TW381025B - Pharmaceutical composition containing a glucosidase inhibitor and a lipase inhibitor - Google Patents

Pharmaceutical composition containing a glucosidase inhibitor and a lipase inhibitor Download PDF

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TW381025B
TW381025B TW083106429A TW83106429A TW381025B TW 381025 B TW381025 B TW 381025B TW 083106429 A TW083106429 A TW 083106429A TW 83106429 A TW83106429 A TW 83106429A TW 381025 B TW381025 B TW 381025B
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inhibitor
acarbose
patent application
glucosidase
lipase
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TW083106429A
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Klaus-Dieter Bremer
Pavel Sawlewicz
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Hoffmann La Roche
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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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Epoxy Compounds (AREA)
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Description

經濟部中央橾準局員工消費合作社印製 A7 B7 五、發明説明（]_ ) 本發明係闞於一種B藥製劑，其包含葡萄糖苷酶和/或 狼粉酶抑制劑與脂肪酶抑制劑Μ當做活性物質Μ及一般的 醫藥載體。 已發現此製劑可Μ用於治療肥胖症。 因此，本發明也翡於使用葡萄糖苷酶和/或載粉海抑制 劑且共同與脂肪酶抑制劑併用而同時地、分別地或慢性間 隔地治療肥胖症。 另外，本發明也鼷於使用葡萄糖脊酶和/或澱粉酶抑制 劑於製備《槩製劑Κ共同與脂肪酶抑制劑併用而治療肥胖 症。 根據本發明而可Μ使用的葡萄糖苷酶和/或毅粉酶抑制 範例是阿卡博醣（acarbose)、脂肪素（adiposine)、歐格 博釀（voSlibose)(A0-128)、美格利酵（miglitol) (Bay-n-1099)、異美格利験（emiglitate)(Bay-〇-1248)、 MDL-25637、、美格利_(caBiglibose)(MDL-73945)、天 達蜜斯鹽（tendamistate)、A卜3688、翠斯達汀 (trestatin)、普達蜜素-Q(pradimicin-Q)和莎博達汀 (sa 1 bostat in)0 脂肪_抑制劑的範例是四氫麗博埵汀（tetrahydro-lipstatin)、篇博達汀（lipstatin)、FL-386、WAY-121898、 Bay-N-3176、 伯 麗樂嗣 （valilactone) 、 萼特拉 斯汀（esterastin)、異美勒 _A (ebelactone A)、異美勒 _B (ebelactone B)和RHC 80267。 在發酵製備胞肪酶抑制劑中所產生的生物質團或發酵餅 -4 - 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐） - .11 .訂------^ (請先閲讀背面之注意事項再填寫本頁) 經濟部中央標準局員工消費合作社印裝 A7 _B7_五、發明説明（2 ) *臀如麗博逹汀（lipstatin)或萼特拉斯汀（esteras-tin)，也可Μ當做脂肪梅抑制。後者乃描述於•譬如歐洲 專利案第ΕΡ-Α 129 748號和美國專利案第USP 4 189 438 號。 已知譬如阿卡博酷（acarbose)的葡萄糖苷酶和/或澱粉 酶抑制劑可延緩碳水化合物的消化。 亦已知譬如四氫鼷博達汀（tetrahydro丨ipstatin) (orli st at)的脂肪酶抑制劑會產生對腸内脂肪酶的部份抑 制作用。 然而，脂肪酶抑制劑本身與節食併合的單一療法通常僅 引起中等程度的體重減輕，而葡萄糖苷酶和/或澱粉酶抑 制劑實際上不會造成體重減輕。現在已意外地發現將葡萄 糖苷酶和/或澱粉酶抑制劑與脂肪_抑制劑合併使用將比 單一療法在實質上會導致更多的體重減輕。這可K由随後 的實驗加Μ ^明： I. 該實驗是由兩個自願者（Α與Β)分兩届試驗期予Μ進行的 。在7天的初步實驗中，於其間自願者不服藥物，確定了 Α姐的2560仟卡平均每日卡洛里量和Β姐的18 50仟卡平均 每日卡洛里量。在接績的14日主要《驗中•自願者每餐接 受120奄克的歐麗仕恬（or list at)和10 0奄克的阿卡博醣 (acarbose)。不附加特別的飲食，並將體力活動減至最低 。在此，如初步賁驗者般，確定A姐的218 5仟卡平均每日 卡洛里量和B姐的20 5 0仟卡平均每日卡洛里最。兩個自願 者的體重減輕將由Μ下的表格予K證實。 (婧先閲讀背面之注意事項再填寫本頁) 裝： -β •丨级 -5 - 本紙張尺度適用中國國家橾準（CNS ) Α4規格（210X297公釐） 經濟部中央標準局負工消费合作社印裝 A7 B7 五、發明説明（3 ) 試驗天數' 糖麗 A B 1 74.3 88.7 2 74.1 88.5 3 74.6 89.1 4 73.9 88.0 5 73.5 88.4 6 73.3 88.2 7 73.0 87.7 8 73.6 87.8 9 73.3 87.7 10 73.1 87.4 11 72.8 87.2 12 72.4 87.5 13 72.4 87.2 14 72.2 86.4 15- 71.9 R6 1 重最減少 2.4 2.6 與此相比較•在使用歐麗仕恬（3x120毫克/天）於安慰 劑-控制之12週賁驗的單一療法案例中，病人的體重減輕 是落在平均1.8公斤（亦即，0.3/14天Mint. J. Obesity 1992; 16 (SuppI.1): 16, Abstr. 063)。 根據本發明，葡萄糖苷_和/或澱粉梅抑制劑可M呈翳 藥製劑的形式，其也包含腊肪梅抑制劑，或者是呈併合著 包含脂肪_抑制劑的添加-鑲錠的形式，而予Κ使用。 較好是使用阿卡博醣和歐麗仕恬。 -6- 本紙張尺度適用中國國家標準（CNS ) Α4规格（210Χ297公釐） ------.--— 1¾衣------11------0 (請先M讀背面之注意事項再填寫本頁) 經濟部中央掠準局貝工消費合作社印製 A7 B7 五、發明説明（4 ) 該活性成份是K 口脹投予，Μ治療肥胖症。 可Μ用每公斤體重約0.003奄克至約20«克，較好是 0.015毫克至10毫克*的葡萄糖苷酶和/或澱粉_抑制劑 ，Μ及約0.15毫克至2 0毫克，較好是0.5毫克至10奄克， 的脂肪酶抑制劑*而每天予Μ投藥》 根據本發明的口眼投槩製劑可以採取錠劑*膠囊·溶液 劑或轧劑的形式。 譬如錠劑和膠囊的固備_型乃包含每劑量單位約0.2毫 克至約100毫克的葡萄耱苷酶和/或澱粉酶抑制劑，Κ及 約10毫克至200毫克的脂肪_抑制劑。 除了治療肥胖症之外，根據本發明的製劑或活性物質併 服法可Μ用於治療或預防通常與過重相闞而產生的疾病， 瞽如糖尿病，高血壓*高血脂和胰島素耐受性癥狀。 在所有的這些皤囑中，可以於上面所給付的劑量範圍内 使用該活性奋質，而其各別劑最乃取決於欲治療疾病的本 質•和病人的年黔及病情，且可由Κ師的權限決定。 藉由随後的實施例更詳细地解說本發明。 使用已知的方法製備Κ下姐合物的翳槩製劑：
啻豳Μ A 軟明膠膠囊： 包一暖蠹的割昼 歐麗仕恬（Or 1 istat) 60牽克 中等鏈三合甘油 450微克 阿卡博醣 50奄克 -7- 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐） ~ 1¾it------银. (請先閱讀背面之注意事項再填寫本頁) 五、發明説明（5 ) 啻淪锎 A7 B7 硬明膠膠囊： 阿卡博釀 歐麗仕恬 结晶乳糖 微晶纖維素 聚乙烯聚吡咯啉嗣 羥甲基澱粉化納 滑石粉 硬脂酸鎂 25.0毫克 30.0奄克 37.0毫克 20.0毫克 8. 5毫克 8 . 5毫克 4. 5毫克 Ί . 5萑克 135.0毫克 經濟部中央標準局貝工消費合作社印製 膠囊充填重量 窗掄例C 錠劑： 阿卡博釀 歐麗仕恬 ^ 無水乳糖 微晶纖維素 聚乙烯聚吡咯啉嗣 羥甲基纖維素 硬脂酸鎂 錠片重量 窖倫例Π 具有控釋活性物質和增加胃滯留時間的錠劑： 阿卡博醣 50.0毫克 25 . 0毫克 30.0奄克 118.8 30.010.0 10.0 1 . 2 225.0奄克 I ^ — I 批衣1T------0 (請先閲讀背面之注意事項再填寫本頁) 8 _ 本紙張尺度適用中國國家標準（CNS ) A4規格（210X297公釐） 五、發明説明（6 ) 歐麗仕恬 粉狀乳糖 羥丙基甲基镅維素 聚乙烯聚吡咯啉酮 滑石粉 膠漿狀矽酸 硬脂酸鎂 裸錠重量 A7 B7 60. 0毫克 70.0毫克 52.5毫克 7.5牽克 8.0毫克 1 . 0毫克 羥丙基甲基纖維素 滑石粉 二氧化钛 膜衣重量 可重行調配命粉末劑 阿卡博酷 歐麗仕恬 乙基香草素 阿斯巴甜 噴软脫脂奶粉 經濟部中央椋準局負工消费合作社印製 總重 250.0毫克 2 . 5毫克 1 . 25毫克 毫克 5.0 奄克 100.0 毫克 120.0 毫克 10.0 毫克 30.0 奄克 4740.0 «京 5000.0 奄克 11 -9— —ί I -- |种衣— 1 (請先閱讀背面之注意事項再填寫本頁) 線 9- 本紙張尺度適用中國國家標準（CNS ) Α4規格（210Χ297公釐）

Claims (1)

  1. 第83106429號專利申請案 中文申請專利範圍修正本（88年9月） A8 88. 9. B8 t C8 D8 公 j 士二 申請專利範圍 一種用於治療肥胖症之醫藥姐合物*其包含做為活性物 質之0.2至100毫克之阿卡博醣（acarbose)與10至200毫 克之四氫麗博達汀（tetrahydrolipstatin)及一般的醫 藥載體。 (請先閱讀背面之注意事項再填寫本頁) 經濟部中央標隼局員工消費合作社印製 本紙張尺度適用中國國家標準（CNS ) A4见格（210X297公釐） 第83106429號專利申請案 中文申請專利範圍修正本（88年9月） A8 88. 9. B8 t C8 D8 公 j 士二 申請專利範圍 一種用於治療肥胖症之醫藥姐合物*其包含做為活性物 質之0.2至100毫克之阿卡博醣（acarbose)與10至200毫 克之四氫麗博達汀（tetrahydrolipstatin)及一般的醫 藥載體。 (請先閱讀背面之注意事項再填寫本頁) 經濟部中央標隼局員工消費合作社印製 本紙張尺度適用中國國家標準（CNS ) A4见格（210X297公釐）
TW083106429A 1993-08-05 1994-07-14 Pharmaceutical composition containing a glucosidase inhibitor and a lipase inhibitor TW381025B (en)

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EP (1) EP0638317B1 (zh)
JP (1) JP2780932B2 (zh)
KR (1) KR100342285B1 (zh)
CN (1) CN1076196C (zh)
AT (1) ATE190503T1 (zh)
AU (1) AU684793B2 (zh)
BR (1) BR9403170A (zh)
CA (1) CA2128044C (zh)
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DE (1) DE59409200D1 (zh)
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ES (1) ES2144019T3 (zh)
GR (1) GR3033643T3 (zh)
HU (1) HU222346B1 (zh)
IL (1) IL110510A (zh)
NO (1) NO313490B1 (zh)
NZ (1) NZ264142A (zh)
PL (1) PL175997B1 (zh)
PT (1) PT638317E (zh)
RU (1) RU2141844C1 (zh)
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