JP3471318B2 - Syringe and container - Google Patents

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 liquid medicine, a nutritional supplement, etc. to a human body. More specifically, the interior of the syringe is divided into two chambers to store the drug components in each chamber, and to administer the drug during administration. Improvement of syringe and container that can mix medicines in two chambers quickly and administer extremely hygiene

[0002]

2. Description of the Related Art A syringe can be filled with a drug solution, a nutrient, or the like in advance and stored, and the container itself can be a syringe by a simple operation.
No. 79539, No. 59-2343, U.S. Pat.
76390, JP-A-48-16489, JP-A-52.
No. 149894, JP-A-59-120166, JP-A-60-501193, and JP-A-61-502099.
No. 1, Japanese Unexamined Patent Publication No. 1-502086, Japanese Patent Publication No. 62-2538.
No. 9 publication is known.

Further, a conventional example of a syringe in which two kinds of medicines, for example, medicines and solvents or medicinal solutions and medicinal solutions, are stored in a single injector / container and the two can be mixed or dissolved to be administered at the time of administration For example, JP-A-51-11169,
No. 52-22391, No. 58-61755, No. 58
-212453, 59-155264, 59-
155264, 60-72561, 61-48.
No. 377, No. 62-5357, JP-A-2-5973.
No. 3, No. 3-82476, No. 4-96762, No. 49-14465, No. 54-22315, No. 2
The techniques described in each publication such as -58446 and 3-29145 are known.

15 and 16 show an example of a known dual-chamber syringe / container. The syringe is divided into two chambers with the first sealing plug 33 as a boundary, and the medicines held in the two chambers can be mixed at the time of use. That is, one end of the tube 29 becomes an opening 31, and a finger-holding flange 32 is provided at the end thereof. 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 are fitted inside the cylinder.
In the illustrated example, the powder medicine 30 is divided into
Distilled water is held in the second chamber 36. Further, one bypass portion 37 is provided from the substantially central tip of the cylinder 29,
When the drug is dissolved / mixed, the second sealing plug 34 is moved to the tip side by a push rod (not shown), and the first sealing plug 33 is bypassed through distilled water to the tip side bypass portion shown by a chain line in the figure. 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 drug 30 in the first chamber to become a drug solution which can dissolve and administer the drug. By-pass EE '
As shown in FIG. 16, the cross section is designed such that the outer circumference of the cylinder and the inner wall of the cylinder have the same thickness and protrude outward in the bypass portion 37.

[0005]

All of the above-mentioned prior arts are mainly aimed at improving the mixing means of two kinds of drugs in a syringe, and completely consider the problem of formulation of drugs in the same shape container. Absent. That is, in the syringe / container having the configuration as shown in FIGS. 15 and 16, the volume required as a space for storing the container in the formulation process and the like becomes very large, and the first sealed stopper after filling the powder drug is used. There is 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 is not good and is not particularly hygienic. Therefore, the basic problem to be solved by the present invention is
The drug can be held and operated in one container at each stage of drug formulation, drug storage, drug mixing, and drug administration, and it is hygienic and stable during manufacturing, storage, and drug administration. There is an improvement in the structure of the syringe / container that can be used as a container. Another issue is the production and storage of unstable drugs such as antibiotics, enzymes, vitamins, serum, and vaccines.
There is an improvement in the structure of the syringe / container suitable for administration.

[0006]

As means for solving the above problems, the present invention is directed to a cylinder inner wall surface at a substantially central position of a cylinder having a tip portion at one end and an opening portion at the other end in a cylinder length direction. A bypass that runs is provided, and the first sealing plug is fitted to the inner surface of the cylinder at a position closer to the cylinder opening than the bypass to form a first chamber between the cylinder tip and the first sealing plug. In the two-chamber syringe / container in which the second sealing plug is fitted to the inner surface of the cylinder at a position closer to the opening of the cylinder than the first sealing plug to form the second chamber between the first sealing plug and the second chamber, One or a plurality of concave grooves are provided on the inner wall surface of the cylinder, and the outer circumference of the cylinder is a cylindrical shape without irregularities. The thickness of the first sealing plug in the cylinder axis direction.
Is shorter than the length of the first bypass and contains a resin containing a cyclic olefin compound or a crosslinked polycyclic hydrocarbon compound as a polymer component, or a resin containing an olefin compound as a polymer component And a mixture of these resins with an olefin resin and / or a synthetic rubber, and a syringe / container. In the manufacturing process of the drug, the syringe / container of the present invention is used for the purpose of preserving the drug, mixing the drug, and further preserving the drug in order to quickly seal the drug in the room after drying or freeze-vacuum drying the drug focused on the inside. The first sealing plug and / or the second sealing plug surface is laminated with a resin film so that it can be suitably used for administration of A particularly preferable embodiment of the present invention is that the rubber plug is sealed and the double-ended needle is attached to the rubber plug so that the rubber plug can be fixed. Also,
If the wall thickness of the cylinder inlet portion of the opening of the cylinder is smaller than the wall thickness inside the cylinder, the sealing plug can be easily pushed.

[0007]

Actions and Examples The structure, action mechanism and other features of the syringe / container of the present invention will be described in detail with reference to examples. FIG. 1 is a schematic cross-sectional view of one embodiment of the present invention, in which a bypass groove running in the cylinder length direction is formed on the inner surface of the injection cylinder (hereinafter, referred to as a cylinder) 2 of a syringe / container 1 from a substantially central end thereof. Hereinafter, the first bypass 11 is provided, and the first sealing plug 8 having a length shorter than the length of the first bypass 11 is located closer to the tube opening 5 of the tube 2 than the first bypass 11 is. The first chamber 7 was formed between the sealing plug 8 and the tip of the cylinder. The first
A second sealing plug 10 is fitted into the cylinder at a position 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 cylinder and a container consisting of two chambers were used. The first sealing plug 8 and the second sealing plug 10 are made of an elastic body having a plurality of annular protrusions on the outer circumference, and in the illustrated example, have three annular protrusions 19, 20 and 21. The diameter is designed to be slightly larger than the inner diameter of the cylinder, and when fitted inside the cylinder, it is in close contact with the inner surface of the cylinder to seal the inside of the chamber, and the inner surface of the cylinder can be moved. For this purpose, the surface of the first sealing plug 8 or the second sealing plug 10 may be laminated with a resin film. Further, 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 end 15 of the upper opening 5 of the tube 2 is formed by tapering the cylindrical wall so that the inside diameter of the tube increases toward the opening, facilitating insertion of the first sealing plug or the second sealing plug into the tube. Designed to

FIGS. 3, 6, and 12 are schematic explanatory views of reference examples of the present invention. In these examples, a sectional view of the second bypass 14 of the cylinder 2 taken along the line BB 'is shown in FIG. 5 or FIG. 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 sectional view taken along the line AA 'of FIG. As shown in the above figures, the present invention is formed by forming a concave groove on the inner wall surface of the injection cylinder without forming a convex shape on the outer surface of the injection cylinder, and by forming a specific resin or resin mixture. It is characterized by points.

In the present invention, as shown in FIG. 3, an inverted U-shaped rubber stopper 4 is mounted inside the tip portion 3 of the cylinder 2 for sealing, and the rubber stopper 4 is inside the tip portion 3 of the cylinder 2. It has a shape that does not have unevenness on the bottom, and double-ended needle 1 together with needle mounting tube 6.
A particularly preferable embodiment is one in which 6 is attached to the tip so as to be fixed, and the inner needle tip of the double-ended needle 16 is designed to penetrate through the center of the inverted U-shaped rubber stopper 4. 6 and 7, the double-ended needle 16 and the inverted U
The reference example of this invention which attached the V-shaped rubber stopper is shown.

The syringe / container of the present invention is as shown in FIG.
The first chamber 7 of the tube 2 is used as a concentrated drug or dry powder drug chamber, and the second chamber 9 is filled with distilled water for injection or a rare drug solution.
Separated with a sealing plug 8, the second sealing plug 10 and a rubber plug 4 seal the tube 2 to store two kinds of drugs. Since the opening or the double-ended needle can be wrapped with the cap 17 and sterilized with ethylene oxide gas, γ rays, etc., the present invention is a very hygienic syringe / container.

FIG. 3 shows the finger hooking flange 23 attached to the cylindrical opening. That is, the finger hook concave portion is fitted and fixed to the opening and the outer peripheral concave portion 22. The device is a device to put a finger on when administering an injection drug or moving a push rod. Since it is configured separately from the cylinder and is not used in the formulation process (filling and freeze-drying), the outer shape of the cylinder can be kept simple in these processes.

8 and 9 are reference examples of the present invention, a structure suitable for use of the syringe-cum-container of the present invention for a drug formulation, that is, for concentrating a rare drug solution, particularly for a freeze-vacuum dried formulation. Explain that there is. The tip 3 of the tube 2 is sealed with a rubber stopper 4, and the tube is charged with an appropriate amount of a thin drug solution 25, which is a raw material of the drug, and is unstable in a sterilized drying chamber (which can be evacuated and air to be sterilized). Drugs such as antibiotics, enzymes, vitamins and other drugs that are easily affected by heat and oxygen require freezing of the undiluted solution and vacuum drying. The conditions are, for example, room temperature of -10 to -60 ° C. That is, it has a preferable shape for cooling using liquid nitrogen gas, concentrating and drying the drug under a very severe condition of a vacuum degree of 10 ^{−3 to} 10 Torr. As shown in FIG. 8, the second bypass and the cylinder 2
Since the openings are made close to each other and a large number of grooves, such as 2 to 8, and the area thereof are wide, and the first annular sealing plug having a large annular shape is inserted in the bypass, the second bypass is used. 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, which is shorter than the first sealing plug, is used, the cost of the apparatus can be reduced and the vapor passage can be shortened to prevent re-deposition.

Further, in the reference example of the present invention, the length of the second bypass is shorter than the thickness of the first sealing plug, and 1/3 to 1 times, preferably 1/2 to 1 times the thickness of the first sealing plug. Can also be The cylinder 2 in FIG. 12 has a second bypass having a length of about 1/2 of that in the case of the second bypass in FIG. 8, but in the example of FIG. 12, the first sealing plug is fixed to the inner wall of the cylinder and the steam 2 is dried.
6 can be evaporated through the bypass 14 as in the case of FIG. FIG. 13 is a sectional view taken along line BB ′ of FIG.
Further, FIG. 14 shows an example in which the length of the second bypass is slightly longer than about 1/3 of the thickness of the first sealing plug, and a cross section taken along a plane perpendicular to the central axis of the cylinder and CC of the cross section. A partial sectional view in the cylinder axis direction of the'direction and DD 'direction is shown. 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 at the time of concentration and drying of the drug can be discharged from the second bypass groove. In this example, since the exhaust passage is short, the manufacturing apparatus can be made small, and exhaust gas does not re-precipitate. However, 1/3 of the first sealing plug
With a shorter bypass, it becomes difficult to push the first sealing plug into the second bypass in the drying chamber and 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 recess in the inner wall, the flow of the refrigerant, that is, liquid nitrogen, is good, for example, during processing in the freeze-drying chamber, and the cylinders with a circular outer shape are mesh-shaped fixtures that contact each other. Since they can be arranged close to each other, the number of processing vessels per unit area is maximized,
A large amount of the bypass portion can be put in the drying chamber as compared with the conventional bypass portion protruding outside the cylinder. In addition, economic efficiency such as equipment construction cost and manufacturing unit cost becomes advantageous. (2) The tip 3 of the cylinder 2 has a round bottom, and the hollow of the injection needle is sealed with an inverted U-shaped rubber stopper to make the design as uneven as possible. That is, the chemical liquid existing at the bottom of the tip of the cylinder can be dried quickly even if frozen. (3) When the concentrated drug in the cylinder 2 is sufficiently concentrated and dried to become a powdered drug, the first sealing plug 8 is operated by the pushing tool 28 in the drying chamber as shown in FIG. By inserting the central part and the upper part of the first bypass 11, the dry powder can be sealed. With the above configuration,
Particularly, in the freeze-drying / sterilization chamber, the injection drug can be sealed in the cylinder 2 with the first sealing plug. The conditions required for such a formulation process can be sufficiently satisfied.

Among many medicines, the medicine powder which is stable in the air and can be sterilized by heating is simply in the sterilization chamber, and in the syringe having only the first bypass in the cylinder 2 of the present invention, the concentrated powder medicine is stored in the first chamber. In addition, the second chamber becomes a container that can be filled with the diluting drug or the two drugs of distilled water. In the operation step of FIG. 9, the cylinder 2 whose first chamber is sealed by the first sealing plug 8 is taken out of the drying chamber, and the second chamber 9 of the cylinder 2 is disposed in the sterilization chamber.
It is filled with a diluent or distilled water for injection (hereinafter, abbreviated as distilled water), and the second sealing plug 10 is quickly capped, and a cap 17 is attached to complete the 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 the distilled water in the two chambers inside the cylinder with the first and second sealing plugs. It is preferable. Further, the opening end 15 of the tube 2 is tapered thin toward the opening, that is, the inner diameter is made thicker to facilitate the insertion of the first and second sealing plugs into the tube 2.

Next, the method for administering the drug stored in the syringe / container of the present invention will be described in detail. As shown in FIG. 10, when using the medicine filled in the reference example of the syringe / container of the present invention, the cap 17 of the opening 5 of the cylinder 2 is removed,
The finger hook flange 23 shown in FIG. 3 is inserted. Next in FIG.
When the push rod tip spiral portion 13 of is inserted into the concave spiral 12 of the second sealing plug 10 of the cylinder 2 and the push rod is pressed in the direction of the tip portion 3 of the cylinder 2, the first sealing plug 8 causes the first bypass 11 to pass. The distilled water flows through the first bypass, enters the first chamber 7, and mixes the concentrated drug or powdered drug with distilled water to become a diluted administrable liquid medicine. At this point, as shown in FIG. 11, the double-ended needle 16 is inserted into the rubber stopper 4 located at the barrel tip 3, the air in the double-ended needle 16 is removed, and the push rod is pushed into the barrel tip to administer the diluted drug solution. be able to. INDUSTRIAL APPLICABILITY As described above, the syringe / container of the present invention is a syringe / container capable of promptly and sanitarily preparing a medicinal solution and immediately administering it by a simple operation.

The material of the syringe barrel used in the syringe / container of the present invention is a resin containing a resin containing a cyclic olefin compound or a crosslinked polycyclic hydrocarbon compound as a polymer component, or an olefin compound Resin as a coalescing component,
In addition, a mixture obtained by further mixing such an resin with an olefin resin and / or a synthetic rubber is used. In addition to the above materials, other resins such as polyethylene, polypropylene, polyethylene terephthalate, ethylene-vinyl alcohol, ethylene-vinyl copolymer, ethylene-vinyl acetate copolymer, nylon and amorphous nylon,
Ethylene propylene copolymer resin, polymethylpentene,
It is also possible to laminate one or more layers of ethylene-butyl copolymer and the like.

Since the first sealing plug or the second sealing plug needs rubber elasticity, its material is synthetic rubber, that is, 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 fluororesin, a resin containing a cyclic olefin compound or a crosslinked polycyclic hydrocarbon compound as a polymer component, and a general-purpose olefin compound as a polymer component It is preferable to use a resin containing

[0020]

The two-chamber syringe / container of the present invention comprises (1)
By providing the bypass groove of the injection cylinder in two steps inside the cylinder without forming a protrusion on the outer periphery of the cylinder, the drug substance solution is concentrated, dried, and powdered in the drug preparation room, and the interior of the syringe and container is quickly It is a hygienic and economical container because it can be sealed in the container. (2) Since the shapes of the first bypass, the first sealing plug, and the tip of the cylinder are designed and combined in an optimal form to match the purpose, the drug substance that is thin and easily decomposed by heat and air can be quickly concentrated. It has the effect of being able to be formulated into a stable, high-quality drug. (3) The syringe / container of the present invention can retain a drug held therein in high quality for a long period of time.

[Brief description of drawings]

FIG. 1 is a schematic cross-sectional view illustrating an embodiment of the syringe / container of the present invention.

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

FIG. 3 is a schematic cross-sectional view illustrating a reference example of the syringe / container of the present invention.

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

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

FIG. 6 is a schematic sectional view for explaining another reference example of the syringe / 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 a formulation state in which a drug solution having a low concentration is concentrated using the syringe / container of the present invention.

9 is a schematic explanatory view showing a state where the first sealing plug is pushed into the cylinder subsequent to the step of FIG.

FIG. 10 is a schematic explanatory view showing a state where the push rod is pushed in, the drug solution and the first sealing plug are press-fitted, and the drug solution flows into the first chamber through the bypass when the syringe / container of the present invention is used.

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.

12 is a schematic cross-sectional view illustrating another embodiment of the syringe / container of the present invention, in which a second bypass having a length of about ½ of that in the case of FIG. 8 is provided.

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

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

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

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

[Explanation of symbols]

1 Syringe / container, 2 cylinders, 3 tip part, 4 rubber stopper, 5 cylinder opening, 6 needle mounting tube, 7 1st
Chamber, 8 1st sealing plug, 9 2nd chamber, 10 2nd sealing plug, 11 1st 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 protrusion, 20
Annular protrusions, 21 annular protrusions, 22 recesses on the outer circumference of the opening, 23 finger flanges, 24 frame type fixtures,
25 source thin chemical liquid, 26 vapor, 27 concentrated drug (powdered drug), 28 push rod (in-cylinder push-in device for the first sealing plug in the drying chamber), 29 injection barrel, 30 barrel tip, 3
1 tube opening, 32 flange, 33 first sealing plug,
34 2nd sealing stopper, 35 1st chamber, 36 2nd chamber, 37 Bypass.

Continuation of the front page (56) Reference JP 62-252407 (JP, A) JP 1-197511 (JP, A) JP 63-77456 (JP, A) JP 4-322662 (JP , A) JP-A-57-22766 (JP, A) JP-A-59-5046 (JP, A) JP-A-62-139668 (JP, A) Actual flat 2-58446 (JP, U) Actual flat 4-77948 (JP, U) U.S. Pat. No. 4,3,574 (JP, Y1) US Patent 2549417 (US, A) (58) Fields investigated (Int.Cl. ⁷ , DB name) A61M 5/24 A61J 1 / 05 A61M 5/28 A61M 5/315

Claims (3)

(57) [Claims] 1. A bypass running in the cylinder length direction is provided on a cylinder inner wall surface at a substantially central position of a cylinder having a tip portion at one end and an opening portion at the other end, and the first sealing plug is provided with the cylinder opening portion from the bypass. A first chamber is formed between the tip of the cylinder and the first sealing plug by being fitted to the inner surface of the cylinder at a position closer to the first sealing plug, and the second sealing plug is positioned 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 plug and the bypass, the bypass has a concave groove shape on the inner wall surface of the cylinder.
One or a plurality of them are provided, and the outer circumference of the cylinder is a cylindrical shape without irregularities, and the thickness of the first sealing plug in the cylinder axis direction is the above
A resin containing a resin having a cyclic olefin compound or a crosslinked polycyclic hydrocarbon compound as a polymer component, or a resin having an olefin compound as a polymer component, which is shorter than one bypass length, and these A container that also serves as a syringe, characterized in that it is made of a mixture of the above resin and an olefin resin and / or synthetic rubber. 2. The first sealing plug and / or the second sealing plug.
Syringe and container according to claim 1 whose surface is characterized by Rukoto such is laminated with a resin film. 3. The inside of the tip of the cylinder has a circular bottom, and
Seal with a rubber stopper so that a double-ended needle cannot
The syringe / container according to claim 1 or 2 , characterized in that the container can be mounted and fixed .