CN113321835A - 一种用于细胞培养袋的薄膜、制备工艺及细胞培养袋 - Google Patents
一种用于细胞培养袋的薄膜、制备工艺及细胞培养袋 Download PDFInfo
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Abstract
本发明公开了一种用于细胞培养袋的薄膜、制备工艺及细胞培养袋,属于生物医药领域,薄膜包括内层和外层,内层为改性EVA淋膜层,外层为FEP膜层,所述内层的厚度为0.03‑0.10mm,外层的厚度为0.05‑0.15mm;采用淋膜工艺在FEP膜表面淋覆改性EVA材料,并通过加热焊接的方法制得细胞培养袋。本发明的制备工艺简单,采用本发明的制备工艺得到的薄膜具有低的水蒸气透过率、高的氧气透过率和高的透光率,由薄膜制得的细胞培养袋抗菌抑菌能力好、机械强度高,因此使用性能好。
Description
技术领域
本发明属于生物医药领域,具体涉及一种用于细胞培养袋的薄膜、制备工艺及细胞培养袋。
背景技术
细胞培养袋是用于细胞培养的一次性使用医用耗材,细胞培养袋应具有良好的生物安全性,确保不会对培养的细胞产生毒性,同时还应当具有一定的透光性,便于从细胞培养袋外部观察到内部的细胞生长状况。
但是现有技术中的细胞培养袋在使用和制备过程中,往往存在如下问题:(1)采用EVA(乙烯-醋酸乙烯酯)膜制作出的细胞培养袋,透光性不高,无法通过显微镜直接观察袋体内的细胞;(2)EVA膜的水蒸气透光率高,对于水蒸气的阻隔性较差,因此使用传统EVA膜制备的细胞培养袋,在进行细胞培养时需要另行使用潮湿的培养箱,操作复杂。
采用FEP(全氟乙烯丙烯共聚物)膜来制备细胞培养袋,可以在一定程度上解决上述两个问题,但是FEP的化学惰性极高,一般情况下较难对其进行加工,且由于加工工艺复杂,由FEP膜制备的细胞培养袋代替密封性难以保证,同时加工设备的成本投入也较高。
发明内容
本发明的目的在于提供一种用于细胞培养袋的薄膜、制备工艺及细胞培养袋,以解决背景技术中提到的技术问题。
为了实现上述目的,本发明公开了一种用于细胞培养袋的薄膜,所述薄膜包括内层和外层,内层为改性EVA淋膜层,外层为FEP膜层,所述内层的厚度为0.03-0.10mm,外层的厚度为0.05-0.15mm。优选为,内层的厚度为0.05mm;外层的厚度为0.1mm。
本发明同时要求保护一种上述薄膜的制备工艺,包括如下步骤:(1)对FEP膜表面进行等离子体表面处理;(2)将改性EVA材料加入挤出机中加热熔融,然后熔体淋覆于FEP膜的表面进行复合;(3)性能检测,收卷。
对FEP膜表面进行低温等离子体处理,即通过低压放电,产生电离气体,在电场作用下,气体中的自由电子从电场中获得能量,成为高能量电子,这些高能量电子与气体中的原子、分子碰撞,如果电子的能量大于分子或原子的激发能,就能产生激发分子和激发原子、自由基、离子和具有不同能量的射线。低温等离子体中的活性离子具有的能量一般接近或超过碳-碳或其他含碳键的键能,因而能与导入系统的气体或固体表面发生化学反应或物理的相互作用,如果采用反应型的氧等离子体,则能与高分子表面发生化学反应而引入大量的含氧基团,使其表面分子链上产生极性,表面张力明显提高,改变其表面活性,即使采用非反应型的Ar等离子体,也能通过表面的交联和蚀刻作用引起的表面物理变化而明显的改善FEP膜表面的接触角和表面能,从而提高表面的粘接效果,然后在其表面进行淋膜,淋膜树脂选用EVA材料,该材料作为热熔胶材料已广泛使用,具备优异的粘接效果。
进一步地,所述改性EVA材料中,按照质量份数计,包括如下组分:EVA 50-95份、PLA(聚乳酸)10-35份、壳聚糖5-15份、EPDM(乙烯、丙烯和非共轭二烯烃的三元共聚物)5-70份。
进一步地,所述EPDM的用量是EVA和PLA用量总和的1/10-1/2。
进一步地,所述EVA中,VA的含量为5-20%。
改性EVA材料中,EVA为基体材料,限制VA的含量为5-20%,EVA材料中VA的含量越高,弹性、柔软性、透明性等也越高,当VA含量减少时,刚性增加,耐磨性和电绝缘性提高,当VA的含量为5-20%时,主要用作热熔粘合剂和弹性薄膜,透明性也较好。
PLA是一种具有一定抗菌能力的聚酯类聚合物材料,属于新型的生物降解材料,加工性、透光度、透气性和生物相容性良好,EVA与PLA搭配使用,可提高薄膜的透气性和透光度。壳聚糖具有良好的抗菌抑菌能力,可为细胞提供无菌等级更高的培养环境。
EPDM是一种橡胶材料,其耐酸碱性能好,耐腐蚀性能强,可作为相容剂,本发明中限制EPDM的用量与EVA和PLA用量总和的配比,可提高PLA、壳聚糖和EVA的相容性,并增加薄膜的机械强度,提高细胞培养袋的使用性能。
本发明同时要求保护一种采用上述制备工艺得到的薄膜制备而成的细胞培养袋。
进一步地,所述细胞培养袋中,细胞培养袋的袋体外层为FEP膜层,内层为改性EVA淋膜层,对内层进行焊接密封处理。
该薄膜制成的细胞培养袋(外层为FEP膜、内层为EVA膜)拥有优异的透光性,可以通过显微镜直接观察,排除了污染细胞组织的风险。
与现有产品相比,本发明的用于细胞培养袋的薄膜、制备工艺及细胞培养袋具有如下优点:
(1)本发明的用于细胞培养袋的薄膜外层为FEP膜,内层为EVA膜,薄膜层间粘接强度高,使用时不会发生层间剥离,使用稳定性好。
(2)本发明在制备薄膜时,先对FEP膜表面进行低温等离子体处理,然后进行EVA淋膜,制备工艺简单,可操作性强;
(3)本发明的细胞培养袋(外层为FEP膜、内层为EVA膜),具有较低的水蒸气透过率,细胞的培养无需在潮湿的培养箱中进行;具有较高的氧气透过率,可为培养袋中的细胞传输高浓度的氧气,满足细胞的生长需要;
(4)本发明的细胞培养袋具有良好的抗菌抑菌能力,更适于对灭菌等级要求高的细胞的培养;同时本发明的细胞培养袋具有较高的机械强度和耐腐蚀性能,因此使用性能好;
(5)本发明的细胞培养袋袋体焊接时采用加温焊接,工艺简单,生产成本低。
附图说明
图1:实施例中用于细胞培养袋的薄膜的结构示意图。
附图标记说明:1-FEP膜层;2-EVA淋膜层。
具体实施方式
下面通过具体实施例进行详细阐述,说明本发明的技术方案。
实施例1
(一)制备用于细胞培养袋的薄膜
采用淋膜工艺,制备用于细胞培养袋的薄膜,薄膜淋膜材料为改性EVA材料,按照质量份数计,改性EVA材料中包括如下组分:EVA 60份、PLA 30份、壳聚糖12份、EPDM 18份;其中EPDM的质量份数是EVA和PLA用量总和的18/(60+30)=1/5。
按照上述配方称取相应原料,将原料混合均匀后,加入挤出机中,进行加热熔融;同时将采购到的整卷FEP膜进行放卷,将FEP膜送入烘箱中进行加热烘干处理,然后对烘干处理后的FEP膜进行低温等离子体表面处理,随后将加热熔融后的改性EVA材料淋覆于FEP膜的表面进行复合;待熔融态的改性EVA材料冷却固化后,将复合膜通过厚度计进行厚度检测,随后进行收卷处理,得到的薄膜记为S1。
S1的总厚度为0.15mm,其中FEP膜的厚度为0.1mm,EVA膜的厚度为0.05mm。
对薄膜S1进行如下性能测试:
(1)氧气透过率测试:参照国际标准ASTM D3985-17中氧气透过率的测试方法,在25℃条件下,薄膜S1的氧气透过率为1935.23cm3/m2·24h。
(2)水蒸气透过率测试:参照国际标准ASTM F1249-20中水蒸气透过率的测试方法,在37.8℃条件下,薄膜S1的水蒸气透过率为0.4412g/m2·24h。
(3)透光率测试:参照国标GB/T2410-2008中的方法,薄膜S1的透光率为94%。
(二)制备细胞培养袋
将步骤(一)中得到的薄膜通过加温焊接的方法制备细胞培养袋,细胞培养袋的袋体外层为FEP膜层,内层为改性EVA淋膜层,在细胞培养袋的接口和封口处对内层进行焊接密封处理,即得到细胞培养袋。
实施例2
采用与实施例1相同的制备工艺制备用于细胞培养袋的薄膜和细胞培养袋,不同之处在于改性EVA材料中的原料种类和原料组成。
该实施例2中,改性EVA材料中包括如下组分:EVA60份、PLA 30份、壳聚糖12份、EPDM 6份;其中EPDM的质量份数是EVA和PLA用量总和的6/(60+30)=1/15。
得到的薄膜记为S2。
S2的总厚度为0.15mm,其中FEP膜的厚度为0.1mm,EVA膜的厚度为0.05mm。
对薄膜S2进行如下性能测试:
(1)氧气透过率测试:参照国际标准ASTM D3985-17中氧气透过率的测试方法,在25℃条件下,薄膜S2的氧气透过率为1891.26cm3/m2·24h。
(2)水蒸气透过率测试:参照国际标准ASTM F1249-20中水蒸气透过率的测试方法,在37.8℃条件下,薄膜S2的水蒸气透过率为0.4936g/m2·24h。
(3)透光率测试:参照国标GB/T2410-2008中的方法,薄膜S2的透光率为91%。
实施例3
采用与实施例1相同的制备工艺制备用于细胞培养袋的薄膜和细胞培养袋,不同之处在于改性EVA材料中的原料种类和原料组成。
该实施例3中,改性EVA材料中包括如下组分:EVA 50份、PLA 10份、壳聚糖5份、EPDM 30份;其中EPDM的质量份数是EVA和PLA用量总和的30/(50+10)=1/2。
得到的薄膜记为S3。
S3的总厚度为0.15mm,其中FEP膜的厚度为0.1mm,EVA膜的厚度为0.05mm。
对薄膜S3进行如下性能测试:
(1)氧气透过率测试:参照国际标准ASTM D3985-17中氧气透过率的测试方法,在25℃条件下,薄膜S3的氧气透过率为1901.35cm3/m2·24h。
(2)水蒸气透过率测试:参照国际标准ASTM F1249-20中水蒸气透过率的测试方法,在37.8℃条件下,薄膜S3的水蒸气透过率为0.4829g/m2·24h。
(3)透光率测试:参照国标GB/T2410-2008中的方法,薄膜S3的透光率为92%。
实施例4
采用与实施例1相同的制备工艺制备用于细胞培养袋的薄膜和细胞培养袋,不同之处在于改性EVA材料中的原料种类和原料组成。
该实施例4中,改性EVA材料中包括如下组分:EVA95份、PLA 35份、壳聚糖15份、EPDM 5份;其中EPDM的质量份数是EVA和PLA用量总和的5/(95+35)=1/26。
得到的薄膜记为S4。
S4的总厚度为0.15mm,其中FEP膜的厚度为0.1mm,EVA膜的厚度为0.05mm。
对薄膜S4进行如下性能测试:
(1)氧气透过率测试:参照国际标准ASTM D3985-17中氧气透过率的测试方法,在25℃条件下,薄膜S4的氧气透过率为1872.39cm3/m2·24h。
(2)水蒸气透过率测试:参照国际标准ASTM F1249-20中水蒸气透过率的测试方法,在37.8℃条件下,薄膜S4的水蒸气透过率为0.5026g/m2·24h。
(3)透光率测试:参照国标GB/T2410-2008中的方法,薄膜S4的透光率为90%。
如图1所示,为上述实施例1-4中用于细胞培养袋的薄膜的结构示意图。内层为EVA淋膜层,外层为FEP膜层。
对比例1
该对比例1中的制备用于细胞培养袋的薄膜为单层EVA膜结构,薄膜通过挤出成型的方法进行制备,薄膜的原材料为改性EVA材料,按照质量份数计,改性EVA材料中包括如下组分:EVA60份、PLA 30份、壳聚糖12份、EPDM 18份;其中EPDM的质量份数是EVA和PLA用量总和的18/(60+30)=1/5。
按照上述配方称取相应原料,将原料混合均匀后,加入挤出机中,进行加热熔融后挤出,得到薄膜,薄膜的厚度为0.1mm。
得到的薄膜记为B1。
对薄膜B1进行如下性能测试:
(1)氧气透过率测试:参照国际标准ASTM D3985-17中氧气透过率的测试方法,在25℃条件下,薄膜B1的氧气透过率为1999.207cm3/m2·24h。
(2)水蒸气透过率测试:参照国际标准ASTM F1249-20中水蒸气透过率的测试方法,在37.8℃条件下,薄膜B1的水蒸气透过率为8.3864g/m2·24h。
(3)透光率测试:参照国标GB/T2410-2008中的方法,薄膜B1的透光率为88%。
然后将薄膜通过加温焊接的方法制备细胞培养袋,在细胞培养袋的接口和封口处进行焊接密封处理,即得到细胞培养袋。
对比例2
该对比例2中的制备用于细胞培养袋的薄膜为单层FEP膜结构,FEP膜为市场采购得到,厚度为0.1mm。
得到的薄膜记为B2。
对薄膜B2进行如下性能测试:
(1)氧气透过率测试:参照国际标准ASTM D3985-17中氧气透过率的测试方法,在25℃条件下,薄膜B2的氧气透过率为1946.54cm3/m2·24h。
(2)水蒸气透过率测试:参照国际标准ASTM F1249-20中水蒸气透过率的测试方法,在37.8℃条件下,薄膜B2的水蒸气透过率为0.5127g/m2·24h。
(3)透光率测试:参照国标GB/T2410-2008中的方法,薄膜B2的透光率为95%。
然后将薄膜通过加温焊接的方法制备细胞培养袋,在细胞培养袋的接口和封口处进行焊接密封处理,但是FEP膜自身粘结性低,无法进行密封处理,因此无法制作细胞培养袋。
根据上述性能测试结果,发现采用本发明的制备方法得到的薄膜具有较高的氧气透过率、较低的水蒸气透过率,和较高的透光率,用作细胞培养时,可为细胞提供足量的氧气,并防止细胞培养袋中的水分流失,无需提供潮湿的培养箱,并且较高的透光率可直接通过显微镜观察到袋体内的细胞生长状况,因此使用更加方便。
以上所述仅为本发明的较佳实施例,并不用于限制本发明,凡在本发明的设计构思之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (7)
1.一种用于细胞培养袋的薄膜,其特征在于:所述薄膜包括内层和外层,内层为改性EVA淋膜层,外层为FEP膜层,所述内层的厚度为0.03-0.10mm,外层的厚度为0.05-0.15mm。
2.一种如权利要求1所述的薄膜的制备工艺,其特征在于:包括如下步骤:(1)对FEP膜表面进行等离子体表面处理;(2)将改性EVA材料加入挤出机中加热熔融,然后熔体淋覆于FEP膜的表面进行复合;(3)性能检测,收卷。
3.如权利要求2所述的薄膜的制备工艺,其特征在于:所述改性EVA材料中,按照质量份数计,包括如下组分:EVA50-95份、PLA10-35份、壳聚糖5-15份、EPDM5-70份。
4.如权利要求3所述的薄膜的制备工艺,其特征在于:所述EPDM的用量是EVA和PLA用量总和的1/10-1/2。
5.如权利要求3所述的薄膜的制备工艺,其特征在于:所述EVA中,VA的含量为5-20%。
6.一种采用如权利要求2-5中任一项所述的制备工艺得到的薄膜制备而成的细胞培养袋。
7.如权利要求6所述的细胞培养袋,其特征在于:所述细胞培养袋中,细胞培养袋的袋体外层为FEP膜层,内层为改性EVA淋膜层,对内层进行焊接密封处理。
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