WO2001091694A1

WO2001091694A1 - Plug-equipped liquid medicine container

Info

Publication number: WO2001091694A1
Application number: PCT/JP2001/004626
Authority: WO
Inventors: Koji Munechika; Hideto Kodaira
Original assignee: Mitsubishi Pharma Corporaion; Showa Denko Plastic Products Co., Ltd.
Priority date: 2000-06-01
Filing date: 2001-05-31
Publication date: 2001-12-06
Also published as: CN1431890A; AU2001260687A1; KR20030011344A; JP2001340429A

Abstract

A plug-equipped liquid medicine container, comprising a liquid medicine container having a liquid medicine storing section with an internal space for storing liquid medicine and an injecting section with a communication passageway communicating with the internal space, and a plug having a microorganism eliminating filter installed in the injection section of the liquid medicine container, wherein the liquid medicine container is of the construction in which it is divided into two chambers partitioned by a peelably heat-sealed partition band, each chamber storing a liquid medicine, the partition band being peeled during use to cause the two chambers to communicate with each other so as to mix the liquid medicines, one chamber storing as a liquid medicine an infusion containing sugar and fatty emulsion, the other chamber storing an infusion containing amino acid and electrolyte.

Description

Specification

Chemical solution container with stopper

Technical field

The present invention relates to a medicinal solution container with a stopper for aseptically and easily performing co-injection of medicinal solutions with each other, specifically, co-injection of another medicinal solution into an injection solution such as an infusion solution.

'' Background technology

In clinical settings, it is common to simultaneously administer multiple types of drug solutions to patients, for example, when continuously administering an injection such as an infusion into a vein. The above-mentioned multiple types of drug solutions are administered by injecting and mixing other drug solutions with the injection solution contained in a drug solution container such as an infusion bag (this is called co-infusion) and mixing them in a drug solution container, To be administered.

If microorganisms (microorganisms) are mixed in from the outside during the co-injection operation, the microorganisms will proliferate in the mixed injection solution during the period when the mixed outgoing solution is being administered to the patient. In particular, when the injection is an infusion for the purpose of providing nutrition, for example, a high calorie infusion, if microorganisms are mixed during the co-infusion operation as described above, a small amount of nutrients may be contained because the microorganisms contain a large amount of nutrient components. There is also a risk of microbial growth during the administration period. In such cases, a large amount of microorganisms may be infused into the patient at the same time as the infusion at a later stage of administration. Patients receiving such mixed injections cause severe side effects such as septic endotoxin shock. Therefore, it is necessary to ensure sterility during co-injection operations, taking patient safety into consideration.

Conventionally, in order to prevent the incorporation of microorganisms due to the co-injection of such solution solutions, the co-infusion operation is performed under aseptic conditions, for example, in a clean bench, or the co-infusion is removed to the injection part of the chemical solution container each time co-infusion is performed. There is known a method of performing aseptic sterilization at the time of a co-injection operation, for example, by co-injection with a bacteria filter attached. When administering to a patient from a drug solution container containing a mixed injection solution, a sterilization filter is attached to the discharge part of the drug solution container, and the drug is administered to the patient after passing through the filter. Methods are also known.

However, when performing co-injection work in a clean bench, it is necessary to disinfect parts (hands, etc.) related to the work of the operator in advance, which makes preparation for the work troublesome. Preparations must be made. As described above, the co-infusion operation performed in a clean bench or the like has a problem that the operation is complicated. In addition, the operation itself is less convenient and difficult to perform smoothly than when the operation is performed outside the clean bench.

When a disinfecting filter is attached to the injection part of the chemical container to perform co-injection work. During the mounting work of this filter, the injection part of the chemical liquid container may be contaminated, so that it is not necessarily aseptic. It is hard to say that work can be done. In addition, the method of installing a disinfecting filter in the discharge part of the drug solution container is not always administered through a disinfecting filter under any circumstances. It is reported that it is only% -80% (Ayumi of Medicine vol. 125, p 1 140 (1993), JJPEN vol. 15, p3 25 (1993) , Nikkan Yakuyo Vol. 38, p 15 9 (1996). However, this method cannot be used when it is desired to administer an infusion solution containing a component having a large particle size, such as a fat emulsion, having a large pore size in a sterilization filter. In general, filters with a pore size of 0.45 m or less that do not allow the passage of microorganisms, and those with a pore size of 0.22 m are commonly used as filters that are generally used as eradication filters. . For example, fat emulsions containing oil droplets having a particle size larger than the pore size of such a sterilizing filter (average particle size of about 0.2 / im to 0.4 m) must pass through the sterilizing filter. Can not.

In this way, co-infusion of drug solutions represented by co-infusion of other drug solutions in infusion administration is frequently performed in medical practice. Therefore, there is a need for the development of a means that can perform the aseptic foam injection operation more easily and more reliably. An object of the present invention is to provide a medical solution container with a stopper that can aseptically perform a co-injection operation between medical solutions.

DISCLOSURE OF THE INVENTION 'The inventors of the present invention have conducted intensive studies to solve the above-mentioned problems, and as a result, the medical solutions can be aseptically and easily co-injected into each other using a solid-state medical solution container having a specific structure. They have found that the object can be achieved, and have completed the present invention.

That is, the present invention is as follows.

[1] A chemical solution container ^ having an internal space for accommodating a chemical solution, a medical solution container having an injection portion having a communication passage communicating with the internal space, and a sterilization filter attached to the injection portion of the chemical solution container. A liquid container provided with a plug having a plug body, wherein the liquid container is separated into two separate chambers by a partition strip which is heat-fused in a detachable state, and It has a structure in which a chemical solution is accommodated, the partition strip is peeled off when used, and the two private rooms are connected to mix the two chemical solutions, and a sugar and fat emulsion is used in one private room as the chemical solution. A liquid medicine container with a stopper that contains an infusion solution containing an amino acid and an electrolyte in the other private room.

[2] The plug body includes a plug member having a substantially cylindrical peripheral wall, and a substantially columnar rubber plug fitted into the peripheral wall,

The above-mentioned [1], wherein a disinfecting co-injection device having an injection needle member is mounted on one end side of the stopper member in the axial direction such that the tip of the injection needle member is on the stopper member side. ] The chemical | medical solution container with a stopper body of Claim.

(3) the injection device, wherein the disinfecting co-injection device has a flow path extending from the injection port at one end in the axial direction to the discharge port at the other end in the axial direction, and has a sterilization filter in the middle of the flow path;

The outlet of the injection member such that the axis thereof substantially coincides with the axis of the injection member. An injection needle member attached to the

The liquid medicine container with a stopper according to the above [2], comprising: a substantially cylindrical housing that accommodates part or all of the injection member and the injection needle member in an internal space thereof.

[4] The drug solution with a stopper according to [3], wherein the injection member and the injection needle member are equipped with a disinfecting co-injection device that is self-reciprocating substantially along the axial direction thereof.

[5] A protruding member protruding from the side wall of the injection member toward the internal space of the housing, and each locking member protruding from the vicinity of both ends in the axial direction of the housing toward the open space thereof and capable of locking to the protruding member. The liquid medicine container with a stopper according to the above [4], further comprising a disinfecting co-infusion tool further comprising:

[6] A fixing member for fixing the injection member to the housing is further provided.A fixing portion of the housing, and a resilient portion is formed on the other end side in the axial direction, which is capable of expanding and contracting substantially along the axial direction. The medicinal solution container with a stopper according to the above [4], which is equipped with a disinfecting mixed injection device characterized by being carried out.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a simplified diagram showing a preferred example of a disinfecting co-infusion device 1 of the present invention.

FIG. 2 is a top view of the disinfecting co-infusion device 1 of FIG.

FIG. 3 is a diagram showing a simplified example of a preferred example of the injection member 2 and the injection needle member 3 of the present invention.

FIG. 4 is a diagram showing step by step a sterile co-infusion operation using the disinfecting co-infusion device 1 of the present invention.

FIG. 5 is a simplified view of another preferred example of the disinfection co-infusion device 41 of the present invention.

FIG. 6 is a diagram showing a preferred example of a concave portion formed on the filter fixing member and a convex portion formed on the housing in FIG. FIG. 7 is a view showing another preferred example of the concave portion formed on the filter fixing member and the convex portion formed on the housing in FIG.

FIG. 8 is a simplified view of another preferred example of the disinfecting co-infusion device 51 of the present invention.

FIG. 9 is a simplified view of the plug 61 using the sterile co-infusion device 1 of the present invention shown in FIGS. 1 to 3.

FIG. 10 is a simplified view of a stoppered chemical solution container 71 of the present invention.

Detailed description of the invention

FIG. 1 is a simplified view of a sterile co-infusion device 1 of a preferred example of the present invention, FIG. 2 is a top view of the sterile co-injection device of FIG. 1, and FIG. 3 is an injection member of the present invention. 2 is a diagram showing a simplified example of a preferred example of the injection needle member 3 and c. FIG. 1 is parallel to the axial direction A of the sterilization co-infusion device 1 of FIG. FIG. 2 is a simplified cross-sectional view taken along a cutting plane line [1-1] passing only through a housing 4 without passing through a sterilization filter 8. FIG. 3 is a simplified cross-sectional view taken along a cutting plane line I.I I-II I including the respective central axes of the injection member 2 and the injection needle member 3 in FIG. As shown in FIG. 1, the disinfecting co-infusion device 1 basically includes an injection member 2, an injection needle member 3 attached to the injection member 2, a part of the injection member 2 and a part of the injection needle member 3. A housing 4 for accommodating is provided. ,

The shape of the injection member 2 is not particularly limited as long as the injection member 2 has a structure having a flow path 7 via an inlet 5, an outlet 6, and a disinfecting filter to be described later. It further comprises a fixing member 13, and as shown in FIGS. 1 and 3, a syringe connecting portion 2 a having an injection port 5 on the axial direction A side of the hollow disk-shaped filter fixing member 13. In addition, an injection needle member mounting portion 2b having a discharge port 6 on the other side in the axial direction A is provided. Inside the filter fixing member 13, a disk-shaped sterilization filter 8 is sandwiched so as to be interposed in the middle of the flow path 7. like this As a material for forming the injection member 2 having a structure, for example, polypropylene, acryl tree, polyester, polycarbonate and the like can be mentioned. The length L1 of the injection member 2 along the axial direction is not particularly limited, but is, for example, 10 mm to 50 mm.

The inlet 5 is a portion into which a chemical solution, also called an inlet, is injected, and preferably has a diameter of 0.1 mm! ~ 10 mm. The syringe connecting portion 2a having such an inlet 5 is realized to have a structure capable of connecting a luer portion of a syringe containing a drug solution to be co-injected, for example, a female luer lock structure, as described later. Further, the discharge port 6 is a portion where the chemical solution injected into the injection member 2 from the injection port 5 is discharged from the injection member 2 after passing through the inside of the flow path 7, and preferably has a diameter of 0.1 min to Selected to be 10 mm. The injection needle mounting portion 2b having such a discharge port 6 is realized to have a structure to which the injection needle member 3 can be mounted, for example, an ozone type luer strip structure.

Further, the injection member 2 has a flow path 7 that extends from the injection port 5 to the discharge port 6. The flow path 7 is a flow path through which a drug solution (another agent) to be co-injected in a co-injection operation described later passes, and a sterilization filter 8 is interposed in the middle of the flow path. As the disinfecting filter 8, one having a large number of micropores generally used in the art is used, and the eye roughness (pore diameter) is more preferably 0.1 μια to 0.5 μm. Is preferably from 0.2 m to 0.45 m, particularly preferably from 0.22 μm. Such a sterilizing filter 8 is fixed inside a filter fixing member 13 which is a hollow disk-shaped protruding member described later. Examples of the material of the sterilization filter 8 include cell ester, hydrophilic polyether sulfone, hydrophilic polyvinylidene fluoride, and hydrophilic polytetrafluoroethylene.

Further, as shown in FIG. 3, preferably, the injection member 2 is a disk-shaped two-layered filter that sandwiches the sterilization filter 8 from the inlet 5 side and the outlet 6 side. It has filter supporting screens 17a and 17b. The filter supporting screens 17a and 7b have an eye size commonly used in the art of 1! O10 O ^ m, and serves to hold the shape of the sterilizing filter 8 with the sterilizing filter 8 interposed therebetween. The filter supporting screens 17 a and 17 b are also fixed in the filter fixing member 13 with the filter 8 sandwiched therebetween, like the sterilization filter 8.

The injection needle member 3 is a member having a generally conical shape, preferably a substantially conical shape. As shown in FIG. 3, the injection needle member 3 has a through hole 11 that extends from the base end 9 to the distal end 10. Such an injection needle member 3 may be one generally used as an injection needle in the medical field, and the diameter of the through hole 1i is not particularly limited, but is preferably 18 G to 2 G. 3G ones are used. The length L2 of the injection needle member 3 along the axial direction is not particularly limited, but is preferably selected to be 5 mm to 20 mm, and more preferably about 10 mm.

As a material for forming such an injection needle member 3, a resin material such as polypropylene, acrylic, or polycarbonate is used, and is not particularly limited.

Such an injection needle member 3 is arranged such that its axis is substantially coincident with the axis of the injection member 2, and the injection needle from the base end 9 side to the other end of the injection member 2 in the axial direction A (discharge port 6 side). Mounted on the member mounting section 2b. The proximal end portion 9 of the injection needle member 3 is realized so as to have a structure that can be attached to the injection portion 2 b. Of the injection member 2, for example, a female luer-strip structure. .

The housing 4 is a cylindrical member that accommodates a part of the injection member 2 and the injection needle member 3 in the internal space 12 thereof, and is preferably realized by a substantially cylindrical member. As shown in the top view of Fig. 2, it is realized in the shape of a perfect circular cylinder. The injection member 2 and the injection needle member 3 are preferably housed so that each axis is substantially coincident with the axis of the housing 4 as shown in FIG. To be housed inside In this specification, the axial directions of the injection member 2, the injection needle member 3, and the housing 4 are all the same direction A.

Although the inner diameter of the housing 4 is not particularly limited, it must be formed to be larger than the outer diameter of the plug member in order to mount the sterilization mixed injection rod 1 of the present invention on the plug member as described later. Yes, it is appropriately selected according to the outer diameter of the plug member to be mounted. The inner diameter of such a housing 4 is preferably selected to be 10 mm to 40 mm, and 15 ιη π! ~ 25 mm It is more preferable to be selected. The length L3 of the housing 4 along the axial direction is not particularly limited, but is preferably 20 mm to 60 mm, and more preferably 30 mm to 50 mm.

Examples of the material forming such a housing 4 include resin materials such as polyethylene, polypropylene, polychlorinated vinyl, vinyl acetate, ethylene monoacetate copolymer, polyester, polyamide, and polyurethane. There is no particular limitation. As will be described later, when the sterilization co-infusion device 1 and the plug member are connected to each other by welding by heating or heat generation by ultrasonic induction or high frequency induction, the housing 4 is melted from the above resin material. It is preferable to select as appropriate according to the material of the plug member to be attached. In the sterilization mixed injection device 1 of the present invention, preferably, the injection member 2. and the injection needle member 3 are reciprocally movable substantially along the axial direction A thereof. In the sterilization co-infusion device 1 shown in FIG. 1, for example, the filter fixing member 13 which is a protruding member and the locking members 14 and 15 which can be locked to the filter fixing member 13 are provided. However, the injection member 2 and the injection needle member 3 are realized to be reciprocally movable.

The filter fixing member 13 is formed so as to protrude from the side wall of the injection member 2 toward the housing cavity 12. Such a filter fixing member 13 can be fixed to the injection member 2 and can be fixed by the respective locking members 14 and 15. The shape is not particularly limited as long as the filter can be stopped and locked, but is preferably realized as a hollow disk shape in which the sterilization filter 8 can be fixed as described above. The filter fixing member 13 more preferably has the same diameter as the diameter of the housing 4, and as will be described later, the end portion 13 a of the filter fixing member 13 Can be slid. The direction in which the filter fixing member 13 projects from the side wall of the injection member 2 is not particularly limited, but preferably, as shown in FIGS. 1 and 3, the filter fixing member 13 projects perpendicular to the axial direction A of the injection member 2. Formed. The filter fixing member 13 is formed integrally with the injection member 2.

The filter fixing member 13 is provided with a linear distance L 4 along the axial direction between the outlet 6 of the injection member 2 and the surface on the side of the outlet 6 as described later. It is appropriately selected depending on the situation, but preferably l O mn! ~ 40 mm, more preferably 15 mix! It is fixed to the side wall of the injection member 2 so as to be about 25 mm.

The locking members 14 and 15 are formed so as to protrude from the vicinity of both ends in the axial direction A of the housing 4 toward the inner space 12 thereof so as to be lockable to the filter fixing member 13. Such locking members 14 and 15 can be fixed to both ends in the axial direction A of the housing 4 and the paging 4, respectively. Not limited. The direction in which each of the locking members 14 and 15 protrudes from the housing 4 is not particularly limited, but is preferably formed so as to protrude perpendicularly to the axial direction A of the housing 4 as shown in FIG. Is done. Each locking member 14, 15 may be formed integrally with the housing 4 as shown in FIG. 1 or may be provided separately from the housing 4. When provided separately from the housing 4, the material for forming the locking members 14 and 15 includes polyethylene, polypropylene, and the like. 4 and the locking members 14 and 15 are fixed to each other as appropriate according to the material forming them. . The distance L5 between the locking members 14 and 15 and the distance L between the other end 4a of the housing 4 in the X-axis direction A and the locking member 15 on the other end side in the axial direction A 6 is also not particularly limited, but as described later, the injection needle member 3 penetrates the rubber stopper of the stopper member when attaching the sterilization mixed injection device of the present invention to the stopper member, or will be described later. The injection needle member 3 is appropriately selected according to the member to be attached so that there is no problem that the injection needle member 3 does not reach the rubber stopper of the stopper member during the co-injection. The distance L5 is preferably selected to be 5 to 20 mm larger than the length along the axial direction of the rubber stopper. The distance L6 is preferably selected to be about 3 mm in length along the axial direction of the lure portion of the syringe to be mounted.

By providing such a filter fixing member 13 and each of the locking members 14 and 15, the structure including the injection member 2, the injection needle member 3, and the filter fixing member 13 is substantially along the axial direction A. Thus, it is possible to reciprocate between the locking members 14 and 15. Conversely, the structure is realized such that the filter fixing member 13 cannot reciprocate to the other side in the axial direction from the position where the filter fixing member 13 is locked by the locking member 15 and 13 is realized such that it cannot reciprocate to one side in the axial direction from the position locked by the locking member 14.

FIG. 4 is a diagram showing stepwise an aseptic co-infusion operation using the disinfecting co-infusion device 1 of the present invention. The disinfecting co-infusion device 1 of the present invention having the above-described structure can be attached to the stopper member 22 of the chemical solution container 21 which is generally widely used in the clinical field, so A simple and more reliable mixing operation can be realized. Hereinafter, refer to FIGS. 4 (a) to 4 (c)! The procedure of the aseptic co-infusion operation using the disinfecting co-infusion device 1 of the present invention will be briefly described. 4 (a) to 4 (c) are simplified cross-sectional views in a virtual plane including the respective central axes of the injection member 2 and the injection needle member 3. First, the disinfecting co-infusion device 1 of the present invention shown in FIGS. 1 to 3 is attached to the stopper member 22 of the chemical solution container 21 as shown in FIG. The disinfecting co-infusion device 1 is fitted with a plug member 22 from the other side of the axis A direction A, in other words, from the tip 10 side of the injection needle member 3. ^The chemical liquid container 21 basically includes a medicine storage part 23 having an internal space 24 for storing a chemical liquid, and an injection part 25 having a communication passage 26 communicating with the internal space 24. Prepare for. The chemical solution storage section 23 stores a chemical solution in advance. The stopper member 22 is a member formed so as to be substantially liquid-tightly connected to the injection part 25 of the chemical solution container 21. For example, as shown in FIG. 4, a substantially cylindrical peripheral wall 27, 27 has a substantially columnar rubber stopper 28 fitted substantially liquid tightly. Such a chemical solution container 21 is formed such that the internal space 24 of the chemical solution storage portion 23 is substantially liquid-tight with the external space 29 of the chemical solution container 21.

In FIG. 4 (a), the tip 10 of the injection needle member 3 is shown pierced without penetrating the stopper 28 of the stopper 22. However, the sterilization co-infusion device 1 of the present invention is not shown. It is not always necessary to attach the rubber plug 28 while piercing it.

Next, as shown in FIG. 4 (b), the luer part 35 of the syringe 30 is inserted into the injection port 5 of the injection member 2 of the sterilization co-infusion device 1 attached to the stopper member 22. '' The syringe 30 is generally used as a syringe or the like, and basically has a flange 3.2 protruding radially outward at one end thereof, and A substantially cylindrical syringe cylinder 31 having a mortar-shaped bottom portion 33 at the other end on the opposite side, and a piston 34 inserted from one end of the syringe cylinder 31 into its internal space. And a luer part 35 formed on the other end side of the syringe cylinder 31. The syringe cylinder 31 contains, in its internal space, a drug solution (other agent) 36 to be mixed with the drug solution in the drug solution container 21. The piston 34 has substantially the same outer diameter as the inner diameter of the syringe tube 31. When the biston 34 is pressed against the other end of the syringe tube 31 and slid, the syringe tube 34 is pressed. The liquid medicine 36 is realized so as to be discharged from the lure part 35 having a hole communicating with the upper space 31.

Next, as shown in FIG. 4C, the injection member 2 is pressed by the syringe 30 along the axial direction A to the other side in the axial direction A. As a result, the structure composed of the injection member 2, the injection needle member 3, and the filter fixing member 13 moves along the axial direction A to the other side of the axial direction A. At this time, at least the distal end portion 10 of the needle member 3 is penetrated through the rubber stopper 28. Through the penetration of the injection needle member 3, the internal space 24 of the drug solution storage portion 23 of the drug solution container 21, the communication passage 26 of the injection portion 25, and the through hole 11 1 of the injection needle member 3 are formed. : The flow path 7 of the injection member 2 communicates. In this state, the piston 36 is pressed against the other end of the syringe cylinder 31 in this state, so that the chemical solution 36 in the syringe cylinder 31 is supplied from the luer section 35 to the injection port 4 of the injection member 2. 5. chemical 3 _{6 c} injected from the injection port 5 in this manner injected into the passes through the sterilization filter 8 in the channel 7, via the through-hole 1 1, communication path 2 6, liquid medicine containing Part 2 3 混 Part 2 Aseptically mixed into space 24.

Here, the filter fixing portion forest 13 is preferably formed to have the same diameter as the diameter of the housing 4 as shown in FIG. In such a mode, the end portion 13a of the filter fixing member 13 on the side away from the injection member 2 comes into contact with the wall surface of the housing 4, and the above-described structure can be reciprocated while sliding. . As a result, the component cannot move to the other side in the axial direction unless it is pressed from one side in the axial direction, and the injection needle member 3 is moved before the co-injection as shown in FIG. 4 (a). Undesirably penetrating the rubber stopper is suppressed, and the T rubber stopper 28 can be first penetrated by pressing with the syringe 30 as described above.

As described above, the co-injection operation using the disinfecting co-infusion device 1 of the present invention requires disinfection of parts (hands and the like) related to the worker's operation in advance compared to the conventional case where the operation is performed in a clean bench. Easier and smoother co-infusion operation It is possible to do. This advantage is particularly pronounced when co-injection operations are performed frequently. Also, if the disinfecting co-injection device 1 of the present invention is attached to the stopper member 22 and then sterilized in advance and sterilized in the chemical solution container 21 together with the disinfecting co-injection device 1, it is possible to perform the conventional method. Unlike the case of performing a co-injection operation by attaching a sterilization filter to the injection part of the chemical container, the co-injection can be performed aseptically without contamination of the injection part of the chemical container during the installation of the filter. It is. Furthermore, since the disinfecting co-infusion device 1 of the present invention is configured to be attached to the trocar 22 on the injection part side of the drug solution container, a disinfecting filter is attached to the discharge portion of the drug solution container as in the prior art. In contrast, even if the drug solution contained in the drug solution container 21 is an infusion solution containing a component having a large particle size, such as a fat emulsion, the pore size of the sterilization filter is large. There is no need to consider whether or not to pass through the filter. Therefore, it is possible to aseptically co-inject a transfusion containing such a fat and an emulsion and administer it to a patient.

As shown in FIGS. 1 and 4 (a), the disinfecting co-infusion device 1 of the present invention preferably covers one end 4b of the housing 4 in the axial direction so as to cover the entire opening of the end 4b. It further has a hermetic seal 38 to be affixed. As a result, as shown in FIG. 4 (a), the internal space 12 of the housing 4 is prevented from communicating with the external space when the sterilization co-infusion device 1 is mounted on the stopper member 22. can do. As a result, if sterilization is performed in the state shown in Fig. 4 (a), this sealed seal can be used for co-infusion as shown in Figs. 4 (b) and (c). The space 12 is also kept aseptically. Therefore, the chemical solution container 21 can be stored with the sterilization mixed injection device 1 shown in FIG. 4 (a) attached to the stopper member 22. By preserving in this way, it is not necessary to attach a sterilization filter each time as described above when co-injection is desired, so that it can be used more easily for aseptic co-infusion.

Further, as shown in FIG. 1 and FIG. Preferably, a flange 39 is formed at one end 4 of the housing 4 in the axial direction so as to protrude radially outward. By further providing such a flange 39, the hermetic seal 38 can be easily fixed. FIG. 5 is a simplified view of another preferred example of the disinfection co-infusion device 41 of the present invention. The sterilization mixed injection device 41 shown in FIG. 5 has a filter fixing member having a concave portion along the axial direction A and a convex portion along the axial direction A protruding from the housing toward the internal space 12. Are the same as those of the sterilization and co-infusion device 1 shown in FIGS. 1 to 3, and the same members are denoted by the same reference numerals as in FIGS. The convex portion is a member formed to protrude from the housing toward the internal space and extending along the axial direction A, and is formed so that the cross-sectional shapes perpendicular to the axial direction A are substantially the same. You. The concave portion formed in the filter fixing member has a shape that fits with the above-mentioned convex portion, and has the same cross-sectional shape perpendicular to the axial direction as the じ -shaped portion. It is formed. The shape of the convex portion and the concave portion is not particularly limited as long as they can be fitted to each other. For example, a wedge-shaped cross-section 43 such as a bowling 42 in FIG. The convex portion 43 such as the filter fixing member 44 in FIG. 7B may be realized by a concave portion 45 that can be fitted. Also, as shown in the housing 46 in FIG. Even if it is realized by a flat plate-shaped convex portion 47 and a concave portion 49 such as the filter fixing member 48 in FIG. 7B that can be fitted with the convex portion 47. Good.

As described above, the concave portion of the filter fixing member and the fi-shaped portion of the housing are formed so as to be fitted to each other, so that during the co-injection operation described above, the concave portion becomes the injection member 2 and the injection needle member 3. Acts as a guide groove for reciprocating motion. Therefore, when the injection member 2 is pressed to the other side in the axial direction A with the syringe, an undesired angle around the axis of the injection member 2 and the injection needle member 3 is obtained. Displacement can be prevented.

FIG. 8 is a 'simplified' view showing another preferred example of a disinfecting co-infusion device 51 of the present invention. The sterilization mixed injection device of the present invention is preferably configured such that the injection member 52 and the injection needle member 53 are reciprocally movable substantially along the axial direction A as described above. It is not limited to the embodiment described above. The sterilization mixed injection device 51 shown in FIG. 8 basically includes an injection member 52, an injection needle member 53, and a housing 54. In this embodiment, the filter fixing member 5 is realized as a fixing member fixed to the housing 54. Among them, the injection member 52 and the injection needle member 53 are the same as the injection member 2 and the normal needle member 3 shown in FIG.

The housing 54 in the example shown in FIG. 8 has a telescopic part 56 on the other end side in the axial direction A than the filter fixing member 55. The extendable portion 56 is not particularly limited as long as it is a structure that can be extended and contracted substantially along the axial direction A, but is preferably realized by a bellows structure as shown in FIG. Even if realized with such a structure, the same effect as that of the disinfecting co-infusion device 1 of the above embodiment can be obtained.

The injection part, the material, the housing, the filter fixing member, and the locking member in the sterilization co-infusion device of each of the above-described embodiments are each formed of a resin material, and can be suitably formed by a conventionally known molding method. By assembling the members thus formed in accordance with each aspect, it is possible to suitably manufacture the sterilization mixed injection device of the present invention. Further, in the present invention, the housing may be realized so as to house all of the injection member and the injection needle member.

FIG. 9 is a simplified view of the plug 61 using the sterile co-infusion device 1 of the present invention shown in FIGS. 1 to 3. The stopper 61 is basically composed of the disinfecting and mixing device 1 of the present invention, and the stopper member 62 to which the disinfecting and mixing device 1 is attached. FIG. 9 shows a virtual plane including the central axes of the injection member 2 and the injection needle member 3. FIG. 4 is a simplified cross-sectional view of a plane.

The plug member 62 is generally widely used in the medical field, and includes a substantially cylindrical peripheral wall 63 and a substantially columnar rubber plug 64 fitted into the peripheral wall 63. Basically have. The peripheral wall 63 is not particularly limited as long as it has a substantially cylindrical shape into which a rubber stopper 64 can be fitted, and may be a rectangular tube shape. It is preferable that the shape and size are appropriately selected so that 4 can be fitted on the outer side of the peripheral wall 63.

The material for forming the peripheral wall 63 is not particularly limited, and examples thereof include resin materials such as polyethylene, polypropylene, polyvinyl chloride copolymer, ethylene monoacetate vinyl copolymer, polyester, polyamide, and polyurethane. . As will be described later, when the medical solution container with a stopper of the present invention is realized by welding to the housing 4 of the sterilization co-infusion device 1 and the injection portion of the drug solution container, the material of the co-infusion device and the drug solution container is required. It can be appropriately selected depending on the situation. The material for forming the rubber stopper 64 is not particularly limited, and examples thereof include synthetic rubbers such as butyl rubber, chlorinated butyl rubber, butadiene rubber, and rubber mixtures thereof.

The body 61 of the present invention is sterilized and mixed in such a manner that the one end 62 a of the stopper member 62 in the axial direction is positioned such that the end 10 of the injection needle member 3 is on the side of the stopper member 62. Tool 1 is installed. The housing 4 and the peripheral wall 63 may be simply fitted together.However, as described above, the housing 4 and the peripheral wall 63 are fused with each other due to heat generated by heating, ultrasonic induction or high frequency induction. It is preferable to wear it.

The peripheral wall 63 of the plug member 6.2 of the present invention preferably has a flange 65 formed radially outward at the other end in the axial direction, as shown in FIG. The flange 65 may be formed integrally with the peripheral wall 63, or may be provided separately from the peripheral wall 63. It is preferably formed of a material that can be welded to the jing 4. By forming the flange 65 with such a material, it is possible to seal the chemical solution container by welding the injection portion of the chemical solution ^^ and the flange 65 to each other as described later. .

FIG. 10 is a simplified view of a stoppered chemical solution container 71 of the present invention. The chemical container 71 with a stopper is basically composed of the stopper 61 described above and a chemical container 72 to which the stopper 1 is attached. FIG. 10 is a simplified cross-sectional view of a virtual plane including the respective central axes of the injection section cow 2 and the injection needle member 3.

The chemical solution container 72 used in the present invention is not limited to 牿 as long as it can be used for medical purposes, but the shape is limited to a multi-package container (double bag) as shown in FIG. Is done. The chemical solution container 72 basically includes a chemical solution storage portion 73 having an internal space 74 for storing a chemical solution, and an injection portion 75 having a communication passage 76 communicating with the internal space 74. Prepare for. In addition, the chemical solution container 72 has a discharge portion 7 for discharging the chemical solution stored in the chemical solution storage portion 73, on the opposite side of the chemical solution storage portion 73 from the side where the injection portion 75 is not formed. 7 in addition.

The chemical solution storage part 73 is a heat-sealed partition that can be peeled off.Two private chambers, the first chamber 73, the injection part 75 side and the discharge part side described later : Isolated in a and second room 73 b. The first chamber 73a and the second chamber 73 contain respective chemicals as described later.

The injection part 75 has a joint part 79 at the end thereof, which is substantially and densely joined to the flange 65 of the member 62 of the plug body 61. The joining portion 79 is a plate-like portion having a hole having the same diameter as that of the communication passage 7 ^: 6, and is, for example ,: polyethylene, polypropylene, polyvinyl chloride, ethylene monoacetate copolymer. It is realized by resin materials such as polyester, polyamide, and polyurethane. Generated by heating, ultrasonic induction or high frequency induction. When the joining portion 79 is to be welded to the flange 65 of the member 62, the material is appropriately selected according to the material of the flange 65.

In this way, the plug 61 is joined to the joining portion 79 of the injection portion 75 of the chemical solution container 72 with the flange 65. The joining is realized such that the inner space 74 of the chemical solution storage portion 73 is maintained substantially liquid-tight with the outer space 80 of the chemical solution container 72. As described above, the stopper 61 of the present invention serves to seal the injection portion 75 of the drug solution container 72 containing the drug solution.

The material for forming the chemical solution container 73 is not particularly limited as long as it is generally used as an infusion container. For example, polyethylene, polypropylene, polyvinyl chloride, ethylene monoacetate copolymer, etc. Examples include resin materials such as coalescing, polyester, polyamide, and polyurethane. Such a chemical solution storage portion 73 may be formed in a shape-retaining property (a box shape using the above-described material) or may be formed in a bag-like shape using a film of the above-described material.

The plug in such a chemical solution container with a plug 71 of the present invention is not limited to the one equipped with the above-described plug 61 of the present invention as long as it has a sterilizing filter. That is, the stopper using the disinfecting mixed injection device 1 of the present invention described above is merely a suitable example, and the scope of the present invention is not limited as long as the stopper is provided integrally with the stopper member of the drug solution container and the disinfecting filter. include. '' Such a drug solution container with a stopper keeps the solution as it is when not co-injected and when the drug solution is administered, and when it is desired to co-inject it, aseptic co-injection operation is easier and more reliable than before. This realizes a chemical solution container that can perform

As the drug solution stored in the drug solution storage portion 73 of the drug solution container with a stopper 71 of the present invention, an infusion solution containing a fat emulsion, sugar, amino acid and an electrolytic solution is used. A fat emulsion is also called an oil-in-water emulsion (oZw emulsion). It basically consists of fat, an emulsifier and an appropriate amount of water. Fats include vegetable oils (eg, Soybean oil, sesame oil, cottonseed oil, olive oil, etc.), fish oil, medium-chain triglycerides

(So-called: MCT). Examples of the emulsifier include phospholipids, and W ion type surfactants. The phospholipids can be natural products (egg yolk: phospholipids, soybean phospholipids, and their purified products) or synthetic products (such as phosphatidylcholine). The composition, fat 0. l wZ V% ~ 3 0 w / v%, preferably from ^{_{1 ν 0/0 ~ 2 0}} w Bruno v%, emulsifier 0. 0 1 V% ~ 1 0 wZ V o / ₀ , preferably 0: l wZv. / _{0 to} 5 w / v%, or 1 to 50 parts by weight per 100 parts by weight of fat, and an appropriate amount of water. The infusion of the present invention comprises an effective amount of sugar for nutritional supplementation. As the sugar, for example, reducing sugars such as glucose, fructose, and xylitol are preferable. The amount of sugar sugar _{5 v ° / 0 ~6 0 w} / v%% preferably 1 0 w / v% ~6 0 w / v%, more preferably 2 0 w / v% ~5 0 w / v% is shown. A specific example of such an infusion is disclosed in Japanese Unexamined Patent Publication No. 5-9-1112, which is an infusion prepared by blending a high-concentration sugar disclosed in Japanese Unexamined Patent Publication No. Hei 5-31025. Infusion containing a fat emulsion having an average particle diameter of 0.17 m or less, and infusion using a buffer solution such as L-histidine or tris disclosed in JP-A-5-65020. Is mentioned.

The infusion of the present invention comprises an amino acid and an electrolyte. Specific examples of such infusions include the formulation before mixing disclosed in JP-A-5-31151 / the formulation after mixing disclosed in JP-A-5-32540, An infusion for peripheral intravenous administration disclosed in Japanese Patent Application Laid-Open No. Hei 6-312293 is exemplified.

Hereinafter, a method for preparing an infusion solution containing the above-mentioned fat emulsion, sugar, amino acid and electrolyte using the drug solution container 72 of the double bag shown in FIG. 10 will be described.

In FIG. 10, the first chamber 73 a on the injection part 75 side contains a fat emulsion and sugar. The second infusion 82 containing amino acid and an electrolyte is accommodated in the second chamber 73 b on the discharge section 77 side. Each of these infusions is used, for example, in Japanese Patent Application Laid-Open No. Hei 5-3-1151, Japanese Patent Application Laid-open No. Hei 5-32540, Japanese Patent Application Laid-Open No. Heisei 5-9-111, JP-A-5-62520, JP-A-5-310825, and then heat-sterilized. Then, at the time of use, the partition strip 78 is peeled off, the first chamber 73a and the second chamber 73b are communicated with each other, and the liquid is mixed to prepare an infusion.

The first infusion 81 containing the fat emulsion and the sugar is, specifically, oil and fat 0, lw /% to 30 w / V%, emulsifier 0.01 wZ V% to 10 V ヅ. And the sugar contains 5 wZV ° to 60 wZV%. The fat emulsion preferably has an average particle size of 0.17 μm or less, and the sugar is preferably a reducing sugar. The first infusion 81 preferably contains L-histidine or tris (hydroxymethyl) aminomethane as a reducing agent. The second infusion 82 containing an amino acid and an electrolyte has a total amino acid content of 1 w / v% to 15 w / v%, and sodium SO mE q ZL to an electrolyte. l SO mE q ZL potassium 40 mE.q ZL ~ l 35 mE q / L, calcium 10 m E q ZL ~ 50 m E q / L, magnesium S mE q Z 30 mE q L, chlorine 0 mE qZL~ 2 2 5 mE q / / L, phosphorus 3 m E q / L~ 4 0 mE q Bruno L and zinc O / mol ZL~: containing LOO / zmol ZL. Of these, phosphorus is formulated as a polyhydric alcohol or sugar phosphate ester, or a salt thereof. These ring liquids 81 and 82 are prepared to have a pH of 5.0 to 8.0 using an organic acid, specifically, citric acid, and contain thioglycerol or dithiothreitol as a coloring inhibitor.

Mixed infusions by peeling the partition strip portion 7 8 formed by mixing both infusions 8 1, 8 2, containing the following ingredients: fat _{5 g / L~ 5 0 g /} / L, emulsifiers 0. 5 gZ L to l 0 gZL, sugar 50 g / L to 250 gZL, L-isoloisin 0.5 gZL to 5 g / L, L-leucine 0.5 g / L to 7 g / L, L-variin 0.S

S gZL L—Lysine 0. S gZL T g L,: L—Methionine 0.1 g gZL to 4 gZL, L—Felualan 0.3 gZL to 5 gZL, L-Threonine 0.3 gZL to 5 gZL L-tryptophan 0.1 g / L to 1 g / L,: L-arginine 3 g / L to 7 gZL, L-histidine 0.2 g / L to 3 gZL, glycine 0.2 g / L to 3 g / L, L-alanine 0.3 gZL to 5 gZL, L-proline, 2 gZL to 5 g L, L-aspartic acid 0.0 3 gZ: L to 2 gZL, L-serine 0. 2 gZL to 3 g / L, L-tyrosine 0. 3 gZL to 0.5 g / L. L-glutamic acid 0.03 g / "L to 2 gZL, L-cystine 0. OS gZL l gZL sodium 1 5 111 £ (1 ~ 60 111 £ «1 ZL, potassium 10 mE qZL ~ 50niE qZL, calcium 3 mE q / L ~ l S inE qZl ^ Magnesium 2 mE qZL ~; L 0mE q / L, Chlorine 0 mE qZL S OmE q / L, V ^ lniEti / L ~ 15 mE qL, zinc 0 / zmol ZL ~ 30 / z mol Z: L.

In the present invention, the infusion stored in the drug solution storage section 73 may further contain vitamins in addition to fatty milk, sugar, amino acids, and electrolytes. Infusions further containing such vitamins include, for example, those disclosed in JP-A-6-209799-JP-A-8709.

In the infusion solution of such an embodiment, the drug solution (other drug) to be co-injected into the infusion solution using the stoppered drug solution container 71 of the present invention includes, for example, vitamins, hypnotics, sedatives, analgesics, vasopressors, Cardiotonic agents, liver activators, antibiotics, anticancer agents, and the like.

The chemical solution container 71 with a stopper according to the present invention can be manufactured according to a known method. First, the chemical solution is introduced into the chemical solution container 72 through the injection section 75, and the chemical solution is After being housed in the housing part 73, the injection part 75 is sealed using the plug 61 as described above. At this time, it is preferable to replace the internal space 74 of the chemical solution container 73 with an inert gas such as nitrogen gas.

The method of heat sterilization of the drug solution container 72 containing the drug solution is not particularly limited, and may be performed by a conventionally known method such as high-pressure steam sterilization, hot water spray sterilization, hot water immersion sterilization, and hot water shower sterilization. it can. At the time of this heat sterilization, for example, as disclosed in Japanese Patent Application Laid-open No. Hei 6-2612992, the ripening and germ-removing bacteria treatment tank 內 is pressurized with air, and the pressure of the saturated steam at the sterilization temperature is reduced to 0%. ^{. 4 kg Z cm 2 ~ 0.} 9 kg Roh cm ^2, preferably heat sterilized under ^{0. 5 kg / cm 2 ~ 0.} 8 kgcm 2 high pressure. The heating sterilization temperature can be appropriately set depending on the sterilization method to be used, but is generally from 100 ^ to 130 * C, usually from 110 to 125 ^. Also, the sterilization time is appropriately adjusted according to the sterilization temperature and the like.

The chemical solution container containing the heat-sterilized chemical solution is made of an oxygen-impermeable plastic material together with an oxygen scavenger, such as Ageless (Mitsubishi Gas Chemical), to prevent deterioration during storage. It may be a double package sealed in a bag. The outer bag may be packed by filling it with an inert gas such as nitrogen gas, or may be vacuum packed.

Further, the disinfecting co-injection device of the present invention is preferably realized so that the injection member and the injection needle member reciprocate substantially along the axial direction, but may not necessarily be reciprocable. The injection needle member and the housing may be integrally formed, and may be realized so as to penetrate the rubber stopper when attached to the stopper member.

Example

EXAMPLES Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited thereto.

Example 1 Preparation of sterilization mixed injection device According to the above-described production method, the sterilization mixed injection device of the present invention having the embodiment shown in FIG. 5 was produced. The Οΰ-shaped portion of the filter fixing member and the convex portion of the hang fitted to each other were realized in the shapes shown in FIG. 6, respectively. The conditions of each member are as follows.

Injection material (My Lettuce GV (Millipore))

Inner diameter: 4 μτη

Outer diameter: 6.6 μm

Pore size of sterilization filter: 0.22 m

Axial length (L 1): 21 mm

Material: polypropylene

Injection needle member

Gauge size: 20 G

Axial length (L 2): 10 mm

Material: Polypropylene

Housing

Outer diameter of cylindrical part: 21 mm

Diameter of cylindrical part: 18 mm

Axial length (L 3): 45 mm

Material: polyethylene

Filter fixing member

Outer diameter: 15 mm

■ Thickness: 4, 5 mm

Distance to outlet (L4): 20 mm

Material: polypropylene

Locking member

Distance between locking members (L5): 35 mm

Distance to the end of the housing (L6): 10 mm Example 2

The sterilization mixed injection device of the present invention prepared in Example 1 was attached to a stopper member, and the housing of the stopper and the peripheral wall of the stopper member were heated at 100 Hz by high-frequency induction. This produced the plug of the present invention. As the stopper member, a member having a rubber wall made of chlorinated butyl rubber and a wall formed so as to cover with a resin made of polyethylene was used.

Example 3

(1) Preparation of infusion solution containing fat emulsion and sugar

Add 66 g of soybean oil, 9.5 g of egg yolk phospholipid and 500 g of pudose to water, coarsely emulsify with a homomixer, and then add water to make the total volume 100,000 ml, and coarsely emulsify. A liquid was obtained. The resulting coarse emulsion was emulsified with a Menton-Gaulin mixer and a modifier (manufactured by Gorin Co., Ltd., type 15M-8TA) until the average particle size became 0.17 m or less to obtain an emulsion. . Water was added to 500 mL of the obtained emulsion to make the total volume 100 mL. The composition of the obtained infusion is shown in Table 1.

^ 1

(2) Preparation of infusion solution containing amino acids and electrolytes

The amino acids and electrolytes shown in Tables 2 and 3 are added to each of the waters for injection heated to about 80 ° C. in a nitrogen stream to each concentration under a nitrogen stream, and dissolved. The pH was adjusted to 6.2. Table 2

(3) Sterilization and preparation of infusion

As the chemical liquid container, a chemical liquid container (made of polyethylene) having a shape as shown in FIG. 10 was used. Of the drug solution storage sections partitioned by the peelable partition band: Into the chamber, 66 O mL of the infusion solution containing the fat emulsion and the sugar obtained in the above (1) was injected from the injection portion while being filled with nitrogen gas. After injection, the injection ^ and the拴体of the present invention prepared in Example 3, sealing the infusion join the club by thermally熔着by by that heating to a high frequency induction in 1 0 OH _Z. In addition, nitrogen gas was injected into the second chamber of the drug solution storage unit from the discharge unit, with 34 OmL of the infusion solution containing the amino acid and the electrolyte obtained in (2) above. After the injection, the discharge part and the ordinary plug member were heat-sealed under the same conditions as above to seal the discharge part. The high-pressure steam sterilization (110, 30 minutes) of the stoppered chemical solution container of the present invention containing each infusion solution as described above was performed, and then cooled to room temperature. The partition strip was peeled off, and the infusions contained in the first and second chambers were mixed sufficiently to obtain an infusion containing a fat emulsion. The composition of the infusion is shown in Table 4. In this manner, a medical solution container with a plug according to the present invention was obtained.

Table 4

Example 4

A vitamin preparation was co-injected into a medicinal solution container with a stopper containing an infusion solution containing the fat emulsion prepared in Example 3. The vitamin preparation was injected into the syringe cylinder 、, and the luer at the tip of the syringe was inserted into the injection port of the injection member. By pressing the syringe, the injection member and the injection needle member moved substantially in the axial direction to the other side in the axial direction, and the distal end portion of the injection needle member penetrated the rubber stopper of the stopper member. Push the piston in and aseptically remove the vitamin Injected into.

Example 5

A sterilization mixed injection device of the present invention in which the housing shown in FIG. : The expansion and contraction part was realized with a bellows structure.

Example 6

A stopper of the present invention was produced in the same manner as in Example 2 except that the sterilization mixed injection device produced in Example 5 was used.

Example 7

A medical solution container with a stopper according to the present invention was produced in the same manner as in Example 3, except that the sterilization mixed injection device produced in Example 5 was used.

Example 8

In the same manner as in Example 4, a vitamin preparation was aseptically injected into the medicinal solution container with a stopper prepared in Example 7.

Industrial applicability

As described above, in the present invention, by using a specific drug solution container with a stopper having a sterilization filter, it is possible to perform a co-infusion operation of another drug while ensuring sterility. In other words, the conventional method, the operation of co-injecting other agents in a clean bench, the operation of attaching a disinfection filter each time and co-injecting other agents, and the use of a medicinal solution prepared at the time of patient administration to the disinfection filter Is not necessary, and operation in a clinical setting is simplified, while safety for patients can be sufficiently ensured. In addition, the present invention uses an infusion solution containing a fat emulsion, which is extremely useful when co-injecting other drugs. This application is based on a patent application No. 2000-165630 filed in Japan, the contents of which are incorporated in full herein.

Claims

The scope of the claims

1. A drug solution storage section having an internal space for storing a drug solution, a drug solution container having an injection section having a communication passage communicating with the internal space, and a sterilization filter attached to the injection section of the drug solution container. A chemical liquid container with a stopper, comprising a stopper and a stopper.

The chemical solution container is separated into two private rooms by a partition strip which is heat-fused in a detachable state, and the individual chemical chambers are respectively filled with a chemical solution. It has a structure in which both compartments are connected to each other to mix both medicinal solutions, and one compartment contains a transfusion containing sugar and fat emulsion as a medicinal solution, and the other compartment contains an infusion containing amino acids and electrolytes. A chemical solution container with a stopper that is housed.

2. The plug includes a plug member having a substantially cylindrical peripheral wall and a substantially columnar rubber plug fitted into the peripheral wall,

A disinfecting co-injection device having an injection needle member is mounted on one end side of the stopper member in the axial direction such that the tip of the injection needle member is located on the member side. 2. The medicinal solution container with a stopper according to claim 1.

3. The sterilizing co-injection device has a flow path extending from an inlet at one axial end to an outlet at the other axial end, and an input material having a sterilizing filter in the middle of the flow path;

An injection needle member attached to an outlet of the injection member such that its axis substantially coincides with the axis of the injection member;

3. The medicinal solution container with a stopper according to claim 2, further comprising a substantially cylindrical housing that accommodates a part or all of the injection member and the injection needle member in an internal space thereof.

4. The drug solution container with a stopper according to claim 3, wherein the injection member and the injection needle member are equipped with a disinfecting co-injection device that is self-reciprocatingly moved substantially along the axial direction thereof.

5. Projecting members projecting from the side wall of the injection member toward the inner space of the housing. Projecting members projecting toward the inner space from the vicinity of both ends in the axial direction of the housing and engaging with the projecting members. 5. The medicinal solution container with a stopper according to claim 4, which is provided with a disinfecting mixture injection tool further comprising a stopper.

6. A fixing member for fixing the injection member to the housing is further provided. The fixing member of the housing is also provided with an upper / lower end. 5. The medicinal solution container with a stopper according to claim 4, which is provided with a disinfectant co-infusion device characterized by comprising: