JP2005047600A - Polypropylene sheet for push through package - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a polypropylene sheet for PTP (push through package) having the same dividing properties as those for polyvinyl chloride, its PTP packaging body, and a method for manufacturing them. <P>SOLUTION: The polypropylene sheet for PTP is characterized by that the whole thickness region of the sheet comprising polypropylene is A, a depth region of a part into which a slit edge for a purpose of providing the dividing properties is inserted from the sheet surface is B (1/2A≤B≤4/5A), a depth region of a part into which the slit edge is not inserted is C (C=A-B), before the slit edge is inserted, crystal regions exists much more in the region C than in the region B and a degree of crystallinity in the whole thickness direction of the sheet is ≤60%, and in addition, after the slit edge is inserted, the degree of crystallinity in the whole thickness direction of the sheet is ≥40%. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

    The present invention relates to a polypropylene sheet for press-through pack (hereinafter referred to as PTP) generally used for solid agent packaging in the field of pharmaceutical packaging, a PTP package comprising the same, and a method for producing them. is there.

  In the field of pharmaceutical packaging, PTP packaging, which is commonly used for packaging solid tablets such as tablets, capsules, etc., has a sheet of mainly hard polyvinyl chloride from the viewpoint of transparency, formability, waist strength, and cost. It is a package that is used as a material, molded into a pocket shape, filled with solid agents (tablets, capsules, etc.), and sealed with a lid made of aluminum foil. Practical use in the first half of the 1960s It has become widespread.

  Most of the contents of tablets and capsules are altered or deformed by moisture absorption. Secondary packaging such as pillow wrapping is applied to the composite film containing aluminum foil, or a hard vinyl chloride sheet is used. Although this has been dealt with by using a sheet in which polyvinylidene chloride resin having excellent moisture resistance is combined by coating or the like, these are expensive and have a problem in cost. In addition, there is an increasing tendency for polyvinyl chloride resin to be avoided from disposal problems. Therefore, recently, a sheet made of a polypropylene resin, which is an olefin resin, has come to be used as a sheet for PTP packaging with attention paid to moisture proofing, low cost and easy processing.

However, as a sheet for PTP, polypropylene is inferior in impact resistance to PVC (especially at low temperatures) and has a narrow molding condition range. There were problems such as troubles in packaging and machine stoppage, poor splitting (ease of cutting when a tablet or capsule was cut into small units by slitting a PTP package). Among these problems, there are several examples of methods for improving impact resistance, moldability, and curling properties. For example, a method of adding a thermoplastic elastomer (TPE) to improve impact resistance (see Patent Document 1), a crystallinity can be suppressed by adding petroleum resin to improve moldability, A method of lowering the modulus of elasticity during heating (see Patent Document 2). In order to improve curling, the crystallinity of polypropylene is obtained by using a crystal nucleating agent, gradually cooling during sheeting, and further annealing the sheet. (Refer to Patent Document 3), further, from the surface of the PTP packaging device, a pinpoint heating method in which the heating part of the heating plate is only formed at a portion to be molded, and a method of correcting curl by a reverse warping device (Patent Document 4) For example).
However, with respect to the splitting property, improvement in the shape and material of the slit blade has been attempted, but since it is inferior to that of vinyl chloride and difficult to split, further improvement is required.

JP-A-8-157659 JP 59-143613 A JP 58-142818 A Japanese Patent Application Laid-Open No. 5-201408

The present invention was made in order to solve the problem that the conventional polypropylene-based PTP package has poor splitting properties, and the object of the present invention is a polypropylene-based PTP sheet having splitting properties similar to those of vinyl chloride and its It is in providing a PTP package and also the manufacturing method thereof.

In the present invention, (1) A is an area of the entire thickness of a sheet mainly composed of polypropylene, and B is a depth area of a portion where a slit blade for the purpose of imparting splitting is inserted from the sheet surface. 2A ≦ B ≦ 4 / 5A), the non-insertion depth region of the slit blade is C (C = A−B), and the region C has more crystal regions than the region B before the slit blade is inserted. And the crystallinity in the whole sheet thickness direction is 60% or less, and after inserting the slit blade, the crystallinity in the whole sheet thickness direction is 40% or more.・ Polypropylene sheet for packs,
(2) A press-through pack package comprising the polypropylene sheet according to (1),
(3) A method for producing a polypropylene sheet for press-through pack according to (1),
(4) A method for producing the press-through pack package according to (2),
It is.

  According to the present invention, it becomes possible to improve the splitting property of the polypropylene-based PTP package, the poor workability at the hospital site caused by the poor splitting property, the elderly can not be split at the time of use, and the aluminum at the time of splitting Can be solved by being pulled by the bottom material sheet and causing the drug inside to jump out.

  The polypropylene resin constituting the sheet of the present invention is not particularly limited, but a crystalline polypropylene resin is preferable, and examples of polypropylene resins that can be preferably used include crystalline propylene homopolymer, crystalline propylene- Examples thereof include an ethylene random copolymer, a crystalline propylene / α-olefin random copolymer, and a crystalline block copolymer of propylene and ethylene and / or α-olefin. Examples of the α-olefin include α-olefins having 4 to 10 carbon atoms such as butene-1, pentene-1, hexene-1, octene-1, and decene-1.

  The polypropylene resin constituting the sheet of the present invention contains various additives such as an antioxidant, an antifogging agent, an antistatic agent, a nucleating agent, an ultraviolet absorber, a pigment, a petroleum resin, and a filler as necessary. You may contain. In addition, an organic polymer other than the polypropylene resin may be blended within the range not hindering the present invention.

    The PTP polypropylene sheet according to the present invention and the PTP package obtained from the PTP polypropylene sheet are inserted through the sheet surface by a slit blade for the purpose of imparting splitting ability to the entire area of the sheet. The depth region of the part is B (1 / 2A ≦ B ≦ 4 / 5A), the non-insertion depth region of the slit blade is C (C = A−B), and the region is more than the region B before the slit blade is inserted. There are more C crystal regions (the crystal region is the total area obtained from the size and number of spherulites obtained by observing a thin film section of a sheet cross section produced by a microtome with a polarizing microscope) and the sheet The degree of crystallinity in the entire thickness direction (the degree of crystallinity is a value calculated by the X-ray diffraction method) is 60% or less, and the thickness of the sheet after inserting the slit blade. Overall crystallinity of 40% or more. Here, when the insertion depth D of the slit blade is larger than 1 / 2A, the target splitting property cannot be achieved, and when it is smaller than 4 / 5A, the split portion is bent and severed and cut before being split. Further, in the region B, the crystal region needs to be relatively suppressed in order to improve the slit blade insertion, and on the contrary, the region C needs to have a relatively high crystal region in order to improve the folding at the time of division. Therefore, the region C has more crystal regions than the region B. As for the crystal level, the entire crystallinity in the sheet thickness direction is 60% or less before the slit blade is inserted, and the entire crystallinity in the sheet thickness direction is 40% or more after the slit blade is inserted. . Here, if the crystallinity in the entire sheet thickness direction is higher than 60% before the slit blade is inserted, it means that the crystallinity is higher than necessary in the region B, and the slit blade is poorly inserted. Divisibility becomes worse. If the crystallinity in the entire sheet thickness direction becomes lower than 40% after inserting the slit blade, it means that the crystallinity in the region C becomes lower than necessary, and the folding at the time of division becomes worse and the splitting property becomes worse. .

The sheet | seat of this invention may be comprised by the single layer which consists of polypropylene resin, and may be comprised by the 2 or more layer which consists of polypropylene resin. In such a multilayer, the crystal states of the regions B and C are relatively easy to adjust. For example, the layer B side is provided with a layer that relatively suppresses the crystalline state of polypropylene by adding random polypropylene or petroleum resin,
Examples of the region C side include using a polypropylene having high stereoregularity, or providing a layer in which the crystal state of polypropylene is relatively high by adding a crystal nucleating agent.
The thickness of the sheet | seat of this invention is not specifically limited, Usually, it is the range of 0.15-0.6 mm, Preferably it is the range of 0.25-0.35 mm.

  The sheet of the present invention can be produced using a conventional sheet molding method such as a T-die molding method or a calendar molding method. When the film formed of the molten resin is cooled and solidified, it is preferable that the cooling rate of the region C is lower than the cooling rate of the region B in order to adjust the crystal state of the region B and the region C. For example, in a T-die molding method using an apparatus equipped with an air chamber (or air knife) and a cooling roll, the surface temperature of the cooling roll is set to 50 ° C. or lower, and the temperature of air supplied to the air chamber (or air knife) Is preferably higher by 10 to 100 ° C. (more preferably 20 to 80 ° C.) than the surface temperature of the cooling roll. Moreover, in the T-die molding method using an apparatus including a cooling roll and a touch roll, the surface temperature of the cooling roll is set to 50 ° C. or lower, and the surface temperature of the touch roll is 10 to 60 ° C. higher than the surface temperature of the cooling roll. (Preferably 20-50 degreeC) It is preferable to make it high. On the other hand, in calendering using an apparatus including a first roll and a second roll, the surface temperature difference between the first roll and the second roll is set to 10 to 60 ° C. (preferably 20 to 50 ° C.). preferable.

  The PTP package of the present invention can be produced by a hot plate compressed air (with plug assist) molding method or a drum heating vacuum molding method. Here, in order to obtain the polypropylene sheet and the polypropylene PTP package of the present invention, the following method may be mentioned. At the time of heating before molding, the surface on the region C side is heated at a relatively higher temperature than the surface on the region B side. Specifically, the region B is preferably equal to or lower than the recrystallization temperature of the polypropylene sheet, and the region C is preferably equal to or higher than the recrystallization temperature. In cooling after heating before molding, the surface on the region B side may be rapidly cooled, and the surface on the region C side may be removed. At the time of sealing, the surface under the region B may be rapidly cooled by cooling the under-seal feed roll as much as possible. When slitting, it is preferable to insert a slit blade near the recrystallization temperature of the polypropylene sheet. When the adjustment at the above-mentioned places is still insufficient or when it is desired to further improve the division property, the adjustment may be made so that the same effect can be obtained at other places.

Hereinafter, the present invention will be described in more detail with reference to examples. However, these are merely examples, and the present invention is not limited to these examples.
<Example 1>

The raw materials shown below were melt-extruded from a multilayer coextrusion die (two-layer multi-manifold die), and both surfaces of the sheet were taken at a cooling temperature of 30 ° C. to produce a sheet having a thickness of 0.30 mm. In addition, each layer thickness was 0.2 / 0.1 mm (slit insertion surface side layer / opposite surface layer).
(Slit insertion surface side layer)
・ Ethylene-propylene random copolymer: PP1 MFR = 1.8
(Opposite side)
・ Polypropylene homopolymer: PP2 MFR = 2.3
・ Metallic phosphate nucleating agent: NA
[Blend ratio: PP2 / NA = 100 / 0.3 (unit: parts by weight)]
Using this sheet, a PTP package was produced under the following conditions. In a PTP molding machine (CBP Co., Ltd. FBP-M2), using a biofermin tablet mold (diameter 10 mmφ, depth 5 mm), line speed 2000 tablets / min, pinpoint heating plate, molding temperature 136 ° C.
Molded at a blow pressure of 0.5 MPa and a mold temperature of 25 ° C., sealed with aluminum foil at 25 ° C., 0.45 MPa and 220 ° C. without filling the contents, and slittered at 120 ° C. After putting, a PTP package was produced by punching into a width of 37 mm, a length of 94 mm, and a corner of 5 mmR.
<Example 2>

The raw materials shown below were melt-extruded from a single-layer extrusion die, and the slit insertion surface was drawn at a temperature of 15 ° C., and the opposite surface was drawn at a temperature of 50 ° C. to produce a single-layer sheet having a thickness of 0.30 mm.
・ Polypropylene homopolymer: PP2 MFR = 2.3
・ Petroleum resin (cyclopentadiene hydrogenated petroleum resin): DCPD softening temperature 125 ℃
[Blending ratio: PP2 / DCPD = 100/10 (unit: parts by weight)]
Using this sheet, a PTP package was produced under the following conditions. In a PTP molding machine (CBP Co., Ltd. FBP-M2), using a biofermin tablet mold (diameter 10 mmφ, depth 5 mm), line speed 2000 tablets / min, pinpoint heating plate, molding temperature 136 ° C.
Molded at a blow pressure of 0.5 MPa and a mold temperature of 25 ° C., sealed with aluminum foil at 25 ° C., 0.45 MPa and 220 ° C. without filling the contents, and slittered at 120 ° C. After putting, a PTP package was produced by punching into a width of 37 mm, a length of 94 mm, and a corner of 5 mmR.
<Example 3>

The raw materials shown below were melt extruded from a single-layer extrusion die, and both surfaces of the sheet were taken out at a cooling temperature of 30 ° C. to produce a single-layer sheet having a thickness of 0.30 mm.
・ Polypropylene homopolymer: PP2 MFR = 2.3
・ Petroleum resin (cyclopentadiene hydrogenated petroleum resin): DCPD softening temperature 125 ℃
[Blending ratio: PP2 / DCPD = 100/10 (unit: parts by weight)]
Using this sheet, a PTP package was produced under the following conditions. In a PTP molding machine (CBP Co., Ltd. FBP-M2), using a tablet for biofermin (diameter 10 mmφ, depth 5 mm), line speed 2000 tablets / min, full surface heating plate, slit blade insertion side Hot plate temperature (molding temperature) 120 ° C, opposite hot plate temperature (molding temperature) 140 ° C, blow pressure 0.5MPa, mold temperature on the slit blade insertion side 15 ° C, mold on the opposite slit blade insertion side Molded at a temperature of 40 ° C., sealed with aluminum foil at 220 ° C. at 0.45 MPa and 220 ° C. under a sealed feed roll 40 ° C. without filling the contents, put a slitter at 120 ° C., then 37 mm in width and length PTP package was produced by punching into 94 mm and 5 mm corner.
<Comparative Example 1>

The raw materials shown below were melt extruded from a single-layer extrusion die, and both surfaces of the sheet were taken out at a cooling temperature of 30 ° C. to produce a single-layer sheet having a thickness of 0.30 mm.
・ Polypropylene homopolymer: PP2 MFR = 2.3
・ Petroleum resin (cyclopentadiene hydrogenated petroleum resin): DCPD softening temperature 125 ℃
[Blending ratio: PP2 / DCPD = 100/10 (unit: parts by weight)]
Using this sheet, a PTP package was produced under the following conditions. In a PTP molding machine (CBP Co., Ltd. FBP-M2), using a biofermin tablet mold (diameter 10 mmφ, depth 5 mm), line speed 2000 tablets / min, pinpoint heating plate, molding temperature 136 ° C. Molded at a blow pressure of 0.5 MPa and a mold temperature of 25 ° C., sealed with aluminum foil at 25 ° C., 0.45 MPa and 220 ° C. without filling the contents, and slittered at 120 ° C. After putting, a PTP package was produced by punching into a width of 37 mm, a length of 94 mm, and a corner of 5 mmR.
<Comparative example 2>

The raw materials shown below were melt-extruded from a multilayer coextrusion die (two-layer multi-manifold die), and both surfaces of the sheet were taken at a cooling temperature of 30 ° C. to produce a sheet having a thickness of 0.30 mm. The thickness of each layer was 0.2 / 0.1 mm (slit insertion surface side layer / opposite surface layer).
(Slit insertion surface side layer)
・ Polypropylene homopolymer: PP2 MFR = 2.3
・ Metallic phosphate nucleating agent: NA
[Blend ratio: PP2 / NA = 100 / 0.3 (unit: parts by weight)]
(Opposite side)
・ Ethylene-propylene random copolymer: PP1 MFR = 1.8
Using this sheet, a PTP package was produced under the following conditions. In a PTP molding machine (CBP Co., Ltd. FBP-M2), using a biofermin tablet mold (diameter 10 mmφ, depth 5 mm), line speed 2000 tablets / min, pinpoint heating plate, molding temperature 136 ° C. Molded at a blow pressure of 0.5 MPa and a mold temperature of 25 ° C., sealed with aluminum foil at 25 ° C., 0.45 MPa and 220 ° C. without filling the contents, and slittered at 120 ° C. After putting, a PTP package was produced by punching into a width of 37 mm, a length of 94 mm, and a corner of 5 mmR.
<Comparative Example 3>

The raw materials shown below were melt extruded from a single-layer extrusion die, and both surfaces of the sheet were taken out at a cooling temperature of 40 ° C. to produce a single-layer sheet having a thickness of 0.30 mm.
・ Polypropylene homopolymer: PP2 MFR = 2.3
Using this sheet, a PTP package was produced under the following conditions. In a PTP molding machine (CBP Co., Ltd. FBP-M2), a biofermin tablet mold (diameter 10 mmφ, depth 5 mm), line speed 2000 tablets / min, full-surface heating plate, molding temperature 142 ° C, Molded at a blow pressure of 0.5 MPa and a mold temperature of 40 ° C., sealed with aluminum foil at 0.45 MPa and 220 ° C. under a sealed feed roll of 40 ° C. without filling the contents, and put a slitter at 120 ° C. After that, a PTP package was produced by punching into a width of 37 mm, a length of 94 mm, and a corner of 5 mmR.

The evaluation method in the present invention is as follows.
Slit insertion depth: After the slit cross section of the PTP package was cut into a thin film, the slit insertion depth was measured with an optical microscope.
Crystal state observation: After the cutting atmosphere is cooled to −80 ° C. with a cryo device, the cross section of each sample is cut with a microtome to form a thin film of about 5 μm, and then the crystal state of regions B and C is observed with a polarizing microscope. did. The crystal regions were compared with the total area obtained from the size and number of spherulites observed.
Crystallinity: Measured by X-ray diffraction method to calculate crystallinity.
Dividing property: After the PTP package was prepared, it was allowed to stand at room temperature for 7 days, and then the sensory evaluation of dividing property was performed three times along the dividing surface. In the results, ◎ means that it is equivalent to the splitting property of the vinyl chloride PTP package.

  According to the present invention, the splitting property of the polypropylene-based PTP package can be improved, and the same handling as that of the vinyl chloride PTP package can be performed when PTP is used.

It is a top view of a PTP package. It is sectional drawing between D-D 'of FIG.

Explanation of symbols

A sheet thickness B insertion depth area of slit blade C non-insertion depth area of slit blade

Claims (4)

  A region of the entire thickness of the sheet mainly composed of polypropylene is A, and a depth region of a portion where the slit blade for the purpose of imparting splitting property is inserted from the sheet surface is B (1 / 2A ≦ B ≦ 4 / 5A), the non-insertion depth region of the slit blade is C (C = A−B), and before the slit blade is inserted, the region C has more crystal regions than the region B, and the sheet Polypropylene sheet for press-through pack, characterized in that the crystallinity in the entire thickness direction is 60% or less, and the crystallinity in the entire thickness direction is 40% or more after inserting the slit blade.   A press-through pack package comprising the polypropylene sheet according to claim 1.   A method for producing a polypropylene sheet for press-through pack according to claim 1   A method for producing a press-through pack package according to claim 2

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