JP2022111328A - 眼科用製品及び粘度低下抑制方法 - Google Patents
眼科用製品及び粘度低下抑制方法 Download PDFInfo
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- 239000008159 sesame oil Substances 0.000 description 1
- URWAJWIAIPFPJE-YFMIWBNJSA-N sisomycin Chemical compound O1C[C@@](O)(C)[C@H](NC)[C@@H](O)[C@H]1O[C@@H]1[C@@H](O)[C@H](O[C@@H]2[C@@H](CC=C(CN)O2)N)[C@@H](N)C[C@H]1N URWAJWIAIPFPJE-YFMIWBNJSA-N 0.000 description 1
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- IWVCMVBTMGNXQD-UHFFFAOYSA-N terramycin dehydrate Natural products C1=CC=C2C(O)(C)C3C(O)C4C(N(C)C)C(O)=C(C(N)=O)C(=O)C4(O)C(O)=C3C(=O)C2=C1O IWVCMVBTMGNXQD-UHFFFAOYSA-N 0.000 description 1
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- 239000011721 thiamine Substances 0.000 description 1
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- 229950010302 tiaramide Drugs 0.000 description 1
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- GFNANZIMVAIWHM-OBYCQNJPSA-N triamcinolone Chemical compound O=C1C=C[C@]2(C)[C@@]3(F)[C@@H](O)C[C@](C)([C@@]([C@H](O)C4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 GFNANZIMVAIWHM-OBYCQNJPSA-N 0.000 description 1
- VSQQQLOSPVPRAZ-RRKCRQDMSA-N trifluridine Chemical compound C1[C@H](O)[C@@H](CO)O[C@H]1N1C(=O)NC(=O)C(C(F)(F)F)=C1 VSQQQLOSPVPRAZ-RRKCRQDMSA-N 0.000 description 1
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
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- 229910052725 zinc Inorganic materials 0.000 description 1
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
- 150000003952 β-lactams Chemical class 0.000 description 1
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Abstract
Description
[1].(A)水溶性高分子化合物、
(B)ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油及びモノステアリン酸ポリエチレングリコールから選ばれる1種又は2種以上の界面活性剤、
(C)ビタミンA、ビタミンE、ジブチルヒドロキシトルエン及び清涼化剤から選ばれる1種以上の成分、及び
(D)下記(D-1)及び(D-2)からなる群から選ばれる1種以上
(D-1)トロメタモール、プロピレングリコール
(D-2)エチレンジアミン酢酸誘導体、エチレンジアミン酢酸誘導体塩、塩酸テトラヒドロゾリン、イプシロンアミノカプロン酸、アラントイン、グリチルリチン酸、グリチルリチン酸塩、クロルフェニラミンマレイン酸塩、ピリドキシン塩酸塩、パンテノール、コンドロイチン硫酸、コンドロイチン硫酸塩、塩化ナトリウム、ネオスチグミンメチル硫酸塩、硫酸亜鉛、フラビンアデニンジヌクレオチドナトリウム、シアノコバラミン、アスパラギン酸、アスパラギン酸塩、アミノエチルスルホン酸
を含有する眼科用組成物と、この眼科用組成物が充填された容器と、この容器を包装する包囲体とを有する眼科用製品であって、
(1)包囲体内への不活性ガス注入、(2)包囲体内への酸素吸収剤の同梱、(3)酸素吸収能を有する容器又は(4)酸素吸収能を有する包囲体のいずれか1以上の手段を用いた眼科用製品。
[2].(D)成分が、(D-1)群から1種以上及び(D-2)群から1種以上である[1]記載の眼科用製品。
[3].(A)成分が、ヒドロキシプロピルメチルセルロース、メチルセルロース、ヒドロキシエチルセルロース、ポリビニルピロリドン、ポリビニルアルコール、カルボキシビニルポリマー、ヒアルロン酸及びその塩から選ばれる1種以上である[1]又は[2]記載の眼科用製品。
[4].(C)成分が、レチノールパルミチン酸エステル、酢酸d-α-トコフェロール、ジブチルヒドロキシトルエン及びメントールから選ばれる1種以上である[1]~[3]のいずれかに記載の眼科用製品。
[5].(A)水溶性高分子化合物、
(B)ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油及びモノステアリン酸ポリエチレングリコールから選ばれる1種又は2種以上の界面活性剤、
(C)ビタミンA、ビタミンE、ジブチルヒドロキシトルエン及び清涼化剤から選ばれる1種以上の脂溶性成分を含有する眼科用組成物と、この眼科用組成物が充填された容器と、この容器を包装する包囲体とを有し、(1)包囲体内への不活性ガス注入、(2)包囲体内への酸素吸収剤の同梱、(3)酸素吸収能を有する容器又は(4)酸素吸収能を有する包囲体のいずれか1以上の手段を用いた眼科用製品において、上記眼科用組成物に、
(D)下記(D-1)及び(D-2)
(D-1)トロメタモール、プロピレングリコール
(D-2)エチレンジアミン酢酸誘導体、エチレンジアミン酢酸誘導体塩、塩酸テトラヒドロゾリン、イプシロンアミノカプロン酸、アラントイン、グリチルリチン酸、グリチルリチン酸塩、クロルフェニラミンマレイン酸塩、ピリドキシン塩酸塩、パンテノール、コンドロイチン硫酸、コンドロイチン硫酸塩、塩化ナトリウム、ネオスチグミンメチル硫酸塩、硫酸亜鉛、フラビンアデニンジヌクレオチドナトリウム、シアノコバラミン、アスパラギン酸、アスパラギン酸塩、アミノエチルスルホン酸
からなる群から選ばれる1種以上を配合することを特徴とする、上記眼科用組成物の粘度低下抑制方法。
[6].(A)水溶性高分子化合物、
(B)ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油及びモノステアリン酸ポリエチレングリコールから選ばれる1種又は2種以上の界面活性剤、
(C)ビタミンA、ビタミンE、ジブチルヒドロキシトルエン及び清涼化剤から選ばれる1種以上の脂溶性成分を含有する眼科用組成物において、
この眼科用組成物が充填された容器と、この容器を包装する包囲体とを有し、(1)包囲体内への不活性ガス注入、(2)包囲体内への酸素吸収剤の同梱、(3)酸素吸収能を有する容器又は(4)酸素吸収能を有する包囲体のいずれか1以上の手段を用いると共に、上記眼科用組成物に、
(D)下記(D-1)及び(D-2)
(D-1)トロメタモール、プロピレングリコール
(D-2)エチレンジアミン酢酸誘導体、エチレンジアミン酢酸誘導体塩、塩酸テトラヒドロゾリン、イプシロンアミノカプロン酸、アラントイン、グリチルリチン酸、グリチルリチン酸塩、クロルフェニラミンマレイン酸塩、ピリドキシン塩酸塩、パンテノール、コンドロイチン硫酸、コンドロイチン硫酸塩、塩化ナトリウム、ネオスチグミンメチル硫酸塩、硫酸亜鉛、フラビンアデニンジヌクレオチドナトリウム、シアノコバラミン、アスパラギン酸、アスパラギン酸塩、アミノエチルスルホン酸
からなる群から選ばれる1種以上を配合することを特徴とする、上記眼科用組成物の粘度低下抑制方法。
[(A)成分]
水溶性高分子化合物としては、ヒドロキシプロピルメチルセルロース(ヒプロメロース)、メチルセルロース、ヒドロキシエチルセルロース等のセルロース系高分子化合物、ポリビニルピロリドン(ポビドン)、ポリビニルアルコール等のポリビニル系高分子化合物、ヒアルロン酸及びその塩、カルボキシビニルポリマー等が挙げられ、1種単独で又は2種以上を適宜組み合わせて用いることができる。このような成分を配合することで、組成物に粘度を付与し、配合された有効成分の眼表面での滞留性を向上し、眼表面に滞留することにより眼表面の乾燥を防止することができる。中でも、ヒドロキシプロピルメチルセルロース、メチルセルロース、ヒドロキシエチルセルロース、ポリビニルピロリドン、カルボキシビニルポリマー、ヒアルロン酸及びその塩が好ましく、ヒドロキシプロピルメチルセルロースがより好ましい。
(B)成分は、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油及びモノステアリン酸ポリエチレングリコールから選ばれる1種又は2種以上の界面活性剤である。
ビタミンA、ビタミンE、ジブチルヒドロキシトルエン及び清涼化剤から選ばれる1種以上の成分であり、この脂溶性成分を1種単独で又は2種以上を適宜組み合わせて用いることができる。ビタミンAには角膜創傷治癒効果等があり、ビタミンAそれ自体の他に、ビタミンA油等のビタミンA含有混合物、ビタミンA脂肪酸エステル等のビタミンA誘導体等が挙げられる。具体的には、レチノールパルミチン酸エステル、レチノール酢酸エステル、レチノール、レチノイン酸、レチノイド等が挙げられる。中でも、レチノールパルミチン酸エステルが好ましい。
(D)下記(D-1)及び(D-2)からなる群から選ばれる1種以上である。(D)成分の配合により、上記(A),(B)成分を併用することによる粘度低下を抑制することができる。
(D-1)トロメタモール、プロピレングリコール
(D-2)エチレンジアミン酢酸誘導体、エチレンジアミン酢酸誘導体塩、塩酸テトラヒドロゾリン、イプシロンアミノカプロン酸、アラントイン、グリチルリチン酸、グリチルリチン酸塩、クロルフェニラミンマレイン酸塩、ピリドキシン塩酸塩、パンテノール、コンドロイチン硫酸、コンドロイチン硫酸塩、塩化ナトリウム、ネオスチグミンメチル硫酸塩、硫酸亜鉛、フラビンアデニンジヌクレオチドナトリウム、シアノコバラミン、アスパラギン酸、アスパラギン酸塩、アミノエチルスルホン酸
本発明の眼科用組成物は液体が好ましく、20℃における粘度は、1~400mPa・sが好ましく、1~100mPa・sがより好ましく、1~60mPa・sがさらに好ましく、1~30mPa・sが特に好ましい。なお、粘度の測定方法はB型粘度計を用いて測定する。
本発明は、眼科用組成物と、この眼科用組成物が充填された容器と、この容器を包装する包囲体とを有する眼科用製品であって、眼科用組成物中の酸素濃度が低減された状態で保存される手段を用いて、上記(A),(B)成分を併用することによる粘度低下をより抑制することができる。手段としては、(1)包囲体内への不活性ガス注入、(2)包囲体内への酸素吸収剤の同梱、(3)酸素吸収能を有する容器又は(4)酸素吸収能を有する包囲体等が挙げられる。このような手段により、上記(A),(B)成分を併用することによる粘度低下をより抑制することができる。なお、包囲体は容器を密封できるものが好ましい。
不活性ガスとしては、窒素、ヘリウム、ネオン、アルゴン等が挙げられる。中でも窒素ガスが好ましい。不活性ガスの濃度は、包囲体とプラスチック製容器との間に形成された空間容積中、好ましくは50容積%以上、より好ましくは80容積%%以上、さらに好ましくは90容積%以上である。上限は特に限定されず、100容積%以下である。このような濃度にするためには、包囲体とプラスチック製容器との間に形成された空間を、不活性ガスで置換すればよい。
具体的には、三菱ガス化学(株)製のエージレス(登録商標)(FX、SP、SS、SPE、ZP、Z-PT、Z-PKC、GLS、GL-M、Z-20PKヤ)、ファーマキープ、(株)常盤産業製のバイタロン、(株)博洋製のサンソレス、パウダーテック(株)製のワンダーキープ、アイリス・ファインプロダクツ(株)製のサンソカット等を用いることができる。
具体的には、東洋製罐(株)製のオキシブロック、三菱ガス化学(株)製のオキシヴァニッシュ等を用いることができる。
具体的には、共同印刷(株)製のオキシキャッチ(登録商標)ICA、シールドエアー社製のCryovac(登録商標) OSフィルム、スタープラスチック工業(株)製のハイスターO2、三菱ガス化学(株)製のエージレスオーマック、東洋製罐(株)製のオキシデック等を用いることができる。
(B)ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油及びモノステアリン酸ポリエチレングリコールから選ばれる1種又は2種以上の界面活性剤、
(C)ビタミンA、ビタミンE、ジブチルヒドロキシトルエン及び清涼化剤から選ばれる1種以上の脂溶性成分を含有する眼科用組成物と、この眼科用組成物が充填された容器と、この容器を包装する包囲体とを有し、(1)包囲体内への不活性ガス注入、(2)包囲体内への酸素吸収剤の同梱、(3)酸素吸収能を有する容器又は(4)酸素吸収能を有する包囲体のいずれか1以上の手段を用いた眼科用製品において、上記眼科用組成物に、
(D)下記(D-1)及び(D-2)
(D-1)トロメタモール、プロピレングリコール
(D-2)エチレンジアミン酢酸誘導体、エチレンジアミン酢酸誘導体塩、塩酸テトラヒドロゾリン、イプシロンアミノカプロン酸、アラントイン、グリチルリチン酸、グリチルリチン酸塩、クロルフェニラミンマレイン酸塩、ピリドキシン塩酸塩、パンテノール、コンドロイチン硫酸、コンドロイチン硫酸塩、塩化ナトリウム、ネオスチグミンメチル硫酸塩、硫酸亜鉛、フラビンアデニンジヌクレオチドナトリウム、シアノコバラミン、アスパラギン酸、アスパラギン酸塩、アミノエチルスルホン酸
からなる群から選ばれる1種以上を配合することを特徴とする、眼科用組成物の粘度低下抑制方法を提供する。好適なもの、量等は上記と同様である。
(B)ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油及びモノステアリン酸ポリエチレングリコールから選ばれる1種又は2種以上の界面活性剤、
(C)ビタミンA、ビタミンE、ジブチルヒドロキシトルエン及び清涼化剤から選ばれる1種以上の脂溶性成分を含有する眼科用組成物において、
この眼科用組成物が充填された容器と、この容器を包装する包囲体とを有し、(1)包囲体内への不活性ガス注入、(2)包囲体内への酸素吸収剤の同梱、(3)酸素吸収能を有する容器又は(4)酸素吸収能を有する包囲体のいずれか1以上の手段を用いると共に、上記眼科用組成物に、
(D)下記(D-1)及び(D-2)
(D-1)トロメタモール、プロピレングリコール
(D-2)エチレンジアミン酢酸誘導体、エチレンジアミン酢酸誘導体塩、塩酸テトラヒドロゾリン、イプシロンアミノカプロン酸、アラントイン、グリチルリチン酸、グリチルリチン酸塩、クロルフェニラミンマレイン酸塩、ピリドキシン塩酸塩、パンテノール、コンドロイチン硫酸、コンドロイチン硫酸塩、塩化ナトリウム、ネオスチグミンメチル硫酸塩、硫酸亜鉛、フラビンアデニンジヌクレオチドナトリウム、シアノコバラミン、アスパラギン酸、アスパラギン酸塩、アミノエチルスルホン酸
からなる群から選ばれる1種以上を配合することを特徴とする、上記眼科用組成物の粘度低下抑制方法を提供する。好適なもの、量等は上記と同様である。
下記表に示す組成の眼科用組成物を、脂溶性成分を(B)成分に溶解した後、他の水溶液成分を溶解した高温(70~95℃)の水溶液に投入することによって下記表に示す組成の眼科用組成物を製造した。得られた眼科用組成物(15mL)をポリエチレンテレフタレート製の点眼剤容器(16mL)に充填した後、酸素吸収剤(エージレス:Z-20PKヤ 三菱ガス化学株式会社製)を同梱したフィルム包装(包囲体)を施した。また、比較例4及び実施例4-1~4-4、ならびに、比較例6及び実施例6-1~6-3については、酸素吸収能を有するフィルム(エージレスオーマック:三菱ガス化学株式会社製)を用いて包装(包囲体)を施した。なお、包囲体の酸素透過係数は10cc/m2・24hr・atm以下である。保存前の粘度をB型粘度計(デジタル粘度計DV2T、英弘精機株式会社製)にて粘度を測定し、50℃・75%RH環境下で2ケ月保存した。保存後、点眼剤を常温(20℃)に戻し、保存前と同様に測定した。得られた粘度から下記式に基づき、各実施例の粘度維持率(%)を求め、以下のように、粘度維持率増強効果(%)を算出した。
粘度維持率(%)=保存後の粘度/保存前の粘度×100
粘度維持率増強効果(%)=[各実施例の粘度維持率(%)/各実施例に対応する比較例の粘度維持率(%)-1]×100
なお、各実施例に対応する比較例とは、(D)成分を含まない比較例をいう。
下記表に示す組成の眼科用組成物を、本発明記載の容器に充填し、本発明記載の包装形態で包装した眼科用製品は、経時による粘度低下が抑制され、有効性や清涼感の持続性に優れ、また、うるおい感の持続性に優れた点眼剤として使用できる。特に、処方例3、5、10~12は、ソフトコンタクトレンズ装用時にも点眼可能なコンタクト用点眼剤として好適である。
・ヒドロキシプロピルメチルセルロース:メトローズ60SH-4000、日局、信越化学工業(株)、重量平均分子量約30万(g/mol)
・メチルセルロース:メトローズSM-4000、日局、信越化学工業(株)、重量平均分子量約36万(g/mol)
・ヒドロキシエチルセルロース:HEC-CF-V、薬添規、住友精化(株)、重量平均分子量約100万(g/mol)
・ポリビニルピロリドン:コリドン90F、日局、BASF(株)、重量平均分子量100万(g/mol)
カルボキシビニルポリマー:Carbopol(登録商標)971PNF、薬添規、ルーブリゾール社
・ヒアルロン酸ナトリウム:バイオヒアルロン酸ナトリウム、資生堂(株)
・ポリオキシエチレン硬化ヒマシ油60:HCO60、薬添規、日本サーファクタント工業(株)
・モノオレイン酸POE(20)ソルビタン(ポリソルベート80):レオドールTW-0120V、花王(株)
・ポリオキシエチレンヒマシ油35:NIKKOL CO-35、日光ケミカルズ(株)
・ステアリン酸ポリオキシル40:NIKKOL MYS-40MV、日光ケミカルズ(株)
・レチノールパルミチン酸エステル:レチノールパルミチン酸エステル、日局、DSMニュートリション ジャパン(株)
・酢酸d-α-トコフェロール:理研Eアセテートα、局外規、理研ビタミン(株)
・ジブチルヒドロキシトルエン:ジブチルヒドロキシトルエン、薬添規、和光純薬工業(株)
(D)成分及びその他の任意成分は、公定書(日本薬局方、日本薬局方外医薬品規格、医薬品添加物規格、等)規格に適合した各種原料を使用した。
Claims (4)
- (A)ヒドロキシプロピルメチルセルロース、
(B)ポリオキシエチレン硬化ヒマシ油及びポリオキシエチレンソルビタン脂肪酸エステルから選ばれる1種又は2種以上の界面活性剤、
(C)ビタミンA、ビタミンE、ジブチルヒドロキシトルエン及びメントールから選ばれる1種以上の成分、及び
(D)下記(D-1)からなる群から選ばれる1種以上及び(D-2)からなる群から選ばれる1種以上
(D-1)トロメタモール
(D-2)イプシロンアミノカプロン酸、アラントイン
を含有する眼科用組成物と、この眼科用組成物が充填された容器と、この容器を包装する包囲体とを有する眼科用製品であって、
(1)包囲体内への不活性ガス注入、(2)包囲体内への酸素吸収剤の同梱、(3)酸素吸収能を有する容器又は(4)酸素吸収能を有する包囲体のいずれか1以上の手段を用いた眼科用製品。 - (C)成分が、レチノールパルミチン酸エステル、酢酸トコフェロール、ジブチルヒドロキシトルエン及びメントールから選ばれる1種以上である請求項1記載の眼科用製品。
- (A)ヒドロキシプロピルメチルセルロース、
(B)ポリオキシエチレン硬化ヒマシ油及びポリオキシエチレンソルビタン脂肪酸エステルから選ばれる1種又は2種以上の界面活性剤、
(C)ビタミンA、ビタミンE、ジブチルヒドロキシトルエン及びメントールから選ばれる1種以上の脂溶性成分を含有する眼科用組成物と、この眼科用組成物が充填された容器と、この容器を包装する包囲体とを有し、(1)包囲体内への不活性ガス注入、(2)包囲体内への酸素吸収剤の同梱、(3)酸素吸収能を有する容器又は(4)酸素吸収能を有する包囲体のいずれか1以上の手段を用いた眼科用製品において、上記眼科用組成物に、
(D)下記(D-1)からなる群から選ばれる1種以上及び(D-2)からなる群から選ばれる1種以上
(D-1)トロメタモール
(D-2)イプシロンアミノカプロン酸、アラントイン
を配合することを特徴とする、上記眼科用組成物の粘度低下抑制方法。 - (A)ヒドロキシプロピルメチルセルロース、
(B)ポリオキシエチレン硬化ヒマシ油及びポリオキシエチレンソルビタン脂肪酸エステルから選ばれる1種又は2種以上の界面活性剤、
(C)ビタミンA、ビタミンE、ジブチルヒドロキシトルエン及びメントールから選ばれる1種以上の脂溶性成分を含有する眼科用組成物において、
この眼科用組成物が充填された容器と、この容器を包装する包囲体とを有し、(1)包囲体内への不活性ガス注入、(2)包囲体内への酸素吸収剤の同梱、(3)酸素吸収能を有する容器又は(4)酸素吸収能を有する包囲体のいずれか1以上の手段を用いると共に、上記眼科用組成物に、
(D)下記(D-1)からなる群から選ばれる1種以上及び(D-2)からなる群から選ばれる1種以上
(D-1)トロメタモール
(D-2)イプシロンアミノカプロン酸、アラントイン
を配合することを特徴とする、上記眼科用組成物の粘度低下抑制方法。
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JP2022099573A (ja) * | 2020-12-23 | 2022-07-05 | 小林製薬株式会社 | 洗眼用組成物 |
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JP7120018B2 (ja) | 2022-08-17 |
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WO2018066651A1 (ja) | 2018-04-12 |
TWI746662B (zh) | 2021-11-21 |
KR20190065237A (ko) | 2019-06-11 |
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