KR102281586B1 - Pouch type medicine packing materials - Google Patents

Abstract

The present invention relates to a packaging material for pharmaceutical packaging, and more particularly, is made by thermal bonding between the inner layers of the front and rear sheets sequentially having a surface layer, an opaque blocking layer, an adhesive layer, and an inner layer, and one side is opened and closed In the pouch-type pharmaceutical packaging material having a zipper formed so as to be possible, at least at a predetermined portion on the front or rear sheet, a translucent window having a translucent blocking layer instead of an opaque blocking layer to check the amount of the contents and a metering scale are provided It relates to a pouch-type pharmaceutical packaging material, characterized in that. According to the present invention, it is easy to measure the contents by providing a light-transmitting window and a measuring scale, and a zipper is provided on one side so that it can be divided, and it is easy to carry and can be used for one-time use, so that it is possible to improve the compliance with the medication and to prevent contamination. and a pouch-type pharmaceutical packaging material that does not cause problems such as deterioration and discoloration, and has excellent moisture and light barrier properties.

Description

Pouch-type pharmaceutical packaging materials {POUCH TYPE MEDICINE PACKING MATERIALS}

The present invention is a packaging material for pharmaceutical packaging, and more specifically, it has excellent moisture and light barrier properties to ensure the stability of the contents, and a zipper is provided on one side for easy portability and distribution, and a light transmitting window and a measuring scale are provided. It relates to a pouch-type pharmaceutical packaging material that is easy to measure the dosage of the contents.

In general, medicines for disease treatment or health promotion are filled and distributed in packaging materials for easy administration and storage. Therefore, it can be said that the role of packaging material is very important in order to prevent deterioration of efficacy due to deterioration or damage of medicines in the process of distribution or storage after being sold to consumers.

Pouch containers are widely used not only for food or cosmetic products, but also as containers for enteral or intravenous nutrients, infusions, and the like, because of their excellent sealing properties and handling properties.

Packaging materials for packaging various pharmaceuticals or chemicals, including antibiotics in dosage form or bulk material form, require airtightness and flexibility as well as stability with respect to the drug. In this regard, only glass vials have been used for the storage of antibiotics as described above. For example, for penicillin-based antibiotics containing amoxicillin, such as Gumentin Syrup™ (Sales: Korea Prime Pharmaceutical), take powder from the bottle and mix it with water as much as the prescribed amount in a container for dispensing, and after suspension It should be stored in refrigerated conditions. If it is not refrigerated and stored for a long time, it may cause loss of potency, deterioration and discoloration.

Recently, due to the rapid development of domestic drug manufacturing technology, various drugs are often exported abroad, so consideration of the geographical environment of the place of production as well as the place of sale is emerging as an important factor in the manufacture of pharmaceutical packaging materials. In particular, in high-temperature and high-humidity regions such as Southeast Asia, moisture barrier properties must be considered to prevent moisture from entering the pharmaceutical product.

Conventional food or pharmaceutical packaging materials consist of a nylon film layer and a polyvinyl chloride film layer directly attached to the upper and lower surfaces of an aluminum foil layer by an adhesive layer.

In this case, there may be a problem in that the adhesion between the films is lowered due to the aluminum foil provided to increase the moisture barrier properties.

In particular, since the basic physical properties of each base material change during the molding process of the packaging material for drug filling, the decrease in adhesive strength inevitably becomes more severe. As a result, the nylon and aluminum foil are eventually separated and the packaging material cannot perform its proper function. Otherwise, the productivity will be significantly reduced. In addition, depending on the molding of the packaging material, the aluminum foil may be ruptured and the drug may be exposed.

On the other hand, nylon, which is widely used for vacuum and liquid freezing and refrigerated packaging, does not have sufficient resistance to damage occurring during handling, and is a major cause of increasing the manufacturing cost of packaging paper or packaging bag due to its relatively high price.

Therefore, alternative films such as PET film may be considered, but PET film has advantages such as excellent mechanical strength, lower price than nylon, and ease of mass production, but there are problems such as pinholes, so airtightness is required. The storage of the contents is somewhat limited.

In addition, in the case of an antibiotic pouch, light blocking properties must also be considered from the viewpoint of maintaining the stability of the antibiotic material.

The prior art for the prior art can be exemplified by the following patent document, whereby all of the contents of the following patent document are cited and incorporated as prior art in the present specification.

US Patent No. 6,962,439 (2005.11.08) US Patent No. 7,029,178 (April 18, 2006)

An object of the present invention is to provide a film having storage safety comparable to that of a film having a metallic barrier layer while using an inexpensive and productive PET film and excluding the use of aluminum foil.

In addition, another object of the present invention is to provide a pouch-type pharmaceutical packaging material that is easy to measure the contents by providing a transparent window and a measuring scale, and has a zipper on one side so that it can be divided after taking divided doses.

The present invention has been devised to solve the problems of the prior art,

In the pouch-type pharmaceutical packaging material, which is made by thermal bonding between the inner layers of the front and rear sheets sequentially having a surface layer, an opaque blocking layer, an adhesive layer, and an inner layer, and a zipper is formed on one side to allow opening and closing, Provided is a pouch-type pharmaceutical packaging material, characterized in that at least a predetermined portion on the front or rear sheet is provided with a light transmitting window having a translucent blocking layer instead of an opaque blocking layer and a metering scale so that the amount of the contents can be checked.

In addition, in the present invention, the opaque blocking layer provides a pouch-type pharmaceutical packaging material comprising titanium dioxide and a color pigment having a maximum absorption wavelength in the range of 400 nm to 560 nm.

In addition, in the present invention, the color pigment having a maximum absorption wavelength in the range of 400 nm to 560 nm is 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4 '-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one], N-(4-chloro-2,5-dimethoxyphenyl )-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide, 2,2'-[(3,3'- dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxo-butanamide, and 2,2′-[ (3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)]-3-oxo-butanamide It provides a pouch-type pharmaceutical packaging material comprising:

In addition, in the present invention, the translucent blocking layer provides a pouch-type pharmaceutical packaging material comprising carbon black and a color pigment having a maximum absorption wavelength in the range of 560 nm to 800 nm.

In addition, in the present invention, the color pigment having a maximum absorption wavelength in the range of 560 nm to 800 nm is copper phthalocyanine blue, carbazole dioxazine violet, and copper polychlorophthalocyanine green, characterized in that it comprises at least one A pouch-type pharmaceutical packaging material is provided.

In addition, in the present invention, there is provided a pouch-type pharmaceutical packaging material for antibiotic packaging having a maximum absorption wavelength in the range of 180 nm or more and 380 nm or less.

In addition, in the present invention, the antibiotic is amoxicillin, streptomycin sulfate, erythromycin or ciprofloxacin provides a pouch-type pharmaceutical packaging material characterized in that.

According to the present invention, it is easy to measure the contents by providing a light-transmitting window and a measuring scale, and a zipper is provided on one side so that it can be divided, and it is easy to carry and can be used for one-time use, so that it is possible to improve the compliance with the medication and to prevent contamination. and a pouch-type pharmaceutical packaging material that does not cause problems such as deterioration and discoloration, and has excellent moisture and light barrier properties.

1 is a view showing the front structure of the pouch-type pharmaceutical packaging material according to the present invention.
2 is a view showing the pouch-type pharmaceutical packaging sheet shown in FIG. 1 .
3 is a view showing an opaque blocking layer and a light transmitting window applied to the pouch-type pharmaceutical packaging sheet shown in FIG. 2 .
4 is a view showing a real sample of the pouch-type pharmaceutical packaging material according to the present invention.

Hereinafter, the present invention will be described in more detail.

The pouch-type pharmaceutical packaging material 1 according to a preferred embodiment of the present invention includes front and rear sheets and a zipper.

The front sheet 10 and the rear sheet 10' have the same size, and both sheets are sealed by thermal bonding so that the contents can be filled therein.

The zipper 20 is located on one side of the front and rear sheets and is heat-bonded like the front and rear sheets to form an adhesive portion 12 .

In addition, both end surfaces of the front sheet and the rear sheet are thermally bonded to form adhesive portions 13a and 13b and are sealed.

At this time, it is preferable that the cut-out grooves 11 are formed in the heat-bonded surface portion of the upper ends of both sides of the zipper.

According to this configuration, the zipper and the sheet are thermally bonded and sealed, and both ends thereof are thermally bonded and sealed to form a filling space with the lower part open, and then the contents are filled therein.

After that, when the filling of the contents into the inner space is completed, the final sealing is performed.

The front and back sheets each have a surface layer 100, an opaque blocking layer 200 formed on a lower surface of the surface layer; an adhesive layer 400 formed on a lower surface of the opaque blocking layer; and an inner layer 500 formed on the lower surface of the adhesive layer; These are formed sequentially.

The surface layer is composed of a polyester film, for example, polyethylene terephthalate (PET), polyethylene 2,6-naphthalate (PEN), poly-1,4-cyclohexanedimethylene terephthalate (PCDT) and polyethylene 2, 6-naphthalate bibenzoate (PENBB). In particular, polyethylene terephthalate (PET) is preferable. Polyethylene terephthalate (PET) is physically and chemically stable, has high mechanical strength, and has excellent heat resistance, durability, chemical resistance, and electrical insulation. there is. In particular, it is preferable as the packaging material of the present invention because of the advantages of excellent hygiene, environment-friendly and easy handling.

It is preferable to use a 12 μm biaxially stretched polyethylene terephthalate film (PET12) as the surface layer. This will be described later in the inner layer below.

The opaque blocking layer includes titanium dioxide and a color pigment having a maximum absorption wavelength in a range of 400 nm or more and 560 nm or less.

The titanium dioxide is divided into two types, anatase and rutile, depending on the crystal form, and absorbs ultraviolet rays of 400 nm or less, and reflects visible and infrared rays exceeding 400 nm. As such, the rutile type is more preferable in terms of light blocking properties.

Based on the total mass of the opaque blocking layer, the content of the titanium dioxide may be 5 wt% or more and 40 wt% or less.

If it is less than 5% by weight out of the above range, there is a disadvantage in that it is difficult to obtain a UV-blocking effect, and if it exceeds 40% by weight, there is a disadvantage in that the adhesion with the adhesive layer formed below is lowered.

Since the color pigment has a maximum absorption wavelength in a range of 400 nm or more and 560 nm or less, there is an advantage in that it has a large reflective effect for near infrared rays and infrared rays. The type of the color pigment is not particularly limited as long as it has a maximum absorption wavelength in the range of 400 nm to 560 nm, but may include, for example, at least one of an orange pigment, a red pigment, and a yellow pigment. Specifically, the color pigment having a maximum absorption wavelength in the range of 400 nm to 560 nm is 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl) )bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one], N-(4-chloro-2,5-dimethoxyphenyl)-3 -hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide, 2,2'-[(3,3'-dichloro[1 ,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxo-butanamide, 2,2'-[(3,3) '-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)]-3-oxo-butanamide , but not limited thereto.

As another preferred embodiment, the opaque blocking layer is composed of a first layer including a color pigment having a maximum absorption wavelength in a range of 400 nm or more and 560 nm or less, and a second layer made of titanium dioxide under the first layer. can In this case, an adhesive layer and an inner layer may be sequentially formed under the second layer.

The transparent window 300 provided with the translucent blocking layer 300a is formed on a predetermined portion on the surface layer instead of the opaque blocking layer, so that the remaining amount of the contents in the container can be checked. The measurement scale 300b is printed around the light transmitting window so that the contents currently contained in the container can be more accurately known as numerical values.

The translucent blocking layer includes carbon black and a color pigment having a maximum absorption wavelength in a range of 560 nm to 800 nm.

It may be more preferable to use titanium dioxide like the opaque blocking layer in terms of light blocking properties, but since titanium dioxide reflects all visible light and it is difficult to check the remaining amount of the contents, it has light transmittance and has a UV blocking function. Use an appropriate amount of carbon black with

The carbon black is a material having a UV blocking effect by absorbing UV rays of 400 nm or less, and the content of the carbon black may be 1 wt% or more and 20 wt% or less based on the total mass of the translucent blocking layer.

If it is less than 1% by weight outside the above range, there is a disadvantage in that it is difficult to obtain a UV blocking effect, and if it exceeds 20% by weight, it is difficult to check the remaining amount of the contents.

The color pigment has a maximum absorption wavelength in the range of 560 nm or more and 800 nm or less, and thus has an advantage in that it has a large blocking effect for near ultraviolet and ultraviolet rays (usually, it reflects a wavelength band corresponding to the complementary color of the maximum absorption wavelength). The type of the color pigment is not particularly limited as long as it has a maximum absorption wavelength in the range of 560 nm or more and 800 nm or less, but may include, for example, at least one of a blue pigment, a purple pigment, and a green pigment. Specifically, the color pigment having a maximum absorption wavelength in the range of 560 nm to 800 nm may include at least one of copper phthalocyanine blue, carbazole dioxazine violet, and copper polychlorophthalocyanine green.

The adhesive layer is formed on the lower surface of the opaque blocking layer, and consists of an adhesive for dry lamination and a curing agent. The curing agent serves to cure the adhesive for dry lamination to exhibit excellent adhesion, and as long as it can be applied to the adhesive for dry lamination, it is not particularly limited and any type can be used, but it is preferably made of diisocyanate. . Preferably, toluene-2,4/2,6-diisocyanate and hexamethylene diisocyanate are used.

The inner layer is a layer located inside the pouch-type pharmaceutical packaging material, and is a layer that is thermally bonded in the process of bonding both end surfaces of the front and rear sheets.

The inner layer is composed of a polyolefin resin, and examples thereof include high-density polyethylene (HDPE), medium-density polyethylene (MDPE), low-density polyethylene (LDPE), polypropylene (PP), and the like. In the present invention, polyethylene resin is preferred. In particular, linear low-density polyethylene (LLDPE) is preferably used. LLDPE has excellent chemical resistance and oxygen barrier properties.

The present inventors manufactured the packaging material by changing the material and thickness in order to find out more preferable material and thickness of the surface layer and inner layer. The number next to the material indicates the thickness (unit: ㎛).

First, when laminated in the order of PET12/PET17/transparent deposition PET12/PE18/LLDPE35, it was judged that it was too stiff and thick, and it was laminated in the order of PET12/LLDPE80. It was confirmed that it was most preferable.

Therefore, it is preferable to use a 50 μm LLDPE film (LLDPE50) as the inner layer.

The drug that can be safely and stably packaged by the packaging material of the present invention is not particularly limited, but considering the degradability by ultraviolet rays, etc., it may be more suitable to consider the maximum absorption wavelength. As an example, an antibiotic having a maximum absorption wavelength in the range of 180 nm or more and 380 nm or less can be mentioned. _{Specifically, the antibiotic having a maximum absorption wavelength (λ max} ) in the range of 180 nm to 380 nm is amoxicillin (λ _max : 195 nm), streptomycin sulfate (λ _max : 194 nm), erythromycin (λ _max : 192 nm) or ciprofloxacin (λ _max : 275 nm).

Hereinafter, the present invention will be described in more detail with reference to examples.

It is clear that the following examples are only for the detailed description of the invention, and are not intended to limit the scope thereof.

Example

sheet manufacture

First, an opaque blocking layer (titanium dioxide, and 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4 as a color pigment) on a PET resin film (surface layer, PET 12) '-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one], N-(4-chloro-2,5-dimethoxyphenyl )-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide, 2,2'-[(3,3'- Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxo-butanamide, 2,2'-[( Printed using 3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)]-3-oxo-butanamide) , a translucent barrier layer (printed using carbon black, and copper phthalocyanine blue, carbazole dioxazine violet, copper polychlorophthalocyanine green as color pigments) and a metering scale were formed and then dried. An adhesive layer was formed by applying an adhesive component consisting of an adhesive for dry lamination and a curing agent to the opaque blocking layer of the PET resin film. The prepared adhesive layer and the LLDPE resin film (inner layer, LLDPE50) were laminated to face each other, and then adhered under pressure to obtain a sheet of the present invention.

Manufacturing of pouch-type pharmaceutical packaging materials

The inner layers of the front and back sheets obtained in the above example were opposed and joined by thermal bonding with a zipper, and both end surfaces were thermally bonded. A pouch-type pharmaceutical packaging material was manufactured by forming cut-out grooves on the heat-bonded surface of both upper ends of the zipper, and cutting the heat-bonded portion of the sheet with the cut-out grooves formed at the center of the cut-out grooves as a starting point.

Experimental example

material dissolution test

The sheet obtained in the above example was requested to the Korea Construction Living Environment Testing Institute and a material dissolution test was performed. The results are shown in Table 1 below.

material test dissolution test lead cadmium Potassium Permanganate
Consumption (mg/L) heavy metal lead
(mg/L) evaporation residue
(mg/L) Example 0 non-detection One
(standard:
below 10) non-detection
(standard:
1 or less) leaching solution
4% acetic acid leaching solution
water 4
(standard:
30 or less) 2
(standard:
30 or less)

As can be seen from the above table, the sheet according to the present invention is found to be harmless to the human body in material and dissolution tests, and thus can be widely used for packaging medicines.

light transmittance, light barrier test

The UV (ultraviolet), VL (visible), and IR (thermal infrared) values were read after inserting the pouch-type pharmaceutical packaging material into the opening of the measuring device using a transmittance measuring instrument (Linshang, China, LS160A Transmission meter). . This light transmittance is expressed as a percentage of the transmitted light with respect to the incident light. The results are shown in Table 2 below.

UV (ultraviolet light) VL (Visible Light) IR (thermal infrared) translucent barrier layer 6% 12% 89% opaque blocking layer 0% 2% 65%

As a result, it was confirmed that the translucent blocking layer was 6% in UV (ultraviolet light) and 12% in VL (visible light), and had low light transmittance and good light blocking properties. In addition, the opaque blocking layer was 0% in UV (ultraviolet light) and 2% in VL (visible light), so it was confirmed that the light transmittance was low and had high light blocking properties.

Storage safety test

After storing the amoxicillin powder in the pouch-type pharmaceutical packaging material prepared in the above example at (25±2)°C, 60%±5%RH, it was observed whether there was a significant change for 12 months. The results are shown in Table 3 below.

3 months 6 months 12 months no change no change no change

From the results of the storage safety test, it was confirmed that even without aluminum foil, moisture and light blocking properties were excellent, so that it was suitable for storage of pharmaceutical (antibiotic) contents.

1: Pouch-type pharmaceutical packaging material 10: Front sheet
10': rear seat 11: cutout groove
12: adhesive part 13a, 13b: adhesive part
20: zipper 100: surface layer
200: opaque blocking layer 300: transparent window
300a: translucent blocking layer 300b: weighing scale
400: adhesive layer 500: inner layer

Claims (7)

In the pouch-type pharmaceutical packaging material, which is made by thermal bonding between the inner layers of the front and rear sheets sequentially having a surface layer, an opaque blocking layer, an adhesive layer, and an inner layer, and a zipper is formed on one side to allow opening and closing,
At least in a predetermined portion on the front or rear sheet, a light transmitting window having a translucent blocking layer instead of an opaque blocking layer and a measuring scale are provided so that the amount of content can be checked
The translucent blocking layer includes carbon black and a color pigment having a maximum absorption wavelength in the range of 560 nm to 800 nm on the entire translucent blocking layer,
The opaque blocking layer includes titanium dioxide and a color pigment having a maximum absorption wavelength in the range of 400 nm to 560 nm throughout the opacity blocking layer,
A pouch-type pharmaceutical packaging material for antibiotic packaging that has a maximum absorption wavelength in the range of 180 nm to 380 nm. delete The method according to claim 1, wherein the color pigment having a maximum absorption wavelength in the range of 400 nm to 560 nm is 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4' -diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one], N-(4-chloro-2,5-dimethoxyphenyl) -3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide, 2,2'-[(3,3'-dichloro [1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxo-butanamide, and 2,2′-[( 3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)]-3-oxo-butanamide Pouch-type pharmaceutical packaging material, characterized in that. delete The pouch according to claim 1, wherein the color pigment having a maximum absorption wavelength in the range of 560 nm to 800 nm comprises at least one of copper phthalocyanine blue, carbazole dioxazine violet, and copper polychlorophthalocyanine green. type pharmaceutical packaging materials. delete The pouch-type pharmaceutical packaging material according to claim 1, wherein the antibiotic is amoxicillin, streptomycin sulfate, erythromycin or ciprofloxacin.

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