TW202218650A - Drug set - Google Patents

Abstract

To enhance the stability of a drug by suppressing oxygen decomposition of a component that deteriorates under the presence of oxygen and that is contained in a drug. A drug set 1 includes a PTP sheet that is partitioned into segments each in which a drug containing a component that deteriorates under the presence of oxygen is contained; an oxygen absorbing agent 4, and an outer bag 2 that contains the oxygen absorbing agent 4 and the PTP sheet and that is formed of a material having a gas-barrier property.

Description

Pharmacy group

The present invention relates to a pharmaceutical group.

Ethinyl estradiol (EE, Ethinyl estradiol) is used as an active ingredient in pharmaceuticals such as oral contraceptives or dysmenorrhea treatment agents. Since EE is decomposed with time under the influence of oxygen, there is a possibility that the quality of the medicament containing EE may decrease with time. As for solutions to improve the stability of EE, those skilled in the art have proposed a method of blending antioxidants in lozenges, or a method of preventing auto-oxidation by using a compound in which EE is encapsulated with cyclodextrin (Patent Documents 1- 3). [Prior Art Literature] [Patent Literature]

[Patent Document 1] International Publication No. 2012/120365 [Patent Document 2] Japanese Patent Laid-Open No. 2009-102424 [Patent Document 3] Japanese Patent Publication No. Hei 10-502362

(The problem that the invention intends to solve)

Here, in addition to the method of mixing additives in the medicine, a method of stabilizing the medicine containing EE by blister packaging (PTP, Press Through Package), which is one of the packaging forms of medicines, is also considered. Polyvinyl chloride (PVC, polyvinyl chloride) is widely used as the material on the container side of sheet PTP (PTP sheet), but PVC cannot completely prevent the penetration of moisture and oxygen in the air.

Therefore, it is considered that the use of PVC and polyvinylidene chloride (PVDC, polyvinylidene chloride) composite (PVC/PVDC), which is more excellent in moisture resistance and gas barrier properties, as the material of PTP sheet is beneficial to the material containing EE. Stabilization of drugs. However, even if a PTP sheet made of PVC/PVDC is used, the decomposition of EE cannot be completely prevented. Therefore, in order to improve the stability of EE, further efforts are required. In addition, other pharmaceuticals containing components degraded by oxygen other than EE also have the same problem.

The pharmaceutical composition of the present invention was invented in view of the above-mentioned problems, and one of the objects thereof is to suppress the oxygen decomposition of the oxygen-degraded components prepared in the pharmaceutical, and to improve the stability of the pharmaceutical. (Technical means to solve problems)

The pharmaceutical composition disclosed herein is configured to include: a PTP sheet that separates and accommodates a pharmaceutical containing components degraded by oxygen; an oxygen scavenger; and a gas barrier material outer bag that combines the oxygen scavenger and the PTP sheet. materials are contained together. (Compared to the efficacy of the prior art)

According to the disclosed pharmaceutical composition, it is possible to suppress the oxygen decomposition of the components prepared in the pharmaceutical that are degraded by oxygen, thereby improving the stability of the pharmaceutical.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. However, the embodiments described below are merely examples, and are not intended to exclude the application of various changes or techniques not shown below. For example, this embodiment can be implemented with various changes in the range which does not deviate from the summary. In addition, in the drawings used in the following description, the part marked with the same symbol means the same or the same part unless otherwise specified.

In this embodiment, it demonstrates based on the PTP sheet of the attitude|position along a horizontal plane. The horizontal plane is set to have a front and rear direction ("F" in the figure represents the front, and "B" represents the rear) and a left-right direction (in the figure, "L" represents the left, and "R" represents the right). . Regarding the left-right direction, the left-right direction is defined on the basis of the state from the front to the rear. In addition, let the action direction of the gravity in the vertical direction be downward (indicated by "D" in the figure), and the opposite direction of the downward direction is upward (indicated by "U" in the figure).

[I. One Embodiment] Hereinafter, the structure of the present invention in the present embodiment will be described in item [1], and the mechanism of action of the present invention will be described in item [2]. Next, the modification is described in the item [3], and the other is described in the item [4].

[1. Composition] FIG. 1 is an exploded perspective view showing a drug set 1 of the present embodiment. The medicine set 1 includes: a carrying package 3 containing a PTP sheet, an oxygen scavenger 4, and an outer bag 2 for accommodating these. In the present embodiment, one carrying package 3 and one oxygen scavenger 4 are accommodated in the inner space 20 of the outer bag 2 . The positional relationship between the carrying package 3 and the oxygen scavenger 4 in the outer bag 2 is not particularly limited. The outer bag 2 is provided with an opening 24 as an opening for communicating the inner space 20 with the outside. The opening 24 is not provided in the unopened outer bag 2 but is formed when the carrying package 3 is used.

FIG. 2 is a diagram schematically showing the unopened outer bag 2 . The outer bag 2 contains a gas-barrier material. Specifically, it is preferable to use a gas-barrier multilayer film, and the multilayer film preferably includes a laminated film having an aluminum vapor deposition layer or an aluminum foil and a resin layer. By this multilayer film, gas and moisture (humidity) can be prevented from permeating from the outside of the outer bag 2 to the inside.

The outer bag 2 may be a substantially rectangular bag shape having a pair of long sides and a pair of short sides. The periphery of the outer bag 2 may be surrounded by the sealing portion 21 . In the present embodiment, the sealing portion 21 is provided on the entire circumference of a substantially rectangular shape.

In the present embodiment, a planned opening portion 22 and a cutting line 23 are provided in the width direction of the short side of the outer bag 2 . As shown in FIG. 1, the opening part 24 is formed by removing the opening planned part 22 which becomes a part of the outer bag 2. As shown in FIG. Specifically, when the planned opening portion 22 is cut along the cutting line 23, the area of the planned opening portion 22 on the outer bag 2 is removed, and the opening portion 24 is opened. In this way, the carrying package 3 can be put in and taken out through the opening 24 .

In the vicinity of the cutting line 23 and the opening part 24, the slide fastener 25 may be provided. The zipper 25 is a re-closable snapper including an engaging protrusion and an engaging recess. The zipper (zip) 25 can be any one such as a chuck, a Slide Fastener, a zipper, and the like. The material of the slide fastener 25 is not particularly limited, for example, it may be made of plastic. The opening part 24 is opened and closed according to the opening and closing of the slide fastener 25 . The outer bag 2 can be hermetically sealed, so the carrying package 3 can be sealed and accommodated in the outer bag 2 again after use or during drug withdrawal, thereby further preventing deterioration of the quality of the medicine.

In the present embodiment, the carrying package 3 of FIG. 1 includes a PTP sheet 30 and a protective case 33 for carrying. Hereinafter, the configuration of the PTP sheet 30 will be described with reference to FIG. 3 , and the configuration of the portable protective case 33 will be described with reference to FIG. 4 .

FIG. 3 is a perspective view schematically showing the PTP sheet 30 . The PTP sheet 30 includes a multilayer laminate sheet having a substantially rectangular shape in plan view. The PTP sheet 30 is composed of a laminate having a base material sheet 31 on the upper surface and a cover film 32 on the lower surface.

In a preferred form, the base material sheet 31 is made of a material having oxygen permeability. The material preferably contains a thermoplastic resin, specifically polyvinyl chloride (PVC). Thereby, the oxygen remaining in the hole and groove portion 31a when the cover film 32 is sealed can be discharged to the outside of the hole and groove portion 31a. The oxygen permeability of the base material sheet 31 is preferably absorbed by the oxygen scavenger 4 packaged in the outer bag 2 together with the oxygen contained in the hole groove portion 31a in which the tablet M is dividedly accommodated (that is, the hole The degree to which the oxygen contained in the groove portion 31a is discharged from the hole groove portion 31a to the outside). Tablet M is a medicament containing components degraded by oxygen such as EE.

The base material sheet 31 is provided with a plurality of hole-groove portions 31a that protrude (bulge) upward. In the present embodiment, the dome-shaped hole and groove portions 31a are formed in a 7×3 arrangement. In each hole and groove portion 31a, as described above, the circular tablets M containing at least EE as an active ingredient are accommodated one by one (separately accommodated).

The cover film 32 includes a single layer of a breakable material such as aluminum foil. The cover film 32 is attached to the lower surface side of the base sheet 31 so as to cover the opening of each hole and groove portion 31a, whereby each hole and groove portion 31a is sealed.

FIG. 4 is a perspective view schematically showing the protective case 33 for carrying. In the present embodiment, the protective case 33 for carrying is a so-called wallet-type sheet case, and includes a paper backing 34 folded in four.

The paper backing 34 connects the front cover 35, the back cover 36, the first clip 37, and the second clip 38 in this order. On the cover sheets 35, the back cover sheets 36, the first clip 37, and the second clip 38, the name of the medicine, usage/dosage, curative effect/effect, precautions for use, expiration date, etc. can also be printed respectively. information (illustration omitted).

The first clip 37 and the second clip 38 are respectively formed with a plurality of holes 37a, 38a whose shape and arrangement correspond to the shape and 7×3 arrangement of the hole grooves 31a of the PTP sheet 30 . The second clip 38 is coated with a micro-adhesive type adhesive 39 for attaching the PTP sheet 30 . In this embodiment, the mounting part which fixes the PTP sheet 30 is comprised by several holes 37a and 38a of the 1st and 2nd clips 37 and 38, and the adhesive agent 39.

FIG. 5 is a perspective view schematically showing the carrying package 3 . In the present embodiment, the carrying package 3 is configured by attaching the PTP sheet 30 to the paper mount 34 . Hereinafter, the installation procedure of the portable package 3 will be described.

First, the PTP sheet 30 is pressed against the adhesive 39 of the second clip 38 so that the dome-shaped hole grooves 31 a of the PTP sheet 30 are inserted into the holes 38 a of the second clip 38 to be fixed. . Next, the second clip 38 to which the PTP sheet 30 is fixed is bent so that the PTP sheet 30 is sandwiched between the first clip 37 and the second clip 38 . After that, the back cover sheet 36 and the cover sheet 35 are sequentially folded so as to wrap the PTP sheet 30 . Through these operations, the wallet-type carrying package 3 folded in 40% is obtained.

When pressed and fixed to the hole groove portion 31a of the second clip 38 from above with a finger, the tablet M breaks through the cover film 32 of the PTP sheet 30, passes through the hole 37a of the first clip 37, and reaches the first clip 37 discharge below.

In this embodiment, the PTP sheet 30 is accommodated in the outer bag 2 in a state of being attached to the paper backing paper 34 . Thereby, the user can easily refer to the information related to the medicine when using the medicine, such as the name of the medicine, usage/dosage, curative effect/effect, precautions for use, and expiration date of the medicine. Moreover, since the time and effort of attaching the PTP sheet 30 to the paper backing paper 34 before use is saved, it can be easily sold in a dispensing pharmacy.

Returning to Figure 1, the oxygen scavenger 4 comprises a pouch filled with an oxygen absorbing substance. The deoxidizer 4 has the function of deoxidizing in the storage environment of the medicine M. By packaging the oxygen scavenger 4 in the outer bag 2 together with the PTP sheet 30, the oxygen in the outer bag 2 when unsealed and the oxygen remaining in the hole groove 31a when the cover film 32 is sealed can be removed. Furthermore, it is also possible to remove oxygen that has penetrated from the outside over time after the outer bag 2 is opened. Thereby, the decomposition of EE contained in the medicine can be suppressed, and further, the quality of the medicine M can be stabilized.

Here, among the oxygen scavengers, a trace amount of water is required for the reaction of absorbing oxygen. When such an oxygen scavenger is used, there is a possibility that the oxygen absorption function will not be exhibited under low humidity. In addition, when an oxygen scavenger containing moisture itself is used, there is a possibility that the moisture is absorbed by the chemical, resulting in decomposition of the chemical or other quality deterioration. Therefore, it is preferable to use the oxygen scavenger 4 which has a moisture absorption (drying) function in addition to the oxygen absorption function of this embodiment. Thereby, the tablet M can be stored in a dry state. Furthermore, in the present embodiment, the PTP sheet 30 is packaged in the outer bag 2 in a state of being attached to the paper liner 34, so that the moisture contained in the paper liner 34 can also be absorbed. In addition, it is also possible to absorb moisture that penetrates from the outside with time after the outer bag 2 is opened. In this way, by using the oxygen scavenger 4 having a moisture absorption (drying) function in addition to the oxygen absorption function, the medicine can be stored in a dry state, and the quality of the medicine can be stabilized.

The type of the oxygen scavenger 4 is not limited as long as it exhibits an oxygen absorption function in the storage environment of the medicine. Moreover, as mentioned above, the oxygen scavenger 4 may further have a moisture absorption (drying) function. As a specific commercial item, the oxygen scavenger of PharmaKeep (registered trademark; manufactured by Mitsubishi Gas Chemical Co., Ltd.) can be mentioned, for example. The oxygen absorption capacity of the oxygen scavenger 4 can be appropriately selected according to the capacity of the outer bag 2 , the number of medicines contained in the PTP sheet 30 , or the size of the paper backing paper 34 .

[2. Mechanism of action] Hereinafter, the mechanism of action of the pharmaceutical group 1 constituted as described above will be described with reference to the results of verification of the improvement of the stability of EE as a pharmaceutical component.

[2-1. Comparison of the materials used for the base sheet of the PTP sheet] [2-1-1. Preparation of sample] First, the preparation of the sample will be described. (1) 28 Jemina (registered trademark) tablets (0.02 mg of ethinyl estradiol and 0.09 mg of Levonorgestrel are prepared in 1 tablet, manufactured by Nobelpharma Co., Ltd.) are separately stored in the wells in which the storage tablets are formed (7 tablets × 4 rows) of PVC material (manufactured by Sumitomo Bakelite Co., Ltd., VSS-F110-UV-3) was sealed with PTP aluminum foil (manufactured by Shohoku Laminate Co., Ltd.) to prepare a PTP sheet. (2) Separately, a PTP sheet produced in the same manner as above using a sheet of PVC/PVDC material (manufactured by Sumitomo Bakelite Co., Ltd., VSL-4610-N) was also prepared. Put the produced PTP sheets into an aluminum bag (manufactured by Japan Manufactured by Co., Ltd., Lamizip stand type AL-11), several kinds of sealed medicine sets are made by heat sealing. The prepared pharmaceutical groups were left at room temperature for one week as measurement samples. (3) In addition, as a reference example for confirming the stabilization effect of the oxygen scavenger, 84 Jemina (registered trademark) formulation tablets were mixed with 3 sheets of paper in a state where they were not housed in the PTP sheet but scattered. The backing paper and 3 oxygen scavengers were put together in the same aluminum bag as above, and sealed samples were also made by heat sealing.

[2-1-2. Experimental method] Next, the experimental method will be described. Each of the prepared samples was placed in a thermostat set at 50°C, and the measurement of ethinyl estradiol was carried out by the following method at the beginning and after storage for 2 months, and the content of ethinyl estradiol was investigated. Change in content (survival rate (%) when the content at the beginning is set to 100).

Hereinafter, the measurement method of ethinyl estradiol will be described. (1) For one tablet, shake extraction was performed with 10 mL of an acetonitrile/water mixture (11:9), filtered through a membrane filter with a pore size of 0.45 μm, and the obtained liquid was used as a sample solution. The prepared sample solution was analyzed by high performance liquid chromatography (HPLC, High Performance Liquid Chromatography) under the following conditions, and the peak area of ethinyl estradiol was obtained. By comparison, the content of ethinyl estradiol was obtained. (2) The following are the conditions for measurement. Detector: UV absorbance photometer (measurement wavelength: 210 nm) Column: Silica octadecyl silanide (5 μm), 4.6 mm ID, 15 cm length Column temperature: about 40℃ Mobile phase: acetonitrile/water mixture (11:9) Flow: 1.2 mL/min Injection volume: 50 μL

[2-1-3. Results] The verification results are shown in Table 1. Table 1 shows the composition of each sample (drug group) and the residual ratio of ethinyl estradiol (EE) after storage for 2 months (storage temperature: 50°C). For the sample (Comparative Example 1) in which the PTP sheet made of PVC/PVDC was placed in an aluminum bag without containing an oxygen scavenger, it was confirmed that after storage for 2 months, the reduction was about 9%. of ethinyl estradiol. In the samples (Example 1, Example 2) in which the PTP sheet made of PVC/PVDC was placed in an aluminum bag together with an oxygen scavenger, it was confirmed that the reduction of ethinyl estradiol was suppressed to about 6 %, the decomposition inhibitory effect of ethinyl estradiol is obtained by encapsulating the oxygen scavenger together with the PTP sheet. From the results of the sample (Reference Example 1) in which the scattered tablet was enclosed with an oxygen scavenger, it was confirmed that the effect of the oxygen scavenger effectively suppressed the decomposition of ethinyl estradiol in the tablet itself. From the results of Examples 1 and 2, it was confirmed that the decomposition inhibitory effect of obtaining ethinyl estradiol was exhibited even when it was separately accommodated in a PTP sheet made of PVC/PVDC. In the samples (Example 3, Example 4) in which the PTP sheet made of PVC was placed in an aluminum bag together with an oxygen scavenger, the decrease in ethinyl estradiol was suppressed to less than about 2%. From this result, it was confirmed that the decomposition of ethinyl estradiol can be suppressed particularly effectively by enclosing a PTP sheet made of oxygen-permeable PVC together with an oxygen scavenger in a gas-barrier bag.

[Table 1] Example form of medicine PTP material Number of paper backing sheets Deoxidizer encapsulated number Survival rate of EE after 2 months Reference Example 1 Lozenges loose 84 lozenges - 3 3 99.3% Comparative Example 1 3 PTP sheets (can hold 84 spindles) PVC/PVDC 3 0 90.9% Example 1 3 PTP sheets (can hold 84 spindles) PVC/PVDC 3 1 94.4% Example 2 3 PTP sheets (can hold 84 spindles) PVC/PVDC 3 3 94.3% Example 3 3 PTP sheets (can hold 84 spindles) PVC 3 1 98.7% Example 4 3 PTP sheets (can hold 84 spindles) PVC 3 3 98.5%

[2-2. Accelerated test of chemical group using PVC material base sheet] [2-2-1. Preparation of sample] First, the preparation of the sample will be described. (1) Separately store 21 Jemina tablets in a sheet of PVC material (manufactured by Sumitomo Bakelite Co., Ltd., VSS-F110-UV-3) formed with slots for storing tablets (7 tablets × 3 rows) Among them, the aluminum foil for PTP (manufactured by Shohoku Laminate Industrial Co., Ltd.) was used for sealing to prepare a PTP sheet. 1 set containing the PTP sheet and paper interlining paper was stored in an aluminum bag having gas barrier properties together with 1 scavenger (manufactured by Mitsubishi Gas Chemical Co., Ltd., PharmaKeep (registered trademark) KD-20) , which was sealed by heat sealing and used as a measurement sample. (2) Separately store 10 Jemina-prepared tablets in a sheet of PVC/PVDC material with grooves for storing tablets (5 tablets × 2 rows), and use aluminum foil for PTP (Shohoku Laminate Industrial Co., Ltd.) Production) of the sealed PTP sheet, and a sample for acquisition as a reference example (the PTP sheet was not stored in the aluminum bag, and the PTP sheet was directly supplied to the following experiment).

[2-2-2. Experimental method] Next, the experimental method will be described. A measurement sample (PTP sheet made of PVC material and a paper backing paper and oxygen scavenger stored in an aluminum bag, Example 5) and a sample for reference example acquisition (made using PVC/PVDC material) were collected. PTP sheet, reference example 2) is placed in a thermostat with a temperature of 40°C±2°C and a humidity of 75%RH±5%RH. Ethinyl estradiol was measured, and changes in the content of ethinyl estradiol were investigated. The measurement was performed using three batches of samples, and the measurement of ethinyl estradiol was performed using the following method.

Hereinafter, the measurement method of ethinyl estradiol will be described. (1) For one tablet, shake extraction was performed with 10 mL of an acetonitrile/water mixture (11:9), filtered through a membrane filter with a pore size of 0.45 μm, and the obtained liquid was used as a sample solution. The prepared sample solution was subjected to HPLC analysis under the following conditions, the peak area of ethinyl estradiol was determined, and the content of ethinyl estradiol was determined based on the comparison with the analysis result of the ethinyl estradiol standard substance. (2) The following are the conditions for measurement. Detector: Fluorometer (excitation wavelength: 281 nm; detection wavelength: 305 nm) Column: Silica octadecyl silanide (5 μm), 4.6 mm ID, 15 cm length Column temperature: about 40℃ Mobile phase: acetonitrile/water mixture (11:9) Flow: 1 mL/min Injection volume: 20 μL

[2-2-3. Results] The results are shown in FIG. 6 . Figure 6 shows the change in the content of ethinyl estradiol (EE) stored at 40°C. Figures PVC No. 1 to 3 show the results of Example 5, and Figures PVC/PVDC No. 1 to 3 show the results of Reference Example 2. In the sample (measurement sample, Example 5) accommodated in the aluminum bag together with the oxygen scavenger, almost no decrease in ethinyl estradiol was observed within 6 months, and it was confirmed that it was extremely stable. On the other hand, in the case of the sample (sample for obtaining reference example, reference example 2) that stored the PTP sheet stored in the PTP of the PVC/PVDC material without being placed in the aluminum bag, it was confirmed within 6 months. About 9% less ethinyl estradiol. From this result, it was confirmed that the reduction of ethinyl estradiol can be effectively suppressed by storing in a PTP sheet of PVC material and storing it in a gas-barrier aluminum bag together with an oxygen scavenger.

[3. Variations] In the verification results of Table 1 above, according to the classification and comparison of materials, it is confirmed that it is better to use PTP sheets made of PVC/PVDC materials (Comparative Example 1, Example 1, Example 2), and it is more preferable to use PTP sheets made of PVC/PVDC materials. PTP sheet made of PVC material (Example 3, Example 4).

As for the reason for the difference in the suppression of decomposition of EE and the reduction of EE contained in PTP sheets of different materials, it is considered that, for example, although it may be due to the presence of The remaining oxygen causes decomposition of EE, but by using a PVC material with a lower gas barrier property than PVDC, the oxygen in the groove portion 31a is efficiently discharged to the outside of the groove portion 31a.

In the verification results shown in Table 1 above, the results differ depending on the material, but when the reference example 1 was compared with the others, it was confirmed that the PTP sheet was accommodated in the PTP sheet by distinction and the In the aluminum bag of the scavenger, both the PVC material and the PVC/PVDC material have a certain effect on the inhibition of the reduction of EE.

It is also contemplated for the substrate sheet 31 to comprise a composite of polyvinyl chloride and polyvinylidene chloride (PVC/PVDC). PVDC has excellent moisture-proof and gas-barrier properties. Therefore, by using the PTP sheet of PVC/PVDC material, the moisture in the outer bag 2 and the moisture in the paper backing paper 34 can be prevented from being absorbed by the medicine, and the outer bag can be prevented from being absorbed by the medicine. The oxygen in 2 penetrates into the hole groove portion 31a. However, as described above, in the case of using PVC/PVDC material to make the base sheet 31, considering the gas barrier properties of PVDC, it is considered that it is preferable to seal the medicine M with the cover film 32 before sealing. The air in the hole groove portion 31a is replaced with an inert gas (nitrogen, argon, etc.). The same is true for the case where both sides of the base material sheet 31 are produced from the material of the cover film 32, such as a single layer of aluminum foil.

Furthermore, as yet another embodiment of the drug set, it may be configured to include a PTP sheet that separates and accommodates a gas-barrier material containing a drug containing components degraded by oxygen, and a gas-barrier material that accommodates the above-mentioned PTP sheet. In addition to the bag, the above-mentioned PTP sheet is divided and accommodated in the above-mentioned drug in a hypoxic state. For example, the pharmaceutical group can use PTP sheet material with low oxygen permeability (or oxygen impermeability) such as PVC/PVDC material, or replace the air in the hole with inert gas during sealing, A hypoxic state is thereby achieved. Furthermore, the PTP sheet of the pharmaceutical group can also have a moisture-proof function. In these aspects, it is preferable to remove the air in the outer bag by degassing or replacing it with an inert gas when the PTP sheet is accommodated in a gas-barrier outer bag and heat-sealed. oxygen. Moreover, when accommodated in the outer bag together with the paper lining paper, a desiccant or a deoxidizer may be packaged together.

[4. Others] In this embodiment, although the outer bag 2 has the zipper 25, the zipper 25 may not be provided. In addition, in this embodiment, although the one carrying package 3 packaged in the outer bag 2 is shown, the number may be several. In this embodiment, the oxygen scavenger 4 is placed in the outer bag 2 together with the carrying package 3, but it may be attached to any part of the paper backing paper 34 of the protective case 33 for carrying. Alternatively, the oxygen scavenger 4 may be inserted between the first clip 37 and the second clip 38 . Thereby, when the carrying package 3 is taken out from the outer bag 2, the oxygen absorption function and the moisture absorption function are also exhibited, so that the decomposition of EE in the medicine can be further suppressed, and the quality of the medicine can be stabilized.

Furthermore, in the above-mentioned embodiment, polyvinyl chloride (PVC) and a composite of polyvinyl chloride and polyvinylidene chloride (PVC/PVDC) are shown as the base sheet 31, but depending on the required performance, As the base material sheet 31, thermoplastic resins known in the industry, such as polypropylene, polyethylene terephthalate, etc., can be used.

In addition, the number or arrangement of the holes 31a of the PTP sheet 30 and the holes 37a and 38a of the first and second clips 37 and 38 may be appropriately considered in consideration of the usage/amount of the medicine, design, operability, etc. change. For example, 7×4 arrangement or zigzag arrangement is also possible.

In addition, the number of the holes and grooves 31a provided in the PTP sheet 30 may be 2 to 31, for example, in combination with the usage/amount. For example, arranging 7 holes and grooves 31a in one row for one week, 7 x 4 rows or 7 x 3 rows, is also more convenient in administration of medication, which is preferable. In this case, the number or arrangement of the holes 37 a and 38 a may be the same as the hole groove portion 31 a of the PTP sheet 30 . Furthermore, the number of holes 37a and 38a may be more than the number of holes 31a of the PTP sheet 30. In this case, a variety of PTP sheets with different numbers of holes 31a can be used. 30 commonly uses a protective case 33 for carrying.

In the present embodiment, the oxygen scavenger 4 is in the shape of a bag, but it is not limited to this, and may be in the form of a pot, a sheet, or a film. In the case of a sheet, it is easy to be enclosed in the outer bag 2 together with the carrying package 3 .

1: Pharmacy group 2: Outer bag 3: Carrying packaging 4: Deoxidizer 20: Interior space 21: Sealing part 22: Opening scheduled part 23: Cut the line 24: Opening 25: zipper 30: PTP sheet 31: substrate sheet 31a: Hole groove part 32: cover film 33: Portable protective case 34: Paper backing 35: Cover Piece 36: Back cover piece 37: 1st clip 37a: hole 38: 2nd clip 38a: hole 39: Adhesive M: Potion (lozenge)

FIG. 1 is an exploded perspective view showing an embodiment of a drug set. Fig. 2 is a diagram schematically showing an outer bag. FIG. 3 is a perspective view schematically showing a PTP sheet. FIG. 4 is a diagram schematically showing a portable protective case. Fig. 5 is a diagram schematically showing a carrying package. Fig. 6 is a graph showing changes in the content of EE.

1: Pharmacy group

2: Outer bag

3: Carrying packaging

4: Deoxidizer

20: Interior space

22: Opening scheduled part

23: Cut the line

24: Opening

25: zipper

Claims (6)

A pharmaceutical group composed of: PTP sheet, which separates and accommodates medicines containing components degraded by oxygen; oxygen scavengers; and A gas-barrier material outer bag containing the above-mentioned oxygen scavenger together with the above-mentioned PTP sheet. The medicine set according to claim 1, wherein the PTP sheet is made of a material having oxygen permeability. The pharmaceutical group of claim 2, wherein the PTP sheet is made of polyvinyl chloride or a compound of polyvinyl chloride and polyvinylidene chloride. The pharmaceutical group according to any one of claims 1 to 3, wherein the oxygen scavenger has a hygroscopic function. The medicine set according to any one of claims 1 to 4, wherein the PTP sheet is accommodated in the outer bag together with a paper backing paper. The medicine set according to claim 5, wherein the PTP sheet is accommodated in the outer bag in a state of being attached to the paper backing paper.

Images