JPS62233162A - Medical container - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to medical containers. In particular, the present invention relates to a medical container that can be soaked in, for example, an infusion solution, an ED (hereinafter abbreviated as ED), or an antibiotic used in a closed medical system.

[Prior Art] In recent years, closed systems have come to be used in medical treatments such as infusions to prevent liquid contents from coming into contact with the outside world. Medical containers used in this closed system must drain the liquid by gravity and the flexibility of the material of the container. Further, it is preferably made of a transparent material so that the liquid content can be monitored from the outside. For this purpose, soft polyvinyl chloride and ethylene-vinyl acetate copolymer have been mainly used as materials for conventional medical infusion containers. On the other hand, ED and antibiotics are encapsulated in aluminum packs, glass bottles, etc. as freeze-dried powders, and are adjusted at the time of use, so they cannot be used in a closed system.

[Problems to be solved by the invention] ED and antibiotics are packed as freeze-dried powders in aluminum packs, glass bottles, etc., and are prepared in separate containers before use. There was a risk of Recently, a method has been developed in which freeze-dried ED and antibiotic powders are sealed in a flexible container and prepared in the container at the time of use.
It is desired that an ED or antibiotic solution be pre-sealed in a flexible container.

As for the material of the container, conventional soft polyvinyl chloride contains a large amount of plasticizer, so the plasticizer may be leached into the content liquid, which is considered a safety issue. Therefore,
Polyolefin resins are considered promising because they are highly safe, have excellent physical properties, and are inexpensive.

However, it has been extremely difficult to produce desired medical containers using such polyolefin resins. In general, polyolefin resins have low dielectric loss and do not generate enough heat to cause welding even if a high frequency electric field is applied to them, so unlike vinyl chloride resins, high frequency sealing is impossible. Therefore, for example, when a medical container is to be formed from an inflation-molded polyolefin tube or two polyolefin sheets, the sheets are overlapped and predetermined portions are welded by impulse sealing or heat sealing. However, unlike high-frequency seals, impulse seals are difficult to weld into complex shapes, and heat seals use external heating, making it difficult to weld materials with different wall thicknesses on the outer periphery of cylinders, etc. Therefore, it has been impossible to successfully form a small-diameter discharge port provided at the upper end of a medical container.

[Means for Solving the Problems] An object of the present invention is to provide a medical container whose at least the inner surface is made of polyolefin resin, which is suitable as an infusion bag, an ED bag, an antibiotic bag, etc. The present inventors conducted various studies on the form and manufacturing method of a medical container whose inner surface is made of polyolefin resin, and found that it is a flexible container that has a discharge port and a container, and the container has a multi-N structure. At least the outer layer is formed of a synthetic resin, the inner layer is formed of a polyolefin resin having a lower melting point than the outer layer, and the outlet part has a multilayer structure, at least the inner layer is a synthetic resin, and the outer layer is formed of a synthetic resin and an outer layer of the container part and the outlet part. The present invention was achieved by discovering that a suitable medical container can be obtained by thermally welding the container part and the outlet part, which are made of a polyolefin resin having a lower melting point than the inner layer of the outlet part. be.

[Action Co. Next, the present invention will be specifically explained based on the drawings.

An example of the medical container of the present invention is shown in FIGS. 1 and 2.

The container part 2 of the medical container 1 is a tube obtained by inflation molding with a multilayer structure, the outer layer 7 of which is formed of a synthetic resin, and the inner layer 8 of which is formed of a polyolefin resin having a lower melting point than the outer layer 7. It was obtained by heat welding the open ends of a shaped sheet. In addition, the inner layer 9 of the outlet portion 3 is formed of synthetic resin, and the outer layer 10 includes an outer layer 7 of the container portion and an inner layer 9 of the outlet portion.
It is coated with a polyolefin resin having a lower melting point. One fused end 4 is provided with a suspension port 5 for suspending the medical container 1, and the other fused end 6 is inserted and welded with a discharge port 3. When the discharge port 3 is thermally welded to the fused end 6, the outer layer 7 of the container portion 2 has a higher melting point than the inner layer 8, so the inner layer 8 melts first due to external heating. At this time, the difference in melting point between the outer layer 7 and the inner layer 8 is 1
Preferably, the temperature is 0°C or higher. Also, the outside JI of the discharge port part 3
Since IIO is the same polyolefin resin as the inner layer 8 of the container part 2, the container part 2 and the outlet part 3 can be easily and reliably welded together. Furthermore, as shown in FIG. 3, it is preferable that the outlet portion 33 has a ring-shaped protrusion 41 on its outer layer 40.

That is, when the discharge port 33 is inserted and welded to the fused end 6, it is possible to more reliably weld the discharge port 33 in a liquid-tight manner.

As the outer layer 7 of the container part 2, linear low density polyethylene, medium density polyethylene, high density polyethylene, polypropylene, olefin elastomer, polyester resin, polyamide wax, polyurethane resin, etc. can be used. Preferably, it is desirable to use linear low-density polyethylene which has excellent flexibility and high bag-breaking strength.

Moreover, as the inner layer 8 of the container part 2, olefin-based resins such as low-density polyethylene, medium-density polyethylene, linear low-density polyethylene, and ethylene-vinyl acetate copolymer having a low melting point can be used.

The thickness of these multilayer sheets can be O01 to 0.5 mm, preferably 0.2 to 0.4 mm. 0.1
If it is less than mm, the bag breakage strength will be poor and the risk of breakage will increase. Moreover, if it is 0.5 mm or more, flexibility and transparency will deteriorate. Furthermore, when the adhesion between the outer layer 7 and the inner layer 8 of the container part is poor, a multilayer sheet having an adhesive layer as an intermediate layer between the outer layer 7 and the inner layer 8 can be used.

The outlet portion 3 can be manufactured by a two-color molding method. For the inner layer 9 of the outlet portion 3, linear low density polyethylene, high density polyethylene, polypropylene, polyester resin, polyamide resin, etc. can be used. The outer layer 10 of the outlet portion 3 may be made of low density polyethylene, medium density polyethylene, straight-sided low density polyethylene, ethylene-vinyl acetate copolymer, or the like. Furthermore, by using the same polyolefin resin as the inner layer 8 of the container part 2, the outer layer 10 of the outlet part 3 is made of the same polyolefin resin as the inner layer 8 of the container part 2.
can be easily and reliably heat welded.

In addition, when the adhesiveness between the inner layer 9 and the outer layer 10 of the outlet part is poor, the outlet part 3 can be manufactured by three-color molding with an adhesive layer as an intermediate layer between the inner layer 9 and the outer layer 10. preferable.

Further, the medical container of the present invention can be obtained by superimposing two multilayer laminate sheets obtained by extrusion molding of the above-mentioned polyolefin resin and thermally welding the peripheral edges thereof.

This medical container 1 encloses a medical solution such as an infusion solution, and is sterilized by high-pressure steam sterilization. Alternatively, the medical container 1 is sterilized with ethylene oxide gas (EOG), and then a powder of ED, antibiotics, etc., or a medical solution containing dissolved ED, antibiotics, etc. is aseptically filled and the discharge port 3 is sealed. . Thereafter, this medical container containing the drug solution is enclosed in a packaging material together with a desiccant agent. By adding a desiccant agent, it is possible to prevent the growth of mold on the surface of medical containers.

In particular, when a medical container is filled with a medical solution, the moisture in the liquid permeates through the container wall, increasing the humidity within the packaging material and making it easy for mold to grow. Even if a polyolefin resin with low water vapor permeability is used for the container part, the humidity will increase during long-term storage and mold will grow. Therefore, by adding a desiccant agent, it is possible to reduce the humidity within the packaging material and prevent the growth of mold. Furthermore, powdered drugs that are susceptible to hydrolysis or deterioration due to moisture, sealed in the medical container 1, can be stored stably for a long period of time by being sealed in the packaging material together with a desiccant agent. For these packaging materials, it is preferable to use a laminate film having an aluminum layer with low water vapor permeability.

[Example] Hereinafter, the present invention will be described in more detail with reference to Examples.

Example 1 Linear low-density polyethylene (trade name: Niboron-shi, manufactured by Toyo Soda Kogyo ■, density: 0.925 g/cm
) and low-density polyethylene (trade name: Hetrocene, manufactured by Toyo Soda Kogyo ■, density: 0.917 g/am3), an inflation tube was produced by co-extrusion molding with the low-density polyethylene as the inner layer. . The thickness of the outer linear low-density polyethylene layer was 250 μm, and the thickness of the inner low-density polyethylene layer was 50 μm. In addition, the discharge port part is made of high-density polyethylene (product name: Niboron Hard, manufactured by Toyo Soda Kogyo ■, density: 0.960)
g/cm3) and low-density polyethylene (product name: Petrocene, manufactured by Toyo Soda Kogyo ■, density: 0.917 g/cm3)
It was produced by two-color molding using cm3). The thickness of the low density polyethylene layer outside the discharge port was 50 μm. Next, one end of the inflation tube was heat-sealed and a suspension port was provided.

At the other end, a discharge port produced by two-color molding was inserted and welded to produce a medical container.

This container was sterilized by EOG, a predetermined amount of antibiotic in powder form was aseptically charged, and the outlet portion was sealed with a linear low-density polyethylene film and fitted with a rubber stopper.

Inject physiological saline into this medical container from the outlet through the rubber stopper to dissolve the antibiotic in the container, then insert the bottle needle of the infusion set into the outlet using normal infusion techniques. The height from the discharge port to the infusion needle is 70cm.
m, and the amount of dripping was adjusted and fixed using a cleanser so that it would be about 10 m 17 minutes, and the relationship between the amount of drained liquid and time was measured, and the amount of drained liquid was almost proportional to time. Further, the amount of remaining liquid after completion of draining was very small at 1 ml.

Example 2 Linear low density polyethylene (product name: Urtozex,
Manufactured by Mitsui Petrochemical Industries ■, density: 0.930 g/c
m3) and low-density polyethylene (product name: Pei Losen, manufactured by Toyo Soda Kogyo ■, density: 0.917 g/c
m3) was used to fabricate an inflation tube by coextrusion molding with low density polyethylene as the inner layer. The thickness of the outer linear low-density polyethylene layer is 1
The thickness of the inner low density polyethylene layer is 100 μm.
It was μm. In addition, the discharge port part is made of high-density polyethylene.Product name: Nipolon Hard, manufactured by Toyo Soda Kogyo ■, density:
0.960 g/c Tn3) and low density polyethylene (product name: Petrocene, manufactured by Toyo Soda Kogyo ■, density:
0.917 g/cd') by two-color molding. The thickness of the low-density polyethylene layer outside the discharge port was 50 μm. A medical container was produced in the same manner as in Example 1 using this inflation tube and a discharge port produced by two-color molding.

This container was sterilized by EOG, a predetermined amount of ED was aseptically charged in powder form, and the outlet portion was sealed with a linear low-density polyethylene film and fitted with a rubber stopper.

Sterile water is injected into this medical container from the outlet through the rubber stopper to dissolve the ED in the container, and then a connecting tube is passed through the outlet according to the usual procedure for administering liquid food through a tube. ,
The height from the outlet to the end of the connecting pipe is 70 cm,
When the dripping amount was adjusted and fixed at about 111 ml/min using a cleanser and the relationship between the amount of drained liquid and time was measured, the amount of drained liquid was almost proportional to time. Further, the amount of remaining liquid after completion of draining was very small at 1 ml.

Example 3 Linear low-density polyethylene (trade name: Moretic, manufactured by Idemitsu Petrochemical ■, density: 0.920 g/cm3) and low-density polyethylene (trade name: Petrocene, manufactured by Toyo Soda Kogyo ■, density: 0.920 g/cm3). 917 g/cm:I), an inflation tube was produced by coextrusion molding with low density polyethylene as the inner layer. The thickness of the outer linear low-density polyethylene layer was 200 μm, and the thickness of the inner low-density polyethylene layer was 100 μm.

In addition, the outlet part is made of polypropylene (Idemitsu Petrochemical (width product, density: 0.90 g/c m3) and low-density polyethylene (product name: Petrocene, Toyo Soda Kogyo (paper product, density: 0.917 g/c TTI3) ) was produced by two-color molding.The thickness of the low-density polyethylene layer outside the discharge port was 50 μm.

A medical container was produced in the same manner as in Example 1 using this inflation tube and a discharge port produced by two-color molding.

This container is sterilized by EOG, a predetermined amount of antibiotic dissolved in physiological saline is aseptically dispensed, the inside of the container and the drug solution are replaced with nitrogen to make it virtually oxygen-free, and the outlet is directly connected. It was sealed with a linear low-density polyethylene film and fitted with a rubber stopper.

In accordance with the usual infusion technique, insert the bottle needle of the infusion set into the discharge port of this medical container, set the height from the discharge port to the infusion needle to be 70 cm, and drip approximately 10 m with a cleanser for 17 minutes. When the relationship between the amount of drained liquid and time was measured, the amount of drained liquid was almost proportional to time. Further, the amount of remaining liquid after completion of draining was very small at 1 ml.

Example 4 Nylon (product name: NOVAMID
A laminate sheet was produced using TI3) with linear low-density polyethylene as the inner layer.

The thickness of the outer nylon layer was 30 μm, and the thickness of the inner low-density polyethylene layer was 250 μm. In addition, the outlet part is made of polypropylene (manufactured by Idemitsu Petrochemical, density: 0
．． 90g/cm”) and linear low-density polyethylene (product name: Moretic, manufactured by Idemitsu Petrochemical ■, density: 0
．． 920 g/Cm3) by two-color molding. The thickness of the linear low-density polyethylene layer outside the discharge port was 50 μm. Next, the two laminate sheets were stacked one on top of the other, and their side peripheral edges and one end were thermally welded by heat sealing, and a hanging opening was provided. At the other end, a discharge port produced by two-color molding was inserted and welded to produce a medical container.

An infusion solution was poured into this container, and the outlet portion was sealed with a linear low-density polyethylene film and a rubber stopper was attached.

This medical container was sterilized using high-pressure steam at 115° C. for 40 minutes, but no significant deformation was observed after sterilization.

In addition, according to the usual infusion technique, the bottle needle of the infusion set was passed through the outlet part, the height from the outlet part to the infusion needle was 70 cm, and the dripping amount was about 10 ml.
When the relationship between the amount of drained liquid and time was measured, the amount of drained liquid was approximately proportional to time. Also,
The amount of remaining liquid after completion of draining was very small at 2 ml.

[Effects of the Invention] As described above, the medical container of the present invention has the following advantages.

(2) Since a layer of polyolefin resin with a low melting point is interposed at the joint between the discharge port part and the container part, the welding can be carried out easily and reliably by heat welding.

■Since the material of the inner layer of the container is polyolefin resin, it is highly safe as it does not contain any highly eluting components such as plasticizers.

■Since the container can be easily submerged, it is possible to conveniently administer infusions, ED, and antibiotics in a closed system.

[Brief explanation of drawings]

FIG. 1 is a front view showing an embodiment of the medical container of the present invention;
FIG. 2 is a vertical sectional view taken along line 1--2 of the same embodiment, and FIG. 3 is a partial sectional view showing another embodiment of the discharge port.

Claims (4)

[Claims] (1) A flexible container having a discharge port and a container,
The container part has a multilayer structure, and at least the outer layer is made of a synthetic resin, and the inner layer is made of a polyolefin resin having a lower melting point than the outer layer.The outlet part has a multilayer structure, and at least the inner layer is made of a synthetic resin and the outer layer is made of a polyolefin resin. A medical container comprising a polyolefin resin having a lower melting point than an outer layer of the container and an inner layer of the outlet, the container and the outlet being thermally welded. (2) The medical container according to claim 1, wherein the outlet portion is molded in multiple colors. (3) The inner layer of the outlet part is linear low-density polyethylene,
High density polyethylene, polypropylene, polyester,
Claim 1: The discharge port is made of at least one type of polyamide, and the outer layer of the outlet portion is made of at least one of low density polyethylene, medium density polyethylene, linear low density polyethylene, and ethylene-vinyl acetate copolymer. Or the medical container described in paragraph 2. (4) The outer layer of the container is made of at least one of linear low-density polyethylene, medium-density polyethylene, high-density polyethylene, polypropylene, olefin elastomer, polyester, polyamide, and polyurethane, and the inner layer of the container is made of low-density polyethylene. , medium density polyethylene,
The medical container according to any one of claims 1 to 3, which is at least one of linear low-density polyethylene and ethylene-vinyl acetate copolymer.