物、或具有下述通式(2)表示的重复单元的聚合物。
(式中,R1、R1’、R2、R2’、R3及R4分别独立,表示氢原子、烃残基、卤原子、酯、腈、吡啶等极性基团。R1和R2、R1’和R2’、R3和R4可以相互键合形成环。m、m’、x及z表示1以上的整数,n、n’及y表示0或1以上的整数。)
具有通式(1)、(1’)表示的重复单元的聚合物是利用公知的开环聚合方法使1或2种以上的降冰片烯类单体进行聚合而成的聚合物或根据常规方法将由此得到的开环聚合物进行加氢而成的聚合物。另一方面,具有通式(2)表示的结构单元的聚合物是利用公知的方法使1或2种以上的降冰片烯类单体和乙烯进行加成共聚而成的聚合物或根据常规方法将由此得到的聚合物进行加氢而成的聚合物。
聚环状烯烃没有特别限定,其玻璃化转变温度(Tg)优选为70℃以上,更优选为80~150℃。聚环状烯烃的分子量没有特别限定,在利用以环己烷为溶剂的凝胶渗透色谱法(GPC)分析测定的数均分子量“Mn”中,优选为1万~10万,更优选为2万~5万。在通过加氢使残留在聚环状烯烃的分子链中的不饱和键饱和时,其加氢率没有特别限定,优选为90%以上,更优选为95%以上,进一步优选为99%以上。
聚环状烯烃的具体例例如可举出:三井化学(株)制的环状烯烃低聚物(商品名“アペル(注册商标)”系列)、JSR(株)制的光学树脂(“ア一トン(注册商标)”)、日本Zeon(株)制的通用透明工程塑料(商品名“ゼオノア(注册商标)”系列)、テイコナGmbH制的商品名“トパス”等。
在聚环状烯烃中,从与邻接于聚环状烯烃层的层(例如后述的弹性体层)的相溶性等观点来考虑,可以使用聚环状烯烃和聚烯烃树脂的混合树脂。该聚烯烃树脂例如可举出:聚乙烯(PE)均聚物、乙烯和碳数3~12的α-烯烃类(例如:1-丁烯、1-戊烯、1-己烯,4-甲基-1-戊烯、1-辛烯、1-癸烯等)的低聚物、聚丙烯(PP)均聚物、丙烯和碳数2~12的α-烯烃类(例如:乙烯、1-丁烯、1-戊烯、1-己烯,4-甲基-1-戊烯、1-辛烯、1-癸烯等)的低聚物。其中,优选为PE均聚物。聚环状烯烃和聚烯烃树脂的混合树脂的优选为方式例如可举出:相对于聚环状烯烃配合有密度0.910~0.930g/cm3的聚乙烯5~40重量%的混合树脂。
聚环状烯烃层的厚度的比例优选为多层基材薄膜的3~10%左右,优选为医疗用阻气薄膜整体厚度的5~10%左右。另外,聚环状烯烃层的厚度优选为10~20μm左右。
由于聚环状烯烃具有硬而脆的性质,因此,弹性体层是为了保护其而设置的层,配置在聚环状烯烃层的两侧的表面。
弹性体层的弹性体例如可举出:聚烯烃类弹性体、苯乙烯类弹性体、尿烷类弹性体等。
聚烯烃类弹性体例如可举出:直链聚乙烯弹性体、乙烯·α-烯烃共聚物弹性体、丙烯·α-烯烃共聚物弹性体等。另外,上述α-烯烃例如可举出:丙烯、1-丁烯、1-戊烯、1-己烯、4-甲基-1-戊烯等碳数3~6的α-烯烃,优选为1-丁烯。
苯乙烯类弹性体例如可举出:苯乙烯-乙烯/丁烯-苯乙烯嵌段共聚物(SEBS)、苯乙烯-丁二烯-苯乙烯嵌段共聚物(SBS)、苯乙烯-异戊二烯-苯乙烯嵌段共聚物(SIS)、用马来酸等改性而成的改性SEBS、苯乙烯-乙烯/丙烯-苯乙烯嵌段共聚物(SEPS)、苯乙烯-乙烯/丁烯嵌段共聚物(SEB)、苯乙烯-乙烯/丙烯嵌段共聚物(SEP)等。
尿烷类弹性体例如可举出:大日精化工业(株)制的热塑性聚氨酯(商品名“レザミンP”)、协和发酵化学(株)制的热塑性聚氨酯(商品名“エステン”)等市售品。
在上述弹性体层中,从与多层基材薄膜中的其它层(例如,聚环状烯烃层)的粘结性及作为医疗用阻气薄膜的安全性等观点来考虑,在上述例示的弹性体中,特别优选为使用聚烯烃类弹性体,更优选为使用乙烯·α-烯烃共聚物弹性体。
另外,从与上述同样的观点来考虑,在上述弹性体层中,上述例示的弹性体是密度0.910~0.930g/cm3的直链聚乙烯和密度0.950~0.970g/cm3的高密度聚乙烯的混合物,相对于上述弹性体层整体,可以使用分别混合了20~30重量%的上述直链聚乙烯、3~10重量%的上述高密度聚乙烯的混合物。
弹性体层的厚度(在设置2层以上弹性体层时,各弹性体层的总厚度)的比例优选为多层基材薄膜的55~80%左右,优选为医疗用阻气薄膜整体厚度的43~62%左右。并且,弹性体层的厚度优选为80~125μm左右。
热封层是在使用本发明的医疗用阻气薄膜形成医疗用袋时作为最内层的层。
热封层的形成材料可以举出聚烯烃。其中,优选为聚乙烯,更优选为密度0.925~0.945g/cm3的直链聚乙烯。
在使用本发明的医疗用阻气薄膜形成具有多个收容腔的医疗用袋(所谓的多腔袋)时,希望在隔开各收容腔的隔壁部分形成所谓的易剥离密封,在这种情况下,为了有利于形成易剥离密封,相对于上述聚乙烯,例如可以将聚丙烯之类的熔点不同且难以互溶的树脂以10~40重量%的比例进行混合。
热封层的厚度的比例优选为多层基材薄膜的厚度的10~25%左右,优选为医疗用阻气薄膜整体厚度的8~19%左右。另外,热封层的厚度优选为15~30μm左右。
在多层基材薄膜中,为了使其成型性良好,优选为在最外层配置聚乙烯层。
作为在多层基材薄膜中形成聚乙烯层的聚乙烯,没有特别限定,例如可举出密度0.930~0.950g/cm3的直链聚乙烯、或在上述直链聚乙烯中以总体的15~40重量%的比例混合密度0.950~0.970g/cm3的高密度聚乙烯而成的混合物。
上述聚乙烯层的厚度的比例优选为多层基材薄膜的20~30%左右,优选为医疗用阻气薄膜整体厚度的14~24%左右。另外,上述聚乙烯层的厚度优选为30~50μm左右。
多层基材薄膜的具体例并不限定于这些,例如可举出,在上述聚环状烯烃层的两侧表面配置一对上述弹性体层,并且,在一个弹性体层的与上述聚环状烯烃层的粘接面相反一侧的表面配置上述热封层,并且,在另一个弹性体层的与上述聚环状烯烃层的粘接面相反一侧的表面配置上述聚乙烯层,由此形成5层结构的层压体。另外,也可以是没有上述聚乙烯层的4层结构的层压体。
多层基材薄膜可以通过用各种共挤出成型法将形成上述层压体的树脂及弹性体材料成型来制作。
另外,多层基材薄膜可以利用吹塑法成型为筒状的吹塑薄膜。此时必须以使热封层配置在吹塑薄膜内侧的方式进行成型。
本发明的医疗用阻气薄膜可以通过用公知的方法将上述多层阻气薄膜和上述多层基材薄膜进行层压来制作。
层压方法优选为上述的干式层压。使用的粘结剂可举出与用于制造上述多层阻气薄膜的同样的粘结剂。
在采用筒状的吹塑薄膜作为多层基材薄膜时,在将筒状的多层基材薄膜叠成平面状的状态下,可以在其正反两个面上将多层阻气薄膜进行层压。
医疗用阻气薄膜的整体厚度没有特别限定,优选为180~240μm左右,更优选为190~220μm左右。
依据上述医疗用阻气薄膜,由于其具有含无机氧化物的蒸镀层的蒸镀拉伸聚酯层及聚环状烯烃层,故可以使医疗用阻气薄膜的气体·水蒸汽阻挡性优良。
另外,(i)上述蒸镀拉伸聚酯层的蒸镀层在成为其基材的拉伸聚酯薄膜中,没有配置在使用上述医疗用阻气薄膜形成的医疗用袋的内表面(即,医疗用阻气薄膜的多层基材薄膜侧),而是配置在上述医疗用袋的外表面(即,拉伸聚酰胺薄膜层、聚乙烯薄膜层侧),被拉伸聚酰胺薄膜层及聚乙烯薄膜层保护,(ii)由于在从上述蒸镀拉伸聚酯层的蒸镀层至上述医疗用袋的外表面之间配置有拉伸聚酰胺层、聚乙烯层,可确保充分的厚度,因此,即使是对医疗用阻气薄膜在高温下实施加热灭菌处理时,也可以发挥优良的气体·水蒸汽阻挡性,而且,可以防止上述蒸镀层的劣化(医疗用阻气薄膜的气体·水蒸汽阻挡性经时降低),维持优良的气体·水蒸汽阻挡性。
另外,由于上述医疗用阻气薄膜具有上述聚乙烯层、弹性体层,因此,可以赋予整个薄膜充分的柔软性,特别是由于在蒸镀拉伸聚酯层、拉伸聚酰胺层的薄膜的表面侧具有上述聚乙烯层,因此,在形成输液袋等时,可以抑制表面产生折痕或条纹。
而且,由于上述医疗用阻气薄膜具有聚环状烯烃层,并且,含有上述聚环状烯烃层的多层基材薄膜的形成不使用粘结剂,因此,可以抑制从上述热封层侧的表面溶出薄膜的配合成分、来自粘结剂的成分。
本发明的医疗用袋可以举出:
(I)其特征在于,由本发明的医疗用阻气薄膜与上述热封层相向地熔敷而成;或
(II)其特征在于,对利用吹塑法将多层基材薄膜成型而成的本发明的医疗用阻气薄膜,将上述多层基材薄膜的开口端进行熔敷而成。
在上述(I)的医疗用袋中,例如,可以将2张本发明的阻气薄膜以使其各自的热封层相向地的方式相重叠,将周边部进行热封,由此形成为袋状。
周边部的热封条件并不限定于这些,在170℃以上、优选为180~200℃热封3~5秒钟左右。
本发明的医疗用袋可以是具有利用易剥离密封部分隔成两个以上收容腔的所谓多腔袋。
形成易剥离密封部时的热封温度并不限定于这些,例如,对医疗用袋在105~115℃下实施灭菌处理后,可适当设定在使易剥离密封的剥离强度为3.92~5.88N/15mm的范围。具体的热封条件可以根据形成热封层的树脂的种类来设定,例如,优选为140~155℃、更优选为140~145℃下热封4~5秒钟左右。
需要说明的是,上述剥离强度根据JISZ0237“胶带·粘合片材试验方法”所述的方法(180℃剥离法)测定。该剥离强度的测定方法如下:将挠性塑料薄膜以易剥离密封部分为起点、以宽度15mm剪取,将由此得到的测定样品的一对薄膜部分在相互180°的角度、以200mm/分钟的速度相互牵拉,测定易剥离密封剥离时的强度(N/15mm)。
在本发明中,从高度维持作为医疗用袋整体的气体·水蒸汽阻挡性的观点来考虑,对医疗用袋的口构件,优选为使用显示优良的气体·水蒸汽阻挡性的材料。
作为这种口构件(口部孔等),例如可举出聚乙烯制的口构件,内部具有乙烯-乙烯醇共聚物(EVOH)、聚环状烯烃等层的口构件。
本发明的医疗用袋优选为在内部填充药液等且密封好的状态下对医疗用袋整体实施加热灭菌处理。
依据本发明的医疗用袋,由于在形成医疗用袋的医疗用阻气薄膜中具有聚环状烯烃层,而且,多层阻气薄膜的蒸镀拉伸聚酯层中的蒸镀层配置在与多层基材薄膜侧的相反的一侧,被拉伸聚酰胺层保护,因此,即使实施在高温下的加热灭菌处理时,也可以发挥优良的气体·水蒸汽阻挡性,而且,可以防止上述蒸镀层的劣化,维持优良的气体·水蒸汽阻挡性。
另外,依据本发明的医疗用袋,由于在形成医疗用袋的医疗用阻气薄膜中具有聚环状烯烃层,而且,含有上述聚环状烯烃层的多层基材薄膜的形成不使用粘结剂,并且,在层压时比使用粘结剂的多层阻气薄膜更配置在医疗用袋的内侧,因此,可以抑制薄膜的配合成分或来自粘结剂的成分的溶出。
实施例
下面,基于实施例及比较例更详细地说明本发明,但本发明不局限于下述实施例。
<医疗用阻气薄膜及医疗用袋的制造>
实施例1
(1)多层阻气薄膜的制作
利用干式层压,将下述氧化铝蒸镀拉伸聚酯层11、拉伸聚酰胺层15及聚乙烯层17的3个层,依次并且分别隔着由下述粘结剂构成的粘结剂层(14,16)进行层压,制作总厚度60μm的多层阻气薄膜10(参照图1)。
在制作多层阻气薄膜10时,拉伸聚酰胺层15隔着粘结剂层14层压在氧化铝蒸镀拉伸聚酯层11的蒸镀层13的表面11a上。另外,聚乙烯层17隔着粘结剂层16层压在拉伸聚酰胺薄膜15中的与蒸镀层13的粘接面15a的相反一侧的表面15b上。
用于制作多层阻气薄膜10的薄膜材料如下所述。
·氧化铝蒸镀拉伸聚酯薄膜:在双向拉伸PET薄膜的表面蒸镀有氧化铝的薄膜(蒸镀层13和拉伸聚酯薄膜12的整体厚度为12μm,蒸镀层13的厚度约为20nm的薄膜,凸版印刷(株)制的透明阻挡薄膜,商品名“GL-AEH”)
·拉伸聚酰胺薄膜:双向拉伸尼龙薄膜(厚15μm,Unitika(株)制,商品名“エンブレムONMB”)
·聚乙烯薄膜:由厚20μm的直链聚乙烯(密度0.920g/cm3、MFR1.0g/10分钟(190℃)、三井化学(株)制、商品名“ウルトゼツク2010”)18和配置在其两面的分别厚5μm的高密度聚乙烯(密度0.950g/cm3、熔体质量流动速率(MFR)1.1g/10分钟、190℃、三井化学(株)制、商品名“ハイゼツクス3300F”)19、20构成的3层共挤出薄膜
·粘结剂:三井武田化学(株)制、商品名“タケラツクA315”
(2)多层基材薄膜的制造
利用共挤出吹塑成型,制作由厚25μm的热封层23、厚55μm的第1弹性体层24、厚10μm的聚环状烯烃层25、厚55μm的第2弹性体层26及厚15μm的聚乙烯层27的5层结构构成的、将上述热封层23配置在内侧而成的筒状的多层基材薄膜(总厚度160μm)22。
构成多层基材薄膜22的各层的形成材料如下所述。
·热封层23:直链聚乙烯(密度0.930g/cm3、三井化学(株)制的商品名“ウルトゼツク3020L”、MFR2.1g/10分钟(190℃))
·第1弹性体层24及第2弹性体层26:直链聚乙烯弹性体(密度0.885g/cm3、三井化学(株)制、商品名“タフマ一A0585”、MFR0.5g/10分钟(190℃))70重量%、直链聚乙烯(密度0.920g/cm3、三井化学(株)制的商品名“ウルトゼツク2010”、MFR1.0g/10分钟(190℃))25重量%及高密度聚乙烯(密度0.965g/Gm3、三井化学制,型号“NZ65150”、MFR 16g/10分钟(190℃))5重量%的混合树脂
·聚环状烯烃层25:降冰片烯类开环聚合物的加氢物(日本Zeon(株)制,商品名“ゼオノア1020R”、比重1.01、玻璃化转变温度(Tg105℃))
·聚乙烯层27:直链聚乙烯(密度0.940g/cm3、三井化学(株)制,商品名“ウルトゼツクス4020L”、MFR2.1g/10分钟(190℃))75重量%和高密度聚乙烯(密度0.965g/cm3、三井化学(株)制,型号“NZ65150”、MFR16g/10分钟(190℃))25重量%的混合树脂
(3)医疗用阻气薄膜的制造
利用干式层压,将由上述(2)得到的多层基材薄膜叠成平面状的状态的正反两面(即,上述多层基材薄膜22的聚乙烯层27侧的表面)和由上述(1)得到的多层阻气薄膜的氧化铝蒸镀拉伸聚酯薄膜侧的表面(与蒸镀层13的相反一侧的表面11b),隔着由上述粘结剂构成的层21进行层压。
由此得到具有图1所示的层结构的筒状的医疗用阻气薄膜。
(4)医疗用袋的制造
将由上述(3)得到的筒状的医疗用阻气薄膜中的一个开口端31在夹持有下述口构件34的状态下进行热封,将另一个开口端32和层压在多层基材薄膜表面的多层阻气薄膜的周边部33进行密封,得到图2所示的医疗用袋30。
上述口构件使用在中间具有乙烯-乙烯醇共聚物(EVOH)的层的聚乙烯制的口部孔34。医疗用阻气薄膜的开口端部分31、32和周边部(层压在多层基材薄膜表面的多层阻气薄膜的接缝部分)33的热封在170℃下实施4.5秒钟。另外,口部孔34通过如下方法固定:在740℃下进行预热后,隔着上述医疗用阻气薄膜在160℃下进行热封4.5秒钟。
在医疗用袋40的收容腔中,填充蒸馏水500ml,进行密封。
实施例2
(1)多层阻气薄膜的制作
与实施例1的(1)同样操作,制作多层阻气薄膜。
(2)多层基材薄膜的制造
作为热封层,取代实施例1的热封层(厚度25μm)23,使用直链聚乙烯(密度0.940g/cm3、三井化学(株)制、商品名“ウルトゼツク4020L”、MFR2.1g/10分钟(190℃))85重量%和聚丙烯(密度0.910g/cm3、三井化学(株)制、型号“J103WA”)15重量%的混合树脂,除此之外,与实施例1的(2)同样操作,制作多层基材薄膜。
(3)医疗用阻气薄膜的制造
作为多层基材薄膜,取代由实施例1制作的多层基材薄膜,使用上述(2)得到的多层基材薄膜,除此之外,与实施例1的(3)同样操作,制作医疗用阻气薄膜。
(4)医疗用袋的制造
将由上述(3)得到的筒状的医疗用阻气薄膜中的一个开口端41在夹持有与实施例1中使用的相同的口构件(口部孔34)的状态下进行热封,将另一个开口端42和层压在多层基材薄膜表面的多层阻气薄膜的接缝部分(周边部)43进行热封,而且,在医疗用袋的收容腔中形成易剥离密封部44,由此得到图4所示的医疗用袋(多腔袋)40。
医疗用阻气薄膜的开口端部分41、42和周边部(层压在多层基材薄膜表面的多层阻气薄膜的接缝部分)43的热封,在170℃下实施4.5秒,易剥离密封部44的热封在130℃下实施4.5秒。口构件通过如下方法固定,在740℃下进行预热后,隔着上述医疗用阻气薄膜,在160℃下进行热封4.5秒。
在医疗用袋40的大收容腔45中,填充蒸馏水700mL,在小收容腔46中填充蒸馏水300mL,进行密封。
比较例1
在具有图1所示层结构的医疗用阻气薄膜中,在多层基材薄膜22中不设置聚环状烯烃层25,除此之外,与实施例1同样操作,制造医疗用阻气薄膜。另外,除使用由此得到的医疗用阻气薄膜之外,与实施例1同样操作,制造图2所示的医疗用袋。
比较例2
在具有图1所示层结构的医疗用阻气薄膜中,对于多层阻气薄膜10的蒸镀拉伸聚酯层11,将拉伸聚酯薄膜12和蒸镀层13的层压方向颠倒,除此之外,与实施例1同样操作,制造医疗用阻气薄膜。另外,除使用由此得到的医疗用阻气薄膜之外,与实施例1同样操作,制造图2所示的医疗用袋。
比较例3
在具有图1所示的层结构的医疗用阻气薄膜中,不设置多层阻气薄膜的聚乙烯层17,并且,将拉伸聚酰胺层的厚度设定为30μm,除此之外,与实施例1同样操作,制造医疗用阻气薄膜。另外,除使用由此得到的医疗用阻气薄膜之外,与实施例1同样操作,制造图2所示的医疗用袋。
<医疗用袋的物性评价>
(1)溶出试验等
对由实施例1~2及比较例1~3得到的医疗用袋实施高压蒸汽灭菌处理(110℃、60分钟)后,剪取试验片。
使用由此得到的试验片,根据日本药典(第14版)第1部的“55.塑料制医药品容器试验法-2.溶出物试验”及“55.-7.细胞毒性试验”、日本药典(第14版)第2部的“13.塑料制医药品容器”的规定(医疗器械及医疗用材料的基础生物学的试验指南I.细胞毒性试验10.使用医疗器械或材料的萃取液的细胞毒性试验、II.致敏性试验及VII.溶血性试验),实施“急性毒性试验”、“致敏性试验”及“溶血性试验”各试验。
(2)透明性、透氧率等的测定
再使用上述试验片,实施日本药典(第14版)第1部的“55.塑料制医药品容器试验法-4.透明性试验”及“55.-5.水蒸汽透过性试验”的各试验,进一步测定透氧率及灭菌收缩率。
透氧率(cm3/m3·日)是在温度20℃、湿度60%RH的条件下,使用透氧率测定仪(MOCON公司(美国)制、仪器名称“OXTRAN2/20”)进行测定的。
透氧率优选为0.2cm3/m3·日以下,更优选为0.1cm3/m3·日以下。
灭菌收缩率(%)是通过比较从实施高压蒸汽灭菌处理前的医疗用袋剪取的试验片和上述试验片的长度而算出的,利用高压蒸汽灭菌处理,可以显示医疗用阻气薄膜收缩的程度。
灭菌收缩率,就MD而言优选为2.5%以下,更优选为1.0%以下,就TD而言,优选为2.5%以下,更优选为1.0%以下。
(3)坠落试验
在对实施例1~2及比较例1~3中得到的医疗用袋各15袋实施高压蒸汽灭菌处理(110℃、60分钟)后,分别将每5袋的医疗用袋在并列的状态下叠置,收容于封装箱内,在0℃下保存2天。保存后,从120cm的高度使医疗用袋坠落10次,确认有没有发生漏液和气体·水蒸汽阻挡性的降低。
就气体·水蒸汽阻挡性而言,与上述同样操作,测定坠落试验后的透氧率和水蒸汽透过率,当透氧率超过0.2cm3/m3·日,及水蒸汽透过率超过0.27g/m2·日时,判定为气体·水蒸汽阻挡性降低。
(4)评价结果
实施例1和2的医疗用袋,在上述(1)的试验中,对任一个评价项目,都满足标准值。相对于此,在比较例1的医疗用袋中,可以看到来自粘结剂的物质的溶出。
另外可知,实施例1和2的医疗用袋都是透明性为82.5%,透氧率为0.04cm3/m3·日(20℃、60%RH)、水蒸汽透过率为0.18g/m2·日(40℃、90%RH)、灭菌收缩率为1.3(MD)、-0.3(TD)的医疗用袋,可见其气体·水蒸汽阻挡性优良,可以非常低地抑制由灭菌处理引起的收缩率。相对于此,比较例2和3的医疗用袋,通过实施灭菌处理,其透氧率和水蒸汽透过率上升,通过对比较例3的医疗用袋实施灭菌处理,可以观察到其透明性降低。
而且,在实施例1和2的医疗用袋中,在实施坠落试验后,完全看不到漏液,其透氧率及水蒸汽透过率几乎没有发生变化。与之相对,在比较例2的医疗用袋中,封装箱3箱中的2箱中含有的医疗用袋发生了漏液。而且,即使是没有发生漏液的医疗用袋,也观察到透氧率及水蒸汽透过率的上升。比较例3的医疗用袋,观察到其柔软性降低,及随之相伴的折痕及条纹的产生。
本发明不限定于上面的记载,在专利权利要求记载的范围内可进行各种方案变更。
需要说明的是,上述发明以本发明例示的实施方式提供,但其仅为例示,并非限定性解释。本领域技术人员所明了的本发明的变形例也包含在后述的权利要求的范围中。
工业实用性
本发明的医疗用阻气薄膜优选为用于医疗,尤其是优选作为收容因氧等气体或水蒸汽等容易发生劣化的药剂的医疗用袋等的形成材料。
另外,本发明的医疗用袋优选为用于医疗,尤其是优选用于收容因氧等气体或水蒸汽等容易发生劣化的药剂。
Claims (10)
1.医疗用阻气薄膜,其特征在于,其具有多层阻气薄膜和粘接于该多层阻气薄膜上的多层基材薄膜,
上述多层阻气薄膜具有:在一侧表面具有无机氧化物的蒸镀层的蒸镀拉伸聚酯层、粘接于上述蒸镀拉伸聚酯层的上述蒸镀层侧表面的拉伸聚酰胺层、粘接于上述拉伸聚酰胺层的与上述蒸镀层的粘接面的相反一侧表面的聚乙烯层,
上述多层基材薄膜具有聚环状烯烃层、粘接于上述聚环状烯烃层的一侧表面的第1弹性体层、粘接于上述第1弹性体层的与上述聚环状烯烃层的粘接面的相反一侧表面的热封层、粘接于上述聚环状烯烃层的另一侧表面的第2弹性体层、粘接于上述第2弹性体层的与上述聚环状烯烃层的粘接面的相反一侧表面的聚乙烯层,并且,上述多层基材薄膜粘接于上述蒸镀拉伸聚酯层的另一侧表面,
上述热封层配置在上述多层基材薄膜的与上述蒸镀拉伸聚酯层的粘接面的相反一侧的表面。
2.如权利要求1所述的医疗用阻气薄膜,其特征在于,上述第1弹性体层和上述第2弹性体层的总厚度为上述多层基材薄膜的厚度的55~80%。
3.如权利要求1所述的医疗用阻气薄膜,其特征在于,上述多层阻气薄膜的聚乙烯层的厚度为上述蒸镀拉伸聚酯层和上述拉伸聚酰胺层的总厚度的1~2倍。
4.如权利要求1所述的医疗用阻气薄膜,其特征在于,上述多层阻气薄膜的聚乙烯层是由密度0.910~0.930g/cm3的直链聚乙烯薄膜和粘接于上述直链聚乙烯薄膜的两侧表面的密度0.950~0.970g/cm3的高密度聚乙烯薄膜构成的3层薄膜,并且,上述直链聚乙烯薄膜每侧的上述高密度聚乙烯薄膜的厚度为上述直链聚乙烯薄膜的厚度的0.2~0.3倍。
5.如权利要求1所述的医疗用阻气薄膜,其特征在于,上述无机氧化物是氧化铝。
6.如权利要求1所述的医疗用阻气薄膜,其特征在于,上述多层基材薄膜是利用吹塑成型形成的筒状薄膜,并且该筒状薄膜的最内层是上述热封层。
7.医疗用袋,其特征在于,
具备医疗用阻气薄膜,该医疗用阻气薄膜具有多层阻气薄膜和粘接于该多层阻气薄膜上的多层基材薄膜,
上述多层阻气薄膜具有:在一侧表面具有无机氧化物的蒸镀层的蒸镀拉伸聚酯层、粘接于上述蒸镀拉伸聚酯层的上述蒸镀层侧表面的拉伸聚酰胺层、粘接于上述拉伸聚酰胺层的与上述蒸镀层的粘接面的相反一侧表面的聚乙烯层,
上述多层基材薄膜具有聚环状烯烃层、粘接于上述聚环状烯烃层的一侧表面的第1弹性体层、粘接于上述第1弹性体层的与上述聚环状烯烃层的粘接面的相反一侧表面的热封层、粘接于上述聚环状烯烃层的另一侧表面的第2弹性体层、粘接于上述第2弹性体层的与上述聚环状烯烃层的粘接面的相反一侧表面的聚乙烯层,并且,上述多层基材薄膜粘接于上述蒸镀拉伸聚酯层的另一侧表面,
上述热封层配置在上述多层基材薄膜的与上述蒸镀拉伸聚酯层的粘接面的相反一侧的表面,
上述医疗用阻气薄膜与上述热封层相向地熔敷。
8.医疗用袋,其特征在于,其将医疗用阻气薄膜中的多层基材薄膜的开口端熔敷而成,
上述医疗用阻气薄膜具有多层阻气薄膜和粘接于该多层阻气薄膜上的多层基材薄膜,
上述多层阻气薄膜具有:在一侧表面具有无机氧化物的蒸镀层的蒸镀拉伸聚酯层、粘接于上述蒸镀拉伸聚酯层的上述蒸镀层侧表面的拉伸聚酰胺层、粘接于上述拉伸聚酰胺层的与上述蒸镀层的粘接面的相反一侧表面的聚乙烯层,
上述多层基材薄膜是利用吹塑成型形成的筒状薄膜,
上述多层基材薄膜具有聚环状烯烃层、粘接于上述聚环状烯烃层的一侧表面的第1弹性体层、粘接于上述第1弹性体层的与上述聚环状烯烃层的粘接面的相反一侧表面的热封层、粘接于上述聚环状烯烃层的另一侧表面的第2弹性体层、粘接于上述第2弹性体层的与上述聚环状烯烃层的粘接面的相反一侧表面的聚乙烯层,并且,上述多层基材薄膜粘接于上述蒸镀拉伸聚酯层的另一侧表面,
上述热封层配置在上述多层基材薄膜的与上述蒸镀拉伸聚酯层的粘接面的相反一侧的表面,
上述筒状的多层基材薄膜的最内层是上述热封层。
9.如权利要求7所述的医疗用袋,其特征在于,对其填充药液并密封后,整体实施加热灭菌。
10.如权利要求8所述的医疗用袋,其特征在于,对其填充药液并密封后,整体实施加热灭菌。
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- 2005-10-13 JP JP2006542925A patent/JP4717007B2/ja not_active Expired - Fee Related
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- 2005-10-13 WO PCT/JP2005/018834 patent/WO2006043459A1/ja active Application Filing
- 2005-10-17 MY MYPI20054858A patent/MY139251A/en unknown
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Also Published As
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JPWO2006043459A1 (ja) | 2008-05-22 |
HK1107058A1 (en) | 2008-03-28 |
TW200626126A (en) | 2006-08-01 |
KR101150566B1 (ko) | 2012-06-08 |
EP1803552B1 (en) | 2014-01-22 |
AU2005297712A1 (en) | 2006-04-27 |
CA2583807C (en) | 2012-07-10 |
CN101044021A (zh) | 2007-09-26 |
JP4717007B2 (ja) | 2011-07-06 |
CA2583807A1 (en) | 2006-04-27 |
ES2457815T3 (es) | 2014-04-29 |
US20080063825A1 (en) | 2008-03-13 |
WO2006043459A1 (ja) | 2006-04-27 |
AU2005297712B2 (en) | 2010-08-19 |
MY139251A (en) | 2009-09-30 |
KR20070085296A (ko) | 2007-08-27 |
EP1803552A1 (en) | 2007-07-04 |
US7914867B2 (en) | 2011-03-29 |
EP1803552A4 (en) | 2013-01-02 |
TWI301411B (en) | 2008-10-01 |
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