Light-proof medicinal outer packaging material and preparation method thereof

Abstract

The invention provides a light-proof medicinal outer packaging material and a preparation method thereof. The outer packaging material comprises a first polymer film layer, a second polymer film layer and a third polymer film layer, wherein inorganic non-metal oxide is evaporated on the surface of one side of the first polymer film layer; the ink layer is applied to one side, evaporated with the inorganic non-metal oxide, of the first polymer film layer in a coating manner; and the second polymer film layer is in dry type compounding with one side, coated with the ink layer, of the first polymer film layer through an adhesive. The light-proof medicinal outer packaging material can effectively avoid light and is excellent in barrier property.

Description

Technical Field

[0001] The invention relates to the technical field of packaging materials, and in particular to a light-proof medicinal outer packaging material and a preparation method thereof. Background Art

[0002] Pharmaceutical outer packaging materials refer to packaging materials that do not directly contact drugs, which can provide protection for the transportation and storage of drugs. For some drugs, photochemical reactions are prone to occur during storage, so it is necessary to consider packaging in a light-shielding or light-avoiding manner. Light-shielding means not being light-transmitting, and light-avoiding means avoiding sunlight. Among them, for drugs whose photochemical reactions are not very strong, light-avoiding packaging is usually used for transportation and storage. For example, common drugs that need to be kept away from light include: levofloxacin hydrochloride for injection, ceftriaxone sodium for injection, sodium nitroprusside for injection, methylcobalamin tablets, etc.

[0003] The pharmaceutical outer packaging materials in the prior art can generally meet the light-shielding requirements, but their disadvantage is that they have poor barrier properties and are difficult to effectively block water vapor and oxygen, thus affecting the stability of the drug. Summary of the invention

[0004] One of the problems solved by the present invention is how to provide an outer packaging material that can meet the light-shielding requirement and has good barrier properties.

[0005] In order to solve at least one of the above problems, the present invention provides a light-proof pharmaceutical outer packaging material, which includes: a first polymer film layer, one side of which is vapor-deposited with an inorganic non-metallic oxide; an ink layer, which is coated on the side of the first polymer film layer on which the inorganic non-metallic oxide is vapor-deposited; and a second polymer film layer, which is dry-compounded with the side of the first polymer film layer coated with the ink layer via an adhesive.

[0006] In any of the above technical solutions, the first polymer film layer is a polyester film layer, and the inorganic non-metallic oxide includes at least one of aluminum oxide and silicon oxide or a combination thereof.

[0007] In any of the above technical solutions, the ink layer is a brown transparent ink layer.

[0008] In any of the above technical solutions, the adhesive is a polyurethane adhesive.

[0009] In any of the above technical solutions, the second polymer film layer is a polyethylene film layer, or a polypropylene film layer, or a polyethylene-polypropylene composite film layer.

[0010] In any of the above technical solutions, the thickness of the first polymer film layer is 10 μm to 15 μm.

[0011] In any of the above technical solutions, the thickness of the second polymer film layer is 20 μm to 100 μm.

[0012] In any of the above technical solutions, the weight of the first polymer film layer is 14g / m 2 -21g / m 2 .

[0013] In any of the above technical solutions, the amount of ink applied is 1.2 g / m 2 -2.0g / m 2 .

[0014] In any of the above technical solutions, the amount of adhesive applied is 1.2 g / m 2 -2.0g / m 2 .

[0015] In any of the above technical solutions, the weight of the second polymer film layer is 18g / m 2 -95g / m 2 .

[0016] In any of the above technical solutions, the light transmittance of the outer packaging material is 60% to 70%.

[0017] In any of the above technical solutions, the water vapor permeability of the outer packaging material is less than or equal to 1.0 g / (m2·24h).

[0018] The present invention also provides a method for preparing a light-proof pharmaceutical outer packaging material, which is used to prepare an outer packaging material according to any of the above technical solutions, and comprises:

[0019] S100, preparing ink coating liquid;

[0020] S200, applying the ink coating liquid to the side of the first polymer film layer on which the inorganic non-metallic oxide is evaporated to form an ink layer;

[0021] S300, applying an adhesive coating to the ink layer, and dry-compounding a second polymer film layer to the ink layer.

[0022] In any of the above technical solutions, the ink coating liquid includes: dye, 10 to 15 parts by mass; butanone, 300 to 350 parts by mass; butyl acetate, 50 to 100 parts by mass; vinyl chloride-vinyl acetate copolymer resin, 85 to 90 parts by mass.

[0023] In any of the above technical solutions, the dye includes a metal complex yellow dye and a metal complex red dye.

[0024] In any of the above technical solutions, the ink coating liquid is prepared by mixing the dye, butanone, butyl acetate and vinyl chloride-vinyl acetate copolymer resin and stirring them evenly to obtain the ink coating liquid.

[0025] Beneficial Effects

[0026] The present invention provides a light-proof medicinal outer packaging material, the purpose of which is to meet the light-proof requirements of the outer packaging material and improve the barrier properties of the outer packaging material. The outer packaging material of the present invention comprises a first polymer film layer and a second polymer film layer. Among them, an inorganic non-metallic oxide is evaporated on one side of the surface of the first polymer film layer. The inorganic non-metallic oxide can improve the barrier properties of the outer packaging material, give it a better ability to block water vapor and oxygen, and can improve the mechanical strength of the outer packaging material. The side of the first polymer film layer on which the inorganic non-metallic oxide is evaporated is also coated with an ink layer, and the ink layer gives the outer packaging material light-proof properties. The second polymer film layer is dry-compounded with the first polymer film layer through an adhesive, and the structure of the first polymer film layer and the second polymer film layer composite can further improve the barrier properties of the outer packaging material. The light transmittance of the outer packaging material obtained by the technical solution of the present invention is 60% to 70%, and its water vapor permeability is less than or equal to 1.0g / (m2·24h). DETAILED DESCRIPTION

[0027] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the following is a detailed description of the specific embodiments of the present invention.

[0028] Unless otherwise specified, the reagents and raw materials used in the present invention can be purchased through commercial channels. The experimental methods in the following examples without specifying specific conditions are selected according to conventional methods and conditions, or according to the product specifications.

[0029] The embodiment of the present invention provides a light-proof pharmaceutical outer packaging material, which is composited by a first polymer film layer and a second polymer film layer. An inorganic non-metallic oxide is vapor-deposited on one side of the first polymer film layer, and an ink layer is applied to the side of the first polymer film layer on which the inorganic non-metallic oxide is vapor-deposited. The second polymer film layer is dry-compounded with the side of the first polymer film layer coated with the ink layer through an adhesive.

[0030] The light-proof medicinal outer packaging material of the present invention is prepared by the following steps:

[0031] S100, preparing ink coating liquid;

[0032] S200, applying the ink coating liquid to the side of the first polymer film layer on which the inorganic non-metallic oxide is evaporated to form an ink layer;

[0033] S300, applying an adhesive coating to the ink layer, and dry-compounding a second polymer film layer to the ink layer.

[0034] The present invention prints an ink layer (preferably transparent brown ink) on an inorganic evaporated polyester film, and then composites it with a dry second polymer (preferably polypropylene or polyethylene), so that the composite film can obtain a good light-proof function, and can better block water vapor and oxygen at the same time, and it is very suitable for the outer packaging of similar quinolone injections. In addition to having the basic functions of dustproof and light-proof, the outer packaging material of the present invention also has good barrier properties under the premise of meeting the transparency requirements. Light-proof is conducive to blocking the photochemical reaction when the medicine is stored, and transparency is conducive to clearly seeing the state of the packaged medicine before use and reading the label, and blocking is conducive to reducing the water escape of injection medicines to maintain the stability of their effective concentration. Therefore, the outer packaging material of the present invention is adopted, which is more beneficial to the protection of medicines.

[0035] The weight of the first polymer film layer is 14 g / m 2 -21g / m 2 , the application amount of ink layer is 1.2g / m 2 -2.0g / m 2 , the amount of adhesive applied is 1.2g / m 2 -2.0g / m 2 The weight of the second polymer film layer is 18 g / m 2 -95g / m 2 .

[0036] The inorganic non-metallic oxide evaporated on the surface of the first polymer film layer helps to improve the barrier properties of the outer packaging material, so that it can better block water vapor and oxygen, and can improve the mechanical strength of the outer packaging material.

[0037] Preferably, the first polymer film layer is a polyester film layer, and the inorganic non-metallic oxide comprises at least one of aluminum oxide and silicon oxide or a combination thereof. The thickness of the first polymer film layer is 10 μm to 15 μm.

[0038] Polyester film is made of polyethylene terephthalate (PET) as raw material, which is made into thick sheets by extrusion and then biaxially stretched to form a film material. Polyester film is a transparent material with a high surface finish. It has good heat resistance, chemical stability, rigidity, hardness and toughness, and relatively good air tightness and barrier properties. In addition, polyester film can maintain good toughness and tenacity even at extreme temperatures (such as minus 70 degrees Celsius). Finally, polyester film has good printing performance and super strong stretchability, which is very suitable for the coating and application of ink layers and the evaporation of inorganic non-metallic oxides. ,

[0039] Preferably, the second polymer film layer is a polyethylene film layer, or a polypropylene film layer, or a polyethylene-polypropylene composite film layer. The thickness of the second polymer film layer is 20 μm to 100 μm. Polyethylene film is a film produced from polyethylene (PE) particles, which has the characteristics of moisture resistance and low moisture permeability. In addition, polyethylene film has good toughness, moisture resistance and heat sealing properties, and is easy to process and shape, and is cheap. Polypropylene film is a film material made from polypropylene (PP) resin. Polypropylene, as a thermoplastic polymer material, has the characteristics of high melting point and excellent comprehensive performance. Polypropylene film has the advantages of low specific gravity, excellent mechanical properties (such as yield strength, tensile strength, surface strength, etc.), good stress cracking resistance and wear resistance, excellent chemical stability, and easy molding and processing.

[0040] Preferably, the ink layer of the present invention is a brown transparent ink layer, which has good light-shielding ability under the premise of ensuring a certain transparency. In the present invention, the ink layer is applied to the first polymer in the following manner: first prepare an ink coating liquid, and then apply the ink coating liquid to the first polymer film layer. Specifically, a gravure anilox roller coater can be used to apply the ink coating liquid. The ink coating liquid of the present invention includes: dye, 10 to 15 parts by mass; butanone, 300 to 350 parts by mass; butyl acetate, 50 to 100 parts by mass; vinyl chloride-vinyl acetate copolymer resin, 85 to 90 parts by mass. Preferably, the dye is prepared by mixing a metal complex yellow dye and a metal complex red dye. The ink coating liquid is prepared by mixing and stirring the dye, butanone, butyl acetate and vinyl chloride-vinyl acetate copolymer resin to obtain an ink coating liquid. Among them, high-speed stirring of the above raw materials can be achieved by magnetic stirring or ultrasonic stirring to ensure the uniformity of the dispersion of the dye in the ink coating liquid. The solid content of the ink coating liquid is preferably 20%. The transparent ink system of resin and dye used in the present invention has a light transmittance that meets the requirements and has good adhesion to the film.

[0041] Preferably, the adhesive is a polyurethane adhesive. The polyurethane adhesive is mainly composed of ammonium isocyanate, polyol, hydrocarbon-containing polyether, polyester and epoxy resin, filler, catalyst and solvent. It is an adhesive containing carbamate group (-NHCOO-) or isocyanate group (-NCO) in the molecular chain, and has excellent bonding properties. Further preferably, the present invention can use a solvent-free polyurethane composite adhesive.

[0042] In order to take into account both the barrier properties and transparency of the film material, the present invention uses a barrier film formed by evaporation of inorganic oxides such as silicon oxide and aluminum oxide, and improves the barrier properties of the outer packaging material by evaporating inorganic oxide particles onto a polyester film layer substrate.

[0043] Inorganic non-metallic oxides such as aluminum oxide and silicon oxide are applied to the polyester film by vapor deposition. Taking aluminum oxide vapor deposition as an example, a clean and flat polyester film is required as the substrate. The polyester film needs to be cleaned before vapor deposition to ensure that its surface is free of impurities, oil and moisture. Preferably, the polyester film can be corona treated before vapor deposition to increase its surface tension and adhesion. After the polyester film substrate is prepared, the polyester film substrate is placed in a vacuum chamber and evacuated using a vacuum pump to remove oxygen and moisture from the surface of the substrate to avoid oxidation and contamination during the vapor deposition process. The vacuum degree is controlled at 4×10 -4 mbar or above to ensure the purity of the evaporation environment. In the evaporation stage, the aluminum material is first placed in the evaporation source and heated to the evaporation temperature to evaporate it into a gaseous state. The evaporation source can be electron beam evaporation, resistance heating evaporation or laser evaporation. The vapor diffuses in the vacuum chamber and deposits on the polyester film substrate to form a uniform aluminum oxide film. Among them, those skilled in the art can control the thickness of the aluminum oxide film by controlling parameters such as evaporation time, evaporation rate and substrate movement speed. After the evaporation is completed, the aluminum oxide film needs to be annealed to eliminate stress and defects in the film and improve its crystallinity and stability. The annealing temperature and time can be set by those skilled in the art according to specific process requirements.

[0044] Taking into account the interface differences and poor bonding strength between the polyester film layer substrate and the inorganic evaporated material, the present invention can, on the one hand, increase the surface polarity of the polyester film layer through physical pretreatment such as corona and plasma, thereby increasing the bonding strength between the polyester film layer and the inorganic evaporated material; on the other hand, the polyester film layer can also be modified to improve the bonding strength between it and the inorganic coating, thereby further improving the barrier properties of the outer packaging material.

[0045] Example 1

[0046] This embodiment provides an outer packaging material, which is prepared by the following steps:

[0047] S1. Mix the raw materials according to the mass ratio of metal complex yellow dye: metal complex red dye: butanone: butyl acetate: vinyl chloride-vinyl acetate copolymer resin = 9:1:300:100:90 and stir at high speed to obtain an ink coating liquid;

[0048] S2. Use a gravure anilox roller coater to evenly coat the ink coating liquid on the surface of the first polymer film layer to form a brown transparent ink layer; control the application amount of the ink layer to 1.5 g / m 2 ; wherein a polyester film with aluminum oxide deposited thereon obtained from commercial purchase is used as the first polymer film layer;

[0049] S3, apply polyurethane adhesive to the ink layer, the amount of adhesive applied is 1.5g / m 2 The side of the first polymer film layer having the ink layer is dry-laminated with a commercially purchased polypropylene film on a dry-type laminating machine to obtain an outer packaging material.

[0050] Example 2

[0051] This embodiment provides an outer packaging material, and the preparation steps thereof are the same as those of Embodiment 1, except that the first polymer film layer used in this embodiment is not commercially purchased, but is prepared by the following steps:

[0052] S1. Place the commercially purchased polyester film in a vacuum chamber, close the vacuum chamber and evacuate it;

[0053] S2, when the vacuum degree reaches 4×10 -4 When the mba is above the limit, the evaporation boat is heated to 1500°C, and the aluminum material and oxygen are vacuum evaporated on the polyester film substrate through the electron beam gun of the electron beam winding coating equipment to obtain the first polymer film layer, and the power density of the electron beam gun is at least 20KW / cm.

[0054] In the above steps, the electron beam gun emits electrons from the cathode surface and accelerates them toward the anode, and then the electron beam is focused by the magnetic field and guided to the crucible to vacuum evaporate 99.9% pure aluminum material and 99.9% pure oxygen on the polyester film substrate, and the aluminum vapor and oxygen react to obtain a first polymer film layer with aluminum oxide evaporated on one side of the surface; the thickness of the first polymer film layer after evaporation is 12μm and the weight is 16.8g / m 2 .

[0055] Example 3

[0056] This embodiment provides an outer packaging material, and the preparation steps are the same as those of Embodiment 1, except that the first polymer film layer used in this embodiment is not commercially purchased, but is prepared and modified by the following steps:

[0057] S1. Place the commercially purchased polyester film in a vacuum chamber, close the vacuum chamber and evacuate it;

[0058] S2, when the vacuum degree reaches 4×10 -4 When the mba is above, the evaporation boat is heated to 1500°C, and the aluminum material and oxygen are vacuum evaporated on the polyester film substrate through an electron beam gun of an electron beam winding coating device to obtain an unmodified first polymer film layer, and the power density of the electron beam gun is at least 20KW / cm;

[0059] S3, according to the mass ratio of photoinitiator 819:1,3-propanedithiol:1-diphenyldiazene oxide:dichloromethane=1:10:25:100, the above raw materials are mixed evenly to prepare a modification treatment agent;

[0060] S4. After the modifying agent is evenly coated on the first polymer film layer, it is irradiated with a 10W 254nm ultraviolet light for 20 minutes. After the irradiation, it is washed with ethanol and dried to obtain a modified first polymer film layer.

[0061] Example 4

[0062] This embodiment provides an outer packaging material, and the preparation steps are the same as those of Embodiment 1, except that the first polymer film layer used in this embodiment is not commercially purchased, but is prepared and modified by the following steps:

[0063] S1. Place the commercially purchased polyester film in a vacuum chamber, close the vacuum chamber and evacuate it;

[0064] S2, when the vacuum degree reaches 4×10 -4 When the mba is above, the evaporation boat is heated to 1500°C, and the aluminum material and oxygen are vacuum evaporated on the polyester film substrate through an electron beam gun of an electron beam winding coating device to obtain an unmodified first polymer film layer, and the power density of the electron beam gun is at least 20KW / cm;

[0065] S3, according to the mass ratio of photoinitiator 819: 1,8-octanedithiol: 1-diphenyldiazene oxide: dichloromethane = 1: 10: 25: 100, the above raw materials are mixed evenly to prepare a modification treatment agent;

[0066] S4. After the modifying agent is evenly coated on the first polymer film layer, it is irradiated with a 10W 254nm ultraviolet light for 20 minutes. After the irradiation, it is washed with ethanol and dried to obtain a modified first polymer film layer.

[0067] Performance Testing

[0068] The water vapor permeability of the outer packaging materials prepared in Examples 1 to 4 was tested using GB / T1037-2021, and the test results and light transmittance test results are listed in Table 1.

[0069] Table 1

[0070] Serial number Water vapor transmission rate Light transmittance Example 1 0.42g / (m2·24h) 68％ Example 2 0.39g / (m2·24h) 65％ Example 3 0.22g / (m2·24h) 66％ Example 4 0.26g / (m2·24h) 62％

[0071] The light transmittance of the samples of Examples 1 to 4 meets the product requirements, can achieve the light-shielding effect, and ensure that the drug status and drug label information can be identified. Without being limited to any theory, the applicant believes that the barrier properties of the outer packaging materials of Examples 3 and 4 are better because Examples 3 and 4 are prepared with a thiol-ene monomer modification agent including a photoinitiator, and the photopolymerization reaction is initiated by light after coating, thereby grafting thiol groups on the polyester film, and the thiol groups can form chemical covalent bonds with the chlorine atoms and / or oxygen atoms of aluminum oxide, thereby improving the adhesion between the aluminum oxide vapor-deposited layer and the polyester film, thereby further improving the barrier properties of the outer packaging material.

[0072] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the scope defined by the claims.

Claims

1. A light-proof pharmaceutical outer packaging material, characterized in that: The outer packaging materials include: A first polymer film layer, wherein an inorganic non-metallic oxide is evaporated on one side of the surface of the first polymer film layer; An ink layer, wherein the ink layer is applied to the side of the first polymer film layer on which the inorganic non-metallic oxide is evaporated; The second polymer film layer is dry-compounded with the side of the first polymer film layer coated with the ink layer through an adhesive.

2. The light-proof pharmaceutical outer packaging material according to claim 1, characterized in that: The first polymer film layer is a polyester film layer, and the inorganic non-metallic oxide comprises at least one of aluminum oxide and silicon oxide or a combination thereof; and / or The ink layer is a brown transparent ink layer; and / or The adhesive is a polyurethane adhesive; and / or The second polymer film layer is a polyethylene film layer, or a polypropylene film layer, or a polyethylene-polypropylene composite film layer.

3. The light-proof pharmaceutical outer packaging material according to claim 1, characterized in that: The thickness of the first polymer film layer is 10 μm to 15 μm; and / or The thickness of the second polymer film layer is 20 μm to 100 μm.

4. The light-proof pharmaceutical outer packaging material according to claim 1, characterized in that: The weight of the first polymer film layer is 14 g / m 2 -21g / m 2 ; and / or The application amount of the ink layer is 1.2 g / m 2 -2.0g / m 2 ; and / or The amount of adhesive applied is 1.2 g / m 2 -2.0g / m 2 ; and / or The weight of the second polymer film layer is 18 g / m 2 -95g / m 2 .

5. The light-proof pharmaceutical outer packaging material according to any one of claims 1 to 4, characterized in that: The light transmittance of the outer packaging material is 60% to 70%.

6. The light-proof pharmaceutical outer packaging material according to any one of claims 1 to 4, characterized in that: The water vapor permeability of the outer packaging material is less than or equal to 1.0 g / (m2·24h).

7. A method for preparing a light-proof pharmaceutical outer packaging material, characterized in that: The preparation method is used to prepare the outer packaging material according to any one of claims 1 to 6, and the preparation method comprises: S100, preparing ink coating liquid; S200, applying the ink coating liquid to the side of the first polymer film layer on which the inorganic non-metallic oxide is evaporated, to form the ink layer; S300, applying the adhesive to the ink layer by coating, and dry-compounding the second polymer film layer to the ink layer.

8. The preparation method according to claim 7, characterized in that: The ink coating liquid comprises: Dye, 10 to 15 parts by mass; Butanone, 300 to 350 parts by mass; Butyl acetate, 50 to 100 parts by mass; Vinyl chloride-vinyl acetate copolymer resin, 85 to 90 parts by mass.

9. The preparation method according to claim 8, characterized in that: The dyes include metal complex yellow dyes and metal complex red dyes.

10. The preparation method according to claim 8, characterized in that: The ink coating liquid is prepared by mixing the dye, the butanone, the butyl acetate and the vinyl chloride-vinyl acetate copolymer resin and stirring them uniformly to obtain the ink coating liquid.