JPH10260U - Rubber stopper for pharmaceuticals - Google Patents

Abstract

(57) [Summary] [Problem] To provide a medicine rubber stopper in a form suitable for use as a container capable of holding a medicine at a high quality for a long period of time and a stopper of a medical device. In addition, the present invention provides a rubber plug which is easy to be plugged in a manufacturing process and has no floating. SOLUTION: In a rubber stopper including an upper top plate having a flange and a body inserted into a container opening formed on a lower surface of the top plate, an outer peripheral portion of the rubber stopper directly below the lower surface of the top plate. Each having 3 to 7 annular projections, each of which forms a band-shaped projection having a width of 2 to 20 mm, and the outer diameter of the projection is 4 to 10% of the inner diameter of the container. A rubber stopper for pharmaceuticals characterized by being large.

Description

[Detailed description of the invention]

[0001]

[Technical field to which the invention belongs]

 The present invention relates to rubber stoppers for pharmaceuticals used in medical containers and medical devices.The rubber stoppers of the present invention can be used as a part of containers and medical devices that can hold pharmaceuticals with high quality for a long period of time. It is.

[0002]

[Prior art]

 Regarding infusions of pharmaceutical containers, the “48th Rubber Plug Test Method for Infusions” and standard values of the 12th Revised Japanese Pharmacopoeia are specified. Regarding other containers for pharmaceutical powders, many rules and requirements are presented from a medical point of view, and they reach as many as 30 items. In order to respond to many of these high demands, the rubber stopper must satisfy the heat resistance, elasticity, and low distortion and improve the medical hygiene. In an inactive resin film (Japanese Utility Model Publication Nos. 44-5751, 44-27753, 45-17831, and 49-21346), Japanese Patent Publication Nos. 52-1355, 54-9119. JP-A-57-53184, JP-A-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 invention]

 In many cases, it can be improved by laminating a resin film on the surface of the above rubber stopper, but unsatisfactory points still remain. It is the fitting between the container mouth and the rubber stopper. This fitability relates to the workability of the drug formulation process and the sealability after formulation, but cannot be improved to satisfy both under the same conditions. As one proposal, there is a technology (Japanese Utility Model Laid-Open Publication No. 61-2233 and Japanese Utility Model Publication No. 61-31441) in which the outer periphery of the upper end of the body at the lower surface of the flange is made a rubber surface and an annular projection is provided on the surface. FIG. 6 shows a cross-sectional view of an example of a rubber plug according to this type of prior art. A trunk 8 and a leg 9 are provided following a top plate 4 having a flange 6 above the rubber plug. It has one small projection 27. Reference numeral 11 denotes a needle sticking position, 13 denotes a resin film laminated on the leg, and 24 denotes a tooth-shaped projection provided on the leg. In such conventional rubber stoppers, a lubricant such as oil or silicone oil is applied to the surface of the rubber stopper to improve the adhesion between the rubber stoppers or the movement of the stoppers, thereby improving the workability of the preparation process, Operability has been improved. However, this lubricant has poor adhesion to the rubber stopper surface, peels off from the rubber surface during the packaging and movement of the rubber stopper and becomes fine particles, and becomes a foreign substance when formulating a drug, and is difficult to operate machinery and equipment. Not only is it a factor that causes abnormalities, it also becomes a toxic substance when it enters the human body with medicines, which is a very serious hygiene problem. The present invention improves the workability and operability in the drug formulation process, and is particularly suitable for the production of freeze-dried products, and can be adhered to the container mouth without using a lubricating oil and with a small stopper force. It is an object of the present invention to provide a rubber stopper having a good sealing property at a container opening, in which the stopper does not move such as floating.

[0004]

[Means for Solving the Problems]

 As a means for solving the above-mentioned problems, the present invention relates to a rubber stopper comprising a top plate having an upper portion having a flange and a body inserted into a container opening formed on the lower surface of the top plate. The outer peripheral portion has 3 to 7 annular projections on the outer peripheral portion immediately below the lower surface of the top plate portion, and the annular projections form a band-shaped projection portion having a width of 2 to 20 mm as a whole. Provided is a rubber stopper for medicine, wherein the diameter is 4 to 10% larger than the inner diameter of the container.

[0005]

[Embodiment of the invention]

 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. FIGS. 1A and 1B are schematic cross-sectional views of specific examples of the rubber stopper of the present invention. In the trunk 8 of the rubber plug 3, a projection 10 having a plurality of projections is provided on the outer periphery of the trunk 8 immediately below the lower surface 7 of the flange 6 of the top plate 4, and the projection 10 is provided. Reference numeral 10 comprises a plurality of annular projections. The example of FIG. 1A has three annular projections 14, 15, and 16, and the example of FIG. 1B has five annular projections 17, 18, 19, 20, 21.

In the present invention, as shown in FIGS. 1 (a) and 1 (b), three to seven annular projections are provided in parallel with the outer periphery of the body just below the lower surface of the top plate. The tip of the projection may have an acute angle as shown in FIG. 2A, or may have a circular tip as shown in FIG. 2B. Although not shown, the tip may have a trapezoidal shape. In the present invention, the above-mentioned 3 to 7 annular projections are provided so as to have a width of 2 to 10 mm as a whole on the outer periphery of the same. In addition, in the present invention, the outer diameter of the tip of the protruding portion of the body portion of the rubber stopper from the container opening is formed so as to be 4 to 10% larger than the inner diameter of the container opening.

[0007] By providing the projection portion 10 having three to seven projections, that is, having three to seven annular small projections in the form of a strip on the outer periphery of the trunk portion immediately below the flange 6, the rubber plug is provided. It can be easily inserted into the container mouth, and can be completely inserted into the container mouth with a small force when plugging the rubber stopper.After insertion, it can adhere to the inner wall of the container mouth and seal the contents well, Airtightness can be maintained. In addition, when the rubber stopper of the present invention is used for a freeze-dried preparation, etc., the degree of 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 carbon dioxide, the rubber stopper is used by the gas pressure. Does not emerge.

The shape of the protrusion on the outer periphery of the body of the present invention is not limited as long as the rubber stopper is of 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 container mouth. It can be applied to rubber stoppers, and is very effective for rubber stoppers having 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. 1A as an example. FIG. 3 shows a specific example of the present invention. In addition, a 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 as shown in FIG. The slidability, fitability, and adhesion of these have been improved.

FIG. 4 shows a rubber stopper for a freeze-dried preparation according to a specific example of the present invention, in which a resin film 13 is laminated on the medicine surface 12 and the top surface, and FIG. (A) Three annular projections 14, 15, 16 similar to (a) are provided, and the leg 9 on which the resin film 13 is laminated is largely cut out, and the tooth-shaped projection 24 is provided on the outer surface of the leg 9 to freeze. This is an example in which the position of the rubber stopper in the drying step can be fixed stably.

As shown in FIG. 5, the medical rubber stopper of the present invention is such that a medicine 2 is placed in a container 1, the rubber stopper 3 of the present invention is inserted into the container mouth 5, and an aluminum cap 25 is wound thereon. Tighten the product. When the medicine in the container 1 is used, purified water for injection is injected with a syringe needle (not shown) from the injection needle piercing portion 11 at the center of the flange 6 of the rubber stopper 3 to dissolve the medicine 2, and the solution Is administered to the human body with a syringe or the like.

The rubber stopper of the present invention has a shape suitable for the injection needle piercing position. That is, as shown in FIG. 1 and FIGS. 3 to 5, the injection needle insertion position 11 is formed in a shallow concave portion, and the opposite surface of the injection needle insertion position 11, that is, the medicine surface 12 is provided with a large recess 26, so that the needle insertion portion 11 is formed. The thickness of the rubber is reduced to prevent rubber tear. However, the rubber stopper 3 may be provided with legs 9 following the body 8 so as to widen the surface so that the contact surface with the inner wall of the container opening 5 is widened.

As a material of the rubber stopper of the present invention, isoprene-isobutylene copolymer rubber (IIR) having heat resistance, oxidation resistance, water resistance, moisture permeation resistance, oxygen permeation resistance and being inert to chemicals is used. ), Halogenated IIR (CIIR, BIIR), isoprene rubber (IR), butadiene rubber (BR), styrene-butadiene rubber (SBR), ethylene propylene terpolymer (EPDM) and the like. In addition, the present invention is also applied to elastic bodies, that is, rubbers, thermoplastic elastomers and the like. For these rubbers, a vulcanizing agent, a vulcanization accelerator, a reinforcing agent, a processing aid, and the like are mixed with a rubber material, and heated and pressed to form a rubber stopper having a shape as shown in FIGS. .

[0013]

[Examples 1 to 4 and Comparative Examples 1 to 4]

 As shown in the table, rubber stoppers for freeze-dried preparations of the present invention having the respective shapes shown in FIGS. 1, 2 and 4 were stoppered in a medicine container having an inner volume of 100 ml and a bottle inner diameter of 22.0 ± 0.1 mm. . The material of the rubber stopper is IIR, the length of the rubber stopper is 30 ± 3 (JIS K6301), the diameter of the trunk 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). 25 rubber stoppers were prepared and stoppered, and the average of the measured values was determined. The results are shown in Table 1. Plug tapping force: Measured using a tension-type rubber tensile tester (manufactured by Shimadzu Corporation). Number of lifted plugs: plugged at normal temperature and normal pressure, and observe the condition after 24 hours. Vacuum retention test: Closed at a vacuum of 10 ± 1 Torr, immediately tightened the aluminum cap, and sampled after 30 days. The degree of vacuum in the inside was measured with an electronic manometer (manufactured by Toyota Koki Co., Ltd.). For comparison, a rubber element with no projection (conventional product), one projection, no projection, the entire body was laminated with resin, silicone oil was applied to the rubber element without projection, and each of 25 rubber stoppers Was stoppered 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, with the rubber stopper of the present invention, the plugging operation to be inserted into the container mouth can be performed with a small force, and the rubber stopper does not float on the container mouth or tilt after being plugged. It is an excellent rubber stopper that has a low rate of air entry after it is stoppered in a vacuum, like a freeze-dried preparation.

[0016]

[Effect of the invention]

 As can be seen from the results of the above Examples and Comparative Examples, the rubber stopper for pharmaceuticals of the present invention can be plugged with a small pressing force into the vial mouth, and can be reliably and completely plugged. It is a rubber stopper that fits on the inner wall of the container opening without floating above the container opening, and has a shape with extremely good sealing performance. Therefore, it is possible to manufacture pharmaceuticals stably and maintain high quality for a long time.

[Brief description of the drawings]

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

FIGS. 2A and 2B are schematic explanatory views showing various shapes of an annular band having a plurality of projections on the outer periphery of a trunk portion of the rubber stopper of the present invention, and FIG.
Shows an example in which the cross section of the tip of the projection has an acute angle shape, and (b) shows an example in which the cross section of the tip of the projection has a circular shape.

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

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

[Description of sign]

 DESCRIPTION OF SYMBOLS 1 Container 2 Medicine 3 Rubber stopper 4 Top plate part 5 Container opening 6 Flange 7 Lower surface of top plate part 8 Body part 9 Leg part 10 Protrusion part 11 Needle stab position 12 Drug surface 13 Resin film 14 Annular projection 15 Annular projection 16 Annular projection 17 Annular Projection 18 Annular projection 19 Annular projection 20 Annular projection 21 Annular projection 24 Leg-shaped projection 25 Aluminum cap 26 Depression 27 Small projection

Claims (1)

[Utility model registration claims] 1. A rubber stopper comprising an upper top plate having a flange and a body inserted into a container opening formed on the lower surface of the top plate, wherein the body is an outer periphery immediately below the lower surface of the top plate. Portion has three to seven annular projections, each of which forms a band-shaped projection having a width of 2 to 20 mm, and the outer diameter of the projection is 4 to 10 from the inner diameter of the container opening. A rubber stopper for pharmaceuticals, characterized in that the stopper is large.