JP5864819B2 - 精神的障害、行動障害および認知障害の予防および治療のための医薬組成物 - Google Patents
精神的障害、行動障害および認知障害の予防および治療のための医薬組成物 Download PDFInfo
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
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- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular 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
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- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
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- 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
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- 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
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Description
(http://www.canonpharma.ru/ru/drugs/expert/doctors/neurology/memantinkanon/)。
メマンチン40.0〜90.0
メラトニン2.0〜5.0
賦形剤2.0〜50.0
結合剤3.5〜10.0
崩壊剤1.5〜10.0
減摩剤0.2〜3.0
で含む医薬組成物である。
本試験の被験者は、混合型認知症患者25名およびアルツハイマー病患者12名であった。患者の平均年齢は、70±3歳である。認知症の診断は、ICD−10[疾病および関連保健問題の国際統計分類、第10版(ICD−10)、第1巻(第1部)、ジュネーブ、WHO、1995、315ページ、510〜1ページ]にある認知症判定規準に従って行われた。認知症(Dimentia)の重症度は、臨床認知症評価尺度−CDR(Clinical Dementia Rating Scale)に従って判定された[Hughes CP、Berg L、Danziger WLら、A new clinical scale for the staging of dementia.、Brit J Psychiatry、1982、140:566〜72ページ]。混合型認知症患者群においては、その値は1.2±0.3、アルツハイマー病群においては−1.1±0.36であった。すべての患者を2つの群に分けた。第1群は、メマンチン50mgを1日1回服用した。第2群は、実施例4によるカプセル剤を服用した。患者には半年にわたり複合的な神経学的試験が実施され、試験には、精神状態の簡単な評価(MMSE)、認知症尺度下での視覚的および聴覚発話的な記憶についての検査、時計描画検査、ならびに注意力についての検査−シュルテテーブル(Schulte Table)が含まれた。アウトカムは、社会科学用統計パッケージ(SPSS)、バージョン10.0を用いて処理した。
Claims (10)
- 精神障害、行動障害および認知障害の予防および治療のための固体剤形の形態の医薬組成物であって、
活性源としてのメマンチンおよびメラトニンと、ラクトース、デンプン、デンプン誘導体、結晶セルロース、スクロース、転化糖、デクストロースおよびデクストレートから選択される少なくとも1つの賦形剤と、カルボキシメチルセルロースナトリウム、クロスカルメロース、ゼリー化デンプンから選択される少なくとも1つの崩壊剤と、ポリビニルピロリドン、ゼラチン、セルロース誘導体、天然ガム、ポリエチレングリコール、アルギン酸ナトリウムから選択される結合剤と、ステアリン酸および/またはその塩、コロイド状二酸化ケイ素、タルク、安息香酸ナトリウム、酢酸ナトリウムおよびオレイン酸ナトリウムから選択される減摩剤とを含むアジュバントと
を含み、重量%単位での成分の含有量が、
メマンチン40.0〜90.0
メラトニン2.0〜5.0
賦形剤2.0〜50.0
結合剤2.0〜10.0
崩壊剤1.5〜10.0
減摩剤0.2〜3.0
であることを特徴とする、医薬組成物。 - メマンチンとメラトニンの組合せを、前記組成物の重量を基準として70〜80%の量で含むことを特徴とする、請求項1に記載の医薬組成物。
- メマンチンとメラトニンの組合せを、前記組成物の重量を基準として70〜80%の量で含み、賦形剤であるラクトース一水和物を、前記組成物の重量を基準として3〜20%の量で含み、崩壊剤である架橋カルボキシメチルセルロースナトリウムを、前記組成物の重量を基準として2〜10%の量で含み、結合剤であるポリビニルピロリドンを、前記組成物の重量を基準として2〜10%の量で含み、減摩剤であるステアリン酸マグネシウムを、前記組成物の重量を基準として0.2〜2.0%の量で含むことを特徴とする、請求項1に記載の医薬組成物。
- メマンチンとメラトニンの組合せを、前記組成物の重量を基準として60〜90%の量で含むことを特徴とする、請求項1に記載の医薬組成物。
- 錠剤の形態であることを特徴とする、請求項1に記載の医薬組成物。
- メマンチン100mgおよびメラトニン5mgを含むことを特徴とする、請求項5に記載の医薬組成物。
- メマンチン150mgおよびメラトニン10mgを含む、請求項5に記載の医薬組成物。
- メマンチン30mgおよびメラトニン3mgを含む、請求項5に記載の医薬組成物。
- 固体カプセル剤の形態であることを特徴とする、請求項1に記載の医薬組成物。
- メマンチン89.83重量%、
メラトニン2.69重量%、
ラクトース2.69重量%、
ポビドン1.80重量%、
クロスカルメロース1.91重量%、
ステアリン酸カルシウム1.08重量%
を含むことを特徴とする、医薬組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
RU2012121410/15A RU2488388C1 (ru) | 2012-05-24 | 2012-05-24 | Фармацевтическая композиция для профилактики и лечения психических, поведенческих, когнитивных расстройств |
RU2012121410 | 2012-05-24 | ||
PCT/RU2012/000888 WO2013176567A1 (ru) | 2012-05-24 | 2012-10-31 | Фармацевтическая композиция для профилактики и лечения психических, поведенческих, когнитивных расстройств |
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JP2015517569A JP2015517569A (ja) | 2015-06-22 |
JP5864819B2 true JP5864819B2 (ja) | 2016-02-17 |
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JP2015513964A Expired - Fee Related JP5864819B2 (ja) | 2012-05-24 | 2012-10-31 | 精神的障害、行動障害および認知障害の予防および治療のための医薬組成物 |
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Country | Link |
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US (1) | US20150157604A1 (ja) |
EP (1) | EP2857011A4 (ja) |
JP (1) | JP5864819B2 (ja) |
KR (1) | KR101581611B1 (ja) |
CN (1) | CN104334166A (ja) |
AU (1) | AU2012380583B2 (ja) |
CA (1) | CA2873891C (ja) |
EA (1) | EA201400973A1 (ja) |
HK (1) | HK1205467A1 (ja) |
IL (1) | IL235852A0 (ja) |
IN (1) | IN2014DN09940A (ja) |
RU (1) | RU2488388C1 (ja) |
UA (1) | UA112352C2 (ja) |
WO (1) | WO2013176567A1 (ja) |
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RU2536270C1 (ru) * | 2013-10-21 | 2014-12-20 | Общество с ограниченной ответственностью ООО "ВАЛЕНТА ИНТЕЛЛЕКТ" | Комбинация для коррекции неврологического и психоэмоционального статуса при органических нарушениях цнс |
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RU2623865C1 (ru) * | 2016-06-29 | 2017-06-29 | Общество С Ограниченной Ответственностью "Валента-Интеллект" | Фармацевтическая композиция, содержащая комбинацию мемантина и мелатонина |
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RU2418586C2 (ru) | 2009-06-11 | 2011-05-20 | Государственное образовательное учреждение высшего профессионального образования "Новосибирский государственный медицинский университет Федерального агентства по здравоохранению и социальному развитию" (ГОУ ВПО НГМУ Росздрава) | Способ коррекции нарушений в репродуктивных органах, вызванных высокой температурой |
RU2428183C1 (ru) | 2010-07-01 | 2011-09-10 | Рина Михайловна Заславская | Адаптоген для метеочувствительных больных стенокардией и артериальной гипертензией и применение мелатонина в качестве адаптогена |
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2012
- 2012-05-24 RU RU2012121410/15A patent/RU2488388C1/ru not_active IP Right Cessation
- 2012-10-31 KR KR1020147032836A patent/KR101581611B1/ko active IP Right Grant
- 2012-10-31 US US14/400,526 patent/US20150157604A1/en not_active Abandoned
- 2012-10-31 EP EP12877152.4A patent/EP2857011A4/en not_active Withdrawn
- 2012-10-31 WO PCT/RU2012/000888 patent/WO2013176567A1/ru active Application Filing
- 2012-10-31 UA UAA201412436A patent/UA112352C2/uk unknown
- 2012-10-31 CN CN201280073167.XA patent/CN104334166A/zh not_active Withdrawn
- 2012-10-31 JP JP2015513964A patent/JP5864819B2/ja not_active Expired - Fee Related
- 2012-10-31 EA EA201400973A patent/EA201400973A1/ru unknown
- 2012-10-31 AU AU2012380583A patent/AU2012380583B2/en not_active Revoked
- 2012-10-31 IN IN9940DEN2014 patent/IN2014DN09940A/en unknown
- 2012-10-31 CA CA2873891A patent/CA2873891C/en not_active Expired - Fee Related
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2014
- 2014-11-23 IL IL235852A patent/IL235852A0/en unknown
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Also Published As
Publication number | Publication date |
---|---|
UA112352C2 (uk) | 2016-08-25 |
EP2857011A4 (en) | 2015-12-02 |
IN2014DN09940A (ja) | 2015-08-14 |
HK1205467A1 (en) | 2015-12-18 |
EA201400973A1 (ru) | 2015-02-27 |
US20150157604A1 (en) | 2015-06-11 |
AU2012380583A1 (en) | 2014-12-18 |
IL235852A0 (en) | 2015-01-29 |
JP2015517569A (ja) | 2015-06-22 |
EP2857011A1 (en) | 2015-04-08 |
CA2873891A1 (en) | 2013-11-28 |
AU2012380583B2 (en) | 2015-01-22 |
RU2488388C1 (ru) | 2013-07-27 |
WO2013176567A1 (ru) | 2013-11-28 |
CN104334166A (zh) | 2015-02-04 |
KR20150005999A (ko) | 2015-01-15 |
KR101581611B1 (ko) | 2015-12-31 |
CA2873891C (en) | 2016-02-16 |
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