CN111907923A - 一种固体药用复合包装材料 - Google Patents
一种固体药用复合包装材料 Download PDFInfo
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- 239000011091 composite packaging material Substances 0.000 title claims abstract description 26
- 229940126589 solid medicine Drugs 0.000 title claims description 6
- 239000010410 layer Substances 0.000 claims abstract description 106
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims abstract description 57
- 229910052782 aluminium Inorganic materials 0.000 claims abstract description 57
- 239000011888 foil Substances 0.000 claims abstract description 34
- 239000002131 composite material Substances 0.000 claims abstract description 27
- 239000004952 Polyamide Substances 0.000 claims abstract description 22
- 229920002647 polyamide Polymers 0.000 claims abstract description 22
- 239000007787 solid Substances 0.000 claims abstract description 20
- 238000013329 compounding Methods 0.000 claims abstract description 19
- 239000004800 polyvinyl chloride Substances 0.000 claims abstract description 18
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- 238000002161 passivation Methods 0.000 claims description 44
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- 239000002253 acid Substances 0.000 claims description 6
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- 229920000178 Acrylic resin Polymers 0.000 claims description 5
- 239000003109 Disodium ethylene diamine tetraacetate Substances 0.000 claims description 5
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims description 5
- 239000011248 coating agent Substances 0.000 claims description 5
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- 235000019301 disodium ethylene diamine tetraacetate Nutrition 0.000 claims description 5
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- -1 rare earth metal salt Chemical class 0.000 claims description 5
- 238000004513 sizing Methods 0.000 claims description 4
- 229910000667 (NH4)2Ce(NO3)6 Inorganic materials 0.000 claims description 2
- 229910004664 Cerium(III) chloride Inorganic materials 0.000 claims description 2
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- BLRPTPMANUNPDV-UHFFFAOYSA-N Silane Chemical compound [SiH4] BLRPTPMANUNPDV-UHFFFAOYSA-N 0.000 description 1
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- 231100000315 carcinogenic Toxicity 0.000 description 1
- HSJPMRKMPBAUAU-UHFFFAOYSA-N cerium nitrate Inorganic materials [Ce+3].[O-][N+]([O-])=O.[O-][N+]([O-])=O.[O-][N+]([O-])=O HSJPMRKMPBAUAU-UHFFFAOYSA-N 0.000 description 1
- 229910000355 cerium(IV) sulfate Inorganic materials 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000011162 core material Substances 0.000 description 1
- 230000007123 defense Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
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- 238000009826 distribution Methods 0.000 description 1
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- 239000005003 food packaging material Substances 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
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- 244000005700 microbiome Species 0.000 description 1
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- 231100000252 nontoxic Toxicity 0.000 description 1
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- 229920006280 packaging film Polymers 0.000 description 1
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- 150000003839 salts Chemical class 0.000 description 1
- 229910000077 silane Inorganic materials 0.000 description 1
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- 239000010959 steel Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D65/00—Wrappers or flexible covers; Packaging materials of special type or form
- B65D65/38—Packaging materials of special type or form
- B65D65/40—Applications of laminates for particular packaging purposes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B15/00—Layered products comprising a layer of metal
- B32B15/04—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B15/08—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
- B32B15/088—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin comprising polyamides
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B15/00—Layered products comprising a layer of metal
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- B32B15/08—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
- B32B15/09—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin comprising polyesters
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B15/00—Layered products comprising a layer of metal
- B32B15/20—Layered products comprising a layer of metal comprising aluminium or copper
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B33/00—Layered products characterised by particular properties or particular surface features, e.g. particular surface coatings; Layered products designed for particular purposes not covered by another single class
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
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Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
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Abstract
本发明涉及一种固体药用复合包装材料,所述的复合包装材料包括多层冷成型铝复合硬片和热封层,其中所述的多层冷成型铝复合硬片由聚酰胺层、铝箔层、聚酰胺层和聚氯乙烯层依次复合而成,所述的热封层依次包括聚酯层、铝箔层、VC胶水层。本发明的固体药用复合包装材料具有较好的表面张力、耐腐蚀、抗穿刺、延展性、密封性等。
Description
技术领域
本发明涉及药用包装领域,尤其涉及了一种固体药用复合包装材料。
背景技术
“药品”作为一种用于预防和治疗疾病的特殊商品,与患者的生命安全息息相关,其质量容不得半点差错。作为药品生产的最后一道防线,药用包装材料作用尤为重要,一方面由于药包材有可能带来细菌和其它微生物,包材中的某些有害物质能被药品溶出而造成药品污染。另外一方面药品中的有些成分能在包装存放过程中被包装材料吸附,或与包装材料发生反应,而直接影响了药品质量或用药剂量,所以药品包装对药品有着不可估量的重要性,特别是直接接触药物的一类包材显得更为重要。
作为常用的药用包装材料——聚酰胺/铝/聚氯乙烯冷冲压成型固体药用复合硬片(opa/al/pvc)包装材料是近几年成熟发展的高档药品、食品包装材料,如中国专利(公开号CN203046365U)公开的一种聚酰胺/铝/聚氯乙烯冷冲压成型固体药用复合硬片,该复合硬片由聚酰胺层、铝箔层和聚氯乙烯层依次复合而成。这种复合硬片易成型为不同形状的泡罩,具有极好的致密性能,能完全隔绝水蒸气、氧气、紫外线,保香性能甚佳,是高档药品、食品包装目前不可替代的材料,但投入市场显现出几个缺点:易穿刺、拉伸性不高,儿童误食安全差。伴随着药品的市场的发放,仿制药的增加,这种老式样包装材料在,在密封性,延展性和成型效果上已经远远不能满足新的仿制药和全自动包装设备的要求。
另外,从我国目前医药工业的统计数据上看,现阶段我国的药品铝箔包材产业在发展和新材料研发方面与欧美、日本等发达国家还是有相当大的差距,大致相当于发达国家十年前的水平,对医药行业的贡献不到20%,欧美发达国家目前已经超过40%。造成以上差距的主要原因:首先是我国制药行业长期以中成药为主,其包装箱单简单且水平较低,西药领域基本以仿制药为主,仿制药的附加值又相对较低,所以制药企业在包装上因考虑其成本因素不愿意过多的投入,从而制约了整个医药包材产业的发展。从当前国家医药包装市场发展的态势来看,主要是以高速度、高效益、低消耗、精细化的方向发展,而现阶段我国的医药包材市场还是粗放型市场,相对国际医药包材市场还有很大的差距。其次因受国家医药体质的限制,加之医药包材企业往往是规模小数量多,同类产品同质化严重,从而形成市场的恶性竞争,所以医药包材在生产设备工艺改进、投入及新材料的研发上相当滞后,影响了整个行业的发展。
随着我国医疗体质改革的不断深入,目前医药包装落后的局面将会得到实质性的转变,医药的包装业也将出现新的局面,目前,国内很多企业也在不断引进和更新包装机械及材料,此外,随着国家加大在创新药方面的投入,药品种类的多元化也会给药品的包装业带来契机。从国际包装协会对我国医药包装的预测判断和目前医药市场的发展综合分析,未来几年将是医药的包装发展的黄金阶段,作为药用包装材料的核心材料——铝箔(因为是各种金属合成,也叫铝合金)扮演者非常重要的作用,不仅要起着阻隔氧气、水汽、太阳光线等作用,还需确保在酸、碱性环境中有着很好的耐腐蚀功能、表面张力,根据国内外各研究机构的研究,钝化处理能极大提升其耐腐蚀及物理性能(包括耐疲劳、拉伸、表面张力等性能),而现如今,铬酸盐钝化处理可形成铬/基体金属的混合氧化物膜层,膜层中的铬主要以三价铬和六价铬形式存在,三价铬作为骨架,而六价铬则具有自修复作用,因而对耐蚀性很高,由于铬酸盐成本低廉,使用方便,因而铬酸盐钝化处理在钢铁、药用包装、航空电子等领域得到了广泛应用。但铬酸盐中六价铬毒性高且易致癌,随着人们对环保意识的增强,含六价铬废料的排放收到了严格的限制,部分发达国家的企业已陆续开发低毒性的无铬钝化工艺,希望能替代铬酸盐钝化。所以研究和开发铝合金环境友好型无铬钝化工艺对我国生态环境的保护、打破发达国家的技术壁垒、提高国际市场的竞争力,具有显著的经济效益和深远的社会意义,目前无铬钝化处理技术在使用上都有一定的局限性,尤其是他们的防腐性能较差,而有较好发展潜力的无铬钝化处理技术如稀土金属盐钝化等,都存在一系列的问题,如:(1)处理时间较长,这会给实际应用带来很大困难,生产周期过长会增加成本,对工业化推广极为不利;(2)几种钝化处理技术的成膜主盐价格十分昂贵,配方成本过高;(3)现提出的工艺处理多数需要高温且步骤复杂,难以维护;(4)有机物钝化如硅烷等属易燃溶剂,且会改变零件的尺寸和导电导热性能。虽然无铬钝化处理技术存在着上述问题,但无铬钝化无疑是环保型钝化发展的方向,仍需要继续努力,不断克服困难,使其能够真正提到铬成为绿色钝化。
另外为了更好的发挥药用包装薄膜的性能,需要铝箔与内外层不同材料的张力要好,不能轻易的分层,就需要对其整体材料进行电晕等处理。
随着人们对环境保护意识的增强,研究和开发无毒或低毒的物质以替代铬酸盐钝化工艺具有重要的意义和良好的前景,因此无铬钝化无疑是发展的方向。
发明内容
本发明的目的在于针对现有技术中存在的问题,提供一种耐腐蚀、抗穿刺、延展性好、密封性好的固体药用复合包装材料。
为了解决上述技术问题,本发明通过下述技术方案得以解决:一种固体药用复合包装材料,所述的复合包装材料包括多层冷成型铝复合硬片和热封层,其中所述的多层冷成型铝复合硬片由聚酰胺层、铝箔层、聚酰胺层和聚氯乙烯层依次复合而成,所述的热封层依次包括聚酯层、铝箔层、VC胶水层。
本发明多层冷成型铝复合硬片通过复合增加一层opa复合,不仅使整个成品的延展性大大提高(opa是具有较强的延展效果来弥补铝箔锻压的不足),同时这种四层复合的设计避免了opa这种材料容易吸潮的缺点。通过让opa复合到al和pvc中间去,这样opa不接触空气中的水分。目前ptp铝箔国内现在的工艺是先用油墨做印刷,在加一层保护层,这样又容易导致油墨对铝箔的侵蚀,会对药品有一定的影响,同时因为铝箔的柔韧性问题,上面的印刷的色彩也不够鲜艳。本发明现在使用pet/al/vc,在pet上面做印刷,再用PET和铝箔复合,用pet的高阻隔性提高产品的密封性,减少油墨对铝箔侵蚀,降低对药品的影响,同时利用pet的抗皱性和包形性来提高成品的可塑性和避免儿童对药品的误扣误食。
作为优选,多层冷成型铝复合硬片中的聚酰胺层的厚度均为0.01-0.04mm,铝箔层的厚度为0.045-0.08mm,聚氯乙烯层的厚度为0.04-0.08mm。
作为优选,热封层中的聚酯层的厚度为0.04-0.08mm,铝箔层的厚度0.01-0.042mm。
作为优选,多层冷成型铝复合硬片以及热封层中各种膜层在复合时均包括钝化处理与电晕处理。
聚酰胺/铝/聚酰胺/聚氯乙烯冷冲压成型固体药用复合硬片(OPA/AL/OPA/PVC);在复合时通过钝化与电晕处理工艺,改善产品的面表的张力、防腐性能、抗穿刺、拉伸性、耐疲劳等性能。通过复合增加一层opa复合,不仅使整个成品的延展性大大提高(opa是具有较强的延展效果来弥补铝箔锻压的不足),同时这种四层复合的设计避免了opa这种材料容易吸潮的缺点,通过让opa复合到al和pvc中间去,这样opa不接触空气中的水分。热封层在复合时通过钝化与电晕处理工艺提高产品高阻隔性,同时利用pet的抗皱性和包形性来提高成品的可塑性和避免儿童对药品的误扣误食。
进一步优选,钝化处理的钝化液为稀土金属盐10-15%,NaOH0.8-1.5%,氟锆酸0.5-1.0%,羟甲基纤维素0.12-0.25%,水性丙烯酸树脂1.2-2.2%,乙二胺四乙酸二钠0.2-0.4%,余量为水。
再进一步优选,稀土金属盐为CeCl3、Ce(NO3)3、Ce(SO4)2、(NH4)2Ce(NO3)6中的一种或多种。
进一步优选,钝化处理的温度为40-60℃。
进一步优选,钝化处理中的涂布上胶量为2-5g/m2。
作为优选,复合时的复合压力为2.2-3.6kg/cm2。
作为优选,铝箔电晕处理的参数电流是5-6安培,其他层的电晕处理电流是2-4安培。铝箔处理前和处理后的表面张力分别为54何64。opa处理前的表面张力为52-54,处理后的表面张力为60-62。pet处理前的表面张力为54,处理后的表面张力为60-62,pvc处理前和处理后的表面张力分别为38和50-54。
与现有技术相比,本发明的固体药用复合包装材料具有较好的表面张力、耐腐蚀、抗穿刺、延展性、密封性等。
具体实施方式
下面结合实施例对本发明作进一步详细描述。
实施例1
一种固体药用复合包装材料,所述的复合包装材料包括多层冷成型铝复合硬片和热封层,其中所述的多层冷成型铝复合硬片由聚酰胺层、铝箔层、聚酰胺层和聚氯乙烯层依次复合而成,所述的热封层依次包括聚酯层、铝箔层、VC胶水层。多层冷成型铝复合硬片中的聚酰胺层的厚度均为0.02mm,铝箔层的厚度为0.06mm,聚氯乙烯层的厚度为0.06mm;热封层中的聚酯层的厚度为0.06mm,铝箔层的厚度0.022mm。多层冷成型铝复合硬片以及热封层中各种膜层在复合时均包括钝化处理与电晕处理。钝化处理的温度为50℃;钝化处理中的涂布上胶量为3.5g/m2;钝化处理的钝化液的组分及其质量百分比为CeCl3 6%,Ce(NO3)36%,NaOH1.2%,氟锆酸0.8%,羟甲基纤维素0.18%,水性丙烯酸树脂1.6%,乙二胺四乙酸二钠0.25%,余量为水。复合时的复合压力为2.8kg/cm2。铝箔电晕处理参数电流是5安培,其他层的电晕处理电流是2安培。
实施例2
一种固体药用复合包装材料,所述的复合包装材料包括多层冷成型铝复合硬片和热封层,其中所述的多层冷成型铝复合硬片由聚酰胺层、铝箔层、聚酰胺层和聚氯乙烯层依次复合而成,所述的热封层依次包括聚酯层、铝箔层、VC胶水层。多层冷成型铝复合硬片中的聚酰胺层的厚度均为0.025mm,铝箔层的厚度为0.052mm,聚氯乙烯层的厚度为0.05mm;热封层中的聚酯层的厚度为0.05mm,铝箔层的厚度0.03mm。多层冷成型铝复合硬片以及热封层中各种膜层在复合时均包括钝化处理与电晕处理。钝化处理的温度为45℃;钝化处理中的涂布上胶量为4g/m2;钝化处理的钝化液的组分及其质量百分比为CeCl38%,Ce(SO4)25%,NaOH0.9%,氟锆酸0.8%,羟甲基纤维素0.15%,水性丙烯酸树脂2.0%,乙二胺四乙酸二钠0.22%,余量为水。复合时的复合压力为3.3kg/cm2。铝箔电晕处理参数电流是5安培,其他层的电晕处理电流是4安培。
实施例3
一种固体药用复合包装材料,所述的复合包装材料包括多层冷成型铝复合硬片和热封层,其中所述的多层冷成型铝复合硬片由聚酰胺层、铝箔层、聚酰胺层和聚氯乙烯层依次复合而成,所述的热封层依次包括聚酯层、铝箔层、VC胶水层。多层冷成型铝复合硬片中的聚酰胺层的厚度均为0.015mm,铝箔层的厚度为0.06mm,聚氯乙烯层的厚度为0.045mm;热封层中的聚酯层的厚度为0.042mm,铝箔层的厚度0.035mm。
多层冷成型铝复合硬片以及热封层中各种膜层在复合时均包括钝化处理与电晕处理。钝化处理的温度为60℃;钝化处理中的涂布上胶量为5g/m2;钝化处理的钝化液的组分及其质量百分比为CeCl310%,NaOH1.5%,氟锆酸0.6%,羟甲基纤维素0.25%,水性丙烯酸树脂1.5%,乙二胺四乙酸二钠0.4%,余量为水。复合时的复合压力为2.2kg/cm2。铝箔电晕处理参数电流是6安培,其他层的电晕处理电流是2安培。
本发明实施例1-3固体药用复合包装材料的性能测试结果如表1所示。
表1
综上所述,本发明的固体药用复合包装材料具有较好的表面张力、耐腐蚀、抗穿刺、延展性、密封性等。
本文中所描述的具体实施例仅仅是对本发明精神作举例说明,并不用于限定本发明的保护范围。本发明所属技术领域的技术人员可以对所描述的具体实施例做各种各样的修改或补充或采用类似的方式替代,但并不会偏离本发明的精神或者超越所附权利要求书所定义的范围。
Claims (10)
1.一种固体药用复合包装材料,其特征在于,所述的复合包装材料包括多层冷成型铝复合硬片和热封层,其中所述的多层冷成型铝复合硬片由聚酰胺层、铝箔层、聚酰胺层和聚氯乙烯层依次复合而成,所述的热封层依次包括聚酯层、铝箔层、VC胶水层。
2.据权利要求1所述的固体药用复合包装材料,其特征在于,多层冷成型铝复合硬片中的聚酰胺层的厚度均为0.01-0.04mm,铝箔层的厚度为0.045-0.08mm,聚氯乙烯层的厚度为0.04-0.08mm。
3.根据权利要求1所述的固体药用复合包装材料,其特征在于,热封层中的聚酯层的厚度为0.04-0.08mm,铝箔层的厚度0.01-0.042mm。
4.根据权利要求1所述的固体药用复合包装材料,其特征在于,多层冷成型铝复合硬片以及热封层中各种膜层在复合时均包括钝化处理与电晕处理。
5.根据权利要求4所述的固体药用复合包装材料,其特征在于,钝化处理的钝化液为稀土金属盐10-15%,NaOH0.8-1.5%,氟锆酸0.5-1.0%,羟甲基纤维素0.12-0.25%,水性丙烯酸树脂1.2-2.2%,乙二胺四乙酸二钠0.2-0.4%,余量为水。
6.根据权利要求5所述的固体药用复合包装材料,其特征在于,稀土金属盐为CeCl3、Ce(NO3)3、Ce(SO4)2、(NH4)2Ce(NO3)6中的一种或多种。
7.根据权利要求4所述的固体药用复合包装材料,其特征在于,钝化处理的温度为40-60℃。
8.根据权利要求4所述的固体药用复合包装材料,其特征在于,钝化处理中的涂布上胶量为2-5g/m2。
9.根据权利要求4所述的固体药用复合包装材料,其特征在于,复合时的复合压力为2.2-3.6kg/cm2。
10.根据权利要求4所述的固体药用复合包装材料,其特征在于,铝箔电晕处理的参数电流是5-6安培,其他层的电晕处理电流是2-4安培。
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CN110670058A (zh) * | 2019-11-08 | 2020-01-10 | 东莞市精诚环保科技有限公司 | 一种无铬钝化剂 |
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