CN114074468A - 药物包装用复合膜材 - Google Patents

药物包装用复合膜材 Download PDF

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CN114074468A
CN114074468A CN202011447913.XA CN202011447913A CN114074468A CN 114074468 A CN114074468 A CN 114074468A CN 202011447913 A CN202011447913 A CN 202011447913A CN 114074468 A CN114074468 A CN 114074468A
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layer
composite film
heat
aluminum foil
pharmaceutical packaging
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廖德超
袁敬尧
郑文瑞
钟敏帆
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Nan Ya Plastics Corp
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Nan Ya Plastics Corp
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Abstract

本发明公开一种药物包装用复合膜材，其包括一热封层、一铝箔层以及一抗冲击层。热封层含有1,4‑丁二醇、间苯二甲酸、异戊二醇以及异丙醇中的至少一种衍生的残基，以使热封层具有130℃至180℃之间的熔点，铝箔层设置于热封层上，且抗冲击层设置于铝箔层上。本发明的药物包装用复合膜材无毒性，且具有优越的抗冲击性能和热封性能。

Description

药物包装用复合膜材
技术领域
本发明涉及一种药物包装材料，特别是涉及一种药物包装用复合膜材。
背景技术
药物是一种用于预防、治疗疾病的特殊商品，其与消费者的健康和生命安全息息相关。包装材料由于会直接接触到药物，包装材料中一旦含有有害物质，在使用过程中就可能被排出而造成药物污染，影响用药安全；此外，若包装材料的阻隔性能不佳，就有可能让水气、氧气和光线透过，导致药物发生化学变化而降低保存期限。因此，有必要对药物包装材料的使用性能加以关注。
现有的药物包装材料大部分是由铝箔、内侧具热封性的聚氯乙烯(PVC)层与外侧塑料层复合而成，惟PVC含有有毒物质塑化剂，会危害人体健康，存在安全上的隐患。另外，市面上虽然有包装材料将PVC替换成环状烯烃共聚物(cyclic olefin copolymer,COC)或非PVC塑料，但环状烯烃共聚物的成本较高，而非PVC塑料也并非完全无毒。
发明内容
本发明所要解决的技术问题在于，针对现有技术的不足提供一种安全无毒的药物包装用复合膜材。
为了解决上述的技术问题，本发明所采用的其中一技术方案是提供一种
药物包装用复合膜材，其包括一热封层、一铝箔层以及一抗冲击层。所述热封层含有1,4-丁二醇、间苯二甲酸、异戊二醇以及异丙醇中的至少一种衍生的残基，而具有130℃至180℃之间的熔点，所述铝箔层设置于所述热封层上，所述抗冲击层设置于所述铝箔层上。
在本发明的一实施例中，所述热封层含有1至50摩尔百分比的1,4-丁二醇衍生的残基、1至50摩尔百分比的间苯二甲酸衍生的残基、1至50摩尔百分比的异戊二醇衍生的残基及/或1至50摩尔百分比的异丙醇衍生的残基。
在本发明的一实施例中，所述热封层含有10摩尔百分比的异戊二醇衍生的残基以及4摩尔百分比的异丙醇衍生的残基。
在本发明的一实施例中，所述抗冲击层的组成包括一抗冲击性高分子，其选自于热塑性聚酯弹性体、尼龙、聚对苯二甲酸丁二醇酯以及聚对苯二甲酸乙二醇酯-1,4-环己烷二甲醇酯所组成的群组。
在本发明的一实施例中，所述抗冲击层是由一聚酯组合物所形成，所述聚酯组合物包含所述抗冲击性高分子，且基于100重量百分比的所述聚酯组合物，所述抗冲击性高分子的含量为1至70重量百分比。
在本发明的一实施例中，所述聚酯组合物还包含一般聚酯，且基于100重量百分比的所述聚酯组合物，所述一般聚酯的含量为30至99重量百分比。
在本发明的一实施例中，所述一般聚酯为聚对苯二甲酸乙二酯。
在本发明的一实施例中，所述热封层的厚度为10微米至200微米，所述铝箔层的厚度为5微米至20微米，且所述抗冲击层的厚度为10微米至100微米。
在本发明的一实施例中，所述药物包装用复合膜材还包括一第一贴合层以及一第二贴合层，所述热封层通过所述第一贴合层结合于所述铝箔层的一表面上，且所述抗冲击层通过所述第二贴合层结合于所述铝箔层的相对另一表面上。
在本发明的一实施例中，所述第一贴合层与所述第二贴合层各为一聚烯烃热熔胶所形成，且所述第一贴合层与所述第二贴合层的厚度各为2微米至5微米。
本发明的其中一有益效果在于，本发明所提供的药物包装用复合膜材，其能通过“热封层为一改性聚酯层，其含有1,4-丁二醇、间苯二甲酸、异戊二醇以及异丙醇中的至少一种衍生的残基”以及“铝箔层设置于热封层上，且抗冲击层设置于铝箔层上”的技术特征，以确保药物的质量和安全性，且所形成的药物包装可以在储存及运输过程中维持完整性。
为使能更进一步了解本发明的特征及技术内容，请参阅以下有关本发明的详细说明与附图，然而所提供的附图仅用于提供参考与说明，并非用来对本发明加以限制。
附图说明
图1为本发明的药物包装用复合膜材的结构示意图。
图2为本发明的药物包装用复合膜材的实施方式示意图。
具体实施方式
以下是通过特定的具体实施例来说明本发明所公开有关“药物包装用复合膜材”的实施方式，本领域技术人员可由本说明书所公开的内容了解本发明的优点与效果。本发明可通过其他不同的具体实施例加以施行或应用，本说明书中的各项细节也可基于不同观点与应用，在不背离本发明的构思下进行各种修改与变更。另外，本发明的附图仅为简单示意说明，并非依实际尺寸的描绘，事先声明。以下的实施方式将进一步详细说明本发明的相关技术内容，但所公开的内容并非用以限制本发明的保护范围。另外，本文中所使用的术语“或”，应视实际情况可能包括相关联的列出项目中的任一个或者多个的组合。
除非另外定义，否则本文中使用的所有技术及科学术语，都具有与本领域技术人员通常所理解含义相同的含义。当术语以单数形式出现时，涵盖此术语的复数形式。
除非另有指示，否则本文中提到的所有百分比都为重量百分比。当提供一系列上、下限范围时，涵盖所提到的范围的所有组合，如同明确列出各组合。
参阅图1所示，本发明一实施例提供一种药物包装用复合膜材Z，其主要包括一热封层1、一铝箔层2及一抗冲击层3，铝箔层2设置于热封层1上，且抗冲击层3设置于铝箔层2上。使用时，热封层1可以在热环境下(如加压的热环境下)发生熔融，铝箔层2具有优越的阻隔性能，能避免药物与水分、气体(氧气)或光线接触发生变质，抗冲击层3能抵抗外力冲击，使药物包装保持完整。
热封层1为一改性聚酯层，其含有1,4-丁二醇、间苯二甲酸、异戊二醇及异丙醇中的至少一种衍生的残基。值得说明的是，1,4-丁二醇、间苯二甲酸、异戊二醇及异丙醇皆可以在聚合过程中形成低聚物混合物，使得基于聚酯的热封层1具有较低的熔点，其为130℃至180℃，从而本发明的复合膜材Z可以在此温度范围下进行热封。此外，热封层1的厚度会影复合膜材Z的热封强度，热封层1的厚度越厚，则复合膜材Z的热封强度越强；基于实用性和成本的考虑，热封层1的厚度可为10微米至200微米。
参阅图2所示，实际应用时，可以将一个或多个药物置于两片复合膜材Z之间，两片复合膜材Z以热封层1朝内的方式重叠在一起，然后进行热压使熔点较低的热封层1发生熔融并结合成一体，如此即完成药物的包装。
在本实施例中，热封层1可含有1至50摩尔百分比的1,4-丁二醇衍生的残基、1至50摩尔百分比的间苯二甲酸衍生的残基、1至50摩尔百分比的异戊二醇衍生的残基及/或1至50摩尔百分比的异丙醇衍生的残基，优选为同时含有10摩尔百分比的异戊二醇衍生的残基及4摩尔百分比的异丙醇衍生的残基。本文所用的术语“残基”，是指化学反应产物中衍生自特定化合物的一基团或单元，例如通过酯化(esterification)或聚缩合(polycondensation)反应所合成的聚酯或共聚酯中，衍生自二酸或二醇成分的基团。
进一步而言，热封层1可由第一聚酯组合物所形成，第一聚酯组合物主要包含一般聚酯及改性剂；例如，可将第一聚酯组合物熔融并押出形成一熔融层，熔融层经过冷却定型即形成热封层1。在第一聚酯组合物中，一般聚酯为聚对苯二甲酸乙二醇酯(PET)，改性剂选自于1,4-丁二醇、间苯二甲酸、异戊二醇及异丙醇中的至少一种；基于100重量百分比的第一聚酯组合物，一般聚酯的含量可为30至99重量百分比，且改性剂的含量可为1至50重量百分比。然而，以上所述只是可行的实施方式，而并非用以限制本发明。在一些实施例中，一般聚酯可为聚对苯二甲酸丙二醇酯(PPT)、聚对苯二甲酸丁二醇酯(PBT)、聚萘二甲酸乙二醇酯(PEN)或聚萘二甲酸丁二醇酯(PBN)。
铝箔层2可由一高纯度铝箔(含有99％以上的铝)或掺杂有金属和非金属元素的改性铝箔所形成，铝箔层2的厚度可为5微米至20微米，且优选为10微米；若铝箔层2太厚(即铝箔层的厚度大于20微米)，则会增加生产成本，若铝箔层2太薄(即铝箔层的厚度小于5微米)，则达不到所需的阻隔效果。值得说明的是，在铝箔层2的存在下，水分、氧气、光线等无法与药物直接接触并产生不利影响，因此可以确保药物的质量和安全性，并延长药物的保质期限。在一些实施例中，为了提高铝箔层2的耐针孔性和延展性，铝箔层2掺杂有铁和硅，其中铁含量可为0.1至5重量百分比，且优选为0.3至1重量百分比，硅含量可为0.1至5重量百分比，且优选为0.3至1重量百分比。
抗冲击层3为一聚酯层，其组成包括一抗冲击性高分子。值得说明的是，在抗冲击层3的存在下，本发明的复合膜材Z的抗冲击强度提高了近一倍，从而所形成的药物包装可以在储存及运输过程中维持完整性。为了达到所需的抗冲击效果，抗冲击层3的厚度可为50微米至100微米。在一些实施例中，抗冲击层3的厚度为55微米、60微米、65微米、70微米、75微米、80微米、85微米、90微米或95微米。
进一步而言，抗冲击层3可由第二聚酯组合物所形成，第二聚酯组合物主要包含一般聚酯及抗冲击性高分子；例如，可将第二聚酯组合物熔融并押出形成一熔融层，熔融层经过冷却定型即形成抗冲击层3。在第二聚酯组合物中，一般聚酯为PET、PPT、PBT、PEN或PBN，且优选为PET，抗冲击性高分子选自于热塑性聚酯弹性体(TPEE)、尼龙(如尼龙6、尼龙11、尼龙66或尼龙12)、聚对苯二甲酸丁二醇酯以及聚对苯二甲酸乙二醇酯-1,4-环己烷二甲醇酯(Polyethylene Terephthalate-Glycol，PETG)所组成的群组；基于100重量百分比的第二聚酯组合物，一般聚酯的含量可为30至99重量百分比，且抗冲击性高分子的存在量可为1至70重量百分比。然而，以上所述只是可行的实施方式，而并非用以限制本发明。
根据实际应用，第二聚酯组合物可包含至少一种功能性添加剂，例如色料、无机类聚酯改质剂、加工流动助剂、成核剂及/或抗氧化剂。进一步而言，添加色料可以改变复合膜材Z的外观颜色，其可举出碳黑、二氧化钛、硫酸钡及碳酸钙。
无机类聚酯改质剂可以提高抗冲击层3的耐热性，且在无机类聚酯改质剂的存在下，抗冲击层3可具有特定的表面粗糙度和雾度。无机类聚酯改质剂的具体例包括：二氧化硅(SiO2)、二氧化钛(TiO2)、氢氧化铝(Al(OH)3)、氧化铝(Al2O3)、氢氧化镁(Mg(OH)2)、氧化镁(MgO)、碳酸钙(CaCO3)、氧化硼(B2O3)、氧化钙(CaO)、钛酸锶(SrTiO3)、钛酸钡(BaTiO3)、钛酸钙(CaTiO3)、钛酸镁(2MgO·TiO2)、二氧化铈(CeO2)、熏硅石(fume silica)、滑石、碳酸钡、硫酸钙、硫酸钡、磷酸锂、磷酸钙、磷酸镁、氮化硼(BN)、氮化铝(AlN)、碳黑及高岭土；无机类聚酯改质剂可以颗粒形式存在，且基于100重量百分比的第二聚酯组合物，无机类聚酯改质剂的含量可为0.01至2重量百分比。
加工流动助剂可以降低熔融押出聚酯原料时的机械扭力，减少聚合物分子链断链。加工流动助剂可为季戊四醇硬脂酸酯(PETS)或其类似物，其在高温下具有良好的热稳定性、低挥发性、较高的流动性和脱模性能，且对部分结晶的聚酯有很好的成核效果；且基于100重量百分比的第二聚酯组合物，加工流动助剂的含量可为0.01至2重量百分比。
成核剂可以提高总结晶度，从而抗冲击层3的耐热性可以得到改善；成核剂也可以促进结晶成长，使得结晶大小微细化，减少大球晶产生，以及可以避免膜面脆化。成核剂可为矿物材料、金属氧化物、硅化合物、有机酸或无机酸的金属盐、磷酸酯金属盐、多元醇衍生物、磺酰亚胺化合物、玻璃粉末、金属粉末或其任意组合；且基于100重量百分比的第二聚酯组合物，成核剂的含量可为0.0003至2重量百分比。
矿物材料作为成核剂，可举出：石墨、滑石及高岭土；金属氧化物作为成核剂，可举出：氧化锌、氧化铝及氧化镁；硅化合物作为成核剂，可举出：氧化硅、硅酸钙及硅酸镁；有机酸或无机酸的金属盐作为成核剂，可举出：碳酸镁、碳酸钙、碳酸钠、碳酸钾等碳酸金属盐、硫酸钡、硫酸钙、苯甲酸钠及对叔丁基苯甲酸铝；磷酸酯金属盐作为成核剂，可举出芳香族磷酸酯金属盐；多元醇衍生物作为成核剂，可举出二亚苄基山梨醇。
作为形成抗冲击层3的第二聚酯组合物的抗氧化剂，可单独或同时使用一级抗氧化剂与二级抗氧化剂；一级抗氧化剂可以快速地与过氧化自由基(peroxy radical,ROO·)发生反应，以终止自由基连锁反应，而二级抗氧化剂可以与氢过氧化物(ROOH)反应，并将其转化为无自由基且无反应活性的产物；值得说明的是，一级抗氧化剂与二级抗氧化剂可以发挥良好的协同作用，以提供更好的抗氧化效果。
一级抗氧化剂可选自于酚类化合物或胺类化合物，具体可举出商标名为Irganox1010、Irganox 1425、Irganox 245、Anox 1315、Anox PP18、Anox 20、Lowinox 1790、Lowinox TBM-68及Naugard 445的市售品；且基于100重量百分比的第二聚酯组合物，一级抗氧化剂的含量可为0.01至1重量百分比。二级抗氧化剂可选自于亚磷类化合物或硫酯类化合物，具体可举出商标名为Sandostab P-EPQ、Irgafos 168及Naugard 412S的市售品；且基于100重量百分比的第二聚酯组合物，二级抗氧化剂的含量可为0.01至1重量百分比。
此外，可以对未延伸的抗冲击层3实施延伸加工，使其具有更优越的机械性能。在一些实施例中，所实施的延伸加工方式可为逐次双轴延伸加工，即未延伸的抗冲击层3先在特定的温度及延伸倍率下进行纵向(或称“长度方向”，MD)延伸加工，然后在特定的温度及延伸倍率下进行横向(或称“宽度方向”，TD)延伸加工；根据实际需要，可将纵向延伸加工与横向延伸加工的顺序反过来。在一些实施例中，所实施的延伸加工方式可为同步双轴延伸加工，即未延伸的抗冲击层3在特定的温度及延伸倍率下同时进行纵向延伸加工与横向延伸加工。
复参阅图1所示，在本实施例中，热封层1可通过一第一贴合层4结合于铝箔层2的一表面(如内表面)上，且抗冲击层3可通过一第二贴合层5结合于铝箔层2的相对另一表面(如外表面)上。第一贴合层4与第二贴合层5各可为一聚烯烃胶层，其组成包括聚烯烃(polyolefin,PO)及热熔胶；第一贴合层4与第二贴合层5的厚度可为2微米至5微米。
表1中列出本发明的药物包装用复合膜材Z的几个代表性实施例，然而，本发明不以所列的例子为限。
表1
Figure BDA0002825393790000071
Figure BDA0002825393790000081
◎代表质量优(very good)
○代表质量良(good)
△代表质量差(poor)
╳代表质量极差(very poor)
实施例的有益效果
本发明的其中一有益效果在于，本发明所提供的药物包装用复合膜材，其能通过“热封层含有1,4-丁二醇、间苯二甲酸、异戊二醇以及异丙醇中的至少一种衍生的残基”以及“铝箔层设置于热封层上，且抗冲击层设置于铝箔层上”的技术特征，以确保药物的质量和安全性，且所形成的药物包装可以在储存及运输过程中维持完整性。
更进一步来说，热封层为一改性聚酯层，本身安全无毒性，不会造成环境污染，可以取代业界普遍使用的聚氯乙烯(PVC)热封层。再者，由于1,4-丁二醇、间苯二甲酸、异戊二醇及异丙醇皆可以在聚合过程中形成低聚物混合物，基于聚酯热封层可具有较低的熔点(熔点为130℃至180℃)，从而本发明的复合膜材可以使用较低的温度进行热封，可降低生产成本；且在实际应用时，可通过调整热封层的厚度来控制热封强度。
更进一步来说，抗冲击层的组成包括一抗冲击性高分子，且抗冲击性高分子选自于热塑性聚酯弹性体(TPEE)、尼龙(如尼龙6、尼龙11、尼龙66或尼龙12)、聚对苯二甲酸丁二醇酯以及聚对苯二甲酸乙二醇酯-1,4-环己烷二甲醇酯(Polyethylene Terephthalate-Glycol，PETG)所组成的群组；因此，本发明的复合膜材Z的抗冲击强度可提高近一倍。
以下以上所公开的内容仅为本发明的优选可行实施例，并非因此局限本发明的权利要求书的保护范围，所以凡是运用本发明说明书及附图内容所做的等效技术变化，均包含于本发明的权利要求书的保护范围内。

Claims (10)

1.一种药物包装用复合膜材，其特征在于，所述药物包装用复合膜材包括：
一热封层，所述热封层含有1,4-丁二醇、间苯二甲酸、异戊二醇以及异丙醇中的至少一种衍生的残基，而具有130℃至180℃之间的熔点；
一铝箔层，所述铝箔层设置于所述热封层上；以及
一抗冲击层，所述抗冲击层设置于所述铝箔层上。
2.根据权利要求1所述的药物包装用复合膜材，其特征在于，所述热封层含有1至50摩尔百分比的1,4-丁二醇衍生的残基、1至50摩尔百分比的间苯二甲酸衍生的残基、1至50摩尔百分比的异戊二醇衍生的残基及/或1至50摩尔百分比的异丙醇衍生的残基。
3.根据权利要求2所述的药物包装用复合膜材，其特征在于，所述热封层含有10摩尔百分比的异戊二醇衍生的残基以及4摩尔百分比的异丙醇衍生的残基。
4.根据权利要求1所述的药物包装用复合膜材，其特征在于，所述抗冲击层的组成包括一抗冲击性高分子，其选自于热塑性聚酯弹性体、尼龙、聚对苯二甲酸丁二醇酯以及聚对苯二甲酸乙二醇酯-1,4-环己烷二甲醇酯所组成的群组。
5.根据权利要求4所述的药物包装用复合膜材，其特征在于，所述抗冲击层是由一聚酯组合物所形成，所述聚酯组合物包含所述抗冲击性高分子，且基于100重量百分比的所述聚酯组合物，所述抗冲击性高分子的含量为1至70重量百分比。
6.根据权利要求5所述的药物包装用复合膜材，其特征在于，所述聚酯组合物还包含一般聚酯，且基于100重量百分比的所述聚酯组合物，所述一般聚酯的含量为30至99重量百分比。
7.根据权利要求6所述的药物包装用复合膜材，其特征在于，所述一般聚酯为聚对苯二甲酸乙二酯。
8.根据权利要求1所述的药物包装用复合膜材，其特征在于，所述热封层的厚度为10微米至200微米，所述铝箔层的厚度为5微米至20微米，且所述抗冲击层的厚度为10微米至100微米。
9.根据权利要求1所述的药物包装用复合膜材，其特征在于，所述药物包装用复合膜材还包括一第一贴合层以及一第二贴合层，所述热封层通过所述第一贴合层结合于所述铝箔层的一表面上，且所述抗冲击层通过所述第二贴合层结合于所述铝箔层的相对另一表面上。
10.根据权利要求1所述的药物包装用复合膜材，其特征在于，所述第一贴合层与所述第二贴合层各为一聚烯烃热熔胶所形成，且所述第一贴合层与所述第二贴合层的厚度各为2微米至5微米。
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