CN100411549C - 制造脂溶性物质的粉状制剂的方法 - Google Patents
制造脂溶性物质的粉状制剂的方法 Download PDFInfo
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- CN100411549C CN100411549C CNB2004800020512A CN200480002051A CN100411549C CN 100411549 C CN100411549 C CN 100411549C CN B2004800020512 A CNB2004800020512 A CN B2004800020512A CN 200480002051 A CN200480002051 A CN 200480002051A CN 100411549 C CN100411549 C CN 100411549C
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Abstract
在一种制造脂溶性物质处于水溶性或水分散性非胶凝基体中的微粒制剂的方法中,通过喷嘴将脂溶性物质和基体成分的水乳剂进料到垂直喷雾塔的上部。通过独立的进口,将粉状淀粉和热空气流也进料到垂直喷雾塔的上部。将冷空气流进料到该喷雾塔的下部,以形成包覆淀粉的、包含基体成分以及脂溶性物质的微粒的流化床。从流化床中收集微粒,并将其排放到干燥器中。
Description
本发明涉及制造脂溶性物质的水分散制剂的新方法。
脂溶性物质,例如脂溶性维生素、类胡萝卜素、多不饱和脂肪酸等的水分散制剂在人类和动物营养领域中发挥着重要的作用。因为此类制剂的水不溶性或其或多或少显著的稳定性和易处理性,它们通常都以乳剂或干粉的形式进入市场。此类制剂的一个共同特征是:活性物质,即脂溶性物质通常被例如***胶或明胶的基体成分(保护性胶质)所包被。该基体成分保证了活性物质的保护或者其稳定,保证了最佳的再吸收,并保证了可能需要的最终制剂的水分散性等。通常使用明胶作为基体成分(保护性胶质),所述明胶源自温血动物,因此也具有某些缺点。仅仅举例而言,这里要提到下列事实:由于宗教原因,基于此类明胶的制剂不能在全世界范围内使用,而且如果不用昂贵的制造方法,这种明胶以及由此制得的粉状制剂无法一直具有所期望的在冷水中的可分散性等。为克服基于明胶的制剂所固有的此类缺陷,人们已经提出用某些木质素衍生物代替明胶作为基体成分,例如见USP 5,668,183。制造此类基于木质素衍生物的粉状制剂的优选方法是淀粉捕捉(starch-catch)法,这是其中被喷洒出的乳剂颗粒被收集于淀粉床中的喷雾-干燥方法。由此获得的产品由被淀粉粘合层所包覆的、包括基体成分和嵌于其中的脂溶性物质的颗粒组成。本文中使用的术语“微粒(beadlet)”指此类颗粒。
微粒不是尘状的,并且具有良好的可流动特性,所以它们提供了优异的处理性能。然而,用所述的淀粉捕捉法制造基于木质素衍生物的微粒以及通常基于非胶凝基体成分的微粒,会伴随有在喷雾塔中沉积物的形成,这就要求中断喷雾-干燥过程来清洗装置。现在已发现:如果将冷空气流引入喷雾塔的下部,因此形成具有比喷雾区域温度远远更低的温度的流化床,从而将微粒从流化床排送到干燥器而完成干燥过程,这样可以显著抑制或大大避免喷雾塔中沉积物的形成。
因此,一方面,本发明涉及制造脂溶性物质在水溶性或水分散性的非胶凝基体中的微粒制剂的方法,所述方法包括
(a)通过喷嘴将所述脂溶性物质和所述基体成分的水乳剂进料到垂直喷雾塔的上部,以及通过独立的进口进料粉状淀粉和热空气流,
(b)将冷空气流进料到所述喷雾塔的下部,以形成淀粉包覆的、包含所述基体成分和所述脂溶性物质的微粒的流化床,以及
(c)从流化床收集所述微粒,并将它们排送到干燥器。
另一方面,本发明涉及基本如图2所示的喷嘴布置。
另一方面,本发明涉及基本如图1所示的装置。
图1示出用于进行本发明方法的装置。喷雾塔可以是任何在其顶部具有多个独立进口的常规喷雾塔,这些进口分别用于含有脂溶性物质、基体成分和辅料的乳剂[1],用于新鲜的热空气[2],以及用于循环热空气和淀粉[6]。在喷雾塔的中部提供有用于供应新鲜淀粉的进口[4]和用于来自干燥器的循环空气[9]的进口。在干燥塔的底部,提供有用于冷空气[3]的进口。通过出口[5],离开喷雾塔的空气和淀粉被循环。微粒,即包含基体以及脂溶性物质的淀粉包覆颗粒被收集于喷雾塔的底部,并通过出口[7]将其排放到干燥器,以根据需要去除残余湿气。
在优选的实施方式中,使用基本如图2所示的喷嘴结构来进行根据本发明的喷雾-干燥方法。所述结构包含第一中空锥体,其上部且较宽端是封闭的,并带有一个或多个用于淀粉/空气分散体的进口。第二内锥体通过如下方式装配到第一中空外锥体中:第二锥体指向朝上地进入所述第一锥体内,在其端部留有在其外表面和第一锥体的内表面之间的环形狭缝,使得淀粉分散体可以穿过锥体。在锥体的轴向上,用于提供乳剂的进口管向下伸出超过第二锥体,其末端设有旋转式雾化器或压力雾化器。雾化器将乳剂、空气和淀粉流分配到喷雾塔内。该结构还具有传统的环形空气进口通道,该通道在外锥体周围,其末端稍高于这两锥体所形成的环形狭缝。最后,该结构具有合适的将其紧紧固定于喷雾塔中的方式,例如螺纹。
喷嘴结构的尺寸并非很严格,取决于对喷洒能力的要求。第一外锥体可以具有大约40至50cm的高度,在其上端可以具有大约30至大约40cm的半径。第二内锥体可以具有大约15至大约25cm的高度,在其下端具有大约20至大约26cm的半径。在内锥体和外锥体之间所形成的狭缝宽度适合在大约3至大约10mm之间。用于提供乳剂的进口管适合具有大约80至大约110mm的直径,旋转式雾化器适合具有大约32至大约42mm的直径。用于提供淀粉的进口管适合具有大约3至大约7mm的直径。用于提供热空气的环形通道适合具有大约50至大约70cm的宽度。
乳剂的温度适合在15℃至80℃的范围内。热空气流和冷空气流的比例如可以在1∶8至1∶4(热∶冷)的范围内。热空气适合具有的温度要能在喷雾区域提供大约40℃至大约200℃,优选大约60℃至大约120℃的温度。优选地,热空气被除湿到例如水含量少于大约3g/kg。为使塔底的内部流化床流化,适合使用水含量低于大约3g/kg的干冷空气(大约5-15℃)。通过控制冷空气的供应和温度,使内部流化床的温度保持在大约0℃至大约40℃的范围内,优选在大约5℃至大约20℃的范围内。
为改进对内部流化床中产品的流化,可加入硅酸[10]。硅酸被连续加入淀粉流[4]中,该淀粉流根据需要进料到内部流化床中以弥补淀粉消耗。此处还可以加入辅料。
用于本发明方法中的淀粉优选是玉米淀粉。术语“脂溶性物质”在本发明的范围中特别包含脂溶性维生素A、D、E和K,类胡萝卜素例如β-胡萝卜素、虾青素、apocarotenal、角黄素、apoester、桔黄素(citranaxanthin)、玉米黄质、叶黄素和番茄红素。多不饱和脂肪酸的例子例如是亚油酸、亚麻酸、花生四烯酸、二十二碳六烯酸、二十碳五烯酸等。然而,很容易考虑到在人类或动物营养中发挥作用的其它脂溶性物质。此类物质,例如前面提到过的,通常以乳剂或干粉的形式进入市场,这是因为它们的水不溶性或者是因为它们或多或少的突出的稳定性和易处理性。具体而言,这里可以提到油和脂肪,例如向日葵油、棕榈油和牛脂。
可用于本发明方法的乳剂中的基体成分优选是木质素衍生物,特别是USP 5,668,183中所述的木质素衍生物,其内容被结合于此以用于参考。木质素磺酸钠、木质素磺酸钙和木质素磺酸铵特别受关注。可以使用若干种木质素衍生物的混合物。用于可有利地加工成根据本发明的微粒制剂(微粒)的乳剂的非胶凝基体成分的其它例子是经改性的淀粉、果胶和纤维素衍生物。根据本发明加工的乳剂还可以含有传统上用于此类制剂中的辅料,例如抗氧化剂,例如丁基化羟基苯甲醚、丁基化羟基甲苯、乙氧喹、生育酚,或者保湿剂,例如甘油、山梨糖醇、聚乙二醇或丙二醇。
通过下述实施例对本发明进行进一步的阐述:
实施例
制备包含3wt%例如d,1-α-生育酚乙酸酯的活性成分、43wt%的水、50wt%木质素磺酸盐和4wt%添加剂的乳剂,并在如图1所示的装置里对其进行加工。下面括号里的标号指图1中的各个标号。
通过进口[4]将玉米淀粉引入喷雾塔中。随后,通过图2所示的喷嘴结构将乳剂流[1]喷到喷雾塔中。在塔顶,进料水含量为8g/kg的80℃热空气[2]。
为使塔底的内部流化床流化,进料水含量为1g/kg的10℃干燥冷空气[3]。
根据需要加入新鲜的玉米淀粉[4],以弥补微粒形成过程所造成的淀粉消耗。为流化内部流化床中的产物,可以向淀粉流中连续地加入硅酸[10]。新鲜的玉米淀粉和硅酸直接进料到内部流化床中。
排出的空气[5]通过椎体中间的圆柱体在塔底离开塔。该空气中的玉米淀粉被旋风分离器分离出,并循环到塔中(直接到雾化区域中)。该空气的温度大约为60℃,水含量为12g/kg。通过雾化器设备内椎体中的两个喷嘴对循环的玉米淀粉[6]进行雾化。被精细分布的玉米淀粉向下落到该椎体和相对的椎体上,随后通过塔中这两个椎体所形成的狭缝滴流。
含有一定湿气的离开喷雾塔的颗粒(微粒)被转移到外部干燥器中,使用已除去湿气的空气来操作该干燥器。离开外部干燥器的微粒[11]具有大约150-500μm的平均直径。
Claims (8)
1. 一种制造下述微粒制剂的方法,所述微粒制剂中,脂溶性物质处于水溶性或水分散性非胶凝基体中,所述方法包括:
(a)通过喷嘴将所述脂溶性物质和所述基体成分的水乳剂进料到垂直喷雾塔的上部,以及通过彼此独立的进口进料粉状淀粉和热空气流,
(b)将冷空气流进料到所述喷雾塔的下部,以形成包覆淀粉的、包含所述基体成分和所述脂溶性物质的微粒的流化床,以及
(c)从流化床收集所述微粒,并将它们排送到干燥器;
其中,所述喷嘴包含:
(a)第一中空锥体,其上部且较宽端是封闭的,并且带有一个或多个用于淀粉/空气分散体的进口;
(b)通过如下方式装配进第一中空外锥体内的第二内锥体,所述方式为:第二锥体指向朝上地进入所述第一锥体内,在其端部留有在其外表面和第一锥体的内表面之间的环形狭缝;
(c)具有封闭末端和小的旁侧开口的旋转式进口管,所述进口管向下伸出超过第二锥体,末端设有旋转式雾化器或压力雾化器;和
(d)环形空气进口通道,该通道环绕于外锥体周围,其下部稍高于这两锥体所形成的环形狭缝。
2. 如权利要求1所述的方法,其中喷雾区域具有大约40℃至大约200℃的温度,所述流化床具有大约0℃至大约40℃的温度。
3. 如权利要求2所述的方法,其中所述喷雾区域具有大约60℃至大约120℃的温度,所述流化床具有大约5至大约20℃的温度。
4. 如权利要求1或2所述的方法,其中用下述喷嘴结构将所述水乳剂、淀粉和热空气流进料到所述喷雾塔中,所述结构包含:
(a)第一中空锥体,其上部且较宽端是封闭的,并且带有一个或多个用于淀粉/空气分散体的进口;
(b)通过如下方式装配进第一中空外锥体内的第二内锥体,所述方式为:第二锥体指向朝上地进入所述第一锥体内,在其端部留有在其外表面和第一锥体的内表面之间的环形狭缝;
(c)具有封闭末端和旋转式雾化器的进口管,所述进口管向下伸出超过第二锥体,末端设有旋转式雾化器或压力雾化器;和
(d)环形空气进口通道,该通道环绕于外锥体周围,其下部稍高于这两锥体所形成的环形狭缝。
5. 如权利要求1或2所述的方法,其中所述基体成分是木质素磺酸盐。
6. 如权利要求1或2所述的方法,其中所述脂溶性物质是维生素A、D、E和K,类胡萝卜素、多不饱和脂肪酸、油或脂肪。
7. 如权利要求1或2所述的方法,其中所述的脂溶性物质是β-胡萝卜素、虾青素、阿朴胡萝卜醛、角黄素、阿朴酯、桔黄素或玉米黄质。
8. 一种喷嘴结构,所述结构包括:
(a)第一中空锥体,其上部且较宽端是封闭的,并且带有一个或多个用于淀粉/空气分散体的进口;
(b)通过如下方式装配进第一中空外锥体内的第二内锥体,所述方式为:第二锥体指向朝上地进入所述第一锥体内,在其端部留有在其外表面和第一锥体的内表面之间的环形狭缝;
(c)具有封闭末端和小的旁侧开口的旋转式进口管,所述进口管向下伸出超过第二锥体,末端设有旋转式雾化器或压力雾化器;和
(d)环形空气进口通道,该通道环绕于外锥体周围,其下部稍高于这两锥体所形成的环形狭缝。
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- 2004-01-06 CN CNB2004800020512A patent/CN100411549C/zh not_active Expired - Fee Related
- 2004-01-06 AT AT04700254T patent/ATE366520T1/de not_active IP Right Cessation
- 2004-01-06 WO PCT/EP2004/000028 patent/WO2004062382A1/en active IP Right Grant
- 2004-01-06 EP EP04700254A patent/EP1581065B1/en not_active Expired - Lifetime
- 2004-01-06 JP JP2006500518A patent/JP4463801B2/ja not_active Expired - Fee Related
- 2004-01-06 KR KR1020057012704A patent/KR101088520B1/ko active IP Right Grant
- 2004-01-06 US US10/541,359 patent/US7691297B2/en active Active
- 2004-01-06 DE DE602004007480T patent/DE602004007480T2/de not_active Expired - Lifetime
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2005
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Also Published As
Publication number | Publication date |
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NO20053214D0 (no) | 2005-06-30 |
EP1581065A1 (en) | 2005-10-05 |
JP4463801B2 (ja) | 2010-05-19 |
EP1581065B1 (en) | 2007-07-11 |
WO2004062382A1 (en) | 2004-07-29 |
DE602004007480D1 (de) | 2007-08-23 |
KR101088520B1 (ko) | 2011-12-06 |
US7691297B2 (en) | 2010-04-06 |
KR20050092037A (ko) | 2005-09-16 |
CN1735350A (zh) | 2006-02-15 |
DE602004007480T2 (de) | 2008-03-13 |
NO329108B1 (no) | 2010-08-23 |
ATE366520T1 (de) | 2007-08-15 |
US20060115534A1 (en) | 2006-06-01 |
NO20053214L (no) | 2005-08-12 |
JP2006517099A (ja) | 2006-07-20 |
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