CN113199839B - 一种防静电无菌药剂袋及其制备方法 - Google Patents
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Abstract
本发明公开了一种防静电无菌药剂袋及其制备方法,采用内外两层包装结构,所述内层结构采用LDPE层,所述外层结构采用ETFE层,外层通过黏结层与内层粘结,所述LDPE层包括以下组分:LDPE 80‑100份、EMA 30‑50份、阻隔材料10‑30份、阻燃母粒1‑5份和抗静电剂5‑8份;所述ETFE层包括以下组分:ETFE 100份、TPE 40‑60份、阻隔材料10‑30份和抗氧化剂2‑4份;所述黏结层为基于Escorez™增粘树脂的热熔胶HMA,本发明的一种防静电无菌药剂袋有良好的透明度和阻隔性,袋子展开后可检查里外是否有异物;有着良好的韧度,力学性能优异,避免因为折痕、堆积挤压、搬运时破袋的风险;可以承受较大的拉力;内外接触层低吸附,有着良好的灭菌性能和抗静电性能。
Description
技术领域
本发明涉及医用包装领域,特别是一种防静电无菌药剂袋及其制备方法。
背景技术
在生产医用药品时,有时候需要用于包装药物或其原料药的药剂袋,为了防止药品或其原料药由于渗出和包装膜内杂质掺入,或者由静电吸附在包装膜表面上的灰尘掺入而引起的污染。
目前,高阻隔医用药剂袋具有较大的市场潜力。其不仅需要包装膜具有高阻隔性、柔韧性、透明性等,还要包装膜在高温蒸汽或γ射线辐照灭菌和储存环境中确保内容物性质稳定,不会产生有毒有害物质迁移吸附影响安全性能。基于此,人们正积极研究各种用于药品、医疗器械包装的新型包装材料,以满足医用包装在性能上各方面和多层次的苛刻要求。
发明内容
本发明的目的是为了解决上述问题,设计了一种一种防静电无菌药剂袋及其制备方法。
实现上述目的本发明的技术方案为,一种防静电无菌药剂袋,采用内外两层包装结构,所述内层结构采用LDPE层,所述外层结构采用 ETFE层,外层通过黏结层与内层粘结;即整体结构层从上到下依次为 ETFE层、黏结层、LDPE层、黏结层、LDPE层、黏结层和ETFE层;所述LDPE层包括以下组分:LDPE 80-100份、EMA 30-50份、阻隔材料10-30 份、阻燃母粒1-5份和抗静电剂5-8份。
为了对本技术方案进行进一步补充,所述ETFE层包括以下组分:ETFE 100份、TPE40-60份、阻隔材料10-30份和抗氧化剂2-4份。
为了对本技术方案进行进一步补充,所述阻隔材料为OpperaTM改性剂。
为了对本技术方案进行进一步补充,所述抗静电剂为聚醚酯酰胺或聚醚酯酰亚胺。
为了对本技术方案进行进一步补充,所述黏结层为基于EscorezTM增粘树脂的热熔胶HMA。
为了对本技术方案进行进一步补充,所述阻燃母粒为溴化环氧树脂。
为了对本技术方案进行进一步补充,所述抗氧化剂为抗氧剂BHT。
为了对本技术方案进行进一步补充,一种防静电无菌药剂袋的制备方法包括以下步骤:
步骤一:将LDPE、EMA、阻隔材料、阻燃母粒和抗静电剂放入搅拌机中混合均匀,通过挤出成型得到LDPE层;
步骤二:将ETFE、TPE、阻隔材料和抗氧化剂中原料共混,然后将上述共混后的材料通过双螺杆挤出机熔融塑化,物料通过机头口模挤出,流涎成均匀熔体后,采用两辊压延机将混料压延成ETFE层;
步骤三:将LDPE层和ETFE层、LDPE层和LDPE层侧边通过基于 EscorezTM增粘树脂的热熔胶HMA-黏结层在温度150℃下进行热压复合,冷却,制成药剂袋。
有益效果
1、有良好的透明度和阻隔性,袋子展开后可检查里外是否有异物
2、有着良好的韧度,力学性能优异,避免因为折痕、堆积挤压、搬运时破袋的风险
3、可以很好的承受较大的拉力;
4、内外接触层层低吸附,有着良好的灭菌性能和抗静电性能。
具体实施方式
下面对本发明进行具体描述,一种防静电无菌药剂袋,采用内外两层包装结构,即整体结构层从上到下依次为ETFE层、黏结层、LDPE 层、黏结层、LDPE层、黏结层和ETFE层。
所述内层结构采用LDPE层,所述外层结构采用ETFE层,外层通过黏结层与内层粘结;所述LDPE层包括以下组分:LDPE 80-100份、 EMA 30-50份、OpperaTM改性剂10-30份、阻燃母粒-溴化环氧树脂1-5 份、和抗静电剂-聚醚酯酰胺5-8份。所述ETFE层包括以下组分:ETFE 100份、TPE 40-60份、OpperaTM改性剂10-30份和抗氧化剂BHT2-4 份。
一种防静电无菌药剂袋的制备方法包括以下步骤:
步骤一:将LDPE、EMA、OpperaTM改性剂、溴化环氧树脂和聚醚酯酰胺放入搅拌机中混合均匀,通过挤出成型得到LDPE层;
步骤二:将ETFE、TPE、OpperaTM改性剂和抗氧化剂BHT中原料共混,然后将上述共混后的材料通过双螺杆挤出机熔融塑化,物料通过机头口模挤出,流涎成均匀熔体后,采用两辊压延机将混料压延成ETFE 层;
步骤三:将LDPE层和ETFE层、LDPE层和LDPE层侧边通过基于 EscorezTM增粘树脂的热熔胶HMA-黏结层在温度150℃下进行热压复合,冷却,制成药剂袋。
实施例1
步骤一:将LDPE80份、EMA30份、OpperaTM改性剂10份、溴化环氧树脂1份和聚醚酯酰胺5份放入搅拌机中混合均匀,通过挤出成型得到LDPE层;
步骤二:将ETFE100份、TPE40份、OpperaTM改性剂10份和抗氧化剂BHT2份中原料共混,然后将上述共混后的材料通过双螺杆挤出机熔融塑化,物料通过机头口模挤出,流涎成均匀熔体后,采用两辊压延机将混料压延成ETFE层;
步骤三:将LDPE层和ETFE层、LDPE层和LDPE层侧边通过基于 EscorezTM增粘树脂的热熔胶HMA-黏结层在温度150℃下进行热压复合,冷却,制成药剂袋。
实施例1试验结果如表1:在温度为130℃、灭菌时间为60min后,药剂袋无变形现象。
表1:实施例1试验结果
实施例2
步骤一:将LDPE85份、EMA35份、OpperaTM改性剂15份、溴化环氧树脂2份和聚醚酯酰胺6份放入搅拌机中混合均匀,通过挤出成型得到LDPE层;
步骤二:将ETFE100份、TPE45份、OpperaTM改性剂15份和抗氧化剂BHT3份中原料共混,然后将上述共混后的材料通过双螺杆挤出机熔融塑化,物料通过机头口模挤出,流涎成均匀熔体后,采用两辊压延机将混料压延成ETFE层;
步骤三:将LDPE层和ETFE层、LDPE层和LDPE层侧边通过基于 EscorezTM增粘树脂的热熔胶HMA-黏结层在温度150℃下进行热压复合,冷却,制成药剂袋。
实施例2试验结果如表2:在温度为130℃、灭菌时间为60min后,药剂袋无变形现象。
表2:实施例2试验结果
实施例3
步骤一:将LDPE90份、EMA40份、OpperaTM改性剂20份、溴化环氧树脂3份和聚醚酯酰胺7份放入搅拌机中混合均匀,通过挤出成型得到LDPE层;
步骤二:将ETFE100份、TPE50份、OpperaTM改性剂20份和抗氧化剂BHT4份中原料共混,然后将上述共混后的材料通过双螺杆挤出机熔融塑化,物料通过机头口模挤出,流涎成均匀熔体后,采用两辊压延机将混料压延成ETFE层;
步骤三:将LDPE层和ETFE层、LDPE层和LDPE层侧边通过基于 EscorezTM增粘树脂的热熔胶HMA-黏结层在温度150℃下进行热压复合,冷却,制成药剂袋。
实施例3试验结果如表3:在温度为130℃、灭菌时间为60min后,药剂袋无变形现象。
表3:实施例3试验结果
实施例4
步骤一:将LDPE95份、EMA45份、OpperaTM改性剂25份、溴化环氧树脂4份和聚醚酯酰胺8份放入搅拌机中混合均匀,通过挤出成型得到LDPE层;
步骤二:将ETFE100份、TPE55份、OpperaTM改性剂25份和抗氧化剂BHT4份中原料共混,然后将上述共混后的材料通过双螺杆挤出机熔融塑化,物料通过机头口模挤出,流涎成均匀熔体后,采用两辊压延机将混料压延成ETFE层;
步骤三:将LDPE层和ETFE层、LDPE层和LDPE层侧边通过基于 EscorezTM增粘树脂的热熔胶HMA-黏结层在温度150℃下进行热压复合,冷却,制成药剂袋。
实施例4试验结果如表4:在温度为130℃、灭菌时间为60min后,药剂袋无变形现象。
表4:实施例4试验结果
实施例5
步骤一:将LDPE100份、EMA50份、OpperaTM改性剂30份、溴化环氧树脂5份和聚醚酯酰胺8份放入搅拌机中混合均匀,通过挤出成型得到LDPE层;
步骤二:将ETFE100份、TPE60份、OpperaTM改性剂30份和抗氧化剂BHT4份中原料共混,然后将上述共混后的材料通过双螺杆挤出机熔融塑化,物料通过机头口模挤出,流涎成均匀熔体后,采用两辊压延机将混料压延成ETFE层;
步骤三:将LDPE层和ETFE层、LDPE层和LDPE层侧边通过基于 EscorezTM增粘树脂的热熔胶HMA-黏结层在温度150℃下进行热压复合,冷却,制成药剂袋。
实施例5试验结果如表5:在温度为130℃、灭菌时间为60min后,药剂袋无变形现象。
表5:实施例5试验结果
结论:从表1-5可知,本发明实施例1-5所制备的药剂袋中的外层性能较与内层性能更为优异。实施例5效果最为优异,LDPE层弹性模量189.7Mpa,拉伸强度81Mpa,撕裂强度达到157N;ETFE层弹性模量196.8Mpa,拉伸强度92Mpa,撕裂强度达到170N,有着良好的阻隔性和抗静电性能。
本药剂袋规格:体积5L,内层厚度0.1mm,外层厚度0.2mm
1、有良好的透明度和阻隔性,袋子展开后可检查里外是否有异物;
2、有着良好的韧度,力学性能优异,避免因为折痕、堆积挤压、搬运时破袋的风险;
3、可以承受较大的拉力;
4、内外接触层层低吸附,有着良好的灭菌性能和抗静电性能。
Claims (4)
1.一种防静电无菌药剂袋,其特征在于,采用内外两层包装结构,内层结构采用LDPE层,外层结构采用ETFE层,外层通过黏结层与内层粘结;即整体结构层从上到下依次为ETFE层、黏结层、LDPE层、黏结层、LDPE层、黏结层和ETFE层;所述LDPE层包括以下组分:
LDPE 80-100份
EMA 30-50份
阻隔材料10-30份
阻燃母粒1-5份
抗静电剂5-8份;
所述ETFE层包括以下组分:
ETFE 100份
TPE 40-60份
阻隔材料10-30份
抗氧化剂2-4份;
所述阻隔材料为Oppera™改性剂;
所述黏结层为基于Escorez™增粘树脂的热熔胶HMA;
防静电无菌药剂袋的制备方法包括以下步骤:
步骤一:将LDPE、EMA、阻隔材料、阻燃母粒和抗静电剂放入搅拌机中混合均匀,通过挤出成型得到LDPE层;
步骤二:将ETFE、TPE、阻隔材料和抗氧化剂共混,然后将共混后的材料通过双螺杆挤出机熔融塑化,物料通过机头口模挤出,流涎成均匀熔体后,采用两辊压延机将混料压延成ETFE层;
步骤三:将LDPE层和ETFE层、LDPE层和LDPE层侧边通过基于Escorez™增粘树脂的热熔胶HMA-黏结层在温度150℃下进行热压复合,冷却,制成药剂袋。
2.根据权利要求1所述的一种防静电无菌药剂袋,其特征在于,所述抗静电剂为聚醚酯酰胺或聚醚酯酰亚胺。
3.根据权利要求1所述的一种防静电无菌药剂袋,其特征在于,所述阻燃母粒为溴化环氧树脂。
4.根据权利要求1所述的一种防静电无菌药剂袋,其特征在于,所述抗氧化剂为抗氧剂BHT。
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