CN1993060A - 可脂溶物质的新型组合物 - Google Patents

可脂溶物质的新型组合物 Download PDF

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CN1993060A
CN1993060A CNA2005800264386A CN200580026438A CN1993060A CN 1993060 A CN1993060 A CN 1993060A CN A2005800264386 A CNA2005800264386 A CN A2005800264386A CN 200580026438 A CN200580026438 A CN 200580026438A CN 1993060 A CN1993060 A CN 1993060A
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艾勒格·范纳
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Abstract

本发明涉及一种可脂溶物质的新型粉末状、可水溶组合物和其水性溶液或乳液，其中，将所述可脂溶物质进行封装作为在基质物质的外部(连续)相中的内部(非连续)相。

Description

可脂溶物质的新型组合物
本发明涉及一种可脂溶物质的新型组合物。更具体地，本发明涉及可脂溶物质的新型粉末状、可水溶组合物和其水性溶液或乳液。本发明的新型组合物可用于食品、饮料、动物饲料、化妆品或药物添加剂，以将所述可脂溶成分混入上述物质中。新型组合物的特定特征在于，将所述可脂溶物质进行封装，以形成处在基质物质的外部(连续)相中的内部(非连续)相。
因此，一方面，本发明涉及一种新型的组合物，该组合物包括：
a)形成外部(连续)相的基质物质；和
b)处在所述基质物质中的内部(非连续)相，所述内部(非连续)相包括
b1)可脂溶的生理学活性成分，所述活性成分包埋在下述b2)中；和
b2)生理学上可接受封装物质，所述封装物质在室温下是固体并且与所述可脂溶的生理学活性成分一起均相地溶于有机溶剂中。
另一方面，本发明涉及一种用于制备上述新型组合物的方法。
另一方面，本发明涉及一种食品或动物饲料或其补充剂或药学上或化妆用配制品，上述产品包括上述组合物。
此处所用术语“可脂溶的活性成分”指可溶在类脂中并且不溶或很少溶于水中的任何生理学活性成分。这种可脂溶活性成分的实例是可脂溶维生素，即，维生素A、D、E和K和其衍生物，诸如维生素A酯，例如，维生素A乙酸酯和棕榈酸酯，和维生素E酯，例如，生育酚乙酸酯；类胡萝卜素和类胡萝卜素衍生物，例如α-或β-胡萝卜素、8′-阿朴-β-胡萝卜醇、8′-阿朴-β-胡萝卜酸酯(诸如胡萝卜酸乙酯)、班蝥黄、虾青素、虾青素酯、番茄红素、叶黄素、玉米黄质或藏花酸和它们的衍生物；多不饱和脂肪酸，例如，二十碳五烯酸、二十二碳六烯酸、花生四烯酸和γ-亚麻酸和/或其乙酯。
术语“封装物质”指任何可食用物质，该物质在应用温度下为固体，能够封装活性成分并且可与活性成分一起溶于同一种溶剂中。优选使用通常可用作包衣材料的物质。更优选使用的是合成或天然蜡或蜡状物质或天然或合成的可食用聚合物。
蜡或蜡状物质优选选自如下，例如，巴西棕榈蜡、蜡大戟蜡、蜂蜡、米糠蜡、甘蔗蜡、日本木蜡、细茎针草蜡、软木蜡、guaruma蜡、小冠椰子蜡、褐煤蜡、鲸油、羊毛脂、水合霍霍巴蜡或石蜡、脂肪、氢化脂肪、脂肪酸单甘油酯、聚丙二醇、聚乙二醇、脂肪酸酯、脂肪酸蔗糖酯、脂肪酸、烃和其氢化产物。
天然可食用聚合物优选选自如下：经改性(例如，经烷基化)的碳水化合物(例如，淀粉、果胶、藻酸盐、角叉菜聚糖、红藻胶、壳聚糖、麦芽糊精、糊精衍生物)、纤维素和纤维素衍生物(例如，纤维素乙酸酯、甲基纤维素、羟丙基甲基纤维素)、树胶或经改性(例如，经烷基化)的树胶(例如，阿拉伯树胶、黄原胶、瓜耳豆胶、达瓦树胶、刺梧桐树胶、黄芪胶、刺槐豆胶、结冷胶)、树脂(例如，虫漆、木松香和诸如柯巴脂、硬树胶和榄香脂的树木树脂)、玉米蛋白。这些聚合物的改性对于改善在有机溶剂中的溶解性可能是必要的。
合成的聚合物优选选自如下：例如聚乙烯和聚丙烯蜡的合成蜡、苯并呋喃-茚树脂(coumarene-indene resins)、聚乳酸(PLA)和聚(乳酸/乙醇酸)(PLGA)、丙烯酸类聚合物(甲基丙烯酸共聚物和氨溶的甲基丙烯酸酯共聚物)、聚原酸酯、聚磷睛、聚酸酐、聚乙交酯(PGA)、聚(∈-己内酯)、聚二氧杂环己酮、三亚甲基碳酸酯、聚(β-羟基丁酸酯)、聚(谷氨酸γ-乙酯)、聚(DTH亚氨基碳酸酯)、聚(双酚A亚氨基碳酸酯)和聚氰基丙烯酸酯，尤其是丙烯酸类聚合物。还可以使用聚乙烯基醇和聚乙烯基吡咯烷酮聚合物。
用在本发明中的优选的封装物质是蜂蜡、巴西棕榈蜡、石蜡、聚乙二醇和氢化脂肪。
活性成分和封装物质的比例通过保护活性成分所必需的封装物质的量和在配制品中活性成分的目标含量来确定。活性成分：封装物质的比可以在约10∶1-约1∶20之间，优选在1∶3-3∶1之间变化。
(活性成分+封装物质)：基质的比根据具体配制品的需要来选择。通常比可以为例如1∶99(1％形)、1∶9(10％形)或1∶1(50％形)。基质的量通过稳定乳液和封装内部(油)相所必需的量来确定。
基质组分优选选自如下：碳水化合物(例如，纤维素、淀粉、经改性的淀粉、糊精、果胶、藻酸盐、角叉菜聚糖、红藻胶、壳聚糖)、树胶(例如，阿拉伯树胶、黄原胶、瓜耳豆胶、达瓦树胶、刺梧桐树胶、黄芪胶、刺槐豆胶、结冷胶)、蛋白质(例如，鱼明胶、家禽明胶和哺乳动物明胶、大豆蛋白、豌豆蛋白、玉米蛋白(来自玉米)、小麦麸质、羽扇豆蛋白、花生蛋白、牛乳蛋白或经水解或经改性的牛乳蛋白，尤其是酪蛋白或乳清蛋白)、木质素和木质素衍生物(木素磺化盐、牛皮纸木质素)、纤维素和纤维素衍生物(例如，羧甲基纤维素、羧乙基纤维素、羟丙基纤维素)。
用在本发明中的优选基质物质是明胶、木素磺化盐、牛乳蛋白或纤水解的牛乳蛋白、植物蛋白或经水解的植物蛋白、或经改性的淀粉，尤其是明胶、酪蛋白和酪蛋白水解物、大豆蛋白，其水解物、木素磺化盐、纤物理改性的大豆蛋白、淀粉、经改性的淀粉，尤其是辛基琥珀酰淀粉、果胶和羧甲基纤维素。
特别优选的基质物质是例如，木素磺化盐、鱼明胶、牛乳蛋白和经水解的植物蛋白，这些基质物质提供冷水可溶的组合物。
作为溶剂，可以使用任何能够溶解活性成分和封装物质的有机溶剂或溶剂组合。优选的是易于从乳液中蒸发的挥发性溶剂和溶剂组合。溶剂的实例是异丙醇、己烷、环己烷、丙酮、甲基乙基甲酮、二氯甲烷、氯仿、甲苯、四氢呋喃、乙酸乙酯。
前述清楚地表明，根据本发明的组合物包括一种基质物质作为连续相，在该连续相中分布了封装物质的颗粒(滴)。在所述封装物质的颗粒(滴)中，分布了可脂溶物质。这种组合物与如下组合物不同，其中，可脂溶物质的颗粒分布在基质物质中(参见，例如EP 564 989)；或可脂溶物质采用包衣材料包覆；或与根据JP 2004196673的组合物不同，其中，含类胡萝卜素的溶液采用包衣溶液乳化，随后冷冻干燥由此制备粉末，其中，活性成分和包衣试剂分布在乳液的不同相中。本发明的组合物由于其独特的结构和制备方式在储存和应用中具有更好的稳定性并显示良好的生物利用率。
如果需要的话，如抗氧剂(丁基化羟基苯甲醚(BHA)、丁基化羟基甲苯(BHT)、乙氧喹(6-乙氧基-1，2-二氢-2，2，4-三甲基-喹啉)等)、乳化剂(例如，卵磷脂)、增塑剂、稳定剂、保湿剂(如，甘油、山梨醇、聚乙二醇)、保护胶体、缓冲剂、佐剂的其它组分可以包括在本组合物中。
根据本发明的组合物的内部相的颗粒尺寸优选小于5μm，更优选小于100μm，例如100nm-500nm。根据本发明的粉末状组合物的颗粒尺寸通常为50-500μm。
活性成分和封装物质优选采用搅拌溶于溶剂中。如果需要的话，溶剂可以如果必要的话在升高压力下进行加热。乳化剂和其它佐剂也可以溶在有机溶剂中。
基质化合物优选采用搅拌溶于水中。如果需要的话，水可以进行加热。乳化剂和其它可水溶佐剂也可以溶在水性相中。
有机相和水性相混合以形成乳液。乳液可以通过本领域技术人员已知的任何合适方法来制备。合适的已知制备方法包括，采用转子-定子系统乳化、高压均化器或超声乳化。为了确保良好的生物利用率，需要小颗粒尺寸的活性成分。因此，乳液液滴的颗粒尺寸应当优选小于5μm，更优选小于1μm，更优选小于0.5μm。
溶剂的蒸发可以通过本领域技术人员已知的任何合适方式来进行。合适的已知蒸发方法是，例如薄膜蒸发或降膜蒸发。蒸发可以在室温下或在所需要的升高温度下采用减压或未采用减压来进行。
尽管在本发明中描述的产品形式优选用作粉末，其它类型的配制品也可以，例如，液体形式、糊状或小球状。粉末状配制品优选通过喷雾干燥或在例如US专利US 6444227中所描述的珠状小球工艺(beadlet process)来制备。还可以使用其它已知的干燥方法。
固体形式也可以例如通过将乳液与粘合剂一起挤出来制备。
液体形式可以通过在溶剂蒸发后使用乳液来制备。
以下实施例进一步说明本发明。
实施例1
2.5％班蝥黄喷雾干燥的粉末
(a)将330g明胶、279g蔗糖、0.75g山梨酸和1.50g苯甲酸钠加入330g蒸馏水中。该明胶混合物通过在约50℃下水合整夜来溶解。
(b)制备以下溶液：
抗坏血酸2.25g
EDTA 0.75g
月桂基硫酸钠12.0g
蒸馏水105.0g
将该溶液加到明胶糖溶液(a)中以形成乳液的水性相。该溶液的pII利用20％w/w的氢氧化钠溶液调节到10.4±0.2。
(c)油相由如下组分通过首先将BHT溶于dl-α-生育酚中(通过将混合物加热到80℃)来制备。
班蝥黄23.3g
丁基化羟基甲苯(BHT)22.5g
dl-α-生育酚22.5g
蜂蜡23.3g和
氯仿525g
将该溶液冷却到55℃，然后与氯仿混合直到得到清澈的溶液。将班蝥黄和蜂蜡在氮气氛下加入该溶液中并溶解。
将水性相和油相都加热到约50-55℃。将油相缓缓加入水性相中，使用高速混合和高剪切混合器。在完成添加后，将乳液温度保持在55℃，同时继续高速剪切混合15分钟。将温度逐渐升高并继续混合直到所有的氯仿被蒸发。该蒸发通常当乳液的温度达到约75℃时完成。
在蒸发过程中，将蒸馏水加入乳液中以保持适于促进蒸发过程的粘度。
在所有氯仿被除去后，加入蒸馏水并使之与乳液充分混合以得到适于喷雾干燥的乳液固含量和粘度。喷雾乳液的粘度应当约100mPas。
乳液在标准喷雾干燥条件下采用喷雾干燥塔喷雾干燥。适当地选择喷雾条件以保持产物温度低于80℃。
实施例2
10％班蝥黄珠状小球
将15g班蝥黄和15g蜂蜡与3g乙氧基喹啉一起溶于600ml氯仿中。将75g木素磺化钠溶于375ml软化水中。该溶液的pH利用20％w/w的氢氧化钠溶液调节到7.5±0.5。将油相缓缓加入水性相中，使用高速混合利高剪切混合器。在完成添加后，将乳液温度保持在50℃，同时继续高速剪切混合15分钟。将温度逐渐升高并继续混合直到所有的氯仿被蒸发。该蒸发通常当乳液的温度达到约75℃时完成。在蒸发过程中，将蒸馏水加入乳液中以保持适当的粘度。
在所有氯仿被除去后，加入蒸馏水并使之与乳液充分混合以得到适于喷雾干燥的乳液固含量和粘度。然后使用实验室喷雾盘将乳液喷入1kg的淀粉流化床中。残余的淀粉通过筛分除去。

Claims (14)

1.一种组合物，所述组合物包括
a)形成外部(连续)相的基质物质；和
b)处在所述基质物质中的内部(非连续)相，所述内部(非连续)相包括
b1)可脂溶的生理学活性成分，所述活性成分包埋在下述b2)中；和
b2)生理学上可接受的封装物质，所述封装物质在室温下是固体并且与所述可脂溶的生理学活性成分一起均相地溶于有机溶剂中。
2.一种组合物，其中，所述封装物质是蜡或蜡状物质。
3.一种组合物，其中，所述封装物质是蜂蜡或巴西棕榈蜡。
4.一种组合物，其中，所述封装物质是树脂、硬化脂或聚合物。
5.如权利要求1-4中任意一项所述的组合物，其中，所述基质物质包括明胶、木素磺化盐、牛乳蛋白或经水解的牛乳蛋白、植物蛋白或经水解的植物蛋白或经改性的淀粉。
6.如权利要求1-5中任意一项所述的组合物，其中，所述可脂溶的生理学活性成分是类胡萝卜素。
7.如权利要求6所述的组合物，其中，所述类胡萝卜素是虾青素或班蝥黄。
8.如权利要求1-5中任意一项所述的组合物，其中，所述可脂溶的生理学活性成分是多不饱和脂肪酸。
9.如权利要求1-8中任意一项所述的组合物，所述组合物是水性乳液。
10.如权利要求1-8中任意一项所述的组合物，所述组合物是固体组合物。
11.如权利要求10所述的组合物，所述组合物是冷水可溶的。
12.如权利要求1-11中任意一项所述的组合物，所述组合物还包括佐剂，例如抗氧化剂、稳定和乳化剂。
13.用于制备权利要求1-12中任意一项所述组合物的方法，所述方法包括如下步骤：将所述可脂溶的生理学活性成分与所述封装物质溶于对于上述两种物质共同的有机溶剂中以得到油相，将所述油相与所述基质物质的水性溶液乳化，将所述有机溶剂蒸发并且如果希望的话将所述乳液转化成固态组合物。
14.一种食品、动物饲料或其补充剂，或药学、化妆用配制品，其包括权利要求1-12中任意一项所定义的组合物。
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