CN110330712A - 一种稳定、可生物降解的医用薄膜材料 - Google Patents
一种稳定、可生物降解的医用薄膜材料 Download PDFInfo
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Abstract
本发明属于医用材料领域,公开了一种稳定、可生物降解的医用薄膜材料,按重量份数计,包括以下组分:聚乙烯25‑40份,壳聚糖10‑30份,羧甲基纤维钠2‑8份,乙酸丁酸纤维素1‑3份,乙酰柠檬酸酯6‑10份,柠檬酸三正丁酯3‑8份,乙二酸二锌酯10‑20,淀粉10‑20份,氧化锌1‑3份,聚乙烯吡咯烷酮0.1‑1份。相对于现有技术,本发明医用薄膜材料安全性好,能耐受高150℃、低温‑25℃;本发明医用薄膜材料具有良好的生物降解性能,在自然条件下,30天降解率高达85.9%,适合用于低温存现血液或医药,对环境友好;本发明制备方法简单,适合工业量产。
Description
技术领域
本发明属于医用材料领域,特别涉及一种稳定、可生物降解的医用薄膜材料。
背景技术
医用薄膜有大量使用聚氯乙烯制备而成的薄膜,但聚氯乙烯薄膜对光、热的稳定性差,而且聚氯乙烯属于世界卫生组织癌症研究机构公布的3类致癌物之中。而医用薄膜往往要求更高的稳定性和安全性,因此,逐渐开发非聚氯乙烯薄膜是很有必要的。
医用的薄膜不仅要求薄膜稳定,可耐高温和低温,而且也需要薄膜具备可生物降解性,医院每天都产生大量的薄膜废弃物,例如手套,存储血液或药品的薄膜类装置等等,若这些薄膜废弃物没有很好的生物降解性,则会造成较大的环境压力。
因此,提供一种耐高低温,且同时具有良好的降解性能的医用薄膜材料十分有必要。
发明内容
针对现有技术的不足,本发明提供一种稳定、可生物降解的医用薄膜材料。本发明所述医用薄膜材料安全性好,能耐受高、低温,还具有良好的生物降解性能,适合用于低温保存血液或医药,对环境友好。
另外,本发明还提供一种稳定、可生物降解的医用薄膜材料的制备方法。
一种稳定、可生物降解的医用薄膜材料,按重量份数计,包括以下组分:
优选的,一种稳定、可生物降解的医用薄膜材料,按重量份数计,包括以下组分:
进一步优选的,一种稳定、可生物降解的医用薄膜材料,按重量份数计,包括以下组分:
优选的,所述氧化锌为纳米氧化锌;进一步优选的,所述氧化锌的粒径为30-60nm。
优选的,所述医用薄膜材料,按重量份数计,还包括1-4份的亚油酸。
优选的,所述淀粉的目数为200-300目。
一种稳定、可生物降解的医用薄膜材料的制备方法,包括以下步骤:
(1)按配方量称取各组分,将聚乙烯、壳聚糖、柠檬酸三正丁酯、淀粉、乙酰柠檬酸酯在混合机中搅拌混合均匀,制得混合物A,备用;
(2)将羧甲基纤维钠、乙酸丁酸纤维素、乙二酸二锌酯、氧化锌、聚乙烯吡咯烷酮搅拌混合,制得混合物B,备用;
(3)将混合物B加入混合物A中,升温至100-105℃,搅拌,出料至挤出机挤出造粒,压延成型,制得所述医用薄膜材料。
优选的,步骤(1)中的搅拌的速度是400-600转/分钟,搅拌的时间是30-50分钟。
优选的,步骤(2)中的搅拌的速度是200-400转/分钟,搅拌的时间是30-40分钟。
优选的,步骤(3)中的搅拌的速度是300-500转/分钟,搅拌的时间是1-2小时。
所述医用薄膜材料的厚度为0.1-1.5mm。
步骤(3)中所述出料、造粒、压延成型过程属于本领域常规技术。
本发明所述医用薄膜材料中的聚乙烯、壳聚糖、氧化锌的联合使用,有利于提高产品的生物降解性能。乙酸丁酸纤维素、乙酰柠檬酸酯、柠檬酸三正丁酯、聚乙烯吡咯烷酮的联合使用有利于改善产品的耐高温和低温性能,对提高产品的机械性能也起到积极作用。
相对于现有技术,本发明的有益效果如下:
(1)本发明所述医用薄膜材料安全性好,能耐受高150℃、低温-25℃;
(2)本发明所述医用薄膜材料具有良好的生物降解性能,在自然条件下,30天降解率高达85.9%,适合用于低温存现血液或医药,对环境友好。
(3)本发明所述制备方法简单,适合工业量产。
具体实施方式
为了让本领域技术人员更加清楚明白本发明所述技术方案,现列举以下实施例进行说明。需要指出的是,以下实施例对本发明要求的保护范围不构成限制作用。
实施例1
一种稳定、可生物降解的医用薄膜材料,按重量份数计,包括以下组分:
所述氧化锌为纳米氧化锌;所述氧化锌的粒径为30-40nm。
所述淀粉的目数为200-250目。
一种稳定、可生物降解的医用薄膜材料的制备方法,包括以下步骤:
(1)按配方量称取各组分,将聚乙烯、壳聚糖、柠檬酸三正丁酯、淀粉、乙酰柠檬酸酯在混合机中搅拌混合均匀,制得混合物A,备用;
(2)将羧甲基纤维钠、乙酸丁酸纤维素、乙二酸二锌酯、氧化锌、聚乙烯吡咯烷酮搅拌混合,制得混合物B,备用;
(3)将混合物B加入混合物A中,升温至100℃,搅拌,出料至挤出机挤出造粒,压延成型,制得所述医用薄膜材料。
步骤(1)中的搅拌的速度是400转/分钟,搅拌的时间是50分钟。
步骤(2)中的搅拌的速度是300转/分钟,搅拌的时间是30分钟。
步骤(3)中的搅拌的速度是400转/分钟,搅拌的时间是1.5小时。
实施例2
一种稳定、可生物降解的医用薄膜材料,按重量份数计,包括以下组分:
所述氧化锌为纳米氧化锌;所述氧化锌的粒径为50-60nm。
所述淀粉的目数为280-300目。
一种稳定、可生物降解的医用薄膜材料的制备方法,包括以下步骤:
(1)按配方量称取各组分,将聚乙烯、壳聚糖、柠檬酸三正丁酯、淀粉、乙酰柠檬酸酯在混合机中搅拌混合均匀,制得混合物A,备用;
(2)将羧甲基纤维钠、乙酸丁酸纤维素、乙二酸二锌酯、氧化锌、聚乙烯吡咯烷酮搅拌混合,制得混合物B,备用;
(3)将混合物B加入混合物A中,升温至105℃,搅拌,出料至挤出机挤出造粒,压延成型,制得所述医用薄膜材料。
步骤(1)中的搅拌的速度是600转/分钟,搅拌的时间是30分钟。
步骤(2)中的搅拌的速度是400转/分钟,搅拌的时间是30分钟。
步骤(3)中的搅拌的速度是400转/分钟,搅拌的时间是1.5小时。
实施例3
一种稳定、可生物降解的医用薄膜材料,按重量份数计,包括以下组分:
所述氧化锌为纳米氧化锌;所述氧化锌的粒径为30-40nm。
所述淀粉的目数为200-300目。
一种稳定、可生物降解的医用薄膜材料的制备方法,包括以下步骤:
(1)按配方量称取各组分,将聚乙烯、壳聚糖、柠檬酸三正丁酯、淀粉、乙酰柠檬酸酯在混合机中搅拌混合均匀,制得混合物A,备用;
(2)将羧甲基纤维钠、乙酸丁酸纤维素、乙二酸二锌酯、氧化锌、聚乙烯吡咯烷酮、亚油酸搅拌混合,制得混合物B,备用;
(3)将混合物B加入混合物A中,升温至102℃,搅拌,出料至挤出机挤出造粒,压延成型,制得所述医用薄膜材料。
步骤(1)中的搅拌的速度是500转/分钟,搅拌的时间是40分钟。
步骤(2)中的搅拌的速度是300转/分钟,搅拌的时间是40分钟。
步骤(3)中的搅拌的速度是500转/分钟,搅拌的时间是1小时。
对比例1
与实施例2相比,对比例1中不含有壳聚糖、氧化锌,其余组分和制备方法与实施例2相同。
对比例2
与实施例2相比,对比例2中不含有乙酸丁酸纤维素、乙酰柠檬酸酯,其余组分和制备方法与实施例2相同。
对比例3
与实施例3相比,对比例3中制备过程中的步骤(1)中的搅拌的速度是200转/分钟,搅拌的时间是60分钟;步骤(2)中的搅拌的速度是100转/分钟,搅拌的时间是60分钟;步骤(3)中的搅拌的速度是200转/分钟,搅拌的时间是2小时。其余组分和制备方法与实施例3相同。
产品效果测试
将实施例1-3和对比例1-3制备的医用薄膜材料以及市售的同类型医用薄膜材料(市售的同类型医用薄膜产品不含有壳聚糖、氧化锌、乙酸丁酸纤维素)先置于150℃下保持1小时,然后置于低温-25℃下保持1小时,再置于150℃下保持1小时,如此循环3次,最后观察医用薄膜材料是否出现脆裂或融化粘连现象,结果如表1所示。
表1:
从表1中可以看出,实施例1-3制备的医用薄膜材料在反复经受高低温处理过程中,依然表现良好的稳定性,不出现脆裂或融化粘连现象。对比例2-3制备的医用薄膜材料以及市售的同类型医用薄膜材料出现一定脆裂及轻微的融化粘连现象。
另外,取实施例2和对比例1制备的医用薄膜材料以及市售的同类型医用薄膜材料(市售的同类型医用薄膜产品不含有壳聚糖、氧化锌、乙酸丁酸纤维素)在模拟的自然条件下,测试30天时的降解率,结果如表2所示。
表2:
从表2中可以看出,实施例1-3制备的医用薄膜材料在自然条件下,30天的降解率明显高于对比例1制备的医用薄膜材料和市售的同类型医用薄膜材料的降解率。
综上所述,本发明实施例1-3制备的医用薄膜材料的稳定性和降解性能良好,适合用于低温存现血液或医药,对环境友好。
Claims (9)
1.一种稳定、可生物降解的医用薄膜材料,其特征在于,按重量份数计,包括以下组分:
2.根据权利要求1所述的医用薄膜材料,其特征在于,按重量份数计,包括以下组分:
3.根据权利要求1或2所述的医用薄膜材料,其特征在于,所述氧化锌为纳米氧化锌,所述纳米氧化锌的粒径为30-60nm。
4.根据权利要求1或2所述的医用薄膜材料,其特征在于,所述医用薄膜材料,按重量份数计,还包括1-4份的亚油酸。
5.一种根据权利要求1-3中任一项所述的医用薄膜材料的制备方法,其特征在于,包括以下步骤:
(1)按配方量称取各组分,将聚乙烯、壳聚糖、柠檬酸三正丁酯、淀粉、乙酰柠檬酸酯在混合机中搅拌混合均匀,制得混合物A,备用;
(2)将羧甲基纤维钠、乙酸丁酸纤维素、乙二酸二锌酯、氧化锌、聚乙烯吡咯烷酮搅拌混合,制得混合物B,备用;
(3)将混合物B加入混合物A中,升温,搅拌,出料至挤出机挤出造粒,压延成型,制得所述医用薄膜材料。
6.根据权利要求5所述的制备方法,其特征在于,步骤(1)中的搅拌的速度是400-600转/分钟,搅拌的时间是30-50分钟。
7.根据权利要求5所述的制备方法,其特征在于,步骤(2)中的搅拌的速度是200-400转/分钟,搅拌的时间是30-40分钟。
8.根据权利要求5所述的制备方法,其特征在于,步骤(3)中的搅拌的速度是300-500转/分钟,搅拌的时间是1-2小时。
9.根据权利要求5所述的制备方法,其特征在于,步骤(3)中的升温的温度为100-105℃。
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