CN111452471B - 一种输液用膜材料 - Google Patents

一种输液用膜材料 Download PDF

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CN111452471B
CN111452471B CN202010425816.4A CN202010425816A CN111452471B CN 111452471 B CN111452471 B CN 111452471B CN 202010425816 A CN202010425816 A CN 202010425816A CN 111452471 B CN111452471 B CN 111452471B
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polypropylene
mass ratio
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inner layer
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CN111452471A (zh
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赵立品
曹志峰
王友清
梁诗雨
何柯
何汀
刘星
谢凤
周小龙
凌英
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CHONGZHOU JUNJIAN PLASTIC CO LTD
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Abstract

本发明公开了一种输液用膜材料，包括外层、次外层、中层、次内层和内层；外层材质为聚丙烯和苯乙烯‑乙烯‑丁烯‑苯乙烯嵌段共聚物的混合物一；次外层材质为聚丙烯和苯乙烯‑乙烯‑丁烯‑苯乙烯嵌段共聚物的混合物二；中层材质为聚丙烯、乙烯‑乙烯醇共聚物和聚丙烯接枝马来酸酐共聚物的混合物三；次内层材质为聚丙烯、聚乙烯和聚乙烯接枝马来酸酐的混合物四；内层材质为环烷烯烃共聚物或环烷烯烃聚合物、聚丙烯和聚乙烯的混合物五。本发明还提供了上述输液用膜材料的应用以及输液软袋和药物包装材料。本发明的膜材料具有优异的药物相容性，能够阻隔气体和水蒸气的渗透，药物不易在材料表面吸附，适用于输液和药物的软袋包装。

Description

一种输液用膜材料
技术领域
本发明属于医用包装材料技术领域，具体涉及一种输液用膜材料。
背景技术
随着输液治疗的普遍应用，输液经过了从开放式、半开放式到全封闭式的过程，而输液包装容器也从最开始的玻璃瓶，发展到PVC软袋、PP塑瓶，到目前最符合环保和使用安全的非PVC软袋。软袋包装实现了输液过程中的全封闭式输液，是未来输液的发展趋势。
目前非PVC输液软袋多为聚丙烯多层共挤膜，存在一定的气体渗透和水蒸汽渗透，并且对药物有一定的吸附性，特别是对蛋白类药物吸附最为严重。聚丙烯多层共挤膜在包装药物时，不仅要增加具有阻水阻气的外包装，而且要考虑包装对药物的吸附，因此，输液软袋适用的包装品种存在一定的局限性。针对现有治疗型输液软包装存在的问题，开发了一种阻水、阻气性好，药物相容性好的输液用膜材。且到目前为止，尚未见针对输液软包装而开发的膜材。
发明内容
针对现有技术中的上述不足，本发明提供了一种输液用膜材料，膜材料具有优异的药物相容性，能够阻隔气体和水蒸气的渗透，药物不易在材料表面吸附，适用于输液和药物的软袋包装。
为实现上述目的，本发明解决其技术问题所采用的技术方案是：提供一种输液用膜材料，从外到内依次包括外层、次外层、中层、次内层和内层；外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比80～99:1～20所得混合物一；次外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比40～80:20～60所得混合物二；中层材质为聚丙烯、乙烯-乙烯醇共聚物和聚丙烯接枝马来酸酐共聚物按质量比30～50:30～50:10～30所得混合物三；次内层材质为聚丙烯、聚乙烯和聚乙烯接枝马来酸酐按质量比10～30:10～30:40～80所得混合物四；内层材质为环烷烯烃共聚物或环烷烯烃聚合物、聚丙烯和聚乙烯按质量比30～60:15～65:5～25所得混合物五。
进一步，混合物一中，聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物质量比为90:10；混合物二中，聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物质量比为60:40；混合物三，聚丙烯、乙烯-乙烯醇共聚物和聚丙烯接枝马来酸酐共聚物质量比为40:40:20；混合物四中，聚丙烯、聚乙烯和聚乙烯接枝马来酸酐质量比为25:25:50；混合物五中，环烷烯烃共聚物或环烷烯烃聚合物、聚丙烯和聚乙烯质量比为45:50:5。
进一步，输液用膜材料厚度为180～250μm。
进一步，外层厚度为20～30μm，次外层厚度为100～150μm，中层厚度为20～30μm，次内层厚度为8～15μm，内层厚度为30～40μm。
进一步，混合物一、混合物二、混合物三、混合物四和混合物五密度分别为0.88～0.92g/cm3、0.88～0.92g/cm3、0.95～1.15g/cm3、0.88～0.92g/cm3和0.95～1.05g/cm3。
进一步，混合物一、混合物二和混合物五在230℃、2.16kg条件下熔融指数分别为5～7g/10min、5～7g/10min和6～12g/10min；混合物三和混合物四在190℃、2.16kg条件下熔融指数分别为1.5～3g/10min和2～4g/10min。
进一步，输液用膜材料通过共挤吹膜制备得到。
上述输液用膜材料在制备输液软袋和药物包装材料中的应用。
一种输液软袋，采用上述的输液用膜材料制备得到。其中，焊接温度为135～155℃，焊接强度大于25N/15mm。
一种药物包装材料，采用上述的输液用膜材料制备得到。
综上所述，本发明具有以下优点：
1、本发明的膜材料具有优异的药物相容性，能够阻隔气体和水蒸气的渗透，药物不易在材料表面吸附，适用于输液和药物的软袋包装。输液用膜材料通过将外层、次外层、中层、次内层和内层共挤吹膜制备得到，相互之间具有较好的相容性，保证膜面平整美观，且具有较好的透明度。
2、内层所用材料主要为聚丙烯、聚乙烯、环烷烯烃均聚物(COP)或环烷烯烃共聚物(COC)组成，对多种药物具有很好的相容性和很低的吸附性，并且具有很低的水蒸气透过率，并且在中层加入了乙烯-乙烯醇共聚物，降低了材料的气体透过率，在最大程度上保证药物的浓度稳定和长期储存有效性，非常适合治疗型输液的软袋包装。
3、将膜材料设置为5层是为了更好的达到膜材料的性能要求，而不设置更多的层数是为了限制膜材料的生产成本。膜材内层与药物相容性好，阻水阻气性好，各层设计出于以下考虑：相邻两层相容性好，不出现分层；内层药物相容性好，热合性好，外层为印刷性好和阻水性，中层为提供阻气性，次内层和次外层为提供强度与外层、中层、内层的相容性。且根据各层的材质，设置为不同的厚度，在满足性能要求的同时，最大限度的控制成本。
附图说明
图1为本发明的示意图；
其中，1、外层；2、次外层；3、中层；4、次内层；5、内层。
具体实施方式
实施例1
一种输液用膜材料，从外到内依次包括外层、次外层、中层、次内层和内层；外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比80:20所得混合物一；次外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比40:60所得混合物二；中层材质为聚丙烯、乙烯-乙烯醇共聚物和聚丙烯接枝马来酸酐共聚物按质量比40:40:20所得混合物三；次内层材质为聚丙烯、聚乙烯和聚乙烯接枝马来酸酐按质量比20:20:60所得混合物四；内层材质为环烷烯烃共聚物或环烷烯烃聚合物、聚丙烯和聚乙烯按质量比40:40:20所得混合物五。
其中，输液用膜材料厚度为197μm；外层厚度为20μm，次外层厚度为100μm，中层厚度为25μm，次内层厚度为12μm，内层厚度为40μm。混合物一、混合物二、混合物三、混合物四和混合物五密度分别为0.88g/cm3、0.88g/cm3、0.95g/cm3、0.88g/cm3和0.95g/cm3。混合物一、混合物二和混合物五在230℃、2.16kg条件下熔融指数分别为5g/10min、5g/10min和6g/10min；混合物三和混合物四在190℃、2.16kg条件下熔融指数分别为1.5g/10min和2g/10min。
一种输液软袋，采用上述的输液用膜材料制备得到。其中，焊接温度为150℃，焊接强度为30N/15mm。
一种药物包装材料，采用上述的输液用膜材料制备得到。
实施例2
一种输液用膜材料，从外到内依次包括外层、次外层、中层、次内层和内层；外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比90:10所得混合物一；次外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比60:40所得混合物二；中层材质为聚丙烯、乙烯-乙烯醇共聚物和聚丙烯接枝马来酸酐共聚物按质量比40:40:20所得混合物三；次内层材质为聚丙烯、聚乙烯和聚乙烯接枝马来酸酐按质量比25:25:50所得混合物四；内层材质为环烷烯烃共聚物或环烷烯烃聚合物、聚丙烯和聚乙烯按质量比45:50:5所得混合物五。
其中，输液用膜材料厚度为220μm；外层厚度为25μm，次外层厚度为130μm，中层厚度为25μm，次内层厚度为10μm，内层厚度为30μm。混合物一、混合物二、混合物三、混合物四和混合物五密度分别为0.90g/cm3、0.90g/cm3、0.99g/cm3、0.90g/cm3和0.99g/cm3。混合物一、混合物二和混合物五在230℃、2.16kg条件下熔融指数分别为6g/10min、6g/10min和9g/10min；混合物三和混合物四在190℃、2.16kg条件下熔融指数分别为8g/10min和3g/10min。
一种输液软袋，采用上述的输液用膜材料制备得到。其中，焊接温度为142℃，焊接强度为27N/15mm。
一种药物包装材料，采用上述的输液用膜材料制备得到。
实施例3
一种输液用膜材料，从外到内依次包括外层、次外层、中层、次内层和内层；外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比85:15所得混合物一；次外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比70:30所得混合物二；中层材质为聚丙烯、乙烯-乙烯醇共聚物和聚丙烯接枝马来酸酐共聚物按质量比45:45:10所得混合物三；次内层材质为聚丙烯、聚乙烯和聚乙烯接枝马来酸酐按质量比25:25:50所得混合物四；内层材质为环烷烯烃共聚物或环烷烯烃聚合物、聚丙烯和聚乙烯按质量比40:45:15所得混合物五。
其中，输液用膜材料厚度为215μm；外层厚度为25μm，次外层厚度为125μm，中层厚度为20μm，次内层厚度为10μm，内层厚度为35μm。混合物一、混合物二、混合物三、混合物四和混合物五密度分别为0.91g/cm3、0.91g/cm3、1.12g/cm3、0.91g/cm3和1.03g/cm3。混合物一、混合物二和混合物五在230℃、2.16kg条件下熔融指数分别为6g/10min、6g/10min和11g/10min；混合物三和混合物四在190℃、2.16kg条件下熔融指数分别为2.6g/10min和3.4g/10min。
一种输液软袋，采用上述的输液用膜材料制备得到。其中，焊接温度为145℃，焊接强度为32N/15mm。
一种药物包装材料，采用上述的输液用膜材料制备得到。
实施例4
一种输液用膜材料，从外到内依次包括外层、次外层、中层、次内层和内层；外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比95:5所得混合物一；次外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比55:45所得混合物二；中层材质为聚丙烯、乙烯-乙烯醇共聚物和聚丙烯接枝马来酸酐共聚物按质量比45:40:15所得混合物三；次内层材质为聚丙烯、聚乙烯和聚乙烯接枝马来酸酐按质量比30:25:45所得混合物四；内层材质为环烷烯烃共聚物或环烷烯烃聚合物、聚丙烯和聚乙烯按质量比40:45:5所得混合物五。
其中，输液用膜材料厚度为235μm；外层厚度为20μm，次外层厚度为150μm，中层厚度为25μm，次内层厚度为10μm，内层厚度为30μm。混合物一、混合物二、混合物三、混合物四和混合物五密度分别为0.92g/cm3、0.92g/cm3、1.15g/cm3、0.92g/cm3和1.05g/cm3。混合物一、混合物二和混合物五在230℃、2.16kg条件下熔融指数分别为7g/10min、7g/10min和12g/10min；混合物三和混合物四在190℃、2.16kg条件下熔融指数分别为3g/10min和4g/10min。
一种输液软袋，采用上述的输液用膜材料制备得到。其中，焊接温度为140℃，焊接强度为38N/15mm。
一种药物包装材料，采用上述的输液用膜材料制备得到。
分别测定实施例1～4所得输液软袋的水蒸气透过率、氧气透过率氮气透过率和二氧化碳透过率，结果见表1。
表1实施例1～4所得输液软袋性能统计表
实施例1 实施例2 实施例3 实施例4
水蒸气透过率(g/(m<sup>2</sup>·24h)) 1.8 1.5 1.7 1.6
氧气透过率(cm<sup>3</sup>/(m<sup>2</sup>·24h·0.1MPa)) 1.2 1 1.3 1.1
氮气透过率(cm<sup>3</sup>/(m<sup>2</sup>·24h·0.1MPa)) 1.1 1.1 1.2 1.4
二氧化碳透过率(cm<sup>3</sup>/(m<sup>2</sup>·24h·0.1MPa)) 1.2 1.1 1.3 1.4
由表1可知，本发明所得的输液用膜材料制成的输液软袋，具有低的氧气透过率、氮气透过率和二氧化碳透过率，能够阻隔气体和水蒸气的渗透，保护内部物质，且由于其具有良好的药物相容性，能够适用于输液和小剂量药物的软袋包装。
虽然结合附图对本发明的具体实施方式进行了详细地描述，但不应理解为对本专利的保护范围的限定。在权利要求书所描述的范围内，本领域技术人员不经创造性劳动即可作出的各种修改和变形仍属本专利的保护范围。

Claims (7)

1.一种输液用膜材料，其特征在于，从外到内依次包括外层、次外层、中层、次内层和内层；所述外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比80～99:1～20所得混合物一；所述次外层材质为聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物按质量比40～80:20～40所得混合物二；所述中层材质为聚丙烯、乙烯-乙烯醇共聚物和聚丙烯接枝马来酸酐共聚物按质量比30～50:30～50:10～30所得混合物三；所述次内层材质为聚丙烯、聚乙烯和聚乙烯接枝马来酸酐按质量比10～30:10～30:40～80所得混合物四；所述内层材质为环烷烯烃共聚物或环烷烯烃聚合物、聚丙烯和聚乙烯按质量比30～60:15～65:5～25所得混合物五；
所述输液用膜材料厚度为180～250μm；所述外层厚度为20～30μm，所述次外层厚度为100～150μm，所述中层厚度为20～30μm，所述次内层厚度为8～15μm，所述内层厚度为30～40μm。
2.如权利要求1所述的输液用膜材料，其特征在于，所述混合物一中，聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物质量比为90:10；所述混合物二中，聚丙烯和苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物质量比为60:40；所述混合物三，聚丙烯、乙烯-乙烯醇共聚物和聚丙烯接枝马来酸酐共聚物质量比为40:40:20；所述混合物四中，聚丙烯、聚乙烯和聚乙烯接枝马来酸酐质量比为25:25:50；所述混合物五中，环烷烯烃共聚物或环烷烯烃聚合物、聚丙烯和聚乙烯质量比为45:50:5。
3.如权利要求1所述的输液用膜材料，其特征在于，所述混合物一、所述混合物二、所述混合物三、所述混合物四和所述混合物五密度分别为0.88～0.92g/cm3、0.88～0.92g/cm3、0.95～1.15g/cm3、0.88～0.92g/cm3和0.95～1.05g/cm3。
4.如权利要求1所述的输液用膜材料，其特征在于，所述混合物一、所述混合物二和所述混合物五在230℃、2.16kg条件下熔融指数分别为5～7g/10min、5～7g/10min和6～12g/10min；所述混合物三和所述混合物四在190℃、2.16kg条件下熔融指数分别为1.5～3g/10min和2～4g/10min。
5.权利要求1～4任一项所述的输液用膜材料在制备输液软袋和药物包装材料中的应用。
6.一种输液软袋，采用权利要求1～4任一项所述的输液用膜材料制备得到。
7.一种药物包装材料，采用权利要求1～4任一项所述的输液用膜材料制备得到。
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