JP2003128095A - Medicinal rubber stopper and production method therefor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a rubber stopper ensuring a desired forming accuracy and having small needle stick resistance even if it is a production model rubber stopper, and also to provide a production method therefor. SOLUTION: The rubber stopper has a structure where a concave portion 12 for a needle stick is formed in a central part of the upper surface in a flange part 11 and a ceiling surface 25 in a central hollow part 24 of the foot 20 is positioned at a side below a lower surface 16 of the flange part 11.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical rubber stopper having a leg portion covered with a resin film and a method for producing the same.

[0002]

2. Description of the Related Art Conventionally, as a medical rubber stopper, a laminated rubber stopper for medical use described in JP-B-5-64062 is known. That is, "a rubber stopper having an annular leg that can be fitted into the container mouth and a flange portion that contacts the upper surface of the container mouth, the upper end outer peripheral base of the leg portion that contacts the inner surface of the container mouth is a rubber element surface, and a fluorine-based material. The resin film is not laminated on the upper end outer peripheral base of the leg portion but is laminated only on the entire surface of the leg portion other than that, the central portion of the leg portion is hollow, and the height of the hollow portion is equal to that of the outer periphery of the leg portion. A medical rubber stopper that is higher than the upper edge of the laminated fluororesin film "
Is.

However, in the above-mentioned pharmaceutical rubber stopper,
If the thickness of the needle stick portion is reduced in order to obtain a rubber stopper having a low needle stick resistance, it is difficult to mold with a desired molding accuracy in a mass production type in which a large number of pieces are taken. On the other hand, in order to obtain a desired molding accuracy, it is necessary to increase the thickness of the needle stick portion, which causes a problem of increasing needle stick resistance.

In view of the above problems, it is an object of the present invention to provide a rubber plug having a small needle stick resistance and a method for manufacturing the rubber plug while ensuring a desired molding accuracy even in a mass-produced rubber plug. .

[0005]

In order to achieve the above object, a needle stick stopper according to the present invention has a flange portion in contact with an upper surface of a container opening, and an annular shape projecting from a lower surface of the flange portion so as to be press fit into the container opening. In the medical rubber stopper, wherein at least a part of the leg portion is covered with a resin film, a recess for needle stick is formed in the central portion of the upper surface of the flange portion, and the central hollow portion of the leg portion is formed. The ceiling surface of is located below the lower surface of the flange portion.

Therefore, according to the present invention, the needle stick portion is formed at a position lower than the upper surface of the flange portion, and the needle stick resistance can be reduced without reducing the thickness of the needle stick portion. Further, since it is not necessary to form the needle stick portion thinly, desired molding accuracy can be secured.

Further, as an embodiment, the depth of the needle sticking recess may be 0.3 mm or more, and may be half or less of the thickness dimension of the flange portion. Furthermore, as another embodiment,
The gap from the lower surface of the flange portion to the end portion of the resin film may be 0.3 mm or more. Then, as another embodiment, the gap from the ceiling surface of the central hollow portion to the end portion of the resin film may be 0.5 mm or less.

Further, in the method for producing a medical rubber stopper according to the present invention, a resin film and an unvulcanized rubber sheet are sequentially stacked on a lower die having a core portion forming a central hollow portion, and the first upper portion is formed. After primary molding by heating and pressing with a mold, the burrs are cut and removed from the primary molded product connected by burrs, and then the primary molded product is inserted into the cavity of the lower mold and positioned, Further, it may be a manufacturing method including a step of stacking unvulcanized rubber sheets and heating and pressurizing them in a second upper mold for secondary formation.

According to the present invention, since the secondary molding is performed with the same lower mold, not only the mold cost can be saved, but also by using the same cavity of the lower mold, the positional deviation can be effectively performed. There is an effect that it can be prevented and a rubber plug with high molding accuracy can be obtained.

[0010]

BEST MODE FOR CARRYING OUT THE INVENTION An embodiment of a medical rubber stopper according to the present invention will be described with reference to the accompanying drawings of FIGS. 1 to 11. The first embodiment according to the present invention is, as shown in FIGS. 1 and 2, a rubber plug 10 including a flange portion 11 and a substantially annular leg portion 20 projectingly provided on a lower surface of the flange portion 11. is there.

As the material of the rubber plug 10 according to this embodiment, for example, materials such as butyl rubber, halogenated butyl rubber, brominated isobutylene / p-methylstyrene copolymer, isoprene rubber, polybutadiene rubber and the like can be used.

The flange portion 11 has a substantially disc shape, and a needle piercing recess 12 is formed in the central portion thereof. The bottom surface of the concave portion 12 has a continuation for identifying the needle stick portion 13,
Alternatively, a discontinuous annular ring 14 is formed.
Further, on the upper surface of the flange portion 11, the concave portion 1
Protrusions 15 are provided on the periphery of 2 at an equal pitch.

As shown in FIGS. 2A and 2B, the leg portion 20 has an annular base portion 21 on the outer periphery slightly protruding, and a lower end edge portion on the outer periphery is an annular tapered surface 22. Further, projections 23 are provided on the lower end portion of the leg portion 20 at equal pitches (FIG. 1B). Further, the ceiling surface 25 of the central hollow portion 24 of the leg portion 20 is located below the lower surface 16 of the flange portion 11.

The surface of the leg portion 20 is covered with a resin film 30. In particular, the resin film 30
Covers up to just before the annular base 21 (FIG. 2).
B). This is to expose the rubber base surface from the annular base portion 21 so that the rubber base surface is brought into close contact with the bottle mouth to ensure airtightness.

The ceiling surface 25 of the central hollow portion 24 of the leg portion 20 is preferably located below the lower surface 16 of the flange portion 11. This is because even if the thickness t of the needle stick portion 13 is constant, the stress applied to the needle stick portion 13 becomes small and the needle stick resistance becomes small by making the needle stick portion 13 concave. In particular, the flange portion 11
It is preferable that the depth dimension A of the needle piercing recessed portion 12 is 0.3 mm or less and half or less of the thickness dimension T of the flange portion 11. Even if the thickness t of the needle stick part 13 is constant, if the thickness t of the needle stick part 13 exceeds half the thickness T of the flange part 11, the support strength of the flange part 11 is reduced during needle sticking, and the rubber plug is This is because there is a risk that it will fall into the vial.

Further, the ceiling surface 25 and the resin film 30
It is preferable that the gap B with the end of the is 0 to 0.5 mm or less. This is because the leg B can be prevented from being deformed at the time of molding by setting the gap B to be 0 or more, and the flange 11 can be prevented from being deformed by pressing it to 0.5 mm or less.

Further, in the medical rubber stopper 10 having the above-mentioned structure, it is preferable that the gap M from the lower surface 16 of the flange portion 11 to the upper end of the resin film 30 is 0.3 mm or more. This is because a part of the annular base portion 21 becomes a rubber surface to ensure airtightness. Therefore, with the rubber stopper having the above-mentioned structure, it is possible to prevent air and moisture from entering after the stopper of the vial is closed and before the aluminum cap is tightened, and the airtightness in the vial can be maintained. become.

The diameter of the needle stick recess 12 is preferably substantially the same as or smaller than the diameter of the ceiling surface 25. Further, a continuous or discontinuous ring 14 may be provided inside the needle puncturing recess 12 to indicate the needle puncture portion, but a simple recess (not shown) may be provided. The diameter of the ring 14 or the depression needs to be substantially the same as or smaller than the diameter of the ceiling surface 25. This is to prevent the needle (not shown) from sticking into the leg portion 20 when the needle is stuck.

As shown in FIGS. 3 and 4, the second embodiment has the same basic structure as that of the first embodiment described above.
The different points are that the annular base portion 21 on the outer periphery of the leg portion 20 is a rounded surface, and that a part of the rounded surface is covered with the resin film 30. The radius of the rounded surface is preferably 0.4 to 2.0 mm. From the lower surface 16 of the flange portion 11 to the resin film 3
This is to ensure moldability even when the distance to the end of 0 is 0.3 mm or more. The dimensions and the like of each part are the same as those in the above-described first embodiment, and the same parts will be denoted by the same reference numerals and description thereof will be omitted. Further, the annular base portion 21 does not necessarily have to be rounded as a whole, and may have a shape in which a straight vertical surface corner is rounded. When the annular base portion 21 has a vertical surface, the amount of depression in the central direction of the annular base portion 21 needs to be 0.05 to 0.5 mm on only one side. This is to prevent the pop-up phenomenon in which the rubber stopper floats up after being plugged.

The third embodiment, as shown in FIGS. 5 to 7, is a case where the present invention is applied to a rubber stopper 10 used for freeze-vacuum drying in a state of half stoppering at a container port (not shown).
That is, the bottom surface annular leg portion 20 is provided on the lower surface 16 of the substantially disk-shaped flange portion 11. The flange portion 11 is formed with a needle stick recess 12 at the center of its upper surface, and projections 17 are radially provided at equal angles around the periphery thereof. The bottom surface of the recess 12 is a needle stick portion 13.

The leg portion 20 has upper and lower outer diameters in two steps, and has a pair of cutout portions 26 at opposite positions, and the ceiling surface 25 of the central hollow portion 24 thereof has the flange portion 11 Is located slightly below the lower surface 16 of the. Further, as shown in FIG. 7B, a rounded surface is formed on the annular base portion 21 on the outer periphery of the leg portion 20 as in the second embodiment.

Further, although the exposed surface of the leg portion 20 is covered with the resin film 30, the gap M from the lower surface 16 of the flange portion 11 to the end portion of the resin film 30 is 0.3 mm or more. preferable.

Next, a method of manufacturing the rubber plug will be described with reference to FIGS. As shown in FIG. 8A, the method for manufacturing a rubber stopper according to the present invention includes a resin film on a lower mold 40 including a core portion 41 forming a central hollow portion 24 and a positioning step portion 42. 30 and the unvulcanized rubber sheet 43 are sequentially stacked, and then heated and pressed by the first upper mold 45 having the pressing convex portion 44, whereby the burr 3 is formed.
A primary molded product 32 which becomes the leg portion 20 connected by 1 is obtained (FIG. 8B). For convenience of explanation, the shape of each part is exaggerated and illustrated.

Then, as shown in FIG. 9A, the cutting blade 46
Also, by cutting and removing the burr 31 with the push-cut table 47, an independent primary molded product 32 that becomes the leg 20 is formed.
Is obtained (FIG. 9B).

Further, as shown in FIG. 10A, the primary molded product 32 is reinserted into the cavity of the lower mold 40 to be positioned. At this time, the upper surface of the primary molded product 32 is located substantially on the same plane as the positioning step 42 of the lower mold 40. Then, after stacking the unvulcanized rubber sheets 48, they are heated and pressed by the second upper mold 49, and the flange portion 11 is integrally molded with the primary molded product 32 that will be the leg portion 20, whereby they are connected by the burr 33. A secondary molded product 34 is obtained (FIG. 10B).

Then, as shown in FIG. 11, the burr 33 is cut and removed by the lower punching die 51 and the upper punching die 52 to complete the rubber stopper 10 as a final product.

As is clear from the above description, the leg portion 20
The rubber base surface is exposed from the annular base portion 21 on the outer circumference. The thickness t of the needle stick 13 located on the bottom surface of the needle stick recess 12 is substantially the same as the thickness T of the flange 11, but the ceiling surface 25 of the central hollow portion 24 is the lower surface 16 of the flange 11. It is located below.

[0028]

Example (Experimental Example 1) The rubber plug shown in the second embodiment was used as a basic form, and the dimensions of each part were changed to observe whether the moldability was good or bad. That is, the gap from the end of the resin film to the lower surface of the flange portion is M, the depth of the needle sticking portion recessed portion provided in the flange portion is A, and the dimensions of M and A are changed and molding is performed. The quality of the sex was visually observed. The outer diameter of the flange is 19.00 mm,
The thickness T of the flange portion was 3.0 mm, the thickness t of the needle stick portion was 2.5 mm, and the outer diameter of the leg portion was 13.0 mm. The observation result is shown in FIG. 12A.

As is apparent from FIG. 12A, the gap dimension M from the end of the resin film to the ceiling surface of the central hollow portion.
It has been found that the desired molding accuracy can be ensured by setting the depth to 0.3 mm to 1.2 mm and the depth dimension A of the needle stick recess to 0.3 mm to 1.8 mm.

(Experimental Example 2) Similar to Experimental Example 1, except that the thickness T of the flange portion was 3.0 mm and the thickness t of the needle stick portion was 3.0 mm, the other experiments described above were performed. Example 2
Similarly, the dimensions of each part were changed and the quality of the moldability was observed. The observation result is shown in FIG. 12B.

As is apparent from FIG. 12B, the gap dimension M from the end of the resin film to the lower surface of the flange portion is 0.3 mm to 2.1 mm, and the depth dimension A of the needle stick recess is 0.3 mm. Therefore, it was found that the desired molding accuracy can be ensured by setting 1.5 mm.

(Experimental example 3) This is an experiment relating to needle stick resistance. That is, the rubber plug having the shape according to the third embodiment is used as a basic state, and the outer diameter of the flange portion is 13.8 mm,
The thickness T of the flange portion is 2.8 mm, the depth A of the recess for the needle stick portion is 0.7 mm, the thickness t of the needle stick portion is 2.3 mm, and the maximum outer diameter of the leg portion is 9.8 mm. The case was used as the sample of Example 1. Therefore, the ceiling surface of the central hollow portion is located below the lower surface of the flange portion. On the other hand, except that the depth dimension A of the needle piercing recess was set to zero and the thickness dimension t of the needle piercing portion was set to 2.3 mm, a sample of Comparative Example 1 was formed in the same manner as in Example 1 except for the above. And Therefore, the ceiling surface of the central hollow portion is located above the lower surface of the flange portion.

The needle stick resistance is measured by press-fitting the sample of the rubber stopper into the bottle mouth of the vial and winding the sample with an aluminum cap. Then, the vial bottle was set on an autograph (Shimadzu AGS-500D) equipped with a test needle (Termo 21G) having a needle diameter of 0.81 mm, and the needle puncture resistance when punctured at a needle puncture speed of 200 mm / min. It was measured. The test needle was replaced for each sample, and the above-described operation was performed on five identical samples to obtain the average value. The measurement result is shown in FIG.

(Experimental Example 4) A rubber plug having a shape according to the second embodiment is used as a basic form, and the outer diameter of the flange portion is 1
Sample of Example 2 in which the thickness T of the flange portion was 3.0 mm, the depth A of the recess for the needle stick portion was 1.0 mm, and the thickness t of the needle stick portion was 2.5 mm. And Therefore, the ceiling surface of the central hollow portion is located below the lower surface of the flange portion. On the other hand, except that the depth dimension A of the needle sticking recess was 0.3 mm and the thickness t of the needle sticking part was 3.0 mm, the other parts were molded in the same manner as in Example 2 described above, and Comparative Example 2 Sample. Therefore, the ceiling surface of the central hollow portion is located above the lower surface of the flange portion.

In the same manner as described above, the needle stick resistance is measured by press-fitting the sample of the rubber stopper into the bottle mouth of the vial and winding and tightening with an aluminum cap. Then, the vial bottle was set on an autograph (Shimadzu AGS-500D) equipped with a test needle (21G manufactured by Terumo) having a needle diameter of 0.81 mm, and a needle stick speed of 200 mm / min.
The resistance to needle stick was measured when the needle was stuck in. The test needle was replaced for each sample, and the above-described operation was performed on five identical samples to obtain the average value. The measurement result is shown in FIG.

(Experimental Example 5) With respect to the samples according to Example 2 and Comparative Example 2 described above, except that a solution injection needle (made by Nipro) having a needle diameter of 5.30 mm is used as a test needle.
Otherwise, the needle stick resistance was measured under the same conditions as in Experimental Example 4 above. The measurement result is shown in FIG.

As is apparent from FIG. 13, even if the needle sticks having the same thickness dimension are provided, when the needle sticks are in a lower position, that is, the ceiling surface of the central hollow portion which is the lower surface of the needle sticks is a flange. It was found that the needle puncture resistance was reduced when it was located below the lower surface of the part.

[0038]

EFFECTS OF THE INVENTION According to the present invention, it is possible to obtain a medical rubber stopper having a small needle stick resistance while ensuring a desired molding accuracy even if a large number of mass-produced rubber stoppers are taken.

[Brief description of drawings]

FIG. 1 shows a first embodiment according to the present invention, FIG. A is a plan view, and FIG. B is a bottom view.

2 shows the first embodiment shown in FIG. 1, FIG. A is a sectional view, and FIG. B is a partially enlarged sectional view of FIG.

FIG. 3 shows a second embodiment according to the present invention, FIG. A is a plan view and FIG. B is a bottom view.

4 shows the second embodiment shown in FIG. 3, FIG. A is a sectional view, and FIG. B is a partially enlarged sectional view of FIG.

FIG. 5 shows a third embodiment according to the present invention, FIG. A is a plan view, and FIG. B is a bottom view.

6 shows the third embodiment shown in FIG. 5, FIG. A is a front view, and FIG. B is a front vertical sectional view.

7 shows the third embodiment shown in FIG. 6, FIG. A is a side partial cross-sectional view, and FIG. B is a partial enlarged cross-sectional view of FIG.

FIG. 8 shows a manufacturing process of an embodiment according to the present invention,
FIG. A shows the primary molding, and FIG. B shows the primary molding.

FIG. 9 shows a manufacturing process of an embodiment according to the present invention,
FIG. A shows the primary punching, and FIG. B shows the punched primary molded product.

FIG. 10 shows a manufacturing process of an embodiment according to the present invention, FIG. A shows a secondary molding, and FIG. B shows a punched secondary molded product.

FIG. 11 shows a manufacturing process of an embodiment according to the present invention, FIG. A shows a secondary stamping, and FIG. B shows a stamped secondary molded product.

FIG. 12 is a graph showing Experimental Examples 1 and 2 relating to the moldability of the present invention.

FIG. 13 is an experimental example 3 relating to needle stick resistance of the present invention.
It is a graph which shows 4,5.

[Explanation of symbols]

10 ... Rubber stopper, 11 ... Flange portion, 12 ... Needle piercing recessed portion, 13 ... Needle piercing portion, 16 ... Lower surface, 20 ... Leg portion, 21 ...
Base portion, 22 ... Annular taper surface, 24 ... Central hollow portion, 25 ...
Ceiling surface, 30 ... Resin film, 40 ... Lower mold, 43, 4
8 ... Rubber sheet, 45 ... First upper mold, 49 ... Second upper mold.

Claims (5)

[Claims] 1. A flange portion in contact with an upper surface of a container opening, and an annular leg portion projecting from a lower surface of the flange portion so as to be press-fitted into the container opening, and at least a part of the leg portion is covered with a resin film. In the medical rubber stopper described above, a needle piercing recess is formed in the central portion of the upper surface of the flange portion, and the ceiling surface of the central hollow portion of the leg portion is located below the lower surface of the flange portion. A rubber stopper for medical use. 2. The medicinal rubber stopper according to claim 1, wherein the depth of the needle sticking recess is 0.3 mm or more and not more than half the thickness dimension of the flange portion. 3. The pharmaceutical rubber stopper according to claim 1, wherein the gap from the lower surface of the flange portion to the end portion of the resin film is 0.3 mm or more. 4. The pharmaceutical rubber stopper according to any one of claims 1 to 3, wherein a gap from a ceiling surface of the central hollow portion to an end portion of the resin film is 0.5 mm or less. 5. A resin film and an unvulcanized rubber sheet are sequentially stacked on a lower mold having a core portion forming a central hollow portion, and the first upper mold is heated and pressurized to perform primary molding.
After cutting and removing the burr from the primary molded product connected by a burr, and then inserting and positioning the primary molded product in the cavity of the lower mold, the unvulcanized rubber sheets are further stacked to form a second upper layer. A method for producing a rubber stopper for medical use, which comprises heating and pressurizing with a mold to form a secondary product.