WO2019159967A1 - プラスチック容器 - Google Patents
プラスチック容器 Download PDFInfo
- Publication number
- WO2019159967A1 WO2019159967A1 PCT/JP2019/005106 JP2019005106W WO2019159967A1 WO 2019159967 A1 WO2019159967 A1 WO 2019159967A1 JP 2019005106 W JP2019005106 W JP 2019005106W WO 2019159967 A1 WO2019159967 A1 WO 2019159967A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- plastic container
- bag
- container according
- bag body
- port member
- Prior art date
Links
- 229920003023 plastic Polymers 0.000 title claims abstract description 73
- 239000004033 plastic Substances 0.000 title claims abstract description 73
- 229920005989 resin Polymers 0.000 claims abstract description 61
- 239000011347 resin Substances 0.000 claims abstract description 61
- 239000000178 monomer Substances 0.000 claims abstract description 29
- JRZJOMJEPLMPRA-UHFFFAOYSA-N olefin Natural products CCCCCCCC=C JRZJOMJEPLMPRA-UHFFFAOYSA-N 0.000 claims abstract description 25
- 229920006125 amorphous polymer Polymers 0.000 claims abstract description 21
- 150000001336 alkenes Chemical class 0.000 claims abstract description 15
- 125000000753 cycloalkyl group Chemical group 0.000 claims abstract description 13
- 229920000098 polyolefin Polymers 0.000 claims abstract description 11
- 230000000379 polymerizing effect Effects 0.000 claims abstract description 5
- -1 polyethylene Polymers 0.000 claims description 44
- 239000004743 Polypropylene Substances 0.000 claims description 28
- 239000007864 aqueous solution Substances 0.000 claims description 22
- JEXVQSWXXUJEMA-UHFFFAOYSA-N pyrazol-3-one Chemical class O=C1C=CN=N1 JEXVQSWXXUJEMA-UHFFFAOYSA-N 0.000 claims description 22
- QELUYTUMUWHWMC-UHFFFAOYSA-N edaravone Chemical group O=C1CC(C)=NN1C1=CC=CC=C1 QELUYTUMUWHWMC-UHFFFAOYSA-N 0.000 claims description 20
- 125000004122 cyclic group Chemical group 0.000 claims description 19
- 229920000089 Cyclic olefin copolymer Polymers 0.000 claims description 17
- 239000004698 Polyethylene Substances 0.000 claims description 16
- 150000003839 salts Chemical class 0.000 claims description 15
- 229920001155 polypropylene Polymers 0.000 claims description 14
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 claims description 10
- 239000005977 Ethylene Substances 0.000 claims description 10
- 230000009477 glass transition Effects 0.000 claims description 9
- 229920000573 polyethylene Polymers 0.000 claims description 9
- 239000004711 α-olefin Substances 0.000 claims description 9
- 239000003814 drug Substances 0.000 claims description 8
- 238000001802 infusion Methods 0.000 claims description 8
- 150000002430 hydrocarbons Chemical group 0.000 claims description 2
- 239000000306 component Substances 0.000 abstract description 31
- 238000003860 storage Methods 0.000 abstract description 21
- 239000005426 pharmaceutical component Substances 0.000 abstract description 2
- 239000010410 layer Substances 0.000 description 89
- 239000000126 substance Substances 0.000 description 25
- 239000002585 base Substances 0.000 description 21
- 230000001954 sterilising effect Effects 0.000 description 21
- 238000004659 sterilization and disinfection Methods 0.000 description 21
- 238000000034 method Methods 0.000 description 20
- 239000000463 material Substances 0.000 description 19
- 229920005672 polyolefin resin Polymers 0.000 description 19
- 238000002360 preparation method Methods 0.000 description 19
- 235000002639 sodium chloride Nutrition 0.000 description 18
- 238000012360 testing method Methods 0.000 description 17
- 229920000642 polymer Polymers 0.000 description 16
- 229950009041 edaravone Drugs 0.000 description 15
- 125000004432 carbon atom Chemical group C* 0.000 description 14
- 239000000203 mixture Substances 0.000 description 14
- PPBRXRYQALVLMV-UHFFFAOYSA-N Styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 description 12
- 239000004840 adhesive resin Substances 0.000 description 12
- 229920006223 adhesive resin Polymers 0.000 description 12
- 238000007789 sealing Methods 0.000 description 12
- 239000000654 additive Substances 0.000 description 11
- 229920001577 copolymer Polymers 0.000 description 11
- 230000003993 interaction Effects 0.000 description 11
- 239000000243 solution Substances 0.000 description 11
- 229920001971 elastomer Polymers 0.000 description 10
- 229920000092 linear low density polyethylene Polymers 0.000 description 10
- 239000004707 linear low-density polyethylene Substances 0.000 description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 10
- 125000004435 hydrogen atom Chemical group [H]* 0.000 description 9
- 125000000217 alkyl group Chemical group 0.000 description 8
- 238000004519 manufacturing process Methods 0.000 description 8
- 239000003002 pH adjusting agent Substances 0.000 description 8
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- 239000000806 elastomer Substances 0.000 description 6
- 238000002474 experimental method Methods 0.000 description 6
- 239000007924 injection Substances 0.000 description 6
- 238000002347 injection Methods 0.000 description 6
- 239000007788 liquid Substances 0.000 description 6
- 238000000465 moulding Methods 0.000 description 6
- 150000001875 compounds Chemical class 0.000 description 5
- 238000013461 design Methods 0.000 description 5
- 238000010438 heat treatment Methods 0.000 description 5
- 150000002848 norbornenes Chemical class 0.000 description 5
- 239000000546 pharmaceutical excipient Substances 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 238000007152 ring opening metathesis polymerisation reaction Methods 0.000 description 5
- VXNZUUAINFGPBY-UHFFFAOYSA-N 1-Butene Chemical compound CCC=C VXNZUUAINFGPBY-UHFFFAOYSA-N 0.000 description 4
- 238000000071 blow moulding Methods 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 238000011049 filling Methods 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 229920001519 homopolymer Polymers 0.000 description 4
- 239000012968 metallocene catalyst Substances 0.000 description 4
- 239000002904 solvent Substances 0.000 description 4
- WKBPZYKAUNRMKP-UHFFFAOYSA-N 1-[2-(2,4-dichlorophenyl)pentyl]1,2,4-triazole Chemical compound C=1C=C(Cl)C=C(Cl)C=1C(CCC)CN1C=NC=N1 WKBPZYKAUNRMKP-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 3
- 101150059062 apln gene Proteins 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 238000007599 discharging Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000003792 electrolyte Substances 0.000 description 3
- 125000002768 hydroxyalkyl group Chemical group 0.000 description 3
- 238000004811 liquid chromatography Methods 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 238000002844 melting Methods 0.000 description 3
- 230000008018 melting Effects 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 230000002093 peripheral effect Effects 0.000 description 3
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 description 3
- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 description 3
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 description 3
- 239000011780 sodium chloride Substances 0.000 description 3
- 238000001179 sorption measurement Methods 0.000 description 3
- HECLRDQVFMWTQS-RGOKHQFPSA-N 1755-01-7 Chemical compound C1[C@H]2[C@@H]3CC=C[C@@H]3[C@@H]1C=C2 HECLRDQVFMWTQS-RGOKHQFPSA-N 0.000 description 2
- HZAXFHJVJLSVMW-UHFFFAOYSA-N 2-Aminoethan-1-ol Chemical compound NCCO HZAXFHJVJLSVMW-UHFFFAOYSA-N 0.000 description 2
- DLFVBJFMPXGRIB-UHFFFAOYSA-N Acetamide Chemical compound CC(N)=O DLFVBJFMPXGRIB-UHFFFAOYSA-N 0.000 description 2
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 2
- 239000004713 Cyclic olefin copolymer Substances 0.000 description 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 229920002633 Kraton (polymer) Polymers 0.000 description 2
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 description 2
- 229940123973 Oxygen scavenger Drugs 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- 241000405115 Zela Species 0.000 description 2
- 235000011054 acetic acid Nutrition 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 229910052783 alkali metal Inorganic materials 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 239000003963 antioxidant agent Substances 0.000 description 2
- 230000004888 barrier function Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 238000005537 brownian motion Methods 0.000 description 2
- 150000001720 carbohydrates Chemical class 0.000 description 2
- 238000012790 confirmation Methods 0.000 description 2
- 238000007334 copolymerization reaction Methods 0.000 description 2
- 239000012153 distilled water Substances 0.000 description 2
- 229920000840 ethylene tetrafluoroethylene copolymer Polymers 0.000 description 2
- 238000001125 extrusion Methods 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 230000036512 infertility Effects 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 238000001746 injection moulding Methods 0.000 description 2
- 238000003475 lamination Methods 0.000 description 2
- JFNLZVQOOSMTJK-KNVOCYPGSA-N norbornene Chemical compound C1[C@@H]2CC[C@H]1C=C2 JFNLZVQOOSMTJK-KNVOCYPGSA-N 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 239000000565 sealant Substances 0.000 description 2
- 239000012453 solvate Substances 0.000 description 2
- 229920002803 thermoplastic polyurethane Polymers 0.000 description 2
- JOXIMZWYDAKGHI-UHFFFAOYSA-N toluene-4-sulfonic acid Chemical compound CC1=CC=C(S(O)(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-N 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 description 1
- 229920003067 (meth)acrylic acid ester copolymer Polymers 0.000 description 1
- LIKMAJRDDDTEIG-UHFFFAOYSA-N 1-hexene Chemical compound CCCCC=C LIKMAJRDDDTEIG-UHFFFAOYSA-N 0.000 description 1
- 229940058020 2-amino-2-methyl-1-propanol Drugs 0.000 description 1
- WSSSPWUEQFSQQG-UHFFFAOYSA-N 4-methyl-1-pentene Chemical compound CC(C)CC=C WSSSPWUEQFSQQG-UHFFFAOYSA-N 0.000 description 1
- 229920002126 Acrylic acid copolymer Polymers 0.000 description 1
- 229920000178 Acrylic resin Polymers 0.000 description 1
- 239000004925 Acrylic resin Substances 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 241000206601 Carnobacterium mobile Species 0.000 description 1
- CPELXLSAUQHCOX-UHFFFAOYSA-N Hydrogen bromide Chemical compound Br CPELXLSAUQHCOX-UHFFFAOYSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 1
- 229920003354 Modic® Polymers 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 230000002292 Radical scavenging effect Effects 0.000 description 1
- BLRPTPMANUNPDV-UHFFFAOYSA-N Silane Chemical compound [SiH4] BLRPTPMANUNPDV-UHFFFAOYSA-N 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 1
- 241001080519 Zera Species 0.000 description 1
- 239000011954 Ziegler–Natta catalyst Substances 0.000 description 1
- 239000006096 absorbing agent Substances 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 150000007513 acids Chemical class 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 150000001340 alkali metals Chemical class 0.000 description 1
- 229910052784 alkaline earth metal Inorganic materials 0.000 description 1
- 150000001342 alkaline earth metals Chemical class 0.000 description 1
- 238000005865 alkene metathesis reaction Methods 0.000 description 1
- 125000003545 alkoxy group Chemical group 0.000 description 1
- 125000004453 alkoxycarbonyl group Chemical group 0.000 description 1
- 125000005078 alkoxycarbonylalkyl group Chemical group 0.000 description 1
- 125000004414 alkyl thio group Chemical group 0.000 description 1
- 125000002947 alkylene group Chemical group 0.000 description 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 150000001408 amides Chemical class 0.000 description 1
- 150000001412 amines Chemical class 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- CBTVGIZVANVGBH-UHFFFAOYSA-N aminomethyl propanol Chemical compound CC(C)(N)CO CBTVGIZVANVGBH-UHFFFAOYSA-N 0.000 description 1
- 229910021529 ammonia Inorganic materials 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 239000002518 antifoaming agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 239000002216 antistatic agent Substances 0.000 description 1
- 125000003118 aryl group Chemical group 0.000 description 1
- 125000004104 aryloxy group Chemical group 0.000 description 1
- 125000001797 benzyl group Chemical group [H]C1=C([H])C([H])=C(C([H])=C1[H])C([H])([H])* 0.000 description 1
- 238000007664 blowing Methods 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- QHIWVLPBUQWDMQ-UHFFFAOYSA-N butyl prop-2-enoate;methyl 2-methylprop-2-enoate;prop-2-enoic acid Chemical compound OC(=O)C=C.COC(=O)C(C)=C.CCCCOC(=O)C=C QHIWVLPBUQWDMQ-UHFFFAOYSA-N 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 1
- 235000015165 citric acid Nutrition 0.000 description 1
- 239000011247 coating layer Substances 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 125000004663 dialkyl amino group Chemical group 0.000 description 1
- 238000004512 die casting Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000009820 dry lamination Methods 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 239000008151 electrolyte solution Substances 0.000 description 1
- 239000003995 emulsifying agent Substances 0.000 description 1
- 229920001038 ethylene copolymer Polymers 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000010101 extrusion blow moulding Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 239000001530 fumaric acid Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 125000005843 halogen group Chemical group 0.000 description 1
- 238000007654 immersion Methods 0.000 description 1
- 239000003978 infusion fluid Substances 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 229920003049 isoprene rubber Polymers 0.000 description 1
- 238000010030 laminating Methods 0.000 description 1
- 229920001684 low density polyethylene Polymers 0.000 description 1
- 239000004702 low-density polyethylene Substances 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 239000001630 malic acid Substances 0.000 description 1
- 235000011090 malic acid Nutrition 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 125000005397 methacrylic acid ester group Chemical group 0.000 description 1
- 229940098779 methanesulfonic acid Drugs 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 235000010755 mineral Nutrition 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 125000001624 naphthyl group Chemical group 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 235000006408 oxalic acid Nutrition 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 239000003208 petroleum Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 229920001083 polybutene Polymers 0.000 description 1
- 229920001225 polyester resin Polymers 0.000 description 1
- 239000004645 polyester resin Substances 0.000 description 1
- 238000006116 polymerization reaction Methods 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 229920005604 random copolymer Polymers 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000011342 resin composition Substances 0.000 description 1
- 238000007151 ring opening polymerisation reaction Methods 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 239000003566 sealing material Substances 0.000 description 1
- 229910000077 silane Inorganic materials 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 230000007480 spreading Effects 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 229920006132 styrene block copolymer Polymers 0.000 description 1
- 125000001424 substituent group Chemical group 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 229920003002 synthetic resin Polymers 0.000 description 1
- 239000000057 synthetic resin Substances 0.000 description 1
- XBFJAVXCNXDMBH-UHFFFAOYSA-N tetracyclo[6.2.1.1(3,6).0(2,7)]dodec-4-ene Chemical compound C1C(C23)C=CC1C3C1CC2CC1 XBFJAVXCNXDMBH-UHFFFAOYSA-N 0.000 description 1
- 229920002725 thermoplastic elastomer Polymers 0.000 description 1
- 239000012929 tonicity agent Substances 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 125000002023 trifluoromethyl group Chemical group FC(F)(F)* 0.000 description 1
- 238000007740 vapor deposition Methods 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 238000004804 winding Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1468—Containers characterised by specific material properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1475—Inlet or outlet ports
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/415—1,2-Diazoles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/0005—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor characterised by the material
- B29C49/0006—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor characterised by the material for heating or cooling
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
- B29C49/04—Extrusion blow-moulding
- B29C49/04116—Extrusion blow-moulding characterised by the die
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B1/00—Layered products having a non-planar shape
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
- B32B27/325—Layered products comprising a layer of synthetic resin comprising polyolefins comprising polycycloolefins
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
- B32B27/327—Layered products comprising a layer of synthetic resin comprising polyolefins comprising polyolefins obtained by a metallocene or single-site catalyst
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B3/00—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form
- B32B3/02—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by features of form at particular places, e.g. in edge regions
- B32B3/08—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by features of form at particular places, e.g. in edge regions characterised by added members at particular parts
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
- B32B7/04—Interconnection of layers
- B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D231/00—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings
- C07D231/02—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings
- C07D231/10—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members
- C07D231/14—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D231/18—One oxygen or sulfur atom
- C07D231/20—One oxygen atom attached in position 3 or 5
- C07D231/22—One oxygen atom attached in position 3 or 5 with aryl radicals attached to ring nitrogen atoms
- C07D231/26—1-Phenyl-3-methyl-5- pyrazolones, unsubstituted or substituted on the phenyl ring
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
- B29C49/04—Extrusion blow-moulding
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/22—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor using multilayered preforms or parisons
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
- B29K2023/04—Polymers of ethylene
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
- B29K2023/10—Polymers of propylene
- B29K2023/12—PP, i.e. polypropylene
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/712—Containers; Packaging elements or accessories, Packages
- B29L2031/7148—Blood bags, medical bags
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2250/00—Layers arrangement
- B32B2250/02—2 layers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2250/00—Layers arrangement
- B32B2250/24—All layers being polymeric
- B32B2250/242—All polymers belonging to those covered by group B32B27/32
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2307/00—Properties of the layers or laminate
- B32B2307/30—Properties of the layers or laminate having particular thermal properties
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2307/00—Properties of the layers or laminate
- B32B2307/70—Other properties
- B32B2307/702—Amorphous
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2307/00—Properties of the layers or laminate
- B32B2307/70—Other properties
- B32B2307/704—Crystalline
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2439/00—Containers; Receptacles
- B32B2439/40—Closed containers
- B32B2439/46—Bags
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2439/00—Containers; Receptacles
- B32B2439/80—Medical packaging
Definitions
- the present invention relates to a plastic container excellent in storage stability of a pharmaceutical preparation having a high affinity with chemicals, in particular, a plastic. More specifically, the innermost layer of the sheet member forming the bag body of the bag is formed by polymerizing at least one or two or more olefin monomers, and at least one of the olefin monomers has a cyclic hydrocarbon skeleton.
- the port member that forms the mouth part of the amorphous polymer that is a monomer and that has a mouth portion relates to a plastic container that mainly includes a crystalline polyolefin having no cyclic hydrocarbon skeleton.
- a soft bag formulation in which an injectable drug is diluted and prepared in advance as a formulation for intravenous infusion and filled in a flexible container (plastic container) made of plastic or the like.
- the soft bag formulation is said to be useful because it reduces the risk of breakage and is excellent in disposal compared to glass bottles and ampoules. .
- some chemicals including radical scavenging preparations have ordinary crystallinity such as polyethylene (hereinafter sometimes referred to as “PE”) and polypropylene (hereinafter sometimes referred to as “PP”).
- PET polyethylene
- PP polypropylene
- Patent Document 1 proposes a multilayer body in which a cyclic polyolefin resin layer is disposed as an innermost layer, and an intermediate layer and an outermost layer are formed from a PE-based resin.
- the plastic container obtained by the Example of patent document 1 has joined the bag body which consists of a multilayer body of the invention, and the opening
- a cyclic polyolefin-based resin which is generally used as a pharmaceutical container and is more expensive than PE-based resin or PP-based resin, as a material for the port member is not only a material cost viewpoint, but also a sheet member and a port member. Since the time for welding becomes long and productivity becomes relatively low, it is not preferable in terms of cost. In addition, after sealing the mouth with a rubber plug or the like, it is necessary to maintain the sealing performance with the cap. However, in order to develop sufficient strength at the joint, the cap member must also be made of a cyclic olefin resin. In this respect, there is a problem of cost.
- Patent Document 2 reports an example in which a bag container is formed from a multilayer sheet in which an innermost layer is made of a PP resin, an intermediate layer is a cyclic polyolefin resin, and an outermost layer is made of a PP resin.
- an aqueous solution of edaravone is contained as the contents, and changes in the component content before and after sterilization at 115 ° C. for 30 minutes are described.
- the present invention has been made in view of the above circumstances, and has an object to provide a plastic container that has excellent storage stability with respect to a pharmaceutical component having a high affinity for plastic and can be mass-produced at low cost. To do.
- the inventors of the present application focused on the relationship between the ratio of the sheet member forming the plastic container and the content contact area of the port member, and the volume of the content to be stored,
- the sheet member constituting the portion is formed from a laminate including the innermost layer made of a specific resin component, and the port member has a material composition mainly composed of a crystalline polyolefin resin, so that the contents can be accommodated in the plastic container.
- the present invention was completed by finding that the product can be stably stored including the sterilization process.
- the innermost layer of the sheet member is formed by polymerizing at least one kind or two or more kinds of olefin monomers, and at least one kind of the olefin monomers is cyclic.
- An amorphous polymer which is a monomer having a hydrocarbon skeleton, is a main component, and the port member is formed mainly of a crystalline polyolefin having no cyclic hydrocarbon skeleton.
- the plastic container of the present invention includes a bag body formed in a bag shape by a sheet member and having an accommodating portion therein, one end communicating with the accommodating portion and the other end opening outside the bag body.
- a monomer is polymerized, and at least one of the olefin monomers is mainly composed of an amorphous polymer that is a monomer having a cyclic hydrocarbon skeleton, and the port member is a crystal having no cyclic hydrocarbon skeleton. It is characterized by being formed of a resin mainly composed of a functional polyolefin.
- the relationship between the content contact area S B (cm 2 ) of the bag body and the content contact area S P (cm 2 ) of the port member preferably satisfies the following (formula 1).
- (Formula 1) 0.01 ⁇ S P / S B ⁇ 0.15
- the crystalline polyolefin may be selected from one or more of polyethylene, polypropylene, and ethylene / ⁇ -olefin copolymer.
- the amorphous polymer may have a glass transition temperature of 70 ° C. or higher.
- the amorphous polymer may have a glass transition temperature of 100 ° C. or higher.
- the plastic container may be in the form of an infusion bag or a blow molded container.
- the contents stored in the plastic container may be a medicine.
- the pharmaceutical may be an aqueous solution containing a pyrazolone derivative or a pharmaceutically acceptable salt thereof.
- the pyrazolone derivative may be 3-methyl-1-phenyl-2-pyrazolin-5-one. It is also a preferable aspect that the plastic container of the present invention is housed in a package having gas barrier properties together with an oxygen scavenger from the viewpoint of storage stability of a chemical solution.
- a plastic container excellent in storage stability of an aqueous solution containing a pharmaceutical ingredient having a high affinity for plastic can be provided at low cost.
- a typical example of a pharmaceutical ingredient having a high affinity with a plastic described in this embodiment is a pyrazolone derivative.
- a pyrazolone derivative a compound represented by the following formula (I) can be used.
- R 1 represents a hydrogen atom, aryl, alkyl having 1 to 5 carbon atoms or alkoxycarbonylalkyl having 3 to 6 carbon atoms in total
- R 2 represents a hydrogen atom, aryloxy, aryl mercapto, carbon number It may represent 1 to 5 alkyl or hydroxyalkyl having 1 to 3 carbon atoms.
- R 1 and R 2 may together represent an alkylene having 3 to 5 carbon atoms.
- R 3 is a hydrogen atom, alkyl having 1 to 5 carbon atoms, cycloalkyl having 5 to 7 carbon atoms, hydroxyalkyl having 1 to 3 carbon atoms, benzyl, naphthyl, phenyl, or the same or different 1
- Up to 3 substituents alkoxy having 1 to 5 carbon atoms, hydroxyalkyl having 1 to 3 carbon atoms, alkoxycarbonyl having 2 to 5 carbon atoms, alkyl mercapto having 1 to 3 carbon atoms, alkyl having 1 to 4 carbon atoms
- It may represent phenyl substituted with amino, selected from the group consisting of amino, dialkylamino having 2 to 8 carbon atoms, halogen atom, trifluoromethyl, carboxyl, cyano, hydroxyl group, nitro, amino, and acetamide.
- a pharmaceutically acceptable salt thereof can also be used.
- Pharmaceutically acceptable salts include salts with mineral acids such as hydrochloric acid, sulfuric acid, hydrobromide, phosphoric acid; methanesulfonic acid, p-toluenesulfonic acid, acetic acid, oxalic acid, citric acid, malic acid, Salts with organic acids such as fumaric acid; salts with alkali metals such as sodium and potassium; salts with alkaline earth metals such as magnesium; ammonia, ethanolamine, 2-amino-2-methyl-1-propanol, etc. Examples include salts with amines.
- the kind of the salt is not particularly limited as long as it is pharmaceutically acceptable.
- a hydrate or solvate thereof can be used as an active ingredient of a drug solution.
- an aqueous solution containing the pyrazolone derivative represented by formula (I) or a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof as an active ingredient, contained in the plastic container of the present embodiment is, for example,
- the concentration of the pyrazolone derivative is about 0.06 mg / mL or more and about 2 mg / mL or less, preferably about 0.3 mg / mL or more and about 0.6 mg / mL or less. It can be prepared by dissolving in a solvent (for example, an infusion solution, etc.), adjusting the pH by adding a pH adjusting agent as desired, and adding other additives as desired.
- the chemical solution used for the preparation of the aqueous solution containing the pyrazolone derivative may be any chemical solution as long as it is generally used as a chemical solution, but preferably electrolytes, saccharides, vitamins, proteins, amino acids.
- electrolytes One or two or more types arbitrarily selected from the above are dissolved in water (for example, distilled water for injection) at an arbitrary concentration.
- electrolyte solution what melt
- dissolved saccharides may be called a sugar solution.
- the electrolyte include sodium chloride.
- sodium chloride or the like is dissolved in water (for example, distilled water for injection) at an arbitrary concentration.
- the content of these substances is preferably sodium chloride, for example, equal to that of physiological saline, that is, 0.9% (W / V).
- the pH adjuster used for the preparation of the aqueous solution containing the pyrazolone derivative can be used without particular limitation as long as it is generally used as a pH adjuster for injections.
- the liquidity of the aqueous solution containing the pyrazolone derivative, that is, the pH can be arbitrarily adjusted by using the above pH adjuster.
- additives used for the preparation of an aqueous solution containing a pyrazolone derivative can be used without particular limitation as long as they are generally used as additives for injections.
- preferable other additives include, for example, pharmaceutical additives as described in Yakuji Nippo Co., Ltd. 2000 “Pharmaceutical Additives Dictionary” (edited by the Japan Pharmaceutical Additives Association). These additives may be added as a salt (for example, a monovalent alkali metal salt such as a sodium salt or a potassium salt) or may be added as a hydrate as desired. These additives are generally blended in a proportion usually used for injections. It is easy for those skilled in the art.
- these additives may be used depending on the purpose of use, for example, stabilizers, surfactants, etc. It can be used properly as an agent, buffer, solubilizer, antioxidant, antifoaming agent, tonicity agent, emulsifier, suspending agent, preservative, soothing agent, solubilizer, solubilizer, etc. .
- These additives can be added to an aqueous solution containing the pyrazolone derivative of this embodiment or other pharmaceuticals in combination of two or more components as desired.
- the addition and mixing operations in the preparation of the aqueous solution can be performed according to ordinary pharmaceutical methods.
- the pyrazolone derivative and the pH adjusting agent may be weighed and mixed, and then dissolved in water, or the aqueous solution containing the pyrazolone derivative may be dissolved in water.
- the weighed pH adjuster may be dissolved.
- a weighed pyrazolone derivative may be dissolved in an aqueous solution containing a pH adjuster.
- aqueous solution containing a pH regulator and an aqueous solution containing a pyrazolone derivative it is also possible to prepare an aqueous solution containing a pH regulator and an aqueous solution containing a pyrazolone derivative, and mix these aqueous solutions so that the concentration of the pyrazolone derivative is the above-mentioned concentration. Also, when other additives are included, it can be similarly prepared.
- the plastic container of the present embodiment is formed in a bag shape by a sheet member 12 and has a housing portion 13 inside, and a bag body 11 attached to the bag body 11 and attached to the housing portion 13.
- the sheet member 12 has a two-layer structure including a base resin layer 12b and an innermost layer 12a.
- the innermost layer 12a is formed by polymerizing at least one or two or more types of olefin monomers, and at least one of the olefin monomers is mainly composed of an amorphous polymer that is a monomer having a cyclic hydrocarbon skeleton.
- the port member 15 is made of a resin mainly composed of crystalline polyolefin having no cyclic hydrocarbon skeleton.
- the “main component” in each layer of the sheet member and the port member means that the ratio of the component of interest to the entire matrix including the component exceeds 50 mass%. It is.
- the plastic container according to the present embodiment uses a sheet member including at least a base resin layer and an innermost layer in this order, overlaps with the innermost layer as an inner surface, seals the periphery, and further includes a port member made of a crystalline polyolefin resin. It can be manufactured by molding into a shape.
- the thickness of the sheet member is not particularly limited, but is preferably 70 to 400 ⁇ m, and more preferably 150 to 300 ⁇ m from the viewpoint of strength and flexibility required as a container.
- the peripheral seal width is not particularly limited, but is 2 to 20 mm, preferably 3 to 7 mm.
- the innermost layer which is a sealant layer mainly composed of an amorphous polymer, has a thickness of 10 to 100 ⁇ m, more preferably 20 to 80 ⁇ m. If the thickness of the innermost layer is less than 10 ⁇ m, the sealing performance may not be sufficient, or the welding strength with the mouth provided as necessary may not be sufficient. Further, when the mouth is welded, the innermost layer is thinned by heating and pressurization, which may cause liquid leakage due to pinholes. The thickness of the innermost layer may exceed 100 ⁇ m, but if the thickness is increased, the flexibility of the container may be inferior. Further, it is not preferable in terms of cost.
- lamination can be performed by coextrusion molding such as multilayer inflation molding and multilayer T die casting, extrusion lamination in which molten resin is directly laminated, or dry lamination using an adhesive.
- amorphous polymer constituting the innermost layer and the resin constituting the base resin layer are laminated by coextrusion molding, these may be laminated directly, but if necessary, the base resin layer and the outermost polymer may be laminated.
- an adhesive resin typified by Mitsui Chemicals' "Admer (registered trademark)", Mitsubishi Chemical “Modic (registered trademark)” and the like can also be used.
- a composition specified by the specification of Japanese Patent Application No. 2017-140246 which was found by the inventors of the present application and has already applied for a patent, may be used.
- the resin contains a resin component composed of linear low density polyethylene, styrene elastomer and polypropylene resin, and the ratio of (linear low density polyethylene) :( total of styrene elastomer and polypropylene resin) is a weight ratio.
- an adhesive resin in the range of 40:60 to 95: 5.
- FIG. 1 illustrates a plastic container 10 in which the innermost layer 12a and the base resin layer 12b of the sheet member 12 are directly laminated
- FIG. 2 illustrates the innermost layer 12a and the base resin layer 12b of the sheet member 12.
- the plastic container 20 in which the adhesive resin layer 12c is laminated as an intermediate layer is illustrated.
- the sheet member of the present embodiment may optionally include an intermediate layer, a printed layer, a vapor deposition layer, a coating layer, and the like as layers other than those illustrated.
- multilayer extrusion blow molding is suitably employed.
- a multilayer coextrusion blow molding method a multi-layer extruder having a plurality of extruders is used to extrude an amorphous polymer and a crystalline polyolefin resin, and if necessary, an adhesive resin and other synthetic resins. Extrusion is performed by melting with a machine, and blow molding is performed by blowing air.
- the preform may be once blow molded after being formed into a preform, or each molten resin layer may be formed into a tubular multilayer parison inside a multilayer parison molding die, and direct blow molding may be performed. Good.
- the PP base resin and PE base resin are mainly used for the base resin layer constituting the sheet member used in the plastic container of the present embodiment.
- the PP resin is a copolymer obtained by copolymerizing a small amount (preferably 10 wt% or less) of an ⁇ -olefin such as ethylene and 1-butene in addition to a homopolymer of propylene, and for example, disclosed in JP-A-2001-226435. It is composed of a copolymer produced by multistage polymerization of propylene and ⁇ -olefin. Moreover, you may use the compound of these homopolymers and copolymers, and another polyolefin and resin.
- the melt flow rate (230 ° C., 21.2 N) value of the resin constituting the base resin layer is preferably 1 to 4 (g / 10 minutes).
- “Zeras (registered trademark)” registered trademark manufactured by Mitsubishi Chemical Corporation can be exemplified.
- low density polyethylene or linear low density polyethylene (linear low density polyethylene) is preferably used.
- the polyethylene preferably has a density in the range of 0.880 to 0.920 g / cm 3 .
- the ⁇ -olefin has 12 or less carbon atoms, and examples thereof include propylene, butene-1, hexene-1, 4-methylpentene-1, and octene-1.
- As said linear low density polyethylene what is manufactured with a metallocene catalyst is preferable.
- Linear low-density polyethylene polymerized with a metallocene catalyst is excellent in transparency and the like because of its small structure heterogeneity. Further, since the molecular weight distribution is uniform, when the linear low density polyethylene is heated, the polyethylene has few bleeds and is less likely to be clouded.
- Polypropylene used for the base resin layer or intermediate layer of the sheet member is manufactured using a Ziegler-Natta catalyst or a metallocene catalyst. Syndiotactic polypropylene produced using a metallocene catalyst is preferable because it is excellent in flexibility and transparency.
- the polypropylene preferably has a melting peak temperature of 110 ° C. or higher, more preferably 120 ° C. or higher. When the polypropylene having the temperature characteristics is used for the intermediate layer, heat resistance is imparted to the plastic container.
- the amorphous polymer that is the main component of the innermost layer used in the sheet member of the present embodiment is composed of at least one or two or more olefin monomers, and at least one of the olefin monomers has a cyclic hydrocarbon skeleton. Is an amorphous polymer. However, when the amorphous polymer consists of only one kind of cyclic olefin monomer (norbornene compound or the like), it may be a ring-opening metathesis polymer such as a norbornene compound, but a single addition polymer such as a norbornene compound or the like. It is preferably not included.
- the amorphous polymer that is the main component of the innermost layer used in the sheet member of the present embodiment is a copolymer composed of two or more kinds of cyclic olefin monomers such as norbornene compounds, or a cyclic olefin such as a cyclic olefin monomer and an ⁇ -olefin.
- cyclic olefin monomers such as norbornene compounds
- a cyclic olefin such as a cyclic olefin monomer and an ⁇ -olefin.
- the above cyclic olefin polymer can be used as the amorphous polymer that is the main component of the innermost layer used in the sheet member of the present embodiment.
- the above cyclic olefin polymer examples include the following.
- a cyclic olefin polymer For the production of a cyclic olefin polymer, generally, there are known a method obtained by hydrogenating a ring-opening metathesis polymer of norbornenes and a method obtained by copolymerization reaction of norbornenes and ⁇ -olefin.
- the basic structure of the cyclic olefin polymer can be expressed as, for example, [Chemical Formula 2] described in JP2011-237572A (see Formula (II) below). That is, it is described as a polymer in which cyclic unit skeletons and ethylene unit skeletons are alternately arranged.
- n is an integer of 1 or more
- R 1 and R 2 represent a hydrogen atom or an alkyl group, and may be the same or different.
- R 1 and R 2 may combine with each other to form a ring.
- the structure represented by the formula (II) may be a homopolymer of one kind of cyclic olefin monomer, that is, a homopolymer (the combination of R 1 and R 2 bonded to n cyclic unit skeletons is the same)
- n cyclic unit skeletons And a combination of R 1 and R 2 bonded to is also included.
- Japanese Patent Application Laid-Open No. 2014-124927 discloses that the chemical structure of “ZEONOR (registered trademark)” 1060R manufactured by ZEON CORPOR
- m and n are integers of 1 or more, and R 1 and R 2 represent a hydrogen atom or an alkyl group, and may be the same or different. R 1 and R 2 may combine with each other to form a ring.
- m and n are integers of 1 or more, and R 1 , R 2 and R 3 represent a hydrogen atom or an alkyl group, and may be the same or different. R 1 and R 2 may be bonded to each other to form a ring.
- a structure in which R 1 , R 2 , and R 3 are all hydrogen atoms in the formula (IV) is typically known as “TOPAS (registered trademark)” sold by Polyplastics Co., Ltd. (Registered trademark) ”is introduced in the general catalog.
- R 1 and R 2 are alkyl groups and R 3 is a hydrogen atom corresponds to “Apel (registered trademark)” sold by Mitsui Chemicals, Inc., and “Apel (registered trademark)” products It is described as a typical structure in the catalog.
- these cyclic olefin polymers are resins having excellent water vapor barrier properties and are easily available. As described above, in the plastic container of the present embodiment, these cyclic olefin polymers can be used as the amorphous polymer that is the main component of the innermost layer, and the cyclic olefin that is the main component of the innermost layer. As the polymer, one kind of polymer can be used alone, or two or more kinds of polymers can be used in combination.
- cyclic olefin polymer commercially available products as described above can also be used.
- examples of the commercially available products include ZEONEX (registered trademark) (manufactured by Nippon Zeon Co., Ltd., ring-opening metathesis polymer hydrogenated polymer of norbornene monomer), TOPAS (registered trademark) (Polyplastics Co., Ltd.) , A copolymer of norbornene and ethylene), ZEONOR (registered trademark) (manufactured by Nippon Zeon Co., Ltd., a copolymer based on ring-opening polymerization of dicyclopentadiene and tetracyclopentadodecene), Apel (registered trademark) (manufactured by Mitsui Chemicals, Inc.) , A copolymer of ethylene and tetracyclododecene), Arton (registered trademark) (manufactured trademark) (manufacture
- resin components include polyethylene, polypropylene, polybutene, ethylene / ⁇ -olefin copolymer, ethylene / (meth) acrylic acid copolymer, ethylene / vinyl acetate copolymer, ethylene / (meth) acrylic acid ester copolymer
- polyolefin resins such as polymers, urethane resins, rubber resins, polyester resins, polyester urethane resins, acrylic resins, amide resins, styrene resins, and silane resins.
- the material constituting the innermost layer of the sheet member is composed of only a cyclic olefin polymer (that is, containing 100% by mass of the cyclic olefin polymer).
- the innermost layer preferably contains a cyclic olefin polymer as a main component, that is, 50% by mass or more, and particularly preferably 70% by mass or more.
- a drug component having a high affinity with a trace component or plastic may be sorbed, and the storage stability of the drug component to be accommodated may be insufficient.
- the materials constituting the innermost layer of the sheet member are antioxidants and ultraviolet absorbers, as long as they do not impair safety and hygiene in order to improve the appearance of the container, stabilize the quality, and provide other required performance. Further, various additives such as an antistatic agent, a lubricant and an antiblocking agent may be contained.
- the plastic container of this embodiment is preferably heat-treated at a temperature of 60 ° C. or higher, or high-pressure steam sterilized at a temperature of over 100 ° C., more preferably at a temperature of 121 ° C.
- the glass transition temperature of the optimum amorphous polymer (cyclic polyolefin) that prevents such a phenomenon must be at least equal to or higher than the temperature of the heat treatment or high-pressure steam sterilization treatment of the container. It is effective that the glass transition temperature of the polymer is 70 ° C. or higher, preferably 100 ° C. or higher, more preferably 130 ° C. or higher.
- At least one or more ports (ports) for discharging the aqueous solution that is the contained material may be provided in a part of the plastic container.
- the mouth part can be used not only for discharging but also as a mouth part for filling.
- the plastic container is a bag-like container, the innermost layer as the sealant layer of the sheet member can be overlapped, and the mouth can be inserted between them to be welded by heat sealing.
- the port member used in the present embodiment has a cylindrical shape such as a cylindrical shape, and the base end portion is inserted into the opening of the bag body and bonded to the sheet members on both sides by bonding or heat sealing. ing.
- the dimensions of the port member are not limited in the present invention. For example, if the outer diameter excluding the convex portion is 4 to 20 mm, the wall thickness is 0.5 to 3 mm, and the length is about 20 to 50 mm, It is suitable as a connection part with a set. Further, the shape of the port member may be a boat shape or the like at the joint with the sheet member in order to increase the joint strength with the bag body.
- the port member is attached with a sealing body (not shown) to prevent leakage to the outside and to prevent dust and bacteria from entering the system and maintain the quality of the contents. Sealed.
- a sealing body an elastic body molded from rubber or elastomer is mainly used.
- a cap is attached or a sealing material is arranged as necessary to fix the sealing body.
- a known method can be employed as a method for manufacturing a normal resin molded product represented by an injection molding method.
- Different materials may be blended or arranged in multiple layers to alleviate the interaction of the contents contained in the plastic container, but in order to maximize the effect of this embodiment, the material is PE or PP.
- a component such as a styrene-based elastomer may be added to the port member within a range that does not impair the heat resistance against the heat treatment. it can. Since the port member of this embodiment can easily join the cyclic olefin-based resin of the sheet member, the time required for sealing can be shortened, so that the productivity of the plastic container is excellent. That is, the plastic container of this embodiment can be provided at low cost.
- a cyclic olefin resin for the innermost layer in order to prevent the interaction between the contents and the plastic container.
- a crystalline polyolefin resin capable of causing the interaction is used as a main component as a port member.
- the content contact portion area occupied by the port member that can interact with the content is less than a certain ratio with respect to the content contact portion area of the entire plastic container. It is desirable to mitigate interaction with the contents of Therefore, the magnitude of the interaction between the contents and the plastic container correlates with the size of the contents contact area of the plastic container with respect to the volume of the contents to be stored, and appropriate design can be performed. desirable.
- a plastic container that is excessively large relative to the volume of the contents not only increases the interaction, but also increases the overall size of the package, which reduces storage efficiency and transport costs. Will be invited.
- a plastic container that is tight with respect to the volume of the contents is excellent in terms of minimizing the interaction, but it may cause overflow when filling the contents and external forces applied during transportation and storage. Since there is no “escape”, the container may be destroyed by impact.
- the cyclic olefin resin is used for the innermost layer of the sheet member, the relationship between the appropriate content volume and the dimensions of the plastic container (that is, the content contact area) is within a certain range. It is desirable to do so.
- Equation 1 the relationship between the content contact area S B (cm 2 ) of the bag body of the plastic container and the content contact area S P (cm 2 ) of the port member is expressed by the following (Equation 1). It is preferable to satisfy. (Formula 1) 0.01 ⁇ S P / S B ⁇ 0.15
- the area of the content contact portion 14 of the bag body 11 corresponds to the inner surface area of the sheet members 15 on both sides facing the housing portion 13, and the joint portion 11 a between the bag body 11 and the port member 15 or the bag body 11.
- the peripheral joint 11b is excluded.
- the area of the content contact portion 17 of the port member 15 includes a portion communicating with the accommodating portion 13 on the one end 15a side.
- the content contact portions 14 and 17 are not limited to the portions where the contents are actually in contact, but include portions that can contact the contents by changing the posture of the plastic container.
- the relationship between the volume V (cm 3 ) of the contents accommodated in the plastic container and the contents contact portion area S P + S B (cm 2 ) of the entire plastic container is also expressed by, for example, (Expression 2). It is desirable that the ratio be a certain ratio. (Formula 2) ⁇ ⁇ V / (S P + S B ) ⁇
- ⁇ and ⁇ are positive coefficients set appropriately.
- the plastic container of the present embodiment is a sealable container, and may be in any form as long as it can maintain the sterility of the contents.
- a container in the form of a blow-molded container such as an infusion bag or a syringe, ampoule or vial used is preferable, and an infusion bag is particularly preferable.
- these forms of containers are preferably transparent and non-colored for the purpose of visual confirmation and confirmation of the formation and mixing of foreign substances, particularly insoluble foreign substances, but the light resistance of the contents and the design of the containers In consideration of the property and convenience, it may be colored within a range that does not impair the visual recognition of the contents.
- the plastic container of the present embodiment is filled with an aqueous solution containing the above-described pyrazolone derivative in the above-mentioned bag with a port (infusion bag, blow molded container, etc.), attached with an elastic body such as a rubber stopper, and assembled with a cap. It can be manufactured by attaching or sealingly forming it by sealing or aluminum cap winding as required. Moreover, it can be set as the plastic container holding sterility by attaching
- examples of a specific sterilization method in the sterilization operation include a hot water immersion sterilization method, a hot water shower sterilization method, and a high-pressure steam sterilization (autoclave) method.
- LLDPE1 Linear low density polyethylene (manufactured by Ube Maruzen Polyethylene, Umerit (registered trademark) 125FN)
- PP polypropylene-based thermoplastic elastomer (manufactured by Mitsubishi Chemical Corporation, Zelas (registered trademark) 7025)
- COP cycloolefin polymer (manufactured by Zeon Corporation, ZEONOR (registered trademark) 690R)
- COC cycloolefin copolymer (manufactured by Polyplastics, TOPAS (registered trademark) 6013F04)
- PP adhesive resin Polypropylene adhesive elastomer (manufactured by Mitsubishi Chemical Corporation, Zelas (registered trademark) MC729)
- Random PP Metallocene-catalyzed polymerized polypropylene (manufactured by Nippon Polypro, Wintech (registered trademark) WFW4M)
- LLDPE2 linear low density polyethylene (
- a port member having an inner diameter of the cylindrical portion of 15 mm, a height of 38 mm, and a thickness of the cylindrical portion of 0.8 mm was obtained by an injection molding method.
- the resin materials used in each test example are shown in Table 1 and Table 2.
- a bag container was manufactured using the sheet member and the port member obtained as described above.
- the bag container had a size that the inner dimension of the bag body was about 140 (mm) ⁇ 105 (mm).
- a port member was sandwiched between two sheets constituting the bag body, and the sheet member and the port member were thermally welded to form a bag container.
- the area of the wetted part (content contact part) of the bag body of the completed bag container was 250 (cm 2 ), and the area of the wetted part (content contact part) of the port member was 20 (cm 2 ). It was.
- the container containing the preparation was sterilized at 105 ° C. for 30 minutes with a high-pressure steam sterilizer, and after cooling was completed, the outside of the container was dried to obtain a bag preparation.
- the bag preparation that has been subjected to the sterilization operation is placed in a dry laminate outer bag having a three-layer structure of biaxially stretched polyester / aluminum foil / linear low density polyethylene, and an oxygen scavenger (“AGELESS” manufactured by Mitsubishi Gas Chemical Co., Ltd.). (Registered trademark) ”), and the opening was heat sealed to complete the preparation of the specimen.
- AGELESS oxygen scavenger
- the prepared bag sample containing the preparation was allowed to stand in an environment of 40 ° C. and 75% relative humidity for 3 months, and the edaravone aqueous solution of the contents was collected from the sample after the storage period. And measured by liquid chromatography.
- Detector UV absorptiometer (measurement wavelength: 243 nm)
- Column A column for liquid chromatography, in which a stainless steel tube having an inner diameter of 4.6 mm and a length of 150 mm is packed with octadecylsilylated silica gel having a particle diameter of 5 ⁇ m.
- Column temperature constant temperature around 40 ° C.
- Flow rate 1.0 mL / min.
- Injection volume 20 ⁇ L
- edaravone remaining rate (%) (peak area of edaravone at the time of sampling) / (peak area of edaravone at the initial value) ⁇ 100 (%)
- Table 4 shows the component residual ratios of edaravone preparations stored in bag containers made of sheet members and port members of Test Examples 1 to 12 having different material compositions.
- Specimens produced according to the present invention show substantially the same storage stability as specimens (Test Examples 5 to 8) in which the wetted parts of the bag container are all made of a cyclic olefin resin. Yes.
- the intermediate layer (adhesive resin layer) of the sheet member contains a cyclic olefin resin
- the specimen of Test Example 9 or 10 in which the wetted part is all PE is ⁇ 5 even after storage at 40 ° C. for 3 months.
- specimens composed only of PE or PP without using a cyclic olefin resin as the sheet material deviate from the standard of the residual rate immediately after sterilization, and then stored at 40 ° C. for 3 months. In addition, the residual rate tends to greatly decrease.
- Experiment 2 Was Seibukuro bag container by the sheet member and the port member used in Test Example 1 of Experiment 1, the wetted area of the port member increases, in order to increase the liquid contact portion area ratio S P / S B, cylindrical The port member whose dimension in the part height direction was extended and the wetted part area was 30, 40, 50 (cm 2 ) was joined. Otherwise, the edaravone remaining rate was determined by the same method as in Experiment 1. The test results in Experiment 2 are listed in Table 5 together with the test results of Test Example 1 in Experiment 1.
- the liquid contact area ratio S P / S B of the port member increased, the interaction between the preparation and the bag container increased, and the residual rate of edaravone during long-term storage tended to decrease gradually. Moreover, when the liquid contact part area of the port member was excessively large, the residual rate after storage at 40 ° C. for 3 months was less than 95%. Therefore, it was shown that the liquid contact area of the port member that can interact with the contents needs to be designed at a low ratio with respect to the liquid contact area of the bag body.
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Mechanical Engineering (AREA)
- Engineering & Computer Science (AREA)
- Manufacturing & Machinery (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Wrappers (AREA)
- Bag Frames (AREA)
Abstract
Description
本願は、2018年2月15日に、日本に出願された特願2018-024825号に基づき優先権を主張し、その内容をここに援用する。
例えば特許文献1には、最内層に環状ポリオレフィン樹脂層を配置し、中間層および最外層をPE系樹脂から形成する多層体が提案されている。特許文献1の実施例により得られるプラスチック容器は、医療容器を同発明の多層体からなる袋本体と、環状ポリオレフィン系樹脂からなる口部を接合している。しかし、医薬容器として汎用的な、PE系樹脂やPP系樹脂と比較して高価な環状ポリオレフィン系樹脂をポート部材の材質として用いることは、材料価格の観点のみならず、シート部材とポート部材を溶着するための時間が長くなり、相対的に低い生産性となるため、コスト面で好ましくない。また、口部をゴム栓等により封止した後、キャップにより密封性を保持する必要があるが、接合部で十分な強度を発現させるためには、キャップ部材も環状オレフィン系樹脂で構成しなければならず、この点でもコスト面の問題がある。
(式1) 0.01≦SP/SB≦0.15
前記非晶性ポリマーのガラス転移温度が、70℃以上であってもよい。
前記非晶性ポリマーのガラス転移温度が、100℃以上であってもよい。
前記プラスチック容器が輸液バッグまたはブロー成形容器の形態であってもよい。
前記医薬品が、ピラゾロン誘導体またはその薬学的に許容され得る塩を含有する水溶液であってもよい。
前記ピラゾロン誘導体が、3-メチル-1-フェニル-2-ピラゾリン-5-オンであってもよい。
本発明のプラスチック容器を、脱酸素剤とともに、ガスバリア性を有する包装体内に収容することも、薬液の保存安定性の点から、好ましい態様である。
本実施形態で述べる、プラスチックとの親和性が高い医薬品成分としては、代表的なものとしてピラゾロン誘導体を挙げることができる。ピラゾロン誘導体は、下記式(I)で表される化合物を用いることができる。
さらに、式(I)で示されるピラゾロン誘導体またはその薬学的に許容され得る塩のほか、それらの水和物若しくは溶媒和物を薬液の有効成分とすることもできる。
PP系樹脂は、プロピレンのホモポリマーのほか、エチレン、1-ブテン等のα-オレフィンを少量(好ましくは10重量%以下)共重合したコポリマーや、例えば特開2001-226435号公報に開示されるプロピレンとα-オレフィンとを多段重合により製造される共重合体等により構成される。また、これらホモポリマーや共重合体と他のポリオレフィンや樹脂とのコンパウンドを用いてもよい。中でも、環状ポリオレフィン層の剛直さを緩和し、多層フィルムの柔軟性を向上させるものとして、医療用容器用として汎用されている曲げ弾性率が400~600MPaの比較的柔軟なグレードのものを用いるのが好適である。また別の観点からはベース樹脂層を構成する樹脂のメルトフローレート(230℃、21.2N)値を1~4(g/10分)とするのが好適である。本実施形態で好適に使用できるベース樹脂層を構成する樹脂の具体例を例示すると、三菱ケミカル株式会社製の「ゼラス(登録商標)」(登録商標)を挙げることができる。特に、融解ピーク温度が160~170℃のPP系樹脂を用いることが好ましい。
シート部材の最内層を構成する材料には、容器外観の向上や品質の安定化、その他必要とされる性能を付与するために、安全衛生性を損なわない範囲で、酸化防止剤、紫外線吸収剤、帯電防止剤、滑剤、ブロッキング防止剤等の各種添加剤等を含有してもよい。
口部の溶着方法は、プラスチック容器が袋状容器である場合は、シート部材のシーラント層である最内層同士を重ね合わせて、その間に口部を挿入してヒートシールで溶着することができる。
(式1) 0.01≦SP/SB≦0.15
(式2) α<V/(SP+SB)<β
<シート部材の製膜>
Tダイ式多層製膜機を用いて、最内層の厚みが30(μm)、シート部材の総厚みが250(μm)となるよう、共押出工法によりシート部材を製膜した。ベース樹脂層がPE系樹脂である場合は、ベース樹脂層と最内層が隣接して配置された2層構成のシートとした。ベース樹脂層がPP系樹脂を主成分とする場合、ベース樹脂層と最内層との間に、接着性樹脂層を配置した3層の構成とした。ベース樹脂層、接着性樹脂層、および最内層として用いた樹脂組成は、表1および表2に一覧として示した。なお、表1において[ ]内の数値は各層の厚みであり、表2における( )の数値は混配の質量比を表す。
PP:ポリプロピレン系熱可塑性エラストマー(三菱ケミカル社製、ゼラス(登録商標)7025)
COP:シクロオレフィンポリマー(日本ゼオン社製、ZEONOR(登録商標)690R)
COC:シクロオレフィンコポリマー(ポリプラスチックス社製、TOPAS(登録商標)6013F04)
PP系接着樹脂:ポリプロピレン系接着性エラストマー(三菱ケミカル社製、ゼラス(登録商標)MC729)
ランダムPP:メタロセン触媒重合ポリプロピレン(日本ポリプロ社製、ウィンテック(登録商標)WFW4M)
LLDPE2:直鎖状低密度ポリエチレン(日本ポリエチレン社製、ハーモレックス(登録商標)NJ744N)
St(スチレン)系エラストマー:スチレン-エチレン-ブチレン-スチレンブロック共重合体(クレイトンポリマー社製、クレイトン(登録商標)G(スチレン含有率13質量%、比重0.90g/cm3、MFR=22g/10min(230℃、5kgf))
射出成形法により、円筒部内径が15mm、高さ38mm、円筒部肉厚が0.8mmのポート部材を得た。各試験例に用いた樹脂材料は、表1および表2に合わせて記載した。
上記により得られたシート部材とポート部材を用い、バッグ容器を製造した。バッグ容器は袋本体の内寸が約140(mm)×105(mm)となる寸法とした。袋本体を構成する2枚のシート間に、ポート部材を挟み込み、シート部材とポート部材を熱溶着してバッグ容器を形成した。出来上がったバッグ容器の袋本体の接液部(内容物接触部)の面積は250(cm2)であり、ポート部材の接液部(内容物接触部)の面積は20(cm2)であった。
上記により製袋した容器内には、下記表3に示す組成(エダラボンモデル製剤の組成)で、pH3.85に調製したエダラボン含有水溶液を製剤とし、容器内に105mLを充填して、接液面がETFE(テトラフルオロエチレン-エチレン共重合体)フィルムでラミネートされた、イソプレンゴム栓および各ポート部材と同一材質のキャップにより密封した。
カラム:内径4.6mm、長さ150mmのステンレス管に粒径5μmのオクタデシルシリル化シリカゲルを充填した液体クロマトグラフィー用カラム。
カラム温度:40℃付近の一定温度。
移動相:メタノール:水:酢酸=49.8:49.8:0.4
流速:1.0mL/min。
注入量:20μL
実験1の試験例1に用いたシート部材およびポート部材によりバッグ容器を製袋したが、ポート部材の接液部面積を大きく、接液部面積比率SP/SBを高くする目的で、円筒部高さ方向の寸法を延長し、接液部面積が30、40、50(cm2)となるポート部材を接合した。それ以外は実験1と同様の手法により、エダラボン残存率を求めた。実験2における試験結果を、実験1の試験例1の試験結果と共に表5に一覧として示した。
Claims (9)
- シート部材により袋状に形成され内部に収容部を有する袋本体と、前記袋本体に取り付けられ前記収容部に一端が連通し、他端の開口部が袋本体より外側に露出した筒状のポート部材とを有するプラスチック容器であって、
前記シート部材はベース樹脂層と最内層とを含む2層以上からなり、前記最内層は、少なくとも1種類または2種類以上のオレフィンモノマーを重合してなり、該オレフィンモノマーのうち少なくとも1種類は環状炭化水素骨格を有するモノマーである非晶性ポリマーが主成分としてなり、
かつ前記ポート部材は、環状炭化水素骨格を有さない結晶性ポリオレフィンを主成分とする樹脂により形成されたことを特徴とする、プラスチック容器。 - 前記袋本体の内容物接触部面積SB(cm2)と、前記ポート部材の内容物接触部面積SP(cm2)との関係性が、下記(式1)を満足することを特徴とする、請求項1に記載のプラスチック容器。
(式1) 0.01≦SP/SB≦0.15 - 前記結晶性ポリオレフィンが、ポリエチレン、ポリプロピレン、エチレン・α-オレフィン共重合体のいずれか1種類以上から選択されることを特徴とする、請求項1または2に記載のプラスチック容器。
- 前記非晶性ポリマーのガラス転移温度が、70℃以上であることを特徴とする、請求項1~3のいずれか1項に記載のプラスチック容器。
- 前記非晶性ポリマーのガラス転移温度が、100℃以上であることを特徴とする、請求項1~4のいずれか1項に記載のプラスチック容器。
- 前記プラスチック容器が輸液バッグまたはブロー成形容器の形態である、請求項1~5のいずれか1項に記載のプラスチック容器。
- 前記プラスチック容器に収容される内容物が医薬品であることを特徴とする、請求項1~6のいずれか1項に記載のプラスチック容器。
- 前記医薬品が、ピラゾロン誘導体またはその薬学的に許容され得る塩を含有する水溶液であることを特徴とする、請求項7に記載のプラスチック容器。
- 前記ピラゾロン誘導体が、3-メチル-1-フェニル-2-ピラゾリン-5-オンであることを特徴とする、請求項8に記載のプラスチック容器。
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020207025094A KR102665924B1 (ko) | 2018-02-15 | 2019-02-13 | 플라스틱 용기 |
EP19754548.6A EP3753543B1 (en) | 2018-02-15 | 2019-02-13 | Plastic container |
US16/969,903 US20210007930A1 (en) | 2018-02-15 | 2019-02-13 | Plastic container |
CN201980013493.3A CN111727030B (zh) | 2018-02-15 | 2019-02-13 | 塑料容器 |
JP2020500519A JP7240374B2 (ja) | 2018-02-15 | 2019-02-13 | プラスチック容器 |
CA3091089A CA3091089A1 (en) | 2018-02-15 | 2019-02-13 | Plastic container |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2018-024825 | 2018-02-15 | ||
JP2018024825 | 2018-02-15 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2019159967A1 true WO2019159967A1 (ja) | 2019-08-22 |
Family
ID=67620009
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2019/005106 WO2019159967A1 (ja) | 2018-02-15 | 2019-02-13 | プラスチック容器 |
Country Status (7)
Country | Link |
---|---|
US (1) | US20210007930A1 (ja) |
EP (1) | EP3753543B1 (ja) |
JP (1) | JP7240374B2 (ja) |
KR (1) | KR102665924B1 (ja) |
CN (1) | CN111727030B (ja) |
CA (1) | CA3091089A1 (ja) |
WO (1) | WO2019159967A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023006565A1 (en) | 2021-07-26 | 2023-02-02 | Medichem, S.A. | Process for preparing formulations of edaravone |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102444788B1 (ko) * | 2020-11-09 | 2022-09-19 | 일진하이솔루스 주식회사 | 수소저장용기 제작용 금형 어셈블리 및 이것을 이용한 수소저장용기 제조 방법 |
Citations (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH0531523B2 (ja) | 1985-05-20 | 1993-05-12 | Mitsubishi Chem Ind | |
JPH05184642A (ja) * | 1991-05-29 | 1993-07-27 | Kawasumi Lab Inc | 医療容器の口部及び医療容器 |
JP2001226435A (ja) | 1999-12-07 | 2001-08-21 | Mitsubishi Chemicals Corp | プロピレン共重合体 |
JP2002528177A (ja) * | 1998-10-23 | 2002-09-03 | アボット・ラボラトリーズ | 形成され、充填され、そして密封される無菌の可撓性容器、及びその可撓性容器のための排液用投与ポート |
JP2008018063A (ja) | 2006-07-13 | 2008-01-31 | Hosokawa Yoko Co Ltd | 医療容器用多層体および医療容器 |
WO2009066752A1 (ja) | 2007-11-22 | 2009-05-28 | Mitsubishi Tanabe Pharma Corporation | 環状ポリオレフィン層を含むプラスチック容器 |
JP2011237572A (ja) | 2010-05-10 | 2011-11-24 | Mitsubishi Plastics Inc | シクロオレフィン系樹脂反射フィルム |
JP2014057723A (ja) * | 2012-09-18 | 2014-04-03 | Fujimori Kogyo Co Ltd | ポート付容器及びその製造方法 |
JP2014124927A (ja) | 2012-12-27 | 2014-07-07 | Lintec Corp | フィルム状封止材、封止シートおよび電子デバイス |
JP2017140246A (ja) | 2016-02-10 | 2017-08-17 | 豊丸産業株式会社 | 遊技機 |
JP2018024825A (ja) | 2016-08-01 | 2018-02-15 | 日本ポリプロ株式会社 | ポリオレフィン系樹脂組成物およびそれを用いたフィルムおよびその製造法 |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2008001496A1 (en) * | 2006-06-28 | 2008-01-03 | Fujimori Kogyo Co., Ltd. | Liquid container |
ES2534740T3 (es) * | 2007-12-20 | 2015-04-28 | Hosokawa Yoko Co., Ltd. | Cuerpo multicapa para recipientes médicos y recipiente médico |
JP5465409B2 (ja) * | 2008-09-29 | 2014-04-09 | テルモ株式会社 | エダラボンのプレミックス製剤 |
US8622213B2 (en) * | 2009-05-22 | 2014-01-07 | Fenwal, Inc. | Containers and components thereof for use in the medical industry and methods to manufacture the same |
JP5045807B2 (ja) * | 2010-11-18 | 2012-10-10 | 東洋製罐株式会社 | 多層プラスチック容器 |
EP2671561B1 (en) * | 2011-02-04 | 2017-06-28 | Terumo Kabushiki Kaisha | Medicine storage container |
-
2019
- 2019-02-13 KR KR1020207025094A patent/KR102665924B1/ko active IP Right Grant
- 2019-02-13 EP EP19754548.6A patent/EP3753543B1/en active Active
- 2019-02-13 WO PCT/JP2019/005106 patent/WO2019159967A1/ja unknown
- 2019-02-13 CA CA3091089A patent/CA3091089A1/en active Pending
- 2019-02-13 CN CN201980013493.3A patent/CN111727030B/zh active Active
- 2019-02-13 JP JP2020500519A patent/JP7240374B2/ja active Active
- 2019-02-13 US US16/969,903 patent/US20210007930A1/en active Pending
Patent Citations (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH0531523B2 (ja) | 1985-05-20 | 1993-05-12 | Mitsubishi Chem Ind | |
JPH05184642A (ja) * | 1991-05-29 | 1993-07-27 | Kawasumi Lab Inc | 医療容器の口部及び医療容器 |
JP2002528177A (ja) * | 1998-10-23 | 2002-09-03 | アボット・ラボラトリーズ | 形成され、充填され、そして密封される無菌の可撓性容器、及びその可撓性容器のための排液用投与ポート |
JP2001226435A (ja) | 1999-12-07 | 2001-08-21 | Mitsubishi Chemicals Corp | プロピレン共重合体 |
JP2008018063A (ja) | 2006-07-13 | 2008-01-31 | Hosokawa Yoko Co Ltd | 医療容器用多層体および医療容器 |
WO2009066752A1 (ja) | 2007-11-22 | 2009-05-28 | Mitsubishi Tanabe Pharma Corporation | 環状ポリオレフィン層を含むプラスチック容器 |
JP2011237572A (ja) | 2010-05-10 | 2011-11-24 | Mitsubishi Plastics Inc | シクロオレフィン系樹脂反射フィルム |
JP2014057723A (ja) * | 2012-09-18 | 2014-04-03 | Fujimori Kogyo Co Ltd | ポート付容器及びその製造方法 |
JP2014124927A (ja) | 2012-12-27 | 2014-07-07 | Lintec Corp | フィルム状封止材、封止シートおよび電子デバイス |
JP2017140246A (ja) | 2016-02-10 | 2017-08-17 | 豊丸産業株式会社 | 遊技機 |
JP2018024825A (ja) | 2016-08-01 | 2018-02-15 | 日本ポリプロ株式会社 | ポリオレフィン系樹脂組成物およびそれを用いたフィルムおよびその製造法 |
Non-Patent Citations (1)
Title |
---|
"Japanese Pharmaceutical Excipients Dictionary", 2000, YAKUJI NIPPO, LIMITED |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023006565A1 (en) | 2021-07-26 | 2023-02-02 | Medichem, S.A. | Process for preparing formulations of edaravone |
Also Published As
Publication number | Publication date |
---|---|
KR102665924B1 (ko) | 2024-05-14 |
CN111727030A (zh) | 2020-09-29 |
KR20200119830A (ko) | 2020-10-20 |
JPWO2019159967A1 (ja) | 2021-02-25 |
EP3753543B1 (en) | 2023-11-22 |
US20210007930A1 (en) | 2021-01-14 |
EP3753543A4 (en) | 2021-11-17 |
JP7240374B2 (ja) | 2023-03-15 |
CN111727030B (zh) | 2023-10-24 |
EP3753543A1 (en) | 2020-12-23 |
CA3091089A1 (en) | 2019-08-22 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
TWI437984B (zh) | 醫療容器用多層體及醫療容器 | |
CA2930072C (en) | Multi-layered plastic polymeric container for the storage of pharmaceutical compositions | |
US9050243B2 (en) | Multilayered body for medical containers and medical container | |
EP2330048B1 (en) | Multilayered liquid container | |
JP5467074B2 (ja) | 医療容器用多層体および医療容器 | |
JP7460679B2 (ja) | 薬液収容プラスチック容器 | |
JP5465409B2 (ja) | エダラボンのプレミックス製剤 | |
WO2019159967A1 (ja) | プラスチック容器 | |
JP2023052479A (ja) | 積層体およびプラスチック容器 | |
JP2018192139A (ja) | 薬液収容プラスチック容器 | |
RU2448677C2 (ru) | Многослойный корпус для медицинских контейнеров и медицинский контейнер |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 19754548 Country of ref document: EP Kind code of ref document: A1 |
|
ENP | Entry into the national phase |
Ref document number: 3091089 Country of ref document: CA Ref document number: 2020500519 Country of ref document: JP Kind code of ref document: A |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
ENP | Entry into the national phase |
Ref document number: 20207025094 Country of ref document: KR Kind code of ref document: A |
|
ENP | Entry into the national phase |
Ref document number: 2019754548 Country of ref document: EP Effective date: 20200915 |