JP2000210369A - Medicinal liquid bag for administration - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make the degree of welding at a peripheral edge uniform and to lessen the generation of pinholes occurring in the difference in the degree of welding of a welded part by forming a soft bag of a thermoplastic flexible synthetic resin and simultaneously heat sealing the entire part of the peripheral edge exclusive of a medicinal liquid discharge port mounting part, thereby forming the welded peripheral edge. SOLUTION: This medicinal liquid bag 1 for administration has a soft bag 2 in which a medicinal liquid is housed and a medicinal liquid discharge port 3 which is fixed thereto. The soft bag 2 is formed of the thermoplastic flexible synthetic resin. The soft bag 2 is formed as the welded peripheral edge 22 obtd. by simultaneously heat sealing the entire part of the peripheral edge exclusive of the medicinal liquid discharge port mounting part 21. The welded peripheral edge 22 is the continuos welded part consisting of the top end welded peripheral edge 22a which exists on one end side of the soft bag 2 and has the medicinal liquid discharge port mounting part 21, the lower side welded peripheral edge 22b which exists on the other end side, the right welded peripheral edge 22c which exists in the side part and the left wide welded peripheral edge 22d and is formed particularly by thermally welding the entire part at a time under the same thermal welding conditions.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a drug solution container for administration containing therein a drug solution such as an infusion solution.

[0002]

2. Description of the Related Art Conventionally, plastic containers used for storing a medical solution such as an infusion solution are made of polyethylene,
A thermoplastic plastic material such as polypropylene or ethylene-vinyl acetate copolymer is formed into a tubular shape by inflation molding, and the upper and lower ends are heat-sealed, high-frequency welded, ultrasonically welded, etc., excluding the outlet port attachment part. It is formed. In some cases, the upper and lower ends and the left and right ends are individually fused. The outlet port is composed of a cap fitted with a rubber stopper and a port main body, is attached to an unfused portion of a plastic container, and is fixed by heat fusion or the like. The infusion solution is stored in a plastic container.
In some cases, chemical solutions are mixed and used.

[0003]

The plastic body of the plastic container used as described above, in which the upper and lower ends are fused to an inflation film while leaving an outlet port attaching portion, is formed by fusing the left and right ends. There is no possibility that the container may be damaged such as a pinhole due to an unexpected impact on the side surface. In order to solve this problem, it is conceivable to fuse the upper and lower ends and the left and right ends, respectively, while leaving the outlet port mounting portion. Also, it is necessary to make the four ends longer than those to be fused at one time. Furthermore, when the upper and lower ends and the left and right ends are individually fused, it is necessary to manage the margin of fusion of the individual fused portions. It is necessary to make the margin uniform, and if there is a large difference in the fusion margin between the upper and lower ends and the left and right ends, liquid leakage may occur.

[0004] The present invention has been made in view of the above-mentioned problems, and has a uniform degree of fusion at the peripheral edge portion by using a material in which all four edges are fused at a time, and a partial fusion force. The present invention is to provide a drug solution container for administration, in which a low portion is not formed, and pinholes are less generated due to a difference in the degree of fusion between the fusion parts.

[0005]

An object of the present invention is to provide a drug solution container for administration comprising a soft bag containing a drug solution and a drug solution discharge port fixed to the soft bag. The bag is a liquid medicine container for administration, which is formed of a thermoplastic flexible synthetic resin, and whose entire peripheral portion except for the liquid solution discharge port mounting portion is a heat-sealed peripheral portion at the same time.

[0006] The fusion peripheral edge is located at one end of the soft bag and has an upper end side fusion peripheral edge having a chemical solution discharge port attaching portion, a lower end side fusion peripheral portion located at the other end side, It is preferable that it is a continuous welded portion composed of a right-side fused peripheral portion and a left-side fused peripheral portion located at the side portions. Further, the soft bag is made of, for example, a tubular blown film formed of a thermoplastic flexible synthetic resin. Further, it is preferable that the entire periphery of the fusion-bonded portion is thermally fused at once under the same thermal fusion condition. Further, it is preferable that the width of the right-side fusion peripheral portion and the width of the left-side fusion peripheral portion are substantially the same.

[0007]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A drug solution container for administration of the present invention will be described with reference to an embodiment shown in the drawings. FIG. 1 is a front view of a drug solution container for administration according to an embodiment of the present invention. FIG. 2 is a sectional view taken along line AA of the drug solution container for administration in FIG. 1. FIG. 3 is an explanatory view of one example of a heat sealing device used for producing the liquid medicine container for administration of the present invention. FIG. 4 is a diagram showing the bottom surface of the heat sealing mold of the heat sealing device shown in FIG.

The drug solution container for administration 1 of the present invention includes a soft bag 2 containing a drug solution, and a drug solution discharge port 3 fixed to the soft bag 2. The soft bag 2 is formed of a thermoplastic flexible synthetic resin, and has a fusion peripheral edge portion 22 in which the entire peripheral edge portion excluding the chemical liquid discharge port attaching portion 21 is heat-sealed at the same time.

A drug solution container 1 for administration of the present invention comprises a soft bag 2 and a drug solution discharge port 3 fixed thereto. The soft bag 2 is a bag having a chemical solution storage chamber 23 inside. One using a tubular inflation film (or inflation sheet) formed by inflation molding, or one obtained by laminating two films (or sheets) formed by a T-die method or the like, and folding one film Any of them may be used.

As a material for forming the soft bag 2, a thermoplastic soft synthetic resin having a certain degree of heat resistance, for example, polyolefin (for example, polyethylene, polypropylene,
A mixture containing a polyolefin such as an ethylene-propylene copolymer, a mixture of polypropylene and polyethylene or polybutene), a partially crosslinked product thereof, an ethylene-vinyl acetate copolymer (EVA), a polyester (polyethylene terephthalate and polybutylene terephthalate), and a soft Various thermoplastic elastomers such as vinyl chloride resin, polyvinyl acetate, polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyester elastomer, styrene elastomer such as styrene / ethylene / butylene / styrene copolymer, or any combination thereof (Blend resin,
A polymer alloy, a laminate, etc.), a resin layer of a relatively hard material such as polyethylene such as polyethylene terephthalate and polyethylene naphthalate, and a polyamide such as nylon, and a resin layer of the above-described soft material (eg, polyethylene). Multi-layer sheets are used.

The thickness of the film material (or sheet material) constituting the soft bag 2 is not particularly limited, and varies depending on the material of the film, but is 0.1 to 0.5 mm. Further, for example, when a soft polyvinyl chloride sheet material is used, the thickness is preferably about 20 to 500 μm. The soft bag 2 has a tensile modulus of 500.
It is desirable to use an extruded film or an inflation-molded tube of not more than MPa, preferably 50 to 300 MPa.

The soft bag has a fused peripheral portion 22 in which the entire peripheral portion except for the chemical solution discharge port attaching portion 21 is heat-sealed at the same time. The fusion peripheral edge 22 is located on one end side of the soft bag and has an upper edge fusion peripheral edge 22a having a chemical solution discharge port attaching portion, the lower edge fusion peripheral edge 22b located on the other end side, and is located on the side. It is a continuous fused portion composed of a right fused peripheral portion 22c and a left fused peripheral portion 22d. In particular, the entire fusion peripheral portion 22 is thermally fused at once under the same thermal fusion conditions. That is,
The heat fusion is partially performed without changing the conditions. In particular, the inner edge portion 22e of the fusion peripheral portion 22 (the portion surrounding the chemical solution storage chamber 23) includes the heat fusion process of the chemical solution discharge port. Also, the whole is a portion that is heat-sealed at a time under the same heat-sealing condition, and at least the inner edge 22
e have the same thermal history as a whole. Further, the inner edge portion 22e is strongly pressed by the other fusion peripheral edge portion during the heat fusion, and has a higher fusion strength than the other portions. Further, a suspension hole 4 is provided substantially at the center of the lower peripheral fusion edge portion 22b. The suspension hole 4 is used for suspending the drug solution container for administration 1 on a hanger when the drug solution in the drug solution storage chamber 23 is administered to a patient.

In the medical solution administration container 1 of this embodiment, a cylindrical inflation film is used as the soft bag 2. The four edges of the end are a fusion peripheral portion 22 that is heat-sealed at one time. As the heat sealing method of the fusion peripheral portion, any method such as heat fusion, high frequency fusion, and ultrasonic fusion may be used. The soft bag 2 is not limited to the inflation film described above, but may be a laminated film of two films or a folded one film as described above.

The size of the soft bag 2 and the fused peripheral portion 2
The size of the soft bag 2 is about 10 to 150 mm, although the size of the soft bag 2 is different depending on the amount of the stored chemical.
The length of the soft bag 2 is preferably about 100 to 300 mm. The width of the medicine storage chamber in the soft bag is 1
The length is preferably about 5 to 145 mm, and the length is preferably about 50 to 250 mm. Further, the width of both sides (right side fusion part, left side fusion part) of the fusion peripheral portion is preferably about 1 to 10 mm, particularly preferably about 3 to 7 mm. Further, the width of the lower portion of the fusion peripheral portion is preferably about 10 to 120 mm, and particularly preferably about 30 to 90 mm. In addition, it is preferable that the width of the right-side fused portion and the left-side fused portion is substantially equal.

The fusion peripheral portion 22 is formed by using, for example, a heat sealing device 30 as shown in FIG. The heat sealing device 30 includes the lower backing plate 3.
4, a frame 32 covering the upper part thereof, a pneumatic cylinder 38 attached to the frame 32 so that a piston 37 hangs down in the direction of the lower receiving plate 34, a mounting plate 39 fixed to the lower end of the piston, and a mounting plate 39 A fixed heat-sealing mold 40 is provided. The heat fusing mold 40 includes a heating element 41 inside. As shown in FIGS. 4 and 5, the heat welding mold 40 includes a heating contact portion 42 formed on the bottom surface and having a shape of a welding peripheral portion. The size of the heating contact,
The shape is appropriately designed depending on the soft bag to be produced. Further, the inner peripheral edge portion 43 of the heating contact portion projects below other portions to form the inner edge portion 22e of the fusion peripheral edge portion 22. Therefore, the inner peripheral edge portion 43 can strongly press the bag forming film.

At the time of forming the soft bag, the soft bag forming film 33 is placed on the lower backing plate 34 of the heat sealing device 30, and the heated heat fusing mold 40 is moved downward, and By narrowing the soft bag forming film 33 between the mold 40 and the lower backing plate 44, the film 33
Is heat-sealed to produce a flexible bag 2 to be used for the drug solution container 1 for administration of the present invention. Note that, instead of the heat fusion mold, an ultrasonic fusion mold or a high frequency fusion mold may be used.

As described above, in the liquid medicine container for administration of the present invention, the entire peripheral portion except the liquid discharge port mounting portion is a heat-sealed peripheral portion at the same time, so that the degree of fusion at the peripheral portion is uniform. Therefore, a portion having a low partial fusion force is not formed, and pinholes due to the fusion portion are less generated. In comparison, when both ends are fused after the upper and lower ends of the soft bag are fused, a portion close to the fused portion in the both-side fusion process is heated by heat transfer but not pressed. However, it may be in a state of being softened and naturally cooled, and the degree of fusion may be lower than that of other parts, which may cause pinholes. However, such a problem does not occur in the present invention.

A liquid storage section is formed inside the soft bag 2 to store an infusion solution (liquid). Infusions include, for example, physiological saline, electrolyte solution, Ringer's solution, high calorie infusion, glucose solution, water for injection, amino acid electrolyte solution, and the like, but are not limited thereto. In addition, the amount of the chemical solution filled in the soft bag 2 is:
Preferably, it is about 78 to 98% of the volume of the soft bag 2.

The chemical solution discharge port 3 is inserted into the chemical solution discharge port mounting portion 21 of the soft bag 2 and fixed to the soft bag 2, and an elastic member provided at an open end of the cylindrical member 51. 52, and a cap member 53 attached to the distal end of the tubular member for fixing the elastic body 52 to the tubular member 51.

The tubular member 51 is a tubular body formed of a hard material or a semi-hard material having at least one end which can be inserted into the chemical solution discharge port mounting portion 21 of the soft bag 2 and has a certain strength. . The tubular member 51 is liquid-tightly fixed to the soft bag 2 by heat fusion. For this reason, a rigid or semi-hard material which is a thermoplastic resin and is used for the tubular member 51. Specifically, rigid polyvinyl chloride, polyethylene, polypropylene, polybutadiene, cyclic polyolefin [specifically, ZEONEX (manufactured by Zeon Corporation)], polypropylene homopolymer, polyolefin such as high-density polyethylene, polystyrene, poly- (4-methylpentene-1), polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate (PMMA), polyacetal, polyarylate, polyacrylonitrile,
Polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PET), polyester such as polybutylene terephthalate, butadiene-styrene copolymer,
Examples include various resins such as aromatic or aliphatic polyamides, or a combination of any of these resins.

The elastic body 52 is capable of penetrating a needle tube (not shown), and can penetrate the needle tube at the time of administration of the medicinal solution to inject the medicinal solution in the medicinal solution container. Further, the elastic body 52 has a self-closing property, and after the needle tube is pulled out from the elastic body, the puncture hole is closed to prevent leakage of the drug solution. As a constituent material of the elastic body 52, a polymer material having flexibility is preferable. For example, a polyethylene-based, polypropylene-based, polyolefin-based elastomer such as an ethylene-propylene copolymer-based elastomer, a polyester-based elastomer, a polyvinyl chloride-based elastomer, Elastic materials such as polyurethane elastomers, polyamide elastomers, thermoplastic elastomers, various rubber materials such as natural rubber, isoprene rubber, silicone rubber, butadiene rubber, and styrene-butadiene rubber, or a combination of any two or more of these materials One.

The cap member 53 has a ring shape, and is screwed, fitted, caulked,
It is fixed by a method such as adhesion or fusion. The material for forming the cap member is not particularly limited, and examples thereof include various resin materials and metal materials.

[0023]

EXAMPLES Next, specific examples of the drug solution container for administration of the present invention will be described. (Example) Using polypropylene, a thickness of 0.3 mm,
A tubular inflation sheet having a width (folding diameter) of 140 mm was produced. Then, using a heat sealing device as shown in FIGS. 3 and 4, the portion to be the fusion peripheral portion is thermally fused, and then cut along the outer edge of the thermal fusion portion.
A soft bag was made. The heat fusion is performed at the fusion temperature (contact type thermometer ANRITSU DIGlTAL SURFACE THERMOMETER HF).
(Measured at T-50) 170-175 ° C., fusion time 2 seconds, fusion surface pressure 6-8 kgf / cm ² .

The formed soft bag has a length of 260
mm, width of the medicine storage room in the soft bag is 130m
m, the length of the medicine storage chamber is 195 mm, the width of both sides of the fusion peripheral portion is 5 mm, and the lower width of the fusion peripheral portion is 35 m.
The width of the upper part of the peripheral portion of the m-fusion was 20 mm.

After inserting the tubular member of the chemical solution discharge port into the unfused portion of the soft bag and attaching it by heat fusion, the bag was filled with 525 ml of physiological saline. And the elastic member and the cap member were attached, and the drug solution container for administration of the present invention was produced. The filling amount of the drug solution (physiological saline) with respect to the volume of the soft bag of the drug solution container was 87.5%.

Then, the drug solution container for administration is placed in a retort-type high-pressure steam sterilizer, and the temperature is 104 ° C. and the gauge pressure is 0.8.
Sterilized at kg / cm ² for 25 minutes. Then, the airtightness of the liquid medicine container for administration prepared as described above and the thickness of the fused portion were measured.

(Measurement of Fused Portion Thickness) In the same manner as in the above-described embodiment, 100 drug solution containers were prepared. For all the liquid medicine containers for administration, four fusion peripheral parts (top fusion part, right fusion part, left fusion part, bottom fusion part)
When the thickness of the inner edge portion (the thinned portion in the fused portion) was measured, the maximum thickness was 0.58 mm and the minimum thickness was 0.54 mm. The wall thickness was measured using a TECLOCK DIAL TICKNESS METER.

(Airtightness test) 100 doses as described above
Inject ink into all chemical liquid containers from the outlet port
After coloring the liquid content, submerge it in a water tank and
0.7kgf / cm pressure ²And pressurize the container for 10 minutes
You. Visually confirm that there is no leakage of the liquid content during pressurization.
As a result, no outflow of internal solution was observed from any of the containers.
I couldn't.

[0029]

The drug solution container for administration of the present invention is a drug solution container for administration comprising a soft bag containing a drug solution and a drug solution discharge port fixed to the soft bag, wherein the soft bag comprises: It is formed of a thermoplastic flexible synthetic resin, and the entire periphery except the chemical solution discharge port mounting portion is a fusion-bonded portion that is heat-sealed at the same time. For this reason, the degree of fusion at the peripheral portion is uniform, a portion having a low partial fusion force is not formed, and the occurrence of pinholes due to the difference in the degree of fusion between the fusion portions is small.

[Brief description of the drawings]

FIG. 1 is a front view of a drug solution container for administration according to an embodiment of the present invention.

FIG. 2 is a sectional view taken along the line AA of the drug solution container for administration of FIG. 1.

FIG. 3 is an explanatory view of an example of a heat sealing device used for producing the liquid medicine container for administration of the present invention.

FIG. 4 is a diagram illustrating a bottom surface of a heat sealing mold of the heat sealing device illustrated in FIG. 3;

FIG. 5 is a view of the heat sealing device of the heat sealing device shown in FIG.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Chemical liquid container for administration 2 Soft bag 3 Chemical liquid discharge port 21 Chemical liquid discharge port attaching part 23 Fusion peripheral edge

Claims (4)

[Claims] 1. A drug solution container for administration, comprising: a soft bag having a drug solution storage chamber and containing a drug solution in the drug solution storage chamber; and a drug solution discharge port fixed to the soft bag. The liquid medicine container for administration is characterized in that the liquid medicine container is made of a thermoplastic flexible synthetic resin, and the entire periphery except the liquid medicine discharge port mounting portion is a heat-sealed peripheral portion at the same time. 2. The fusion-bonded peripheral portion is located at one end of the soft bag and has an upper-end fusion-bonded peripheral portion having a chemical solution discharge port attaching portion, a lower-end fusion-bonded peripheral portion located at the other end, The liquid medicine container for administration according to claim 1, wherein the liquid medicine container for administration is a continuous fused portion including a right-side fused peripheral portion and a left-side fused peripheral portion located at a side portion. 3. The liquid medicine container for administration according to claim 1, wherein the soft bag is formed of a tubular blown film formed of a thermoplastic flexible synthetic resin. 4. An inner peripheral portion of the fusion peripheral portion surrounding the chemical solution storage chamber has the same heat history as a whole.
A drug solution container for administration according to any one of the above.