JPH11253526A - Sealing member, substance deterioration preventive structure using the same, and container for transfusion - Google Patents

Abstract

PROBLEM TO BE SOLVED: To perform a sealing while gas is passable, and facilitate the fitting in a passage by a method wherein a sealing member is formed into a cap-shape, and the bottom part is thinly molded with a polymer compound through which a gas in a substance housing chamber can pass. SOLUTION: This sealing member 1 is injection-molded using a silicone elastomer into a cap-shape comprising a thicker body part 2 and a thinner bottom part 3. The thickness of the bottom part 3 is set to be 30-300 μm, e.g. approx. 100 μm, and the outer diameter of the body part 2 is set to be approx. 6.4 mm, and the inner diameter of the body part 2 is set to be approx. 4.0 mm in the vicinity of the bottom part 3, and approx. 4.8 mm in the vicinity of the top. A sealing is performed by fitting the sealing member 1 in a passage 6. Thus, from one side to the other side of the passage 6, moisture and a gas such as oxygen can pass through the thinner bottom part 3. For example, by fitting the sealing member 1 in the passage 6 which communicates a substance housing chamber 4 comprising a material through which oxygen or the like permeates, and a deterioration preventive agent housing chamber 5 for the substance, the substance can be prevented from deteriorating.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a sealing member, a structure for preventing deterioration of a substance using the sealing member, and an infusion container, and more specifically, to a passage for communicating with a medicine chamber for accommodating a medicine. And a sealing member for permeablely sealing a gas such as moisture and oxygen, and a structure for preventing deterioration of the medicine for removing gas such as moisture and oxygen from the medicine chamber by using the sealing member and preventing deterioration of the medicine, and a concrete example thereof. It relates to an example of an infusion container.

[0002]

2. Description of the Related Art Conventionally, in a medical institution such as a hospital, a medicine contained in a medicine container such as a vial is distilled water,
It is dissolved in a solution such as a physiological saline solution or a glucose solution and used for infusion. In such a case, the glass vial containing the drug is connected in series to the dissolution solution container containing the dissolving solution so that the two containers can be aseptically communicated during use. Infusion containers have been proposed.

On the other hand, a medicine is accommodated in a soft or hard synthetic resin container, and the medicine container and a solution container containing a solution are connected in series so that they can communicate with each other at the time of use. Transfusion containers have also been proposed (International publication: W
O96 / 25136). However, when the drug is contained in a synthetic resin container instead of a glass vial like this infusion container, the synthetic resin container appears to be hermetically sealed. Gases such as moisture and oxygen permeate little by little from a solution container or the like.

[0004] On the other hand, some medicines stored in a medicine container are deteriorated by such a slight amount of gas such as moisture or oxygen, and are markedly colored or their content is reduced. Therefore, it is conceivable to use a membrane filter that can transmit gas such as moisture or oxygen in the passage leading to the medicine container. However, since this membrane filter is small in size and has no fixing means itself, a separate fixing means is required, so that there is a problem that the fixing work is troublesome, and furthermore, the membrane filter is required to guarantee sterility. Test was required, and there was a problem from the point of validation.

Thus, one of the main objects of the present invention is
It is an object of the present invention to provide a sealing member which can seal a passage so that gas can pass therethrough with a simple configuration, facilitates installation in the passage, and further facilitates validation.

[0006]

SUMMARY OF THE INVENTION The present invention is a cap-like sealing member for sealing a substance storage chamber by being fitted in or fitted into a passage leading to a substance storage chamber for storing a substance. A sealing member whose bottom is formed of a polymer compound so as to be thin so as to allow gas in the substance storage chamber to pass therethrough is provided.

That is, according to the present invention, a sealing member for a passage is provided.
By forming the cap into a thin shape with a polymer compound so that the gas can pass through the bottom of the cap, the gas in the substance storage chamber can be taken out in a sealed state with a simple structure, and can be easily installed in the passage. And the need for a sterility test is eliminated. In the present invention, gas permeable means that solids such as dry chemicals and liquids such as water can be sealed, but gases such as moisture and oxygen can be permeable. Then, it is molded into a cap shape (or container shape) using a polymer compound,
The bottom is thinned.

[0008] As the polymer compound used here,
Silicone elastomer, polyethylene and the like can be mentioned, but silicone elastomer is preferable. The thickness of the polymer compound is preferably 30 μm to 300 μm,
m is more preferable. On the other hand, the body of the cap-shaped sealing member has a thickness of 1.0 to 1.5 m near the bottom.
m, preferably about 1.2 mm, 0.6 to
Set to 1.0 mm. The length of the torso is 3.0 to 10.0
mm, preferably between 5.0 and 6.0 mm. The inner diameter of the cap-shaped sealing member is 1 mm to 10 mm. The cap-shaped sealing member of such a size is used by being fitted (pressed) into the passage leading to the substance storage chamber or fitted outside the passage (covered from the outside at the open end of the passage). However, it is preferable to use it by fitting it outside the passage.

In the present invention, the substance stored in the substance storage chamber includes a drug, a chemical substance, a food, and the like, and a drug (for example, an antibiotic) is more preferable. According to another aspect of the present invention, there is provided a substance storage chamber for storing a substance, a deterioration preventing agent storage chamber for storing a deterioration preventing agent for the substance, a passage communicating between the two storage chambers, and a fitting fit into the passage. Or a cap-shaped sealing member fitted outside the passage to partition both storage chambers in a sealed state, and the bottom of the sealing member is formed of a polymer compound to be thin so as to allow gas in the substance storage chamber to pass therethrough. Provided is a structure for preventing deterioration of a material.

According to yet another aspect of the present invention, there is provided a medicine chamber for accommodating a medicine, a dissolving liquid chamber connected to a bottom of the medicine chamber and having an opening sealed by the bottom, Communication means for communicating the mouth of the liquid chamber, a deterioration preventing agent storage chamber for storing a deterioration preventing agent for the medicine, a passage communicating between the deterioration preventing agent storage room and the medicine chamber, and fitting into the passage Or a cap-shaped sealing member fitted to the outside of the passage, and the bottom of the sealing member is formed of a polymer compound so as to be thin so that the gas in the medicine chamber can be transmitted to the deterioration preventing agent storage chamber. An infusion container is provided.

[0011]

Embodiments of the present invention will be described below with reference to the drawings. It should be noted that the present invention is not limited by this. FIG. 1 is a cross-sectional view showing one embodiment of a sealing member according to the present invention, FIG. 2 is an enlarged view of a main part thereof, and FIG. 3 is a schematic configuration explanation showing a structure for preventing deterioration of a medicine using the sealing member of FIG. FIG.

1 and 2, a sealing member 1 is cap-shaped (or container-shaped) and has a thick body 2 and a thin bottom 3, both of which are made of a silicone elastomer by injection molding. It is integrally molded. Here, the bottom has a thickness of about 100 μm, the outer diameter of the body is 6.4 mm, and the inner diameter is 4.0 mm near the bottom and 4.8 mm near the top.

Thus, when the cap-shaped sealing member 1 is fitted into the passage or fitted outside the passage to seal the passage,
Gases such as moisture and oxygen can be transmitted from one side of the passage to the other through the thin bottom 3. For example, as shown in FIG. 3, as a substance storage chamber 4 for storing a drug (not shown) integrally molded of a material permeable to moisture or oxygen such as polypropylene, and a deterioration preventing agent for preventing deterioration of the drug and the like. 1 and 2 are provided in a passage 6 for connecting a deterioration preventing agent storage chamber 5 for storing a desiccant and an oxygen scavenger (not shown).
(To cover the lower opening of the passage 6). Thus, even if gas such as moisture (gas) or oxygen gradually enters the substance storage chamber 4, the gas permeates through the thin bottom 3 of the sealing member 1 to the alteration preventing agent chamber 5, so that the desiccant and degassing are performed. It is adsorbed by the oxygen agent and can prevent deterioration of the drug, and can maintain its appearance and content.

Next, an embodiment in which the sealing member is used for an infusion container will be described. FIG. 4 is a front view including a cross section of a main part showing an infusion container, FIG. 5 is a cross-sectional view taken along line AA of FIG.
FIG. 6 is a schematic diagram illustrating a state in which the projecting pieces of FIG. 4 are pushed down to form a communication hole. 4 to 6, the infusion container 20 mainly includes a medicine chamber 11, a solution chamber 12, and a cap member 13 provided in the medicine chamber 11 and having a medicine taking-out section 14.

The medicine chamber 11 has a cap member 1 at the upper end.
3 is a wide-mouthed container having a mouth portion 11a to which the device 3 can be attached, and a bottom portion 16 having a communication hole 15 described later. The medicine chamber 11 is integrally formed of polypropylene. The stored medicine is, for example, an antibiotic. The solution chamber 12 is formed in a strict bag shape from a transparent polypropylene or a copolymer sheet of polypropylene and polyethylene, and has sufficient flexibility. At the upper part of the solution chamber 12, an opening 12b connected to a port 11b formed at the lower end of the medicine chamber 11 is provided.
Are formed. At the edge 12a at the lower end of the solution chamber 12, a suspension hole 31 as a suspension support is formed. As the dissolving solution, for example, physiological saline is put.

At the bottom 16 of the medicine chamber, which connects the medicine chamber 11 and the solution chamber 12 in a liquid-tight manner, a communication hole 15 for communicating the medicine chamber 11 and the solution chamber 12 is formed. A solid, substantially conical protruding piece 17 that projects into the medicine chamber 11 while sealing the communication hole 15 is joined to the container with the center X of the container shifted (eccentric). The projecting piece 17
The polypropylene, which is a forming material of the drug chamber 11, is formed of a mixture of polyethylene and polypropylene, which are poorly compatible with each other, and is slightly weaker than the drug chamber 11. 16 are formed integrally.

The cap member 13 is provided at the lower part of the inner wall in the medicine chamber 1.
1 is fitted to the outer wall of the medicine chamber 11 so as to be rotatable by itself.
The mouth 11a is sealed. The lid 13a of the cap member 13 is formed with a cutout hole 13b as a drug solution take-out portion through which a puncture needle connected to one end of the infusion device can penetrate. A rubber stopper (plug) 30 of the cap member 13 is inserted into the mouth 11 a of the medicine chamber 11 to make the medicine chamber 11 airtight. Although the concave portion 30a is exposed by the cutout hole 13b, the cutout hole 13b is protected by a medicine deterioration preventing agent storage chamber 19 described later so that the surface of the rubber plug 30 is not contaminated. The concave portion 30a appears through the cutout hole 13b.

On the lower surface of the rubber stopper 30, there are formed a lower concave portion 30b for facilitating the penetration of the puncture needle and an engaging hole 30c for engaging with (the upper end of) the protruding piece 17. The lid 13a of the cap member 13 is connected to a chemical-deterioration-preventing agent storage chamber 19 so as to cover the lid 13a, and contains therein a desiccant (eg, silica gel) 19a and a deoxidizer (eg, active iron oxide) 19b. Is stored. 19c is an upper cover of the storage room 19, and 19d is a storage member
It is a tension piece when it is removed from

The lid 13a of the cap member 13 and the rubber stopper 3
At 0, a narrow tube portion 21 as a passage penetrating these is fixed, and the sealing member 1 is covered (fitted) at the lower end opening of the narrow tube portion. As this sealing member 1, FIGS.
The one described in the above is used. The inner diameter of the thin tube portion is 5.2 mm and the outer diameter is 6.6 mm. The medicine filling part 25 for accommodating the medicine is substantially composed of the rubber stopper 30 and the medicine chamber 11.
It is a space separated by. Moisture and oxygen permeating into the medicine filling section 25 from the outside or from the solution chamber enter the desiccant 19a stored in the medicine alteration preventing agent storage chamber 19 through the thin tube section 21 through the thin bottom 3 of the sealing member 1. It is adsorbed by the oxygen scavenger 19b to prevent deterioration of the medicine.

The medicine chamber 11 is filled with a medicine into the medicine filling section 25, the rubber stopper 30 of the cap member 13 is inserted into the opening 11a, the engaging hole 30c is engaged with the projecting piece 17, and the lid of the cap member is closed. (The outer frame) 13a is fitted, and then the thin tube portion 21 is attached through the lid portion 13a of the cap member and the rubber plug 30 (the lid portion 13a of the cap member and the rubber plug 30).
Are formed in advance to allow the thin tube portion 21 to penetrate), and a chemical alteration preventing agent from above the cap member 13 so as to cover the upper end opening of the thin tube portion 21 and the cutout hole 13 b of the cap member 13. The storage chamber 19 is detachably attached by heat welding or the like.

With such a configuration, when the cap member 13 is rotated during use, the rubber stopper 30 is accordingly rotated.
Is rotated, and the projecting piece 17 that rotates through the engagement hole 30c of the rubber stopper 30 is twisted off from the bottom 16 of the medicine chamber 11, so that the large communication hole 15 can be easily formed between the medicine chamber 11 and the solution chamber 12. (In particular, see FIG. 6). Next, by standing the medicine deterioration preventing agent storage chamber 19 side down or pressing the solution chamber 12, the solution flows into the drug chamber 11 through the communication hole 15, and the drug and the solution are mixed. You. At this time, since the sealing member 1 allows the liquid (water) to permeate, the water does not come into contact with the desiccant or the oxygen scavenger. After that, the chemical-deterioration preventing agent storage chamber 19 is moved to the tension piece 1.
9d, the cut-out hole 13b as the drug solution take-out part 14 is opened, the puncture needle connected to one end of the infusion device is inserted into the exposed recess 30a of the rubber stopper 30, and the rubber stopper 30 is pierced. Suspension hole 3 of solution chamber 12
When the product 1 is put on a stand, a drug solution obtained by mixing a drug and a solution can be taken out to the other end of the infusion device as an infusion. The infusion container 20 can be stored in a line or in a stand-by state if the infusion container 20 is allowed to stand on its own with the flat surface of the medicine alteration preventing agent storage chamber 19 or the lid 13a after removing this storage chamber facing down.

[0022]

FIG. 4 shows a thin tube portion covered with a sealing member (inner diameter 4 mm, bottom thickness 100 μm) made of silicone elastomer.
Infusion container [Silica gel 5
g and oxygen absorber Ageless (Mitsubishi Gas Chemical) storage]
, The permeation of oxygen and moisture from the drug compartment under each storage condition was as follows. (1) The oxygen concentration in the medicine room after storage at 25 ° C. for 7 days was 4.6% (initial: 20.9%). (2) When stored in an environment at 25 ° C. and a relative humidity of 33% for 20 days, the increase in moisture absorption (moisture permeation) of the silica gel in the drug deterioration preventing agent storage room was 39.6 mg.

[0023]

According to the present invention, the sealing member for the passage is
By forming the cap into a thin shape with a polymer compound so that the gas can pass through the bottom, the gas in the substance storage can be taken out in a sealed state with a simple configuration, and it is easy to attach to the passage. In addition, validation can be facilitated.

[Brief description of the drawings]

FIG. 1 is a sectional view showing one embodiment of a sealing member according to the present invention.

FIG. 2 is an enlarged view of a main part thereof.

FIG. 3 is a schematic structural explanatory view showing a structure for preventing deterioration of a medicine using the sealing member of FIG. 1;

FIG. 4 is a front view including an essential part cross-sectional view showing one embodiment of an infusion container according to the present invention.

FIG. 5 is a sectional view taken along line AA of FIG. 4;

6 is a schematic diagram illustrating a state in which the projecting pieces of FIG. 4 are pushed down to form a communication hole.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Sealing member 2 Body 3 Bottom 4 Substance storage room 5 Deterioration preventing agent storage room 6 Passage 11 Chemical room 11a Mouth 11b Port 12 Dissolution chamber 12a Edge 12b Mouth 13 Cap member 13a Lid 13b Notch hole 14 Drug Take-out part 15 Communication hole 16 Bottom part 17 Projection piece 19 Drug deterioration preventing agent storage chamber 19a Desiccant 19b Deoxidizer 19c Top lid 19d Tension piece 20 Infusion container 21 Narrow tube part 22 Lower end opening 25 Drug filling part 30 Rubber stopper 30a Recess 30b Lower Recess 30c Engagement hole 31 Hanging hole

 ────────────────────────────────────────────────── ─── Continuing on the front page (72) Inventor Jun Futagawa 3-9-3 Honjo Nishi, Kita-ku, Osaka-shi, Osaka Nissha Corporation (72) Inventor Mitsuru Hasegawa 3-9-1 Honjo-Nishi, Kita-ku, Osaka, Osaka No. 3 Nissho Co., Ltd. (72) Inventor Mitsuo Murakami 3-9-3 Honjo Nishi, Kita-ku, Osaka City, Osaka Nissha Co., Ltd.

Claims (11)

[Claims] 1. A cap-shaped sealing member that fits in or is fitted outside of a passage leading to a substance storage chamber for storing a substance and seals the substance storage chamber, the bottom of which is a substance storage chamber. A sealing member formed of a high-molecular compound so as to be permeable to the above gases. 2. The sealing member according to claim 1, wherein the polymer compound is a silicone elastomer. 3. The sealing member according to claim 2, wherein the bottom has a thickness of 30 μm to 300 μm. 4. The sealing member according to claim 2, wherein the inner diameter of the bottom is 1 mm to 10 mm. 5. A substance storage chamber for storing a substance, a deteriorating agent storing chamber for storing a deteriorating agent for a substance, a passage communicating between the two storing chambers, and a fitting in or out of the passage. And a cap-shaped sealing member for partitioning the two storage chambers into a sealed state, wherein the bottom of the sealing member is formed of a polymer compound so as to be permeable to gas in the substance storage chamber and is thinly formed of a polymer compound. Prevention structure. 6. The structure according to claim 5, wherein the polymer compound is a silicone elastomer. 7. The structure according to claim 6, wherein the bottom has a thickness of 30 μm to 300 μm. 8. The structure for preventing deterioration of a substance according to claim 5, wherein the substance is a drug and the agent for preventing deterioration of the substance is a desiccant and / or an oxygen scavenger. 9. A communication means for connecting a medicine chamber for accommodating a medicine, a dissolving liquid chamber connected to a bottom of the medicine chamber and having an opening sealed by the bottom, and a communication between the bottom of the medicine chamber and the opening of the dissolving liquid chamber. A deterioration preventing agent storage chamber for storing a deterioration preventing agent for a medicine, a passage communicating between the deterioration preventing agent storage room and the medicine chamber, and a cap fitted in the passage or fitted outside the passage. An infusion container comprising a sealing member in the shape of a solid, and a bottom portion of the sealing member formed of a polymer compound so as to be thin so that gas in the medicine chamber can be transmitted to the alteration preventing agent storage chamber. 10. The infusion container according to claim 9, wherein the polymer compound is a silicone elastomer. 11. The thickness of the bottom is 30 μm to 300 μm.
The infusion container according to claim 10, which is: