CN108340647A - 一种液液多室袋用五层共挤输液膜及其制备方法 - Google Patents

一种液液多室袋用五层共挤输液膜及其制备方法 Download PDF

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CN108340647A
CN108340647A CN201810063919.3A CN201810063919A CN108340647A CN 108340647 A CN108340647 A CN 108340647A CN 201810063919 A CN201810063919 A CN 201810063919A CN 108340647 A CN108340647 A CN 108340647A
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吴青
万鹏
楚文军
肖怀泽
叶血清
宋小东
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Hubei Huaqiang Technology Co., Ltd
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Abstract

本发明涉及的是一种液液多室袋用静脉输液膜，采用的是五层的结构，A层为产品的内层，是改性乙烯‑丙烯聚合物和SEBS或SEPS的混合物。B层为产品的次内层，为聚乙烯层。C层为产品中间层，为聚乙烯层。D层为产品的次外层，是乙烯甲基丙烯酸酯聚合物。E层为产品的外层，是PET类共聚物。本发明的液液多室袋用静脉输液膜材，除了具有普通输液用膜透明度好，柔韧性，阻隔性等性能外，还兼具有热合强度5‑10N/15mm的弱焊热封性能以及热合强度大于20N/15mm的强焊热封性能，既能满足周边强悍和中部弱焊的工艺要求，保证灭菌和储运过程中各腔室完全隔离，使用时又能通过适当外力使中部弱焊轻易开启，隔断多室相通、液液混合。

Description

一种液液多室袋用五层共挤输液膜及其制备方法
技术领域
本发明涉及一种静脉输液药品包装用膜，具体地说是一种兼具有弱焊和强悍热封性能的用于液液多室袋的五层共挤膜。
技术背景
现应用比较广泛的输液包装为玻璃瓶和硬质塑料瓶，它们存在一个弱点，即在使用过程中需形成空气回路，从而增加了输液过程中的二次污染，特别是在医院杂菌较多和卫生条件较差的地方使用。PVC输液软袋在使用过程可依靠自身张力压迫药液滴出，大大降低了药液被二次污染的概率，但缺点是其中含有增塑剂邻苯二甲酸二异辛酯(DEHP)是一种有害物质，严重危害人体健康，国家食品药品监督管理局早在2000年9月即叫停了PVC输液袋的注册。近年来，发达国家输液产品普遍使用非PVC多层共挤膜。
同时临床治疗过程中，医生通常需要将2～4种不同的成分的药液混合后给患者使用，通常注射用溶剂，和使用的不同成分的药液分别用玻璃瓶、输液袋或塑料瓶盛装，使用与储存都极不方便，而且使用时，为了将几种不容成分的药液混合，通常需要将一种成分药液从原容器中取出，并注入到另一种成分的药液中，这些过程不仅费时，在配制过程中还容易产生大量不溶性微粒、出现配错和细菌污染等二次污染，给临床用药带来隐患。液液多室袋就可以很好的解决这个问题，在灭菌和储运过程中各腔室是完全隔离的，使用时又能通过适当外力使中部弱焊轻易开启，隔断多室相通、液液混合。
非PVC多层共挤膜有主要有两种类型，五层共挤输液用膜和三层共挤输液用膜，三层共挤输液用膜较五层共挤输液用膜硬，在低温下容易发脆破裂，从而造成漏液。并且三层共挤膜的三层材料全部采用聚丙烯，五层共挤膜的外层材料为PET类共聚物，因此五层共挤膜经过热合制成输液袋，耐热性能较好，强悍区域具有更宽的热合窗口。
发明内容
本发明目的就是为了解决以上问题并提供一种兼具有热合强度5-10N/15mm的弱焊热封性能以及热合强度大于20N/15mm的强焊热封性能，能在低温下使用，强悍区域具有较宽的热合窗口，用于液液多室袋的五层共挤输液用膜。
为实现上述目的，本发明采用如下技术方案，一种液液多室袋用静脉输液膜材，它由五层材料共挤而成，如图1所示，五层具体结构如下：
A层：为产品的内层，其材料为改性乙烯-丙烯聚合物和SEBS或SEPS的混合物，改性乙烯-丙烯聚合物的含量在60％-95％之间，SEBS或SEPS的含量在5％-40％之间，A层的厚度在30-50μm。本层的主要功能为弱焊强悍的热封性，与药物的相容性。
B层：为产品的次内层，其材料为为聚乙烯，厚度在10-20μm。聚乙烯包括传统高密度聚乙烯、低密度聚乙烯以及乙烯与α-烯烃共聚物。本层的主要起到粘连内层与中间层的作用。
C层：为产品的中间层，其材料为为聚乙烯，厚度在80-140μm。聚乙烯包括传统高密度聚乙烯、低密度聚乙烯以及乙烯与α-烯烃共聚物。本层的主要作用是阻隔性、柔韧性、良好的透明性。
D层：为产品的次外层，其材料为是乙烯甲基丙烯酸酯聚合物，厚度在10-30μm。本层的主要起到粘连中间层与外层的作用。
E层：为产品的外层，是PET类共聚物，厚度在10-40μm。本层的主要作用是提供袋的耐候性、阻隔性及高温灭菌和热封时的耐热性。
该五层共挤膜的总厚度为160-200μm。
上述A层中所用的改性乙烯-丙烯聚合物为医疗级别，具有特定的熔点，密度为0.89-0.93g/cm3，熔融指数为5.0-10.0g/10min，含量在60％-95％之间。SEBS或SEPS的熔指在3.0-6.0g/10min，含量在5％-40％之间，层厚度在30-50μm。
上述B层所用的聚乙烯，熔点在60-120℃之间，密度为0.88-0.94g/cm3，熔融指数为 0.5-3.0g/10min，厚度在10-20μm。
上述C层所用的聚乙烯，熔点在90-120℃之间，密度为0.9-0.94g/cm3，熔融指数为0.5-1.5g/10min，厚度在80-140μm。
上述D层所用的乙烯甲基丙烯酸酯聚合物，熔点在80-100℃之间，密度为0.9-1.1g/cm3，熔融指数为2-10g/10min，厚度在10-30μm。
上述E层所用的PET类共聚物，熔点在200-240℃之间，密度为1.0-1.2g/cm3，熔融指数为10-20g/10min，厚度在10-40μm。
本发明还提供了一种上述五层共挤膜的制备方法，方法为：生产设备为五层共挤吹膜机组，生产过程在百级或万级净化环境内进行，原材料经挤出机螺杆挤出后，再经模头重新分配挤出，A挤出机温度为160-250℃，B挤出机温度为140-230℃，C挤出机温度为140-230℃， D挤出机温度为140-230℃，E挤出机温度为180-250℃，模头温度为160-250℃。采用平面叠加模头，经模头挤出后由百级风形成下吹膜泡，吹胀比在1.5-3之间，膜泡由百级风和纯化水冷却，经人字夹板折合平整后，进入收卷机进行收卷。
制多室袋采用的热合工艺是：
弱悍温度区间：上模板130-140℃，下模板120-145℃
强悍温度区间：上模板155-175℃，下模板120-145℃
热合时间1.1s，热合压力0.4MPa
与现有多层共挤输液用膜相比，本发明的有益效果有：
(1)内层材料具有热合强度小于10N/15mm的弱焊热封性能以及热合强度大于20N/15mm的强焊热封性能，完全满足周边强悍和中部弱焊的工艺要求。
(2)本发明采用五层的结构，相比于三层共挤输液用膜，具有更好的柔韧性，即使是在0℃以下的环境下，该膜任具有很好的柔软性和物理机械性能。
(3)本发明采用五层的结构，相比于三层共挤输液用膜，强悍区域具有更宽的热合窗口。
(4)本发明采用五层的结构，中间层采用的聚乙烯和外层采用的PET类共聚物，使得该输液用膜比其他五层共挤输液用膜表现出更加优异的氧气、氮气、水蒸气的阻隔性能。
(5)高温灭菌温度可达到121℃，30min，无任何变形，灭菌后弱悍强度和强悍强度保持不变。
附图说明
图1是本发明的结构示意图。
具体实施方式
如图1所示，为本发明液液多室袋用五层共挤膜的各层分布情况。由图1可知，本发明液液多室袋用五层共挤膜从结构组成上分别为内层A，粘结层B、中间层C、粘接层D、外层E。
该五层共挤膜的总厚度为160-200μm。
内层A中所用的改性乙烯-丙烯聚合物为医疗级别，具有特定的熔点，密度为0.89-0.93g/cm3，熔融指数为5.0-10.0g/10min，含量在60％-95％之间。SEBS或SEPS的熔指在3.0-6.0g/10min，含量在5％-40％之间，层厚度在30-50μm。
粘结层B所用的聚乙烯，熔点在60-120℃之间，密度为0.88-0.94g/cm3，熔融指数为 0.5-3.0g/10min，厚度在10-20μm。
中间层C所用的聚乙烯，熔点在90-120℃之间，密度为0.9-0.94g/cm3，熔融指数为0.5-1.5g/10min，厚度在80-140μm。
粘结层D所用的乙烯甲基丙烯酸酯聚合物，熔点在80-100℃之间，密度为0.9-1.1g/cm3，熔融指数为2-10g/10min，厚度在10-30μm。
外层E所用的PET类共聚物，熔点在200-240℃之间，密度为1.0-1.2g/cm3，熔融指数为 10-20g/10min，厚度在10-40μm。
实施例1：
A层的厚度为40μm
B层的厚度为10μm
C层的厚度为100μm
D层的厚度为15μm
E层的厚度为15μm
实施例2：
A层的厚度为50μm
B层的厚度为20μm
C层的厚度为80μm
D层的厚度为10μm
E层的厚度为20μm
实施例3：
A层的厚度为30μm
B层的厚度为10μm
C层的厚度为130μm
D层的厚度为10μm
E层的厚度为20μm
对上述三个实施例通过实验得到如下技术数据：

Claims (8)

1.一种液液多室袋用五层共挤输液膜材，其特征在于：
第一层为内层A，其材料为改性乙烯-丙烯聚合物和SEBS或SEPS的混合物，改性乙烯-丙烯聚合物的含量在60%-95%之间，SEBS或SEPS的含量在5%-40%之间，厚度在30-50μm；
第二层为粘结层B，其材料为聚乙烯，厚度在10-20μm；
第三层为中间层C，其材料为聚乙烯，厚度在80-140μm；
第四层为粘结层D，其材料为是乙烯甲基丙烯酸酯聚合物，厚度在10-30μm；
第五层为外层E，是酯类共聚物，厚度在10-40μm。
2.如权利要求1所述的五层共挤输液用膜，其特征在于，上述A层中所用的改性乙烯-丙烯聚合物密度为0.89-0.93g/cm3，熔融指数为5.0-10.0g/10min，含量在60%-95%之间，SEBS或SEPS的熔指在3.0-6.0g/10min，含量在5%-40%之间。
3.如权利要求1所述的五层共挤输液用膜，其特征在于，上述B层所用的聚乙烯，熔点在60-120℃之间，密度为0.88-0.94g/cm3，熔融指数为0.5-3.0g/10min。
4.如权利要求1所述的五层共挤输液用膜，其特征在于，上述C层所用的聚乙烯，熔点在90-120℃之间，密度为0.9-0.94g/cm3，熔融指数为0.5-1.5g/10min。
5.如权利要求3或4所述的五层共挤输液用膜，其特征在于，所述的聚乙烯包括传统高密度聚乙烯、低密度聚乙烯或乙烯与阿尔法-烯烃共聚物中的一种或多种。
6.如权利要求1所述的五层共挤输液用膜，其特征在于，上述D层所用的乙烯甲基丙烯酸酯聚合物，熔点在80-100℃之间，密度为0.9-1.1g/cm3，熔融指数为2-10g/10min。
7.如权利要求1所述的五层共挤输液用膜，其特征在于，上述E层所用的PET类共聚物，熔点在200-240℃之间，密度为1.0-1.2g/cm3，熔融指数为10-20g/10min。
8.如权利要求1-7任一项所述的五层共挤输液用膜的制备方法，其特征在于：原材料经挤出机螺杆挤出后，再经模头重新分配挤出，A挤出机温度为160-250℃，B挤出机温度为140-230℃，C挤出机温度为140-230℃，D挤出机温度为140-230℃，E挤出机温度为180-250℃，模头温度为160-250℃，采用平面叠加模头，经模头挤出后由百级风形成下吹膜泡，吹胀比在1.5-3之间，膜泡由百级风和纯化水冷却，经人字夹板折合平整后，进入收卷机进行收卷。
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