JP2016182307A - Medical multi-chamber container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical multi-chamber container which does not cause interlayer separation between an intermediate layer and an inner layer in a heat seal part even when high-temperature high pressure steam sterilization using an overkill method is performed.SOLUTION: A medical multi-chamber container is composed of thermoplastic olefin-based resin sheets 11, 12 and has an inner surface layer 13, an outer surface layer 14, and an intermediate layer 15. The inner surface layer is formed by thermoplastic propylene-based resin composition composed of propylene resin and ethylene-α-olefin copolymer, the outer surface layer is formed by an ethylenic polymer, and the intermediate layer is formed by an ethylenic polymer lower in bending modulus of elasticity than the inner surface layer and the outer surface layer forming materials. The container has an inner surface layer fusion part composed of two inner surface layers facing a peripheral edge part. A proportion of thickness of the inner surface layer in the inner surface layer fusion part and thickness of the intermediate layer in the respective sheets is 1:14 to 2:1.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a medical multi-chamber container made of a thermoplastic resin.

Glass containers, plastic bags, and the like are used as containers for chemicals to be injected into the body such as infusions. The glass bottle has a problem that it is heavy and easily broken due to impact or dropping during transportation. At present, plastic containers made of materials such as polyethylene and polypropylene have been used as medical containers.
A medical container using a medical plastic container is formed into a sheet shape or a tube shape by a T-die method or an inflation method, and then a bag-shaped container body is formed by heat fusion or the like, and a chemical solution is filled from an opening. The opening is hermetically sealed and sterilized by high-pressure steam sterilization or the like.

  Polyethylene is inferior in heat resistance, and high-pressure steam sterilization at 120 ° C. is difficult, so it must be sterilized at a low temperature. Polypropylene is superior to other materials in that steam sterilization at 120 ° C. is possible, but it is inferior in impact resistance at low temperatures, and in particular, the seal part formed by heat fusion is largely peeled off. There was a problem that it was likely to occur when subjected to an impact. Furthermore, the conventional polyethylene-based bag material has a problem of low transparency and poor visibility.

  In medical containers, flexibility is required to improve drainage, transparency to confirm the contents, and impact resistance at low temperatures to prevent destruction during use and transportation. is necessary. Furthermore, the molding stability when molding the container sheet is also a necessary matter. In view of such problems, a polypropylene resin composition containing a styrenic thermoplastic elastomer having high flexibility and impact resistance and excellent transparency has been proposed.

  In addition, as a medical infusion container, a medical multi-chamber container divided into two chambers by a detachable partition formed by a weak seal portion has come to be used. In order to prevent administration of the drug solution stored in the container in an unmixed state, for example, as shown in Japanese Patent Application Laid-Open No. 9-327498 (Patent Document 1), it is for communication inhibition that separates a drug discharge port and a compartment storing a drug. The applicant of the present application has proposed a multi-chamber container having a weak seal portion.

Moreover, as a medical infusion container, what was formed of multilayer sheets, such as Unexamined-Japanese-Patent No. 2013-81494 (patent document 2) and Unexamined-Japanese-Patent No. 2012-143629 (patent document 3), is proposed.
In recent years, an overkill method, which is performed at a sterilization temperature of 121 ° C., has been recommended as an autoclave sterilization method.

JP-A-9-327498 JP2013-81494A JP2012-143629

Although the medical multi-chamber container of Patent Documents 2 and 3 seems to be useful as a medical container, the present inventor has intensively studied, and as a high-pressure steam sterilization method performed at a sterilization temperature of 120 ° C. From the heat history, it has been found that in the peripheral heat seal portion, the heat seal is strengthened, but delamination between the intermediate layer and the inner surface layer or in-layer breakage in the intermediate layer may occur. Due to such peeling, since the impact resistance of the peeled portion is lowered, it may cause a bag breakage when an external force is applied such as dropping or pressing during use, and there is a possibility that the stored chemical solution may leak.
The object of the present invention is to use a sheet made of a thermoplastic olefin resin having a three-layer structure, having transparency, flexibility, good low temperature impact resistance, heat seal properties, and using an overkill method. Even for high-temperature and high-pressure steam sterilization, there is very little leakage of stored chemicals due to delamination between the inner layer and inner surface of the heat-sealed part, inner layer breakage in the intermediate layer, and resulting bag breakage. A multi-chamber container is provided.

What achieves the above object is as follows.
(1) A container body having a medicine chamber formed by heat-sealing a sheet formed of a thermoplastic resin composition, and a discharge port heat-sealed to the container body so as to communicate with a lower end portion of the medicine chamber And the medicine chamber is divided into a first medicine chamber and a second medicine chamber by a detachable partition, and the discharge port is formed in the container body. A medical multi-chamber container fixed to communicate with the lower end of the drug room,
The sheet is a multilayer structure sheet made of a thermoplastic olefin resin including an inner surface layer, an outer surface layer, and an intermediate layer located between the inner surface layer and the outer surface layer,
The inner surface layer is a thermoplastic propylene containing 65 to 75 wt% of a propylene resin having a melting temperature of 120 ° C. or more and 25 to 35 wt% of an ethylene-α-olefin copolymer having a melting temperature of 90 ° C. or less. Formed of a resin-based resin composition,
The outer surface layer is formed of a first ethylene polymer polymerized using a metallocene catalyst,
The intermediate layer is formed of a second ethylene polymer polymerized using a metallocene catalyst having a lower flexural modulus than the outer surface layer forming material and the inner surface layer forming material,
The container body is formed by laminating the sheet so that the inner surface layers face each other, heat-sealing the peripheral portion, and has an inner surface layer fusion portion including the two inner surface layers at the peripheral portion. And
And the medical multi-chamber container whose ratio of the thickness of the said inner surface layer melt | fusion part in the said heat-sealed peripheral part and the thickness of the said intermediate | middle layer in each said sheet | seat is 1: 14-2: 1.

(2) The medical multi-chamber container according to (1), wherein the second ethylene polymer has a lower density and a lower melting temperature than the first ethylene polymer.
(3) In the above (1) or (2), the first ethylene polymer and the second ethylene polymer are ethylene / α-olefin copolymers polymerized using a metallocene catalyst. The medical multi-chamber container as described.
(4) The first ethylene polymer has a melt mass flow rate of 1.0 g / 10 min to 1.2 g / 10 min (JIS K6922-1), a density of 921 to 940 kg / m ³ , The above (1) which is an ethylene / α-olefin copolymer polymerized by using a metallocene catalyst having a melting temperature of 129 to 131 ° C. and a flexural modulus (JIS K6922-2, ISO1872-2) of 150 to 500 MPa. The medical multi-chamber container according to any one of (1) to (3).
(5) The second ethylene polymer has a melt mass flow rate of 1.3 g / 10 min to 1.5 g / 10 min (JIS K6922-1), a density of 910 to 920 kg / m ³ , The melting temperature is 125 to 128 ° C., the flexural modulus (JIS K6922-2, ISO1872-2) is 150 to 400 MPa, and the value of the flexural modulus is smaller than that of the first ethylene polymer used. The medical multi-chamber container according to any one of the above (1) to (4), which is an ethylene / α-olefin copolymer polymerized using a metallocene catalyst.
(6) The thermoplastic propylene-based resin composition has a melt mass flow rate (JIS K7210 A method, condition M, 230 ° C., 2.16 load) of 4/10 minutes to 10/10 minutes, and a density of 850 to 910 kg. / M ³ , the medical multi-chamber container according to any one of (1) to (4), wherein the melting temperature is 110 to 180 ° C. and the flexural modulus (JIS K7171) is 80 to 2000 MPa.

(7) Any of (1) to (6) above, wherein the medicine is stored in each of the first medicine chamber and the second medicine chamber and is autoclaved at a temperature of 120 ° C. or higher. A multi-chamber container for medical use according to 1.
(8) The medical multi-chamber container according to any one of (1) to (7), wherein the intermediate layer is thicker than the inner surface layer and the outer surface layer.
(9) The medical multi-chamber container according to any one of (1) to (8), wherein a ratio of the thickness of the inner surface layer to the thickness of the intermediate layer is 1:14 to 2: 1.
(10) The thermoplastic propylene-based resin composition includes, as the propylene-based resin, 50 to 60 wt% of the propylene-ethylene random block copolymer (A), 10 to 10% of the propylene-ethylene block copolymer (C). The medical multi-chamber container according to any one of (1) to (9), wherein 20 wt% and 25 to 35 wt% of the ethylene-α-olefin copolymer (B) are contained.

(11) The propylene-ethylene random block copolymer (A) satisfies the following conditions (Ai) to (A-iii), and the ethylene-α-olefin copolymer (B) satisfies the following conditions ( The medical treatment according to (10), wherein B-i) to (B-iii) are satisfied, and the propylene-ethylene block copolymer (C) satisfies (Ci) to (C-iii). Multi-chamber container.
(Ai) Propylene-ethylene random copolymer component (A1) having a melting peak temperature of 125 to 135 ° C. and an ethylene content of 1.5 to 3.0 wt% in DSC measurement in the first step using a metallocene catalyst. ), And propylene-ethylene random block copolymer obtained by sequential polymerization of propylene-ethylene random copolymer component (A2) having an ethylene content of 8-14 wt% in the second step. Being a polymer (A-ii) Melt flow rate (JIS K7210 A method condition M, 230 ° C. 2.16 kg) is in the range of 4 to 10 g / 10 min. (A-iii) obtained by solid viscoelasticity measurement In the temperature-loss tangent (tan δ) curve, the temperature-loss tangent representing the glass transition observed in the range of −60 to 20 ° C. tan [delta) that curve shows the single peak at 0 ℃ below (B-i) Density in the range of ^{0.870~0.890g / cm 3 (B-ii} ) a melting peak in DSC measurement The temperature is 80 ° C. or less (B-iii) The melt flow rate (JIS K7210 A method, condition D, 190 ° C., 2.16 kg) is in the range of 2.0 to 5.0 g / 10 min (C-i ) 65 to 75 wt% of the polypropylene component (C1) having a melt flow rate (JIS K7210 A method condition M, 230 ° C., 2.16 load) in the range of 100 to 200 g / 10 min in the first step, and ethylene in the second step Obtained by sequential polymerization of propylene-ethylene random copolymer component (C2) having a content of 4 to 8 wt% and a weight average molecular weight of 800,000 to 3 million, 35 to 25 wt%. (C-ii) Molecular weight distribution (Mw / Mn) which is the ratio of the weight average molecular weight (Mw) and the number average molecular weight (Mn) determined by gel permeation chromatography measurement ) Is in the range of 9.0 to 15.0. (C-iii) Melt flow rate (JIS K7210 A method condition M, 230 ° C., 2.16 load) of the entire propylene-based resin component (C) is 2. It must be in the range of 0 to 8.0 g / 10 min.

  The medical multi-chamber container of the present invention includes a container body having a medicine chamber formed by heat-sealing a sheet formed of a thermoplastic resin composition, and heat-sealing the container body so as to communicate with a lower end portion of the medicine chamber. The medicine chamber is further divided into a first medicine chamber and a second medicine chamber by a detachable partition portion, and the discharge port is provided in the container body. It is a medical multi-chamber container fixed so as to communicate with the lower end of the drug chamber. The sheet is a multilayer structure sheet made of a thermoplastic olefin resin and includes an inner surface layer, an outer surface layer, and an intermediate layer located between the inner surface layer and the outer surface layer, and the inner layer has a melting temperature of 120 ° C. or higher. It is formed of a thermoplastic propylene resin composition containing 65 to 75 wt% of a propylene resin and 25 to 35 wt% of an ethylene-α-olefin copolymer having a melting temperature of 90 ° C. or less. The intermediate layer is formed by using a metallocene catalyst that has a lower flexural modulus than the outer surface layer forming material and the inner surface layer forming material, and is formed of a first ethylene polymer polymerized using a metallocene catalyst. The container body is formed by laminating sheets with the inner surface layers facing each other, and heat-sealing the peripheral edge. Has an inner surface layer fused portion comprising two inner surface layers on the periphery. And ratio of the thickness of the inner surface layer fusion | melting part in the peripheral part heat-sealed and the thickness of the intermediate | middle layer in each sheet | seat is set to 1: 14-2: 1.

  This container is formed of a thermoplastic olefin resin sheet having a three-layer structure made of the above-mentioned material, and the thickness of the inner surface layer fused portion at the heat-sealed peripheral portion and the thickness of the intermediate layer in each sheet. Since the ratio to the thickness is from 1:14 to 2: 1, it has transparency, flexibility, low temperature impact resistance, good heat seal properties, and high temperature and high pressure steam using the overkill method. Even when sterilization is performed, there is very little leakage of the stored chemical solution due to delamination between the intermediate layer and the inner surface layer in the heat seal portion, intralayer rupture in the intermediate layer, and bag breakage thereby.

FIG. 1 is a front view of an embodiment of the medical multi-chamber container of the present invention. 2 is a cross-sectional view taken along line AA in FIG. FIG. 3 is an enlarged view of the vicinity of the partition portion of FIG.

The medical multi-chamber container of the present invention will be described using an embodiment shown in the drawings.
FIG. 1 is a front view of an embodiment of the medical container of the present invention. In addition, the upper side in the figure is described as “upper end” and the lower side is described as “lower end”.
The medical multi-chamber container 1 of the present invention communicates with a container body 2 having a drug chamber formed by heat-sealing sheets 11 and 12 formed of a thermoplastic resin composition, and a lower end portion of the drug chamber. A discharge port 3 heat-sealed in the container body 2, and the drug chamber is divided into a first drug chamber 21 and a second drug chamber 22 by a partition part 9 from which the internal space can be peeled, and The discharge port 3 is fixed to the container body so as to communicate with the lower end of the first drug chamber.

The sheets 11 and 12 are a multilayer structure sheet made of a thermoplastic olefin resin including an inner surface layer 13, an outer surface layer 14, and an intermediate layer 15 positioned between the inner surface layer 13 and the outer surface layer 14.
The inner surface layer is a thermoplastic propylene resin containing 65 to 75 wt% of a propylene resin having a melting temperature of 120 ° C. or more and 25 to 35 wt% of an ethylene-α-olefin copolymer having a melting temperature of 90 ° C. or less. It is formed of a resin composition. The outer surface layer is formed of a first ethylene polymer polymerized using a metallocene catalyst. The intermediate layer is formed of a second ethylene polymer polymerized using a metallocene catalyst having a lower flexural modulus than the outer surface layer forming material and the inner layer forming material.
The container body is formed by laminating the sheets so that the inner surface layers face each other, heat-sealing the peripheral portion, and has an inner surface layer fusion portion composed of two inner surface layers on the peripheral portion, and The ratio of the thickness of the inner surface layer fused portion in the heat-sealed peripheral edge portion to the thickness of the intermediate layer in each sheet is 1:14 to 2: 1.

  And in this Example, the container main body 2 is formed by laminating | stacking the sheets 11 and 12 so that the inner surface layer 13 may face, and heat-sealing a peripheral part. The seal strength at the peripheral edge (after sterilization) is higher by about 3 to 30 N / 10 mm than the seal strength of the central weak seal portion described later, and specifically, it is preferably 50 to 80 N / 10 mm. Moreover, the partition part 9 is also formed by heating a part of the inner surface layer 13 which opposes, The center part 9a can be peeled.

The medical multi-chamber container 1 of this embodiment is made of a flexible material, and a container body in which an internal space is divided into a first drug chamber 21 and a second drug chamber 22 by a detachable partition 9. (Soft bag) 2, the discharge port 3 communicating with the lower end of the first drug chamber 21, the first drug stored in the first drug chamber 21, and the second drug chamber 22 A second drug. Further, the medical multi-chamber container 1 of this embodiment includes a peelable communication inhibiting weak seal portion 10 that inhibits communication between the first drug chamber 21 and the discharge port 3.
As shown in FIG. 1, the medical multi-chamber container 1 includes a soft bag 2, a first medicine, a second medicine, a discharge port 3, and a mixed injection port 4.

In addition, as shown in FIG. 1, the soft bag 2 of the present invention includes a first drug chamber 21, a second drug chamber 22, a partition 9, a weak seal 10 for blocking communication, and a discharge port attached. A part 27, a mixed injection port attaching part 28, and a medicine injection part 29.
The soft bag 2 includes a cylindrical sheet formed by an inflation molding method, for example, a cylindrical sheet manufactured by various methods such as a blow molding method, a bag-like sheet that seals the entire outer periphery of the cylindrical sheet, A bag-shaped sheet with two edges sealed, a sheet formed by laminating two sheets, and sealing the peripheral edge of the sheet, folding the single sheet in half, and bending portion (side portion 7 or 8) Any of the bag-like sheets sealed on the other three sides may be used.

  In the soft bag 2 of this embodiment, an upper end side seal portion 5 and a lower end side seal portion 6 are provided. The upper end side seal portion 5 and the lower end side seal portion 6 are wide and strong seal portions. Moreover, the side parts 7 and 8 which are strong seal parts may be provided in the side of the soft bag 2. FIG. Further, as shown in FIG. 1, a discharge port mounting portion 27 for mounting the discharge port 3 and a drug injection for injecting a drug into the first drug chamber 21 are inserted into the lower end side seal portion 6 of the soft bag 2. A portion 29 is provided.

  The discharge port attaching portion 27 and the drug injecting portion 29 are non-seal portions in which a part of the lower end side seal portion 6 communicates with the inside and the outside of the soft bag 2. And the chemical | medical agent injection | pouring part 29 is sealed by the seal | sticker part 6a after chemical | medical agent injection | pouring. In addition, although it is preferable that the chemical | medical agent injection | pouring part 29 is provided in the lower end side seal part 6, it may be provided in the side parts 7 and 8, and does not need to be provided. The upper end side seal portion 5 is provided with a mixed injection port attaching portion 28 for attaching a mixed injection port. The mixed injection port mounting portion 28 is a non-seal portion formed so that a part of the upper end side seal portion 5 communicates with the inside and the outside of the soft bag. Note that the mixed injection port attachment portion 28 is not necessarily provided. Moreover, you may provide the same non-seal part in the same position as a chemical | medical agent injection | pouring part of a 2nd chemical | medical agent chamber. In addition, the injection part of the medicine in the second medicine chamber may be provided in the side parts 7 and 8.

  As shown in FIG. 1, the soft bag 2 is divided into a first drug chamber 21 and a second drug chamber 22 by a partitioning portion 9. And in the medical multiple-chamber container 1 of this Example, the partition part 9 is formed by the center weak seal part 9a and the side part seal part 9b formed in the both sides part or both sides of the center weak seal part 9a. Yes. In the Example of this invention, the partition part 9 is provided so that the whole horizontal direction of the chemical | medical agent chamber of the soft bag 2 may be crossed, as shown in FIG.

The central weak seal portion 9a continues between the two side seal portions 9b extending from the side portions (side seal portions) 7 and 8 of the soft bag 2 toward the center of the soft bag 2, respectively. It is provided to connect. The central weak seal portion 9a and the side seal portion 9b are formed by fusing the sheet material of the soft bag 2 so as to be peelable in a strip shape. With such a configuration, only the central weak seal portion 9a is formed near the center of the medicine chamber, and side seal portions 9b are formed on both sides thereof so as to overlap the central weak seal portion 9a. Further, in this embodiment, the side seal portion 9b is wider than the central weak seal portion 9a, and its upper edge is curved toward the upper end side of the soft bag as it goes to the side portion. . For this reason, when the 2nd chemical | medical agent chamber 22 is compressed, the chemical | medical agent in the chemical | medical agent chamber 22 is comprised so that it may go to the center weak seal | sticker part 9a.
In the medical multi-chamber container 1 of this embodiment, the side seal portion 9b is wider than the central weak seal portion 9a, but may have the same or narrower width. .

The partition part 9 of the embodiment peels off when one of the drug chambers is strongly pressed with a finger or the like (for example, when pressed or squeezed), and the first drug chamber 21 and the second drug chamber 22 are peeled off. Can communicate with each other. Further, the central weak seal portion 9a is easier to peel off than the communication inhibition portion 10 when the second drug chamber 22 is compressed.
Further, the side seal portion 9b of the embodiment is more difficult to peel off than the central weak seal portion 9a and the communication inhibition portion 10.

  The peeling strength of the partition portion 9 (the weak central seal portion 9a) was not peeled off by the pressure applied to the soft bag 2 in the form of two-fold packaging during transportation, and the soft bag 2 was strongly pressed with fingers (squeezed). It is preferable that it peels occasionally. The partition portion 9 is preferably formed by fusing the soft bag 2. The fusion is preferably thermal fusion, high frequency fusion, ultrasonic fusion or the like. Since the soft bag 2 has the two drug chambers 21 and 22 divided into the partition portions 9 in this way, drugs of different components can be mixed aseptically in the soft bag 2.

  Moreover, in the Example shown in FIG. 1, although the partition part 9 is provided linearly with respect to the soft bag 2, it is not limited to this. In the embodiment of the present invention, the partition portion 9 is configured by the central weak seal portion 9a and the side seal portion 9b, but is not limited thereto, and is configured by only the central weak seal portion 9a. May be. Moreover, it is preferable that the side part seal part 9b does not peel in a normal usage method. The side seal portion 9b is preferably formed by fusing the soft bag 2 by heat fusion, high frequency fusion, ultrasonic fusion, or the like. The side seal portion 9b may be a strong seal portion that cannot be peeled off.

  Specifically, the seal strength (initial peel strength after sterilization) of the weak seal portion (central weak seal portion) 9a is preferably 1 to 10 N / 10 mm, particularly 2 to 6 N / 10 mm. If the seal strength is within this range, the central weak seal part will not be accidentally peeled off during transportation or storage, and the work of peeling the central weak seal part is easy. The seal strength (initial peel strength) of the side seal portion is preferably 3N / 10 mm or more, particularly 4N / 10 mm or more.

  As the difference in seal strength between the central weak seal portion and the side seal portion (initial peel strength difference), the seal strength of the side seal portion is 3 to 3 from the seal strength (initial peel strength) of the central weak seal portion. It is preferably 30 N / 10 mm, particularly 4 to 25 N / 10 mm larger. In this way, when any one of the drug chambers is pressed, it is possible to prevent the entire weak partitioning part for partitioning from being peeled off at once, and to ensure at least peeling from the central weak sealing part. Further, in the medical container of the present invention, as shown in FIG. 2 and described later, the seal strength gradually rises as the heat seal temperature (mold temperature) rises. By appropriately changing, a desired seal strength can be imparted to the heat seal portion.

  In the embodiment of the present invention, the side seal portions 9b are formed on both sides of the central weak seal portion 9a, but the side seal portions 9b may not be formed, and the easily peelable central weak seal is not required. The soft bag 2 may be partitioned only by the part 9a. Further, the portion corresponding to the side seal portion 9b may be a strong seal. Even if the portion corresponding to the side seal portion 9b is cut out to form the flexible bag 2 like a gourd and a weak seal portion is provided at the constricted portion of the gourd, the same effect as the side weak seal 9b is obtained. be able to.

  When the side seal portion 9b is provided, the length of the central weak seal portion 9a (excluding the side seal portion 9b) is preferably 0.2 to 0.8 with respect to the lateral width of the drug chamber. In particular, it is preferably 0.3 to 0.7. Specifically, the length of the central weak seal portion 9a is preferably 70 to 120 mm, particularly 80 to 110 mm when the width is 240 mm, although it depends on the width of the medicine chamber. The width of the central weak seal portion 9a is preferably 8 to 20 mm, particularly 10 to 15 mm. The width of the side seal portion 9b is preferably 6 to 50 mm, particularly 8 to 30 mm.

  Moreover, as shown in FIG. 1, it is preferable that the partition part 9 is provided in the position which becomes the upper direction of the communication inhibition part 10 mentioned later, especially the vertical direction. Moreover, it is preferable that the side part seal | sticker part 9b is provided in the both sides of the position which becomes the perpendicular direction upper direction of the communication inhibition part 10, as shown in the figure. By providing the partition portion 9 at such a position, when the partition portion 9 is peeled off, the portion where the communication inhibiting portion 10 of the soft bag 2 is formed swells greatly, so that the communication inhibiting portion 10 is easily peeled off. Become.

  Note that the side seal portion 9b may be a seal portion that cannot be substantially peeled off. The part corresponding to the side seal part 9b does not necessarily have to be a peelable seal, and the part may be a strong seal part. In addition, the partition part 9 (central weak seal part 9a) does not need to be formed in strip | belt shape. For example, the partition part 9 (central weak seal part 9a) may be formed in V shape, a semicircle shape, and a semi-elliptical shape. Moreover, the partition part 9 (central weak seal part 9a) may become what peels easily by being produced thinly. Further, in this embodiment, since the discharge port 3 and the weak seal portion 10 for inhibiting communication are provided near the center of the lower portion of the soft bag 2, the central weak seal portion 9 a is correspondingly located near the center of the soft bag 2. Is provided. When the discharge port 3 and the weak seal portion 10 for inhibiting communication are provided at positions close to the side of the soft bag 2, the central weak seal portion 9 a is also near the center in the lateral direction of the soft bag 2. It is preferable to provide it at a position close to the side side.

The volume ratio between the first drug chamber 21 and the second drug chamber 22 divided by the partition 9 is preferably 1: 1 to 1: 5. The volume of the first drug chamber 21 of the medical multi-chamber container 1 should be as small as possible.
With such a configuration, when the second medicine chamber 22 is compressed (for example, when pressed or squeezed), the weak seal portion 10 for inhibiting communication is easily peeled off with one action.

  The medical multi-chamber container 1 includes a communication inhibition unit 10. In the medical multi-chamber container 1 of this embodiment, the communication inhibition part is formed by a weak seal part for communication inhibition. And in the medical multi-chamber container 1 of this Example, the communication inhibition part 10 is formed so that the upper direction of the discharge port 3 may be surrounded. A third chamber 23 isolated from the first drug chamber 21 is formed by the communication inhibition unit 10. The third chamber 23 is an empty room. However, the third chamber 23 may contain a predetermined liquid (for example, water for injection or physiological saline). The third chamber 23 may be in a dry state, but may be filled with a small amount of liquid for sterilization. Furthermore, a passage through which a slight amount of moisture such as water vapor passes may be formed in the weak seal portion 10 for inhibiting communication, and may communicate with the first drug chamber 21 at the above level. The weak seal portion 10 for inhibiting communication can be formed by heat sealing (thermal fusion, high frequency fusion, ultrasonic fusion) of the sheet material.

It is preferable that the communication inhibition part 10 is formed at a position below the central weak seal part 9a portion of the partition part 9. By being formed in such a position, when the first drug chamber 21 or the second drug chamber 22 is pressed (for example, when pressed or squeezed), the communication inhibiting unit 10 is peeled off as described above. It becomes easy to do.
In the embodiment shown in FIG. 1, the communication inhibiting portion 10 is formed in an inverted U-shape (in other words, a U-shape) whose legs are open (in other words, a trapezoid whose short side is on the upper side). Further, the communication inhibiting part 10 may have a polygonal shape such as a triangular shape or a quadrangular shape with the discharge port 3 at the bottom, a substantially semicircular shape, or a substantially semielliptical shape. In addition, when the communication inhibition part 10 has a corner | angular part in an outer periphery, it is preferable that the edge is not formed in a corner | angular part.

The strength for peeling of the communication inhibiting portion 10 is larger than the strength for peeling of the partition weak seal portion (central weak seal portion 9a). Moreover, the weak seal part 10 for communication inhibition is easier to peel off than the side seal part 9b in the embodiment of the present invention.
In the medical multi-chamber container 1, the weak seal portion 10 for blocking communication is peeled off after the partition portion 9 (central weak seal portion 9a) is peeled by pressing the first drug chamber 21. May be. If it is such, the 1st chemical | medical agent chamber 21 of the soft bag 2 can be pressed, and the weak seal part 10 for communication inhibition can be peeled with the force of the fluid at the time of peeling of the partition part 9. FIG.

  Further, the weak seal portion 10 for inhibiting communication has the same seal strength as that of the weak seal portion for inhibiting communication, or slightly higher than the seal strength of the partition portion 9 (central weak seal portion 9a). It can be configured by strengthening. The seal strength (initial peel strength after sterilization) of the weak seal portion for inhibiting communication is 2 to 25 N / 10 mm, preferably 4 to 20 N / 10 mm, particularly 6 to 15 N / 10 mm. In the medical container of the present invention, as shown in FIG. 2 and will be described later, the seal strength gradually increases as the heat seal temperature (mold temperature) rises. By giving a 1-10 degreeC difference in the heat seal temperature of a seal | sticker part and a partition part (center weak seal part), it becomes possible to provide desired seal strength with a seal strength difference to each heat seal part.

  The seal strength (initial peel strength) of the weak seal portion for inhibiting communication is preferably 2N / 10 mm or more, particularly 4N / 10 mm or more. The difference in seal strength between the central weak seal part and the weak seal part for communication inhibition (initial peel strength difference) cannot be generally described because of the influence of the shape of the container and each seal part. The seal strength of the seal portion is preferably 0.1 to 10 N / 10 mm, particularly 1 to 5 N / 10 mm greater than the seal strength (initial peel strength) of the central weak seal portion.

In this way, when any one of the drug chambers is pressed, the weak seal part for communication inhibition is prevented from being peeled off before the partition part 9, and the peeling from at least the central weak seal part 9a is ensured. It will be a thing.
A specific method for measuring the peel strength can be performed as follows. The measurement value when the medical container was cut into a length of 10 mm in the width direction of the container and the seal portion of each cut piece was peeled off at a tensile speed of 300 mm / min. Average value.
In the medical multi-chamber container 1, the ratio of the lateral length of the central weak seal portion 9a to the length (shortest distance) between the upper end of the weak seal portion 10 for inhibiting communication and the upper end of the medicine discharge port is 0.2 to 3 is preferable, and 0.5 to 2 is more preferable. In particular, it is preferably 0.7 to 1.5. Moreover, it is preferable that the width | variety (band width) of the weak seal part 10 for communication inhibition is 2-20 mm, especially 4-12 mm.

The container main body (soft bag) 2 of the medical multi-chamber container of the present invention is formed by two thermoplastic resin sheets 11 and 12. The thermoplastic resin sheets 11 and 12 include an inner surface layer 13, an outer surface layer 14, and an intermediate layer 15 located between the inner surface layer 13 and the outer surface layer 14.
Although the thickness of the sheets 11 and 12 constituting the flexible bag 2 is not particularly limited, it is usually preferably about 100 to 550 μm, and more preferably about 200 to 400 μm.

The inner surface layer 13 is a thermoplastic propylene containing 65 to 75 wt% of a propylene resin having a melting temperature of 120 ° C. or more and 25 to 35 wt% of an ethylene-α-olefin copolymer having a melting temperature of 90 ° C. or less. It is formed by a system resin composition. The thermoplastic propylene-based resin composition used for forming the inner surface layer has a melt mass flow rate of 4/10 minutes to 8/10 minutes, a density of 850 to 910 kg / m ³ , and a melting temperature of 110 to 180. It is preferable that it is 80-2000 Mpa, and a bending elastic modulus (JIS K7171).

The outer surface layer is formed of a first ethylene polymer polymerized using a metallocene catalyst. The first ethylene polymer is preferably an ethylene / α-olefin copolymer polymerized using a metallocene catalyst.
Furthermore, the first ethylene polymer used for forming the outer surface layer has a melt mass flow rate of 1.0 g / 10 min to 1.2 g / 10 min, a density of 921 to 940 kg / m ³ , and a melt. An ethylene / α-olefin copolymer polymerized using a metallocene catalyst having a temperature of 129 to 131 ° C. and a flexural modulus (JIS K6922-2, ISO1872-2) of 150 to 500 MPa is preferable.

The intermediate layer is formed by the amount of the outer surface layer forming material (first ethylene polymer) and the second ethylene polymer polymerized using a metallocene catalyst having a lower flexural modulus than the inner layer forming material. ing. The second ethylene polymer is preferably one having a lower density and a lower melting temperature than the first ethylene polymer. The second ethylene polymer is preferably an ethylene / α-olefin copolymer polymerized using a metallocene catalyst.
As the ethylene-α-olefin copolymer used for forming the outer surface layer and the intermediate layer, for example, the α-olefin is preferably propylene, butene, pentene, hexene, octene, or methylpentene. In particular, an ethylene-hexene copolymer is preferable.

Further, the second ethylene polymer used for forming the intermediate layer has a melt mass flow rate of 1.3 g / 10 min to 1.5 g / 10 min, a density of 910 to 920 kg / m ³ , and a melt. A first ethylene polymer having a temperature of 125 to 128 ° C., a flexural modulus (JIS K6922-2, ISO1872-2) of 150 to 400 MPa, and a flexural modulus value used for forming the outer surface layer; It is preferably an ethylene / α-olefin copolymer polymerized using a metallocene-based catalyst smaller than the thermoplastic propylene-based resin composition used for forming the inner surface layer. The value of the flexural modulus of the second ethylene polymer used for forming the intermediate layer may be 50 to 200 MPa less than the value of the elastic modulus of the first ethylene polymer used for forming the outer surface layer. preferable. Moreover, it is preferable that the value of the bending elastic modulus of the second ethylene polymer used for forming the intermediate layer is substantially the same as the elastic modulus of the thermoplastic propylene resin composition used for forming the inner surface layer.

  The container body 2 is formed by laminating the sheets 11 and 12 so that the inner surface layer 13 faces each other, and heat-sealing the peripheral portion, and an inner surface layer fusion portion composed of two inner surface layers is formed on the peripheral portion. Have. And ratio of the thickness of the inner surface layer fusion | melting part in the peripheral part heat-sealed and the thickness of the intermediate | middle layer in each sheet | seat is set to 1: 6-12: 7. In the medical container according to the present invention, in the peripheral heat seal part, such a thick structure and the material for forming each layer have the above-described physical properties, so that even if high temperature high pressure steam sterilization using an overkill method is performed, In the seal portion, the occurrence of in-layer breakage in the intermediate layer and the inner surface layer and in the intermediate layer is extremely small, and the film has good transparency, flexibility, low temperature impact resistance, and good heat seal characteristics. In addition, it is preferable that ratio of the thickness of the inner surface layer melt | fusion part in the heat-sealed peripheral part and the thickness of the intermediate | middle layer in each sheet | seat is 1: 14-2: 1. In this way, in the peripheral heat seal part, each of the two intermediate layers has at least the same thickness as or more than that of the inner surface layer fusion part. Internal peeling can be prevented more reliably.

  The intermediate layer 15 in each of the sheets 11 and 12 is thicker than the inner surface layer 13 and the outer surface layer 14. The ratio of the thickness of the inner surface layer 13 to the thickness of the intermediate layer 15 is preferably 1:14 to 2: 1, and particularly preferably 1: 5 to 2: 1. The thickness of the inner surface layer 13 is preferably 5 to 70% of the thickness of the sheets 11 and 12, and particularly preferably 20 to 70%. Further, the thickness of the outer surface layer 14 is preferably 5 to 20% of the thickness of the sheets 11 and 12, and particularly preferably 5 to 15%. And it is preferable that the thickness of an intermediate | middle layer is 10 to 50% of the thickness of a sheet | seat, and it is especially preferable that it is 10 to 40%.

And the thermoplastic propylene-type resin composition used for formation of an inner surface layer is demonstrated in detail.
As described above, the thermoplastic propylene-based resin composition includes 65-75 wt% of a propylene-based resin having a melting temperature of 120 ° C. or higher, and an ethylene-α-olefin copolymer having a melting temperature of 90 ° C. or lower. It is formed of a thermoplastic propylene resin composition containing 25 to 35 wt%.
The propylene-based resin is preferably a propylene-based block polymer. In particular, the propylene-ethylene random block copolymer (A) is 65 to 75 wt%, and the propylene-ethylene block copolymer (C) is 25. It is preferable to contain -35 wt%.

  Further, the propylene-ethylene random block copolymer (A) satisfies the following conditions (Ai) to (A-iii), and the ethylene-α-olefin copolymer (B) satisfies the following conditions (Bi ) To (B-iii), and the propylene-ethylene block copolymer (C) preferably satisfies (Ci) to (C-iii).

(Ai) Propylene-ethylene random copolymer component (A1) having a melting peak temperature of 125 to 135 ° C. and an ethylene content of 1.5 to 3.0 wt% in DSC measurement in the first step using a metallocene catalyst. ), And propylene-ethylene random block copolymer obtained by sequential polymerization of propylene-ethylene random copolymer component (A2) having an ethylene content of 8-14 wt% in the second step. Being a polymer (A-ii) Melt flow rate (JIS K7210 A method condition M, 230 ° C. 2.16 kg) is in the range of 4 to 10 g / 10 min. (A-iii) obtained by solid viscoelasticity measurement In the temperature-loss tangent (tan δ) curve, the temperature-loss tangent representing the glass transition observed in the range of −60 to 20 ° C. It tan [delta) curve shows a single peak at 0 ℃ below

(B-i) The density is in the range of 0.870 to 0.890 g / cm ³ (B-ii) The melting peak temperature in DSC measurement is 80 ° C. or less (B-iii) Melt flow rate (JIS) K7210 Method A Condition D, 190 ° C. 2.16 kg) is in the range of 2.0 to 5.0 g / 10 min.

(Ci) 65-75 wt% of a polypropylene component (C1) having a melt flow rate (JIS K7210 A method, condition M, 230 ° C., 2.16 load) in the range of 100 to 200 g / 10 min in the first step, A propylene-ethylene block copolymer obtained by sequentially polymerizing 35-25 wt% of a propylene-ethylene random copolymer component (C2) having an ethylene content of 4-8 wt% and a weight average molecular weight of 800,000-3 million in two steps. (C-ii) The molecular weight distribution (Mw / Mn), which is the ratio of the weight average molecular weight (Mw) and the number average molecular weight (Mn) determined by gel permeation chromatography, is 9.0 to 15 (C-iii) Melt flow rate of the entire propylene resin component (C) (JIS K7210 A method conditions) , 230 ° C., 2.16 load) in the range of 2.0~8.0g / 10min.

  And the container main body 2 includes a region that is not heat-sealed by the propylene-based resin (specifically, a propylene-based block polymer) by being weakly sealed by heat sealing in the partitioning portion 9. It can be peeled off. The partition portion 9 is formed by heat sealing at a temperature lower than the melting point of the propylene-based resin that is the main component and higher than the melting point of the ethylene-α-olefin copolymer.

  Drugs are stored in the drug rooms 21 and 22 of the soft bag 2. The chemical chambers 21 and 22 are different in that they coexist with each other, such as precipitation due to coexistence, separation of components that may change over time or coloration / decomposition due to temporary heating, etc. It is preferred that the components are contained.

  As such a drug (infusion solution), for example, it is necessary to mix two or more drugs at the time of infusion, such as peritoneal dialysis solution, transcentral vein infusion, transperipheral vein injection, liquid nutrient, etc. Some are preferable. Examples of the infusion include physiological saline, electrolyte solution, Ringer's solution, high-calorie infusion, glucose solution, water for injection, amino acid electrolyte solution, and the like, but are not limited thereto. For example, a glucose electrolyte solution is stored in one of the drug rooms and an amino acid solution is stored in the other, and water-soluble vitamins such as vitamin B1, vitamin B2, vitamin B6, vitamin C, panthenol, and nicotinamide are stabilized in both chambers. It can be sorted and stored as appropriate in consideration of the properties and the like.

  In the medical multi-chamber container 1, the separation part 9 and the weak seal part 10 for blocking communication due to the compression of the first medicine chamber 21 and the partition part 9 and the communication due to the compression of the second medicine chamber 22 are used. There is a difference in the peeling workability of the weak seal portion 10 for inhibition. The superiority or inferiority in the difference in peeling workability here is a comparison of which one of the drug chambers can be easily peeled off the partition 9 and the weak seal portion 10 for inhibiting communication when both drug chambers are compressed individually. It is a result.

  In the medical multi-chamber container 1 according to the present invention, the separation part 9 and the communication inhibition part 10 are peeled in one order by pressing either the first medicine chamber 21 or the second medicine chamber 22 in this order. It has become. However, in the medical multi-chamber container 1 of the present invention, as described above, the separation workability of the partition part 9 and the communication inhibiting part 10 by the compression of the first drug chamber 21 and the partitioning by the pressure of the second drug chamber 22 are performed. There is a difference in the separation workability of the part 9 and the communication inhibition part 10. This is caused by the ease of deformation of the medicine chamber, the size of the medicine chamber, the amount of medicine filled in the medicine chamber, and the like. And, the superiority or inferiority of workability is determined as to which of the first drug chamber 21 and the second drug chamber 22 is better when the one-action partitioning portion and the communication inhibiting portion are continuously peelable. The standard.

Further, the upper end side seal portion 5 of the soft bag 2 is provided with a hole (hanging portion) 25 for hanging on a hanger or the like.
As shown in FIG. 1, the discharge port 3 is attached to a discharge port attachment portion 27 formed in the lower end side seal portion 6 of the soft bag 2. The discharge port mounting portion 27 is provided at the center of the lower end side seal portion 6. The medical multi-chamber container 1 includes a mixed injection port 4 for mixing chemical solutions. By doing in this way, components other than the chemical | medical agent put into the medical multiple-chamber container 1 can be mixedly injected before use. The discharge port 3 and the mixed injection port 4 are attached to the soft bag 2 by high frequency fusion, heat fusion, ultrasonic fusion, or the like. As the discharge port 3 and the mixed injection port 4, known ones can be used.

  In the medical multi-chamber container 1 of this embodiment, as described above, the medicine is stored in each of the first medicine chamber 21 and the second medicine chamber 22, and the high-pressure steam at a temperature of 120 ° C. or higher. Sterilized. As high pressure steam sterilization conditions, it is preferable to carry out at 120 degreeC which is overkill conditions (ISO / TS 17665-2).

The thermoplastic propylene-based resin composition used for forming the inner surface layer of the container body in this example will be described in more detail.
The first and second thermoplastic propylene resin compositions are a propylene block copolymer, an ethylene-α-olefin copolymer, and a homopolypropylene mixture. Specifically, the thermoplastic propylene-based resin composition has a propylene-ethylene random block copolymer (A) of 50 to 60 wt% and a propylene-ethylene block copolymer (C) as a propylene-based block copolymer. What contains 10-20 wt% and 25-35 wt% of ethylene-alpha-olefin copolymers (B) is preferable.

And it is preferable that a propylene-ethylene random block copolymer (A) satisfy | fills the above-mentioned conditions (Ai)-(A-iii).
Moreover, it is preferable that an ethylene-alpha-olefin copolymer (B) satisfy | fills the above-mentioned conditions (Bi)-(B-iii).
The propylene-ethylene block copolymer (C) preferably satisfies (Ci) to (C-iii).

Details of the propylene-based block copolymer component (A) will be described.
The propylene-based block copolymer component (A), which is a propylene-ethylene random block copolymer used as a main component of the propylene-based block copolymer composition, has high transparency, flexibility, and impact resistance. Resin.

The propylene block copolymer component (A) satisfies the following requirements.
The propylene block copolymer component (A) uses a metallocene catalyst and has a melting peak temperature Tm (A) in the DSC measurement (differential scanning calorimetry) in the first step of 125 to 135 ° C. and an ethylene content of 1. 50 to 60 wt% of propylene-ethylene random copolymer component (A1) in the range of 5 to 3.0 wt%, and propylene-ethylene random copolymer component (A2) having an ethylene content of 8 to 14 wt% in the second step Can be obtained by sequential polymerization of 50 to 40 wt%.

(2) Component (A1) (2-1) Melting peak temperature Tm (A) of component (A1)
The component (A1) produced in the first step is a component that determines crystallinity in the propylene-based block copolymer component (A). In order for the component (A) to exhibit heat resistance, the component (A1) ) Must have a relatively high melting peak temperature Tm (A). However, on the other hand, if Tm (A) is too high, flexibility is insufficient, and in order to control heat seal characteristics, a second propylene-based block copolymer that is a propylene-ethylene random copolymer component described later is used. It is necessary that the difference from the melting peak temperature Tm (C) of the coalescing component (C) is large. Therefore, the melting peak temperature Tm (A) of the component (A1) needs to be in the range of 125 to 135 ° C.

That is, when the melting peak temperature Tm (A) is 125 ° C. or lower, the container is likely to be deformed or fused when subjected to high-pressure steam sterilization under chemical filling conditions. Tm (A) needs to be 125 ° C. or higher, preferably 128 ° C. or higher.
On the other hand, when Tm (A) is high, the heat resistance is improved, but not only the flexibility and transparency are easily inhibited, but also the difference from the melting peak temperature Tm (C) of the component (C) is reduced. Therefore, the heat seal curve suddenly rises and it becomes difficult to control multi-stage stable peel strength, so Tm (A) needs to be 135 ° C. or less, preferably 133 ° C. or less. It is.

(2-2) Ethylene content E (A1) of component (A1)
The melting peak temperature Tm (A) of the component (A1) is controlled by the ethylene content, and the ethylene content E (A1) of the component (A1) in the present invention is in the range of 1.5 to 3.0 wt%. When the ethylene content is 1.5 wt% or less, Tm (A) is too high, and when it is 3.0 wt% or more, it is too low.

(2-3) Proportion of component (A1) in propylene-based block copolymer component (A) W (A1)
The proportion W (A1) of the component (A1) in the propylene-based block copolymer component (A) is a component that imparts heat resistance to the component (A), but if there is too much W (A1), flexibility And the impact resistance cannot be fully exhibited, and transparency may be impaired. Therefore, the ratio of the component (A1) needs to be 60 wt% or less.
On the other hand, if the proportion of the component (A1) becomes too small, the heat resistance is lowered even if the melting peak temperature Tm (A) is sufficient, and the container is deformed when autoclaved under high pressure steam sterilization. And the ratio of the component (A1) must be 50 wt% or more.

(3) About component (A2) (3-1) Ethylene content E (A2) in component (A2)
The propylene-ethylene random copolymer component (A2) produced in the second step is a component necessary for improving the flexibility, impact resistance, and transparency of the propylene-based block copolymer component (A). . Generally, in the propylene-ethylene random copolymer, the crystallinity is lowered and the flexibility improving effect is increased by increasing the ethylene content. Therefore, the ethylene content E (A2) in the component (A2) is 8 wt% or more. It is necessary to be. When E (A2) is 8 wt% or less, sufficient flexibility cannot be exhibited, and it is preferably 10 wt% or more.

  On the other hand, if the ethylene content is excessively increased to lower the crystallinity of the component (A2), the compatibility between the component (A1) and the component (A2) is reduced, and the component (A2) is not compatible with (A1). To form a domain. In such a phase separation structure, if the refractive index of the matrix and the domain are different, the transparency is drastically lowered. Therefore, the ethylene content of the propylene-ethylene random copolymer component (A2) in the propylene-based block copolymer component (A) used in the present invention needs to be 14 wt% or less, preferably 12 wt% or less. It is.

(3-2) Proportion of component (A2) in propylene-based block copolymer component (A) W (A2)
When the proportion of the component (A2) is too large, the heat resistance is lowered. Therefore, the proportion W (A2) of the component (A2) needs to be suppressed to 50 wt% or less.
On the other hand, since the improvement effect of a softness | flexibility and impact resistance is not acquired when the ratio of a component (A2) becomes too small, the ratio of a component (A2) needs to be 40 wt% or more.

(4) Specific components (A1) and (A2) of ethylene components E (A1) and E (A2) and component amounts W (A1) and W (A2) of components (A1) and (A2) Each ethylene content and component amount are quantified by a material balance at the time of polymerization (material balance) and various known analysis methods. In addition, about the measuring method used in this invention, the detail is described in an Example.

(5) Melt flow rate of propylene-based block copolymer component (A) MFR (A)
The MFR of the propylene-based block copolymer component (A) needs to be in the range of 4 to 10 g / 10 min.
The melt flow rate MFR (A) of the entire propylene-based block copolymer component (A) is determined by the ratio of each component (A1) and (A2) to each MFR (respectively referred to as MFR (A1) and MFR (A2)). However, in the present invention, if the overall MFR is in the range of 4 to 10, each MFR is arbitrary as long as the object of the present invention is not impaired. However, when the MFRs of the two are greatly different, an appearance defect or the like may occur. Therefore, both MFR (A1) and MFR (A2) of each component are preferably in the range of 4 to 10 g / 10 min.

  If the MFR is low, not only the motor load and the tip pressure increase, but also the problem that the surface of the film becomes rough and the appearance deteriorates, so the MFR needs to be 4 g / 10 min or more, preferably It is 5 g / 10 min or more. On the other hand, if the MFR is too high, the molding tends to be unstable and it is difficult to obtain a uniform film. Therefore, the MFR needs to be 10 g / 10 min or less, preferably 8 g / 10 min or less. is there. In addition, the melt flow rate (MFR) of each resin in the present invention is according to JIS K7210 A method condition M, test temperature: 230 ° C., nominal load: 2.16 kg, die shape: diameter 2.095 mm, length 8.00 mm. It was measured under the conditions of

(6) Determination of glass transition temperature by solid viscoelasticity measurement In the propylene-based block copolymer component (A), in a temperature-loss tangent (tan δ) curve obtained by solid viscoelasticity measurement (DMA), -60 to 20 It is necessary that the peak of the tan δ curve representing the glass transition observed in the range of 0 ° C. shows a single peak at 0 ° C. or lower.

  When the propylene-based block copolymer component (A) has a phase separation structure, the glass transition temperature of the amorphous part contained in the component (A1) and the glass transition temperature of the amorphous part contained in the component (A2) are Since each is different, there are a plurality of peaks. In this case, there arises a problem that the transparency is remarkably deteriorated. Usually, the glass transition temperature in the propylene-ethylene random copolymer is observed in the range of −60 to 20 ° C., and whether or not the phase separation structure is taken can be determined in the tan δ curve in the solid viscoelasticity measurement in this range, Avoidance of the phase separation structure that affects the transparency of the molded product is brought about by having a single peak below 0 ° C. A specific method of solid viscoelasticity measurement (DMA) is described in Examples.

(7) Method for Producing Propylene Block Copolymer Component (A) The method for producing the propylene block copolymer component (A) used in the present invention is described in JP-A-2005-248156 and JP-A-4156491. It is preferable to use this method.
Moreover, as a metallocene catalyst, what is disclosed by Unexamined-Japanese-Patent No. 2005-248156 can be used. Representative metallocene compounds include bis (cyclopentadienyl) zirconium dichloride, bis (indenyl) zirconium dichloride, bis (azurenyl) zirconium dichloride, bis (4,5,6,7-tetrahydroindenyl) zirconium dichloride, ( Cyclopentadienyl) (3,4-dimethylcyclopentadienyl) zirconium dichloride, methylenebis (cyclopentadienyl) zirconium dichloride, methylene (cyclopentadienyl) (3,4-dimethylcyclopentadienyl) zirconium dichloride, Isopropylidene (cyclopentadienyl) (3,4-dimethylcyclopentadienyl) zirconium dichloride, methylenebis (indenyl) zirconium dichloride, ethylene 1,2-bis (4-phenyl) Nylindenyl) zirconium dichloride, dimethylsilylene (cyclopentadienyl) (tetramethylcyclopentadienyl) zirconium dichloride, dimethylsilylenebis (indenyl) zirconium dichloride, dimethylsilylene (cyclopentadienyl) (fluorenyl) zirconium dichloride, methylphenylsilylene Bis {1- (2-methyl-4,5-benzoindenyl)} zirconium dichloride, dimethylsilylenebis {1- (2-methyl-4H-azurenyl)} zirconium dichloride, dimethylsilylenebis [1- {2-methyl -4- (4-chlorophenyl) -4H-azurenyl}] zirconium dichloride, dimethylsilylenebis {1- (2-ethyl-4-naphthyl-4H-azurenyl)} zirconium dichloride. De, dimethyl gel Mi Len bis (indenyl) zirconium dichloride, dimethyl gel Mi (cyclopentadienyl) (fluorenyl) such as zirconium dichloride can be exemplified. The metallocene catalyst is not limited to the above.

Next, the ethylene-α-olefin copolymer component (B) contained in the first and second propylene-based resin compositions will be described.
The ethylene-α-olefin copolymer component (B) has the following conditions (Bi) to (B-iii).
(B-i) The density is in the range of 0.870 to 0.890 g / cm ³ (B-ii) The melting peak temperature in DSC measurement is 80 ° C. or less (B-iii) Melt flow rate (JIS) K7210 Method A, Condition D, 190 ° C., 2.16 kg) is in the range of 2.0 to 5.0 g / 10 min. In the present invention, this ethylene-α-olefin copolymer component (B) is contained. As a result, good impact resistance and heat sealing properties are imparted to the sheet formed using the resin composition.

  Component (B) has the effect of improving the impact strength of the composition at low temperatures. Since the propylene-based resin composition may be refrigerated during storage or transportation of the product, impact resistance at a low temperature is necessary so that no breakage occurs at this time. At this time, if the amount of the component (B) is too small, there arises a problem that not only the heat seal characteristics are sufficient but also the impact resistance is insufficient.

  The medical container of the present invention is formed by heat sealing a sheet. Heat sealing is a process in which resin is fused by applying heat and pressure and then cooled and solidified. At this time, the peel strength varies depending on the thickness and shape of the sheet, the seal temperature, the pressure, the time, etc., but in order to control the peel strength, it is important to set a small change in strength with respect to the heat seal temperature . That is, in the actual heat sealing process, the peel strength is controlled by the temperature of the heating part, but the actual temperature has fluctuations due to disturbances such as errors and ambient temperature, and the change in strength with respect to the heat sealing temperature is abrupt. If it is, peeling strength will change a lot by fluctuation of temperature, and it will be difficult to obtain stable peeling strength. First, the first heat seal characteristic requires a strength range of about 1 to 10 N / 10 mm, preferably 2 to 6 N / min, which is a weak seal strength that can be peeled relatively easily when the container is squeezed by hand. It is to exhibit a weak seal characteristic that allows strength management at a set strength of ± 1 N / 10 mm within a strength range of about 10 mm, and it is important that the influence of the seal strength is small on heat seal temperature fluctuations.

The ethylene-α-olefin copolymer component (B) is poorly compatible with the propylene-based block copolymer components (A) and (C), has a phase separation structure, and has a large difference in melting temperature. . Component (B) appears to form domains in propylene-based block copolymer components (A) and (C). For this reason, the heat seal temperature is low in the whole composition as long as the propylene block copolymer component (A) or (C) is not melted and heat-sealed, but the component (B) is at a melting temperature. Only the portion where the component (B) is present on the surface is fused, and in order to show a low fusion strength compared to the whole, the amount and the melting temperature are adjusted to adjust the weak seal. It is thought that the characteristics can be controlled.
In addition, when the refractive index of the ethylene-α-olefin copolymer component (B) is significantly different from that of the component (A), the transparency of the composition deteriorates, so it is also important to match the refractive indexes. These melting temperature and refractive index can be controlled by the density, and it is necessary to set the density within a specific range in order to achieve both heat seal characteristics and transparency.

(1) Density For the above reasons, the ethylene-α-olefin copolymer component (B) used in the present invention needs to have a density in the range of 0.870 to 0.890 g / cm ³ .
If the density is too low, the difference in refractive index is increased and the transparency is deteriorated. When the density is less than 0.870, the transparency required for the present invention cannot be ensured and is 0.870 or more. Is necessary, and preferably 0.875 or more.
On the other hand, if the density becomes too high, the crystallinity becomes high, so that the flexibility, impact resistance and transparency are likely to deteriorate, and the difference between the melting temperature of component (A) and the melting temperature of component (B). When there is no more, it becomes difficult to control the heat seal characteristics, so it is necessary to be 0.890 or less, preferably 0.885 or less.

(2) Melting temperature T (B)
As described above, in order to control the seal strength in a relatively weak heat seal strength region of about 1 to 10 N / 10 mm, it is important to separate the melting temperatures of the component (A) and the component (B). The melting peak temperature T (B) of the component (B) needs to be 80 ° C. or lower. If T (B) is 80 ° C or less, the seal strength can be set within a range of ± 1N / 10mm in the strength region of 1-10N / 10mm, and if T (B) exceeds 80 ° C The heat seal temperature range is narrow, and stable heat seal strength cannot be obtained.

(3) Melt flow rate (JIS K7210 A method condition D, 190 ° C., 2.16 kg)
The resin composition of the present invention needs to have an appropriate fluidity in order to ensure moldability. If the viscosity of the component (B) is too high, the fluidity will be insufficient, resulting in poor dispersion. By doing so, transparency and impact resistance are likely to be reduced, and problems such as variations in heat seal characteristics are likely to occur. Therefore, the ethylene-α-olefin copolymer component (B) in the present invention is required to have a melt flow rate of 2.0 g / 10 min or more, preferably 2.5 or more. On the other hand, if the melt flow rate is too high, the stability during molding is lowered, and it is easy to cause problems such as uneven thickness of the film and reduced impact resistance. Since it melts at a lower temperature than the component (A), if the viscosity is too low, it tends to bleed to the surface due to the heat seal pressure, and the heat seal controllability deteriorates, so the melt flow rate is 5.0 g / 10 min or less. It must be present, and is preferably 4.5 g / 10 min or less.

(4) Ratio of component (B) in resin composition The ratio of component (B) in the resin composition needs to be in the range of 25 to 35 wt%. That is, since the component (B) exists as a domain in the component (A) and has a lower melting temperature than the component (A), only the component (B) melts in a low temperature range, so that the heat seal strength is increased. The low area is controlled. At this time, if the amount of the component (B) is too small, not only the amount of the component (B) present on the film surface decreases, but the strength at the time of weak sealing becomes too low to perform sufficient control, There is a problem that the impact resistance is insufficient and the product is broken during transportation. On the other hand, if the amount is too large, the component (B) is present on the surface in a large amount, which may cause fusion during heat sterilization. The proportion of the component (B) in the present invention in the composition needs to be in the range of 25 to 35 wt%, and if it is less than 25 wt%, the weak seal property is insufficient, and the flexibility, resistance The impact property becomes insufficient, and when it is 35 wt% or more, the heat resistance is insufficient, so it cannot be used.

(5) Method for Producing Ethylene-α-Olefin Copolymer Component (B) The ethylene-α-olefin copolymer component (B) of the present invention is used to reduce the refractive index difference from the component (A). It is necessary to lower the density, and it is desirable that the crystallinity and molecular weight distribution are narrow in order to suppress stickiness and bleed out. Therefore, it is desirable to use a metallocene catalyst capable of narrowing crystallinity and molecular weight distribution for the production of component (B).

(5-1) Metallocene Catalyst As the metallocene catalyst, various known catalysts used for the polymerization of ethylene-α-olefin copolymers can be used. Specific examples include metallocene catalysts described in JP-A-58-19309, JP-A-59-95292, JP-A-60-35006, and JP-A-3-16388. .

(5-2) Polymerization method As a specific polymerization method, a slurry method, a gas phase fluidized bed method or a solution method in the presence of these catalysts, or a pressure of 200 kg / cm ² or more, a polymerization temperature of 100 ° C. or more. And pressurized bulk polymerization method. A preferable production method includes high-pressure bulk polymerization. The ethylene-α-olefin copolymer component (B) can be appropriately selected from those commercially available as metallocene polyethylene. Examples of commercially available products include DuPont Dow Affinity (registered trademark) and Engage (registered trademark), Nippon Polyethylene Corporation Kernel (registered trademark), Exxon Corporation EXACT (registered trademark), and the like.
In these uses, the density, melting peak temperature, and MFR grade, which are requirements of the present invention, may be selected.
Further, the ethylene-α-olefin copolymer may be a copolymer composed of one kind of α-olefin other than ethylene and ethylene as long as the above conditions (Bi) to (B-iii) are satisfied. And a copolymer comprising two or more α-olefins other than ethylene.

Next, the propylene-based block copolymer component (C) that is a propylene-ethylene block copolymer contained in the first and second propylene-based resin compositions will be described.
This propylene-based block copolymer component (C) has the conditions (C-i) to (C-iii).
(Ci) 65-75 wt% of a polypropylene component (C1) having a melt flow rate (JIS K7210 A method, condition M, 230 ° C., 2.16 load) in the range of 100 to 200 g / 10 min in the first step, A propylene-ethylene block copolymer obtained by sequentially polymerizing 35-25 wt% of a propylene-ethylene random copolymer component (C2) having an ethylene content of 4-8 wt% and a weight average molecular weight of 800,000-3 million in two steps. Be a polymer

(C-ii) The molecular weight distribution (Mw / Mn), which is the ratio of the weight average molecular weight (Mw) and the number average molecular weight (Mn) determined by gel permeation chromatography measurement, is in the range of 9.0 to 15.0. Exist (C-iii) The range of the melt flow rate (JIS K7210 A method condition M, 230 ° C., 2.16 load) of the entire propylene block copolymer component (C) is 2.0 to 8.0 g / 10 min. Be in

And in this invention, the favorable heat seal characteristic is given to the sheet | seat formed using the resin composition by containing the propylene-type block copolymer component (C) which is a 2nd propylene-ethylene block copolymer. Has been granted.
It is desirable that the propylene-based resin composition has multi-stage stable peel strength controllability. In the resin composition of the present invention, by containing the component (B) described above, a sealing temperature in a weak seal strength region that is relatively easily peelable, such as about 1 to 10 N / 10 mm, preferably about 2 to 6 N / 10 mm. In contrast, it is possible to exhibit a stable weak seal characteristic. However, it can be easily peeled off, but in addition to the weak seal region of 1 to 10 N / 10 mm, the second heat seal property is higher, about 2 to 25 N / 10 mm, preferably 4 to 20 N, more preferably 6 to It is desirable to control the seal strength in a 15N peel strength region. Further, in order to obtain a product having a stable peel strength, it is necessary to make the change in strength in this region as small as possible with respect to the heat seal temperature as in the case of 1 to 10 N / 10 mm. At this time, in order to control the strength at a set strength of ± 2 N / 10 mm in a strength range of 2 to 25 N / 10 mm, it is necessary to improve the propylene-based block copolymer component itself, and the propylene-based block copolymer component (C) Is a component for controlling this.

  That is, the propylene-based block copolymer component (A) used as a main component in the present invention is produced by a metallocene-based catalyst, and has both high flexibility and transparency. Since the crystallinity distribution of the components is narrow and melts at a specific temperature at a time, the rise in heat seal strength with respect to temperature is rapid. If the distribution of crystallinity is expanded, the higher the crystallinity, the higher the melting temperature, so the heat-sealing strength against temperature will be gentle, but the effect will be sufficient if the melted components easily flow due to the pressure during heat-sealing. Not. At this time, since the propylene block copolymer component (A) produced by the metallocene catalyst has a narrow molecular weight distribution and does not have a high molecular weight component, the propylene block copolymer component (A) easily flows due to pressure during heat sealing. By including the coalescence component (C), it is possible to provide a crystalline distribution, and at the same time to provide a distribution in the molecular weight, thereby making it possible to gently change the heat seal strength with respect to the temperature on the high strength side. .

(1) Basic rules The propylene block copolymer component (C) has a melt flow rate (JIS K7210 A method, condition M, 230 ° C., 2.16 load) in the first step in the range of 100 to 200 g / 10 min. Sequential polymerization of propylene-ethylene random copolymer component (C2) with 65 to 75 wt% of polypropylene component (C1), ethylene content of 4 to 8 wt% and weight average molecular weight of 80 to 3 million in the second step It is obtained by doing.

(2) About component (C1) Component (C1) is a polypropylene component and is a component with high crystallinity. This component has a higher melting temperature than component (A) in the composition, and is a component for smoothening the change in heat seal strength with respect to temperature by suppressing fusion at the temperature at which component (A) melts. . Therefore, the component (C1) needs to have higher crystallinity than the component (A), and is preferably a polypropylene component composed only of propylene.

(2-1) Melt flow rate of component (C1) (JIS K7210 A method, condition M, 230 ° C., 2.16 load)
As will be described later, the component (C2) needs to have a high molecular weight. However, if the molecular weight of the entire component (C) is high, the fluidity is poor and the component cannot be sufficiently dispersed in the composition. Not only is it insufficient, but it also causes uneven flow and poor appearance called gel and fish eye, so it is necessary to ensure the fluidity of the entire component (C) by increasing the fluidity of the component (C1). It is. Therefore, the melt flow rate of the component (C1) needs to be at least 100 g / 10 min. On the other hand, even if the melt flow rate is too high, uneven flow tends to occur, impact resistance and flexibility. Therefore, the melt flow rate of the component (C1) in the present invention needs to be in the range of 100 to 200 g / 10 min.

(3) Component (C2) Component (C2) is a component for suppressing a rapid increase in heat seal strength by reducing fluidity when the crystal component of component (A) is melted. In order to suppress an increase in heat seal strength by lowering the fluidity, it is necessary that the component (C2) is also melted when the component (A) is melted. Therefore, the component (C2), unlike the component (C1), needs to lower the crystallinity, and the crystallinity is controlled by the ethylene content, so the ethylene content needs to be 4 to 8 wt%. It is.

(3-1) Weight average molecular weight Component (C2) is required to suppress a rapid increase in heat seal strength by inhibiting component (A) from melting and flowing due to heat seal pressure during heat sealing. is there. At this time, if the molecular weight of the component (C2) is low, the effect of inhibiting the flow is insufficient, and the heat seal characteristics cannot be sufficiently improved. Therefore, the component (C2) needs to have a weight average molecular weight (Mw) determined by gel permeation chromatography (GPC) of 800,000 or more. Further, if the molecular weight becomes too high, the dispersibility deteriorates, so it is necessary to be less than 3 million.

(3-2) Ratio W (C2) of component (C2) in component (C)
Since the component (C2) has a very high molecular weight, if the proportion W (C2) in the component (C) is too large, the component (C) cannot be sufficiently dispersed in the composition, and the heat seal characteristics In addition to not being able to improve the above, it may cause problems such as deterioration of physical properties and poor appearance, so that it is necessary to be 35 wt% or less. On the other hand, if the amount of the component (C2) is too small, the flexibility decreases due to the necessity of a large amount of the component (C) in the composition in order to exhibit sufficient heat sealing properties, and the transparency decreases. Since there is a possibility of incurring, it is necessary to be 25 wt% or more.

(4) The ratio of the component (C) in a composition The ratio for which a component (C) accounts in a composition needs to be the range of 10-20 wt%. In the present invention, the component (C) is a component for improving the heat seal characteristics on the high strength side, and in order to impart a crystallinity distribution to the component (A) and control the melting behavior of the crystal, In order to suppress the flow of the component (C1) and the component (A) due to the pressure at the time of heat sealing, a high molecular weight component (C2) is included, thereby suppressing a rapid increase in heat seal strength with respect to temperature. ing. When the amount of the component (C) is too small, the high crystalline component and the high molecular weight component are insufficient, and a sufficient effect of improving the heat seal characteristics cannot be obtained. Furthermore, the effect of improving sheet formability due to insufficient melt tension cannot be exhibited. On the other hand, when the amount of the component (C) is too large, physical properties such as flexibility and transparency are significantly deteriorated, and the quality required for the resin composition of the present invention cannot be satisfied.

  When the ratio of the component (C) in the composition in the present invention is less than 10 wt%, sufficient heat seal characteristics cannot be imparted, so that it is necessary to be 10 wt% or more, preferably 12 wt%. That's it. On the other hand, since physical properties deteriorate at 20 wt% or more, it is necessary to be less than 20 wt%, preferably less than 18 wt%.

(5) About molecular weight distribution (Mw / Mn) which is a ratio of the weight average molecular weight (Mw) and the number average molecular weight (Mn) obtained by gel permeation chromatography measurement (GPC) of component (C1). Since the component (C) is composed of the component (C1) and the component (C2) having greatly different molecular weights, the ratio between the weight average molecular weight (Mw) and the number average molecular weight (Mn) determined by gel permeation chromatography (GPC). It is necessary that the molecular weight distribution (Mw / Mn) is 9.0 or more. When the molecular weight distribution is less than 9.0, the effect of improving the heat seal characteristics is not sufficient, and when it is 15.0 or more, the dispersibility is deteriorated.

(6) Melt flow rate of component (C1) (JIS K7210 A method, condition M, 230 ° C., 2.16 load) Component (C) used in the present invention contains component (C2) having a high molecular weight. Nevertheless, sufficient dispersion in the composition is necessary. For this purpose, the component (C) needs to have an appropriate fluidity, and the melt flow rate, which is a measure of fluidity, needs to be in the range of 2.0 to 8.0 g / 10 min. When the melt flow rate is less than 2.0, the dispersion deteriorates, causing not only flow irregularities, gels and fish eyes, but also poor appearance, and heat seal characteristics are difficult to stabilize, and sufficient effects can be obtained. Absent. On the other hand, in the case of 8.0 or more, problems such as physical properties such as impact resistance and a decrease in flexibility occur, and it becomes difficult to obtain the effect of improving the heat seal characteristics.

(7) Production method The component (C) is composed of a component (C1) having a low molecular weight and a component (C2) having a very high molecular weight, but these components are extremely different in fluidity, so they are mixed by melt-kneading. Is virtually impossible. On the other hand, it is not preferable from the viewpoint of cost and environment to blend in a solvent. Therefore, the component (C) used in the present invention must be polymerized and dispersed by sequentially polymerizing the component (C1) in the first step and the component (C2) in the second step.
As the catalyst system for obtaining the component (C), a catalyst mainly composed of a titanium-containing solid catalyst component and an organoaluminum compound, or a metallocene transition metal compound having at least one π-electron conjugated ligand is used. Can do. Here, the component (C2) is preferably produced from a material mainly composed of a titanium-containing solid catalyst component and an organoaluminum compound since the higher the molecular weight component, the greater the effect of improving the heat seal characteristics.

The titanium-containing solid catalyst component is selected from a known supported catalyst component obtained by contacting a solid magnesium compound, titanium tetrahalide and an electron donating compound, and a known catalyst component containing titanium trichloride as a main component. The aluminum compound of the promoter is represented by the general formula AlRnX3 ^-n (wherein R represents a hydrocarbon group having 2 to 10 carbon atoms, and n represents a number of 3 ≧ n> 1.5). When the titanium-containing solid catalyst component is a carrier-supported catalyst component containing a solid magnesium compound, it is preferable to use AlR ³ or a mixture of AlR ³ and AlR ² X, while titanium trichloride or titanium trichloride is mainly used. When the catalyst component is included as a component, it is preferable to use AlR ² X. Furthermore, in the present invention, a known electron donating compound can be used as the third component in addition to the catalyst and cocatalyst components. The polymerization reaction for obtaining the component (C) can be carried out in the presence of an inert solvent such as hexane or heptane, in the absence thereof, that is, in the presence of liquid propylene or even in gas phase propylene. The reaction can be carried out batchwise using one polymerization tank, or can be carried out continuously by connecting two or more polymerization tanks in series.

The order of the polymerization may be performed in two stages in which the component (C1) is first polymerized and then the component (C2) is polymerized, and additional polymerization may be performed in three stages and four stages.
The catalyst is generally added prior to polymerization in the first stage. Replenishment of the catalyst in the subsequent stage is not necessarily excluded, but it is preferable to add the catalyst in the first stage in order to obtain characteristics that cannot be obtained by resin blending.
In the step (1) for obtaining the component (C1), propylene is polymerized in the presence of hydrogen. Hydrogen is controlled so that the MFR of the polymer obtained in step (1) is in the range of 100 to 200. In general, the hydrogen concentration (in the case of slurry polymerization, the concentration in the gas phase portion, in the polymerization in liquid propylene or in the gas phase method indicates the content in the monomer) is added in an amount of 1 to 50 mol%, preferably 3 to 30 mol%.

The polymerization temperature in step (1) is generally 40 to 90 ° C., and 65 to 75% by weight of the total polymerization amount is produced.
The step (2) for obtaining the component (C2) is polymerization for obtaining a high molecular weight component, and the polymerization is allowed to proceed in a substantially hydrogen-free state with a hydrogen concentration of 0.1 mol% or less. The weight average molecular weight of the polymer obtained in the step (2) is 800,000 to 3,000,000.
The polymerization temperature is usually 40 to 90 ° C., preferably 50 to 80 ° C., and the monomer concentration is controlled so that ethylene is included as a comonomer and the comonomer content is in the range of 4 to 8% by weight.

The propylene-based resin composition used in the present invention may contain an additional component (additive). As the additive, an antioxidant, a neutralizing agent or the like is used.
Antioxidant is an additive for suppressing thermal stability during molding processing of the resin composition and thermal deterioration of the molded body, and it is necessary to use an additive that has little influence on the contents. Preference is given to tetrakis [methylene-3- (3 ′, 5′-di-t-butyl-4′-hydroxyphenyl) propionate] methane, octadecyl-3- (3,5-di-) as phenolic antioxidants. It is preferable to avoid t-butyl-4-hydroxyphenyl) propionate, tris (2,4-di-t-butylphenyl) phosphite as a phosphorus-based antioxidant, and those that are easily hydrolyzed. The addition amount is preferably the minimum necessary for ensuring the stability of the resin composition, and is preferably suppressed to 2000 ppm or less. As the neutralizing agent, calcium stearate can be used, but it may cause insoluble fine particles to be generated even after high-pressure steam sterilization depending on the contents, and therefore the addition amount is desirably 200 ppm or less.

Example 1
(Example of inner layer 40 μm, intermediate layer 220 μm, outer layer 20 μm)
(1) Preparation of thermoplastic propylene resin composition pellets for inner surface layer formation The following were used as the propylene resin component (A).
Propylene-ethylene random copolymer component using a metallocene catalyst and having a melting peak temperature Tm (A) of 125 to 135 ° C. and an ethylene content of 1.5 to 3.0 wt% in DSC measurement in the first step Propylene-ethylene random copolymer obtained by sequential polymerization of 50 to 40 wt% of (A1) and propylene-ethylene random copolymer component (A2) having ethylene content of 8 to 14 wt% in the second step. A polymer was used. The propylene-based resin component (A) has a melting peak temperature Tm (A) of 130 ° C., an ethylene content in the component (A1) of 2.2 wt%, a ratio of the component (A1) of 56 wt%, a component ( The ethylene content in A2) was 11 wt%, the ratio of component (A2) was 44 wt%, the glass transition temperature was -8.6 ° C, and the MFR of the entire component (A) was 6 g / 10 min.

The following were used as the ethylene / α-olefin copolymer (B).
A copolymer of ethylene and hexene-1 was prepared. The catalyst was prepared by the method described in JP-T-7-508545. That is, to the complex dimethylsilylene bis (4,5,6,7-tetrahydroindenyl) hafnium dimethyl 2.0 mmol, tripentafluorophenyl boron was added in an equimolar amount to the above complex, and diluted to 10 liters with toluene. A catalyst solution was prepared.

A mixture of ethylene and 1-hexene was supplied to a stirred autoclave type continuous reactor having an internal volume of 1.5 liter so that the composition of 1-hexene was 73% by weight, and the pressure in the reactor was maintained at 130 MPa. The reaction was performed at 127 ° C. The polymer production per hour was about 2.5 kg.
The obtained ethylene / α-olefin copolymer had a density of 0.88 g / cc, a melting peak temperature Tm (B) of 60 ° C., and an MFR of 3.5 g / 10 min.

The following were used as a propylene-type resin component (C).
65 to 75 wt% of the polypropylene component (C1) having a melt flow rate (JIS K7210 A method condition M, 230 ° C., 2.16 load) in the range of 100 to 200 g / 10 min in the first step, ethylene content in the second step Of propylene-ethylene block copolymer was obtained by sequentially polymerizing propylene-ethylene random copolymer component (C2) having a weight average molecular weight of 80 to 3 million by 35 to 25 wt%.

The propylene-based resin component (C) has an MFR of the entire component (C) of 5.4 g / 10 min, an overall molecular weight distribution (Mw / Mn) of 13.7, a C1 component ratio of 70 wt%, and a C2 component ratio. However, 30 wt% and C2 component ethylene content were 6 wt%.
The above component (A), component (B) and component (C) are weighed so as to be 58, 27, and 15 wt%, respectively, and put into a Henschel mixer, and then the component (A), component (B) and component ( The following antioxidant and neutralizer were added to 100 parts by weight of the mixture of C), and the mixture was sufficiently stirred and mixed.

Antioxidant: Tetrakis [methylene-3- (3 ′, 5′-di-t-butyl-4′-hydroxyphenyl) propionate] methane (Ciba Specialty Chemicals Co., Ltd. Irganox 1010) 0.08 weight Parts, 0.02 parts by weight of tris (2,4-di-t-butylphenyl) phosphite (Irgaphos 168 manufactured by Ciba Specialty Chemicals Co., Ltd.), octadecyl-3- (3,5-di-t-butyl) -4-Hydroxyphenyl) propionate (Irganox 1076 manufactured by Ciba Specialty Chemicals Co., Ltd.) 0.015 parts by weight Neutralizer: Calcium stearate (Ca-St manufactured by Nitto Kasei Kogyo Co., Ltd.) 0.003 parts by weight

Granulation In a PCM twin screw extruder manufactured by Ikegai Seisakusho with a screw diameter of 30 mm, the melted resin extruded from the strand die was melted and kneaded in a cooling water tank at a screw rotation speed of 200 rpm, a discharge rate of 10 kg / hr, and an extruder temperature of 190 ° C. The material was taken out while being cooled and solidified, and the strand was cut into a diameter of about 2 mm and a length of about 3 mm using a strand cutter to obtain a propylene-based resin composition raw material pellet.
The propylene-based resin had a melt mass flow rate of 5 g / 10 min, a density of 900 kg / m ³ , a melting temperature of 160 ° C., a flexural modulus of 100 MPa, and a tensile modulus of 130 MPa.

(2) Preparation of ethylene / α-olefin copolymer for forming outer layer Nipolon Z (registered trademark) FY11 (Tosoh Corporation) as pellets of ethylene / α-olefin copolymer polymerized using a metallocene catalyst Manufactured, ethylene / hexene copolymer, melt mass flow rate 1.1 g / 10 min, density 930 kg / m ³ , melting temperature 130 ° C., flexural modulus 360 MPa, tensile elastic modulus 390 MPa).

(3) Preparation of ethylene / α-olefin copolymer for intermediate layer formation As pellets of ethylene / α-olefin copolymer polymerized using a metallocene catalyst, Nipolon Z (registered trademark) FY12 (Tosoh Corporation) Manufactured, ethylene / hexene copolymer, melt mass flow rate 1.4 g / 10 min, density 915 kg / m ³ , melting temperature 128 ° C., flexural modulus 170 MPa, tensile elastic modulus 160 MPa).

Preparation of medical container (1) Preparation of sheet Each raw material pellet prepared as described above is supplied to a circular die with a kneading function (inflation die) for three layers, and a circular die residence time with a kneading function (190 ° C) Kneading time) In 5 minutes, the inner surface layer is formed of the above-described inner surface layer forming resin composition, the intermediate layer is formed of the above described intermediate layer forming resin composition, and the outer surface layer is the above described outer surface layer forming resin. A tubular sheet formed of the composition is extruded, cooled with a water-cooling ring, and then a sheet with a thickness of 0.3 mm and a folded diameter of 190 mm is drawn at a speed of 18 m / min to produce an inflation sheet having a three-layer structure. did.
The inner layer thickness of the sheet is 40 μm (14.3% of the sheet thickness), the intermediate layer thickness is 220 μm (78.6% of the sheet thickness), and the outer surface layer thickness is 20 μm (sheet). 7.1% of the thickness).

(2) Preparation of medical container The above sheet is cut into a length of 300 mm, and the upper end is 20-30 mm wide from the upper end of the sheet and the lower end is 20 mm wide from the lower end of the sheet except the discharge port mounting portion, the injection port mounting portion and the drug injection portion. A container body having a peripheral portion was produced by heat sealing using a single-sided heating mold under conditions of ˜30 mm, a mold temperature of 240 ° C., and a time of 4 seconds.
Moreover, the 7-mm width part of the center part of a container main body was heat-sealed using the double-sided heating metal mold | die on conditions with a mold temperature of 120 degreeC, and time 3 seconds, and the weak seal part for partition parts which can be peeled was formed. Next, the weak seal portion for inhibiting communication with a width of 7 mm is heat-sealed using a double-sided heating die under the conditions of a mold temperature of 130 ° C. and a time of 5 seconds. The peelable weak seal portion for inhibiting communication was formed. And the cylindrical port member was inserted in each of the discharge port mounting part and injection | pouring port mounting part of a container main body, and it heat-sealed using the double-sided heating metal mold | die, and adhered to the container main body. In addition, a cap member equipped with a rubber elastic member was ultrasonically fused to the opening of the port member fixed to the discharge port mounting portion, and the opening was sealed.

  And after filling 350 ml of 10 wt / v% amino acid aqueous solution from the opening of the port member fixed to the injection | pouring port mounting part in one chemical | medical agent chamber side divided by the weak seal part, the rubber-made elastic member is filled in the opening of the port member. The cap member equipped with was ultrasonically fused to seal the opening. After filling 150 ml of 10.7 wt / v% glucose / electrolyte aqueous solution from the drug injection part on the other drug room side, the single-sided heating mold is used for the drug injection part at a width of 10 mm, a mold temperature of 210 ° C., and a time of 3 seconds. Was heat sealed.

(3) Sterilization The medical container containing the chemical solution prepared as described above is placed in a high-pressure steam sterilizer and sterilized in a nitrogen atmosphere at a temperature of 121 ° C. and a gauge pressure of 0.5 kg / cm ² hours and 15 minutes. Then, the medical multi-chamber container (Example 1) containing the chemical solution of the present invention shown in FIG. 1 was produced. In addition, the thickness of the inner surface layer fusion part in the peripheral heat seal part of the medical multi-chamber container (Example 1) is 80 μm, the thickness of the intermediate layer in each sheet is 220 μm, and the ratio between the two is 80: 220 (4:11).

(Example 2)
(Example of inner layer 80 μm, intermediate layer 180 μm, outer layer 20 μm)
The same procedure as in Example 1 was performed except that the amount of resin material discharged for forming each layer in the production of the sheet was adjusted. The inner layer was formed from the inner layer forming resin composition described above, and the intermediate layer was formed from the above intermediate layer forming resin. A tube-shaped sheet formed by the composition and having an outer surface layer formed by the above-described resin composition for forming an outer surface layer is extruded, cooled by a water-cooling ring, and then a sheet having a thickness of 0.3 mm and a folding diameter of 190 mm is 18 m / min. By pulling at a speed, an inflation sheet having a three-layer structure was produced.
The inner layer thickness of the sheet is 80 μm (28.6% of the sheet thickness), the intermediate layer thickness is 180 μm (64.3% of the sheet thickness), and the outer surface layer thickness is 20 μm (sheet). 7.1% of the thickness).
And it carried out similarly to Example 1 except having used the sheet | seat of vapor | steam, and produced the medical multi-chamber container (Example 2) containing the chemical | medical solution of this invention shown in FIG. In addition, the thickness of the inner surface layer fusion part in the peripheral heat seal part of the medical multi-chamber container (Example 2) is 160 μm, the thickness of the intermediate layer in each sheet is 180 μm, and the ratio between the two is 16:18 (8: 9).

Example 3
(Example of inner layer 20 μm, intermediate layer 240 μm, outer layer 20 μm)
The same procedure as in Example 1 was performed except that the amount of resin material discharged for forming each layer in the production of the sheet was adjusted. The inner layer was formed from the inner layer forming resin composition described above, and the intermediate layer was formed from the above intermediate layer forming resin. A tube-shaped sheet formed by the composition and having an outer surface layer formed by the above-described resin composition for forming an outer surface layer is extruded, cooled by a water-cooling ring, and then a sheet having a thickness of 0.3 mm and a folding diameter of 190 mm is 18 m / min. By pulling at a speed, an inflation sheet having a three-layer structure was produced.
The inner layer thickness of the sheet is 80 μm (28.6% of the sheet thickness), the intermediate layer thickness is 180 μm (64.3% of the sheet thickness), and the outer surface layer thickness is 20 μm (sheet). 7.1% of the thickness).
And it carried out similarly to Example 1 except having used the sheet | seat of vapor | steam, and produced the medical multi-chamber container (Example 3) containing the chemical | medical solution of this invention shown in FIG. In addition, the thickness of the inner surface layer fusion part in the peripheral heat seal part of the medical multi-chamber container (Example 3) is 40 μm, the thickness of the intermediate layer in each sheet is 240 μm, and the ratio between the two is 40: 240 (1: 6).

Example 4
(Example of inner layer 120 μm, intermediate layer 140 μm, outer layer 20 μm)
The same procedure as in Example 1 was performed except that the amount of resin material discharged for forming each layer in the production of the sheet was adjusted. The inner layer was formed from the inner layer forming resin composition described above, and the intermediate layer was formed from the above intermediate layer forming resin. A tube-shaped sheet formed by the composition and having an outer surface layer formed by the above-described resin composition for forming an outer surface layer is extruded, cooled by a water-cooling ring, and then a sheet having a thickness of 0.3 mm and a folding diameter of 190 mm is 18 m / min. By pulling at a speed, an inflation sheet having a three-layer structure was produced.
The inner layer thickness of the sheet is 120 μm (42.9% of the sheet thickness), the intermediate layer thickness is 140 μm (50.0% of the sheet thickness), and the outer surface layer thickness is 20 μm (sheet). 7.1% of the thickness).
And it carried out similarly to Example 1 except having used the sheet | seat of vapor | steam, and produced the medical multi-chamber container (Example 4) containing the chemical | medical solution of this invention shown in FIG. In addition, the thickness of the inner surface layer fusion part in the peripheral heat seal part of the medical multi-chamber container (Example 4) is 240 μm, the thickness of the intermediate layer in each sheet is 140 μm, and the ratio between the two is 24:14 (12: 7).

(Comparative Example 1)
(Example of inner layer 160 μm, intermediate layer 100 μm, outer layer 20 μm)
The same procedure as in Example 1 was performed except that the amount of resin material discharged for forming each layer in the production of the sheet was adjusted. The inner layer was formed from the inner layer forming resin composition described above, and the intermediate layer was formed from the above intermediate layer forming resin. A tube-shaped sheet formed by the composition and having an outer surface layer formed by the above-described resin composition for forming an outer surface layer is extruded, cooled by a water-cooling ring, and then a sheet having a thickness of 0.3 mm and a folding diameter of 190 mm is 18 m / min. By pulling at a speed, an inflation sheet having a three-layer structure was produced.
The inner layer thickness of the sheet is 160 μm (57.1% of the sheet thickness), the intermediate layer thickness is 100 μm (35.7% of the sheet thickness), and the outer surface layer thickness is 20 μm (sheet). 7.1% of the thickness).
And it carried out similarly to Example 1 except having used the sheet | seat of vapor | steam, and produced the medical multi-chamber container (comparative example 1) shown in FIG. In addition, the thickness of the inner surface layer fusion part in the peripheral heat seal part of the medical multi-chamber container (Comparative Example 1) is 320 μm, the thickness of the intermediate layer in each sheet is 100 μm, and the ratio between the two is 32:10 (16: 5).

(4) Evaluation of medical container (4-1) Evaluation of transparency After leaving the sterilized medical containers of Examples 1 to 4 and Comparative Example 1 in a nitrogen atmosphere for 48 hours, When a part was cut out and the underwater transmittance at a wavelength of 450 mm was measured with a Shimadzu double-beam self-recording spectrophotometer UV-300, the underwater transmittance was as shown in Table 1.
(4-2) Evaluation of flexibility The sterilized medical container sheets of Examples 1 to 4 and Comparative Example 1 are 100 mm in the longitudinal direction (MD) of the sheet, and the direction perpendicular to the MD direction (TD ) Was cut into a length of 100 mm and a width of 10 mm to obtain a test piece, and the tensile strength was measured according to JIS K7161, and the elastic modulus was as shown in Table 1.

[Table 1]
Underwater permeability Tensile modulus (Mpa)
(%) Flow direction (MD) Vertical direction (TD)
Example 1 80 187 183
Example 2 81 192 170
Example 3 79 185 182
Example 4 80 183 168
Comparative Example 1 82 196 193

(4-3) Measurement of seal strength About 10 medical containers containing chemical solutions after sterilization of Examples 1 to 4 and Comparative Example 1, the peripheral portion was cut out in a direction parallel to the inflation direction with a length of 100 mm and a width of 10 mm, and 200 mm When the 180 ° peel strength was measured at a speed of 1 min / min, the peel strength was as shown in Table 2, and the presence or absence of peeling at other than the heat seal surface during the peel test was as shown in Table 2. It was.

[Table 2]
Peripheral portion Existence of exfoliation other than heat seal surface Example 1 43N 0/10
Example 2 42N 0/10
Example 3 42N 0/10
Example 4 41N 0/10
Comparative Example 1 20N 2/10

(4-4) Drop test Ten sterilized medical containers containing sterilized liquids of Examples 1 to 4 and Comparative Example 1 were stored at 4 ° C for 24 hours or more and then dropped from the height of 100 cm to the bottom. The maximum number of drops was 10. Liquid leakage was not confirmed in all the medical containers of Examples and Comparative Examples.

DESCRIPTION OF SYMBOLS 1 Medical multiple-chamber container 2 Container main body 3 Discharge port 4 Mixed injection port 5 Upper end side seal part 6 Lower end side seal part 9 Partition part 9a Central weak seal part 9b Side part seal part 10 Weak seal part 21 for communication inhibition First medicine Chamber 22 Second drug chamber

Claims (11)

A container body having a medicine chamber formed by heat-sealing a sheet formed of a thermoplastic resin composition; and a discharge port heat-sealed to the container body so as to communicate with a lower end portion of the medicine chamber. Further, the drug chamber has an internal space divided into a first drug chamber and a second drug chamber by a detachable partition, and the discharge port is provided in the container main body with respect to the first drug chamber. A medical multi-chamber container secured to communicate with the lower end,
The sheet is a multilayer structure sheet made of a thermoplastic olefin resin including an inner surface layer, an outer surface layer, and an intermediate layer located between the inner surface layer and the outer surface layer,
The inner surface layer is a thermoplastic propylene containing 65 to 75 wt% of a propylene resin having a melting temperature of 120 ° C. or more and 25 to 35 wt% of an ethylene-α-olefin copolymer having a melting temperature of 90 ° C. or less. Formed of a resin-based resin composition,
The outer surface layer is formed of a first ethylene polymer polymerized using a metallocene catalyst,
The intermediate layer is formed of a second ethylene polymer polymerized using a metallocene catalyst having a lower flexural modulus than the outer surface layer forming material and the inner surface layer forming material,
The container body is formed by laminating the sheet so that the inner surface layers face each other, heat-sealing the peripheral portion, and has an inner surface layer fusion portion including the two inner surface layers at the peripheral portion. And
And the ratio of the thickness of the inner surface layer fusion part in the heat-sealed peripheral edge part and the thickness of the intermediate layer in each of the sheets is 1:14 to 2: 1. Multi-chamber container. 2. The medical multi-chamber container according to claim 1, wherein the second ethylene polymer has a lower density and a lower melting temperature than the first ethylene polymer. The medical multiple chamber according to claim 1 or 2, wherein the first ethylene polymer and the second ethylene polymer are ethylene / α-olefin copolymers polymerized using a metallocene catalyst. container. The first ethylene-based polymer has a melt mass flow rate of 1.0 g / 10 min to 1.2 g / 10 min (JIS K6922-1), a density of 921 to 940 kg / m ³ , and a melting temperature. The ethylene / α-olefin copolymer polymerized using a metallocene catalyst having a bending elastic modulus of 129 to 131 ° C. and a flexural modulus (JIS K6922-2, ISO1872-2) of 150 to 500 MPa. The medical multi-chamber container according to any one of the above. The second ethylene-based polymer has a melt mass flow rate of 1.3 g / 10 min to 1.5 g / 10 min (JIS K6922-1), a density of 910 to 920 kg / m ³ , and a melting temperature. 125-128 ° C., flexural modulus (JIS K6922-2, ISO1872-2) is 150-400 MPa, and the value of the flexural modulus is smaller than that of the first ethylene polymer used. The medical multi-chamber container according to any one of claims 1 to 4, which is an ethylene / α-olefin copolymer polymerized using The thermoplastic propylene-based resin composition has a melt mass flow rate (JIS K7210 A method condition M, 230 ° C., 2.16 load) of 4/10 minutes to 10/10 minutes, and a density of 850 to 910 kg / m ^3. The medical multi-chamber container according to any one of claims 1 to 4, which has a melting temperature of 110 to 180 ° C and a flexural modulus (JIS K7171) of 80 to 2000 MPa. The medical compound according to any one of claims 1 to 6, wherein a medicine is housed in each of the first medicine chamber and the second medicine chamber and is autoclaved at a temperature of 120 ° C or higher. Chamber container. The medical multi-chamber container according to any one of claims 1 to 7, wherein the intermediate layer is thicker than the inner surface layer and the outer surface layer. The medical multi-chamber container according to any one of claims 1 to 8, wherein a ratio of a thickness of the inner surface layer to a thickness of the intermediate layer is 1:14 to 2: 1. The thermoplastic propylene-based resin composition includes, as the propylene-based resin, a propylene-ethylene random block copolymer (A) of 50 to 60 wt%, a propylene-ethylene block copolymer (C) of 10 to 20 wt%, The medical multi-chamber container according to any one of claims 1 to 9, containing 25 to 35 wt% of the ethylene-α-olefin copolymer (B). The propylene-ethylene random block copolymer (A) satisfies the following conditions (Ai) to (A-iii), and the ethylene-α-olefin copolymer (B) satisfies the following conditions (Bi The medical multi-chamber container according to claim 10, wherein the propylene-ethylene block copolymer (C) satisfies (Ci) to (C-iii). .
(Ai) Propylene-ethylene random copolymer component (A1) having a melting peak temperature of 125 to 135 ° C. and an ethylene content of 1.5 to 3.0 wt% in DSC measurement in the first step using a metallocene catalyst. ), And propylene-ethylene random block copolymer obtained by sequential polymerization of propylene-ethylene random copolymer component (A2) having an ethylene content of 8-14 wt% in the second step. Being a polymer (A-ii) Melt flow rate (JIS K7210 A method condition M, 230 ° C. 2.16 kg) is in the range of 4 to 10 g / 10 min. (A-iii) obtained by solid viscoelasticity measurement In the temperature-loss tangent (tan δ) curve, the temperature-loss tangent representing the glass transition observed in the range of −60 to 20 ° C. tan [delta) that curve shows the single peak at 0 ℃ below (B-i) Density in the range of ^{0.870~0.890g / cm 3 (B-ii} ) a melting peak in DSC measurement The temperature is 80 ° C. or less (B-iii) The melt flow rate (JIS K7210 A method, condition D, 190 ° C., 2.16 kg) is in the range of 2.0 to 5.0 g / 10 min (C-i ) 65 to 75 wt% of the polypropylene component (C1) having a melt flow rate (JIS K7210 A method condition M, 230 ° C., 2.16 load) in the range of 100 to 200 g / 10 min in the first step, and ethylene in the second step Obtained by sequential polymerization of propylene-ethylene random copolymer component (C2) having a content of 4 to 8 wt% and a weight average molecular weight of 800,000 to 3 million, 35 to 25 wt%. (C-ii) Molecular weight distribution (Mw / Mn) which is the ratio of the weight average molecular weight (Mw) and the number average molecular weight (Mn) determined by gel permeation chromatography measurement ) Is in the range of 9.0 to 15.0. (C-iii) Melt flow rate (JIS K7210 A method condition M, 230 ° C., 2.16 load) of the entire propylene-based resin component (C) is 2. It must be in the range of 0 to 8.0 g / 10 min.

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