HRP20200037T4 - TABLETA KOJA SADRŽI 7-[4- (4-BENZO [b] TIOFEN-4-YL-PIPERAZIN-1-YL) BUTOKSI]-1H-KINOLIN-2-ON ILI NJEGOVU SOL - Google Patents
TABLETA KOJA SADRŽI 7-[4- (4-BENZO [b] TIOFEN-4-YL-PIPERAZIN-1-YL) BUTOKSI]-1H-KINOLIN-2-ON ILI NJEGOVU SOL Download PDFInfo
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- HRP20200037T4 HRP20200037T4 HRP20200037TT HRP20200037T HRP20200037T4 HR P20200037 T4 HRP20200037 T4 HR P20200037T4 HR P20200037T T HRP20200037T T HR P20200037TT HR P20200037 T HRP20200037 T HR P20200037T HR P20200037 T4 HRP20200037 T4 HR P20200037T4
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Classifications
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- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Psychiatry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Supply Of Fluid Materials To The Packaging Location (AREA)
- Basic Packing Technique (AREA)
Claims (7)
1. Tableta koja sadrži 7- [4- (4-benzo [b] tiofen-4-il-piperazin-1-il) butoksi] -1H-kinolin-2-on ili njegovu sol kao aktivni sastojak, pomoćnu tvar (a), vezivo (b), sredstvo za razgradnju (c) i mazivo (d),
naznačena time što je pomoćna tvar (a) barem jedan član izabran iz skupine koja se sastoji od laktoze, kukuruznog škroba i mikrokristalne celuloze;
vezivo (b) je hidroksipropil celuloza;
sredstvo za razgradnju (c) je barem jedan član izabran iz skupine koja se sastoji od nisko supstituirane hidroksipropil celuloze, kroskarmeloza natrija i natrijevog karboksimetil škroba; i
mazivo (d) je magnezijev stearat:
tableta koja dodatno sadrži premazni sloj na svojoj površini, pri čemu navedeni premazni sloj sadrži bojilo (e), a bojilo (e) sadrži željezov oksid.
2. Tableta u skladu sa zahtjevom 1, koja sadrži:
0.05 do 25% težine 7- [4- (4-benzo [b] tiofen-4-il-piperazin-l-il) butoksi] -lH-kinolin-2-ona ili njegove soli;
10 do 98.5% težine pomoćne tvari (a);
0.1 do 20% težine veziva (b);
1 do 25% težine sredstva za razgradnju (c); i
0.1 do 10% težine maziva (d), u odnosu na težinu obložene tablete prije nanošenja premaza.
3. Tableta u skladu sa zahtjevom 1 ili 2, naznačena time što na 1 težinski dio 7- [4- (4-benzo [b] tiofen-4-il-piperazin-1-il) butoksi] -1H-kinolin-2-on ili njegove soli, tableta sadrži:
1 do 2000 težinskih dijelova pomoćne tvari (a);
0.01 do 100 težinskih dijelova veziva (b);
0.1 do 500 težinskih dijelova sredstva za razgradnju (c); i
0.01 do 50 težinskih dijelova maziva (d).
4. Tableta u skladu sa zahtjevom 4, naznačena time što tableta sadrži 0.1 do 50% težine boje (e) u odnosu na težinu zaštitnog sloja.
5. Tableta u skladu s bilo kojim od zahtjeva 1 do 5, dobivena formiranjem, u tabletu, granulirane tvari dobivene mokrom granulacijom.
6. Tableta prema bilo kojem od zahtjeva 1 do 5, naznačena time što tableta ne sadrži povidon ili krospovidon.
7. Postupak za proizvodnju tableta, postupak uključuje korake:
(1) granulacija smjese koja sadrži 7- [4- (4-benzo [b] tiofen-4-il-piperazin-l-il) butoksi] -lH-kinolin-2-on ili njegovu sol, pomoćnu tvar (a), vezivo (b) i sredstvo za razgradnju (c), te daljnjim postupkom umiješano mazivo (d);
(2) oblikovanje dobivene smjese u tabletu, i
(3) miješanje sredstva za premazivanje, bojila (e) i tekućeg medija za dobivanje smjese za premazivanje, te premazivanje površine tablete smjesom za premazivanje,
naznačen time što je pomoćni sastojak (a) barem jedan član izabran iz skupine koja se sastoji od laktoze, kukuruznog škroba i mikrokristalne celuloze; vezivo (b) je hidroksipropil celuloza; sredstvo za razgradnju (c) je barem jedan član izabran iz skupine koja se sastoji od nisko supstituirane hidroksipropil celuloze, kroskarmeloza natrija i natrijevog karboksimetil škroba; i
mazivo (d) je magnezijev stearat; i
gdje mješavina za premaz sadrži željezov oksid kao bojilo (e).
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2011227057 | 2011-10-14 | ||
| EP12840025.6A EP2767285B2 (en) | 2011-10-14 | 2012-10-12 | TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF |
| PCT/JP2012/076415 WO2013054872A1 (ja) | 2011-10-14 | 2012-10-12 | 7-[4-(4-ベンゾ[b]チオフェン-4-イル-ピペラジン-1-イル)ブトキシ]-1H-キノリン-2-オン又はその塩を含む錠剤 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20200037T1 HRP20200037T1 (hr) | 2020-03-20 |
| HRP20200037T4 true HRP20200037T4 (hr) | 2025-05-23 |
Family
ID=48081918
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200037TT HRP20200037T4 (hr) | 2011-10-14 | 2012-10-12 | TABLETA KOJA SADRŽI 7-[4- (4-BENZO [b] TIOFEN-4-YL-PIPERAZIN-1-YL) BUTOKSI]-1H-KINOLIN-2-ON ILI NJEGOVU SOL |
Country Status (34)
| Country | Link |
|---|---|
| US (8) | US20140234417A1 (hr) |
| EP (1) | EP2767285B2 (hr) |
| JP (2) | JP6084161B2 (hr) |
| KR (1) | KR102072371B1 (hr) |
| CN (2) | CN103889425B (hr) |
| AP (1) | AP2014007564A0 (hr) |
| AR (1) | AR088319A1 (hr) |
| AU (1) | AU2012321723C1 (hr) |
| BR (1) | BR112014008603A2 (hr) |
| CA (1) | CA2851588C (hr) |
| CL (1) | CL2014000909A1 (hr) |
| CO (1) | CO6950480A2 (hr) |
| CY (1) | CY1122460T1 (hr) |
| DK (1) | DK2767285T4 (hr) |
| EA (1) | EA032930B1 (hr) |
| ES (1) | ES2762479T5 (hr) |
| FI (1) | FI2767285T4 (hr) |
| HR (1) | HRP20200037T4 (hr) |
| HU (1) | HUE047493T2 (hr) |
| IL (1) | IL231513B (hr) |
| IN (1) | IN2014DN02055A (hr) |
| JO (1) | JO3753B1 (hr) |
| LT (1) | LT2767285T (hr) |
| MX (1) | MX376092B (hr) |
| MY (1) | MY173370A (hr) |
| PH (1) | PH12014500607A1 (hr) |
| PL (1) | PL2767285T5 (hr) |
| PT (1) | PT2767285T (hr) |
| SG (2) | SG2014013783A (hr) |
| SI (1) | SI2767285T2 (hr) |
| TW (1) | TWI634908B (hr) |
| UA (1) | UA114411C2 (hr) |
| WO (1) | WO2013054872A1 (hr) |
| ZA (1) | ZA201402333B (hr) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI320783B (en) | 2005-04-14 | 2010-02-21 | Otsuka Pharma Co Ltd | Heterocyclic compound |
| JO3753B1 (ar) * | 2011-10-14 | 2021-01-31 | Otsuka Pharma Co Ltd | قرص يتألف من 7-[4-(4-بينزو[بي]ثيوفين-4-ايل-ببرازين-1-1ايل)بوتكسيل]-1اتش-كوينولين-2-وان أو ملح منه |
| JOP20200109A1 (ar) | 2012-04-23 | 2017-06-16 | Otsuka Pharma Co Ltd | مستحضر قابل للحقن |
| JP5936732B1 (ja) * | 2015-03-05 | 2016-06-22 | 日本カラコン合同会社 | フィルムコーティング組成物 |
| CN105106142B (zh) * | 2015-09-22 | 2018-05-22 | 成都欣捷高新技术开发有限公司 | 一种含有依匹哌唑的冻干口服制剂及其制备方法 |
| CN106994119A (zh) * | 2016-01-22 | 2017-08-01 | 浙江华海药业股份有限公司 | 含有依匹哌唑或其盐的口腔崩解片及其制备方法 |
| CA3014090A1 (en) * | 2016-02-19 | 2017-08-24 | Jiangsu Hengrui Medicine Co., Ltd. | Pharmaceutical composition containing jak kinase inhibitor or pharmaceutically acceptable salt thereof |
| KR20190022709A (ko) * | 2016-06-28 | 2019-03-06 | 가부시키가이샤 니폰 고킨 소고 겐큐쇼 | 부형제 및 정제 |
| CN109475557B (zh) * | 2016-07-27 | 2022-01-07 | 日本脏器制药株式会社 | 含有甲氨蝶呤的薄膜包衣片 |
| US11123300B2 (en) * | 2016-08-16 | 2021-09-21 | Hexal Ag | Immediate release tablet of a benzothiophene compound |
| US20200093821A1 (en) | 2016-08-16 | 2020-03-26 | Hexal Ag | Pharmaceutical Compositions of a Benzothiophene Compound |
| CN106496206A (zh) * | 2016-08-31 | 2017-03-15 | 安徽省润生医药股份有限公司 | 一种依匹哌唑新的制备方法 |
| JP7053645B2 (ja) * | 2017-02-23 | 2022-04-12 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 化合物iiiの新しい医学的使用 |
| JP7166754B2 (ja) * | 2017-11-22 | 2022-11-08 | 沢井製薬株式会社 | ダサチニブ無水物含有製剤 |
| EP3501506B1 (en) | 2017-12-19 | 2019-10-09 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Pharmaceutical tablet composition comprising brexpiprazole |
| EP3545950A1 (en) | 2018-03-26 | 2019-10-02 | Adamed sp. z o.o. | Pharmaceutical composition comprising brexpiprazole |
| JPWO2021029020A1 (hr) * | 2019-08-13 | 2021-02-18 | ||
| WO2021095092A1 (ja) * | 2019-11-11 | 2021-05-20 | 大塚製薬株式会社 | 口腔内崩壊錠 |
| CN112168794A (zh) * | 2020-10-27 | 2021-01-05 | 浙江诺得药业有限公司 | 一种布瑞哌唑片的制备方法 |
| WO2022218358A1 (zh) * | 2021-04-13 | 2022-10-20 | 上海博志研新药物技术有限公司 | 一种布瑞哌唑物口腔薄膜剂、其制备方法及应用 |
| EP4374856A1 (en) | 2022-11-23 | 2024-05-29 | Sanovel Ilac Sanayi Ve Ticaret A.S. | A process for tablets comprising brexpiprazole |
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| US6562375B1 (en) * | 1999-08-04 | 2003-05-13 | Yamanouchi Pharmaceuticals, Co., Ltd. | Stable pharmaceutical composition for oral use |
| AU2002353659A1 (en) * | 2001-12-18 | 2003-07-15 | Synthon B.V. | Simvastatin dosage forms |
| AU2003223093B2 (en) * | 2002-05-03 | 2010-02-04 | Israel Institute For Biological Research | Methods and compositions for treatment of central and peripheral nervous system disorders and novel compounds useful therefor |
| OA13050A (en) | 2003-04-29 | 2006-11-10 | Pfizer Ltd | 5,7-diaminopyrazolo [4,3-D] pyrimidines useful in the treatment of hypertension. |
| CN100480279C (zh) * | 2003-06-09 | 2009-04-22 | 陶氏环球技术公司 | 稳定的有机硼烷聚合反应引发剂和可聚合的组合物 |
| JP2006061067A (ja) * | 2004-08-26 | 2006-03-09 | Asahi Kasei Life & Living Corp | 酸素インジケーター |
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| JP4315393B2 (ja) | 2005-04-14 | 2009-08-19 | 大塚製薬株式会社 | 複素環化合物 |
| TWI320783B (en) * | 2005-04-14 | 2010-02-21 | Otsuka Pharma Co Ltd | Heterocyclic compound |
| DE602006004694D1 (de) | 2006-01-05 | 2009-02-26 | Teva Pharma | Feuchtgranulierungsmethode zur Herstellung pharmazeutischer Aripiprazolzusammensetzungen |
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| RU2470635C2 (ru) * | 2007-05-11 | 2012-12-27 | Сантен Фармасьютикал Ко., Лтд. | Профилактическое или терапевтическое средство, применяемое при заболеваниях заднего отдела глаза |
| TW200924768A (en) | 2007-10-12 | 2009-06-16 | Astrazeneca Ab | Composition |
| JP5463564B2 (ja) * | 2009-05-22 | 2014-04-09 | 国立大学法人信州大学 | 耐熱性及び耐塩性セルラーゼ製剤 |
| TR201000948A1 (tr) | 2010-02-09 | 2011-08-22 | Sanovel İlaç San.Ve Ti̇c.A.Ş. | Aripiprazol formülasyonları. |
| TWI636784B (zh) * | 2011-04-05 | 2018-10-01 | 大塚製藥股份有限公司 | 含7-〔4-(4-苯並〔b〕噻吩-4-基-哌-1-基)丁氧基〕-1H-喹啉-2-酮之醫藥組成物與套組,以及彼之用途 |
| US9839684B2 (en) | 2011-04-06 | 2017-12-12 | Biovaxim Limited | Pharmaceutical compositions comprising inactivated HIV viral particles and non-pathogenic lactobacilli for the induction of antigen-specific immunotolerance |
| JO3753B1 (ar) * | 2011-10-14 | 2021-01-31 | Otsuka Pharma Co Ltd | قرص يتألف من 7-[4-(4-بينزو[بي]ثيوفين-4-ايل-ببرازين-1-1ايل)بوتكسيل]-1اتش-كوينولين-2-وان أو ملح منه |
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2012
- 2012-10-04 JO JOP/2012/0301A patent/JO3753B1/ar active
- 2012-10-09 TW TW101137267A patent/TWI634908B/zh active
- 2012-10-12 MY MYPI2014700632A patent/MY173370A/en unknown
- 2012-10-12 SI SI201231718T patent/SI2767285T2/sl unknown
- 2012-10-12 AP AP2014007564A patent/AP2014007564A0/xx unknown
- 2012-10-12 PT PT128400256T patent/PT2767285T/pt unknown
- 2012-10-12 EP EP12840025.6A patent/EP2767285B2/en active Active
- 2012-10-12 CN CN201280050586.1A patent/CN103889425B/zh active Active
- 2012-10-12 US US14/351,325 patent/US20140234417A1/en not_active Abandoned
- 2012-10-12 AR ARP120103801A patent/AR088319A1/es not_active Application Discontinuation
- 2012-10-12 ES ES12840025T patent/ES2762479T5/es active Active
- 2012-10-12 CN CN201710266863.7A patent/CN107397730A/zh active Pending
- 2012-10-12 WO PCT/JP2012/076415 patent/WO2013054872A1/ja not_active Ceased
- 2012-10-12 HR HRP20200037TT patent/HRP20200037T4/hr unknown
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- 2012-10-12 JP JP2013538582A patent/JP6084161B2/ja active Active
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2014
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