JP2001212236A - Syringe/container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an improved double-room type syringe/container. SOLUTION: The double-room type syringe/container has bypasses running in the length direction of a syringe barrel on the internal wall surface nearly at the center of the barrel. A first sealing plug is fitted on the inner surface of the barrel at a position nearer to the opening of the barrel than the bypasses to form a first room between the top of the barrel and the first sealing plug. A second sealing plug is fitted on the inner surface of the barrel at a position nearer to the opening of the barrel than the first sealing plug to form a second room between the first sealing plug and the second sealing plug. The bypasses are one or plural recessed grooves on the inner wall surface of the barrel, and the outer shape of the barrel is cylindrical without unevenness on the surface. The barrel is made of a specific resin or resin mixture such as cyclic olefin or crosslinking polycyclic hydrocarbon resins. The syringe/container can be used sanitarily and stably in the manufacturing processes such as vacuum freeze-drying, or in the preservation of medicines, mixing of medicines, and dispensing medicines. Further, since there is no unnecessary unevenness on the outer surface, the syringe/container can be disposed closely, so that the equipment cost and the production cost can be reduced.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a syringe / container for administering a medicinal solution, a nutrient or the like to a human body. More specifically, the syringe is divided into two chambers, each of which stores a drug component and which is used for administration. Improving a syringe / container that can mix two chambers quickly and administer it extremely hygienically

[0002]

2. Description of the Related Art A syringe is filled with a drug solution, a nutrient and the like in advance, stored, and the container itself can be used as a syringe by a simple operation.
No. 79439, Japanese Utility Model Application Laid-Open No. 59-2343, Japanese Unexamined Patent Application Publication No.
No. 76390, JP-A-48-16489, JP-A-52
JP-A-149894, JP-A-59-120166, JP-A-60-501193, JP-A-61-502099
No., JP-A-1-502086, JP-B-62-2538
No. 9 is known.

Further, a conventional example of a syringe in which two kinds of medicines, for example, a medicine and a solvent or a medicine and a medicine, are stored in one syringe and container, and both can be mixed or dissolved for administration. As described in JP-A-51-11691,
Nos. 52-22391, 58-61755, and 58
-212453, 59-155264, 59-
No. 155264, No. 60-72561, No. 61-48
377, 62-5357, JP-A-2-5973
No. 3-82476, No. 4-96762, No. 49-14465, No. 54-22315, No. 2
The technology described in each gazette such as -58446 and 3-29145 is known.

FIGS. 15 and 16 show an example of a known two-chamber syringe / container. The syringe is divided into two chambers with the first sealing stopper 33 as a boundary, and the medicine held in the two chambers can be mixed at the time of use. That is, one end of the cylinder 29 becomes an opening 31 and a finger hanging flange 32 is provided at the end. The other tip 30 is elongated and the tip is sealed with a rubber stopper. A first sealing plug 33 and a second sealing plug 34 are fitted in the cylinder 29, and a first chamber 35 and a second chamber 36
In the example shown, the powder medicine 30 is placed in the first chamber 35,
The second chamber 36 holds distilled water. Also, one bypass portion 37 is provided substantially at the center end of the cylinder 29,
At the time of dissolving and mixing the medicine, the second sealing stopper 34 is moved to the distal end side by a push rod (not shown), and the first sealing stopper 33 is moved to the distal end side by a dashed line in the drawing via distilled water. By moving to the position of 37, the distilled water in the second chamber 36 flows into the first chamber 35 and is mixed with the powdered medicine 30 in the first chamber, thereby dissolving the medicine to become a medicinal solution that can be administered. EE 'in the bypass section
As shown in FIG. 16, the outer periphery of the cylinder and the inner wall of the cylinder have the same thickness and are designed to protrude outward at the bypass portion 37.

[0005]

All of the above-mentioned prior arts are mainly aimed at improving means for mixing two drugs in a syringe, and completely consider the problem of formulation of drugs in the same shape container. Absent. That is, in the case of the syringe / container in the form shown in FIGS. 15 and 16, the volume required as a space for storing the container in the preparation process or the like becomes very large, and the first sealing stopper after filling with the powdered drug is used. There was a problem that the workability of fitting and fitting of the second sealing plug after filling the second chamber with distilled water or the like was not good, and it was not particularly preferable in terms of hygiene. Therefore, the basic problem to be solved by the present invention is:
In each stage of drug formulation, drug preservation, drug mixing, and drug administration, the drug can be held and operated in a single container, and it is hygienic and stable in manufacturing, storage, and drug administration. Another object of the present invention is to improve the structure of a syringe / container that can be used. Other challenges include the production, storage, and storage of unstable drugs, especially antibiotics, enzymes, vitamins, serum, and vaccines.
There is an improvement in the structure of the syringe / container suitable for administration.

[0006]

As a means for solving the above-mentioned problems, the present invention is directed to a cylinder inner wall having a front end portion at one end and an opening portion at the other end, which is disposed substantially at the center of a cylinder inner wall surface. A running bypass is provided, and a first sealing plug is fitted to the inner surface of the cylinder at a position closer to the opening of the cylinder than the bypass to form a first chamber between the tip of the cylinder and the first sealing plug. In a two-chamber syringe / container in which a second sealing plug is fitted to the inner surface of the cylinder at a position closer to the cylinder opening than the first sealing plug to form a second chamber with the first sealing plug, the bypass is One or more concave grooves are provided on the inner wall surface of the cylinder, and the outer periphery of the cylinder is cylindrical without irregularities, and a cyclic olefin-based compound or a crosslinked polycyclic hydrocarbon-based compound is used as a polymer component. Resin containing resin, or resin containing olefinic compound as a polymer component, and Providing a syringe and container, characterized in that comprises a mixture of these resins and olefin resins and / or synthetic rubber. In order to seal the syringe / container of the present invention in the chamber immediately after drying or freeze-vacuum-drying the drug focused on the inside in the drug manufacturing process,
In addition, in order to be suitably used for preservation of medicine, mixing of medicine, and administration of medicine, the thickness of the first sealing stopper in the cylinder axis direction is shorter than the length of the first bypass. (1) that the surface of the sealing stopper and / or the second sealing stopper is laminated with a resin film, and that the inside of the tip of the cylinder has a circular bottom,
It is a particularly preferred embodiment of the present invention that the rubber stopper is sealed with a rubber stopper so as not to have irregularities, and the rubber stopper is formed in a shape that can be fixed by attaching a double-ended needle to the rubber stopper. If the wall thickness of the opening of the tube at the tube entrance is smaller than the wall thickness of the inside of the tube, it is easy to push the sealing plug.

[0007]

Operation and Embodiment The structure, operation mechanism and other features of the syringe / container of the present invention will be described in detail with reference to embodiments. FIG. 1 is a schematic cross-sectional view of an embodiment of the present invention, in which a bypass groove (running in the length direction of a cylinder) is formed in an inner surface of a syringe / container 1 at a position substantially at the center of a syringe tube (hereinafter, referred to as a tube) 2. A first sealing plug 8 having a length shorter than the length of the first bypass 11 is positioned closer to the cylinder opening 5 of the cylinder 2 than the first bypass 11, The first chamber 7 was formed between the sealing stopper 8 and the tip of the cylinder. The first
A second sealing plug 10 is fitted into the cylinder closer to the cylinder opening 5 than the sealing plug 8 to form a second chamber 9 between the first sealing plug 8 and the second sealing plug 10. A two-chamber tube and container were used. The first sealing plug 8 and the second sealing plug 10 are made of an elastic body having a plurality of annular projections on the outer periphery, and have three annular projections 19, 20, and 21 in the example shown in FIG. The diameter is designed to be slightly larger than the inner diameter of the cylinder, and when fitted in the cylinder, the interior is tightly contacted with the inner surface of the cylinder so that the interior of the room can be sealed and the inner surface of the upper cylinder can be moved. For this purpose, the surface of the first sealing plug 8 or the second sealing plug 10 can be laminated with a resin film. The second sealing plug 10 is provided with a spiral recess 12 in the direction of the opening of the cylinder, and the recess 12 is designed to fit into the spiral projection 13 at the tip of the push rod shown in FIG. The distal end 15 of the upper opening 5 of the cylinder 2 is tapered so that the inside diameter of the cylinder increases toward the opening to facilitate insertion of the first or second sealing plug into the cylinder. Designed to be.

FIGS. 3, 6, and 12 are schematic explanatory views of a reference example of the present invention. In these examples, a sectional view taken along the line BB 'of the second bypass 14 of the cylinder 2 is shown in FIGS. It is provided as shown in FIG. The number of the second bypass grooves is preferably 2 to 8, and the number of the first bypass 11 is preferably 1 to 4 as shown in the AA 'sectional view of FIG. As shown in the above figures, the present invention does not provide a convex shape on the outer surface of the injection cylinder, but forms a concave groove on the inner wall surface in the cylinder, and is formed of a specific resin or a resin mixture. It is characterized by points.

In the present invention, as shown in FIG. 3, an inverted U-shaped rubber plug 4 is mounted inside the distal end portion 3 of the cylinder 2 to seal it. The shape is such that there is no unevenness on the bottom.
A particularly preferable embodiment is designed so that the inner end of the double-ended needle 16 can penetrate the center of the inverted U-shaped rubber stopper 4 while the inner end of the double-ended needle 16 can be fixed. 6 and 7 also show a double-ended needle 16 and an inverted U
7 shows a reference example of the present invention in which a letter-shaped rubber stopper is attached.

The syringe / container of the present invention, as shown in FIG.
The first chamber 7 of the cylinder 2 is a chamber for a concentrated drug or a dry powder drug, and the second chamber 9 is filled with distilled water for injection or a rare drug solution.
The tube 2 is separated by the sealing stopper 8 and the cylinder 2 is sealed by the second sealing stopper 10 and the rubber stopper 4, and two kinds of medicines are stored. Since the opening or the double-ended needle can be wrapped in the cap 17 and sterilized with ethylene oxide gas, γ-ray, or the like, the present invention is a very sanitary syringe and container.

FIG. 3 shows a finger hanging flange 23 attached to the cylindrical opening. That is, the finger hooking recess is fitted into the opening and the outer circumferential recess 22 and fixed. The device is a device for placing a finger when administering an injection or moving a push rod. Since it is constituted separately from the cylinder and is not used in the preparation process (filling, freeze-drying), the outer shape of the cylinder can be kept in a simple cylindrical shape in these steps.

FIGS. 8 and 9 show a reference example of the present invention, which is a structure suitable for use in a drug formulation, that is, for concentrating a dilute drug solution, especially for a freeze-vacuum-dried formulation. Explain that there is. The distal end 3 of the cylinder 2 is sealed with a rubber stopper 4, and an appropriate amount of a thin chemical solution 25, which is a raw material of a medicine, is charged into the cylinder, and is unstable in a sterilized drying chamber (a vacuum can be created, and the air to be introduced can be sterilized). For the preparation of drugs that are easily affected by heat or oxygen, such as antibiotics, enzymes, and vitamins, the stock solution is frozen and vacuum-dried. The conditions are, for example, a room temperature of -10 to -60C. That is, it has a preferable shape for cooling using liquid nitrogen gas and concentrating and drying the drug under extremely severe conditions of a vacuum degree of 10 ^{-3 to} 10 Torr. As shown in FIG.
The opening is made closer, a large number of grooves such as 2 to 8 grooves are provided, and the area thereof is widened. In the bypass, a thick multi-annular first sealing plug is inserted. 14
The passage of the vapor 26 of the concentrate 25 during the drying of the liquor indicates the effect of the distillation column. If the second bypass is shorter than the first sealing plug, the cost of the apparatus can be reduced, and the vapor passage can be shortened, so that re-deposition can be prevented.

In the embodiment of the present invention, the length of the second bypass is shorter than the thickness of the first sealing plug, and is 1/3 to 1 times, preferably 1/2 to 1 times the thickness of the first sealing plug. It can also be. The cylinder 2 in FIG. 12 has a second bypass having a length of about の that of the second bypass in FIG. 8, but in the example of FIG.
6 can be evaporated through the bypass 14 as in the case of FIG. FIG. 13 is a sectional view taken along the line BB 'of FIG.
FIG. 14 shows an example in which the length of the second bypass is set to be slightly longer than about 1/3 of the thickness of the first sealing plug. ′ Direction and DD ′ direction in the axial direction of the cylinder. Although the second bypass is short, it is sufficiently fixed to the inner wall of the cylinder as shown in the figure, and the vapor during the concentration and drying of the medicine can be exhausted from the second bypass groove. In this example, since the exhaust passage is short, the manufacturing apparatus can be reduced in size, and exhaust and the like do not reprecipitate. However, 1/3 of the first sealing stopper
If the bypass is shorter, it is difficult to push the first sealing plug into the second bypass in the drying chamber or to stably hold the sealing plug on the inner wall of the cylinder during drying.

The reason why the syringe / container of the present invention is suitable for the above conditions is as follows. (1) The outer shape of the cylinder 2 is circular, and the first bypass and the second
Since the bypass is provided as a concave depression on the inner wall, the flow of the refrigerant, that is, liquid nitrogen, is good during processing in, for example, a freeze-drying chamber. The number of processing vessels per unit area is maximized,
A larger amount can be put into the drying chamber than a conventional bypass portion protruding outside the cylinder. In addition, economy such as equipment construction cost and manufacturing unit cost becomes advantageous. (2) The tip 3 of the cylinder 2 was made round bottom, and the recess of the injection needle was sealed with an inverted U-shaped rubber stopper, and the design was made as uneven as possible. In other words, the chemical solution present at the bottom of the tube tip can be dried quickly even if frozen. (3) When the concentrated medicine in the cylinder 2 is sufficiently concentrated and dried to be powdered, the first sealing plug 8 is operated by the push-in tool 28 in the drying chamber as shown in FIG. The dry powder can be hermetically sealed by inserting it into the central part and the upper part of the first bypass 11. With the above configuration, the drying room,
In particular, the injection can be sealed in the cylinder 2 with the first sealing stopper in the freeze vacuum drying / sterilization chamber. The conditions required for such a formulation process can be sufficiently satisfied.

Among many drugs, drug powders that are stable even in the air and can be sterilized by heat are stored in a mere sterilization chamber in a syringe having only the first bypass in the cylinder 2 of the present invention. In addition, the second chamber is a container that can be filled with a diluent or two drugs of distilled water. In the operation step shown in FIG. 9, the cylinder 2 in which the first chamber is sealed with the first sealing stopper 8 is taken out of the drying chamber, and the second chamber 9 of the cylinder 2 is placed in the sterilization chamber.
Is filled with a diluent or distilled water for injection (hereinafter abbreviated as distilled water), the second sealing stopper 10 is quickly stoppered, and the cap 17 is further attached to obtain a completed product.

In the present invention, the diameter of the stopper is designed to be 3 to 14% larger than the inner diameter of the cylinder in order to completely seal the medicine and distilled water in the two chambers in the cylinder with the first sealing stopper and the second sealing stopper. Is preferred. In addition, the opening end 15 of the cylinder 2 is tapered toward the opening and is made thinner, that is, the inner diameter is increased, so that the first sealing plug and the second sealing plug can be easily inserted into the cylinder 2.

Next, the method of administering the medicine stored in the syringe / container of the present invention will be specifically described. As shown in FIG. 10, when using the medicine filled in the syringe / container reference example of the present invention, the cap 17 of the opening 5 of the cylinder 2 is removed,
The finger hook 23 shown in FIG. 3 is inserted. Next, FIG.
When the push rod tip spiral portion 13 is inserted into the concave spiral 12 of the second sealing plug 10 of the cylinder 2 and the push rod is pressed into the distal end portion 3 of the cylinder 2, the first sealing plug 8 is turned into the first bypass 11. , The distilled water flows through the first bypass and enters the first chamber 7, where the concentrated or powdered drug and the distilled water are mixed to obtain a diluted and administrable liquid medicine. At this time, as shown in FIG. 11, the double-ended needle 16 is inserted into the rubber stopper 4 located at the cylinder tip portion 3, the air in the double-ended needle 16 is removed, and the push rod is pushed into the cylinder tip portion to administer the diluent drug solution. be able to. As described above, the syringe / container of the present invention is a syringe / container that can quickly and hygienically prepare a drug solution with a simple operation and immediately administer it.

As the material of the syringe used in the syringe and container of the present invention, a resin containing a resin containing a cyclic olefin compound or a crosslinked polycyclic hydrocarbon compound as a polymer component, or an olefin compound is used. Resin as a coalescing component,
A mixture obtained by further mixing an olefin resin and / or a synthetic rubber with such a resin is used. Further resins in the above materials, for example, polyethylene, polypropylene, polyethylene terephthalate, ethylene-vinyl alcohol, ethylene-vinyl copolymer, ethylene-vinyl acetate copolymer, nylon and amorphous nylon,
Ethylene propylene copolymer resin, polymethylpentene,
One or more layers of an ethylene-butyl copolymer or the like can be laminated.

Since the first sealing plug or the second sealing plug needs rubber elasticity, its material may be synthetic rubber, ie, isoprene, polybutadiene, ethylene propylene terpolymer, isoprene-isobutylene copolymer, thermoplastic elastomer, etc. The crosslinked product is also preferable in that it has heat resistance. Further, as the resin film for laminating a part of the sealing plug, a resin containing a fluorine-based resin, a cyclic olefin-based compound or a crosslinked polycyclic hydrocarbon-based compound as a polymer component, and a general-purpose olefin-based compound as a polymer component It is preferable that the resin is made of a resin.

[0020]

According to the present invention, the two-chamber syringe / container is (1)
By providing the bypass groove of the injection cylinder in the cylinder in two stages without forming a protrusion on the outer periphery of the cylinder, the drug substance solution is concentrated, dried, and powdered in the drug formulation chamber, and the chamber of the syringe / container is quickly opened. The container is hygienic and economical because it can be sealed. (2) The first bypass, the first sealing plug, and the tip of the cylinder are designed and combined in an optimal form so as to meet the purpose, so that the drug substance that is thin and easily decomposed by heat and air is also concentrated quickly. It is effective in being able to be formulated into a stable, high-quality drug. (3) The syringe / container of the present invention can store the held drug in high quality for a long time.

[Brief description of the drawings]

FIG. 1 is a schematic sectional view illustrating an embodiment of a syringe and a container according to the present invention.

FIG. 2 is an explanatory diagram of a push rod.

FIG. 3 is a schematic sectional view illustrating a reference example of a syringe and container according to the present invention.

FIG. 4 is a sectional view taken along line AA ′ of a first bypass portion in FIGS. 1 and 6;

FIG. 5 is a sectional view taken along line BB ′ of the second bypass portion in FIGS. 1 and 6;

FIG. 6 is a schematic cross-sectional view illustrating another reference example of a syringe and a container of the present invention.

FIG. 7 is a cross-sectional view of a double-ended needle attached to the syringe / container of the present invention shown in FIG.

FIG. 8 is a schematic explanatory view showing the condition of a preparation for concentrating a drug solution having a low concentration using a syringe and a container of the present invention.

FIG. 9 is a schematic explanatory view showing a state in which the first sealing plug is pushed into the cylinder following the step of FIG. 8;

FIG. 10 is a schematic explanatory view showing a state in which a push rod is pushed in to use a syringe and a container of the present invention, and a drug solution and a first sealing stopper are press-fitted and a drug solution flows into a first chamber through a bypass.

FIG. 11 is a schematic explanatory view showing a state in which a double-ended needle is inserted into the syringe / container of the present invention to administer a drug solution.

FIG. 12 is a schematic cross-sectional view illustrating another embodiment of the syringe / container according to the present invention, in which a second bypass having a length of about 1/2 of that in FIG. 8 is provided.

FIG. 13 is a sectional view taken along line BB 'of the second bypass portion in FIG.

FIG. 14 is an explanatory view showing a cross section and a partial cross section of another reference example of the syringe and container of the present invention, in which a short second bypass is provided.

FIG. 15 is a schematic explanatory view showing a bypass projecting to the outer periphery of an injection cylinder in a conventional dual-chamber syringe / container.

FIG. 16 shows E- of the conventional dual-chamber syringe / container of FIG.
It is E 'sectional drawing.

[Explanation of symbols]

1 syringe and container, 2 cylinders, 3 tip, 4 rubber stopper, 5 cylinder opening, 6 needle mounting tube, 7 first
Chamber, 8 first sealing stopper, 9 second chamber, 10 second sealing stopper, 11 first bypass, 12 concave spiral, 13
Convex spiral, 14 second bypass, 15 end of opening, 16 double-ended needle, 17 opening or tip cap, 18 rubber packing, 19 annular projection, 20
Annular projections, 21 annular projections, 22 depressions around the opening, 23 finger flanges, 24 frame-type fixtures,
25 thin liquid medicine of source, 26 vapor, 27 concentrated medicine (powder medicine), 28 push rod (in-cylinder insertion tool of the first sealing stopper in the drying chamber), 29 syringe barrel, 30 tip of cylinder, 3
1 cylinder opening, 32 flange, 33 first sealing plug,
34 second sealing stopper, 35 first chamber, 36 second chamber, 37 bypass.

Claims (4)

[Claims] 1. A bypass running in the length direction of a cylinder is provided on an inner wall surface of the cylinder at a position substantially at the center of the cylinder having an end at one end and an opening at the other end. At a position closer to the inner surface of the cylinder, a first chamber is formed between the distal end of the cylinder and the first sealing plug, and the second sealing plug is located at a position closer to the cylinder opening than the first sealing plug. In a two-chamber syringe / container fitted to the inner surface to form a second chamber between the first sealing stopper and the first sealing stopper, the bypass has a concave groove shape on the inner wall surface of the cylinder.
A resin or a resin containing a resin having a polymer component of a cyclic olefin-based compound or a crosslinked polycyclic hydrocarbon-based compound, or a olefin-based compound. And a mixture of these resins with an olefin resin and / or a synthetic rubber. 2. The syringe and container according to claim 1, wherein the thickness of the first sealing plug in the cylinder axis direction is shorter than the length of the first bypass. 3. The syringe and container according to claim 1, wherein the surface of the first sealing stopper and / or the second sealing stopper is laminated with a resin film. 4. The cylinder according to claim 1, wherein the inside of the tip of the cylinder has a circular bottom and is sealed with a rubber stopper so as not to have irregularities, and a double-ended needle is attached to the rubber stopper and fixed. 4. The syringe and container according to any one of 1 to 3.