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CN1325049C - 含有表没食子儿茶素没食子酸酯的组合物 - Google Patents

含有表没食子儿茶素没食子酸酯的组合物 Download PDF

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CN1325049C
CN1325049C CNB028097823A CN02809782A CN1325049C CN 1325049 C CN1325049 C CN 1325049C CN B028097823 A CNB028097823 A CN B028097823A CN 02809782 A CN02809782 A CN 02809782A CN 1325049 C CN1325049 C CN 1325049C
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C－C·彻恩
B·莱尤恩伯格
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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Abstract

流动性得到改进的表没食子儿茶素没食子酸酯(EGCG)制剂，该制剂通过将EGCG与多糖、特别是果胶混合形成粉末或颗粒而获得。

Description

含有表没食子儿茶素没食子酸酯的组合物
本发明涉及一种呈粉末和/或颗粒形式的组合物，该组合物含有(-)-表没食子儿茶素没食子酸酯(以下称为EGCG)作为主要组分，并含有多糖。
EGCG是绿色茶植物Camellia sinensis的叶子中所包含的多酚类物质中最值得关注的化合物，因为它显示出强的抗氧化剂效果。此外，还证实EGCG具有抗突变作用、抗菌作用，而且还对血液中的胆固醇含量具有有益的效果。EGCG可以通过描述于例如欧洲专利申请1077 211 A2中的工艺来获得。通常情况下，所生产出的EGCG是晶体粉末的形式，其流动性非常差。粉末流动性差会导致晶体粉末难以在片剂制剂和其它需要粉末能够自由流动的应用中使用。
现已发现，以粉末或颗粒形式获得的含有EGCG与多糖的组合物具有改进的流动性。
因此，一方面，本发明涉及一种呈粉末或颗粒形式的组合物，该组合物含有(a)(-)-表没食子儿茶素没食子酸酯，和(b)多糖。
另一方面，本发明涉及一种本发明组合物的生产方法。
再一方面，本发明涉及多糖、特别是果胶用于改进EGCG粉末流动性的用途。
本发明中所用的多糖的实例是果胶；藻酸盐；淀粉；纤维素衍生物，如羟丙基甲基纤维素和羧甲基纤维素；角叉菜胶；琼脂；阿拉伯树胶；瓜尔豆胶；黄原胶及其混合物。优选的多糖是果胶或藻酸盐，首选是果胶。
果胶是一种多糖并且在诸如书名为“工业用树胶(Industrial Gums)”的书籍，第三版，Academic Press，Inc.，1993，第257页中有所描述。市售的果胶通常从柑橘类水果皮或苹果果渣生产。其它可能的来源是糖用甜菜、向日葵和芒果。在本发明范围内使用的优选的果胶是柑橘果胶，其颜色通常比苹果果胶浅，因此不会给粒状产品带来明显的颜色。
以组合物的总重量计，多糖的使用量优选为约0.1wt％至约5wt％。如果使用果胶作为多糖，则其使用量以组合物的总重量计优选为约0.1wt％至约1wt％。如果使用藻酸盐作为多糖，则其使用量以组合物的总重量计优选为约0.1wt％至约1wt％。如果使用淀粉作为多糖，则其使用量以组合物的总重量计优选为约0.1wt％至约5wt％。
本发明的组合物可以通过本领域已知的用于生产粉末或颗粒的任何方法来生产。优选的方法是流化床粒化、高剪切粒化、挤出、喷雾干燥和湿法制粒。
为通过喷雾干燥来获得本发明的组合物，则制备所有组分的含水浆液是方便的。浆液中的固体含量优选为约10-70wt％，并且优选为约25-50wt％。然后，将浆液按本领域已知的方式喷雾干燥。
为通过流化床粒化来获得本发明的组合物，则使用已知的流化床粒化设备是方便的，所说的流化床粒化设备包括装配有喷雾器件的流化床干燥装置。优选地，让EGCG形成流化床，将此流化床通过空气或惰性气体如氮气流化。将一种或多种多糖溶解在合适量的水中，并且以雾化的形式喷洒到流化的颗粒上，以致于使粒化和干燥操作在单独一个步骤中同时完成。或者，将一种或多种多糖与EGCG混合，并且将流化床通过用空气或惰性气体如氮气流化。将合适量的水以雾化的形式喷洒到流化的颗粒上，以致于粒化和干燥操作在单独一个步骤中同时完成。将粒化过程持续到获得合意的颗粒或粉末为止。粒化过程结束时，可以将颗粒过筛，以便将颗粒按粒度筛分。尽管颗粒的粒度对本发明来说不是非常关键的，但出于实践目的，优选在50-2000微米之间，更优选在100-1000微米之间。
根据EGCG预计的用途或所需的应用，可以将如此获得的组合物进一步加工。例如，可以用常规的压片方法和机械装置将组合物压成片剂。可以任选地将粉末或颗粒进一步与润滑剂或润滑剂的混合物混合，然后压成片剂。如果使用附加的润滑剂，则润滑剂优选选自硬脂酸或其镁盐或钙盐，或者二十二烷酸甘油酯45(Compritol 888 ATO)，其量按组合物的总重量计算，优选为约0.5-4wt％。或者，可以将组合物与赋形剂混合。赋形剂的实例是糊精化的蔗糖(Di Pac sugar)、微晶纤维素或淀粉。
本发明将通过以下实施例作进一步举例说明。
实施例1
可以使用通过EP 1 077 211 A2中公开的工艺获得的EGCG粉末。通过将27.3g果胶(果胶USP，含水量8.4％，Danisco Ingredients，丹麦)溶解于1000g水中，制备果胶溶液。将EGCG粉末放入Glatt流化床制粒机中(Uniglatt型，Glatt GmbH，德国)并且喷洒果胶溶液的细雾。适宜的粒化条件如下：
EGCG粉末：594g
果胶溶液：246.6g
果胶溶液喷雾速率：6.7g/分钟
入口空气温度：80℃
出口空气温度：40℃
以颗粒的重量计，离开装置的颗粒所具有的含水量为约0.2wt％。
实施例2
通过将5.82g果胶(果胶USP/100，含水量8.96％，CP Kelco，丹麦)溶解于174.2g水中，制备果胶溶液。将EGCG粉末放入Glatt流化床制粒机中(Uniglatt型，Glatt GmbH，德国)并且喷洒果胶溶液的细雾。适宜的粒化条件如下：
EGCG粉末：445.5g
果胶溶液：150g
果胶溶液喷雾速率：6.7g/分钟
入口空气温度：80℃
出口空气温度：40℃
粒化结束时，将颗粒干燥约5分钟，以便达到含水量约0.2wt％，以颗粒的重量计。筛选分析得到如下的颗粒粒度分布。
颗粒粒度微米 ＞850 ＞800 ＞600 ＞425 ＞250 ＞160 ＞125 ＜125
 wt％ 1  0  6  15  26  28  9  13
使用Agway试验，比较粒化的EGCG与EGCG粉末(粒化用的起始原料)的粉末流动性。在测试中，按如下描述测定流动性：将100g颗粒放在11mm开口的玻璃漏斗中，将玻璃漏斗暂时密封。通过松开封条来开始测定。流动性测定为每100g颗粒的全部粉末流过漏斗所花费的时间，以秒计。
所获得的产品的100g样品流过11mm开口Agway漏斗所花费的时间为9.2秒。EGCG粉末不能流动，而粒化的EGCG显出用于压片的可接受的流动性，并且在各种食品和饮料应用中具有改进的加工性能。

Claims (7)

1、一种呈粉末或颗粒形式的组合物，该组合物含有：a)(-)-表没食子儿茶素没食子酸酯，和b)选自下列的多糖：果胶。
2、权利要求1的组合物，其中多糖的含量以组合物的总重量计为0.1wt％至5wt％。
3、权利要求2的组合物，其中多糖的含量以组合物的总重量计为0.1wt％至1wt％。
4、权利要求1-3任一项组合物的制备方法，包括制备所有组分的含水浆液，其固体含量为10-70wt％，然后将浆液按已知的方式喷雾干燥。
5、权利要求4的方法，其中固体含量为25-50wt％。
6、权利要求1-3任一项组合物的制备方法，包括在装配有喷雾器件的流化床干燥设备中形成含或不含多糖的(-)-表没食子儿茶素没食子酸酯的流化床，所说的流化床通过空气或惰性气体流化，并且将多糖的水溶液或仅用水以雾化的形式喷洒到流化的颗粒上，直至获得所需的颗粒或粉末为止，其中所述多糖是果胶。
7、果胶用于改进(-)-表没食子儿茶素没食子酸酯粉末流动性的用途。
CNB028097823A 2001-07-30 2002-07-22 含有表没食子儿茶素没食子酸酯的组合物 Expired - Fee Related CN1325049C (zh)

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AU2002327893A1 (en) 2003-02-17
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CN1509186A (zh) 2004-06-30
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CA2450772C (en) 2008-09-30
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DE60225560T2 (de) 2009-04-02
DE60225560D1 (de) 2008-04-24
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JP2005501833A (ja) 2005-01-20
MXPA04000618A (es) 2005-06-17

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