JP2006280795A - Plug for liquid medicament and liquid medicament container having the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a plug for liquid medicament surely preventing floating during a time from plugging a container mouth till turningly fastening it with a cap and facilitating the molding. <P>SOLUTION: This plug for the liquid medicament comprises a top plate part 11 having an outside diameter larger than the inside diameter of the mouth of the container to be filled with liquid medicament, and a leg part 20 projecting at the center of the lower face of the top plate part 11. After plugging the mouth of the container, this plug for the liquid medicament is turned and fastened with the cap. A central space part 21 is provided at the center of the lower face of the leg part 20, at least a notched window part 22 is provided in a side, and the maximum outside diameter of the leg part 20 is positioned on the upper side edge part 23 of the notched window 22. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a liquid preparation stopper and a liquid preparation container including the same.

  Conventionally, as a stopper for a liquid preparation, a rubber stopper has been used as a typical one, and after a leg portion is plugged into a bottle mouth, it is fastened and fixed with an aluminum cap. Before the tightening operation is completed, the rubber stopper may be lifted, tilted, or dropped from the bottle mouth. Further, when the aluminum cap is wound around the inclined rubber plug, the aluminum cap is in an obliquely fogged state, resulting in poor tightening. For this reason, the sterility of the liquid preparation filled in the bottle cannot be guaranteed, and the yield is poor.

  In particular, among the bottles to which the liquid stoppers for liquid preparations are attached, the bottles that are not mixedly used are reduced in size by reducing the head space in order to save labor and reduce the inventory volume. Is considered. In this case, in order to facilitate material management and increase production efficiency, it is considered to unify the size and shape of the bottle mouth and to share the rubber stopper.

As a rubber stopper to be wound with an aluminum cap in order to prevent lifting after being plugged into the bottle mouth, for example, an upper top plate portion having a flange portion and a container formed on the lower surface of the top plate portion A rubber plug comprising a body portion inserted into a mouth, wherein the body portion has a plurality of protrusions provided in a mesh shape on an outer peripheral portion immediately below the lower surface of the top plate portion, and the protrusion portion Has an outer diameter slightly larger than the inner diameter of the container port (see Patent Document 1).
Registered Utility Model No. 2583368

  However, in the rubber plug, it is necessary to form a plurality of protrusions on the outer peripheral surface of the body portion in a mesh shape, so that the molding operation is not easy and dimensional accuracy is likely to vary. For this reason, it is difficult to surely prevent lifting after being plugged into the bottle mouth, and there is a problem that a desired yield cannot be obtained.

  In view of the above-described problems, the present invention can reliably prevent lifting after being plugged into a container opening and then being tightened with a cap, and a liquid preparation mouthplug that can be easily molded and a liquid stopper provided therewith It is an object of the present invention to provide a preparation container.

Means for Solving the Problems and Effects of the Invention

  In order to solve the above-mentioned problems, the liquid preparation mouthpiece according to the present invention has a top plate portion having an outer diameter larger than the inner diameter of the container mouth of the container filled with the liquid preparation, and is provided at the center of the lower surface of the top plate portion. In the liquid preparation plug, which is formed by a leg portion and is stoppered by a cap after being plugged into the container mouth of the container, a central space portion is provided at the center of the lower surface of the leg portion, and at least on the side surface One notch window portion is provided, and the maximum outer diameter of the leg portion is positioned on the upper edge of the notch window portion.

  According to the present invention, since the central space portion and the notch window portion are provided in the leg portion to limit the volume of the leg portion, it is possible to suppress a significant increase in internal pressure in the head space of the container stoppered with the cap. It is possible to surely prevent the stopper plug from being lifted. In addition, since it is not necessary to form a large number of protrusions on the outer peripheral surface of the leg as in the conventional example, molding is easy and dimensional accuracy is less likely to vary. Can be prevented more reliably.

As an embodiment according to the present invention, a pair of notch windows may be formed on the side surfaces of the leg so as to face each other.
According to this embodiment, since the notch window part is provided in the position which a leg part opposes, balance is good and a plug becomes difficult to incline.

As other embodiment concerning this invention, it is good also considering the outer periphery shape of a leg part as a drum drum shape.
According to the present embodiment, since the maximum outer diameter of the leg portion is located on the upper edge of the cutout window portion, the portion that is in surface contact with a certain width region and is in pressure contact with the inner peripheral surface of the container mouth By being continuous, it is possible to more reliably prevent the plug from being lifted.

As another embodiment according to the present invention, an annular rib may be provided on the outer peripheral surface of the leg portion above the upper edge portion of the cutout window portion.
According to the present embodiment, the annular rib is continuously pressed against the inner peripheral surface of the container mouth, the contact portion is continuous, and the contact pressure is increased, so that the plug is more difficult to lift.

In another embodiment according to the present invention, the volume of the leg may be 25% or less of the volume of the head space of the container.
According to this embodiment, a significant increase in internal pressure in the head space of the container is suppressed, and the plug can be prevented from rising.

As a new embodiment according to the present invention, the volume of the leg may be set so that the internal pressure of the head space after being plugged into the container mouth of the container does not exceed 13 Kpa.
According to the present embodiment, a significant increase in internal pressure in the head space is suppressed, and there is an effect that the stopper can be prevented from rising more reliably.

  As another embodiment according to the present invention, the plug may be a rubber plug, and the cap may be an aluminum cap.

  The liquid preparation container according to the present invention may be provided with the above-described liquid preparation plug or the above-mentioned liquid preparation plug and cap. The liquid preparation may be a preparation selected from the group consisting of human serum albumin, human immunoglobulin and human haptoglobulin.

An embodiment of a liquid preparation plug according to the present invention will be described with reference to the accompanying drawings of FIGS.
In the present invention, “bottle” and “container” are used synonymously, and any one provided with the stopper of the present invention is included in the present invention. As a suitable container of the present invention, as a bottle, for example, a glass-made one (for example, hard glass, soft glass, soft alkali-dealtered glass, or an inner wall thereof coated with silicon or the like) Etc. are exemplified. A typical example of the plug is a rubber plug, and an aluminum cap is preferable as a cap to be wound after being plugged. These will be described below by way of example, but the present invention is not limited to these unless it exceeds the gist.

  In the first embodiment, as shown in FIGS. 1 and 2, the top plate portion 11 having an outer diameter larger than the inner diameter of the bottle mouth 31 of the bottle 30 filled with the liquid preparation 32 (see FIG. 5B), and the bottle The rubber plug 10 includes a leg portion 20 press-fitted into the mouth 31.

  As shown in FIG. 5B, in the present application, the head space 33 refers to an internal space that remains after the bottle 30 is filled with the liquid preparation 32. An annular shallow groove 34 that increases the contact area with the rubber stopper 10 is formed on the inner peripheral surface of the bottle mouth 31 of the bottle 30 in order to improve the sealing performance.

  As shown in FIG. 1, the top plate 11 is provided with a pair of needle piercing recesses 13, 13 on the bottom surface of a recess 12 provided at the center of the top surface. Further, protrusions 14 are provided around the recess 12 at a constant pitch.

  The leg portion 20 has a drum drum shape and projects from the center of the lower surface of the top plate portion 11, and a central space portion 21 having a substantially truncated cone shape is formed at the center of the lower surface of the leg portion 20. ing. Further, a pair of cutout window portions 22 and 22 are formed on the side surface of the leg portion 20 so as to face each other. However, since the upper edge portion 23 of the cutout window portion 22 is located below the maximum outer diameter of the leg portion 20, the bottle mouth 31 is continuously sealed by the leg portion 20.

The frustoconical central space portion 21 and the cutout window portion 23 reduce the volume of the leg portion 20, thereby suppressing a significant increase in internal pressure in the head space 33 and preventing the rubber plug 10 from being lifted. In particular, if the volume of the leg portion 20 is 25% or less, particularly 20% or less of the head space, it is suitable for preventing the rubber plug 10 from being lifted.
Further, the volume of the leg portion 20 is such that the internal pressure of the head space 33 after the rubber plug 10 is plugged into the bottle mouth 31 does not exceed 13 Kpa, and particularly if the volume is 12 Kpa or less, the rubber plug 10 is lifted. It is suitable for preventing.

The bottle 30 to which the rubber stopper 10 is attached has a capacity of 10 mL to 500 mL, mainly 20 mL to 250 mL. Examples of the bottle 30 include those made of glass (for example, hard glass, soft glass, dealkalized soft glass, or those whose inner walls are coated with silicon or the like).
A rubber plug 10 is a typical example of a plug, and an aluminum cap is preferable as a cap that is tightened after being plugged. As long as the gist is not exceeded, the invention is not limited to these.
Furthermore, as the liquid preparation 32 filled in the bottle 30, for example, in addition to infusion preparations such as physiological saline, distilled water for injection, glucose solution, electrolyte infusion, amino acid infusion, intravenous fat emulsion, contrast agent, Examples include preparations such as human serum albumin, human immunoglobulin and human haptoglobulin, and other plasma fraction preparations.

  In particular, in this embodiment, in order to reduce the size of the bottle, the bottle mouth 31 is formed so that the head space 33 is smaller than the conventional one.

As shown in FIGS. 3 and 4, the second embodiment is substantially the same as the first embodiment described above, and is different in that an annular rib 24 is formed on the outer peripheral surface of the leg portion 20. For this reason, the same number is attached | subjected about the same part and description is abbreviate | omitted.
According to the present embodiment, there is an advantage that the annular rib 24 is more strongly pressed against the inner peripheral surface of the bottle mouth 31 and can be prevented more reliably.

(Floating test)
(Examples 1 to 4)
As shown in FIG. 6, the rubber plug had a maximum height of 12.3 mm, an outer diameter of the top plate portion of 28.4 mm, and a maximum thickness of the top plate portion of 4.8 mm. The leg portion had a maximum outer diameter of 19.6 mm, a height of 7.5 mm, and a radius of outer periphery of 9.0 mm. Furthermore, the substantially frustoconical central space provided at the center of the lower surface of the leg portion had a depth of 6.0 mm, a lower diameter of 13.5 mm, and an upper diameter of 11.5 mm. Then, four kinds of samples were prepared by providing a notch window portion having a depth of 3.5 mm in the leg portion with varying width dimensions. In addition, the recessed part 12 as shown in FIG. 1A is not provided in the center of the top surface of the top plate part of Examples 1 to 4.

(Examples 5 to 8)
The rubber plug has the outer shape shown in FIGS. 1 and 6, has a maximum height of 11.8 mm, an outer diameter of the top plate portion of 28.4 mm, and a maximum thickness of the top plate portion of 4.3 mm. The leg portion had a maximum outer diameter of 19.6 mm, a height of 7.5 mm, and a radius of the outer peripheral surface of 12.75 mm. Furthermore, the substantially frustoconical central space provided at the center of the lower surface of the leg portion had a depth of 5.5 mm, a lower diameter of 14 mm, and an upper diameter of 11.5 mm. Then, four kinds of samples were prepared by providing a notch window portion having a depth of 3.5 mm in the leg portion with varying width dimensions.

(Comparative Example 1)
Except that the notch window portion was not provided, the sample having the same shape as the rubber plug used in Examples 1 to 4 was used as a sample.

(Comparative Example 2)
Of the leg portions of Examples 5 to 8, a sample that was uniformly cut at a height of 3.5 mm from the lower end portion was used as a sample.

  The used glass bottle has the outer shape shown in FIG. 5 and has a height of 105 mm, a maximum outer diameter of 52 mm, an outer diameter of the narrow neck of 24.5 mm, an outer diameter of the bottle mouth of 28.9 mm, a minimum inner diameter of the bottle mouth of 18.7 mm, and an internal volume. 142.5 mL.

  Then, the glass bottle is filled with water so that a predetermined amount of head space can be secured. The sample of the rubber plug was punched and then left at room temperature without being wrapped with an aluminum cap, and it was visually observed whether or not the rubber plug was lifted within 3 minutes. The observation results are shown in the upper part of each column in FIG. The middle row of each column shows the volume of the rubber plug leg and the volume of the head space, and the lower row shows the volume ratio of the rubber plug leg to the head space.

  As is apparent from FIG. 7, it has been found that when the volume ratio of the rubber plug leg portion to the head space exceeds 15%, the rubber plug is easily lifted.

(Internal pressure measurement)
(Examples 1 to 8 and Comparative Examples 1 and 2)
The internal pressure was measured using the rubber stoppers according to Examples 1 to 8 and Comparative Examples 1 and 2 and the glass bottles described above as samples.

  The measurement method was as follows. After filling the bottle with a predetermined amount of water and plugging the rubber stopper, the syringe needle attached to the digital pressure sensor (manufactured by Keyence Corporation) was left unwound with an aluminum cap. The rubber plug was pierced and the internal pressure was measured. The above measurement is repeated 5 times in total, and the upper and lower limit values and the average value of the internal pressure are shown in FIG. For convenience of explanation, the test results of FIG. 7 are also displayed.

  As is apparent from FIG. 8, it has been found that the rubber plug is likely to float from an internal pressure of about 11 Kpa.

  The stopper for liquid preparations according to the present invention and the container for liquid preparations having the same can be applied to various pharmaceuticals.

1A is a perspective view, FIG. 2B is a longitudinal sectional view, and FIG. 2C is a longitudinal sectional view at a different position. 2A and 2B are a plan view and a bottom view of the liquid preparation plug shown in FIG. FIG. 3A is a perspective view, FIG. 3B is a longitudinal sectional view, and FIG. 3C is a longitudinal sectional view at a different position, showing a second embodiment of the mouthpiece for liquid preparation according to the present invention. 4A and 4B are a plan view and a bottom view of the liquid preparation plug shown in FIG. 5A and 5B are a front view and a partially enlarged cross-sectional view of a bottle to which the liquid preparation spigot according to the present invention is attached. It is the front view and bottom view which show the sample of the stopper used in an Example. It is a chart which shows a floating test result. It is a graph which shows the internal pressure measurement result of a head space.

Explanation of symbols

10: Rubber stopper 11: Top plate part 12: Recess 13: Recess for needle insertion 14: Protrusion 20: Leg part 21: Central space part 22: Notch window part 23: Upper edge part 24: Annular rib 30: Bottle 31: Bottle mouth 32: Liquid preparation 33: Head space 34: Asahi groove

Claims (11)

After the top plate portion having an outer diameter larger than the inner diameter of the container mouth of the container filled with the liquid preparation, and a leg portion protruding from the center of the lower surface of the top plate portion, after being plugged into the container mouth of the container In the mouthpiece for liquid preparations wound with a cap,
A central space portion is provided at the center of the lower surface of the leg portion, and at least one notch window portion is provided on a side surface, and a maximum outer diameter of the leg portion is located on an upper edge of the notch window portion. A mouthpiece for a liquid preparation characterized by the above.   The mouthpiece for a liquid preparation according to claim 1, wherein a pair of cutout windows are formed on the side of the leg so as to face each other.   The mouthpiece for a liquid preparation according to claim 1 or 2, wherein the outer peripheral shape of the leg portion is a drum drum shape.   4. The mouthpiece for a liquid preparation according to any one of claims 1 to 3, wherein an annular rib is provided on the outer peripheral surface of the leg portion above the upper edge portion of the cutout window portion.   The mouthpiece for a liquid preparation according to any one of claims 1 to 4, wherein the volume of the leg portion is 25% or less of the headspace volume of the container.   The liquid formulation mouth according to any one of claims 1 to 5, wherein the volume of the leg portion is set so that the internal pressure of the head space after being plugged into the container mouth of the container does not exceed 13 Kpa. plug.   The plug for liquid preparation according to any one of claims 1 to 6, wherein the plug is a rubber plug.   The cap for a liquid preparation according to any one of claims 1 to 7, wherein the cap is an aluminum cap.   A liquid preparation container comprising the mouthpiece for liquid preparation according to any one of claims 1 to 8.   A liquid preparation container comprising the liquid preparation plug and cap according to any one of claims 1 to 8. The liquid preparation container according to claim 9 or 10, wherein the liquid preparation is a preparation selected from the group consisting of human serum albumin, human immunoglobulin and human haptoglobulin.

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