JPH0626876U - Rubber stopper for medicine - Google Patents

Abstract

(57) [Summary] [Purpose] To provide a rubber stopper for medicines used for medicine containers and medical devices. A rubber stopper comprising an upper top plate portion having a flange and a body part formed in a lower surface of the upper top plate part and inserted into a container opening, wherein the body part is provided on an outer peripheral portion immediately below the lower surface of the top plate part. A rubber stopper for pharmaceuticals, comprising a plurality of annular or mesh-shaped protrusions, wherein the protrusions have an outer diameter slightly larger than the inner diameter of the container opening. The rubber stopper of the present invention is easy to stopper in the formulation process, etc., and has a secure fit to the inner wall of the container mouth and a tight seal of the container, so that pharmaceuticals can be manufactured safely and kept in high quality for a long time. can do.

Description

[Detailed description of the device]

[0001]

[Industrial applications]

 The present invention relates to a container for medicines, a rubber stopper for medicines used in medical devices, and the rubber stopper of the present invention can be used as a container that can hold medicines in high quality for a long period of time, and as one component of medical equipment. Is.

[0002]

[Prior art]

 Among the drug containers, regarding the infusion solution, the “48 Rubber stopper test method for infusion solution” and the standard value of the 12th revised Japanese Pharmacopoeia are defined. Regarding other pharmaceutical powder containers, many regulations and requirements have been presented from a pharmaceutical standpoint, and they have reached 30 items. In order to meet many of these high-level requirements, the rubber stopper has a surface that contacts pharmaceuticals and liquid chemicals in order to satisfy the heat resistance, elasticity, and low distortion and to improve the medicinal hygiene. Is laminated with an inert resin film (Japanese Utility Model Publication Nos. 44-5751, 44-27753, 45-17831, 49-21346, Japanese Patent Publications 52-1355, 54-9119). 57-53184, 63-43104, JP-A-61-272134, JP-A-2-23961, JP-A-3-136820, JP-A-3-143446, and JP-A-4-2362).

[0003]

[Problems to be solved by the device]

 There are many points that can be improved by laminating a resin film on the surface of the above rubber plug, but there are still unsatisfactory points. It is the fitting property of the container mouth and the rubber stopper. This fitting property is related to the workability of the drug formulation process and the sealing property after formulation, but it cannot be improved to satisfy both under the same conditions. As one proposal, there is a technique in which the outer circumference of the upper end of the body on the lower surface of the flange is a rubber surface and an annular projection is provided on the surface (Japanese Utility Model Laid-Open Nos. 61-2233 and 61-31441). FIG. 6 shows a cross-sectional view of an example of a rubber stopper according to the prior art of this kind. A top plate portion 4 having a flange 6 at the top of the rubber stopper is provided with a body portion 8 and leg portions 9 and a body portion 8 is provided. It has one small protrusion 27. Reference numeral 11 is a needle stick position, 13 is a resin film laminated on the leg portion, and 24 is a tooth-shaped projection provided on the leg portion. In such conventional rubber stoppers, a lubricant such as oil or silicone oil is applied to the surface of the rubber stoppers so that the rubber stoppers can adhere to each other or the stoppers can be moved smoothly. The operability is improved. However, this lubricant has poor adhesiveness to the rubber stopper surface, peels off from the rubber surface during packaging and movement of the rubber stopper, and becomes fine particles. Not only is it a factor causing abnormalities, but it becomes a poisonous substance when it enters the human body together with drugs, which is a very hygienic problem. INDUSTRIAL APPLICABILITY The present invention improves the workability and operability in the drug formulation process, and is particularly suitable for the production of freeze-dried formulations. It is an object of the present invention to provide a rubber stopper having a well-sealed shape at the container opening, which does not cause movement such as lifting of the stopper.

[0004]

[Means for Solving the Problems]

 As a means for solving the above problems, the present invention relates to a rubber stopper comprising an upper top plate portion having a flange and a body portion inserted into a container mouth formed on the lower surface of the top plate portion. The drug product is characterized in that the portion has a plurality of annular or mesh-like protrusions on the outer peripheral portion immediately below the lower surface of the top plate portion, and the outer diameter of the protrusion portion is slightly larger than the inner diameter of the container mouth. Provide a rubber stopper for.

[0005]

[Action and Example]

 The shape of the rubber stopper for pharmaceuticals according to the present invention will be described with reference to FIG. 1 showing an embodiment of the present invention, and FIGS. 1A and 1B are schematic cross-sectional views of a specific example of the rubber stopper of the present invention. In the body portion 8 of the rubber stopper 3, a protrusion portion 10 having a plurality of protrusions is provided on the outer periphery of the body portion 8 immediately below the lower surface 7 of the flange 6 of the top plate portion 4. 10 is composed of a plurality of annular protrusions. The example of FIG. 1 (a) has three annular projections 14, 15, 16 and the example of FIG. 1 (b) has five annular projections 17, 18, 19, 20, 21.

In the present invention, as shown in FIGS. 1 (a) and 1 (b), a plurality of annular projections may be provided parallel to the outer periphery of the body immediately below the lower surface of the top plate. As shown in (c) and (d) of FIG. 2, which is a schematic illustration of the embodiment, the small projections alternately form peaks (projections) and valleys (recesses) to form a mesh-like projection 22. , 23, and the strip-shaped projection portion 10 having the entire width may be provided on the outer periphery of the body portion. In FIGS. 2 (c) and 2 (d), the shaded portions mean peaks (protrusions), and the white portions mean valleys (recesses). In the mesh-shaped projections, the mesh direction may be the vertical and horizontal directions as shown in FIG. 2 (c), or the oblique directions as shown in FIG. 2 (d). For the sake of simplification in the figure, one protrusion that is one point of the mesh is shown as a protrusion with a square shape, but the shape is not limited to this, and various protrusions of various cross-sectional shapes can be assembled. Is. The tip shape of the protrusion may be such that the tip has an acute angle as shown in FIG. 2A, or the tip may have a circular shape as shown in FIG. 2B. Although not shown, the tip may have a trapezoidal shape. The same applies to the tip shape of the mesh-shaped projections. In the present invention, it is practically preferable that the plurality of annular projections or mesh-shaped projections described above are provided on the outer circumference of the same portion so as to have a width of 2 to 10 mm. Of course, the present invention is effective even outside this range. Further, in the present invention, the outer diameter of the tip of the protruding portion of the body portion of the rubber stopper is slightly larger than the outer diameter of the container, but preferably the outer diameter is 4 to 10% larger.

In this way, a plurality of projections are provided, that is, three to seven annular small projections are provided in a strip shape, or vertical and horizontal mesh-like projections or inclined mesh-like projections are provided in a strip shape. By providing the protruding portion 10 on the outer circumference of the body immediately below the flange 6, the rubber stopper can be easily inserted into the container opening, and the rubber stopper can be completely inserted into the container opening with a small force. After that, the contents can be closely adhered to the inner wall of the container mouth to seal the contents well, and the airtightness can be maintained for a long time. In addition, when the rubber stopper of the present invention is used for freeze-dried preparations, etc., the vacuum retention in the preparation process is improved, and even when the inside of the container is replaced with a gas such as nitrogen or carbonic acid gas, the rubber stopper is caused by the gas pressure. Never rises.

The above-mentioned protrusion shape of the outer periphery of the body of the present invention is not limited to any type of rubber stopper as long as it is a type including a top plate with a flange and a body formed on the lower surface of the top plate and inserted into the mouth of the container. It can be applied to rubber stoppers, and is also very effective for rubber stoppers that have legs following the trunk. The application of the protruding portion according to the present invention to various rubber stoppers will be described by taking the annular protrusion shown in FIG. 1 (a) as an example. FIG. 3 shows a specific example of the present invention. Also, since the resin film 13 is laminated on the top surface and the surface of the body 8 is provided with three ring-shaped projections 14, 15 and 16 similar to those in FIG. The slippage, fitability, and adhesion are improved.

FIG. 4 shows a rubber stopper for a freeze-dried preparation, which is a specific example of the present invention, in which a resin film 13 is laminated on the drug surface 12 and the top surface, and a rubber blank is formed on the outer circumference of the body portion. The same three annular protrusions 14, 15 and 16 as in (a) above are provided, and further, the leg portion 9 having the resin film 13 laminated thereon is largely cut out, and the tooth-shaped protrusion 24 is provided on the outer surface of the leg portion 9 to freeze. This is an example in which the position of the rubber stopper during the drying process can be fixed stably.

As shown in FIG. 5, the rubber stopper for pharmaceuticals of the present invention puts the drug 2 in the container 1, plugs the rubber stopper 3 of the present invention into the container mouth 5, and wraps the aluminum cap 25 on it. Tighten to make a product. When using the drug in the container 1, purified water for injection is injected with an injection needle (not shown) from the injection needle puncture portion 11 at the center of the flange 6 of the rubber stopper 3 to dissolve the drug 2 and the solution. Is administered to the human body using a syringe or the like.

The rubber stopper of the present invention has a shape suitable for the injection needle insertion position. That is, as shown in FIGS. 1 and 3 to 5, the injection needle stick position 11 is formed in a shallow concave portion, and a large recess 26 is provided on the surface opposite to the needle stick position 11, that is, on the medicine surface 12, so that the needle stick portion 11 is formed. The thickness of the rubber is thin to prevent the rubber from breaking. However, in order to widen the contact surface with the inner wall of the container port 5, the rubber plug 3 may be provided with the leg portion 9 following the body portion 8 to widen the surface.

The material of the rubber stopper of the present invention is isoprene-isobutylene copolymer rubber (II R, which has heat resistance, oxidation resistance, water resistance, moisture permeation resistance, oxygen permeation resistance and is inert to chemicals. ), Halogenated IIR (CIIR, BIIR), isoprene rubber (IR), butadiene rubber (BR), styrene-butadiene rubber (SBR), ethylene propylene terpolymer (EPDM), etc. It is also applicable to other elastic bodies, such as rubbers and thermoplastic elastomers. To these rubbers, a rubber material is mixed with a vulcanizing agent, a vulcanization accelerator, a reinforcing agent, a processing aid, and the like, which is heated and pressed to form a rubber stopper having a shape as shown in FIGS. 1 to 4. .

Examples 1 to 6 and Comparative Examples 1 to 4 In a drug container having an internal capacity of 100 ml and a bottle inner diameter of 22.0 ± 0.1 mm, as shown in the table, as shown in FIGS. The rubber stopper for freeze-dried preparation of the present invention in each shape was capped. The material of the rubber stopper is IIR, the thickness of the rubber stopper is 30 ± 3 (JISK6301), the diameter of the body of the rubber stopper is 22.6 ± 0.2 mm, and the diameter of the small protrusion of the rubber stopper is 23.0 ± 0.2 mm ( 4.5% larger than the body diameter). Twenty-five rubber stoppers were prepared and capped, and the average of the measured test values was obtained and shown in Table 1. Plugging force of stopper: Measured using a tension type rubber tensile tester [Shimadzu Corporation]. Number of lifted plugs: Cap at room temperature and pressure and observe the condition after 24 hours Vacuum retention test: Plug at a vacuum of 10 ± 1 Torr, quickly wrap the aluminum cap, and inspect for 30 days. The degree of vacuum inside was measured with an electronic manometer [manufactured by Toyota Koki Co., Ltd.]. Also, for comparison, a rubber blank surface without protrusions (conventional product), one protrusion, no protrusion, the entire body was laminated with resin, silicone oil was applied to the rubber blank surface without protrusions, and 25 rubber plugs each for ~ Was capped in the same medicine container as above and evaluated in the same manner. The results are also shown in Table 1.

[0014]

[Table 1]

As shown in Table 1, in the rubber stopper of the present invention, the tapping operation to be inserted into the container mouth can be performed with a small force, and the rubber stopper does not float up on the container mouth or tilt after being capped. It is an excellent rubber stopper that does not allow air to enter after it has been stoppered in a vacuum like freeze-dried preparations.

[0016]

[Effect of device]

 As shown by the results of the above Examples and Comparative Examples, the pharmaceutical rubber stopper of the present invention can be stoppered with a small pressing force into the medicine bottle mouth, and can be surely and completely stoppered. It is a rubber stopper that fits to the inner wall of the container mouth without floating above the container mouth and has a shape with extremely good sealing performance. Therefore, it is possible to stably manufacture pharmaceutical products and maintain high quality for a long time.

[Brief description of drawings]

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

FIG. 2 is a schematic explanatory view showing various shapes of an annular band body having a plurality of protrusions on the outer periphery of the body portion of the rubber plug of the present invention, FIG.
Is an example in which the tip cross section of the protrusion has an acute angle shape, (b) is an example in which the tip cross section of the protrusion is circular, (c) is an example in which peaks and troughs of the projection are continuously formed vertically and horizontally to form a mesh pattern, d) represents an example showing an example in which peaks and valleys of protrusions are obliquely continuously formed to repeatedly form a mesh pattern.

FIG. 3 is a schematic cross-sectional view showing an example of a resin laminated rubber stopper which is another embodiment of the rubber stopper of the present invention.

FIG. 4 is a schematic cross-sectional view showing an example of a rubber stopper for freeze-dried preparations, which is another embodiment of the rubber stopper of the present invention and is laminated with a resin.

FIG. 5 is a schematic explanatory view showing a state in which the rubber stopper of the present invention is applied to a container.

FIG. 6 is a schematic sectional view showing a conventional rubber plug.

[Explanation of sign]

 DESCRIPTION OF SYMBOLS 1 container 2 drug 3 rubber stopper 4 top plate part 5 container mouth 6 flange 7 top plate part lower surface 8 body part 9 leg part 10 protrusion part 11 needle stick position 12 drug surface 13 resin film 14 annular protrusion 15 annular protrusion 16 annular protrusion 17 annular Protrusions 18 Annular protrusions 19 Annular protrusions 20 Annular protrusions 21 Annular protrusions 22 Mesh protrusions 23 Mesh protrusions 24 Leg teeth protrusions 25 Aluminum caps 26 Recesses 27 Small protrusions

Claims (1)

[Scope of utility model registration request] 1. A rubber plug comprising an upper top plate portion having a flange and a body portion inserted into a container opening formed on the lower surface of the top plate portion, wherein the body portion has an outer periphery immediately below the lower surface of the top plate portion. A rubber stopper for pharmaceuticals, characterized in that it has a plurality of annular or mesh-shaped projections on its part, and the projections have an outer diameter slightly larger than the inner diameter of the container opening.