CN101888787A - 脂溶性活性成分的粉状制剂 - Google Patents
脂溶性活性成分的粉状制剂 Download PDFInfo
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- CN101888787A CN101888787A CN2008801197289A CN200880119728A CN101888787A CN 101888787 A CN101888787 A CN 101888787A CN 2008801197289 A CN2008801197289 A CN 2008801197289A CN 200880119728 A CN200880119728 A CN 200880119728A CN 101888787 A CN101888787 A CN 101888787A
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Abstract
本发明公开了一种或多种脂溶性活性成分的(精细分裂的)粉状制剂，其中包含改性食物淀粉和一种或多种选自聚甘油酯的组分，还公开了含有所述制剂的食物组合物，特别是饮料。
Description
本发明涉及一种或多种脂溶性活性成分的干燥的(精细分裂的)粉状制剂，本发明还涉及含有所述制剂的食物组合物，特别是饮料。
本文使用的术语“脂溶性活性成分”是指：选自维生素A、D、E、K及其衍生物的维生素；类胡萝卜素；多不饱和脂肪酸和调味物质或芳香物质以及它们的混合物。多不饱合脂肪酸的优选的例子是例如亚油酸、亚麻酸(linolenic acid)、花生四烯酸、二十二碳六烯酸、二十碳五烯酸等等。优选的脂溶性活性成分是类胡萝卜素，特别是β-胡萝卜素、番茄红素、叶黄素、胭脂树橙(bixin)、虾青素、阿朴胡萝卜醛、β-阿朴-8′-胡萝卜醛、β-阿朴-12′-胡萝卜醛、角黄素、隐黄素、柠檬黄质和玉米黄素。特别优选的是β-胡萝卜素。
用于封装脂溶性活性成分的方法是本领域公知的。用于保护灵敏活性并同时实现和维持生物利用率与高着色强度(如果需要的话，例如在类胡萝卜素的情况下)的一种便利的方法是以所谓“微珠”(beadlet)的形式配制活性成分。
在本文中使用时，术语“微珠”是指小的离散颗粒，其具有直径50-1000μm的平均颗粒尺寸，并且通常是接近球形的。微珠含有经封装形式的一种或多种活性成分。
将下述乳液或悬浮液干燥时获得微珠，所述乳液或悬浮液由水性基质相中的活性成分的小亲脂微滴(droplet)组成，微滴尺寸在约1nm到约1000nm范围内。所述亲脂微滴和/或基质可含有其他成分，如抗氧化剂、增塑剂和乳化剂。
图1展示了如例如EP-937412-A1中所述用于制备脂溶性活性成分粉状(微珠)制剂的常见方法的一部分：用下述油相和含有可膨胀胶体的水性(基质)相(3)制备所谓的预-乳液(4)，所述油相除了活性成分以外还含有一种或多种油(1)和一种或多种溶剂(2)。溶剂的去除得到无溶剂的(即干型(ready-to-dry-))乳液(5)，然后可以通过标准方法使其干燥，从而得到粉状制剂。
微珠在干燥步骤期间形成，即微珠是固体并含有小的亲脂微滴，其中活性成分包埋于由固体组分形成的基质中，使得亲脂微滴均匀地分布于基质中。基质中亲脂微滴的典型尺寸在从约1nm到约1000nm、优选从约150nm到约400nm、更优选从约200nm到约300nm的范围内。
干燥步骤可使用本领域技术人员已知的任何常规干燥步骤，在任何合理的温度下进行。加热至约40℃到60℃是优选的。
优选的是喷雾干燥和/或粉末捕获方法，其中被喷雾的悬浮液微滴在吸附剂(如淀粉或硅酸钙或硅酸或碳酸钙或其混合物)的床上被捕获并随后干燥。如果使用粉末捕获方法，则微珠表面上还含有一层捕获介质。该层导致微珠的粗糙表面。捕获介质通常是淀粉、硅酸盐或磷酸盐。
如果将微珠分散于水中，则基质的组分被溶解，而带有活性成分的亲脂微滴保持不变，即重建了具有小颗粒尺寸(从约1nm到约1000nm、优选从约150nm到约400nm、更优选从约200nm到约300nm)的原始乳液或悬浮液。因此保持了纳米-乳液或纳米-悬浮液的高生物利用率和着色强度。
为了降低亲脂活性成分和水性基质之间的界面张力，在乳液/悬浮液的制备期间乳化剂是必需的。形成乳液/悬浮液后，乳化剂使分散于水相中的小亲脂微滴稳定。
作为可用于微珠制造中的乳化剂，可以使用大分子如水胶体。大分子具有额外地使微滴空间稳定的优点。为了实现小亲脂微滴的最佳稳定化，必须正确地选择乳化剂的特性。
通常用于制造微珠的乳化剂是明胶、蛋白质、淀粉、果胶、阿拉伯胶、黄原胶、瓜尔胶、豆角胶(caroub gum)、木质素磺酸盐(lignosulfonate)、藻酸盐、纤维素、纤维素衍生物例如羧甲基纤维素，和/或改性多糖。
对微珠自身的整个生产过程而言，即对必须被稳定化的不同类型的乳液而言，和对微珠的最终应用(其可以例如在饮料或食品中)而言，将所述大分子乳化剂与辅助乳化剂组合来获得期望的乳化和稳定特性通常是有利的。
如果例如使用明胶作为乳化剂，则通常使用棕榈酸抗坏血酸酯作为辅助乳化剂，因为脂肪酸的抗坏血酸酯具有良好的乳化特性并同时发挥抗氧化剂的作用，特别是与其他抗氧化剂如α-生育酚组合时。
为了开发无动物成分的微珠形式，越来越多地使用改性食物淀粉代替明胶。不幸的是，这些淀粉的乳化特性不如明胶强大，并且与辅助乳化剂的性能良好的组合是未知的，如与棕榈酸抗坏血酸酯的组合是不合适的，这主要是因为棕榈酸抗坏血酸酯的水溶液具有大于7的高pH值。
因此，以下发明的一个目的是改进改性淀粉的乳化特性和提供含有一种或多种脂溶性活性成分的干燥的(精细分裂的)粉状制剂，优选微珠制剂，其中基质材料应当是改性食物淀粉。另外，粉状制剂应当满足生产期间和食物组成中的通常需求，例如对氧化是稳定的、在产物中均匀分布并随时间保持，等等。
出人意料地发现，本发明的目的通过包含改性食物淀粉、一种或多种脂溶性活性成分和一种或多种选自聚甘油酯的组分的粉状制剂实现。
本领域技术人员不能预见根据本发明的粉状制剂会解决上述问题。
在本文中使用时，术语“改性食物淀粉”是指由通过已知的化学方法用疏水片段取代的淀粉制成的改性淀粉。例如，可用环状二羧酸酐如琥珀酸酐和/或戊二酸酐处理淀粉，所述酸酐用烷烃基或烯烃基取代。
本发明的一种尤其优选的改性淀粉具有下式(I)：
其中St是淀粉，R是亚烷基且R′是疏水基。优选地，R是低级亚烷基，如二亚甲基(dimethylene)或三亚甲基(trimethylene)。R′可以是烷基或链烯基，优选地具有5到18个碳原子。式(I)的一种优选的改性淀粉是辛烯基琥珀酸淀粉钠(“OSA-淀粉”)。在本文中使用时，术语“OSA-淀粉”表示用辛烯基琥珀酸酐(OSA)处理的任何淀粉(来自任何天然来源，如玉米、小麦、木薯、马铃薯，或是合成的)。取代程度(即相对于羟基总数而言酯化的羟基数)通常在从0.1％到10％的范围内、优选在从0.5％到5％的范围内、更优选在从2％到4％的范围内变化。
OSA-淀粉可含有其他水胶体，如淀粉、麦芽糖糊精、碳水化合物、胶质(gum)、玉米糖浆等，并可选地含有任何典型的乳化剂(作为共乳化剂)，如脂肪酸单甘油酯和二甘油酯、脂肪酸的多甘油酯、卵磷脂、脱水山梨醇单硬脂酸酯和植物纤维和/或糖。
OSA-淀粉可以商品名HiCap 100、Capsul、Capsul HS、Purity Gum2000、UNI-PURE、HYLON VII等从例如National Starch商业获得；或从Roquette Frères商业获得；或以商品名C*EmCap从CereStar商业获得；或从Tate&Lyle商业获得。
如果粉状制剂中改性食物淀粉(一种或多种化合物)的量以制剂的总重为基础在按重量计从30％到65％、优选按重量计从40％到50％的范围内，则是有利的。
在本文中使用时，术语“聚甘油酯”是指脂肪酸的聚甘油酯。优选地，多聚甘油片段主要由二聚、三聚和四聚甘油组成，最大聚合度达到十聚甘油。如果少于10％的多聚甘油具有等于或大于七聚甘油的聚合度，则是特别优选的。根据本发明的多聚甘油酯可分散于水中和溶于油中。HLB值为5到8、优选地为6到7的多聚甘油酯是最优选的。本发明的多聚甘油酯例如可以商品名“Rikemal JV-3081”从Riken Vitamins商业获得。
如果粉状制剂中聚甘油酯(一种或多种化合物)的量以制剂的总重为基础在按重量计从0.1％到10％、优选按重量计从0.5％到2％的范围内，则是有利的。
根据本发明，如果脂溶性活性成分(一种或多种化合物)的量以粉状制剂的总重为基础在按重量计从2％到20％、优选按重量计从5％到15％的范围内，则是有利的。
抗氧化剂防止活性成分的氧化，因此保持活性成分的期望特性，例如生物活性、颜色和/或颜色强度。根据本发明，可以使用脂溶性和/或水溶性抗氧化剂。优选的水溶性抗氧化剂为例如抗坏血酸或其盐，优选地为抗坏血酸钠。优选的脂溶性抗氧化剂是例如生育酚(合成或天然的)；丁基羟基甲苯(BHT)；丁基羟基茴香醚(BHA)；乙氧喹(EMQ)；没食子酸丙酯；叔丁基羟基喹啉。dl-生育酚是特别优选的。
根据本发明，如果抗氧化剂(一种或多种化合物)的量以粉状制剂的总重为基础在按重量计从0.1％到10％、优选按重量计从0.5％到3％的范围内，则是有利的。
可以使用增塑剂来调控基质的机械特性。从而可以控制柔韧性、柔软性、弹性和压缩性。根据本发明，优选的增塑剂可选自甘油、单糖、二糖和寡糖；蔗糖、转化糖(inverted sucrose)、甘油、山梨醇、葡萄糖(糖浆)、果糖、乳糖、麦芽糖、蔗糖、聚乙二醇、糖醇和淀粉水解产物(例如糊精和麦芽糖糊精)是优选的。麦芽糖糊精是特别优选的。
根据本发明，如果增塑剂(一种或多种化合物)的量以粉状制剂的总重为基础在按重量计从5％到50％、优选按重量计从5％到30％的范围内，则是有利的。
也可以通过配制期间的额外步骤使基质疏水，从而使得粉状制剂不再可分散于水中。这可通过例如使基质交联来实现。
在本发明的一个优选的实施方案中，粉状制剂可含有其他佐剂，所述佐剂优选地选自甘油三酯(油和/或脂肪)，更优选的来自植物油和/或脂肪，优选地为玉米油、向日葵油、大豆油、红花油、菜籽油、花生油、棕榈油、棕仁油、棉籽油、和/或椰子油，包括其精馏的级分。甘油三酯还可优选地是所谓的MCT(中链甘油三酯)，即中链脂肪酸(优选链长度为6到12个碳原子的饱和脂肪酸)和甘油的酯。
根据本发明，如果甘油三酯(一种或多种化合物)的量以粉末制剂的总重为基础在按重量计从1％到15％、优选地按重量计从2％到10％的范围内，则是有利的。
在本发明方法的一个优选的实施方案中，可以向粉末中添加一种或多种流动调节剂(flow-conditioning agent)(也称作抗结块剂、流动增强剂)，即在干燥步骤期间添加或向步骤d)中获得的产物中添加。优选的流动调节剂是例如(亲水的)气相法二氧化硅(fumed silica)，例如可以商品名
从Degussa商业获得的哪些。
根据本发明，如果组合物中流动调节剂(一种或多种化合物)的量以粉状制剂的总重为基础在按重量计从0.1％到1％的范围内，则是有利的。
如果通过干燥步骤获得的粉状制剂中残余的水分含量以粉状制剂的总重为基础在从1重量％到8重量％、优选从1重量％到3重量％的范围内，则是有利的。
本发明的粉状制剂可以精细分裂的粉末形式(平均颗粒尺寸为直径0.5-50μm)、微珠形式(平均颗粒尺寸为直径50-1000μm)或细粒或颗粒的形式(平均颗粒尺寸为直径大于1mm)存在。微珠是特别优选的。
本发明还涉及含有根据本发明的粉状制剂的组合物，特别是含有所述粉状制剂的食物组合物或膳食补剂。
根据本发明的膳食补剂可优选地是片剂、细粒、胶囊、糊剂、凝胶、粉末，其可还含有本领域技术人员通常已知的赋形剂。
根据本发明，含有粉状制剂的饮料是特别优选的食物组合物。本发明的饮料可以是基础组合物(base composition)，其使用时能够或者必须向其中添加水或另一液体饮料组合物(例如乳、酪乳(buttermilk)、发酵乳(soured milk)、酸乳(饮品)、果汁等)。基础组合物可以被制备为干燥的粉末产物(即食饮料)，其在消耗前要与水或另一液体饮料组合物混合，呈必须向其中添加水或另一液体饮料组合物的浓缩物，或呈不需要向其中添加液体的饮料。即食饮料(例如泡腾制剂形式)是特别优选的。
根据本发明，优选的食物组合物的其他例子是谷物和棒，例如谷物棒、巧克力棒、糖果棒，其除本发明的粉状制剂以外还含有本领域技术人员普遍已知的额外成分，例如坚果、水果、多种形式的谷粒、椰子、杏仁糖(marzipan)、焦糖(caramel)、牛轧糖(nougat)、曲奇、太妃糖(toffee)、翻糖(fondant)和/或法奇软糖(fudge)，所述棒通常用巧克力包裹。
本发明还通过以下的实施例阐述。
实施例：
将23.0g晶体β-胡萝卜素、2.0g dl-α-生育酚、1.0g聚甘油酯RikemalJV-3081和11.0g玉米油溶于合适的溶剂中(油相)。在50-60℃搅拌下将该溶液添加至90.0g改性食物淀粉、13.0g蔗糖和230.0g水的溶液中。
用转子-定子-匀化器将该预乳液匀化10分钟。最后用高压匀化器匀化乳液。
在接下来的步骤中通过蒸馏去除剩余的溶剂，并通过标准粉末捕获方法干燥无溶剂的乳液。获得β-胡萝卜素含量为12.1％的92.4g微珠。
饮料(ACE饮料)
通过将ACE饮料基础(含有果汁浓缩物、抗坏血酸、橙油、维生素E、水和根据实施例的β-胡萝卜素产物形式)与糖浆、水和苯甲酸钠混合制备ACE饮料。将饮料装填在玻璃瓶中后进行巴氏消毒步骤。
Claims (10)
1.粉状制剂，其含有改性食物淀粉、一种或多种脂溶性活性成分和一种或多种选自聚甘油酯的组分。
2.根据权利要求1的制剂，其特征是所述改性食物淀粉是辛烯基琥珀酸淀粉钠。
3.根据权利要求1或2的制剂，其特征是所述制剂中的改性食物淀粉(一种或多种化合物)的量以所述制剂的总重量为基础在按重量计从30％到65％、优选地按重量计从40％到50％的范围内。
4.根据前述任一项权利要求的制剂，其特征是所述脂溶性活性成分(一种或多种化合物)选自维生素A、D、E、K及其衍生物；类胡萝卜素；多不饱和脂肪酸和调味剂物质与芳香物质。
5.根据权利要求4的制剂，其特征是所述脂溶性活性成分(一种或多种化合物)选自类胡萝卜素。
6.根据权利要求5的制剂，其特征是所述脂溶性活性成分是β-胡萝卜素。
7.根据前述任一项权利要求的制剂，其特征是所述聚甘油酯(一种或多种化合物)选自最大聚合度达到十聚甘油的聚甘油酯。
8.根据前述任一项权利要求的制剂，其特征是所述聚甘油酯(一种或多种化合物)选自HLB值为5到8、优选地为6到7的聚甘油酯。
9.根据前述任一项权利要求的制剂，其特征是所述粉状制剂中聚甘油酯(一种或多种化合物)的量以所述制剂的总重为基础在按重量计从0.1％到10％的范围内。
10.根据前述任一项权利要求的制剂，其特征是所述粉状制剂中聚甘油酯(一种或多种化合物)的量以所述制剂的总重为基础在按重量计从0.5％到2％的范围内。
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| PCT/EP2008/010255 WO2009071286A1 (en) | 2007-12-05 | 2008-12-04 | Pulverous formulation of a fat-soluble active ingredient |
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| CN102907746A (zh) * | 2012-10-29 | 2013-02-06 | 华南理工大学 | 利用辛烯基琥珀酸淀粉钠制备橙油饮料乳液的方法 |
| CN108813557A (zh) * | 2018-04-08 | 2018-11-16 | 长江大学 | 一种α淀粉-聚甘油酯复合乳化剂及其制备方法 |
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| WO2015044222A1 (en) * | 2013-09-24 | 2015-04-02 | Dsm Ip Assets B.V. | Stable formulations for coloring beverages and food products |
| PH12014000123A1 (en) * | 2014-04-22 | 2015-11-09 | Kimes Priscila F | Ready-to-eat, gluten-free and ketogenic coconut meat-based cereal |
| WO2021165288A1 (en) * | 2020-02-18 | 2021-08-26 | Basf Se | Stable fat-soluble vitamin powders |
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| FR2411216A1 (fr) * | 1977-12-06 | 1979-07-06 | Telecommunications Sa | Procede de fabrication de produits extrudes a base de compositions polyolefiniques |
| US6110502A (en) * | 1998-02-19 | 2000-08-29 | Mcneil-Ppc, Inc. | Method for producing water dispersible sterol formulations |
| DE69935946T2 (de) * | 1998-06-24 | 2007-09-06 | Dsm Ip Assets B.V. | Vitaminpulver zur verwendung für getränke |
| JP2000026283A (ja) * | 1998-07-10 | 2000-01-25 | Nisshin Oil Mills Ltd:The | 油性組成物を含有した粉末組成物 |
| ES2213949T3 (es) * | 1999-07-02 | 2004-09-01 | Cognis Iberia, S.L. | Microcapsulas i. |
| US20060034937A1 (en) * | 1999-11-23 | 2006-02-16 | Mahesh Patel | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| DE10253111A1 (de) * | 2002-11-13 | 2004-05-27 | Basf Ag | Pulverförmige Phytosterol-Formulierungen |
| JP4327037B2 (ja) * | 2004-07-15 | 2009-09-09 | 理研ビタミン株式会社 | チョコレート粉末の製造方法 |
| TW200806306A (en) * | 2006-02-24 | 2008-02-01 | Kaneka Corp | Oil-in-water emulsion composition containing licorice-derived polyphenol |
| CA2654031C (en) * | 2006-06-05 | 2016-05-24 | Ocean Nutrition Canada Limited | Microcapsules with improved shells |
| DE202006010606U1 (de) * | 2006-07-07 | 2007-11-22 | Sensient Food Colors Germany Gmbh & Co. Kg | Zubereitung für Lebensmittel |
| US20080124387A1 (en) * | 2006-11-27 | 2008-05-29 | Kapac, Llc | Methods and formulations for enhancing the absorption and decreasing the absorption variability of orally administered drugs, vitamins and nutrients |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102907746A (zh) * | 2012-10-29 | 2013-02-06 | 华南理工大学 | 利用辛烯基琥珀酸淀粉钠制备橙油饮料乳液的方法 |
| CN102907746B (zh) * | 2012-10-29 | 2013-12-11 | 华南理工大学 | 利用辛烯基琥珀酸淀粉钠制备橙油饮料乳液的方法 |
| CN108813557A (zh) * | 2018-04-08 | 2018-11-16 | 长江大学 | 一种α淀粉-聚甘油酯复合乳化剂及其制备方法 |
| CN108813557B (zh) * | 2018-04-08 | 2022-08-02 | 长江大学 | 一种α淀粉-聚甘油酯复合乳化剂及其制备方法 |
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| WO2009071286A1 (en) | 2009-06-11 |
| JP2011505156A (ja) | 2011-02-24 |
| US20100272862A1 (en) | 2010-10-28 |
| EP2217091A1 (en) | 2010-08-18 |
| KR20100100839A (ko) | 2010-09-15 |
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