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1. 发明专利

JP2015057380A 加熱溶融押出担体用ヒプロメロース酢酸エステルコハク酸エステル、加熱溶融押出用組成物及び加熱溶融押出成型物の製造方法有权
标题翻译：用作高熔体挤出载体的丙烯酸乙酯酯，热熔融挤出组合物，以及用于生产高熔点挤出物的方法
公开(公告)号：JP2015057380A
公开(公告)日：2015-03-26
申请号：JP2014162437
申请日：2014-08-08
申请人：信越化学工業株式会社 , Shin Etsu Chem Co Ltd
发明人： MARUYAMA NAOAKI , WARASHINA SHOGO , KUSAKI FUMIE , OHARA SAKAE , KIKUCHI KAZUKI
IPC分类号： A61K47/38 , A61K31/4422 , A61K45/00
CPC分类号： A61K31/4422 , A61K9/146 , A61K9/20 , A61K47/38 , Y10T428/2982
摘要：【課題】薬物との混合均一性に優れた加熱溶融押出成型物及び加熱溶融押出における粉体供給をスムーズに行うことができる加熱溶融押出成型物の製造方法を提供する。【解決手段】乾式レーザー回折法による体積平均粒子径(D50)が70〜300μmであり、かつゆるめ嵩密度が0.25〜0.40g/cm3である加熱溶融押出担体用HPMCASが提供され、このHPMCASと薬物を少なくとも含む加熱溶融押出用組成物が提供される。また、乾式レーザー回折法による体積平均粒子径(D50)が70〜300μmであり、かつゆるめ嵩密度が0.25〜0.40g/cm3であるHPMCASと薬物を少なくとも含む加熱溶融押出組成物を、前記HPMCASの溶融温度以上、又は前記HPMCAS及び前記薬物を共に溶融することになる温度以上の加熱溶融温度で加熱溶融し、押出しする工程を少なくとも含む加熱溶融押出成型物の製造方法が提供される。【選択図】なし
摘要翻译：要解决的问题：提供与药物具有优异的均匀混溶性的热熔挤出物，以及其中可以平滑地供给粉末以进行热熔挤出的热熔挤出物的制备方法。解决方案：提供了HPMCAS 用作通过干式激光衍射法测定的体积平均粒径（D）为70-300μm并且松散体积密度为0.25-0.40g / cm 3的热熔挤出载体; 和至少包含HPMCAS和药物的热熔挤出组合物。还提供了一种生产热熔挤出物的方法，该方法至少包括以下步骤：将具有体积平均粒径（D）为70-300μm的至少HPMCAS至少包含70-300μm的HPMCAS热熔融为热熔挤出组合物，在等于或高于HPMCAS的熔融温度的热熔融温度下，或在等于或等于或等于或等于或等于或等于或等于或等于或等于高于HPMCAS和药物两者融化的温度; 并挤出热熔融组合物。

2. 发明专利

JP2008133259A Solid preparation of solid dispersion and method for producing the same 有权
标题翻译：固体分散体的固体制备及其制造方法
公开(公告)号：JP2008133259A
公开(公告)日：2008-06-12
申请号：JP2007206389
申请日：2007-08-08
申请人： Shin Etsu Chem Co Ltd , 信越化学工業株式会社
发明人： HOSHINO TAKASHI , KUSAKI FUMIE , MARUYAMA NAOAKI , NISHIYAMA YUICHI , FUKUI IKUO , UMEZAWA HIROSHI
IPC分类号： A61K47/38 , A61K9/14 , A61K31/4422 , A61K47/32 , A61P9/00
摘要： PROBLEM TO BE SOLVED: To provide a solid preparation comprising a solid dispersion that allows rapid dissolution of a drug in the preparation without lowering the solubility of the solid dispersion, and a method for producing the preparation.
SOLUTION: The invention provides a solid preparation of a solid dispersion containing a sparingly soluble drug, a water-soluble polymer and a disintegrant, wherein the disintegrant is a low-substituted hydroxypropylcellulose having an average particle diameter of 10-100 μm and a specific surface area of ≥1.0 m
2 /g determined by the BET method. The invention further provides a method for producing the solid preparation of a solid dispersion comprising the spraying of a water-soluble polymer solution containing a sparingly soluble drug dispersed or dissolved in the solution to a powder mixed with a disintegrant comprising a low-substituted hydroxypropylcellulose having an average particle diameter of 10-100 μm and a specific surface area of ≥1.0 m
2 /g determined by the BET method, and the granulation and drying of the sprayed product.
COPYRIGHT: (C)2008,JPO&INPIT
摘要翻译：要解决的问题：提供一种固体制剂，其包含固体分散体，其允许药物在制剂中快速溶解而不降低固体分散体的溶解度，以及制备该制剂的方法。解决方案：本发明提供了含有微溶药物，水溶性聚合物和崩解剂的固体分散体的固体制剂，其中崩解剂是平均粒径为10-100μm的低取代羟丙基纤维素，通过BET法测定的≥1.0μm 2 / g的比表面积。本发明还提供一种制备固体分散体的固体制剂的方法，其包括将含有分散或溶解在该溶液中的微溶性药物的水溶性聚合物溶液喷雾到与包含低取代羟丙基纤维素的崩解剂混合的粉末中，通过BET法测定的平均粒径为10〜100μm，比表面积≥1.0m2 / SP / g，喷雾产物的造粒和干燥。版权所有（C）2008，JPO＆INPIT

3. 发明专利

JP2014122328A Cleaning composition and cleaning method of extrusion molding machine or injection molding machine 审中-公开
标题翻译：挤出成型机或注塑机清洗组合物和清洗方法
公开(公告)号：JP2014122328A
公开(公告)日：2014-07-03
申请号：JP2013231657
申请日：2013-11-08
申请人： Shin Etsu Chem Co Ltd , 信越化学工業株式会社
发明人： NIINOBE SHINGO , HAYAKAWA KAZUHISA , KUSAKI FUMIE
IPC分类号： C11D7/44 , B29C45/17 , B29C47/08 , C08J3/12 , C11D7/26 , C11D7/32
CPC分类号： C11D7/5022 , B29C47/0877 , B29C47/0881 , C11D3/222 , C11D3/225 , C11D7/261 , C11D7/3218 , C11D11/0041
摘要： PROBLEM TO BE SOLVED: To provide a cleaning composition of an extrusion molding machine or an injection molding machine, which exhibits an excellent cleaning effect, hardly exerts a grinding action to avoid such a chance that the inside of the molding machine is worn by cleaning, and is removed easily from the molding machine even when the cleaning composition is left behind in the molding machine after it is discharged and to provide a cleaning method of the extrusion molding machine or the injection molding machine.SOLUTION: The cleaning composition of the extrusion molding machine or the injection molding machine contains cellulose ether and one or more solvents selected from water-soluble polyhydric alcohol, polyhydric alcohol ether, and ethanolamines. The concentration of the cellulose ether in the solvent is 10 mass% or higher.
摘要翻译：要解决的问题：为了提供显示出优异的清洁效果的挤出成型机或注射成型机的清洗组合物，几乎不发生研磨作用，以避免通过清洁磨损成型机内部的机会，并且即使当清洁组合物在排出之后留在成型机中时也容易地从成型机除去并提供挤出成型机或注射成型机的清洁方法。解决方案：挤出成型的清洁组合物机器或注塑机含有纤维素醚和一种或多种选自水溶性多元醇，多元醇醚和乙醇胺的溶剂。溶剂中的纤维素醚的浓度为10质量％以上。

4. 发明专利

JP2008133258A Solid preparation of enteric solid dispersion and method for producing the same 有权
标题翻译：固体分散体的固体制备及其生产方法
公开(公告)号：JP2008133258A
公开(公告)日：2008-06-12
申请号：JP2007206388
申请日：2007-08-08
申请人： Shin Etsu Chem Co Ltd , 信越化学工業株式会社
发明人： KUSAKI FUMIE , HOSHINO TAKASHI , MARUYAMA NAOAKI , NISHIYAMA YUICHI , FUKUI IKUO , UMEZAWA HIROSHI
IPC分类号： A61K47/38 , A61K9/20 , A61K31/4418 , A61K47/32 , A61P9/12
摘要： PROBLEM TO BE SOLVED: To provide a solid preparation comprising an enteric solid dispersion that allows rapid dissolution of a drug in the preparation without lowering the solubility of the solid dispersion, and a method for producing the preparation.
SOLUTION: The invention provides a solid preparation of a solid dispersion containing a sparingly soluble drug, an enteric polymer and a disintegrant, wherein the disintegrant is a low-substituted hydroxypropyl cellulose having an average particle diameter of 10-100 μm and a specific surface area of ≥1.0 m
2 /g determined by BET method. The invention further provides a method for producing the solid preparation of an enteric solid dispersion comprising the spraying of an enteric polymer solution containing a sparingly soluble drug dispersed or dissolved in the solution to a powder mixed with a disintegrant comprising a low-substituted hydroxypropyl cellulose having an average particle diameter of 10-100 μm and a specific surface area of ≥1.0 m
2 /g determined by BET method, and the granulation and drying of the sprayed product.
COPYRIGHT: (C)2008,JPO&INPIT
摘要翻译：待解决的问题：提供一种包含肠溶固体分散体的固体制剂，其允许药物在制剂中快速溶解而不降低固体分散体的溶解度，以及制备该制剂的方法。解决方案：本发明提供了含有微溶药物，肠溶性聚合物和崩解剂的固体分散体的固体制剂，其中崩解剂是平均粒径为10-100μm的低取代羟丙基纤维素， BET比表面积≥1.0m 2 / g。本发明还提供一种生产肠溶性固体分散体的固体制剂的方法，包括将含有分散或溶解于该溶液中的微溶性药物的肠溶性聚合物溶液喷雾到与包含低取代羟丙基纤维素的崩解剂混合的粉末中，通过BET法测定的平均粒径为10〜100μm，比表面积≥1.0m2 / SP / g，喷雾产物的造粒和干燥。版权所有（C）2008，JPO＆INPIT

5. 发明专利

JP2008044927A Enteric-coated preparation covered with enteric coating material for site-specific delivery of drug to site within small intestine 审中-公开
标题翻译：用于肠内特异性输送药物的肠溶包衣制剂，用于小型肠内营养
公开(公告)号：JP2008044927A
公开(公告)日：2008-02-28
申请号：JP2007041004
申请日：2007-02-21
申请人： Shin Etsu Chem Co Ltd , 信越化学工業株式会社
发明人： KUSAKI FUMIE , KOKUBO HIROYASU , SAKUMA NOBUYUKI , YAMASHITA SHINJI
IPC分类号： A61K47/38 , A61K9/22
摘要： PROBLEM TO BE SOLVED: To provide an enteric-coated preparation prepared by using an enteric coating material capable of delivering a drug to a site in the small intestine in a site-specific manner.
SOLUTION: The invention provides an enteric-coated preparation covered with an enteric coating material for delivering a drug to a site in the small intestine in a site-specific manner, wherein, in the Dissolution Test as specified in the Japanese Pharmacopoeia Fourteenth Edition, no dissolution of the drug is observed in the Japanese Pharmacopoeia first liqiud (pH 1.2) while dissolution of the drug is observed in the Japanese Pharmacopoeia second liquid (pH 6.8) 20 minutes or later from the start of the Dissolution Test. The enteric coating material is preferably selected from the group consisting of hydroxypropylmethyl cellulose acetate succinate, hydroxypropylmethyl cellulose phthalate, methacrylic acid copolymer and carboxymethylethyl cellulose.
COPYRIGHT: (C)2008,JPO&INPIT
摘要翻译：待解决的问题：提供通过使用能够以特定地点方式将药物递送到小肠部位的肠溶衣材料制备的肠溶衣制剂。解决方案：本发明提供了一种用肠溶衣材料覆盖的肠溶衣制剂，用于以特定地点方式将药物递送至小肠部位，其中在日本药典第十四版中规定的溶出度试验版本中，从溶出试验开始20分钟以后，在日本药典第一次（pH 1.2）中观察到药物溶解，而在日本药典第二液体（pH6.8）中观察到药物的溶解。肠溶衣材料优选选自乙酸琥珀酸羟丙基甲基纤维素，邻苯二甲酸羟丙基甲基纤维素，甲基丙烯酸共聚物和羧甲基乙基纤维素。版权所有（C）2008，JPO＆INPIT

6. 发明专利

JP2007308480A Solid preparation containing enteric solid dispersion 审中-公开
标题翻译：含固体分散体的固体制剂
公开(公告)号：JP2007308480A
公开(公告)日：2007-11-29
申请号：JP2007087958
申请日：2007-03-29
申请人： Shin Etsu Chem Co Ltd , 信越化学工業株式会社
发明人： HOSHINO TAKASHI , KUSAKI FUMIE , FUKUI IKUO
IPC分类号： A61K47/38 , A61K9/14 , A61K9/20 , A61K47/32
CPC分类号： A61K47/38 , A61K9/1652 , A61K31/4422 , A61K47/26 , A61K47/36
摘要： PROBLEM TO BE SOLVED: To provide a solid preparation containing an enteric solid dispersion rapidly eluting a medicine in the preparation without damaging the elution property of the solid preparation, or a method for preparing the same. SOLUTION: This tablet of the enteric solid dispersion containing a hardly dissolvable medicine, an enteric polymer, an excipient and a disintegrating agent, wherein, at least mixed powder containing the excipient and disintegrating agent is covered with a solid dispersion containing the hardy dissolvable medicine and the enteric polymer, and the method for producing the solid preparation is provided by spraying the enteric polymer solution obtained by dispersing or dissolving the hardly dissolvable medicine over the mixed powder of the excipient and disintegrating agent, granulating and drying. COPYRIGHT: (C)2008,JPO&INPIT
摘要翻译：要解决的问题：提供一种含有肠溶固体分散体的固体制剂，其快速洗脱制剂中的药物而不损害固体制剂的洗脱性能，或其制备方法。解决方案：含有难溶解药物的肠溶固体分散体片剂，肠溶性聚合物，赋形剂和崩解剂，其中至少含有赋形剂和崩解剂的混合粉末被含有硬脂酸的固体分散体覆盖可溶性药物和肠溶性聚合物，并且通过将分散或溶解难溶性药物得到的肠溶性聚合物溶液喷雾到赋形剂和崩解剂的混合粉末上，制粒和干燥来提供固体制剂的制备方法。版权所有（C）2008，JPO＆INPIT

7. 发明专利

JP2007308479A Solid-dispersed substance preparation 审中-公开
标题翻译：固体分散物质的制备
公开(公告)号：JP2007308479A
公开(公告)日：2007-11-29
申请号：JP2007087957
申请日：2007-03-29
申请人： Shin Etsu Chem Co Ltd , 信越化学工業株式会社
发明人： HOSHINO TAKASHI , KUSAKI FUMIE , FUKUI IKUO
IPC分类号： A61K9/16 , A61K31/4422 , A61K47/32 , A61K47/38 , A61P9/12
CPC分类号： B05D1/02 , A61J3/005 , A61K9/146 , A61K9/1623 , A61K9/1652 , A61K9/167 , A61K9/2077 , A61K31/4422
摘要： PROBLEM TO BE SOLVED: To provide a granular preparation or tablet preparation of a solid-dispersed substance rapidly eluting a medicine in the preparation without damaging the elution property of the solid dispersion. SOLUTION: This granular preparation of the solid-dispersed substance containing a hardly soluble medicine, a water-soluble polymer, an excipient and a disintegrating agent is provided by having 1 to 10 mass% content of the water-soluble polymer and 15 to 50 mass% content of the disintegrating agent. Also the granular preparation of the solid-dispersed substance containing the hardly soluble medicine, water-soluble polymer, excipient and disintegrating agent is provided by having 1 to 5 mass% content of the water-soluble polymer and 15 to 50 mass% content of the disintegrating agent, and the method for producing the granular or tablet preparation of the solid-dispersed substance comprises the processes of spraying the solution of water-soluble polymer, obtained by dispersing or dissolving the hardly soluble medicine over the mixed powder of the excipient and disintegrating agent, then granulating and drying. COPYRIGHT: (C)2008,JPO&INPIT
摘要翻译：待解决的问题：提供固体分散物质的颗粒制剂或片剂制剂，其快速洗脱制剂中的药物而不损害固体分散体的洗脱性能。解决方案：含有难溶性药物，水溶性聚合物，赋形剂和崩解剂的固体分散物质的这种粒状制剂是通过含有1〜10质量％的水溶性聚合物和15 至50质量％的崩解剂含量。另外，含有难溶性药物，水溶性聚合物，赋形剂和崩解剂的固体分散物质的粒状制剂是通过使1〜5质量％的水溶性聚合物含量和15〜50质量％崩解剂和固体分散物质的颗粒状或片剂制剂的制造方法包括通过将难溶性药物分散或溶解在赋形剂的混合粉末中而得到的水溶性聚合物溶液的喷雾和分解的方法制剂，然后造粒和干燥。版权所有（C）2008，JPO＆INPIT

8. 发明专利

JP2013047258A Solid preparation containing enteric solid dispersion 有权
标题翻译：含固体分散体的固体制剂
公开(公告)号：JP2013047258A
公开(公告)日：2013-03-07
申请号：JP2012240328
申请日：2012-10-31
申请人： Shin-Etsu Chemical Co Ltd , 信越化学工業株式会社
发明人： HOSHINO TAKASHI , KUSAKI FUMIE , FUKUI IKUO
IPC分类号： A61K47/38 , A61K9/16 , A61K9/20 , A61K47/32
摘要： PROBLEM TO BE SOLVED: To provide a solid preparation containing an enteric solid dispersion rapidly dissolving a drug in the preparation without damaging the dissolution properties of the solid preparation, or a method for preparing the same.SOLUTION: The solid preparation comprising a soluble drug, an enteric polymer, an excipient and a disintegrator comprises a granular product wherein a mixed powder comprising at least the excipient and the disintegrator is partly or entirely covered with the solid dispersion comprising a hardly soluble drug and the enteric polymer. The invention provides the solid preparation in which the release of the hardly soluble drug in the stomach is suppressed so that the dissolution rate of the hardly soluble drug using the Japanese Pharmacopoeia first liquid (artificial gastric fluid) after 120 minutes elapse is 10 mass% or less of the initial concentration of the drug administered, or a method for producing the same.
摘要翻译：待解决的问题：提供一种固体制剂，其含有快速溶解药物的肠溶固体分散体，而不损害固体制剂的溶解性能，或其制备方法。解决方案：包含可溶性药物，肠溶性聚合物，赋形剂和崩解剂的固体制剂包括颗粒产品，其中至少包含赋形剂和崩解剂的混合粉末部分或完全被固体分散体覆盖，所述固体分散体包含几乎不含可溶性药物和肠溶性聚合物。本发明提供了抑制难溶性药物在胃中的释放的固体制剂，使得使用日本药典第一液体（人造胃液）的120分钟后难溶性药物的溶出速度为10质量％所用药物的初始浓度较少，或其制备方法。版权所有（C）2013，JPO＆INPIT

9. 发明专利

JP2013147512A Solid dispersion preparation 有权
标题翻译：固体分散体制备
公开(公告)号：JP2013147512A
公开(公告)日：2013-08-01
申请号：JP2013098337
申请日：2013-05-08
申请人： Shin-Etsu Chemical Co Ltd , 信越化学工業株式会社
发明人： HOSHINO TAKASHI , KUSAKI FUMIE , FUKUI IKUO
IPC分类号： A61K9/16 , A61K31/4422 , A61K47/32 , A61K47/38 , A61P9/12
摘要： PROBLEM TO BE SOLVED: To provide a granular preparation or a tablet preparation of a solid dispersion capable of rapidly eluting a medicine in the preparation without damaging the elution property of the solid dispersion.SOLUTION: There is provided a granular preparation of a solid dispersion containing a hardly soluble medicine, a water-soluble polymer, an excipient and a disintegrating agent, the content of the water-soluble polymer being 1 to 10 mass% and the content of the disintegrating agent being 15 to 50 mass%. There is also provided a tablet preparation of the solid dispersion containing the hardly soluble medicine, water-soluble polymer, excipient and disintegrating agent, the content of the water-soluble polymer being 1 to 5 mass% and the content of the disintegrating agent being 15 to 50 mass%.
摘要翻译：要解决的问题：提供能够在制剂中快速洗脱药物而不损害固体分散体的洗脱性能的固体分散体的颗粒制剂或片剂制剂。溶液：提供含有难溶性药物，水溶性聚合物，赋形剂和崩解剂，水溶性聚合物的含量为1〜10质量％，崩解剂的含量为15〜50质量％。还提供了含有难溶性药物，水溶性聚合物，赋形剂和崩解剂的固体分散体的片剂，水溶性聚合物的含量为1〜5质量％，崩解剂的含量为15 至50质量％。

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