CN105619981A - Medical packing easy-to-tear-off film and preparation method thereof - Google Patents

Medical packing easy-to-tear-off film and preparation method thereof Download PDF

Info

Publication number
CN105619981A
CN105619981A CN 201510976659 CN201510976659A CN105619981A CN 105619981 A CN105619981 A CN 105619981A CN 201510976659 CN201510976659 CN 201510976659 CN 201510976659 A CN201510976659 A CN 201510976659A CN 105619981 A CN105619981 A CN 105619981A
Authority
CN
Grant status
Application
Patent type
Prior art keywords
layer
medical
ethylene
film
heat seal
Prior art date
Application number
CN 201510976659
Other languages
Chinese (zh)
Other versions
CN105619981B (en )
Inventor
王光华
程立坤
刘子明
徐小明
Original Assignee
湖北恒泰橡塑有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/06Layered 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
    • B32B27/08Layered 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 of synthetic resin
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/30Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/306Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl acetate or vinyl alcohol (co)polymers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/32Layered products comprising a layer of synthetic resin comprising polyolefins
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/36Layered products comprising a layer of synthetic resin comprising polyesters
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00Layers arrangement
    • B32B2250/033 layers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/30Properties of the layers or laminate having particular thermal properties
    • B32B2307/306Resistant to heat
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/30Properties of the layers or laminate having particular thermal properties
    • B32B2307/31Heat sealable
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/40Properties of the layers or laminate having particular optical properties
    • B32B2307/412Transparent
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00Properties of the layers or laminate
    • B32B2307/50Properties of the layers or laminate having particular mechanical properties
    • B32B2307/546Flexural strength; Flexion stiffness
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00Containers; Receptacles
    • B32B2439/80Medical packaging

Abstract

The invention discloses a medical packing easy-to-tear-off film and a preparation method thereof. The medical packing easy-to-tear-off film comprises four layers of structures from inside to outside: a thermal bonding layer, a structural layer, an adhesive layer and an outer layer, wherein the thermal bonding layer is prepared from mixed resin consisting of medical-level polyethylene, ethylene-vinyl acetate and ethylene-methyl acrylate; the structural layer is prepared from medical-level polyethylene; the adhesive layer is prepared from maleic anhydride modified ethylene-octene copolymer; the outer layer is prepared from a polyester elastomer. The medical packing easy-to-tear-off film disclosed by the invention can realize sterilization using high-temperature steam at 121 to 135 DEG C or gamma-ray irradiation, and can be stored under the temperature lower than minus 25 DEG C. Furthermore, the film is good in transparency, less in migration separates and good in medicament compatibility, is extremely high in easy-to-tear-off property, and can meet the performance requirement on medical packing, so that the convenience and the safety of medicament taking by a patient are improved.

Description

一种医用包装易揭膜及其制备方法 A medical packaging easily removing film and preparation method

技术领域 FIELD

[0001] 本发明涉及医用包装材料的技术领域,更具体地是指一种医用包装易揭膜及其制备方法。 [0001] The present invention relates to the field of medical packaging materials, more specifically, refers to a medical packaging easily removing film and its preparation method.

背景技术 Background technique

[0002] 医用包装膜具有较大的市场潜力,而药品、医疗器械对包装膜的要求较高,其不仅需要保证膜的柔韧性、阻隔性、透明性等,还要考虑其在消毒和储存环境中确保内容物稳定,不会产生有毒有害物质迀移吸附影响安全性能。 [0002] Medical packaging film having a large market potential, and drugs and medical devices require a higher packaging film, which involves not only the flexibility of the film, barrier property, transparency and the like, but also their sterilization and storage environment to ensure that the contents of the stable, does not produce toxic and hazardous substances Gan shift adsorption affect safety performance. 基于此,人们正积极研究各种用于药品、医疗器械包装的新型包装材料,以满足医用包装在性能上各方面和多层次的苛刻要求。 Based on this, we are actively studying new packaging materials for a variety of medicines, medical equipment packaging, medical packaging in order to meet the demanding requirements of multi-level and all aspects of the performance.

[0003] 以往,人们在日常使用过程中,常发现商品包装袋很难打开,或在一些杯体包装中盖膜与杯体都是"死封",很难将盖膜从杯体上揭开等,诸如此类的情形给消费者带来诸多不便。 [0003] In the past, people in their daily use, often found difficult to open bags of goods, or the film and the cup are "dead letters" in a number of cup packaging, it is difficult to expose the cover film from the cup open and so on, like the case of inconvenience to consumers. 而近年来生产厂家都慢慢关注此问题,产品包装越来越人性化,因此易开启包装也成为了软包装行业的研究方向。 In recent years manufacturers have slowly Watch this problem, product packaging more user-friendly, easy-open packaging therefore also become research flexible packaging industry. 根据开启方式不同,易开启包装分易撕型与易揭型。 Depending on the way open, easy tear open the package type and sub-type easy to expose. 易撕型主要通过在包装袋上打撕裂口、撕裂线或易撕复合膜的方式来实现,而易揭包装主要是控制包装材料的热合强度,使得包装材料热合后既能起到密封的效果,又能通过适当的力破坏热合层将其揭开。 After the tear-type is mainly achieved by hitting the bag mouth tear, tear line, or a composite film easily tearable manner, easily exposing the packaging is mainly controlled heat seal strength packaging material, the packaging material such that the sealing functions both heat effect, but also to destroy the heat seal layer which is opened by an appropriate force.

[0004] 当前,国内外医用包装易揭膜生产方法主要有:干式复合、无溶剂复合、多层共挤挤出等。 [0004] Currently, domestic and medical packaging easily removing film production methods are: dry compound, solvent-free compound, a multilayer co-extrusion and the like. 干式复合是目前国内应用最多的一种复合方式,其工艺的特点是操作简单,层间搭配也灵活多样,但其最大的缺陷是热合层容易被胶粘剂渗出污染,造成热合强度稳定性差, 另胶粘剂中的有机溶剂难以去除,容易出现溶剂残留超标的情况,并且浪费能源,干燥的废气和有机溶剂挥发也会污染环境。 Dry compound is currently the most widely used in a composite manner, which process is characterized by simple operation, interlayer matching is also flexible, but its biggest drawback is the heat seal layer is easily adhesive bleeding contaminated, resulting in poor heat seal strength stability, another adhesive is difficult to remove the organic solvent, where the solvent residues prone to excessive, and waste of energy, the drying gas and volatilize the organic solvent will pollute the environment. 无溶剂复合的生产过程中无溶剂残留,废气排放少污染环境小,但因为主剂和固化剂的比例控制不稳定,生产工艺条件复杂、成本高、层间剥离力小等诸多因素没有得到广泛应用。 Solvent-free compound in the production process no solvent residue, low environmental pollution emissions small, but the ratio of the main agent and a curing agent unstable control, complicated production process conditions, high cost, and small interlayer peel strength and many other factors have not been widely application. 目前最有前景的多层共挤挤出方法,它是采用三台以上的挤出机,将不同功能的树脂原料如尼龙(PA)、聚乙烯(PE)、聚丙烯(PP)等分别熔融挤出, 通过各自的流道在模头处共挤汇合,再经过流延拉伸或吹胀成型,冷却共挤在一起。 The most promising multilayer co-extrusion method, which use three or more extruders, the molten resin material are different functions such as nylon (PA), polyethylene (PE), polypropylene (PP), etc. extruded, co-extruded through the respective flow channels merge at the die, and then after casting or stretch blow molding, coextrusion with cooling. 多层共挤包装膜不仅能够很好满足各种医用包装的需要,具有干式复合膜无法比拟的优点,还可以灵活设计出不同性能的薄膜,易于调整热合层材料,满足不同包装的需求。 Multilayer coextruded packaging film not only able to meet the needs of various medical packaging, has the advantage of a dry composite membrane can not be compared, but also the flexibility properties of thin films having different design, easy to adjust the heat seal layer material, different packaging needs. 但目前国内外共挤医用包装易揭膜结构和材料选择不合理,存在如下缺点: But at home and abroad easily removing film coextruded medical packaging structure and material selection unreasonable, the following disadvantages:

[0005] (1)以聚丙烯(PP)为主体结构不能满足小于_25°C低温储存和γ射线辐照灭菌,容易造成低温脆化和辐照裂解,不利于人体的健康。 [0005] (1) polypropylene (PP) as the main structure does not meet the low temperature storage is less than _25 ° C and γ-ray irradiation sterilization, and likely to cause low temperature irradiation embrittlement cracking, is not conducive to human health.

[0006] (2)以聚乙烯(PE)为主体结构不能满足121~135°C,30min高温蒸汽灭菌技术要求,聚乙烯(PE)熔点低、耐高温性能差,经高温蒸汽灭菌后容易产生收缩和皱折。 [0006] (2) of polyethylene (PE) as a main structure can not satisfy 121 ~ 135 ° C, 30min technical requirements of high temperature steam sterilization, polyethylene (PE) low melting point and poor high temperature performance, high temperature steam sterilized prone to shrinkage and wrinkling.

[0007] (3)以尼龙(PA)、聚乙烯(PE)或聚丙烯(PP)为主体结构,尼龙(PA)作为表层在高温蒸汽灭菌时,尼龙(PA)灭菌后吸水容易出现白化现象,透光率低、雾度大,存在用药安全风险;在γ射线辐照灭菌时,尼龙(PA)中酰胺键容易断裂,导致膜材表面褐化及膜材溶出物增加,这些物质容易迀移到包装物中或被包装物吸附。 [0007] (3) nylon (PA), polyethylene (PE) or polypropylene (PP) as the main structure, nylon (PA) as a surface layer at a high temperature steam sterilization, nylon (PA) is prone to water absorption after sterilization whitening phenomenon, low light transmittance, haze is large, there is a risk of drug safety; when γ ray irradiation sterilization, nylon (PA) in the amide bond is easily broken, resulting in browning and membrane surface membrane eluted matter increases, these Gan substances that can move in the packaging or wrapper adsorption.

发明内容 SUMMARY

[0008] 本发明的目的就是要提供一种医用包装易揭膜及其制备方法。 [0008] The object of the present invention is to provide a medical package easily removing film and its preparation method. 该医用包装易揭膜不仅可以采用121~135°C高温蒸汽或γ射线辐照灭菌,还可以在低于-25°C条件下储存。 The medical packaging may be employed not only easily removing film 121 ~ 135 ° C high temperature steam or γ-ray irradiation sterilization, can also be stored in conditions below -25 ° C. 此外,膜材透明度好,迀移析出物少,药物相容性优良,而且具有极佳的易揭性,能够满足医用包装的性能要求,提高病人用药的方便性和安全性。 Furthermore, good transparency membrane, Gan shift less precipitate was excellent pharmaceutical compatibility, and has excellent properties easy to expose, to meet the performance requirements of medical packaging, to improve the convenience and safety for the patient medication.

[0009] 为实现上述目的,本发明提供的一种医用包装易揭膜,它包括四层结构,从内至外依次为:热合层、结构层、粘合层、外层;其中,所述热合层由医用级的聚乙烯、乙烯_乙酸乙烯酯和乙烯-丙烯酸甲酯组成的混合树脂构成;所述结构层由医用级的聚乙烯构成;所述粘合层由马来酸酐改性乙烯辛烯共聚物构成;所述外层由聚酯弹性体构成。 [0009] To achieve the above object, the present invention provides a medical package easily removing film, four-layer structure comprising, from inside to outside as follows: heat seal layer, a structural layer, an adhesive layer, an outer layer; wherein said heat seal layer of a medical grade polyethylene, ethylene-vinyl acetate and ethylene _ - a mixed resin constituting methacrylate; the structural layer is composed of a medical grade polyethylene; the adhesive layer of maleic anhydride-modified ethylene octene copolymer; the outer layer comprises a polyester elastomer.

[0010] 进一步地,所述热合层的原料按重量百分数计包括:聚乙烯30~80%、乙烯-乙酸乙烯酯10~40%、乙烯-丙烯酸甲酯10~30%。 [0010] Further, the material of the heat seal layer comprising in weight percent: 30 to 80% polyethylene, ethylene - vinyl acetate 10% to 40%, ethylene - methyl acrylate 10 to 30%.

[0011]作为优选方案地,所述热合层的原料按重量百分数计包括:聚乙烯50~70%、乙烯-乙酸乙烯酯15~25%、乙烯-丙烯酸甲酯15~25%。 [0011] As a preferred embodiment, the material of the heat seal layer comprising in weight percent: 50 to 70% polyethylene, ethylene - 15 to 25% vinyl acetate, ethylene - methyl acrylate 15 to 25%.

[0012]进一步地,所述热合层中聚乙稀的恪体流动指数为0.5~10g/10min,恪点为80~ 120°C,密度为0.89~0.94g/cm3;所述热合层中乙烯-乙酸乙烯酯的熔体流动指数为0.5~ 5g/10min,其中,乙酸乙稀酯含量为5~30% ;所述热合层中乙稀-丙稀酸甲酯的恪体流动指数为0.5~10g/10min,其中,丙烯酸甲酯含量为10~35%。 [0012] Further, the heat seal layer of polyethylene Verified flow index of 0.5 ~ 10g / 10min, Ke point of 80 ~ 120 ° C, a density of 0.89 ~ 0.94g / cm3; the heat seal layer of ethylene - vinyl acetate melt flow index of 0.5 ~ 5g / 10min, wherein the ethylene acid acetate content of 5 to 30%; the heat seal layer, ethylene - acrylic ester thereof Verified flow index of from 0.5 to 10g / 10min, wherein the methyl acrylate content of 10 to 35%.

[0013]作为优选方案地,所述热合层中聚乙稀的恪体流动指数为1~5g/10min,恪点为90 ~115°C,密度为0.90~0.93gg/cm3;所述热合层中乙烯-乙酸乙烯酯的熔体流动指数为1~ 3g/10min,其中,乙酸乙稀酯含量为8~25% ;所述热合层中乙稀-丙稀酸甲酯的恪体流动指数为2~8g/10min,其中,丙烯酸甲酯含量为15~30%。 [0013] As a preferred embodiment, the heat sealing layer of LDPE Verified flow index of 1 ~ 5g / 10min, Ke point of 90 ~ 115 ° C, a density of 0.90 ~ 0.93gg / cm3; the heat seal layer ethylene - vinyl acetate melt index of 1 ~ 3g / 10min, wherein the ethylene acid acetate content of 8 to 25%; the heat seal layer, ethylene - acrylic ester thereof Verified flow index 2 ~ 8g / 10min, wherein the methyl acrylate content of 15 to 30%.

[0014]进一步地,所述结构层中聚乙稀的恪体流动指数为0.3~8g/10min,恪点为90~ 125°C,密度为0.89 ~0.96g/cm3〇 [0014] Furthermore, the structural layer of polyethylene Verified flow index of 0.3 ~ 8g / 10min, Ke point of 90 ~ 125 ° C, a density of 0.89 ~ 0.96g / cm3〇

[0015]作为优选方案地,所述结构层中聚乙稀的恪体流动指数为0.5~5g/10min,恪点为95 ~115。 [0015] As a preferred embodiment, the structural layer of polyethylene Verified flow index of 0.5 ~ 5g / 10min, Ke point of 95 to 115. (:,密度为0.90~0.948/〇113〇 (:, A density of 0.90 to 0.948 / 〇113〇

[0016] 进一步地,所述粘合层中马来酸酐改性乙烯辛烯共聚物的熔体流动指数为0.3~ 10g/10min,熔点为45~95°C,其中,马来酸酐含量为0.1~3%,密度为0.85~0.90g/cm 3。 [0016] Further, the adhesive layer has a melt flow index of maleic anhydride-modified ethylene-octene copolymer is 0.3 ~ 10g / 10min, a melting point of 45 ~ 95 ° C, wherein the maleic anhydride content is 0.1 to 3%, a density of 0.85 ~ 0.90g / cm 3.

[0017] 作为优选方案地,所述粘合层中马来酸酐改性乙烯辛烯共聚物的熔体流动指数为0· 5~5g/10min,熔点为50~75°C,其中,马来酸酐含量为0 ·3~1 · 5%,密度为0·86~0·88g/ cm3。 [0017] As a preferred embodiment, the adhesive layer has a melt flow index of maleic anhydride-modified ethylene-octene copolymer is 0 · 5 ~ 5g / 10min, a melting point of 50 ~ 75 ° C, wherein the maleic anhydride content of from 0 · 3 to 1 · 5%, a density of 0 · 86 ~ 0 · 88g / cm3.

[0018]进一步地,所述外层中聚酯弹性体的恪体流动指数为2~20g/10min,恪点为180~ 240°C,密度为1 ·0~1 · 25g/cm3〇 [0018] Further, the outer layer flow index Verified polyester elastomer is 2 ~ 20g / 10min, Ke point of 180 ~ 240 ° C, a density of 1 · 0 ~ 1 · 25g / cm3〇

[0019 ]作为优选方案地,所述外层中聚酯弹性体的恪体流动指数为3~15 g/10m i η,恪点为190~220°C,密度为1 · 1 ~1 · 2g/cm3〇 [0019] As a preferred embodiment, the outer layer flow index Verified polyester elastomer is 3 ~ 15 g / 10m i η, Ke point of 190 ~ 220 ° C, a density of 1 · 1 ~ 1 · 2g / cm3〇

[0020]进一步地,所述医用包装易揭膜的总厚度为70~200um,其中,热合层占总厚度的10~15%,结构层占总厚度的60~80%,粘合层占总厚度的5~10%,外层占总厚度的5~ 15%〇 [0020] Further, the total thickness of the medical packaging is easily removing film 70 ~ 200um, wherein the heat seal layer of 10 to 15% of the total thickness, 60 to 80% of the total thickness of the structural layer, the adhesive layer total 5 to 10% of the thickness of 5 to 15% of the total thickness of the outer square

[0021]本发明的制备方法,包括如下步骤:首先将热合层的原料置入混料机中混合均匀, 混合时间3~6min,再将热合层、结构层、粘合层、外层的原料利用真空吸料机分别吸入挤出机料斗中,然后采用上吹风冷、下吹水冷和流延共挤生产工艺成膜,收卷后将膜放置在C〇60 的辐照室或高能电子射线室中进行辐射交联,最后采用分切机分切,即得医用包装易揭膜。 [0021] The production method of the present invention, comprising the steps of: a first heat seal layer material into the blender mixing, mixing time 3 ~ 6min, then the heat seal layer, a structural layer, an adhesive layer, the outer layer material a vacuum suction machine suction hopper of the extruder are then cooled using the hair, and the tubular quench co-extrusion cast film deposition process, after winding of the film is placed C〇60 or high-energy electron beam irradiation chamber radiation crosslinking chamber, slitter cutting Finally, removing film easy to obtain medical packaging. [0022]进一步地,所述辐射交联过程中,辐射剂量为6~15Mard,凝胶含量为35~65%。 [0022] Further, the process of radiation cross-linking, the radiation dose of 6 ~ 15Mard, a gel content of 35 to 65%. [0023]作为优选方案地,所述辐射交联过程中,辐射剂量为8~12Mard,凝胶含量为45~ 55%〇 [0023] As a preferred embodiment, the process of radiation cross-linking, the radiation dose of 8 ~ 12Mard, a gel content of 45 to 55% billion

[0024] 进一步地,所述分切机采用带离子风除静电、负压吸尘装置的分切机,分切生产环境洁净级别为C级背景下A级。 [0024] Further, the cutting machine with a cutting machine using electrostatic ion wind in addition, the negative pressure of the suction device, clean and cut production environment for the C-class level A background level.

[0025] 与现有技术相比,本发明的优点在于: [0025] Compared with the prior art, advantages of the present invention:

[0026]其一,本发明采用辐射交联技术处理产品提高耐温性能,灭菌温度可达135°C,不易产生变形,确保无菌要求(F〇>12),解决聚乙烯(PE)或其共聚物灭菌温度不能高于IHTC 难题,大大提高药品或医疗器械无菌保证值。 [0026] First, the present invention uses a radiation crosslinking techniques to improve the heat resistance treatment products, sterilization temperature up to 135 ° C, deformation is not easy to ensure sterility requirements (F〇> 12), solve the polyethylene (PE) or copolymers thereof not be higher than the sterilization temperature IHTC problem, greatly improving the sterility assurance value pharmaceuticals or medical devices.

[0027]其二,本发明材料组成全为惰性的医用高分子材料与包装物不易发生反应,迀移析出物极少,且不会对药物产生吸附而降低疗效,使用后回收再利用十分方便,若焚烧处理时不会产生二恶英,对环境造成影响极小,达到包装减量化、节能化目的,属环保产品。 [0027] Second, the composition of the present invention are all inert materials of medical polymer materials and packaging reactions less likely to occur, Gan shifted little precipitate, the drug will not reduce the efficacy of adsorption generated, recycling after use very convenient It does not produce dioxins if incinerated, causing minimal impact on the environment, to packaging reduction, energy conservation purpose, an environmentally friendly product. [0028] 其三,本发明采用聚乙烯(PE)、乙烯-乙酸乙烯酯(EVA)和乙烯-丙烯酸甲酯(EMA) 共混物作为热合层材料,具有良好的透明性,柔软性,热封性,可以采用高温热压或高频二种焊接方式快速热封,封口性能可靠并具有易揭性。 [0028] Third, the present invention is polyethylene (PE), ethylene - vinyl acetate (EVA) and an ethylene - methyl acrylate (EMA) as a heat seal layer blend material having good transparency, flexibility, heat sealability, can be used two kinds of high temperature hot welding or high-frequency heat-sealing quick, reliable sealing performance and having a property easy to expose.

[0029] 其四,本发明生产过程从原始粒料到制膜、辐射交联和分切均在洁净环境内进行, 避免微粒和其他污染,最大限度保证了产品的卫生性能。 [0029] Fourth, the production process of the present invention, radiation crosslinking and cutting are carried out in a clean environment from the original film to the pellets, other particles and avoid contamination, to ensure maximum performance of the sanitary product.

[0030] 其五,本发明各组成材料中结晶度低和吸水率小,经高温蒸汽灭菌后不会出现白化现象,透光率高,雾度小,降低治疗和用药安全风险。 [0030] Fifth, the various components of the present invention is a low crystallinity material and small water absorption, whitening phenomenon does not occur after the high temperature steam sterilization, high transmittance, low haze, and drug treatment to reduce security risks.

[0031] 其六,本发明采用聚乙烯(PE)作为结构层,耐低温到可达-35°c,完全解决医用包装易揭膜灭菌温度U 121°c)和耐低温(<-25°C)不能同时相互兼顾难题。 [0031] Sixth, the present invention employs polyethylene (PE) as a structural layer of low temperature resistant up to -35 ° c, medical packaging easy to completely solve the sterilization temperature Jiemo U 121 ° c) and low temperature (<-25 ° C) can not take into account another problem.

[0032]其七,本发明采用聚酯弹性体(TPEE)作为外层,解决尼龙(PA)在γ射线灭菌时出现膜材表面褐化、溶出物增加和卷曲难题,改性聚酯抗卷曲性能良好,非对称结构也不会出现卷曲,从而使包装焊接十分顺利。 [0032] Seventh, the present invention is a polyester elastomer (TPEE) as an outer layer, solving nylon (PA) occurs at the membrane surface browning γ ray sterilization, and elution was increased curling problem, anti-modified polyester good crimp properties, asymmetric structures curling does not occur, so that the packaging welding smoothly.

附图说明 BRIEF DESCRIPTION

[0033]图1为本发明的生产工艺流程图。 [0033] FIG 1 FIG production process of the present invention.

具体实施方式 detailed description

[0034]以下结合具体实施例对本发明作进一步的详细说明: [0034] The following embodiments in conjunction with specific embodiments of the present invention will be further described in detail:

[0035]实施例1: 一种医用包装易揭膜的原料组分(物质计量单位均按重量百分数计): [0036] (1)热合层:聚乙烯30%、乙烯-乙酸乙烯酯40%、乙烯-丙烯酸甲酯30%,所述热合层中聚乙烯的熔体流动指数(190°C,2.16kg)为0.5g/10min,熔点为80~120°C,密度为0.89g/cm 3;所述热合层中乙稀-乙酸乙稀酯的恪体流动指数(190°C,2 . 16kg)为0.5g/ lOmin,其中,乙酸乙烯酯含量为5%;所述热合层中乙烯-丙烯酸甲酯的熔体流动指数(190 °C,2.16kg)为0.5g/10min,其中,丙烯酸甲酯含量为10% ; [0035] Example 1: A medical package easily removing film feed components (substances measurement units are by weight percent): [0036] (1) a heat seal layer: 30% of polyethylene, ethylene - 40% vinyl acetate , ethylene - methyl acrylate 30%, the heat seal layer of polyethylene has a melt flow index (190 ° C, 2.16kg) of 0.5g / 10min, a melting point of 80 ~ 120 ° C, a density of 0.89g / cm 3 ; the heat seal layer is ethylene - ethylene acid ester thereof Verified flow index (. 190 ° C, 2 16kg) was 0.5g / lOmin, wherein the vinyl acetate content of 5%; the heat seal layer, an ethylene - acrylate melt flow index (190 ° C, 2.16kg) of 0.5g / 10min, wherein the methyl acrylate content of 10%;

[0037] (2)结构层:聚乙烯,该聚乙烯的熔体流动指数(190°C,2.16kg)为0.3g/10min,熔点为90°C,密度为0.89g/cm3; [0037] (2) a structural layer: polyethylene, which polyethylene has a melt flow index (190 ° C, 2.16kg) of 0.3g / 10min, a melting point of 90 ° C, a density of 0.89g / cm3;

[0038] (3)粘合层:马来酸酐改性乙烯辛烯共聚物,该马来酸酐改性乙烯辛烯共聚物的熔体流动指数(190°C,2.16kg)为0.3g/10min,熔点为45°C,其中,马来酸酐含量为0.1 %,密度为0·85g/cm3; [0038] (3) an adhesive layer: maleic anhydride-modified ethylene octene copolymer, melt flow index of the maleic anhydride-modified ethylene-octene copolymer (190 ° C, 2.16kg) of 0.3g / 10min a melting point of 45 ° C, wherein the maleic anhydride content of 0.1%, a density of 0 · 85g / cm3;

[0039] (4)外层:聚酯弹性体,该聚酯弹性体的熔体流动指数(190°C,2. 16kg)为2g/ lOmin,熔点为180°C,密度为1.0g/cm3〇 [0039] (4) layer: polyester elastomer, a melt flow index of the polyester elastomer (. 190 ° C, 2 16kg) was 2g / lOmin, a melting point of 180 ° C, a density of 1.0g / cm3 〇

[0040]上述医用包装易揭膜的总厚度为70um,其中,热合层的厚度为7um,结构层的厚度为55um,粘合层的厚度为4um,外层的厚度为4um〇[00411本发明的制备方法: [0040] The total thickness of the medical package for easily removing film 70um, wherein the thickness of the heat seal layer of 7um, the thickness of the structure layer 55um, 4um thickness of the adhesive layer, the outer layer having a thickness of 4um〇 [00411 invention preparation method:

[0042]首先将热合层的原料置入混料机中混合均匀,混合时间3min,再将热合层、结构层、粘合层、外层的原料利用真空吸料机分别吸入挤出机料斗中,然后采用上吹风冷、下吹水冷和流延共挤生产工艺成膜,收卷后将膜放置在C〇60的辐照室或高能电子射线室中进行辐射交联,辐射剂量为15Mard,凝胶含量为35%,最后采用分切机分切,即得医用包装易揭膜。 [0042] First, the heat seal layer material into the blender mixing, mixing time 3min, then the heat seal layer, a structural layer, an adhesive layer, the outer layer of material using vacuum suction machine extruder were suction hopper and hair using the cold, the tubular quench co-extrusion and cast film forming process, after winding of the film is placed C〇60 high energy electron beam irradiation chamber or chambers radiation crosslinking, the radiation dose 15Mard, a gel content of 35%, cutting slitting Finally, removing film easy to obtain medical packaging.

[0043]实施例2:-种医用包装易揭膜的原料组分(物质计量单位均按重量百分数计): [0044] (1)热合层:聚乙烯80%、乙烯-乙酸乙烯酯10%、乙烯-丙烯酸甲酯10%,所述热合层中聚乙烯的熔体流动指数(190°C,2.16kg)为10g/10min,熔点为120°C,密度为0.94g/ cm3;所述热合层中乙稀-乙酸乙稀酯的恪体流动指数(190 °C,2.16kg)为5g/1Omiη,其中,乙酸乙烯酯含量为30%;所述热合层中乙烯-丙烯酸甲酯的熔体流动指数(190°C,2.16kg)为10g/10min,其中,丙烯酸甲酯含量为35% ; [0043] Example 2: - removing film types of medical packaging easy to feedstock components (substances measurement units are by weight percent): [0044] (1) a heat seal layer: 80% of polyethylene, ethylene - vinyl acetate 10% , ethylene - methyl acrylate 10%, the heat seal layer of polyethylene has a melt flow index (190 ° C, 2.16kg) of 10g / 10min, a melting point of 120 ° C, a density of 0.94g / cm3; the heat seal layer of ethylene - ethylene acid ester thereof Verified flow index (190 ° C, 2.16kg) of 5g / 1Omiη, wherein the vinyl acetate content of 30%; the heat seal layer, an ethylene - methyl acrylate melt flow index (190 ° C, 2.16kg) of 10g / 10min, wherein the methyl acrylate content of 35%;

[0045] (2)结构层:聚乙烯,该聚乙烯的熔体流动指数(190°C,2.16kg)为8g/10min,熔点为125°C,密度为0.96g/cm3; [0045] (2) a structural layer: polyethylene, which polyethylene has a melt flow index (190 ° C, 2.16kg) of 8g / 10min, a melting point of 125 ° C, a density of 0.96g / cm3;

[0046] (3)粘合层:马来酸酐改性乙烯辛烯共聚物,该马来酸酐改性乙烯辛烯共聚物的熔体流动指数(190°C,2.16kg)为10g/10min,熔点为95°C,其中,马来酸酐含量为3%,密度为0.90g/cm3 ; [0046] (3) an adhesive layer: maleic anhydride-modified ethylene octene copolymer, melt flow index of the maleic anhydride-modified ethylene-octene copolymer (190 ° C, 2.16kg) of 10g / 10min, a melting point of 95 ° C, wherein the maleic anhydride content of 3%, a density of 0.90g / cm3;

[0047] (4)外层:聚酯弹性体,该聚酯弹性体的熔体流动指数(190°C,2.16kg)为20g/ lOmin,熔点为240°C,密度为1.25g/cm3〇 [0047] (4) layer: polyester elastomer, a melt flow index of the polyester elastomer (190 ° C, 2.16kg) of 20g / lOmin, a melting point of 240 ° C, a density of 1.25g / cm3〇

[0048]上述医用包装易揭膜的总厚度为lOOum,其中,热合层的厚度为15um,结构层的厚度为65um,粘合层的厚度为IOum,外层的厚度为IOum0 [0049]本发明的制备方法: [0048] The total thickness of the medical package for easily removing film lOOum, wherein the heat seal layer thickness of 15um, 65um thickness of the structure layer, the thickness of the adhesive layer is IOum, the outer layer having a thickness of IOum0 [0049] The present invention preparation method:

[0050]首先将热合层的原料置入混料机中混合均匀,混合时间6min,再将热合层、结构层、粘合层、外层的原料利用真空吸料机分别吸入挤出机料斗中,然后采用上吹风冷、下吹水冷和流延共挤生产工艺成膜,收卷后将膜放置在C〇60的辐照室或高能电子射线室中进行福射交联,福射剂量为6Mard,凝胶含量为65 %,最后米用分切机分切,即得医用包装易揭膜。 [0050] First, the heat seal layer material is mixed into the blender, mixing time 6min, then the heat seal layer, a structural layer, an adhesive layer, the outer layer of material using vacuum suction machine extruder were suction hopper and hair using the cold, the tubular quench co-extrusion and cast film forming process, after winding of the film is placed C〇60 or high-energy electron beam irradiation chamber for Four exit chamber crosslinking, irradiation dose of Fu 6Mard, a gel content of 65% and then cut with a slitter meters, removing film easy to obtain medical packaging.

[0051]实施例3:-种医用包装易揭膜的原料组分(物质计量单位均按重量百分数计): [0052] (1)热合层:聚乙烯50%、乙烯-乙酸乙烯酯30%、乙烯-丙烯酸甲酯20%,所述热合层中聚乙烯的熔体流动指数(190°C,2.16kg)为8g/10min,熔点为80~120°C,密度为0.9g/ cm3;所述热合层中乙稀-乙酸乙稀酯的恪体流动指数(190 °C,2.16kg)为3g/1Omiη,其中,乙酸乙烯酯含量为20%;所述热合层中乙烯-丙烯酸甲酯的熔体流动指数(190°C,2.16kg)为5g/lOmin,其中,丙稀酸甲酯含量为20 % ; (2)结构层:聚乙稀,该聚乙稀的恪体流动指数(190°(:,2.161^)为58/101^11,熔点为100°(:,密度为0.918/〇11 3; [0051] Example 3: - Species medical packaging easily removing film feed components (substances measurement units are by weight percent): [0052] (1) a heat seal layer: 50% of polyethylene, ethylene - vinyl acetate 30% , ethylene - methyl acrylate 20%, the heat seal layer of polyethylene has a melt flow index (190 ° C, 2.16kg) of 8g / 10min, a melting point of 80 ~ 120 ° C, a density of 0.9g / cm3; the said heat seal layer of ethylene - ethylene acid ester thereof Verified flow index (190 ° C, 2.16kg) is 3g / 1Omiη, wherein the vinyl acetate content of 20%; the heat seal layer, an ethylene - methyl acrylate the melt flow index (190 ° C, 2.16kg) of 5g / lOmin, wherein the acrylic ester content of 20%; (2) a structural layer: polyethylene, the polyethylene of the Verified flow index (190 ° (:, 2.161 ^) 58/11 ^ 101, a melting point of 100 ° (:, density of 0.918 / 〇11 3;

[0053] (3)粘合层:马来酸酐改性乙烯辛烯共聚物,该马来酸酐改性乙烯辛烯共聚物的熔体流动指数(190°C,2.16kg)为5g/10min,熔点为50°C,其中,马来酸酐含量为2%,密度为0.88g/cm3 ; [0053] (3) an adhesive layer: maleic anhydride-modified ethylene octene copolymer, melt flow index of the maleic anhydride-modified ethylene-octene copolymer (190 ° C, 2.16kg) of 5g / 10min, a melting point of 50 ° C, wherein the maleic anhydride content of 2% and a density of 0.88g / cm3;

[0054] (4)外层:聚酯弹性体,该聚酯弹性体的熔体流动指数(190°C,2.16kg)为IOg/ lOmin,熔点为200°C,密度为1 · lg/cm3〇 [0054] (4) layer: polyester elastomer, a melt flow index of the polyester elastomer (190 ° C, 2.16kg) of IOg / lOmin, a melting point of 200 ° C, a density of 1 · lg / cm3 〇

[0055]上述医用包装易揭膜的总厚度为150um,其中,热合层的厚度为20um,结构层的厚度为lOOum,粘合层的厚度为8um,外层的厚度为22um〇[0056]本发明的制备方法: [0055] The total thickness of the medical package for easily removing film 150um, wherein the heat seal layer thickness of 20um thickness of the structure layer lOOum, 8um thickness of the adhesive layer, the outer layer having a thickness of 22um〇 [0056] The present the method of the invention was prepared:

[0057]首先将热合层的原料置入混料机中混合均匀,混合时间5min,再将热合层、结构层、粘合层、外层的原料利用真空吸料机分别吸入挤出机料斗中,然后采用上吹风冷、下吹水冷和流延共挤生产工艺成膜,收卷后将膜放置在C〇60的辐照室或高能电子射线室中进行辐射交联,辐射剂量为12Mard,凝胶含量为40%,最后采用分切机分切,即得医用包装易揭膜。 [0057] First, the heat seal layer material is mixed into the blender, mixing time 5min, then the heat seal layer, a structural layer, an adhesive layer, the outer layer of material using vacuum suction machine extruder were suction hopper and hair using the cold, the tubular quench co-extrusion and cast film forming process, after winding of the film is placed C〇60 high energy electron beam irradiation chamber or chambers radiation crosslinking, the radiation dose 12Mard, a gel content of 40%, cutting slitting Finally, removing film easy to obtain medical packaging.

[0058]实施例4: 一种医用包装易揭膜的原料组分(物质计量单位均按重量百分数计): [0059] (1)热合层:聚乙烯70%、乙烯-乙酸乙烯酯20%、乙烯-丙烯酸甲酯10%,所述热合层中聚乙烯的熔体流动指数(190°C,2.16kg)为8g/10min,熔点为90°C,密度为0.89g/cm3; 所述热合层中乙稀-乙酸乙稀酯的恪体流动指数(190 °C,2.16kg)为2g/IOmin,其中,乙酸乙烯酯含量为10%;所述热合层中乙烯-丙烯酸甲酯的熔体流动指数(190°C,2.16kg)为2g/ lOmin,其中,丙烯酸甲酯含量为30% ; [0058] Example 4: A medical packaging of easily removing film feed components (substances measurement units are by weight percent): [0059] (1) a heat seal layer: 70% polyethylene, ethylene --20% vinyl acetate , ethylene - methyl acrylate 10%, the heat seal layer of polyethylene has a melt flow index (190 ° C, 2.16kg) of 8g / 10min, a melting point of 90 ° C, a density of 0.89g / cm3; the heat seal layer of ethylene - ethylene acid ester thereof Verified flow index (190 ° C, 2.16kg) of 2g / IOmin, wherein the vinyl acetate content of 10%; the heat seal layer, an ethylene - methyl acrylate melt flow index (190 ° C, 2.16kg) of 2g / lOmin, wherein the methyl acrylate content of 30%;

[0060] (2)结构层:聚乙烯,该聚乙烯的熔体流动指数(190°C,2.16kg)为7g/10min,熔点为110°C,密度为0.96g/cm3; [0060] (2) a structural layer: polyethylene, which polyethylene has a melt flow index (190 ° C, 2.16kg) of 7g / 10min, a melting point of 110 ° C, a density of 0.96g / cm3;

[0061] (3)粘合层:马来酸酐改性乙烯辛烯共聚物,该马来酸酐改性乙烯辛烯共聚物的熔体流动指数(190°(:,2.161^)为98/101^11,熔点为50°(:,其中,马来酸酐含量为2.5%,密度为0.90g/cm3 ; [0061] (3) an adhesive layer: maleic anhydride-modified ethylene octene copolymer, melt flow index of the maleic anhydride-modified ethylene-octene copolymer (190 ° (:, 2.161 ^) is 98/101 ^ 11, a melting point of 50 ° (:, wherein the maleic anhydride content of 2.5%, a density of 0.90g / cm3;

[0062] (4)外层:聚酯弹性体,该聚酯弹性体的熔体流动指数(190°C,2.16kg)为18g/ lOmin,熔点为190°C,密度为1.2g/cm3〇 [0062] (4) layer: polyester elastomer, a melt flow index of the polyester elastomer (190 ° C, 2.16kg) of 18g / lOmin, a melting point of 190 ° C, a density of 1.2g / cm3〇

[0063]上述医用包装易揭膜的总厚度为180um,其中,热合层的厚度为24um,结构层的厚度为120um,粘合层的厚度为18um,外层的厚度为18um〇[0064]本发明的制备方法: [0063] The total thickness of the medical package for easily removing film 180um, wherein the heat seal layer thickness of 24um, the thickness of the structure layer 120um, 18um thickness of the adhesive layer, the outer layer having a thickness of 18um〇 [0064] The present the method of the invention was prepared:

[0065]首先将热合层的原料置入混料机中混合均匀,混合时间5min,再将热合层、结构层、粘合层、外层的原料利用真空吸料机分别吸入挤出机料斗中,然后采用上吹风冷、下吹水冷和流延共挤生产工艺成膜,收卷后将膜放置在C〇60的辐照室或高能电子射线室中进行辐射交联,辐射剂量为SMarcU凝胶含量为45%,最后采用分切机分切,即得医用包装易揭膜。 [0065] First, the heat seal layer material is mixed into the blender, mixing time 5min, then the heat seal layer, a structural layer, an adhesive layer, the outer layer of material using vacuum suction machine extruder were suction hopper and hair using the cold, the tubular quench co-extrusion and cast film forming process, after winding of the film is placed C〇60 high energy electron beam irradiation chamber or chambers radiation crosslinking, the radiation dose for the condensate SMarcU 45% gel content, shear slitter Finally, removing film easy to obtain medical packaging.

[0066]实施例5:-种医用包装易揭膜的原料组分(物质计量单位均按重量百分数计): [0066] Example 5: - Species medical packaging easily removing film feed components (substances measurement units are by weight percent):

[0067] (1)热合层:聚乙烯60%、乙烯-乙酸乙烯酯25%、乙烯-丙烯酸甲酯15%,所述热合层中聚乙烯的熔体流动指数(190°C,2.16kg)为lg/10min,熔点为115°C,密度为0.93g/cm3; 所述热合层中乙稀-乙酸乙稀酯的恪体流动指数(190 °C,2.16kg)为Ig/IOmin,其中,乙酸乙烯酯含量为25%;所述热合层中乙烯-丙烯酸甲酯的熔体流动指数(190°C,2.16kg)为Sg/ lOmin,其中,丙烯酸甲酯含量为30% ; [0067] (1) a heat seal layer: 60% of polyethylene, ethylene - 25% vinyl acetate, ethylene - methyl acrylate 15%, the melt flow index of the polyethylene heat seal layer (190 ° C, 2.16kg) of lg / 10min, a melting point of 115 ° C, a density of 0.93g / cm3; heat seal layer of the ethylene - ethylene acid ester thereof Verified flow index (190 ° C, 2.16kg) of Ig / IOmin, wherein vinyl acetate content of 25%; the heat seal layer, an ethylene - methyl acrylate melt flow index (190 ° C, 2.16kg) of Sg / lOmin, wherein the methyl acrylate content of 30%;

[0068] (2)结构层:聚乙烯,该聚乙烯的熔体流动指数(190°C,2.16kg)为0.5g/10min,熔点为95°C,密度为0.94g/cm3; [0068] (2) a structural layer: polyethylene, which polyethylene has a melt flow index (190 ° C, 2.16kg) of 0.5g / 10min, a melting point of 95 ° C, a density of 0.94g / cm3;

[0069] (3)粘合层:马来酸酐改性乙烯辛烯共聚物,该马来酸酐改性乙烯辛烯共聚物的熔体流动指数(190°C,2.16kg)为0.5g/10min,熔点为75°C,其中,马来酸酐含量为1.5%,密度为O·88g/cm3; [0069] (3) an adhesive layer: maleic anhydride-modified ethylene octene copolymer, melt flow index of the maleic anhydride-modified ethylene-octene copolymer (190 ° C, 2.16kg) of 0.5g / 10min a melting point of 75 ° C, wherein the maleic anhydride content of 1.5%, a density of O · 88g / cm3;

[0070] (4)外层:聚酯弹性体,该聚酯弹性体的熔体流动指数(190°C,2.16kg)为15g/ lOmin,熔点为220°C,密度为1.2g/cm3〇 [0070] (4) layer: polyester elastomer, a melt flow index of the polyester elastomer (190 ° C, 2.16kg) of 15g / lOmin, a melting point of 220 ° C, a density of 1.2g / cm3〇

[0071]上述医用包装易揭膜的总厚度为200um,其中,热合层的厚度为30um,结构层的厚度为138um,粘合层的厚度为12um,外层的厚度为20um〇[0072]本发明的制备方法: [0071] The total thickness of the medical package for easily removing film 200um, wherein the heat seal layer thickness of 30um thickness of the structure layer 138um, 12um thickness of the adhesive layer, the outer layer having a thickness of 20um〇 [0072] The present the method of the invention was prepared:

[0073]首先将热合层的原料置入混料机中混合均匀,混合时间6min,再将热合层、结构层、粘合层、外层的原料利用真空吸料机分别吸入挤出机料斗中,然后采用上吹风冷、下吹水冷和流延共挤生产工艺成膜,收卷后将膜放置在C〇60的辐照室或高能电子射线室中进行辐射交联,辐射剂量为IOMard,凝胶含量为55%,最后采用分切机分切,即得医用包装易揭膜。 [0073] First, the heat seal layer material is mixed into the blender, mixing time 6min, then the heat seal layer, a structural layer, an adhesive layer, the outer layer of material using vacuum suction machine extruder were suction hopper and hair using the cold, the tubular quench co-extrusion and cast film forming process, after winding of the film is placed C〇60 high energy electron beam irradiation chamber or chambers radiation crosslinking, the radiation dose IOMard, a gel content of 55%, cutting slitting Finally, removing film easy to obtain medical packaging.

[0074] 实施例6:效果例 Effect Example: 6 Example [0074] Embodiment

[0075] 1、参照《最终灭菌医疗器械的包装》(GBT19633-2005)、《国家药包材标准热合强度测定法》(YBB00122003)检验上述各实施例热合强度,热合条件为:压力:0.2MPa,时间:1s, 其中实施例1和普通膜检验结果对比见表1,单位以N/15mm表示。 [0075] 1, reference to "the final sterilizing a medical device packaging" (GBT19633-2005), "heat seal strength of the national drug packaging standard assay" (YBB00122003) test above embodiments each heat seal strength, heat sealing conditions: Pressure: 0.2 MPa, time: 1s, which Comparative Example 1 and test results are shown in Table 1 Common film, expressed in units of N / 15mm.

[0076]表1热合强度检验报告 [0076] Table 1 heat seal strength test report

Figure CN105619981AD00081

[0078]从上述表1可以发现同样的热合温度,实施例的热合强度相对较小;实施例热合强度最大在10N/15mm左右,即使是最大值也容易揭开;在易揭5~10N/15mm情况下,实施例所对应的热合温度范围宽广,这样就降低了生产时对热合温度和压力的控制要求,可使成品热合质量稳定可靠。 [0078] From the above Table 1 can be found in the same heat sealing temperature, embodiment heat seal strength embodiment is relatively small; heat seal strength Example Maximum about 10N / 15mm, even when the maximum value can be easily opened; in easy to expose 5 ~ 10N / at 15mm, the embodiment of the heat sealing temperature corresponding to a wide range, thus reducing the requirements for controlling the temperature and pressure of heat production, heat sealing can be stabilized and reliable quality of the finished product.

[0079] 2、以压力:O · 2MPa,时间:Is,热合温度:155°C,聚丙烯(PP)杯体材料为试验条件, 检验上述各实施例和普通膜135°C、12min高温灭菌试验前后的热合强度和揭开痕迹情况, 各检验结果对比见表2,单位以N/15mm表示。 [0079] 2, pressure: O · 2MPa, time: Is, sealing temperature: 155 ° C, polypropylene (PP) cup material is a test condition, each of the above embodiments and the common film 135 ° C, 12min temperature off heat seal strength and uncover traces bacteria before and after the test, each of the comparison test results shown in Table 2, expressed in units of N / 15mm.

[0080]表2高温灭菌试验前后热合检验报告 [0080] TABLE 2 Test before and after high-temperature sterilization heat test report

Figure CN105619981AD00091

[0082] 在上述热合条件下,从表2可以发现各实施例高温灭菌前后热合强度基本保持在8 ~10N/15mm之间,灭菌前后无大的变化,揭开强度适当,方便开启。 [0082] In the heat bonding conditions can be found from Table 2 before and after the heat seal strength of various embodiments autoclaved embodiment substantially maintained between 8 ~ 10N / 15mm, no big change before and after sterilization, opened suitable strength, easy to open. 不论灭菌前后,剥离各实施例后,观察易揭膜与聚丙烯(PP)杯体材料面,不离层无拉丝,痕迹光滑,证明此为材料层内剥离,即剥离层与聚丙烯(PP)杯体材料密封牢度好,从而有效地避免了泄漏的问题。 Regardless of before and after sterilization, peeling embodiments, removing film material is easy to observe the surface of polypropylene (PP) cup, no drawing layer separated, smooth traces, showing that the material of the release layer, i.e. the release layer and the polypropylene (PP ) material of the sealing cup fastness, thus effectively avoiding the problem of leakage.

[0083] 3、根据美国药典USP35〈88〉、《国家药包材标准》YBB00012003、YBB00032003及YBB00052003进行检验,检验上述各实施例产品生物安全性能,其中实施例3检验结果见表3〇 [0083] 3, according to U.S. Pharmacopeia USP35 <88>, "the national drug packaging standards" YBB00012003, YBB00032003 YBB00052003 and inspected to the above-described embodiments the performance of each product biosafety embodiments, Example 3 wherein test results are shown in Table embodiment 3〇

[0084]表3生物安全性能检验报告 [0084] Table 3 bio-safety inspection reports

Figure CN105619981AD00092

[0087] 4、根据国家食品药品监督管理局(SFDA)对药品、医疗器械包装材料申报注册技术要求及美国药典USP35〈87〉进行检验,检验上述各实施例产品化学性能,其中实施例4检验结果见表4。 [0087] 4. The State Food and Drug Administration (SFDA) of drug, medical device packaging materials Technical Requirements for Registration and reporting USP USP35 <87> are inspected to the above-described various embodiments chemical properties of the product of Example, Example 4 wherein test embodiment The results are shown in Table 4.

[0088]表4化学性能检验报告 [0088] Table 4 Chemical properties test report

Figure CN105619981AD00101

[0090] 5、本发明委托蚌埠丰原涂山制药有限公司进行了药物相容性试验,以下为实施例2试验结论。 [0090] 5, the present invention is entrusted Bengbu BBCA Pharmaceutical Co., Ltd. were Tushan drug compatibility test, the following conclusions Test Example 2. 按照《中华人民共和国药典》2010年版二部附录XIXC药物稳定性试验指导原则和《药品包装材料与药物相容性试验指导原则》(YBB00142002)中的要求,经过光照试验、加速试验、长期试验结果表明,使用本发明提供的医用包装易揭膜与高密度聚乙烯(HDPE)瓶体材料包装多种药品,放置在不同环境条件下,各项检测指标无明显变化且均符合规定,证明本医用包装易揭膜与药物未发生物理、化学、生物的反应,质量稳定不影响药品原来特性,符合药物相容性试验要求,具体试验结果见表5和表6。 According to "People's Republic of China Pharmacopoeia" 2010 edition test guidelines for drug stability Appendix XIXC and "compatibility test guidelines for drug packaging materials and drugs" requirement (YBB00142002) is, after lighting tests, accelerated tests, long-term results shows that the use of the present invention provides medical packaging easily removing film and high density polyethylene (HDPE) bottle packaging material a variety of drugs, placed under different environmental conditions, no significant change in the detection of indicators and comply with the requirements, the present medical proof packaging and easily removing film drug reactions physical, chemical, biological did not occur, without affecting the quality and characteristics of the original drugs, medication compliance compatibility test requirements, particularly the test results in table 5 and table 6.

[0091] 表5医用包装易揭膜与吡嗪酰胺片相容性试验报告 [0091] TABLE 5 Easy removing film medical packaging compatibility test report and Pyrazinamide Tablets

Figure CN105619981AD00111

[0093]表6医用包装易揭膜与枸椽酸喷托维林片相容性试验报告 [0093] Table 6 with citric acid medical packaging easily removing film sheet Pentoxyverine compatibility test report

Figure CN105619981AD00121

[0095] 6、本发明分别作为包装膜、盖膜委托稳健实业(深圳)有限公司进行密封试验,另取普通易揭膜、高热合强度膜同法操作,以聚丙烯(PP)为杯体材料包装纱布(规格:10*10* 8),进行12ΐΓ、30πΰη高温灭菌,在相同规格的瓦楞纸箱内分别摆放上述样品,每箱100包, 每层60箱,共8层,总计480箱,将上述6种样品分别置于汽车内进行长途运输,运输里程共计约3000Km。 [0095] 6, respectively, as a packaging film of the present invention, the cover film commissioned robust Industries (Shenzhen) Co., sealing tests, an alternative common and easy removing film, heat bonding method is the same strength of the film, polypropylene (PP), a cup body packaging gauze (size: 10 * 10 * 8), for 12ΐΓ, 30πΰη autoclaving, the above samples were placed in the same box of corrugated, each containing 100 packets, each tank 60, a total of 8 layers, a total of 480 case, the above six samples were a total of about 3000Km transported over long distances, the car placed on the transport mileage.

[0096] 检测方法:运输完毕后,将瓦楞纸箱打开并从外包装袋中取出样品,目测是否有漏包,记录漏包数;如未漏包,将试验样品置于万能试机上两平行平板之间,施加约IOKPa的内压,维持10S,观察是否有漏包,并记录漏包数,实施例3具体试验结果见表7。 [0096] Detection method: After the completion of the transport, the corrugated open and samples were taken from the packaging bag, whether visually tainted packet, recording the number of missing packets; if not drain bag, the test sample was placed on two parallel plates universal test machine between about IOKPa internal pressure is applied to maintain 10S, observe whether tainted packet, and records the number of missing packets, specific test results of examples 3 are shown in Table 7.

[0097] 表7漏包试验报告 [0097] Table 7 reports the leakage test package

Figure CN105619981AD00131

[0099]试验结果表明:本发明的包装密封性与高热合强度膜相当,并优于普通易揭膜包装。 [0099] The results showed: with heat seal packing of the present invention, bonding strength of the film is relatively and easily removing film superior to the conventional package.

Claims (10)

  1. 1. 一种医用包装易揭膜,其特征在于,它包括四层结构,从内至外依次为:热合层、结构层、粘合层、外层;其中,所述热合层由医用级的聚乙烯、乙烯-乙酸乙烯酯和乙烯-丙烯酸甲酯组成的混合树脂构成;所述结构层由医用级的聚乙烯构成;所述粘合层由马来酸酐改性乙烯辛烯共聚物构成;所述外层由聚酯弹性体构成。 A medical packaging easily removing film, characterized in that it comprises a four-layer structure, from inside to outside as follows: heat seal layer, a structural layer, an adhesive layer, an outer layer; wherein the heat seal layer is made of medical grade polyethylene, ethylene - vinyl acetate and ethylene - methyl acrylate hybrid resin composition constituting; the structural layer is composed of a medical grade polyethylene; the adhesive layer formed of a maleic anhydride-modified ethylene octene copolymer; the outer layer is made of a polyester elastomer.
  2. 2. 根据权利要求1所述的医用包装易揭膜,其特征在于,所述热合层的原料按重量百分数计包括:聚乙稀30~80%、乙稀-乙酸乙稀酯10~40%、乙稀-丙稀酸甲酯10~30%。 The medical package of claim 1, wherein the easily removing film, characterized in that the material of the heat seal layer comprising in weight percent: 30 to 80% polyethylene, ethylene - ethylene acid ester 10 to 40% , ethylene - acrylic ester 10% to 30%.
  3. 3. 根据权利要求1或2所述的医用包装易揭膜,其特征在于,所述热合层中聚乙烯的熔体流动指数为0 · 5~10g/10min,熔点为80~120°C,密度为0 · 89~0 · 94g/cm3;所述热合层中乙烯-乙酸乙烯酯的熔体流动指数为0.5~5g/10min,其中,乙酸乙烯酯含量为5~30%;所述热合层中乙烯-丙烯酸甲酯的熔体流动指数为0.5~10g/10min,其中,丙烯酸甲酯含量为10 ~35%〇 The medical package of claim 12 or claim easily removing film, wherein, in the heat seal layer of polyethylene a melt flow index of 0 · 5 ~ 10g / 10min, a melting point of 80 ~ 120 ° C, a density of 0 · 89 ~ 0 · 94g / cm3; the heat seal layer, an ethylene - vinyl acetate melt flow index of 0.5 ~ 5g / 10min, wherein the vinyl acetate content of 5 to 30%; the heat seal layer ethylene - methyl acrylate having a melt index of 0.5 ~ 10g / 10min, wherein the methyl acrylate content of 10 to 35% billion
  4. 4. 根据权利要求1所述的医用包装易揭膜,其特征在于,所述结构层中聚乙烯的熔体流动指数为〇· 3~8g/10min,熔点为90~125°C,密度为0 · 89~0 · 96g/cm3。 The medical package according to claim 1 easily removing film, characterized in that the structural layer of polyethylene has a melt flow index of square · 3 ~ 8g / 10min, a melting point of 90 ~ 125 ° C, a density of 0 · 89 ~ 0 · 96g / cm3.
  5. 5. 根据权利要求1所述的医用包装易揭膜,其特征在于,所述粘合层中马来酸酐改性乙烯辛烯共聚物的熔体流动指数为0.3~10g/10min,熔点为45~95°C,其中,马来酸酐含量为0· 1~3%,密度为0·85~0·90g/cm3〇 The medical package of claim 1, wherein the easily removing film, wherein the adhesive layer has a melt flow index of maleic anhydride-modified ethylene-octene copolymer is 0.3 ~ 10g / 10min, a melting point of 45 ~ 95 ° C, wherein the maleic anhydride content of from 0 · 1 to 3%, a density of 0 · 85 ~ 0 · 90g / cm3〇
  6. 6. 根据权利要求1所述的医用包装易揭膜,其特征在于,所述外层中聚酯弹性体的熔体流动指数为2~20g/10min,熔点为180~240°C,密度为1.0~1.25g/cm 3。 The medical package according to claim 1 easily removing film, characterized in that the outer layer melt flow index of the polyester elastomer is 2 ~ 20g / 10min, a melting point of 180 ~ 240 ° C, a density of 1.0 ~ 1.25g / cm 3.
  7. 7. 根据权利要求1所述的医用包装易揭膜,其特征在于,所述医用包装易揭膜的总厚度为70~200um,其中,热合层占总厚度的10~15%,结构层占总厚度的60~80%,粘合层占总厚度的5~10%,外层占总厚度的5~15%。 The medical package according to claim 1 easily removing film, characterized in that the total thickness of the medical packaging is easily removing film 70 ~ 200um, wherein the heat seal layer of 10 to 15% of the total thickness of the structural layer comprises 60 to 80% of total thickness, the total thickness of the adhesive layer is 5 to 10%, 5 to 15% of the total layer thickness.
  8. 8. -种医用包装易揭膜的制备方法,其特征在于,包括如下步骤:首先将热合层的原料置入混料机中混合均匀,混合时间3~6min,再将热合层、结构层、粘合层、外层的原料利用真空吸料机分别吸入挤出机料斗中,然后采用上吹风冷、下吹水冷和流延共挤生产工艺成膜,收卷后将膜放置在C〇60的辐照室或高能电子射线室中进行辐射交联,最后采用分切机分切,即得医用包装易揭膜。 8. - The method of producing a medical package easily removing film, characterized by comprising the steps of: a first heat seal layer material into the blender mixing, mixing time 3 ~ 6min, then the heat seal layer, the structural layer, an adhesive layer, an outer layer of material using vacuum suction feeder hopper of the extruder are then cooled using the hair, and the tubular quench co-extrusion cast film deposition process, the film is placed after winding C〇60 the high-energy irradiation chamber or an electron beam radiation crosslinking chamber, slitter cutting Finally, removing film easy to obtain medical packaging.
  9. 9. 根据权利要求8所述的医用包装易揭膜的制备方法,其特征在于,所述辐射交联过程中,辐射剂量为6~15Mard,凝胶含量为35~65%。 9. The method of claim 8 prepared easily removing film medical packaging according to claim, wherein, during the radiation crosslinking, the radiation dose of 6 ~ 15Mard, a gel content of 35 to 65%.
  10. 10. 根据权利要求8或9所述的医用包装易揭膜的制备方法,其特征在于,所述分切机采用带离子风除静电、负压吸尘装置的分切机。 10. The medical package of claim 8 or claim 9 in the preparation of easily removing film, wherein said cutting machine with cutting machine employed in addition to electrostatic ion wind, the negative pressure of the suction device.
CN 201510976659 2015-12-22 A medical packaging easily removing film and preparation method CN105619981B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 201510976659 CN105619981B (en) 2015-12-22 A medical packaging easily removing film and preparation method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN 201510976659 CN105619981B (en) 2015-12-22 A medical packaging easily removing film and preparation method

Publications (2)

Publication Number Publication Date
CN105619981A true true CN105619981A (en) 2016-06-01
CN105619981B CN105619981B (en) 2018-07-24

Family

ID=

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106273957A (en) * 2016-08-03 2017-01-04 湖北恒泰橡塑有限公司 Co-extruded film for peritoneal dialysis solution bag and method for preparing same

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0069495A2 (en) * 1981-07-02 1983-01-12 W.R. GRACE &amp; CO. Heat-shrinkable thermoplastic packaging film and receptacles formed therefrom
JP2004276601A (en) * 2003-02-28 2004-10-07 Toray Ind Inc Polypropylene film for thermocompression bonding print lamination and print laminate
CN1663775A (en) * 2005-02-01 2005-09-07 陈亦锋 Multilayer co-extrusion transfusion film and manufacturing method thereof
CN101559854A (en) * 2009-05-21 2009-10-21 陈亦锋 Film for suction plastic packaging of medical equipment and method for preparing same
CN201338791Y (en) * 2008-09-28 2009-11-04 葛敬银 Flexible packing multi-layer coextrusion heat-sealing film used for getting rid of compositing cementing compound

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0069495A2 (en) * 1981-07-02 1983-01-12 W.R. GRACE &amp; CO. Heat-shrinkable thermoplastic packaging film and receptacles formed therefrom
JP2004276601A (en) * 2003-02-28 2004-10-07 Toray Ind Inc Polypropylene film for thermocompression bonding print lamination and print laminate
CN1663775A (en) * 2005-02-01 2005-09-07 陈亦锋 Multilayer co-extrusion transfusion film and manufacturing method thereof
CN201338791Y (en) * 2008-09-28 2009-11-04 葛敬银 Flexible packing multi-layer coextrusion heat-sealing film used for getting rid of compositing cementing compound
CN101559854A (en) * 2009-05-21 2009-10-21 陈亦锋 Film for suction plastic packaging of medical equipment and method for preparing same

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106273957A (en) * 2016-08-03 2017-01-04 湖北恒泰橡塑有限公司 Co-extruded film for peritoneal dialysis solution bag and method for preparing same

Similar Documents

Publication Publication Date Title
US5565160A (en) Squeezable tubular container and process for the production thereof
WO2004018556A1 (en) Oxygen-absorbing resin composition and layered product
US5341557A (en) Use of non-adhesive stretch-film as a laboratory container closure
JP2001039475A (en) Resin composition, laminate, container and container lid
JPH09234832A (en) Oxygen absorbing multi-layer film and its manufacture
CN101376730A (en) Thermoplastic elastomer material, preparation thereof and method for manufacturing medicinal bottle stopper by using the same
CN101659141A (en) Ultra-low temperature heat sealing polypropylene casting film
WO1995013918A1 (en) Multi-layered polymer based film structure for medical grade products
JP2004143310A (en) Resin composition having drying ability, and laminate and packaging form using the same
US20070082150A1 (en) Stack sealable heat shrinkable film
CN1736813A (en) Foodstuff packaging membrane and its manufacturing method
CN101792558A (en) Inner cap material for transfusion packages, and preparation method and applications thereof
CN1880182A (en) High barrier aluminum-plating composite film for packing liquid dairy product
CN101624112A (en) Composite membrane for sauce and preparation method thereof
CN101427979A (en) Method for preparing semi-coating medical rubber plug
CN104354414A (en) High-temperature-resistant clean type self-adhesive protection film and preparation method thereof
CN201737295U (en) Covering film with composite structure
CN201064962Y (en) Eight-layer bottom-blowing method coextrusion high-obstruction thin film
CN102190824A (en) Hot-seal functional stretch film
CN1970288A (en) Seven-layer coextrusion membrane for transfusion and its production method
JP2007283565A (en) Gas barrier film, packaging material using it and package
CN101665174A (en) Hot melt adhesive aluminum foil sealing film and manufacturing method thereof
CN201068267Y (en) Sheet material for packing foodstuff
JP2000079663A (en) Easy unsealable laminated film, lid material and container
CN201105860Y (en) Novel fresh meat thermal shrinkage keeping-fresh bag film

Legal Events

Date Code Title Description
C06 Publication
C10 Entry into substantive examination