JP5347092B2 - アンドログラフィス抽出物製剤 - Google Patents
アンドログラフィス抽出物製剤 Download PDFInfo
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- JP5347092B2 JP5347092B2 JP2008556636A JP2008556636A JP5347092B2 JP 5347092 B2 JP5347092 B2 JP 5347092B2 JP 2008556636 A JP2008556636 A JP 2008556636A JP 2008556636 A JP2008556636 A JP 2008556636A JP 5347092 B2 JP5347092 B2 JP 5347092B2
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- Prior art keywords
- powder
- weight
- extract
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Classifications
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/19—Acanthaceae (Acanthus family)
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Botany (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Inorganic Chemistry (AREA)
- Medical Informatics (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Immunology (AREA)
- Pain & Pain Management (AREA)
- Pulmonology (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
アンドログラフィス・パニクラタ(Burm.f.)ネース(Andrographis paniculata(Burm.f.)Nees)は、疾患、例えば、炎症性疾患、免疫疾患、呼吸器系疾患、および癌などを治療するのに用いられる、伝統的な中国の薬草である。例えば、Shen Y.C.ら、Br.J.Pharmacol.2002、135(2):399〜406;Rajagopal S.ら、J.Experimental Therapeutics and Oncology、2003、3:147〜158;およびWangら、China Pharmaceuticals、2003、12(10):72〜73を参照されたい。その主有効成分は、アンドログラホリド、ネオアンドログラホリド(neoandrographolide)、14−デオキシアンドログラホリド、および14−デオキシ−11,12−ジデヒドロアンドログラホリド(didehydroandrographolide)である。
(2)固体残留物を除去し、濾液を2回ブレンドし、
(3)地上部の代わりに固体残留物をステップ(1)で用いること以外は、上記2ステップを再び行い、
(4)すべての濾液を合わせ、濃縮し、
(5)デキストリンの水溶液を調製し、
(6)濃縮した溶液を、デキストリン溶液と合わせ、
(7)合わせた溶液を、噴霧乾燥させ、乾燥した残留物を粉砕することによって、1〜180μmの粉末サイズを有する粉末を得る。
[実施例]
方法:薬局方の第2法
回転速度:毎分75回転
媒体:ドデシル硫酸ナトリウムの0.2%水溶液
媒体体積:900ml
本発明のいくつかの実施形態を説明してきた。しかし、本発明の精神および範囲から逸脱することなく、様々な改変を行うことができることが理解されよう。したがって、他の実施形態も、特許請求の範囲内にある。
Claims (5)
- 50〜90重量%のアンドログラフィス・パニクラタ(Andrographis paniculata)抽出物、および10〜20重量%のブロッキング剤を含み、前記抽出物および前記ブロッキング剤が、両方とも粉末形態であり、それぞれ、1〜180μmおよび1〜160μmの範囲の粉末サイズを有し、均一に混合されており、前記ブロッキング剤が、ヒドロキシプロピルメチルセルロース(K100M)およびヒドロキシプロピルメチルセルロース(K15M)の1:1〜2:3の混合物である、医薬製剤。
- 5〜15重量%の孔形成剤をさらに含む、請求項1に記載の製剤であって、
前記孔形成剤が、粉末形態であり、1〜200μmの範囲の粉末サイズを有し、ラクトース、デンプン、微結晶フィブリン及びその混合物からなる群より選択される、製剤。 - 前記抽出物が、7〜10重量%のアンドログラホリド、2〜4重量%のネオアンドログラホリド、0〜2重量%の14−デオキシアンドログラホリド、および1〜3重量%の14−デオキシ−11,12−ジデヒドロアンドログラホリドを含み、前記孔形成剤が、ラクトース、デンプン、微結晶フィブリン、またはその混合物である、請求項2に記載の製剤。
- 0.1〜20重量%のフィラー、0.5〜2重量%の滑沢剤、または1〜5重量%のグリダント(glidant)をさらに含み、前記フィラーが、第二リン酸カルシウム、α化デンプン、デキストリン、硫酸カルシウム、またはその混合物であり、前記滑沢剤が、ステアリン酸マグネシウム、PEG4000、またはPEG6000であり、前記グリダントが、フレンチチョークまたは酸化ケイ素である、請求項1に記載の製剤。
- 医薬製剤を調製するための方法であって、
1〜180μmの範囲の粉末サイズを有する粉末アンドログラフィス・パニクラタ抽出物50〜90重量%、および1〜160μmの範囲の粉末サイズを有する粉末ブロッキング剤10〜20重量%を含有する混合物を提供すること、ならびに
前記混合物を凝集させることによって顆粒を形成すること
を含み、前記顆粒は、1〜1500μmの範囲の粉末サイズを有し、前記ブロッキング剤が、ヒドロキシプロピルメチルセルロース(K100M)およびヒドロキシプロピルメチルセルロース(K15M)の1:1〜2:3の混合物である、方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US77788706P | 2006-02-28 | 2006-02-28 | |
US60/777,887 | 2006-02-28 | ||
PCT/CN2007/000616 WO2007098686A1 (en) | 2006-02-28 | 2007-02-27 | Andrographis extract formulations |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2009528301A JP2009528301A (ja) | 2009-08-06 |
JP5347092B2 true JP5347092B2 (ja) | 2013-11-20 |
Family
ID=38458661
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008556636A Expired - Fee Related JP5347092B2 (ja) | 2006-02-28 | 2007-02-27 | アンドログラフィス抽出物製剤 |
Country Status (4)
Country | Link |
---|---|
US (2) | US20070202164A1 (ja) |
EP (1) | EP1996165A4 (ja) |
JP (1) | JP5347092B2 (ja) |
WO (1) | WO2007098686A1 (ja) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
HUE025117T2 (en) | 2004-04-28 | 2016-02-29 | Nutrition Science Partners Ltd | Raw extracts from Andrographis paniculata |
US20090117209A1 (en) * | 2007-11-02 | 2009-05-07 | Hutchison Medipharma Enterprises Limited | Andrographis paniculata extract |
CN104274440B (zh) * | 2013-07-11 | 2017-04-26 | 成都中医药大学 | 穿心莲内酯复合粒子及其制备方法 |
CN110585138B (zh) * | 2019-09-29 | 2021-08-03 | 黑龙江中医药大学 | 穿心莲颗粒及其制备方法 |
CN112826817A (zh) * | 2019-11-22 | 2021-05-25 | 江西青峰药业有限公司 | 一种穿心莲内酯磺化物的药物组合物及其制备方法 |
Family Cites Families (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MY113429A (en) * | 1995-02-28 | 2002-02-28 | Univ Temple | Controlled release tablet containing swellable polyethylene oxide |
US20030059471A1 (en) * | 1997-12-15 | 2003-03-27 | Compton Bruce Jon | Oral delivery formulation |
JP2000034224A (ja) * | 1998-05-11 | 2000-02-02 | Freunt Ind Co Ltd | 徐放性錠剤、その添加剤組成物及びそれらの製造方法 |
WO2000037055A1 (en) * | 1998-12-18 | 2000-06-29 | Abbott Laboratories | Controlled release formulation of divalproex sodium |
ES2263643T3 (es) * | 2000-07-28 | 2006-12-16 | Immupharm Aps | Uso de hidroxietilrutosidos para el tratamiento de los sintomas del r esfriado comun, de la fiebre de heno y de infecciones relacionadas con el tacto respiratorio. |
US6629835B2 (en) * | 2000-08-01 | 2003-10-07 | Metaproteomics, Llc | Combinations of diterpene triepoxide lactones and ditepene lactones or triterpenes for synergistic inhibition of cyclooxygenase-2 |
US6358526B1 (en) * | 2000-08-16 | 2002-03-19 | Rexall Sundown | Method of making tablets and tablet compositions produced therefrom |
US7270835B2 (en) * | 2001-06-20 | 2007-09-18 | Metaproteomics, Llc | Compositions that treat or inhibit pathological conditions associated with inflammatory response |
EP1291015A1 (en) * | 2001-09-10 | 2003-03-12 | Lunamed AG | Dosage forms having prolonged active ingredient release |
US6642276B2 (en) * | 2001-10-01 | 2003-11-04 | M/S Ind-Swift Limited | Controlled release macrolide pharmaceutical formulations |
US20030101076A1 (en) * | 2001-10-02 | 2003-05-29 | Zaleski John R. | System for supporting clinical decision making through the modeling of acquired patient medical information |
US6753017B2 (en) * | 2001-11-07 | 2004-06-22 | Jrs Pharma Lp | Process for preparing dry extracts |
JP2003171301A (ja) * | 2001-11-09 | 2003-06-20 | Mahidol Univ | 歯周炎治療における補助剤としてのカルメグゲル |
CN1626076B (zh) * | 2003-12-11 | 2010-10-06 | 天津天士力制药股份有限公司 | 一种穿心莲内酯滴丸及其制备方法 |
KR20070026398A (ko) * | 2004-02-03 | 2007-03-08 | 우니베르시다드 오스뜨랄 데 칠레 | Ppar-감마 수용체의 활성화에 의한 자가면역 질환 및알츠하이머병의 치료에 유용한, 천심련으로부터 추출된랍단 디테르펜을 포함하는 조성물 |
AU2005221711A1 (en) * | 2004-03-11 | 2005-09-22 | Hutchison Medipharma Ltd. | Andrographolide and analogues as inhibitors of TNFalpha and IL-1betaexpression |
HUE025117T2 (en) * | 2004-04-28 | 2016-02-29 | Nutrition Science Partners Ltd | Raw extracts from Andrographis paniculata |
AU2004318976B2 (en) * | 2004-04-29 | 2009-04-09 | Lotus Pharmaceutical Co., Ltd. | Oral modified-release lozenges and their preparation method |
EP1758554A1 (en) * | 2004-06-12 | 2007-03-07 | Passion For Life Healthcare Limited | Soluble strip for oral or topical adminstration |
WO2006008115A1 (en) * | 2004-07-16 | 2006-01-26 | Universidad Austral De Chile | Diterpenic labdans as immunostimulants for treating infectious diseases |
US20090117209A1 (en) * | 2007-11-02 | 2009-05-07 | Hutchison Medipharma Enterprises Limited | Andrographis paniculata extract |
-
2007
- 2007-02-13 US US11/674,557 patent/US20070202164A1/en not_active Abandoned
- 2007-02-27 WO PCT/CN2007/000616 patent/WO2007098686A1/en active Application Filing
- 2007-02-27 EP EP07711017A patent/EP1996165A4/en not_active Withdrawn
- 2007-02-27 JP JP2008556636A patent/JP5347092B2/ja not_active Expired - Fee Related
-
2010
- 2010-12-15 US US12/969,395 patent/US20110142944A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
US20070202164A1 (en) | 2007-08-30 |
US20110142944A1 (en) | 2011-06-16 |
WO2007098686A1 (en) | 2007-09-07 |
EP1996165A1 (en) | 2008-12-03 |
JP2009528301A (ja) | 2009-08-06 |
EP1996165A4 (en) | 2012-09-19 |
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