KR20180138196A - Pouch type medicine packing materials - Google Patents

Abstract

The present invention relates to a medicine packing material. More particularly, the present invention relates to a pouch type medicine packing material formed by thermal bonding between the inner layer of a rear sheet and a front surface sequentially provided with a surface layer, an opaque blocking layer, an adhesive layer, and an inner layer and having a zipper on one side for opening. Provided at a predetermined part on the rear sheet or the front surface at the least are a weighing scale and a light-transmitting window provided with a translucent blocking layer instead of the opaque blocking layer so that the amount of content can be confirmed. The present invention is provided with the light-transmitting window and the weighing scale, and thus content measurement is facilitated. The zipper is provided on one side, and thus separated administration is possible. The pouch type medicine packing material is highly portable and disposable, and thus medication compliance can be improved and problems such as contamination, deterioration, and discoloration can be addressed. The pouch type medicine packing material is excellent in moisture and light blocking properties.

Description

{POUCH TYPE MEDICINE PACKING MATERIALS}

The present invention relates to a packaging material for packaging a medicament, more specifically, it is excellent in water and light shielding properties to ensure the stability of the contents and has a zipper on one side and is portable and easy to carry. The present invention relates to a pouch-type pharmaceutical packaging material which is easy to measure the dosage of the contents.

In general, medicines for treating diseases or promoting health are filled and packaged in packaging materials for easy administration and storage. Therefore, the role of packaging material is very important to prevent the deterioration of drug efficacy due to the deterioration or damage of medicines during the process of distribution or after being sold to consumers.

The pouch container is widely used not only for foodstuffs or cosmetics but also as an enteral nutrient, a vein nutrient, and a sap because it is excellent in sealing property and handling property.

Various pharmaceutical or chemical packaging materials, including antibiotics, in the form of dosage forms or bulk materials, require not only airtightness and flexibility, but also drug stability. In this regard, only glass vials have been used to store such antibiotics. For example, penicillin-based antibiotics containing amoxicillin such as Genten Syrup ™ (Distributor: Korea Prime Pharmaceuticals) are prepared by taking the powder from the bottle and mixing it with water in the preparation container for mixing with the prescribed volume, Store in refrigeration condition. If it is not stored in the refrigerator for a long time, it may cause loss of potency, deterioration, discoloration, and it may cause inconvenience of the medication if it is difficult to travel for a long time or to store in a refrigerator.

In recent years, due to the rapid development of domestic drug manufacturing technology, various pharmaceuticals are exported overseas. Therefore, considering the geographical environment of the sales site as well as the production site, it is becoming an important factor in the manufacture of pharmaceutical packaging materials. In particular, in hot and humid areas such as Southeast Asia, moisture barrier must be considered to prevent moisture from getting on the medicine.

Conventional food or medicine packaging materials are formed by bonding a nylon film layer and a poly vinyl chloride film layer directly on the upper and lower surfaces of an aluminum foil layer by an adhesive layer.

In this case, there is a problem that the adhesive strength between the films is lowered due to the aluminum foil provided for enhancing the moisture barrier property.

In particular, since the basic physical properties of each substrate are changed during the molding process of the packaging material for filling the medicines, the deterioration of the adhesive strength is inevitably further intensified. As a result, the nylon and the aluminum foil are eventually separated, But the merchandise will also fall significantly. In addition, the aluminum foil ruptures due to the molding of the packaging material, and the medicine may be exposed.

On the other hand, nylon, which is widely used for vacuum and liquid freezing and cold packaging, is not only resistant to breakage during handling, but also has a relatively high price, which is a major reason for increasing the cost of packaging or packaging bags.

However, PET film is excellent in mechanical strength, inexpensive compared to nylon, and easy in mass production. However, since it has problems such as pinholes and the like, airtightness is required There is a limit to the storage of contents.

Also, in the case of an antibiotic pouch, the light blocking property must be considered from the viewpoint of maintaining the stability of the antibiotic substance. Therefore, in order to achieve such light blocking property, it has been necessary to use aluminum foil conventionally.

The conventional literature on the prior art can be exemplified in the following Patent Documents, and all of the contents of the following Patent Documents can be cited as a prior art in this specification.

U.S. Patent No. 6,962,439 (November 11, 2005) U.S. Patent No. 7,029,178 (Apr. 18, 2006)

The object of the present invention is to provide a film having a storage safety that is as good as that of a film having a metallic barrier layer, while using an inexpensive and high-productivity PET film while excluding the use of aluminum foil.

Another object of the present invention is to provide a pouch-type medicament packaging material which has a light transmitting window and a weighing scale and is easy to measure contents, and has a zipper on one side,

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

1. A pouch-shaped medical package comprising a front surface layer, an opaque blocking layer, an adhesive layer, and an inner surface layer, wherein the inner surface layers of the front surface and the back surface sheet are thermally adhered to each other, Wherein at least a predetermined portion of the front or back sheet is provided with a translucent window having a translucent barrier layer instead of the opaque barrier layer and a weighing scale so that the amount of the contents can be checked.

In the present invention, the opacifying barrier layer comprises a titanium dioxide and a color pigment having a maximum absorption wavelength in a range of 400 nm or more and 560 nm or less.

In the present invention, the color pigment having the maximum absorption wavelength in the range of 400 nm or more and 560 nm or less is 4,4 '- [(3,3'-dichloro [1,1'-biphenyl] Bis (azo)] bis [2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one], N- (4-chloro-2,5-dimethoxyphenyl ) - 3 - [(2-methoxy-5 - [(phenylamino) carbonyl] phenyl] azo] naphthalene- Bis (azo)] bis [N- (2,4-dimethylphenyl) -3-oxo-butanamide, and 2,2 '- [ (At least one of 3,3'-dichloro [1,1'-biphenyl] -4,4'-diyl) bis (azo)] bis [N- (2- methylphenyl)] - 3- The present invention also provides a pouch-type pharmaceutical packaging material,

In the present invention, the translucent barrier layer comprises carbon black and a color pigment having a maximum absorption wavelength in a range of 560 nm to 800 nm.

Further, in the present invention, the color pigment having a maximum absorption wavelength in the range of 560 nm to 800 nm includes at least one of copper phthalocyanine blue, carbazol dioxide photographic violet, and copper polychlorophthalocyanine green Pouch type medicine package.

The present invention also provides a pouch-type pharmaceutical packaging material for antibiotic packaging having a maximum absorption wavelength in the range of 180 nm to 380 nm.

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

According to the present invention, it is possible to easily measure contents with a light transmitting window and a measuring scale, and it is possible to dispose the zipper on one side and to carry it easily and to use it once, And does not cause problems such as deterioration and discoloration, and is excellent in moisture and light shielding property.

1 is a view showing a frontal structure of a pouch-shaped medicament packing material according to the present invention.
FIG. 2 is a view showing the sheet for a pouch-shaped pharmaceutical packaging material shown in FIG. 1. FIG.
FIG. 3 is a view showing an opaque barrier layer and a translucent window applied to the sheet for a pouch-shaped pharmaceutical packaging material shown in FIG. 2. FIG.
FIG. 4 is a view showing a physical sample of a pouch-type medicament packaging material according to the present invention.

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

The pouch-shaped medicament packaging material 1 according to the 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 in the inside.

The zipper 20 is positioned at one side of the front and rear sheets and is thermally bonded together with the front and back sheets to form the bonding portion 12. [

In addition, both end faces of the front sheet and the back sheet are thermally adhered to form bonding portions 13a and 13b and sealed.

At this time, it is preferable that cutout grooves 11 are formed on the heat-bonded surface portions of both upper ends of the zipper.

With such a configuration, the zipper and the sheet are sealed by heat, and both ends of the zipper and the sheet are sealed by heat sealing to form a filling space in a state where the lower portion is opened, and then the contents are filled inside.

Thereafter, when filling of the contents is completed in the internal space, it is finally sealed.

The front and back sheets each have a surface layer (100), an opaque blocking layer (200) formed on the 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 a lower surface of the adhesive layer; Are sequentially formed.

(PET), polyethylene 2,6-naphthalate (PEN), poly-1,4-cyclohexanedimethylene terephthalate (PCDT) and polyethylene 2, polyethylene terephthalate Naphthalate < / RTI > bibenzoate (PENBB). Particularly preferred is polyethylene terephthalate (PET). Polyethylene terephthalate (PET) is physically and chemically stable, has high mechanical strength, and is excellent in heat resistance, durability, chemical resistance and electrical insulation, and is widely used in various industrial products such as medical, electronic, packaging and photographic film have. In particular, it is advantageous as a packaging material of the present invention because it has an advantage of being excellent in hygiene, environmentally friendly, and easy to handle.

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

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

The titanium dioxide is divided into two types of anatase (rutile) and anatase (rutile) depending on the crystal form. The titanium dioxide absorbs ultraviolet rays of 400 nm or less, reflects visible light and infrared rays of more than 400 nm, , And a rutile type is more preferable in terms of light blocking property.

The content of the titanium dioxide may be 5 wt% or more and 40 wt% or less based on the total mass of the opaque barrier layer.

If it is out of the above range and less than 5% by weight, it is difficult to obtain an ultraviolet shielding effect. If it exceeds 40% by weight, the adhesive strength to the adhesive layer formed at the bottom is lowered.

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

In another preferred embodiment, the opaque barrier layer comprises a first layer comprising a color pigment having a maximum absorption wavelength in the range of 400 nm to 560 nm, and a second layer comprising titanium dioxide below the first layer . In this case, an adhesive layer and an inner surface layer may be sequentially formed under the second layer.

A translucent window 300 having a translucent barrier layer 300a instead of the opaque barrier layer is formed on a predetermined portion of the surface layer so that the remaining amount of the contents inside the container can be checked. Around the light-transmitting window, a weighing scale 300b is printed so that the content contained in the present container can be more accurately known as a numerical value.

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

Although it is more preferable to use titanium dioxide like the opaque barrier layer in terms of light blocking property, it is difficult to confirm the remaining amount of the contents by reflecting all the visible light, so that the titanium dioxide has a light- Use an appropriate amount of carbon black.

The carbon black absorbs ultraviolet rays of 400 nm or less and has a UV blocking effect. 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 barrier layer.

If it is out of the above range and less than 1% by weight, it is difficult to obtain an ultraviolet shielding effect. If it exceeds 20% by weight, it is difficult to confirm the remaining amount of the content.

The color pigment has a maximum absorption wavelength in the range of 560 nm to 800 nm, which is advantageous in that it has a large shielding effect against near ultraviolet rays and ultraviolet rays (normally, it reflects the 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 a range of 560 nm to 800 nm, and may include at least one of, for example, a blue pigment, a violet pigment and a green pigment. Specifically, the color pigment having the maximum absorption wavelength in the range of 560 nm to 800 nm may include at least one of copper phthalocyanine blue, carbazole dioxide photographic violet, and copper polychlorophthalocyanine green.

The adhesive layer is formed on the lower surface of the opaque barrier layer, and is composed of an adhesive for dry lamination and a curing agent. The hardening agent serves to harden the dry lamination adhesive to exhibit an excellent adhesive strength, and is not particularly limited as long as it can be applied to the dry lamination adhesive, but any of them can be used, but it is preferable that the hardening agent is composed of diisocyanate . Preferably, toluene-2,4 / 2,6-diisocyanate, hexamethylene diisocyanate is used.

The inner surface layer is a layer positioned inside the pouch-shaped medicament packaging material and is thermally adhered in the process of adhering the both end surfaces of the front surface and the back surface sheet.

The inner surface layer is made of a polyolefin resin, and examples thereof include high density polyethylene (HDPE), medium density polyethylene (MDPE), low density polyethylene (LDPE) and polypropylene Particularly, linear low density polyethylene (LLDPE) is preferably used. LLDPE has excellent chemical resistance and oxygen barrier properties.

The present inventors made different materials and thicknesses of the packaging material in order to determine the material and thickness of the more preferable surface layer and inner surface layer. The number next to the material indicates the thickness (unit: 탆).

First, when laminating in the order of PET12 / PET17 / transparent vapor-deposited PET12 / PE18 / LLDPE35, laminating was performed in the order of PET12 / LLDPE80 under the condition that the laminate was too stiff and thick and laminating in order of PET12 / LLDPE50 Most preferred.

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

The agent that can be safely and stably packed by the packaging material of the present invention is not particularly limited, but considering the possibility of decomposition by ultraviolet rays, etc., it may be more appropriate to consider the maximum absorption wavelength. As an example thereof, an antibiotic having a maximum absorption wavelength in the range of 180 nm to 380 nm may be mentioned. Specifically, the antibiotic having a maximum absorption wavelength (λ _max) in the range of less than the 180㎚ 380㎚ is amoxicillin (λ _max: 195㎚), streptomycin sulfate (λ _max: 194㎚), erythromycin (λ _max: 192 nm) or ciprofloxacin (? _Max : 275 nm).

Hereinafter, the present invention will be described in more detail by way of examples.

It is to be understood that the following embodiments are for the purpose of illustration only and are not intended to limit the scope of the present invention.

Example

Manufacture of sheet

First, on an PET resin film (surface layer, PET 12), an opaque barrier layer (titanium dioxide, and 4,4 '- [(3,3'-dichloro [1,1'- biphenyl] Bis (azo)] bis [2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one], N- (4-chloro-2,5-dimethoxyphenyl ) - 3 - [(2-methoxy-5 - [(phenylamino) carbonyl] phenyl] azo] naphthalene- Bis (azo)] bis [N- (2,4-dimethylphenyl) -3-oxo-butanamide, 2,2 '- [ Bis (azo)] bis [N- (2-methylphenyl)] - 3-oxo-butanamide as a starting material. , A translucent barrier layer (carbon black, and printing using copper phthalocyanine blue, cobrazole dioxazine violet, and copper polychlorophthalocyanine green as color pigments) and a weighing scale were formed and then dried. An adhesive layer composed of an adhesive for dry lamination and a curing agent was applied to the opaque barrier layer of the PET resin film to form an adhesive layer. The prepared adhesive layer and the LLDPE resin film (inner surface layer, LLDPE50) were laminated facing each other and then bonded under pressure to obtain the sheet of the present invention.

Manufacture of packaging materials for pouch-type medicines

The inner surface layers of the front and back sheets obtained in the above example were opposed to each other and bonded to each other by thermal bonding with a zipper, and both end surfaces were thermally adhered. The pouch-shaped medicament packaging material was prepared by forming cutting grooves on thermally adhered surface portions of upper and lower ends of the zipper and cutting the thermally adhered portions formed with the cut grooves of the sheet from the center portion of the cut grooves.

Experimental Example

Material elution  exam

The sheet obtained in the above example was submitted to the Korea Institute of Construction & Living Environment & Testing to perform a material dissolution test. 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) Leach solution
4% acetic acid Leach 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 has proven to be harmless to human body in the material and dissolution test, and can be widely used for packing medicine.

Light transmittance, light Barrier property  exam

The UV (ultraviolet), VL (visible light), and IR (thermal infrared) values were read out after inserting the pouch type medicine packing material into the opening of the measuring instrument using a permeability measuring instrument (LS160A Transmission meter, manufactured by Linshang, China) . The light transmittance is a percentage of the transmitted light with respect to the incident light. The results are shown in Table 2 below.

UV (ultraviolet) VL (visible light) IR (thermal infrared) Translucent barrier layer 6% 12% 89% Opaque barrier layer 0% 2% 65%

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

Storage safety test

The amoxicillin powder was stored in the pouch-type pharmaceutical packaging material prepared in the above example at 25 ± 2 ° C and 60% ± 5% RH, and the amoxicillin powder was observed 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 stability test, it was confirmed that it is suitable for storing the contents of medicines (antibiotics), because it is excellent in water and light shielding properties even without aluminum foil.

1: Pouch type medicine packing material 10: Front sheet
10 ': back sheet 11: cut-out groove
12: Adhesive parts 13a and 13b:
20: zipper 100: surface layer
200: opaque barrier layer 300: light transmitting window
300a: translucent barrier layer 300b: weighing scale
400: adhesive layer 500: inner surface layer

Claims (7)

1. A pouch-shaped medical package comprising a front surface layer, an opaque blocking layer, an adhesive layer, and an inner surface layer, wherein the inner surface layers of the front surface and the back surface sheet are thermally adhered to each other,
Wherein at least a predetermined portion on the front or back sheet is provided with a translucent window having a translucent barrier layer instead of an opaque barrier layer and a weighing scale so that the amount of the contents can be checked. The pouch-shaped medicament packaging material according to claim 1, wherein the opacifying barrier layer comprises titanium dioxide and a color pigment having a maximum absorption wavelength in a range of 400 nm to 560 nm. The color pigment according to claim 2, 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] Bis (azo)] bis [2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol- (2-methoxy-5 - [(phenylamino) carbonyl] phenyl] azo] naphthalene-2-carboxamide, 2,2 '- [(3,3'-dichloro Bis [(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. Wherein the pouch-shaped medicament packaging material is a pouch-shaped medicament packing material. The pouch-shaped medicament packaging material according to claim 1, wherein the translucent barrier layer comprises carbon black and a color pigment having a maximum absorption wavelength in a range of 560 nm to 800 nm. The color pigment according to claim 4, wherein the color pigment having a maximum absorption wavelength in the range of 560 nm to 800 nm includes at least one of copper phthalocyanine blue, cobrazed dioxazine violet, and copper polychlorophthalocyanine green. Medicines packaging materials. The pouch-shaped medicament packaging material according to claim 1, which has a maximum absorption wavelength in the range of 180 nm or more and 380 nm or less. [Claim 7] The pouch-type pharmaceutical packing material according to claim 6, wherein the antibiotic is amoxicillin, streptomycin sulfate, erythromycin or ciprofloxacin.

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