JPH09627A - Syringe serving also as container - Google Patents

Abstract

PURPOSE: To improve efficiency in the manufacturing process by forming an air outlet communicating with the inside of a syringe, through a notch or a hole with a rubber stopper and a head cap placed on the syringe barrel and half-capped. CONSTITUTION: A near cylindrical head cap 12 is tightly engaged with the tip end of a syringe barrel 2 and a planar rubber stopper 11, and then a hollow thin tubular body 17 is continuously protruded on the top face 16 of the head cap 12. Then, a notch 15 is formed on the open end 14 of the head cap 12 to form an exhaust passage, i.e., an outlet 25 for the air inside the syringe in the assembly where the thin tubular body 17 of the head cap 12 is covered with a cap 18 and protruded above the tip end opening 10 of the syringe 1. In this case, a planar rubber stopper 11 is in a half-capped state adhering to the inner wall of the top face 16 of the head cap 12. Thus, the device increases efficiency in the manufacturing process, preventing contamination of the rubber stopper 11 for example, and enhancing the hygienic aspect.

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 drugs, nutrients and the like to a living body such as a human body, and more specifically, the efficiency of the step of formulating an unstable drug in the syringe / container. The present invention relates to a syringe / container capable of achieving efficient operation.

[0002]

2. Description of the Related Art As a method for preparing injectable drugs, nutrients, etc., a method of simply injecting and filling a glass container in a sterile room, or a freeze-drying method of injecting a rare raw material drug solution and then concentrating and drying it However, in each case, the drug in the container was dissolved in distilled water for injection to a prescribed concentration at the time of administration, and then the drug solution was sucked up into a syringe and administered via an injection needle. In recent years, it has been possible to stably store both medicines, nutrients, and diluting liquids such as distilled water for injection by means such as dividing one syringe into a plurality of chambers. A syringe / container has been proposed in which the drug can be diluted to a specified concentration in the container by communicating, and can be directly administered via an injection needle attached to the tip part. It is excellent in various aspects such as various administrations.

[0003]

By the way, recently, in storing and administering a drug in the above-mentioned syringe / container,
Various problems have been found in terms of quality and hygiene, and in order to improve these problems, the present inventors have already disclosed the problems in JP-A-6-209996, JP-A-6-254160, and Japanese Patent Application No. No. 6-149771 proposes a new syringe / container. The present invention aims at further improvement as a syringe / container used particularly for unstable drugs, drugs requiring titer retention, etc., and satisfies the latest requirements more than conventional products in terms of hygiene. It is intended to propose a new syringe / container that can.

[0004]

Means for Solving the Problems As a means for solving the above problems, the present invention includes 1) a syringe barrel, a sealing plug for sealing an open end of the syringe barrel, and a tip of an end portion of the syringe barrel on which a needle is attached. A syringe / container having at least a rubber stopper for sealing an end opening and a head cap for covering the rubber stopper and the tip opening, wherein the head cap covers and tightly engages with the tip portion of the syringe barrel. A head cap body, a tubular thin cylinder protruding from the top surface of the head cap body, and a tip opening cap of the thin cylinder, and the head cap body has a notch or a hole from the open end side. A syringe / container, characterized in that the notch or hole can form an exhaust port communicating with the inside of the injection cylinder when the rubber stopper and the head cap are put on the injection cylinder to be in a half stoppered state. , 2) The head cap has one or more notches or holes. 3) The syringe / container described in 1) above, 3) one or more recesses in the inner wall of the head cap body are engageable with projections on the outer surface of the tip end of the syringe barrel. The syringe / container according to 1) or 2) above, 4) the rubber stopper is flat or has legs and is adhered to the inner wall surface of the top surface of the head cap. 5) The syringe and container according to any one of 3 to 3), 5) the rubber stopper has a leg that is closely fitted and inserted into the distal end portion of the syringe barrel, and the leg has a notch to cut the head cap. The syringe / container according to any one of 1) to 4) above, wherein the exhaust port can be formed by disposing the exhaust port at the same position as the notch or the hole, 6) the syringe barrel of the syringe / container,
A second sealing plug is provided between the tip of the barrel and a sealing plug that seals the open end of the injection barrel, and is divided into two chambers. The syringe barrel has a bypass groove for communicating the two chambers. The syringe according to any one of 1) to 5) above, which is provided so that a diluting liquid in one chamber can be injected into another chamber filled with a concentrated drug via the bypass. It also provides a container.

[0005]

OPERATIONS AND EXAMPLES FIG. 1 is a schematic explanatory view showing an embodiment of the present invention, showing a state of a product in which a drug (concentrated drug etc.) is filled in a syringe / container 1 of the present invention. In FIG. 1 (a), the syringe barrel 2 of the syringe / container 1 (hereinafter,
The open portion 3 (also abbreviated as a cylinder) is a rubber stopper having a synthetic resin film laminated on the surface thereof, which serves as a sliding stopper, and a recess corresponding to the protrusion 5 at the end of the cylinder 2. It is configured so that it can be hermetically sealed by the cap 6 having. A high airtightness is obtained by the sealing plug 4 and the cap 6, and during the formulation process in which the diluting drug is efficiently injected into the cylinder 2 to concentrate the drug, the product becomes a product after the concentration is completed and the concentrated drug is stored in the cylinder. It is possible to maintain a sufficiently high quality even during long-term storage. (B) in Fig. 1 is the injection needle part,
(c) shows a push rod having a spiral portion 8 corresponding to the concave spiral 9 of the sealing plug 4. These (a) to (c) form a set of products. The syringe / container of the present invention is characterized in that a rubber stopper 11 and a head cap 12 having a novel structure are provided on the tip end port 10 side of such a syringe / container.

2 (a), 2 (b) and 2 (c) are sectional views showing various embodiments of the head cap according to the present invention. As shown in FIG. 2, the head cap is a substantially cylindrical head cap body (hereinafter, abbreviated as a body) 12 that covers the tip of the injection cylinder and the flat rubber stopper 11 or the rubber stopper with a leg 26, and the top surface of the body 12. An open side end 14 of the main body 12 is composed of a hollow cylindrical body (fine cylindrical body) 17 having an internal space continuously protruding above the upper portion 16.
A notch 15 as shown in the figure is provided. In the combination with the rubber stopper with legs in (c), the notch 15 has the same contour as the notch 28 in the leg of the rubber stopper. Body 1
The inner wall of 2 is provided with one or two or more recesses 19 corresponding to the projections of the injection cylinder, and the upper portion of the recess 19 is referred to as a fixing portion 13. The mouth of the tip of the thin cylindrical body 17 is a cap 18
Covered with. The head cap and the rubber stopper 11 of the present invention are not attached after the concentrated drug is filled in the cylinder, but are attached to the cylinder 2 as shown in FIG. 3 prior to the concentration step.
The details will be described below.

FIG. 3 is a schematic cross-sectional view for explaining the operation of the head cap according to the present invention. First, the syringe / container, sealing stopper, rubber stopper, head cap, etc. to be used are sterilized in advance, Separately sterilized drug solution raw material is filled in the cylinder 2, but in the case of the flat rubber stopper as in this example, it is convenient to preliminarily adhere it to the inner wall of the top surface of the head cap. Next, cover the thin cylindrical body 17 of the head cap with the cap 18 so that the upper portion of the notch 15 of the head cap body 12 is exposed above the tip opening 10 of the syringe to form an exhaust passage inside the injection, that is, an exhaust opening 25. Assemble to. At this time, since the flat rubber plug 11 is adhered to the inner wall surface of the top surface 16 of the head cap body 12, there is no concern that it will come off, and the head cap should be placed at a position where the syringe is covered about half of the final stopper position. Therefore, in the present specification, this is referred to as a half stoppered state. In order to realize this state, a plurality of annular protrusions 23 are provided on the outer wall of the syringe tip portion 37 as shown in the figure, and the inner wall surface of the main body of the cap has a plurality of recesses 19 corresponding to the protrusions 23 and recesses and recesses. The fixing portion 13 is caught on the projection 23 and stabilizes the half stoppered state.

[0008] When the semi-stoppered state is set in this way, the syringe / container with a head cap is transferred into the concentration tank, and the air inside and outside the cylinder 2 is decompressed and evacuated to dilute the inside of the cylinder 2. The agent evaporates to become vapor 24 and is discharged from the exhaust port 25, and the raw material chemical liquid is concentrated and dried. Preferably, the raw material drug solution is cooled to about -5 to -30 ° C and dried (lyophilized). As a matter of course, all of these series of operations are performed under aseptic conditions. After the drug solution is completely dried, the head cap and the flat rubber stopper 11 are completely plugged into the tip of the cylinder in the same concentrating tank, and the inside of the cylinder 2 is sealed, so that the drug in the cylinder 2 becomes a preparation. Become.

FIG. 4 is a schematic cross-sectional view showing another embodiment of the present invention. A rubber stopper 26 having a leg 27 is half-stopped on the distal end opening 10 of the syringe barrel 2 and further the present invention is concerned. The figure shows a state in which the head cap is covered. The leg 27 of the rubber stopper 26 is provided with a notch 28, and in the example shown in the figure, the notch 28 of the leg 27 is provided.
And the notch 15 from the opening 14 side of the head cap body 12
Overlap with and form the exhaust port 25. In the same manner as described above, when the rare raw material drug solution is filled in the cylinder and then transferred to the concentration tank, and the inside and outside of the cylinder 2 are depressurized and vacuumed, the vapor 24 is formed by the upper portions of the notches 15 and 28. The liquid medicine is exhausted from the exhaust port 25 and concentrated and dried. Then, in the same concentrating tank, the rubber stopper 26 with legs is completely capped together with the head cap placed thereon, and the inside of the cylinder 2 is completely sealed.
This makes the drug a formulation.

A rubber stopper 26 having a notch in such a leg
Then, by providing an annular protrusion on the outer peripheral portion of the leg, it is possible to easily obtain a half-plugged state in which the leg itself is safely locked on the tip opening of the tube 2. Therefore, unlike the case of the flat rubber plug 11 of FIG. 3, it is not necessary to bond the rubber plug to the inner wall surface of the top surface of the head cap, and the exhaust port can be formed. Further, due to the presence of the legs 27, the sealing performance inside the cylinder 2 can be further improved.

FIG. 5 is a schematic sectional view showing still another embodiment of the present invention. In the example of FIG. 5, the head cap body 1
2 is provided with a hole 29, and the hole 29 is used as an exhaust port for vapor when the rare chemical is concentrated and dried. The hole 29 is provided at a position corresponding to the notch 26 of the leg 26 of the rubber stopper 26 with legs to be combined. Further, in this example, the protrusion 3 is provided at the end of the head cap body 12.
8 is provided, and the projection 38 is a projection for tightening the lower end portion of the outer ring wall provided at the tip of the injection cylinder 2, and the head cap is stably locked to the tip of the syringe to prevent it from falling off. .
In Figure 5, the rubber plug is

FIG. 6 is a schematic sectional view showing a further embodiment of the present invention, which is an example of a syringe / container filled with two kinds of medicines. Opening portion 3 of syringe barrel (abbreviated as barrel) 30
1 is sealed with a second sealing plug 32 and a cap 33, and a bypass groove 34 is provided in substantially the center of the cylinder 30.
The first sealing plug 35 is further arranged, and the purified water for injection 36 is filled in the space (room) formed between the first sealing plug 35 and the second sealing plug 32. The space (chamber) formed between the first sealing plug 35 and the tip of the cylinder is filled with a rare drug solution, and the flat rubber stopper 11 is placed on the tip portion 37 of the syringe 30, and the cylinder 3
The tip portion 37 of No. 0 and the flat rubber stopper 11 are fixed by the head cap body 12 to make a half stoppered state to concentrate and dry the drug solution, and then completely stopper and seal. The tip of the thin cylindrical body 17 of the head cap is sealed with the cap 17.

When the concentrated drug 7 as shown in FIG. 1 prepared by using the syringe / container of the present invention as described above is used, the diluent is filled in another syringe and the needle of the syringe is filled. 1) is inserted from the thin cylindrical body 17 of the head cap, the concentrated drug is dissolved, and then the double-ended hollow needle 20 shown in FIG. 1 (b) is again inserted into the thin cylindrical body 17, and the needle base 21 is attached to the tip of the thin cylindrical body 17. The drug solution that is fixed and flows out through the hollow needle 20 and the dosing needle 22 flows out and is administered. Further, the push rod shown in (c) can be used as a slip stopper by attaching the spiral portion 8 to the concave spiral recess 9 provided in the rubber stopper 4 that seals the open end 3 of the cylinder 2. . Further, in the two-chamber type syringe / container of FIG. 6, the concentrated drug can be diluted by using a bypass at the time of use, which is very convenient.

In the above description, the head cap has one cutout or hole, but it is a preferred embodiment to have one or more cutouts or holes. By providing a plurality of exhaust ports, the vapor divergent flow passage in the cylinder is widened, the concentration and drying times are shortened, and the production efficiency of the preparation is improved.

The material of the head cap according to the present invention includes:
Various widely used synthetic resins can be used, and for example, one or more selected from the group consisting of polyethylene, polypropylene, polyester, polycarbonate, polysulfone, polymethylpentene, polyallate, polyamito, modified phenylene oxide, and liquid crystal ester can be used. Can be mentioned. Alternatively, these synthetic resins may be blended with silicon oxide, aluminum oxide, synthetic fibers, acid clay, clay and the like, and further blended by known techniques such as antioxidants and processing aids. In any case, it is desirable to satisfy hygiene with respect to chemicals. The head cap according to the present invention can be manufactured by applying various known techniques such as kneading and injection molding using these materials as raw materials.

Materials other than the head cap of the syringe / container of the present invention can be made of materials known in the technical field of this kind, and can be selected from the same synthetic resins as the head cap of the present invention. As for the molding, any known resin molding technique can be applied. For example, it can be manufactured by premixing, kneading at a high temperature, and steps such as injection molding and cooling.

[0017]

INDUSTRIAL APPLICABILITY The present invention is a syringe / container, which is provided with a notch or a hole in a head cap for fixing a rubber stopper which covers the tip of an injection cylinder and seals the tip.
In a drug formulation process that requires drying and vacuum freeze-drying processes, the rubber stopper can be stably and easily half-capped to secure a steam exhaust port, thereby increasing the efficiency of the formulation process. In addition, since it is possible to prevent contamination of the rubber plug and the like in the step, hygiene is improved. Further, when the evaporation and drying are completed, the rubber stopper is completely capped as it is to be in a sealed state and immediately covered with the head cap, so that hygiene can be maintained and the sealing stopper can be improved. In addition, the top side of the head cap is a protruding thin cylindrical body, and when injecting the drug in the cylinder, injecting dilution water,
It serves as a flow passage for drug solution administration and, at the same time, serves as a needle mounting portion that engages with a needle base such as a dosing needle or a hollow needle. In the present invention, all the washing and sterilization processes are completed beyond the concentration step, and even the complete plugging and head cap covering can be performed in the concentration step, so the head cap portion is highly hygienic, so attach the needle as it is. It is also advantageous that it can be diluted or administered immediately.

[Brief description of drawings]

FIG. 1 is a schematic sectional view showing an embodiment of the present invention.

FIG. 2 is a schematic cross-sectional view showing various examples of combinations of a head cap and a rubber stopper of a syringe / container according to the present invention.

FIG. 3 is a schematic cross-sectional view for explaining the action of the combination of the head cap and the rubber stopper of the syringe / container according to the present invention in the formulation process.

FIG. 4 is a schematic cross-sectional view for explaining the action of another combination of the head cap and the rubber stopper of the syringe / container according to the present invention in the formulation step.

FIG. 5 is a schematic sectional view showing still another embodiment of the present invention.

FIG. 6 is a schematic cross-sectional view showing one embodiment of the syringe / container of the present invention capable of holding two kinds of contents.

[Explanation of symbols]

1 syringe and container, 2 injection cylinder (cylinder),
3 open part, 4 sealing plug, 5 protrusion,
6 Cap, 7 Concentrated drug (lyophilized drug), 8 Spiral part, 9 Concave spiral, 10
Tip port, 11 Flat rubber stopper, 12
Head cap body, 13 fixed part, 14
Opening part, 15 notches, 16 top surface,
17 thin cylinder, 18 cap, 19
Recess, 20 hollow needle, 21
Needle base, 22 dosing needles, 23 protrusions
24 steam, 25 exhaust port, 2
6 rubber stoppers with legs, 27 legs, 28 notches,
29 holes, 30 syringe / container (cylinder), 31 open part, 32 second sealing plug (sliding plug), 33 cap, 34 bypass groove, 35 first sealing plug (sliding plug), 36 purified water for injection, 37 tip Department. 38 Protrusions.

Claims (6)

[Claims] 1. A syringe barrel, a sealing stopper for sealing the open end of the syringe barrel, a rubber stopper for sealing the tip end port of the end of the syringe barrel where the injection needle is attached, and the rubber stopper and the tip end port. A syringe / container having at least a head cap for covering the head cap body, wherein the head cap covers and tightly engages with a distal end portion of the syringe barrel, and a tubular thin body protruding from a top surface of the head cap body. A semi-cylindrical body and a tip end opening cap of the thin cylindrical body, the head cap body has a notch or a hole from the open end side, and the rubber stopper and the head cap are covered on the syringe barrel and a half stopper A syringe / container, wherein the notch or hole can form an exhaust port communicating with the inside of the syringe barrel when brought into a state. 2. The syringe / container according to claim 1, wherein one or more notches or holes are provided in the head cap. 3. The syringe / container according to claim 1 or 2, wherein one or more recesses in the inner wall of the head cap body are engageable with projections on the outer surface of the tip end of the syringe barrel. 4. The rubber stopper is flat or has legs,
The syringe / container according to any one of claims 1 to 3, which is adhered to an inner wall surface of the top surface of the head cap. 5. The rubber stopper has a leg that is closely fitted into the distal end portion of the syringe barrel, and the leg has a notch and is arranged at the same position as the notch or hole of the head cap. The syringe / container according to any one of claims 1 to 4, wherein the exhaust port can be formed by the. 6. The syringe barrel of the syringe / container is divided into two chambers by having a second sealing plug between the barrel tip and a sealing plug that seals the open end of the syringe barrel. The injection cylinder is provided with a bypass groove for connecting the two chambers, and the diluent in one chamber can be injected into the other chamber filled with the concentrated drug via the bypass. The syringe and container according to any one of claims 1 to 5.