CN112208175A - 一种药用复合膜及其制备方法 - Google Patents
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Abstract
本发明公开一种药用复合膜，所述药用复合膜包括：复合膜内层、中层和外层；所述内层原料包括：68wt％～77wt％的低密度聚乙烯、12wt％～21wt％的中密度聚乙烯与2wt％～20wt％乙丙共聚物；所述中层原料为聚酰胺或改性聚酰胺；所述外层原料包括：95～99wt％的聚丙烯‑聚乙烯共聚物和1wt％～5wt％的抗静电剂。所述药用复合膜无增塑剂使用，力学性好，阻隔性强，热封性好，抗静电能力好，利于用于药用产品包装和运输。
Description
技术领域
本发明涉及工业包装领域领域，具体涉及一种药用复合膜及其制备方法。
背景技术
国内外输液包装有玻璃瓶，塑料瓶和塑料袋三种型式。塑料袋输液由于其具有便于工作运输，仓储体积小，在使用过程不需要向药液中引入空气，避免空气中的灰尘，微生物污染药液等优点，正逐渐取代玻璃瓶和塑料瓶。目前常用的PVC塑料材料中由于增塑剂等助剂导致药液被二次污染，给临床用药带来潜在安全隐患。特别是PVC膜生产过程中加入的增塑剂(DEHP)是一种有害物质，严重危害人体健康，因而国家药品监督管理局已明令限制使用。
发明内容
有鉴于此，本发明提供了一种药用复合膜及其制备方法，所述药用复合膜无增塑剂使用，力学性好，阻隔性强，热封性好，抗静电能力好，利于用于药用产品包装和运输。
为解决以上技术问题，本发明提供的技术方案是提供一种药用复合膜，所述药用复合膜包括：复合膜内层、中层和外层；所述内层原料包括：68wt％～77wt％的低密度聚乙烯、12wt％～21wt％的中密度聚乙烯与2wt％～20wt％乙丙共聚物；所述中层原料为聚酰胺或改性聚酰胺；所述外层原料包括：95～99wt％的聚丙烯-聚乙烯共聚物和1wt％～5wt％的抗静电剂。
优选的，所述内层原料包括：70wt％～75wt％的低密度聚乙烯、15wt％～20wt％的中密度聚乙烯与5wt％～15wt％乙丙共聚物。
优选的，所述内层原料包括：72wt％的低密度聚乙烯、18wt％的中密度聚乙烯与10wt％乙丙共聚物。
优选的，所述外层原料包括：97.8～98.2wt％聚丙烯-聚乙烯共聚物和1.8wt％～2.2wt％的抗静电剂。
优选的，所述外层原料包括：98wt％的聚丙烯-聚乙烯共聚物和2wt％的抗静电剂。
优选的，所述聚丙烯-聚乙烯共聚物中聚丙烯的含量为20～30wt％；聚乙烯的含量为70～80wt％
优选的，所述改性聚酰胺为聚氯乙烯改性的聚酰胺或丙烯酸酯改性的聚酰胺。
优选的，所述中层原料为聚酰胺。
优选的，所述抗静电剂为乙氧基胺或单甘脂油酸酰胺。
优选的，内层的厚度为50～60μm；中层的厚度为20～30μm；外层的厚度为30～40μm。
本发明还提供了一种上述的药用复合膜的制备方法，包括：将所述内层原料、所述中层原料和所述外层原料熔融共挤出吹塑、拉伸、冷却定型、分切、除静电后收卷得到所述药用复合膜。
优选的，所述熔融温度为160℃～350℃
优选的，所述冷却温度为10～12℃。
优选的，分切过程具体为经第一次牵引切边，展平轴展平后，第二次牵引切边。
优选的，所述吹塑过程采用洁净度物100级的空气。
本申请药用复合膜内层原料采用低密度聚乙烯、中密度聚乙烯和乙丙共聚物，不含有可析出的小分子物质，使药用复合膜的表面张力值能保持长久，同时也有利于复合剥离力的提高，扩大热封温度范围，保证生物相容性，对药液没有影响；乙丙共聚物加入起到乳化剂的作用，促使低密度聚乙烯和中密度聚乙烯的分散相微细化、均匀分散，提高粘合强度，进而提高了药用复合膜的横向、纵向拉伸强度。
本申请药用复合膜中间层采用聚酰胺或改性聚酰胺，起到阻隔增强的作用。
本申请药用复合膜外层原料聚丙烯-聚乙烯共聚体具有优良的抗污染性，能很好地解决粉剂包装热封问题。并且热封温度有明显的下降，更适合于快速包装，同时加入抗静电剂增加外层抗静电能力，增加运输存储安全性。
本申请制备除静电后收卷得到复合膜
本申请与现有技术相比，其详细说明如下：
本申请提供的药用复合膜优选内层、中层和外层原料，无增塑剂使用，使药用复合膜，力学性好，阻隔性强，热封性好，抗静电能力好，利于用于药用产品包装和运输；
本申请提供的制备方法采用共挤出吹塑、拉伸、冷却定型、分切、除静电后收卷，工艺简单，制备的药用复合膜机构稳定性强、平整，便于贮存运输。
具体实施方式
为了使本领域的技术人员更好地理解本发明的技术方案，下面结合具体实施例对本发明作进一步的详细说明。
实施例1
按如下方法制备药用复合膜：
药用复合膜内层原料包括：68wt％的低密度聚乙烯、12wt％的中密度聚乙烯与20wt％乙丙共聚物；中层原料为聚酰胺；外层原料包括：95wt％的聚丙烯-聚乙烯共聚物和5wt％的乙氧基胺，所述聚丙烯-聚乙烯共聚物中聚丙烯的含量为20wt％；聚乙烯的含量为80wt％。
将所述内层原料、所述中层原料和所述外层原料160℃～350℃熔融共挤出，洁净度物100级的空气吹塑，拉伸，冷却温度为10～12℃冷却水冷却定型，经第一次牵引切边，展平轴展平后，第二次牵引切边，除静电器除静电后收卷得到所述药用复合膜。
得到的所述药用复合膜内层的厚度为50～60μm；中层的厚度为20～30μm；外层的厚度为30～40μm，层次分明、美观、复合紧密、不起泡、不破裂。
实施例2
按如下方法制备药用复合膜：
药用复合膜内层原料包括：70wt％的低密度聚乙烯、15wt％的中密度聚乙烯与15wt％乙丙共聚物；中层原料为聚氯乙烯改性的聚酰胺；外层原料包括：97.8wt％的聚丙烯-聚乙烯共聚物和2.2wt％的乙氧基胺，所述聚丙烯-聚乙烯共聚物中聚丙烯的含量为20wt％；聚乙烯的含量为80wt％。
将所述内层原料、所述中层原料和所述外层原料160℃～350℃熔融共挤出，洁净度物100级的空气吹塑，拉伸，冷却温度为10～12℃冷却水冷却定型，经第一次牵引切边，展平轴展平后，第二次牵引切边，除静电器除静电后收卷得到所述药用复合膜。
得到的所述药用复合膜内层的厚度为50～60μm；中层的厚度为20～30μm；外层的厚度为30～40μm，层次分明、美观、复合紧密、不起泡、不破裂。
实施例3
按如下方法制备药用复合膜：
药用复合膜内层原料包括：72wt％的低密度聚乙烯、18wt％的中密度聚乙烯与10wt％乙丙共聚物；中层原料为丙烯酸酯改性的聚酰胺；外层原料包括：98wt％的聚丙烯-聚乙烯共聚物和2wt％的乙氧基胺，所述聚丙烯-聚乙烯共聚物中聚丙烯的含量为25wt％；聚乙烯的含量为75wt％。
将所述内层原料、所述中层原料和所述外层原料160℃～350℃熔融共挤出，洁净度物100级的空气吹塑，拉伸，冷却温度为10～12℃冷却水冷却定型，经第一次牵引切边，展平轴展平后，第二次牵引切边，除静电器除静电后收卷得到所述药用复合膜。
得到的所述药用复合膜内层的厚度为50～60μm；中层的厚度为20～30μm；外层的厚度为30～40μm，层次分明、美观、复合紧密、不起泡、不破裂。
实施例4
按如下方法制备药用复合膜：
药用复合膜内层原料包括：75wt％的低密度聚乙烯、20wt％的中密度聚乙烯与5wt％乙丙共聚物；中层原料为聚酰胺；外层原料包括：98.2wt％的聚丙烯-聚乙烯共聚物和1.8wt％的单甘脂油酸酰胺，所述聚丙烯-聚乙烯共聚物中聚丙烯的含量为30wt％；聚乙烯的含量为70wt％。
将所述内层原料、所述中层原料和所述外层原料160℃～350℃熔融共挤出，洁净度物100级的空气吹塑，拉伸，冷却温度为10～12℃冷却水冷却定型，经第一次牵引切边，展平轴展平后，第二次牵引切边，除静电器除静电后收卷得到所述药用复合膜。
得到的所述药用复合膜内层的厚度为50～60μm；中层的厚度为20～30μm；外层的厚度为30～40μm，层次分明、美观、复合紧密、不起泡、不破裂。
实施例5
按如下方法制备药用复合膜：
药用复合膜内层原料包括：77wt％的低密度聚乙烯、21wt％的中密度聚乙烯与2wt％乙丙共聚物；中层原料为聚酰胺；外层原料包括：99wt％的聚丙烯-聚乙烯共聚物和1wt％的单甘脂油酸酰胺，所述聚丙烯-聚乙烯共聚物中聚丙烯的含量为30wt％；聚乙烯的含量为70wt％。
将所述内层原料、所述中层原料和所述外层原料160℃～350℃熔融共挤出，洁净度物100级的空气吹塑，拉伸，冷却温度为10～12℃冷却水冷却定型，经第一次牵引切边，展平轴展平后，第二次牵引切边，除静电器除静电后收卷得到所述药用复合膜。
得到的所述药用复合膜内层的厚度为50～60μm；中层的厚度为20～30μm；外层的厚度为30～40μm，层次分明、美观、复合紧密、不起泡、不破裂。
实施例6
将实施例1～5制得的药用复合膜编号A～E，测试其性能,结果见表1。
表1
由表1可知，抗拉伸强度、抗撕裂性、抗压性力学性能较好，水蒸汽透过量和氧气透过量低，阻隔性好，热封性能好，表面抗静电能力好能够满足药用包装的需求。
以上仅是本发明的优选实施方式，应当指出的是，上述优选实施方式不应视为对本发明的限制，本发明的保护范围应当以权利要求所限定的范围为准。对于本技术领域的普通技术人员来说，在不脱离本发明的精神和范围内，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种药用复合膜，其特征在于，所述药用复合膜包括：复合膜内层、中层和外层；所述内层原料包括：68wt％～77wt％的低密度聚乙烯、12wt％～21wt％的中密度聚乙烯与2wt％～20wt％乙丙共聚物；所述中层原料为聚酰胺或改性聚酰胺；所述外层原料包括：95～99wt％的聚丙烯-聚乙烯共聚物和1wt％～5wt％的抗静电剂。
2.根据权利要求1的药用复合膜，其特征在于，所述内层原料包括：70wt％～75wt％的低密度聚乙烯、15wt％～20wt％的中密度聚乙烯与5wt％～15wt％乙丙共聚物。
3.根据权利要求1的药用复合膜，其特征在于，所述外层原料包括：97.8～98.2wt％的聚丙烯-聚乙烯共聚物和1.8wt％～2.2wt％的抗静电剂。
4.根据权利要求1的药用复合膜，其特征在于，所述聚丙烯-聚乙烯共聚物中聚丙烯的含量为20～30wt％；聚乙烯的含量为70～80wt％。
5.根据权利要求1的药用复合膜，其特征在于，所述改性聚酰胺为聚氯乙烯改性的聚酰胺或丙烯酸酯改性的聚酰胺。
6.根据权利要求1的药用复合膜，其特征在于，所述抗静电剂为乙氧基胺或单甘脂油酸酰胺。
7.根据权利要求1的药用复合膜，其特征在于，内层的厚度为50～60μm；中层的厚度为20～30μm；外层的厚度为30～40μm。
8.一种权利要求1至6任一项所述的药用复合膜的制备方法，其特征在于，包括：将所述内层原料、所述中层原料和所述外层原料熔融共挤出吹塑、拉伸、冷却定型、分切、除静电后收卷得到所述药用复合膜。
9.根据权利要求7的制备方法，其特征在于，所述冷却温度为10～12℃。
10.根据权利要求7的制备方法，其特征在于，分切过程具体为经第一次牵引切边，展平轴展平后，第二次牵引切边。
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