JP3109486U - Packaging for drugs containing photodegradable components - Google Patents

Abstract

PROBLEM TO BE SOLVED: To sufficiently prevent the photodegradation of a photodegradable component-containing pharmaceutical over a wide range of types, to be able to sufficiently visually recognize the inside from the outside, to suppress the manufacturing cost, and to prevent misalignment, etc. Provide packaging without problems.
A cover, a container, or a package for shielding external light that degrades vitamins, wherein the transmittance of light having a wavelength shorter than 450 nm is less than 1%, and light having a wavelength of 450 to 500 nm is transmitted. It is characterized by being formed of a translucent plastic film having a transmittance of 3% or less and a transmittance of visible light having a wavelength of 600 nm or more of 80% or more.
[Selection] Figure 1

Description

  The present invention is intended to prevent degradation of pharmaceuticals containing light-degradable components including components that degrade by light, such as vitamins, amino acids, cephem antibiotics, fosfomycin antibiotics, etc. The present invention relates to a packaging such as a cover, a container, or a container-containing bag, which is prevented from being translucent and made visible inside.

  Conventionally, for example, infusion solutions used in the medical field often mix several types of vitamins. Since many vitamins are susceptible to photodegradation, it has been conventionally proposed to use a container or cover having light-shielding properties (for example, Japanese Utility Model Publication No. 56-101345, Japanese Utility Model Publication 57). No. 187532, JP-A-7-163635, etc.).

  In addition, a cover having a light shielding property provided with a window portion having a transparent or high visible light transmittance is known (for example, Japanese Utility Model Laid-Open No. 56-104539, Japanese Patent Application Laid-Open No. 2003-275280). Issue gazette).

However, what is disclosed in Japanese Utility Model Laid-Open No. 56-101345 also transmits light in the wavelength region of 450 to 500 nm, and thus the stability of vitamin B2 and vitamin B12, etc., which tend to decompose in that wavelength region, is not sufficient.

  In addition, the one disclosed in Japanese Utility Model Publication No. 57-187532 has a problem that it is difficult to check the scale and the content liquid written on the container because the transmittance of light having a long wavelength (wavelength region of 600 nm or more) is low. is there.

  Further, those disclosed in JP-A-7-163635 may have insufficient light-shielding properties at wavelengths of 450 nm or less, and the stability of vitamin B2 and vitamin B12 may not be sufficient at wavelengths of 450 nm to 500 nm. .

  Further, the one disclosed in Japanese Utility Model Laid-Open No. 56-104539 has a problem that the light shielding effect at the corners is lost due to light leakage from the window, and the structure is not simple and the manufacturing cost increases.

  Furthermore, in the light shielding cover disclosed in Japanese Patent Application Laid-Open No. 2003-275280, the structure is not simple and the manufacturing cost increases, and the scale marked on the infusion container and the position of the window portion of the light shielding cover that covers the infusion container There has been a problem that it may shift.

  Therefore, the present invention sufficiently prevents the photodegradation of the photodegradable component-containing pharmaceuticals over a wide range of types, allows the inside to be sufficiently visually recognized from the outside, reduces the manufacturing cost, and provides a positional shift. The purpose is to provide packaging that is free from problems.

  In order to achieve the above object, the packaging according to the present invention is a packaging including a cover, a container, or a bag for shielding external light that degrades a photodegradable component-containing drug, and has a wavelength shorter than 450 nm. It is formed of a translucent plastic film that has a light transmittance of less than 1%, a light transmittance of 450 to 500 nm, a light transmittance of 3% or less, and a visible light transmittance of a wavelength of 600 nm or more of 80% or more. It is characterized by.

  The translucent plastic film preferably has a visible light transmittance of 70% or more at a wavelength of 550 nm or more and less than 600 nm.

  The translucent plastic film preferably has a transmittance of light having a wavelength shorter than 450 nm of 0.1% or less.

  It is preferable that the packaging is provided with an ultraviolet absorbing property by the translucent plastic film containing an ultraviolet absorber or by laminating an ultraviolet absorbing film on the translucent plastic film.

  The photodegradable component-containing pharmaceutical contains at least one selected from the group consisting of vitamin A, vitamin B2, and vitamin C, or vitamin A, vitamin B2, vitamin C, vitamin B1, vitamin B12, and It is preferable to contain at least one selected from the group consisting of vitamin E.

  The packaging is preferably a container including an infusion bag, an infusion bottle, an ampoule, or a prefilled syringe, or a cover of the container containing the photodegradable component-containing medicine.

  It is preferable to laminate a polyethylene film, a polypropylene film, or an ethylene vinyl acetate film as the innermost layer on the translucent plastic film.

  The packaging according to the present invention is such that the translucent plastic film forming the packaging is less than 1% in transmittance of light having a wavelength shorter than 450 nm and less than 3% in transmittance of light having a wavelength of 450 to 500 nm. By doing so, it is possible to effectively prevent deterioration of photodegradable components such as vitamin B2 and vitamin B12, and to improve visibility by setting the transmittance of visible light of 600 nm or more to 80% or more. In addition, such a configuration can reduce the manufacturing cost, and there is no problem such as misalignment.

  Embodiments of packaging according to the present invention will be described below with reference to FIGS. In addition, the same code | symbol was attached | subjected to the same component through the whole figure.

  The packaging according to the present invention has a transmittance of light having a wavelength shorter than 450 nm of less than 1%, a transmittance of light having a wavelength of 450 to 500 nm of 3% or less, and a transmittance of visible light of 600 nm or more of 80% or more. It is formed of a translucent plastic film.

  The translucent plastic film preferably has a visible light transmittance of 70% or more at a wavelength of 550 nm or more and less than 600 nm. Further, the transmittance of light having a wavelength shorter than 450 nm is preferably 0.1% or less from the viewpoint of stability of vitamin B2 and vitamin B12 that tend to decompose even in this wavelength region.

  As shown in FIG. 1, such a translucent plastic film 1 is obtained by printing an ink containing a desired amount of a desired pigment and / or dye on a transparent film to be a base material 2 to form an ink layer 3. be able to.

The plastic film used as the base material 2 can employ, for example, a transparent plastic film such as polyethylene, polypropylene, polyethylene terephthalate, polyamide, and ethylene vinyl acetate film.

  The ink may be, for example, a yellow pigment such as CI Pigment Yellow 12,13,1,4,17,81,83,87,95,109, or an orange pigment such as CI Pigment Orange 16,36,38,43, etc. An example of the ink is mixed and dispersed in an amount. Alternatively, an ink obtained by red pigment such as C.I. Pigment Red 5, 22, 38, 144, 146, 185 alone or mixed with other pigments or dyes can be used.

  By adding an ultraviolet absorber such as a benzotriazole-based compound, a benzophenone-based compound, a salicylate-based compound, or a triaryltriazine-based compound to the ink, an ultraviolet absorbing performance may be imparted to the translucent plastic film, or As shown in FIG. 2, an ultraviolet absorbing film 4 containing the ultraviolet absorber may be laminated.

  By forming the translucent plastic film 1, it can be used as a primary container such as an infusion bag body, an infusion bottle, an ampoule, or a prefilled syringe, or a secondary container such as an outer bag or a light shielding cover of these primary containers. . That is, the packaging in this invention includes these primary containers and secondary containers. In addition, a conventionally well-known form can be employ | adopted for the form itself of these primary containers and secondary containers.

  FIG. 3 shows an example of a light-shielding cover obtained by molding the translucent plastic film. In FIG. 3, the light shielding cover 5 is placed on the infusion bag body 6 to shield the infusion bag body 6 from light. The infusion bag main body 6 is formed with a hanging tongue piece 6a at the upper part and a needle stick seal port part 6b at the lower part. The light shielding cover 5 has a full lower opening, and a partial opening for passing the hanging tongue piece 6a is formed in the upper part.

  In addition, when the final form of the packaging is a primary container, in order to avoid contact between the photodegradable component-containing drug and the ink layer 3 or the ultraviolet absorbing film 4, as shown in FIGS. The translucent plastic film 1 is preferably laminated with a transparent polyethylene film, a transparent polypropylene film, or a transparent ethylene vinyl acetate film as the innermost layer 7.

  When such an innermost layer 7 is not provided, the semitransparent plastic film 1 is formed by applying the ink layer 3 on the outer surface of the substrate 2, but when the innermost layer 7 is provided, the inner side of the translucent plastic film 1 or The innermost layer 7 can be formed by lamination either on the outside or on both sides.

  The packaging obtained in this way will be clarified in Examples described later, and exhibits an excellent light-shielding effect for pharmaceuticals containing photodegradable components such as vitamin B2, vitamin B12, vitamin A, or vitamin C. In addition, moderate visibility can be secured.

Example An ink in which 5 parts by weight of CI Pigment Orange 43 is mixed and dispersed with 100 parts by weight of an acrylic resin as a color developing agent is printed on a polyethylene terephthalate film having a thickness of 12 μm to produce a translucent plastic film. Further, an ultraviolet absorbing film and a 30 μm-thick LLDPE (linear low density polyethylene) film are laminated on the translucent plastic film so as to have a total thickness of 70 μm (see FIG. 4). A cover (see FIG. 3) was produced.

Comparative Example An ink in which 5 parts by weight of a red pigment is mixed and dispersed with 100 parts by weight of a urethane resin as a color developing agent is printed on a polyethylene terephthalate film having a thickness of 12 μm to produce a translucent plastic film. A transparent plastic film was laminated with a polyethylene film having a thickness of 40 μm to give a total thickness of 55 μm, and an infusion back cover was manufactured.

  Table 1 shows the results of measuring the wavelength light (nm) and the transmittance (%) of the wavelength light for the infusion bag covers obtained in the above Examples and Comparative Examples.

  For measurement of the light transmittance, UV-1600 manufactured by Shimadzu Corporation was used.

  Vitamin B2 and vitamin B12 are easily decomposed by light in the wavelength region of 450 to 500 nm. From Table 1, it can be seen that the transmittance in the wavelength region is smaller than that in the comparative example. Moreover, since the transmittance | permeability is larger than a comparative example in the wavelength range of 550 nm or more, it turns out that visibility is improving.

Test Examples Solutions containing various vitamins are contained in an infusion bag, and the infusion bag is covered with the infusion bag cover obtained in the above-described Examples and Comparative Examples, and the remaining rate of vitamin after a predetermined time (%) And the visibility was also confirmed visually. The residual ratio was measured based on the UV-Vis spectrophotometry method of Japanese Pharmacopoeia.

  First, in order to test the residual rate of vitamin A, the outer bag of Neopalene (1000 ml) (registered trademark) manufactured by Otsuka Pharmaceutical Factory, Ltd. is removed and covered with the infusion bag cover of Examples and Comparative Examples. Table 2 shows the results of measuring the residual ratio of vitamin A (%) after 24, 48 hours. An ultraviolet absorptiometer (measurement wavelength: 275 nm) was used for the measurement of the residual rate.

  From Table 2 above, it can be seen that the residual rate of vitamin A is higher in the example than in the comparative example. Also, the visibility of the example was better than that of the comparative example.

  Next, in order to test for the residual rate of vitamin B2, remove the outer bag of Neoparen (1000 ml) (registered trademark) manufactured by Otsuka Pharmaceutical Factory, and cover with the infusion bag cover of Examples and Comparative Examples. Table 3 shows the results of measuring the residual ratio (%) of vitamin B2 after 12, 24 and 48 hours. For the measurement of the residual rate, a fluorometer (excitation wavelength: 470 nm, fluorescence wavelength: 520 nm) was used.

  From Table 3 above, it can be seen that the residual ratio of vitamin B2 is higher in the example than in the comparative example. Also, the visibility of the example was better than that of the comparative example.

  Next, in order to test the residual ratio of vitamin C, one set of Otsuka MV Note (4 ml) (registered trademark) manufactured by Otsuka Pharmaceutical Factory Co., Ltd. in 900 ml of Aminotripa No. 2 (registered trademark) manufactured by Otsuka Pharmaceutical Factory Table 4 shows the results of measurement of the residual ratio (%) of vitamin C (ascorbic acid) after 0, 12, 24, and 48 hours after mixed injection and covering with the infusion bag covers of Examples and Comparative Examples. An indophenol titration method was used to measure the residual rate.

  From Table 4 above, it can be seen that the residual ratio of vitamin C is higher in the example than in the comparative example. Also, the visibility of the example was better than that of the comparative example.

  Next, in order to test the residual ratio of vitamin B12, one set of Otsuka MV Note (4 ml) (registered trademark) manufactured by Otsuka Pharmaceutical Factory Co., Ltd. in 900 ml of Aminotripa No. 2 (registered trademark) manufactured by Otsuka Pharmaceutical Factory Table 5 shows the results of co-injection and covering with the infusion bag covers of Examples and Comparative Examples, and measuring the residual rate (%) of vitamin B12 after 0, 12, 24, and 48 hours. For the measurement of the residual rate, an ultraviolet absorptiometer (measurement wavelength 548 nm) was used.

  From Table 4 above, it can be seen that the residual ratio of vitamin B12 is inferior to that of the comparative example, although the example is slightly inferior to the comparative example. Regarding visibility, the example was better than the comparative example.

  Next, in order to test the residual rate of vitamin E, remove the outer bag of Neopalene (1000 ml) (registered trademark) manufactured by Otsuka Pharmaceutical Factory, and cover with the infusion bag cover of Examples and Comparative Examples. Table 6 shows the results of measuring the residual rate (%) of vitamin E after 12, 24 and 48 hours. An ultraviolet absorptiometer (measurement wavelength: 275 nm) was used for the measurement of the residual rate.

  From Table 6 above, it can be seen that the residual rate of vitamin E is higher in the example than in the comparative example. Also, the visibility of the example was better than that of the comparative example.

  Next, in order to test the residual ratio of vitamin B1, remove the outer bag of Neopalene (1000 ml) (registered trademark) manufactured by Otsuka Pharmaceutical Factory, and cover with the infusion bag cover of Examples and Comparative Examples. Table 7 shows the results of measuring the residual ratio (%) of vitamin B1 after 12, 24 and 48 hours. The residual ratio was measured using an ultraviolet absorptiometer (measurement wavelength 260 nm).

  From Table 7 above, it can be seen that the residual ratio of vitamin B1 is almost the same in the example and the comparative example, and there is almost no decrease in both. Also, the visibility of the example was better than that of the comparative example.

It is sectional drawing which shows one Embodiment of the translucent plastic film which is a component of the packages which concern on this invention. It is sectional drawing which shows other embodiment of the translucent plastic film which is a component of the packaging which concerns on this invention. It is a front view which shows one Embodiment of the packaging which concerns on this invention. It is sectional drawing which shows other embodiment of the translucent plastic film which is a component of the packages which concern on this invention. It is sectional drawing which shows other embodiment of the translucent plastic film which is a component of the packages which concern on this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Translucent plastic film 2 Base material 3 Ink layer 4 Ultraviolet absorption film 5 Shading cover 6 Infusion bag main body 7 Innermost layer

Claims (9)

A package including a cover, a container, or a bag for shielding external light that degrades a pharmaceutical agent containing a photodegradable component, wherein the transmittance of light having a wavelength shorter than 450 nm is less than 1%, and the wavelength is 450 to 500 nm. The said packaging characterized by being formed with the translucent plastic film whose transmittance | permeability of light is 3% or less, and the transmittance | permeability of visible light with a wavelength of 600 nm or more is 80% or more. The packaging according to claim 1, wherein the translucent plastic film has a visible light transmittance of 70% or more at a wavelength of 550 nm or more and less than 600 nm. The packaging according to claim 1 or 2, wherein the translucent plastic film has a transmittance of light having a wavelength shorter than 450 nm of 0.1% or less. The said translucent plastic film contains an ultraviolet absorber, or it has an ultraviolet-absorbing performance by laminating an ultraviolet-absorbing film on the said translucent plastic film, The any one of Claims 1-3 characterized by the above-mentioned. Packaging. The packaging according to any one of claims 1 to 4, wherein the photodegradable component-containing pharmaceutical contains at least one selected from the group consisting of vitamin A, vitamin B2, and vitamin C. The said photodegradable component containing pharmaceutical contains at least 1 sort (s) chosen from the group which consists of vitamin A, vitamin B2, vitamin C, vitamin B1, vitamin B12, and vitamin E of Claims 1-4 characterized by the above-mentioned. Packaging according to any of the above. The packaging according to any one of claims 1 to 6, wherein the packaging is a container including an infusion bag, an infusion bottle, an ampoule, or a prefilled syringe. The package for a vitamin-containing solvent according to any one of claims 1 to 6, wherein the package is a cover of the container containing the photodegradable component-containing medicine. The packaging according to any one of claims 1 to 8, wherein a transparent polyethylene film, a transparent polypropylene film, or a transparent ethylene vinyl acetate film is laminated on the translucent plastic film as an innermost layer.

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