JP4581331B2 - Drug-filled multi-chamber bag - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention separates and holds a plurality of active ingredients blended in a medical fluid such as an intravenous infusion, a liquid nutrient, a peritoneal dialysis solution, etc., and easily mixes the plurality of active ingredients immediately before administration. about the drug-filled multi-chamber back grayed that can be.
[0002]
[Prior art]
Conventionally, a container made of a thermoplastic resin or a glass container is used in order to store and store medicines and nutrients. Medical solutions such as injections, infusion solutions for intravenous administration, dialysis solutions, eye drops, ophthalmic perfusates and organ preservation solutions are almost liquid-tightly filled and sterilized or sterilized. One of these product forms is a kit product that is on the market. The kit product is a combination of a drug and a medical device or two or more drugs as a single administration system, and is intended to reduce the burden at the time of dispensing in a medical institution, prevent bacterial contamination, and prevent foreign substances from being mixed. Examples of kit products are prefilled disposable injections (prefilled syringe products), two-chamber mixed-type infusions called double bags, such as “PN Twin” (trade name) manufactured by Ajinomoto Pharma. The kit product has advantages such as prevention of errors during dispensing and quick response in an emergency.
[0003]
Double bags and prefilled syringes are commercially available with two containers divided into compartments, but have the disadvantage of not being able to cope with the addition of additional drugs or nutrients. In order to solve this problem, a medical container including three chambers has been proposed in, for example, patent literature. In the invention of Patent Document 1, a flexible bag is partitioned by a peelable seal, and a chamber for storing a third medicine is provided. However, when a multi-compartment room is provided, an extremely careful opening operation is required to ensure communication between all the compartments and mixing of the components, and there is a problem in quick response in an emergency. Moreover, when it is administered to a patient with a section that is not opened, a solution different from the administrable liquid property being supplied, leading to the occurrence of side effects.
[0004]
Patent Document 2 discloses a multi-chamber infusion container in which a first container for storing a liquid drug and a second container for storing a solid drug are integrated. The multi-chamber infusion container includes a partition member 30 between the first container and the second container, and the partition member includes a hollow portion that connects the adjacent first and second containers so that they can communicate with each other. It has the cover body 32 which seals one end of a hollow part. The lid body 32 is connected to the main body of the partition member 30 via a thin portion, and is opened by deforming the partition member. This multi-chamber infusion container has a disadvantage that a small amount of a plurality of drugs cannot be separated and stored. In some cases, medical solutions such as infusions are mixed with antibiotics and vitamins depending on the pathology of the patient to whom they are administered. In addition, storage stability can be expected to be improved by separating and storing various active ingredients in multiple chambers. However, providing multiple compartments or compartments for the container complicates the manufacturing process of the container, and can be used during use. There is a problem that convenience of the service is reduced.
[0005]
[Patent Document 1]
JP 2000-501324 A [Patent Document 2]
Japanese Patent Laid-Open No. 2000-87350
[Problems to be solved by the invention]
In view of the current situation, an object of the present invention is to provide a multi-chamber bag containing medicines that can be easily mixed in a container with three or more kinds of medicines that are currently in increasing demand. Another object of the present invention is to provide a drug kit product that stores a relatively large amount of drug solution in a bag-like container and stores a relatively small amount of a plurality of drugs in a large number of small-volume drug storage chambers. Further, an object of the present invention is to partition the drug solution storage chamber and the drug storage chamber by a weak seal portion, and apply a pressing force to the drug solution in the bag-like container from the outside of the container, thereby providing a space between the drug solution storage chamber and the drug storage chamber. A drug-filled container set that can peel the weak seal part and make the liquid communication state between the drug solution storage chamber and each drug storage chamber, and can easily mix the containers in other chambers even when urgent is required Is to provide.
[0007]
Another object of the present invention is to provide a drug-containing multi-chamber bag capable of mixing a plurality of small amounts of drugs in a plurality of drug storage chambers while maintaining aseptic conditions with an infusion contained in a flexible container. It is. Another object of the present invention is to provide a drug-containing multi-chamber bag capable of simultaneously aseptically mixing a plurality of drugs contained in a drug-containing multi-chamber bag by a single operation. Furthermore, an object of the present invention is to provide a port member for allowing a chemical solution in a multi-chamber bag to flow out to an infusion tube via a hollow needle or the like, or allowing an additional chemical solution to be injected into the multi-chamber bag via a hollow needle. That is. Other objects and advantages of the present invention will become apparent in the drawings and the following description.
[0008]
[Means for Solving the Problems]
The multi-chamber bag containing medicines of the present invention has first and second chemical solution storage chambers for storing a chemical solution, and a drug storage chamber for storing a drug. The first chemical solution storage chamber and the second chemical solution storage chamber are formed in a bag-like container composed of first and second resin films that are joined at the end edge portion and the side edge portion, respectively, so as to be liquid-tight. A box member having an opening is disposed between the first and second chemical solution storage chambers, and a portion between the opening of the box member and the first resin film is bonded by a weak seal portion. The weak seal portion is peeled off by applying a pressing force from the outside of the container to the chemical solution in the first storage chamber or the second storage chamber, and the peripheral portion of the opening is separated from the first resin film.
[0009]
The drug storage chamber communicates with the opening and is formed in a box member so as to be liquid-tight. When the weak seal portion is peeled off, the drug storage chamber, the first storage chamber, and the second storage chamber communicate with each other. The chamber solution and drug are mixed. The box member has a plurality of openings and a plurality of medicine storage chambers. The weak seal portion is peeled off by applying a pressing force from the outside of the container to the chemical solution in the first storage chamber or the second storage chamber, the peripheral portion of the opening is separated from the first film, and the weak seal portion is peeled off The first storage chamber, the second storage chamber, and the respective drug storage chambers are communicated to mix the chemical solution and the drug in each of the storage chambers.
[0010]
The drug-containing multi-chamber bag of the present invention includes a port member. The port member has a rubber stopper that can pierce a hollow needle, is configured to be able to inject a chemical solution into the chemical solution storage chamber, or to be able to extract a chemical solution from the chemical solution storage chamber, and is disposed at the edge of the bag-like container. The The port member includes a cylinder and a holder, and the cylinder, the holder, and the inner wall surface of the container body are all formed of a propylene / α-olefin random copolymer having a VICAT softening point of 121 ° C. or higher.
[0011]
The port member of the present invention is attached to the edge of a bag-like container forming a multi-chamber bag containing medicine. The multi-chamber bag containing medicine includes a first chemical solution storage chamber and a second chemical solution storage chamber in which chemical solutions are respectively stored. The port member includes a rubber plug, a cylinder, and a holder. The rubber stopper can be pierced by a hollow needle, and the liquid in the container body can be poured out or injected into the container body through the hollow needle that pierces the rubber stopper. The cylindrical body has an inner end disposed inside the container body, an outer peripheral surface that is liquid-tightly bonded to the resin film forming the container body, an outer end that engages with the rubber stopper, and a collar portion that supports the holder. Have
[0012]
The holder has an annular top plate portion, a cylindrical portion extending downward from the outer periphery of the top plate portion, and a protruding portion formed at an end of the cylindrical portion. The tip of the ridge is brought into contact with an annular recess provided in the collar, and the tip of the ridge and the annular recess are welded. Preferably, the tip of the ridge portion and the annular recess are heat-welded by ultrasonic energy. A peripheral portion of the rubber stopper is sandwiched between the upper end portion of the cylindrical body and the holder.
[0013]
The rubber plug has a disc portion that closes the hollow portion near the outer end, an inner annular hanging portion that extends downward from the outer periphery of the disc portion, and an outer peripheral surface that fits into the cylindrical peripheral surface near the outer end. , An annular plate portion extending radially outward from the outer peripheral surface, an outer annular hanging portion depending from the outer periphery of the annular plate portion, an outer annular convex portion extending upward from the outer periphery of the annular plate portion, and the outer peripheral surface and outward A lower annular groove formed between the annular hanging portions and an upper annular groove formed between the outer side of the disk portion and the outer annular convex portion are provided.
[0014]
Examples of drugs contained in the multi-chamber bag of the present invention are infusion preparations in which vitamins are added to sugar / electrolyte / amino acid solutions for high-calorie infusions that can be used as starting solutions and maintenance solutions for transcentral parenteral nutrition therapy . In this case, the sugar / electrolyte / amino acid solution is accommodated in the drug solution storage chamber, and the vitamins are stored in two or more drug storage chambers. Vitamins for high calorie infusion are vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin A, vitamin D, vitamin E, vitamin K, vitamin H, folic acid, pantothenic acids, nicotinic acids, In order to stably store the composition without changing the composition, it is separated from each other in two or more drug storage chambers and separated from the high-calorie infusion component.
[0015]
The peripheral vein or axillary vein infusion containing the same components as the high calorie infusion sugar, electrolyte, and amino acid solution can also contain drugs such as vitamins using the multi-chamber bag of the present invention. In addition to blending vitamins in each of the aforementioned infusions, trace element preparations (trade names: Elemental Note, Elemate Note, Ajinomoto Pharma Co., Ltd.) containing each source of iron, manganese, copper, zinc, and iodine vitamins It is also a preferred combination of drugs to be housed separately.
[0016]
The multi-chamber bag of the present invention can be used as a filling container for various drugs for the purpose of reducing or omitting stabilizers and preservatives. For example, an amino acid infusion containing at least the essential amino acids L-tryptophan, L-methionine, L-lysine, L-phenylalanine, L-leucine, L-isoleucine, L-valine, L-threonine (for example, manufactured by Ajinomoto Pharma) (Trade name Aminic) contains L-tryptophan and L-cysteine, which have a problem in storage stability, and is added with a stabilizer such as sulfite. L-tryptophan and L-cysteine are each dissolved in a liquid solution that can be stored stably, separated from other amino acids, and stored in a multi-chamber bag so that they can be stored without causing changes in the composition between amino acids. It is possible to reduce or omit the stabilizer.
[0017]
High calorie infusion sugar / electrolyte / amino acid solution, peptic ulcer for injection, for example, ranitidine hydrochloride, roxatidine hydrochloride, cimetidine, famotidine and other H ₂ blockers, and liver damage agents such as glycyrrhizin, glycine, In order to be able to mix cysteine, they can be accommodated in the multi-chamber bag of the present invention. The multi-chamber bag of the present invention can be used as a drug-containing container for home high-calorie infusion therapy by injecting a peptic ulcer agent or a liver injury solvent into an empty room communicating with a co-injectable introduction means.
[0018]
BEST MODE FOR CARRYING OUT THE INVENTION
FIG. 1 is a schematic plan view showing a drug-containing multi-chamber bag according to a first embodiment of the present invention, and FIG. 2 is a schematic end view of a box member incorporated in the multi-chamber bag of FIG. As shown in FIG. 1, a multi-chamber bag 1 containing medicines includes a chemical solution storage chamber 4 that stores chemical solutions M1 and M2, a port member 3, and a plurality of drug storage chambers 61 and 62 that store drugs N1, N2, and N3. 63. The chemical solution storage chamber 4 is formed in the bag-like container 2. The bag-like container 2 is formed by bonding two resin films to each other at the end edge portions 23 and 24 and the side edge portions 25 and 25.
[0019]
The port member 3 includes a rubber stopper 33 that can be pierced with a hollow needle, and is configured to be able to inject a chemical solution into the chemical solution storage chamber 4 or to extract a chemical solution from the chemical solution storage chamber 4. In the embodiment shown in FIGS. 1, 3, and 5, the chemical solution storage chamber 4 includes a first storage chamber 41 and a second storage chamber 42 defined by a weak seal portion 44. The weak seal portion 44 is peeled off by applying a pressing force from the outside of the container to the chemical solution M1 in the first storage chamber 41 or the chemical solution M2 in the second storage chamber 42, and communicates the first storage chamber and the second storage chamber. Let One port member 3 is disposed at each of the upper and lower edge portions 23 and 24 of the bag-like container 2.
[0020]
The plurality of medicine storage chambers 61, 62, 63 are formed inside the box member 5 disposed at one end edge 23 of the bag-like container 2. The box member 5 includes a lid member 55 that forms a wall surface portion of each medicine storage chamber 61, 62, 63. When the box member 55 is not deformed, the lid member 55 partitions the drug storage chambers 61, 62, and 63 in a sealed state with respect to the drug solution storage chamber 4, and the box member 5 receives the deformation force from the outside and deforms to open. The drug storage chambers 61, 62, 63 are in fluid communication with the drug solution storage chamber 4.
[0021]
The plurality of drug storage chambers 61, 62, 63 can be sealed separately, and when the lid member 55 is moved to the open position, each of the drug storage chambers 61, 62, 63 communicates with the drug solution storage chamber 4. The The plurality of drug storage chambers 61, 62, 63 have drug solution injection ports 51, 52, 53, respectively, as shown in FIG. Additional chemical solutions are injected into the respective drug storage chambers 61, 62, and 63 as necessary through the chemical solution injection ports 51, 52, and 53.
[0022]
The multi-chamber bag 1 of FIG. 1 stores the infusion component in the first storage chamber 41 and the second storage chamber 42, respectively, and stores the drugs N1, N2, and N3 in the drug storage chambers 61, 62, and 63, respectively. The drugs N1, N2, and N3 are vitamins, minerals, and other drugs, for example. When administering the infusion, the box member 5 is manually deformed from the outside of the container, the lid member 55 is opened, the drug storage chambers communicate with the first storage chamber 41, and the drug storage chambers 61, 62, 63 The medicine is mixed with the chemical liquid M1 in the first storage chamber.
[0023]
By applying pressure from the outside to one or both of the first storage chamber 41 and the second storage chamber 42, the weak seal portion 66 is peeled off. When the weak seal portion 66 is peeled off, the first storage chamber 41, the second storage chamber 42, and the drug storage chambers 61, 62, 63 communicate with each other. As a result, the drug solutions M1 and M2 are mixed, and the drugs N1, N2, and N3 in the drug storage chambers 61, 62, and 63 are mixed with the drug solutions M1 and M2. The mixed drug solution in which the drug solutions M1 and M2 and the drugs N1, N2, and N3 are mixed is supplied to the patient via a hollow needle, an infusion tube (not shown), and the like through the drug solution injection and extraction port 3 on the second storage chamber side. The multi-chamber bag 1 is provided with a hanging hole 25 substantially at the center of the edge 23. At the time of infusion administration, the multi-chamber bag 1 is suspended at a predetermined height position using the suspension holes 25.
[0024]
The bag-like container 2 and the box member 6 of the present invention are made of a thermoplastic resin. This thermoplastic resin is suitable for chemicals and nutrients that contain heat resistance, mechanical strength, flexibility, chemical resistance, especially moldability, gas barrier properties, flex resistance, transparency, and UV shielding properties. It is said. The bag-like container 2 can be formed of a thermoplastic resin film having a single layer structure or a laminated structure of two or more layers. As the thermoplastic resin, one kind or a mixture of two or more kinds can be used. A thermoplastic resin modified by introducing a functional group into the molecular chain is also used.
[0025]
The thermoplastic resin forming the bag-shaped container 2 is, for example, polyolefin such as polyethylene, polypropylene, ethylene-α-olefin copolymer, polystyrene, polycarbonate, polyester such as polyethylene terephthalate or polybutylene terephthalate, polyacetal, polyamide, polyphenylene ether, Polyethersulfone, polysulfone, ethylene-vinyl acetate copolymer, polyvinyl chloride, polyvinylidene chloride, polyphenylene sulfide, fluororesin, acrylic resin, cyclic polyolefin and the like. Among these, polyethylene, polypropylene, ethylene-α-olefin copolymer, and polyethylene terephthalate are preferable.
[0026]
The drug storage chambers 61, 62, and 63 are preferably made of a resin with low drug adsorption. Examples of such resins include polyethylene naphthalate, cyclic polyolefin, ethylene-tetrafluoroethylene copolymer, and polyethersulfone. And polysulfone. It is good to set it as the structure provided in a contact surface with the said 3 types of resin chemical | medical agents.
[0027]
The surface of the film or sheet forming the multi-chamber bag of the invention can be subjected to surface treatment as necessary. Examples of such surface treatment methods include corona discharge treatment, plasma treatment, flame treatment, sputtering treatment, solvent treatment, ultraviolet treatment, infrared treatment, ozone treatment, and polishing treatment. When the film forming the container body is a laminated structure, it is possible to improve the adhesive strength between the layers by using a hot melt adhesive, a polyurethane adhesive or the like between the layers as necessary.
[0028]
An embodiment of the port member 3 will be described with reference to FIGS. As shown in FIG. 1, the port member 3 is attached to the edge 24 of the bag-like container that forms the multi-chamber bag 1 containing a medicine. The port member 3 includes a rubber plug 80, a cylindrical body 30, and a holder 70. The rubber stopper 80 can be pierced by a hollow needle (not shown), and the liquid in the container body can be poured out or injected into the container body through the hollow needle that pierces the rubber stopper 80. The cylindrical body 30 includes an inner end 31 disposed inside the container main body, an outer peripheral surface 35 that is liquid-tightly bonded to a resin film forming the container main body, an outer end 36 that engages with the rubber plug 80, and a holder. 70 has a flange 32 for supporting 70.
[0029]
The holder 70 has an annular top plate portion 71, a cylindrical portion 72 extending downward from the outer periphery of the top plate portion, and a ridge portion 73 formed at the end of the cylindrical portion. The tip of the ridge portion 73 is brought into contact with the annular recess 33 provided in the flange portion 32, and the tip of the ridge portion 73 and the annular recess 33 are welded. Preferably, the tip of the protrusion 73 and the annular recess 33 are heat-welded with ultrasonic energy. A peripheral portion of the rubber plug 80 is sandwiched between the outer end 36 of the cylindrical body 30 and the holder 70.
[0030]
The rubber plug 80 includes a disc portion 81 that closes a hollow portion near the outer end 36, an inner annular hanging portion 82 that extends downward from the outer peripheral portion of the disc portion, and a cylindrical peripheral surface 34 near the outer end 36. The outer peripheral surface 83 fitted to the outer peripheral surface 83, the annular plate portion 84 extending radially outward from the outer peripheral surface 83, the outer annular hanging portion 86 depending from the outer periphery of the annular plate portion 84, and the upward extending from the outer periphery of the annular plate portion 84. An outer annular projection 87, a lower annular groove 85 formed between the outer circumferential surface 83 and the outer annular hanging portion 86, and an outer annular projection 87 formed between the outer side of the disk portion 81 and the outer annular projection 87. It has an upper annular groove 88.
[0031]
FIG. 9 is a schematic cross-sectional view of the port member 3 in which the holder 70, the cylindrical body 30, and the rubber plug 80 are combined. The rubber plug 80 closes the upper opening of the cylinder 30 and is sandwiched between the outer end 36 of the cylinder 30 and the holder 70. The holder 70 is fixed to the cylindrical body 30 by welding the tip of the protrusion 73 and the annular recess 33 of the cylindrical body 30. The outer surfaces of the rubber plug 80 and the holder 70 are covered with a protective cap 90. When the chemical solution in the bag-like container is poured out through the port member, the protective cap 90 is removed, the hollow needle is pierced so as to cross the disc portion 81 of the rubber plug 80, and the chemical solution is poured out through the hollow needle. Can do. The outer surface of the disc portion 81 is kept clean until the protective cap 90 is removed.
[0032]
【The invention's effect】
The multi-chamber bag with medicine of the present invention is provided with a plurality of medicine storage chambers in a box member having an opening, the box member is disposed between the first chemical solution storage chamber and the second chemical solution storage chamber, and the periphery of the opening of the box member The first resin film forming the portion and the bag-like container is bonded by the weak seal portion, and when administering the drug, the weak seal portion is peeled off by applying force manually from the outside of the container, and the first chemical solution storage chamber, Since the two drug solution storage chambers and the plurality of drug storage chambers communicate with each other, a plurality of drug solutions and drugs can be mixed aseptically in the container by one operation. In addition, since the multi-chamber bag containing medicines of the present invention is stored in a separated state without exposing a plurality of medicines and medicines to the outside air, it is possible to prevent changes due to oxygen in the outside air and changes in the mixture of medicines. In use, the medicines stored in a plurality of chambers can be easily mixed in a sterile state without malfunction in a short time.
[0033]
In the present invention, the upper annular groove provided in the flange portion of the cylindrical body and the protruding portion of the holder are heat-welded by ultrasonic vibration energy to form a welded portion, and the gap between the flange portion of the cylindrical body and the holder is formed. Strongly connected. Therefore, even when a bag-like container contains a chemical solution and is maintained at 121 ° C. for 20 minutes in a high-pressure chamber for sterilization and a relatively large pressure acts on the rubber stopper of the port member from inside the container, the rubber stopper is retained. It is firmly pressed by the tool and does not come out. Moreover, since the welding part formed between an upper annular groove and the protrusion part of a holder is visible from the exterior of a port member, the test | inspection of a welding part is easy.
[Brief description of the drawings]
FIG. 1 is a schematic plan view showing a multi-chamber bag containing medicine according to a first embodiment of the present invention.
FIG. 2 is a schematic cross-sectional view taken along line TT in FIG.
3 is a schematic cross-sectional view taken along line SS in FIG.
FIG. 4 is a schematic perspective view of a box member incorporated in the multi-chamber bag containing medicine according to the present invention.
FIG. 5 is a schematic perspective view seen from the opening side of a box member incorporated in the multi-chamber bag containing medicine according to the present invention.
FIG. 6 is a schematic cross-sectional view of a port member holder according to an embodiment of the present invention.
FIG. 7 is a schematic cross-sectional view of a cylindrical body of an embodiment of a port member.
FIG. 8 is a schematic cross-sectional view of a rubber plug of an embodiment of a port member.
FIG. 9 is a schematic cross-sectional view of a combination of a holder, a cylinder, and a rubber plug of an embodiment of a port member.
[Explanation of symbols]
G1, G2: Gas, M1, M2: Chemical solution, N1, N2, N3: Drug, 1: Multi-chamber bag, 2: Container body, 3: Port member, 6: Box member, 21: First resin film, 22: 2nd resin film, 23, 24: edge part, 25: side edge part, 27: strong seal part, 29: suspension hole, 30: cylinder, 31: inner end, 32: collar part, 33: annular Recess, 34: inner peripheral surface, 35: outer peripheral surface, 36: outer end, 41: first chemical solution storage chamber, 42: second chemical solution storage chamber, 60: box member, 61, 62, 63: drug storage chamber, 65, 651, 652, 653: Opening, 66, 661, 662, 663: Weak seal part, 67, 671, 672, 673: Outer surface of box member, 68, 69: End surface of box member, 70: Holder, 71 : Top plate portion, 72: cylindrical portion, 73: ridge portion, 74 inner peripheral surface of top plate, 75: annular convex portion, 80 Rubber stopper, 81: disc part, 82: inner annular hanging part, 83: outer peripheral surface, 84: annular plate part, 85: lower annular groove, 86: outer annular hanging part, 87: outer annular convex part, 88: Upper annular groove, 90: Protective cap.

Claims (3)

A multi-chamber bag containing a medicine having first and second medicine storage chambers for storing a medicine and a medicine storage chamber for storing a medicine,
The first chemical solution storage chamber and the second chemical solution storage chamber are formed in a bag-like container composed of the first and second resin films joined at the end edge portion and the side edge portion, respectively, so as to be liquid-tight, and between the two chambers. A box member having a plurality of openings and a plurality of drug storage chambers is disposed, and the first drug solution storage chamber and the second drug solution storage chamber are connected via the box member, and around each opening of the box member The portion and the first resin film are bonded by a weak seal portion, and the bottom portion facing the opening of the box member and the second resin film are bonded by a strong seal portion, communicated with the opening and in the box member The liquid seal is formed so that the weak seal portion is peeled off by applying a pressing force from the outside of the container to the chemical solution in the first storage chamber or the second storage chamber, thereby separating the peripheral portion of the opening and the first resin film, thereby Medicine storage chamber, first storage chamber and first storage chamber Medicated multi-chamber bag accommodating chamber chemical and agents each accommodation chamber is communicated with are mixed.   The multi-chamber bag containing a medicine according to claim 1, comprising a port member disposed at an edge of the bag-like container, the port member including a rubber stopper capable of penetrating a hollow needle and containing a chemical solution A multi-chamber bag containing a medicine configured to be able to inject a medicine into a chamber or to extract a medicine from a medicine storage chamber.   The multi-chamber bag containing a medicine according to claim 2, wherein the port member includes a cylinder and a holder, and the inner wall of the cylinder and the holder and the container main body each have a propensity of 121 ° C or higher for a VICAT softening point. A multi-chamber bag containing a drug formed of an α-olefin random copolymer.

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