JP2004337318A - Medical double-chamber container and manufacturing method therefor - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical double-chamber container and a manufacturing method therefor, which enable manufacture using relatively small-scale equipment even in the case of the container for a special drug such as a steroid drug, a biological preparation or an anticancer drug, and which enable a production of many types. <P>SOLUTION: This medical double-chamber container is equipped with: a small container 11 wherein the steroid drug, the biological preparation or the anticancer drug is housed and which can be unsealed by an external force; a flexible container body 5 which has a storage chamber 9 for housing the small container 11 and wherein a solution or a diluent is housed in the storage chamber 9; and a drug ejecting part 7 which is attached to the container body 5 and which communicates with the storage chamber 9. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a multi-chamber medical container capable of storing a plurality of medicines individually and mixing the medicines at the time of use, and a method for producing the same.
[0002]
[Prior art]
As a so-called kit product used for dissolving a powder in a dissolving solution or diluting a concentrating agent, for example, there is one described in Patent Document 1. In this document, a container in which a solution is stored and a vial in which a drug is stored are connected by a double-ended needle. In this kit product, a double-ended needle is inserted into caps of both the container and the vial by pressing the vial against the container. Thereby, the container and the vial communicate with each other, and the medicine and the solution can be mixed.
[0003]
However, since such a kit product has a large number of parts, there is a problem that the manufacturing cost is high, the bulk is bulky, and it is difficult to separate and discard the kit product. Therefore, at present, a multi-chamber container as described in Patent Document 2 is becoming mainstream.
[0004]
The double-chamber container described in Patent Literature 2 has two chambers partitioned by partitioning means that can communicate with each other, and the powder medicine and the solution are sealed in these chambers. Further, the chamber in which the powdered drug is sealed is covered with a gas-impermeable or moisture-impermeable outer wall, and a desiccant or a deoxidizing material is sealed in a space between the chamber and the outer wall, Prevents drying of powdered medicine. And this double-chamber container is used as follows. That is, by pressing one of the chambers, the pressure in the chamber is increased, whereby the partitioning means is opened and the powdered medicine and the solution are mixed. Subsequently, when the mouth provided in one chamber is opened, the mixed medicine can be discharged.
[0005]
[Patent Document 1]
JP-A-6-22272 [0006]
[Patent Document 2]
JP-A-4-364851
[Problems to be solved by the invention]
However, the above-described multi-chamber container has the following problems. For example, drugs such as steroids and biologicals are required to be manufactured in dedicated equipment. Therefore, in order to store such drugs in the multi-chamber container, it is necessary to add to the equipment for manufacturing the container. It is necessary to provide a dedicated manufacturing facility for manufacturing the above-mentioned medicine. Therefore, there is a problem that the manufacturing equipment becomes large.
[0008]
In addition, it is necessary to take measures such as preventing adsorption to the container and blocking light, depending on the chemical, so the entire container must be formed of materials corresponding to these individually, which is not suitable for multi-product production. Have been.
[0009]
The present invention has been made in order to solve the above-mentioned problems, and it is possible to manufacture even a special drug such as a steroid drug, a biological drug, or an anticancer drug on a relatively small-scale facility, and moreover, An object of the present invention is to provide a medical double-chamber container capable of producing varieties and a method for manufacturing the same.
[0010]
[Means for Solving the Problems]
A medical double-chamber container according to the present invention has been made to solve the above-described problem, and includes a small container that stores a steroid, a biological agent, or an anticancer agent and that can be opened by external force, and the small container. Having a storage chamber for storing a solution or a diluting liquid in the storage chamber, and a medicine discharge unit attached to the container main body and communicating with the storage chamber. I have.
[0011]
According to this configuration, when the small container is pressed from the outside of the container body, the small container is opened, so that the steroid agent, biological material, or anticancer agent (hereinafter, referred to as “steroid agent”) is dissolved or diluted. Can be easily mixed with liquids. Thereby, the administration operation of the medicine can be easily performed.
[0012]
In addition, since steroids and the like are required to be manufactured in dedicated manufacturing equipment, manufacturing a multi-chamber container containing steroids and the like in one manufacturing facility requires a large-scale manufacturing facility. There's a problem. On the other hand, in the multi-chamber container according to the present invention, since the steroid agent and the like are stored in a small container separate from the container body, only the small container for storing the steroid agent and the like is manufactured, and thereafter, A multi-chamber container can be manufactured by storing the small container in the container body in another manufacturing facility. Thus, if a small container is manufactured for each different steroid agent or the like, a plurality of types of multi-chamber containers can be manufactured with one facility regardless of the type of the steroid agent or the like. As a result, it is possible to prevent an increase in the size of the manufacturing equipment, and it is possible to produce a wide variety of products at low cost.
[0013]
Further, since the steroid agent or the like is stored in a small container separate from the container body, only this small container can be made of a material corresponding to the steroid agent or the like. Therefore, even when, for example, a steroid agent or the like has an adsorbing property, the entire container does not need to be made of a material for preventing adsorption, and only small containers need to be used, thereby reducing manufacturing costs. can do.
[0014]
The small container as described above is preferably fixed to the inner wall surface of the storage room. In this case, since the small container is fixed in the storage chamber, it is easy to apply an external force, and it is easy to open the small container.
[0015]
Note that the small container can be configured in various modes. For example, it can be made of a flexible plastic container or a hard plastic capsule. However, in any case, it is preferable that a part of the small container is easily broken or configured to be easily opened, so that when the small container is pressed from the outside of the container body, the medicine can be easily formed. Can be drained.
[0016]
In addition, the method for producing a multi-chamber medical container according to the present invention includes a first step of producing a small container containing a steroid agent, a biological preparation, or an anticancer agent and capable of being opened by external force, and the production of the small container. In a manufacturing facility different from the maintenance, a second step of forming a container main body having a storage room by a flexible material, and storing a solution or a diluting liquid and the small container in a storage room of the container main body, And a third step of sealing the chamber.
[0017]
According to this method, the small container is manufactured by a different manufacturing facility from the container main body. Therefore, for example, when the type, volume, etc. of the steroid agent is changed, it is sufficient to respond to this change only at the facility that manufactures the small container, and it is not possible to make a major change at the manufacturing facility side of the container body. Absent. That is, even if the small container is changed, a common manufacturing facility for the container body can be used. Therefore, it is possible to flexibly respond to a change in the type of a steroid or the like.
[0018]
In particular, steroids, etc., must be manufactured in dedicated equipment.However, according to this method, only small containers need to be manufactured in dedicated equipment. Can be prevented. As a result, it is possible to efficiently manufacture a plurality of types of containers containing different medicines, and as a result, it is possible to reduce the manufacturing cost.
[0019]
In the third step, the small container can be fixed to the inner wall surface of the storage room. Thereby, since the small container is fixed in the storage chamber, it is easy to apply an external force during use, and it is easy to open the small container.
[0020]
The steroid agent referred to in the present invention refers to an agent having a so-called steroid skeleton in a chemical structure. Specifically, anti-inflammatory agents such as hydrocortisone sodium succinate, methylprednisolone sodium succinate, dexamethasone sodium phosphate and betamethasone sodium phosphate can be mentioned as typical examples.
[0021]
In addition, the biological product referred to in the present invention is a biological product in the category of efficacy, and includes vaccines, toxins and toxoids, antitoxin and anti-leptospira sera, blood products, and other biological products. Product. The present invention includes, among the above, those used after dilution or dissolution. Specific examples thereof include a dried tissue culture inactivated rabies vaccine, a dried diphtheria horse antitoxin, a dried tetanus horse toxin, a dried horse antitoxin, a dried botulinum horse toxin, a dried brown horse antitoxin, eptacogalpha, octocogalpha, lurioctocogalpha. , Dried sulfonated human immunoglobulin, dried pepsin-treated human immunoglobulin, dried and concentrated human blood coagulation factor VIII, dried human fibrinogen, purified tuberculin, interferon alpha, interferon beta, selmoleukin, teseleukin, and basiliximab. .
[0022]
Further, the anticancer agent referred to in the present invention may be any of various conventionally known ones. Specific examples thereof include, for example, cyclophosphamide, ranimustine, ifosfamide, dacarbacine, munistin hydrochloride, fluorouracil, methotrexate, cytarapine, enositabine, etoboside, paclitaxel, docetaxel hydrate, vincristine hydrochloride, irinotecan hydrochloride, evirubicin hydrochloride, virarubicin hydrochloride. Doxorubicin hydrochloride, mitoxantrone hydrochloride, dinostatin stimaramamer, idarubicin hydrochloride, mitomycin C, bleomycin hydrochloride, peplomycin sulfate, aclarubicin hydrochloride, daunomycin hydrochloride, carboplatin, cisplatin, nedaplatin, L-asparaginase, lentinan and the like can be exemplified. Particularly preferred anticancer agents include those selected from cisplatin, fluorouracil and carboplatin.
[0023]
Known solutions corresponding to steroids and the like can be used as the dissolving solution and diluting solution.
[0024]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, an embodiment of a medical double-chamber container according to the present invention will be described with reference to the drawings. FIG. 1 is a plan view of a multi-chamber medical container according to the present embodiment, and FIG. 2 is a cross-sectional view of FIG.
[0025]
As shown in FIG. 1, the medical multi-chamber container 1 is connected to the container main body 5, which is formed in a bag shape by heat-sealing the peripheral portions 3 of two rectangular films, and is connected to the container main body 5. And a medicine discharge section 7 having a rubber stopper (not shown) inside. The container body 5 has a storage chamber 9 for storing a medicine, and the storage chamber 9 stores a physiological saline solution a as a solution and a small container 11. The medicine discharge section 7 is attached to one end of the container main body 5 so that the medicine in the storage chamber 9 can be discharged. A hanging hole 17 for hanging the container is formed at the other end of the container body 5.
[0026]
The container body 5 is made of a flexible material capable of pressing the small container 11 in the storage chamber 9 from the outside as described later, and is made of, for example, polyethylene, polypropylene, polycyclic olefin, or the like. can do.
[0027]
The small container 11 is formed of a plastic film having a peripheral portion 12 heat-sealed, and contains therein any one of the above-mentioned steroids, biological preparations, and anticancer agents b (hereinafter, referred to as “steroid agent”). B) is stored. The heat-sealed portion of the periphery can be opened by applying an external force. Then, as shown in FIG. 2, this peripheral portion is fixed to the inner wall surface of the storage chamber 9 by heat fusion H. In addition, as a material constituting the small container 11, for example, polyethylene, polypropylene, polycyclic olefin, or the like can be selected. In addition, techniques such as aluminum lamination, vapor deposition, and lamination can be applied as necessary.
[0028]
Next, a method for manufacturing the multi-chamber container configured as described above will be described with reference to FIG. First, a steroid agent or the like b is manufactured by a dedicated facility, and this is sealed in the small container 11. The small container 11 is heat-sealed so that the peripheral portion 12 can be opened as described above. Then, the small container 11 is transported to equipment for manufacturing the container body. In the facility for manufacturing the container body, as shown in FIG. 3A, the peripheral portions of the two films are heat-sealed to form a bag-shaped container body 5 having a storage chamber therein. At this time, the peripheral portion 3 of the container main body 5 is heat-fused to leave the one side 3a in order to insert the small container 11 and the solution a.
[0029]
Next, as shown in FIG. 3B, after the transported small container 11 is inserted into the storage room 9 from the open portion 3a where the heat fusion is not performed, the small container 11 is inserted into the storage room 9. Heat fusion to the wall. Thereby, the small container 11 is fixed in the storage room 9. Subsequently, the solution a is injected into the storage chamber 9. Thereafter, as shown in FIG. 3C, one end of the medicine discharge section 7 is inserted into the open section 3a, and the open section 3a is heat-sealed together with the discharge section 7 to seal the container body 5. Thus, the multi-chamber container 1 is completed. In the above process, depending on the amount of the solution a, the small container 11 can be fixed in the storage chamber 9 after the solution a is injected.
[0030]
The multi-chamber container thus manufactured is used as follows. First, the small container 11 is pressed from the outside of the container body 5, and the peripheral portion 12 of the small container 11 is opened. Thereby, the steroid agent b flows out of the small container 11 and is dissolved in the solution a. In this state, when a conduit (not shown) with a puncture needle is connected to the medicine discharge section 7, the medicine in the container 1 can be administered to the patient.
[0031]
As described above, according to the present embodiment, the small container 11 for storing the steroid agent b is separate from the container body 5. Therefore, if only the small container 11 for storing the steroid agent b is manufactured, and then the small container 11 is stored in the container body 5, the small container 11 and the container body 5 can be manufactured by different manufacturing facilities. can do. In particular, since the steroid agent b is required to be manufactured in a dedicated facility, such a configuration eliminates the need to manufacture a multi-chamber container in one facility, thus increasing the size of the manufacturing facility. Can be prevented.
[0032]
If, for example, the type, volume, and the like of the steroid agent b are changed, only the facility that manufactures the small container 11 needs to respond to the change. No major changes are made. That is, even if the small container 11 is changed, a common manufacturing facility for the container main body 5 can be used. Therefore, it is possible to flexibly respond to a change in the type of the steroid agent b and the like, and it is possible to efficiently perform multi-product production.
[0033]
For example, when the steroid agent b has an adsorbing property or is a drug that requires light shielding, only the small container 11 may be made of an anti-adsorption material or a light shielding material. Therefore, it is not necessary to make the entire container 5 correspond to the steroid agent or the like, and as a result, the cost can be reduced.
[0034]
As mentioned above, although one Embodiment of this invention was described, this invention is not limited to this, A various change is possible unless it deviates from the meaning. For example, in the above embodiment, the dissolving liquid is injected into the storage chamber 9, but it may be changed to a diluting liquid depending on the steroid or the like stored in the small container 11. Known diluents corresponding to steroids and the like can be used.
[0035]
In the above embodiment, the peripheral portion 12 of the small container 11 is heat-sealed in the storage chamber 9, but a portion inside the peripheral portion 12 may be fixed to the storage chamber 9. Further, as long as the small container 11 can be fixed, a method other than the heat fusion can be adopted. Further, the small container 11 may be suspended in the solution without fixing the small container 11 to the storage chamber 9.
[0036]
In addition, the configuration of the small container 11 is not limited to the above, and it is sufficient that the small container 11 is configured to be opened by pressing from the outside of the container body 5. For example, the small container 11 can be formed of a hard plastic container. At this time, if a thin portion is formed in a part of the small container 11 and the portion is pressed from the outside so that the portion is easily broken, the medicine can flow out. Alternatively, one end of the plastic container may be closed with a cap so that the cap can be removed by an operation from the outside of the container body 5.
[0037]
Further, the small container 11 can be made of a material having gas barrier properties and light-shielding properties, depending on the type of steroid agent or the like to be stored. Alternatively, after storing the small container 11 in another gas barrier or light shielding bag, the bag can be inserted into the storage chamber 9. At this time, a deoxidizer can be arranged in the bag.
[0038]
【The invention's effect】
As is apparent from the above description, according to the present invention, even a special drug such as a steroid, a biologic, or an anticancer drug can be manufactured on a relatively small-scale facility, and a wide variety of products can be produced. Becomes possible.
[Brief description of the drawings]
FIG. 1 is a plan view showing an embodiment of a multi-chamber medical container according to the present invention.
FIG. 2 is a sectional view of FIG.
FIG. 3 is a view showing a method of manufacturing the medical multiple-chamber container of FIG.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Medical double-chamber container 3 Peripheral part 5 Container main body 9 Storage room 11 Small container

Claims (4)

A small container that contains a steroid agent, a biological agent, or an anticancer agent and can be opened by external force,
Having a storage chamber for storing the small container, a flexible container body for storing a solution or diluent in the storage chamber,
A multi-chamber medical container, comprising: a medicine discharge portion attached to the container main body and communicating with the storage chamber. The medical double-chamber container according to claim 1, wherein the small container is fixed to an inner wall surface of the storage room. A first step of producing a small container in which a steroid agent, a biological agent, or an anticancer agent is stored and can be opened by external force;
A second step of forming a container body having a storage chamber with a flexible material in a manufacturing facility different from the manufacturing and maintenance of the small container;
A third step of storing the solution or diluent and the small container in the storage chamber of the container body and sealing the storage chamber. The method according to claim 3, wherein in the third step, the small container is fixed to an inner wall surface of the storage room.

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