WO2011093389A1 - Medicine storage container - Google Patents

Medicine storage container Download PDF

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Publication number
WO2011093389A1
WO2011093389A1 PCT/JP2011/051630 JP2011051630W WO2011093389A1 WO 2011093389 A1 WO2011093389 A1 WO 2011093389A1 JP 2011051630 W JP2011051630 W JP 2011051630W WO 2011093389 A1 WO2011093389 A1 WO 2011093389A1
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WO
WIPO (PCT)
Prior art keywords
medicine
container
container body
wall
mouth
Prior art date
Application number
PCT/JP2011/051630
Other languages
French (fr)
Japanese (ja)
Inventor
伸吾 小山
真司 八巻
Original Assignee
テルモ株式会社
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Publication of WO2011093389A1 publication Critical patent/WO2011093389A1/en

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
    • B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
    • B65D1/0223—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by shape
    • B65D1/0292—Foldable bottles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers

Definitions

  • the present invention relates to a medicine container.
  • the medicine storage bag placement portion (stage) of the freeze-drying apparatus It is placed on the top in a collapsed state. In this state, the medicine storage bag placement unit is cooled together with the medicine storage bag. Thereby, the liquid composition in the medicine storage bag is freeze-dried, and a powder medicine is generated in the medicine storage bag.
  • An object of the present invention is to provide a medicine container that is suitable for upright and can efficiently produce medicine in the upright state.
  • the present invention provides: A container body having a mouth through which liquid can enter and exit on the distal end side and made of a flexible material, and stored in the container body and dissolved by the liquid flowing in through the mouth.
  • a medicine container comprising a medicine
  • the container body defines a storage space for storing the medicine, and has a pair of wall portions facing each other, One wall portion of the pair of wall portions is formed in at least a part of the wall portion, and is deformed when the liquid is filled in the storage space to increase a volume of the storage space.
  • Have The other wall portion of the pair of wall portions is a medicine storage container characterized in that an average thickness thereof is larger than an average thickness of the deformable portion.
  • the average thickness of the other wall portion is 1.4 to 20 times the average thickness of the deformed portion.
  • a gap is formed between the one wall portion and the other wall portion in an initial state where the liquid is not yet filled in the container body. Is preferred.
  • the mouth portion has a cylindrical shape, When the mouth portion is viewed from the distal end side, a part of the outer peripheral surface of the base end portion of the mouth portion and the surface of the other wall portion are on the same straight line, or the base end portion of the mouth portion It is preferable that a part of the inner peripheral surface and the back surface of the other wall portion are on the same straight line.
  • the container body is manufactured by blow molding.
  • the medicine container of the present invention it is preferable that the medicine is dried by freeze-drying.
  • the deforming portion is formed in the vicinity of the central portion of the one wall portion.
  • a valve body made of an elastic material and having an openable / closable opening / closing portion is attached to the mouth portion.
  • FIG. 1 is a perspective view (a diagram showing an initial state) showing a medicine container of the present invention.
  • FIG. 2 is a cross-sectional view taken along line AA in FIG. 3 is a cross-sectional view taken along line BB in FIG.
  • FIG. 4 is a cross-sectional view of the medicine container shown in FIG.
  • FIG. 5 is a cross-sectional view taken along the line CC in FIG.
  • FIG. 1 is a perspective view showing a medicine container of the present invention
  • FIG. 2 is a cross-sectional view taken along line AA in FIG. 1
  • FIG. 3 is a cross-sectional view taken along line BB in FIG. 1
  • FIG. 5 is a cross-sectional view taken along the line CC in FIG. 2.
  • the upper side in FIGS. 1 and 2 is referred to as “tip”, “up” or “upper”, and the lower side is referred to as “base”, “lower” or “lower”.
  • the drug container 1 is composed of a hollow container body 2 and a powdery medicine Q stored in the container body 2.
  • the drug container 1 shown in FIG. The medicine Q is stored in the container body 2 in advance in the initial state (unused state) shown in FIG.
  • This medicine Q is dissolved by, for example, a solution R filled from a syringe (not shown) through the mouth portion 7 of the container body 2.
  • the drug Q dissolved in the solution R is referred to as “medical solution P”.
  • the state shown in FIG. 4 in which the container body 2 is filled with the solution R is referred to as a “solution-filled state”.
  • the container body 2 is composed of a body part 3 having a storage space 31 for storing the medicine Q, and a mouth part 7 provided at the front end part of the body part 3.
  • the “initial state” is referred to unless otherwise specified.
  • the volume of the storage space 31 in the initial state is not particularly limited, but is preferably 1 to 50 mL, for example, and more preferably 3 to 30 mL.
  • the body portion 3 includes a first wall portion 32a and a second wall portion (the other wall portion) 32b facing each other, and outer peripheries of the first wall portion 32a and the second wall portion 32b. And a frame portion 33 provided on the side.
  • a storage space 31 is defined by the first wall portion 32 a, the second wall portion 32 b, and the frame portion 33.
  • the first wall 32a is recessed near the center.
  • This recessed portion (hereinafter referred to as “deformation portion 35”) is a portion that is deformed when the storage space 31 is filled with the solution R and increases the volume of the storage space 31.
  • the recessed deformed portion 35 has a top portion 322 located at the bottom thereof and an inclined portion 323 formed on the outer peripheral side of the top portion 322.
  • the inclined portion 323 is a portion formed to be inclined from the frame portion 33 side toward the top portion 322.
  • the thickness (thickness) is gradually reduced to satisfy t a1 ⁇ t a2 ⁇ t a3 ⁇ t a4 (see FIG. 2) and t b1 ⁇ t b2 ⁇ t b3 ⁇ t b4 (see FIG. 3).
  • the thickness t a4 (t b4 ) of the second wall portion 32 b is 1.4 to 20 times the thickness t a1 (t b1 ) of the deformed portion 35, particularly the top portion 322.
  • it is 2.0 to 10 times.
  • the container body 2 having such a thickness relationship has mechanical strength maintained up to the frame portion 33 having a thickness of t a3 (t b3 ). Further, the container body 2 has a structure in which when the solution R is filled, the container body 2 starts to be deformed from an intermediate portion 324 between the frame portion 33 and the inclined portion 323 (a portion of the thickness t a2 (t b2 )).
  • the solution R filled through the mouth 7 mainly passes the top portion 322 upward in the drawing. Push up.
  • the intermediate portion 324 is a portion that is easily deformed as described above, the deformable portion 35 is easily protruded from the recessed state shown in FIG. Will increase in volume.
  • the storage space 31 with the increased volume is filled with a sufficient amount of the drug Q, that is, the drug Q that can be dissolved without excess or deficiency, so that the drug solution P can be generated.
  • the second wall portion 32b is the thickest portion, that is, a portion where the average thickness is thicker than the average thickness of the deformable portion 35.
  • the container body 2 stands upright from the second wall portion 32b having the largest thickness so that the mouth portion 7 is positioned upward in the vertical direction, the container body 2 is maintained in the upright state (see FIG. 2). Therefore, when the container body 2 is regarded as a human body, the container body 2 functions like a “spine” and has a shape suitable for upright. Thereby, when the medicine storage container 1 in an upright state is placed on, for example, the stage 101 of the freeze-drying apparatus 10 described later, the medicine storage container 1 is stably placed on the stage 101 in the upright state. Placed.
  • the thickness of the second wall portion 32b is set to such an extent that the second wall portion 32b is not substantially deformed when the solution is filled (see FIG. 4). Thereby, the second wall 32b is prevented from being unintentionally deformed, for example, from the initial state to the solution filling state, so that the upright state of the container body 2 can be reliably maintained.
  • the gap 311 is formed. That is, in the initial state, the top portion 322 of the first wall portion 32a and the second wall portion 32b are provided so that the inner surfaces (rear surfaces) 321 face each other in a non-contact manner.
  • the solution R that has flowed in through the mouth portion 7 can pass through the gap 311, and thus quickly reaches the entire storage space 31. Thereby, the solution R can be easily and reliably filled, and thus the drug Q is dissolved in the solution R.
  • the gap distance d1 in the initial state is not particularly limited, but is preferably 0.5 to 25 mm, for example, and more preferably 1 to 15 mm.
  • the gap distance d1 is within such a numerical range, the container body 2 can be stably manufactured when the container body 2 is manufactured by blow molding.
  • a band-shaped frame portion 33 is provided on the outer peripheral side of the first wall portion 32a and the second wall portion 32b so as to surround these wall portions.
  • the shape of the medicine container 1 in the initial state is maintained by the frame portion 33, and thus the medicine container 1 is easily expanded when the solution R is filled. Further, the shape of the medicine container 1 in the state of being filled with the dissolution liquid is also maintained, and therefore, for example, the medicine container 1 can be easily grasped.
  • the frame portion 33 is formed with a flat bottom portion 336 at the base end portion thereof.
  • the container body 2 (including the body portion 3 and the cylindrical portion 72 of the mouth portion 7) as described above is made of a flexible material, that is, a soft resin material.
  • the soft resin material is not particularly limited.
  • EVA ethylene-vinyl acetate copolymer
  • PET polyethylene terephthalate
  • PBT polybutylene terephthalate
  • examples thereof include various thermoplastic elastomers such as polyester, soft polyvinyl chloride, polyvinylidene chloride, silicone, polyurethane, and polyamide elastomer, or any combination thereof (blend resin, polymer alloy, laminate, etc.).
  • drum 3 may be comprised by the single layer, and may be comprised by the laminated body by which the several
  • the container body 2 made of such a soft resin material is manufactured by blow molding.
  • the inner surface of the container body 2 can be made smooth.
  • the drug Q may be sandwiched near the fused portion and may not be in contact with the solution R. Such a problem can be prevented in the case of the container body 2 that has been made.
  • the mouth portion 7 through which the solution R flows and the solution P flows out is disposed on the distal end side of the drug container 1.
  • a valve body 5 having a self-occlusion property made of an elastic material is attached to the mouth portion 7.
  • a rubber stopper or the like that can be punctured with a needle may be used.
  • the mouth portion 7 includes a cylindrical portion 72 having a cylindrical shape protruding from the frame portion 33 and a lid portion 73 attached to the cylindrical portion 72.
  • the cylindrical portion 72 has a part of the outer peripheral surface 726 and the surface of the second wall portion 32 b in a cross-sectional view (the same applies when the mouth portion 7 is viewed from the distal end side).
  • 326 is on the same straight line, and a part of the inner peripheral surface 727 of the cylindrical part 72 and the inner surface 321 of the second wall part 32b are preferably on the same straight line. Thereby, the thickness of the 2nd wall part 32b is fully securable.
  • the tubular portion 72 has a valve body installation portion 721 formed therein.
  • the valve body setting portion 721 is divided into a second lumen portion 723 and a third lumen portion 724 that is located on the proximal end side and is smaller in diameter than the inner diameter of the second lumen portion 723. be able to.
  • bore part 724 is a little larger than the largest outer diameter of the trunk
  • an inner protrusion 725 made of a tubular body is provided at the center of the bottom surface 722 of the cylindrical portion 72.
  • the internal protrusion 725 supports the inside of the valve body 5 and causes the valve body 5 to buckle. Can be prevented. Further, when the solution R passes through the mouth portion 7, it is possible to prevent the solution R from staying.
  • the lid portion 73 has a lumen portion that accommodates the valve body 5 therein, and is connected to the cylindrical portion 72.
  • the lid portion 73 is made of, for example, a hard resin material.
  • a first lumen portion 731 into which a later-described head portion 50 of the valve body 5 can be inserted, and the first lumen portion 731 are communicated with and expanded from the first lumen portion 731.
  • a diameter fitting portion 733 is formed.
  • the first lumen portion 731 is formed so that its shape corresponds to the outer shape of the head 50 of the valve body 5.
  • the fitting part 733 is a part that fits to the outer peripheral part of the cylindrical part 72.
  • the lid part 73 and the cylindrical part 72 are connected in a liquid-tight manner, and accordingly, it is possible to prevent the dissolution liquid R inside the mouth part 7 from leaking between the lid part 73 and the cylindrical part 72. it can.
  • the first lumen portion 731 and the second lumen portion 723 communicate with each other, and the first lumen portion 731 and the second lumen portion are connected.
  • the valve body 5 can be installed in the space formed by the 723 and the third lumen portion 724.
  • a male screw portion 738 is formed on the outer periphery of the lid portion 73.
  • the male screw portion 738 is a portion that is screwed with the syringe when the syringe is connected to the mouth portion 7.
  • the inner lumen functions as a flow path through which the solution R can pass.
  • a valve body 5 is installed in the mouth portion 7.
  • the valve body 5 include various rubber materials such as isoprene rubber, and various thermoplastic elastomers such as polyolefin, and one or more of these can be used in combination.
  • an elastic material moderate elasticity can be obtained on the tip surface 511 of the valve body 5.
  • the valve body 5 includes a tubular body portion 55 and a head portion 50 provided integrally with one end portion of the body portion 55.
  • the head 50 has a bottomed cylindrical shape, and has a lumen portion 515 through which the solution R and the drug solution P can pass, and a slit (open / close) that reaches the lumen portion 515 from the flat distal end surface 511.
  • Part) 512 The slit 512 has a substantially single character shape. Since the shape of the slit 512 is so simple, the front end surface 511 is deformed when the vicinity of the slit 512 of the front end surface 511 is pressed, and thus the slit 512 is reliably opened. Further, when the pressing is released, the front end surface 511 is restored, so that the slit 512 is reliably closed. Thus, the valve body 5 has a self-occlusion property.
  • the mouth portion 7 can be easily and reliably sealed / unsealed.
  • the head portion 50 is inserted into the first lumen portion 731 of the lid portion 73, and the slit 512 is closed.
  • the trunk portion 55 is formed of a cylindrical body having a bellows shape. That is, the body 55 has a bellows shape in which the large-diameter ring portion 552 and the small-diameter ring portion 553 are alternately arranged in the axial direction in the outer shape. Such a body portion 55 functions as a deforming portion that urges the head portion 50 in a direction in which the head portion 50 is inserted into the first lumen portion 731 of the lid portion 73.
  • the medicine Q is accommodated in the container body 2 having the above-described configuration.
  • the drug Q is not particularly limited.
  • an anticancer drug, an immunosuppressive drug, or the like which is dangerous when a medical worker touches it accidentally, or a drug that needs to be dissolved when using antibiotics, hemostatic agents, etc.
  • Drugs that require dilution such as drugs for children, vaccines, heparin, drugs for children, etc.
  • the solution R for dissolving the drug Q is filled in the drug container 1 using a syringe as described above, and can be, for example, physiological saline.
  • Drug Q is obtained by drying a liquid composition containing the drug Q by freeze-drying.
  • the drug Q is produced in the container body 2 using the freeze-drying apparatus 10 as follows.
  • the freeze-drying apparatus 10 has a plate-like stage 101 (see FIG. 2).
  • the freeze-drying apparatus 10 is configured so that the stage 101 can be cooled.
  • the container body 2 is placed on the stage 101 in an upright state, and the liquid composition is filled in the storage space 31 in this state. Since the container main body 2 is suitable for upright as described above, the upright state is maintained, and therefore, the container body 2 is prevented from falling unintentionally. Then, the stage 101 is cooled together with the container body 2 on the stage 101. Since the container body 2 is in surface contact with the stage 101 via the flat bottom portion 336, the liquid composition in the storage space 31 is lyophilized to obtain the medicine Q.
  • the liquid Q in the storage space 31 can be freeze-dried in an upright state to efficiently manufacture the medicine Q.
  • the container body 2 is placed in an upright state on the stage 101.
  • the number of placement of the container main body 2 placed on the stage 101 is larger than when the container main body 2 is placed in a tilted state.
  • the medicine container 1 in the initial state shown in FIG. 1 and a syringe filled with the solution R are prepared.
  • This syringe is filled with a solution R having a sufficient amount to dissolve the drug Q in the drug container 1.
  • the syringe pusher is pressed.
  • the solution R in the syringe is injected into the drug container 1 through the mouth portion 7 of the drug container 1, and the drug container 1 is filled with the solution (see FIG. 4).
  • the injected dissolving solution R first flows down the storage space 31 along the frame portion 33 and then enters the gap 311. As a result, the entire storage space 31 is filled with the solution R.
  • the solution R since the solution R tries to spread the top portion 322 of the first wall portion 32a outward, the intermediate portion 324 starts to deform, and the volume of the storage space 31 increases. Increase.
  • the solution R can be easily and surely filled in the medicine container 1.
  • the filling amount of the solution R can be set to be equal to or less than the maximum volume of the storage space 31 of the medicine storage container 1.
  • the syringe from which the drug solution P has been aspirated can be used, for example, for drug solution administration to a patient.
  • medical agent storage container is arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.
  • the container body is not limited to those manufactured by blow molding, and may be manufactured by, for example, joining a pair of halves that form the container body.
  • the medicine container may be prefilled with an inert gas such as nitrogen.
  • an inert gas such as nitrogen.
  • the medicine to be stored is in a powder form in each of the above embodiments, but is not limited thereto, and may be in a tablet form, a gel form, or a liquid form, for example.
  • valve body is attached to the mouth portion of the medicine storage container in each of the embodiments described above, the present invention is not limited to this, and the valve body may be omitted.
  • the drug storage container of the present invention has a mouth part through which liquid can enter and exit on the tip side, a container body made of a flexible material, and housed in the container body, via the mouth part
  • a medicine storage container including a medicine dissolved by the flowed-in liquid, wherein the container main body defines a storage space for storing the medicine, and has a pair of wall portions facing each other, One wall portion of the wall portions is formed in at least a part thereof, and has a deformation portion that deforms when the storage space is filled with the liquid and increases the volume of the storage space, The other wall portion of the pair of wall portions has an average thickness that is greater than an average thickness of the deformable portion.
  • the medicine storage container When the container body stands upright so that the mouth portion is positioned vertically upward, the upright state is reliably maintained by the thicker wall portion of the pair of wall portions.
  • the medicine storage container When the medicine storage container is placed on a flat plate such as a table in the upright state, the medicine storage container is stably placed on the flat plate.
  • the medicine container is suitable for upright.
  • the freeze-drying apparatus When the medicine stored in the container body is obtained by freeze-drying a liquid composition containing the medicine, the freeze-drying apparatus has the above-described flat plate stage on the stage.
  • the medicine container filled with the liquid composition is placed in an upright state, and the medicine container is cooled together with the stage in this state. Thereby, the said liquid composition is cooled reliably and, therefore, a chemical
  • the medicine container can be efficiently produced by cooling the liquid composition in the container body in an upright state. Therefore, the medicine storage container of the present invention has industrial applicability.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Ceramic Engineering (AREA)
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Abstract

A medicine storage container comprises: a container body consisting of a flexible material and having on the front end side thereof a mouth section through which liquid can enter and exit the container body; and medicine contained within the container body and dissolved by liquid flowing into the container body through the mouth section. In the medicine storage container, the container body has a pair of wall sections which defines a storage space for storing the medicine and which faces each other. One of the pair of wall sections has a deformation section which is formed at at least a part of said wall section and which, when the liquid is filled into the storage space, deforms to increase the volume of the storage space. The average thickness of the other wall section is greater than the average thickness of the deformation section.

Description

薬剤収納容器Drug storage container
　本発明は、薬剤収納容器に関する。 The present invention relates to a medicine container.
　抗がん剤、免疫抑制剤等、医療従事者が誤って触れると危険な粉末薬剤は、可撓性を有する薬剤バッグに予め収納されているものがある。この薬剤収納バッグとしては、２枚のシート材の縁部同士を融着したものを用いることができる（例えば、特許文献１参照）。特許文献１に記載の薬剤収納バッグに収納されている粉末薬剤は、当該薬剤収納バッグに設けられた口部を介して充填された溶解液によって溶解され、この状態で用いられる。 Some anti-cancer drugs, immunosuppressive drugs, and the like, which are dangerous when touched by medical personnel, are pre-stored in flexible drug bags. As this chemical | medical agent storage bag, what fused the edge part of two sheet | seat materials can be used (for example, refer patent document 1). The powder medicine accommodated in the medicine storage bag described in Patent Document 1 is dissolved by the solution filled through the mouth provided in the medicine storage bag and used in this state.
　この特許文献１に記載の薬剤収納バッグでは、例えば粉末薬剤が、該薬剤を含有する液状組成物を凍結乾燥により乾燥して製造される場合、凍結乾燥装置の薬剤収納バッグ載置部（ステージ）上に、倒れた状態で載置される。そして、この状態で、薬剤収納バッグ載置部を薬剤収納バッグごと冷却する。これにより、薬剤収納バッグ内の液状組成物が凍結乾燥されて、当該薬剤収納バッグ内で粉末薬剤が生成される。 In the medicine storage bag described in Patent Document 1, for example, when a powder medicine is produced by drying a liquid composition containing the medicine by freeze-drying, the medicine storage bag placement portion (stage) of the freeze-drying apparatus It is placed on the top in a collapsed state. In this state, the medicine storage bag placement unit is cooled together with the medicine storage bag. Thereby, the liquid composition in the medicine storage bag is freeze-dried, and a powder medicine is generated in the medicine storage bag.
　ところで、同じ面積の薬剤収納バッグ載置部上に、特許文献１に記載の複数の薬剤収納バッグが倒れた状態で載置されるのと、複数の薬剤収納バッグが直立して載置されるのとでは、前者の方が後者よりも薬剤収納バッグの載置数が少なくなる。このため、薬剤を効率的に製造することができない、すなわち、一度に凍結乾燥することができる薬剤収納バッグの数量が少なくなるという問題があった。 By the way, on the medicine storage bag placement portion of the same area, the plurality of medicine storage bags described in Patent Document 1 are placed in a collapsed state, and the plurality of medicine storage bags are placed upright. In the case of the former, the number of loaded medicine storage bags is smaller in the former than in the latter. For this reason, there has been a problem in that the number of drug storage bags that cannot be manufactured efficiently, that is, can be freeze-dried at a time, is reduced.
特開２００６－２０６１１８号公報JP 2006-206118 A
　本発明の目的は、直立に適し、また、その直立状態で薬剤を効率的に製造することができる薬剤収納容器を提供することにある。 An object of the present invention is to provide a medicine container that is suitable for upright and can efficiently produce medicine in the upright state.
　上記目的を達成するために、本発明は、
　先端側に液体が出入り可能な口部を有し、可撓性を有する材料で構成された容器本体と、該容器本体内に収納され、前記口部を介して流入した前記液体によって溶解される薬剤とを備える薬剤収納容器であって、
　前記容器本体は、前記薬剤を収納する収納空間を画成し、互いに対向する一対の壁部を有し、
　前記一対の壁部のうちの一方の壁部は、少なくともその一部に形成され、前記収納空間内に前記液体が充填された際に変形して、前記収納空間の容積を増大させる変形部を有し、
　前記一対の壁部のうちの他方の壁部は、その平均厚さが前記変形部の平均厚さよりも厚くなっていることを特徴とする薬剤収納容器である。 In order to achieve the above object, the present invention provides:
A container body having a mouth through which liquid can enter and exit on the distal end side and made of a flexible material, and stored in the container body and dissolved by the liquid flowing in through the mouth. A medicine container comprising a medicine,
The container body defines a storage space for storing the medicine, and has a pair of wall portions facing each other,
One wall portion of the pair of wall portions is formed in at least a part of the wall portion, and is deformed when the liquid is filled in the storage space to increase a volume of the storage space. Have
The other wall portion of the pair of wall portions is a medicine storage container characterized in that an average thickness thereof is larger than an average thickness of the deformable portion.
　また、本発明の薬剤収納容器では、前記他方の壁部の平均厚さは、前記変形部の平均厚さの１．４～２０倍であるのが好ましい。 In the medicine container of the present invention, it is preferable that the average thickness of the other wall portion is 1.4 to 20 times the average thickness of the deformed portion.
　また、本発明の薬剤収納容器では、前記容器本体内に未だ前記液体が充填されていない初期状態で、前記一方の壁部と前記他方の壁部との間には、間隙が形成されているのが好ましい。 In the medicine container according to the present invention, a gap is formed between the one wall portion and the other wall portion in an initial state where the liquid is not yet filled in the container body. Is preferred.
　また、本発明の薬剤収納容器では、前記口部は、その形状が筒状をなしており、
　前記口部を先端側から見たとき、該口部の基端部の外周面の一部と前記他方の壁部の表面とが同一直線上にあるか、または、前記口部の基端部の内周面の一部と前記他方の壁部の裏面とが同一直線上にあるのが好ましい。 Moreover, in the medicine container of the present invention, the mouth portion has a cylindrical shape,
When the mouth portion is viewed from the distal end side, a part of the outer peripheral surface of the base end portion of the mouth portion and the surface of the other wall portion are on the same straight line, or the base end portion of the mouth portion It is preferable that a part of the inner peripheral surface and the back surface of the other wall portion are on the same straight line.
　また、本発明の薬剤収納容器では、前記容器本体は、ブロー成形により製造されたものであるのが好ましい。 In the medicine container of the present invention, it is preferable that the container body is manufactured by blow molding.
　また、本発明の薬剤収納容器では、前記薬剤は、凍結乾燥により乾燥したものであるのが好ましい。 In the medicine container of the present invention, it is preferable that the medicine is dried by freeze-drying.
　また、本発明の薬剤収納容器では、前記変形部は、前記一方の壁部の中央部付近に形成されているのが好ましい。 Moreover, in the medicine container according to the present invention, it is preferable that the deforming portion is formed in the vicinity of the central portion of the one wall portion.
　また、本発明の薬剤収納容器では、前記口部には、弾性材料で構成され、開閉自在な開閉部を有する弁体が装着されているのが好ましい。 Further, in the medicine container according to the present invention, it is preferable that a valve body made of an elastic material and having an openable / closable opening / closing portion is attached to the mouth portion.
図１は、本発明の薬剤収納容器を示す斜視図（初期状態を示す図）である。FIG. 1 is a perspective view (a diagram showing an initial state) showing a medicine container of the present invention. 図２は、図１中のＡ－Ａ線断面図である。FIG. 2 is a cross-sectional view taken along line AA in FIG. 図３は、図１中のＢ－Ｂ線断面図である。3 is a cross-sectional view taken along line BB in FIG. 図４は、図１に示す薬剤収納容器の溶解液充填状態の横断面図である。FIG. 4 is a cross-sectional view of the medicine container shown in FIG. 図５は、図２中のＣ－Ｃ線断面図である。FIG. 5 is a cross-sectional view taken along the line CC in FIG.
　以下、本発明の薬剤収納容器を添付図面に示す好適な実施形態に基づいて詳細に説明する。
  図１は、本発明の薬剤収納容器を示す斜視図、図２は、図１中のＡ－Ａ線断面図、図３は、図１中のＢ－Ｂ線断面図、図４は、図１に示す薬剤収納容器の溶解液充填状態の横断面図、図５は、図２中のＣ－Ｃ線断面図である。なお、以下では、説明の都合上、図１および図２中の上側を「先端」、「上」または「上方」、下側を「基端」、「下」または「下方」と言う。 Hereinafter, the medicine container of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.
1 is a perspective view showing a medicine container of the present invention, FIG. 2 is a cross-sectional view taken along line AA in FIG. 1, FIG. 3 is a cross-sectional view taken along line BB in FIG. 1, and FIG. FIG. 5 is a cross-sectional view taken along the line CC in FIG. 2. In the following, for convenience of explanation, the upper side in FIGS. 1 and 2 is referred to as “tip”, “up” or “upper”, and the lower side is referred to as “base”, “lower” or “lower”.
　図１に示す薬剤収納容器１は、中空の容器本体２と、容器本体２内に収納された粉末状の薬剤Ｑとで構成されている。薬剤Ｑは、薬剤収納容器１が図１に示す初期状態（未使用状態）で、予め容器本体２に収納されている。この薬剤Ｑは、例えばシリンジ（図示せず）から容器本体２の口部７を介して充填された溶解液Ｒによって溶解される。以下、薬剤Ｑが溶解液Ｒによって溶解されたものを「薬液Ｐ」と言う。また、容器本体２に溶解液Ｒが充填された図４に示す状態を「溶解液充填状態」と言う。 1 is composed of a hollow container body 2 and a powdery medicine Q stored in the container body 2. The drug container 1 shown in FIG. The medicine Q is stored in the container body 2 in advance in the initial state (unused state) shown in FIG. This medicine Q is dissolved by, for example, a solution R filled from a syringe (not shown) through the mouth portion 7 of the container body 2. Hereinafter, the drug Q dissolved in the solution R is referred to as “medical solution P”. The state shown in FIG. 4 in which the container body 2 is filled with the solution R is referred to as a “solution-filled state”.
　容器本体２は、薬剤Ｑを収納する収納空間３１を有する胴部３と、胴部３の先端部に設けられた口部７とで構成されている。以下の説明では、特に断らない限り、「初期状態」についてのものを言う。なお、初期状態での収納空間３１の容積は、特に限定されないが、例えば、１～５０ｍＬであるのが好ましく、３～３０ｍＬであるのがより好ましい。 The container body 2 is composed of a body part 3 having a storage space 31 for storing the medicine Q, and a mouth part 7 provided at the front end part of the body part 3. In the following description, the “initial state” is referred to unless otherwise specified. The volume of the storage space 31 in the initial state is not particularly limited, but is preferably 1 to 50 mL, for example, and more preferably 3 to 30 mL.
　胴部３は、互いに対向する第１の壁部（一方の壁部）３２ａおよび第２の壁部（他方の壁部）３２ｂと、第１の壁部３２ａおよび第２の壁部３２ｂの外周側に設けられた枠部３３とを有している。そして、胴部３では、第１の壁部３２ａと第２の壁部３２ｂと枠部３３とにより、収納空間３１が画成されている。 The body portion 3 includes a first wall portion 32a and a second wall portion (the other wall portion) 32b facing each other, and outer peripheries of the first wall portion 32a and the second wall portion 32b. And a frame portion 33 provided on the side. In the body portion 3, a storage space 31 is defined by the first wall portion 32 a, the second wall portion 32 b, and the frame portion 33.
　第１の壁部３２ａは、その中央部付近が凹没している。この凹没した部分（以下「変形部３５」と言う）は、収納空間３１内に溶解液Ｒが充填された際に変形して、収納空間３１の容積を増大させる部分である。この凹没した変形部３５は、その底部に位置する頂部３２２と、頂部３２２の外周側に形成された傾斜部３２３とを有している。 The first wall 32a is recessed near the center. This recessed portion (hereinafter referred to as “deformation portion 35”) is a portion that is deformed when the storage space 31 is filled with the solution R and increases the volume of the storage space 31. The recessed deformed portion 35 has a top portion 322 located at the bottom thereof and an inclined portion 323 formed on the outer peripheral side of the top portion 322.
　傾斜部３２３は、枠部３３側から頂部３２２に向かって傾斜して形成された部分である。 The inclined portion 323 is a portion formed to be inclined from the frame portion 33 side toward the top portion 322.
　そして、厚さ（肉厚）は、ｔａ１＜ｔａ２＜ｔａ３＜ｔａ４（図２参照）、ｔｂ１＜ｔｂ２＜ｔｂ３＜ｔｂ４（図３参照）となるよう漸減している。具体的には、第２の壁部３２ｂの厚さｔａ４（ｔｂ４）は、変形部３５、特に、頂部３２２の厚さｔａ１（ｔｂ１）の１．４～２０倍であるのが好ましく、２．０～１０倍であるのがより好ましい。 The thickness (thickness) is gradually reduced to satisfy t a1 <t a2 <t a3 <t a4 (see FIG. 2) and t b1 <t b2 <t b3 <t b4 (see FIG. 3). . Specifically, the thickness t a4 (t b4 ) of the second wall portion 32 b is 1.4 to 20 times the thickness t a1 (t b1 ) of the deformed portion 35, particularly the top portion 322. Preferably, it is 2.0 to 10 times.
　このような厚さの大小関係を有する容器本体２は、厚さがｔａ３（ｔｂ３）の枠部３３までは、機械的強度が保たれている。また、容器本体２は、溶解液Ｒを充填したときに、枠部３３と傾斜部３２３（厚さｔａ２（ｔｂ２）の部分）との中間部分３２４から変形し始める構造となっている。 The container body 2 having such a thickness relationship has mechanical strength maintained up to the frame portion 33 having a thickness of t a3 (t b3 ). Further, the container body 2 has a structure in which when the solution R is filled, the container body 2 starts to be deformed from an intermediate portion 324 between the frame portion 33 and the inclined portion 323 (a portion of the thickness t a2 (t b2 )).
　図３、図４に示すように、容器本体２では、初期状態から溶解液充填状態となる際には、口部７を介して充填された溶解液Ｒは、主に頂部３２２を図中上方へ押し上げる。このとき、前述したように中間部分３２４が変形し易い部分となっているため、変形部３５が図３に示す凹没した状態から容易に図４に示す突出した状態となり、よって、収納空間３１の容積が増大することとなる。そして、この容積が増大した収納空間３１には、薬剤Ｑを十分に、すなわち、過不足なく溶解することができる程度の薬剤Ｑが充填され、よって、薬液Ｐを生成することができる。 As shown in FIG. 3 and FIG. 4, in the container body 2, when the solution is filled from the initial state, the solution R filled through the mouth 7 mainly passes the top portion 322 upward in the drawing. Push up. At this time, since the intermediate portion 324 is a portion that is easily deformed as described above, the deformable portion 35 is easily protruded from the recessed state shown in FIG. Will increase in volume. The storage space 31 with the increased volume is filled with a sufficient amount of the drug Q, that is, the drug Q that can be dissolved without excess or deficiency, so that the drug solution P can be generated.
　第２の壁部３２ｂは、前述したようにその厚さが最も厚い、すなわち、その平均厚さが変形部３５の平均厚さよりも厚い部分である。この厚さが最も厚い第２の壁部３２ｂより、容器本体２は、口部７が鉛直方向上方に位置するように直立した際に、その直立状態が維持される（図２参照）。従って、容器本体２では、当該容器本体２を人体と見立てた場合、その「背骨」のような機能を果たし、直立に適した形状のものとなっている。これにより、直立した状態の薬剤収納容器１を例えば後述する凍結乾燥装置１０のステージ１０１上に載置した際、当該薬剤収納容器１は、その直立状態のまま、安定してステージ１０１上に載置される。 As described above, the second wall portion 32b is the thickest portion, that is, a portion where the average thickness is thicker than the average thickness of the deformable portion 35. When the container body 2 stands upright from the second wall portion 32b having the largest thickness so that the mouth portion 7 is positioned upward in the vertical direction, the container body 2 is maintained in the upright state (see FIG. 2). Therefore, when the container body 2 is regarded as a human body, the container body 2 functions like a “spine” and has a shape suitable for upright. Thereby, when the medicine storage container 1 in an upright state is placed on, for example, the stage 101 of the freeze-drying apparatus 10 described later, the medicine storage container 1 is stably placed on the stage 101 in the upright state. Placed.
　なお、第２の壁部３２ｂは、その厚さが溶解液充填状態で実質的に変形しない程度に設定されているのが好ましい（図４参照）。これにより、第２の壁部３２ｂが例えば初期状態から溶解液充填状態までの間に不本意に変形するのが防止され、よって、容器本体２の直立状態を確実に維持することができる。 In addition, it is preferable that the thickness of the second wall portion 32b is set to such an extent that the second wall portion 32b is not substantially deformed when the solution is filled (see FIG. 4). Thereby, the second wall 32b is prevented from being unintentionally deformed, for example, from the initial state to the solution filling state, so that the upright state of the container body 2 can be reliably maintained.
　また、図２、図３に示すように、容器本体２内に未だ溶解液Ｒが充填されていない初期状態では、第１の壁部３２ａの頂部３２２と第２の壁部３２ｂとの間には、間隙３１１が形成されている。すなわち、初期状態で第１の壁部３２ａの頂部３２２と第２の壁部３２ｂとは、各内面（裏面）３２１同士が非接触で対向して設けられている。口部７を介して流入した溶解液Ｒは、間隙３１１を通過することができ、よって、収納空間３１全体に迅速に行き渡る。これにより、溶解液Ｒを容易かつ確実に充填することができ、よって、薬剤Ｑが溶解液Ｒに溶解される。 As shown in FIGS. 2 and 3, in an initial state where the container body 2 is not yet filled with the solution R, the gap between the top portion 322 of the first wall portion 32a and the second wall portion 32b. The gap 311 is formed. That is, in the initial state, the top portion 322 of the first wall portion 32a and the second wall portion 32b are provided so that the inner surfaces (rear surfaces) 321 face each other in a non-contact manner. The solution R that has flowed in through the mouth portion 7 can pass through the gap 311, and thus quickly reaches the entire storage space 31. Thereby, the solution R can be easily and reliably filled, and thus the drug Q is dissolved in the solution R.
　なお、初期状態での間隙距離ｄ１は、特に限定されないが、例えば、０．５～２５ｍｍであるのが好ましく、１～１５ｍｍであるのがより好ましい。間隙距離ｄ１がこのような数値範囲内であることにより、容器本体２をブロー成形により製造する場合、当該容器本体２を安定して製造することができる。 The gap distance d1 in the initial state is not particularly limited, but is preferably 0.5 to 25 mm, for example, and more preferably 1 to 15 mm. When the gap distance d1 is within such a numerical range, the container body 2 can be stably manufactured when the container body 2 is manufactured by blow molding.
　図１に示すように、第１の壁部３２ａおよび第２の壁部３２ｂの外周側には、これらの壁部を囲むように帯状の枠部３３が設けられている。この枠部３３により、初期状態での薬剤収納容器１の形状が維持され、よって、溶解液Ｒを充填した際に、薬剤収納容器１が膨張し易くなる。また、溶解液充填状態での薬剤収納容器１の形状も維持され、よって、例えば当該薬剤収納容器１を把持し易くなる。 As shown in FIG. 1, a band-shaped frame portion 33 is provided on the outer peripheral side of the first wall portion 32a and the second wall portion 32b so as to surround these wall portions. The shape of the medicine container 1 in the initial state is maintained by the frame portion 33, and thus the medicine container 1 is easily expanded when the solution R is filled. Further, the shape of the medicine container 1 in the state of being filled with the dissolution liquid is also maintained, and therefore, for example, the medicine container 1 can be easily grasped.
　また、枠部３３には、その基端側の部分に平坦な底部３３６が形成されている。これにより、薬剤収納容器１を凍結乾燥装置１０のステージ１０１上に載置した際、薬剤収納容器１は、ステージ１０１と平面で接することとなる（図２参照）。これにより、薬剤収納容器１は、直立状態がより確実に維持され、よって、安定してステージ１０１上に載置されることとなる。なお、図２に示すように、収納空間３１中の薬剤Ｑは、初期状態で底部３３６付近に位置している。 Further, the frame portion 33 is formed with a flat bottom portion 336 at the base end portion thereof. Thereby, when the medicine storage container 1 is placed on the stage 101 of the freeze-drying apparatus 10, the medicine storage container 1 comes into contact with the stage 101 in a plane (see FIG. 2). Thereby, the medicine container 1 is more reliably maintained in an upright state, and is thus stably placed on the stage 101. As shown in FIG. 2, the medicine Q in the storage space 31 is located near the bottom 336 in the initial state.
　以上のような容器本体２（胴部３と口部７の筒状部７２とを含む）は、可撓性を有する材料、すなわち、軟質樹脂材料で構成されている。この軟質樹脂材料としては、特に限定されないが、例えば、ポリエチレン、ポリプロピレン、ポリブタジエン、エチレン－酢酸ビニル共重合体（ＥＶＡ）のようなポリオレフィン、ポリエチレンテレフタレート（ＰＥＴ）、ポリブチレンテレフタレート（ＰＢＴ）のようなポリエステル、軟質ポリ塩化ビニル、ポリ塩化ビニリデン、シリコーン、ポリウレタン、ポリアミドエラストマー等の各種熱可塑性エラストマーあるいはこれらを任意に組み合わせたもの（ブレンド樹脂、ポリマーアロイ、積層体等）が挙げられる。また、胴部３は、単層で構成されていてもよいし、複数の層が積層された積層体で構成されていてもよい。 The container body 2 (including the body portion 3 and the cylindrical portion 72 of the mouth portion 7) as described above is made of a flexible material, that is, a soft resin material. The soft resin material is not particularly limited. For example, polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), polyethylene terephthalate (PET), and polybutylene terephthalate (PBT). Examples thereof include various thermoplastic elastomers such as polyester, soft polyvinyl chloride, polyvinylidene chloride, silicone, polyurethane, and polyamide elastomer, or any combination thereof (blend resin, polymer alloy, laminate, etc.). Moreover, the trunk | drum 3 may be comprised by the single layer, and may be comprised by the laminated body by which the several layer was laminated | stacked.
　また、このような軟質樹脂材料で構成される容器本体２は、ブロー成形により製造される。ブロー成形で製造することにより、容器本体２の内面を平滑なものとすることができる。例えば２枚のシート材の縁部同士を融着した従来の薬液収納容器の場合、薬剤Ｑが融着部付近に挟まり、溶解液Ｒに接触することができないことがあるが、ブロー成形で製造した容器本体２の場合、このような不具合を防止することができる。 Further, the container body 2 made of such a soft resin material is manufactured by blow molding. By manufacturing by blow molding, the inner surface of the container body 2 can be made smooth. For example, in the case of a conventional chemical solution storage container in which the edges of two sheet materials are fused together, the drug Q may be sandwiched near the fused portion and may not be in contact with the solution R. Such a problem can be prevented in the case of the container body 2 that has been made.
　薬剤収納容器１の先端側には、溶解液Ｒが流入したり、薬液Ｐが流出したりする口部７が配置されている。図２に示すように、この口部７には、弾性材料で構成された、自己閉塞性を有する弁体５が装着されている。なお、弁体５の代わりに、針により穿刺することができるゴム栓等であってもよい。 The mouth portion 7 through which the solution R flows and the solution P flows out is disposed on the distal end side of the drug container 1. As shown in FIG. 2, a valve body 5 having a self-occlusion property made of an elastic material is attached to the mouth portion 7. Instead of the valve body 5, a rubber stopper or the like that can be punctured with a needle may be used.
　口部７は、枠部３３から突出した円筒状をなす筒状部７２と、筒状部７２に装着される蓋部７３とを備えている。 The mouth portion 7 includes a cylindrical portion 72 having a cylindrical shape protruding from the frame portion 33 and a lid portion 73 attached to the cylindrical portion 72.
　図５に示すように、筒状部７２は、横断面視で（口部７を先端側から見たときについても同様）、その外周面７２６の一部と、第２の壁部３２ｂの表面３２６とが同一直線上にあり、筒状部７２の内周面７２７の一部と、第２の壁部３２ｂの内面３２１とが同一直線上にあることが好ましい。これにより、第２の壁部３２ｂの厚さを十分に確保することができる。 As shown in FIG. 5, the cylindrical portion 72 has a part of the outer peripheral surface 726 and the surface of the second wall portion 32 b in a cross-sectional view (the same applies when the mouth portion 7 is viewed from the distal end side). 326 is on the same straight line, and a part of the inner peripheral surface 727 of the cylindrical part 72 and the inner surface 321 of the second wall part 32b are preferably on the same straight line. Thereby, the thickness of the 2nd wall part 32b is fully securable.
　また、筒状部７２は、その内部に弁体設置部７２１が形成されている。この弁体設置部７２１は、第２の内腔部７２３と、それより基端側に位置し、第２の内腔部７２３の内径よりも縮径した第３の内腔部７２４とに分けることができる。また、第３の内腔部７２４の内径は、後述する弁体５の胴部５５の最大外径より若干大きいのが好ましい。 Further, the tubular portion 72 has a valve body installation portion 721 formed therein. The valve body setting portion 721 is divided into a second lumen portion 723 and a third lumen portion 724 that is located on the proximal end side and is smaller in diameter than the inner diameter of the second lumen portion 723. be able to. Moreover, it is preferable that the internal diameter of the 3rd lumen | bore part 724 is a little larger than the largest outer diameter of the trunk | drum 55 of the valve body 5 mentioned later.
　また、筒状部７２の底面７２２の中心部には、管状体で構成された内部突起７２５が設けられている。口部７にシリンジが接続されて、弁体５が下方に向かって押圧され始めたとき、この内部突起７２５により、弁体５の内部が支えられて、弁体５に座屈が生じるのを防止することができる。また、溶解液Ｒが口部７内を通過するに際し、溶解液Ｒの滞留が生じるのを防ぐことができる。 Also, an inner protrusion 725 made of a tubular body is provided at the center of the bottom surface 722 of the cylindrical portion 72. When the syringe is connected to the mouth portion 7 and the valve body 5 starts to be pressed downward, the internal protrusion 725 supports the inside of the valve body 5 and causes the valve body 5 to buckle. Can be prevented. Further, when the solution R passes through the mouth portion 7, it is possible to prevent the solution R from staying.
　蓋部７３は、内部に弁体５を収納する内腔部を有し、筒状部７２に連結されるものである。この蓋部７３は、例えば、硬質樹脂材料で構成されている。 The lid portion 73 has a lumen portion that accommodates the valve body 5 therein, and is connected to the cylindrical portion 72. The lid portion 73 is made of, for example, a hard resin material.
　蓋部７３の内部には、後述する弁体５の頭部５０が挿入可能な第１の内腔部７３１と、第１の内腔部７３１に連通し、第１の内腔部７３１より拡径した嵌合部７３３とが形成されている。 Inside the lid portion 73, a first lumen portion 731 into which a later-described head portion 50 of the valve body 5 can be inserted, and the first lumen portion 731 are communicated with and expanded from the first lumen portion 731. A diameter fitting portion 733 is formed.
　第１の内腔部７３１は、その形状が弁体５の頭部５０の外形に対応するよう形成されている。 The first lumen portion 731 is formed so that its shape corresponds to the outer shape of the head 50 of the valve body 5.
　また、嵌合部７３３は、筒状部７２の外周部に嵌合する部位である。これにより、蓋部７３と筒状部７２とが液密に連結され、よって、口部７の内部の溶解液Ｒが蓋部７３と筒状部７２との間から漏れるのを防止することができる。また、蓋部７３と筒状部７２とが連結した際、第１の内腔部７３１と第２の内腔部７２３とが連通し、第１の内腔部７３１、第２の内腔部７２３および第３の内腔部７２４で形成された空間に弁体５を設置することができる。 Further, the fitting part 733 is a part that fits to the outer peripheral part of the cylindrical part 72. Thereby, the lid part 73 and the cylindrical part 72 are connected in a liquid-tight manner, and accordingly, it is possible to prevent the dissolution liquid R inside the mouth part 7 from leaking between the lid part 73 and the cylindrical part 72. it can. Further, when the lid portion 73 and the cylindrical portion 72 are connected, the first lumen portion 731 and the second lumen portion 723 communicate with each other, and the first lumen portion 731 and the second lumen portion are connected. The valve body 5 can be installed in the space formed by the 723 and the third lumen portion 724.
　蓋部７３の外周部には、雄ネジ部７３８が形成されている。雄ネジ部７３８は、シリンジが口部７に接続される際に、当該シリンジと螺合する部分である。 A male screw portion 738 is formed on the outer periphery of the lid portion 73. The male screw portion 738 is a portion that is screwed with the syringe when the syringe is connected to the mouth portion 7.
　このような構成の口部７では、その内側の内腔部が、溶解液Ｒが通過可能な流路として機能する。 In the mouth portion 7 having such a configuration, the inner lumen functions as a flow path through which the solution R can pass.
　図２に示すように、口部７には、弁体５が設置されている。弁体５は、例えばイソプレンゴム等のような各種ゴム材料、ポリオレフィン系等の各種熱可塑性エラストマーが挙げられ、これらのうちの１種または２種以上を混合して用いることができる。このような弾性材料を用いることにより、弁体５の先端面５１１に適度な弾性を得ることができる。これにより、口部７にシリンジを接続した際、当該シリンジの端面と先端面５１１とが液密に密着ことができる。 As shown in FIG. 2, a valve body 5 is installed in the mouth portion 7. Examples of the valve body 5 include various rubber materials such as isoprene rubber, and various thermoplastic elastomers such as polyolefin, and one or more of these can be used in combination. By using such an elastic material, moderate elasticity can be obtained on the tip surface 511 of the valve body 5. Thereby, when a syringe is connected to the mouth part 7, the end surface of the said syringe and the front end surface 511 can adhere | attach liquid-tightly.
　弁体５は、管状の胴部５５と、胴部５５の一端部に一体的に設けられた頭部５０とを有している。 The valve body 5 includes a tubular body portion 55 and a head portion 50 provided integrally with one end portion of the body portion 55.
　頭部５０は、その形状が有底筒状をなしており、溶解液Ｒや薬液Ｐが通過可能な内腔部５１５と、平面状の先端面５１１から内腔部５１５に到達するスリット（開閉部）５１２とが形成されている。このスリット５１２は、その形状がほぼ一文字状をなしている。スリット５１２の形状がこのように簡単であることにより、先端面５１１のスリット５１２付近を押圧した際に当該先端面５１１が変形し、よって、スリット５１２が確実に開口する。また、この押圧を解除した際には、先端面５１１が復元し、よって、スリット５１２が確実に閉じる。このように弁体５は、自己閉塞性を有するものである。 The head 50 has a bottomed cylindrical shape, and has a lumen portion 515 through which the solution R and the drug solution P can pass, and a slit (open / close) that reaches the lumen portion 515 from the flat distal end surface 511. Part) 512. The slit 512 has a substantially single character shape. Since the shape of the slit 512 is so simple, the front end surface 511 is deformed when the vicinity of the slit 512 of the front end surface 511 is pressed, and thus the slit 512 is reliably opened. Further, when the pressing is released, the front end surface 511 is restored, so that the slit 512 is reliably closed. Thus, the valve body 5 has a self-occlusion property.
　また、このようなスリット５１２の作動により、口部７を容易かつ確実に封止／封止解除することができる。 In addition, by the operation of the slit 512, the mouth portion 7 can be easily and reliably sealed / unsealed.
　また、頭部５０は、前述したような押圧力が付与されていないとき、蓋部７３の第１の内腔部７３１に挿入され、スリット５１２が閉じている。 Further, when the pressing force as described above is not applied, the head portion 50 is inserted into the first lumen portion 731 of the lid portion 73, and the slit 512 is closed.
　胴部５５は、蛇腹状をなす筒状体で構成されている。すなわち、胴部５５は、外形において大径リング部５５２と小径リング部５５３とが軸方向に交互に配列された蛇腹状をなしている。このような胴部５５は、頭部５０が蓋部７３の第１の内腔部７３１に挿入される方向に付勢する変形部として機能している。 The trunk portion 55 is formed of a cylindrical body having a bellows shape. That is, the body 55 has a bellows shape in which the large-diameter ring portion 552 and the small-diameter ring portion 553 are alternately arranged in the axial direction in the outer shape. Such a body portion 55 functions as a deforming portion that urges the head portion 50 in a direction in which the head portion 50 is inserted into the first lumen portion 731 of the lid portion 73.
　以上のような構成の容器本体２内には、薬剤Ｑが収納されている。この薬剤Ｑとしては、特に限定されないが、例えば、抗がん剤、免疫抑制剤等、医療従事者が誤って触れると危険な薬剤や、抗生剤、止血剤等の使用にあたって溶解が必要な薬剤、小児用の薬剤等の希釈が必要な薬剤、ワクチン、ヘパリン、小児用の薬剤等の複数回取り分ける薬剤等が挙げられる。また、この薬剤Ｑを溶解する溶解液Ｒは、前述したようにシリンジを用いて薬剤収納容器１に充填され、例えば、生理食塩水とすることができる。 The medicine Q is accommodated in the container body 2 having the above-described configuration. The drug Q is not particularly limited. For example, an anticancer drug, an immunosuppressive drug, or the like, which is dangerous when a medical worker touches it accidentally, or a drug that needs to be dissolved when using antibiotics, hemostatic agents, etc. Drugs that require dilution, such as drugs for children, vaccines, heparin, drugs for children, etc. The solution R for dissolving the drug Q is filled in the drug container 1 using a syringe as described above, and can be, for example, physiological saline.
　薬剤Ｑは、当該薬剤Ｑを含む液状組成物を凍結乾燥により乾燥することによって得られるものである。この場合、容器本体２内で薬剤Ｑは、凍結乾燥装置１０を用いて、次のようにして製造される。凍結乾燥装置１０は、平板状をなすステージ１０１を有している（図２参照）。この凍結乾燥装置１０では、ステージ１０１を冷却することができるよう構成されている。 Drug Q is obtained by drying a liquid composition containing the drug Q by freeze-drying. In this case, the drug Q is produced in the container body 2 using the freeze-drying apparatus 10 as follows. The freeze-drying apparatus 10 has a plate-like stage 101 (see FIG. 2). The freeze-drying apparatus 10 is configured so that the stage 101 can be cooled.
　まず、容器本体２は、直立状態でステージ１０１に載置されており、この状態で収納空間３１内に前記液状組成物が充填されている。容器本体２は、前述したように直立に適したものであるため、直立状態が維持され、よって、不本意に倒れたりするのが防止される。そして、ステージ１０１上の容器本体２ごと、当該ステージ１０１を冷却する。容器本体２は、その平坦な底部３３６を介して、ステージ１０１と面接触しているため、収納空間３１内の液状組成物が凍結乾燥され、薬剤Ｑが得られる。 First, the container body 2 is placed on the stage 101 in an upright state, and the liquid composition is filled in the storage space 31 in this state. Since the container main body 2 is suitable for upright as described above, the upright state is maintained, and therefore, the container body 2 is prevented from falling unintentionally. Then, the stage 101 is cooled together with the container body 2 on the stage 101. Since the container body 2 is in surface contact with the stage 101 via the flat bottom portion 336, the liquid composition in the storage space 31 is lyophilized to obtain the medicine Q.
　このように、薬剤収納容器１では、直立状態で収納空間３１内の液状組成物を凍結乾燥して、薬剤Ｑを効率的に製造することができる。また、前述したように、容器本体２は、ステージ１０１上では直立状態で載置される。このため、容器本体２を倒した状態で載置した場合よりも、ステージ１０１に載置される容器本体２の載置数が多くなる。これにより、多くの容器本体２を凍結乾燥することができ、よって、薬剤Ｑを収納した薬剤収納容器１を一度に多数製造することができる。 Thus, in the medicine storage container 1, the liquid Q in the storage space 31 can be freeze-dried in an upright state to efficiently manufacture the medicine Q. Further, as described above, the container body 2 is placed in an upright state on the stage 101. For this reason, the number of placement of the container main body 2 placed on the stage 101 is larger than when the container main body 2 is placed in a tilted state. Thereby, many container main bodies 2 can be lyophilized | freeze-dried, Therefore, many chemical | medical agent storage containers 1 which stored the chemical | medical agent Q can be manufactured at once.
　次に、薬剤収納容器１の使用方法の一例について詳細に説明する。
　［１］　まず、図１に示す初期状態の薬剤収納容器１と、溶解液Ｒが充填されたシリンジとを用意する。このシリンジには、薬剤収納容器１中の薬剤Ｑを溶解するのに十分な液量の溶解液Ｒが充填されている。 Next, an example of a method for using the medicine container 1 will be described in detail.
[1] First, the medicine container 1 in the initial state shown in FIG. 1 and a syringe filled with the solution R are prepared. This syringe is filled with a solution R having a sufficient amount to dissolve the drug Q in the drug container 1.
　［２］　次に、薬剤収納容器１の口部７とシリンジとを接続する。このとき、前述したように、口部７の弁体５が基端方向に向かって押圧されて、当該弁体５のスリット５１２が開状態となる。これにより、薬剤収納容器１内とシリンジ内とが連通する。 [2] Next, the mouth 7 of the medicine container 1 and the syringe are connected. At this time, as described above, the valve body 5 of the mouth portion 7 is pressed in the proximal direction, and the slit 512 of the valve body 5 is opened. Thereby, the inside of the medicine container 1 and the inside of the syringe communicate.
　［３］　次に、シリンジの押し子を押圧操作する。これにより、シリンジ内の溶解液Ｒが薬剤収納容器１の口部７を介して薬剤収納容器１内に注入され、薬剤収納容器１が溶解液充填状態となる（図４参照）。注入された溶解液Ｒは、まず、収納空間３１を枠部３３に沿って流下し、次いで、間隙３１１に入り込む。これにより、収納空間３１全体が溶解液Ｒで満たされる。また、このとき、前述したように、溶解液Ｒが第１の壁部３２ａの頂部３２２を外方に向かって押し広げようとするため、中間部分３２４が変形し始めて、収納空間３１の容積が増大する。このように、薬剤収納容器１では、当該薬剤収納容器１内に溶解液Ｒを容易かつ確実に充填することができる。 [3] Next, the syringe pusher is pressed. Thereby, the solution R in the syringe is injected into the drug container 1 through the mouth portion 7 of the drug container 1, and the drug container 1 is filled with the solution (see FIG. 4). The injected dissolving solution R first flows down the storage space 31 along the frame portion 33 and then enters the gap 311. As a result, the entire storage space 31 is filled with the solution R. At this time, as described above, since the solution R tries to spread the top portion 322 of the first wall portion 32a outward, the intermediate portion 324 starts to deform, and the volume of the storage space 31 increases. Increase. Thus, in the medicine container 1, the solution R can be easily and surely filled in the medicine container 1.
　また、溶解液Ｒを充填しても、薬剤収納容器１の収納空間３１の容積が増大するため、当該収納空間３１の圧力上昇を抑制することができ、よって、溶解液Ｒのシリンジへの逆流を防止することができる。また、溶解液Ｒの充填量は、薬剤収納容器１の収納空間３１の最大容積以下とすることができる。 Further, even if the dissolution liquid R is filled, the volume of the storage space 31 of the medicine storage container 1 increases, so that an increase in the pressure of the storage space 31 can be suppressed. Can be prevented. Further, the filling amount of the solution R can be set to be equal to or less than the maximum volume of the storage space 31 of the medicine storage container 1.
　［４］　次に、シリンジが接続された薬剤収納容器１全体を振盪する。これにより、溶解液Ｒで薬剤Ｑがより確実に溶解され、よって、薬液Ｐが生成される。 [4] Next, the entire medicine container 1 connected to the syringe is shaken. Thereby, the medicine Q is more reliably dissolved in the solution R, and thus the medicine P is generated.
　［５］　次に、シリンジの押し子を引張り操作する。これにより、薬剤収納容器１内の薬液Ｐをシリンジ内に吸引することができる。この薬液Ｐの吸引量は、シリンジの押し子の引張り量に応じて適宜調整することができる。 [5] Next, the syringe pusher is pulled. Thereby, the chemical | medical solution P in the chemical | medical agent storage container 1 can be attracted | sucked in a syringe. The suction amount of the chemical liquid P can be appropriately adjusted according to the pull amount of the pusher of the syringe.
　そして、薬液Ｐが吸引されたシリンジを、例えば、患者への薬液投与に用いることができる。 And the syringe from which the drug solution P has been aspirated can be used, for example, for drug solution administration to a patient.
　以上、本発明の薬剤収納容器を図示の実施形態について説明したが、本発明は、これに限定されるものではなく、薬剤収納容器を構成する各部は、同様の機能を発揮し得る任意の構成のものと置換することができる。また、任意の構成物が付加されていてもよい。 As mentioned above, although illustrated embodiment of the chemical | medical agent storage container of this invention was described, this invention is not limited to this, Each part which comprises a chemical | medical agent storage container is arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.
　また、容器本体は、ブロー成形により製造されたものに限定されず、例えば、容器本体となる一対の半割体同士を接合することにより製造されたものであってもよい。 Further, the container body is not limited to those manufactured by blow molding, and may be manufactured by, for example, joining a pair of halves that form the container body.
　また、初期状態で、薬剤収納容器には、例えば、窒素等のような不活性ガスが予め充填されていてもよい。これにより、薬剤の種類にもよるが、当該薬剤が酸化するのを防止することができる。 In the initial state, the medicine container may be prefilled with an inert gas such as nitrogen. Thereby, although depending on the kind of the medicine, it is possible to prevent the medicine from being oxidized.
　また、収納される薬剤としては、前記各実施形態では粉末状のものであったが、これに限定されず、例えば、錠剤状、ゲル状、液状のものであってもよい。 In addition, the medicine to be stored is in a powder form in each of the above embodiments, but is not limited thereto, and may be in a tablet form, a gel form, or a liquid form, for example.
　また、薬剤収納容器の口部には、前記各実施形態では弁体が装着されているが、これに限定されず、弁体が省略されていてもよい。 In addition, although the valve body is attached to the mouth portion of the medicine storage container in each of the embodiments described above, the present invention is not limited to this, and the valve body may be omitted.
　本発明の薬剤収納容器は、先端側に液体が出入り可能な口部を有し、可撓性を有する材料で構成された容器本体と、該容器本体内に収納され、前記口部を介して流入した前記液体によって溶解される薬剤とを備える薬剤収納容器であって、前記容器本体は、前記薬剤を収納する収納空間を画成し、互いに対向する一対の壁部を有し、前記一対の壁部のうちの一方の壁部は、少なくともその一部に形成され、前記収納空間内に前記液体が充填された際に変形して、前記収納空間の容積を増大させる変形部を有し、前記一対の壁部のうちの他方の壁部は、その平均厚さが前記変形部の平均厚さよりも厚くなっている。そのため、口部が鉛直上方に位置するように容器本体が直立した際に、一対の壁部のうちの平均厚さが厚い方の壁部により、その直立状態が確実に維持される。そして、その、直立状態で薬剤収納容器をテーブル等のような平板上に載置した際、当該薬剤収納容器は、安定して平板上に載置される。このように、薬剤収納容器は、直立に適したものとなっている。また、容器本体に収納される薬剤が、当該薬剤を含む液状組成物を凍結乾燥させることにより得られるものである場合には、凍結乾燥装置は、それが有する平板状をなすステージ上に、前記液状組成物が充填された薬剤収納容器を直立した状態で載置し、この状態でステージごと薬剤収納容器を冷却する。これにより、前記液状組成物が確実に冷却され、よって、薬剤が確実に得られる。このように、薬剤収納容器は、直立状態で、容器本体内の前記液状組成物を冷却して、薬剤を効率的に製造することができる。従って、本発明の薬剤収納容器は、産業上の利用可能性を有する。 The drug storage container of the present invention has a mouth part through which liquid can enter and exit on the tip side, a container body made of a flexible material, and housed in the container body, via the mouth part A medicine storage container including a medicine dissolved by the flowed-in liquid, wherein the container main body defines a storage space for storing the medicine, and has a pair of wall portions facing each other, One wall portion of the wall portions is formed in at least a part thereof, and has a deformation portion that deforms when the storage space is filled with the liquid and increases the volume of the storage space, The other wall portion of the pair of wall portions has an average thickness that is greater than an average thickness of the deformable portion. Therefore, when the container body stands upright so that the mouth portion is positioned vertically upward, the upright state is reliably maintained by the thicker wall portion of the pair of wall portions. When the medicine storage container is placed on a flat plate such as a table in the upright state, the medicine storage container is stably placed on the flat plate. Thus, the medicine container is suitable for upright. When the medicine stored in the container body is obtained by freeze-drying a liquid composition containing the medicine, the freeze-drying apparatus has the above-described flat plate stage on the stage. The medicine container filled with the liquid composition is placed in an upright state, and the medicine container is cooled together with the stage in this state. Thereby, the said liquid composition is cooled reliably and, therefore, a chemical | medical agent is obtained reliably. Thus, the medicine container can be efficiently produced by cooling the liquid composition in the container body in an upright state. Therefore, the medicine storage container of the present invention has industrial applicability.

Claims (6)

  1. 　先端側に液体が出入り可能な口部を有し、可撓性を有する材料で構成された容器本体と、該容器本体内に収納され、前記口部を介して流入した前記液体によって溶解される薬剤とを備える薬剤収納容器であって、
    　前記容器本体は、前記薬剤を収納する収納空間を画成し、互いに対向する一対の壁部を有し、
    　前記一対の壁部のうちの一方の壁部は、少なくともその一部に形成され、前記収納空間内に前記液体が充填された際に変形して、前記収納空間の容積を増大させる変形部を有し、
    　前記一対の壁部のうちの他方の壁部は、その平均厚さが前記変形部の平均厚さよりも厚くなっていることを特徴とする薬剤収納容器。     A container body having a mouth through which liquid can enter and exit on the distal end side and made of a flexible material, and stored in the container body and dissolved by the liquid flowing in through the mouth. A medicine container comprising a medicine,
    The container body defines a storage space for storing the medicine, and has a pair of wall portions facing each other,
    One wall portion of the pair of wall portions is formed in at least a part of the wall portion, and is deformed when the liquid is filled in the storage space to increase a volume of the storage space. Have
    The other wall part of the pair of wall parts has an average thickness larger than an average thickness of the deformed part.
  2. 　前記他方の壁部の平均厚さは、前記変形部の平均厚さの１．４～２０倍である請求項１に記載の薬剤収納容器。 The drug container according to claim 1, wherein an average thickness of the other wall portion is 1.4 to 20 times an average thickness of the deformed portion.
  3. 　前記容器本体内に未だ前記液体が充填されていない初期状態で、前記一方の壁部と前記他方の壁部との間には、間隙が形成されている請求項１または２に記載の薬剤収納容器。 The medicine container according to claim 1 or 2, wherein a gap is formed between the one wall portion and the other wall portion in an initial state in which the liquid is not filled in the container body. container.
  4. 　前記口部は、その形状が筒状をなしており、
    　前記口部を先端側から見たとき、該口部の基端部の外周面の一部と前記他方の壁部の表面とが同一直線上にあるか、または、前記口部の基端部の内周面の一部と前記他方の壁部の裏面とが同一直線上にある請求項１ないし３のいずれかに記載の薬剤収納容器。     The mouth has a cylindrical shape,
    When the mouth portion is viewed from the distal end side, a part of the outer peripheral surface of the base end portion of the mouth portion and the surface of the other wall portion are on the same straight line, or the base end portion of the mouth portion The medicine container according to any one of claims 1 to 3, wherein a part of the inner peripheral surface of the first wall and the back surface of the other wall portion are on the same straight line.
  5. 　前記容器本体は、ブロー成形により製造されたものである請求項１ないし４のいずれかに記載の薬剤収納容器。 The medicine container according to any one of claims 1 to 4, wherein the container body is manufactured by blow molding.
  6. 　前記薬剤は、凍結乾燥により乾燥したものである請求項１ないし５のいずれかに記載の薬剤収納容器。 The medicine container according to any one of claims 1 to 5, wherein the medicine is dried by freeze-drying.
PCT/JP2011/051630 2010-01-28 2011-01-27 Medicine storage container WO2011093389A1 (en)

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