RU2448677C2 - Multilayered case for medical containers, and medical container - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to containers for storage of medical liquids. A multilayered case which is used to form a medical container comprises an inside layer consisting of cyclic polyolefine, an intermediate layer which is formed near said inside layer and as a major component contains low-density linear polyethylene prepared with using a catalyst with a single cross-linking point, and an external layer containing high density polyethylene. The group of inventions also refers to a medical container comprising a medical liquid compartment formed by said multilayered case.

EFFECT: group of inventions provides preparing the heat-resistant multilayered case for medical containers wherein the inside layer without using an adhesive shows suitable adhesion to an intermediate layer and provides adhesion resistance when formed in the form of a film; thus high pressure vapour sterilisation of the container comprising the medical liquid compartment formed by said multilayered case insignificantly deteriorate such properties as transparency and lamination resistance.

11 cl, 7 dwg, 2 tbl, 15 ex

Description

FIELD OF TECHNOLOGY

The present invention relates to a multilayer case for medical containers and a medical container, which contains a compartment for storing medical fluid formed from a multilayer case for medical containers.

BACKGROUND OF THE INVENTION

Examples of medical containers used in the medical field formed from polymers include ampoules, vessels, syringes, and infusion bags made of films. In addition, examples of such polymers include polyolefins such as polyethylene and polypropylene, as well as styrene-based elastomers, vinyl chloride polymers, ethylene-vinyl acetate copolymers and cyclic polyolefins.

Among these polymers, polyethylene exhibits excellent hygienic properties, is flexible and does not produce toxic gases when burned, and is thus widely used for medical containers. However, it is known that if polyethylene is used for a compartment inside a medical container that is in contact with a medical fluid, then polyethylene can adsorb certain medicines, for example lipophilic vitamins, from the medical fluid, which leads to a decrease in the concentration of these drugs during storage.

In summary, cyclic polyolefins capable of inhibiting any reduction in titer of a particular drug caused by adsorption or absorption of the drug exhibit excellent transparency, heat resistance and hygienic properties, and also provide excellent barrier properties, including low water vapor transmission rate, and increasingly used as material for medical containers. One example of a medical container that uses a cyclic polyolefin is a pre-filled syringe, in which the syringe chamber is pre-filled with a drug, and such pre-filled syringes are widely used.

In addition, Patent Document 1 discloses a medical container that has a multilayer structure in which a cyclic polyolefin layer formed from a norbornene-based thermoplastic limit polymer is combined with a synthetic polymer layer and / or a protective layer or the like.

Patent Document 2 discloses a medical container formed of a multilayer film having a surface layer, a flexible layer, a protective layer and a sealing layer, in which a cyclic polyolefin and an ethylene-α-olefin copolymer are used as a protective layer, and an ethylene-α-olefin copolymer Used as the main component of other layers.

Patent Document 3 discloses a laminated film in which a layer B consisting of linear low density polyethylene having a specific melting point and a Vicat softening temperature is laminated to any one or both surfaces of layer A consisting of a polymer such as a cyclic polyolefin, and also disclosed is a medical container in which this laminated film is used.

In addition, patent document 4 discloses a medical container that uses a laminated film obtained by laminating a sealant layer, which as a main component contains a polymer based on a cyclic polyolefin with a certain glass transition temperature, on a substrate that contains a polymer based on polyolefin with a certain melting point.

[Patent Document 1] Japanese Patent Publication (Issued) No. 3227709

[Patent Document 2] International Patent Publication 03/097355, pamphlet

[Patent Document 3] Unexamined Japanese Patent Application, First Publication No. 2004-167800

[Patent Document 4] Unexamined Japanese Patent Application, First Publication No. 2005-254508

DESCRIPTION OF THE INVENTION

PROBLEMS SOLVED BY THE INVENTION

However, in paragraph 0027 of patent document 1 and paragraph 0004 of patent document 2, it is disclosed that the disadvantage of cyclic polyolefins is poor adhesion. Thus, in the manufacturing process of the multilayer film described in Patent Document 1, conditions require the use of adhesive when laminating a cyclic polyolefin layer to other layers. However, it is possible that components obtained from the adhesive will leak from the multilayer film in which the adhesive is used. Thus, for hygienic reasons, the use of this type of multilayer films in medical containers and, in particular, as inner layers located close to the medical fluid is undesirable.

In the technology disclosed in Patent Document 2, a cyclic polyolefin is mixed with an ethylene-α-olefin copolymer to improve the adhesion ability of the cyclic polyolefin, and this mixture is used to form a protective layer. However, such mixing with an ethylene-α-olefin copolymer causes a deterioration in the barrier properties of the protective layer, through which absorption of the drug by a layer adjacent to the protective layer is possible. In addition, when increasing the thickness of the protective layer in an attempt to improve the barrier properties, a problem arises that increasing the thickness causes a corresponding loss of flexibility.

In addition, the temperature resistance of the medical containers disclosed in Patent Documents 3 and 4 does not meet the requirements, and these materials are not suitable for medical containers that must be sterilized using high pressure steam or the like. In addition, the laminated films disclosed in patent documents 3 and 4 also have a tendency to such a disadvantage as low adhesion resistance.

The present invention has been made in the light of the circumstances described above and aims to provide a multilayer body for medical containers in which the innermost layer formed of a cyclic polyolefin without suitable adhesive exhibits suitable adhesion to another layer that exhibits excellent heat resistance and which provides suitable adhesion resistance when forming in the form of a film, as well as providing a medical container formed from this multi-layer body for medical containers, which is least affected by degradation of properties such as transparency and resistance to peeling, even when steam sterilized under high pressure or the like.

MEANS FOR SOLVING PROBLEMS

The multilayer casing for medical containers of the present invention is used to form a medical container and contains at least the innermost layer consisting of a cyclic polyolefin, an intermediate layer that is formed near the innermost layer and contains as its main component a linear low density polyethylene obtained with using a catalyst with a single center of polymerization, and the outermost layer, which contains high density polyethylene.

The cyclic polyolefin is preferably a ring opening hydrogenated polymerization product of a cyclic olefin monomer.

The density of linear low density polyethylene is preferably not less than 0.860 g / cm ³ but less than 0.940 g / cm ³ .

The density of high density polyethylene is preferably in the range from 0.940 to 0.970 g / cm ³ .

The outermost layer is preferably either a mixture of high density polyethylene and high pressure polyethylene and low density, or consists only of high density polyethylene.

The multilayer body for medical containers of the present invention preferably has a total thickness in the range of 60 to 1000 μm, consists of three layers — the innermost layer 5 to 100 microns thick, the intermediate layer and the outermost layer 5 to 100 microns thick.

The medical container of the present invention comprises a compartment for storing medical fluid in which at least a storage compartment is formed from the aforementioned multi-layer body for medical containers.

In this case, the multilayer body for medical containers may be a blow molded body. In addition, the multilayer case for medical containers may be a film, and the storage compartment may be manufactured by hot forming the film or may be formed in the form of a bag.

EFFECT OF THE INVENTION

The present invention makes it possible to provide a multilayer body for medical containers in which the innermost layer is formed of a cyclic polyolefin which, without the use of adhesive, exhibits suitable adhesion to another layer that exhibits excellent heat resistance and which provides suitable adhesion resistance when forming in the form of a film, and also provide a medical container formed from this multi-layer casing for medical containers, which is the least It results in deterioration of properties such as transparency and resistance to peeling, even when steam sterilized under high pressure or the like.

BRIEF DESCRIPTION OF THE DRAWINGS

1 is a cross-sectional view that illustrates one example of a multilayer body of the present invention.

FIG. 2 (A) is a plan view illustrating one example of a medical container of the present invention, and FIG. 2 (B) is a cross-sectional view along line I-I 'in FIG. 2 (A).

FIG. 3 (A) is a top view that illustrates another example of a medical container of the present invention, and FIG. 3 (B) is a top view that illustrates another example of an opening region.

Fig. 4 (A) is a front view, and Fig. 4 (B) is a side view of a molded film product that is used to make the medical container shown in Fig. 3.

5 is a top view that illustrates another example of a medical container of the present invention.

6 is a top view that illustrates a multi-chamber medical container, which is one example of a medical container of the present invention.

Fig. 7 (A) is a schematic diagram that illustrates the peeling test that was used in the examples, and Fig. 7 (B) is a top view that illustrates a method for producing a sample for use, which is shown in Fig. 7 (A) )

DESCRIPTION OF CONVENTIONS

10 Laminated housing

11 The innermost layer

12 intermediate layer

13 The outermost layer

20, 30, 40 Medical container

50 Multi-chamber medical container

BEST MODE FOR CARRYING OUT THE INVENTION

The following is a more detailed description of the present invention.

The multilayer case for medical containers of the present invention is used to form a medical container and, in particular, it can be used to form a storage compartment inside the medical container in which the medical fluid is stored. The multilayer body contains at least the innermost layer consisting of a cyclic polyolefin, an intermediate layer that is formed next to the innermost layer and as the main component contains linear low density polyethylene obtained using a catalyst with a single polymerization center, and the outermost layer, which contains high density polyethylene.

1 is a diagram that illustrates a multilayer case for medical containers (which will hereinafter be referred to simply as a "multilayer case") 10, which is one example of the present invention.

The multilayer body 10 of this example is a three-layer structure made by laminating, in the above order, the innermost layer 11, consisting of a cyclic polyolefin, an intermediate layer 12, which contains as a main component a linear low density polyethylene obtained using a single-center catalyst polymerization, and the outermost layer 13, which contains high density polyethylene, and formed in the form of a film using the multilayer method I-blow method or a multilayer extrusion molding through a T-shaped head with an air-cooled or water cooled or the like. In the present invention, the general term “film” is used for films and sheets.

The innermost layer 11 becomes the inner surface when the medical container is formed from the multilayer body 10, and therefore, is in direct contact with the medical fluid contained within the medical container. The innermost layer 11 is formed of a cyclic polyolefin.

Cyclic polyolefins exhibit minimal adsorption or absorption of drugs, and the reduction in titer of the medical fluid contained within the medical container can be reduced by forming the medical container from the multilayer body 10 so that the layer consisting of the cyclic polyolefin acts as the innermost layer 11. In addition to Moreover, cyclic polyolefins exhibit excellent barrier properties, including low water vapor transmission rate, and also exhibit excellent hygienic properties, releasing extremely few pollutants, which also makes cyclic polyolefins an ideal material for the inner layer 11. In addition, cyclic polyolefins also have suitable heat resistance and transparency, and both of these properties are ideal for use in medical containers that must be sterilized with using steam under high pressure or the like, and preferably should be transparent, so that you can visually control the content a container from the outside.

Examples of cyclic polyolefins include ring-opening cyclic olefin monomer polymerization products and hydrogenated derivatives of such ring-opening ring polymerization products, cyclic olefin monomer addition polymers and addition copolymers of a cyclic olefin monomer and another monomer that can be copolymerized with a cyclic olefin. Among them, hydrogenated ring-opening polymerization products of cyclic olefin monomers are preferred in terms of heat resistance, mechanical strength, and the like. In addition, from the point of view of obtaining a polymer having weak adsorption properties, the use of exclusively hydrocarbon cyclic olefin monomer is preferred.

Although there are no specific restrictions on cyclic olefin monomers, typical examples include norbornene-based monomers and monocyclic olefin monomers. The norbornene-based monomer is a monomer whose monomer structure contains a unit derived from the norbornene structure, and specific examples include bicyclo [2.2.1] hept-2-ene (trivial name: norbornene), tricyclo [4.3.0.1 ^2,5 ] deca-3,7-diene (trivial name: dicyclopentadiene), 7,8-benzotricyclo [4.3.0.1 ^2,5 ] deca-3-ene (trivial name: methanotetrahydrofluorene) and tetracyclo [4.4.0.1 ^2,5 .1 ^7.10 ] dodeca-3-ene (trivial name: tetracycline dodecene). In addition, these norbornene-based monomers may contain a hydrocarbon group of 1-3 carbon atoms. Specific examples of monocyclic olefin monomers include cyclohexene, cycloheptene and cyclooctene. These cyclic olefin monomers can be used individually or in combinations of two or more types of cyclic olefin monomers.

The ring-opening cyclic olefin monomer polymerization product is obtained by cyclic olefin monomer polymerization by an exchange reaction in the presence of a known ring-opening polymerization catalyst. In addition, a hydrogenated ring opening olefin monomer polymerization product is obtained by hydrogenating a ring opening polymerization product using a known hydrogenation catalyst.

Examples of other monomers that can be additively copolymerized with a cyclic olefin monomer include α-olefins of 2-20 carbon atoms such as ethylene, propylene, 1-butene and 1-hexene. Any of these α-olefins can be used individually or in combination of two or more types of α-olefins. Additive (co) polymers of cyclic olefin monomer can be obtained by polymerization using a standard catalyst consisting of a titanium or zirconium compound and an organoaluminum compound.

Among the various cyclic polyolefins available on the market, examples of cyclic olefin monomer additive (co) polymers include APEL (registered trademark) products manufactured by Mitsui Chemicals, Inc., and TOPAS (registered trademark) manufactured by Ticona GmbH, while examples of hydrogenated ring opening olefin monomer polymerization products include ZEONOR (registered trademark) and ZEONEX (registered trademark) products which oizvodyatsya by Zeon Corporation.

The glass transition temperature (also hereinafter referred to as Tg) of the cyclic polyolefin is preferably in the range from 70 to 180 ° C and more preferably from 100 to 140 ° C. If the Tg is less than 70 ° C, then the heat resistance of the medical container formed from the multilayer body 10 will tend to decrease, and the medical container may not be suitable for sterilization using high pressure steam or the like. Conversely, if Tg exceeds 140 ° C, then the formability and heat sealing quality of the multilayer body may be impaired. In the present description, the glass transition temperature refers to a value that is measured in accordance with JIS K 7121 using a differential scanning calorimeter (hereinafter referred to as DSC) and which is mainly contained in catalogs and technical data provided by the manufacturer.

The Tg of the cyclic polyolefin can be arbitrarily selected using a method in which those cyclic polyolefins from a plurality of cyclic polyolefins that exhibit suitable compatibility are mixed together in an appropriate ratio. The degree of compatibility of the cyclic polyolefin mixture can be determined by DSC in order to measure the Tg of the mixture. If the mixture has suitable compatibility, then only one Tg is observed, while in cases with not quite sufficient compatibility, several Tg is observed. A mixture with sufficient compatibility is preferred because it is able to provide a combination of some level of heat resistance that can withstand the temperature of the planned high-pressure steam sterilization and suitable formability.

Although the innermost layer 11 consists of a cyclic polyolefin, it can also include the usual amounts of any additives that are typically used in the polymer field, for example antistatic agents, antioxidants, lubricants, anti-fog agents, ultraviolet absorbers and neutralizing agents, provided that the addition of these additives does not weaken the effects of the present invention.

The intermediate layer 12, formed near the innermost layer 11 described above, was obtained using a catalyst with a single polymerization center, an example of which is a metallocene catalyst, and as a main component contains linear low density polyethylene (hereinafter also referred to as LLDPE) with a density not less than 0.860 g / cm ³ but less than 0.940 g / cm ³ . As used herein, the expression “main component” indicates that the content is at least 50% by weight.

This type of LLDPE, obtained using a catalyst with a single center of polymerization, exhibits excellent adhesion to cyclic polyolefins, and is least affected by the adhesion ability even when exposed to high temperature and high humidity during high pressure steam sterilization. Thus, by providing this type of intermediate layer 12 containing LLDPE as the main component near the innermost layer 11 consisting of a cyclic polyolefin, other layers can be attached conveniently and firmly using this intermediate layer 12. In addition, the LLDPE obtained using a catalyst with a single center of polymerization, exhibits excellent transparency and is least affected by the deterioration of this transparency, even when exposed to high temperature and high crap. For these reasons, a multilayer body 10 provided with this type of intermediate layer 12 is ideal for forming medical containers that require high pressure steam sterilization.

It is convenient to use any LLDPE product obtained using a catalyst with a single polymerization center and having a density of at least 0.860 g / cm ³ but less than 0.940 g / cm ³ , although among these products it is preferable to use LLDPE having a density in the range from 0.900 to 0.917 g / cm ³ because it gives the multilayer body 10 and the medical container excellent heat resistance, which does not experience any problems, even when sterilized using high pressure steam at 121 ° C, and able to prevent any deterioration in the resistance to peeling of the intermediate layer 12 from the innermost layer 11 when sterilizing a medical container formed from a multilayer body 10 using high pressure steam. If the density of LLDPE is less than 0.860 g / cm ³ , then the heat resistance may deteriorate. Conversely, if the density of LLDPE exceeds 0.940 g / cm ³ , then the transparency and impact strength of the container may deteriorate.

In addition, a combination of several types of LLDPE with different densities can be used as LLDPE obtained using a catalyst with a single polymerization center.

In addition, among the various LLDPE products obtained using a catalyst with a single polymerization center, preferred are those in which the distribution of the composition of ethylene and α-olefin, measured by composition analysis, clearly indicates excellent processability and impact strength. Examples of commercially available products that exhibit these property types and are convenient to use include HARMOREX (registered trademark) products manufactured by Japan Polyethylene Corporation, UMERIT (registered trademark) manufactured by Ube Industries, Ltd., and EVOLUE (registered trademark) brand) manufactured by Prime Polymer Co., Ltd.

As the main component, the intermediate layer 12 contains LLDPE obtained using a catalyst with a single center of polymerization, specifically in an amount of at least 50% by weight, and from the point of view of achieving suitable flexibility, this amount is preferably at least 65% by weight and more preferably 80% by mass or more, although the intermediate layer 12 may also contain other polyethylenes or cyclic polyolefins, provided that the addition of these other compounds does not weaken the adhesion to the inner layer 11. In particular, if high density polyethylene having a density that exceeds the density of LLDPE obtained using a catalyst with a single polymerization center is used in combination with LLDPE in an amount that is preferably not more than 30% by weight and more preferably not more than 25% by mass, the heat resistance can be improved, and also any deterioration in the adhesion ability of the intermediate layer 12 caused by steam sterilization under high pressure can be reduced. Thus, in addition to this, it is possible to achieve another advantage, which lies in the excellent appearance of the multilayer body 10, if you use a combination of LLDPE with other polyethylene or cyclic polyolefins.

In addition, the intermediate layer 12 may also include the usual amounts of any additives that are typically used in the field of polymers, for example antistatic agents, antioxidants, lubricants, antifog agents, ultraviolet absorbers and neutralizing agents, provided that the addition of these additives is not weakens the effects of the present invention.

The outermost layer 13 becomes the outermost layer if the medical container is formed from a multilayer body 10 and contains high density polyethylene (hereinafter also referred to as HDPE).

By providing a layer containing HDPE as the outermost layer 13, the heat resistance of the fabricated multilayer body 10 can be improved, and a medical container that is least affected by the deterioration of the properties of the medical container, for example, from deformation of the surface of the container after high steam sterilization, can be formed pressure. In addition, in the case of a multilayer body 10 in the form of a film, for example, such as that illustrated in figure 1, for storage or handling the product will often be wound in the form of a roll, and the provision of a layer containing HDPE as the outermost layer 13 ensures that that the multilayer body 10 will exhibit excellent adhesion resistance.

It is convenient to use any HDPE product with a density in the range of 0.940 to 0.970 g / cm ³ , although among such HDPE products the use of HDPE with a density of 0.945 to 0.970 g / cm ³ gives the multilayer body 10 excellent heat resistance and adhesion resistance. In addition, you can also use a combination of several types of HDPE with different densities.

The ideal amount of HDPE in the outermost layer 13 varies depending on the density of HDPE, but, for example, if the density of HDPE is in the range of 0.945 to 0.970 g / cm ³ , this ensures that the HDPE content in the outermost layer 13 is at least at least 20% by mass, will make it possible to form a medical container with suitable heat resistance, which is least affected by the deterioration of the properties of the container, even when sterilized using high-pressure steam at 121 ° C. However, in order to achieve a more stable level of heat resistance and excellent adhesion resistance, the HDPE content in the outermost layer 13 is preferably at least 30% by mass, more preferably 70% by mass or more, and most preferably 100% by mass.

However, other polymers can also be included in the outermost layer 13 in order to increase the stability of the molding, and in such cases the HDPE content can be changed accordingly. Examples of such other polymers include polyolefins other than HDPE and other polyethylene polymers, for example, the use of linear low density polyethylene and high pressure and low density polyethylene is particularly favorable. Among them, the use of high pressure and low density polyethylene in combination with HDPE gives a more significant increase in the stability of the molding of the outermost layer 13. High pressure and low density polyethylene preferably has a density in the range from 0.910 to 0.935 g / cm ³ and more preferably from 0.920 to 0.935 g / cm ³ .

In addition, the outermost layer 13 may also include the usual amounts of any additives that are typically used in the field of polymers, for example antistatic agents, antioxidants, lubricants, antifog agents, ultraviolet absorbers and neutralizing agents, provided that the addition of these additives does not weaken the effects of the present invention. In addition, the outermost layer 13 can also be modified, for example by crosslinking with an electron beam, in order to further improve the heat resistance.

Although there are no specific limitations on the total thickness of the multilayer body 10, its thickness is generally in the range of 60 to 1000 μm, and if factors such as the flexibility and strength of the multilayer body 10 are taken into account, the thickness is preferably in the range of 100 to 600 microns, and more preferably 100 to 400 microns.

Although there are no specific limitations on the thickness of each layer, the thickness of the innermost layer 11 is preferably in the range of 5 to 100 microns, and the thickness of the outermost layer 13 is preferably in the range of 5 to 100 microns. If the thickness of the innermost layer 11 is less than 5 μm, then there is a possibility that the drug contained inside the container can be adsorbed more quickly, whereas if the thickness exceeds 100 μm, the flexibility and quality of heat sealing of the multilayer body 10 achieved during the formation a medical container from a multilayer body 10 may be degraded. In addition, if the thickness of the outermost layer 13 is less than 5 μm, then there is a possibility that the heat resistance of the multilayer body 10 may deteriorate, while if the thickness exceeds 100 μm, transparency may be deteriorated.

Thus, in the case of the multi-layer body 10 consisting of three layers, the total thickness preferably corresponds to a value in the range of 60 to 1000 μm, the thickness of the innermost layer 11 preferably corresponds to the range of 5 to 100 μm, and the thickness of the outermost layer itself preferably corresponds to the range of 5 to 100 μm, and the remaining thickness corresponds to the thickness of the intermediate layer 12.

In cases where the multilayer body 10, consisting of three layers, is a film, the thickness of the innermost layer 11 is preferably 5 to 100 μm, the thickness of the intermediate layer 12 is preferably 50 to 300 microns, and the thickness of the outermost layer is preferably from 5 to 100 microns.

As described above, the multilayer housing 10 shown in FIG. 1 consists of three layers, of which the innermost layer 11, consisting of a cyclic polyolefin, and the outermost layer 13, containing HDPE, are conveniently joined together by an intermediate layer 12 located between them, and despite the fact that this structure has satisfactory properties for use as a multilayer case 10 for a medical container, one or more additional layers can be provided between the intermediate layer 12 and the outer layer 13, which will create a multilayer body of four layers or more in order to give the structure other additional properties. Examples of such additional layers include a gas-insulating polymer layer formed from an ethylene-vinyl alcohol copolymer or the like, an adhesive polymer layer formed from an ethylene-vinyl acetate copolymer or the like, an ultraviolet-free layer that is formed from a polyolefin polymer, containing iron oxide or the like, or an oxygen scavenging layer that is formed from a cobalt salt and a polyamide polymer such as MXD nylon derived from xylylenediamine and α, ω- ineynoy aliphatic dibasic acid, e.g. adipic acid.

In addition, the multilayer body does not have to have the configuration of the multilayer body 10 in the form of a film, for example, shown in figure 1, and, which is described in detail below, can also take a three-dimensional shape of a multilayer body, such as a body formed by blow molding, which is formed with using the multi-layer blow molding method (multi-layer hollow molding method).

The medical container of the present invention relates to a compartment for storing medical fluid, where at least the storage compartment is formed from a multilayer body described above. The multilayer housing is arranged so that the innermost layer forms the inner surface of the storage compartment and the outermost layer forms the outer surface. Furthermore, in addition to the storage compartment, the medical container typically contains an opening region that acts as an opening for introducing and extracting the medical fluid.

Specific examples of the medical container of the present invention are described below with reference to the drawings.

Figure 2 shows a medical container 20, in which the storage compartment 21 and the region of the opening 22 are molded in an integrated manner using the multi-layer blow molding method. The upper compartment of this medical container 20 functions as a suspension portion 23 that has a suspension hole formed therein, while the lower region of the opening 22 is hermetically sealed with a rubber stopper 22a that is made using an injection molding method to provide a layer of synthetic polymer that can be welded to the innermost layer 11 around the outer periphery on the sides of a circular cylindrical rubber material that can be pierced with an injection needle.

This medical container 20 can be manufactured using a conventional multi-layer blow molding method using a multi-layer blow molding machine. In other words, a multilayer blowing blank is extruded and then inserted into a die casting mold, after which purified air is pumped into the multilayer blow molding blank. Using a die casting mold that integrally shapes the storage compartment 21 and the opening region 22, the medical container 20 shown in FIG. 2 can be formed from a hollow body formed by blow molding. In addition, the accuracy of transferring the injection mold can be improved when, before inserting the multilayer preform for blowing into the injection mold, pre-inflating is preliminarily carried out using purified air, and then, after closing the injection mold, carry out laying inside the mold for injection molding under negative pressure using the vacuum holes provided in the mold for injection molding.

Other possible methods for forming the hole region, in addition to the multi-layer blow molding method described above, in which the hole region is integrally formed together with the storage compartment, include methods, for example, shown in FIG. 3 and described below, in which a separately manufactured cylindrical part is attached to a heat-sealable storage compartment, and methods in which a cylindrical part is provided as an insert used in a blow molding method with an insert that combined with a storage compartment during the molding process. In cases where a cylindrical type part is used, in addition to those configurations in which the rubber plug 22a is inserted inside the cylindrical part to seal the container, another configuration is possible, described in detail below with reference to FIG. 3 (B), in which the rubber the plug is inserted inside the cylindrical part, a ring-shaped cap is put on the periphery of the rubber plug, and then, using ultrasound or the like, the cap is welded to the cylindrical part.

FIG. 3 (A) shows a medical container 30 formed from a storage compartment 31 that was formed by hot forming the film, and an area of the hole 32, which is a cylindrical part that is hermetically sealed with a rubber stopper 32a attached by heat sealing . The storage compartment 31 of this medical container 30 is formed by overlaying two film-molded products 10 'shown in FIG. 4, which are then bonded to the peripheral parts 33 of these two molded products by heat sealing.

In other words, in the manufacture of such a medical container 30, first, by means of a hot molding method, for example vacuum molding or injection molding, film multilayer bodies 10 are formed, for example, as shown in FIG. 1, which have a concave depression in the central part of the film, which corresponds to the internal shape of the storage compartment 31, and thereby the film molded articles 10 ′ shown in FIG. 4 are obtained. Then, two such obtained film-shaped molded articles 10 ′ are stacked on top of one another so that the concave impressions face each other. Then the cylindrical part is placed in a predetermined position and the peripheral parts of the two film-molded products 10 'are fastened by heat sealing. The temperature of the heat seal varies depending on the total thickness of the multilayer body 10 and, although there are no specific restrictions, it is preferably in the range of about 150 to 280 ° C. In addition, after heat sealing, you can trim the peripheral parts if necessary. Using this method, the formation of the storage compartment 31 and the formation of the region of the hole 32 by heat sealing of the cylindrical part occurs simultaneously, which makes it possible to manufacture the medical container 30 shown in FIG. 3 (A).

Also, the formation of the storage compartment 31 and the formation of the region of the hole 32 can be carried out in separate stages.

The material for the cylindrical part used in forming the region of the hole 32 is preferably the same cyclic polyolefin as is used for the innermost layer 11 of the multilayer body 10, since it provides more convenient bonding to the storage compartment 31 by heat sealing. However, this material is not limited to cyclic polyolefin, provided that heat sealing can be used to seal tightly with the storage compartment 31, and it is also possible to use, for example, LLDPE products obtained using a catalyst with a single polymerization center, or materials having the same the composition as the intermediate layer 12. In addition, it is also possible to use a multilayer material in which heat sealing is used on the surface of the cylindrical part that is heat-sealed the first polymer. An alternative to forming the region of the hole 32 from the cylindrical part and the rubber stopper 32a is shown in FIG. 3 (B) and that the rubber stopper 32b is inserted into the cylindrical part, an annular cap 32c is put on the periphery of the rubber stopper 32b and then by ultrasound or what Similarly, the cap 32c is welded to the cylindrical part.

Figure 5 shows the so-called film bag medical container 40, which includes a storage compartment 41, consisting of a film multilayer case 10, such as that shown in figure 1, and formed in the form of a bag, and the region of the hole 42 formed from a cylindrical part.

The medical container 40 of this example, which uses a multilayer body formed in the form of a cylinder using a multilayer blowing method or the like, can be manufactured by heat sealing both end sections of the multilayer body to form a storage compartment 41, heat sealing the cylindrical part in a predetermined location at one of the end portions to form an area of the hole 42, and forming a part for hanging at the other end portion. Heat welding of two end sections and heat welding of a cylindrical part can be carried out simultaneously or in separate stages. In addition, instead of using the aforementioned cylindrical multilayer case, two multilayer cases 10 can be used, for example, those shown in FIG. 1, and in this case, two multilayer cases are superimposed on each other and then heat-seal the peripheral parts to form a compartment for storage.

In addition, in this example, the region of the hole 42 is sealed by a cylindrical part, which is formed from a cyclic polyolefin or LLDPE obtained using a catalyst with a single center of polymerization, a rubber stopper 42a that can be pierced with an injection needle, and an annular cap 42b that is worn on the periphery rubber plug 42a.

In the medical containers described above, at least the storage compartment is formed of a multilayer body that contains the innermost layer consisting of a cyclic polyolefin, an intermediate layer, which as the main component contains linear low density polyethylene obtained using a catalyst with a single polymerization center, and the outermost layer, which contains high density polyethylene, and therefore all layers are joined together in a favorable way, and the medical container is It gives suitable hygienic properties, excellent heat resistance and to a lesser extent suffers deterioration in properties such as transparency and peel strength even when sterilized using high-pressure steam.

The medical container is not limited to configurations containing one storage compartment, and, for example, as shown in FIG. 6, a multi-chamber medical container 50 may be formed in which the storage compartment 51 is divided into several sections using a dividing jumper 52, which can be used for the formation of internal connections between several sections, and in the corresponding sections several medical fluids can be separately stored.

In the multi-chamber medical container 50 shown in FIG. 6, the dividing jumper 52 is formed so as to extend across the bag-shaped storage compartment 51, thereby dividing the storage compartment 51 into a first storage section 51a and a second storage section 51b. When using the multi-chamber medical container 50, the user can destroy the separation jumper 52 by applying external pressure to either the first storage section 51a or the second storage section 51b, thereby allowing the medical fluid inside the first storage section 51a to mix with the medical fluid inside a second storage section 51b.

There are no particular limitations of the method used to form the separating jumper 52, and, for example, when heat sealing is performed during the formation of the storage compartment 51, at the same time, a separating jumper 52 can be formed using heat welding. the jumper 52 can also be formed in a separate stage using a conventional welding method other than heat welding, such as pulsed welding. In addition, in cases where the storage compartment 51 is made by blow molding, a housing that forms the separation jumper 52 may be provided inside the injection mold used in the blow molding process, so that the separation jumper 52 can be formed during the blow molding process.

In addition, although not shown in the figures, if necessary, the medical container of the present invention may comprise a light protection layer for protecting the medical fluid, this light protection layer provided on the outside of the container, and in particular on the outside of the storage compartment. Examples of materials that are conveniently used as such a light-protective layer include a metal foil, for example, aluminum foil, vacuum-sprayed aluminum films, laminated films consisting of a metal foil and a synthetic polymer film, and synthetic polymer films containing pigment. Among these light-protective layers, aluminum foil and a vacuum-sprayed aluminum film exhibit not only suitable light-shielding properties, but also have suitable moisture-insulating, oleophobic and water-repellent properties and, therefore, are preferred from the point of view of increasing the long-term storage parameters of the medical fluid contained within the medical container. In addition, this light-protective layer can be provided in a manner that allows the layer to be removed from the medical container so that the medical fluid is visible from the outside during use of the medical container.

In the above description, as an example of a drug contained within the medical container of the present invention, a medical fluid was used, but it is also possible to use a medicinal product that is not a medical fluid, but is to some extent formed from a powder composition, such as an antibiotic. In addition, specific examples of medical fluid include, but are not limited to, medical fluids that are used as injectable solutions, for example, contrast agents, antimicrobials, physiological salines, and drugs for the cardiovascular system.

EXAMPLES

The following is a more detailed description of the present invention based on a number of examples, although the present invention is in no way limited to the examples described below.

[Example 1]

The medical container 20 shown in FIG. 2 and filled with 100 ml of water was made by the method described below.

First, a multi-layer blow molding method using a multi-layer blow molding machine was used to integrally mold a storage compartment 21 and an opening region 22 of a blow molded body with a three-layer structure that contains an innermost layer 30 μm thick, an intermediate layer 250 μm thick and the outermost layer is 20 microns thick, which are laminated in the order shown. Then, the inside of the storage compartment 21 was filled with 100 ml of water through the region of the opening 22, and by heat sealing the rubber stopper 22a was secured inside the region of the opening 22 in order to seal the medical container 20. The rubber stopper 22a was injection molded to provide a layer, consisting of a cyclic polyolefin “ZEONEX” (manufactured by Zeon Corporation) (hereinafter referred to as “COP1”), which has a melt flow rate (hereinafter referred to as “MFR”, where the load during all measurements The MFR was 21.18 N in all examples and comparative examples), determined at a temperature of 280 ° C in accordance with ISO 1133, which is 17 g / 10 min, and a glass transition temperature of 136 ° C around the outer periphery of the rubber stopper.

For the innermost layer, a cyclic polyolefin mixture was used that contained COP1 and the cyclic polyolefin “ZEONOR 1020R” (manufactured by Zeon Corporation) (hereinafter referred to as “COP2”), which had an MFR determined at 280 ° C in accordance with ISO 1133, equal to 20 g / 10 min, and a glass transition temperature of 102 ° C, which were mixed in a mass ratio of 1: 1. For this mixture of cyclic polyolefins, only one Tg was observed, which was 119 ° C.

For the intermediate layer, a mixture was used that contained “HARMOREX” (manufactured by Japan Polyethylene Corporation), which is LLDPE obtained using a catalyst with a single polymerization center (hereinafter also referred to as “single-center LLDPE”) and has MFR = 1 g / 10 min at a temperature of 190 ° C and a density of 0.906 g / cm ³ , and NOVATEC (manufactured by Japan Polyethylene Corporation), which is a HDPE that has an MFR of 3.5 g / 10 at a temperature of 190 ° C min and a density of 0.956 g / cm ³ , which were mixed in a mass ratio of 8: 2.

For the outermost layer, NOVATEC HDPE (manufactured by Japan Polyethylene Corporation) was used, which has an MFR of 3.5 g / 10 at a temperature of 190 ° C min and a density of 0.955 g / cm ³ .

The medical container 20 of FIG. 2 prepared in this way, was sterilized by high pressure steam for 30 minutes at 121 ° C. using a high pressure steam sterilizer and evaluated the properties of the container before and after sterilization using the methods described below. The evaluation results are shown in the tables below.

In the examples and comparative examples, the adhesion resistance and molding stability were evaluated only in those cases where a film was formed to form the storage compartment, and not in examples such as Example 1 in which the storage compartment was formed by multi-layer blow molding.

(Evaluation Methods)

(1) Adhesion Resistance

Two multilayer cases measuring 10 cm × 10 cm were superimposed so that the outermost layers of the two bodies formed contact, a load of 98 N / 100 cm ^{2 was} applied, and the bodies were left in this state for 24 hours at a temperature of 60 ° C. Then the shells were cooled to room temperature and after eliminating the load, the two films were delaminated. The ease of this delamination was evaluated using the two gradations listed below.

A: Exfoliation was easy.

X: there was resistance to delamination.

(2) peeling resistance

Sample strips S 15 mm wide were cut from medical containers before and after steam sterilization under high pressure and, as shown in the diagram in Fig. 7 (A), the peeling resistance in the T configuration of the innermost layer 11 from the intermediate layer 12 was measured in accordance with JIS K 6854-3 at a tensile speed of 300 mm / min. This test was performed using a tensile tester. In the figure, the symbols P denote the fixtures of the tensile tester.

In order to achieve the state shown in Fig. 7 (A), in which only the innermost layer 11 of sample S was torn in the fracture region V, first, as shown in the top view of Fig. 7 (B), the teeth C were placed in two opposite positions on the longitudinal edges of the specimen S cut from the medical container, and then the specimen S was pulled in the longitudinal direction, which is indicated by the arrows depicted in Fig. 7 (B). This pulling made it possible to obtain a sample in which only the innermost layer 11 was completely torn in the position of the C teeth, while the other layers remained intact. Thus, after placing the sample in the tensile tester as shown in FIG. 7 (A), it was possible to measure the peeling resistance in the contact area between the innermost layer 11 and the intermediate layer 12.

(3) Transparency

Haze was measured before and after steam sterilization under high pressure in accordance with JIS K 7136.

(4) Heat Resistance

The medical container was fixed on a perforated metal tray with round holes and subjected to steam sterilization under high pressure using a high pressure spray steam sterilizer, and the appearance of the medical container was visually evaluated.

O: no deformation or shrinkage was observed after sterilization.

A: slight deformation and / or shrinkage was observed, for example, surface roughness.

x: there was significant deformation and / or shrinkage, and imprints from the round holes in the tray formed on the container.

(5) Stability of molding

The stability of the shape of the film in the form of a tube during blow molding and the level of wrinkling on the film were evaluated.

O: the shape of the tube remained constant and no wrinkles were observed on the film.

X: the shape of the tube was unstable and deviations were observed in the diameter of the tube. Folds were observed in some areas of the film.

[Example 2]

The medical container 20 was made in the same manner as in Example 1, except that the composition of the outermost layer and the configuration of the opening region 22 were changed.

For the outermost layer, a mixture containing high pressure and low density polyethylene "NOVATEC" (manufactured by Japan Polyethylene Corporation), which has an MFR of 1.1 g / 10 min at a temperature of 190 ° C and a density of 0.927 g / cm ³ , and high density polyethylene "NOVATEC" (manufactured by Japan Polyethylene Corporation), which has a MFR = 3.5 g / 10 min at a temperature of 190 ° C and a density of 0.956 g / cm ³ , which were mixed in the dry state in a mass ratio of 7: 3.

The area of the hole 22 was made by heating; in the injection mold preheated to a temperature of 250 ° C, a cylindrical part formed from a cyclic polyolefin was made by injection molding, and then the cylindrical part was inserted into the region of the opening 22 of the storage compartment 21 formed from the blow molded case shown in FIG. 2, and then heat sealing was performed at a temperature of 220 ° C. In addition, after filling the container with 100 ml of water, the rubber stopper was inserted into the cylindrical part, the annular cap was placed so as to close the periphery of the rubber stopper, and then the cylindrical part and cap were fastened by ultrasonic welding. COP1 was used for the cylindrical part and cap. Then the container was evaluated in the same manner as in example 1. The results are shown in tables.

[Example 3]

With the exception that only COP2 was used to form the innermost layer, a medical container 20 was made and evaluated in the same manner as in Example 1. The results are shown in tables.

In this example, a stopper was used as the rubber stopper 22a, which was made using the injection molding method to provide a layer consisting of LLDPE used in the intermediate layer around the outer periphery of the rubber stopper.

[Example 4]

Except that in the process of forming the intermediate layer, only HARMOREX single-center LLDPE (manufactured by Japan Polyethylene Corporation) was used, which has an MFR of 3.5 g / 10 min at a temperature of 190 ° C and a density of 0.918 g / cm ³ , medical container 20 was made and then evaluated in the same manner as in example 3. The results are shown in tables.

In this example, a stopper was used as the rubber stopper 22a, which was made using the injection molding method to provide a layer consisting of LLDPE used in the intermediate layer around the outer periphery of the rubber stopper.

[Example 5]

Except that in the process of forming the intermediate layer, only one-center UMERIT LLDPE (manufactured by Ube Industries, Ltd.) was used, which has an MFR of 4.0 g / 10 min at a temperature of 190 ° C and a density of 0.931 g / cm ³ , a medical container 20 was made and then evaluated in the same manner as in example 3. The results are shown in tables.

In this example, a stopper was used as the rubber stopper 22a, which was made using the injection molding method to provide a layer consisting of LLDPE used in the intermediate layer around the outer periphery of the rubber stopper.

[Example 6]

Except that for the formation of the intermediate layer, a mixture containing one-center LLDPE “UMERIT 0520F” (manufactured by Ube Industries, Ltd.), which has an MFR = 2.0 g / 10 min at a temperature of 190 ° C and a density of 0.904 g / cm ³ and HDPE "NOVATEC" (manufactured by Japan Polyethylene Corporation), which has an MFR = 3.5 g / 10 min at a temperature of 190 ° C and a density of 0.956 g / cm ³ mixed together in a mass ratio of 8: 2, medical container 20 was made and then evaluated in the same manner as in example 1. The results are shown in tables.

In this example, an injection molded stopper was used as the rubber stopper 22a to provide a layer consisting of COP1 around the outer periphery of the rubber stopper.

[Example 7]

The medical container 30 shown in FIG. 3 and filled with 100 ml of water was made by the method described below.

First, a multi-layer blow-molding method was used using a multi-layer blow-molding machine to produce a three-layer film obtained by blowing and consisting of the innermost layer 10 μm thick, an intermediate layer 220 μm thick and the outermost layer 20 μm thick, laminated in the above order.

Then, a piece of film cut from the film made by blowing was softened by heating by radiation in a heating device set to 300 ° C, and then a piece of film was formed in a vacuum molding apparatus using an injection mold with an ambient temperature, whereby film molded product 10 ', which is shown in Fig.4.

Then, two such film-molded articles 10 'were superimposed on each other by concave depressions to each other, the peripheral parts of the two film-molded articles were heat-sealed, and then a cylindrical injection molded cyclic polyolefin was attached to form a hole region 32.

After filling the storage compartment 31 with 100 ml of water through the region of the hole 32, a rubber stopper 32b was inserted into the cylindrical part, then the annular cap 32c was placed so that it covered the periphery of the rubber stopper 32b, and then the cylindrical part and cap 32c were fastened by ultrasonic welding, as shown figure 3 (B). For the cylindrical part and cap 32c, COP1 was used.

The innermost layer, the intermediate layer and the outermost layer were made using the polymers described in Example 1.

The sealed medical container 30 was then evaluated. The results are shown in tables.

[Example 8]

The medical container 40 shown in FIG. 5 and filled with 100 ml of water was prepared as described below.

First, a film with a three-layer structure, obtained by blowing, was made in the same way as in example 7.

Then, both ends of this blown film were heat-sealed to form a bag, and the cylindrical part that was injection molded COP2 was heat-sealed to one end of the bag, thereby forming an opening region 42 at one end of the film bag storage compartment 41.

After filling the storage compartment 41 with 100 ml of water through the region of the opening 42, the rubber stopper 42a was inserted into the cylindrical part, the annular cap 42b was placed so that it covered the periphery of the rubber stopper 42a, and then the cylindrical part and cap 42b were fastened by ultrasonic welding. COP1 was used to make the cylindrical part and cap 42b.

The sealed medical container 40 was then evaluated. The results are shown in tables.

[Example 9]

Except that for the outermost layer, a mixture containing high pressure and low density polyethylene "NOVATEC" (manufactured by Japan Polyethylene Corporation) was used, which has an MFR of 1.1 g / 10 min at a temperature of 190 ° C and a density of 0.927 g / cm ³ and high density polyethylene "NOVATEC" (manufactured by Japan Polyethylene Corporation), which has a MFR = 3.5 g / 10 min at a temperature of 190 ° C and a density of 0.956 g / cm ³ , which were mixed in a mass ratio of 7: 3, a medical container 40 was made and then evaluated in the same manner as in Example 8. The results of pr listed in table.

[Example 10]

Except that for the outermost layer, a mixture was used that contained NOVATEC linear low density polyethylene (manufactured by Japan Polyethylene Corporation), which was prepared using a Ziegler catalyst and which had an MFR of 2.0 g / 10 min at 190 ° C and a density of 0.936 g / cm ³ and high density polyethylene "NOVATEC" (manufactured by Japan Polyethylene Corporation), which has an MFR = 3.5 g / 10 min at a temperature of 190 ° C and a density of 0.956 g / cm ³ , which mixed in a mass ratio of 7: 3, a medical container 40 was made and then ivali same manner as in Example 8. The results are shown in tables.

[Comparative example 1]

Except that the main component of the intermediate layer was replaced from the single-center LLDPE used in Example 1 to LLDPE (manufactured by Japan Polyethylene Corporation), which was prepared using a Ziegler catalyst and which had an MFR of 1.1 g / 10 min at a temperature of 190 ° C and density 0.906 g / cm, the medical container was molded and then evaluated in the same manner as in example 1. The evaluation results are shown in tables.

[Comparative example 2]

Except that for the formation of the intermediate layer, only MORETEC LLDPE (manufactured by Prime Polymer Co., Ltd.) was used, which was prepared using a Ziegler catalyst and which had an MFR of 2.0 g / 10 min at a temperature of 190 ° C and a density of 0.920 g / cm ³ , the medical container was molded and then evaluated in the same manner as in Example 1. The evaluation results are shown in tables.

[Comparative example 3]

Except that just a two-layer structure was used without forming the outermost layer, which consisted of the innermost layer and the intermediate layer, the medical container was molded and then evaluated in the same manner as in Example 1. The evaluation results are shown in tables.

[Comparative example 4]

Except that the material used to form the outermost layer was replaced with the HDPE used in Example 1, simply with MORETEC LLDPE (manufactured by Prime Polymer Co., Ltd.), which was prepared using a Ziegler catalyst and which has MFR = 2.0 g / 10 min at a temperature of 190 ° C and a density of 0.920 g / cm ³ , the medical container was molded and then evaluated in the same manner as in example 1. The evaluation results are shown in tables.

[Comparative example 5]

Except that the material used to form the outermost layer was replaced from the HDPE used in Example 1 with MORETEC LLDPE (manufactured by Prime Polymer Co., Ltd.), which was prepared using a Ziegler catalyst and which has MFR = 2.0 g / 10 min at a temperature of 190 ° C and a density of 0.920 g / cm, the medical container was molded and then evaluated in the same manner as in example 8. The evaluation results are shown in tables.

In examples 1 to 3 and from 6 to 10, in which one-center LLDPE was used as the main component of the intermediate layer and this LLDPE was used in combination with HDPE, medical containers were made that not only showed excellent heat resistance, but any reduction was suppressed peeling resistance and transparency caused by steam sterilization under high pressure. In contrast, in the case of the medical container made in comparative example 1, in which Ziegler-LLDPE was used in combination with HDPE, the decrease in peeling resistance and transparency caused by steam sterilization under high pressure was significant. A comparison of Examples 4 and 5, in which only one-center LLDPE was used for the intermediate layer, and comparative example 2, in which only Ziegler-LLDPE was used for the intermediate layer, revealed a similar trend.

In comparative example 3, in which the outermost layer was not provided, steam sterilization under high pressure caused not only a significant decrease in transparency, but also the heat resistance deteriorated. Even in comparative examples 4 and 5, in which the outermost layer did not contain HDPE, a trend was observed similar to comparative example 3. In examples 9 and 10, in which high-pressure and low-density polyethylene was used in combination with HDPE as components of the outermost layer stability of molding exceeded the stability of molding, which was observed in examples 7 and 8, in which the outermost layer contained only HDPE.

In addition, the adhesion resistance of the film in example 8 was suitable, while the adhesion resistance in comparative example 5 was low.

INDUSTRIAL APPLICABILITY

The present invention provides a multilayer housing for medical containers in which the innermost layer formed of a cyclic polyolefin, without the use of adhesive, exhibits suitable adhesion to another layer that exhibits excellent heat resistance and which provides suitable adhesion resistance when it is formed into a film, and also provide a medical container formed from this multi-layer casing for medical containers, which is the least It also benefits from deterioration of properties such as transparency and resistance to peeling, even when steam sterilized under high pressure or the like. Thus, the present invention is very effective in view of the industrial perspective.

Claims (11)

1. A multilayer body for medical containers, which is used to form a medical container, including at least
the innermost layer consisting of a cyclic polyolefin,
the intermediate layer, which is formed next to the specified inner layer and as the main component contains linear low density polyethylene obtained using a catalyst with a single center of polymerization, and
the outermost layer containing high density polyethylene. 2. The multilayer body for medical containers according to claim 1, where the specified cyclic polyolefin is a hydrogenated polymerization product of a cyclic ring-opening olefin monomer. 3. The multilayer case for medical containers according to claim 1, where the density of the specified linear low density polyethylene is not less than 0.860 g / cm ³ but less than 0.940 g / cm ³ . 4. The multilayer case for medical containers according to claim 1, where the density of the specified high density polyethylene is in the range from 0.940 to 0.970 g / cm ³ . 5. The multilayer body for medical containers according to claim 1, where the specified outermost layer is a mixture of the specified high density polyethylene and high pressure polyethylene and low density. 6. The multilayer case for medical containers according to claim 1, where the specified outermost layer consists only of the specified high density polyethylene. 7. The multilayer case for medical containers according to claim 1, which has a total thickness in the range of 60 to 1000 μm and consists of three layers consisting of the indicated innermost layer with a thickness of 5 to 100 microns, the specified intermediate layer and the specified outermost layer thickness from 5 to 100 microns. 8. A medical container, which includes a compartment for storing medical fluid, where at least said storage compartment is formed from a multilayer body for medical containers according to claim 1. 9. The medical container of claim 8, wherein said multilayer body for medical containers is a blow molded case. 10. The medical container of claim 8, where the specified multilayer case for medical containers is made of a multilayer film, and the specified storage compartment is made by hot molding of the specified film. 11. The medical container of claim 8, where the specified multilayer body for medical containers is made of a multilayer film, and the specified storage compartment is made by forming a multilayer film in the form of a bag.

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