JPH0928798A - Combination syringe and container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To quickly fill an unstable medicine in a combination syringe and container, to improve the holding of quality, to simplify a treating process and to improve workability by forming a head cap with a thin cylinder and a thin cylinder tip cap and providing plural dents advancing from an open terminal on a tip mouth side to a top panel side. SOLUTION: A rubber cock 11 is adhered closely on a tip mouth 10 on which the injection needle of a syringe 2, etc., is mounted, and the rubber cock 11 is fixed and sealed by covering it with the head cap 2 from the upper side. The head cap 12 is formed of the tip mouth 10, a cylindrical fixing part 13 which covers the rubber cock 11, and a tubular thin cylinder 17 protruding over the top panel 16, and the tip of the thin cylinder 17 is covered with a cap 18. Plural recessed groove shape dents 15 are provided in an axial direction from the open terminal 14 side of the head cap 12. The length L of the dent 15 is formed longer than the axial direction length H of the tip mouth 10 part of the cylinder 2 held in the cap 12 when a semi-cocked state is set.

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 administrating medicines, nutrients, etc. to a living body such as a human body.
More specifically, the present invention relates to a syringe / container capable of realizing an efficient operation in the process of formulating an unstable drug in the syringe / container.

[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 a drug can be diluted to a specified concentration in the container by communicating with each other, and can be administered as it is via an injection needle attached to the tip. It has been widely used due to various excellent features such as reliability of dilution operation and quick administration without taking out a drug. The method of formulation using such a syringe and container is such that the dust on the surface of the device such as the syringe, slipper, rubber stopper, etc. is cleaned and sterilized (usually by heating), while the drug to be filled is the raw material. Purify the fine particles in the drug solution to the extent of filtration, fill the drug solution in the syringe barrel and container in an aseptic state in a sterile room, seal with a rubber stopper and a cap, and finally obtain a high-pressure steam sterilization step. , It is a product as a syringe containing a drug. Further, in recent years, various problems have been found in terms of quality and hygiene when storing and administering a drug in a syringe / container as described above, and the present inventor intends to improve the problem. Have already been disclosed in JP-A-6-209996, JP-A-6-254160, and Japanese Patent Application No. 6-149.
No. 771 proposes a new syringe / container.

[0003]

In all of the above-mentioned prior arts, the filling of the medicine into the syringe is a complicated work process, and problems regarding quality such as reduction of the potency of the drug solution during heat sterilization and simplification of the sterilization process. In addition, there are still many problems to be solved, such as cost reduction of formulation equipment, long-term quality maintenance of pharmaceutical products and reduction of product prices. The present invention is particularly suitable for manufacturing a syringe / container formulation filled with an unstable drug or a drug that needs to retain its potency, etc. It is an object to be solved to provide a syringe / container having a new structure, which can realize improvement in quality maintenance of pharmaceuticals, simplification of working process, and improvement of workability.

[0004]

[Means for Solving the Problems] As means for solving the above-mentioned problems, the present invention provides: 1) an injection cylinder, 2) a sealing plug for sealing the open end of the injection cylinder, 3) the open end and the seal An open-end cap overlaid on the stopper, 4) a rubber stopper for sealing the tip end port of the injection needle mounting side end of the syringe barrel, and 5) a head cap over the rubber stopper and the tip end port, In the syringe / container including at least the head cap, the rubber cap and a substantially tubular fixing portion for closely covering the tip end side of the cylinder, and a protrusion from the top surface of the fixing portion to communicate with the internal space of the fixing portion. It is composed of a tubular thin cylinder and a tip cap of the thin cylinder, and the inner wall of the fixing portion has a plurality of recesses extending from the open end on the tip mouth side to the top surface side, and the inner wall of the top surface of the head cap has When holding the one with the rubber stopper fixed to the tip port in a half stoppered state, the recess communicates the inside and outside of the cylinder. Providing a syringe and container, characterized in that as it can form a passage. As a particularly preferred embodiment of the present invention, the rubber stopper is a flat plate,
The above-mentioned syringe / container is characterized in that the projection provided on the inner wall of the head cap is retained at the tip end opening to maintain the half-capped state. As another particularly preferable embodiment of the present invention, when the rubber stopper is provided with a leg having a notch, and a projection provided on the outer periphery of the leg is locked to the tip end port to maintain a half stoppered state. The syringe / container is characterized in that the cutout portion, the fixed portion inner space and the recess can communicate with each other to form the passage. In a particularly preferred embodiment of the present invention, the injection cylinder has a protrusion on the outer wall on the tip end side, and is provided on the inner wall on the open end side of the head cap when the rubber stopper and the head cap are completely plugged. In addition, the above-mentioned syringe / container is characterized in that the lower protrusion and the protrusion on the outer wall of the tip end are engaged with each other. As another particularly preferable embodiment of the present invention, the injection cylinder has one chamber inside, or the inside of the cylinder is divided into two chambers by another sealing stopper, and is provided at a substantially central portion of the cylinder. The syringe / container according to any one of claims 1 to 4, wherein the two chambers can be communicated with each other by a bypass groove.

[0005]

BEST MODE FOR CARRYING OUT THE INVENTION The structure, working mechanism and other features of the syringe / container of the present invention will be described in detail with reference to Examples. 1 (a), (b) and (c) are schematic cross-sectional views individually showing a syringe / container body portion, a push rod and a needle portion of a syringe / container according to an embodiment of the present invention. FIG.
(A) is a schematic cross-sectional view of an injection cylinder (abbreviated as a cylinder) 2 of a syringe / container 1 in the cylinder axis direction, and an open end 3 of the cylinder 2 is a sealing stopper 4 which also serves as a sliding stopper made of an elastic material such as rubber. Is inserted and sealed, and the open end cap 6 is covered from the outside to prevent the sealing plug from falling off. The sealing plug 4 has a spiral recess 9 at the rear part, and the convex spiral part 8 of the push rod shown in FIG. 1B is fitted into the recess 9 to attach the push rod, and the push rod is pushed to seal. The drug (concentrated drug) 7 in the cylinder 2 is flushed away by moving the stopper 4 to the side of the distal end opening 10 so that the drug can be administered. Further, a protrusion 5 is provided on the outer periphery of the open end 3 to ensure the engagement with the cap and to enhance the airtightness.

The other end of the cylinder 2 serves as a tip opening 10 for attaching an injection needle or the like. The tip opening 10 tightly seals a rubber stopper 11, and a head cap 12 is put over the rubber stopper 11 to cover the rubber stopper. 11 is fixed, the sealing is ensured, and the airtightness is enhanced. Since the airtightness is ensured in the cylinder 2 as described above, the quality of the drug 7 such as a concentrated drug by freeze-drying in the cylinder 2 does not deteriorate even if it is stored for a long period of time.

The head cap 12 is a fixed portion 13 which is a substantially cylindrical body capable of closely covering the tip end opening 10 of the cylinder 2 and the rubber plug 11 and a top surface 16 of the fixed portion 13 so as to protrude from the fixed portion. It is composed of a tubular thin cylinder 17 communicating with the inside of 13. The tip of the thin cylindrical body 17 is covered with a cap 18.

The first feature of the present invention resides in the internal structure of the fixing portion 13 of the head cap 12. 2 is a cross-sectional view of the head cap according to the present invention, which is taken along the line AA 'and BB' in FIG.
The cross section and the CC ′ cross section are respectively taken along the lines (A), (B), and FIG.
It is shown in (C). As shown in FIGS. 2 and 3, the fixing portion 13
The inner wall is provided with a plurality of recessed groove-shaped recesses 15 in the axial direction from the open end 14 side of the head cap 12, and the length (L) of the recesses 15 is a half-stopped state as described later. Axial length (H) of the tip opening portion of the cylinder 2 held in the cap
Designed to be longer. Further, the inner wall 20 of the fixing portion 13 is provided with a plurality of upper protrusions 25 at positions not overlapping the recesses 15 in the radial cross section, and the lower ends of the upper protrusions 25 have a length (H) from the open end 14. Is located in. The upper protrusion 25 serves as a stable stop plate for supporting the head cap 12 on the tip opening 10 and holding it in a half stoppered state. A plurality of lower protrusions 24 are provided along the circumference of the inner wall 20 at a position not overlapping the recess 15 on the inner wall following the open end 14, and the lower protrusions 24 on the tip end port 10 side of the cylinder 2 are described later. The head cap 12 is securely fixed by engaging with a protrusion provided on the outer wall.

FIG. 4 is a schematic sectional view for explaining the operation of the head cap according to the present invention. After sterilizing each part of the syringe / container in advance, a separately sterilized drug solution is injected and filled into the cylinder 2 in which the open end 3 is sealed with the sealing plug 4 and fixed with the open end cap 6. The head cap 12 is a thin cylindrical body 1.
7 is covered with a cap 18, and a rubber plug 11 is adhered to the inner wall surface of the top surface 16 and is covered on the tip end port 10 side of the cylinder 2. At this time, the upper projection 25 of the inner wall 20 of the fixing portion 13 is covered.
However, the head cap 1
2 is not completely plugged but is held in a locked state (FIG. 4). This state is called a half stopper state. At this time, the lower end of the upper protrusion 25 is at the position (H) from the open end 14,
The length of the recess 15 is (L) longer than (H). Therefore,
The end of the recess 15 is located above the upper edge of the tip opening 10,
A passage 27 communicating with the inside of the cylinder 2 is formed between the upper end of the tip opening 10 and the upper edge.

By thus filling the inside with the chemical liquid and transferring the head cap to the concentrating tank with the head cap half-capped, the inside and outside of the cylinder 2 are kept in a reduced pressure or vacuum atmosphere. The solvent of the chemical liquid in the cylinder 2 is evaporated, and the vapor 26 is exhausted from the interior of the cylinder through the passage 27 as an exhaust port to dry the chemical liquid. Preferably, the temperature of the raw material drug solution is cooled to about 0 to −30 ° C. and freeze-dried. 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 12 and the rubber stopper 11 are completely capped on the tip mouth side of the cylinder 2 in the same concentration tank to seal the inside of the cylinder 2 to obtain a completed preparation.

FIG. 5 is a schematic cross-sectional view for explaining another embodiment of the syringe / container according to the present invention. As shown in FIG. 5 (a), the head cap 12 is half-capped and the recess 15 is passed through (passage port).
The chemical solution is concentrated and dried as 27, and is completely stoppered after the chemical solution is concentrated as shown in (b), and a lower protrusion 24 of the inner wall 20 continuing to the open end 14 is provided on the outer wall of the tube 2 on the tip opening 10 side. Engages with the annular projection 30 provided to ensure a tight seal.

FIG. 6 is a schematic sectional view for explaining another embodiment of the syringe / container according to the present invention.
9 has an annular projection 30 on the outer side of the tip opening 10 as in FIG. In this example, the rubber plug 33 has a leg 31 on the lower surface of the top surface, and the leg 31 has a leg projection 32 on the outer peripheral portion. The leg projection 32 is engaged with the upper edge of the tip opening 10. It can maintain the half stoppered state. In addition, the leg 31 has a notch 3
In the half-stopped state, the notch 34, the space inside the fixing portion 13 of the head cap 35 and the recess 15 communicate with each other to form a passage 27, which serves as an exhaust port for the vapor 26 during concentration and drying. Can act. Further, in this example, a projection 36 having a cross section as shown in FIG. 5 is formed in the recess 15 on the side of the open end 14, and this projection part is formed on the annular projection 30 provided on the outer wall of the tube 2 of the tip opening 10. Engagement ensures a tight seal.

As described above, the first feature of the present invention is to use the head cap having the recess on the inner wall of the fixed portion, which can form the passage when the stopper is half closed.
The rubber plug shape may be a flat plate shape as shown in FIG. 1 or the legged rubber plug shown in FIG. The half-plugged state may be achieved by providing an upper projection on the inner wall of the head cap as described above, or by providing a leg projection on the outer circumference of the leg of the rubber stopper to be combined. Both may be made visible for a more secure engagement. Further, in order to ensure the sealing performance when the plug is completely closed, a lower protrusion 24 may be provided on the inner wall of the open end of the head cap, or the inner wall portion including the recessed portion may be made to project from the open end. Good (Figure 5).

Further, in the syringe / container of the present invention, the shape of the cylinder may be provided with the projection 30 on the outer wall of the distal end opening side as described above, or is not included in the scope of the present invention. FIG. 7 is a schematic cross-sectional view showing a state in which a syringe / container (abbreviated as “syringe”) in which the inside of a syringe is divided into two chambers is filled with two kinds of drug solutions according to one embodiment of the present invention. The cylinder 37 of the syringe / container has an open end 38 sealed with a second sealing plug 39 and an open end cap 40, and has a bypass groove 41 at approximately the center of the cylinder 37. The chamber between the first sealing stopper 42 and the second sealing stopper 39 is filled with purified water 43 for injection, and the chamber between the first sealing stopper 42 and the tip opening 10 is filled with a medicine. Holds (concentrated drug) 7. A rubber stopper 33 with legs is fixed to the tip end port 10 of the cylinder 37 by a head cap 35, and a thin cylindrical body 44 projects from the top surface of the head cap 35. The thin cylindrical body 44 is a cap 45.
Sealed. A recess 15 is provided on the inner wall of the fixed portion of the head cap 35.

In the case of using the preparation of the present invention in which the drug is filled in the syringe-cum-container as described above and administering it to a human body, in the type of FIG. 1, it is diluted in a separately prepared syringe with an injection needle. The liquid is filled, and the injection needle is inserted by inserting a rubber stopper through the thin cylindrical body 17 of the head cap 14,
The diluent is transferred into the cylinder to dissolve and dilute the concentrated drug in the cylinder. Next, the hollow needle 21 of the double-headed needle shown in FIG. 1 (c) is inserted into the thin cylindrical body 17, and the needle base 22 is fixed to the tip of the thin cylindrical body, while the sealing plug 4 is shown in FIG. By attaching the push rod shown in (1) and pushing the push rod into the cylinder 2, the diluted drug solution is administered via the inside of the administration needle 23.

In the case of a preparation of a syringe / container which holds the concentrated drug 7 and the purified water for injection 43 in two chambers as shown in FIG. 7, it is first formed between the first sealing plug 42 and the second sealing plug 39. Purified water 43 for injection is filled in the space (room). Next, a rare raw material drug is filled in the space (chamber) formed between the first sealing plug 42 and the tip end opening 10 of the cylinder, and the rubber stopper 33 with legs is fixed to the inner wall of the top surface of the head cap 35. Then, the head cap 35 is covered so that the protrusion 32 on the outer circumference of the leg of the rubber stopper 33 with the leg is engaged with the tip end opening 10 of the cylinder. That is, it is in a half stoppered state. When the inside of the cylinder 29 is depressurized or vacuumed in this half-stopped state, the rare raw material chemical vapor 26 flows out through the notch 34 of the rubber stopper 33 with legs, the passage 27 formed by the fixed portion internal space and the recess 15. Is exhausted to the outside of the cylinder. The drug solution is concentrated,
After being dried, the head cap 35 is quickly and completely plugged in the concentration tank, so that the tip end port 10 can be hygienically sealed with the rubber plug 33 and the head cap 35.

As described above, in the injection cylinder having at least the head cap having the recess serving as the passage in the inner wall according to the present invention, the flow of the high-pressure steam is completely sterilized by the high-pressure steam when the cylinder, the rubber stopper, etc. are completely sterilized. It is preferable that there are a plurality of recesses for smoothing and improving the exhaust speed. In particular, as a rubber stopper with legs, one having two notches is widely used, so that one having two recesses is suitable for combination with this.

Materials for forming the head cap according to the present invention include general-purpose synthetic resins such as polyethylene, polypropylene, polyester, polycarbonate, polysulfone,
One or more selected from the group consisting of polymethylpentene, polyarylate, polyamide, modified phenylene oxide and liquid crystal ester, or the above synthetic resin containing silicon oxide, aluminum oxide, synthetic fiber, clay, antioxidant, processing aid, etc. It is possible to appropriately select a compound obtained by blending in accordance with a known technique. In any case, it is desirable to satisfy hygiene with respect to chemicals. Various known processing techniques such as uniform kneading of these blends according to a known technique and injection molding into a mold can be applied for molding. Also, the tubular portion that serves as the syringe / container of the present invention may be made of the same material as the head cap or may be made of a different material, and similarly known technology can be applied to the molding. Further, rubber stoppers, sealing stoppers (slip stoppers), caps, push rods, double-ended needles, etc. can be formed by applying known techniques to materials known in this technical field.

[0019]

As described above, according to the present invention, the head cap of the injection cylinder is provided with a recess having a certain length from the open end on the tip end side, so that the recess can be formed inside and outside the cylinder in a half stoppered state. Since the passage can communicate with each other, high-pressure steam sterilization can be performed with the syringe, rubber stopper, and slip stopper assembled. Further, after the sterilization, the medicine can be promptly and hygienically filled with the medicine, and the treatment such as concentration, drying and vacuum freeze drying can be performed, and the medicine can be sealed in the syringe barrel with the cap and the rubber stopper in the filling chamber. By attaching the rubber stopper to the inner wall of the cap top surface in advance by adhesion or the like, the work can be performed accurately and quickly. Therefore, it can be extremely hygienically and efficiently prepared as a syringe assembly that also serves as a container for medicines, and at the same time, the sealing property in the cylinder can be improved as compared with the conventional product. In addition, the thin cylindrical body on the top surface of the head cap of the present invention is used as an inlet for diluting water into the cylinder at the time of drug administration, as an outflow passage for the drug solution diluted to the administration concentration, and as a hollow needle or an administration needle. Can act as a mounting.

[Brief description of drawings]

FIG. 1 is a schematic cross-sectional view individually showing a syringe / container main body portion, a push rod and a needle portion of a syringe / container according to an embodiment of the present invention.

FIG. 2 is a schematic sectional view illustrating a specific example of the head cap according to the present invention.

3 is a cross section taken along the line AA ′ of the head cap of FIG. 2, BB ′.
It is a sectional view showing a section and a CC 'section, respectively.

FIG. 4 is a schematic cross-sectional view for explaining the action of the head cap of another embodiment of the syringe / container of the present invention.

FIG. 5 is a schematic cross-sectional view for explaining the operation of the head cap of another embodiment of the syringe / container of the present invention.

FIG. 6 is a schematic cross-sectional view for explaining the action of the head cap of another embodiment of the syringe / container of the present invention.

FIG. 7 is a schematic explanatory view showing another embodiment of the syringe / container of the present invention, in which a rubber stopper with a leg is used in a two-chamber type injection cylinder.

[Explanation of symbols]

1 syringe and container, 2 syringes, 3
Open end, 4 sealing plug (sliding plug), 5 protrusion,
6 open end caps, 7 drugs (concentrated drugs),
8 spiral part, 9 concave spiral, 10 tip opening, 11 rubber stopper, 12 head cap, 13 fixed part, 14 open end,
15 hollows, 16 top surface, 17 thin cylindrical body, 18 cap, 19 cap,
20 inner wall, 21 hollow needle, 22 needle base, 23 dosing needle, 24 lower protrusion, 25 upper protrusion, 26 vapor,
27 passage, 28 tip flange, 29 syringe barrel, 30 tip protrusion, 31 legs,
32 leg projection, 33 rubber stopper with leg,
34 notches, 35 head caps, 3
6 protrusions, 37 syringe barrels, 38 open ends,
39 Second sealing plug, 40 Open end cap,
41 bypass groove, 42 first sealing plug, 43 purified water, length of L recess, H length from lower end of upper projection to open end.

Claims (5)

[Claims] 1. A syringe barrel, 2) a sealing plug that seals the open end of the syringe barrel, 3) an open end cap that covers the open end and the sealing plug, and 4) an injection of the syringe barrel. In a syringe / container comprising at least a rubber stopper for sealing a tip end port of a needle mounting side end, and 5) a head cap covering the rubber cap and the tip end port, the head cap is made of the rubber. A stopper and a substantially cylindrical fixing portion that closely covers the tip end side of the cylinder; a tubular thin cylindrical body that projects from the top surface of the fixing portion and communicates with the internal space of the fixing portion; The inner wall of the fixed portion has a plurality of recesses from the open end on the tip end side toward the top surface side,
When the one in which the rubber plug is fixed to the top wall of the head cap is held at the tip end in the half stoppered state, the recess can form a passage that connects the inside and the outside of the cylinder. Syringe and container. 2. The rubber plug has a flat plate shape, and a protrusion provided on the inner wall of the head cap is locked to the tip end opening to maintain a half-plugged state. The syringe and container described. 3. The rubber stopper is provided with a leg having a notch, and when a protrusion provided on the outer periphery of the leg is locked to the tip end port to maintain a half stopper state, The syringe / container according to claim 1, wherein the interior space of the fixed portion and the recess are communicated with each other to form the passage. 4. The injection cylinder has a protrusion on the outer wall on the tip end side, and when the rubber stopper and the head cap are completely stoppered, a lower protrusion and the tip provided on the inner wall on the open end side of the head cap. The syringe-cum-container according to any one of claims 1 to 3, wherein the projection on the outer wall of the end opening is engaged with the projection. 5. The injection cylinder has a single chamber inside, or the inside of the cylinder is divided into two chambers by another sealing stopper, and the two chambers are separated by a bypass groove provided at a substantially central portion of the cylinder. The syringe / container according to any one of claims 1 to 4, which is capable of communicating.