JP2000116749A - Infusion container - Google Patents

Abstract

(57) [Summary] [PROBLEMS] To connect a flexible container containing a dissolving solution and a vial containing a drug by a simple operation while reliably maintaining a sterile state, and mix and dissolve the drug and the dissolving solution. Of infusion containers that can be used. SOLUTION: A flexible container 1 for storing a solution or a diluting liquid, which has a closed mouth member 2 having a filling and taking out liquid medicine outlet at one end and a mouth member with a partition wall connected to a vial bottle 8 at the other end. One end has a sharp shape that can penetrate the partition wall 6 of the flexible container mouth member, and at least one stopper is inserted into the vial by pressing at the other end side. Sometimes the vial has a communication hole that opens into the vial, and the vial is sealed with a hollow cylindrical plug 7 that seals the vial on the bottom wall. An infusion container characterized by being connected by a body 7.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an infusion container which can be used for instillation or the like as it is after dissolution of a drug, and which can mix and dissolve a drug and a diluent or a dissolution solution by a particularly simple method. It concerns containers.

[0002]

2. Description of the Related Art From the viewpoint of the stability and efficacy of a drug solution for infusion, a powdery, granular, or liquid drug (hereinafter, referred to as "drug") contained in a vial and a dissolution solution contained in a main body of the infusion container. Alternatively, a method of mixing a diluent (hereinafter referred to as a “dissolution solution”) when necessary to obtain a drug solution prepared for infusion required for infusion is generally performed. As a specific method of obtaining this infusion preparation drug solution, a vial with a stopper such as a rubber stopper containing a drug and a solution are stored,
Immediately after dissolving or diluting the drug, a synthetic resin infusion container whose opening is used as a drip infusion container sealed with a thin membrane or rubber stopper can be pierced into the mouth stopper and the membrane or rubber stopper. A method of dissolving or diluting a drug using a set arranged on both sides of a tubular double-ended needle and communicating with the double-ended needle when an infusion operation is necessary is performed.

In a method of connecting a vial to a membrane or rubber stopper of a synthetic resin infusion container with a tubular double-ended needle, if this operation is performed in a hospital room or a place where air is not purified, the membrane or Harmful bacteria or foreign matter may adhere to the double-ended needle or the rubber stopper surface, and may be mixed into the infusion leaves. Conventionally, in order to solve this problem, a method of covering the communication portion has been adopted. In this method, the number of steps of removing the coating for each communication increases, and at this time, the sterility is broken by removing the coating, and there is a possibility that harmful bacteria may adhere. As an improved method of this method, there is a method in which a pseudo seal is provided at several places in an infusion container and the pseudo seal portion is peeled off to communicate with each other. In this improved method, the pseudo-sealed portion could be kept in an aseptic condition, but the structure became complicated, and there was a problem in the packing method and the like, resulting in an increase in cost.

[0004]

SUMMARY OF THE INVENTION According to the present invention, a flexible container containing a solution and a vial containing a drug are communicated by a simple operation while reliably maintaining a sterile state, whereby the drug and the solution are dissolved. It is an object of the present invention to provide an infusion container capable of mixing and dissolving.

[0005]

SUMMARY OF THE INVENTION The present invention relates to a solution or dilution comprising: [1] a closed port member having a filling and taking out port at one end, and a port member with a partition wall connected to a vial at the other end. A flexible container for accommodating a liquid, and one end having a sharp end capable of penetrating the partition wall of the flexible container mouth member, and at least one stopper plug being pressed on the other end side surface. And a vial having a communication hole whose communication hole is opened in the vial when it is intruded into the vial, and which is sealed by a hollow cylindrical stopper that seals the vial with a bottom wall. Infusion container characterized by being connected by a mouth member and the plug,
[2] The infusion container according to the above [1], wherein the hollow cylindrical stopper is a hollow cylindrical body having a bulged portion at the vial inlet so as not to fall into the vial and a flange on the side of the opening member with a partition wall.

[3] A flexible container for containing a dissolving or diluting liquid, having a closed mouth member having a filling and taking-out port at one end and a mouth member with a partition wall connected to the vial at the other end. One end has a shape capable of penetrating the partition wall of the flexible container opening member, and the other end side has a communication hole opened in the vial when the stopper is pressed into the vial by pressing. A vial having a cylinder and sealed by a double hollow cylindrical stopper that seals the vial with a side wall of the inner cylinder, wherein the vial with the partition wall is connected to the vial with the stopper. Infusion container,
And [4] the above object by developing the infusion container according to any one of the above [1] to [3], wherein the mouth member having a drug solution outlet, the mouth member with a partition wall, and the plug are made of a thermoplastic resin. Was solved.

[0007]

DESCRIPTION OF THE PREFERRED EMBODIMENTS An infusion customer device of the present invention will be described based on an embodiment shown in the drawings. FIG. 1 is a sectional view showing an entire infusion container according to one embodiment of the present invention. FIG. 2 shows a vial 8 and a mouth member 6 with a partition wall 61 before use in FIG.
FIG. 3 is a sectional view showing a state in which the vial 8 and the flexible container 1 are in communication with each other in use.
It is a sectional view showing a coupling state of the vial 8 and.

In FIG. 1, a flexible container 1 is a flexible container for storing a solution, and is made of a material having transparency for confirming contents and heat resistance for sterilizing a retort. Preferred materials include a single polyolefin film, a laminated film of two or more polyolefins,
Examples include a laminated film of a polyolefin and another synthetic resin. The method for producing the flexible container 1 is not particularly limited, but for example, it is advantageous to cut a tubular film obtained by general single-layer or laminated inflation molding in plastic molding and seal the upper and lower portions thereof before use. It is.

One side of the flexible container 1 is made of a polyolefin as a main material, and is filled with a dissolving solution or, after preparing an infusion solution, a chemical solution outlet member 2 for taking out the infusion solution is attached to the sealing portion 4 of the cylindrical film. Glued. At this time, it is advantageous in terms of cost and performance to perform sealing by heat sealing. For filling the flexible container 1 with the solution, for example, after filling the solution from the mouth member 2, the flexible container 1 is sealed with a rubber stopper 13.
Examples of the solution include physiological saline, glucose solution, distilled water for injection, and various other electrolyte-containing solutions.

On the other side of the flexible container 1, an opening member 6 with a partition made mainly of polyethylene is adhered to the sealing portion 5 of the cylindrical film. Also in this case, heat sealing is advantageous in cost and performance. This mouth member 6 has relatively elasticity,
It is necessary to enable a sufficiently airtight joint when the plug 7 is inserted. The partition 61 is made of the flexible container 1.
The inner liquid is isolated from the outside air, can be sealed tightly, and breaks when pressed by the stopper 7. The partition wall 61 may be a film made of polyolefin or the like or a partition wall whose connection portion with the inner periphery of the mouth member is formed thin and easily broken when pressed. Further, it is preferable that the mouth member 6 has a flange 62 or the like for putting a finger when pressing the plug 7 to the mouth member 6. Only the outer periphery of the mouth member 6 is a flexible container.
It can be formed by using a material which can be welded to the first and the inside using one or more kinds of other general synthetic resins. It can be formed by assembling or welding several types of parts.

As shown in FIG. 2, the vial 8 is
Sealed. The stopper 7 sealing the vial 8 can be made of a general synthetic resin, for example, polyethylene, polypropylene, polystyrene, ABS,
Polycarbonate and the like can be used, and in particular, polyethylene and polypropylene are preferable from the viewpoint of hygiene and disposal. Further, an elastic body such as synthetic rubber or natural rubber may be interposed between the vial 8 and the stopper 7 in order to increase the hermeticity with the vial. It is also possible to use several kinds of materials or to assemble or weld several kinds of parts.

The structure of the plug 7 is such that the tip 72 is a flexible container.
A hollow cylindrical body 71 having a sharp shape (it is also possible to provide a one-character or a ten-blade blade shape at the tip) to penetrate the first partition wall, and the vial 8 is sealed with the bottom wall 76 I have to. Close to the bottom wall 76, the hollow cylindrical portion 71
One or more communication holes 75 are provided in the side wall of the cylindrical portion. The contact hole 75 is connected to the hollow portion of the cylindrical body, but prior to use are closed in close contact with the mouth portion side wall of the vial 8, in a vial bottle 8 as shown in FIG. 3 in use When invaded, the communication hole 75 opens into the vial 8 and the hollow cylindrical body is in communication with the vial.

[0013] Consequently, since the partition wall 61 is broken vial 8 and the flexible container 1 is communicated with, solution in the flexible container 1 is moved becomes free vial 8, vials 8
Can be dissolved or diluted to prepare an infusion suitable for infusion. It is preferable to provide a notch groove 77 in the peripheral wall of the bottom wall 76 of the plug 7. The notch groove 7
Numeral 7 serves to discharge the vapor from the notch groove 77 by evacuating the inside of the vial 7 by freeze-pressing the stopper 7 lightly when freeze-drying the drug contained in the vial. After the medicine has been sufficiently lyophilized, the stopper 7 is pushed in, the notch groove 77 is closed by the side wall of the vial 8 , and the vial 8 is sealed.

The external shape of the plug 7 is that it is inserted into the mouth member 6 with a partition wall and is connected in a sealed state without breaking the partition wall 61. The vial 8 can be hermetically sealed by using a pressure.
And have elasticity that allows the two to communicate with each other by further invading the vial 8 . To make it easier to apply this pressure and not to break the seal easily,
The outer diameter of the stopper 7 may be slightly larger than the vial inlet, or a slight bulge 74 may be provided at the vial inlet of the stopper 7.
It is preferable that the vial does not penetrate unless pressure is applied. Similarly, the outer diameter of the plug 7 is formed slightly larger than the inner diameter of the opening member 6 with a partition wall, for example, so as to prevent the breakage of the partition wall 61 by the distal end portion 72. It is necessary to keep it. In order to easily apply a pressure for breaking the partition wall 61, it is preferable to provide a flange 73 or a projection, for example, to put a finger on the plug 7.

Another embodiment is a double hollow cylindrical plug as shown in FIGS. This type of plug 7
As in the case of the hollow cylindrical plug 7, the tip 72 breaks through the partition 61 of the port member 6 with a partition. Before use, the rear end of the plug 7 closes the hollow portion 78 of the plug 7 with the inner cylinder bottom wall 79 formed of a plastic cylinder or the like and the side wall of the plug 7. By adjusting the length, the contact surface with the side wall can be lengthened to adjust the sealing strength. Also in this case, it is preferable to provide a cutout groove 77 for vacuum drying the vial 8 . At the time of use, when pressure is applied so that the stopper 7 and the partition member-equipped mouth member 6 are in close contact with each other, as shown in FIG.
8 , the inner cylinder communication hole 9 is opened in the vial, and then, as shown in FIG.
1 and the vial 8 and the flexible container 1 are electrically connected as shown in FIG. At this time, the inner cylinder bottom wall 79 is not dropped into the vial 8 and the inner cylinder 78 is
It is preferable to provide a flange or a protrusion on the plug 7 and the inner cylinder 78 as is usually done so that a sufficient pressure can be applied to 1. In the case of the present embodiment, there is an advantage that the mixing operation is facilitated because the area of the inner cylinder communication hole can be increased.

After filling the dissolving solution, the flexible container 1 sealed by the opening member 6 with the partition wall and the vial 8 sealed by the stopper 7 are each required and suitable sterilization and disinfection treatment, for example, Performs processes such as retort sterilization, ethylene oxide gas sterilization, and radiation sterilization. Next, after the sterilization treatment, the mouth member 6 and the plug 7 are connected in a sterile room or the like to obtain an infusion container. In the infusion container according to the present invention having the above-described structure, before use, the vial 8 and the flexible container 1 are in close contact with the stopper 7 of the vial mouth and the partition member-equipped mouth member 6 of the flexible container, so that the vial 8 and the flexible container 1 can be connected from outside. Prevents the invasion of harmful bacteria. In use, the stopper 7 of the vial 8 is placed in a flexible container.
When applying pressure to the first partition wall with opening member 6 partition wall 61 of the partition wall with opening member 6 is pierced and contact holes 75 a hollow cylindrical body 71 to penetrate the vial 8 is opened in a vial bottle 8 In addition, the vial and the flexible container communicate with each other, so that the medicine and the solution can be mixed.

[0017]

The infusion container of the present invention has a small number of parts.
It is easy to manufacture, has a structure with good productivity,
Even after filling the medicine, each medicine is kept in a separated state until it is used, and when used, the space between the mouth member with the partition and the vial is compressed to break the partition and the vial of the hollow cylindrical body is connected to the vial. By opening the vial and connecting the vial and the flexible container, mixing can be easily performed while maintaining a sterile state. In addition, when used as an infusion bag, it is not necessary to let in air from the outside, so even if the environmental conditions are poor, the prepared drug will not be contaminated by bacteria in the air, etc. Is an infusion container that can be manufactured almost entirely of plastics, is easy to dispose, has sanitary quarantine protection, and has excellent storage properties before use and disposability after use.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view showing one embodiment of an infusion container of the present invention.

FIG. 2 is an enlarged sectional view of the vicinity of a mouth member in FIG. 1;

FIG. 3 is an enlarged cross-sectional view of the vicinity of a mouth member for explaining a use state.

FIG. 4 is an enlarged sectional view of the vicinity of a double hollow cylindrical plug according to another embodiment of the present invention.

FIG. 5 is an enlarged cross-sectional view near the double hollow cylindrical plug showing an intermediate stage during communication.

FIG. 6 is an enlarged cross-sectional view of the vicinity of a double hollow cylindrical plug showing a communication completed state.

DESCRIPTION OF SYMBOLS 1 Flexible container 2 Dissolution liquid filling and removing port member 3 Rubber stopper 4 Heat seal section 5 Heat seal section 6 Partition member with partition 61 Partition 62 Flange 7 Plug body 71 Hollow cylindrical body 72 Sharp Shaped end 73 Flange 74 Swelling part 75 Communication hole 76 Bottom wall 77 Notch groove 78 Inner cylinder 79 Inner cylinder bottom wall 8 Vial bottle 9 Inner cylinder communication hole

 ──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Takayuki Mizuo 3-2-2 Chidoricho, Kawasaki-ku, Kawasaki-ku, Kawasaki-shi, Kanagawa Prefecture Kawasaki Lab. 3-chome, Showa Denko KK Kawasaki Laboratory F-term (reference) 3E064 AA01 BA22 BA24 BB03 EA30 FA04 HR02 HR05 HR08 HS03 HS04

Claims (4)

[Claims] 1. A flexible container for storing a solution or a diluting liquid, having a closed mouth member having a filling and chemical solution outlet at one end and a mouth member with a partition wall connected to a vial at the other end. The tip of the flexible container opening member is capable of penetrating the partition wall of the flexible container opening member, and has a sharp tip, and at least one communication hole is formed at the other end side when the stopper is pushed into the vial by pressing. A vial having a communication hole that opens into the vial and sealed with a hollow cylindrical plug that seals the vial with a bottom wall is connected to the port member with a partition and the plug. An infusion container characterized by the above-mentioned. 2. The infusion container according to claim 1, wherein the hollow cylindrical stopper is a hollow cylindrical body having a bulged portion at the vial inlet so as not to fall into the vial and a flange on the side of the mouth member with a partition wall. . 3. A flexible container for storing a dissolving or diluting liquid, having a closed mouth member having a filling and chemical solution outlet at one end, and a partitioning mouth member connected to a vial bottle at the other end. The end of the flexible container opening member is shaped to be able to penetrate the partition wall, the inner cylinder whose communication hole is opened in the vial when the stopper is pressed into the vial by pressing the other end side. And a vial sealed by a double hollow cylindrical stopper that seals the vial with the inner cylinder side wall, wherein the vial with the partition wall and the stopper are connected by the stopper. Infusion container. 4. A port member having a chemical solution discharge port, a port member with a partition wall, and a plug are made of a thermoplastic resin.
The infusion container according to any one of the above.