CN1246798A - 胃肠道脂酶抑制剂的用途 - Google Patents
胃肠道脂酶抑制剂的用途 Download PDFInfo
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- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
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- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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Abstract
胃肠道脂酶抑制剂用于生产治疗或预防Ⅱ型糖尿病口服药物的用途,以及如此生产的该药物。
Description
糖尿病是一种以葡萄糖利用异常为特征并且伴有血糖浓度升高的疾病。最常见的糖尿病形式是非胰岛素依赖性糖尿病(NIDDM:II型)。仅美国就有一千万以上的人受到II型糖尿病的困扰。最初用于治疗II型糖尿病肥胖病人的手段是减轻体重。其它类型的治疗包括口服降糖药和胰岛素。参见:Gregerman,MD,《代谢与内分泌疑难问题》,第10部分,第72章.糖尿病(977-989)。
本发明涉及胃肠道脂酶抑制剂用于生产治疗或预防II型糖尿病的口服制剂的用途。本发明另一方面涉及用于治疗或预防II型糖尿病的口服制剂,其特征是含有胃肠道脂酶抑制剂。胃肠道脂酶抑制剂优选四氢脂抑素(tetrahydrolipstatin)。
四氢脂抑素,也就是orlistat,是已知用于控制或预防肥胖和高血脂的化合物。参见美国专利号4,598,089,授权于1986年7月1日,其同时公开了制备四氢脂抑素的过程。
目前惊奇地发现,口服一种胃肠道脂酶抑制剂,优选四氢脂抑素,对于治疗和预防II型糖尿病非常有用。优选口服胃肠道脂酶抑制剂60-720毫克/天,每天分2-3次服用。
其中优选180-360毫克/天,最优选360毫克/天,胃肠道脂酶抑制剂优选每天分两次或者,特别的,分三次给受试者服用。优选的受试者是肥胖或超重的人群,即体重指数为25或25以上的人。一般说来,胃肠道脂酶抑制剂优选在消化含脂肪饮食的一到两小时内服用。一般说来,用于预防II型糖尿病,优选的服药以治疗:1)有明显的II型糖尿病家族史并且体重指数为25或25以上的人;或2)葡萄糖耐受受损并且体重指数为25或25以上的人。这里所用的“明显的家族史”指的是至少有一个一级亲属患有II型糖尿病的人。一般说来,葡萄糖耐受受损可以通过口服葡萄糖耐受实验诊断。
四氢脂抑素能以常规的口服组合物,如片剂、糖衣片、硬或软的明胶胶囊、乳剂或者悬浮剂向人施用。能用于片剂、糖衣片、糖衣丸和硬明胶胶囊的载体的例子有乳糖、玉米淀粉或其衍生物,滑石粉、硬脂酸或其盐等。适于软明胶胶囊的载体例如:植物油、蜡、脂肪、半固体和液体多元醇等。另外,药剂可以包含防腐剂、助溶剂、稳定剂、保温剂、乳化剂、甜味剂、上色剂、香味剂、改变渗透压的盐类、缓冲液、包被剂或抗氧化剂。它们也可以含有其它有治疗价值的物质。其配制可以方便的单位剂量的形式,也可以用任何药物领域已知的方法制备。
优选地,按照实施例1的配方施用四氢脂抑素。实施例1
成分 | 含量(毫克/胶囊) |
四氢脂抑素 | 120.00 |
微晶纤维素(微晶纤维素PH-101) | 93.60 |
淀粉乙醇酸钠(PRIMOJEL) | 7.20 |
十二烷基硫酸钠 | 7.20 |
聚乙烯吡咯烷酮(Povidone(K-30)) | 12.00 |
纯水* | |
滑石粉 | 0.24 |
总量 | 240.24毫克 |
*制备过程中移出步骤:1.在合适的搅拌器中混合四氢脂抑素、微晶纤维素和淀粉乙醇酸钠。2.在纯水中,采用聚乙烯吡咯烷酮和十二烷基硫酸钠溶液使之颗粒化。3.将颗粒通过挤压机并且将挤压物通过成球机形成药丸。4.药丸于30℃干燥。5.加入滑石粉并且搅拌。6.填入硬的明胶胶囊。实施例2
成分 | 含量(毫克/胶囊) |
四氢脂抑素 | 60 |
微晶纤维素(微晶纤维素PH-101) | 46.8 |
淀粉乙醇酸钠 | 3.6 |
十二烷基硫酸钠 | 3.6 |
聚乙烯吡咯烷酮 | 6.0 |
纯水* | |
滑石粉 | 0.12 |
总量 | 120.12毫克 |
*制备过程中移出步骤:1.在合适的搅拌器中混合四氢脂抑素、微晶纤维素和淀粉乙醇酸钠。2.在纯水中,采用聚乙烯吡咯烷酮和十二烷基硫酸钠溶液使之颗粒化。3.将颗粒通过挤压机并且将挤压物通过成球机形成药丸。4.药丸于30℃干燥。5.加入滑石粉并且搅拌。6.填入硬的明胶胶囊。实施例3
成分 | 含量 毫克/胶囊 | |
四氢脂抑素 | 60 | 120 |
乳糖 | 40 | 80 |
微晶纤维素 | 60 | 120 |
乙醇酸钠淀粉 | 5.7 | 11.4 |
十二烷基硫酸钠 | 20 | 40 |
聚乙烯吡咯烷酮 | 10 | 20 |
纯水* | ||
滑石粉 | 0.2 | 0.4 |
总量 | 195.9毫克 | 391.8毫克 |
*制备过程中移出步骤:1.在合适的搅拌器中混合四氢脂抑素、乳糖、微晶纤维素和淀粉乙醇酸钠。2.在纯水中,采用聚乙烯吡咯烷酮和十二烷基硫酸钠溶液使之颗粒化。3.将颗粒通过挤压机并且将挤压物通过成球机形成药丸。4.药丸于30℃干燥。5.加入滑石粉并且搅拌。6.填入硬的明胶胶囊。实施例4
非胰岛素依赖的糖尿病病人的研究
进行一年双盲、安慰剂对照的研究,对象为321例非胰岛素依赖的糖尿病用磺脲类药物稳定的病人。结果显示,30%用四氢脂抑素治疗(120毫克,每天三次)的病人获得至少5%的体重基线的下降,与之相比,服用安慰剂的病人仅有13%(P<0.001)。四氢脂抑素同时提高这些病人的血糖控制能力,证据是统计学上显著性降低血红蛋白Alc水平(与安慰剂组比较提高0.5%,P<0.001)和服用磺酰类药物的剂量。在本研究中,有43%的接受四氢脂抑素治疗的病人能够减少或间断服用口服降糖药,与之相比是只有29%的接受安慰剂治疗的病人有同样效果,P<0.001。与基线水平相比,快速葡萄糖维持的平均水平在服用四氢脂抑素组基本不变(-0.02mmol/L),而在安慰剂组上升(+0.54mmol/L),P<0.05。用四氢脂抑素治疗组与安慰剂组相比,总胆固醇、低密度脂蛋白胆固醇、低密度脂蛋白/高密度脂蛋白比值和甘油三酯均有统计学意义上的显著改善。实施例5
肥胖病人中的葡萄糖耐受
在肥胖病人中进行为期两年包括口服葡萄糖耐受实验的研究,病人的基础口服葡萄糖耐受实验(OGTT)水平有正常的、受损的或糖尿病性的。比较了在两年的四氢脂抑素(n=242)(120毫克,每天口服三次)或安慰剂治疗组中从正常的基线OGTT至糖尿病性或受损的OGTT的发展过程。在四氢脂抑素治疗组,分别有0.0%和6.2%的病人从正常发展为糖尿病性的和受损的,与之相比,安慰剂治疗组分别有1.5%和12.4%,P<0.01。而在发现有基线水平OGTT受损的病人中,伴随一到两年四氢脂抑素或安慰剂治疗,发展为正常或恶化为糖尿病状态的比较结果如下表,两个治疗组之间差别是十分显著的:
治疗前人群OGTT基线状态 | 治疗后正常病人 | 治疗后糖尿病性病人 |
受损的 | 一年治疗 | 一年治疗 |
安慰剂组 n=48 | 45.8% | 10.4% |
四氢脂抑素* n=115 | 72,2% | 2.6% |
受损的 | 两年治疗 | 两年治疗 |
安慰剂组 n=40 | 47.5% | 7.5% |
四氢脂抑素** n=60 | 71.7% | 1.7% |
*P<0.01和**P<0.05,Fish’s精密检验。
Claims (4)
1.胃肠道脂酶抑制剂用于生产治疗或预防II型糖尿病口服药物的用途。
2.按照权利要求1的用途,其中胃肠道脂酶抑制剂是四氢脂抑素。
3.一种用于治疗或预防II型糖尿病的口服药物,其特征在于含有一种有效剂量的胃肠道脂酶抑制剂。
4.权利要求3中的口服药物,其中胃肠道脂酶抑制剂是四氢脂抑素。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US3738397P | 1997-02-05 | 1997-02-05 | |
US60/037,383 | 1997-02-05 |
Publications (2)
Publication Number | Publication Date |
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CN1246798A true CN1246798A (zh) | 2000-03-08 |
CN1154505C CN1154505C (zh) | 2004-06-23 |
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CNB988023245A Expired - Lifetime CN1154505C (zh) | 1997-02-05 | 1998-01-29 | 胃肠道脂酶抑制剂的用途 |
Country Status (28)
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US (1) | US6147108A (zh) |
EP (1) | EP1017408B1 (zh) |
JP (1) | JP2001509173A (zh) |
KR (1) | KR100479968B1 (zh) |
CN (1) | CN1154505C (zh) |
AR (1) | AR011106A1 (zh) |
AT (1) | ATE292975T1 (zh) |
AU (1) | AU740375B2 (zh) |
BR (1) | BR9807655A (zh) |
CA (1) | CA2278854C (zh) |
CZ (1) | CZ295567B6 (zh) |
DE (1) | DE69829763T2 (zh) |
DK (1) | DK1017408T3 (zh) |
ES (1) | ES2239799T3 (zh) |
HK (1) | HK1025251A1 (zh) |
HU (1) | HU230834B1 (zh) |
ID (1) | ID22650A (zh) |
IL (1) | IL131007A0 (zh) |
ME (1) | ME00578A (zh) |
NO (1) | NO324452B1 (zh) |
NZ (1) | NZ336755A (zh) |
PL (1) | PL191222B1 (zh) |
PT (1) | PT1017408E (zh) |
RU (1) | RU2201272C2 (zh) |
TR (1) | TR199901853T2 (zh) |
WO (1) | WO1998034630A1 (zh) |
YU (1) | YU34199A (zh) |
ZA (1) | ZA98753B (zh) |
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EP1017408B1 (en) * | 1997-02-05 | 2005-04-13 | F. Hoffmann-La Roche Ag | Use of tethrahydrolipstatin in the treatment of diabetes type ii |
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US7510849B2 (en) * | 2004-01-29 | 2009-03-31 | Glucolight Corporation | OCT based method for diagnosis and therapy |
EP2626368B1 (en) | 2004-07-19 | 2016-12-21 | Biocon Limited | Insulin-oligomer conjugates, formulations and uses thereof |
US8036727B2 (en) * | 2004-08-11 | 2011-10-11 | Glt Acquisition Corp. | Methods for noninvasively measuring analyte levels in a subject |
US7254429B2 (en) | 2004-08-11 | 2007-08-07 | Glucolight Corporation | Method and apparatus for monitoring glucose levels in a biological tissue |
CA2604653A1 (en) | 2005-04-13 | 2006-10-19 | Glucolight Corporation | Method for data reduction and calibration of an oct-based blood glucose monitor |
US8217025B2 (en) * | 2006-11-17 | 2012-07-10 | Harbor Therapeutics, Inc. | Drug screening and treatment methods |
EP2036575B1 (en) * | 2007-09-12 | 2010-08-18 | Mader S.r.l. | Pharmaceutical compositions for oral use for treating patients affected by obesity |
US20100317642A1 (en) * | 2007-10-15 | 2010-12-16 | Inventis Dds Pvt Limited | Pharmaceutical composition of orlistat |
AU2008313248B2 (en) | 2007-10-16 | 2012-04-26 | Biocon Limited | An orally administerable solid pharmaceutical composition and a process thereof |
US8768423B2 (en) | 2008-03-04 | 2014-07-01 | Glt Acquisition Corp. | Multispot monitoring for use in optical coherence tomography |
US8309107B2 (en) * | 2008-10-06 | 2012-11-13 | Banner Pharmacaps, Inc. | Stable solutions of orlistat for pharmaceutical dosage forms |
FR3017536B1 (fr) * | 2014-02-18 | 2017-05-26 | Univ La Rochelle | Compositions pour la prevention et/ou le traitement de pathologies liees a l'alpha-glucosidase |
JP2019515654A (ja) * | 2016-03-16 | 2019-06-13 | ザ ジェイ. デヴィッド グラッドストーン インスティテューツ | 肥満及び/又は糖尿病を処置するための方法及び組成物、並びに候補処置薬剤を識別するための方法及び組成物 |
US20190022061A1 (en) * | 2017-07-21 | 2019-01-24 | Kieu Hoang | Statins (Atorvastatin) can lower blood sugar level in diabetic |
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CA1247547A (en) * | 1983-06-22 | 1988-12-28 | Paul Hadvary | Leucine derivatives |
CA1270837A (en) * | 1984-12-21 | 1990-06-26 | Hoffmann-La Roche Limited | Oxetanones |
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CA2035972C (en) * | 1990-02-23 | 2006-07-11 | Martin Karpf | Process for the preparation of oxetanones |
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US5130333A (en) * | 1990-10-19 | 1992-07-14 | E. R. Squibb & Sons, Inc. | Method for treating type II diabetes employing a cholesterol lowering drug |
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EP1017408B1 (en) * | 1997-02-05 | 2005-04-13 | F. Hoffmann-La Roche Ag | Use of tethrahydrolipstatin in the treatment of diabetes type ii |
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1998
- 1998-01-29 EP EP98908008A patent/EP1017408B1/en not_active Revoked
- 1998-01-29 ES ES98908008T patent/ES2239799T3/es not_active Expired - Lifetime
- 1998-01-29 DK DK98908008T patent/DK1017408T3/da active
- 1998-01-29 KR KR10-1999-7006983A patent/KR100479968B1/ko not_active IP Right Cessation
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- 1998-01-29 CZ CZ19992651A patent/CZ295567B6/cs not_active IP Right Cessation
- 1998-01-29 YU YU34199A patent/YU34199A/sh unknown
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- 1998-01-29 NZ NZ336755A patent/NZ336755A/en not_active IP Right Cessation
- 1998-01-29 AT AT98908008T patent/ATE292975T1/de active
- 1998-01-29 AU AU66169/98A patent/AU740375B2/en not_active Expired
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- 1998-01-29 JP JP53371598A patent/JP2001509173A/ja active Pending
- 1998-01-29 ZA ZA98753A patent/ZA98753B/xx unknown
- 1998-01-29 CN CNB988023245A patent/CN1154505C/zh not_active Expired - Lifetime
- 1998-01-29 BR BR9807655-8A patent/BR9807655A/pt not_active Application Discontinuation
- 1998-01-29 WO PCT/EP1998/000468 patent/WO1998034630A1/en active IP Right Grant
- 1998-02-03 AR ARP980100471A patent/AR011106A1/es not_active Application Discontinuation
-
1999
- 1999-07-30 NO NO19993717A patent/NO324452B1/no not_active IP Right Cessation
- 1999-10-04 US US09/411,554 patent/US6147108A/en not_active Expired - Lifetime
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2000
- 2000-07-21 HK HK00104500A patent/HK1025251A1/xx not_active IP Right Cessation
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