JP2002306569A - Rubber stopper for medical use - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prevent tight adhesion between the top face flange and the top face when a stopper is fully driven by preventing adhesion between medical rubber stoppers and securing transportation property in a parts feeder. SOLUTION: The medical stopper is provided with the top face flange 1 having a piercing part 1a and a flange part 1b, a stopper leg 2 which is projected on the lower surface of the top face flange 1 and fitted into a medical vessel opening and adhesion preventing projections 7 radially arranged in an outer periphery part on the upper surface of the top face flange 1. Each projection 7 is shorter in an outer edge direction side or an inner edge direction side compared with the other when viewed from a vertically upper part and is provided with a top face which is inclined downward in the inner edge direction or the outer edge direction when viewed in a horizontal direction.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a rubber stopper for a medical container, and more particularly to a medical stopper for sealing and closing a mouth of a vial for storing a freeze-dried preparation.

[0002]

2. Description of the Related Art Medical rubber stoppers applied to the mouth of pharmaceutical containers are required to have high quality and physical properties. For example, the quality characteristics required of a medical rubber stopper that seals or closes the opening of a vial storing antibiotics and other preparations conform to the 13th edition of the Japanese Pharmacopoeia Rubber Infusion Rubber Plug Test. Should. Furthermore, medical rubber stoppers that seal the opening of vials include gas permeation resistance, non-elution properties, high cleanliness, chemical resistance, needle stick resistance, self-sealing properties, high sliding properties, etc. Item is required.

[0003] A rubber stopper for lyophilization is used as a part of a container for a lyophilized preparation, like a vial. The rubber stopper for freeze-drying has a top flange having a puncturing portion that allows a syringe needle of a syringe to be pierced, a flange portion in contact with the upper end surface of the medical container opening, and a stopper leg inserted into the medical container opening. It is composed.

[0004] The preparation for freeze-vacuum drying is required to prevent contact with moisture and air, and to prevent the invasion of moisture and air from the outside during the sealed storage, or to maintain the airtightness inside the vial. In addition, isobutylene / isoprene copolymer (butyl rubber) or the like is generally used as a material for medical rubber stoppers. Then, when administering the drug to the patient, the injection needle for injecting the drug solution is punctured into the puncture part of the stopper and used.

In order to obtain a preparation by freeze-drying method, a vial is filled with a predetermined amount of a drug solution, and a rubber stopper having an opening on a stopper leg is provided in an opening of the vial so that water vapor of the drug solution can easily pass therethrough. It is mounted in a half-plugged state, stored in a shelf in a freeze-drying cabinet, and freeze-vacuum-dried while maintaining the inside of the freeze-drying cabinet at a predetermined temperature and vacuum. Freeze-vacuum drying in a freeze-drying chamber is usually performed at a temperature of −30 to −45 ° C. and a drug solution is frozen.
Degree of vacuum 1 to 0.03 Torr and temperature -20 ° C to +3
Maintain at 0 ° C. and perform primary drying within the range of 12 to 36 hours. Further, the temperature is maintained at + 20 ° C to + 40 ° C,
The freeze-drying of the preparation is completed by secondary drying within a range of 6 hours.

Next, the interior of the freeze-drying chamber is pressurized with nitrogen at normal pressure (−300).
mmH ₂ O〜0), the rubber stopper is pressed by a stainless steel pressing plate on the freeze-drying shelf, and is completely inserted into the mouth of the vial and plugged. The plugging conditions at this time are as follows: pressing force 1 to 5 kg per vial, pressing time 1 to 20
Generally, the number of pressing times is about 1 to 2 times. The vial in which the rubber stopper has been completely closed is taken out of the freeze-drying cabinet, transported to the next step, and an aluminum cap is wound around the rubber stopper, stoppered to obtain a preparation. The vials used include a straight vial, an inverted taper vial, and a closure stop vial that has improved hop-up prevention and airtightness due to differences in mouth shape.

[0007] A medical rubber stopper sometimes comes into close contact with the rubber stopper during washing or sterilization. If the rubber stopper is in close contact with the rubber stopper during cleaning or sterilization, cleaning and sterilization may not be sufficient at the close contact area, and it is necessary to prevent the medical rubber stoppers from sticking to each other. is there.

[0008] In a medical rubber stopper, there is a case where the rubber stopper and the cap wound around the rubber stopper are in close contact with each other. When the cap and the rubber stopper are in close contact with each other, the cap and the rubber stopper are in close contact with each other and it is difficult to remove the cap and the rubber stopper.

In addition, when a medical rubber stopper is transported by a parts feeder, it is necessary to improve transportability.

For this purpose, a plurality of projections are evenly arranged on the outer peripheral portion of the top surface of the rubber plug. FIG. 12 is a schematic diagram of a medical rubber stopper according to the related art, and is a diagram described from above vertically. The protrusion 47 provided on the medical rubber stopper according to FIG.
Is substantially rectangular when viewed from above vertically. FIG. 13 shows a top flange 41 of the medical rubber stopper according to FIG.
13 (a) is a view of the projection 47 as viewed from above vertically, and FIG. 13 (b) is a view of the projection 47 as viewed from the horizontal direction. FIG.

A plurality of projections 47 arranged on the top surface of the rubber plug
As a result, it was possible to prevent the products from sticking together at the time of washing or the like. In addition, strong adhesion between the cap and the rubber stopper was prevented, and the cap and the rubber stopper could be easily removed. In addition, when transported by the parts feeder, the transportability of the medical rubber stopper could be improved.

However, the effect of preventing the close contact between the top surface flange and the top plate at the time of full stoppering in the freeze-drying chamber was not sufficient. In other words, in the freeze-drying chamber, when performing the entire stoppering, the top surface flange and the top plate may be in close contact with each other, and in such a case, when the top plate is lifted, the vial bottle is simultaneously lifted with the top plate. Become. If the vial is lifted with the top plate, the vial may fall, and if the vial falls, the contents may be scattered due to damage. In particular, in the case of a medical rubber plug in which the fingering portion of the top flange is formed in a step-down shape, the top flange and the top plate may be in close contact with each other at all times. AGVs (automated guided vehicles) for loading and unloading vials into and out of the freeze-drying cabinet
When が is used, disturbance of the row of vials, falling bottles, or broken bottles in the freeze-drying chamber becomes a serious problem.

Therefore, it is conceivable that a circular arc-shaped projection is provided on the outer peripheral portion of the upper surface of the top flange of the medical rubber plug. However, even when an arc-shaped projection is provided on the outer peripheral portion of the upper surface of the top flange, the degree of achievement of the effect of preventing adhesion is often affected by the hardness of the rubber and the size of the arc-shaped projection. . Therefore, depending on the hardness of the rubber and the size of the arc-shaped projection, the arc-shaped projection may be crushed at the time of full plugging, and when the arc-shaped projection is crushed, the top flange and the top plate may be crushed. The contact area between the top surface flange and the top plate may be in close contact with each other.

Therefore, a technique has been proposed in which the height of a protrusion provided on the outer peripheral portion of the upper surface of the top flange of the medical rubber stopper is relatively high. However, even when a relatively high protrusion is provided on the outer peripheral portion of the upper surface of the top flange, at the time of full plugging, when the top plate is pressed against the top flange,
The projection sometimes fell. Therefore, when the load at the time of tapping was released, the vial sometimes moved due to the twisting of the projection. In addition, there is a problem that a problem occurs when the aluminum cap is wound over from above.

On the other hand, as a technique for preventing the top flange and the top plate from adhering to each other at the time of full stoppering in the freeze-drying chamber, a technique of laminating a plastic film on the top face of the top flange of the medical rubber stopper is proposed. Have been. According to this technique, the top plate does not come into close contact with the plastic film during the entire stoppering, so that the top surface flange and the top plate can be prevented from sticking to each other. However,
Laminating the plastic film on the top flange increases the manufacturing cost of the medical rubber stopper. In addition, when a medical rubber stopper in which a plastic film is laminated on the upper surface of the top flange, when the injection needle is fingered on the fingering portion, the plastic film deflowers, and the deflowered portion is not resealed. Therefore, a medical rubber stopper in which a plastic film is laminated on the upper surface of the top flange has a problem in resealability at the time of puncturing.

[0016]

SUMMARY OF THE INVENTION The present invention has been made to solve the above-mentioned problems, and prevents medical rubber stoppers from adhering to each other during washing, sterilization, etc., and ensures transportability in a parts feeder. Another object of the present invention is to provide a medical rubber stopper which can prevent the adhesion between the top flange and the top plate at the time of full stoppering in the freeze-drying chamber.

[0017]

According to a first aspect of the present invention, there is provided a medical rubber stopper comprising a puncturing portion which allows a syringe needle of a syringe to be punctured and a flange portion which is in contact with an upper end surface of a medical container opening. A top flange having the top flange, a plug leg protruding from the lower surface of the top flange and fitted into the mouth of the medical container, and a protrusion for preventing adhesion arranged radially on the outer periphery of the upper surface of the top flange. A medical rubber stopper, wherein the projection is one of an outer edge side or an inner edge side shorter than the other when viewed from above vertically, and when viewed from the horizontal, an inner edge or outer edge direction. The medical rubber stopper is a hill-shaped projection having a top surface inclined and lowered toward any one of them.

Further, the medical rubber stopper according to the present invention, as described in claim 2, has a top surface flange having a puncturing portion capable of puncturing the injection needle of the syringe and a flange portion in contact with the upper end surface of the medical container opening. A medical rubber plug having a plug leg protruding from the lower surface of the top flange and fitted into the mouth of the medical container, and a protrusion for preventing adhesion radially arranged on the outer peripheral portion of the upper surface of the top flange. Wherein the projection has a triangular shape when viewed from above vertically, and a hill-shaped projection having a top surface inclined and lowered in one of an inner edge direction and an outer edge direction when viewed from a horizontal direction. Which is a medical rubber stopper.

According to a third aspect of the present invention, there is provided a medical rubber stopper according to the first or second aspect, wherein the number of the protrusions is 4 to 12. .

[Action] As described in claim 1, the medical rubber stopper according to the present invention has a puncture portion that allows a syringe needle of a syringe to be punctured and a flange portion that contacts the upper end surface of the medical container opening. A medical device having a top flange, a plug leg protruding from a lower surface of the top flange and fitted into the mouth of the medical container, and a protrusion for preventing adhesion arranged radially on an outer peripheral portion of an upper surface of the top flange. In the rubber stopper, when viewed from above vertically, either one of the outer edge side or the inner edge side is shorter than the other, and when viewed from the horizontal direction, the inner edge or the outer edge direction. It is a hill-shaped projection having a top surface inclined and lowered toward any one of them.

[0021] When viewed from vertically above, one of the side edges in the outer edge direction and the inner edge direction side is shorter than the other. Therefore, the projection has a taper portion in a vertical direction from the outer edge to the inner edge or from the inner edge to the outer edge on both sides when viewed from above vertically.

Further, the projection has a top surface which is inclined downward in one of the inner edge direction and the outer edge direction when viewed from the horizontal direction. That is, the projection has a tapered portion in horizontal view from the outer edge to the inner edge or from the inner edge to the outer edge even when viewed from the horizontal direction.

Further, in the medical rubber plug according to the present invention, the projection has a triangular shape when viewed from above vertically, and has an inner edge direction when viewed from horizontal. Alternatively, it is a hill-shaped projection having a top surface inclined and lowered in one of the outer edge directions.

The protrusion has a triangular shape when viewed from above vertically, and both oblique sides of the triangle are tapered portions in a vertical view.

Further, the projection has a top surface which is inclined downward in one of the inner edge direction and the outer edge direction when viewed from the horizontal direction. That is, the projection has a tapered portion in horizontal view from the outer edge to the inner edge or from the inner edge to the outer edge even when viewed from the horizontal direction.

As described above, in the medical rubber stopper according to the present invention, the projection provided on the top surface flange is vertical in both the invention described in claim 1 and the invention described in claim 2. It is a hill-shaped projection having a tapered portion both when viewed from above and when viewed from the horizontal direction.

Therefore, in the medical rubber stopper according to the present invention, when the top flange is pressed against the top plate at the time of full plugging, the top plate comes into contact with the top flange at the hill portion of the hill-shaped projection. I do. That is, when the top flange is pressed against the top plate at the time of full plugging, the top plate contacts the top flange at a portion where the taper portion in the horizontal direction has a high taper. For this reason, when pressure is applied by the top plate, a gap is formed around the projection, and the rubber stopper top surface does not become a suction cup, so that it does not adhere. In this way, when the top flange is pressed against the top plate during full tapping, the contact area of the portion that receives the maximum pressure can be reduced, and the top flange becomes a suction cup and adheres tightly. It is possible to prevent it.

On the other hand, in the medical rubber stopper according to the present invention, when the top flange is released from the pressing force by the top plate, the top plate gradually releases the contact from the hill portion of the hill-shaped projection and from the top flange. Is done. That is, the contact of the top plate from the top flange is gradually released from the tapered portion of the tapered portion in the horizontal view. When the pressure on the top plate is released, the repulsive force of the projection not only causes the top plate to separate along the taper portion in horizontal view, but also causes the top plate to slide along the taper portion in vertical view, and Since it separates from the face flange, it does not adhere to the top plate. In this way, when the pressing force of the top plate is released from the top flange, the rubber repulsion force
Since the pressure is gradually released from the highest part of the hill-shaped protrusion, it does not adhere to the top plate.

The number of protrusions provided on the top flange of the medical rubber stopper according to the present invention is preferably 4 to 12 as described in claim 3. If the number of projections is less than 4, the adhesion between the top flange 1 of the rubber plug and the cap can be prevented to some extent, but the adhesion between the top flange and the pressing plate tends to be inferior. This is because the adhesion between the stopper and the cap may be insufficient.

[0030]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 is a schematic view of a specific example of a medical rubber stopper according to the present invention. At the center of the top surface flange 1 is provided a puncturing portion 1a that allows a syringe needle of a syringe to be punctured. The diameter of the top flange is 10 to 32 mm.

FIG. 2 shows the medical rubber stopper according to FIG.
FIG. 3 is a cross-sectional view taken along a plane '′, and is a diagram illustrating a medical rubber stopper according to the present invention from a horizontal side direction. Top flange 1
Is provided with a puncturing portion 1a that allows a syringe needle of a syringe to be punctured, and a flange portion 1b that is in contact with the upper end surface of the medical container opening. Further, below the top flange 1, there is provided a stopper leg 2 which projects from the lower surface of the top flange 1 and is fitted into the mouth of the medical container.

FIG. 3 is a view for explaining the medical rubber plug according to the present invention from the horizontal side by viewing the medical rubber plug in FIG. 2 from the direction of arrow C.

FIG. 4 is a view for explaining the projections 7 arranged on the outer peripheral portion of the upper surface of the top flange of the medical rubber stopper according to the present invention. Among them, FIG. FIG. 4B is a view of the protrusion 7 viewed from the horizontal direction.

As shown in FIG. 4A, the projection 7
When viewed from vertically above, it has a substantially trapezoidal shape, and includes an outer edge side 7b, an inner edge side 7c, and a tapered portion 7a in a vertical direction. In this embodiment, the inner side 7c is shorter than the outer side 7b.

As shown in FIG. 4 (a), corners at respective boundaries between the outer side 7b, the inner side 7c, and the tapered portion 7a in the vertical direction in an equilateral trapezoidal shape. Is formed in a rounded round shape. The height of the isosceles trapezoid is shown as a width 7g.
Also, as shown in FIG. 4A, the outer edge direction side 7b and the inner edge direction side 7c in the isosceles trapezoid are:
Each of them can be formed by an arc indicated by a radius R. In this embodiment, the projection 7 is formed in a substantially equilateral trapezoidal shape, but is not limited to this shape.

As shown in FIG. 4B, the projection 7
It has a trapezoidal shape when viewed from the horizontal direction. The trapezoidal shape includes a tapered portion 7d in a horizontal view, an outer edge 7e, an inner edge 7f, and a width 7g. Further, as shown in FIG. 4B, the corners at the boundaries between the tapered portion 7 d, the outer side 7 e, and the inner side 7 f in the trapezoidal shape are rounded. Although it is formed in a shape, it is not limited to this shape.

Assuming that the diameter of the top flange is 10 to 32 mm, the side edge 7b in the outer edge direction is 1.0 to 4.0 in the shape of a trapezoid of an equal leg when the projection 7 is viewed from vertically above.
mm. Outer edge side 7b is:
If the diameter is smaller than 0 mm, it is difficult to properly prevent the top surface flange from becoming a suction cup and closely adhering when pressed against the top plate during full stoppering. . On the other hand, if the outer edge direction side 7b is larger than 4.0 mm, the area where the top plate and the top surface flange come into contact with each other at the time of full plugging may increase. In addition, when the protrusion 7 is viewed from above vertically, in an equilateral trapezoidal shape, the inner edge side 7c is preferably 3.0 mm or less. On the other hand, the inner edge side 7c is
If it is larger than 3.0 mm, the area where the top plate and the top surface flange come into contact with each other at the time of full tapping may increase.

When the projection 7 is viewed from the horizontal direction,
In the trapezoidal shape, the outer edge 7e is preferably 0.5 mm or more. When the outer edge 7e is smaller than 0.5 mm, when the stopper is fully pressed,
This is because close contact of the top flange is expected. Further, in the trapezoidal shape when the protrusion 7 is viewed from the horizontal direction, the inner side portion 7f is preferably from 0 to 1.0 mm. When the inner side 7c is larger than 1.0 mm, the top plate may be in close contact with the top plate due to an increase in the area of contact between the top plate and the top plate flange during full plugging. Because it is possible.

FIG. 5 is a schematic view of another specific example of the medical rubber stopper according to the present invention, and is a diagram which is described from above vertically. The protrusion 17 provided on the medical rubber stopper according to FIG. 5 is different from the protrusion 7 provided on the medical rubber stopper according to FIG. , And are symmetrically configured.

FIG. 6 is a view for explaining the projections 17 arranged on the outer peripheral portion of the upper surface of the top flange of the medical rubber stopper shown in FIG. 5, and FIG. FIG. 6B is a view of the protrusion 17 viewed from the horizontal direction.

As shown in FIG.
Is substantially trapezoidal in shape when viewed from above vertically, and is configured to include an outer edge side 17b, an inner edge side 17c, and a tapered portion 17a in a vertical direction. In this embodiment, the inner side 17c is longer than the outer side 17b.

As shown in FIG. 6 (a), a trapezoidal shape with an equal leg, an outer edge side 17b, and an inner edge side 17c
The corner at the boundary between the tapered portion 17a and the vertical-view tapered portion 17a can be formed in a rounded round shape, but is not limited to the round shape. The height of the isosceles trapezoid is shown as a width 17g.

As shown in FIG. 6B, the protrusion 17
Has a trapezoidal shape when viewed from the horizontal direction. And
The trapezoidal shape has a tapered portion 17d in horizontal view and an outer side portion 17e.
And an inner side portion 17f and a width portion 17g.

The projection 17 'as another embodiment of the projection 17 shown in FIG. 5 can be constituted as follows. That is, the projection 17 ′ has a substantially equilateral trapezoidal shape when viewed from above vertically, and has an outer edge side, an inner edge side, and a taper portion in a vertical direction, and is configured to have an inner edge side. The side is longer than the side in the outer edge direction. The projection 17 ′ has a trapezoidal shape when viewed from the horizontal direction, and the trapezoidal shape is configured to have a tapered portion in a horizontal view, an outer side portion, an inner side portion, and a width portion. The side is configured to be higher than the inner side. FIG. 7 shows a state in which the projections 17 'configured as described above are provided on the top flange and cut along AA' corresponding to FIG.

As described above, the projection according to the present invention has the first
As a configuration, when viewed from above vertically, the outer edge direction side is longer than the inner edge direction side, and when viewed from the horizontal direction, when it is a hill-shaped projection having a top surface inclined and lowered toward the inner edge direction, As a second configuration, when viewed from vertically above, the outer edge side is shorter than the inner edge side, and when viewed from the horizontal direction, when it is a hill-shaped projection having a top surface inclined and lowered toward the outer edge Or, as a third configuration, a hill-shaped projection having a top surface inclined downward toward the outer edge when viewed from vertically above, the outer edge side is longer than the inner edge direction, and when viewed from the horizontal direction. In some cases, or as a fourth configuration,
When viewed from vertically above, the side edge in the outer edge direction may be shorter than the side edge in the inner edge direction, and when viewed from the horizontal direction, it may be a hill-shaped projection having a top surface inclined and lowered toward the inner edge direction.

FIG. 8 is a schematic view of another specific example of the medical rubber stopper according to the present invention, and is a view which is described from above vertically. The protrusion 27 provided on the medical rubber stopper according to FIG. 8 has a substantially isosceles triangle shape when viewed from above vertically.

FIG. 9 is a view for explaining the projections 27 arranged on the top flange of the medical rubber stopper shown in FIG. 8, and FIG. 9A is a view of the projections 27 as viewed from above vertically. FIG. 9B is a view of the protrusion 27 viewed from the horizontal direction.

As shown in FIG.
Has a substantially isosceles triangle shape when viewed from above vertically,
It is configured to have a bottom side 8a and a tapered portion 8b (generating line 8b) in a vertical view. The width, which is the height of the substantially isosceles triangle, is indicated by 8c.

As shown in FIG. 9A, the angle at the boundary between the base 8a and the two tapered portions 8b, 8b in a substantially isosceles triangle is defined as:
It is also possible to form a rounded round shape.
In this embodiment, the projection 27 is formed in a substantially isosceles triangle, but is not limited to this shape.

As shown in FIG.
Has a substantially trapezoidal shape when viewed from the horizontal direction. The substantially trapezoidal shape includes a tapered portion 8d in horizontal view and an outer edge 8.
e, an inner side portion 8f, and a busbar 8b. Further, as shown in FIG. 9 (b), in the trapezoidal shape, the corner at the boundary between the tapered portion 8d in horizontal view, the outer edge 8e, and the inner edge 8f is rounded. It is also possible to form in shape.

FIG. 10 is a schematic view of another specific example of the medical rubber stopper according to the present invention, and is a view which is described from above vertically.
The projection 37 provided on the medical rubber stopper according to FIG. 10 has a substantially isosceles triangle shape when viewed from above vertically. The protrusion 37 provided on the medical rubber stopper according to FIG.
The projection 27 provided on the medical rubber stopper according to the above is inverted and replaced.

FIG. 11 is a view for explaining the protrusion 37 arranged on the top flange of the medical rubber stopper shown in FIG.
Among them, FIG. 11A is a diagram of the protrusion 37 viewed from above vertically, and FIG. 11B is a diagram of the protrusion 37 viewed from horizontal direction.

As shown in FIG. 11A, the protrusion 37
Has a substantially isosceles triangle shape when viewed from above vertically,
Bottom 18a, tapered portion 18b in vertical view (bus 18b)
And is configured. The width, which is the height of the approximately isosceles triangle, is indicated by 18c.

As shown in FIG. 11A, the boundary between the base 18a and the two tapered portions 18b, 18b in a substantially isosceles triangle is formed to be angular. However, it is also possible to make the corners round.

As shown in FIG. 11B, the protrusion 37
Has a square shape when viewed from the horizontal direction. The rectangular shape includes a tapered portion 18d in a horizontal view, an outer edge 18e, an inner edge 18f, and a bus 18b. Further, as shown in FIG. 11B, the trapezoidal shape has a tapered portion 18d in a horizontal view and an outer edge portion 18d.
Although each boundary between e and the inner side 18f is formed to be angular, the corner may be formed in a round shape.

FIG. 14 is a diagram showing a pressure distribution in a state where the top flange of the medical rubber stopper is pressed by the pressing plate.
Among them, (a) is a pressure distribution when the top flange 1 of the medical rubber plug according to the present invention is pressed by the pressing plate, and (b) is a top flange 4 of the conventional medical rubber plug.
1 is a pressure distribution in a state where 1 is pressed by a pressing plate. FIG.
In FIG. 4, the part where the color is dark is a part where pressure is applied, the part where the color is light is a part where pressure is weak, and the part where the color is white is a part where pressure is not applied. Here, the measurement of the pressure distribution on the top flange was performed by placing a pressure-sensitive paper on the top flange and using a vacuum plug tester to lower the pressing plate from above and plug the rubber plug. . When the diameter of the top flange is 19φ, 1
A pressure of 5 kgf was applied per vial.

The top surface flange 1 of the medical rubber plug according to the present invention has an inner edge side shorter than the outer edge side when viewed from above vertically, and is directed toward the inner edge direction when viewed from the horizontal direction. A hill-shaped projection 7 having a top surface inclined and lowered is provided. On the other hand, the top flange 41 of the conventional medical rubber plug is provided with a substantially rectangular protrusion 47 which is substantially rectangular when viewed from above vertically and also when viewed from the horizontal direction.

As shown in FIG. 14 (b), in the conventional medical rubber stopper, pressure is applied almost uniformly over the entire top surface flange 41.

As shown in FIG. 14B, in the conventional medical rubber stopper, there is no passage for the air to escape from the puncture part to the outside through the base of the projection.

On the other hand, as shown in FIG. 14A, in the medical rubber stopper according to the present invention, pressure is applied to the projection 7 and the portion between the projections 7. The pressure is applied differently in each part. In particular, the periphery of the projection becomes a portion where the pressure is low, and forms a passage through which air escapes from the puncture portion to the outside through the base of the projection, that is, a gap that does not adhere to the top plate.
Therefore, in the medical rubber stopper according to the present invention, when the top flange is pressed against the top plate at the time of full tapping, the contact area of the portion receiving the maximum pressure can be reduced, and the top flange is sucker. Thus, it is possible to prevent adhesion.

Top flanges 1, 11, 2 of medical rubber stopper
It is possible to apply a coating having excellent slidability to the upper surfaces of the rubber members 1 and 31 for the purpose of improving and improving the adhesiveness which is a basic property of the rubber. Top flange 1, 11, 2
There is a possibility that a trace amount of the silicone coated on 1, 31 may be transferred to the formulation machine or into the medical container and cause a foreign matter of fine particles. The amount of coating can be reduced.

[0062]

EXAMPLE As an example, nine materials in which a medical rubber stopper according to the present invention was half-tapped in a vial were prepared. on the other hand,
As a comparative example, nine vials were prepared by half-stopping the medical rubber stopper according to the present invention. Nine samples were set on a stopper tester with a SUS mirror-finished top plate. And
All stoppers were performed with a load of 5 kgf per vial. 20
After being left in a pressurized state for minutes, the pressure was released, and the adhesion between the top surface flange and the top plate was observed.

A protrusion having the shape shown in FIG. 4 is provided on the top flange of the medical rubber stopper according to the present invention. That is, a projection 7 having a substantially trapezoidal shape when viewed from above vertically and a substantially trapezoidal shape when viewed from the horizontal direction is provided on the upper surface of the top flange. The diameter of the top flange is 19φ. In the isosceles trapezoidal shape viewed from vertically above, the side in the outer edge direction was 2.0 mm and the side in the inner edge direction was 1.0 mm. In addition, a round portion is provided at a corner portion in the trapezoidal shape of an equal leg. In the trapezoidal shape viewed from the horizontal direction, the outer side is 0.8 mm and the inner side is 0.1 mm.
4 mm.

As comparative examples, comparative examples 1 and 2 were prepared. In Comparative Example 1, four semi-cylindrical protrusions were uniformly arranged radially on the upper surface of the top flange. Also, in Comparative Example 2, the arc-shaped protrusion was 6 mm on the upper surface of the top flange.
The pieces were evenly arranged radially.

[0065] The medical rubber stopper according to the example was tested for 10 tests.
I went there. The results are shown in Table 1 below. Comparative Example 1
Each of the medical rubber stoppers according to Comparative Example 2 and the medical rubber stopper was tested five times. The results are shown in Table 2 below. As a result of the test, whether there is no close contact between the top flange and the top plate,
It was examined whether there was no movement of the vial in which the medical rubber stopper was sealed, and whether there was turbulent movement of the row of vials in which the medical rubber stopper was sealed. And when it corresponded to them, it was shown as "the number of moved bottles" in the table below.

[0066]

[Table 1]

[0067]

[Table 2]

The rubber stopper for medical use according to the present invention has three rows and three rows, a total of nine vials are arranged, and even when the test is performed 10 times, the top flange is not released even after the pressure is completely released. No adhesion between the glass and the top plate was observed, and the vial was 9
None of the books were in close contact with each other, and no disturbance of the vial rows or movement of the bottles was observed. On the other hand, in the case of the medical rubber stopper according to Comparative Example 1, the test was performed five times, and as a result, the adhesion between the top flange and the top plate was observed at all plugging. Disorders and movements were observed in the vial rows. Similarly, in the case of the medical rubber stopper according to Comparative Example 2, the test was performed five times, and as a result, the adhesion between the top flange and the top plate was observed when the pressure was released after all stoppers were completed. Furthermore, after all stoppering was performed, turbulence and movement were observed in the row of vials.

It should be understood that the embodiments and examples disclosed this time are illustrative in all aspects and not restrictive. The scope of the present invention is defined by the terms of the claims, rather than the description above, and is intended to include any modifications within the scope and meaning equivalent to the terms of the claims.

[0070]

According to the medical rubber stopper of the present invention, when viewed from above vertically on the outer peripheral portion of the upper surface of the top flange, one of the outer edge side and the inner edge direction side is shorter than the other. When viewed from the horizontal direction, a unique configuration is employed in which hill-shaped projections having a top surface inclined and lowered in one of the inner edge direction and the outer edge direction are arranged. Due to its unique configuration, it is possible to prevent the medical rubber stoppers from sticking together during washing, sterilization, etc., and to ensure the transportability of the parts feeder, and furthermore, to ensure that At the time of tapping, a medical rubber stopper capable of preventing the adhesion between the top flange and the top plate could be provided. As described above, the medical rubber stopper according to the present invention has a further effect while securing the effects of the conventional medical rubber stopper, and the medical rubber stopper according to the present invention brings about the advantages brought to the industry. It is immeasurable.

[Brief description of the drawings]

FIG. 1 is a view for explaining a medical rubber stopper according to the present invention from above vertically.

FIG. 2 is a diagram illustrating a medical rubber stopper according to the present invention from a horizontal direction.

FIG. 3 is a view for explaining a medical rubber stopper according to the present invention from a horizontal direction.

FIG. 4 is a view for explaining a projection arranged on a top flange of the medical rubber stopper according to the present invention, wherein (a)
Is a view of the projection as viewed from above vertically, and (b) is a view of the projection as viewed from the horizontal direction.

FIG. 5 is a diagram illustrating a medical rubber stopper according to another embodiment of the present invention from above vertically.

FIG. 6 is a view for explaining a projection arranged on a top flange of a medical rubber plug according to another embodiment of the present invention, wherein (a) is a view of the projection as viewed from above vertically;
(B) is the figure which looked at the protrusion from the horizontal direction.

FIG. 7 is a view illustrating a medical rubber stopper according to another embodiment of the present invention from a horizontal direction.

FIG. 8 is a view for explaining a medical rubber stopper according to another embodiment of the present invention from above vertically.

FIG. 9 is a view for explaining a projection arranged on a top flange of a medical rubber plug according to another embodiment of the present invention, wherein (a) is a view of the projection as viewed from above vertically;
(B) is the figure which looked at the protrusion from the horizontal direction.

FIG. 10 is a diagram illustrating a medical rubber stopper according to another embodiment of the present invention from above vertically.

FIG. 11 is a diagram illustrating a projection disposed on a top flange of a medical rubber stopper according to another embodiment of the present invention;
Among them, (a) is a view of the projection viewed from above vertically,
(B) is the figure which looked at the protrusion from the horizontal direction.

FIG. 12 is a view for explaining a conventional medical rubber stopper from above vertically.

FIG. 13 is a view for explaining projections arranged on a top flange of a conventional medical rubber stopper, in which (a)
Is a view of the projection as viewed from above vertically, and (b) is a view of the projection as viewed from the horizontal direction.

14A and 14B are diagrams illustrating a pressure distribution state on a top flange, in which (a) is a pressure distribution on the top flange of the medical rubber stopper according to the present invention, and (b) is a comparative example. It is a pressure distribution on the top flange of the medical rubber plug.

[Explanation of symbols]

1, 11, 21, 31, 41 Top flange, 2 plug legs, 7, 17, 27, 37, 47 protrusions.

 ──────────────────────────────────────────────────続 き Continued on the front page F term (reference) 3E084 AA12 AB05 BA01 CA01 CC03 DA01 DB13 DC03 FA09 FC07 GA08 JA20 LA30 LD30

Claims (3)

[Claims] 1. A top surface flange having a puncturing portion capable of puncturing a syringe needle of a syringe and a flange portion in contact with an upper end surface of a medical container opening; And a protrusion for preventing adhesion radially disposed on the outer peripheral portion of the upper surface of the top flange, the medical rubber plug comprising: One of the side or the inner edge direction side is shorter than the other, and when viewed from the horizontal direction, it is a hill-shaped projection having a top surface that is inclined downward in either the inner edge direction or the outer edge direction. Rubber stopper. 2. A top surface flange having a puncturing portion capable of piercing a syringe needle of a syringe and a flange portion in contact with an upper end surface of a medical container opening; And a protrusion for preventing adhesion radially arranged on the outer peripheral portion of the upper surface of the top flange. A medical rubber stopper, which is a hill-shaped projection having a top surface inclined and lowered in one of an inner edge direction and an outer edge direction when viewed from a horizontal direction. 3. The medical rubber stopper according to claim 1, wherein the number of the protrusions is 4 to 12.