CN1662224B - 用于产生厌腻效应和用于减轻体重的药剂 - Google Patents
用于产生厌腻效应和用于减轻体重的药剂 Download PDFInfo
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- CN1662224B CN1662224B CN038139502A CN03813950A CN1662224B CN 1662224 B CN1662224 B CN 1662224B CN 038139502 A CN038139502 A CN 038139502A CN 03813950 A CN03813950 A CN 03813950A CN 1662224 B CN1662224 B CN 1662224B
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- Prior art keywords
- medicament
- present
- aluminum
- acid
- anionic polymer
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Abstract
本发明涉及用于产生厌腻效应和用于减轻体重的经改善的药剂，其由至少一种阴离子聚合物的干燥多孔性凝胶或泡沫组成，在此凝胶或泡沫以铝盐的形式存在。此外，本发明的药剂还适合于调节胆固醇代谢。
Description
本发明涉及用于产生厌腻效应和用于减轻体重的药剂。此外，本发明的药剂同样适合于调节胆固醇代谢。
已经进行了大量的尝试，以通过使用药物的方式来减少人体中多余的脂肪积聚，或者防止其出现。例如存在所谓的抑食欲药，其试图以生物化学的方式引起对于进食的厌恶。这种药剂部分地具有显著的有害副作用。
除了大量已知的饮食建议之外，还存在机械的和电机械的药剂，使用这种药剂将可以定向地分解脂肪或者形成肌肉。然而，这种药剂的效用是非常成问题的。
从DE 4025912中已知一种用于口服的药剂，其由在胃中可溶的并从而释放出内含物的容器组成。这种容器用一种物质进行填充，该物质在胃中释放之后其体积变大，由此使身体产生厌腻感。这种厌腻药剂的缺点是存在肠梗阻的风险。
此外，从DE 199 42 417中已知一种具有稳定交联的横向链的海绵型制剂，该制剂在胃中增大了其体积，因此引起厌腻感。然而，这种药剂的制备要求附加的处理步骤以用于引入稳定的横向交联。
可是，由于不断增加的健康意识，用于产生厌腻效应的药剂的进一步改进具有高的医学和经济重要性。
本发明的任务为提供一种经改进的用于口服的药剂，该药剂比该类型的已知药剂有更大的胃停留时间，由此引起更有效的厌腻效应。此外，其还会适合用于减轻体重。其用于调节胆固醇水平的能力是同样有利的，因为超重通常伴随着过高的胆固醇水平。此外，有希望从价格便宜的没有健康风险的原料中简单地制备得到该药剂。
该任务通过一种用于产生厌腻效应和用于减轻体重的药剂而得到解决，该药剂由至少一种阴离子聚合物的干燥多孔性凝胶或泡沫组成，在此凝胶或泡沫以铝盐的形式存在。
根据本发明优选的阴离子聚合物为多糖和其中含有多糖醛酸的多糖，如藻酸和其盐(藻酸盐)。但是，根据本发明也可以使用低度酯化的果胶、黄原胶、黄蓍胶、硫酸软骨素以及所有其他含有糖醛酸的化合物。使用合成的或半合成的纤维素衍生物如羧甲基纤维素或者使用聚丙烯酸酯也是可以考虑的。
根据本发明，干燥的凝胶或泡沫是有利的，其含有阴离子聚合物的混合物，优选为前面提及的阴离子多糖，特别优选为含有多糖醛酸的和低度酯化的多糖的混合物，尤其为含有具有藻酸盐和果胶的混合物。
藻酸是线性的多糖醛酸，其由比例变化的D-甘露糖醛酸和L-古洛糖醛酸组成，这两种糖醛酸通过β-糖苷键而相互连接，由此羧基是非酯化的。一个分子的藻酸可以由大约150-1050个糖醛酸单位构成，因此平均分子量可以在30-200kDa的范围内变化。
多糖藻酸是褐藻的细胞壁的一种组分。在此，藻的干物质中藻酸的比例为直至40％。用根据现有技术本身已知的方法通过碱提取可获得藻酸。因此，结果所得的粉末状的藻酸是纯植物性的，并具有高的生物相容性。这种藻酸能够吸收其自重300倍数量的水，从而形成高度粘稠的溶液。在存在多价阳离子的情况下，藻酸形成所谓的凝胶。Shapiro I.等人(Biomaterials，1997，18：583-90)描述了在存在二价阳离子如钙或钡的情况下藻酸盐凝胶的形成。可是，由于钡的毒性，其不适合于在生物药物中使用。除了氯化钙之外，葡萄糖酸钙也提供了合适的二价阳离子。使用镁盐或者不同的在生理上无疑虑的二价阳离子的混合物也是可以考虑的。
关于阴离子聚合物，使用低度酯化的果胶根据本发明也是有利的。果胶由通过α-1，4-糖苷键连接的半乳糖醛酸单位的链所组成，半乳糖醛酸单位的羧基直至20-80％经甲醇酯化。将果胶区分为高度酯化的(＞50％)和低度酯化的(＜50％)果胶。摩尔质量在10-500kDa之间变化。用根据现有技术本身已知的方法通过酸提取可从柑桔果皮、水果渣或甜菜片中获得果胶。因此，结果所得的果胶(苹果果胶、柑桔果胶)是纯植物性的，并具有高的生物相容性。其能够吸收水而形成凝胶。
在此，在存在二价阳离子如钙或钡的情况下使用果胶凝胶也是已知的。可是，钡在此也是由于其毒性而不适合于在生物药物中使用。除了氯化钙之外，葡萄糖酸钙提供了合适的二价阳离子。使用镁盐或者不同的在生理上无疑虑的二价阳离子的混合物也是可以考虑的。
此外，根据本发明以有利的方式使用果胶的特征在于果胶具有降低胆固醇的特性。这一特性在本发明的意义中是具有优点的，因为超重通常伴随着过高的胆固醇水平。
用于从藻酸盐制备干凝胶或干泡沫的方法是已知的。在此，例如制备藻酸钠的水溶液，并通过添加钙盐而变浓。通过通入空气和视情况在添加表面活性剂之后可获得凝胶或泡沫。通过冷冻和随后的冻干而从藻酸盐凝胶或泡沫中制备出干凝胶或干泡沫(海绵)。含有果胶的凝胶或泡沫的制备以类似的方式进行，这与制备含有阴离子聚合物的混合物的凝胶或泡沫是同样的。
除了添加无机或有机钙盐如氯化钙或葡萄糖酸钙之外，使用镁盐以及不同的在生理上无疑虑的二价阳离子的混合物也是可以考虑的。
根据本发明特别优选的是添加在生理上无疑虑的三价阳离子的盐，优选为可溶性铝盐。在此，可以在前述类型的制备方法之后通过向阴离子聚合物(优选为藻酸盐和/或果胶)水溶液中添加可溶性铝盐来制备本发明的药剂。特别合适的可溶性铝盐为氯化铝或硫酸铝。可溶性铝盐可以单独或联合使用。根据本发明，在制备本发明的药剂中，除了本身可以单独或联合使用的可溶性铝盐之外，二价阳离子如钙或镁盐或者其联合另外也是可以使用的。
因此，本发明的目标也是用于制备一种经改善的药剂的方法，该药剂用于达到厌腻效应或者用于减轻体重，在该方法中使用含有三价阳离子的水溶性盐来生产至少一种阴离子聚合物的干燥的凝胶或泡沫，该水溶性盐优选为铝盐，特别优选为氯化铝或硫酸铝。此外，另外也可以使用在生理上无疑虑的二价阳离子的盐，以及可以考虑二价和/或三价阳离子的盐的联合。此外，根据本发明还包括单独或联合使用阴离子聚合物。
用于口服的本发明的药剂含有至少一种以铝盐形式存在的阴离子聚合物。
本发明的药剂有利地含有藻酸或果胶或者其联合作为阴离子聚合物。优选地，本发明的药剂作为藻酸铝或果胶酸铝或者藻酸铝和果胶酸铝的混合物而存在。
三价阳离子的盐(优选为铝盐的形式)与阴离子聚合物(优选为藻酸盐或果胶)形成比迄今所使用的二价阳离子的盐更稳定的复合物。此外，铝与钡相比在生理上是无疑虑的。本发明的阴离子聚合物与三价阳离子的盐的更稳定的相互作用赋予本发明的药剂有利的特性，即该药剂一方面在pH值为1-5优选为1-4的溶液中，特别优选为在pH值为与胃相当或者胃本身的pH的溶液中不溶或难以溶解，另一方面在pH值为大约6-7的中性至弱酸性溶液中，优选为在pH值为与肠相当或者肠本身的pH的溶液中完全溶解。含有藻酸铝的本发明药剂的溶解例如在大约3.3-3.7的pK值开始。
除了前述的本发明的药剂在其溶解性上的性能之外，该药剂此外还具有有利的特性，即其具有增加的形状稳定性。这种形状稳定性首先在含有以其铝盐形式存在的阴离子聚合物的混合物的药剂中，优选为在由藻酸铝和果胶酸铝所组成的混合物中特别明显地表现出来。在本发明的意义中将形状稳定性理解为，与含有单独的阴离子聚合物钙盐的凝胶或泡沫相比，含有阴离子聚合物铝盐的本发明药剂在pH值为大约1-5的溶液中不收缩。也就是说由阴离子聚合物钙盐所组成的已知药剂具有这样的缺点，即其在酸性溶液中至少损失其体积的三分之一，大多数情况下甚至于还要更多。因此，本发明药剂的形状稳定性的优点对于其用于产生厌腻效应或者用于减轻体重的特性产生直接的正面影响，因为当本发明的药剂进入胃中时不会与迄今已知的药剂在此情况下一样出现体积损失。对于这种情况，根据本发明不需要通过服用增加了个数的厌腻剂来大致地补偿体积损失。这对于消费者是一个适意的附带效果。
此外，在本发明的药剂中，凝胶或泡沫在患者服用期间优选地以压缩形式存在。在另一个实施方案中，本发明的药剂也可以在服用期间咀嚼和/或吞咽运动进行压缩。然后，所摄入的本发明的药剂通过在胃中吸收液体而体积增大，这引起所希望的产生厌腻效应并伴随减轻体重的效果。
此外，本发明的药剂例如可以片剂、胶囊、糖衣药丸的形式，或者作为颗粒或粉末或者其他布置而存在。此外，本发明的药剂可以具有涂层作为外层。根据本发明，在本发明的制备方法的变化形式中，在本发明的药剂上涂布上称为涂层的外层，这种外层可以含有另外的辅助物质或活性物质，例如使得易于吞咽或服用本发明药剂的化合物，专业人员已知其称作“包裹”化合物或者包糖衣剂。该外层可以是漆层或者其他的保护层，该层使得易于服用本发明的药剂，而且其首先在胃肠道中(例如在胃液的影响下)溶解。
本发明的药剂还可以含有其他的辅助物质和/或活性物质。
例如将下列物质理解为“辅助物质”，但并非用于限制本发明：水不溶性辅助物质或其混合物，例如脂质，另外还有脂肪醇，如鲸蜡醇、硬脂醇和鲸蜡醇硬脂醇混合物；甘油酯，如甘油单硬脂酸酯或者植物油的单、二和三甘油酯的混合物；经氢化的油，如氢化蓖麻油或氢化棉籽油；蜡，如蜂蜡或巴西棕榈蜡；固体烃，如石蜡或地蜡；脂肪酸，如硬脂酸；某些纤维素衍生物，如乙基纤维素或乙酰基纤维素；聚合物或共聚物，例如聚烯如聚乙烯，聚乙烯化合物如聚氯乙烯或聚乙酸乙烯酯，以及氯乙烯-乙酸乙烯酯共聚物和与巴豆酸的共聚物，或者丙烯酸酯和甲基丙烯酸酯的聚合物和共聚物如丙烯酸酯和甲基丙烯酸甲酯的共聚物；或者表面活性剂，如多乙氧基醚(Polysorbat 80)或Docusat。
例如将维生素、微量元素或药物活性物质理解为“活性物质”。范例性地例举了下列物质，但这并非用于限制本发明：
抑食欲药的实例为：安非拉酮、芬氟拉明、芬普雷司、左丙己君、马吲哚、美芬雷司、甲胺苯丙酮、去甲麻黄碱、去甲伪麻黄碱。
抑制病毒药的实例为：阿昔洛韦、西多福韦、去羟肌苷、泛昔洛韦、膦甲酸、更昔洛韦、拉米夫定、利托那韦、扎西他滨、齐多夫定。
维生素的实例为：阿法骨化醇、蒜硫胺素、抗坏血酸、生物素、骨化二醇、骨化三醇、维生素D3、维生素B12、麦角骨化醇、叶酸、羟钴胺、烟酰胺、泛酸、维生素K1、维生素B6、视黄醇、核黄素、硫胺、生育酚、反式骨化二醇。
在此可能附加地进行延迟的活性物质释放。
除了所述的辅助物质和活性物质之外，本发明的药剂还可以附加地含有不会对活性物质的释放产生明显影响的填充剂、崩解剂、粘合剂和润滑剂以及赋形剂。此外实例还有膨润土(氧化铝-氧化硅-水合物)，硅酸，纤维素(通常为微晶纤维素)或纤维素衍生物如甲基纤维素、羧甲基纤维素钠，糖如乳糖、淀粉如玉米淀粉或其衍生物如羧甲基淀粉钠、淀粉糨糊，磷酸盐如磷酸二钙或三钙，明胶，硬脂酸或其合适的盐如硬脂酸镁或硬脂酸钙，滑石，胶体氧化硅等类似的辅助物质。
本发明还涉及使用本发明的药剂用于产生厌腻效应和用于减轻体重。同样也包括使用本发明的药剂用于调节胆固醇代谢。
此外，可以考虑使用本发明的药剂来制备用于产生厌腻效应和用于减轻体重的组合物。似乎也包括使用本发明的药剂来制备用于调节胆固醇代谢的组合物。
本发明通过下面的实施例来进行更详细的描述，但是这些实施例并非用于限制本发明：
制备实施例1
藻酸钠 300g
氯化铝 30g
水 12l
制备实施例2
藻酸钠 400g
硫酸铝 50g
水 12l
制备实施例3
藻酸钠 200g
苹果或柑桔果胶 200g
氯化铝 30g
水 12l
制备实施例4
藻酸钠 400g
氯化镁 4g
氯化铝 20g
氯化钙 10g
水 12l
制备实施例5
藻酸钠 300g
氯化铝 30g
多乙氧基醚 20g
水 12l
将前述配方的溶液以大约4cm的厚度冷冻成板块，随后在冻干机中冻干。在干燥之后，视情况可以进行压缩。随后由板块制备出相应的施用形式，如片剂或胶囊。
使用实施例
将干燥的藻酸铝凝胶置于人工胃液和肠液中，并对其溶解进行研究。在此，本发明的藻酸铝干凝胶在pH值为1.2-4.5的溶液中是不溶的。在pH7的溶液中，本发明的藻酸铝干凝胶在30分钟内完全溶解。
Claims (7)
1.用于产生厌腻效应和用于减轻体重的药剂，该药剂由至少一种阴离子聚合物的干燥多孔性凝胶或泡沫组成，其特征在于含有藻酸盐或果胶或者其联合作为阴离子聚合物，并以铝盐形式存在。
2.根据权利要求1所述的药剂，其特征在于其以压缩形式存在。
3.根据权利要求1或2所述的药剂，其特征在于以藻酸铝、果胶酸铝或者其联合形式存在。
4.根据权利要求1或2所述的药剂，其特征在于附加地含有活性物质。
5.根据权利要求1或2所述的药剂，其特征在于含有维生素、微量元素或药物活性物质作为活性物质。
6.根据权利要求1或2所述的药剂，其特征在于以片剂、胶囊、糖衣药丸的形式，或者作为颗粒或粉末进行给药。
7.根据权利要求1-6中任何一项所述的药剂用于制备组合物的用途，该组合物用于产生厌腻效应和用于减轻体重。
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| MX2009003807A (es) * | 2006-10-17 | 2009-04-22 | Unilever Nv | Composicion alimenticia que comprende burbujas de gas y procedimiento para prepararla. |
| ZA200901780B (en) * | 2006-10-17 | 2010-06-30 | Unilever Plc | Food composition comprising gas bubbles and process for preparing it |
| AU2007312499B2 (en) * | 2006-10-17 | 2011-09-15 | Unilever Plc | Food composition comprising gas bubbles and process for preparing it |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4520015A (en) * | 1982-06-14 | 1985-05-28 | Bernard Pesche | Method for manufacturing a product for destroying harmful animals |
| CN1097307A (zh) * | 1993-07-16 | 1995-01-18 | 青岛海洋大学 | 海藻减肥剂 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE1470890A1 (de) * | 1964-06-05 | 1969-02-20 | Sartorius Membranfilter Gmbh | Verfahren zur Herstellung von Alginatmembranen |
| GB1474891A (en) * | 1975-03-27 | 1977-05-25 | Inst Elementoorganiche Soedine | Synthetic caviar and method of preparing same |
| PT1117379E (pt) * | 1998-10-07 | 2005-10-31 | Giltech Ltd | Formulacao espumante e espuma |
-
2003
- 2003-04-15 US US10/511,518 patent/US20050222082A1/en not_active Abandoned
- 2003-04-15 CN CN038139502A patent/CN1662224B/zh not_active Expired - Fee Related
- 2003-04-15 EP EP03746298A patent/EP1494655A1/de not_active Withdrawn
- 2003-04-15 AU AU2003226811A patent/AU2003226811A1/en not_active Abandoned
- 2003-04-15 WO PCT/EP2003/003910 patent/WO2003086360A1/de not_active Application Discontinuation
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4520015A (en) * | 1982-06-14 | 1985-05-28 | Bernard Pesche | Method for manufacturing a product for destroying harmful animals |
| CN1097307A (zh) * | 1993-07-16 | 1995-01-18 | 青岛海洋大学 | 海藻减肥剂 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1662224A (zh) | 2005-08-31 |
| EP1494655A1 (de) | 2005-01-12 |
| US20050222082A1 (en) | 2005-10-06 |
| AU2003226811A1 (en) | 2003-10-27 |
| WO2003086360A1 (de) | 2003-10-23 |
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