CN100534431C - 用于口服的烟酸缓释组合物 - Google Patents
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Abstract
一种用于口服的烟酸缓释组合物,包含烟酸、由亲水性聚合物和疏水性聚合物组成的用于缓释的载体、和药学可接受的添加剂,所述亲水性聚合物是聚环氧乙烷和天然胶,所述组合物能维持烟酸的恒定释放速率。
Description
技术领域
本发明涉及一种用于口服的烟酸缓释组合物。
背景技术
烟酸用于降低血液中的低密度脂蛋白胆固醇和甘油三酯水平,其口服疗法用于治疗高胆固醇血症、高甘油三脂血症和由此引发的疾病。
可以以(Kos Pharmaceuticals,Inc.)片剂的形式从市场上购得烟酸,其包含500mg、750mg或者1000mg单位的烟酸,并且基于效力和耐受性来分别确定其每日剂量,但是不超过最大推荐剂量每天2,000mg。烟酸引起副作用比如恶心、腹胀、腹泻和脸红,这可以通过降低最小和/或维持剂量或者通过施用缓释组合物来避免。
现有的烟酸缓释组合物基于使用亲水性聚合物羟丙基甲基纤维素作为缓释烟酸的载体。例如,美国专利No.6,406,715公开了一种含有烟酸和羟丙基甲基纤维素的定时释放烟酸制剂;美国专利No.5,126,145公开了一种含有两种不同类型的羟丙基甲基纤维素和疏水性成分的缓释烟酸制剂。但是,这些现有的缓释组合物具有生产程序复杂和生产成本高的问题。
因此,需要开发一种可以利用经济方法生产的烟酸缓释组合物。
发明内容
因此,本发明的目的是提供一种烟酸缓释组合物,其可以长时间维持烟酸的均匀释放并且可以容易地制备。
依照本发明的一个方面,提供一种用于口服的烟酸缓释组合物,包含作为活性成分的烟酸、由亲水性聚合物和疏水性聚合物组成的用于缓释的载体、和药学可接受的添加剂,其中亲水性聚合物是聚环氧乙烷和天然胶的混合物。
附图说明
通过本发明的下述说明并结合下列附图,本发明的上述和其它目的和特征将变得明显,其中附图分别为:
图5:本发明实施例1中制备的缓释片剂的体外释放特征随释放口转速(therotation ratio of the release port)的变化;
图7:实施例7和对比实施例1和3中制备的缓释片剂的体外释放特征。
具体实施方式
本发明的烟酸缓释组合物可以通过使用由亲水性聚合物和疏水性聚合物组成的用于缓释的载体来维持高水溶性烟酸的恒定释放速率,其中亲水性聚合物是聚环氧乙烷和天然胶的混合物。
本发明的组合物的每种成分详细描述如下:
(1)药物活性成分
本发明的缓释组合物的活性成分是用于治疗高脂血症的烟酸。
(2)用于缓释的载体
本发明的用于缓释的载体由亲水性聚合物和疏水性聚合物组成,其中亲水性聚合物是聚环氧乙烷和天然胶的混合物。
聚环氧乙烷可以选自平均分子量在100,000-7,000,000范围内的那些,或者也可以使用两种或多种具有不同分子量的聚环氧乙烷的混合物。
本发明所用的天然胶可以是黄原胶、刺槐豆胶、瓜耳胶或者其混合物。
依照本发明,活性成分和用于缓释的载体的重量比优选在1∶0.01-1∶1、优选1∶0.1-1∶0.5的范围内。对于载体而言,亲水性聚合物和疏水性聚合物的重量比优选在1∶0.1-1∶2.0范围内。对于亲水性聚合物而言,聚环氧乙烷和天然胶优选以1∶0.01-1∶5.0、优选1∶0.1-1∶4.0范围内的重量比混合。
(3)药学可接受的添加剂
本发明的药物组合物可以配制来口服。用于口服的制剂可具有多种形式,比如片剂、丸剂、粉剂、囊剂(sachet)、软和硬胶囊、溶液、混悬剂、乳剂、糖浆剂、颗粒、咀嚼片、胶冻剂等等,其可包含常规的添加剂,比如稀释剂(例如乳糖、葡萄糖、蔗糖、甘露醇、山梨糖醇、纤维素和/或甘氨酸)、润滑剂(例如二氧化硅、滑石、硬脂酸或者其锌盐、镁盐或者钙盐,和/或聚乙烯醇)、粘合剂(例如硅酸铝镁、淀粉糊、明胶、黄蓍胶、甲基纤维素、羧甲基纤维素钠和/或聚乙烯吡咯烷酮、羟丙基纤维素和Kofobidon(VA64,BASF,德国)、和任选的崩解剂(例如淀粉、琼脂、藻酸或者其钠盐)、泡腾剂混合物、吸收剂、着色剂、调味剂和甜味剂。
优选地,片剂可以生产为由颗粒形成部分和混合物部分组成的双系统,其中每一部分可以含有一部分用于缓释的载体。颗粒形成部分还可以含有粘合剂比如聚乙烯吡咯烷酮从而有助于药物流动的稳定性。
依照本发明,活性成分和药学可接受的添加剂的重量比范围可以为1∶0.001-1∶0.1,优选为1∶0.005-1∶0.05。
所述组合物可以是经过消毒的,并且可以另外包含防腐剂、稳定剂、润湿剂、乳化剂、渗透压调节剂、缓冲剂等等。
本发明的药物组合物可以每日施用。活性成分的每日典型剂量为约1-60mg/kg,优选5-40mg/kg,并且可以单剂施用,也可以分剂施用。但是,应该理解的是,应当根据多种相关因素确定实际施用的活性成分的量,所述因素包括待治疗病况、所选择的施用途径、个体患者的年龄和体重以及患者症状的严重程度;因此,上述的建议剂量不应该以任何方式理解为限制本发明的范围。
下面的实施例用来进一步说明本发明而非限定其范围。
实施例:烟酸缓释片的制备
实施例1
500g烟酸(Danil fine chemicals corporation)和38g聚环氧乙烷(WSRAggutinant,分子量5,000,000,Union Carbide)各自通过30号筛网过滤并一起混合。将混合物置于高速混合器(SPG-2,Fujipaudal)中,并将粘合剂溶液加入到混合器中,所述的粘合剂溶液是由14g溶解于蒸馏水/异丙醇混合物(1∶1 v/v)中的聚乙烯吡咯烷酮(K-90,BASF)组成的,然后以100-1,000rpm的速度混合3min得到颗粒。将所述颗粒干燥并通过30号筛网过滤。此后,将75g聚醋酸乙烯酯/聚乙烯吡咯烷酮混合物(SR,BASF)、37g黄原胶(Cpkelco)、22g刺槐豆胶(Sigma,USA)和7g二氧化硅加入到颗粒中并混合30min。最后,加入7g硬脂酸镁粉末,混合3min,并压缩得到含有表1中组合物的片剂。
实施例2-13
含有表1中列举的组合物的片剂通过重复实施例1的步骤制得。
对比实施例1-3
含有表2中列举的组合物的片剂通过重复实施例1的步骤制得。
试验实施例1:体外释放试验
根据韩国药典(Korea pharmacopoeia)中描述的释放试验方法(桨法),进行实施例1-13中制备的片剂和对比制剂缓释片(Kos Pharmaceuticals,Inc.)的体外释放试验,以此根据释放速率,比较聚环氧乙烷、天然胶和聚醋酸乙烯酯/聚乙烯吡咯烷酮混合物作为缓释载体的有效性。在以下条件下测定每个片剂中烟酸的释放模式。
-释放试验系统:Erweka DT 80
-释放溶液:韩国药典中描述的崩解试验的第3个方法(水)
-释放溶液的温度:37±0.5℃
-释放溶液总量:900ml
-转速:50rpm
-试样收集时间:在1、3、5、7、9、12和24h时收集等量释放溶液,通过0.45μm膜过滤,用作试验样品。对释放溶液取样以后,释放试验系统内重新加入等量的新鲜释放溶液。
-分析方法:以蒸馏水为参照,260nm处测定样品和标准溶液的吸光度,计算相应的释放率。
-计算释放量:累积释放量
由附图1-4可见,随着聚环氧乙烷或者天然胶的量的增加,释放速率变慢。尤其是实施例1和7中的片剂以与对比制剂相似的释放模式连续释放药物。
试验实施例2:体外释放试验
通过重复试验实施例1中的方法对实施例1中制备的片剂和对比制剂进行体外释放试验,除了将转速变为75rpm、100rpm和150rpm。
由附图5和6可见,实施例1中的片剂显示与对比制剂相同的稳定释放模式,甚至在高转速下也没有初始的药物爆释(burst release)。
试验实施例3:体外释放试验
通过重复试验实施例1中的方法进行体外释放试验,除了使用实施例7和对比实施例1-3中制备的片剂。
由附图7可见,对比实施例1的不含有聚环氧乙烷的片剂和对比实施例3的不含有天然胶的片剂在初始阶段显示出药物爆释,对比实施例2的不含有聚醋酸乙烯酯/聚乙烯吡咯烷酮混合物的片剂显示出比所希望的释放速率慢得多的释放速率。
虽然就上述具体实施方案对本发明进行了描述,但是,应当承认,可以进行许多改进和变化,并且这些改进和变化也落在如所附权利要求书所定义的本发明范围内。
Claims (4)
1.一种用于口服的烟酸缓释组合物,包含作为活性成分的烟酸、由亲水性聚合物和疏水性聚合物组成的用于缓释的载体、和药学可接受的添加剂,其中所述亲水性聚合物是聚环氧乙烷和天然胶的混合物,所述聚环氧乙烷的平均分子量为100,000-5,000,000,所述天然胶为黄原胶和刺槐豆胶的混合物;并且所述疏水性聚合物为聚醋酸乙烯酯或聚醋酸乙烯酯/聚乙烯吡咯烷酮的混合物。
2.权利要求1的组合物,其中所用烟酸和载体的重量比范围为1∶0.01-1∶1。
3.权利要求1的组合物,其中所用亲水性聚合物和疏水性聚合物的重量比范围为1∶0.1-1∶2.0。
4.权利要求1的组合物,其中所述混合物中聚环氧乙烷和天然胶的重量比范围为1∶0.01-1∶5.0。
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KR100836960B1 (ko) * | 2007-09-07 | 2008-06-10 | 주식회사 서울제약 | 새로운 나이아신 제어방출형 제제 |
JP2009256237A (ja) * | 2008-04-16 | 2009-11-05 | Daiichi Sankyo Healthcare Co Ltd | 固形製剤 |
CN102908327B (zh) * | 2011-08-05 | 2015-03-11 | 江苏恒瑞医药股份有限公司 | 伊伐布雷定或其可药用盐的缓释制剂 |
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WO1999017771A1 (en) * | 1997-10-02 | 1999-04-15 | H. Lundbeck A/S | Granular preparations of 5-(2-ethyl- 2h-tetrazol- 5-yl)-1-methyl-1, 2,3,6-tetrahydropyridine |
JPH11335268A (ja) * | 1998-05-20 | 1999-12-07 | Kowa Co | 有核錠 |
SE9802973D0 (sv) * | 1998-09-03 | 1998-09-03 | Astra Ab | Immediate release tablet |
US6500459B1 (en) | 1999-07-21 | 2002-12-31 | Harinderpal Chhabra | Controlled onset and sustained release dosage forms and the preparation thereof |
DE10015479A1 (de) * | 2000-03-29 | 2001-10-11 | Basf Ag | Feste orale Darreichungsformen mit retardierter Wirkstofffreisetzung und hoher mechanischer Stabilität |
WO2003004009A1 (en) * | 2001-07-02 | 2003-01-16 | Geneva Pharmaceuticals, Inc. | Pharmaceutical composition |
-
2004
- 2004-05-28 KR KR1020040038026A patent/KR100574554B1/ko not_active IP Right Cessation
-
2005
- 2005-05-27 US US11/569,269 patent/US7759368B2/en not_active Expired - Fee Related
- 2005-05-27 CN CNB2005800170177A patent/CN100534431C/zh not_active Expired - Fee Related
- 2005-05-27 EP EP05744971A patent/EP1765340A4/en not_active Withdrawn
- 2005-05-27 WO PCT/KR2005/001566 patent/WO2005115387A1/en active Application Filing
- 2005-05-27 JP JP2007514903A patent/JP4961338B2/ja not_active Expired - Fee Related
Non-Patent Citations (2)
Title |
---|
烟酸缓释片的研制及其释药特性的研究. 吴海燕等.中国医院药学杂志,第24卷第2期. 2004 |
烟酸缓释片的研制及其释药特性的研究. 吴海燕等.中国医院药学杂志,第24卷第2期. 2004 * |
Also Published As
Publication number | Publication date |
---|---|
JP4961338B2 (ja) | 2012-06-27 |
EP1765340A1 (en) | 2007-03-28 |
WO2005115387A1 (en) | 2005-12-08 |
KR20050113396A (ko) | 2005-12-02 |
EP1765340A4 (en) | 2012-05-09 |
JP2008501014A (ja) | 2008-01-17 |
KR100574554B1 (ko) | 2006-04-27 |
CN1956717A (zh) | 2007-05-02 |
US7759368B2 (en) | 2010-07-20 |
US20090042952A1 (en) | 2009-02-12 |
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