JP3892162B2 - Drug container for administration - Google Patents

Description

[0001]
[Technical field to which the invention belongs]
The present invention relates to a drug solution container for administration containing a drug solution such as an infusion.
[0002]
[Prior art]
Conventional plastic containers used to store medicinal solutions such as infusions are made of thermoplastic plastic materials such as polyethylene, polypropylene, and ethylene-vinyl acetate copolymer into a cylindrical shape by inflation molding and attached to the outlet port. The upper and lower ends are formed by heat fusion, high frequency fusion, ultrasonic fusion, etc., leaving portions. Some are formed by individually fusing the upper and lower ends and the left and right ends.
The discharge port is composed of a cap with a rubber stopper and a port body, and is attached to an unfused portion of a plastic container and fixed by heat fusion or the like. A plastic container contains an infusion solution, which may be used alone or in combination with another drug / chemical solution.
[0003]
[Problems to be solved by the invention]
As the container body of the plastic container used as described above, the upper and lower ends are fused to the inflation film leaving the outlet port mounting portion, and there are no fused portions at the left and right ends. Container damage such as pinholes may occur due to impact or the like.
In order to solve this problem, it is conceivable that the upper and lower ends and the left and right ends are fused while leaving the discharge port attaching portion. In this case, a separate fusion process is required, and the time required for manufacturing is also required. However, the length of the four ends is longer than that for fusing at one end. Furthermore, when individually fusing the upper and lower ends and the left and right ends, it is necessary to manage the fusing margin of the individual fusing portions, and the overlapping portions of the fusing portions of the upper and lower ends and the left and right ends are fused in terms of airtightness. 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, there is a risk of liquid leakage.
[0004]
The present invention has been made in view of the above-mentioned problems, and by using a material in which the four ends are fused at a time, the degree of fusion at the peripheral edge is uniform, and the portion having a low partial fusion force Therefore, the present invention provides a drug solution container for administration with less occurrence of pinholes due to the difference in the degree of fusion at the fusion part.
[0005]
[Means for Solving the Problems]
What achieves the above-mentioned object is a drug solution container for administration comprising a drug solution storage chamber and a soft bag in which the drug solution is stored in the drug solution storage chamber, and a drug solution discharge port fixed to the soft bag, The soft bag is formed of a thermoplastic flexible synthetic resin, and includes a fusion peripheral portion where the entire peripheral portion excluding the chemical solution discharge port attaching portion is heat-sealed at the same time .
The soft bag is made of a cylindrical inflation film formed of a thermoplastic flexible synthetic resin, and the fusion peripheral edge is a peripheral edge excluding the chemical solution discharge port attaching part after the cylindrical inflation film is produced. The inner peripheral portion of the fusion peripheral portion surrounding the chemical solution storage chamber has the same heat history and is heated from the other fusion peripheral portions. It is a drug solution container for administration which is strongly pressed at the time of fusing and has a higher fusing strength than other parts .
[0006]
And the said fusion peripheral part is located in the one end side of this soft bag, and the upper end side fusion peripheral part which has a chemical | medical solution discharge port attaching part, the lower end side fusion peripheral part located in the other end side, and a side part It is preferable that it is the continuous melt | fusion part which consists of the right-hand side fusion peripheral part and left-hand side fusion peripheral part which are located. Furthermore, it is preferable that the widths of the right side fusion peripheral part and the left side fusion peripheral part are substantially the same.
[0007]
DETAILED DESCRIPTION OF THE INVENTION
The drug solution container of the present invention will be described with reference to the embodiments 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. 2 is a cross-sectional view taken along the line AA of the drug solution container of FIG. FIG. 3 is an explanatory diagram of an example of a heat seal apparatus used for producing the drug solution container of the present invention. FIG. 4 is a view showing the bottom surface of the heat fusion mold of the heat sealing apparatus shown in FIG. 3.
[0008]
The administration drug solution container 1 of the present invention includes a soft bag 2 in which a drug solution is stored, 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 a fusion peripheral portion 22 in which the entire peripheral portion excluding the chemical solution discharge port attaching portion 21 is heat-sealed at the same time.
[0009]
The drug solution container 1 of the present invention comprises a soft bag 2 and a drug solution discharge port 3 fixed to the soft bag 2.
The soft bag 2 is a bag-like one having a chemical solution storage chamber 23 therein. Using a cylindrical inflation film (or inflation sheet) molded by inflation molding, or laminating two films (or sheets) molded by the T-die method, etc. Folding one film Any of them may be used.
[0010]
As a material for forming the soft bag 2, a thermoplastic soft synthetic resin having a certain degree of heat resistance, for example, a polyolefin (for example, a mixture containing polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer, a mixture of polypropylene and polyethylene or polybutene). Further, these partially crosslinked products, ethylene-vinyl acetate copolymer (EVA), polyester (polyethylene terephthalate, polybutylene terephthalate), soft vinyl chloride resin, polyvinyl acetate, polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, Various thermoplastic elastomers such as polyester elastomers, styrene elastomers such as styrene / ethylene / butylene / styrene copolymers, or any combination thereof Products (blend resins, polymer alloys, laminates, etc.), polyester layers such as polyethylene terephthalate, polyethylene naphthalate, polyamide layers such as nylon, and the above-mentioned soft materials (eg, polyethylene) A multilayer structure sheet comprising the above resin layers is used.
[0011]
The thickness of the film material (or sheet material) constituting the flexible bag 2 is not particularly limited, and is 0.1 to 0.5 mm although it varies depending on the constituent material of the film. For example, when a soft polyvinyl chloride sheet material is used, the thickness is preferably about 20 to 500 μm. As the soft bag 2, it is desirable to use an extruded film or a blown tube having a tensile elastic modulus of 500 MPa or less, preferably 50 to 300 MPa.
[0012]
And the soft bag is the fusion | melting peripheral part 22 by which the whole peripheral part except the chemical | medical solution discharge port attaching part 21 was heat-sealed simultaneously. The fusion peripheral part 22 is located on one side of the soft bag and has an upper end side fusion peripheral part 22a having a chemical solution discharge port mounting part, a lower end side fusion peripheral part 22b located on the other end side, and a side part. This is a continuous fusion part composed of the right fusion peripheral part 22c and the left fusion peripheral part 22d. In particular, the fusion peripheral edge 22 is thermally fused at a time under the same thermal fusion conditions. That is, it is performed without partially changing the heat-sealing conditions. In particular, the inner edge portion 22e (the portion surrounding the chemical solution storage chamber 23) of the fusion peripheral edge portion 22 performs the heat fusion process of the chemical solution discharge port. Even if included, the whole is a part heat-sealed at the same time under the same heat-sealing condition, and at least the inner edge part 22e of the fusion peripheral part 22 has the same heat history. Further, the inner edge portion 22e is pressed more strongly at the time of heat fusion than the other fusion peripheral portions, and the fusion strength is higher than the other portions. Furthermore, the suspension hole 4 is provided in the approximate center of the lower end side fusion peripheral part 22b. The suspension hole 4 is used to suspend the administration drug solution container 1 on a hanger when the drug solution in the drug solution storage chamber 23 is administered to a patient.
[0013]
In the drug solution administration container 1 of this embodiment, a tubular inflation film is used as the soft bag 2, and the tubular inflation film leaves the discharge port mounting portion 21 and has four sides on the upper and lower ends and the left and right ends. The end is a fusion peripheral edge 22 heat sealed at a time. As a heat sealing method for the peripheral edge of the fusion, any method such as heat fusion, high frequency fusion, ultrasonic fusion or the like may be used. The soft bag 2 may not be an inflation film as described above, but may be a laminate of two films as described above or a folded one film.
[0014]
Although the size of the soft bag 2 and the size of the fusion peripheral edge 22 vary depending on the amount of the stored chemical solution, the width of the soft bag 2 is about 10 to 150 mm, and the length of the soft bag 2 is 100. About 300 mm is suitable. The width of the medicine storage chamber in the soft bag is preferably about 15 to 145 mm, and the length is preferably about 50 to 250 mm. Further, the width of both side portions (the right side fused portion and the left side fused portion) of the fusion peripheral edge portion is preferably about 1 to 10 mm, and particularly preferably about 3 to 7 mm. Further, the width of the lower portion of the fusion peripheral edge is preferably about 10 to 120 mm, and particularly preferably about 30 to 90 mm. In addition, it is preferable that the width | variety is substantially equal in the right side fusion | fusion part and the left side fusion | fusion part.
[0015]
And formation of the fusion | melting peripheral part 22 is performed by using the heat seal apparatus 30 as shown in FIG. 3, for example. The heat sealing device 30 is fixed to a lower plate 34, a frame 32 covering the upper side of the lower plate 34, a pneumatic cylinder 38 attached to the frame 32 so that the piston 37 hangs in the direction of the lower plate 34, and a lower end of the piston. There are provided a mounting plate 39 and a heat fusion mold 40 fixed to the mounting plate. The mold for heat fusion 40 includes a heating element 41 inside. As shown in FIGS. 4 and 5, the heat fusion mold 40 includes a heating contact portion 42 having a fusion peripheral edge shape formed on the bottom surface. The size and shape of the heating contact portion are appropriately designed depending on the soft bag to be produced. Moreover, in order to form the inner edge part 22e of the fusion | melting peripheral part 22, the inner peripheral part 43 of a heating contact part protrudes below from other parts. Therefore, the inner peripheral edge portion 43 can strongly press the bag forming film.
[0016]
And at the time of soft bag formation, the film 33 for soft bag formation is mounted on the backing plate 34 of the heat-seal apparatus 30, and the metal mold | die 40 heated is moved down, By narrowing the soft bag forming film 33 between the lower receiving plates 44, the portion that becomes the fusion peripheral portion of the film 33 is heat-sealed, and the soft bag 2 used for the drug solution container 1 of the present invention is provided. Produced. Note that an ultrasonic fusion die or a high frequency fusion die may be used instead of the thermal fusion die.
[0017]
Thus, in the medicinal solution container of the present invention, since the entire peripheral portion except the chemical solution discharge port mounting portion is a heat-sealed peripheral portion at the same time, the degree of fusion at the peripheral portion is uniform. In addition, a portion having a low partial fusion force is not formed, and the occurrence of pinholes due to the fusion portion is small. Compared to this, if both sides are fused after fusing the upper and lower ends of the soft bag, the portion adjacent to the portion fused in the side end fusing process is heated by heat transfer but not pressed. In some cases, it becomes softened and naturally cooled, resulting in a decrease in the degree of fusion compared to other parts, which causes pinholes. However, such a problem does not occur in the present invention.
[0018]
Inside the soft bag 2, a chemical solution storage part is formed to store an infusion solution (chemical solution). Examples of the infusion include 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. Moreover, it is preferable that the chemical | medical solution amount with which the soft bag 2 is filled is about 78 to 98% with respect to the volume of the soft bag 2. FIG.
[0019]
The chemical liquid discharge port 3 is inserted into the chemical liquid discharge port mounting portion 21 of the soft bag 2 and fixed to the soft bag 2; an elastic body 52 provided at the open end of the cylindrical member 51; In order to fix the elastic body 52 to the tubular member 51, a cap member 53 attached to the tip of the tubular member is provided.
[0020]
The cylindrical member 51 is a cylindrical body formed of a hard material or a semi-hard material having at least one end that can be inserted into the chemical liquid discharge port mounting portion 21 of the soft bag 2 and having a certain degree of strength. The tubular member 51 is liquid-tightly fixed to the soft bag 2 by heat fusion. For this reason, the cylindrical member 51 is made of a thermoplastic resin and a hard or semi-hard material. Specifically, hard 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), polyesters such as polybutylene terephthalate, butadiene-styrene copolymers, various resins such as aromatic or aliphatic polyamide, or any of these Those combined, and the like.
[0021]
The elastic body 52 can pierce a needle tube (not shown), and can pierce the needle tube at the time of drug solution administration to infuse the drug solution in the drug solution container for administration. Further, the elastic body 52 has a self-occlusion property, and after the needle tube is extracted 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 polyolefin-based elastomer such as a polyethylene-based, polypropylene-based, or ethylene-propylene copolymer system, a polyester-based elastomer, a polyvinyl chloride-based elastomer, Elastic materials such as various elastomeric materials such as polyurethane elastomers, polyamide elastomers, thermoplastic elastomers, natural rubber, isoprene rubber, silicone rubber, butadiene rubber, styrene-butadiene rubber, or a combination of any two or more of these materials Can be mentioned.
[0022]
The cap member 53 has a ring shape and is fixed to the opening end of the cylindrical member 51 by a method such as screwing, fitting, caulking, 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]
【Example】
Next, specific examples of the drug solution container of the present invention will be described.
(Example)
A cylindrical inflation sheet having a thickness of 0.3 mm and a width (folded diameter) of 140 mm was produced using polypropylene. And after heat-sealing the part used as a fusion | melting peripheral part using the heat seal apparatus as shown in FIG.3 and FIG.4, a soft bag is cut | disconnected along the outer edge of a heat-fusion part. Produced. The heat fusion is performed under the conditions of a fusion temperature (measured with a contact thermometer ANRITSU DIGlTAL SURFACE THERMOMETER HFT-50) at 170 to 175 ° C., a fusion time of 2 seconds, and a fusion surface pressure of 6 to 8 kgf / cm ² . I went.
[0024]
The formed soft bag has a length of 260 mm, a width of the medicine storage chamber in the soft bag of 130 mm, a length of the medicine storage chamber of 195 mm, and a width of both sides of the fusion peripheral edge of 5 mm. The width of the lower part of the peripheral edge of the attachment was 35 mm, and the width of the upper part of the peripheral part of the fusion was 20 mm.
[0025]
After inserting the cylindrical member of the chemical solution discharge port into the unfused portion of the soft bag and attaching it by heat fusion, 525 ml of physiological saline was filled in the bag. And the elastic member and the cap member were attached, and the chemical | medical solution container for administration of this invention was produced. The filling amount of the chemical solution (physiological saline) with respect to the volume of the soft bag of the chemical solution container was 87.5%.
[0026]
The drug solution container for administration was placed in a retort type high-pressure steam sterilizer and sterilized at a temperature of 104 ° C. and a gauge pressure of 0.8 kg / cm ² for 25 minutes.
And the airtightness of the chemical | medical solution container for administration produced as mentioned above and the thickness of the fused part were measured.
[0027]
(Measurement of fused part thickness)
100 drug solution containers for administration were prepared by the same method as in the above example. For all of the drug container for administration, the inner peripheral portion (the portion where the fusion portion is thin) at the four fusion peripheral portions (the upper fusion portion, the right fusion portion, the left fusion portion, and the lower fusion portion) ) Was measured, the maximum thickness was 0.58 mm, and the minimum thickness was 0.54 mm. The wall thickness was measured with a TECLOCK DIAL TICKNESS METER.
[0028]
(Airtightness test)
After injecting ink from the outlet port into all of the 100 drug solution containers described above and coloring the content liquid, it is submerged in the water tank and the container body is held for 10 minutes at a bag internal pressure of 0.7 kgf / cm ^2. Pressurize. When it was visually confirmed that there was no leakage of the content liquid during pressurization, no outflow of the internal solution was observed from any of the containers.
[0029]
【The invention's effect】
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 is made of thermoplastic flexible While being formed of a synthetic resin, the entire peripheral portion excluding the chemical solution discharge port mounting portion is a fused portion heat-sealed at the same time.
For this reason, the fusion degree in a peripheral part is uniform, a part with a partial low fusion power is not formed, and there is little generation | occurrence | production of the pinhole resulting from the difference in the fusion degree of a fusion | melting part.
[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.
2 is a cross-sectional view taken along the line AA of the drug solution container for administration in FIG. 1. FIG.
FIG. 3 is an explanatory view of an example of a heat seal device used for producing a drug solution container for administration of the present invention.
4 is a view showing a bottom surface of a heat-sealing mold of the heat sealing apparatus shown in FIG. 3. FIG.
5 is a view of the heat sealing device shown in FIG. 4 as viewed from the upper surface of the heat fusion mold. FIG.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Administration chemical | medical solution container 2 Soft bag 3 Chemical solution discharge port 21 Chemical solution discharge port attachment part 23 Fusion peripheral part

Claims (3)

A drug solution container comprising a drug solution storage chamber and a soft bag in which a drug solution is stored in the drug solution storage chamber, and a drug solution discharge port fixed to the soft bag, wherein the soft bag is thermoplastic. It is formed of a flexible synthetic resin, and has a fusion peripheral portion where the entire peripheral portion excluding the chemical solution discharge port mounting portion is heat-sealed at the same time ,
The soft bag is made of a cylindrical inflation film formed of a thermoplastic flexible synthetic resin, and the fusion peripheral edge is a peripheral edge excluding the chemical solution discharge port attaching part after the cylindrical inflation film is produced. The inner peripheral portion of the fusion peripheral portion surrounding the chemical solution storage chamber has the same heat history and is heated from the other fusion peripheral portions. A drug solution container for administration , which is strongly pressed at the time of fusing and has a higher fusing strength than other portions .   The fusion peripheral edge is located on one end side of the soft bag and at the upper end fusion peripheral part having a chemical solution discharge port mounting part, the lower end fusion peripheral part located on the other end side, and the side part. The medicinal solution container for administration according to claim 1, which is a continuous fusion part comprising a right fusion peripheral part and a left fusion peripheral part. The drug solution container for administration according to claim 1 or 2, wherein the right-side fusion peripheral edge and the left-hand fusion peripheral edge have substantially the same width.

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