JP2017221371A - Medicine container plug body, method of manufacturing medicine container plug body, medicine container plug member, and medicine stored medicine container using the medicine container plug member - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medicine container plug body using a rubber material and a thermoplastic elastomer, which causes no elution of a rubber material component, has excellent sealability even after the extraction of a medical needle, and can hold a plate-like rubber member at an appropriate position in the plug body.SOLUTION: A medicine container plug body 1 includes a plate-like rubber member 4, and an upper formation part 2 and a lower formation part 3 for cooperatively encapsulating it. The lower formation part includes a bottom plate part 31 closely adhering to the undersurface of the plate-like rubber member 4, and a plurality of lower leg parts 32 extending from the peripheral edge part of the bottom plate part 31 in an upper formation part 2 direction, and the upper formation part includes an upper plate part 21 closely adhering to the top surface of the plate-like rubber member 4, and a plurality of upper leg parts 22 for filling the space between the leg parts of the lower formation part 3. The tip of the upper leg part includes an inside extension part 25 extending in an undersurface direction of the plate-like rubber member.SELECTED DRAWING: Figure 5

Description

  The present invention relates to a plug for a drug container, a method for manufacturing a plug for a drug container, a plug member for a drug container, and a drug container in which the drug is stored.

  Conventionally, many medical containers in which a medicine is stored in a container sealed with a rubber stopper have been provided. And the influence which the rubber stopper used for a medical container has on the chemical | medical agent accommodated in a container is also examined. Effects such as denaturation of drugs and reduction of drug content are being investigated. Specifically, drug adsorption on the surface of the rubber plug, drug sorption on the rubber plug due to drug sorption inside the rubber plug, and elution of a rubber plug forming component from the rubber plug material. Drugs that are likely to cause such problems include protein preparations such as insulin, growth hormone, erythropoietin, granulocyte colony stimulating factor, antibodies, vaccines, peptide preparations such as calcitonin, nitroglycerin, isosorbide nitrate, nicardipine hydrochloride, etc. Are known.

As a rubber stopper for a medicine container, a so-called vial bottle, one in which an inert film is laminated on a portion of a rubber stopper that comes into contact with a medicine has been proposed as disclosed in JP-A-2014-79373 (Patent Document 1). In Patent Document 1, a fluorine resin or an olefin resin is exemplified as an inert film laminated on a rubber stopper. Further, Patent Document 1 discloses that the flange top surface or the inert film laminated surface is surface-coated with non-reactive silicone or reactive silicone.
Japanese Utility Model Laid-Open No. 2-147131 (Patent Document 2) discloses a composite rubber stopper for an infusion device in which a self-sealing rubber core portion is enclosed and integrated inside a thermoplastic elastomer stopper. .

JP 2014-79373 A 2-147131

Although the thing of patent document 1 is also effective, it uses an inactive film and a rubber stopper may become hard, and such a rubber stopper is punctured with a puncture member such as an injection needle a plurality of times. In some cases, the drug leaked from the puncture mark. In addition, as shown in Patent Document 2, in particular, the one shown in the drawing of Patent Document 2, although drawing is possible, the rubber core portion is actually placed at an appropriate position of the thermoplastic elastomer plug. It has been extremely difficult to arrange these.
An object of the present invention is a plug for a drug container using both a rubber material and a thermoplastic elastomer, which does not adsorb drug, does not elute a rubber plug forming component from the rubber plug material, and can puncture a medical needle. Drug container plug body that is good and has a good sealing property even after removal, and that can be used to hold a plate-like member made of a rubber material in a good position in the plug body, its manufacturing method, and a plug for a drug container The present invention relates to a member and a medicine container in which a medicine is stored using the member.

What achieves the above object is as follows.
(1) A rubber plate-like member, a thermoplastic elastomer upper forming portion in close contact with the upper surface of the rubber plate-like member, and a thermoplastic elastomer lower forming portion in close contact with the lower surface of the rubber plate-like member. A plug for a drug container in which the entire rubber plate-like member is encapsulated by the upper forming portion and the lower forming portion,
The lower forming portion includes a bottom plate portion that is in close contact with the lower surface of the rubber plate-like member, and a plurality of lower leg portions that extend from a peripheral portion of the bottom plate portion toward the upper forming portion, and the upper forming portion. Is formed so as to make up between the leg portions of the lower formation portion, and an upper plate portion that is in close contact with the upper surface of the rubber plate-like member, and extends from the peripheral portion of the upper plate portion toward the lower formation portion. A plurality of upper legs, and the upper legs extend in the direction of the lower surface of the rubber plate-like member and have an inner extending portion that is in close contact with the peripheral edge of the lower surface of the rubber plate-like member. A plug for a drug container.

(2) The said lower formation part has a notch part formed in the side surface of the said baseplate part, The said upper leg part of the said upper formation part supplements the said notch part as described in said (1). Drug container stopper.
(3) The lower leg portion of the lower forming portion has a recess extending inward of the lower leg portion from a side surface of the lower leg portion, and a side portion of the notch portion of the bottom plate portion is the lower leg portion. The upper forming portion extends in the concave portion direction and is integrated with the concave portion, and the upper forming portion compensates the concave portion of the lower leg portion of the lower forming portion and the notch portion of the bottom plate portion. Caps for drug containers.
(4) The lower leg portion of the lower forming portion has a recess extending inward of the lower leg portion from both side surfaces of the lower leg portion, and both side portions of the notch portion of the bottom plate portion are formed on the lower leg portion. In the above (2), the upper forming part is integrated with the concave part, and the upper forming part compensates the concave part of the lower leg part of the lower forming part and the notch part of the bottom plate part. The stopper for a medicine container as described.
(5) The stopper for a medicine container according to (3) or (4), wherein the concave portion of the lower leg portion extends from a lower end to an upper end of the lower leg portion.
(6) The lower forming portion has 3 to 5 upper leg portions extending in the direction of the upper forming portion, and 3 to 5 lower leg gaps formed between the plurality of lower leg portions, The upper forming part is a plug for a medicine container according to any one of the above (1) to (5), wherein the upper forming part includes 3 to 5 upper leg parts formed so as to fill the gap between the lower leg parts.
(7) The piercing resistance of the upper plate portion of the upper forming portion and the piercing resistance of the bottom plate portion of the lower forming portion are smaller than the piercing resistance of the rubber plate member (1) to (6) ) A plug for a drug container according to any one of the above.
(8) The thickness of the rubber plate-like member is 1/10 to 4/5 of the thickness of the central portion of the plug body. The drug container according to any one of (1) to (7) above Plug body.
(9) The thickness of the upper plate portion of the upper forming portion is 1/6 to 5/6 of the thickness of the central portion of the plug body according to any one of (1) to (8) above. Drug container stopper.
(10) The drug according to any one of (1) to (9), wherein a thickness of the bottom plate portion of the lower forming portion is 1/6 to 5/6 of a thickness of a central portion of the plug body. Container closure.

Moreover, what achieves the said objective is as follows.
(11) A plug member for a drug container comprising a cylindrical member made of a thermoplastic resin and a plug for a drug container that is fixed in one end portion of the cylindrical member and closes the one end portion, wherein the drug container A plug member for a drug container, wherein the plug body is the drug container plug according to any one of (1) to (10).
Moreover, what achieves the said objective is as follows.
(12) A drug container main body having an opening, a plug member for the drug container according to (11) that is attached to the opening of the drug container main body and seals the opening, and the drug container main body A medicine container with medicine stored therein.

Moreover, what achieves the said objective is as follows.
(13) A rubber plate-shaped member, an upper forming portion made of a thermoplastic elastomer in close contact with the upper surface of the rubber plate-shaped member, and in close contact with the lower surface of the rubber plate-shaped member and fixed to the upper forming portion. And a lower part forming portion made of thermoplastic elastomer, and the rubber plate member is entirely encapsulated by the upper forming portion and the lower forming portion. A method for producing a plug for a drug container produced by molding,
The manufacturing method includes a plate-shaped member preparation step of preparing the rubber plate-shaped member,
The peripheral edge of the rubber plate member is held at a plurality of sites in the cavity of the mold so that a gap is formed between the lower surface of the rubber plate member and the inner surface of the mold. A lower forming part molding step in which a plate-like member held by a plurality of parts is placed in a lower forming part molding die, and a thermoplastic elastomer melt is injected to a peripheral edge and a bottom of the plate-like member; In a state where the shaped member and the lower forming part are placed in an upper forming part molding die, and the holding part of the rubber plate-like member in the lower forming part molding step is removed, and the part is a gap. A method for producing a plug for a drug container, comprising: an upper forming portion molding step of injecting a thermoplastic elastomer melt into an upper portion, a peripheral portion, and the gap of a lower forming portion having the rubber plate-like member.
(14) In the lower forming portion molding step, the thermoplastic elastomer melt is injected from the outside of the periphery of the plate-like member so that the thermoplastic elastomer melt does not directly contact the plate-like member. The method for producing a plug for a drug container according to (13) above.
(15) The upper forming part molding step is such that the thermoplastic elastomer melt flows into the upper surface of the rubber plate-like member after contacting the lower forming part formed in the lower forming part molding step. The method for producing a plug for a pharmaceutical container according to the above (13) or (14), wherein the injection is performed.

The stopper for a drug container of the present invention includes a rubber plate-shaped member, an upper forming portion made of a thermoplastic elastomer that is in close contact with the upper surface of the rubber plate-shaped member, and a thermoplastic elastomer that is in close contact with the lower surface of the rubber plate-shaped member. A plug member for a medicine container having a lower forming part made of rubber and the entire rubber plate-like member being encapsulated by the upper forming part and the lower forming part. The lower forming portion has a bottom plate portion that is in close contact with the lower surface of the rubber plate-like member, and a plurality of lower leg portions that extend from the peripheral portion of the bottom plate portion toward the upper forming portion, and the upper forming portion is made of rubber plate An upper plate portion that is in close contact with the upper surface of the member, and a plurality of upper leg portions that extend from the peripheral portion of the upper plate portion in the direction of the lower formation portion and are formed so as to compensate between the legs of the lower formation portion, The upper leg portion has an inner extending portion that extends in the lower surface direction of the rubber plate-like member and is in close contact with the peripheral edge portion of the lower surface of the rubber plate-like member.
This plug for drug containers maintains sufficient flexibility, does not adsorb drugs, does not dissolve rubber plug forming components from the rubber plug material, and provides good resealability even after multiple punctures. Have. The rubber plate member is located between the lower forming portion and the upper forming portion, and the upper leg portion of the upper forming portion has a lower inner extending portion extending in the lower surface direction of the rubber plate member. The rubber plate member is held at a good position in the stopper.

The plug member for a drug container according to the present invention includes a cylindrical member made of a thermoplastic resin, and a plug member for a drug container that is fixed in one end portion of the cylindrical member and closes the one end portion. And the stopper for medicine containers is the above-mentioned stopper for medicine containers.
This plug member for the drug container maintains sufficient flexibility, does not adsorb the drug, does not elute the rubber plug forming component from the rubber plug material, and has good resealability even after multiple punctures. Have. The rubber plate member is located between the lower forming portion and the upper forming portion, and the upper leg portion of the upper forming portion has a lower inner extending portion extending in the lower surface direction of the rubber plate member. The rubber plate member is held at a good position in the stopper.

In addition, the medicine container in which the medicine is stored according to the present invention includes a medicine container main body having an opening, the medicine container plug member attached to the opening of the medicine container main body and sealing the opening, and the medicine container main body. And a medicine stored in the container.
This medicine container in which medicine is stored does not adsorb medicine and does not dissolve rubber stopper forming components from the rubber stopper material, and also has good resealability even when puncturing is performed a plurality of times. The rubber plate member is located between the lower forming portion and the upper forming portion, and the upper leg portion of the upper forming portion has a lower inner extending portion extending in the lower surface direction of the rubber plate member. The rubber plate member is held at a good position in the stopper.

In addition, the method for producing a plug for a pharmaceutical container according to the present invention includes a rubber plate-like member, an upper forming portion made of a thermoplastic elastomer adhered to the upper surface of the rubber plate-like member, and a lower surface of the rubber plate-like member. A stopper for a medicine container having a lower forming portion made of a thermoplastic elastomer that is closely attached and fixed to an upper forming portion, and the entire rubber plate member is encapsulated by the upper forming portion and the lower forming portion. It is a manufacturing method of the plug for medicine containers manufactured by injection molding using a metallic mold. The manufacturing method of the present invention includes a plate-like member preparation step for preparing a rubber plate-like member, and a peripheral edge of the rubber plate-like member so that a gap is formed between the lower surface of the rubber plate-like member and the inner surface of the mold. The rubber plate-like member partial holding step for holding the portion at a plurality of sites, and the plate-like member held by the partial holding step are placed in the lower forming portion molding die, and are placed on the peripheral edge and bottom of the plate-like member Lower forming portion molding step for injecting the thermoplastic elastomer melt, the plate-like member and the lower forming portion are placed in the upper forming portion molding die, and the portion holding the rubber plate-like member is removed, and the gap In this state, an upper forming portion molding step is performed in which a thermoplastic elastomer melt is injected into the upper portion, the peripheral portion, and the gap of the lower forming portion having the rubber plate member.
According to this manufacturing method, it is possible to satisfactorily manufacture the above-described plug for a medicine container in which the rubber plate-like member is located at a favorable site between the lower forming portion and the upper forming portion.

FIG. 1 is a front view of a plug for a drug container according to an embodiment of the present invention. FIG. 2 is a plan view of the medicine container stopper shown in FIG. FIG. 3 is a bottom view of the drug container stopper shown in FIG. 1. FIG. 4 is a cross-sectional view taken along line AA in FIG. 5 is a cross-sectional view taken along line BB in FIG. 6 is a perspective view of the medicine container stopper shown in FIG. FIG. 7 is a perspective view showing the components of the plug for the drug container shown in FIG. FIG. 8 is a plan view of a lower part forming part of the plug for a medicine container shown in FIG. FIG. 9 is a bottom view of the upper forming part of the plug for the drug container shown in FIG. FIG. 10 is a perspective view of a plug for a drug container according to another embodiment of the present invention. FIG. 11 is a perspective view showing the components of the plug for the drug container shown in FIG. FIG. 12 is a front view of a plug member for a drug container that is an embodiment of the present invention. FIG. 13 is a longitudinal sectional view of the plug member for the drug container shown in FIG. FIG. 14 is a front view of a medicine container in which medicine is stored according to an embodiment of the present invention. 15 is a plan view of the medicine container with medicine stored in FIG. FIG. 16 is a bottom view of the medicine container with medicine stored in FIG. 17 is a cross-sectional view taken along the line CC of FIG. FIG. 18 is a front view of a medicine container in which the medicine is another embodiment of the present invention. FIG. 19 is a longitudinal sectional view of a medicine container in which medicine is stored according to another embodiment of the present invention. FIG. 20 is an explanatory diagram for explaining a method for producing a plug for a pharmaceutical container according to the present invention. FIG. 21 is explanatory drawing for demonstrating the manufacturing method of the stopper for pharmaceutical containers of this invention. FIG. 22 is an explanatory diagram for explaining a method for producing a plug for a drug container according to the present invention. FIG. 23 is explanatory drawing for demonstrating the manufacturing method of the plug for pharmaceutical containers of this invention. FIG. 24 is an explanatory diagram for explaining a method for producing a plug for a drug container according to the present invention. FIG. 25 is an explanatory diagram for explaining a method for producing a plug for a drug container according to the present invention. FIG. 26 is an explanatory diagram for explaining a method for producing a plug for a drug container according to the present invention. FIG. 27 is a perspective view of a plug for a drug container according to another embodiment of the present invention. 28 is a bottom view of the drug container stopper shown in FIG. 27. FIG. 29 is a cross-sectional view taken along the line DD of FIG. FIG. 30 is an explanatory diagram for explaining a manufacturing method of the drug container stopper shown in FIGS. 27 to 29. FIG. 31 is an explanatory diagram for explaining a method of manufacturing the plug for a medicine container shown in FIGS.

The stopper for a medicine container of the present invention will be described with reference to the embodiments shown in the drawings.
As shown in FIGS. 1 to 7, the plug 1 for a medicine container according to the present invention includes a rubber plate-like member 4 and an upper formation portion 2 made of a thermoplastic elastomer that is in close contact with the upper surface 41 of the rubber plate-like member 4. And a lower portion 3 made of thermoplastic elastomer that is in close contact with the lower surface 42 of the rubber plate-like member 4, and the entire rubber plate-like member 4 is encapsulated by the upper portion 2 and the lower portion 3. ing.
The lower forming portion 3 includes a bottom plate portion 31 that is in close contact with the lower surface of the rubber plate-like member 4, and a plurality of lower leg portions 32a, 32b, 32c, and 32d that extend from the periphery of the bottom plate portion 31 in the direction of the upper forming portion 2. And have. The upper forming portion 2 has an upper plate portion 21 that is in close contact with the upper surface of the rubber plate-like member 4 and extends from the peripheral edge portion of the upper plate portion 21 toward the lower forming portion, and between the lower leg portions of the lower forming portion 3 (gap 33a). 33b, 33c, 33d) are provided with a plurality of upper legs 22a, 22b, 22c, 22d. Further, the upper leg portions 22 a, 22 b, 22 c, 22 d extend in the direction of the lower surface 42 of the rubber plate member 4, and the inner extension portions 25 a, 25 b, which are in close contact with the peripheral portion of the lower surface 42 of the rubber plate member 4, 25c, 25d.

  A plug 1 for a medicine container according to the present invention includes a rubber plate-like member 4, an injection molded thermoplastic elastomer upper forming portion 2, and a similarly molded thermoplastic elastomer lower forming portion 3. It is formed by. The rubber plate-like member 4 is entirely encapsulated by the upper forming portion 2 and the lower forming portion 3 and is not exposed to the outer surface of the plug body 1.

As the rubber plate-like member 4, a disc-like member as shown in FIG. 7 is suitable.
The thickness of the plate-like member 4 is preferably 0.5 to 5 mm, and particularly preferably 1 to 3 mm. Further, the thickness of the rubber plate-like member 4 is preferably 1/10 to 4/5 of the thickness of the central portion of the plug 1, and particularly preferably 1/6 to 1/5. . Moreover, 5-15 mm is preferable and, as for the diameter of the plate-shaped member 4, 9-13 mm is especially preferable. The diameter of the plate-like member 4 is preferably 1/2 to 5/6 of the diameter of the plug in the arrangement portion of the plate-like member 4, and particularly preferably 2/3 to 3/4.
As the rubber plate-like member 4, a member that can be pierced by a medical needle and that retains sealing properties even if it is removed after piercing is used. Examples of the rubber include those obtained by vulcanizing or crosslinking various rubber materials such as natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber. In particular, a crosslinked product of diene rubber is preferable from the viewpoint of having elastic characteristics and capable of γ-ray sterilization, electron beam sterilization, and high-pressure steam sterilization.

  As shown in FIGS. 1 to 7, the lower forming portion 3 includes a bottom plate portion 31 that is in close contact with the lower surface of the rubber plate-like member 4, and a plurality of lower legs that extend from the peripheral portion of the bottom plate portion 31 toward the upper forming portion 2. It has portions 32a, 32b, 32c, 32d and inter-leg gaps 33a, 33b, 33c, 33d. The bottom plate portion 31 and the plurality of lower leg portions 32a, 32b, 32c, and 32d form a storage portion for the plate-like member 4. Further, as shown in FIGS. 7 and 8, the bottom plate portion 31 includes a plurality of (four in this embodiment) arcuate cutout portions (side cutout portions) 34 provided on the peripheral edge portion. As shown in FIGS. 7 and 8, the notch 34 extends over the entire inter-leg gaps 33a, 33b, 33c, and 33d. The peripheral portion of the placed plate-like member 4 partially protrudes from the bottom plate portion 31 (at the side cutout portion 34). For this reason, in this portion, the bottom surface of the plate-like member 4 is exposed from the bottom plate portion 31.

  Further, in the lower forming portion 3 of this embodiment, the lower leg portions 32a, 32b, 32c, 32d are located on the lower leg portion from the side surfaces (both side surfaces in this embodiment) of the lower leg portions 32a, 32b, 32c, 32d. It has a recess 35 extending inward. And the side part (in this embodiment both sides) of the notch part 34 of the baseplate part 4 is extended in the recessed part 35 direction of a lower leg part, ie, the inner side of a lower leg part. And the side part (in this embodiment both sides) of the notch part 34 of the baseplate part 31 is integrated with the recessed part 35 of a lower leg part.

  Furthermore, in the lower forming part 3 of this embodiment, the recesses 35 provided on the side surfaces of the lower leg parts 32a, 32b, 32c, 32d extend from the lower end of the lower leg part to the upper end of the leg part. . In this embodiment, the recesses 35 are respectively formed inside both side portions of the lower leg portions 32a, 32b, 32c, and 32d. Only one may be used. Further, both side portions of the notch portion 34 of the bottom plate portion 31 also extend into the lower leg portion. Therefore, the lower leg portions 32 a, 32 b, 32 c, and 32 d are connected to the bottom plate portion 31 by connection portions formed between the cutout portions 34. In addition, although it is preferable to provide the recessed part 35 of a lower leg part inside the both sides of lower leg part 32a, 32b, 32c, 32d, you may provide it only in one side part. In addition, by providing such a recess 35, it is possible to prevent the rubber plate from falling off during molding. Moreover, although it is preferable that the side part of the notch part 34 of the baseplate part 31 is extended to the inner side of a lower leg part, what extended only one side and what does not have an extended part may be sufficient.

  In this embodiment, as shown in FIGS. 1 and 4, the bottom surface of the bottom plate portion 31 and the lower surfaces of the lower leg portions 32a, 32b, 32c, and 32d form the same plane. Note that the bottom surface of the bottom plate portion 31 may be slightly depressed from the bottom surfaces of the lower leg portions 32a, 32b, 32c, and 32d. The diameter of the notch 34 of the bottom plate 31 is slightly smaller than the diameter of the rubber plate member 4. In this way, a part of the upper forming portion 2 extends to the lower surface of the rubber plate-like member 4 at the notch portion 34, and the position of the rubber plate-like member 4 is within the plug body 1. Fixing is certain. The diameter difference between the bottom plate portion 31 and the rubber plate-like member 4 at the notch is preferably 1 to 4 mm, and particularly preferably 1.5 to 3 mm. Moreover, it is preferable that both centers are in the substantially same position. Further, the diameter of the bottom plate portion 31 (specifically, the diameter of the portion other than the notch portion and the diameter of the circle formed by the inner surface of the leg portion) is substantially the same as the diameter of the rubber plate member 4.

  In the plug 1 of this embodiment, the lower forming portion 3 has four lower leg portions 32a, 32b, 32c, and 32d, and similarly four inter-leg gaps 33a, 33b, 33c, and 33d. The number of legs and the space between legs is preferably 3 to 5. The leg occupancy ratio of the leg-to-leg gap is preferably 1: 4 to 4: 1, and particularly preferably 1: 2 to 2: 1 in the leg: leg gap (upper leg described later). .

  In the plug 1 of this embodiment, the lower leg is larger than the gap between the legs (upper leg) (having a higher outer occupancy), and the leg: the gap between the legs (upper part). Leg) is approximately 5: 4. However, the present invention is not limited to this, and for example, lower leg portions 32a, 32b, and 32c included in the lower forming portion 3a, such as the plug 1a for the drug container of the embodiment shown in FIGS. 32d may be smaller than the upper leg portions 22a, 22b, 22c, 22d (inter-leg gaps 33a, 33b, 33c, 33d) provided in the upper forming portion 2a.

  In the plug 1a for a medicine container according to this embodiment, the bottom plate portion 31 includes a side cutout portion as in the plug 1 described above. However, in the drug container plug 1a of this embodiment, the lower legs 32a, 32b, 32c, and 32d provided in the lower forming portion 3a do not have the recess provided in the plug 1 described above, The part does not have a part extending to the concave part. In addition, as a plug body, a lower leg part 32a, 32b, 32c, 32d may be provided with a recessed part, and the notch part of the baseplate part 31 may not extend in a recessed part. Further, as the plug body, the lower leg portions 32a, 32b, 32c, and 32d may not be provided with a recess, and the notch portion of the bottom plate portion 31 may extend to the inside of the leg portion.

  1-6 mm is preferable and, as for the thickness of the baseplate part 31, 2-4 mm is especially preferable. Moreover, it is preferable that the thickness of the baseplate part 31 is 1/6-5/6 of the thickness of the center part of the stopper 1, and it is especially preferable that it is 1/3-1/2. Moreover, 12-24 mm is preferable and, as for the diameter (diameter of the largest diameter part) of the baseplate part 31, 14-20 mm is especially preferable. 1-6 mm is preferable and, as for the protrusion height from the upper surface 31a of the baseplate part 31 of the lower leg parts 32a, 32b, 32c, 32d, 2-4 mm is especially preferable. Moreover, 0.5-5 mm is preferable and, as for the thickness of the radial direction of a leg part, 1-3 mm is especially preferable. Moreover, 12-24 mm is preferable and, as for the outer diameter of the largest diameter part of the lower formation part 3, 14-20 mm is especially preferable.

  As shown in FIGS. 1 to 7, the upper forming portion 2 extends from the upper plate portion 21 in close contact with the upper surface of the rubber plate-like member 4 and the peripheral portion of the upper plate portion 21 toward the lower forming portion. A plurality of upper leg portions 22 a, 22 b, 22 c, and 22 d are formed so as to fill the gaps 33 a, 33 b, 33 c, and 33 d between the legs of the forming portion 3. Thereby, the space | interval 33a, 33b, 33c, 33d between leg parts is the state filled with the upper leg part formation material without the clearance gap. Further, when the upper forming portion 2 is viewed as a single unit, there are upper leg gaps 26a, 26b, 26c, 26d between the upper leg portions 22a, 22b, 22c, 22d.

  In this embodiment, as shown in FIGS. 1 and 4, the bottom surface of the bottom plate portion 31 and the lower leg portions 32a, 32b, 32c, and 32d form the same plane. Note that the bottom surface of the bottom plate portion 31 may be slightly depressed from the bottom surfaces of the lower leg portions 32a, 32b, 32c, and 32d.

  As described above, the bottom plate portion 31 of the lower forming portion 3 has the side cutout portion 34, and the upper leg portions 22 a, 22 b, 22 c, and 22 d compensate the cutout portion 34 of the bottom plate portion 31. It has inner extension parts (lower inner extension parts) 25a, 25b, 25c, 25d. The front ends of the inner extending portions 25 a, 25 b, 25 c, 25 d are in contact with the peripheral edge of the lower surface of the rubber plate-like member 4. And the upper surface of the front-end | tip part of inner side extension part 25a, 25b, 25c, 25d is closely_contact | adhered to the peripheral part of the lower surface of the rubber plate-like member 4. Therefore, the rubber plate-like member 4 is in a state of being sandwiched by the upper plate portion 21 and the inner extending portions 25a, 25b, 25c, and 25d at the peripheral portion. An annular rib 23 is provided on the upper surface of the upper plate portion 21, and a recess 24 is formed therein.

  The material for forming the upper leg portions 22a, 22b, 22c, and 22d fills the gaps between the lower leg portions 32a, 32b, 32c, and 32d of the lower forming portion 3, and the inside of the lower leg portions 32a, 32b, 32c, and 32d. The recessed portion 35 formed in the above and the cutout portion 34 formed on the side surface of the bottom plate portion 31 are also filled. Therefore, the upper leg portions 22 a, 22 b, 22 c, and 22 d of the upper forming portion 2 are in a state of biting into the inner side of the lower leg portion of the lower forming portion 3. For this reason, the upper formation part 2 and the lower formation part 3 are also in a combined state, and the contact area between the two is wide and difficult to separate. Moreover, the plug 1 has substantially no void inside.

  And the upper part formation part 2 forms the whole top form of the plug 1, the part of the side form, and the part of the bottom form. The bottom forming part 3 forms most part of the bottom surface form of the plug 1 and a part of the side surface form.

  The thickness of the upper plate portion 21 is preferably 1 to 6 mm, and particularly preferably 2 to 3 mm. Further, the thickness of the upper plate portion 31 is preferably 1/6 to 5/6, and particularly preferably 1/3 to 1/2 of the thickness of the central portion of the plug body 1. Further, the diameter of the upper plate portion 21 (the diameter of the maximum diameter portion) is preferably 12 to 24 mm, and particularly preferably 14 to 20 mm. 2-8 mm is preferable and, as for the height of the upper formation part 2, 3-6 mm is especially preferable.

  Further, in this embodiment, as shown in FIGS. 1, 3, and 4, the bottom surface of the plug body 1, in other words, the bottom surface of the bottom plate portion 31 of the lower forming portion, the lower legs 32a, 32b, 32c, and 32d. The bottom surface and the bottom surfaces of the upper leg portions 22a, 22b, 22c and 22d of the upper forming portion 2 form the same plane. Note that the bottom surfaces of the upper leg portions 22a, 22b, 22c, and 22d may be slightly depressed from the bottom surfaces of other portions, or may be slightly protruded.

  Examples of the thermoplastic elastomer used in the upper forming portion and the lower forming portion include olefin-based elastomers (polyethylene elastomer, polypropylene elastomer), amide-based elastomers (polyamide elastomer), styrene-based elastomers (for example, styrene-butadiene-styrene copolymer, styrene- A thermoplastic elastomer such as isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), polyurethane, or urethane elastomer can be suitably used.

  The piercing resistance of the upper plate portion 21 of the upper forming portion 2 in the plug 1 is preferably smaller than the piercing resistance of the rubber plate member 4. Moreover, it is preferable that the piercing resistance of the bottom plate part 31 of the lower formation part 3 in the plug body 1 is smaller than the piercing resistance of the rubber plate member 4. By doing in this way, the plug body 1 as a whole can have a low piercing resistance. The piercing resistance of the upper plate portion 21 of the upper forming portion 2 is preferably 1/3 to 2/3 of the piercing resistance of the rubber plate-like member 4. Similarly, the piercing resistance of the bottom plate portion 21 of the lower forming portion 2 is preferably 1/3 to 1/2 of the piercing resistance of the rubber plate-like member 4.

  As the thermoplastic elastomer used for the upper forming portion and the lower forming portion, it is preferable to use the same elastomer or the same type of elastomer. In addition, as a thermoplastic elastomer used for an upper formation part and a lower formation part, if it has compatibility, it can be used.

  The stopper 1 for a medicine container according to this embodiment has a rubber plate-like member 4 placed in a mold, a thermoplastic elastomer melt is injected to form the lower forming portion 3, and then the thermoplastic elastomer melt. And is formed by forming the upper forming part 2. By doing in this way, in the plug body 1 completed, the deformation | transformation of the site | part shape | molded initially can be made few. The formation order of the lower formation part and the upper formation part may be reversed.

  And by using what has compatibility as a thermoplastic elastomer used for an upper formation part and a lower formation part, at the time of formation of the formation part injected later, an upper formation part and a lower formation part adhere. And since the upper formation part and lower part formation which encapsulate the rubber-made plate-like member 4 shrinks a little after cooling, the rubber-made plate-like member 4 is made of rubber by the shrinkage of the upper formation part and the lower formation part after cooling The rubber plate-like member 4 is slightly pressed while being in close contact with the plate-like member 4.

  Since the rubber plate-like member 4 is entirely encapsulated by the upper forming portion and the lower forming portion, the rubber plate-like member 4 may not have adhesiveness with the thermoplastic elastomer used for the upper forming portion and the lower forming portion. The rubber plate-like member 4 may be fixed to the thermoplastic elastomer used in the upper forming portion and the lower forming portion by surface processing such as surface treatment or surface film formation.

  As surface treatment, plasma treatment, discharge treatment such as corona discharge treatment, surface treatment for surface modification treatment agents such as isocyanate compounds, epoxy compounds, ethyleneimine compounds, amine compounds, RFL (resorcin formalin latex) are used. it can.

Next, a method for producing a plug for a drug container according to the present invention will be described with reference to FIGS.
The method for producing a plug for a drug container according to the present invention comprises a rubber plate-shaped member, an upper forming portion made of a thermoplastic elastomer adhered to the upper surface of the rubber plate-shaped member, and a lower surface of the rubber plate-shaped member. And a stopper for a pharmaceutical container having a lower part made of thermoplastic elastomer fixed to the upper part and the whole rubber plate-like member is encapsulated by the upper part and the lower part. It is a manufacturing method of the stopper for chemical | medical agents manufactured by injection molding using.

  In the production method of the present invention, the plate member preparation step for preparing the rubber plate member, and the periphery of the rubber plate member so that a gap is formed between the lower surface of the rubber plate member and the inner surface of the mold. Is held at a plurality of parts in the cavity of the mold, and the plate-like member held by the plurality of parts in the cavity is placed in the mold for forming the lower forming part, and is placed on the periphery and bottom of the plate-like member. Lower part forming step for injecting thermoplastic elastomer melt, plate-like member and lower forming part are placed in upper forming part molding die, and rubber plate-like member holding part in lower forming part forming step (Specifically, withdrawn), the upper portion of the lower forming portion having the rubber plate-like member, the peripheral portion and the upper portion for injecting the thermoplastic elastomer melt into the gap in a state where the portion is a gap And a partial molding step.

In the manufacturing method of the present invention, first, a plate-shaped member preparation step for preparing a rubber plate-shaped member is performed.
As the rubber plate-like member 4, a disk-like member as shown in FIG. 7 is prepared. The thickness of the plate-like member 4 is preferably 0.5 to 5 mm, and particularly preferably 1 to 3 mm. Moreover, 5-18 mm is preferable and, as for the diameter of the plate-shaped member 4, 9-13 mm is especially preferable. Examples of the rubber include those obtained by vulcanizing or crosslinking various rubber materials such as natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber. In particular, a crosslinked product of diene rubber is preferable from the viewpoint of having elastic characteristics and capable of γ-ray sterilization, electron beam sterilization, and high-pressure steam sterilization.

Next, a lower part forming step is performed.
In the lower forming portion forming step, first, as shown in FIG. 20, a plurality of peripheral portions of the rubber plate member are formed so that a gap is formed between the lower surface of the rubber plate member 4 and the inner surface of the mold. The rubber plate-like member part held at the site is held. Specifically, the peripheral edge of the rubber plate member is held at a plurality of sites in the mold cavity so that a gap is formed between the lower surface of the rubber plate member and the inner surface of the mold.

  A plug molding die 100 as shown in FIG. 20 is prepared. The plug forming mold 100 includes a lower forming part bottom forming mold 110 having a function of holding the plate-like member 4 and a lower forming part side forming mold 120. The lower forming part bottom molding die 110 is a cylindrical mold main body 111, a core 112 that is movably disposed in the cylindrical main body 111, and a movably disposed between the cylindrical main body 111 and the core 112. Plural (specifically, four) plate-like member holding pins 113a, 113b, 113c are provided. And the holding | maintenance part 114a, 114b, 114c formed by the internal step part is provided in the front-end | tip of plate-shaped member holding | maintenance pin 113a, 113b, 113c.

  Then, by attaching the rubber plate-like member 4 to the holding portions 114a, 114b, 114c of the plate-like member holding pins 113a, 113b, 113c, between the lower surface of the rubber plate-like member and the inner surface of the mold. A void is formed. In other words, in the state where there is a gap between the lower surface of the rubber plate member 4 and the inner surface of the mold (between the front end surfaces of the core 112), the peripheral portion of the rubber plate member has a plurality of holding pins 113a and 113b. , 113c holds the rubber plate member. Thereby, the rubber plate-like member partial holding step is completed.

Next, the plate-like member 4 held by the rubber-made plate-like member partial holding step is put into a lower forming portion molding die, and a thermoplastic elastomer melt is injected to the peripheral portion and the bottom portion of the plate-like member.
In this step, as shown in FIG. 21, the plate-like member 4 held by the lower forming portion bottom forming mold 110 is inserted into the lower forming portion side forming mold 120. As shown in FIG. 20, the lower forming portion bottom molding die 110 is moved toward the lower forming portion side molding die 120, and as shown in FIG. The plate-like member 4 held by the plate-like member holding pins 113a, 113b, 113c is housed, and the lower forming portion side portion forming die 120 is brought into contact with the lower forming portion bottom portion forming die 110. .

  As shown in FIG. 21, a lower forming portion forming space is formed between the lower forming portion side forming mold 120 and the lower forming portion bottom forming mold 110. And the space | gap between the lower surface of the rubber-made plate-shaped member 4 and the lower formation part bottom part shaping | molding metal mold | die 110 comprises a part of lower formation part formation space. The lower forming part side molding die 120 includes a lower forming part side part shape forming surface 101 on the inner surface. Further, in this embodiment, the lower forming portion side molding die 120 has a cylindrical die main body 121 and a columnar core 122 disposed therein. The lower forming part side part molding die 120 may be an integral part. In the state shown in FIG. 21, the rubber plate-like member 4 has its lower surface and side portions held by a plurality of plate-like member holding pins 113a, 113b, 113c, and its upper surface is a lower forming portion side portion molding die 120. Specifically, it is in a state of being in contact with the lower surface of the columnar core 122. The rubber plate-like member 4 is sandwiched between a plurality of plate-like member holding pins 113a, 113b, 113c and a lower forming portion side portion forming die 120 (columnar core 122).

  Then, in the state shown in FIG. 21, a molten thermoplastic elastomer is injected from the gate 123 into the above-mentioned mold inner space. Thereby, as shown in FIG. 22, the lower formation part 3 is formed. And the plate-shaped member 4 is in the state hold | maintained by the inner surface of the leg part of the lower formation part 3 which contact | abuts on the side surface. Thereby, a lower formation part formation process is completed. Then, the lower forming portion side portion molding die 120 in the state shown in FIG. 21 is released. For example, the separation can be performed by holding the columnar core 122 in the state shown in FIG. 21, retreating only the cylindrical mold main body 121, retreating from the lower forming portion 3, and then retreating the columnar core 122. it can. Accordingly, as shown in FIG. 23, the lower forming portion bottom molding die 110 holds the plate-like member 4 and the lower forming portion 3.

  In the lower forming portion forming step, it is preferable to inject the thermoplastic elastomer melt from the outside of the periphery of the plate member 4 so that the thermoplastic elastomer melt does not directly contact the plate member 4. Therefore, in the mold used in this step, a gate 123 is provided at a position which is the lower surface of the lower forming portion side portion forming die 120 and the upper surface of the leg forming portion of the lower forming portion 3. . As a result, the resin injected from the gate 123 does not directly contact the rubber plate-like member 4, but once flows into the lower forming portion 3 and then comes into contact. For this reason, the rubber plate-like member 4 is hardly deformed by the injected resin.

  Next, an upper formation part shaping | molding process is performed. In this step, as shown in FIG. 23, an upper forming portion molding die 130 is prepared. The upper forming portion molding die 130 includes an upper forming portion outer surface forming surface 103 on the inner surface. Then, as shown in FIG. 23, the lower forming portion bottom forming mold 110 holding the plate-like member 4 and the lower forming portion 3 is moved in the direction of the prepared upper forming portion forming mold 130, and shown in FIG. Similarly, the lower forming part 3 holding the plate-like member 4 is housed therein, and the upper forming part molding die 130 is brought into contact with the lower forming part bottom molding die 110.

  Then, as shown in FIG. 23, the cylindrical mold main body 111 of the lower forming portion bottom molding die 110 is left, and the core 112 and the plurality of plate-shaped member holding pins 113a, 113b, 113c are detached, instead. The columnar core 115 is inserted. Accordingly, as shown in FIG. 24, the cavity is formed by removing the holding portion of the rubber plate member (specifically, the plate member holding pins 113a, 113b, 113c are retracted). It has a gap. In this way, the upper forming portion forming space 104 is formed between the lower forming portion bottom forming die 110 and the upper forming portion forming die 130 (within the cavity). Further, in this embodiment, the upper forming portion molding die 130 has a die main body 131 having a gate 133 and a demolding columnar portion 132 disposed therein. The upper forming part molding die 130 may be a single piece.

Then, in the state shown in FIG. 24, a thermoplastic elastomer melt is injected from the gate 133 into the upper formation portion forming space 104 in the mold. Thereby, as shown in FIG. 24, the upper formation part 2 is formed and the stopper 1 is completed. The plate-like member 4 is in a state of being entirely wrapped between the lower forming portion 3 and the upper forming portion 2. Thereby, an upper formation part formation process is completed.
In the upper forming part molding step, the thermoplastic elastomer melt is injected so as to flow into the upper surface of the rubber plate-like member 4 after contacting the lower forming part 3 formed in the lower forming part molding step. Preferably it is done.

  In the mold used in this step, as shown in FIG. 24, the upper forming part molding die 130 has a lower surface and a peripheral part, and any leg part of the lower forming part 3 (specifically, the lower leg part). A gate 133 is provided at a position above 32b). For this reason, the resin injected from the gate 133 diffuses into the upper forming portion forming space 104 after contacting the leg portion of the lower forming portion 3 without directly contacting the rubber plate-like member 4. For this reason, the rubber plate-like member 4 is hardly deformed by the injected resin. Further, the resin pressure injected into the upper portion of the rubber plate-like member 4 is evenly applied to the rubber plate-like member 4 and acts to press the rubber plate-like member 4 against the bottom plate portion 31 of the lower forming portion 3. Therefore, the deformation and movement of the rubber plate-like member 4 are further restricted. Moreover, since the lower leg part 32b is connected with the bottom plate part 31 as shown in FIGS. 7 and 4, since it has sufficient rigidity, deformation due to the injection resin hardly occurs. Therefore, in this step, the deformation of the rubber plate member 4 and the lower forming portion 3 is small.

  Further, the upper forming portion molding die 130 and the lower forming portion side molding die 120 used in this step have the positions of the respective gates 123 and 133 with respect to the lower forming portion bottom molding die 110. It is located above the lower forming part bottom molding die 110 and on the same extension line. For this reason, injection molding of the lower forming part and the upper forming part can be performed by the same injection machine.

  Then, as shown in FIG. 26, after the lower forming portion bottom forming mold 110 is retracted, the plug body 1 is moved forward by moving the demolding columnar portion 132 of the upper forming portion forming mold 130 forward. Detach from the upper forming part molding die 130.

  Note that the plug for a drug container according to the present invention may be a plug 1b for a drug container as shown in FIGS. 27 is a perspective view of a plug for a drug container according to this embodiment, FIG. 28 is a bottom view of the plug for a drug container according to this embodiment, and FIG. 29 is a cross-sectional view taken along the line DD of FIG. FIG.

The only difference between the drug container stopper 1b of this embodiment and the drug container stopper 1 described above is that the bottom surface has a key-shaped recess 38.
Similarly to the above-described drug container plug 1, the drug container plug 1 b of this embodiment also has a rubber plate-like member 4 and an upper portion made of a thermoplastic elastomer in close contact with the upper surface 41 of the rubber plate-like member 4. Part 2 and a lower part 3b made of a thermoplastic elastomer that is in close contact with the lower surface 42 of rubber plate-like member 4, and the entire rubber plate-like member 4 is covered by upper forming part 2 and lower forming part 3b. Wrapped.

  As shown in FIGS. 27 to 29, a plurality of key-like recesses 38 extending upward are formed on the lower surface of the plug 1b. In this embodiment, the key-like recess 38 is formed on the lower surface of the lower forming portion 3b. Note that the key-shaped recess 38 may be provided on the lower surface of the upper formation portion 2.

  The key-shaped recess 38 includes a portion extending upward from the bottom surface and a portion extending horizontally from the upper portion of the portion extending upward (vertically upward). For this reason, it is a key. In this embodiment, the horizontally extending portion extends in the outer surface direction from the upwardly extending portion. The horizontally extending portion may extend inward from the upwardly extending portion.

  Moreover, the key-shaped recessed part 38 in this Example is provided in the position which becomes a little inside from the outer edge of the lower surface of the plug 1b (specifically, the lower part formation part 3b). For this reason, the key-shaped recessed part 38 is not exposed to the side surface of the lower part formation part 3b. However, the key-like recess extends upward from the vicinity of the outer edge of the lower surface of the plug 1b (specifically, the lower forming portion 3b) so as to partially scrape the side surface upward, and from the upper part of the upwardly extending portion. You may provide the part extended inside a stopper.

  Further, in the plug 1b of this embodiment, a plurality of key-like recesses 38 are formed on the lower surface. In particular, in this embodiment, a group of key-like recesses composed of a plurality (specifically, 2 to 5) of key-like recesses 38 is formed so as to be equiangular with the central axis of the plug 1b. Yes. The number of key-shaped recess groups is preferably 3 or more. Note that the number of the key-like recesses 38 is preferably plural, but may be only one.

  And the stopper 1b for medicine containers of this Example is manufactured by the method substantially the same as the stopper 1 for medicine containers mentioned above. 30 and 31 are explanatory views for explaining a method of manufacturing the plug for a medicine container shown in FIGS. 27 to 29. FIG.

  Also in the manufacturing method of the plug for medicine container of this embodiment, the plate-shaped member preparation step for preparing the rubber plate-shaped member, and the gap is formed between the lower surface of the rubber plate-shaped member and the inner surface of the mold. The peripheral portion of the rubber plate-like member is held at a plurality of parts in the cavity of the mold, and the plate-like member held by the plurality of parts in the cavity is put into the lower forming part molding die, and the plate In the lower forming part molding step for injecting the thermoplastic elastomer melt to the peripheral part and the bottom part of the shaped member, and in the lower forming part forming step, the plate-like member and the lower forming part are placed in the upper forming part molding die. The holding part of the rubber plate-like member is removed (specifically, retracted), and the upper part, the peripheral part and the gap of the lower forming part having the rubber plate-like member are thermoplastic in a state where the part is made a gap. Upper forming component for injecting elastomer melt Performing the process.

  And also in the manufacture of the plug for a drug container of this embodiment, substantially the same mold as that described above is used. A substantial difference between the mold 100a used for the drug container stopper of this embodiment and the above-described mold 100 is the presence or absence of the key-shaped protrusion 117 for forming the key-shaped recess.

  As shown in FIG. 30, a lower forming portion bottom molding die 110a in the die 100a has a holding function of the plate-like member 4 similar to that of the die 100 described above, and is provided on the upper surface of the cylindrical die main body 111a. A plurality of formed key-like protrusions 117 are provided. The key-shaped protrusion 117 is for forming the above-described key-shaped recess 38 on the bottom surface of the plug body 1a. The key-shaped protrusion 117 is formed in the vicinity of the annular inner edge of the cylindrical mold body 111a. In particular, in the mold 100a, the key-like protrusion 117 is provided so as to be positioned between a plurality (specifically, four) of plate-like member holding pins 113a, 113b, 113c.

  The key-shaped protruding portion 117 includes a shaft portion that extends upward (specifically, vertically upward) from the upper surface of the cylindrical mold body 111a, and a bent portion that extends in the horizontal direction from the tip portion of the shaft portion. In this embodiment, the bent portion extends in the direction of the outer edge of the cylindrical mold body 111a. The bent portion may extend in the direction of the inner edge of the cylindrical mold body 111a.

  Also in the manufacture of the drug container stopper of this embodiment, as shown in FIG. 30, the rubber plate member is formed so that a gap is formed between the lower surface of the rubber plate member 4 and the inner surface of the mold. A rubber plate-like member is held at a plurality of portions around the peripheral edge of the plate. 21 and 22, the held plate-like member 4 is placed in the lower forming portion molding die, and the thermoplastic elastomer melt is injected into the peripheral portion and the bottom portion of the plate-like member. The forming part is injection molded. Then, similarly to FIG. 23, it is assumed that the lower forming part upper bottom forming mold is separated, and the lower forming part bottom forming mold holds the plate-like member 4 and the lower forming part 3. 24 and 25, the plate-like member 4 and the lower forming portion 3 held by the lower forming portion bottom molding die are arranged in the upper forming portion molding die, and the thermoplastic elastomer is melted. The product is injected and the upper forming part is injection molded.

  Then, as shown in FIG. 31, the upper forming portion bottom molding die 130a and the lower forming portion bottom molding die 110a are separated (for example, the upper forming portion bottom molding die 130a is moved upward). Thus, the molded plug 1b is held by the key-shaped protrusion formed on the lower forming portion bottom molding die 110a, and thus is exposed without following the upper forming portion bottom molding die 130a. . For this reason, in this embodiment, the upper forming portion bottom molding die 130a does not have the demolding columnar portion 132 that the above-described upper forming portion molding die 130 has.

Next, the plug member 10 for a medicine container according to the present invention will be described with reference to the examples shown in FIGS.
The plug member 10 for a drug container according to the present invention includes a cylindrical member 5 made of a thermoplastic resin, and a plug 1 for a drug container that is fixed in one end portion of the cylindrical member 5 and closes the one end portion. As the plug 1 for the medicine container, the one described above is used.
As shown in FIGS. 12 and 13, the plug member 10 includes a tubular member (annular cap) 5 made of thermoplastic resin and a plug 1 for a medicine container mounted on the tubular member (annular cap) 5. Become. The plug member 10 is a combination of a plug body (rubber plug) 1 and a cap 5.

The cylindrical member (annular cap) 5 includes a cylindrical main body 51 having a mounting portion of the plug body 1, a protruding portion (annular protruding portion) 53 protruding outward from a lower end side portion of the cylindrical main body 51, And a fusion rib 54 that protrudes downward from the lower surface of the protrusion (annular protrusion) 53.
As shown in FIG. 13, the cylindrical member (annular cap) 5 includes a disk-shaped upper plate portion 52 including an opening 55. The annular rib 54 is an annular rib extending downward from a position slightly inside the outer edge of the protruding portion (flange) 53.

  The plug body 1 is accommodated in the cylindrical main body 51 with a part of the upper surface exposed at the opening 55. In this embodiment, the plug 1 is fixed at a portion that contacts the inner surface of the cylindrical main body 51. Such a form can be obtained by injection-molding a resin compatible with the thermoplastic elastomer forming the outer surface of the plug body in a state where the formed plug body 1 is housed in the mold. it can.

  As described above, the cylindrical member (annular cap) is formed of a thermoplastic resin that is compatible with the thermoplastic elastomer that forms the outer surface of the plug. For example, polyolefin (polyethylene, polypropylene, ethylene-propylene copolymer, polypropylene and polyethylene or polybutene) may be used depending on the thermoplastic elastomer used for the plug body. Mixture), polyester (polyethylene terephthalate, polybutylene terephthalate), polyamide, polyvinylidene chloride, polyvinylidene fluoride, and the like.

  The cylindrical member (annular cap) is highly compatible with the material for forming the opening of the drug container described later (the container body 6 in the embodiment shown in FIG. 14 and the container body 14 in the embodiment shown in FIG. 19). Particularly preferably, it is preferable to use the same or the same resin. Further, the forming material of the cylindrical member (annular cap) is formed from the forming material of the opening of the drug container (the container body 6 in the embodiment of FIG. 14 described later, and the container body 14 in the embodiment of FIG. 19), Those having a low melting point are preferred.

Next, the medicine container 20 with medicine stored according to the present invention will be described with reference to the embodiments shown in FIGS.
The medicine container 20 with medicines of the present invention includes a medicine container body 6 having an opening 61, a medicine container plug member 10 that is attached to the opening 61 of the medicine container body 6 and seals the opening 61, and a medicine. And a medicine 7 stored in the container body 6.

  The drug container 20 of this embodiment includes a container main body 6 integrally including a container main body 60 and a tubular opening 61, and a drug container plug member 10 including a plug 1 is used as a port portion. The plug member 10 for the medicine container is fused to the tubular opening 61 of the container body 6. The medicine container 20 includes a medicine 7 filled in the container body 6.

  As shown in FIGS. 14 to 17, the container body 6 includes a substantially cylindrical tubular opening 61 having an opening at the upper end, a flat tubular upper part 62 that is continuous with the tubular opening 61 and extends downward, and a cylinder. A flat cylindrical body 63 that is continuous with the cylindrical upper part 62 and extends downward, and a flat cylindrical lower part 64 that is continuous with the cylindrical cylindrical part 63 and extends downward.

The tubular opening 61 is a cylindrical portion extending a predetermined length with substantially the same inner diameter. In this embodiment, the tubular opening 61 forms a port portion in cooperation with the plug member 10 for a medicine container including the plug body 1.
The tubular opening 61 includes a plug member fixing portion (flange portion) 71 protruding outward from the side surface portion. In this embodiment, the upper surface of the plug member fixing portion 71 is an annular flat portion. Further, the container body 6 has a closed lower surface portion 68, and a projecting portion 69 that protrudes downward is formed on the lower surface portion 68. The protruding portion 69 functions as a mounting holding portion for the suspension member 8. In the suspension member 8 of this embodiment, the drug container can be suspended by being bent.

  The container body 6 includes upper central portions 62a and 62b provided on the front and back surfaces of the cylindrical upper portion 62 on the long axis side (opposite each other across the long axis), and the upper central portion extends from the upper end to the lower end. The wall thickness is gradually getting thinner. The container body 6 of this embodiment includes two upper side portions provided at both ends of the flat cylindrical upper portion 62 on the long axis side. The two upper side portions are close to each other toward the tubular opening 61. Further, the upper side portion is a curved portion that protrudes outward in a substantially arc shape.

  The container body 6 includes a flat cylindrical body 63 that is continuous with the lower end of the flat cylindrical upper portion 62 and extends downward. Moreover, the flat cylindrical trunk | drum 63 is provided with the two trunk | drum side parts 66a and 66b which follow the lower end of an upper side part, and extend below. The body side portions 66a and 66b are curved portions that project outward in a substantially arc shape.

  The container body 6 includes a flat cylindrical lower part 64 that is continuous with the lower end of the flat cylindrical body 63 and extends downward. The flat cylindrical lower portion 64 is continuous with two lower side portions 65a and 65b provided at both ends of the long axis of the flat cylindrical lower portion 64, and the lower side portions 65a and 65b are lower ends of the trunk side portions 66a and 66b. And extends to the closed lower surface portion 68. As shown in FIG. 4, the flat cylindrical lower portion 64 is formed such that the width decreases toward the lower side (lower surface portion 68) and the thickness gradually decreases.

  The container body 6 is formed of a thermoplastic resin. Examples of the thermoplastic resin that forms the container body 6 include polyolefin (polyethylene, polypropylene, ethylene-propylene copolymer, a mixture of polypropylene and polyethylene or polybutene), polyester (polyethylene terephthalate, polybutylene terephthalate), polyamide, and polychlorinated. Examples include vinylidene and polyvinylidene fluoride. Among these, a polypropylene resin excellent in heat resistance is most preferable.

  The inner volume of the container body 6 is preferably 50 to 1600 ml, and the diameter of the protruding portion 69 is preferably about 2 to 5 mm. The thickness of the container body 60 of the container body 6 is preferably 0.1 to 0.5 mm, the width of the container body 60 of the container body 6 is 60 to 150 mm, and the thickness of the container body 60 of the container body 6 is The length is preferably 110 to 250 mm.

Next, the port of the medicine container 20 will be described.
In the medicine container 20 of this embodiment, the port is a discharge port.
The port is composed of the tubular opening 61 of the container main body 6 described above and the plug member 10 for the drug container fixed to the tubular opening 61. The drug container plug member 10 includes a plug body 1 and a cylindrical member 5. The plug 1 and the cylindrical member 5 are as described above.
As shown in FIG. 17, the cylindrical member (annular cap) 5 is formed such that the lower surface of the cylindrical main body portion 51 and the protruding portion (annular protruding portion) 52 is the upper annular flat portion of the plug member fixing portion 71 of the flange portion 71. Oppositely, the fusion rib is melted and fixed to the upper annular flat portion (sealing member fixing portion) of the flange portion 71.

The drug container of the present invention may be a soft bag type drug container 30 as shown in FIG.
And as the medicine container 30 of this embodiment, what is composed of the above-described tubular member 9 and the medicine container plug member 10 including the plug body 1 is used as a discharge port located at the lower part. Further, in the drug container 30 of this embodiment, the mixture injection port located above is composed of the above-described tubular member 9 and the drug container plug member 10 including the plug body 1. Note that the medicine container 30 may include only a discharge port.

  The specific content of the port is substantially the same as that of the medicine container 20 described above. In the drug container 30 of this embodiment, a soft container 82 is used. The tubular member 9 is formed by a member separate from the soft container 82 and is fixed to the soft container 82 by fixing portions 97 and 98.

  Further, the soft container (container body) 82 of this embodiment is formed of a sheet-like cylindrical body. The container main body 82 is formed with a partition portion 89 that divides the internal storage portion and constitutes a releasable partition portion, and is partitioned into a first chemical solution chamber 91 and a second chemical solution chamber 92. In the drug container 30, the tubular member 9 is attached to the first chemical chamber 91 of the container body 82. The first chemical solution chamber 91 stores the first chemical solution, and the second chemical solution chamber 92 stores the second chemical solution. The container body 82 of this embodiment includes an upper seal portion 85, a lower seal portion 86, and side seal portions 87 and 88.

   The partition portion 89 includes a peelable partition weak seal portion 89a that traverses the container body 82 in the entire lateral direction, and a substantially non-peelable strong seal portion 89b provided in the branch portions at both ends of the weak seal portion 89a. I have. Moreover, although the volume of the medicine container 30 varies depending on the type of medicine accommodated therein, the volume of the first chemical liquid chamber is usually preferably about 50 to 5000 ml, and the volume of the second chemical liquid chamber. However, it is preferable that it is about 50-5000 ml.

  As a medicine stored in each chemical solution room, a chemical solution, a powder, etc. can be considered. In particular, in the drug container of the present invention, the first drug solution is preferably a drug solution. The second chemical solution may be either a chemical solution or a powder. A chemical solution is preferable. Examples of the combination of the first chemical solution and the second chemical solution include combinations of an amino acid electrolyte solution and a glucose solution, a glucose solution and a sodium bicarbonate solution, and the like.

  And in the chemical | medical agent container 30 of this Example, the peelable communication inhibition weak seal part 98 which inhibits communication with the tubular member 9 and the inside of the container main body 82 is provided. Therefore, the tubular member (discharge port) 9 communicates with the empty chamber 93 in the container main body 82 but does not communicate with the first chemical chamber 121. The above-described weak seal portions 89a and 98 are formed by heat-sealing the sheet material in a band shape (thermal fusion, high-frequency fusion, ultrasonic fusion, etc.).

The medicine container in which the medicine is stored according to the present invention may be a vial type medicine container 40 as shown in FIG.
And also in the chemical | medical agent container 40 of this Example, what consists of the tubular opening part 16 mentioned above and the plug member 10 for pharmaceutical containers provided with the plug 1 is used as a port. In addition, the drug container 40 of this embodiment includes a container main body 14 in which the drug 18 is accommodated, and the container main body 14 includes a main body portion 15 and a tubular opening 16 positioned above the main body portion 15. The tubular opening 16 is formed integrally with the container main body in the same manner as the drug container 20 described above. And on the upper surface of the flange part 19 of the tubular opening part 16, the plug member 10 for a medicine container provided with the plug body 1 is fused. The specific contents of the port in this container are substantially the same as those of the medicine container 20 described above.

Hereinafter, specific examples of the present invention will be described.
Example 1
1) Preparation of rubber plate member A disc-shaped rubber plate having the shape shown in FIG. 7 was prepared using butyl rubber. The rubber plate was produced by press-molding and vulcanizing a vulcanizable rubber composition in which an additive was added to butyl rubber. The obtained rubber plate had an outer diameter of 11 mm and a wall thickness of 1 mm.

2) Injection molding of lower forming portion After mounting the disk-shaped rubber plate in a mold as shown in FIGS. 20 to 25, a styrene thermoplastic elastomer [Lavalon (registered trademark) PJ6300C, Mitsubishi, which is a thermoplastic elastomer, The lower formation part was created by injection-molding] [made by Chemical Co., Ltd.]. The thickness of the lower formation part in the lower part of the rubber plate was 2.5 mm.

3) Injection molding of the upper forming portion After the lower forming portion is formed at the lower portion of the disc-shaped rubber plate as described above, a styrenic thermoplastic elastomer [Lavalon (registered) is placed in a mold as shown in FIGS. (Trademark) PJ6300C] was formed by injection molding to form an upper forming portion. The thickness of the upper formation part in the upper part of the rubber plate was 6.3 mm. In this way, a plug for a drug container of the present invention was prepared. The outer diameter of the plug for the drug container was 16 mm, and the wall thickness at the center was 9.8 mm.

4) After placing the plug for the drug container of the present invention prepared as described above in a cylindrical member forming mold (not shown), a thermoplastic resin having compatibility with the thermoplastic elastomer is used. By injection molding a certain polypropylene [Novatech (registered trademark) PP, manufactured by Nippon Polypro Co., Ltd.], a cylindrical member (cap portion) enclosing the outer periphery of the plug for the drug container is formed, and the drug of the present invention A container stopper member was prepared.

(Experiment)
The following tests were conducted on the plug for drug container and the plug member for drug container of Example 1.
(Experiment 1: Eluent test)
The test was carried out based on “7.03 Rubber stopper test for infusion” described in the Japanese Pharmacopoeia. No eluate was detected from the plug for the drug container of Example 1.

(Experiment 2: Resealability test)
After fixing the stopper member for the medicine container of Example 1 to the opening of the polypropylene vial container containing 10 ml of water by heat sealing, it is sterilized by high-pressure steam (109 ° C., 12 min), thereby filling the liquid-filled medicine container Several were made. Insert the plastic drug discharge needle (outside diameter: approx. 4 mm) for infusion set with the four drug container plug members facing downwards, and remove it after 24 hours. Check for liquid leakage after removal. As a result, no liquid leakage was confirmed from any drug container. Similarly, with the four medicine container plug members facing downward, the injection needle (18G) was pierced, removed after 24 hours, and the presence or absence of liquid leakage after removal was confirmed. Liquid leakage was not confirmed.

DESCRIPTION OF SYMBOLS 1 Drug container plug body 2 Upper formation part 22a, 22b, 22c, 22d Upper leg part 25a, 25b, 25c, 25d Inner extension part 3 Lower formation part 32a, 32b, 32c, 32d Lower leg part 4 Rubber plate shape Member 6 Medicine container body 8 Medicine 10 Medicine container medicine container

Claims (15)

A rubber plate-like member, a thermoplastic elastomer upper forming portion in close contact with the upper surface of the rubber plate-like member, and a thermoplastic elastomer lower forming portion in close contact with the lower surface of the rubber plate-like member. And the whole of the rubber plate-like member is a plug for a medicine container that is encapsulated by the upper forming part and the lower forming part,
The lower forming portion includes a bottom plate portion that is in close contact with the lower surface of the rubber plate-like member, and a plurality of lower leg portions that extend from a peripheral portion of the bottom plate portion toward the upper forming portion, and the upper forming portion. Is formed so as to make up between the leg portions of the lower formation portion, and an upper plate portion that is in close contact with the upper surface of the rubber plate-like member, and extends from the peripheral portion of the upper plate portion toward the lower formation portion. A plurality of upper legs, and the upper legs extend in the direction of the lower surface of the rubber plate-like member and have an inner extending portion that is in close contact with the peripheral edge of the lower surface of the rubber plate-like member. A plug for a pharmaceutical container, characterized in that The said lower formation part has a notch part formed in the side surface of the said baseplate part, The said upper leg part of the said upper formation part is filling the said notch part, The stopper for medicine containers of Claim 1 body. The lower leg portion of the lower forming portion has a recess extending inward of the lower leg portion from a side surface of the lower leg portion, and a side portion of the notch portion of the bottom plate portion is the recess portion of the lower leg portion. 3. The medicine container according to claim 2, wherein the upper forming part extends in a direction and is integrated with the concave part, and the upper forming part compensates the concave part of the lower leg part of the lower forming part and the notch part of the bottom plate part. Plug body. The lower leg portion of the lower forming portion has a recess extending inward of the lower leg portion from both side surfaces of the lower leg portion, and both side portions of the notch portion of the bottom plate portion are formed on the lower leg portion. 3. The medicine container according to claim 2, wherein the medicine container extends in a recess direction and is integrated with the recess, and the upper forming part fills the recess of the lower leg part of the lower forming part and the notch part of the bottom plate part. Plug body. The stopper for a medicine container according to claim 3 or 4, wherein the concave portion of the lower leg portion extends from a lower end to an upper end of the lower leg portion. The lower forming portion has 3 to 5 upper leg portions extending in the direction of the upper forming portion and 3 to 5 lower inter-leg gaps formed between the plurality of lower leg portions, and the upper forming portion The medicine container plug according to any one of claims 1 to 5, further comprising 3 to 5 upper legs formed so as to fill the gap between the lower legs. The piercing resistance of the upper plate portion of the upper forming portion and the piercing resistance of the bottom plate portion of the lower forming portion are smaller than the piercing resistance of the rubber plate member. Caps for drug containers. The plug for a drug container according to any one of claims 1 to 7, wherein the thickness of the rubber plate-like member is 1/10 to 4/5 of the thickness of the central portion of the plug. The stopper for a drug container according to any one of claims 1 to 8, wherein a thickness of the upper plate portion of the upper forming portion is 1/6 to 5/6 of a thickness of a central portion of the stopper. The plug for a drug container according to any one of claims 1 to 9, wherein a thickness of the bottom plate portion of the lower forming portion is 1/6 to 5/6 of a thickness of a central portion of the plug. A plug member for a drug container comprising a cylindrical member made of a thermoplastic resin and a plug for a drug container that is fixed in one end of the cylindrical member and closes the one end, the plug for the drug container A plug member for a drug container according to claim 1, wherein the plug member is a drug container plug body according to claim 1. A drug container main body having an opening, a plug member for the drug container according to claim 11 attached to the opening of the drug container main body and sealing the opening, and housed in the drug container main body. A medicine container in which medicine is stored, comprising a medicine. A rubber plate-like member, a thermoplastic elastomer upper forming portion that is in close contact with the upper surface of the rubber plate-like member, and a thermoplastic that is in close contact with the lower surface of the rubber plate-like member and is fixed to the upper forming portion. A plug member for a medicine container having an elastomer lower part and the rubber plate-like member entirely encapsulated by the upper part and the lower part is manufactured by injection molding using a mold. A method for producing a plug for a drug container, comprising:
The manufacturing method includes a plate-shaped member preparation step of preparing the rubber plate-shaped member,
The peripheral edge of the rubber plate member is held at a plurality of sites in the cavity of the mold so that a gap is formed between the lower surface of the rubber plate member and the inner surface of the mold. A lower forming part molding step in which a plate-like member held by a plurality of parts is placed in a lower forming part molding die, and a thermoplastic elastomer melt is injected to a peripheral edge and a bottom of the plate-like member; In a state where the shaped member and the lower forming part are placed in an upper forming part molding die, and the holding part of the rubber plate-like member in the lower forming part molding step is removed, and the part is a gap. A method for producing a plug for a drug container, comprising: an upper forming part molding step of injecting a thermoplastic elastomer melt into an upper part, a peripheral part, and the gap of a lower forming part having the rubber plate-like member. The thermoplastic resin melt is injected from the outside of the periphery of the plate-like member so that the thermoplastic elastomer melt does not directly contact the plate-like member in the lower forming portion forming step. A method for producing a plug for a pharmaceutical container according to claim 1. In the upper forming part molding step, the thermoplastic elastomer melt is injected so as to flow into the upper surface of the rubber plate member after contacting the lower forming part formed in the lower forming part molding step. The method for producing a plug for a drug container according to claim 13 or 14.

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