JPH10179688A - Sealing plug body for medicine vessel and medicine vessel assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To improve sealability of a medicine vessel assembly to improve long term quality assurance performance of medicine, by laminating a synthetic resin film not to contaminate medicine on the surface except a solid rubber plain face part at the base part and sealing the opening part by tightly attaching the rubber plain face part on the upper edge face and the inner wall face. SOLUTION: In a rubber plug 10, a base part 13 with the outer diameter larger than that of a flange is protruded from the lower face of the top face 11 with flange, a solid rubber plain face continuous in a base part outer periphery face 18a, and the base part 13 has a leg part 14 protruded at the inner edge of a base part outer periphery flat face 19a. Faces other than the solid rubber plain face at the base part 13 are laminated with a synthetic resin film layer 15 which does not contaminate a medicine. In a medicine vessel assembly, a rubber plug 10 is fit in a vessel 2 and covered by a cap 20 to tightly fix the rubber plug 10 to the vessel 2, and a top face flange lower face 17a and a base part outer periphery part 18a are fit in the inner wall of the mouth of the vessel 2. Thereby the area of the solid rubber plain face becomes large to improve salability.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a sealed closure for pharmaceuticals and a pharmaceutical container assembly, and more particularly to a rubber stopper for a vial having a novel structure with improved sealing performance, and a pharmaceutical container assembly comprising a vial and a rubber stopper. About. The product of the present invention can stably maintain and store pharmaceuticals for a long period of time.

[0002]

2. Description of the Related Art The standard for pharmaceutical containers is JIS.
There is an R3523 tube bottle for injection, and the well-known technology in this field is described in detail in documents such as Masayasu Sugihara, “Packaging Design of Pharmaceuticals”, published by Nanzando (1984). In addition, a known standard test method is defined for maintaining the quality of pharmaceutical products. With respect to the rubber stopper for sealing the container, test methods and standards are prescribed in Japanese Pharmacopoeia Law “Rubber stopper test method for infusion”, US Pharmacopoeia Law XXII and the like.

The present inventors have already disclosed a technique of laminating a synthetic resin film on the surface of a molded rubber as a rubber stopper capable of complying with the above regulations, as described in JP-B-2-40491 and JP-B-3-402.
No. 97 and Japanese Patent No. 2545540. As a result, a fluorine-based synthetic resin with excellent chemical resistance is laminated on the part that may come into contact with the chemical (referred to as the “chemical contact part”), and the other part of the rubber elastic body with excellent airtightness Leaving it airtight,
In addition to good penetration resistance, chemical resistance, and long-term storage stability, the amount of fine particles in vials is significantly reduced, so that the quality of drugs can be greatly improved compared to conventional rubber stoppers. It is effective and is now widely used in this field.

[0004]

SUMMARY OF THE INVENTION It is an object of the present invention to further improve the hermeticity of a conventional pharmaceutical container assembly comprising a rubber stopper, a pharmaceutical container, a rubber stopper and a cap, and thereby to improve the long-term quality assurance of pharmaceuticals. It was done as.

[0005]

As a means for solving the above-mentioned problems, the present invention provides (1) a top surface with a flange which is engaged with an upper edge surface of an opening of a container for a medicine, and a projection projecting from a lower surface of the top surface. A rubber stopper having a base fitted into the opening,
At least the surface of the lower surface of the flange and the outer peripheral surface of the base that continues to the lower surface of the flange is a continuous rubber surface, and a surface excluding the rubber surface of the base is laminated with a synthetic resin film that does not contaminate pharmaceuticals, The sealing plug of a pharmaceutical container, wherein the rubber element surface portion is in close contact with an upper edge surface of the opening portion and an inner wall surface following the upper edge surface to seal the opening portion. The base lower surface is flat or at least an annular flat surface is provided on the outer edge,
The sealing plug of the pharmaceutical container according to the above (1), which has legs protruding from an inner edge of the annular flat surface, (3) a container for a pharmaceutical, and an opening of the container. A pharmaceutical container assembly comprising a rubber stopper for sealing the container and a cap for covering the rubber stopper and fixing and locking the rubber stopper and the container body, wherein the container is parallel to the outer periphery of the opening from the upper edge surface to the inner wall surface of the opening. An annular notch, wherein the rubber stopper has a top surface with a flange that is locked to the upper edge surface, a base portion that projects from a lower surface of the top surface, and that is inserted into the opening; and a lower surface of the flange and the base portion. At least the surface of the outer peripheral surface following the lower surface of the flange is a continuous rubber surface, and the base is laminated with a synthetic resin film whose surface excluding the rubber surface is not contaminated with pharmaceuticals. Ring A flat flat surface is provided, the rubber element surface portion is fitted in close contact with the upper edge surface of the opening and the cutout wall surface following the upper edge surface, and the outer edge portion of the lower surface of the base is in close contact with the bottom surface of the notch. A drug container assembly characterized by stopping and sealing the opening, (4) the lower surface of the base has a cylindrical or notched cylindrical leg protruding at the inner edge of the annular flat surface, The part is fitted on the inner wall surface following the cutout of the container, (5) the pharmaceutical container assembly according to the above (3), (5) the inner wall opening inner wall following the cutout of the container has a cylindrical shape or a funnel. The pharmaceutical container assembly according to the above (3) or (4), characterized in that it has a shape, (6) an uneven pattern is formed on the top surface of the rubber stopper, or a synthetic resin fine particle layer is laminated. (3) above
The pharmaceutical container assembly according to any one of (1) to (5),
(7) Any of the above (3) to (6), wherein the width of the annular surface where the rubber surface on the lower surface of the top flange of the rubber stopper and the upper edge of the container opening flange contact each other is 2 to 12 mm. The pharmaceutical container assembly according to the above, (8) the rubber stopper is an isoprene-isobutylene copolymer rubber or a halide thereof, a copolymer of an isoprene-isobutylene copolymer rubber and a third component, isoprene rubber, butadiene rubber, ethylene-propylene copolymer. Polymerized rubber or rubber obtained by copolymerizing ethylene-propylene with a third component, thermoplastic elastomer, styrene
Isoprene rubber, characterized in that it comprises a rubber composition containing nitrile rubber solution-polymerized as a main component (3) or above
The pharmaceutical container assembly according to any of (7), (9).
Synthetic resin that does not contaminate the drug is a fluorine-based synthetic resin, polypropylene, polyethylene terephthalate, polycarbonate, polymethylpentene, polyethylene, olefin-based thermoplastic elastomer, ethylene-propylene copolymer, polyacetate, cyclic olefin-based compound or cross-linked polycyclic The above (3), which comprises at least one selected from synthetic resins having a formula hydrocarbon compound as a polymer component.
The pharmaceutical container assembly according to any one of (1) to (8),
And (10) the container is made of at least one selected from polycarbonate, polymethylpentene, polypropylene, polyethylene terephthalate, a synthetic resin having a fluorine-based synthetic resin, a cyclic olefin-based compound or a crosslinked polycyclic hydrocarbon as a polymer component. The above is characterized by being
(3) The pharmaceutical container assembly according to any one of (9) to (9), (11) ethylene vinyl alcohol, polyamide, liquid crystal polymer, polyethylene naphthalate, polyacrylonitrile on the inner surface and / or outer surface of the container body. A pharmaceutical container assembly according to any one of the above (3) to (10), which is formed by laminating.

[0006]

DESCRIPTION OF THE PREFERRED EMBODIMENTS First, the features of the present invention will be briefly described. Sealing plug of the present invention (hereinafter abbreviated as "rubber plug")
As shown in the perspective view from the lower surface side of FIG. 3, a base 13 having an outer diameter smaller than the outer diameter of the flange protrudes from the lower surface of the top surface 11 with flange, and the flange lower surface 17a and the base outer peripheral surface 1 are formed.
8a, a continuous rubber surface (shown by oblique lines) is formed, and the base 13 may have legs 14 projecting at the inner edge of the base outer edge flat surface 19a as shown, or a flat plate without legs. It may be. A synthetic resin film layer that does not contaminate the medicine is laminated on the surface other than the rubber surface of the base (including the leg). Therefore, a synthetic resin film can be laminated slightly over the base outer peripheral surface 18a from the base outer edge flat portion 19a side.

Further, in the pharmaceutical container assembly of the present invention, as shown in FIG. 1, a rubber stopper 10 is plugged on the container 2 and a cap 20 is further placed thereon, so that the rubber stopper 10 and the container 2 are fixed. The lower surface 17a of the top flange and the outer peripheral portion 18a of the base fit into the inner wall of the mouth of the container. That is, the flange lower surface 1 of the rubber surface
7a is in close contact with the upper edge surface 17b of the mouth of the container 2, and the base outer peripheral surface 18a is a cutout wall surface 1 provided on the inner wall of the mouth of the container.
The base outer edge flat surface 19a on which the synthetic resin film layer is laminated is tightly locked to the cutout bottom surface 19b. ADVANTAGE OF THE INVENTION According to this invention, the area of a rubber | gum raw surface part is large and sealing property improves. The width of the rubber surface corresponds to the upper edge surface 17b and the cutout wall surface 18b of the container, and is not particularly limited. According to experiments conducted by the inventors of the present invention, the width of the rubber surface is usually 18a.
(W in FIG. 2) and the width of 19a (H in FIG. 2)
Approximately 12 mm, preferably about 2 to 10 mm, sufficiently sealed and sealed. The part facing the medicine in the container is completely laminated with synthetic resin film and has a cut-out bottom 1
Since the synthetic resin film layer is also laminated on the base outer edge flat surface 19a that is in contact with the base material 9b, there is no problem of pharmaceutical contamination due to the rubber material. The invention is particularly advantageous for sealing pharmaceutical containers with large openings.

[0008]

EXAMPLES The present invention will be described in more detail with reference to the following Examples, but it should not be construed that the present invention is limited thereto. FIG.
FIG. 2 is a cross-sectional view showing one embodiment of the medicine container assembly of the present invention in a state where the medicine is filled and sealed. In FIG. 1, a medicine (FIG. 2) is placed inside a container 2 which is a vial bottle.
(Not shown in the figure).
On the surface facing the medicine, a rubber stopper 10 laminated with a synthetic resin film 15 that does not contaminate the medicine is stoppered and sealed,
A cap 20 covers the entire outer periphery of the rubber stopper 10, and the cap 20 is strongly locked to the lower surface 9 of the mouth flange of the container by an annular claw 22 provided on an inner wall of an open end 21 of the rubber stopper 10 so as to hold the rubber stopper 10 to the container. It is fixed to the main body 3.

FIG. 2 is a partial sectional view showing a state in which the medicine container assembly of FIG. 1 is separated into parts. In the container 2 of this embodiment, the inner and outer diameters of the container main body 3 decrease toward the opening 4 to form a neck, but an opening flange 6 is formed annularly on the outer peripheral surface of the opening 4. On the inner wall surface 8 of the mouth, an annular cutout 7 is provided from the upper edge surface of the opening 5 to the bottom surface of the container and parallel to the outer periphery of the opening. The upper edge surface 17b of the opening 5, the surface 18b substantially parallel to the opening outer wall of the notch 7, and the bottom surface 19b of the notch 7 have a stepped cross section in this embodiment.

On the other hand, the rubber stopper 10 shown in FIG.
A base 13 having an outer diameter smaller than the outer diameter of the top flange protrudes from the lower surface of the top surface 11 having the base 2, and a substantially cylindrical leg 14 protrudes from the inner edge of the outer flat surface 19a on the lower surface of the base.
FIG. 3 is a perspective view of the rubber stopper of FIG. 2 as viewed from the lower surface side of the top surface. The feature of the rubber stopper of the present invention is that
a, the base outer peripheral surface 18a has a cross-sectional shape corresponding to the cross section formed by the upper edge surface of the container 2 and the wall surface 18b of the notch 7, and the top flange lower surface 17a and the base outer peripheral surface 18
In a, a continuous rubber surface portion (a portion shown by oblique lines in FIG. 3)
However, a synthetic resin film layer 15 that does not contaminate the medicine is laminated on the surface of the base (including the legs) other than the rubber surface of the base outer peripheral surface 18a. Further, in this embodiment, the base outer peripheral surface 18a and the outer edge flat surface 19a
Is formed in a step shape corresponding to the wall surfaces 18b, 19b of the notch 7. The leg 14 has a notch 15 extending from the inner end of the container toward the top surface. The notch 15 is for facilitating the filling of the medicine.

When the rubber stopper 10 is plugged into the container 2, the container 2
The step formed by the notch in the inside, the top flange of the rubber plug, and the base can be fitted. That is, the lower surface 17a of the top flange of the rubber plug 10 is tightly engaged with the upper edge surface 17b of the opening, the outer peripheral surface 18a of the base is closely attached to the wall surface 18b of the container 2,
The base outer edge flat surface 19a is tightly locked on the bottom surface 19b. At this time, the top surface flange lower surface 17a and the base outer peripheral surface 1
Since 8a remains a continuous rubber surface, the sealing property is very high. Further, since the legs 14 are all laminated by the synthetic resin film layer 15 from the base outer edge flat surface 19a, even if the medicine stored in the container penetrates to the bottom surface 19b side of the cutout, the base outer edge flat surface 19a does not. Since there is no rubber surface, there is no risk of contamination. In addition, since the rubber surface portion is in close contact with the container in a wide area on both the wall surface and the upper edge surface of the notch 7, the sealing performance is greatly improved.

More specifically, the area of the rubber bottom surface of the lower surface 17a of the top flange and the outer peripheral surface 18a of the base is made substantially equal to the area of the upper edge surface 17b and the cutout wall surface 18b of the corresponding container 2. Specifically in FIG. 2, 1-5% greater than the vessel inside diameter R ₁ of the wall cutout a base lower outer diameter R _2. In addition, the depth H of the base outer peripheral surface 18a is equal to or larger than the depth h of the cutout wall surface 18b by up to 3%. Rubber stopper 1
0 is covered with a cap 20 after stoppering, and the open end 2 of the cap is
When the claws 22 provided on the inner wall surface of the container 1 are fixed to the lower surface 9 of the mouth flange of the container 2, the rubber stopper, which has been increased by 1 to 5% as described above, is pressed against the container opening 5 to provide a high degree of hermetic sealing. Can be realized.

A concave portion 23 provided at the center of the upper surface of the top surface of the rubber stopper 10 serves to reduce the thickness of the rubber stopper at the portion where the injection needle is inserted. Further, an annular projection 24 is provided to indicate the injection needle insertion position.

FIG. 4 shows another embodiment of the sealing plug according to the present invention, wherein the same reference numerals as in FIGS. 1 and 2 denote the same parts. In this embodiment, the top flange lower surface 17a and the base outer peripheral surface 18a have curved cross sections as shown, so that the area of the rubber element surface is larger, and the synthetic resin fine particle layer 25 is formed on the upper surface of the top surface 11. It is laminated to form fine irregularities (sea islands) and prevents the top surface 11 from sticking.

FIG. 5 is a sectional view showing a container 2 and a rubber stopper 10 of another embodiment of the pharmaceutical container assembly of the present invention. In the present embodiment, the container body 3 of the container 2 has the funnel-shaped opening 5 having a neck 26 formed at the lower part of the opening 5 and then increasing in diameter toward the opening. It is. A notch 7 is provided on the inner wall surface of the mouth flange 6, but the inner wall surface 8 of the mouth has a funnel shape. Corresponding to this funnel shape, the rubber plug 10 has a base 13 protruding from the lower surface of the top surface 11 having the top surface flange 12, and the top surface flange lower surface 17a and the base outer peripheral surface 18a are continuous rubber elementary surfaces. At the inner edge of the base outer edge flat surface 19a of the base 13, there is a leg 14 corresponding to the funnel shape of the inner wall surface of the mouth of the container 2, and the surface of the base (including the leg) excluding the rubber surface is used for the preparation of medicine. Is laminated with a synthetic resin film layer 15 which does not contaminate it. Reference numeral 16 denotes a cutout of the leg.

In the embodiment shown in FIG. 5, the width of the base outer edge flat surface 19a and the bottom surface 19b of the notch 7 of the container are larger than those of FIG. 1, but the width W of the rubber element surface portion 17a and the outer peripheral surface 18a of the base. Has a depth H of about 4 mm in total, and was sufficiently sealed and sealed. Further, the claw 22 of the cap 20 not shown is omitted.
Is very firmly fixed to a projection 6 ′ provided on the outer peripheral portion of the lower surface 9 of the mouth flange of the rubber plug 10.
0 and the container 2 can be fixed.

FIG. 6A is a sectional view showing a container 2 and a rubber stopper 10 of another embodiment of the pharmaceutical container assembly of the present invention. Although the container 2 forms a short neck 27 between the main body 3 and the opening 5, the inner wall surface of the mouth at the neck is substantially vertical. The mouth flange 6 is wide and long (depth), the width w of the upper edge surface 17b, the notch wall surface 18b
And the width m of the notch bottom surface 19b are both sufficiently large. Therefore, the lower surface 1 of the flange of the sealing rubber plug 10 is formed.
7a, the area of the continuous rubber surface formed by the base outer peripheral surface 18a is sufficiently large. In this embodiment, the base lower surface is flat and has no legs, but the rubber stopper is stably fitted into the container mouth. By closing the cap and locking the cap (not shown) to the lower surface 9 of the mouth flange with the claws 22, complete sealing can be achieved.

A synthetic resin film layer 15 which does not contaminate the medicine is laminated on the lower surface of the flat base 13.
A concave portion 23 for piercing the injection needle is provided on the upper surface, and an annular protrusion 28 is provided near the outer edge of the upper surface of the top surface to facilitate the cap tightening.

FIG. 6B shows another embodiment of the rubber stopper of the present invention applicable to the container 2 shown in FIG. In this example, a short leg is provided on the base 13, and the leg is inserted into the mouth inner wall surface 8 of the container 2 and crimped,
Furthermore, the sealing performance is improved. The concave portion 23 for puncturing the injection needle on the top surface 11 is formed large, and an annular protrusion 28 is formed as in the case of (A).

FIG. 7 is a sectional view showing the vicinity of an opening of a container 2 and a rubber stopper 10 of still another embodiment of the pharmaceutical container assembly of the present invention. In this embodiment, the opening 4 of the container 2 has an opening flange 6 in which the width w of the upper edge surface 17b with respect to the diameter of the opening 4 is very large. Therefore, notch bottom 1
The width m of 9b is considerably smaller than w. An elongated neck 27 is formed between the container body 3 and the opening 5,
The mouth inner wall surface 8 is substantially vertical. Corresponding to the shape of the opening 5, the rubber plug 10 has a top flange 12 having a wide top surface 11, a wide bottom surface 17 a having a wide width W, and a base portion 1.
The step portion 3 and the leg portion 14 have a stepped cross section, and are formed so that the stepped cross section structure and the mouth cutout can be fitted and adhered by stoppering. Top flange lower surface 17a and base outer peripheral surface 18a
Forms a continuous rubber surface, and a projection 28 is provided on the rubber surface of the base outer peripheral surface 18a. Therefore, the rubber stopper 10 is stoppered, and the rubber stopper 10 and the container 2 are fixed by a cap (not shown). , The rubber surface part is notched on the upper edge surface 17b and the wall surface 1
Pressing to 7c further improves the sealing performance.

In the rubber plug 10 of the embodiment shown in FIG. 7, the projection 28 can be held in a half-plugged state by engaging the projection 28 with the upper edge surface 17b. At this time, cutout 1 of leg 14
Since 6 is cut out above the position of the projection 28, a passage for chemical vapor such as vacuum drying can be formed. Further, since the center portion of the rubber plug is extremely thin due to the concave groove 23 and the notch 16 on the upper surface of the top surface, the rubber plug has a small resistance to injection needle stick. Further, unevenness 29 is provided on the upper surface of the top surface 11 in a sea-island shape or as a pattern to prevent sticking. 1 to 6 have the same meaning.

In the above description, as the pharmaceutical container assembly of the present invention, a notch is provided in the inner wall of the opening end of the pharmaceutical container, and the upper edge surface and the notched wall surface are continuous with the lower surface of the top surface flange of the rubber plug and the outer peripheral surface of the base. An example in which the rubber element surface is locked and adhered is shown, but the sealing plug (rubber stopper) of the present invention locks and adheres the lower surface of the top flange to the upper edge surface even when there is no notch in the container opening. Then, the base outer peripheral rubber element surface can be tightly pressed against the inner wall of the container mouth to seal the container mouth.

Next, the materials constituting the pharmaceutical container assembly of the present invention will be described. Examples of the material of the container for pharmaceuticals include glass, synthetic resin, and a composition thereof.
Conventionally, glass used in this type of field may be used as the glass. For example, an injection puncture vial (JIS3521) is shown in FIG.
This is a very advantageous glass container to which the present invention is applied, because the opening of the embodiment of the present invention has a notch of a similar form.

The synthetic resin used in the container of the present invention includes
For example, polycarbonate (PC), polymethylpentene (PMP), soft or crystalline polypropylene (P
P), polyethylene terephthalate (TEP), fluorine-based synthetic resin (PF), a synthetic resin containing a cyclic olefin-based compound or a crosslinked polycyclic hydrocarbon as a polymer component, and at least one selected from the compositions of these synthetic resins. Particularly preferred are mentioned.

Further, the aforementioned PC, PMP, PP, TE
On the inner surface and / or outer surface of the container body composed of one or more selected from P, PF, a synthetic resin containing a cyclic olefin compound or a crosslinked polycyclic hydrocarbon as a polymer component, and a composition of these synthetic resins, Ethylene vinyl alcohol (EV
OH), polyamide (including cyclic polyamide) (P
A) a container in which one or more layers selected from the group consisting of A), a liquid crystal polymer (LCP), polyethylene naphthalate (PEN), and polyacrylonitrile (PAN) are laminated in one or more layers is also particularly preferred. The pharmaceutical container according to the present invention is formed of glass or synthetic resin according to a known technique in this kind of technical field.

As the material used for the cap of the present invention,
Examples thereof include aluminum or a synthetic resin and a composition thereof. Examples of the synthetic resin include polyamide (PA), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polypropylene, potamethylpentene,
Polycarbonate, polyether / ether ketone, polyether ketone, polyacetal, modified polypropylene ether, cyclic olefin-based resin, and the like, and a composition in which a reinforcing agent, a bactericidal and antifungal agent, and other known additives are added to these synthetic resins. Objects and the like.

The rubber used for the plug (top surface, base, legs) of the rubber stopper of the present invention is, for example, a copolymer rubber (IIR) of isoprene and isobutylene, a halogenated rubber of IIR or a third component. Copolymer rubber (BIIR, CII
R, NBIIR), isoprene rubber (IR), butadiene rubber (BR), ethylene propylene copolymer rubber (EP
R), EPR rubber (EPD)
M), thermoplastic elastomer (TPO), styrene-isoprene rubber (SIR), solution-polymerized nitrile rubber (S
A crosslinked rubber having a composition containing (NBR) as a main component is particularly preferable.

Examples of the material of the synthetic resin film that does not contaminate the medicine to be laminated on the rubber stopper of the present invention include fluorine synthetic resin (PE), soft or crystalline polypropylene (P).
P), polyethylene phthalate (TEP), polycarbonate (PC), polymethylpentene (PMP), polyethylene containing ultrahigh molecular weight (including ultrahigh molecular weight polyethylene) (PE), olefin-based thermoplastic elastomer (OTPE), ethylene propylene Copolymer (EP
R), polyacetate (PAC), a polymer containing a cyclic olefin compound or a crosslinked polycyclic hydrocarbon compound as a polymer component, and one or more selected from these compositions. The thickness of the synthetic resin film lamination is 0.01-0.
About 5 mm is common.

Further, the combination of the above-mentioned drug container made of a synthetic resin, a rubber stopper laminated with a synthetic resin film that does not contaminate the drug, and a cap makes it possible to maintain the quality of the drug for a long period of time. Even when nitrogen gas or chlorofluorocarbon gas is replaced, complete sealing can be achieved.

An example of a method for forming a rubber stopper laminated with the synthetic resin film of the present invention is as follows. First, a compounding agent such as a cross-linking agent, a processing aid, a reinforcing agent, and the like are uniformly mixed with the synthetic rubber with a mixing kneader, and the mixture is parted into an appropriate thickness (5 to 20 mm). A synthetic resin film to be laminated is bonded according to a known technique. Next, according to the present invention, for example, a mold corresponding to the container opening as shown in FIGS. 2 and 5 to 7 is formed into a lower mold and an upper mold, and a synthetic resin film laminated on the lower surface in the mold. Rubber, a rubber sheet is superimposed on it, for example, mold temperature 140-200
C., mold pressure 30 to 100 kg / cm ² , pressurization for 12 to 6 minutes, etc., cross-linking, forming a rubber stopper, removing the rubber stopper from the mold, and adding laminated rubber stoppers one by one Cut and remove burrs. Thus, the rubber stopper of the present invention is obtained. Since the laminated rubber stopper of the present invention is required to have a high degree of hygiene, the rubber stopper is washed with an alkali, a detergent solution, and a water solution, vacuum dried, and sterilized before use.

[0031]

The sealing plug (rubber stopper) of the present invention has a large area of the rubber surface, and the rubber surface can be locked and adhered from the upper edge of the container opening to the inner wall surface of the container. The tightness of the container has been improved, and it can be applied particularly to a container having a wide open mouth and can be sufficiently sealed. Further, in the pharmaceutical container assembly of the present invention, the rubber surface portion is locked and adhered from the upper edge surface of the container mouth to the wall surface of the cutout of the container, and the flat surface of the rubber stopper base is locked and adhered to the cutout bottom surface. Very high sealing performance. Also, since the synthetic resin film layer is continuously laminated from the surface in contact with the notch bottom surface from the surface in contact with the container inner wall of the rubber stopper, the risk of contaminating the drug is eliminated,
ADVANTAGE OF THE INVENTION According to this invention, the medicine filled and stored in the container can hold | maintain with ensuring quality for a long term.

[Brief description of the drawings]

FIG. 1 is a schematic sectional view illustrating one embodiment of a pharmaceutical container assembly of the present invention.

FIG. 2 is a schematic explanatory view showing a state where the medicine container assembly of FIG. 1 is separated into respective parts.

FIG. 3 is a perspective view showing a state of a lower surface of a top surface of the sealing plug (rubber plug) of FIGS. 1 and 2;

FIG. 4 is a schematic sectional view showing another embodiment of the sealing plug (rubber plug) of the present invention.

FIG. 5 is a schematic sectional view showing a rubber stopper and a container mouth of another embodiment of the medicine container assembly of the present invention.

FIG. 6 is a schematic sectional view showing a rubber stopper and a container mouth of another embodiment of the medicine container assembly of the present invention.

FIG. 7 is a schematic sectional view showing a rubber stopper and a container mouth of another embodiment of the medicine container assembly of the present invention.

[Explanation of symbols]

1 pharmaceutical container assembly,
2 container, 3 container body, 4 open mouth,
5 opening, 6 opening flange,
6 'projection, 7 notch, 8
Mouth inner wall surface, 9 Mouth flange lower surface, 10
Rubber stopper, 11 top, 12 top flange, 13 base, 14 legs, 1
5 synthetic resin film lamination, 16 leg cutout,
17a Top flange lower surface, 17b Upper edge surface, 18a
Base outer peripheral surface, 18b notch wall surface, 19a base outer edge flat portion, 19b notch bottom surface, 20 cap, 21 open end, 22 nail,
23 concave groove 24 annular projection, 25
Synthetic resin fine particle layer, 26
Neck, 27 neck, 28 annular projection.

Claims (11)

[Claims] 1. A rubber stopper having a top surface with a flange that is locked to an upper edge surface of an opening of a container for a medicine, and a base protruding from a lower surface of the top surface and inserted into the opening. The bottom surface of the base and the outer peripheral surface of the base at least a surface following the lower surface of the flange is a continuous rubber surface, and the surface excluding the rubber surface of the base is laminated with a synthetic resin film that does not contaminate pharmaceuticals, and the rubber A sealing plug for a pharmaceutical container, wherein a bare surface portion is sealed to an upper edge surface of the opening portion and an inner wall surface following the upper edge surface to seal the opening portion. 2. The lower surface of the base has a flat plate shape, or at least an annular flat surface provided on an outer edge thereof, and has a leg projecting from an inner edge of the annular flat surface. The sealed stopper of the pharmaceutical container according to the above. 3. A pharmaceutical container assembly comprising a pharmaceutical container, a rubber stopper for tightly sealing an opening of the container, and a cap for covering the rubber stopper and for fixing and locking the rubber stopper and the container body. Has an annular notch extending from the upper edge surface of the opening to the inner wall surface and parallel to the outer periphery of the opening, and the rubber stopper projects from the top surface with a flange that is locked to the upper edge surface and the lower surface of the top surface with the opening. A base portion to be inserted into the portion, at least a surface of the lower surface of the flange and an outer peripheral surface of the base portion following the lower surface of the flange is a continuous rubber surface, and the surface of the base portion excluding the rubber surface portion is used for pharmaceutical products. A synthetic resin film that does not contaminate is laminated, and the base lower surface is provided with an annular flat surface at least on the outer edge,
The rubber surface portion is tightly fitted to the upper edge surface of the opening and the cutout wall surface following the upper edge surface, and the outer edge portion of the lower surface of the base is tightly locked to the bottom surface of the notch to seal the opening. A pharmaceutical container assembly, wherein the assembly is stopped. 4. The base lower surface has a cylindrical or notched cylindrical leg protruding at an inner edge of the annular flat surface,
4. The pharmaceutical container assembly according to claim 3, wherein said leg is fitted on an inner wall surface following the notch of said container. 5. The pharmaceutical container assembly according to claim 3, wherein the inner wall of the mouth following the cutout of the container has a cylindrical shape or a funnel shape. 6. The pharmaceutical container assembly according to claim 3, wherein an uneven pattern is formed on the top surface of the rubber stopper or a synthetic resin fine particle layer is laminated. 7. The width of the annular surface where the rubber surface on the lower surface of the top flange of the rubber stopper and the upper edge surface of the container mouth contact each other is 2 to 12 mm. A pharmaceutical container assembly according to claim 1. 8. The rubber stopper according to claim 1, wherein the rubber stopper is isoprene-isobutylene copolymer rubber or a halide thereof, a copolymer of isoprene-isobutylene copolymer rubber and a third component, isoprene rubber, butadiene rubber, ethylene-propylene copolymer rubber or ethylene. 8. A rubber composition mainly comprising a rubber obtained by copolymerizing propylene and a third component, a thermoplastic elastomer, a styrene-isoprene rubber, and a solution-polymerized nitrile rubber. A pharmaceutical container assembly according to any one of the above. 9. Synthetic resins that do not contaminate pharmaceuticals are fluorine-based synthetic resins, polypropylene, polyethylene terephthalate, polycarbonate, polymethylpentene, polyethylene, olefin-based thermoplastic elastomers, ethylene-propylene copolymers, polyacetates, and cyclic olefin-based resins. The pharmaceutical container assembly according to any one of claims 3 to 8, comprising at least one selected from a compound or a synthetic resin containing a crosslinked polycyclic hydrocarbon compound as a polymer component. 10. The container body is made of at least one selected from the group consisting of polycarbonate, polymethylpentene, polypropylene, polyethylene terephthalate, a fluorine-based synthetic resin, a cyclic olefin-based compound or a synthetic resin containing a crosslinked polycyclic hydrocarbon as a polymer component. The pharmaceutical container assembly according to any one of claims 3 to 9, wherein: 11. The container according to claim 9, wherein ethylene vinyl alcohol, polyamide, liquid crystal polymer, polyethylene naphthalate, and polyacrylonitrile are laminated on the inner surface and / or outer surface of the container body. The pharmaceutical container assembly according to any one of claims 10 to 13.