JP5479029B2 - Combination of rubber stopper (B) for vial and plastic cap (C) - Google Patents

Description

The present invention relates to a combination of a rubber stopper (B) for a vial and a plastic cap (C) . More specifically, the rubber stopper plugged into the mouth of the vial does not rotate, and the rubber stopper is strengthened more firmly. It is related with the combination of the rubber stopper (B) for plastics which can hold | maintain, and a plastic cap (C) .

Conventionally, so-called vials are widely used as storage containers for various drugs such as pharmaceuticals. Vials used for these vials (hereinafter, vials are sometimes simply referred to as vials) include those made of glass and those made of synthetic resin. Synthetic resins are increasing in terms of stability. On the other hand, glass vials have extremely high gas barrier properties compared to synthetic resin vials, and therefore glass vials are used for drug containers that require high gas barrier properties.

  In any case, the vial is used after the medicine is accommodated, the vial mouth is sealed with a rubber stopper, and the inside of the vial is sealed. Furthermore, if the vial is subjected to treatment such as heat sterilization, the rubber stopper may come off from the vial. For the purpose of ensuring the sealing performance, an aluminum or plastic cap is generally fitted over the bottom of the lip of the vial mouth while wrapping the rubber stopper. The aluminum cap that has been widely used conventionally is caulked below the lip of the vial mouth due to the excellent deformability of the aluminum, and exhibits excellent anti-detachment properties of the rubber stopper. However, in recent years, there are many cases where chemical filling work is performed in a clean room, and during the production and use, aluminum particles are generated and scattered due to collisions between caps, etc., and separation of aluminum after use There is a problem that disposal is difficult, and in recent years, the use of aluminum caps tends to be avoided.

  For this reason, the use of plastic caps is increasing. On the other hand, for example, lyophilization treatment of the drug in the vial and subsequent sealing, etc., and the diversification of the drug accommodated in the vial is remarkable. In recent years, various devices having various functions by devising shapes have been proposed (see Patent Documents 1 and 2, etc.). However, when compared with the aluminum cap, the plastic cap has a problem that it is inferior in engagement with the vial than the aluminum cap. This is different from an aluminum cap in which aluminum is deformed freely along the lip of the vial mouth and is easily and firmly squeezed into the vial mouth. One of the reasons is that a claw for engagement is provided and the claw is fixed by engaging the claw with the lip of the vial opening.

  For this reason, if the above-mentioned engagement between the vial and the plastic cap is weak, the cap is easily detached from the vial. On the other hand, if the engagement between the vial and the cap is too high, it is difficult to plug the cap itself. Therefore, in the case of a plastic cap, high dimensional accuracy is required for both the cap and the vial. On the other hand, when both the cap and the vial are made of synthetic resin, it is possible to increase the dimensional accuracy of both because it is molded into a predetermined shape by calculating up to shrinkage deformation at the time of cooling, In the case of glass vials, the dimensional error is an order of magnitude larger than that of synthetic resin vials, so even if the dimensional accuracy of the plastic cap is increased, it is difficult to sufficiently prevent the cap from being detached. is there. The applicant has already dealt with such a problem with the tightness of the rubber stopper plugged into the mouth portion of the vial not only in the case of the synthetic resin vial but also in the case of the glass vial having a lower dimensional accuracy than this. A proposal has been made on the inner surface shape of a plastic cap for vials (see Patent Document 3). With this cap, the inner diameter of the skirt is made larger than the outer diameter of the lip of the vial, and a plurality of protrusions are formed on the inner surface of the skirt so as to be perpendicular to the top surface. It has a structure to do.

JP 2007-2117007 Japanese Patent No. 3487748 JP 2009-137641 A

  The above-mentioned conventional plastic cap can firmly hold the rubber stopper plugged into the mouth of the vial, can prevent the detachment surely, and has an extremely high effect especially on the upward force. It is almost impossible to remove the cap once plugged by hand. However, when a strong force is applied to the plastic cap in the lateral direction, the stoppered cap may rotate. According to the study by the present inventors, such rotation does not occur during normal production or use, and even if the cap is rotated by applying a force in the lateral direction, it is sealed with a rubber stopper. However, it is desirable not to rotate even in such a case because the material contained in the vial is for medical use. The reason why the plastic cap rotates when a strong force is applied in the lateral direction is that, as shown in FIG. 2, the structure for fixing the plastic cap has claws provided at a plurality of locations on the inner peripheral surface of the cap. This is considered to be a locking claw that engages below the lip of the vial and is fixed to the mouth of the vial by these claw. That is, when a synthetic resin cap is fitted to the mouth of a vial with a rubber stopper plugged, the claw is caught under the lip, so that the state is strong against upward force. Since it is maintained, the cap does not move, and even if a large force is applied upward, the cap does not come off. On the other hand, when a force is applied in the lateral direction, the plastic cap has an inner peripheral surface that is in contact with both the lip and the claw that engages below the lip of the vial. Since there is no structure that prevents movement in the direction, when a strong force is applied in the lateral direction, the plastic cap moves in the lateral direction along the contact surface with the lip, and rotation of the cap occurs.

Accordingly, an object of the present invention is a combination of a rubber stopper and a synthetic resin cap, which can be smoothly applied to either a synthetic resin or glass vial, and the mouth of the vial with the rubber stopper plugged. When applied to a rubber cap and synthetic resin cap, the cap will not come off even if a strong force is applied upward, and the cap will not rotate even if a strong force is applied in the lateral direction. Is to provide a combination with.

The above object is achieved by the present invention described below. That is, the present invention relates to a vial stopper (B) and a plastic cap (vials) that constitute a vial together with a vial bottle (A) having an annular lip (A2) having an opening (A1) formed at the center. C), and the rubber plug (B) is used by being plugged into the opening (A1) in a state in which detachment is prevented, and has a side wall (B2) and has a flat plate shape. It has a protruding shade (B1) and a leg (B3) extending below the shade (B1), and the plastic cap (C) is plugged into the opening (A1). Further, in order to prevent the rubber stopper (B) from being detached, the rubber stopper (B) is wrapped and fitted over the lip (A2) of the opening (A1) of the vial (A). And an opening (C10 at the center) A top surface portion (C1) having a top surface and a top surface portion (C1) hanging from the outer periphery, the inner diameter (a) of which is larger than the outer diameter (b) of the lip (A2) of the vial (A). A cylindrical skirt portion (C3) having an open lower end, and a plurality of locking claws engaged with the inner surface of the skirt portion (C3) below the lip (A2) of the vial (A) (C5), the top surface portion (C1), and the skirt portion (C3) provided at the inner portion of the shoulder portion of the cap, and the plastic cap (C) is the vial (A) When the lip (A2) of the opening (A1) is fitted to the lip (A2), the cap (B1) of the rubber plug (B) plugged in a state in which the opening (A1) is prevented from being detached. ) 2-16% in the radial direction and 20-60% in the height direction A rubber plug for a vial, characterized by having a continuous or intermittent annular convex portion (C2) in which a dimensional relationship with the rubber plug (B) is set. A combination of (B) and a plastic cap (C) is provided.

The following are mentioned as a preferable form of the said invention. The convex portion (C2) in the case of the continuous annular said rubber contact with the entire circumference of the plug side wall of the (B) (B2), also in the case of annular shape and the intermittent, the rubber plug (B ) the side wall (B2) of that range 35 to 75% of the entire circumference is one that is configured to abut the. It said skirt portion (C3) is the inner surface of its, having a plurality of protrusions formed in a direction perpendicular to the top surface portion (C1) (C4). The top surface portion (C1) is, on the rear surface of its said when fitted into the lip (A2) of the opening of the vial (A) (A1), the above end portion of said rubber plug (B) cap portion (B1) convex portion against the upper surface of the (C11) having a. Wherein the plurality of ridges (C4), said skirt portion (C3) at regular intervals in the inner surface are formed a plurality of locations, said locking claw (C5), the group of the plurality of ridges (C4) while, that have been made multiple several Tokorokatachi. The top surface portion (C1) is, on the upper surface of that, it has a eliminable cover a finger (D).

According to the present invention, it can be applied smoothly to both synthetic resin or glass vials, and when a rubber stopper is fitted into the mouth of a vial that has been stoppered, a strong force is applied upward. It is possible to provide a combination of a rubber stopper (B) for a vial and a plastic cap (C) in which the cap does not rotate even if a strong force is applied in the lateral direction. it can.

Explanatory drawing of the relationship between the cap of an example used for this invention , a vial, and a rubber stopper. Explanatory drawing of the state which applied the cap of an example used for this invention to the vial. Sectional drawing explaining the state of the cap part of the rubber plug at the time of applying the cap of an example used for this invention. The figure for demonstrating the circular-arc-shaped convex part C2 provided in the inner side of the shoulder part of the example cap shown in FIG. 6 used for this invention. The perspective view which looked at the cap of another example used for the present invention from the upper part. The perspective view which looked at the cap of the example of FIG. 5 used for this invention from the downward direction. The perspective view which looked at the cap of the example of FIG. 5 used for this invention from another downward angle. The perspective view which looked at the cap of another example used for the present invention from the upper part. The perspective view which looked at the cap of the example of FIG. 8 used for this invention from the downward direction.

Next, the present invention will be described in more detail with reference to the drawings showing the best mode for carrying out the invention. The plastic cap C used in the present invention is shown in FIGS. 1 and 2 which are partially sectional views, FIG. 5 which is a perspective view seen from above, and FIGS. 6 and 7 which are perspective views seen from below. vial a is a cap for detachment preventing the rubber plug B which seals the opening A1 (hereinafter, sometimes referred to simply vial a vial a). The cap C is composed of a top surface portion C1 having an opening C10 at the center and a cylindrical skirt portion C3 depending from the outer periphery of the top surface portion C1 and having an open lower end, as shown in FIG. As described above, the inner diameter a of the skirt portion C3 is formed larger than the outer diameter b of the lip A2 of the vial A, and a plurality of the inner surfaces of the skirt portion C3 are engaged below the lip A2 of the vial A. A locking claw C5 is provided. For this reason, when the cap of the present invention is applied and fitted to the rubber plug B that has been plugged, the cap locking claw C5 is engaged below the lip A2 as shown in FIG. Even if this force is applied, the cap does not come off and the rubber stopper B can be prevented from being detached.

In a preferred embodiment of the cap C used in the present invention , a plurality of protrusions C4 are formed on the inner surface of the skirt portion C3 in a direction perpendicular to the top surface portion C1. The cap of the present invention is effective even when the lip A2 is inferior in dimensional accuracy as in the case of a glass vial or the like because the structure of the inner surface of the skirt C3 is as described above. Applicable. This point will be described later.

As shown in FIG. 1, in addition to the basic configuration described above, the cap C used in the present invention is formed on the inner portion of the shoulder portion of the cap formed by the top surface portion C1 and the skirt portion C3. The cap C2 is provided in contact with a part of the side wall B2 of the rubber plug B that is plugged in a state in which the opening A1 is prevented from being detached by the cap. And the convex part C2 which contact | connects a part of side wall B2 of this rubber stopper B is the width | variety which makes the state which compressed the cap part B1 of the part 2 to 16 % in radial direction, and height of the said side wall B2 and having a height of the ring-like shape corresponding to the 20% to 60%. Since the cap C used in the present invention is provided with the convex portion C2, when the cap of the present invention is fitted into the opening of a vial stoppered with a rubber stopper, the rubber in the portion in contact with the convex portion C2 The cap portion of the stopper is fixed in a compressed state in the radial direction and the height direction (see FIG. 2). For this reason, the cap used in the present invention is firmly fixed to the force in the upward direction, and is also firmly fixed to the vial and the rubber stopper against the force in the lateral direction. Even if it receives a strong force, the cap does not rotate.

Protrusions C2 provided in the cap C to be used in the present invention, the entire circumference in contact with a continuous circular ring-shaped side wall B2 is a side of the cap portion B1 of the rubber plug B, ie, over the entire circumference 360 ° formed may be, or, as part of the entire circumference 360 ° of the sidewall B2 of the rubber stopper B are in contact may be formed in a plurality of intermittent circle ring shape. According to the study by the present inventors, a plurality of intermittent portions are formed so that the convex portion C2 is in contact with a range of 35% or more (125 ° or more) of the entire circumference of the side wall B2 which is the side surface of the cap portion B1 of the rubber plug B. be formed separately in an annular shape with, as a portion cap portion B1 of the rubber stopper is contracted is sufficient, it can sufficiently exhibit the effect of the present invention. More specifically, in the case of forming the convex portion C2 at a plurality of intermittent state, divided into a circular ring shape, preferably in a 35% ~75% (125 ° ~270 °) degrees. As described below, there is a case where a state where the shape of the convex portion C2 for manufacturing reasons is divided into a plurality of intermittent circle ring-shaped, 35% to 75% of the entire circumference (125 ° ~270 °) degree If it is provided in the range, the cap portion B1 of the rubber plug B is compressed as defined in the present invention, and the effects of the present invention are obtained.

In order to further enhance the effect of preventing the rotation of the cap C used in the present invention , as shown in FIGS. 8 and 9, the top surface portion C1 of the cap C is formed with a plurality of convex portions C11. It is preferable to do. The larger the number of convex portions C11 is, the higher the effect of preventing the rotation of the cap C is. However, since the shape of the cap becomes complicated and there is a concern that the yield may be reduced, it is usually preferable that the number is about 4 to 20. In addition, it is preferable that the tip has an acute-angled shape, but it is necessary to prevent the film from being damaged or the rubber plug from being damaged when the film is laminated on the top surface of the cap portion B1 of the rubber plug. These are designed appropriately in consideration of these factors.

The rubber plug combined with the cap C in the present invention is listed below in order to ensure higher sealing performance and to suppress the rotation of the rubber plug together with the cap against the lateral force from the surface of the material. It is preferable. That is, it is preferable that a plastic film is laminated on the leg portion of the rubber stopper and no lubricant such as silicone is applied. Moreover, it is preferable that the lower part of the cap part is a rubber surface, and further, the base of the leg part of the rubber plug is also a rubber surface. Further, it is preferable that the top surface of the cap portion of the rubber plug is not coated with a lubricant such as silicone. When lubrication is required on the top of the cap portion of the rubber plug, a plastic film is laminated. The lubricant may move to a portion other than the coating portion in the rubber plug cleaning process or the like, and when it adheres to the lower portion or the like of the cap portion, the rotation of the rubber plug is promoted. In addition, as a plastic film, general plastic films, such as polyethylene, a polypropylene, a fluorine resin, can be used.

There are various methods for forming the cap locking claw C5 on the inner surface of the cap C. For example, by forming the cap locking claw C5 from the top surface portion C1 side of the cap C, the large locking claw C5 can be easily formed. In this case, for example, as shown in FIG. 5 and the like, through holes C9 are formed by the number of cap locking claws C5 along the outer periphery of the top surface portion C1 of the cap C. In the example of the cap shown in FIG. 5, four large cap locking claws C5 are formed. Therefore, as shown in FIG. 5, through holes C9 are formed by the number of cap locking claws C5. The portion where the convex portion C2 is provided is inevitably cut away, and the shape of the convex portion C2 becomes a plurality of arcs. On the other hand, the cap locking claw C5 can also be formed from the lip A2 side of the vial A. In this case, the convex portion C2 is a circle in contact with the entire circumference of the side wall B2 of the cap portion B1 of the rubber plug B. In other words, it can be formed in a state over the entire circumference of 360 °. In order to achieve both the ease of stoppering when the cap C used in the present invention is stoppered with a stopper, and fixing it more firmly, the formation range of the convex portion C2 is 50% of the entire circumference. It is preferable to be about ˜75% (180 ° to 270 °).

A cover D may be provided integrally with the cap C used in the present invention. That is, the cap C and the cover D are respectively formed of, for example, a synthetic resin such as polypropylene, and as shown in FIG. 5 and the like, the protrusions C12 whose tops are flat are simultaneously formed at several places on the top surface C1, A form in which the cover D is bonded and fixed by using an adhesive or heat fusion using the top is preferable (see FIG. 2 and the like). Of course, the cap C and the cover D can be integrally formed by various methods. The cover D is not essential in the present invention, but is preferably provided to prevent dust and the like from adhering to the opening C10 of the cap C. The cover D is preferably formed with one or a plurality of finger hooks D1 formed over the entire circumference or partially. The user can easily remove the cover D by placing a finger on the finger hook D1 as necessary.

  The top surface portion C1 of the cap C has a disc shape, and an opening portion C10 through which a needle of a syringe can pass is formed at the center portion. The size of the opening portion C10 exhibits the above-described action. There are no particular restrictions. A cylindrical skirt portion C3 is formed downward from the outer periphery of the top surface portion C1, and an inclined portion C7 for facilitating mounting of the cap C on the vial A is formed below the skirt portion C3.

The cap C used in the present invention is preferably one in which a plurality of protrusions (ribs) C4 are provided on the inner surface of the skirt C3 as shown in FIGS. In the example shown in FIG. 6 and the like, two pairs of ridges C4 are provided on the inner surface of the skirt portion C3 at regular intervals, but two ridges C4 are a pair. It is not essential, and only one or three or more may be used. Further, the protrusions C4 may be provided on the inner surface of the skirt portion C3 at two or more positions, more preferably at four or more positions with a certain distance from each other.

  When the cap C is attached to the vial A, the protrusion C4 is in contact with the outer peripheral surface of the lip A2 around the opening A1 of the vial A, and the dimensional error of the lip A2 of the vial, particularly the glass vial A Has the action of absorbing That is, if the inner diameter of the circle formed by the tip of the protrusion C4 is designed to be the same as or slightly smaller than the diameter b of the lip A2 of the vial A, there is a dimensional error in the lip A2 of the vial A. Even if the outer diameter b of A2 is the same as or slightly smaller than the inner diameter of the circle formed by the tip of the ridge C4 of the cylindrical skirt C3, the outer peripheral surface of the lip A2 is in contact with the top surface of the ridge C4. To minimize the backlash of the cap C. When the outer diameter b of the lip A2 is larger than the inner diameter of the circle formed by the tip of the ridge C4, the ridge C4 is elastically deformed to contact the outer peripheral surface of the lip A2, and the cap C is plugged. Avoid defects. In this way, the allowable dimensional error range between the lip A2 of the vial and the cap C is widened, and the possibility of detachment of the cap C is reduced while maintaining good capping performance of the cap C.

The ridge C4 is provided in a direction perpendicular to the top surface portion C1 in a range excluding the inclined portion C7 on the inner surface of the skirt portion C3, but the ridge C4 faces the outer peripheral surface of the lip A2 of the vial A. As long as it is located, its length is not particularly limited, and its width is not particularly limited. Further, the top of the protrusion C4 may be flat or have an angle. The height and width of the protrusion C4 vary according to the size of the vial in which the cap C of the present invention is used, but generally the height is 0.1 to 3 mm and the width e is 0.5 to 5 mm. It is preferable that it is a grade.

As shown in FIGS. 1, 2 and 6, etc., the cap used in the present invention is provided with a reverse claw-shaped locking claw C5 inside the skirt C3. When fitted to the vial A, the tip of the C5 is elastically deformed inward and descends, and in the lowered state, the C5 abuts against the concave portion at the lower part of the lip A2 to prevent the cap C from being detached. In the example shown in FIG. 6 and the like, four locking claws C5 are formed between the pair of protrusions C4, one each, and the number of the locking claws C5 is the number of the protrusions C5. Although it is not particularly limited as in the case of the strip C4, it is preferable that at least two are formed. A recess C6 is preferably formed on the surface of the skirt portion C3 inside the locking claw C5 so that the locking claw C5 is easily elastically deformed inward (skirt side). The locking claw C5 itself is known, and the shape of the locking claw C5 is not particularly limited.

The method of using the cap C in the present invention will be described with reference to the drawings. In FIG. 1, the cover D and the cap C are drawn separately, but actually the cover D and the cap C are integrated as described above.

First, after filling a desired medicine into the vial A, a rubber stopper B of an appropriate size is fitted into the opening A1 of the vial A, and the vial A is sealed. In this state, the rubber stopper B may be detached when the vial A is handled, for example, during heat sterilization. Therefore, when the cap C is fitted into the vial A sealed with the rubber stopper B, preferably using a stopper, the reverse claw-shaped locking claw C5 is moved to the lip A2 as the cap C is lowered. When the tip of the locking claw C5 passes the outer peripheral surface of the lip A2, the locking claw C5 is in its original state. The rubber plug B and the cap C are fixed. When the cap C used in the present invention is fitted to the vial A, the reverse claw-shaped locking claw C5 is engaged under the lip A2 as described above (see FIG. 2). Even if a strong force is applied in the upward direction of the cap C used in the present invention , the cap is not removed by the locking claw C5 engaged below the lip A2. Furthermore, since the cap C used in the present invention has a structure in which the convex portion C2 is provided on the inner portion of the shoulder portion of the cap C, the cap C is shown in FIGS. 2 and 3 when the cap C is fixed. As described above, a part of the cap portion B1 of the rubber plug B is compressed by the convex portion C2. For this reason, even if a strong force is applied to the cap C used in the present invention , a part of the cap portion B1 of the rubber plug B is pressed, so that the cap does not move in the lateral direction. .

In the example described above, the rubber stopper B is fitted into the opening A1 of the vial A, and after the vial A is sealed, the cap C is fitted using a stopper, etc., but the present invention is not limited to this. . For example, in the structure having the structure shown in FIGS. 5 to 9, the rubber stopper B is held in the cap C, and the cap C is placed on the opening A1 of the vial A in this state, and then a stopper is used. Thus, the cap C can be fitted. As described above, in the cap C used in the present invention , the rubber stopper B is held in the cap C, and the rubber stopper can be half-plugged into the opening A1 of the vial A in this state. This is extremely effective in the case of freeze-drying a liquid chemical solution filled in the container. That is, by using the cap C in the present invention, a freeze drying process, stoppered gas generated in the vial, and at the same time can be evacuated rapidly along the rubber plug in a state of being half-stroke stopper, after lyophilization completion The rubber plug can be completely plugged very quickly by using a container. Furthermore, as described above, the plugged state is not only to realize a stronger fixed state in the upward direction, but also to the strong lateral force, which is the main problem of the present invention. In this case, the problem of occurrence of rotation of the cap C is solved.

  When the cap C is fitted, the inner diameter of the circle formed by the tip of the ridge C4 of the skirt C3 and the outer diameter b of the lip A2 of the vial A are the same or the tip of the ridge C4 of the skirt C3. Ideally, the inner diameter of the circle formed by is slightly smaller than the outer diameter b of the lip A2 of the vial A. However, in reality, in the case of vial A, particularly glass vial A, there is inevitably a dimensional error due to the above-described circumstances, and cap C fits into vial A even if the dimensional accuracy of cap C is increased. In some cases (not easy to detach or difficult to plug) may occur.

  In the present invention, taking into account the dimensional error of the vial A, the inner diameter a of the skirt C3 is made larger than the outer diameter b of the lip A2 of the vial A by the predicted dimensional error of the vial A, and at the same time the inner surface of the skirt C3. The above-mentioned protrusion C4 is provided on the end, and the inner diameter of the circle formed by the tip of the protrusion C4 is reduced by the size error predicted for the vial A, so that the dimension of the lip A2 of the vial A is shifted to the larger one. In such a case, the dimensional error can be absorbed by elastic deformation of the protrusion C4. Even when the size of the lip A2 of the vial A is shifted to the smaller side, the outer peripheral surface of the lip A2 is in contact with the top of the ridge C4, and the size of the lip A2 of the vial A is a predetermined size. The outer peripheral surface of the lip A2 abuts on the protrusion C4 by somewhat elastically deforming the top of the protrusion C4. In any case, since the contact between the skirt portion C3 and the outer peripheral surface of the lip A2 at the time of fitting is performed by the protrusion C4 having a small contact area, a large force is not necessary for fitting the cap C. Excellent in plugging performance.

As described above, in the present invention, such as glass vials, it is preferred that the dimensions of the lip A2 of the vial A to apply the cap C of the present invention to shake easy vials A. The cap C used in the present invention absorbs the dimensional error of the vial A, so that a large force is not required when the cap C is fitted, and the inner peripheral surface of the skirt C3 and the outer peripheral surface of the lip A2 are Since the cap C is always in contact, the cap C does not blur, the detachability of the cap C is lowered, and the yield of the cap C during use can be remarkably improved. Of course, the combination of the rubber stopper and the cap of the present invention is not limited to a glass vial, but is also useful for a synthetic resin vial.

Next, the present invention will be described more specifically with reference to examples and comparative examples.
[Example 1]
A cap in combination structure specified in the present invention (the shape of FIG. 6), the inner diameter of the cap a: 21 mm, outer diameter of the lip of the vial b: 20 mm, the circle formed by the tip of the protrusion C4 cap Ten polypropylene caps having an inner diameter of 20 mm, a height of the protrusion C4 of 0.5 mm, and a width of the protrusion C4 of 0.5 mm were produced. Further, a convex portion C <b> 2 is provided inside the shoulder portion of the cap C. The convex portion C2, as shown in FIG. 4, has a partial annular shape, divided into four portions, while the entire circumference 360 °, one by one place 50 °, to 200 ° in total It is in a state of being provided across (see FIG. 4). The outer diameter r of the cap part B1 of the rubber stopper B applied to the vial is equal to the outer diameter b of the lip part of the vial, r is 20 mm, and the height h is h: 3 mm. As the rubber stopper B, a chlorinated butyl rubber stopper (manufactured by Daikyo Seiko Co., Ltd.), which has been conventionally used for a vial stopper, was used. As shown in FIG. 3, the convex portion C2 provided on the inner side of the shoulder portion of the cap C has a height h1 of 1.8 mm (corresponding to 60% of the side wall B2 of the shade portion), and rubber. The width r1 of the convex part C2 for compressing the cap shade B1 in the radial direction is 1 mm (corresponding to 5% of the shade diameter r).

[Example 2]
Ten polypropylene caps were produced in the same manner as in Example 1 except that the height h1 of the convex portion C2 was 1.0 mm (corresponding to 33% of the side wall B2 of the shade portion).

Example 3
Ten polypropylene caps were produced in the same manner as in Example 1 except that the height h1 of the convex part C2 was 0.6 mm (corresponding to 20% of the side wall B2 of the shade part).

Example 4
The shape of the convex portion C2 is such that the height h1 is 1.0 mm (corresponding to 33% of the side wall B2 of the shade portion), and the width r1 of the convex portion C2 is 0.2 mm (1 of the radius r of the shade portion). 10 caps made of polypropylene were produced in the same manner as in Example 1 except that it was equivalent to%.

Example 5
The shape of the convex portion C2 is such that the height h1 is 1.0 mm (corresponding to 33% of the side wall B2 of the shade portion), and the width r1 of the convex portion C2 is 1.5 mm (the radius r of the shade portion 7). 10 polypropylene caps were produced in the same manner as in Example 1 except that it was equivalent to 5%.

[Comparative example]
Ten polypropylene caps having the same structure and dimensions as in Example 1 except that the convex portion C2 was not provided on the inner side of the cap were used as comparative examples.

"Desorption and rotation test"
Examples 1 to 5 in which the openings of the plastic vials are sealed with rubber stoppers and the caps are fitted, 10 samples for each of the comparative examples, and glass vials. Samples 3 and 5 were used. Each sample was placed in an autoclave (Hiclave HV-25 manufactured by Hirayama Seisakusho) and held at 121 ° C. for 60 min to confirm the presence or absence of cap detachment. In both Examples and Comparative Examples, occurrence of cap detachment was observed. I couldn't. Furthermore, a test was applied in which a strong force was applied by hand to each of the caps of the samples of the above examples and comparative examples. As a result, neither the samples of Examples 1 to 5 fitted to plastic vials nor the samples of Examples 1, 3, and 5 fitted to glass vials rotated the cap. It was. However, all of the comparative examples rotated in the lateral direction although there was a slight difference in force.

According to the present invention, it can be applied smoothly to either a synthetic resin or glass vial, and can also be applied smoothly to freeze-drying, and a cap is fitted to the mouth of the vial with a rubber stopper plugged. When combined, the cap will not come off even if a strong force is applied in the upward direction, and the rubber plug and the synthetic resin cap will not rotate even if a strong force is applied in the lateral direction . A combination is provided.

A: vial A1: opening A2: Lip B: rubber stopper B1: cap portion B2: the side wall of the cap portion B3: leg C: Cap C1: top surface portion C2: protrusion C3: skirt C4: ridge C5: Locking claw C6: Concave portion C7: Inclined portion C8: Protrusion C9: Through hole C10: Opening portion C11: Convex portion C12: Protrusion D: Cover D1: Finger hook

Claims (6)

A combination of a rubber stopper (B) for a vial and a plastic cap (C) that constitutes a vial together with a vial (A) having an annular lip (A2) with an opening (A1) formed in the center There,
The rubber plug (B) is used by being plugged into the opening (A1) in a state in which detachment is prevented, and has a side wall (B2) having a side wall (B1) projecting into a flat plate shape and the Having leg portions (B3) extending below the cap portion (B1), and
The plastic cap (C) wraps the rubber stopper (B) and prevents the vial stopper (B) from detaching the rubber stopper (B) plugged into the opening (A1). The top surface portion (C1) having the opening portion (C10) in the center and the outer surface of the top surface portion (C1) depending on the lip (A2) of the opening portion (A1). A cylindrical skirt portion (C3) having an inner diameter (a) larger than an outer diameter (b) of the lip (A2) of the vial (A) and having an open lower end; and the skirt A plurality of locking claws (C5) that engage with the inner surface of the portion (C3) below the lip (A2) of the vial (A), the top surface portion (C1), and the skirt portion (C3) Provided in the inner part of the shoulder of the cap to be formed, When the plastic cap (C) is fitted to the lip (A2) of the opening (A1) of the vial (A), the plastic cap (C) is hit with the opening (A1) being prevented from being detached. Between the rubber plug (B) so that the cap (B1) of the plugged rubber plug (B) is compressed by 2 to 16% in the radial direction and 20 to 60% in the height direction. A combination of a rubber stopper (B) for a vial and a plastic cap (C) characterized by having a continuous or intermittent annular protrusion (C2) having a dimensional relationship set . The convex portion (C2) in the case of the continuous annular said rubber contact with the entire circumference of the plug side wall of the (B) (B2), also in the case of annular shape and the intermittent, the rubber plug (B the combination of the rubber stopper of the vial of claim 1 configured so that the range 35 to 75% of the entire circumference in contact (B) and a plastic cap (C) of the side wall (B2) of). It said skirt portion (C3) is the inner surface of its rubber stopper for a vial according to claim 1 or 2 having a plurality of ridges (C4) which is formed in a direction perpendicular to the top surface portion (C1) Combination of (B) and plastic cap (C) . The top surface portion (C1) is, on the rear surface of its said when fitted into the lip (A2) of the opening of the vial (A) (A1), the above end portion of said rubber plug (B) the combination of the rubber stopper of the vial according to any one of claims 1 to 3 (B) and a plastic cap (C) having a protrusion (C11) to contact the upper surface of the cap portion (B1). Wherein the plurality of ridges (C4), said skirt portion (C3) at regular intervals in the inner surface are formed a plurality of locations, said locking claw (C5), the group of the plurality of ridges (C4) during the combination of the rubber stopper of the vial of claim 3 which is made double several Tokorokatachi (B) and a plastic cap (C). The top surface portion (C1) is, on the upper surface of that, the rubber plug (B) and a plastic cap vial according to claim 1 having eliminable cover (D) with a finger Combination with (C) .

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