JP2015042276A - Vial - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a vial that reliably prevents a solution from scattering to the outside of a container body.SOLUTION: A vial according to the present invention comprises: a cylindrical container body 2 in which an upper end part and a lower end part are open; a sealing member 3 that seals the upper end part of the container body 2; and a sliding member 4 arranged so as to be capable of sealing a drug in the container body 2 between the sealing member 3 and the sliding member 4 and sliding in the container body 2 in the longitudinal direction of the container body 2.

Description

  The present invention relates to a vial containing a drug such as a lyophilizing agent.

  For example, as shown in Patent Document 1, a conventional vial has an upper end of a container main body that is sealed with a sealing member having a rubber stopper, and contains a drug such as a lyophilized preparation. . The vial constructed in this manner is punctured with a syringe stopper needle, and a liquid such as distilled water is injected into the container body to dissolve the freeze-dried preparation, and the solution containing this freeze-dried preparation is dissolved. It is used to be put back into the syringe by aspiration with a syringe and finally administered to the human body.

JP-A-9-286453

  Various proposals have been made regarding the above-described vials with respect to the sealing member that seals the opening of the container main body, but few proposals have been made regarding the container main body. When the vial is used, the applicant may inject a liquid into the container body with a syringe and suck the solution, and the container body may be in a positive pressure state. In this state, the needle is removed from the rubber stopper. It has been found that the solution in the container body may scatter when extracted. Then, this invention makes it a subject to provide the vial which prevents reliably that a solution disperses outside the container main body.

  The vial according to the present invention includes a cylindrical container body with one end and the other end opened, a sealing member that seals one end of the container body, and the container between the sealing member and the medicine. A sliding member that is hermetically sealed in the main body and is slidably installed in the container body in the length direction of the container body.

  According to the vial, the storage space in which the medicine is stored is defined by the container body, the sealing member, and the sliding member. Among these, since the sliding member is slidably installed in the container body, it is possible to keep the pressure in the accommodation space constant by sliding the sliding member due to increase or decrease of the pressure in the accommodation space. As a result, it is possible to prevent the inside of the accommodation space from becoming a positive pressure, and thus to prevent the solution from splashing outside when the syringe is removed. In addition, the opening part of the other end part may be formed in the other end surface of the container main body, and may be formed in the other end side surface part of the container main body.

  The vial can have various configurations. For example, it is preferable that the container main body has an anti-extraction means for preventing the sliding member from being extracted at the other end. As the removal preventing means, the other end surface of the container main body having an opening at the center can be used.

  The sealing member includes an elastic member that seals an opening at one end of the container main body, a holding member that is fixed to one end of the container main body while holding the elastic member so that at least part of the elastic member is exposed, It can be set as the structure containing. In order to maintain a sterile condition, it is preferable to cover the exposed portion of the elastic member with a seal or a cap.

  Moreover, the thickness of the said sliding member can be stably slid within a container main body by setting it as 1/3 or more of the internal diameter of a container main body, Preferably it is 1/2 or more.

  ADVANTAGE OF THE INVENTION According to this invention, the vial which prevents reliably that a solution disperses outside the container main body can be provided.

FIG. 1 is a side sectional view of a vial according to this embodiment. FIG. 2 is an explanatory diagram showing an operation when a liquid is injected into the vial according to the present embodiment. FIG. 3 is an explanatory view showing an operation when the solution in the vial according to the present embodiment is sucked. FIG. 4 is a bottom view showing a modification of the bottom surface of the container body in the vial according to another embodiment. FIG. 5 is a side sectional view of a vial according to another embodiment. FIG. 6 is a side sectional view showing a modification of the sliding member according to the present embodiment. FIG. 7 is a side sectional view showing a modified example of the vial according to the present embodiment. FIG. 8 is a side sectional view showing a modified example of the vial according to the present embodiment. FIG. 9 is a side sectional view showing a modified example of the vial according to the present embodiment. FIG. 10 is a side sectional view showing a modified example of the vial according to the present embodiment.

  Hereinafter, embodiments of the vial according to the present invention will be described with reference to the drawings.

  As shown in FIG. 1, the vial 1 has a container body 2, and the upper end of the container body 2 is sealed by a sealing member 3. A sliding member 4 slidable in the vertical direction (length direction) is installed inside the container body 2, and a powder preparation A such as a freeze-dried preparation is formed between the sealing member 3 and the sliding member 4. It is accommodated in the container main body 2 between. In addition, the space between the sealing member 3 and the sliding member 4 in the container main body 2 is referred to as an accommodation space S and will be described below.

  The container body 2 has a cylindrical shape with an upper end and a lower end opened, and the material thereof is not particularly limited, but may be made of glass or a transparent resin, for example. In addition, the material which does not shrink | contract in the freeze-drying process mentioned later so that a clearance gap between the sliding members 4 may not be preferable is preferable. An opening 211 having a diameter smaller than the inner diameter of the container body 2 is formed on the lower end surface 21 of the container body 2. Since the lower end surface 21 is formed in this way, a sliding member 4 described later is prevented from dropping from the lower end of the container body 2, and the lower end surface 21 corresponds to the removal preventing means of the present invention. An annular protrusion 22 is formed on the outer peripheral surface of the upper end portion of the container body 2. The capacity of the storage space S is preferably equal to or smaller than the volume of the syringe 5 so that the entire amount of the solution in the storage space S can be surely inhaled by the syringe 5 described later, and is particularly limited. However, it is preferably about 1 to 50 ml. Further, the space defined between the sliding member 4 and the lower end surface 21 in the container body 2 is sufficiently large so that the liquid in the syringe 5 to be described later can be reliably injected into the accommodation space S. It is preferable to have a large volume, and it is preferable to be equal to or larger than the volume of the syringe 5. Moreover, the opening part 211 does not need to be circular, and can be rectangular.

  The sealing member 3 includes a rubber plug 31 that seals the upper end of the container body 2 and a holding member 32 that holds the rubber plug 31 so that the rubber plug 31 does not come off. The rubber plug 31 includes a small-diameter portion 311 and a large-diameter portion 312. When the rubber plug 31 is completely pushed into the upper end opening of the container body 2, the small-diameter portion 311 is inserted into the container body 2 and has a large diameter. A shoulder formed between the portion 312 and the small diameter portion 311 is in contact with the upper edge of the container body 2. The outer diameter of the small-diameter portion 311 of the rubber plug 31 is preferably formed larger than the inner diameter of the container body 2, so that the small-diameter portion 311 is fitted when inserted into the upper end of the container body 2. It will be in a state and the upper end of the container main body 2 can be sealed.

  The holding member 32 mainly includes a circular top plate portion 321 and a side wall portion 322 extending downward from the periphery of the top plate portion 321. An opening 3211 is formed at the center of the top plate 321, and the seal 33 is detachably pasted on the top plate 321 so as to close the opening 3211 and prevent the rubber plug 31 from coming into contact with outside air. Has been. In a state where the holding member 32 is attached to the container main body 2, the lower end edge of the side wall portion 322 contacts the annular protrusion 22 of the container main body 2, and the side wall portion 322 and the upper end portion of the container main body 2 are fitted. Instead of fitting the holding member 32 to the upper end portion of the container body 2, the holding member 32 and the container body 2 can be welded using heat welding, ultrasonic welding, or the like.

  The sliding member 4 has a substantially cylindrical shape and is installed in the container body 2 in a state in which it can slide in the vertical direction. The sliding member 4 is made of a material having rubber elasticity, and can preferably be made of natural rubber, isoprene rubber, butyl rubber, silicon rubber, thermoplastic elastomer, or the like. In addition, the material which does not shrink | contract in the freeze-drying process mentioned later so that a clearance gap between the container main bodies 2 may not be preferable is preferable. The outer diameter of the sliding member 4 is formed to be larger than the inner diameter of the container main body 2, whereby the sliding member 4 is accommodated in the container main body 2 in a state compressed in the radial direction. S can be sealed. The thickness t of the sliding member 4 should be at least 1/3, preferably 1/2 or more of the inner diameter of the container body 2 so that the sliding member 4 can slide up and down stably in the container body 2. preferable. The slidability can be improved by applying liquid silicon to at least the outer peripheral surface of the sliding member 4.

  Next, a method of using the vial 1 configured as described above will be described.

  First, a freeze-dried preparation A to be stored in the container body 2 of the vial 1 is prepared. Specifically, when the drug is a liquid, first, the drug solution in which the powder is dissolved is aseptically filtered through a filter and filled in the accommodation space S. After filling the chemical solution into the container body 2, the rubber plug 31 is pushed halfway into the upper end of the container body 2. Then, after the chemical solution is freeze-dried, the water is removed by applying a vacuum, and the rubber stopper 31 is pushed to the end to seal the freeze-dried preparation A in the container body 2. If the drug is powder from the beginning, the powdered drug is aseptically filled into the container body 2 and the rubber stopper 31 is pushed into the upper end of the container body 2 to seal the drug in the container body 2.

  Subsequently, a syringe 5 containing liquid such as distilled water for injection, physiological saline, and 5% glucose solution is prepared. Further, the rubber plug 31 is exposed from the opening 3211 of the holding member 32 by peeling the seal 33 from the holding member 32 of the vial 1. Then, as shown in FIG. 2, the needle of the syringe 5 is pierced through the rubber stopper 31 exposed through the opening 3211 of the holding member 32, and the plunger 51 is pushed in so that the liquid contained in the syringe 5 is discharged. Injection into the accommodation space S. At this time, the pressure in the storage space S temporarily becomes positive, but the sliding member 4 slides downward as the pressure in the storage space S rises. Return from positive pressure to atmospheric pressure.

  And as shown in FIG. 3, the solution in the accommodation space S is sucked with the syringe 5 so that the solution of the freeze-dried preparation dissolved in the liquid is returned to the syringe 5 side. At this time, the pressure in the accommodation space S temporarily becomes a negative pressure, but the sliding member 4 moves upward as the pressure in the accommodation space S decreases. Immediately return from negative pressure to atmospheric pressure. As described above, since the pressure in the accommodation space S is kept constant as the sliding member 4 slides in the vertical direction, it remains inside when the needle of the syringe 5 is removed from the rubber stopper 31. It is possible to reliably prevent the dissolved liquid and the like from splashing outside the vial 1.

  As mentioned above, although embodiment of this invention was described, this invention is not limited to these, A various change is possible unless it deviates from the meaning of this invention.

  For example, in the above-described embodiment, the container body 2 has a cylindrical shape with substantially the same diameter from the upper end to the lower end. The portion outside the sliding range does not have to have the same diameter. Moreover, it is not limited to cylindrical shape, For example, you may make it a rectangular tube shape.

  Moreover, in the said embodiment, although the lower end surface 21 in which the opening part 211 was formed was used as the removal prevention means, if it can prevent that the sliding member 4 falls from the lower end of the container main body 2, it will be limited especially to this. Instead, for example, as shown in FIG. 4, it is possible to open the lower end of the container body 2 and provide a cross-shaped member at the lower end. Further, instead of forming an opening in the lower end surface of the container body 2, as shown in FIG. 5, by forming at least one opening 211 on the side surface of the lower end portion of the container body 2, a removal preventing means is provided. You can also.

  Moreover, although the sliding member 4 was demonstrated as the solid in the said embodiment, as shown in FIG. 6, the cavity part 41 may be formed.

  In the above embodiment, the seal 33 is attached to the holding member 32 in order to keep the rubber stopper 31 in a sterile state. However, as shown in FIG. It is also possible to attach a cap 34 having a projection 341 that fits with 3211 on the top plate 321.

  Further, the sealing member can be structured as shown in FIG. The sealing member 3a mainly includes a bomb stopper 31a and a holding member 32a that can be attached to the upper end of the container body 2 while holding the rubber stopper 31a. The rubber plug 31a is not punctured with an injection needle, but a path for injecting the liquid in the syringe into the accommodation space S by deforming the rubber plug 31a by pressing the rubber plug 31a with the tip of the syringe. Is formed. The holding member 32a is mainly composed of an upper part 321a and a lower part 322a. As a manufacturing method of the sealing member 3a, first, the lower portion 322a of the holding member 32a is made of a hard resin and welded to the upper end portion of the container body 2, and then the rubber stopper 31a is made to the lower portion 322a. Weld. Thereafter, the upper part 321a of the holding member 32a is made of a hard resin and welded to the lower part 322a. In addition, in order to improve the sealing property of the holding member 32a and the container main body 2, the sealing member 34 formed with a thermoplastic elastomer etc. can also be provided. The hard resin used as the holding member 32a is preferably polypropylene, polyethylene, or polyethylene terephthalate from the viewpoint of safety when coming into contact with the medicine. Further, the material of the rubber plug 31a is preferably a thermoplastic elastomer from the viewpoint of safety when contacting the drug. In addition, as a modification of this sealing member 3a, it can also be set as a shape as shown, for example in FIG.

  Moreover, in the said embodiment, although powder preparations, such as a lyophilized preparation, were accommodated in the accommodation space S, as shown in FIG. 10, liquid agents, such as a chemical | medical solution, can also be accommodated. In this case, after filling the storage space S with the liquid agent, it can be sterilized by an electron beam sterilization method, a steam sterilization method, or the like.

1 vial 2 container body 3 sealing member 4 sliding member A lyophilized preparation (drug)

Claims (5)

A cylindrical container body having one end and the other end opened;
A sealing member for sealing one end of the container body;
A sliding member that seals the drug in the container body with the sealing member, and that is slidable in the length direction of the container body in the container body;
Vial with.   The vial according to claim 1, wherein the container main body is formed with an anti-extraction means for preventing the sliding member from being extracted at the other end.   The vial according to claim 2, wherein the removal preventing means is the other end surface of the container main body having an opening formed in a central portion.   The sealing member includes: an elastic member that seals an opening at one end of the container main body; and a holding member that is fixed to one end of the container main body while holding the elastic member so that at least part of the elastic member is exposed. The vial according to claim 1, comprising:   The vial according to any one of claims 1 to 4, wherein the sliding member has a thickness of 1/3 or more of an inner diameter of the container body.

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