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2. 发明公开

KR1020120116545A 아세클로페낙 함유 방출제어형 정제 有权
标题翻译：控制释放包含ACECLOFENAC的片剂
公开(公告)号：KR1020120116545A
公开(公告)日：2012-10-23
申请号：KR1020110034022
申请日：2011-04-13
申请人： 안국약품 주식회사
发明人： 어진 , 한창균 , 정현근 , 김양중 , 김종걸 , 이정화 , 하남성
IPC分类号： A61K9/24 , A61K9/22 , A61K9/20 , A61K31/216
CPC分类号： A61K31/216 , A61K9/2086
摘要： PURPOSE: An aceclofenac containing release control tablet is provided to show anti-inflammatory effects by taking the tablet once a day and to drastically enhance administration convenience. CONSTITUTION: A release control tablet contains aceclofenac as active ingredient and has slow release layer and rapid release layer which are adjacent to each other. The rapid release layer comprises 25-35 wt% of aceclofenac, 3-6 wt% of disintegrant of croscarmellose sodium, crospovidone or starch sodium gluconate. 10-14 wt% of D-mannitol, lactose or excipient of microcrystalline cellulose, 0.5-1.5 wt% of hydroxypropyl cellulose, povidone, binder of gelatin, or methyl cellulose, and 1-2 wt% of hard silicon dioxide, lubricant of magnesium stearate or talc. The slow-release layer comprises 28-38 wt% of acroclofenac, 6-10 wt% of Hypromellose and 0.7-9 wt% of polyethylene oxide, 4-7 wt% of microcrystalline cellulose, corn starch, or refractory excipient of the potato starch, 0.5-1.5 wt% of hydroxypropyl cellulose, povidone, binder of gelatin or methyl cellulose, and 1-2 wt% of hard silicon dioxide, lubricant of magnesium stearate and talc based on the weight of the tablet. [Reference numerals] (AA) Experiment result of elution rate of practical example 1-3; (BB) 0.5 hour; (CC) 1 hour; (DD) 2 hours; (EE) 5 hours; (FF) 8 hours; (GG) 12 hours; (HH) 24 hours; (II) Practical example 1; (JJ) Practical example 2; (KK) Practical example 3
摘要翻译：目的：提供含有醋氯芬酸的释放控制片剂，通过每天服用片剂一次显示抗炎作用，并显着增强给药方便性。构成：释放控制片含有醋氯芬酸作为活性成分，并具有彼此相邻的缓释层和快速释放层。快速释放层包含25-35重量％的醋氯芬酸，3-6重量％的交联羧甲基纤维素钠崩解剂，交联聚维酮或淀粉葡糖酸钠。 10-14重量％的D-甘露糖醇，乳糖或微晶纤维素赋形剂，0.5-1.5重量％的羟丙基纤维素，聚维酮，明胶或甲基纤维素的粘合剂和1-2重量％的硬二氧化硅，镁的润滑剂硬脂酸盐或滑石。缓释层包含28-38wt％的acroclofenac，6-10wt％的羟丙基纤维素和0.7-9wt％的聚环氧乙烷，4-7wt％的微晶纤维素，玉米淀粉或马铃薯淀粉的耐火赋形剂，0.5-1.5重量％的羟丙基纤维素，聚维酮，明胶或甲基纤维素的粘合剂和1-2重量％的硬二氧化硅，基于片剂重量的硬脂酸镁和滑石的润滑剂。（附图标记）（AA）实施例1-3的洗脱实验结果; （BB）0.5小时; （CC）1小时; （DD）2小时; （EE）5小时; （FF）8小时; （GG）12小时; （HH）24小时; （二）实践例1; （JJ）实践例2; （KK）实践示例3

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