Blister package for medicines made of same material and preparation method of blister package

Abstract

The invention discloses a blister package for medicines made of the same material and a preparation method of the blister package, and relates to the technical field of medicine packaging.The blister package comprises a polyolefin transparent sheet blister and a polyolefin cover film.The preparation method comprises the steps that S1, materials are prepared; s2, preparing a polyolefin transparent sheet bubble cap; s3, a polyolefin cover film is prepared, surface corona treatment is conducted on the polyolefin cover film, and then printing is conducted; and S4, the prepared blister packages of the medicines made of the same material are tested. The same polyolefin material system is adopted, the five-layer co-extrusion and three-layer co-extrusion structural design is combined with the synergistic proportion of the cycloolefin polymer, the polyvinyl alcohol and the inorganic filler, medicine blister packaging with high barrier property, high transparency, recoverability and excellent heat sealing performance is achieved, traditional chlorine-containing and aluminum-plastic composite packaging is replaced, and the packaging effect is good. The requirements of environmental protection and medicine protection are considered, the requirements of multiple scenes such as printing and sterilization are met, existing packaging equipment is adapted, and a better use prospect is brought.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical packaging, in particular to a same-material medicine blister packaging and a preparation method thereof. BACKGROUND

[0002] The present medicine blister packaging is a PVC (polyvinyl chloride) transparent sheet and an aluminum-plastic composite film heat-sealed product, which is a common packaging form for solid medicines. The PVC is cast into a transparent sheet roll, coated with a thin layer of high-barrier PVDC (polyvinylidene chloride), and then formed by secondary heating and vacuum forming. Solid medicines such as tablets, pills, and capsules are filled into the grooves, and then bonded with an aluminum foil coated with plastic hot melt glue by heating, to form an independent sealed packaging (blister packaging). In addition to being used for medicine packaging, the blister packaging is also widely used in food, cosmetics, and car incense, etc. It is convenient, economical and practical, has good protection performance, fast production speed, low cost, convenient storage and transportation, and good safety.

[0003] The cover film of the aluminum-plastic composite film is formed by coating aluminum foil and hot melt glue to form a heat-sealing layer, and the barrier property of the blister packaging is ensured by the aluminum foil. However, since the cover film is generally bonded to the transparent sheet, the aluminum foil cannot be completely separated from the blister during the recycling process due to its thinness, which greatly reduces the recyclability and cannot meet the increasingly stringent environmental protection policy requirements.

[0004] The transparent sheet blister material is usually polyvinyl chloride (PVC), polyethylene terephthalate (PET), polypropylene (PP), polyethylene (PE), polystyrene (PS), etc. The water and oxygen barrier property of the above-mentioned materials is slightly poor, and a layer of PVDC needs to be coated to increase the barrier property to ensure the shelf life of the medicine. The year 2025 is the target time for using single-material recyclable products initiated by international organizations. PVC and PVDC contain chlorine, which has certain harmful effects on the human body and the environment. Therefore, the current blister packaging has begun to promote high-barrier polymer materials such as non-PVC and non-PVDC. However, there is still no corresponding blister packaging product on the market that can meet the requirements of recyclability, child protection, high barrier, low-temperature heat sealing, heat resistance and high rigidity, easy printing, etc. SUMMARY

[0005] To solve the above technical problems, a same-material medicine blister packaging and a preparation method thereof are provided, which solve the above problems.

[0006] To achieve the above purposes, the technical scheme adopted by the present application is as follows:

[0007] The same-material medicine blister packaging in the technical scheme of the present application is divided into a polyolefin transparent sheet blister and a polyolefin cover film.

[0008] Transparent polyolefin sheet blisters are produced using a multi-layer co-extrusion film blowing unit. The multi-layer extruders all use polyolefin materials, as well as biodegradable materials and inorganic fillers with a total content of less than 10%.

[0009] Furthermore, the multi-layer co-extrusion blown film unit is an air-cooled three-layer, five-layer, seven-layer, nine-layer film blowing unit, or a water-cooled bottom-blowing three-layer, five-layer, seven-layer co-extrusion blown film unit, or one or more of the above models.

[0010] Furthermore, the polyolefin resin is one or more of cycloolefin polymer COP, cycloolefin copolymer COC, polyethylene PE, and polypropylene PP.

[0011] Furthermore, the degradable material is one or more of PVA polyvinyl alcohol and PLA polylactic acid.

[0012] Furthermore, the inorganic filler is one or more of hydrotalcite, talc, diatomaceous earth, and precipitated barium sulfate.

[0013] The preferred water-cooled down-blowing five-layer co-extrusion film blowing unit is: the outer layer is 20% to 50% high-pressure low-density polyethylene, 80% to 50% metallocene polyethylene, and the layer thickness is 25-35μm; the sub-outer layer is 20% to 50% cycloolefin polymer, 80% to 50% high-pressure low-density polyethylene, and the layer thickness is 30-40μm; the middle layer is 60% to 80% high-density polyethylene, 20% to 10% cycloolefin polymer, and 20% to 10% polyvinyl alcohol, and the layer thickness is 40-50μm; the sub-inner layer is 20% to 50% cycloolefin polymer, 80% to 50% high-pressure low-density polyethylene, and the layer thickness is 30-40μm; the inner layer is 20% to 50% high-pressure low-density polyethylene, 80% to 50% metallocene polyethylene, and the layer thickness is 25-35μm.

[0014] Outer layer: low-density polyethylene 15%-45%: high-density polyethylene 82%-50%, inorganic filler 3%-5%, layer thickness: 25-35μm; Second outer layer: cycloolefin polymer 20%-50%, low-density polyethylene 80%-50%, layer thickness: 30-40μm; Middle layer: high-density polyethylene 50%-80%, cycloolefin polymer 20%-10%, polyvinyl alcohol 30%-10%, layer thickness: 40-50μm; Second inner layer: cycloolefin polymer 20%-50%, low-density polyethylene 80%-50%, layer thickness: 30-40μm; Inner layer: High-pressure low-density polyethylene 20% to 50%, metallocene polyethylene 80% to 50%, layer thickness: 25-35μm

[0015] Furthermore, the thickness of the 5-layer co-extruded transparent sheet blister is 150-200 μm; the thickness of the outer layer, sub-outer layer, middle layer, sub-inner layer, and inner layer are 25-35 μm, 30-40 μm, 40-50 μm, 30-40 μm, and 25-35 μm, respectively.

[0016] Furthermore, the outer layer formulation comprises the following components by weight: 15% to 45% high-pressure low-density polyethylene (HPLDPE), 82% to 50% metallocene polyethylene (MPE), and 3% to 5% inorganic filler for the inner layer. This formulation not only offers excellent extrusion processing performance, high melt strength, good stiffness, and film-forming properties, but also boasts high transparency, high rigidity, and ease of printing.

[0017] Furthermore, the inner layer's composition by weight is: 20%-50% high-pressure low-density polyethylene (HPLDPE) and 80%-50% metallocene polyethylene (MPE). This formulation not only offers excellent extrusion processing properties, but also boasts high transparency, high strength, puncture resistance, and high heat-sealing strength, effectively protecting the contents. The MPE's exceptional tear strength, heat-sealing strength, and puncture resistance ensure that the contents remain intact.

[0018] Furthermore, the sub-outer layer and the sub-inner layer have the same formula, including the following components in percentage by mass: 20% to 50% cycloolefin polymer and 80% to 50% high-pressure low-density polyethylene. The formula of this layer is mainly to provide excellent water vapor barrier properties, taking into account extrusion processing performance, while providing high rigidity to provide protection against high environmental temperatures. Cyclic olefin polymer has excellent water vapor barrier properties, and its raw steam (WVTR) barrier performance is more than 100 times that of polyethylene. Cyclic olefin polymer is a thermoplastic plastic, but the pure material is thinner and the products are highly transparent, rigid, and hard, and are prone to brittle cracking or whitening at creases. Its blending with highly transparent high-pressure low-density polyethylene can just solve the brittle cracking problem.

[0019] Furthermore, the middle layer formulation includes the following components by weight: 50% to 80% high-density polyethylene (HDPE), 20% to 10% cycloolefin polymer (COP), and 30% to 10% polyvinyl alcohol (PVA). This layer formulation primarily provides excellent water vapor and oxygen barrier properties while also taking into account extrusion processability. Cyclic olefin polymer (copolymer) exhibits excellent water vapor barrier properties, with a raw steam (WVTR) barrier performance over 100 times that of polyethylene. However, its oxygen barrier performance is generally similar to that of polyethylene. Polyvinyl alcohol exhibits excellent oxygen (OTR) barrier properties, less than 0.5 cm³ / (m²·24h·0.1MPa). This oxygen barrier performance significantly surpasses that of five-layer coextruded films using EVOH as a barrier layer and PVDC high-barrier coated films, and is approaching that of aluminum foil. However, COP is soluble in water, so the design of the middle layer with the film material provides water barrier protection, with outer and inner layers, and sub-outer and sub-inner layers. High-density polyethylene has good rigidity, high stiffness and low price. Its use in thicker middle layers makes the product more competitive in the market.

[0020] Furthermore, the high-pressure low-density polyethylene has a melting point greater than 110°C, a density ≥0.918g / cm3, and a melt index of 0.3~1g / 10min; the high-density polyethylene has a melting point greater than 130°C, a density ≥0.945g / cm3, and a melt index of 0.1~0.8g / 10min; the metallocene polyethylene has a melting point of 110°C, a density ≥0.9180.918g / cm3, and a melt index of 0.3~1g / 10min.

[0021] Furthermore, the cyclic polyolefin resin is one or more of cyclic olefin copolymer (COC) and cyclic olefin polymer (COP).

[0022] Furthermore, the density of PVA polyvinyl alcohol is ≥1.21 g / cm3, the melting point is about 220°C, the glass transition temperature is 75-85°C, the degree of polymerization is ≥1700, and the degree of alcoholysis is ≥88%.

[0023] The present invention adopts a five-layer composite technology. The outer layer is based on polyolefin material and inorganic fillers are added to improve the rigidity, heat resistance, barrier properties and printability of the film surface. The secondary middle layer is polyethylene and cycloolefin resin that is completely compatible with polyethylene to improve water vapor barrier properties and rigid toughness. The middle layer of polyethylene, cycloolefin resin and polyvinyl alcohol improves water vapor barrier properties, oxygen barrier properties, carbon dioxide barrier properties and rigid toughness. The inner layer mainly considers the heat sealing performance and drug safety performance. Pure polyethylene and low-temperature heat-sealed metallocene polyethylene materials are used to meet the requirements of low-temperature heat sealing while meeting biocompatibility and drug safety. The above formula and good compatibility between the layers ensure good adhesion between the layers, while ensuring the good mechanical properties of the blister packaging film. By matching with a single-material recyclable cover film, the recyclable function of a packaging system can be achieved.

[0024] The polyolefin cover film is produced by a multi-layer co-extrusion blown film unit. The multi-layer extruders all use polyolefin materials, as well as biodegradable materials and inorganic fillers with a total content of less than 10% (Group Standard T / SHBX005-2022 polyolefin packaging film and bags of the same material).

[0025] Furthermore, the multi-layer co-extrusion blown film unit is an air-cooled top-blowing three-layer, five-layer, seven-layer, nine-layer co-extrusion blown film unit, or a water-cooled bottom-blowing three-layer, five-layer, seven-layer co-extrusion blown film unit, or one or more of the above two types.

[0026] Furthermore, the polyolefin resin is one or more of polyethylene, polypropylene, and ethylene-propylene copolymer.

[0027] Furthermore, the degradable material is one or more of PVA, polyvinyl alcohol, and EVOH.

[0028] Furthermore, the inorganic filler is one or more of hydrotalcite, talc, diatomaceous earth, and precipitated barium sulfate.

[0029] The preferred production method is air-cooled upward blowing three-layer co-extrusion air-cooled film blowing unit. The air-cooled upward blowing equipment is inexpensive, has a simple process route, a high degree of automation, a higher yield and lower production cost, and is more suitable for carbon reduction and low-cost intelligent manufacturing.

[0030] Outer layer: low-density polyethylene 15% to 45%; high-density polyethylene 82% to 50%, inorganic filler 3% to 5%, layer thickness: 30-40μm Middle layer: high-density polyethylene 50% to 80%, cycloolefin resin 20% to 10%, polyvinyl alcohol 30% to 10%, layer thickness: 40-50μm Inner layer: High-pressure low-density polyethylene 20% to 50%, metallocene polyethylene 80% to 50%, layer thickness: 20-30μm

[0031] Furthermore, the outer layer formulation comprises the following components by weight: 15% to 45% high-pressure low-density polyethylene (HPLDPE), 82% to 50% metallocene polyethylene (MPE), and 3% to 5% inorganic filler for the inner layer. This formulation not only offers excellent extrusion processing performance, high melt strength, good stiffness, and film-forming properties, but also boasts high transparency, high rigidity, and ease of printing.

[0032] Furthermore, the middle layer formulation includes the following components by weight: 50%-80% high-density polyethylene (HDPE), 20%-10% cycloolefin polymer (COP), and 30%-10% polyvinyl alcohol (PVA). This layer formulation primarily provides excellent water vapor and oxygen barrier properties while also ensuring extrusion processability. COP exhibits excellent water vapor barrier properties, with a raw steam (WVTR) barrier performance over 100 times that of polyethylene, but its oxygen barrier performance is generally similar to that of polyethylene. Polyvinyl alcohol (PVA) exhibits excellent oxygen barrier performance (OTR), less than 0.5 cm³ / (m²·24h·0.1 MPa). Its OTR significantly surpasses that of multilayer co-extruded films using EVOH as a barrier layer and PVDC high-barrier coated films, approaching that of aluminum foil. However, VPA is water-soluble, requiring the design of an intermediate layer with the film material, including outer and inner layers, and sub-outer and sub-inner layers, to provide water barrier protection. High-density polyethylene offers excellent rigidity, high stiffness, and low cost, making its use in a thicker middle layer more competitive in the market.

[0033] Furthermore, the inner layer's composition by weight is: 20%-50% high-pressure low-density polyethylene (HPLDPE) and 80%-50% metallocene polyethylene (MPE). This formulation not only offers excellent extrusion processing properties, but also boasts high transparency, high strength, puncture resistance, and high heat-sealing strength, effectively protecting the contents. The MPE's exceptional tear strength, heat-sealing strength, and puncture resistance ensure that the contents remain intact.

[0034] The present invention also provides a method for preparing the novel recyclable high-barrier transparent blister, comprising the following steps:

[0035] Through five-layer co-extrusion blown film equipment at 145-235℃, water-cooled and blown to form a high-barrier transparent sheet with a thickness of 140-200μm;

[0036] The high-barrier transparent sheet is heated to 125-145°C for the second time, and the "grooves" of solid pharmaceutical capsules and tablets are completed by the blister forming process, and the high-barrier transparent sheet blisters are prepared by cutting equipment.

[0037] Furthermore, the five-layer co-extrusion blown film equipment in step (1) is a water-cooled bottom-blowing film blowing unit;

[0038] Furthermore, the set temperatures of the five extruders and die heads of the five-layer co-extrusion blown film equipment in step (1) are:

[0039] Extruder A (outer layer), 145℃165℃175℃185℃195℃215℃215℃;

[0040] Extruder B (secondary outer layer), 145℃165℃175℃185℃195℃215℃235℃;

[0041] Extruder C (middle layer), 145℃165℃175℃185℃195℃215℃235℃;

[0042] Extruder D (secondary inner layer), 145℃165℃175℃185℃195℃215℃235℃;

[0043] Extruder E (inner layer), 145℃165℃175℃185℃195℃215℃215℃;

[0044] Machine head temperature: 195℃215℃225℃225℃215℃.

[0045] Furthermore, the thickness of the five-layer co-extruded high barrier transparent sheet in step (1) is 140-200 μm;

[0046] Furthermore, the temperature of the five-layer co-extruded high barrier transparent sheet blister process in step (2) is 125-145°C;

[0047] The present invention also provides a method for preparing the novel recyclable high-barrier transparent blister cover film, comprising the following steps:

[0048] (1) Through three-layer co-extrusion blown film equipment at 145-235℃, air-cooled and blown to form a high-barrier transparent sheet with a thickness of 90-120μm;

[0049] (2) After the high-barrier transparent sheet undergoes surface corona treatment (38-42 dynes), the drug and food information is printed to obtain a high-barrier blister packaging cover film.

[0050] Furthermore, the three-layer co-extrusion blown film equipment in step (1) is an air-cooled upward blowing film blowing unit;

[0051] Furthermore, the set temperatures of the three extruders and die heads of the three-layer co-extrusion blown film equipment in step (1) are: extruder A (outer layer), 145°C 165°C 175°C 185°C 195°C 215°C 215°C;

[0052] Extruder B (middle layer), 145℃165℃175℃185℃195℃215℃235℃;

[0053] Extruder C (inner layer), 145℃165℃175℃185℃195℃215℃215℃;

[0054] Machine head temperature: 195℃215℃225℃215℃.

[0055] Furthermore, the thickness of the five-layer co-extruded high barrier transparent sheet in step (1) is 90-1200 μm;

[0056] Furthermore, the corona treatment effect of the three-layer co-extruded high barrier cover film in step (2) is 38-42 dynes;

[0057] Compared with the prior art, the present invention has the following beneficial effects:

[0058] (1) Using multi-layer composite extrusion molding technology, combined with the special physical and chemical properties of the raw materials, a blister packaging system with good water vapor and oxygen barrier properties, high transparency, high rigidity, high temperature resistance, and printability is obtained;

[0059] (2) Based on polyolefin resin, inorganic fillers and compatible resins are added, and the rational combination of different formulations between layers is combined to achieve a perfect match of interlayer functionality, which can not only achieve heat resistance of the outer layer and high barrier properties in the middle layer, but also ensure low-temperature heat sealing of the inner layer and the blister cover film;

[0060] (3) The new recyclable high-barrier blister packaging made of the same material of the present invention is an optimal material for carbon reduction;

[0061] (4) The good compatibility between the layers of the sheet film of the high-barrier transparent blister of the present invention ensures good adhesion between the layers without delamination. The hard plastic cycloolefin polymer (copolymer) in the middle layer ensures both high barrier properties of the material and high rigidity and other mechanical properties of the material.

[0062] (5) The novel recyclable high-barrier blister packaging made of the same material of the present invention can be applied to blister packaging for medicine, medical treatment, and food packaging, and has good recyclability;

[0063] (6) The new recyclable high-barrier blister packaging made of the same material of the present invention can replace the existing market applications of blisters made of PVC transparent sheets or PVC transparent sheets coated with PVDC and aluminum foil cover film PTP. The carbon footprint brought about by the production process is greatly reduced, which is beneficial to environmental protection. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] Figure 1 It is a preparation process framework diagram of the present invention. DETAILED DESCRIPTION

[0065] The following description is intended to disclose the present invention so that those skilled in the art can implement the present invention. The preferred embodiments described below are merely examples, and those skilled in the art may conceive of other obvious variations.

[0066] Example 1

[0067] The method for preparing the novel recyclable high-barrier blister packaging film of this embodiment comprises the following steps:

[0068] The five-layer co-extrusion water-cooled blown film blowing unit co-extrudes at 145-235℃ and water-cooled blown to form a 175μm thick high barrier transparent sheet. The set temperatures of the five extruders and die heads of the five-layer co-extrusion blown film equipment are:

[0069] Extruder A (outer layer), 145℃165℃175℃185℃195℃215℃215℃;

[0070] Extruder B (secondary outer layer), 145℃165℃175℃185℃195℃215℃235℃;

[0071] Extruder C (middle layer), 145℃165℃175℃185℃195℃215℃235℃;

[0072] Extruder D (secondary inner layer), 145℃165℃175℃185℃195℃215℃235℃;

[0073] Extruder E (inner layer), 145℃165℃175℃185℃195℃215℃215℃;

[0074] Machine head temperature: 195℃215℃225℃225℃215℃.

[0075] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 30μm; Second outer layer: COC081240%, LDPE2420D60%, layer thickness 35μm; Middle layer: HDPE609860%, COC081215%, PVA17%~9425%, layer thickness: 45μm; Second inner layer: COC081240%, LDPE2420D60%, layer thickness: 35μm; Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 30μm

[0076] (2) The high-barrier transparent sheet is heated to 125-145°C for the second time, and the "grooves" of solid pharmaceutical capsules and tablets are completed by the blister forming process, and the high-barrier transparent sheet blisters are prepared by cutting equipment.

[0077] The present invention also provides a method for preparing the novel recyclable high-barrier transparent blister cover film, comprising the following steps:

[0078] (3) Through the three-layer co-extrusion air-cooled blown film equipment, co-extrusion is carried out at 145-235℃, and air-cooled blown film is formed into a high-barrier transparent sheet with a thickness of 105μm; the set temperatures of the three extruders and the die head of the three-layer co-extrusion blown film equipment are:

[0079] Extruder A (outer layer), 145℃165℃175℃185℃195℃215℃215℃;

[0080] Extruder B (middle layer), 145℃165℃175℃185℃195℃215℃235℃;

[0081] Extruder C (inner layer), 145℃165℃175℃185℃195℃215℃215℃;

[0082] Head temperature: 195℃215℃225℃215℃

[0083] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 35μm Middle layer: HDPE609850%, COC081225%, PVA17%~9425%, layer thickness: 45μm Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 25μm

[0084] (4) After the high-barrier transparent sheet is subjected to surface corona treatment (40 dynes), pharmaceutical and food information is printed to obtain a high-barrier blister packaging cover film.

[0085] The low-density polyethylene is LDPE2420D from COSCO Shell; the high-density polyethylene is HDPE6098 from Sinopec; the inorganic filler is HT3 hydrotalcite from Kaisima New Materials Technology Co., Ltd.; the cyclic olefin copolymer is COC0812 from Liaoning Luhua Hongjin New Materials Co., Ltd.; the polyvinyl alcohol is PVA17-94 from Kuraray of Japan; and the metallocene polyethylene is mLLDPE1018MA from ExxonMobil.

[0086] Example 2 COC + PVA lower limit = barrier property decreases, tear strength increases, and rigidity decreases

[0087] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 30μm; Second outer layer: COC081220%, LDPE2420D80%, layer thickness 35μm; Middle layer: HDPE609880%, COC081210%, PVA17%~9410%, layer thickness: 45μm; Second inner layer: COC081220%, LDPE2420D80%, layer thickness: 35μm; Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 30μm

[0088] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 35μm Middle layer: HDPE609880%, COC081210%, PVA17%~9410%, layer thickness: 45μm Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 25μm

[0089] Example 3 COC + PVA upper limit = barrier properties increased significantly, tear strength decreased, and rigidity increased

[0090] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 30μm; Second outer layer: COC081250%, LDPE2420D50%, layer thickness 35μm; Middle layer: HDPE609850%, COC081220%, PVA17%~9430%, layer thickness: 45μm; Second inner layer: COC081250%, LDPE2420D50%, layer thickness: 35μm; Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 30μm

[0091] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 35μm Middle layer: HDPE609850%, COC081220%, PVA17%~9430%, layer thickness: 45μm Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 25μm

[0092] Example 4COC replaces cop

[0093] Japan Zeon ZEONEXCOP690R medical type = increased light transmittance and good barrier properties

[0094] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 30μm; Second outer layer: COC081240%, LDPE2420D60%, layer thickness 35μm; Middle layer: HDPE609860%, COC081215%, PVA17%~9425%, layer thickness: 45μm; Second inner layer: COC081240%, LDPE2420D60%, layer thickness: 35μm; Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 30μm

[0095] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 35μm Middle layer: HDPE609850%, COC081225%, PVA17%~9425%, layer thickness: 45μm Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 25μm

[0096] Detection indicators

[0097] Comparative Example 1 = Removing COC (HDPE in equal proportion) leads to a sharp drop in water vapor barrier properties and a decrease in rigidity

[0098] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 30μm; Second outer layer: HDPE609840%, LDPE2420D60%, layer thickness 35μm; Middle layer: HDPE609875%, PVA17%~9425%, layer thickness: 45μm; Second inner layer: HDPE609840%, LDPE2420D60%, layer thickness: 35μm; Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 30μm

[0099] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 35μm Middle layer: HDPE609875%, PVA17%~9425%, layer thickness: 45μm Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 25μm

[0100] Comparative Example 2 = PVA's oxygen barrier property drops sharply

[0101] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 30μm; Second outer layer: COC081240%, LDPE2420D60%, layer thickness 35μm; Middle layer: HDPE609860%, COC081240%, layer thickness: 45μm; Second inner layer: COC081240%, LDPE2420D60%, layer thickness: 35μm; Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 30μm

[0102] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 35μm Middle layer: HDPE609850%, COC081250%, layer thickness: 45μm Inner layer: LDPE2420D30%, mLLDPE1018MA70%, layer thickness: 25μm

[0103] Comparative Example 3 = mLLDPE (replacing HDPE) has poor low-temperature heat sealing properties and slightly higher rigidity

[0104] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 30μm; Second outer layer: COC081240%, LDPE2420D60%, layer thickness 35μm; Middle layer: HDPE609860%, COC081215%, PVA17%~9425%, layer thickness: 45μm; Second inner layer: COC081240%, LDPE2420D60%, layer thickness: 35μm; Inner layer: LDPE2420D30%, HDPE609870%, layer thickness: 30μm

[0105] Outer layer: LDPE2420D30%: HDPE609867%, hydrotalcite 3%, layer thickness: 35μm Middle layer: HDPE609850%, COC081225%, PVA17%~9425%, layer thickness: 45μm Inner layer: LDPE2420D30%, HDPE609870%, layer thickness: 25μm

[0106] Blister Packaging System Performance Test Results

[0107] 1. Surface tension, which characterizes printability and printing fastness, is tested using a dyne pen according to GB / T22237-2008 "Determination of surface tension of surfactants";

[0108] 2. Light transmittance: This indicates the clarity of the blister contents under natural light. It is tested using a visible light transmittance tester according to GB / T2410-2008 “Determination of light transmittance and haze of transparent plastics”.

[0109] 3. Water vapor barrier property (WVTR), YBB00092003-2015 "Determination of water vapor transmission rate", tested using Jinan Blue Light Electromechanical Technology Co., Ltd. C390H water vapor transmission tester, unit: g / (m²·24h);

[0110] 4. Oxygen barrier property (OTR), YBB00132002-2015: tested with a water vapor transmission tester C230H produced by Jinan Blue Light Electromechanical Technology Co., Ltd., unit: cm³ / (m²·24h·0.1MPa);

[0111] 5. Heat seal strength, which indicates the heat seal firmness of the blister and cover film, is tested using the Jinan Saicheng HST-H3 heat seal tester in accordance with YBB00122003-2015 "Determination of Heat Seal Strength". The unit is N / 15cm.

[0112] 6. Tear strength, characterizing mechanical strength, test method: right-angle tear strength test, standard QB / T1130-1991, tested with a universal tensile testing machine, unit: KN / m;

[0113] 7. Elastic modulus, characterizing rigidity, test method: universal tensile test, standard ASTM D1681348.6, unit: MPa;

[0114] 8. Temperature resistance, which characterizes the ability to withstand high temperature sterilization. Use 121°C steam high temperature sterilization for 45 minutes to observe the integrity and deformation of the blister system;

[0115] 9. Dissolution test, microbial limit, abnormal toxicity.

[0116] According to the National Drug and Food Administration and the national drug packaging container standards, the obtained blister packaging cover film meets the blister system, can meet the protective packaging of drugs such as tablets and capsules, has excellent heat sealing strength and surface heat resistance, and also meets the requirements of the blister packaging machine.

[0117] Example 2 COC+PVA lower limit = barrier property decreases, tear strength increases, and rigidity decreases;

[0118] Example 3 COC + PVA upper limit = barrier properties increased greatly tear strength decreased rigidity;

[0119] Example 4COC replaced cop = transparency barrier property slightly increased;

[0120] Comparative Example 1 = Removing COC (HDPE replacement in equal proportion) leads to a sharp drop in water vapor barrier properties and a decrease in rigidity;

[0121] Comparative Example 2 = PVA's oxygen barrier property dropped sharply;

[0122] Comparative Example 3 = mLLDPE (replacing HDPE) has poor low-temperature heat sealing properties and slightly greater rigidity;

[0123] Finally, it should be noted that the specific embodiments described herein are merely illustrative of the spirit of the present invention and are not intended to limit the manner in which the present invention is intended to be practiced. Persons skilled in the art may make various modifications, additions, or substitute similar methods for the described embodiments. It is not necessary and impossible to provide comprehensive examples of all manner of practice. However, obvious variations or modifications derived from the essential spirit of the present invention remain within the scope of protection of the present invention, and interpreting them as any additional limitations would be contrary to the spirit of the present invention.

[0124] Transparent sheet blister test indicators:

[0125] Case Transmittance% Water vapor WVTRg / (m²·24h) Oxygen OTR cm³ / (m²·24h·0.1MPa) Temperature resistance Heat sealing strength N / 15mm Surface tension dyn / cm Tear strength KN / m Elastic modulus MPa Example 1 86 0.29 0.38 OK 25.2 40 136 23.4 Example 2 84 0.81 0.91 OK 24.9 40 520 11 Example 3 83 0.12 0.15 OK 24.8 40 96 135 Example 4 88 0.24 0.39 OK 25.0 40 134 22.8 Comparative Example 1 80 480 0.41 NG 25.1 40 564 6.8 Comparative Example 2 84 0.30 1290 OK 25.0 40 136 22.8 Comparative Example 3 80 0.29 0.38 OK 12.0 40 140 25

[0126] Blister cover film testing indicators

[0127] Case Transmittance% Water vapor WVTR Oxygen OTR Temperature resistance Heat sealing strength N / 15mm Surface tension dyn / cm Tear strength MPa Elastic modulus MPa Example 1 85 0.31 0.42 OK 25.1 40 130 22 Example 2 84 0.85 0.94 OK 25.2 40 512 12 Example 3 82 0.12 0.19 OK 25.1 40 86 131 Example 4 88 0.26 0.41 OK 25.0 40 128 22 Comparative Example 1 81 482 0.45 NG 24.9 40 580 6.3 Comparative Example 2 84 0.32 1380 OK 25.2 40 135 22 Comparative Example 3 79 0.30 0.42 OK 12.1 40 129 24.8

[0128] In summary, the advantages of the present invention are:

[0129] Through a multi-layer co-extrusion structure design and specific component ratios, the blister packaging combines high barrier properties (water vapor WVTR as low as 0.12g / (m²・24h), oxygen OTR as low as 0.15cm³ / (m²・24h・0.1MPa)), high transparency (transmittance up to 88%), high rigidity (elastic modulus up to 135MPa), and excellent temperature resistance (no abnormalities after high-temperature sterilization at 121°C), effectively ensuring the stability of drugs throughout their shelf life.

[0130] The outer layer has good printability (surface tension 38-42 dynes), and the inner layer and cover film can achieve high-strength, low-temperature heat sealing (heat sealing strength ≥ 24.8N / 15mm), meeting the requirements of blister packaging machines. The tear strength is moderate (96-564KN / m), ensuring both packaging protection and easy opening.

[0131] It uses the same polyolefin material system, does not contain harmful ingredients such as PVC and PVDC, is highly recyclable, complies with carbon reduction policy requirements, solves the problem of traditional aluminum-plastic composite film being difficult to completely separate and recycle, and significantly reduces the carbon footprint of the production process;

[0132] The synergistic effect of cycloolefin polymer (COP / COC) and polyvinyl alcohol (PVA) ensures high barrier properties while utilizing the compatibility of interlayer materials to solve the problem of PVA dissolving in water. The addition of inorganic fillers improves the rigidity and heat resistance of the material, and the complementary functions of each layer achieve optimal performance.

[0133] It meets the strict standards for pharmaceutical packaging and has passed tests such as extractables, microbial limits and abnormal toxicity. It is suitable for solid pharmaceutical packaging such as tablets and capsules. It can also be expanded to the food and medical fields, replacing traditional PVC / PVDC blister packaging to improve packaging safety and environmental protection.

[0134] The above shows and describes the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The above embodiments and descriptions merely illustrate the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. A blister pack of medicines made of the same material, characterized in that: include: A polyolefin transparent sheet blister and a polyolefin cover film, both of which are based on polyolefin materials and contain a total content of less than 10% of degradable materials and inorganic fillers; The polyolefin transparent sheet blister is a five-layer co-extruded structure, which comprises an outer layer, a sub-outer layer, a middle layer, a sub-inner layer and an inner layer from the outside to the inside. The polyolefin cover film is a three-layer co-extruded structure, which comprises an outer layer, a middle layer and an inner layer from the outside to the inside.

2. A blister pack of medicines made of the same material according to claim 1, characterized in that: The outer layer of the polyolefin transparent sheet blister is prepared based on a specific composition ratio, including the following components in percentage by weight: High-pressure low-density polyethylene 15% to 45%, metallocene polyethylene 82% to 50%, inorganic filler 3% to 5%, layer thickness 25-35μm; The sub-outer layer and the sub-inner layer are prepared based on the same formula, and both include the following components in percentage by weight: 20% to 50% cycloolefin polymer and 80% to 50% high-pressure low-density polyethylene, and the layer thickness is 30-40 μm. The middle layer comprises the following components in percentage by mass: 50% to 80% high-density polyethylene, 20% to 10% cycloolefin polymer, and 30% to 10% polyvinyl alcohol, with a layer thickness of 40-50 μm; The inner layer comprises the following components in percentage by mass: 20% to 50% of high-pressure low-density polyethylene and 80% to 50% of metallocene polyethylene, with a layer thickness of 25-35 μm.

3. The blister pack of medicines made of the same material according to claim 1, characterized in that: The outer layer of the polyolefin cover film comprises the following components in percentage by mass: 15% to 45% high pressure low density polyethylene, 82% to 50% metallocene polyethylene, 3% to 5% inorganic filler, and a layer thickness of 30-40 μm; The middle layer comprises the following components in percentage by mass: 50% to 80% high-density polyethylene, 20% to 10% cycloolefin polymer, and 30% to 10% polyvinyl alcohol, with a layer thickness of 40-50 μm; The inner layer comprises the following components in percentage by mass: 20% to 50% of high-pressure low-density polyethylene and 80% to 50% of metallocene polyethylene, with a layer thickness of 20-30 μm.

4. The blister pack of medicines made of the same material according to claim 1, characterized in that: The cycloolefin polymer is selected based on material properties and is one or a combination of cycloolefin copolymer and cycloolefin polymer; The degradable material is one or a combination of polyvinyl alcohol and polylactic acid; The inorganic filler is one or a combination of two of hydrotalcite, talc powder, diatomaceous earth and precipitated barium sulfate.

5. The blister pack of medicines made of the same material according to claim 4, characterized in that: The melting point of high-pressure low-density polyethylene is greater than 110°C, the density is greater than or equal to 0.918g / cm³, and the melt index is 0.3 to 1g / 10min; The melting point of high-density polyethylene is greater than 130°C, the density is greater than or equal to 0.945g / cm³, and the melt index is 0.1 to 0.8g / 10min; The melting point of metallocene polyethylene is 110°C, the density is ≥0.918g / cm³, and the melt index is 0.3-1g / 10min; The density of polyvinyl alcohol is ≥1.21g / cm³, the melting point is about 220℃, the glass transition temperature is 75~85℃, the degree of polymerization is ≥1700, and the degree of alcoholysis is ≥88%.

6. A method for preparing blister packaging of medicines made of the same material, characterized in that: The preparation steps are: S1. Prepare materials, including raw materials for preparing various layers of polyolefin transparent sheet blisters and polyolefin cover films; S2. Prepare polyolefin transparent sheet blisters by co-extruding at 145-235°C using a five-layer co-extrusion blown film machine, water-cooling and blow-forming a high-barrier transparent sheet with a thickness of 140-200 μm, then heating it to 125-145°C, forming grooves using a blister process, and cutting the resulting film. S3. Prepare a polyolefin cover film by co-extruding at 145-235° C. using a three-layer co-extrusion blown film machine, air-cooling and blow-forming a high-barrier transparent sheet with a thickness of 90-120 μm, performing a surface corona treatment to achieve a surface tension of 38-42 dynes, and then printing. S4. Test the prepared medicine blister packages made of the same material.

7. The method for preparing a blister package of medicines made of the same material according to claim 6, characterized in that: The heating method of the blister process in step S2 is secondary heating, and the temperature control accuracy of the heating equipment is ±2°C. The corona treatment in step S3 adopts a high-frequency and high-voltage corona machine, and the processing speed is 30-50m / min.

8. The method for preparing a blister package of medicines made of the same material according to claim 6, characterized in that: When preparing the polyolefin transparent sheet blister in step S2, the five-layer co-extrusion blown film equipment is a water-cooled bottom blown film unit, and the temperature settings of the five extruders and the die are as follows: Extruder A outer layer: 145℃, 165℃, 175℃, 185℃, 195℃, 215℃, 215℃; Extruder B outer layer: 145℃, 165℃, 175℃, 185℃, 195℃, 215℃, 235℃; Extruder C middle layer: 145℃, 165℃, 175℃, 185℃, 195℃, 215℃, 235℃; Extruder (D times): 145℃, 165℃, 175℃, 185℃, 195℃, 215℃, 235℃; Extruder E inner layer: 145℃, 165℃, 175℃, 185℃, 195℃, 215℃, 215℃; Head temperature: 195℃, 215℃, 225℃, 225℃, 215℃; In the blister forming process, the high barrier transparent sheet is placed in a heating device and heated at a temperature of 125-145°C. After heating is completed, blister forming is performed to form grooves.

9. The method for preparing a blister package of medicines made of the same material according to claim 6, characterized in that: When preparing the polyolefin cover film in step S3, the three-layer co-extrusion blown film equipment is an air-cooled top blown film blowing unit, and the temperatures of the three extruders and the die are set as follows: Extruder A outer layer: 145℃, 165℃, 175℃, 185℃, 195℃, 215℃, 215℃; Extruder B middle layer: 145℃, 165℃, 175℃, 185℃, 195℃, 215℃, 235℃; Extruder C inner layer: 145℃, 165℃, 175℃, 185℃, 195℃, 215℃, 215℃; Head temperature: 195℃, 215℃, 225℃, 215℃; The corona treatment uses a high-frequency and high-voltage corona machine with a treatment speed of 30 to 50 m / min. After the treatment, the sheet is printed.

10. The method for preparing a blister package of medicines made of the same material according to claim 6, characterized in that: The tests on the blister packaging of medicines made of the same material in step S4 include light transmittance, water vapor barrier properties, oxygen barrier properties, heat seal strength, tear strength, elastic modulus and temperature resistance tests.

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