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1. 发明授权

US08044086B2 Oxidative degradation products of atorvastatin calcium 有权
标题翻译：阿托伐他汀钙的氧化降解产物
公开(公告)号：US08044086B2
公开(公告)日：2011-10-25
申请号：US11632608
申请日：2005-07-15
申请人： Rok Grahek , Darko Kocjan , Andrej Bastarda , Andrej Kocijan , Matjaz Kracun
发明人： Rok Grahek , Darko Kocjan , Andrej Bastarda , Andrej Kocijan , Matjaz Kracun
IPC分类号： A01N43/38 , A01N43/36
CPC分类号： C07D498/14 , C07D207/416 , C07D301/00 , C07D303/48 , C07D493/04
摘要： The present invention relates to oxidative degradation products of atorvastatin calcium and the process of the preparation thereof. The present invention also relates to atorvastatin calcium substantially free of oxidative degradation products and the pharmaceutical compositions containing such atorvastatin calcium.
摘要翻译：本发明涉及阿托伐他汀钙的氧化降解产物及其制备方法。本发明还涉及基本上不含氧化降解产物的阿托伐他汀钙和含有这种阿托伐他汀钙的药物组合物。

2. 发明授权

US5854390A Chromatographic purification of vancomycin hydrochloride by use of preparative HPLC 失效
标题翻译：使用制备型HPLC对盐酸万古霉素进行色谱纯化
公开(公告)号：US5854390A
公开(公告)日：1998-12-29
申请号：US875442
申请日：1997-07-28
申请人： Rok Grahek , Andrej Bastarda
发明人： Rok Grahek , Andrej Bastarda
IPC分类号： C07K1/16 , A61K38/00 , C07K9/00 , G01N30/02 , C07K5/12 , A61K38/12
CPC分类号： C07K9/008 , A61K38/00 , G01N30/02
摘要： The present invention discloses a new method for the purification of vancomycin hydrochloride by preparative HPLC (method of displacement chromatography), whereby the chromatographic purity of the product is essentialy improved. The chromatography is performed on a reverse stationary phase with a mobile phase consisting of an organic or inorganic acid or of a buffer with possible additives, with different displacing agents, at a defined pH and temperature as well as the amount and concentration of vancomycin hydrochloride. The process is distinguished by the excellent yield and exceptional chromatographic purity 95.5% area of the obtained product and, besides, it represents an ecologically irreproachable process. The vancomycin hydrochloride purified according to the present invention is useful for all types of application since the portion of impurities it contains is for one third lower than in hitherto known commercially available products.
摘要翻译： PCT No.PCT / SI96 / 00002 Sec。 371日期1997年7月28日第 102（e）日期1997年7月28日PCT提交1996年2月6日PCT公布。第WO96 / 24614号公报日期1996年8月15日本发明公开了一种通过制备型HPLC（置换色谱法）纯化万古霉素盐酸盐的新方法，从而提高了产品的色谱纯度。色谱法在反相固定相上进行，流动相由有机或无机酸组成的流动相或具有可能的添加剂的缓冲液，不同的置换剂在规定的pH和温度以及盐酸万古霉素的量和浓度下进行。该方法的优点是获得的产品的优异的产率和卓越的色谱纯度达95.5％，此外，它代表了一个生态无法应对的过程。根据本发明纯化的万古霉素盐酸盐可用于所有类型的施用，因为其含有的杂质的部分比目前已知的市售产品低三分之一。

3. 发明申请

US20110184172A1 PROCESS FOR THE PREPARATION OF METHYL ESTER OF ROSUVASTATIN 有权
标题翻译：制备罗司他汀甲酯的方法
公开(公告)号：US20110184172A1
公开(公告)日：2011-07-28
申请号：US12672119
申请日：2008-08-01
申请人： Andrej Bastarda , Rok Grahek , Martin Crnugelj
发明人： Andrej Bastarda , Rok Grahek , Martin Crnugelj
IPC分类号： C07D239/42
CPC分类号： C07D239/42
摘要： Process for the preparation of enantiomerically pure methyl ester of rosuvastatin has been developed, wherein the crude methyl ester ester is first purified by preparative chromatography, followed by crystallization.
摘要翻译：已经开发了用于制备罗苏伐他汀的对映体纯的甲基酯的方法，其中粗制甲基酯酯首先通过制备型色谱法纯化，随后结晶。

4. 发明申请

US20100056605A1 OXIDATIVE DEGRADATION PRODUCTS OF ATORVASTATIN CALCIUM 审中-公开
标题翻译： ATORVASTATIN钙的氧化降解产物
公开(公告)号：US20100056605A1
公开(公告)日：2010-03-04
申请号：US12613787
申请日：2009-11-06
申请人： Rok Grahek , Darko Kocjan , Andrej Bastarda , Andrej Kocijan , Matjaz Kracun
发明人： Rok Grahek , Darko Kocjan , Andrej Bastarda , Andrej Kocijan , Matjaz Kracun
IPC分类号： A61K31/40 , C07D498/14 , C07D493/04 , C07D207/30
CPC分类号： C07D498/14 , C07D207/416 , C07D301/00 , C07D303/48 , C07D493/04
摘要： The present invention relates to oxidative degradation products of atorvastatin calcium and the process of the preparation thereof. The present invention also relates to atorvastatin calcium substantially free of oxidative degradation products and the pharmaceutical compositions containing such atorvastatin calcium.
摘要翻译：本发明涉及阿托伐他汀钙的氧化降解产物及其制备方法。本发明还涉及基本上不含氧化降解产物的阿托伐他汀钙和含有这种阿托伐他汀钙的药物组合物。

5. 发明授权

US09149460B2 Coated particles and pharmaceutical dosage forms 有权
标题翻译：涂层颗粒和药物剂型
公开(公告)号：US09149460B2
公开(公告)日：2015-10-06
申请号：US11862470
申请日：2007-09-27
申请人： Vlasta Humar , Mateja Burjak , Rok Grahek , Mateja Salobir , Janez Kerc , Klemen Kocevar
发明人： Vlasta Humar , Mateja Burjak , Rok Grahek , Mateja Salobir , Janez Kerc , Klemen Kocevar
IPC分类号： A61K9/24 , A61K31/225 , A61K31/40 , A61K9/20 , A61K9/28
CPC分类号： A61K9/5047 , A61K9/2009 , A61K9/2018 , A61K9/2054 , A61K9/2866 , A61K31/40
摘要： The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.
摘要翻译：本发明涉及包含对环境影响敏感的活性物质的包衣颗粒和药物剂型。本发明的涂层提供活性物质对于环境影响的稳定性和保护，特别是通过涂覆从氧化和/或环境湿度。

6. 发明申请

US20080242725A1 Pharmaceutical Composition 审中-公开
标题翻译：药物组成
公开(公告)号：US20080242725A1
公开(公告)日：2008-10-02
申请号：US10590780
申请日：2005-02-28
申请人： Janez Kerc , Peter Svete , Zdenka Jerala-Strukelj , Vlasta Humar , Rok Grahek , Breda Husu-Kovacevic
发明人： Janez Kerc , Peter Svete , Zdenka Jerala-Strukelj , Vlasta Humar , Rok Grahek , Breda Husu-Kovacevic
IPC分类号： A61K31/225 , A61K47/26 , A61P9/10
CPC分类号： A61K9/1652 , A61K31/4184 , A61K31/695 , C07C67/62 , C07C2602/28 , C07C69/33
摘要： Stabilized pharmaceutical compositions comprising polymorphs of active pharmaceutical ingredients susceptible to conversion to alternate polymorph forms are prepared by a process of wet granulation in which the ratios of active, fillers, and granulating liquid are controlled in order to avoid polymorphic interconversions.
摘要翻译：包含易于转化为交替多晶型形式的活性药物成分的多晶型物的稳定化药物组合物是通过湿法制粒方法制备的，其中控制活性成分，填充剂和制粒液体的比例以避免多晶型相互转化。

7. 发明申请

US20080138429A1 Coated Particles and Pharmaceutical Dosage Forms 有权
标题翻译：涂层颗粒和药物剂型
公开(公告)号：US20080138429A1
公开(公告)日：2008-06-12
申请号：US11862470
申请日：2007-09-27
申请人： Vlasta HUMAR , Mateja Burjak , Rok Grahek , Mateja Salobir , Janez Kerc , Klemen Kocevar
发明人： Vlasta HUMAR , Mateja Burjak , Rok Grahek , Mateja Salobir , Janez Kerc , Klemen Kocevar
IPC分类号： A61K9/50 , A61K31/401
CPC分类号： A61K9/5047 , A61K9/2009 , A61K9/2018 , A61K9/2054 , A61K9/2866 , A61K31/40
摘要： The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.
摘要翻译：本发明涉及包含对环境影响敏感的活性物质的包衣颗粒和药物剂型。本发明的涂层提供活性物质对于环境影响的稳定性和保护，特别是通过涂覆从氧化和/或环境湿度。

8. 发明申请

US20070208071A1 Oxidative Degradation Products of Atorvastatin Calcium 有权
标题翻译：阿托伐他汀钙的氧化降解产物
公开(公告)号：US20070208071A1
公开(公告)日：2007-09-06
申请号：US11632608
申请日：2005-07-15
申请人： Rok Grahek , Darko Kocjan , Andrej Bastarda , Andrej Kocijan , Matjaz Kracun
发明人： Rok Grahek , Darko Kocjan , Andrej Bastarda , Andrej Kocijan , Matjaz Kracun
IPC分类号： A61K31/403 , A61K31/401 , C07D487/02
CPC分类号： C07D498/14 , C07D207/416 , C07D301/00 , C07D303/48 , C07D493/04
摘要： The present invention relates to oxidative degradation products of atorvastatin calcium and the process of the preparation thereof. The present invention also relates to atorvastatin calcium substantially free of oxidative degradation products and the pharmaceutical compositions containing such atorvastatin calcium.
摘要翻译：本发明涉及阿托伐他汀钙的氧化降解产物及其制备方法。本发明还涉及基本上不含氧化降解产物的阿托伐他汀钙和含有这种阿托伐他汀钙的药物组合物。

9. 发明申请

US20070032549A1 Process for obtaining HMG-CoA reductase inhibitors of high purity 审中-公开
标题翻译：获得高纯度HMG-CoA还原酶抑制剂的方法
公开(公告)号：US20070032549A1
公开(公告)日：2007-02-08
申请号：US11581637
申请日：2006-10-16
申请人： Rok Grahek , Dusan Milivojevic , Andrej Bastarda
发明人： Rok Grahek , Dusan Milivojevic , Andrej Bastarda
IPC分类号： A61K31/22 , A61K31/366
CPC分类号： C07C67/52 , A61K31/22 , A61K31/366 , B01D15/422 , C07C69/33
摘要： Lovastatin, pravastatin, simvastatin, mevastatin, atorvastatin, and derivatives and analogs thereof are known as HMG-CoA reductase inhibitors and are used as antihypercholesterolemic agents. The majority of them are produced by fermentation using microorganisms of different species identified as species belonging to Aspergillus, Monascus, Nocardia, Amycolatopsis, Mucor or Penicillium genus, Streptomyces, Actinomadura, Micromonospora, some are obtained by treating the fermentation products using the method of chemical synthesis or they are the products of total chemical synthesis. The purity of the active ingredient is an important factor for manufacturing the safe and effective pharmaceutical, especially if the pharmaceutical product must be taken on a longer term basis in the treatment or prevention of high plasma cholesterol. The accumulation of the impurities from the pharmaceuticals of lower purity may cause many side effects during the medical treatment. The present invention relates to a new industrial process for the isolation of HMG-CoA reductase inhibitors using so-called displacement chromatography. Use of the invention enables one to obtain HMG-CoA reductase inhibitors of high purity, with high yields, lower production costs and suitable ecological balance.
摘要翻译：洛伐他汀，普伐他汀，辛伐他汀，美伐他汀，阿托伐他汀及其衍生物和类似物被称为HMG-CoA还原酶抑制剂，并用作抗高胆固醇血症药。其中大多数是通过使用不同种类的微生物鉴定为属于曲霉属，红曲霉属，诺卡氏菌属，无性系，毛霉属或青霉属，链霉菌属，放线菌属，微单孢菌属的发酵产生的，一些是通过使用化学方法处理发酵产物合成或它们是总化学合成的产物。活性成分的纯度是制造安全有效的药物的重要因素，特别是如果药物产品必须长期服用于治疗或预防高血浆胆固醇。来自低纯度药物的杂质的积累可能在治疗期间引起许多副作用。本发明涉及使用所谓的位移色谱法分离HMG-CoA还原酶抑制剂的新工业方法。使用本发明可以获得高纯度的HMG-CoA还原酶抑制剂，具有高产率，降低生产成本和合适的生态平衡。

10. 发明授权

US08309719B2 Process for the preparation of methyl ester of rosuvastatin 有权
标题翻译：罗苏伐他汀甲酯制备方法
公开(公告)号：US08309719B2
公开(公告)日：2012-11-13
申请号：US12672119
申请日：2008-08-01
申请人： Andrej Bastarda , Rok Grahek , Martin Crnugelj
发明人： Andrej Bastarda , Rok Grahek , Martin Crnugelj
IPC分类号： C07D239/02
CPC分类号： C07D239/42
摘要： Process for the preparation of enantiomerically pure methyl ester of rosuvastatin has been developed, wherein the crude methyl ester ester is first purified by preparative chromatography, followed by crystallization.
摘要翻译：已经开发了用于制备罗苏伐他汀的对映体纯的甲基酯的方法，其中粗制甲基酯酯首先通过制备型色谱法纯化，随后结晶。

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