Medicine container

Abstract

To provide a medicine container which can achieve productivity improvement associated with simplification of a manufacturing process.SOLUTION: A medicine container includes a container body which has a mouth part communicating the other container and a plug part for sealing the mouth part and accommodates a medicine, a communication member which is attached to the container body in an air-tight manner and is attachable to the other container, and a cap including a cylinder part attached to the communication member in an air-tight manner and a lid part provided on one end of the cylinder part. The communication member includes a cylindrical main part and a double-ended needle which is held by the main part and is movable to penetrate the plug part. The double-ended needle is a hollow member having a first opening end part and a second opening end part. The first opening end part is positioned in a first internal space provided by the communication member and the container body and extends to the plug part, the second opening end part is positioned in a second internal space provided by the communication member and the cap and extends to the lid part, and the cap has a vent hole.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to medication containers. [Background technology]

[0002] As an infusion container, an infusion container with a double-ended needle for communicating with other drug containers is known. Patent Document 1 below discloses an infusion container with a double-ended needle that is provided with a communication port for communicating with other drug containers. For safety reasons, medical containers such as infusion containers are usually sterilized. High-pressure steam sterilization (autoclave) is sometimes used as the sterilization method. High-pressure steam sterilization is a sterilization method that is effective against bacteria (spores) that cannot be killed at high temperatures of around 100°C. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 4048337 Summary of the Invention [Problem to be solved by the invention]

[0004] In the infusion container disclosed in Patent Document 1, a support ring that holds the double-ended needle and a cap are airtightly attached to maintain the sterilization of the double-ended needle and other components. Furthermore, the support ring and the communication port are also airtightly attached. Therefore, if the infusion container is sterilized while the support ring and cap of the infusion container are attached to the communication port, there is a concern that the double-ended needle and other components may not be sufficiently sterilized. To address this concern, for example, an assembly consisting of the support ring, cap, and double-ended needle, and another assembly consisting of the container body and the communication port, are each autoclaved. That is, to address this concern, multiple sterilization processes are performed. After the sterilization processes are completed, the assembly is attached to the communication port in a hygienic environment, such as a clean room, to manufacture the infusion container. To improve the productivity of pharmaceutical containers such as infusion containers, it is desirable to simplify the manufacturing process of infusion containers.

[0005] An object of the present disclosure is to provide a drug container that can improve productivity by simplifying the manufacturing process. [Means for solving the problem]

[0006] A drug container according to one aspect of the present disclosure comprises a container body for containing a drug, the container body having a mouth portion communicating with another container and a stopper portion sealing the mouth portion, a communicating member airtightly attached to the container body and attachable to another container, a tubular portion airtightly attached to the communicating member, and a cap having a lid portion attached to one end of the tubular portion, the communicating member having a tubular main portion and a double-ended needle held in the main portion and movable to penetrate the stopper portion, the double-ended needle being a hollow member having a first opening end and a second opening end, the first opening end being located in a first internal space defined by the communicating member and the container body and extending toward the stopper portion, and the second opening end being located in a second internal space defined by the communicating member and the cap and extending toward the lid portion, the cap having an air vent.

[0007] In this drug container, the first open end of the double-ended needle, which is a hollow member, is located in a first internal space defined by the communicating member and the container body, and the second open end of the double-ended needle is located in a second internal space defined by the communicating member and the cap. As a result, the vent in the cap communicates not only with the second internal space but also with the first internal space via the double-ended needle. Therefore, even if the drug container is subjected to a sterilization process such as autoclaving while the communicating member is airtightly attached to the container body and the cap is airtightly attached to the communicating member, the interior of the communicating member, the interior of the cap, and components housed in the communicating member and / or the cap, such as the double-ended needle, are sterilized effectively. Therefore, the sterilization of the double-ended needle and other components of the drug container can be completed with only a single sterilization process. Furthermore, after the sterilization process, there is no need to perform an assembly process in a sanitary environment. Therefore, the manufacturing process for the drug container can be simplified, thereby improving productivity.

[0008] The vent may be located in the lid, in which case the vent can be easily formed in the cap.

[0009] The cap may cover the vent hole and further include a porous sterile packaging material. In this case, steam can penetrate into the interior space of the cap through the porous sterile packaging material, thereby effectively sterilizing components such as double-ended needles. In addition, the sterilization state of the double-ended needles can be easily maintained.

[0010] The second open end may be located closer to the lid than to the upper end of the main body. In this case, the double-ended needle can be easily inserted into various other drug solution stoppers. In addition, the drug container can be easily mixed with other drug containers with necks, such as infusion bags.

[0011] The tubular portion has a recess that covers the upper end of the main portion, and the recess has a bottom that contacts the top surface of the upper end, a first protruding portion that is located outside the upper end in a plan view and protrudes toward the upper end, and a second protruding portion that is located inside the upper end and near the mouth in a plan view, and the tip of the second protruding portion is located outside the inner edge of the upper end in a plan view. In this case, because the inner surface of the main portion and the cap are press-fitted, airtightness between the communicating member and the cap is likely to be maintained even if the communicating member and the cap shrink.

[0012] The upper end portion may be sandwiched between the first protrusion and the second protrusion, in which case the airtightness between the communication member and the cap is well maintained.

[0013] The thickness of the upper end portion may be greater than the thickness of the second protruding portion, in which case a gap is less likely to form between the upper end portion and the second protruding portion after sterilization, thereby maintaining good airtightness between the communicating member and the cap.

[0014] The heat shrinkage rate of the main material contained in the cap may be smaller than that of the main material contained in the communicating member, and the heat shrinkage rate of the cap may be larger than that of the communicating member, in which case the airtightness between the communicating member and the cap is well maintained even after sterilization.

[0015] The medication may be an infusion formulation containing potassium chloride. [Effects of the Invention]

[0016] According to one aspect of the present disclosure, it is possible to provide a drug container that can realize improved productivity by simplifying the manufacturing process. [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 1 is a front view showing a drug container according to an embodiment. [Figure 2] FIG. 2 is an exploded view of the drug container according to the embodiment. [Figure 3] FIG. 3 is a top view of the container body. [Figure 4] FIG. 4 is a cross-sectional view of the communication member and the cap. [Figure 5] FIG. 5 is a schematic perspective view of the communication member. [Figure 6] FIG. 6 is an exploded view of the communication member. [Figure 7] FIG. 7 is a cross-sectional view of the main body and the support. [Figure 8] FIG. 8 is a perspective view of the cap. [Figure 9] FIG. 9 is a front view of the cap. [Figure 10] FIG. 10 is a partial cross-sectional view of the communication member and the cap. [Figure 11] FIG. 11 is an enlarged view of the main part of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0018] A preferred embodiment of one aspect of the present invention will be described in detail below with reference to the accompanying drawings. In the following description, the same elements or elements having the same functions will be designated by the same reference numerals, and redundant description will be omitted.

[0019] FIG. 1 is a front view showing a drug container according to an embodiment. FIG. 2 is an exploded view of the drug container according to an embodiment. The drug container 100 shown in FIGS. 1 and 2 is a member configured to be able to airtightly contain a drug (not shown) and to allow the drug to be easily removed. The drug removed from the drug container 100 can be supplied to, for example, another container while maintaining the airtight state. This allows the drug contained in the container body 1 and the contents contained in the other container to be mixed while maintaining a sterilized state. At least one of the drug and the contents is liquid. If the contents are solid, the drug can function as a dissolving liquid for the contents. In this embodiment, the drug contained in the drug container 100 is a liquid infusion preparation containing potassium chloride.

[0020] As shown in FIG. 1, the drug container 100 is an assembly including a container body 1 that accommodates a drug, a communicating member 2 that is airtightly attached to the container body 1, and a cap 3 that is airtightly attached to the communicating member 2. FIG. 1 shows the drug container 100 before use. The structure of the drug container 100 before use will be described below unless otherwise specified. The upright state of the drug container 100 corresponds to the state of the drug container 100 shown in FIG. 1. Therefore, the vertical direction on the paper in FIG. 1 corresponds to the vertical direction of the drug container 100. The horizontal direction on the paper in FIG. 1 may be referred to as the first direction, and the direction perpendicular to the vertical direction and the first direction may be referred to as the second direction. In this embodiment, the sterilization process of the communicating member 2 and the cap 3 in the drug container 100 is performed with the communicating member 2 attached to the container body 1 and the cap 3 attached to the communicating member 2. As described above, the container body 1, the communicating member 2, and the cap 3 are airtightly integrated with each other. Therefore, a sterilized state is maintained at least inside the communicating member 2 and the cap 3 in the drug container 100. In this embodiment, the sterilization process is high-pressure steam sterilization using an autoclave or the like, but is not limited to this. In high-pressure steam sterilization, for example, the communicating member 2 and the cap 3 are exposed to steam at 100°C or higher.

[0021] Fig. 3 is a top view of the container body. As shown in Figs. 1 to 3, the container body 1 is a member for storing a drug in a sterile state. The container body 1 has a container portion 10 for accommodating the drug, a mouth portion 11 provided on the container portion 10, and a stopper portion 12 for sealing the mouth portion 11. The container portion 10 is flexible and can therefore be deformed when pressed from the outside. The container portion 10 is a molded body made of a resin such as a polyolefin such as polyethylene or polypropylene, or a polyester such as polyethylene terephthalate. The shape of the container portion 10 is not particularly limited.

[0022] The mouth portion 11 is a portion for communicating with another container, and has a cylindrical shape protruding from the container portion 10. In this embodiment, the mouth portion 11 is provided at the upper end of the container portion 10, but is not limited to this. The mouth portion 11 is molded simultaneously with the container portion 10. In this case, the container portion 10 and the mouth portion 11 are airtightly and continuously connected. An annular protrusion 11a is provided on the outer surface of the mouth portion 11. The protrusion 11a is a hook portion used when transporting the container body 1 during the manufacture of the drug container 100, for example. For example, the container body 1 can be easily transported by hooking the protrusion 11a onto the claws of a transport device.

[0023] The stopper 12 is a member that seals the container 10 and is attached to the mouth 11. The stopper 12 has a main body 13 and a sealing portion 14. The main body 13 is a resin molded body that covers at least the tip of the mouth 11. The main body 13 may have a molded body of the resin described above, or may have a molded body of a resin different from the above resins (e.g., polyvinyl chloride). The main body 13 is airtightly attached to the mouth 11. For example, the main body 13 and the mouth 11 may be heat-welded to each other. A cylindrical portion 13a is provided at the center of the main body 13, but this is not limited thereto. The sealing portion 14 is inserted into the main body 13 and closes the cylindrical portion 13a, and is airtightly attached to or embedded in the main body 13. The sealing portion 14 has a blocking portion 14a that closes the cylindrical portion 13a and an annular portion 14b that protrudes from the top surface of the main body 13. The closing portion 14a is located at the center of the main body 13 and is exposed through the cylindrical portion 13a. The double-ended needle 22 (described in detail later) provided on the communicating member 2 can penetrate through the closing portion 14a. The annular portion 14b maintains an airtight state between the container main body 1 and the communicating member 2 and is in contact with the bottom surface of the communicating member 2. The annular portion 14b melts and adheres to the bottom surface of the communicating member 2 due to the heat generated during the sterilization process, thereby maintaining the airtight state between the stopper portion 12 and the communicating member 2. The annular portion 14b has at least a portion that is annular in shape and surrounds the cylindrical portion 13a in a plan view. In this embodiment, the annular portion 14b has multiple protrusions that protrude radially from the above portion to ensure good fixation of the sealing portion 14 to the main body 13. The annular portion 14b, for example, passes through a gap G that is annular in shape in a plan view and provided in the main body 13, and is in close contact with the communicating member 2. In this way, the annular portion 14b is brought into close contact with the communicating member 2, thereby airtightly connecting the container body 1 and the communicating member 2. From the viewpoint of maintaining a good airtight state between the container body 1 and the communicating member 2, the annular portion 14b may be, for example, heat-welded to the communicating member 2. The annular portion 14b may be inserted into a groove that is provided in the communicating member 2 and has a circular ring shape in a plan view.

[0024] The sealing portion 14 is formed, for example, from a rubber material, a thermoplastic elastomer, a polyolefin resin, or the like. The rubber material or thermoplastic elastomer is a nitrile rubber such as butyl rubber or nitrile butadiene rubber, a urethane rubber, a fluororubber, a silicone rubber, or the like. From the viewpoint of preventing or suppressing drug adsorption, the sealing portion 14 may be formed from butyl rubber. The sealing portion 14 may be molded, for example, by pouring a thermoplastic resin into the main body 13 held in a mold.

[0025] Fig. 4 is a cross-sectional view of the communicating member and the cap. Fig. 5 is a schematic perspective view of the communicating member. Fig. 6 is an exploded view of the communicating member. As shown in Figs. 4 to 6, the communicating member 2 is a member used to supply the drug in the container body 1 to another container while maintaining the sterilization state, and is attachable to the other container. The communicating member 2 has a main portion 21, a double-ended needle 22 housed in the main portion 21, and a support 23 that supports the double-ended needle 22.

[0026] The main portion 21 is a cylindrical, hollow member attached to the container body 1. The main portion 21 includes a cylindrical portion 21a, an annular bottom portion 21b that closes a portion of the lower end of the cylindrical portion 21a, a first opening 21c defined by the upper end E of the cylindrical portion 21a, a second opening 21d defined by the inner edge of the bottom portion 21b, and a protrusion 21e protruding from the bottom surface of the bottom portion 21b. The central axis of the main portion 21 coincides with the centers of the cylindrical portion 21a, the first opening 21c, and the second opening 21d, but is not limited thereto. Although not shown, a stopper 12 is inserted into the second opening 21d, and the annular portion 14b is in close contact with the bottom portion 21b. This creates an airtight internal space within the container body 1, consisting of the stopper 12, the communicating member 2, and the cap 3. As shown in FIG. 4, this internal space is divided into two by a support 23. Specifically, a first internal space S1 is defined by the container body 1, the main portion 21 of the communicating member 2, and the support 23, and a second internal space S2 is defined by the support 23 of the communicating member 2 and the cap 3. The first internal space S1 and the second internal space S2 are connected to each other via a double-ended needle 22 or the like. The upper end E of the tubular portion 21a is the portion of the tubular portion 21a that is closest to the lid portion 32 of the cap 3 (details will be described later), and is also the portion that maintains airtightness with the cap 3. The diameter R1 (inner diameter) of the upper end E of the main portion 21 may be, for example, the largest in the main portion 21.

[0027] The protruding portion 21e has a plurality of projections 21e1 extending from the bottom portion 21b and an annular portion 21e2 connecting the tips of the projections 21e1. In a plan view, the inner circumferential surface of the annular portion 21e2 is located inside the projections 21e1. As a result, the annular portion 21e2 is hooked onto the bottom surface of the stopper portion 12 in the drug container 100.

[0028] The cylindrical portion 21a is a portion capable of holding the support 23 and has a substantially cylindrical shape. The outer diameter of the cylindrical portion 21a at and near the first opening 21c is smaller than the outer diameter of the cylindrical portion 21a at and near the second opening 21d, but is not limited to this. The outer surface of the cylindrical portion 21a is provided with a plurality of first protrusions 21f to which the cap 3 is engaged and threads 21g to which the cap 3 is screwed. The plurality of first protrusions 21f are located in the central portion of the cylindrical portion 21a in the up-down direction and are provided intermittently along the circumferential direction. In this embodiment, the upper and lower surfaces of each first protrusion 21f are inclined surfaces, but this is not limited to this. Furthermore, of the two side surfaces of each first protrusion 21f that intersect in the circumferential direction, one side surface is inclined and the other side surface is upright along the radial direction of the cylindrical portion 21a. As a result, after the cap 3 is attached to the communicating member 2, the movement of a cap ring 35 (see FIG. 8 described later) included in the cap 3 is restricted by the plurality of first protrusions 21f. The thread 21g extends on the outer surface along the circumferential direction of the cylindrical portion 21a (hereinafter simply referred to as the circumferential direction). At least one of the pair of ends of the thread 21g gradually becomes thinner in the circumferential direction, but this is not limited to this.

[0029] FIG. 7 is a cross-sectional view of the main portion and the support. The cross-section of FIG. 7 differs from the cross-section of FIG. 4. As shown in FIG. 7, a plurality of second raised portions 21h and a plurality of third raised portions 21i are provided on the inner surface of the tubular portion 21a. In this embodiment, the plurality of second raised portions 21h are portions that hold the support 23 and are provided intermittently along the circumferential direction, but this is not limited thereto. For example, the second raised portions 21h may have a ring shape extending from the inner surface of the tubular portion 21a toward the center. In the vertical direction, a gap between two adjacent second raised portions 21h overlaps one of the plurality of third raised portions 21i. In this embodiment, the upper and lower surfaces of each second raised portion 21h are inclined surfaces, but this is not limited thereto. The plurality of third raised portions 21i are portions that restrict movement of the support 23 in the vertical direction and are provided intermittently along the circumferential direction. The height of each third raised portion 21i is greater than the height of each second raised portion 21h. Furthermore, the multiple third raised portions 21i are located closer to the first opening 21c than the multiple second raised portions 21h. As a result, the presence of the multiple third raised portions 21i prevents the support 23 from moving closer to the first opening 21c than the multiple third raised portions 21i. Additionally, before use of the drug container 100, the position of the support 23 relative to the main portion 21 is determined by the multiple second raised portions 21h and the multiple third raised portions 21i. Note that, in the vertical direction, the gap between two adjacent third raised portions 21i overlaps with one of the multiple second raised portions 21h.

[0030] The double-ended needle 22 is a hollow member used to connect the container body 1 with another container, and is held by the main portion 21 and is provided movably so as to penetrate the stopper portion 12. In this embodiment, the double-ended needle 22 is held by the main portion 21 via a support 23. The double-ended needle 22 has, for example, a shaft shape extending in the vertical direction. In a plan view, the double-ended needle 22 overlaps the first opening 21c and the second opening 21d. As shown in FIG. 4, the double-ended needle 22 has a first puncture needle 22a, a second puncture needle 22b, and a tube portion 22c.

[0031] As shown in FIG. 4, first puncture needle 22a is an open end (first open end) that penetrates closure portion 14a when drug container 100 is in use, and is located at the lower end of double-ended needle 22. First puncture needle 22a is located in first internal space S1 and extends toward stopper portion 12. Before drug container 100 is in use, first puncture needle 22a faces closure portion 14a. Second puncture needle 22b is an open end (second open end) that penetrates the stopper of another container when drug container 100 is in use, and is located at the upper end of double-ended needle 22. Second puncture needle 22b is located in second internal space S2 and extends toward lid portion 32 of cap 3 (see FIG. 8 described later). Before drug container 100 is in use, second puncture needle 22b is located closer to lid portion 32 than to upper end E of main portion 21. Pipe portion 22c is a hollow portion extending linearly between first puncture needle 22a and second puncture needle 22b. Pipe portion 22c forms a passage through which at least liquid can flow. A portion of pipe portion 22c is located in first internal space S1, and another portion of pipe portion 22c is located in second internal space S2.

[0032] The support body 23 is a member that supports the double-ended needle 22 and is engaged with the main portion 21. The support body 23 has a plate-shaped central portion 23a that supports the double-ended needle 22, and a tubular portion 23b that is provided to surround the central portion 23a.

[0033] The central portion 23a is a portion through which the double-ended needle 22 passes and has a substantially disk shape. The central portion 23a is provided with a plurality of protrusions 23c positioned to surround the double-ended needle 22 in a plan view. The plurality of protrusions 23c are provided intermittently along the circumferential direction and protrude upward. The plurality of protrusions 23c can function as support portions when another container is pressed against the double-ended needle 22. The central portion 23a may be provided with an opening that communicates with the first internal space S1 and the second internal space S2.

[0034] The tubular portion 23b is a portion that maintains the posture of the double-ended needle 22 and the central portion 23a and has a substantially cylindrical shape. The lower end of the tubular portion 23b may be located below the central portion 23a and above the first puncture needle 22a. That is, the lower end of the tubular portion 23b may be located closer to the first opening 21c of the main portion 21 than the first puncture needle 22a. The upper end of the tubular portion 23b may be located above the central portion 23a and below the second puncture needle 22b. That is, the upper end of the tubular portion 23b may be located closer to the second opening 21d of the main portion 21 than the second puncture needle 22b. A plurality of raised portions 23d extending in the circumferential direction are provided on the outer surface of the tubular portion 23b. The plurality of raised portions 23d are provided intermittently in the circumferential direction.

[0035] When the support 23 is held by the main portion 21, each raised portion 23d of the support 23 rests on the upper surface of the second raised portion 21h of the main portion 21. In other words, when the support 23 is held by the main portion 21, each raised portion 23d is positioned between the second raised portion 21h and the third raised portion 21i in the vertical direction. This ensures that the support 23 is engaged with the main portion 21 and that there is sufficient space to push the double-ended needle 22 into place before co-infusion. By pressing the support 23 toward the second opening 21d of the main portion 21, each raised portion 23d climbs over the second raised portion 21h. This releases the engagement of the support 23 with the main portion 21, allowing the support 23 to move within the main portion 21 toward the second opening 21d. For example, to attach another container to the support 23, the support 23 is pressed toward the second opening 21d via the other container. As a result, second puncture needle 22b punctures the stopper of the other container, and support body 23 moves toward container body 1. Then, first puncture needle 22a punctures stopper portion 12 of container body 1. As a result, the interior of container body 1 and the interior of the other container are connected via double-ended needle 22. Note that movement of support body 23 toward first opening 21c is restricted by third protrusion 21i. This makes it difficult for main body 21 to come off support body 23 after support body 23 and main body 21 are assembled.

[0036] The main portion 21, the double-ended needle 22, and the support 23 are each a resin molded body made of, for example, polyolefin, polyester, polycarbonate, ABS resin, or the like. From the standpoint of chemical resistance, heat resistance, and the like, the main material of each of the main portion 21, the double-ended needle 22, and the support 23 may be polypropylene, or the like. The support 23 is molded integrally with the double-ended needle 22, but is not limited to this. For example, the double-ended needle 22 may fit snugly into the support 23, or may be screwed onto it. In this embodiment, at least the main portion 21 is formed by injection molding. For this reason, although not shown, a mark (gate) for the resin injection port into the mold during injection molding is provided in at least the main portion 21.

[0037] Fig. 8 is a perspective view of the cap. Fig. 9 is a front view of the cap. As shown in Figs. 8 and 9, cap 3 is a member that protects communicating member 2 and is a screw cap that is airtightly attached to communicating member 2. Cap 3 has a tubular portion 31 that is airtightly attached to communicating member 2, a lid portion 32 that is provided at one end of tubular portion 31 in the vertical direction, an air vent 33, a porous sterilized packaging material 34 that covers vent 33, and a cap ring 35 that is connected to the other end of tubular portion 31 via multiple connecting portions C.

[0038] The cylindrical portion 31 is the main body of the cap 3 and has a generally truncated cone shape. The cylindrical portion 31 has a base portion 41 and a side portion 42 that connects the base portion 41 and the lid portion 32. The base portion 41 is a portion of the cap 3 that is airtightly attached to the communicating member 2 and has a ring shape in a plan view. As shown in FIG. 4, the inner surface of the base portion 41 is provided with a female thread 41a that screws into the thread 21g of the main portion 21. The outer surface of the side portion 42 is provided with, for example, a plurality of grooves that are provided intermittently along the circumferential direction and extend in the vertical direction. This improves the ease with which a user of the drug container 100 can grip the cap 3.

[0039] FIG. 10 is a partial cross-sectional view of the communicating member and the cap. FIG. 11 is an enlarged view of the main portion of FIG. 10. As shown in FIGS. 10 and 11, the tubular portion 31 is formed by the upper end of the base portion 41 and an inner protrusion 42a protruding from the bottom of the side portion 42, and has a recess 51 covering the upper end E of the main portion 21. When the cap 3 is airtightly attached to the communicating member 2, the upper end E of the main portion 21 is accommodated within the recess 51. Therefore, the recess 51 can also function as a accommodating portion for the upper end E. The recess 51 has a bottom portion 52 that contacts the top surface E1 of the upper end E, a first protrusion 53 located outside the upper end E in a plan view and protruding toward the upper end E, and a second protrusion 54 located inside the upper end E and closer to the mouth 11 than the upper end E in a plan view. The inner protrusion 42a is a portion that protrudes downward along the inner circumferential surface of the side portion 42, has a ring shape in a plan view, and may exhibit elasticity. The diameter R2 of the inner protrusion 42a of the side portion 42 is smaller than the diameter R1. The sum of the diameter R2 and the thickness of the inner protrusion 42a is substantially the same as the diameter R1.

[0040] The bottom portion 52 is located at the upper end of the recessed portion 51 and has a substantially ring-like shape in a planar view. Before use of the drug container 100 (i.e., before opening the cap 3), the bottom portion 52 may be in close contact with the top surface E1 of the upper end portion E. In this case, the bottom portion 52 and the upper end portion E can maintain airtightness between the cap 3 and the communicating member 2. The first protrusions 53 are portions that protrude from the outer surface 51a of the recessed portion 51 and the bottom portion 52 toward the main portion 21. The first protrusions 53 may be provided intermittently along the circumferential direction, or may have a ring-like shape extending along the circumferential direction in a planar view. From the viewpoint of airtightness between the cap 3 and the communicating member 2, the first protrusions 53 may have a ring-like shape extending along the circumferential direction in a planar view. In this case, the first protrusions 53 may be in close contact with the upper end portion E. This allows airtightness between the cap 3 and the communicating member 2 to be well maintained.

[0041] The second protrusion 54 protrudes radially outward from the inner protrusion 42a that forms the inner surface 51b of the recess 51 and has a ring shape in a plan view extending in the circumferential direction. In a plan view, the tip 54a of the second protrusion 54 is located outward from the inner edge E2 of the upper end E. The thickness of the upper end E is greater than the thickness of the second protrusion 54 (the amount of protrusion of the second protrusion 54 along the radial direction). As a result, the second protrusion 54 is press-fitted into the upper end E on the inner surface side of the main portion 21, and the inner protrusion 42a and the upper end E are in close contact with each other. This makes it possible to maintain good airtightness between the upper end E and the second protrusion 54. To facilitate press-fitting of the second protrusion 54 into the upper end E, the lower surface of the second protrusion 54 may be an inclined surface. The upper end E may be sandwiched between the first protrusion 53 and the second protrusion 54. In this case, even if the communicating member 2 and the cap 3 shrink during sterilization of the drug container 100, a gap is unlikely to occur between the communicating member 2 and the cap 3 within the recess 51. Therefore, the airtightness between the communicating member 2 and the cap 3 can be well maintained.

[0042] Returning to Figures 8 and 9, the lid portion 32 is located at the upper end of the cap 3 and is connected to the side portion 42 of the tubular portion 31. The lid portion 32 is molded integrally with the tubular portion 31. The vent hole 33 is an opening for communicating the inside and outside of the cap 3 and is located in the lid portion 32. In this embodiment, the vent hole 33 is located at the center of the lid portion 32 and has a circular shape in a plan view. The porous sterilized packaging material 34 is a sheet member that allows gas or steam to pass through but not bacteria, and is in close contact with the lid portion 32. The porous sterilized packaging material 34 is, for example, sterilized paper or a fibrous nonwoven fabric. By providing the vent hole 33 and the porous sterilized packaging material 34 in the cap 3, the second internal space S2 communicates with the outside of the container body 1 via the vent hole 33 and the porous sterilized packaging material 34. The first internal space S1 also communicates with the second internal space S2 via the double-ended needle 22. When drug container 100 is subjected to high-temperature sterilization treatment such as autoclaving, high-temperature steam passes through porous sterilization packaging material 34. This allows the inside of main portion 21, double-ended needle 22, support 23, and the inside of cap 3, etc., of drug container 100 to be sterilized satisfactorily.

[0043] The cap ring 35 is a member (tamper-evidence ring) for determining whether the cap 3 of the drug container 100 has been opened even once. When the connection portion C breaks and the cap ring 35 is separated from the tubular portion 31, it can be determined that the cap 3 has been opened. The connection portion C is hooked to the first raised portion 21f of the communicating member 2. When the cap 3 is opened, the cap 3 moves away from the communicating member 2 while the connection portion C remains hooked to the first raised portion 21f. At this time, the connection portion C breaks, so that the tubular portion 31 of the cap 3 moves away from the communicating member 2, and the cap ring 35 remains on the communicating member 2.

[0044] The cylindrical portion 31, the lid portion 32, the cap ring 35, and the connecting portion C of the cap 3 are each a resin molded body made of, for example, polyolefin, polyester, polyvinyl chloride, polycarbonate ABS resin, or the like. From the viewpoint of chemical resistance, heat resistance, and the like, the main material of the cap 3 may be polypropylene, or the like. In this embodiment, the cylindrical portion 31, the lid portion 32, the cap ring 35, and the connecting portion C are integrally injection molded. For this reason, although not shown, a mark (gate) for a resin injection port into a mold during injection molding is provided, for example, on the cylindrical portion 31.

[0045] In this embodiment, the thermal shrinkage rate of the main material contained in the cap 3 is smaller than the thermal shrinkage rate of the main material contained in the communicating member 2. For example, when the main material (first main material) of the communicating member 2 and the main material (second main material) contained in the cap 3 are the same material (e.g., polyolefin), the first main material and the second main material differ from each other in at least one of molecular weight, degree of polymerization, etc.

[0046] Additionally, in this embodiment, the thermal shrinkage rate of the cap 3 is greater than that of the communicating member 2. This difference in thermal shrinkage rate occurs due to differences in thickness and shape between the components. Therefore, in this embodiment, the thermal shrinkage rate of the main material itself is smaller for the cap 3 than for the communicating member 2, while the thermal shrinkage rate of the cap 3 itself is greater than that of the communicating member 2 itself. The thermal shrinkage rates of the communicating member 2 itself and the cap 3 itself are each obtained based on the difference between the dimensions after wet heat heating at 121°C for 15 minutes and the dimensions before heating. As a specific example, the thermal shrinkage rate of the communicating member 2 is obtained by dividing the difference in the dimensions of the communicating member 2 before and after heating by the dimensions of the communicating member 2 before heating. The above dimensions include at least the dimension along the X-axis direction defined below and the dimension along the Y-axis direction defined below. The direction passing through the gate provided in the communicating member 2 is defined as the Y-axis direction, and the direction perpendicular to the Y-axis direction in a planar view is defined as the X-axis direction.

[0047] By making the thermal shrinkage rate of the main material contained in cap 3 smaller than that of the main material contained in communicating member 2 and larger than that of cap 3, the difference between the thermal shrinkage rates of communicating member 2 and cap 3 after heating can be reduced. For example, the difference in the thermal shrinkage rate along the X-axis direction and the difference in the thermal shrinkage rate along the Y-axis direction can each be set to 0.5% or less. Therefore, even after the heating described above, the airtightness between communicating member 2 and cap 3 can be maintained favorably. On the other hand, if the thermal shrinkage rate of the main material contained in cap 3 is larger than that of the main material contained in communicating member 2, or if the thermal shrinkage rate of the main material contained in cap 3 is the same as that of the main material contained in communicating member 2, at least one of the difference in the thermal shrinkage rate along the X-axis direction and the difference in the thermal shrinkage rate along the Y-axis direction tends to exceed 0.5%. In this case, the airtightness between communicating member 2 and cap 3 tends to be poor after the heating described above.

[0048] In the drug container 100 according to the present embodiment described above, the first puncture needle 22a of the double-ended needle 22, which is a hollow member, is located in the first internal space S1, and the second puncture needle 22b of the double-ended needle 22 is located in the second internal space S2. As a result, the vent 33 of the cap 3 communicates not only with the second internal space S2, but also with the first internal space S1 via the double-ended needle 22. Therefore, even if the drug container 100 is autoclaved with the communicating member 2 airtightly attached to the container body 1 and the cap 3 airtightly attached to the communicating member 2, heated steam reaches the inside of the communicating member 2, the inside of the cap 3, and components housed in the communicating member 2 and / or the cap 3, such as the double-ended needle 22. Therefore, the inside of the communicating member 2, the inside of the cap 3, and the above-mentioned components, such as the double-ended needle 22, are all sterilized satisfactorily. Therefore, the sterilization of the double-ended needle 22 and the like can be completed with only one sterilization process for the drug container 100. In addition, after the single sterilization process, there is no need to perform an assembly process in a sanitary environment. Therefore, when manufacturing drug container 100, the manufacturing process can be simplified, and productivity can be improved.

[0049] In this embodiment, the ventilation hole 33 is located in the lid portion 32. This allows the ventilation hole 33 to be easily formed in the cap 3. In addition, the cap 3 has a porous sterilized packaging material 34 that covers the ventilation hole 33. This allows steam to enter the first internal space S1 and the second internal space S2 through the porous sterilized packaging material 34, thereby ensuring good sterilization of components such as the double-ended needle 22. This also makes it easy to maintain the sterilized state of the double-ended needle 22. Furthermore, because the ventilation hole 33 is located in the lid portion 32, the porous sterilized packaging material 34 can be easily attached, further improving productivity.

[0050] A drug container according to one aspect of the present invention is as described in the following [1] to [9], for example, and has been described in detail based on the above embodiment. [1] A container body having a mouth portion communicating with another container and a plug portion sealing the mouth portion, and containing a medicine; a communication member that is airtightly attached to the container body and can be attached to the other container; a cap having a tubular portion airtightly attached to the communication member and a lid portion provided at one end of the tubular portion; Equipped with the communicating member has a cylindrical main portion and a double-ended needle that is held by the main portion and is movable to penetrate the stopper portion, The double-ended needle is a hollow member having a first open end and a second open end, the first opening end is located in a first internal space defined by the communicating member and the container body and extends toward the stopper portion; the second opening end is located in a second internal space defined by the communicating member and the cap and extends toward the lid portion; The cap has a vent. Medicine container. [2] The drug container described in [1], wherein the vent is located in the lid portion. [3] The drug container described in [1] or [2], wherein the cap further has a porous sterile packaging material covering the ventilation hole. [4] The drug container according to any one of [1] to [3], wherein the second open end is located closer to the lid portion than the upper end of the main portion. [5] The cylindrical portion has a recess covering an upper end of the main portion, the recess has a bottom portion in contact with a top surface of the upper end portion, a first protruding portion located outside the upper end portion in a plan view and protruding toward the upper end portion, and a second protruding portion located inside the upper end portion and near the mouth portion in a plan view, The drug container according to any one of [1] to [4], wherein a tip of the second protrusion is located outside an inner edge of the upper end portion in a plan view. [6] The drug container according to [5], wherein the upper end portion is clamped between the first protrusion and the second protrusion. [7] A drug container according to [5] or [6], wherein the thickness of the upper end portion is greater than the thickness of the second protrusion portion. [8] The thermal shrinkage rate of the main material contained in the cap is smaller than the thermal shrinkage rate of the main material contained in the communicating member, The drug container according to any one of [1] to [7], wherein the thermal shrinkage rate of the cap is greater than the thermal shrinkage rate of the communicating member. [9] The drug container according to any one of [1] to [8], wherein the drug is an infusion preparation containing potassium chloride.

[0051] However, one aspect of the present invention is not limited to the above embodiment, the above modified example, and the above [1] to [9]. One aspect of the present invention can be further modified without departing from the gist thereof. For example, in the above embodiment, the vent is located in the lid portion of the cap, but this is not limited thereto. For example, the vent may be located in the tubular portion of the cap. In this case, the same effect can be achieved. Also, although the vent is covered with sterilized paper, this is not limited thereto. The vent does not have to be covered with sterilized paper. In this case, a film or the like that covers the vent may be attached to the drug container after sterilization in a sanitary environment. Even in this case, the manufacturing process can be simplified compared to assembling each component of the drug container. [Example]

[0052] The present disclosure will be explained in more detail by the following examples, but the present disclosure is not limited to these examples.

[0053] (Experimental Example 1) Using the first polypropylene as the main material, a communicating member 2 was injection-molded using an injection molding machine (diameter R1 (target value) shown in FIG. 6: 30.7 mm, wall thickness (target value): 0.9 mm). Also, using the first polypropylene as the main material, a cap 3 was injection-molded using an injection molding machine (diameter R2 (target value) shown in FIG. 10: 29.45 mm, wall thickness (target value): 0.62 mm). Next, the cap 3 was airtightly attached to the communicating member 2 by screwing it onto the communicating member 2. Then, the communicating member 2 was airtightly attached to a container body 1 prepared in advance. By repeating the above steps, a plurality of drug containers were manufactured. Next, some of the drug containers were sterilized by subjecting some of the drug containers to moist heat heating under conditions of 121°C and 15 minutes. Here, the dimension of the communicating member 2 along the X-axis direction, the dimension of the communicating member 2 along the Y-axis direction, the dimension of the cap 3 along the X-axis direction, and the dimension of the cap along the Y-axis direction were measured. The above dimensions were measured not only for the communicating member and cap before sterilization, but also for the communicating member and cap after sterilization. The dimensions of the communicating member 2 and the shrinkage rate associated with sterilization are shown in Table 1 below. The dimensions of the cap 3 and the shrinkage rate associated with sterilization are shown in Table 2 below.

[0054] (Airtightness confirmation test) An airtightness confirmation test, as described below, was conducted on five unsterilized and five sterilized drug containers. In the airtightness confirmation test, the unsterilized and sterilized drug containers were first placed in water to increase the internal pressure of each drug container. This confirmed whether bubbles would form between the communicating member 2 and the cap 3 when the internal pressure was set to 10 kPa, 20 kPa, or 30 kPa. The results of the airtightness confirmation test at each internal pressure are shown in Table 3 below. Note that in each fraction shown in Table 3, the denominator indicates the number of drug containers tested, and the numerator indicates the number of drug containers that leaked. Therefore, the "3 / 5" in Table 3 indicates that three of the five drug containers tested leaked.

[0055] (Experimental Example 2) A plurality of drug containers were manufactured in the same manner as in Experimental Example 1, except that the communicating member 2 was formed by injection molding using a second polypropylene having a lower thermal shrinkage rate than the first polypropylene. The dimensions of the communicating member 2 in Experimental Example 2 and the shrinkage rate associated with the sterilization treatment are shown in Table 1 below. The dimensions of the cap 3 in Experimental Example 2 and the shrinkage rate associated with the sterilization treatment are shown in Table 2 below. In Experimental Example 2, an airtightness confirmation test was also conducted on five unsterilized drug containers and five sterilized drug containers. The results of the airtightness confirmation test in Experimental Example 2 are shown in Table 3 below.

[0056] (Experimental Example 3) A plurality of drug containers were manufactured in the same manner as in Experimental Example 1, except that the cap 3 was formed by injection molding using the second polypropylene. The dimensions of the communicating member 2 in Experimental Example 3 and the shrinkage rate associated with the sterilization treatment are shown in Table 1 below. The dimensions of the cap 3 in Experimental Example 3 and the shrinkage rate associated with the sterilization treatment are shown in Table 2 below. In addition, in Experimental Example 3, an airtightness confirmation test was conducted on five unsterilized drug containers and ten sterilized drug containers. The results of the airtightness confirmation test in Experimental Example 3 are shown in Table 2 below.

[0057] [Table 1]

[0058] [Table 2]

[0059] [Table 3]

[0060] In Experimental Example 1, the difference between the sterilization shrinkage rate of the communicating member 2 along the X-axis direction and the sterilization shrinkage rate of the cap 3 along the X-axis direction (hereinafter referred to as the "X-axis sterilization shrinkage rate difference") was 0.5% or less. On the other hand, the difference between the sterilization shrinkage rate of the communicating member 2 along the Y-axis direction and the sterilization shrinkage rate of the cap 3 along the Y-axis direction (hereinafter referred to as the "Y-axis sterilization shrinkage rate difference") exceeded 0.5%. Furthermore, in Experimental Example 2, the X-axis sterilization shrinkage rate difference and the Y-axis sterilization shrinkage rate difference both exceeded 0.5%. In both Experimental Examples 1 and 2, when the internal pressure of a portion of the pharmaceutical container after sterilization reached 10 kPa, the airtight state between the communicating member 2 and the cap 3 was not maintained. In contrast, in Experimental Example 3, the X-axis sterilization shrinkage rate difference and the Y-axis sterilization shrinkage rate difference were each 0.45% or less. In Experimental Example 3, even when the internal pressure of the medicine container after sterilization reached 30 kPa, the airtight state between communicating member 2 and cap 3 was maintained. [Explanation of symbols]

[0061] 1...container body, 2...communicating member, 3...cap, 10...container portion, 11...mouth portion, 11a...projection, 12...plug portion, 13a...cylindrical portion, 14...sealing portion, 14a...closure portion, 14b...annular portion, 21...main portion, 21a...tubular portion, 21b...bottom portion, 21c...first opening, 21d...second opening, 21e...protruding portion, 21f...first raised portion, 21g...screw, 21h...second raised portion, 21i...third raised portion, 22...double-ended needle, 22a...first puncture needle (first opening end), 22b...second puncture needle (second opening end) Tube portion, 23...support, 23a...central portion, 23b...tubular portion, 23c...convex portion, 23d...raised portion, 31...tubular portion, 32...lid portion, 33...vent hole, 34...porous sterilized packaging material, 35...cap ring, 41...base portion, 41a...female thread, 42...side portion, 51...recess, 51a...outer surface, 51b...inner surface, 52...bottom, 53...first protrusion, 54...second protrusion, 54a...tip, 100...medicine container, C...connection portion, E...upper end, E1...top surface, E2...inner edge, S1...first internal space, S2...second internal space.

Claims

1. a container body having a mouth portion communicating with another container and a plug portion sealing the mouth portion, the container body containing a medicine; a communication member that is airtightly attached to the container body and can be attached to the other container; a cap having a tubular portion airtightly attached to the communication member and a lid portion provided at one end of the tubular portion; Equipped with the communicating member has a cylindrical main portion and a double-ended needle that is held by the main portion and is movable to penetrate the stopper portion, the double-ended needle is a hollow member having a first open end and a second open end; the first opening end is located in a first internal space defined by the communicating member and the container body and extends toward the stopper portion; the second opening end is located in a second internal space defined by the communicating member and the cap and extends toward the lid portion; The cap has a vent. Medicine container.

2. The drug container of claim 1 , wherein the vent is located in the lid.

3. The drug container of claim 1 or 2, wherein the cap further comprises a porous sterile packaging material covering the vent hole.

4. The drug container according to claim 1 or 2, wherein the second open end is located closer to the lid portion than an upper end of the main portion.

5. the cylindrical portion has a recess that covers an upper end of the main portion, the recess has a bottom portion in contact with a top surface of the upper end portion, a first protruding portion located outside the upper end portion in a plan view and protruding toward the upper end portion, and a second protruding portion located inside the upper end portion and near the mouth portion in a plan view, The drug container according to claim 1 or 2, wherein a tip of the second protrusion is located outside an inner edge of the upper end portion in a plan view.

6. The drug container according to claim 5 , wherein the upper end portion is sandwiched between the first protrusion and the second protrusion.

7. The drug container according to claim 5 , wherein the thickness of the upper end portion is greater than the thickness of the second protrusion portion.

8. a thermal shrinkage rate of a main material included in the cap is smaller than a thermal shrinkage rate of a main material included in the communicating member; The drug container according to claim 1 or 2, wherein the cap has a thermal shrinkage rate greater than that of the communicating member.

9. 3. The drug container according to claim 1, wherein the drug is an infusion preparation containing potassium chloride.

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