CN1241991C - 明胶组合物 - Google Patents

明胶组合物 Download PDF

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CN1241991C
CN1241991C CNB98811268XA CN98811268A CN1241991C CN 1241991 C CN1241991 C CN 1241991C CN B98811268X A CNB98811268X A CN B98811268XA CN 98811268 A CN98811268 A CN 98811268A CN 1241991 C CN1241991 C CN 1241991C
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R·斯科特
D·凯德
何雄伟
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Warner Lambert Co LLC
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Abstract

本发明涉及包含附加固化系统的明胶组合物，其用于医药、兽医、食品、化装或其它像用于包裹食物、肉冻或果冻之薄膜的产品，优选用作像软或硬明胶胶囊的预分装制剂，其中所用明胶不是来源于猪牛而优选来源于鱼、家禽或植物。尤其优选的是，从鱼明胶制备的薄膜组合物用于制备硬明胶胶囊。

Description

明胶组合物
本发明涉及包含附加固化系统的明胶组合物，其用于医药、兽医、食品、化装或其它像用于包裹食物、肉冻或果冻之薄膜的产品，优选用作像软或硬明胶胶囊的预分装制剂，其中所用明胶不是来源于猪牛而优选来源于鱼、家禽或植物。尤其优选的是，从鱼明胶制备的薄膜组合物用于制备硬明胶胶囊。
本发明的第二方面是这种薄膜组合物在使用常规蘸胶成型工艺制备硬明胶胶囊中的应用。
传统上用于硬明胶胶囊的明胶从含有胶原的哺乳动物组织，尤其是例如猪皮或牛骨中抽提制备。人们优选使用猪牛来源的明胶是因其胶化、薄膜形成和表面活性的特性。使用蘸胶成型工艺制备硬明胶胶囊充分利用了其胶化和薄膜形成的能力。这种胶囊按如下方法制备：将模杆浸入热明胶溶液，从明胶液中移出模杆，通过冷却干燥使附着于杆上的明胶液固化，从杆上剥离如此形成的明胶壳。浸蘸后模杆上溶液的固化是获得均匀厚度的胶囊壳的关键步骤。
鱼胶原是明胶的另一来源。然而，人们早已认识到鱼胶原来源的明胶缺乏哺乳动物明胶那样的胶化和固化能力，因此限制了鱼胶原的应用。其仅适用于希望得到不形成凝胶的高粘度溶液的产品，如在胶水或食品制造中。在预分装制剂领域，鱼明胶可用于制备微胶囊(WO 9620612)。
A.N.Fraga等将常温下鱼明胶的机械性能描述为玻璃样物质的易碎的性状特征(见J.Polym.Mater.5(1988)49-55)。对于明胶胶囊，此种脆性是非常不希望的。
Norland产品公司指出鱼明胶水溶液在低至10℃仍保持液态，而哺乳动物明胶水溶液必须加热至30℃以上才保持液态(见ResearchDisclosure 1987，788)。由于过低的胶化温度，鱼明胶这种性质不允许其在常规温度的传统蘸胶成型工艺中使用。
B.Leuenberger描述了不同哺乳动物明胶和鱼明胶的粘性和凝胶化性质，结论是在需要无凝胶形成的高溶液粘度的应用中鱼明胶可能有用(见Food Hydrocolloids 1991，353-361)。
令人惊奇的是现发现在鱼明胶水溶液中添加一种固化系统，鱼明胶可用于制备具有常规性质的明胶组合物。
因此，本发明的目的是提供明胶组合物，用于医药、兽医、食品、化装或其它像用于包裹食物、肉冻或果冻之薄膜的产品，优选用作像软或硬明胶胶囊的预分装制剂，其中所用明胶不是来源于猪牛而优选来源于鱼、家禽或植物，并在所述明胶水溶液中加入一种固化系统。尤其优选的是，从鱼明胶制备的明胶组合物用于制备硬明胶胶囊。
令人惊奇的是此目的可通过添加固化系统达到，从而允许使用广泛的非猪牛来源的明胶来制备人们消费的明胶产品，避免了伦理和文化问题。在通常不足以胶化的明胶溶液中添加固化系统，使其具有特定的所需要的胶化特性，尤其是用于硬明胶胶囊的制备。在制备硬明胶胶囊中极为重要的是防止浸蘸后留在模杆上待形成薄膜的明胶溶液顺杆流动。否则获得的薄膜将不具有所需的均一厚度。
因此，采用制备常规硬明胶胶囊同样的设备和同样范围的工艺条件可从非哺乳动物的明胶来源制备硬明胶胶囊。而且，由本发明组合物制备的胶囊具有同样的尺寸规格，允许胶囊使用者采用现有的填充机而无需特殊的新设备。由本发明明胶组合物制备的胶囊也具有可接受的机械和溶解性质。
浸蘸液中的所述明胶浓度按重量计算在10％到60％范围，优选20％到40％。
所述固化系统包含一种水胶体或水胶体混合物，此外还可包含阳离子和/或螯合剂。
适合的水胶体或产生协同特性的混合物可选自天然海藻，天然种子胶，天然植物分泌物，天然果实抽提物，生物合成胶，生物合成经过加工的淀粉或纤维素材料，优选多糖。
优选的多糖有藻酸盐，琼脂胶，瓜尔胶，刺槐豆胶(角豆)，角叉菜胶，塔拉(tara)胶，阿拉伯树胶，茄替胶，卡欧属阔叶树胶(Khayagrandifoliagum)，黄蓍胶，刺梧桐树胶，果胶，阿拉伯聚糖，黄原胶，吉兰糖(gellan)，淀粉，魔芋甘露聚糖，半乳甘露聚糖，海萝聚糖，以及其它细胞外多糖。优选细胞外多糖。
优选的细胞外多糖有黄原胶，阿西坦(acetan)，吉兰糖，威兰(welan)，拉姆散(rhamsan)，红藻胶，琥珀酰聚糖，小核菌聚糖，裂裥菌素，罗望子胶，凝胶多糖，支链淀粉，或葡聚糖。
优选的水胶体有K-角叉菜胶，吉兰糖胶，或像黄原胶和刺槐豆胶或黄原胶和魔芋甘露聚糖的组合。
具体地，在上述固化系统中，优选附加阳离子的K-角叉菜胶系统和附加阳离子的吉兰糖胶系统。它们在低浓度时能产生高胶体强度，并具有极好的与明胶相容的性质。
水胶体在明胶水溶液中的量按重量计算优选0.01％到5％之间，尤其优选0.03％到1.0％之间。
所述阳离子优选选自K+、Na+、Li+、NH4 +、Ca++或Mg++，对于K-角叉菜胶优选K+、NH4 +或Ca++。阳离子的量在明胶水溶液中按重量计算优选低于3％，尤其是0.01％到1％。
优选的螯合剂有乙二胺四乙酸，乙酸，硼酸，柠檬酸，依地酸，葡糖酸，乳酸，磷酸，酒石酸，或它们的盐类，偏磷酸盐，二羟基乙基甘氨酸，卵磷脂，β-环糊精或上述物质的组合。尤其优选乙二胺四乙酸或其盐类或柠檬酸或其盐类。其量按浸蘸液的重量计算优选低于3％，尤其是0.01到1％。
因此，由所述溶液制备的明胶胶囊或薄膜，按重量计算包含7％到17％的水，83％到93％的明胶，0.01％到10％、优选0.05％到5％的水胶体，少于5％、根据所用水胶体不同优选0.01％到3％的阳离子，和可选择的少于5％、优选0.01％到3％的螯合剂。
制备含有本发明明胶组合物的胶囊或薄膜可使用常规机器和常规工艺如挤压成形，注入成形，浇铸成形或浸蘸成形。
本发明明胶组合物还可含有明胶重量0％到40％的可接受的增塑剂。适宜的增塑剂有聚乙二醇，丙三醇，山梨醇，蔗糖，玉米糖浆，果糖，琥珀酸二辛酯磺酸钠，柠檬酸三乙酯，柠檬酸三丁酯，1，2-丙二醇，单、二或三醋酸甘油，天然胶或类似物，以及上述物质之混合物。
另一方面本发明的明胶组合物还可含有基于纤维素醚重量0％到10％的可药用或可食用的着色剂。所述着色剂可选自有偶氮一、奎酞酮(quinophthalone)-、三苯甲烷-、呫吨-或靛青类染料，铁氧化物或氢氧化物，二氧化钛或天然染料或上述物质的混合物。例如专利蓝V，酸性亮绿BS，红2G，偶氮玉红，丽春红4R，苋菜红，D+C红33，D+C红22，D+C红26，D+C红28，D+C黄10，黄2G，FD+C黄5，FD+C黄6，FD+C红3，FD+C红40，FD+C蓝1，FD+C蓝2，FD+C绿3，亮黑BN，碳黑，氧化铁黑，氧化铁红，氧化铁黄，二氧化钛，核黄素，胡萝卜素，花青素，姜黄，胭脂虫抽提物，叶绿素(clorophyllin)，角黄素，焦糖，或甜菜苷。
由本发明的明胶组合物制备的成型终产物可用适宜的包衣剂包衣，如醋酞纤维素，聚邻苯二甲酸醋酸乙烯酯，甲基丙烯酸明胶，羟丙甲纤维素邻苯二甲酸酯，羟丙基甲基纤维素邻苯二甲酸酯，羟烷基甲基纤维素邻苯二甲酸酯，或上述物质之混合物，以提供肠溶性等性质。
本发明的明胶组合物可用于制备容器，以提供诸如农用化学品、种子、药草、食品、染料、药物、调味剂和类似物的单位剂量形式。所述容器还可以具有包衣。
本发明的明胶组合物可用于将囊片包装入胶囊，尤其是以防伪形式。囊片包装入胶囊的过程优选将填充有囊片的胶囊部件一起冷收缩，其包含步骤：提供空的胶囊部件，给至少一个所述胶囊部件填充一或更多个囊片，将所述胶囊部件装在一起，通过冷收缩处理组合好的胶囊部件。
本发明的明胶组合物也可用于两个半胶囊的胶囊形成和密封，处理方法是将一或多层组合物施于帽体衔接处，或采用液体融合法，即将填充的胶囊以醇水溶液润湿，其会渗入帽体重叠的空隙中，然后将胶囊干燥。
本发明的一个具体实施方案是由鱼油填充的鱼明胶制备的硬明胶胶囊。
此明胶组合物的改良性质可通过下列实施例来说明：
实施例1
3.39千克去离子水中加入5克醋酸钾(溶液中按重量计算为0.10％)，接着在约70℃搅拌情况下加入10克k-角叉菜胶(按重量计算为0.20％)。获得澄清溶液后，在60摄氏度缓慢搅拌情况下加入1.60千克鱼明胶(按重量计算为32％)，至明胶完全溶解和溶液泡沫消除。
然后将如此配制的鱼明胶倾入常规硬明胶胶囊生产设备的中试机器的浸蘸盘中。当保持浸蘸鱼明胶液的温度在50℃左右时，通过常规工艺就可制备出具有常规硬明胶胶囊尺寸规格的1号尺寸的天然透明硬鱼明胶胶囊。
实施例2
根据实施例1配制的5千克鱼明胶液在60℃时加入预先分散在少量水中的32.6克二氧化钛。溶液混匀后倾入浸蘸盘，按实施例1制备1号尺寸的白色不透明硬鱼明胶胶囊。
两个实施例制备的胶囊均具有极好的溶出性质，见图1，图中显示从浸入37℃去离子水中的胶囊溶解出的对乙酰氨基酚百分数(USP XXIII)，作为溶出时间的函数显示。

Claims (27)

1.一种明胶组合物，包含83-93重量％的鱼明胶、7-17重量％的水、0.01-10重量％的水胶体固化系统，其中所述水胶体固化系统选自天然海藻、天然种子胶、天然植物分泌物、天然果实抽提物、生物合成胶、生物合成经过加工的淀粉、纤维素材料和多糖，其中各组分含量的总和为100％。
2.根据权利要求1的明胶组合物，其中所述固化系统进一步含有阳离子和/或螯合剂。
3.根据权利要求1的明胶组合物，其中所述水胶体固化系统的量为0.05-5重量％。
4.根据权利要求2的明胶组合物，其中所述阳离子的量为小于5重量％。
5.根据权利要求4的明胶组合物，其中所述阳离子的量为0.01-3重量％。
6.根据权利要求1的明胶组合物，其中所述固化系统进一步含有螯合剂或螯合剂的混合物，其量小于5重量％。
7.根据权利要求6的明胶组合物，其中所述螯合剂的量为0.01-3重量％。
8.根据权利要求1的明胶组合物，其中所述固化系统的水胶体选自多糖。
9.根据权利要求1的明胶组合物，其中所述固化系统的水胶体选自藻酸盐，琼脂胶，瓜尔胶，刺槐豆胶，角叉菜胶，塔拉胶，阿拉伯胶，茄替胶，卡欧属阔叶树胶，黄蓍胶，刺梧桐树胶，果胶，阿拉伯聚糖，黄原胶，吉兰糖，淀粉，魔芋甘露聚糖，半乳甘露聚糖，海萝聚糖。
10.根据权利要求1的明胶组合物，其中所述固化系统的水胶体选自细胞外多糖。
11.根据权利要求1的明胶组合物，其中所述固化系统的水胶体选自黄原胶，阿西坦，吉兰糖，威兰，拉姆散，红藻胶，琥珀酰聚糖，小核菌聚糖，裂裥菌素，罗望子胶，凝胶多糖，支链淀粉，或葡聚糖。
12.根据权利要求1的明胶组合物，其中所述固化系统的水胶体选自吉兰糖胶或k-角叉菜胶。
13.根据权利要求6的明胶组合物，其中所述固化系统中螯合剂或螯合剂的混合物选自乙二胺四乙酸，乙酸，硼酸，柠檬酸，依地酸，葡糖酸，乳酸，磷酸，酒石酸，或它们的盐类，偏磷酸盐，二羟基乙基甘氨酸，卵磷脂，或β-环糊精。
14.根据权利要求13的明胶组合物，其中所述螯合剂或螯合剂混合物选自乙二胺四乙酸或其盐类，或柠檬酸或其盐类。
15.根据权利要求1到14任一项的明胶组合物，其还包含基于明胶重量的0％到40％的增塑剂。
16.根据权利要求15的明胶组合物，其中所述增塑剂或增塑剂混合物选自聚乙二醇，丙三醇，山梨醇，蔗糖，玉米糖浆，果糖，琥珀酸二辛酯磺酸钠，柠檬酸三乙酯，柠檬酸三丁酯，1，2-丙二醇，单、双或三醋酸甘油，或天然胶。
17.根据权利要求1到14任一项的明胶组合物，其还包含基于明胶重量的0％到10％的着色剂。
18.根据权利要求17的明胶组合物，其中所述着色剂或着色剂混合物选自偶氮-，奎酞酮-，三苯甲烷-，呫吨，或靛青类染料，铁氧化物或氢氧化物，二氧化钛或天然染料。
19.根据权利要求17的明胶组合物，其中所述着色剂或着色剂混合物选自专利蓝V，酸性亮绿BS，红2G，偶氮玉红，丽春红4R，苋菜红，D+C红33，D+C红22，D+C红26，D+C红28，D+C黄10，黄2G，FD+C黄5，FD+C黄6，FD+C红3，FD+C红40，FD+C蓝1，FD+C蓝2，FD+C绿3，或亮黑BN。
20.根据权利要求17的明胶组合物，其中所述着色剂或着色剂混合物选自炭黑，氧化铁黑，氧化铁红，氧化铁黄，二氧化钛，核黄素，胡萝卜素，花青素，姜黄，胭脂虫红抽提物，叶绿素，角黄素，焦糖，或甜菜苷。
21.根据权利要求1到20任一项的明胶组合物用于制备用以提供农用化学品、种子、药草、食品、染料、药剂、或调味剂的单位剂量形式的容器的用途。
22.根据权利要求21的用途，其中所述容器是一种药用胶囊。
23.根据权利要求21或22的用途，其中所述容器具有包衣。
24.根据权利要求23的用途，其中所述包衣选自醋酞纤维素，聚邻苯二甲酸醋酸乙烯酯，甲基丙烯酸明胶，羟丙甲纤维素邻苯二甲酸酯，羟丙基甲基纤维素邻苯二甲酸酯，羟烷基甲基纤维素邻苯二甲酸酯，或上述物质的混合物。
 25.根据权利要求22的用途，其中所述胶囊的半胶囊用一层或多层根据权利要求1到20的明胶组合物密封。
26.根据权利要求22的用途，其中所述胶囊的半胶囊通过液体融合法密封。
27.根据权利要求1到20任一项的明胶组合物用于制备囊片的用途。
28.以采用蘸胶成型工艺从明胶水溶液生产硬明胶胶囊的方法，其中采用的明胶组合物包含：83-93重量％的鱼明胶、7-17重量％的水、0.01-10重量％的水胶体固化系统，其中所述水胶体固化系统选自天然海藻、天然种子胶、天然植物分泌物、天然果实抽提物、生物合成胶、生物合成经过加工的淀粉、纤维素材料和多糖，其中各组分含量的总和为100％。
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* Cited by examiner, † Cited by third party
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CN103385523A (zh) * 2013-07-15 2013-11-13 浙江蓝美农业有限公司 一种蓝莓果汁制品在线澄清工艺及蓝莓果汁下胶剂
CN103385523B (zh) * 2013-07-15 2014-07-09 浙江蓝美农业有限公司 一种蓝莓果汁制品在线澄清工艺及蓝莓果汁下胶剂

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JP4294862B2 (ja) 2009-07-15
DE69828310D1 (de) 2005-01-27
ID25786A (id) 2000-11-02
EP1042405B1 (en) 2004-12-22
US7008639B2 (en) 2006-03-07
US20010024678A1 (en) 2001-09-27
US20040224025A1 (en) 2004-11-11
ES2235380T3 (es) 2005-07-01
AU1380199A (en) 1999-07-19
ATE285449T1 (de) 2005-01-15
DE69828310T2 (de) 2005-05-25
CA2303852A1 (en) 1999-07-08
WO1999033924A1 (en) 1999-07-08
KR20010033605A (ko) 2001-04-25
CA2303852C (en) 2008-03-18
US6770294B2 (en) 2004-08-03
JP2003521551A (ja) 2003-07-15
KR100607008B1 (ko) 2006-08-01
EP1042405A1 (en) 2000-10-11
DK1042405T3 (da) 2005-04-18
PT1042405E (pt) 2005-03-31
CN1279701A (zh) 2001-01-10

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