JP2001046473A - Heat resistant medical container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical container which can withstand high-pressure steam sterilization at temperatures of 121 deg.C and higher and which has separable seal parts. SOLUTION: This medical container 10 has separable seal parts on portions of container walls made of a multilayer structure and is subjected to high- pressure steam sterilization, together with medical solutions 16, 18 contained therein. In this case, the outermost layer of the container walls is made from not less than one or two kinds of polyethylenes with an average density of not less than 0.940 g/cm3 and the innermost layer of the container walls is made from a layer of mixed resins consisting of a linear polyethylene with a density of 0.925 to 0.952 g/cm3 and a polypropylene, the mixing ratio (linear polyethylene/polypropylene) of the linear polyethylene to the polypropylene ranging from 5/5 to 8/2.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a heat-resistant medical container containing a chemical solution. The present invention relates to a resin container having flexibility and transparency, and more particularly to a heat-resistant medical container that can withstand high-pressure steam sterilization at a temperature of 121 ° C. or higher.

[0002]

2. Description of the Related Art Medical containers are replacing glass containers with resin containers. Since the resin container is a flexible container, it does not require an air needle or the like at the time of use, and thus is preferable for a medical container. Its disposal is also easier than glass containers. The resin used for the container is polyvinyl chloride, ethylene-vinyl acetate copolymer, polyethylene or the like. Particularly, polyethylene resin containers are frequently used because of the problem of container disposal and the fact that the contents are not adversely affected.

[0003]

In general, it is desirable that the wall of a medical resin container is excellent in heat resistance, transparency and flexibility (dropping property of a liquid content). As such a resin container, there is a polyethylene container. It is known that conventional polyethylene containers have excellent heat resistance, transparency, and flexibility. However, when high-pressure steam sterilization is performed on such a container, the heating temperature is 115 ° C. or less. High pressure steam sterilization of such containers at higher temperatures may deform the containers. In addition, there may be a case where the inner walls or the outer walls of the container adhere to each other, so that the walls cannot be completely separated from each other. For this reason, a polyethylene container for medical use having more heat resistance is desired. Recently, a heat-resistant container using high-density polyethylene has been proposed (JP-A-4-266759).
No.). In this polyethylene container, the container wall has a laminated structure of different kinds of resins. The outer layer of the container wall is made of a resin in which low-density polyethylene is mixed with high-density polyethylene of about 5 to 40%. The heat resistance of the container wall is maintained by high-density polyethylene. Some medical containers are provided with a seal that can peel off the inner walls of the container. When a peelable seal is provided on a medical container, the inside of the medical container may be divided into two or more chambers, or drug components which react easily with each other may be separately placed in a plurality of containers until immediately before use. The use of such a peelable seal as a means for isolating a chamber of a container or a means for closing a communicating portion between connected containers has an advantage that aseptic mixing can be performed by operation from the outside of the container at the time of use. Because. However, if the conventional peelable seal is subjected to a heat treatment at a temperature of 121 ° C. as described above, the peel strength of the seal may not function properly. An object of the present invention is to provide a medical container having a peelable seal that can withstand high-pressure steam sterilization at a temperature of 121 ° C. or higher.

[0004]

According to the present invention, there is provided a container having a peelable seal portion in a part of the container walls, the container wall having a multilayer structure, and a high-pressure steam together with the contained chemical liquid. In the heat-resistant medical container to be sterilized, the outermost layer of the container wall is made of one or more polyethylenes having an average density of 0.940 g / cm ³ or more, and the innermost layer has a density of 0. 925 to 0.952 g / cm ³ A mixed resin layer of linear polyethylene and polypropylene, wherein the mixing ratio of the linear polyethylene and polypropylene (linear polyethylene / polypropylene) is 50/50 to 80/2.
The object has been achieved by providing a heat-resistant medical container characterized by being in the range of 0.

The heat-resistant medical container of the present invention has a peelable seal on a part of the container walls. Generally, there is a case where the respective drug components are separately housed in a container or the like, and these are used aseptically mixed at the time of use. For example, when the lyophilized product and its solution are contained in separate containers connected to each other, or as in a high-calorie infusion container, the amino acid component solution and the sugar solution are contained in separate chambers in the container. For example. When the peelable seal according to the present invention is provided between the connection part of the separate containers and the chamber for separating the inside of the container, when mixing at the time of use, when the peelable seal is opened, each drug component can be used It can be mixed aseptically.

When the medical container is made of resin, the peelable seal can be usually formed by external heating such as heat sealing or impulse sealing or by internal heating such as ultrasonic bonding or high frequency bonding. The peelable seal is also referred to as a peel seal or a weak seal. By pressing the container from the outside, the seal which can be peeled when the inside is brought into a certain pressure rising state, or the container outer wall is gripped. Refers to a seal that can be peeled off when pulled. The peel strength of such a peelable seal is such that the pressure applied to the container is 0.01 to 1.0 k.
gf / cm ² , especially 0.05 to 0.4 kgf / cm ²
It is desirable to have the strength to be peeled by the pressure increase.

[0007] The container wall has a multilayer resin structure. The heat-resistant medical container of the present invention basically has transparency and flexibility. The transparency of the container is such that impurities such as precipitates and fine particles in the chemical solution contained in the container can be confirmed. The container is flexible enough to allow the contained drug solution to drop naturally from an outlet or the like to which a drip needle or the like is attached. The above heat resistant medical container is blow molded,
It is formed by pressure forming, vacuum forming, injection molding, or formed by cutting a film or sheet appropriately and sealing the peripheral edge by heat welding. When the container wall has a multilayer structure of resin, it is formed by co-extrusion of each resin in blow molding, pressure molding, vacuum molding, injection molding or the like.
When a film or sheet is used, the film or sheet is formed by co-extrusion, or each resin film is individually formed and then laminated.

[0008] The heat-resistant medical container of the present invention is used for infusion, dialysate,
A medicinal solution such as an organ preservation solution is contained. After the chemical solution is stored in the container, it is subjected to steam sterilization together with the container. The steam sterilization is different from the conventional one, and is desirably performed at a temperature of 121 ° C. or higher. At such a processing temperature, sterilization of the chemical solution can be performed completely and quickly.

The outermost layer of the container wall has an average density of 0.9.
It is composed of one or more polyethylenes of 40 g / cm ³ or more. The polyethylene may include high, medium or low-density linear polyethylene, low density polyethylene, and the like. Further, the linear polyethylene includes a metallocene-catalyzed linear polyethylene obtained by a metallocene catalyst. The polyethylene may be a single kind of polyethylene or a mixed resin of a plurality of polyethylenes, but the average density of the whole polyethylene must be 0.940 g / cm ³ or more. If the density of the polyethylene component falls below the above range, sufficient heat resistance cannot be imparted to the outer surface of the container.

[0010] The linear polyethylene is obtained by ionic polymerization. The ionic polymerization uses a Ti-based catalyst (Ziegler method), a Cr-based catalyst (Philip method), or a Zi-based catalyst (Kamminsky method). Above all, the metallocene-catalyzed linear polyethylene obtained by the metallocene catalyst by the Kaminsky method has narrow molecular weight distribution and stereoregularity. For this reason, a container material to be subjected to a heat treatment is particularly desirable in that heat deformation and blocking hardly occur. As the polymerization process, a solution method, a slurry method, or a gas phase method is used under the conditions in a range of from atmospheric pressure to 100 (kg / cm ² ). The linear polyethylene has a density of 0.880 to 0.97.
Range of 0 g / cm ^3, it is desirable in particular in the range of 0.940~0.952g / cm ^3. In order to adjust the density of the linear polyethylene, a small amount of α-olefin is copolymerized. When the α-olefin is copolymerized by several percent, short-chain branches are introduced into the main chain of the linear low-density polyethylene, and the linear polyethylene is reduced in density. α-olefins are propylene, butene-1, hexene-1, 4-methylpentene-1, and octene-1. The biquad softening point temperature (JIS: K6760 method) of the linear polyethylene is 105 to 13
It is desirable to be in the range of 5 ° C. As the linear polyethylene, one having sufficient heat resistance, transparency and flexibility is selected.

The low-density polyethylene is 1000-3
It is produced by radical polymerization under high pressure of 000 kg / cm ² . During the radical polymerization, a branched chain comparable to the main chain is generated by a hydrogen abstraction reaction in the molecule, and the polyethylene has a low density. The density of the above polyethylene is 0.91
0 to 0.935 g / cm ³ , especially 0.922 to 0.9
It is desirable to be in the range of 33 g / cm ³ . Also, since medical bags are required to have as high a heat resistance as possible, the low-density polyethylene has a biquad softening point (JI
S: K6760 method) is preferably in the range of 95 to 110 ° C.

The innermost layer has a density of 0.925 to 0.9.
It is composed of a mixed resin layer of 52 g / cm ³ of linear polyethylene and polypropylene. As the linear polyethylene, the same one as described above is used, but the above-mentioned density range,
In particular, a linear polyethylene having a density of 0.928 to 0.940 g / cm ³ is desirable. If the density of the linear polyethylene falls below the above range, the peeling of the peelable seal described above becomes firm after high-pressure steam sterilization at a temperature of 121 ° C. or higher, and the seal may not be easily opened during use. When the density of the linear polyethylene exceeds the above range, the transparency of the container wall is deteriorated.

The polypropylene is a polypropylene that is polymerized using a Ziegler-Natta catalyst. The polypropylene is a polypropylene that is polymerized using a metallocene catalyst. The above polypropylene has a small amount of α-
It may be a random copolymer obtained by copolymerizing an olefin. The polypropylene polymerized using the Ziegler-Natta catalyst is mainly isotactic polypropylene. The polypropylene polymerized using the metallocene catalyst is mainly an isotactic polypropylene and a syndiotactic polypropylene. The isotactic may contain a small amount of a by-product atactic polymer or the like. However, it is desirable that the above-mentioned isotactic polypropylene is obtained by removing the atactic polymer.

Polypropylene polymerized using the above metallocene catalyst is desirable because the catalyst is soluble and has only one active site, so that its molecular weight and stereoregularity distribution are narrow. The syndiotactic polypropylene is polymerized using a metallocene catalyst comprising a cyclopentadienyl ring and a fluorenyl ring. Since the above-mentioned syndiotactic polypropylene is softer and more transparent than isotactic polypropylene, it is desirable to apply it to a flexible medical bag. The propylene / α-olefin copolymer is a propylene / ethylene random copolymer, a propylene / butene random copolymer, a propylene / ethylene / butene copolymer, or the like. It is desirable that the α-olefin in the copolymer is contained in the range of 1 to 10% by weight, particularly 3 to 7% by weight. α-olefins are propylene, butene-1, hexene-1, 4-methylpentene-1, and octene-1. By copolymerizing the α-olefin with propylene, flexibility and transparency can be imparted to the polymer. In general, a nucleating agent or the like is added to polypropylene to impart transparency. However, such a nucleating agent may not be used in a medical bag, so that the above copolymer is preferably used. The above polypropylene has a biquad softening point temperature (JIS: K6758
Method) is preferably a temperature of 140 ° C. or higher, and a polypropylene having the above temperature characteristics can exhibit heat resistance. The mixing ratio of the linear polyethylene and the polypropylene (linear polyethylene / polypropylene) is 50 /
In the range of 50-80 / 20, especially 60 / 40-70 / 3
It is desirable to be in the range of 0. When the mixing ratio is within the above range, by changing the setting of the sealing temperature condition, it becomes extremely easy to form a container by selectively using a non-peelable fixed seal and a peelable seal.

In the medical container according to the present invention thus configured, the outermost layer and the innermost layer, particularly, the outermost layer have heat resistance due to high density polyethylene. Further, the innermost layer has heat resistance because it is a resin mixed layer of linear polyethylene and polypropylene. For this reason, thermal deformation is suppressed by the outer layer and the inner layer, and thermal deformation such as flapping or unevenness on the outer surface and the inner surface of the container wall hardly occurs. It withstands high-pressure steam sterilization at a temperature of 121 ° C., and the transparency and appearance of the container wall are not easily reduced during the sterilization. Also,
Since the density of the linear polyethylene in the inner layer is not less than a predetermined value, the function of the peelable seal can be maintained after the high-pressure steam sterilization.

According to a second aspect of the present invention, there is provided the heat-resistant medical container according to the first aspect, wherein the innermost linear polyethylene is a metallocene-catalyzed linear polyethylene obtained by using a metallocene catalyst. . As described above, the metallocene catalyst-based linear polyethylene has a narrow molecular weight distribution and a limited stereoregularity. For this reason,
This has the effect of increasing the transparency of the container wall. The peelable seal and the fixed seal have the following effects.
The metallocene catalyst-based linear polyethylene keeps the function of the peelable seal stable. That is, the temperature range at the time of sealing can be widened, and the sealing strength after high-pressure steam sterilization is maintained at a stable and constant strength. Further, the seal strength after the high-pressure steam sterilization treatment at a temperature of 121 ° C. does not decrease for the fixed seal portion that cannot be peeled off. This is to improve the safety of the container sufficiently, while the sealing strength of the conventional linear polyethylene is significantly reduced.

According to a third aspect of the present invention, there is provided the heat-resistant medical container according to the first or second aspect, wherein the outermost polyethylene is a mixed resin layer of a metallocene-catalyzed linear polyethylene and a low-density polyethylene. And the mixing ratio of the metallocene-catalyzed linear polyethylene to the low-density polypropylene (metallocene-catalyzed linear polyethylene / low-density polyethylene) is in the range of 95/5 to 50/50. When the metallocene-catalyzed linear polyethylene is used as the outermost layer polyethylene, the transparency of the outermost layer is increased even after high-pressure steam sterilization, and the appearance of the container surface is improved. The outermost layer polyethylene is a resin mixture of the metallocene catalyst-based linear polyethylene and the low density polyethylene. If only the metallocene-catalyzed linear polyethylene is used, the moldability of the multilayer structure at the time of extrusion is deteriorated. Therefore, it is desirable to mix low-density polyethylene. Even in such a case, it is desirable that the average density of the total of both polyethylenes is 0.940 g / cm ³ or more.

According to a fourth aspect of the present invention, there is provided the heat-resistant medical container according to the third aspect, wherein the container wall has an intermediate layer, and the innermost layer has a thickness of 20 μm or more. Has a thickness of 50 to 200 μm, the outermost layer has a thickness of 40 μm or less, and the intermediate layer has a low density of linear polyethylene having an average density of 0.925 to 0.940 g / cm ^3. It consists of a mixed resin layer with polyethylene, and the mixing ratio of the above linear polyethylene and low density polypropylene (linear polyethylene / low density polyethylene)
4. The heat-resistant medical container according to claim 3, wherein is in the range of 90/5 to 40/60.

Usually, in a heat-resistant medical container, when the container wall is formed only of the innermost layer on which a peelable seal layer is formed and the outermost layer which becomes a heat-resistant layer during high-pressure steam sterilization, the thickness of the container wall is increased. Can be reduced to only about 100 μm. If the thickness of the container wall exceeds 100 μm in the above two layers, the transparency of the container wall as a medical container is lost. Although the transmittance of the medical container wall is required to be 55% or more, it is difficult for the container wall in the two layers to achieve the transmittance. When the thickness of the container wall is about 100 μm, the mechanical strength of the medical container becomes a problem. Therefore, in the heat-resistant medical container according to the fourth aspect, it is desirable to provide a relatively transparent intermediate layer as a mechanical reinforcing layer in addition to the innermost layer and the outermost layer.

In the container wall, the intermediate layer comprises a mixed resin layer of linear polyethylene and low-density polyethylene having an average density in the range of 0.925 to 0.940 g / cm ³ . The average density of the linear polyethylene and the low-density polyethylene is particularly preferably in the range of 0.928 to 0.935 g / cm ³ . If the average density of the mixed resin of the two components is within the above range, the transparent layer and the temperature of 121 ° C.
The intermediate layer can sufficiently withstand high-pressure steam sterilization. If the average density of the mixed resin of the two components is below the above range, devitrification and pock-like white turbidity are observed in the intermediate layer after sterilization of the container. If the average density of the mixed resin of the two components exceeds the above range, the transparency becomes poor, so that the intermediate layer cannot be made sufficiently thick.

The mixing ratio of the above-mentioned linear polyethylene and low-density polypropylene (linear polyethylene / low-density polyethylene) is in the range of 95/5 to 40/60, particularly 80/20 to
It is desirable to be in the range of 50/50. When the mixing ratio of the two-component mixed resin is within the above range, the heat resistance as the intermediate layer is sufficiently observed, the adhesion to the innermost layer and the outermost layer is good, and the moldability is sufficiently observed. In particular, if the linear polyethylene is a metallocene-catalyzed linear polyethylene, the moldability associated with the combination with the low-density polyethylene is sufficiently obtained. If the value of the mixing ratio of the two components exceeds the above range, the extrudability of the multilayer structure becomes poor. When the value of the mixing ratio of the two components is below the above range, the heat resistance of the intermediate layer becomes poor, and distortion such as wrinkles appears in the resin container, which is not preferable as a medical container.

The thickness of the innermost layer in the container wall is 20 μm.
m, the thickness of the intermediate layer is in the range of 50 to 300 μm, and the thickness of the outermost layer is 40 μm or less.
In particular, the thickness of the innermost layer in the container wall is 30 μm or more and 100 μm or less, the thickness of the intermediate layer is 60 μm or more and 180 μm or less, and the thickness of the outermost layer is 30 μm.
Hereinafter, it is 10 μm or more. When the thickness of each layer is within the above range, the container wall can obtain sufficient transparency as a medical container even after steam sterilization at a temperature of 121 ° C., and can sufficiently obtain mechanical strength as a medical container wall. .

When the thickness of the innermost layer falls below the above range,
Both peelable and non-peelable fixed seals cannot be accurately formed and provided. If the thickness of the innermost layer is too large, the transparency of the container wall is adversely affected. When the thickness of the outermost layer exceeds the above range, the transparency of the container wall becomes poor, and it becomes impossible to provide an intermediate layer having a sufficient thickness. If the thickness of the outermost layer is too small, the moldability of the container wall deteriorates and molding becomes impossible. If the thickness of the intermediate layer is less than the above range, sufficient mechanical strength cannot be provided to the medical container wall as the intermediate layer. If it exceeds the above range,
Decreases the transparency of the entire medical container wall.

In the heat-resistant medical container constructed as described above, since the intermediate layer is transparent, the entire thickness of the container wall can be increased to about 330 μm.
When the thickness of the outer layer of the container wall is 30 μm or less and the thickness of the inner layer of the container wall is in the range of 20 to 60 μm, the flexibility and transparency of the container wall are not lost. For this reason, sufficient mechanical strength can be imparted to the container wall. Therefore, the state of the medical solution in the medical container can be sufficiently observed, and the container wall sufficiently maintains the natural drip property at the time of infusion.

[0025] The medical container according to claim 5 of the present invention comprises:
The medical container according to claim 4, wherein the linear polyethylene of the intermediate layer is a metallocene-catalyzed linear polyethylene obtained using a metallocene catalyst. The use of the metallocene-catalyzed linear polyethylene as the linear polyethylene in the intermediate layer enhances the transparency and flexibility of the intermediate layer and makes the medical container wall desirable. In such a case, it is desirable to mix low-density polyethylene in the intermediate layer in order to enhance moldability.

[0026]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments of the medical container of the present invention will be described in detail. FIG. 1 is a plan view of an embodiment relating to the medical container of the present invention. FIG. 2 is a cross-sectional view of the sheet of the embodiment relating to the medical container of the present invention. FIG. 3 is an enlarged cross-sectional view of the sheet of the embodiment relating to the medical container of the present invention.

As shown in FIG. 1, the medical container 10 according to the present embodiment has two chambers 12 and 14, and the chambers 12 and 14 accommodate different chemical solutions 16 and 18. Each room 12, 14
Are respectively provided with ports 20 and 22 of a filling port and a discharging port. As shown in FIG. 2 and FIG.
It is formed from two sheets 24 and 26. Each sheet 24,
Reference numeral 26 denotes a laminated structure in which the respective films are laminated. When the sheets 24 and 26 become the walls of the container 10, the outer layer 32 is formed as a heat-resistant resin layer,
4 is formed as a reinforcing resin layer, and the inner layer 36 is formed as a peelable heat seal layer and a non-peelable fixed seal layer.

The respective sheets 24 and 26 have their peripheral edges 28 fixedly sealed. The peripheral portion 28 is heat-sealed at a temperature of 280 ° C. for 6 seconds. During this thermal bonding seal, the inner layer 36 completely dissolves and participates in the fixed seal. Each sheet 2
A detachable seal 30 is formed at the center of each of the seals 4 and 26, and the medical container 10 is divided into the chambers 12 and 14 by the seal 30. The isolation seal part 30 has a temperature of 13
Heat sealed at 0 ° C. for 10 seconds. Then, the inner layers 36, 36 of the sheets 24, 26 are sealed with each other by heat bonding to form a seal portion 30 which can be peeled from the outside when used. After the medical container 10 is filled with the liquid medicines 16 and 18 from the outlets, the chambers 12 and 14 are sealed, and the medical container 10 is subjected to high-pressure steam sterilization at a temperature of 121 ° C. for 20 minutes. In use, such a medical container 10 is prepared by peeling off the isolation seal portion 30 and then using each of the chemical solutions 16 and 18.
Are aseptically mixed and drip or the like is performed. In addition, during storage, the easily reacting chemical solutions 16, 18 can be placed in a state of being isolated from each other.

The sheet 24 of each embodiment of the medical container,
Table 1 shows the resin films of the outer layer 32, the intermediate layer 34, and the inner layer 36 constituting the film 26, and their thicknesses. Each resin film of Table 1 in each of Examples 1 to 3 and Comparative Examples 1 to 9 is made of the following materials. Among the components in each resin film, low-density polyethylene is called LDPE, linear polyethylene is called L-PE, metallocene-catalyzed linear polyethylene is called MLPE, and polypropylene is PPE.
Let it be P.

[0030]

[Table 1]

A medical container 10 was prepared from each sheet, and its heat resistance, transparency, spontaneous dropping property and sealing property were measured. The following items were measured for heat resistance. Whether or not blocking occurs on the inner wall of the container. It is also whether or not cloudiness or spots occur on the container wall. Further, whether or not the container wall is deformed such as wrinkles is determined. Those in which all of these items were good were regarded as having good heat resistance. At least one
Those having a defect in one of the items were regarded as having no heat resistance. Transparency was measured by the following method. A portion of the wall having a uniform thickness is taken from the sterilized container, and a measurement sample is prepared from this portion. Each sample is 0.9 × 4c
Five pieces cut to the size of m are produced. Fill the cell for measuring the ultraviolet absorption spectrum with water and immerse each sample in the water in the cell. The control is a cell filled with water only. The transmittance of each cell at a wavelength of 450 nm is measured by a light transmission measurement method. If the transmittance of the container wall is less than 55%, it is not allowed. The spontaneous dropping property was measured by the following method. A drip needle is connected to the outlet of the medical container, and a venous needle is placed 1.5 m below the position of the drip needle. The amount of liquid dropped from the venous needle is measured every unit time. ：: Variation of the drop amount per minute in each section is 8
It is within 0%. ×: Variation of the drop amount per minute in each section is 8
It is less than 0%. The peeling property of the isolation seal part 30 is examined by checking whether the peelable seal part is sufficiently peeled when the outside is manually pressed so as to press the chamber 12 of the medical container 10 to 0.2 kg / cm ² . According to the Japanese Pharmacopoeia 13th Edition “Plastic Drug Container Test Method”, the tight sealing property of the peripheral portion 28 is examined by examining pin holes and the like when the inside of the container 10 is pressurized to 1.5 kg / cm ^2. Those without holes shall be accepted without leakage. Table 2 shows the results of the above evaluation.

[0032]

[Table 2]

As shown in Table 2 above, the heat-resistant medical containers according to Examples 1 to 4 maintain the transparency of the container wall sufficiently after the high-pressure steam sterilization at a temperature of 121 ° C. There was no such thing. Further, while the peelable seal could be opened favorably, no leakage or the like occurred in the peripheral fixed seal forming the container. In Comparative Example 1, the thickness of the heat-resistant layer, which is the outermost layer, was too large, resulting in poor transparency. The average density D of the polyethylene in the intermediate layer is
Since it was 0.922 g / cm ³ , no heat resistance was observed in the intermediate layer, wrinkles occurred on the container wall, and deformation of the container itself was observed. In Comparative Example 2, as in Comparative Example 1, poor transparency was caused by the presence of the outermost layer, and wrinkles and the like occurred on the container wall because the intermediate layer did not have heat resistance. In Comparative Example 3, the density of the outermost layer of polyethylene was high, and its role as a heat-resistant layer was sufficiently observed. Although the intermediate layer was protected, poor transparency was observed. In Comparative Examples 4 and 5, since the average density of polyethylene in the intermediate layer of the container wall was low, wrinkles and pock-like irregularities occurred on the container wall. The shape also changed. In Comparative Examples 1 to 5, there was no problem as a medical container having a peelable seal. However, the strength of the fixed seal at the periphery of the container after the high-pressure steam sterilization treatment at a temperature of 121 ° C. was lower than that of the Example. There was a tendency to. This is considered to be due to the difference in the linear polyethylene used for the innermost layer.

[0034]

As described above, in the heat-resistant medical container according to the present invention, the outermost layer of the container wall has an average density of 0.5.
940 g / cm ³ or more of one or more polyethylenes, and the innermost layer has a density of 0.925 to 0.9.
52 g / cm ^{3 It is} composed of a mixed resin layer of linear polyethylene and polypropylene, and the mixing ratio of the linear polyethylene and polypropylene (linear polyethylene / polypropylene) is in the range of 5/5 to 8/2. It can have a peelable seal that can withstand high-pressure steam sterilization at a temperature of at least 0 ° C.

[Brief description of the drawings]

FIG. 1 is a plan view of a medical container according to an embodiment of the present invention.

FIG. 2 is a sectional view of a sheet according to an embodiment of the medical container of the present invention.

FIG. 3 is an enlarged sectional view of a sheet of an embodiment relating to the medical container of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 10 Medical container 12, 14 chamber 16, 18 Chemical solution 20, 22 Outlet 24, 26 Sheet 28 Peripheral part 30 Isolation seal part 32 Outer layer 34 Intermediate layer 36 Inner layer

──────────────────────────────────────────────────の Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI Theme coat ゛ (Reference) B65D 30/22 B65D 30/22 G 65/40 65/40 D 81/24 81/24 JA61J 1/00 331C F-term (Reference) 3E064 AA01 BA26 BA30 BC01 EA30 HT07 3E067 AA03 AB81 AC06 BA12A BB15A BB16A CA07 CA11 CA16 CA24 EA06 GC01 3E086 AD01 BA04 BA15 BB22 BB41 BB51 BB74 CA02 DC04 DC02 DC02 DC02 DC02 AK06C AK07B AK63A AK63B AK63C AL05A AL05B BA02 BA03 BA07 BA10A BA10B BA15 DA02 GB17 GB66 JA13A JA13B JA13C JB07 JC00 JJ03 YY00A YY00B YY00C

Claims (5)

[Claims] 1. A container having a peelable seal portion on a part of container walls, and the container wall has a multilayer structure,
Further, in a heat-resistant medical container which is subjected to high-pressure steam sterilization together with a contained chemical solution, the outermost layer of the container wall is made of one or more types of polyethylene having an average density of 0.940 g / cm ³ or more. The inner layer is composed of a mixed resin layer of linear polyethylene and polypropylene having a density of 0.925 to 0.952 g / cm ³ , and the mixing ratio of the linear polyethylene and polypropylene (linear polyethylene / polypropylene) is 50/50. ~
A heat-resistant medical container characterized by being in the range of 80/20. 2. The heat-resistant medical container according to claim 1, wherein the linear polyethylene in the innermost layer is a metallocene-catalyzed linear polyethylene obtained using a metallocene catalyst. 3. The polyethylene of the outermost layer comprises a mixed resin layer of a metallocene-catalyzed linear polyethylene and a low-density polyethylene, and a mixing ratio of the metallocene-catalyzed linear polyethylene to a low-density polypropylene (metallocene-catalyzed linear polyethylene). Polyethylene / low density polyethylene)
The heat-resistant medical container according to claim 1 or 2, wherein the temperature is in the range of 50 to 50/50. 4. The container wall has an intermediate layer, the innermost layer has a thickness of 20 μm or more, and the intermediate layer has a thickness of 50 to 50 μm.
In the range of 300 μm, and the thickness of the outermost layer is 40 μm
The following, the intermediate layer, the average density is 0.925 ~
It consists of a mixed resin layer of linear polyethylene and low-density polyethylene in the range of 0.940 g / cm ³ , and the mixing ratio of the above-mentioned linear polyethylene and low-density polypropylene (linear polyethylene / low-density polyethylene) is 95/5. ~ 40/6
The heat-resistant medical container according to claim 3, wherein the temperature is in the range of 0. 5. The heat-resistant medical container according to claim 4, wherein the linear polyethylene of the intermediate layer is a metallocene-catalyzed linear polyethylene obtained by using a metallocene catalyst.