Self-heat-sealing material for medicine packaging as well as preparation method and application of self-heat-sealing material

Abstract

The invention provides a self-heat-sealing material for medicine packaging as well as a preparation method and application thereof. The self-heat-sealing material for medicine packaging is prepared from the following raw materials in parts by weight: 23 to 44 parts of hot melt adhesive, 55 to 75 parts of polypropylene and 0.01 to 2 parts of reinforcing agent. The product provided by the invention is simple in preparation process, is used for being compounded with a flash evaporation method high-density polyethylene fiber material, does not need to use glue, can form a transparent structure after hot melting, is convenient to intuitively observe the heat sealing effect, and is good in impermeability, low in peel strength and convenient to use.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical packaging technology, specifically relating to a self-heat-sealing material for pharmaceutical packaging, its preparation method, and its application. Background Technology

[0002] Existing Tyvek materials (or similar materials produced by flash evaporation) typically play a crucial role as a sterile barrier in primary packaging for RTU products (referring to pharmaceutical packaging components that have been sterilized and delivered using packaging that has undergone integrity testing). However, they require adhesive application before heat sealing with PP (polypropylene) or PS (polystyrene) boxes. There are usually two types of adhesives: water-based adhesives and hot melt adhesives. Both require a process step of uniformly coating Tyvek materials first. The adhesive application method also brings many drawbacks, such as the odor of the adhesive causing occupational hazards, the adhesive peeling off easily forming particulate contamination of RTU products, the adhesive coating greatly reducing the permeability of Tyvek, the heat-sealing weld surface easily having passages, and the heat-sealing weld integrity being difficult to observe. At the same time, the adhesives used are basically dependent on imports, which means that the application of flash evaporation materials in the last mile is still limited by the adhesive.

[0003] CN214650267U discloses an easy-tear aluminum foil bag, which includes a composite aluminum foil paper layer and a second composite aluminum foil paper layer of the same size as the composite aluminum foil paper layer. The composite aluminum foil paper layer includes a first composite aluminum foil paper layer and a Tyvek paper layer with the same structure as the second composite aluminum foil paper layer. The two sides of the Tyvek paper layer are heat-pressed onto the two sides of the first composite aluminum foil paper layer, respectively; the lower edge of the Tyvek paper layer is heat-pressed onto the upper edge of the first composite aluminum foil paper layer; the edges of the composite aluminum foil paper layer and the edges of the second composite aluminum foil paper layer are heat-pressed to form the aluminum foil bag body; the aluminum foil bag body has a reserved inlet; the first composite aluminum foil paper layer includes a barrier base layer, a reinforcing protective outer layer, and a protective inner layer. The reinforcing protective outer layer in this application can withstand high-temperature sterilization, which expands the application range of the aluminum foil bag and is conducive to its widespread use. However, this product has a multi-layer structure, and the manufacturing process is relatively complex.

[0004] CN1733551A discloses a method for manufacturing a breathable and convertible packaging bag, specifically a method for manufacturing a medical packaging bag that can be sterilized using gases such as ethylene oxide and then converted into a sealed structure after sterilization. The method is characterized by employing four different methods for manufacturing a packaging bag that first undergoes gas sterilization and then converts to a sealed structure, achieving both sterilization and sealing simultaneously. The advantages of this invention are its simplicity and convenience, making it particularly suitable for medical personnel. However, it also suffers from a complex preparation process and difficulty in operation.

[0005] Therefore, how to provide a solution that can overcome the dependence on adhesives in existing technologies, while having a simple preparation process and excellent results, has become an urgent problem to be solved. Summary of the Invention

[0006] To address the shortcomings of existing technologies, the present invention aims to provide a self-heat-sealing material for pharmaceutical packaging, its preparation method, and its applications. The product provided by this invention has a simple preparation process, is used in composites with flash-evaporated high-density polyethylene fiber materials without the need for adhesives, and forms a transparent structure after heat melting, allowing for easy and direct observation of the heat-sealing effect. Furthermore, it exhibits good impermeability, low peel strength, and ease of use.

[0007] To achieve this objective, the present invention adopts the following technical solution:

[0008] In a first aspect, the present invention provides a self-heating sealing material for pharmaceutical packaging, wherein the raw materials for preparing the self-heating sealing material for pharmaceutical packaging include, by weight, 23-44 parts of hot melt adhesive, 55-75 parts of polypropylene and 0.01-2 parts of reinforcing agent.

[0009] The number of parts of hot melt adhesive can be 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, or 44, etc.; the number of parts of polypropylene can be 55, 60, 65, 70, or 75, etc.; and the number of parts of reinforcing agent can be 0.01, 0.05, 0.1, 0.5, 1, 1.5, or 2, etc., but is not limited to the values ​​listed above. Other unlisted values ​​within the above range are also applicable.

[0010] The above method involves compounding hot melt adhesive with polypropylene components and combining them with reinforcing agents to form a homogeneous material. The preparation process is simple. When used in composites with flash-evaporated high-density polyethylene fiber materials, no glue is required. After hot melting, a transparent structure is formed, which makes it easy to observe the heat-sealing effect. It also has good impermeability, low peel strength, and is convenient to use.

[0011] Preferably, the hot melt adhesive includes any one or a combination of at least two of the following: EVA (ethylene-vinyl acetate copolymer), EVAL (ethylene-vinyl acetate-vinyl alcohol terpolymer), EAA (ethylene-acrylic acid copolymer), EEA (ethylene-ethyl acrylate copolymer), LDPE (low-density polyethylene), SBS (styrene-butadiene-styrene block copolymer), SIS (styrene-isoprene-styrene block copolymer), POE (polyolefin elastomer), APAO (ethylene-propylene-1-butene polymer), PES (thermoplastic polyester), PU (polyurethane), or PA (polyamide).

[0012] Preferably, the hot melt adhesive includes EVA, LDPE, and POE.

[0013] The above-mentioned specific hot melt adhesive combinations can further improve the product's performance.

[0014] Preferably, the mass ratio of EVA, LDPE and POE is (4-6):(2-4):(1-3).

[0015] Preferably, the reinforcing agent comprises any one or a combination of at least two of titanium dioxide, calcium carbonate, mica, talc, or calcium stearate.

[0016] Secondly, the present invention provides a method for preparing a self-heat-sealing material for pharmaceutical packaging as described above, the method comprising the following steps:

[0017] The hot melt adhesive, polypropylene, and reinforcing agent are mixed and melt-extruded to obtain the self-heating sealant for pharmaceutical packaging.

[0018] The self-heat-sealing material for pharmaceutical packaging prepared by the above method is a homogeneous system with a simple preparation process, and is more suitable for industrial production than conventional composite film systems.

[0019] Preferably, the extrusion is performed using a twin-screw extruder, wherein the heating zone temperature of the extruder is 210-250℃, the die temperature is 190-230℃, and the screw speed is 40-70 r / min.

[0020] The heating zone temperature can be 210℃, 220℃, 230℃, 240℃ or 250℃, etc., the die head temperature can be 190℃, 200℃, 210℃, 220℃ or 230℃, etc., and the screw speed can be 40 r / min, 45 r / min, 50 r / min, 55 r / min, 60 r / min, 65 r / min or 70 r / min, etc., but is not limited to the values ​​listed above. Other values ​​not listed within the above range are also applicable.

[0021] Preferably, the process after melt extrusion further includes cooling and pelletizing the material.

[0022] Thirdly, the present invention provides the application of the self-heating sealing material for pharmaceutical packaging as described above in the preparation of high-density polyethylene fiber packaging by flash evaporation.

[0023] Fourthly, the present invention also provides a method for preparing high-density polyethylene fiber material packaging by flash evaporation, the preparation method comprising the following steps:

[0024] The pharmaceutical packaging is formed using a self-heat-sealing material as described above, then covered with flash-evaporated high-density polyethylene fiber material, and heat-sealed to obtain the flash-evaporated high-density polyethylene fiber material packaging.

[0025] The above method directly heat-seals the self-heat-sealing material for pharmaceutical packaging with flash-evaporated high-density polyethylene fiber material without the need for glue, reducing dependence on glue. Furthermore, it forms a transparent structure after heat melting, making it easy to visually observe the heat-sealing effect. It also has good impermeability, low peel strength, and is convenient to use.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] This invention provides a self-heat-sealing material for pharmaceutical packaging. It is made by compounding hot melt adhesive with polypropylene components and combining them with reinforcing agents to form a homogeneous material. The preparation process is simple. When used in composite with flash-evaporated high-density polyethylene fiber materials, no glue is required. After hot melting, it can form a transparent structure, which makes it easy to observe the heat-sealing effect. It also has good impermeability, low peel strength, and is easy to use. Attached Figure Description

[0028] Figure 1 The image shows the results of the dye penetration test for the product in Example 1. Detailed Implementation

[0029] The technical solution of the present invention will be further illustrated below through specific embodiments. Those skilled in the art should understand that the embodiments described are merely illustrative of the present invention and should not be construed as limiting the invention in any way.

[0030] In the following example, the polypropylene was purchased from Nordea and its grade is HG820MO;

[0031] LDPE was purchased from Sinopec Beijing Yanshan Branch, grade 1C7A;

[0032] POE was purchased from Dow Chemical Company, USA, and its brand name is 8842.

[0033] EVA was purchased from Guangdong Zhongke Refining & Chemical Co., Ltd., and its grade is UE281.

[0034] Example 1

[0035] This embodiment provides a self-heat-sealing material for pharmaceutical packaging, and the specific raw materials used in its preparation are as follows (in parts by weight):

[0036] 65 parts polypropylene, 35 parts hot melt adhesive (EVA, LDPE, POE, mass ratio 5:3:2), and 1 part titanium dioxide reinforcing agent.

[0037] The preparation method is as follows:

[0038] According to the formula, the raw materials are placed in a high-speed mixer for premixing. The temperature of the high-speed mixer is set to 40℃ and the stirring speed is set to 350r / min. The premixed raw materials are then fed into an extruder for melt mixing. The extruder is a twin-screw extruder. The temperature of the heating zone of the extruder is set to 220℃, the die temperature is set to 200℃, and the screw speed is set to 50r / min. The molten material is extruded from the die into a strip shape, cooled, and then pelletized. The cooling method is water cooling, and the pellets are cut into 4mm diameter raw material particles using a pelletizer.

[0039] Example 2

[0040] This embodiment provides a self-heat-sealing material for pharmaceutical packaging, and the specific raw materials used in its preparation are as follows (in parts by weight):

[0041] 75 parts polypropylene, 44 parts hot melt adhesive (EVA, LDPE, POE, mass ratio 4:2:1), and 2 parts titanium dioxide reinforcing agent.

[0042] The preparation method is as follows:

[0043] According to the formula, the raw materials are placed in a high-speed mixer for premixing. The temperature of the high-speed mixer is set to 35℃ and the stirring speed is set to 400r / min. The premixed raw materials are then fed into an extruder for melt mixing. The extruder is a twin-screw extruder. The temperature of the heating zone of the extruder is set to 210℃, the die temperature is set to 190℃, and the screw speed is set to 40r / min. The molten material is extruded from the die into a strip shape, cooled, and then pelletized. The cooling method is water cooling, and the pellets are cut into 3mm diameter raw material particles using a pelletizer.

[0044] Example 3

[0045] This embodiment provides a self-heat-sealing material for pharmaceutical packaging, and the specific raw materials used in its preparation are as follows (in parts by weight):

[0046] 55 parts polypropylene, 23 parts hot melt adhesive (EVA, LDPE, POE, mass ratio 6:4:3), and 0.01 parts calcium carbonate reinforcing agent.

[0047] The preparation method is as follows:

[0048] According to the formula, the raw materials are placed in a high-speed mixer for premixing. The temperature of the high-speed mixer is set to 45℃ and the stirring speed is set to 300r / min. The premixed raw materials are then fed into an extruder for melt mixing. The extruder is a twin-screw extruder. The temperature of the heating zone of the extruder is set to 250℃, the die temperature is set to 230℃, and the screw speed is set to 70r / min. The molten material is extruded from the die into a strip shape, cooled, and then pelletized. The cooling method is water cooling, and the pellets are cut into 5mm diameter raw material particles using a pelletizer.

[0049] Example 4

[0050] This embodiment provides a self-heating sealing material for pharmaceutical packaging. The specific raw materials are the same as in Example 1, except that they do not contain EVA and the reduced portion is allocated to LDPE and POE in proportion.

[0051] The preparation method is the same as in Example 1.

[0052] Example 5

[0053] This embodiment provides a self-heating sealing material for pharmaceutical packaging. The specific raw materials are the same as in Example 1, except that LDPE is not included and the reduced portion is allocated to EVA and POE in proportion.

[0054] The preparation method is the same as in Example 1.

[0055] Example 6

[0056] This embodiment provides a self-heating sealing material for pharmaceutical packaging. The specific raw materials are the same as in Example 1, except that POE is not included and the reduced portion is allocated to LDPE and EVA in proportion.

[0057] The preparation method is the same as in Example 1.

[0058] Comparative Example 1

[0059] This comparative example provides a self-heating sealing material for pharmaceutical packaging. The specific raw materials are the same as in Example 1, except that polypropylene is replaced with an equal amount of HDPE (high-density polyethylene, purchased from Formosa Plastics TAISOX, grade 7200).

[0060] The preparation method is the same as in Example 1.

[0061] Comparative Example 2

[0062] This comparative example provides a self-heating sealing material for pharmaceutical packaging. The specific raw materials are the same as in Example 1, except that the hot melt adhesive is replaced with an equal amount of polypropylene.

[0063] The preparation method is the same as in Example 1.

[0064] Application Example 1

[0065] This application example provides a flash-evaporation method for packaging high-density polyethylene fiber materials, the preparation method of which is as follows:

[0066] The self-heat-sealing material for pharmaceutical packaging provided in Example 1 was molded, covered with a flash-evaporated high-density polyethylene fiber material of appropriate size, and heat-sealed with the flash-evaporated high-density polyethylene fiber breathable material under the conditions of 0.5 MPa, 150°C and 20 s. After cooling for 10 s, the preparation was completed.

[0067] Application Example 2-6 and Comparison with Application Example 1-2

[0068] Application Examples 2-6 and Comparative Application Examples 1-2 respectively provide a flash-process high-density polyethylene fiber material packaging. The preparation method is the same as that of Application Example 1, except that the self-heating sealing material for pharmaceutical packaging provided in Example 1 is replaced with the self-heating sealing material for pharmaceutical packaging provided in Examples 2-6 and Comparative Examples 1-2.

[0069] Effect test:

[0070] The flash-evaporation method for packaging high-density polyethylene fiber materials provided in Application Examples 1-6 and Comparative Application Example 1-2 was tested using the following methods:

[0071] Peel strength test

[0072] Refer to YY / T 0698.5 "Requirements and test methods for sealable combination bags and rolls composed of breathable materials and plastic films".

[0073] Take one intact package of this product, remove the box, and cut five strips of the welded surface into specimens with a width of 15.0±0.1mm. Place the cut specimens in an environment of 23±2℃ and 50±5%RH for at least 4 hours and conduct the test under these conditions. Place the cut specimens on the fixture of a universal testing machine. Set the test speed to 300±30mm / min. Record the average force value during the peeling process of each strip, which is the peel strength.

[0074] Acceptance criteria: Peel strength should be ≥1.2N / 15mm; Peel characteristics: no over-welding, continuous and unblemished glue transfer, and the width of heat seal on all four sides should be basically consistent.

[0075] Permeability test (methylene blue permeability test)

[0076] Refer to YY / T 0681.4 "Test Methods for Sterile Medical Device Packaging - Part 4: Determination of Leakage in Air-Permeable Packaging by Dye Penetration Method".

[0077] Take one of these products and apply a sufficient amount of dye (dye solution ratio (weight percentage): Triton X-100 / Toluidine Blue / Water = 0.5 / 0.05 / 94.5) to the sealing area of ​​the packaging material, ensuring the dye forms a depth of approximately 5mm at the sealed edge of the packaging. Hold for 5 seconds and observe the dye penetration. Visually inspect the heat-sealed area; there should be no solution channels.

[0078] Microbial permeability test

[0079] Tested in accordance with the Chinese Pharmacopoeia 9650 "Guidelines for the Sealing of Aseptic Drug Packaging Systems".

[0080] All the above tests were conducted after steam sterilization, ethylene oxide sterilization, and irradiation sterilization, respectively (the peel strength was taken as the average value).

[0081] The test results are as follows:

[0082]

[0083] Figure 1 The image shows the results of the dye penetration test for the product in Example 1. It can be observed that after heat-sealing the product of Example 1 with flash-evaporated high-density polyethylene fiber material, a transparent structure was formed, facilitating observation of the heat-sealing effect. Furthermore, the dye was completely unable to penetrate the transparent structure, demonstrating the product's excellent anti-penetration effect.

[0084] The data above shows that the product provided by the present invention has good impermeability, low peel strength, and is easy to use. Comparing application examples 1-6 and comparative application examples 1-2, it can be seen that by selecting specific raw materials, the present invention enables the product to be bonded to flash-evaporated high-density polyethylene fiber materials without the use of glue, and can effectively improve impermeability, reduce peel strength, and facilitate use.

[0085] The applicant declares that the present invention is illustrated by the above embodiments to demonstrate the self-heating sealing material for pharmaceutical packaging, its preparation method, and its application. However, the present invention is not limited to the above embodiments, that is, it does not mean that the present invention must rely on the above embodiments to be implemented. Those skilled in the art should understand that any improvements to the present invention, equivalent substitutions of the raw materials of the product of the present invention, addition of auxiliary components, and selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

[0086] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solution of the present invention, and these simple modifications all fall within the protection scope of the present invention.

[0087] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not describe the various possible combinations separately.

Claims

1. A self-heat-sealing material for pharmaceutical packaging, characterized in that, The raw materials for preparing the self-heat-sealing material for pharmaceutical packaging include, by weight, 23-44 parts of hot melt adhesive, 55-75 parts of polypropylene, and 0.01-2 parts of reinforcing agent.

2. The self-heat-sealing material for pharmaceutical packaging according to claim 1, characterized in that, The hot melt adhesive includes any one or a combination of at least two of EVA, EVAL, EAA, EEA, LDPE, SBS, SIS, POE, APAO, PES, PU, ​​or PA.

3. The self-heat-sealing material for pharmaceutical packaging according to claim 2, characterized in that, The hot melt adhesive includes EVA, LDPE and POE.

4. The self-heating sealing material for pharmaceutical packaging according to claim 3, characterized in that, The mass ratio of EVA, LDPE and POE is (4-6):(2-4):(1-3).

5. The self-heat-sealing material for pharmaceutical packaging according to any one of claims 1-4, characterized in that, The reinforcing agent includes any one or a combination of at least two of titanium dioxide, calcium carbonate, mica, talc, or calcium stearate.

6. A method for preparing a self-heat-sealing material for pharmaceutical packaging according to any one of claims 1-5, characterized in that, The preparation method of the self-heat-sealing material for pharmaceutical packaging includes the following steps: The hot melt adhesive, polypropylene, and reinforcing agent are mixed and melt-extruded to obtain the self-heating sealant for pharmaceutical packaging.

7. The preparation method according to claim 6, characterized in that, The extrusion is carried out using a twin-screw extruder, wherein the heating zone temperature of the extruder is 210-250℃, the die temperature is 190-230℃, and the screw speed is 40-70 r / min.

8. The preparation method according to claim 6 or 7, characterized in that, The process after melt extrusion also includes cooling and pelletizing the material.

9. The application of a self-heating sealing material for pharmaceutical packaging according to any one of claims 1-5 in the preparation of high-density polyethylene fiber material packaging by flash evaporation.

10. A method for preparing packaging of high-density polyethylene fiber material by flash evaporation, characterized in that, The preparation method includes the following steps: The pharmaceutical packaging material according to any one of claims 1-5 is molded, then covered with flash-evaporated high-density polyethylene fiber material, and heat-sealed to obtain the flash-evaporated high-density polyethylene fiber material packaging.

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