CN1679551A - 药物组合物 - Google Patents
药物组合物 Download PDFInfo
- Publication number
- CN1679551A CN1679551A CNA2005100510503A CN200510051050A CN1679551A CN 1679551 A CN1679551 A CN 1679551A CN A2005100510503 A CNA2005100510503 A CN A2005100510503A CN 200510051050 A CN200510051050 A CN 200510051050A CN 1679551 A CN1679551 A CN 1679551A
- Authority
- CN
- China
- Prior art keywords
- valsartan
- pharmaceutically acceptable
- capsule
- hydrate
- acceptable salt
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Images
Classifications
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- Psychiatry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
1 | 2 | 3 | 4 | |
成分 | 组成/单位(mg) | 组成/单位(mg) | 组成/单位(mg) | 组成/单位(mg) |
制粒 | ||||
Diovan药物材料 | 20.0 | 40.0 | 80.0 | 320.0 |
氢氯噻嗪药物材料 | --- | --- | ||
微晶纤维素(NF,Ph.Eur.)/Avicel PH 102 | 62.0 | 124.0 | 54.0 | 216.0 |
交联聚维酮(NF,Ph.Eur.) | 10.0 | 20.0 | 20.0 | 80.0 |
胶态无水二氧化硅(Ph.Eur.)/胶态二氧化硅(NF)/Aerosil 200 | 0.5 | 1.0 | 0.75 | 3.0 |
硬脂酸镁(NF,Ph.Eur.) | 1.0 | 2.0 | 2.5 | 10.0 |
混合 | ||||
胶态无水二氧化硅(Ph.Eur.)/胶态二氧化硅(NF)/Aerosil 200 | 0.5 | 1.0 | 0.75 | 3.0 |
硬脂酸镁,NF,Ph.Eur. | 1.0 | 2.0 | 2.0 | 8.0 |
药芯重/批重 | 95.0/47.5kg | 190.0/47.5kg | 160.0/48.0kg | 640.0/73.5kg |
参数 | 40mg片剂(处理A)最小二乘方平均值a(N) | 40mg胶囊参照物(处理B)最小二乘方平均值a(N) | 最小二乘方平均值之比° | 最小二乘方平均值之比的90%置信区间c |
AUCallAUCinfCmax | 6.732(60)6.859(60)1.245(60) | 3.922(60)4.037(60)0.681(60) | 1.721.701.83 | (1.49,1.97)(1.48,1.95)(1.57,2.13) |
参数 | 320mg片剂(处理A)最小二乘方平均值a(N) | 2*160mg胶囊参照物(处理B)最小二乘方平均值a(N) | 最小二乘方平均值之比a | 最小二乘方平均值之比的90%置信区间c |
AUCallAUCinfCmax | 36.53(60)37.32(60)6.23(60) | 29.39(60)30.17(60)4.88(60) | 1.241.241.28 | (1.14,1.35)(1.14,1.35)(1.15,1.41) |
制剂 | 统计 | Tmax(h) | Cmax(mg/l) | AUC最后(h·mg/l) | AUC全部(h·mg/l) | AUC0-8(h·mg/l) |
片剂胶囊 | N1)=61平均值SD最小值中值最大值CV%几何平均值95%CI的LL95%CI的ULN=60平均值SD最小值中值最大值CV%几何平均值95%CI的LL95%CI的UL | 2.320.751.502.004.0332.22.212.122.513.320.991.504.006.0329.83.173.073.58 | 1.4250.5780.1521.2843.36340.51.3011.2771.5730.7600.3860.0720.7411.86350.80.6530.6600.860 | 7.5142.9600.8067.13115.63739.46.8616.7568.2724.1902.1320.4724.0769.78550.93.5883.6394.741 | 7.7192.9920.9227.34615.89338.87.0736.9528.4854.3472.1900.4724.24410.01850.43.7333.7814.913 | 7.8363.0241.1047.50216.19238.67.2027.0628.6114.4612.2270.4724.35110.14049.93.8433.8855.036 |
制剂 | 统计 | Tmax(h) | Cmax(mg/l) | AUClast(h·mg/l) | AUCall(h·mg/l) | AUC0-8(h·mg/l) |
片剂胶囊 | N=60平均值SD最小值中值最大值CV%几何平均值95%CI的LL95%CI的ULN=60平均值SD最小值中值最大值CV%几何平均值95%CI的LL95%CI的UL | 2.860.921.003.004.1732.32.702.623.103.280.991.003.016.0030.33.123.023.54 | 6.5092.6732.4l6.0714.0941.16.0325.8197.2005.5342.5452.054.7311.8146.04.9984.8766.19l | 37.7714.9015.0835.6583.8839.435.1033.9341.6232.2914.0911.2929.4573.8143.629.4828.6535.93 | 38.2414.8615.0835.6583.8838.935.6034.4042.0832.7414.0511.5930.0573.8142.929.9829.1136.37 | 39.1815.2916.2137.3286.8439.036.4535.2243.1333.5114.2011.7330.975.2642.430.7229.8437.18 |
Claims (12)
Applications Claiming Priority (2)
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US59968700A | 2000-06-22 | 2000-06-22 | |
US09/599,687 | 2000-06-22 |
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CNB018115527A Division CN1221256C (zh) | 2000-06-22 | 2001-06-20 | 药物组合物 |
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CN1679551A true CN1679551A (zh) | 2005-10-12 |
CN100450478C CN100450478C (zh) | 2009-01-14 |
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CNB018115527A Expired - Fee Related CN1221256C (zh) | 2000-06-22 | 2001-06-20 | 药物组合物 |
CNB2005100510503A Expired - Fee Related CN100450478C (zh) | 2000-06-22 | 2001-06-20 | 药物组合物 |
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CNB018115527A Expired - Fee Related CN1221256C (zh) | 2000-06-22 | 2001-06-20 | 药物组合物 |
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EP (2) | EP1296677A2 (zh) |
JP (3) | JP2003535895A (zh) |
KR (2) | KR100659644B1 (zh) |
CN (2) | CN1221256C (zh) |
AU (2) | AU2001285768B2 (zh) |
BR (1) | BR0111868A (zh) |
CA (1) | CA2411882C (zh) |
CZ (1) | CZ20024180A3 (zh) |
EC (1) | ECSP024389A (zh) |
HK (2) | HK1052868A1 (zh) |
HU (1) | HUP0301390A3 (zh) |
IL (2) | IL153428A0 (zh) |
MX (1) | MXPA02012683A (zh) |
NO (1) | NO20026123L (zh) |
NZ (2) | NZ540748A (zh) |
PL (1) | PL358290A1 (zh) |
RU (1) | RU2333757C2 (zh) |
SG (1) | SG162605A1 (zh) |
SK (1) | SK18062002A3 (zh) |
WO (1) | WO2001097805A2 (zh) |
ZA (1) | ZA200210359B (zh) |
Cited By (2)
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CN112807286A (zh) * | 2021-01-20 | 2021-05-18 | 海南皇隆制药股份有限公司 | 一种缬沙坦分散片制备方法和缬沙坦分散片 |
CN112826806A (zh) * | 2021-01-20 | 2021-05-25 | 海南皇隆制药股份有限公司 | 一种缬沙坦片制备方法和缬沙坦片 |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2002533390A (ja) * | 1998-12-23 | 2002-10-08 | ノバルティス アクチエンゲゼルシャフト | At−1またはat−2レセプターの増加に関連する疾患の処置のための、at−1レセプターアンタゴニストまたはat−2レセプターモジュレーターの使用 |
US7468390B2 (en) | 2002-01-17 | 2008-12-23 | Novartis Ag | Methods of treatment and pharmaceutical composition |
MXPA04006917A (es) * | 2002-01-17 | 2004-12-06 | Novartis Ag | Composiciones farmaceuticas que comprenden inhibidores de valsartan y endopeptidasa neutra. |
GB0209265D0 (en) | 2002-04-23 | 2002-06-05 | Novartis Ag | Organic compounds |
TWI299663B (en) * | 2002-05-14 | 2008-08-11 | Novartis Ag | Methods of treatment |
KR20080083071A (ko) * | 2003-08-08 | 2008-09-12 | 아지노모토 가부시키가이샤 | 나테글리니드 함유 제제 |
WO2006021443A2 (en) * | 2004-08-26 | 2006-03-02 | Novartis Ag | Composition comprising an at1 receptor blocker and a macrolide t-cell immunomodulator |
AU2005318365B2 (en) | 2004-12-24 | 2011-02-03 | Krka, D.D., Novo Mesto | Solid pharmaceutical composition comprising valsartan |
JP2009001520A (ja) * | 2007-06-21 | 2009-01-08 | Kowa Co | ジフェンヒドラミン含有固形製剤 |
AU2008311053B2 (en) | 2007-10-09 | 2012-08-30 | Novartis Ag | Pharmaceutical formulation of valsartan |
WO2009059605A1 (en) * | 2007-11-08 | 2009-05-14 | University Of Copenhagen | Small scale solid state screening |
EP2067470A1 (en) * | 2007-12-03 | 2009-06-10 | Laboratorios Lesvi, S.L. | Pharmaceutical compositions containing valsartan and process for its preparation |
WO2011102702A2 (en) | 2010-02-16 | 2011-08-25 | Krka, D. D., Novo Mesto | Process for the preparation of oral solid dosage forms comprising valsartan |
CN102362865B (zh) * | 2011-10-28 | 2013-06-26 | 山东司邦得制药有限公司 | 一种含有盐酸贝尼地平和缬沙坦的复方制剂及其应用 |
WO2013098578A1 (en) | 2011-12-31 | 2013-07-04 | Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi | Immediate release pharmaceutical composition of valsartan hydrochlorothiazide |
WO2013098576A1 (en) | 2011-12-31 | 2013-07-04 | Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi | Immediate release pharmaceutical composition of valsartan |
CN103599084B (zh) * | 2013-11-22 | 2018-10-30 | 威海迪素制药有限公司 | 一种降压组合物 |
EP4295839A1 (en) | 2022-06-20 | 2023-12-27 | KRKA, d.d., Novo mesto | Combination of valsartan and indapamide |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
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DE122007000050I1 (de) | 1990-02-19 | 2007-11-08 | Novartis Ag | Acylverbindungen |
HUT76542A (en) | 1994-03-17 | 1997-09-29 | Ciba Geigy Ag | Use of valsartan for the preparation of pharmaceutical composition serving for the treatment of diabetic nephropathy |
ATE225657T1 (de) * | 1995-10-06 | 2002-10-15 | Novartis Erfind Verwalt Gmbh | Ati-rezeptorantagonisten zur verhinderung und behandlung des postischemischen nervenversagens und zum schutze ischemischer nieren |
AU1791497A (en) * | 1996-02-29 | 1997-09-16 | Novartis Ag | At1 receptor antagonist for the stimulation of apoptosis |
EP0904060B1 (en) * | 1996-05-20 | 2003-12-10 | Janssen Pharmaceutica N.V. | Antifungal compositions with improved bioavailability |
GB9613470D0 (en) * | 1996-06-27 | 1996-08-28 | Ciba Geigy Ag | Small solid oral dosage form |
US6541669B1 (en) * | 1998-06-08 | 2003-04-01 | Theravance, Inc. | β2-adrenergic receptor agonists |
SE9802973D0 (sv) * | 1998-09-03 | 1998-09-03 | Astra Ab | Immediate release tablet |
JP2002533390A (ja) * | 1998-12-23 | 2002-10-08 | ノバルティス アクチエンゲゼルシャフト | At−1またはat−2レセプターの増加に関連する疾患の処置のための、at−1レセプターアンタゴニストまたはat−2レセプターモジュレーターの使用 |
CN1651087A (zh) * | 2000-04-12 | 2005-08-10 | 诺瓦提斯公司 | 有机化合物的联合形式 |
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Cited By (2)
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CN112807286A (zh) * | 2021-01-20 | 2021-05-18 | 海南皇隆制药股份有限公司 | 一种缬沙坦分散片制备方法和缬沙坦分散片 |
CN112826806A (zh) * | 2021-01-20 | 2021-05-25 | 海南皇隆制药股份有限公司 | 一种缬沙坦片制备方法和缬沙坦片 |
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