CN117048165A - 聚酯/低密度聚乙烯药用复合硬片及其制备方法和应用 - Google Patents
聚酯/低密度聚乙烯药用复合硬片及其制备方法和应用 Download PDFInfo
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Abstract
本发明属于医药包装材料技术领域,具体涉及聚酯/低密度聚乙烯药用复合硬片及其制备方法和应用。所述的聚酯/低密度聚乙烯药用复合硬片,由0.2‑0.3mm厚的聚酯片和0.03‑0.05mm厚的低密度聚乙烯薄膜经双组分胶粘剂复合得到;所述聚酯片和低密度聚乙烯薄膜的表面达因值≥38达因。本发明的聚酯/低密度聚乙烯药用复合硬片,原料安全环保,结构简单,阻隔性能好,热封成型性优异,适合用于药用口服液灌装包装材料。
Description
技术领域
本发明属于医药包装材料技术领域,具体涉及聚酯/低密度聚乙烯药用复合硬片及其制备方法和应用。
背景技术
目前,药用口服液一般采用复合塑料包装,现有的包装材料一般为聚氯乙烯/低密度聚乙烯或者其他含有聚氯乙烯的材料,其中聚氯乙烯为3类致癌物,因此需要对口服药包装材料进行进一步研究。
例如,专利CN112959786A中公开了一种口服液体PET-PCTFE-PE复合硬片,包括外层聚酯层、中间层聚三氟氯乙烯层和内层聚乙烯层,聚三氟氯乙烯层的原料包括:聚三氟氯乙烯、α-氧化铝负载铜粉、铝粉和聚乙烯蜡;聚乙烯层的原料包括:聚乙烯、聚氯乙烯和铝粉;中间层聚三氟氯乙烯层分别与外层聚酯层和内层聚乙烯层热压固定。该发明通过在PET和PE层之间设计PCTFE(聚三氟氯乙烯层)层,使复合膜片材料具有良好的阻隔性,满足药物包装需求。
专利CN113043691A中公开了一种口服液体多层复合硬片,包括依次连接的PVC外层膜、PET片材层、PVDC膜层和改性PE内膜,改性PE内膜包括如下组分:聚乙烯,丙烯酸羟乙酯,介孔纳米碳酸钙,改性纳米微粒填充的中空纤维,聚碳酸酯/纳米SiO2复合材料,热稳定剂,流动改性剂和成膜剂。该发明的复合硬片中,介孔内的流动改性剂和成膜剂流出后可以使改性粒子成膜,实现对受损部分的填充和固化修复,具有自修复功能。
但是,包括上述复合硬片在内的现有医用复合硬片材料大多采用三层或三层以上结构,并在主体聚合物材料中加入一定的助剂来实现相应的功能性。一方面,三层或三层以上结构会增加复合硬片的厚度,影响其热封性;另一方面,复合硬片中添加助剂,在后期使用过程中容易迁移析出,从而影响药物质量。
发明内容
本发明的目的是:提供一种聚酯/低密度聚乙烯药用复合硬片,原料安全环保,结构简单,阻隔性能好,热封成型性优异;本发明还提供其制备方法和在药用口服液灌装包装材料方面的应用。
本发明所述的聚酯/低密度聚乙烯药用复合硬片,由0.2-0.3mm厚的聚酯片和0.03-0.05mm厚的低密度聚乙烯薄膜经双组分胶粘剂复合得到;所述聚酯片和低密度聚乙烯薄膜的表面达因值≥38达因。
本发明中,所述聚酯片采用聚对苯二甲酸乙二酯(PET)材料,优选为华润化工新材有限公司的CR-8863AA,其特性粘度为0.80dl/g,熔融温度为245℃,二甘醇含量1.3wt.%,端羟基含量27mmol/kg。
本发明中,所述低密度聚乙烯膜薄膜优选为合肥美邦新材料有限公司的MB-110,其表面达因值≥38达因,摩擦系数≤0.30,拉伸强度≥10MPa,断裂伸长率≥150%。
本发明中,所述双组分胶粘剂优选为南通高盟新材料有限公司的YH7166H,其25℃粘度为5000mPa.s,不挥发物≥64wt.%,色号80#。
本发明中,聚酯片的宽度范围为600-900mm,低密度聚乙烯薄膜的宽度范围为605-905mm,聚酯片比低密度聚乙烯薄膜的宽度小5-10mm。
本发明所述的聚酯/低密度聚乙烯药用复合硬片的制备方法,包括以下工序:聚酯片制备→涂布双组分胶粘剂→烘干→复合低密度聚乙烯薄膜→熟化→分切。
优选的,聚酯片制备工序为:将聚对苯二甲酸乙二酯(PET)通过真空吸料通入挤出机料斗,经平双螺杆挤出机塑化,再经熔体计量泵计量挤出、过滤、模头出片、三辊压光后,进行电晕处理,使其表面达因值≥38达因,得到聚酯片。
进一步优选的,平双螺杆挤出机塑化时,各区加热温度为:1区180-185℃,2区220-225℃,3区245-250℃,4区255-260℃,5区260-265℃。
进一步优选的,熔体计量泵挤出、过滤、模头出片温度均为260-265℃,三辊压光温度为20-30℃。
优选的,涂布双组分胶粘剂工序中,采用单头涂布机,双组分胶粘剂涂布量3-5g/m2。
优选的,烘干工序中,加热功率20-30kW,烘干温度65-85℃。
优选的,复合低密度聚乙烯薄膜工序中,采用热合工艺,热合温度150-160℃,热合时间1-3s,易氧化物≤1.3mL。
优选的,熟化工序中,熟化功率10-15kW,熟化时间60-80h。
本发明所述的聚酯/低密度聚乙烯药用复合硬片的应用,用于药用口服液灌装包装材料。
与现有技术相比,本发明的有益效果如下:
(1)本发明采用聚酯片和低密度聚乙烯薄膜作为主体材料,经双组分胶粘剂复合得到药用复合硬片,所采用的原料安全环保,且双层结构的设计易于加工,产品的综合成本低;
(2)本发明采用特定指标的聚酯材料和聚乙烯薄膜作为原料,并对复合硬片厚度进行调整,得到的聚酯/低密度聚乙烯药用复合硬片阻隔性能好,热封成型性优异,满足药用口服液灌装包装材料的要求。
具体实施方式
下面结合实施例对本发明作进一步说明,实施例中所使用的原料,如无特别说明,均为市售常规原料;实施例中所使用的工艺方法,如无特别说明,均为本领域常规方法。
实施例中所采用的部分原料说明如下:
聚对苯二甲酸乙二酯:华润化工新材有限公司生产的CR-8863AA,其特性粘度为0.80dl/g,熔融温度为245℃,二甘醇含量1.3wt.%,端羟基含量27mmol/kg;
低密度聚乙烯膜薄膜:合肥美邦新材料有限公司生产的MB-110,其表面达因值≥38达因,摩擦系数≤0.30,拉伸强度≥10MPa,断裂伸长率≥150%;
双组分胶粘剂:南通高盟新材料有限公司生产的YH7166H,其25℃粘度为5000mPa.s,不挥发物≥64wt.%,色号80#。
实施例1
一种聚酯/低密度聚乙烯药用复合硬片,由0.25mm厚、800mm宽的聚酯片和0.04mm厚、810mm宽的低密度聚乙烯薄膜经双组分胶粘剂复合得到。
制备方法包括以下工序:
(1)聚酯片制备:将聚对苯二甲酸乙二酯通过真空吸料通入挤出机料斗,经平双螺杆挤出机塑化,各区加热温度为:1区180℃,2区220℃,3区245℃,4区260℃,5区265℃,再在260℃温度下经熔体计量泵计量挤出、180目自动换滤网过滤、衣架模头出片,在25℃温度下经三辊压光后,进行电晕处理,使其表面达因值≥38达因,得到聚酯片;
(2)涂布双组分胶粘剂:采用单头涂布机,双组分胶粘剂涂布量4g/m2;
(3)烘干:烘干箱长度22m,加热功率25kW,烘干温度75℃,进风机3台,排风机5台;
(4)复合低密度聚乙烯薄膜:采用热合工艺,热合温度155℃,热合时间2s,易氧化物≤1.3mL;
(5)熟化:熟化间空间尺10m×3m×3m,熟化功率12kW,熟化时间70h;
(6)分切,即得聚酯/低密度聚乙烯药用复合硬片。
实施例2
一种聚酯/低密度聚乙烯药用复合硬片,由0.2mm厚、600mm宽的聚酯片和0.03mm厚、605mm宽的低密度聚乙烯薄膜经双组分胶粘剂复合得到。
制备方法包括以下工序:
(1)聚酯片制备:将聚对苯二甲酸乙二酯通过真空吸料通入挤出机料斗,经平双螺杆挤出机塑化,各区加热温度为:1区185℃,2区225℃,3区250℃,4区255℃,5区260℃,再在260℃温度下经熔体计量泵计量挤出、180目自动换滤网过滤、衣架模头出片,在20℃温度下经三辊压光后,进行电晕处理,使其表面达因值≥38达因,得到聚酯片;
(2)涂布双组分胶粘剂:采用单头涂布机,双组分胶粘剂涂布量3g/m2;
(3)烘干:烘干箱长度22m,加热功率20kW,烘干温度65℃,进风机3台,排风机5台;
(4)复合低密度聚乙烯薄膜:采用热合工艺,热合温度150℃,热合时间3s,易氧化物≤1.3mL;
(5)熟化:熟化间空间尺10m×3m×3m,熟化功率15kW,熟化时间60h;
(6)分切,即得聚酯/低密度聚乙烯药用复合硬片。
实施例3
一种聚酯/低密度聚乙烯药用复合硬片,由0.3mm厚、900mm宽的聚酯片和0.05mm厚、905mm宽的低密度聚乙烯薄膜经双组分胶粘剂复合得到。
制备方法包括以下工序:
(1)聚酯片制备:将聚对苯二甲酸乙二酯通过真空吸料通入挤出机料斗,经平双螺杆挤出机塑化,各区加热温度为:1区185℃,2区225℃,3区250℃,4区255℃,5区260℃,再在260℃温度下经熔体计量泵计量挤出、180目自动换滤网过滤、衣架模头出片,在30℃温度下经三辊压光后,进行电晕处理,使其表面达因值≥38达因,得到聚酯片;
(2)涂布双组分胶粘剂:采用单头涂布机,双组分胶粘剂涂布量5g/m2;
(3)烘干:烘干箱长度22m,加热功率30kW,烘干温度85℃,进风机3台,排风机5台;
(4)复合低密度聚乙烯薄膜:采用热合工艺,热合温度160℃,热合时间1s,易氧化物≤1.3mL;
(5)熟化:熟化间空间尺10m×3m×3m,熟化功率10kW,熟化时间80h;
(6)分切,即得聚酯/低密度聚乙烯药用复合硬片。
对比例1
本对比例与实施例2的不同点仅在于,聚酯/低密度聚乙烯药用复合硬片中,聚酯片厚度为0.15mm。
对比例2
本对比例与实施例3的不同点仅在于,聚酯/低密度聚乙烯药用复合硬片中,聚酯片厚度为0.35mm。
将上述实施例和对比例制备的聚酯/低密度聚乙烯药用复合硬片进行性能测试,其中水蒸气通过量参照标准YBB 00092003-2015进行测试,氧气透过量参照标准YBB00082003-2015进行测试,热封强度参照标准YBB 00122003-2015进行测试(热封条件:155℃,1.5s)。
测试结果如表1所示。
表1
从表1可以看出,本发明实施例1-3制备的聚酯/低密度聚乙烯药用复合硬片阻隔性能好,热封成型性优异,满足10mL药用口服液灌装包装材料的要求;对比例1的聚酯片材厚度在0.20mm以下,手感强度差,热封成型性不好;对比例2的聚酯片材厚度0.30mm以上,热封成型性有所下降,且聚酯片材厚度的增加会增加生产成本。
Claims (9)
1.一种聚酯/低密度聚乙烯药用复合硬片,其特征在于:由0.2-0.3mm厚的聚酯片和0.03-0.05mm厚的低密度聚乙烯薄膜经双组分胶粘剂复合得到;所述聚酯片和低密度聚乙烯薄膜的表面达因值≥38达因;
聚酯片采用聚对苯二甲酸乙二酯材料,其特性粘度为0.80dl/g,熔融温度为245℃,二甘醇含量1.3wt.%,端羟基含量27mmol/kg;
低密度聚乙烯膜摩擦系数≤0.30,拉伸强度≥10MPa,断裂伸长率≥150%;
双组分胶粘剂25℃粘度为5000mPa.s,不挥发物≥64wt.%,色号80#。
2.根据权利要求1所述的聚酯/低密度聚乙烯药用复合硬片,其特征在于:聚酯片的宽度范围为600-900mm,低密度聚乙烯薄膜的宽度范围为605-905mm,聚酯片比低密度聚乙烯薄膜的宽度小5-10mm。
3.一种权利要求1或2所述的聚酯/低密度聚乙烯药用复合硬片的制备方法,其特征在于:包括以下工序:聚酯片制备→涂布双组分胶粘剂→烘干→复合低密度聚乙烯薄膜→熟化→分切。
4.根据权利要求3所述的聚酯/低密度聚乙烯药用复合硬片的制备方法,其特征在于:聚酯片制备工序为:将聚对苯二甲酸乙二酯通过真空吸料通入挤出机料斗,经平双螺杆挤出机塑化,再经熔体计量泵计量挤出、过滤、模头出片、三辊压光后,进行电晕处理,使其表面达因值≥38达因,得到聚酯片。
5.根据权利要求4所述的聚酯/低密度聚乙烯药用复合硬片的制备方法,其特征在于:平双螺杆挤出机塑化时,各区加热温度为:1区180-185℃,2区220-225℃,3区245-250℃,4区255-260℃,5区260-265℃;
熔体计量泵挤出、过滤、模头出片温度均为260-265℃,三辊压光温度为20-30℃。
6.根据权利要求3所述的聚酯/低密度聚乙烯药用复合硬片的制备方法,其特征在于:涂布双组分胶粘剂工序中,采用单头涂布机,双组分胶粘剂涂布量3-5g/m2。
7.根据权利要求3所述的聚酯/低密度聚乙烯药用复合硬片的制备方法,其特征在于:烘干工序中,加热功率20-30kW,烘干温度65-85℃。
8.根据权利要求3所述的聚酯/低密度聚乙烯药用复合硬片的制备方法,其特征在于:复合低密度聚乙烯薄膜工序中,采用热合工艺,热合温度150-160℃,热合时间1-3s,易氧化物≤1.3mL;
熟化工序中,熟化功率10-15kW,熟化时间60-80h。
9.一种权利要求1或2所述的聚酯/低密度聚乙烯药用复合硬片的应用,其特征在于:用于药用口服液灌装包装材料。
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CN1197818A (zh) * | 1997-02-26 | 1998-11-04 | 东丽株式会社 | 聚酯薄膜及其制造方法 |
CN104476881A (zh) * | 2014-12-23 | 2015-04-01 | 祁阳五洲医药包装有限公司 | 一种聚酯/低密度聚乙烯包装用复合膜及其制备方法 |
CN106183301A (zh) * | 2016-08-26 | 2016-12-07 | 南通惠得成包装材料有限公司 | 一种耐酸、耐碱腐蚀的硬片 |
KR20180088077A (ko) * | 2017-01-26 | 2018-08-03 | 양재형 | 적층시트로 이루어진 포장지 및 이의 제조방법 |
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BE604778A (zh) * | 1960-06-09 | 1961-12-08 | ||
CN1197818A (zh) * | 1997-02-26 | 1998-11-04 | 东丽株式会社 | 聚酯薄膜及其制造方法 |
CN104476881A (zh) * | 2014-12-23 | 2015-04-01 | 祁阳五洲医药包装有限公司 | 一种聚酯/低密度聚乙烯包装用复合膜及其制备方法 |
CN106183301A (zh) * | 2016-08-26 | 2016-12-07 | 南通惠得成包装材料有限公司 | 一种耐酸、耐碱腐蚀的硬片 |
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