CN113002092A - 核酸检测试剂灌封用pet/pe复合片及其制备方法 - Google Patents
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Abstract
本发明涉及医药包装材料技术领域,具体涉及一种核酸检测试剂灌封用PET/PE复合片及其制备方法。所述的核酸检测试剂灌封用PET/PE复合片,包括聚对苯二甲酸乙二醇酯硬片和在其表面通过无溶剂胶水复合工艺复合的低密度聚乙烯膜;聚对苯二甲酸乙二醇酯硬片厚度为0.20‑0.35mm,低密度聚乙烯膜厚度为0.03‑0.05mm。本发明的核酸检测试剂灌封用复合片,采用无溶剂胶水进行复合,减少环境污染,且使聚对苯二甲酸乙二醇酯与低密度聚乙烯高速复合,提高产能;本发明还提供其制备方法。
Description
技术领域
本发明涉及医药包装材料技术领域,具体涉及一种核酸检测试剂灌封用PET/PE复合片及其制备方法。
背景技术
医药包装是医药产业的重要组成部分,直接接触药品的包装材料容器是构成药品的基本要素,对药品质量和用药安全有重要影响。
目前国内普遍采用聚氯乙烯硬片和有溶剂胶水与聚乙烯膜复合,胶水要加入15-25%的溶剂,搅拌均匀流动性好涂布,复合前要把15-25%的溶剂高温挥发排放后才能复合,排放的溶剂都是有害物质,污染环境。而且聚氯乙烯硬片中含有微量的氯乙烯单体,氯乙烯单体在贮存期间会释放出来,对药品有害处。
专利CN201320006339.3公开了一种环保改性聚酯聚氯乙烯、聚乙烯、聚偏二氯乙烯固体药用复合硬片,包括表层、中间层和内层,所述表层为聚酯聚氯乙烯,中间层为聚乙烯层,内层为聚偏二氯乙烯层,在聚酯聚氯乙烯层与聚乙烯层之间以及聚乙烯层与聚偏二氯乙烯层之间均设有酒精-水性丙烯酸酯改性胶粘剂层。其采用无毒酒精-水性丙烯酸酯改性胶粘剂,韧性好,同时也保持了该药用复合片良好的综合使用性能。
专利CN202010529124.4公开了一种高阻隔聚氯乙烯-聚乙烯复合片材及其制备方法与应用,由从内至外依次排列的聚乙烯层、第一聚丙烯酰胺层、聚氨酯胶水层、第二聚丙烯酰胺层和聚氯乙烯层组成。该复合片材阻隔性好,能够作为医用包装材料使用,保证承装药品的长期稳定性,经检测,使用其制备的塑料瓶能大幅度提高抗病毒口服液的保质期。
以上专利中均采用聚氯乙烯膜,其含有微量的氯乙烯单体,氯乙烯单体在贮存期间会释放出来,对药品有害。
发明内容
本发明要解决的技术问题是提供一种核酸检测试剂灌封用PET/PE复合片,采用无溶剂胶水进行复合,减少环境污染,且使聚对苯二甲酸乙二醇酯与聚乙烯高速复合,提高产能;本发明还提供其制备方法。
本发明所述的核酸检测试剂灌封用PET/PE复合片,包括聚对苯二甲酸乙二醇酯(PET)硬片和在其表面通过无溶剂胶水复合工艺复合的低密度聚乙烯(PE)膜。
聚对苯二甲酸乙二醇酯硬片厚度为0.20-0.35mm,优选为0.32mm。
低密度聚乙烯膜厚度为0.03-0.05mm,优选为0.045mm。
低密度聚乙烯膜的宽度比聚对苯二甲酸乙二醇酯硬片的宽度宽10mm。
优选地,聚对苯二甲酸乙二醇酯硬片宽度为800mm,低密度聚乙烯膜宽度为810mm。
无溶剂胶水为上海康达公司生产,型号为KD-ZB201,
本发明所述的核酸检测试剂灌封用PET/PE复合片的制备方法,包括以下步骤:
(1)将聚对苯二甲酸乙二醇酯进行干燥、结晶,然后依次进行流延、压光、电晕、切边、收卷,得到聚对苯二甲酸乙二醇酯硬片;
(2)将低密度聚乙烯吹膜、单片收卷,得到低密度聚乙烯膜;
(3)采用高速无溶剂复合机,将无溶剂胶水通过混胶枪混胶,均布在网纹辊上,网纹辊的胶转移到聚对苯二甲酸乙二醇酯硬片上,再用展平辊复合上低密度聚乙烯膜,复合后进行熟化、降温、分切、包装,即得到核酸检测试剂灌封用PET/PE复合片。
步骤(1)中,干燥温度为100-120℃,干燥时间为30-60min;优选地,干燥温度为110℃,干燥时间为50min。
步骤(1)中,结晶温度为120-130℃,结晶时间为60-90min;优选地,结晶温度为125℃,结晶时间为70min。
步骤(1)中,流延采用双平流延,流延温度为260-270℃,优选为266℃。
步骤(1)中,压光采用三辊压光,压光温度为50-60℃,优选为55℃。
步骤(2)中,吹膜采用旋转模具吹膜,吹膜温度为215-225℃,优选为220℃。
步骤(3)中,混胶枪转速为450-550r/min,优选为500r/min;布胶量为10-15g/m2,优选为12g/m2。
步骤(3)中,熟化温度为70-80℃,熟化时间为50-80h;优选地,熟化温度为75℃,熟化时间为60h。
具体地,所述核酸检测试剂灌封用PET/PE复合片的制备方法,包括以下步骤:
(1)将聚对苯二甲酸乙二醇酯投入不锈钢干燥机内,在100-120℃温度下搅拌干燥30-60min,再在120-130℃温度下结晶60-90min,然后在260-270℃温度下双平流延,在50-60℃温度下三辊压光,最后进行电晕、切边、收卷,得到聚对苯二甲酸乙二醇酯硬片;
(2)将低密度聚乙烯在215-225℃温度下通过旋转模具吹膜,单片收卷,得到低密度聚乙烯膜;
(3)采用高速无溶剂复合机,将无溶剂胶水通过混胶枪混胶,均布在网纹辊上,网纹辊的胶转移到聚对苯二甲酸乙二醇酯硬片上,布胶量为10-15g/m2,再用展平辊复合上低密度聚乙烯膜,复合后在70-80℃熟化50-80h,再降温、分切、包装,即得到核酸检测试剂灌封用PET/PE复合片。
与现有技术相比,本发明有以下有益效果:
(1)本发明采用无溶剂胶水进行涂布,复合过程中无有害物质排出,安全环保,且聚对苯二甲酸乙二醇酯硬片和聚乙烯膜复合速率高,与常规方法相比,产量提高二倍;
(2)本发明采用聚对苯二甲酸乙二醇酯硬片和聚乙烯膜复合,不含聚氯乙烯,制备的复合片安全可靠,确保了药物在储存过程中无污染。
具体实施方式
下面结合具体实施例对本发明进行进一步说明,不能理解为对本发明保护范围的限制,该领域的技术熟练人员可以根据上述内容对本发明做出一些非本质的改进和调整。
实施例1
按照以下方法制备核酸检测试剂灌封用PET/PE复合片:
(1)将聚对苯二甲酸乙二醇酯投入不锈钢干燥机内,在110℃温度下搅拌干燥50min,再在125℃温度下结晶70min,然后在266℃温度下双平流延,在55℃温度下三辊压光,最后进行电晕、切边、收卷,得到聚对苯二甲酸乙二醇酯硬片,厚度为0.32mm,宽度为800mm;
(2)将低密度聚乙烯在220℃温度下通过旋转模具吹膜,单片收卷,得到低密度聚乙烯膜,厚度为0.045mm,宽度为810mm;
(3)采用高速无溶剂复合机,将无溶剂胶水KD-ZB201通过混胶枪混胶,均布在网纹辊上,网纹辊的胶转移到聚对苯二甲酸乙二醇酯硬片上,混胶枪转速为500r/min,布胶量为12g/m2,再用展平辊复合上低密度聚乙烯膜,复合后在75℃熟化60h,再降温、分切、包装,即得核酸检测试剂灌封用PET/PE复合片。
实施例2
按照以下方法制备核酸检测试剂灌封用PET/PE复合片:
(1)将聚对苯二甲酸乙二醇酯投入不锈钢干燥机内,在100℃温度下搅拌干燥60min,再在120℃温度下结晶90min,然后在260℃温度下双平流延,在50℃温度下三辊压光,最后进行电晕、切边、收卷,得到聚对苯二甲酸乙二醇酯硬片,厚度为0.35mm,宽度为800mm;
(2)将低密度聚乙烯在215℃温度下通过旋转模具吹膜,单片收卷,得到低密度聚乙烯膜,厚度为0.05mm,宽度为810mm;
(3)采用高速无溶剂复合机,将无溶剂胶水KD-ZB201通过混胶枪混胶,均布在网纹辊上,网纹辊的胶转移到聚对苯二甲酸乙二醇酯硬片上,混胶枪转速为500r/min,布胶量为12g/m2,混胶枪转速为550r/min,布胶量为15g/m2,再用展平辊复合上低密度聚乙烯膜,复合后在80℃熟化80h,再降温、分切、包装,即得核酸检测试剂灌封用PET/PE复合片。
实施例3
按照以下方法制备核酸检测试剂灌封用PET/PE复合片:
(1)将聚对苯二甲酸乙二醇酯投入不锈钢干燥机内,在120℃温度下搅拌干燥30min,再在130℃温度下结晶60min,然后在270℃温度下双平流延,在60℃温度下三辊压光,最后进行电晕、切边、收卷,得到聚对苯二甲酸乙二醇酯硬片,厚度为0.20mm,宽度为800mm;
(2)将低密度聚乙烯在225℃温度下通过旋转模具吹膜,单片收卷,得到低密度聚乙烯膜,厚度为0.03mm,宽度为810mm;
(3)采用高速无溶剂复合机,将无溶剂胶水KD-ZB201通过混胶枪混胶,均布在网纹辊上,网纹辊的胶转移到聚对苯二甲酸乙二醇酯硬片上,混胶枪转速为550r/min,布胶量为10g/m2,再用展平辊复合上低密度聚乙烯膜,复合后在70℃熟化50h,再降温、分切、包装,即得核酸检测试剂灌封用PET/PE复合片。
将实施例1-3制备的核酸检测试剂灌封用复合片进行性能检测和卫生检测,结果如表1所示。
表1实施例1-3的性能检测和卫生检测结果
从表1可以看出,本发明制备的核酸检测试剂灌封用PET/PE复合片质量稳定,安全可靠。
Claims (10)
1.一种核酸检测试剂灌封用PET/PE复合片,其特征在于:包括聚对苯二甲酸乙二醇酯硬片和在其表面通过无溶剂胶水复合工艺复合的低密度聚乙烯膜;
聚对苯二甲酸乙二醇酯硬片厚度为0.20-0.35mm;
低密度聚乙烯膜厚度为0.03-0.05mm;
低密度聚乙烯膜的宽度比聚对苯二甲酸乙二醇酯硬片的宽度宽10mm。
2.根据权利要求1所述的核酸检测试剂灌封用PET/PE复合片,其特征在于:聚对苯二甲酸乙二醇酯硬片宽度为800mm,低密度聚乙烯膜宽度为810mm。
3.根据权利要求1所述的核酸检测试剂灌封用PET/PE复合片,其特征在于:无溶剂胶水型号为KD-ZB201。
4.一种权利要求1-3任一项所述的核酸检测试剂灌封用PET/PE复合片的制备方法,其特征在于:包括以下步骤:
(1)将聚对苯二甲酸乙二醇酯进行干燥、结晶,然后依次进行流延、压光、电晕、切边、收卷,得到聚对苯二甲酸乙二醇酯硬片;
(2)将低密度聚乙烯吹膜、单片收卷,得到低密度聚乙烯膜;
(3)采用高速无溶剂复合机,将无溶剂胶水通过混胶枪混胶,均布在网纹辊上,网纹辊的胶转移到聚对苯二甲酸乙二醇酯硬片上,再用展平辊复合上低密度聚乙烯膜,复合后进行熟化、降温、分切、包装,即得到核酸检测试剂灌封用复合片。
5.根据权利要求4所述的核酸检测试剂灌封用PET/PE复合片的制备方法,其特征在于:步骤(1)中,干燥温度为100-120℃,干燥时间为30-60min。
6.根据权利要求4所述的核酸检测试剂灌封用PET/PE复合片的制备方法,其特征在于:步骤(1)中,结晶温度为120-130℃,结晶时间为60-90min。
7.根据权利要求4所述的核酸检测试剂灌封用PET/PE复合片的制备方法,其特征在于:步骤(1)中,流延采用双平流延,流延温度为260-270℃;压光采用三辊压光,压光温度为50-60℃。
8.根据权利要求4所述的核酸检测试剂灌封用PET/PE复合片的制备方法,其特征在于:步骤(2)中,吹膜采用旋转模具吹膜,吹膜温度为215-225℃。
9.根据权利要求4所述的核酸检测试剂灌封用PET/PE复合片的制备方法,其特征在于:步骤(3)中,混胶枪转速为450-550r/min,布胶量为10-15g/m2。
10.根据权利要求4所述的核酸检测试剂灌封用PET/PE复合片的制备方法,其特征在于:步骤(3)中,熟化温度为70-80℃,熟化时间为50-80h。
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