JP2020049229A - Medical packaging sheet and medical packaging material - Google Patents

Abstract

To provide a medical packaging sheet having self-adhesion resistance as well as provide a medical packaging material formed using the medical packaging sheet.SOLUTION: A medical packaging sheet 30 has a layer including thermoplastic resin on at least one surface. On a surface 30a of a layer 31 including the thermoplastic resin of one medical packaging sheet is superposed a surface on the opposite side to a layer including the thermoplastic resin of another medical packaging sheet. When, after that, a friction test and measurement are performed in a manner compliant to JISK 7125 using the one medical packaging sheet and the other medical packaging sheet, a coefficient of static friction of the surface having the layer including the thermoplastic resin of the one medical packaging sheet is equal to or larger than 0.1 and equal to or smaller than 2.5.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a medical packaging sheet and a medical packaging material.

  Conventionally, a sheet material used for forming a packaging material for contents for medical use has been required to have the following two performances. The first required performance is that the packaged contents be visible, that is, transparency. The second required performance is such a strength that the packaging material is not damaged even if the contents are packaged. Various studies have been made to improve the above-described two characteristics of the sheet material used for forming the packaging material for the contents for medical use.

  For example, the following technology focuses on the improvement of the above two characteristics required for a sheet material used for forming a packaging material for contents for medical use.

  Patent Document 1 discloses a sheet material used for forming a packaging material obtained by molding a resin composition containing two types of hydrogenated block copolymers and a polyolefin resin in a specific ratio. .

JP 2010-106200 A

  The conventional sheet material has such strength that the packaging material is not damaged even if the content is wrapped, and is transparent enough that the content can be visually recognized when the packaging material is formed using the sheet material. It can be expected that some effect can be achieved. However, the present inventor has found that even when a conventional sheet material is used, the yield of a packaging material that achieves both good adhesion and slippage between the sheet materials and sufficient transparency is not sufficiently improved. . The inventor of the present invention has conducted intensive studies on forming a packaging material using a conventional sheet material, and has found the following problems.

In the case of a conventional sheet material, when manufacturing a packaging material, the surface state of the sheet material may be slightly changed. The present inventor has found that a subtle change in the surface state of a conventional sheet material affects the productivity and quality of the packaging material. Accordingly, the present inventors have conducted intensive studies to suppress the occurrence of subtle changes in the surface state of the sheet material, and as a result, in order to improve the productivity and quality of the packaging material, prevent the sheet materials from sticking together. It was found that it was important to improve the performance. As described above, the conventional sheet material has room for improvement in preventing mutual adhesion between the sheet materials.
In addition, the sheet material before processing is usually in a state of being wound up in a roll shape, that is, in a state of a raw sheet in most cases, and in order to manufacture a packaging material, a necessary amount of the raw material is required. It was necessary to unwind and use the sheet material.

  Then, this invention makes it a subject to provide the medical packaging sheet provided with the mutual adhesion prevention property, and to provide the medical packaging material formed using the said medical packaging sheet.

  The present inventor has conducted extensive studies to achieve the above object, and as a result, it was possible to control the value of the static friction coefficient of the surface having a layer containing a thermoplastic resin in the medical packaging sheet measured under specific conditions. The present inventors have obtained knowledge that is effective as a design guideline for improving the anti-cohesion property, and completed the present invention.

According to the present invention, a medical packaging sheet having a layer containing a thermoplastic resin on at least one surface,
The surface of the layer containing the thermoplastic resin of one medical packaging sheet is superimposed on the surface of the other medical packaging sheet opposite to the layer containing the thermoplastic resin, and the one medical packaging sheet is Friction of the surface of the one medical packaging sheet having the layer containing the thermoplastic resin when a friction test is performed according to JIS K 7125 using the medical packaging sheet and the other medical packaging sheet. A medical packaging sheet having a coefficient of 0.1 or more and 2.5 or less is provided.

  Further, according to the present invention, there is provided a medical packaging material formed from the medical packaging sheet.

  ADVANTAGE OF THE INVENTION According to this invention, while providing the medical packaging sheet provided with the adhesion prevention property, the medical packaging material formed using the said medical packaging sheet can be provided.

It is a figure for explaining the manufacturing method of the medical packaging sheet concerning this embodiment. It is a typical sectional view showing the layer structure of the medical packaging sheet concerning this embodiment. It is a figure which shows the infusion bag which has the packaging material which concerns on this embodiment.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same components are denoted by the same reference numerals, and description thereof will not be repeated.

<Medical packaging sheet>
The medical packaging sheet in the present embodiment has a layer containing a thermoplastic resin on at least one surface. This medical packaging sheet, the surface of the layer containing the thermoplastic resin of one medical packaging sheet, the other side of the layer containing the thermoplastic resin of the medical packaging sheet is overlapped with the surface on the opposite side, Using the one medical packaging sheet and the other medical packaging sheet, a layer containing a thermoplastic resin in the one medical packaging sheet was measured by performing a friction test according to JISK 7125. The surface has a coefficient of static friction 1 of 0.1 or more and 2.5 or less. By doing so, it is possible to realize a medical packaging sheet having sufficient anti-adhesion property so that the sheet materials can be prevented from adhering to each other during unwinding from the raw material. .

  The medical packaging sheet in the present embodiment described above is used to form a packaging material for contents for medical use. Here, the contents for medical use in the present embodiment include, for example, physiological saline, glucose solution, infusion preparation used as infusion at medical sites such as Ringer's solution, blood components used when transfusing blood at medical sites, and the like. Refers to liquids and, for example, medical instruments such as syringes, scalpels, and rubber stoppers.

  As described in the section of the background art, a medical packaging sheet has conventionally been required to have the following two performances. The first performance required for a medical packaging sheet is such transparency that the packaged contents can be visually recognized. The second performance required for the medical packaging sheet is such a strength that the packaging material formed using the medical packaging sheet is not damaged even if the contents are packaged. Specifically, in the present embodiment, the above strength refers to the adhesiveness of the medical packaging sheet forming the packaging material, that is, the sealing strength and the breaking strength of the material itself.

  However, the technical level required for medical packaging sheets has been increasingly higher in recent years. Therefore, the medical packaging sheet is required to have the following two performances in addition to the two performances described above. The third performance required for the medical packaging sheet is that impurities do not transfer from the inner surface of the packaging material formed using the medical packaging sheet to the contents contained in the packaging material, that is, low performance. Dissolvable. The fourth performance required for the medical packaging sheet is that the physical properties of the sheet do not change significantly before and after the sterilization treatment.

  In view of the technical level required for such a medical packaging sheet, the present inventor has found that there is room for improvement in the conventional medical packaging sheet in terms of the property of preventing the sheets from sticking together.

  The medical packaging sheet according to the present embodiment is controlled such that the static friction coefficient 1 of the surface having the layer containing the thermoplastic resin in the medical packaging sheet measured under the specific conditions as described above becomes a specific value. Things. By doing so, the slipperiness of the surface of the medical packaging sheet can be improved. Therefore, the medical packaging sheet according to the present embodiment can realize sufficient anti-adhesion property to the extent that the sheet materials can be prevented from adhering to each other during unwinding from the raw material. It becomes possible. In addition, the medical packaging sheet according to the present embodiment can, of course, satisfy the above four required performances.

  Regarding the medical packaging sheet according to the present embodiment, the surface of the layer containing the thermoplastic resin of one of the medical packaging sheets is the surface opposite to the layer containing the thermoplastic resin of the other medical packaging sheet. When the one medical wrapping sheet and the other medical wrapping sheet are superimposed and subjected to a friction test according to JIS K 7125 and measured, the thermoplasticity in the one medical wrapping sheet is measured. The coefficient of static friction 1 of the surface having the layer containing the resin is 0.1 or more and 2.5 or less, preferably 0.1 or more and 2 or less. By doing so, the mutual adhesion preventing property of the medical packaging sheet can be further improved. When processing the medical packaging sheet according to the present embodiment into a raw fabric, the surface of the layer containing the thermoplastic resin of the medical packaging sheet, the layer opposite to the layer containing the thermoplastic resin of the medical packaging sheet. It is wound so that the surface overlaps. Therefore, it is possible to control the value of the coefficient of static friction of the surface having the layer containing the thermoplastic resin in the medical packaging sheet measured under the specific conditions described above, and the sheet slidability with respect to the medical packaging sheet is improved. Can be provided.

  The medical packaging sheet in the present embodiment, the surface of the layer containing the thermoplastic resin of one medical packaging sheet is overlapped with the surface of the other medical packaging sheet opposite to the layer containing the thermoplastic resin. In addition, using the one medical packaging sheet and the other medical packaging sheet, a load of 1 kg is applied to the one medical packaging sheet and the other medical packaging sheet by 24. After a long time, when a friction test was performed according to JIS K 7125 and measured, the static friction coefficient 2 of the surface of the one medical packaging sheet having the layer containing the thermoplastic resin was 0.1 to 2.5. It is preferable that it is below, and it is more preferable that it is 0.1 or more and 2 or less. This makes it possible to further improve the anti-cohesion property of the surface of the layer containing the thermoplastic resin of the sheet.

  The medical packaging sheet in the present embodiment is obtained by superposing the surface of the thermoplastic resin layer of another medical packaging sheet on the surface of the thermoplastic resin layer of one medical packaging sheet, When the one medical packaging sheet and the other medical packaging sheet are subjected to a friction test in accordance with JIS K 7125 and measured, the one medical packaging sheet has a layer containing a thermoplastic resin. The static friction coefficient 3 of the surface is preferably 0.1 or more and 2.0 or less, more preferably 0.1 or more and 1.8 or less, and even more preferably 0.1 or more and 1.6 or less. This makes it possible to further improve the anti-cohesion property of the surface of the layer containing the thermoplastic resin of the sheet.

  It is preferable that a plurality of irregularities are formed on the surface of the layer containing the thermoplastic resin of the medical packaging sheet in the present embodiment. Hereinafter, a medical packaging sheet in which a plurality of irregularities are formed on the surface of a layer containing a thermoplastic resin will be described as an example.

In the medical packaging sheet according to the present embodiment, when the thickness of the medical packaging sheet is T, the arithmetic mean roughness (Ra) of the surface on which the irregularities are formed per unit sheet thickness, Ra / T is not less than 4 × 10 ^{−4 and not} more than 2 × 10 ⁻² , and the value of the average unevenness interval (Rsm) of the surface on which the unevenness is formed per unit sheet thickness, Rsm / T, is 0. It is preferable that it is 4 or more and 4.5 or less. As for the value of Ra / T and the value of Rsm / T, the value of Ra / T is 6.6 × 10 ⁻⁴ or more and 1.3 × 10 ⁻³ or less, and the value of Rsm / T is More preferably, it is 0.6 or more and 2.7 or less. By doing so, it is possible to improve the mutual adhesion preventing property of the medical packaging sheet.

  Here, the arithmetic average roughness (Ra) generally means, when a mean line is drawn on a roughness curve formed on a cross section of a measurement object, for a plurality of irregularities formed on the surface. Mean the value of the height of the convex portion and the concave portion in μm. Note that the average line is defined as S1 when the sum of the areas of the convex portions located above the average line is S1 and the sum of the areas of the concave portions located below the average line is S2. = S2 is a line drawn on the roughness curve. Based on the above-described definition of the arithmetic average roughness (Ra), the scale of Ra / T in the present embodiment is used for a plurality of irregularities formed on the surface of the medical packaging sheet from the top of the concave to the convex. Is an index indicating how much the height up to the top of the sheet occupies the sheet thickness. The arithmetic average roughness (Ra) can be measured according to JIS-B0601 (1994).

  The average roughness interval (Rsm) generally indicates an average value of the roughness period in a roughness curve formed on a cross section of the measurement object. Based on the definition of the average concavo-convex interval (Rsm) described above, the scale of Rsm / T in the present embodiment relates to the thickness of the sheet and the plurality of concavities and convexities formed on the surface of the medical packaging sheet. It is an index indicating the balance with the formation interval of the irregularities in the in-plane direction of the sheet. In addition, the unevenness average interval (Rsm) can be measured according to JIS-B0601 (1994).

  In view of the above, the plurality of irregularities formed on the surface of the medical packaging sheet according to the present embodiment have Ra / T values and Rsm / T values of the specific values, respectively, as described above. In the case where the sheet material is controlled so that the sheet material does not adhere to the surface of the sheet when the sheet material is unwound, sufficient anti-adhesion property can be suppressed. Unevenness can be formed in an exquisite state to such an extent that can be imparted.

  The thickness T of the medical packaging sheet is preferably 100 μm or more, and more preferably 150 μm or more, from the viewpoint of improving the strength of the sheet forming the packaging material.

  The thickness T of the medical packaging sheet is preferably 350 μm or less, and more preferably 300 μm or less, from the viewpoint of improving the visibility of the contents when the packaging material is formed using the sheet.

  The arithmetic average roughness (Ra) of the surface of the medical packaging sheet on which the irregularities are formed is preferably from 0.15 μm to 2 μm, and more preferably from the viewpoint of improving the cohesion prevention of the sheet. , 0.2 μm or more and 1 μm or less.

  The average spacing (Rsm) of the irregularities on the surface of the medical packaging sheet where the irregularities are formed is preferably 150 μm or more and 450 μm or less, more preferably 200 μm or more, from the viewpoint of improving the cohesion prevention of the sheet. It is 400 μm or less.

  The irregularities formed on the medical packaging sheet may be formed on both sides of the sheet, but are preferably formed only on one side of the sheet from the viewpoint of satisfying the above four required characteristics. When the irregularities are formed only on one side of the sheet, the irregularities are arranged on the side in contact with the contents in the packaging material formed using the sheet from the viewpoint of satisfying the above four required characteristics. Is more desirable.

  The concavo-convex shape is not limited as long as the value of Ra / T and the value of Rsm / T satisfy the specific conditions described above. This concavo-convex shape may be a rectangular, diamond-shaped, triangular, wavy, elliptical, circular, trapezoidal or other cross-sectional structure, or may be a pyramid, a cone, or any other geometrical shape. Even if it is, various picture patterns, such as a leather crest, satin, cloth, synthetic leather-like longing pattern, and striped pattern, may be used.

In the medical packaging sheet according to the present embodiment, when the thickness of the medical packaging sheet is T, the value of the maximum protrusion height (Rp) of the surface on which the unevenness is formed per unit sheet thickness, that is, , Rp / T is preferably 1.1 × 10 ⁻³ or more and 2 × 10 ⁻² or less, more preferably 1.6 × 10 ⁻³ or more and 1 × 10 ⁻² or less. By doing so, a good raw material can be produced using the sheet, and a packaging material having an excellent balance between transparency and seal strength can be produced using the sheet, and the sheet The anti-cohesion property can be improved. The maximum projection height (Rp) can be measured according to JIS-B0601 (1994).

  Here, the maximum projection height (Rp) is generally defined as an average line obtained by drawing an average line on a roughness curve formed on a cross section of a measurement object for a plurality of irregularities formed on the surface. It refers to a value indicating the maximum height of the convex portion located above. Note that the average line is defined as S1 when the sum of the areas of the convex portions located above the average line is S1 and the sum of the areas of the concave portions located below the average line is S2. = S2 is a line drawn on the roughness curve. Based on the definition of the maximum protrusion height (Rp) described above, when the value of Rp / T is controlled for a plurality of irregularities formed on the surface of the medical packaging sheet according to the present embodiment, Variations in the degree of unevenness with respect to the sheet thickness can be suppressed. Therefore, when the value of Rp / T is controlled so as to satisfy the specific condition in the medical packaging sheet according to the present embodiment, the cohesion prevention of the sheet can be further improved.

  The maximum protrusion height (Rp) of the surface of the medical packaging sheet where the irregularities are formed is preferably 0.4 μm or more and 2 μm or less, and more preferably from the viewpoint of improving the cohesion prevention of the sheet. , 0.5 μm or more and 1.5 μm or less.

  Further, the medical packaging sheet according to the present embodiment may have a single-layer structure or a multi-layer structure as long as unevenness is formed on one surface. From the viewpoint of improving the slipperiness, it is preferable to form a multilayer structure in which the outer layer formulation can be changed.

  Hereinafter, with respect to the material components forming the medical packaging sheet according to the present embodiment, the sheet has an uneven layer having a surface on which the unevenness is formed, and an uneven layer on the surface opposite to the surface on which the unevenness is formed. A description will be given by taking as an example a case of a two-layer structure including a non-concavo-convex layer having a surface on which no irregularities are formed.

  It is preferable that the material forming the surface of the concavo-convex layer does not substantially contain an additive from the viewpoint of enhancing the low elution property of the packaging material formed using the medical packaging sheet according to the present embodiment. In addition, as the additives according to the present embodiment, for example, lubricating agents such as erucamide, higher fatty acid amide, higher fatty acid esters, silica, diatomaceous earth, calcium carbonate, anti-blocking agents such as talc, crosslinking agents, antioxidants, Examples include ultraviolet absorbers, light stabilizers, fillers, antistatic agents such as glycerin esters of fatty acids having 8 to 22 carbon atoms, sorbitan acid esters and polyethylene glycol esters, dyes and coloring agents. When additives are included, they may be included in a range that is compatible with the dissolution test and the incineration test, which are tests on plastic drug containers made by the Japanese Pharmacopoeia.

  The material for forming the surface of the non-concavo-convex layer suppresses the adhesion of impurities from the surface of the non-concavo-convex layer to the surface of the concavo-convex layer when unwound from the raw fabric, and the medical packaging according to the present embodiment From the viewpoint of enhancing the low dissolution property of the packaging material formed using the sheet, it is preferable that the above-mentioned additive is not contained.

  Further, in the medical packaging sheet according to the present embodiment, the thermoplastic resin forming at least one surface is a linear low-density polyethylene from the viewpoint of improving the above-mentioned four properties required for the medical packaging sheet. It is preferable to include a resin. The material forming the surface of the uneven layer and the material forming the surface of the non-uneven layer are both straight-chain low-molecular materials from the viewpoint of improving the four properties required for the medical packaging sheet described above. It is preferable to include a density polyethylene resin.

  From the viewpoint of increasing the sheet strength at the time of heat sealing of the medical packaging sheet according to the present embodiment and improving the slipperiness of the sheet, the surface of the uneven layer is preferably a linear low-density polyethylene resin, a medium-density polyethylene, or a high-density polyethylene. High density polyethylene, ethylene-α olefin polymer polymerized using a metallocene catalyst, polypropylene, ethylene-vinyl acetate copolymer, ionomer resin, ethylene-acrylic acid copolymer, ethylene-methyl acrylate copolymer, ethylene- Polyacrylic resin such as methacrylic acid copolymer, ethylene-methyl methacrylate copolymer, ethylene-propylene copolymer, methylpentene polymer, polybutene polymer, polyethylene or polypropylene is converted to acrylic acid, methacrylic acid, maleic acid, and maleic anhydride. , Fumaric acid, itacone Acid-modified polyolefin resin modified with an unsaturated carboxylic acid and the like, polyvinyl acetate resins, poly (meth) that is formed of a material containing a polyolefin resin such as acrylic resin.

  The surface of the non-concavo-convex layer is polymerized using a linear low-density polyethylene resin, a medium-density polyethylene, a high-density polyethylene, and a metallocene catalyst from the viewpoint of improving the sheet slipperiness of the medical packaging sheet according to the present embodiment. Ethylene-α olefin polymer, polypropylene, ethylene-vinyl acetate copolymer, ionomer resin, ethylene-acrylic acid copolymer, ethylene-methyl acrylate copolymer, ethylene-methacrylic acid copolymer, ethylene-methacrylic acid Polyolefin resins such as methyl copolymers, ethylene-propylene copolymers, methylpentene polymers, polybutene polymers, polyethylene or polypropylene are converted to unsaturated acids such as acrylic acid, methacrylic acid, maleic acid, maleic anhydride, fumaric acid, itaconic acid, etc. Acid modification modified with carboxylic acid Li olefin resins, polyvinyl acetate resins, poly (meth) material or polyamide comprises a polyolefin-based resin such as an acrylic resin, to be formed by a polyester resin preferred.

  In addition, the surface of the uneven layer and the surface of the non-uneven layer may be formed using the same material with the same composition, but from the viewpoint of improving the slipperiness of the sheet, are formed with at least different materials. Is desirable.

<Method of manufacturing medical packaging sheet>
The manufacturing method of the medical packaging sheet in the present embodiment is different from the conventional manufacturing method, and it is necessary to control the manufacturing conditions of at least the layer containing the thermoplastic resin at a high level. That is, for the first time by a manufacturing method that highly controls various factors according to the following two conditions, the value of the static friction coefficient of the surface having the layer containing the thermoplastic resin in the medical packaging sheet measured under specific conditions is as described above. A medical packaging sheet having a specific numerical value can be obtained.
(1) Selection of resin material for forming layer containing thermoplastic resin (2) Method for forming layer containing thermoplastic resin

Hereinafter, an example of the method for manufacturing the medical packaging sheet according to the present embodiment will be described. However, the method for manufacturing the medical packaging sheet of the present embodiment is not limited to the following example. An example of the method for manufacturing the medical packaging sheet according to the present embodiment will be specifically described later in Examples.

(1) Selection of Resin Material for Forming Layer Containing Thermoplastic Resin In order to realize the medical packaging sheet having the anti-adhesion property according to the present embodiment, an appropriate material is selected in accordance with the conditions for forming unevenness described later. It is necessary to select a resin material. Specifically, in order to realize the medical packaging sheet according to the present embodiment, for the resin material forming the layer containing the thermoplastic resin, the conditions for forming the layer containing the thermoplastic resin described in (2) below. Therefore, it is necessary to appropriately combine various factors such as the type of the resin, the composition, the density, and the cured state.

Next, (2) a method for forming a layer containing a thermoplastic resin will be described.
In order to obtain the medical packaging sheet in the present embodiment, it is necessary to employ conditions suitable for the resin material forming the layer containing the thermoplastic resin described in the above (1). Specifically, the embossing roll cooling conditions when embossing the sheet, it is particularly highly controlled and combined with various factors such as the uneven shape formed on the embossing roll surface used when embossing is performed. It becomes important. As a method of manufacturing the medical packaging sheet according to the present embodiment, as long as the above-mentioned factors can be controlled and combined at a high level, the film can be formed by the inflation method or by the T-die method. However, it is preferable to adopt a method of forming a film by the T-die method from the viewpoint of excellent sheet productivity, sheet thickness control, and surface shape control.

  Hereinafter, an example of the method for manufacturing the medical packaging sheet according to the present embodiment will be described. However, the method for manufacturing the medical packaging sheet of the present embodiment is not limited to the following example.

  The method for manufacturing a medical packaging sheet described below is a method for manufacturing a packaging sheet 30 (FIG. 2) used to form a packaging material 11 (FIG. 3) for packaging contents 20 for medical use.

As shown in FIG. 1, this manufacturing method includes a step of forming a packaging sheet 30 having a plurality of layers or a single layer using a T-die 40, and a cooling roll which is a roll that is engaged with the packaging sheet 30 at the most upstream position. 50, and cooling the packaging sheet 30.
The material constituting the layer (the inner layer 31) including the one surface 30a of the packaging sheet 30 does not substantially include an additive.
Irregularities are formed on the surface of the cooling roll 50.
In the step of cooling the packaging sheet 30, the layer (the inner layer 31) including the one surface 30 a of the packaging sheet 30 is subjected to embossing by the cooling roll 50.
By performing unevenness processing on the layer (the inner layer 31) including the one surface 30a of the packaging sheet 30, the surface of the layer can have good slipperiness.

  The packaging sheet 30 is a medical packaging sheet used to form a packaging material for packaging the contents 20 for medical use. The wrapping material wraps the contents 20 in a state of being in direct contact with the contents 20.

  As shown in FIGS. 2 and 3, the packaging sheet 30 can have, for example, a two-layer structure including an inner layer 31 and an outer layer 32.

The packaging material 11 has a housing portion for housing the contents 20 by partially bonding the inner layers 31 by heat sealing to form a seal portion 11a such that the inner layer 31 is on the inner side and the outer layer 32 is on the outer side. 12 are processed.
The packaging material 11 is provided with a conduit 14 for discharging the contents 20 from the storage section 12 and a stopper 15 for opening and closing the tip of the conduit 14 as necessary.
Further, a hanging hole 13 for hanging the packaging material 11 and eventually the infusion bag 10 is formed in the seal portion 11a as necessary.

  The manufacturing apparatus 100 shown in FIG. 1 includes a T-die 40, a cooling roll 50, a take-up roll 110 that takes up a raw roll 90, and a package roll 30 between the cooling roll 50 and the take-up roll 110. And a plurality of rolls 60, 70, and 80 to be combined.

The T-die 40 has a first inlet 41a into which the material forming the outer layer 32 is introduced and a second inlet 41b into which the material forming the inner layer 31 is introduced.
The manufacturing apparatus 100 includes a first extruder (not shown) for melting and kneading the material constituting the outer layer 32 and extruding the same, and a second extruder for melting and kneading and kneading the material constituting the inner layer 31 (not shown). ). The material extruded from the first extruder is introduced into the first inlet 41a, and the material extruded from the second extruder is introduced into the second inlet 41b.
The T-die 40 further has a first flow path 42a communicating with the first introduction port 41a and a second flow path 42b communicating with the second introduction port 41b.
The first flow path 42a allows the material forming the outer layer 32 to flow downstream while spreading in a sheet shape (film shape). The second flow path 42b allows the material constituting the inner layer 31 to flow downstream while spreading in a sheet shape (film shape).
Further, a joining channel 43 is formed in the T-die 40. The downstream end of the first flow passage 42a and the downstream end of the second flow passage 42b are connected to the upstream end of the joining flow passage 43.
The first flow path 42a and the second flow path 42b merge into one merge flow path 43, so that the material forming the outer layer 32 expanded by the first flow path 42a and the material forming the outer layer 32 are expanded by the second flow path 42b. The material constituting the inner layer 31 is laminated on each other.
The merging flow path 43 is formed by laminating the material forming the outer layer 32 expanded by the first flow path 42a and the material forming the inner layer 31 expanded by the second flow path 42b on the downstream side. To flow.
The downstream end of the joining channel 43 is a discharge port 44 for discharging the packaging sheet 30 to the outside of the die 40.
From the discharge port 44, the packaging sheet 30 formed by laminating the outer layer 32 and the inner layer 31 with each other is discharged.
In addition, this drawing illustrates a two-layer multi-manifold die as an example. However, a die that is laminated in two or more layers is used, and the same resin is flowed from a plurality of extruders to form two layers. Is also good. Further, three or more layers may be formed by using three or more different resins. Further, a method of forming a multilayer sheet using a feed block may be used.

The cooling roll 50 is a roll that engages with the packaging sheet 30 discharged from the T die 40 at the uppermost stream (engages first) and cools the packaging sheet 30.
The surface of the inner layer 31 is engaged with the cooling roll 50.
Irregularities are formed on the surface of the cooling roll 50. Therefore, when the cooling sheet 50 is cooled by the cooling roll 50, the unevenness on the surface of the cooling roll 50 is transferred to the surface of the inner layer 31, so that the unevenness is formed on the surface of the inner layer 31.

The packaging sheet 30 that has been cooled by the cooling rolls 50 and has irregularities on its surface is thereafter sequentially engaged with the plurality of rolls 60, 70, and 80, and then wound up by the winding roll 110.
By winding the wrapping sheet 30 around the winding roll 110, a raw roll 90 obtained by winding the raw material of the wrapping sheet into a roll is obtained.

Here, the temperature of the cooling roll 50 is, for example, a temperature lower than the melting temperature of the material constituting the inner layer 31 (the layer including the one surface 30a of the packaging sheet 30) by 150 ° C. or more (the melting temperature −150 ° C. or less). It is more preferable to set the temperature to 180 ° C. or lower than the melting temperature (the melting temperature −180 ° C. or lower).
By doing so, it is possible to sufficiently cool the packaging sheet 30 and to form irregularities having a desired shape, and to perform the packaging sheet for the cooling roll 50 and the subsequent rolls 60, 70, and 80. 30 can be suppressed. In addition, it is possible to suppress blocking when the wound packaging sheet 30 is fed out.
In addition, by setting the temperature of the cooling roll 50 sufficiently low in this way, even if the packaging sheet 30 is subjected to unevenness processing (embossing), the transparency of the packaging sheet 30 can be secured.

  Here, preferably, the portion of the packaging sheet 30 that is engaged with the cooling roll 50 is not a roll that sandwiches the packaging sheet 30 together with the cooling roll 50 but is urged against the cooling roll 50 by an air knife. . In this way, by energizing the packaging sheet 30 against the cooling roll 50 with air, it is possible to suppress the surface roughness of the packaging sheet 30 from becoming too large, and to improve the transparency of the packaging sheet 30. In addition, the packaging sheet 30 can be subjected to the required unevenness of surface roughness.

  The temperature of the cooling roll 50 is preferably 15 ° C. or higher, more preferably 20 ° C. or higher. By doing so, the packaging sheet 30 can be stably engaged with the cooling roll 50 at the time of film formation, and the packaging sheet 30 can be formed stably. Can be suppressed.

<Medical packaging materials>
The medical packaging material according to the present embodiment is formed from the medical packaging sheet. By doing so, it is possible to realize a medical packaging material that satisfies the above-mentioned four technical levels and has good yield and good quality.

  As shown in FIG. 3, the medical packaging material according to the present embodiment can be used, for example, as an infusion bag. Specifically, FIG. 3 shows a case where a medical liquid (physiological saline, glucose solution, Ringer's solution, or the like) as a content 20 is placed on a packaging material 11 manufactured using a packaging sheet 30 that is a medical packaging sheet. 1 shows an infusion bag 10 containing an infusion preparation to be used as an infusion at a site and a liquid such as a blood component used when transfusing blood at a medical site.

  Although the embodiments of the present invention have been described above, these are merely examples of the present invention, and various configurations other than the above can be adopted.

  Hereinafter, the present invention will be described with reference to Examples and Comparative Examples, but the present invention is not limited thereto.

<Example 1>
Using a linear low density polyethylene resin (LLDPE) (125FN, manufactured by Ube Maruzen Polyethylene Co., Ltd.), a single-layer sheet having a thickness of 250 μm was formed by an extrusion T-die method. The obtained single-layer sheet was processed by a winding device so as to be in the state of an original sheet. In the extrusion T-die method described above, a cooling roll replaced with a single-sided embossed cooling roll was used as an extrusion T-die apparatus. The single-sided embossing cooling roll was used by controlling the temperature to 30 ° C. with cooling water at the time of film formation.

<Example 2>
The linear low-density polyethylene resin (LLDPE) used in Example 1 was used as an inner layer, and a blend layer of the above-mentioned linear low-density polyethylene resin and a low-density polyethylene resin (F222NH, manufactured by Ube Maruzen Polyethylene Co., Ltd.) was formed on the outer layer. A sheet was produced in the same manner as in Example 1 except that the sheets were laminated.

<Comparative Example 1>
A sheet was produced in the same manner as in Example 1, except that the cooling roll in the extrusion T-die apparatus was changed to a mirror roll.

<Comparative Example 2>
A sheet was produced in the same manner as in Example 1, except that the sheet was formed by an inflation method instead of the extrusion T-die method.

  The following evaluations were performed using the medical packaging sheets obtained in Examples and Comparative Examples. Table 1 shows the results.

<Evaluation>
-Static friction coefficient 1: The surface of the layer containing the thermoplastic resin of one medical packaging sheet is superimposed on the surface of the other medical packaging sheet opposite to the surface having the layer containing the thermoplastic resin, and Using one medical packaging sheet and the other medical packaging sheet, a static friction coefficient of a surface having a layer containing a thermoplastic resin in the one medical packaging sheet is measured by performing a friction test according to JIS K7125. did.

-Static friction coefficient 2: the surface of the layer containing the thermoplastic resin of one medical packaging sheet is overlapped with the surface of the other medical packaging sheet opposite to the surface having the layer containing the thermoplastic resin, and Using one medical packaging sheet and the other medical packaging sheet, the coefficient of static friction of the surface of the one medical packaging sheet having a layer containing a thermoplastic resin is determined by comparing the one medical packaging sheet with the other medical packaging sheet. After applying a load of 1 kg to the medical packaging sheet for 24 hours, a friction test was performed in accordance with JIS K7125 and measured.

-Static friction coefficient 3: the surface of the layer containing the thermoplastic resin of one medical packaging sheet is superimposed on the surface of the layer containing the thermoplastic resin of one medical packaging sheet, and Using the other medical packaging sheet, the coefficient of static friction of the surface of the one medical packaging sheet having the layer containing the thermoplastic resin was measured by performing a friction test according to JIS K7125.

Arithmetic average roughness (Ra): The surface of the concavo-convex layer of the sheet was measured for the center n = 3 using “Handysurf E-35B manufactured by Tokyo Seimitsu Co., Ltd.” according to JIS B0601 (1994). The unit was μm.

Average roughness interval (Rsm): The surface of the uneven layer of the sheet was measured for the center n = 3 using "Handysurf E-35B manufactured by Tokyo Seimitsu Co., Ltd." according to JIS B0601 (1994). The unit was μm.

-Maximum protrusion height (Rp): The surface of the uneven layer of the sheet was measured at the center n = 3 using "Handysurf E-35B manufactured by Tokyo Seimitsu Co., Ltd." in accordance with JIS B0601 (1994). The unit was μm.

-Film slipperiness: the one medical packaging sheet in which the surface of the one medical packaging sheet on which the unevenness is formed is overlapped with the surface of the other medical packaging sheet opposite to the surface on which the unevenness is formed. Using the above and the other medical packaging sheet, the static friction coefficient of the one medical packaging sheet having the unevenness was measured by performing a friction test according to JISK 7125. Based on the obtained measurement results, the medical packaging sheets obtained in Examples and Comparative Examples were evaluated according to the following evaluation criteria. If no irregularities are formed on the surface of the medical packaging sheet, the surface of the other medical packaging sheet opposite to the one surface is overlapped on one surface of one medical packaging sheet. In addition, perform a friction test.
◎: Static friction coefficient value of 0.1 or more and 1.3 or less ○: Static friction coefficient value of more than 1.3 and 2.0 or less X: Static friction coefficient value of more than 2.0

-Sealing property: the one medical packaging sheet and the other medical packaging in which the uneven surface of another medical packaging sheet is superimposed on the surface of one medical packaging sheet where the irregularities are formed A load of 0.3 MPa was applied to the sheet at 200 ° C. for 3 seconds using a hot plate descent type sealing machine to produce a seal sample. Next, the obtained seal sample was cut into a strip having a width of 15 mm to prepare a test piece. The test piece was peeled off at a speed of 100 mm / min using a tensile / compression testing machine (manufactured by A & D Corporation), and the maximum load was measured. The unit was N / 15 mm.

-Impact resistance: The tensile impact strength of the obtained medical packaging sheet was measured in accordance with JIS K7160 (Method A). The unit was kJ / m ² .

-External haze: About the medical packaging sheet, the haze value was measured using the haze meter (made by Nippon Denshoku Industries Co., Ltd., NDH-2000). The measurement of the haze value was carried out from the side of the medical packaging sheet opposite to the side on which the irregularities were formed. The unit is%.

Internal haze: A transparent tape was applied to both sides of the medical packaging sheet to prepare a sheet sample in a state where the influence of irregularities formed on the surface of the sheet was eliminated. The haze value of the obtained sheet sample was measured using a haze meter (NDH-2000, manufactured by Nippon Denshoku Industries Co., Ltd.). The unit is%.

  The sheets of Examples 1 and 2 were all excellent in anti-adhesion properties, whereas the sheets of Comparative Examples 1 and 2 were insufficient in terms of anti-adhesion properties. .

DESCRIPTION OF SYMBOLS 10 Infusion bag 11 Packaging material 11a Seal part 12 Storage part 13 Hanging hole 14 Conduit 15 Plug 20 Content liquid (content)
30 Packaging sheet 30a One surface 31 Inner layer 32 Outer layer 40 T die 41a First inlet 41b Second inlet 42a First flow path 42b Second flow path 43 Merging flow path 44 Discharge port 50 Cooling roll 60 Roll 70 Roll 80 Roll 90 material roll 100 manufacturing device 110 take-up roll

According to the present invention, on at least one surface, a medical package sheet having an uneven layer having a surface of thermoplastic resin unrealized irregularities are formed,
The thickness of the medical packaging sheet is 100 μm or more and 350 μm or less,
The surface of the layer containing the thermoplastic resin of one medical packaging sheet is superimposed on the surface of the other medical packaging sheet opposite to the layer containing the thermoplastic resin, and the one medical packaging sheet is Using the packaging sheet for the other and the other medical packaging sheet, when measured by performing a friction test according to JISK 7125, a surface having a layer containing the thermoplastic resin in the one medical packaging sheet , static friction coefficient between the surface opposite to the layer containing the thermoplastic resin of said other of the medical packaging sheet state, and are 0.1 to 2.5,
Assuming that the thickness of the medical packaging sheet is T, the value of the arithmetic average roughness (Ra), Ra / T, of the surface on which the irregularities are formed per unit sheet thickness is 4 × 10 ⁻⁴ or more 2 × is ^{10 -2,} and the value of the average irregularity interval of the surface irregularities per unit thickness of the sheet is formed (Rsm), Rsm / T is 0.4 to 4.5, for medical A packaging sheet is provided.

Although the embodiments of the present invention have been described above, these are merely examples of the present invention, and various configurations other than the above can be adopted.
Hereinafter, examples of the reference embodiment will be additionally described.
1. At least one surface, a medical packaging sheet having a layer containing a thermoplastic resin,
The surface of the layer containing the thermoplastic resin of one medical packaging sheet is superimposed on the surface of the other medical packaging sheet opposite to the layer containing the thermoplastic resin, and the one medical packaging sheet is Friction between the surface of the one medical packaging sheet having the layer containing the thermoplastic resin when a friction test is performed according to JIS K 7125 using the medical packaging sheet and the other medical packaging sheet. A medical packaging sheet having a coefficient of 0.1 or more and 2.5 or less.
2. The surface of the layer containing the thermoplastic resin of one medical packaging sheet is superimposed on the surface of the other medical packaging sheet opposite to the layer containing the thermoplastic resin, and the one medical packaging sheet is After applying a load of 1.0 kg to the one medical packaging sheet and the other medical packaging sheet for 24 hours using the medical packaging sheet and the other medical packaging sheet, JISK The coefficient of static friction of the surface of the one medical packaging sheet having the layer containing the thermoplastic resin is from 0.1 to 2.5 when measured by performing a friction test according to 7125. The medical packaging sheet according to 1.
3. On the surface of the layer containing the thermoplastic resin of one of the medical packaging sheets, the surface of the layer containing the thermoplastic resin of the other medical packaging sheet is overlapped, and the one medical packaging sheet and Using the other medical packaging sheet and performing a friction test according to JIS K 7125 and measuring, the static friction coefficient of the surface of the one medical packaging sheet having the layer containing the thermoplastic resin is 0. Is not less than 1 and not more than 2; Or 2. The medical packaging sheet according to 1.
4. 1. has a multilayer structure; To 3. The medical packaging sheet according to any one of the above.
5. The thermoplastic resin includes a linear low-density polyethylene resin. To 4. The medical packaging sheet according to any one of the above.
6. Used to form packaging materials for medical applications. To 5. The medical packaging sheet according to any one of the above.
7. 1. To 6. A medical packaging material formed from the medical packaging sheet according to any one of the above.
8. 6. the content is a liquid; 4. The medical packaging material according to 1.

Claims (8)

At least one surface, a medical packaging sheet having a layer containing a thermoplastic resin,
The surface of the layer containing the thermoplastic resin of one medical packaging sheet is superimposed on the surface of the other medical packaging sheet opposite to the layer containing the thermoplastic resin, and the one medical packaging sheet is Friction between the surface of the one medical packaging sheet having the layer containing the thermoplastic resin when a friction test is performed according to JIS K 7125 using the medical packaging sheet and the other medical packaging sheet. A medical packaging sheet having a coefficient of 0.1 or more and 2.5 or less.   The surface of the layer containing the thermoplastic resin of one medical packaging sheet is superimposed on the surface of the other medical packaging sheet opposite to the layer containing the thermoplastic resin, and the one medical packaging sheet is After applying a load of 1.0 kg to the one medical packaging sheet and the other medical packaging sheet for 24 hours using the medical packaging sheet and the other medical packaging sheet, JISK 2. The static friction coefficient of the surface of the one medical packaging sheet having the layer containing the thermoplastic resin, when measured by performing a friction test according to 7125, is 0.1 to 2.5. The medical packaging sheet according to 1.   On the surface of the layer containing the thermoplastic resin of one of the medical packaging sheets, the surface of the layer containing the thermoplastic resin of the other medical packaging sheet is overlapped, and the one medical packaging sheet and Using the other medical packaging sheet and performing a friction test according to JIS K 7125 and measuring, the static friction coefficient of the surface of the one medical packaging sheet having the layer containing the thermoplastic resin is 0. 3. The medical packaging sheet according to claim 1, wherein the number is 1 or more and 2 or less.   The medical packaging sheet according to any one of claims 1 to 3, which has a multilayer structure.   The medical packaging sheet according to any one of claims 1 to 4, wherein the thermoplastic resin includes a linear low-density polyethylene resin.   The medical packaging sheet according to any one of claims 1 to 5, which is used to form a packaging material for contents for medical use.   A medical packaging material formed from the medical packaging sheet according to any one of claims 1 to 6.   The medical packaging material according to claim 7, wherein the content is a liquid.

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