CN1055292A - 包胶囊香味剂和生物粘合剂的薄荷糖膏压片剂 - Google Patents
包胶囊香味剂和生物粘合剂的薄荷糖膏压片剂 Download PDFInfo
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- CN1055292A CN1055292A CN91102016A CN91102016A CN1055292A CN 1055292 A CN1055292 A CN 1055292A CN 91102016 A CN91102016 A CN 91102016A CN 91102016 A CN91102016 A CN 91102016A CN 1055292 A CN1055292 A CN 1055292A
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Abstract
本文介绍一种溶解于口腔的糖膏压片剂,它包含
香味成分与生物粘合剂均匀混合。该香味成分和生
物粘合剂混合物提供了独特口感,当糖膏剂溶解于口
腔时,香味成分粘附于口腔分泌物区。还介绍一种糖
膏压片剂,其特征在于其中含有分散相的单一制品顺
序地定时释放至少一种香味成分。可制备具有亲水
释放系统的香味成分和生物粘合剂混合物,提供开始
速释香味和独特口感,或作为憎水释放系统的一部
分,提供延长释放香味和独特口感,还介绍制备含独
特香味释放系统和口感的糖膏压片剂的方法。
Description
本发明涉及在口腔里停留一定时间慢慢食完的糖膏剂。具体地说,本发明提供连同压片剂中其它成分一起在口腔中速溶和定时释放辨味成分的糖膏压片剂。所述辨味成分如香味剂、增甜剂及它们的混合物。
香味剂释放系统是公知的,根据它们的物理特征(即液体、乳状、糊状或固体),可以分成不同类型。每一类型香味剂不仅所述特征不同,而且各自的用途也不相同,及其制造方法同样也各不相同。
以往,注意力集中在香味剂材料的制备上。具体来说,试图提供的香味剂材料应供给较高浓度和较长时间持续释放香味。
特别为解决香味油的难题,人们已作了各种努力,试图用胶囊包复香味油或使用干成分延长香味释放。另外,注意力还指向缓释剂的研制,该制剂将缓释香味,并可在较长时间内均匀释放。
喷雾干燥是包胶囊或固定香味技术中最广泛采用的一种方法,也是现有技术中最佳方法。采用挤压法也可使香味固定,其中,香味油和水溶性糖或糖混合物一起共挤压、干燥和研磨。这些产品以干混合物形式供给,当其与水接触就速释香味,这类产品一般含10%至15%(重量)香味油。先有技术中有关延长香味扩散的广泛论述参见共同公布的待决美国专利申请档案号PD 3939-07-DAS和美国专利申请档案号PD 2084(本文均引为参考文献)。这些共同公布的申请公开了在一定时间内开始速释香味成分和定时释放同一香味成分或第二香味成分的糖膏压片剂组合物及其制备方法。这些香味释放系统的应用改善了糖膏释放能力,既能开始速释香味成分又能延长香味成分的释放。虽然上述香味释放系统显示了香味释放的惊人改进,但本发明提供另一种解决香味释放的方法。
近年来,已探索具粘合性能的水溶性聚合物可用作生物效应剂的释放系统。已研究出的聚合物例如聚丙烯酸和羟丙基甲基纤维素提供了粘附于口腔、颈、胃肠、鼻和眼粘膜作为给药路线的释放系统。根据预定量生物效应剂设计聚合物,并同时根据所选粘膜类型来选择剂型。
基于口腔粘膜的口腔路线常常取决于易受胃肠酶和/或肝“第一通道”效应(即通过肝的第一通道期间药物失去活性)失去活性影响的生物效应剂的给药。口腔给药还可用于生物效应剂(例如具有短期生物活性的硝化甘油)的释放。
因此,本发明的目的之一是提供能向口腔开始速释以及定时释放香味成分的多相压片剂。
本发明的目的之二是提供含有生物粘合剂的压片剂,以助香味成分向口腔释放。
本发明的目的之三是提供能提高和改善令消费者满意的感觉反应的压片剂。
本发明的目的之四是提供含有香味成分的压片剂,当含于口腔内时,香味成分粘附于口腔粘膜。
本发明提供了由粘附于口腔分泌物区的片剂产生独特的生物粘合口感的压片剂,并向口腔定时释放香味成分。本发明可包括提供片剂物理结构的第一相和在一定时间内定时释放香味成分的第二相。该第一、第二相或第一、第二两相均可含有使糖膏粘附于口腔粘膜和口腔内舌部的生物粘合剂。
本发明还提供了一种香味成分与生物粘合剂均匀混合的压片剂,以供给使香味成分粘附于口腔分泌物区具有独特口感的糖膏剂。在这一实施例中,香味成分和生物粘合剂可作为提供开始速释香味和具特殊口感的亲水系统的一部分。或者,香味成分和生物粘合剂可作为提供定时释放香味和使香味成分粘附于口腔分泌物区较长时间的憎水系统的一部分。
本发明压片剂包括:第一香味成分均匀混入亲水组合物中,以便对口腔瞬时释放第一成分,该第一香味成分可包含在第一相、第二相中,或包含在第一和第二两相中。适宜的亲水组合物可选自聚合物体系、树胶、明胶、淀粉、改性淀粉和其它成膜剂。与之混合的香味成分的量可约为亲水组合物总量的1%至30%(重量)。
本发明还包括第二香味成分,它包囊在混有生物粘合剂的憎水组合物中,以期向口腔定时释放第二成分以及使糖膏片剂粘附于口腔分泌物区。该包胶囊香味成分可包含在第一相、第二相中,或包含在第一和第二两相中,以便提供可选择的香味释放顺序。
憎水组分可选自适于喷雾凝结香味成分和生物粘合剂的脂肪、蜡、树脂和它们的混合物,憎水组分的含量一般约为0.5%至30%(重量)。
生物粘合剂可选自如甲基纤维素、丙烯酸酯和树胶,其含量约为憎水组合物总量的0.5%至30%。香味成分的量还可约为憎水组合物的约3%至30%。
本发明还涉及制备具有两相和能够粘附于口腔分泌物区以定时释放香味的糖膏压片剂的方法。该方法包括先制备第一香味成分和第二香味成分,然后制备第一结构相,其中包括一种或两种香味成分,接着制备含生物粘合剂的第二相,其中包含任一种或两种香味成分。将这些相合并在一起形成压片剂。在一优选实施例中,糖膏片剂呈芯一壳结构,其中外壳部分是硬糖果质地和结构,并且至少包含亲水香味组分,因此,它在口腔里一开始就能散发高浓度香味。在此优选实施例中,外壳部分还可包含或不包含少量喷雾凝结的亲水/生物粘合剂的香味组合物。这样,外壳部分将在口腔内维持持续高浓度的香味,而与中心部分所含成分无关。同样,内含生物粘合剂的组合物,其中外壳部分促使糖膏粘附于口腔的分泌物区。所述外壳还可任意包括瞬间除臭剂,例如葡萄糖酸铜。
在同一优选实施例中,中心部分优选至少包括憎水性包胶囊的生物粘合香味剂组合物,并且最好为较软质地。外壳部分最好按下述方法成形,即,用成形腔压制半片,接着在该腔中放置含生物粘合剂的预成形第二相,由此形成另一半外壳部分,此后,将该片剂压制成本发明产品。
含第一香味成分的亲水组合物的制备方法可采用本领域公知的喷雾干燥技术或挤压技术。
包胶囊的含第二香味成分的生物粘合剂/憎水组合物的制备方法是:首先在搅拌下将脂肪、蜡或其混合物加热至熔点,然后维持温度约为65-75℃,可以将乳化剂加到所得熔融物中,这样制备的释放系统包括增甜剂,另外再加入增甜剂。
对于上述混合物,可在搅拌下将生物粘合剂材料(例如聚合物或树胶)加入熔融的憎水组合物中,使生物粘合剂分散于憎水组合物中。
在香味成分和憎水/生物粘合剂成分合并之前,将防结块剂(如二氯化硅)加到香味成分中,混合成浆料。然后,将该浆料加到憎水/生物粘合剂成分中,搅拌所得组合物,直至形成第一均匀混合物。
然后,将乳化的香味油加到熔融的憎水/生物粘合剂成分中,搅拌成均匀混合物,此后可喷雾凝结成固体颗粒。
鉴于本发明,可提供糖膏压片剂,不仅能开始散发很浓的香味,而且能包复口腔分泌物区,由于香味成分粘附于口腔粘膜表面,并在其上滞留较长时间,因而可持续释放高浓度香味。
本发明的另一优点是能够提供具有独特口感的糖膏剂。一开始,外壳部分可产生特有的口感,但是,当糖膏制剂溶解于口腔里时,生物粘合剂的作用更趋明显,可使口腔内香味感觉延长。
本发明具有分散相的特性,可以使压片剂由其它彼此互相作用的各成分组成。这样在同一糖膏组成中不适于释放。因此,有可能制备通常混合互相作用的香味物质的压片剂,并保持各成分基本上分散的,直至该压片剂放入口腔里被溶解,释放香味成分以供使用者享用。
本发明包括含糖和无糖糖膏压片剂,压片的尺寸和重量取决于预期的产品。通常,这类片剂的重量约1.5至1.8g。
为了更好地理解本发明和其它目的,结合附图详述如下,在所附权利要求书中指出了本发明的范围。
图1是表示含本发明香味释放系统的加薄荷味糖膏压片剂和对照的含普通液体薄荷香味的糖膏压片剂试验感觉评估试验结果的图。
图2是根据本发明优选实施例制备的糖膏压片剂的透视图。
图3是图2所示压片的沿3-3线的剖面图,显示外壳第一相完全包封中心第二相。
图4是沿图2所示压片的4-4线的剖面图,显示第一相完全包封第二相。
图5是按本发明另一实施例制备的糖膏压片剂的透视图。
图6是图5所示片剂的剖面图。
根据本发明,公开了具有用生物粘合剂混合香味成分的糖膏压片剂,提供其控制释放香味和独特的口感。通过包含至少两种物理相的压片剂,可实现在片剂内所含香味成分的控制释放。由不同物理相提供改善香味成分的释放能力可构成香味顺序释放系统。在这一实施例中,至少由于第二相的生物粘合剂的粘合特性,在口腔分泌物区和牙齿上形成独特的香味包复膜,从而提供了持久的香味释放。
本发明涉及新的极有效糖膏剂型,令使用者享受独特的生物粘合剂口感和特殊感觉的满足。
因此,所述压片剂可包括:
(a)第一香味成分,其含量约为亲水组合物的0.1%至0.5%(重量),并与之均匀混合,提供活性成分的瞬时释放;
(b)第二香味成分,其含量约为含生物粘合剂的憎水胶囊组合物的3%至30%(重量),以便当该片剂和包胶囊的香味成分粘附于口腔分泌物区时,提供第二香味成分释放一定时间。
总的说来,糖膏压片剂包含香味成分的量约为片剂总量的0.1%至0.5%。
此外,单一香味成分可与生物粘合剂一起包含在糖膏压片剂中,以提供具有开始速释香味和口感的亲水释放系统性能或另与提供延长香味释放时间和独特口感的憎水释放系统合并的产品。
有效香味剂可选自合成香味液体,例如合成香味油及香味芳香剂和/或油;和/或取自植物、叶子、花、水果等的液体、含油树脂或提取物;及它们的混合物。优选的香味成分选自绿薄荷油,樟油,冬青油(水杨酸甲酯)和胡椒薄荷油,丁香油,香叶油,茴香油,桉叶油,麝香草油,雪松叶油,肉豆蔻油,多香果,蒿油,肉豆蔻,苦杏仁油和肉桂油。有效的香味剂还有人造、天然和合成香味剂,包括水果香味剂(例如香草)和柑桔类油(如包括柠檬、橙、葡萄,酸橙和葡萄柚的油),水果主要包括苹果、梨、桃子、葡萄、草莓、樱桃、李、菠萝、杏等。
预期适宜的辅助香味剂包括天然和人造香味剂及薄荷等,例如胡椒薄荷、薄荷醇、人造香草、樟、各种水果香味剂、各自单独成分和混合物等。这类香味剂的使用量通常取决于所用的香味胶囊释放系统,例如可达最终压片组合物重量的10%左右。这样,辅助香味剂可存在于包胶囊的香味释放系统中并可任意存在于压片组合物中。
与第一香味成分混合的亲水组合物可选自适于现有技术公知的喷雾干燥工艺和技术的化合物。
例如,亲水组合物可按公知的喷雾干燥技术制备。在这一方法中,通常先将香味油与分散于水中的成膜剂混合,然后乳化成稳定的乳剂,乳化是必要的,因为香味油不溶于溶解成膜剂所必需的水中。如果香味成分是化学不稳定物质,则维持干燥器较低的入口温度(即155℃左右)及最少滞留时间是有利的。空气干燥条件取决于乳剂和产品特征,例如所需产品的颗粒尺寸。还试图改进利用热从乳剂中除去水,其中包括将脱水溶剂用作干燥介质而不用热空气,还可考虑采用冷冻干燥。
非限制性的列举适宜的亲水化合物包括聚合物体系、树胶、明胶、淀粉、改性淀粉和其它成膜剂。树胶可选自阿拉伯树胶,合成生物聚合胶,琼脂,藻酸盐(钠盐),角叉胶,古尔胶,刺梧桐胶,刺槐豆胶,黄蓍胶,达瓦树胶(ghatto),纤维素醚(其中包括MethocelTM和EthocelTM,由Dow化学公司提供的产品)和丙烯酸盐(如CarbopolR)。
与亲水组合物均匀混合的香味成分的量约为亲水组合物总量的0.1%至0.5%(重量)。依次,亲水组合物的量约为压片剂的82%至99%以上(重量),亲水组合物的量优选为压片剂的86%至96%,最佳约为90%至94%。
与第二香味剂和生物粘合剂包胶囊的憎水组合物优选的制备方法是将香味成分和生物粘合剂与憎水物质一起喷雾凝结。适宜的憎水材料的实例包括脂肪、蜡、树脂和它们的混合物。在一优选实施例中,憎水组合物提供了在结构上与亲水组合物不同的口感,例如憎水组合物可比亲水组合物更软而韧。
憎水组合物的量可约为压片剂的0.1%至18%(重量),憎水组合物的量优选为约4%至14%,更优选约为6%至10%(重量)。
生物粘合剂是指那些粘附于生物膜的分泌物区并由略为粘着至实际上永久粘上的化合物。就本发明的目的而言,生物粘合剂意指那些适于放置在口腔内的化合物。虽然生物粘合剂已用于生物效应剂的释放,但仍发现它们使停留于口腔一段时间慢慢耗尽的糖膏大大地增加了香味释放。当生物粘合剂与香味成分混合并用憎水材料(例如脂肪、蜡或树脂)喷雾凝结时,可发现由于使香味成分粘附于口腔分泌物区而增加憎水胶囊提供的定时释放香味,在连续释放香味的同时提供独特的感觉,舌、齿和粘膜均舒适地复有持久的香味释放组合物。
相对来说,采用诸如支链淀粉、羧甲基纤维素、钠、羟乙基纤维素之类的化合物可获得强粘合作用。采用丙烯酸盐、明胶、石尔胶、刺梧酮胶和黄蓍胶可获得适中的粘合作用,而采用琼脂、藻酸、羧甲基纤维素、钙、葡聚糖、甲基纤维素、果胶、聚乙二醇和聚乙烯吡咯烷酮,则提供低粘合作用。
生物粘合剂的量约为憎水组分的0.5%至30%(重量),其优选量约为7%至2.5%,更优选量约为18%至22%。
如上所述,第二香味成分和生物粘合剂一般采用喷雾凝结同诸如脂肪、蜡、树脂和它们的混合物一起包胶囊的。
除香味成分之外,生物粘合剂可同诸如瞬间新鲜剂、瞬间除臭剂、抗龈炎剂和它们的混合物之类的生物效应剂一起包胶囊。适宜的瞬间新鲜剂包括如α紫罗酮,甲基紫罗酮,薄荷醇,甘草,玖瑰油,堇菜叶,水杨酸盐,仙客来,茉莉油,榄香油,丁香油,小豆蔻油,茴香油,没药树脂和它们的混合物。适宜的瞬间除臭剂包括如葡萄糖酸铜。抗龈炎剂包括如洗必太、百里酚、薄荷醇、水杨酸甲酯、桉树脑和它们的混合物。
本文所用的喷雾凝结方法述及通过热控制喷嘴供给第二均匀混合物,在密闭的温度调节室内形成雾化液滴,在温度较低(如25℃)的环境气氛下,使液滴冷却和凝结。调节喷嘴压力以控制液滴粒度、液滴冷却和凝结,一旦它们从喷嘴喷出,即与较冷的环境接触。这一方法的结果可得到接近椭球或圆球形的颗粒或团块。
适宜的脂肪包括脂肪酸如氢化或部分氢化油,代表性的材料包括棕榈油,棕榈仁油,豆蔻油,棉籽油,花生油,菜油,米糠油,葵花籽油,红花油和它们的混合物。可作为本文所述脂肪的其它材料还可选自甘油一酸酯,甘油二酸酯,甘油三酯酯,聚甘油酯,山梨醇酯和它们的混合物。当憎水材料仅为脂肪时,所用脂肪量约为憎水组合物的50%至85%(重量),该憎水组合物的其余部分可包括:香味成分的量约为5%至30%(重量),生物粘合剂的量约为0.5%至30%,以及乳化剂、稀释剂和防结块剂。
适宜的蜡包括天然蜡,合成蜡和它们的混合物。具体说来,这些材料可选自石蜡、蜂蜡、巴西蜡棕树蜡、小烛树蜡、纯羊毛蜡、月桂果蜡、甘蔗蜡、矿脂、碳蜡、鲸蜡、米糖蜡、微晶蜡和它们的混合物。当憎水材料仅为蜡时,所用脂肪量约为45%至85%。在这一实施例中,该憎水组合物的其余部分包括:香味成分的量约为5%至30%,生物粘合剂量约为0.5%至30%。
适宜的树脂可选自部分氢化木松香的季戊四醇酯,木松香的季戊四醇酯,木松香的甘油酯,部分二聚松香的甘油酯,聚合松香的甘油酯,浮油松香的甘油酯,木松香的甘油酯和部分氢化的木/树胶松香,以及松香的部分氢化甲酯,例如α-蒎烯或β-蒎烯的聚合物;包括多萜及其混合物的萜烯松香。当憎水材料仅为树脂时,所用树脂的量约为憎水组合物的20%至80%(重量),该憎水组合物的其余部分包括:香味成分含量约为5%至30%,生物粘合剂的量约为0.5%至30%。
当然,以上所述仅为说明本发明,并不是对合适的憎水材料的限制。上述憎水材料可互相混合而呈现基本相同的性质。
憎水组合物可任意包括含量至多为10%(重量)的乳化剂。在采用乳化剂的情况下,适宜的乳化剂包括脂肪酸的甘油一酸酯、甘油二酸酯和甘油三酸酯,聚甘油酯等。更具体地说,乳化剂可选自卵磷脂,硬脂酸盐,硬脂酸盐的酯衍生物,almitate,棕榈酸盐的酯衍生物,油酸盐,油酸盐的酯衍生物,甘油酯,蔗糖聚酯,聚甘油酯和它们的组合物。在一优选实施例中,所用乳化剂成分的量约为憎水胶囊组合物的2%至7%(重量)。在另一优选实施例中,乳化剂含量约为4%至6%(重量)。
根据本发明的另一实施例,憎水组合物可与稀释剂、润滑剂和/或粘合剂混合。所述各剂是公知的。例如,稀释剂可包括乳糖、微晶纤维素NF、或淀粉、滑石粉、山梨醇、甘露糖醇、聚右旋糖、碳酸钙、PalatinitR、麦芽糖醇、木糖醇、其它糖醇和糖。润滑剂包括如硬脂酸或硬酯酸镁。适宜的粘合剂的实例是聚乙二醇。
本发明包括含糖和无糖糖膏压片剂。可将增甜剂加到一种香味组合物或或两种香味组合物中,其用量可约为胶囊的30%(重量)以下,优选为约12%至13%(重量),得到香味和甜味的混合感觉。本发明考虑的那些增甜剂包括天然的和人造的,均为现有技术所公知。
适宜的增甜剂可选自下述物质(非限制于此):糖,例如蔗糖、葡萄糖(玉米糖浆)、右旋糖、转化糖、左旋糖和它们的混合物、糖精及其各种盐(例如钠或钙盐);环己烷氨基磺酸及其各种盐(例如钠盐);二肽增甜剂(例如天冬酰苯丙氨酸甲酯);二氢查耳酮化合物,甘草甜;stevia Rebaudiana(卡哈苡苷);甘草甜,二钾甘草甜,苯丙氨酸1-甲酯(Aspartame);蔗糖的氯衍生物,黄烷酮醇(dihydroflavinol);羟基愈创木酚酯;L-氨基二羧酸偕二胺;L-氨基二羧酸氨基链烯酸酯酰胺;糖醇,例如山梨醇、山梨醇浆、甘露糖醇、木糖醇等。还可考虑另外的增甜剂是不可发酵的糖代用品(氢化淀粉水解物)(参见美国再公告专利第26,959号)。还可考虑的增甜剂如下:合成增甜剂3,6-二氢-6-甲基1-1-1,2,3-噁噻嗪-4-酮-2,2-二氧化物,尤其是其钾盐(acesulfame-K)、钠盐和钙盐(参见德国专利第2,001,017.7号),4,1′-6,-三氯-4,1′,6′-三脱氧半乳糖蔗糖(trideoxygalactosucrose)(Sucralose,为McNeil Specialty Products公司的市售产品,Skillman,New Jersey);L-α-天冬氨酰基-N-(2,2,4,4-四甲基-3-thietanyl)-D-丙氨酸酰胺水合物(Alitame,为Pfizer的市售产品,纽约);和thaumatin(Talin)。
当上述增甜剂和未列举的同样强增甜剂包含在可食入产品中时,常常出现特殊问题,例如,某些增甜剂存在稳定性问题,其中如在醛、酮、水份等存在下,Aspartame分解为不希望的副产品。同样地,其它增甜剂显示苦的回味,例如Saccharin(美国俄亥俄州辛辛那提市PMC Specialty Group Inc.的市售产品)、Stevioside、Acesulfame-K、甘草甜及其盐和Talin。将上述增甜剂混入本发明释放系统,可克服它们在现有应用中的缺点,因为本发明释放系统的稳定性和辨味能力为这些强增甜剂提供了必要的保护,改善和增加了它们在可食产品中的甜味。
本发明的糖膏压片剂还可任意包括着色剂,其含量约为1%至6%(重量)。着色剂可包括其它适于食品、药物和化妆用品的染料,以及称作FD&C染料等。适用于上述应用范围的材料最好是水溶性的。说明实例包括靛类染料、称作FD&C蓝2号即5,5′-靛蓝二磺酸的二钠盐。同样地,称作FD&C绿1号染料包括三苯甲烷染料,即为4-[4-N-乙基-对磺基苄胺基)二苯基亚甲基]-[1-(N-乙基-N-对锍苄基)-2-5-环己二烯亚氨基]的一钠盐。所有列举的FD&C染料和它们的相应化学结构可参见Kirk-Othmer Encyclopedia of ChemicalTechnology第5卷857-884页(本文引为参考文献)。
关于糖膏压片制剂,可含有成片基材和各种添加剂如增甜剂和香味剂。所用成片基材根据下述各因素而改变,例如基材类型、要求的脆性和适于最终产品的其它成分。该糖膏压片剂还可包括普通添加剂:香味剂、着色剂、乳化剂和附加填充剂。可以实施改变这些糖膏剂的范围很宽,并在熟悉本领域的技术人员的能力范围内,尤其有关附加的组合物填充剂、香味成分的应用和着色剂的应用等。
在有水分的情况下,对水分敏感和易受破坏的成分特别受益于本发明,因为可延长它们受保护时间。此外,在必须改变控制释放香味和/或不正常味道增甜剂的情况下,由于释放可直接地与所需的组合物比例相关联,本发明是非常有效的。这样,如可将具有很苦味的香味成分通过简单地供给对使用者感觉无害的低浓度控制释放对个体给药。另一应用是以很低浓度提供持续释放高甜度增甜剂,以致甚至不增加增甜剂总量,也使糖膏压片组合物可持续延长一段时间。
制备包括本发明持久释放香味并具有生物粘合剂性能的糖膏压片剂的代表性方法如下:
首先制备该压片剂的在结构上起支持作用的第一相。将增甜剂/填充剂(例如糖或山梨醇)充分混合(如5分钟)后,加入瞬时除臭剂(如葡萄糖酸铜)。此后继续混合一定时间(例如约3分钟),使各成分足以有效分散,然后将喷雾干燥的香味成分(例如胡椒薄荷)加到上述各成分中,继续混合。业已发现,约再混合3分钟就足以混合喷雾干燥的香味成分,接着,必要时加入着色剂和润滑剂与上述各成分混合。例如,已发现混合约2分钟后,着色剂和润滑剂已充分分散于混合物中。
另外,制备含憎水性包胶囊香味成分和生物粘合剂的至少第二相。例如,用脂肪作为憎水胶囊材料源。搅拌下熔融脂肪和乳化剂,并维持约65至75℃的温度,此后,在继续搅拌下,将生物粘合剂(例如聚合物/树脂混合物)加到熔融的脂肪中,达到充分分散。分别将防结块剂例如磷酸钙、硬脂酸钙、硅酸镁(滑石粉)或二氧化硅(SyloidR)加到香味油中,混合成浆料。接着在搅拌下,将该浆料加到憎水/生物粘合剂混合物中,直至形成均匀混合物。此后,将含脂肪、乳化剂、生物粘合剂、防结块剂和香味油的热熔融混合物喷雾凝结成憎水性包胶囊的香味成分和生物粘合剂。最后,将该包胶囊的生物粘合香味剂混入第二相中,详述如下:
任意地将稀释剂和润滑剂混合约10分钟,接着加入粘合剂与上述各成分混合一定时间(例如2分钟)充分分散。然后,加入憎水性包胶囊的香味成分和生物粘合剂,继续混合约2分钟,完成该相的制备。
此后,在压片机中分别压制各相,得到本发明的糖膏压片剂。
对芯一壳片剂而言,先压制中心部分以备置于外壳部分中。先将一半外壳放在压片模中压制,预压制的中心部分置于其上,接着依次放置另一半外壳材料,然后将整个片剂组合体压成本发明的两相产品。
现参照附图3-5,附图表示可按本发明制备糖膏压片剂的实施例。这类产品的共同特征在于它们各自包括至少两个分散相,第一相在结构上支持压片剂的形状,实际上包复作为中心部分存在的第二相。所叙述的类型都具有一般的环形平面轮廓形状(例如圆柱形),但应当理解还可形成其它形状。图6表示本发明的另一实施例,其中,第一相一般是中央和环形部分,第二相被固定在其两侧上,所得片剂的横截面如图6所示。
除了提供持久的香味释放和独特的粘附性能外,还可看到本发明很容易在压片剂的各分散相中使用各种着色剂和/或香味成分。在一优选实施例中,该压片剂释放两种或多种不同的香味,开始在第一相释放,以及在粘附于口腔分泌物区的第二相释放瞬时新鲜的薄荷香味,并释放一段时间。
以上通过示例的描述履行了申请人公开实施本发明最佳方法的义务。因此,对熟悉本领域的技术人员来说可以改变上述方法,本文考虑了所有这类变更,并作为本文的一部分。
用本发明的糖膏剂进行试验,与不含憎水性包胶囊香味成分和生物粘合剂的糖膏产品相比较,可发现不仅口腔分泌物区生物粘合剂的香味明显增强,而高浓度香味的释放时间也得到延长。
实施例
下述实施例用以进一步了解本发明,决不限制本发明的有效范围。
实施例1
按下述配方制备对照的糖膏压片剂。
对照试样
成分 %(重量)
外壳成分
糖 97.676
瞬间除臭剂 0.748
润滑剂 0.234
香味剂粒 1.280
液体香味剂 0.062
100.00
中心部分
脂肪胶囊 -
稀释剂 -
0.0
此外,按下述配方制备本发明具有新的憎水性包胶囊生物粘合香味剂的糖膏剂。
表 Ⅰ
按本发明制备代表性的脂肪胶囊制剂,详述如下。
脂肪胶囊
成分 %(重量)
部分氢化的豆油(脂肪) 48.00
甘油-硬脂酸酯(乳化剂) 5.00
植物油混合物(脂肪) 10.00
防结块剂(Syloid) 2.00
香味油(胡椒薄荷) 15.00
羟乙基纤维素,粘度2000(生物粘合剂) 20.00
100.00
表 Ⅱ
本发明试样
成分 %(重量)
实施例Ⅰ 实施例Ⅱ 实施例Ⅲ
外壳成分
糖 97.676 97.676 97.676
瞬间除臭剂 0.748 0.748 0.748
润滑剂 0.234 0.234 0.234
香味剂粒 1.280 1.280 1.280
(8%香味剂)
液体香味剂 0.062 0.062 0.062
100.00 100.00 100.00
中心部分
脂肪胶囊 100.00 59.88 40.32
(15%香味剂)
稀释剂 - 42.12 59.68
100.00 100.00 100.00
片剂重量比
外壳/中心 94/6 90/10 85/15
根据表Ⅱ所述各种比例,按上述方法制备以上组合物,具有多种胶囊系统的糖膏压片剂。然后将对照试样和本发明实施例Ⅰ试样进行感觉评质试验,结果示于图1。
参照图1,评质结果说明显著地改进了压片剂产品。本发明产品一开始就散发香味,并持续香味浓度。一开始散发的高浓度香味超过对照组的试样,而且通过30分钟试验,本发明试样以高浓度香味释放的持久性十分明显。与对照制剂不同,30分钟之后,对照制剂已无香味浓度感觉,而本发明产品仍能提供足够香味释放60分钟以上。
除了延长香味释放时间外,本发明产品为使用者提供独特口感。当含憎水性包胶囊香味成分和生物粘合剂的糖膏剂在口腔里释放时,使用者能获得独特的持久包复憎水性胶囊香味剂。该憎水性胶囊香味剂在口腔的所有分泌物区缓慢溶解,连续以高浓度释放香味达30分钟或更长时间。
当香味油粘附于口腔分泌物区时,按本发明制备的显示出降低开始的香味散发和提高整个消耗过程香味浓度的压片剂可设计和精制成实际上可提供任何适于口腔的释放型式。迄今,现有的压片剂无法达到这些性能。含憎水性包胶囊香味剂的糖膏剂具有独特生物粘合性能,提供了独特口感。这对现有压片剂来说,至今也不可能达到。
尽管已叙述了目前认为优选的本发明实施例,但熟悉本领域的技术人员将意识到在不背离本发明的精神下,可以作出许多改变和改进,所有这类改变和改进均在本发明范围内给以权利保护。
Claims (61)
1、一种溶解于口腔、具有定时释放香味成分并能够粘附于口腔分泌物区的糖膏压片剂,它包括:
香味成分与生物粘合剂均匀混合,从而当所述压片剂溶解于口腔里时,所述香味成分和生物粘合剂粘附于口腔的分泌物区。
2、按权利要求1的压片剂,进一步包括两个或两个以上物理相,第一相提供用于所述片剂的物理结构;
第二相提供结构上不同于所述第一相的口感。
3、按权利要求1的压片剂,其中所述香味成分选自香味剂、增甜剂和它们的混合物。
4、按权利要求3的压片剂,其中所述香味剂选自绿薄荷油、樟油、冬青油(水杨酸甲酯)、胡椒薄荷油、柠檬油、橙油、葡萄油、酸橙油、葡萄柚油、苹果香精、草莓香精、樱桃香精、菠萝香精、香蕉油和它们的混合物。
5、按权利要求4的压片剂,其中所述香味剂的量为所述片剂重量的0.15%至0.35%
6、按权利要求3的压片剂,其中所述增甜剂选自基于氨基酸的增甜剂,二肽增甜剂、甘草甜、糖精及其盐、双氧噁噻嗪盐、环己氨磺酸盐、卡哈苡苷、talin、蔗糖的氯衍生物、二氢查耳酮化合物和它们的混合物。
7、按权利要求3的压片剂,其中所述增甜剂的量为5000ppm以下。
8、按权利要求1的压片剂,其中所述生物粘合剂选自支链淀粉、羧甲基纤维素、羟乙基纤维素、丙烯酸酯、明胶、古尔胶、刺梧酮胶、黄蓍胶、琼脂、藻酸、葡聚糖、甲基纤维素、果胶、聚乙二醇、聚乙烯吡咯烷酮和它们的混合物。
9、按权利要求8的压片剂,其中所述生物粘合剂的量为所述片剂重量的0.5%至30%。
10、按权利要求8的压片剂,其中所述生物粘合剂的量为所述片剂重量的7%至25%。
11、按权利要求8的压片剂,其中所述生物粘合剂的量为所述片剂重量的18%至22%。
12、按权利要求1的压片剂,进一步包括所述生物粘合剂与生物效应剂均匀混合。
13、按权利要求12的压片剂,其中所述生物效应剂选自瞬间新鲜剂、瞬间除臭剂、抗龈炎剂和它们的混合物。
14、按权利要求13的压片剂,其中所述瞬间新鲜剂选自α紫罗酮、甲基紫罗酮、薄荷醇、甘草、玖瑰油、堇菜叶、水杨酸盐、仙客来、茉莉油、榄香油、小豆蔻油、茴香油、没药树脂和它们的混合物。
15、按权利要求13的压片剂,其中所述瞬间除臭剂是葡萄糖酸铜。
16、按权利要求13的压片剂,其中所述抗龈炎化合物选自洗必太、百里酚、薄荷醇、水杨酸甲酯、桉树脑和它们的混合物。
17、一种具有两种或两种以上性质不同的的物理相并对口腔提供选择定时释放香味成分的压片剂,它包括:
(a)为所述片剂提供物理结构的第一相;
(b)提供口感的第二相,其结构上不同于所述第一相;
(c)第一香味成分均匀混入亲水组合物,向口腔瞬时释放所述第一香味成分,并形成所述第一相、第二相之一的一部分和所述第一、第二两相的一部分;
(d)第二香味成分包囊于含生物粘合剂的憎水组合物中,向口腔定时释放所述第二香味成分,并形成所述第一相、第二相之一的一部分和所述第一、第二两相的一部分,从而,当所述压片剂和所述第二香味成分粘附于口腔分泌物区时,所述含第二香味成分和生物粘合剂的相提供定时释放所述第二香味成分。
18、按权利要求17的压片剂,其中所述第一和第二香味成分选自香味剂、增甜剂和它们的混合物。
19、按权利要求17的压片剂,其中所述亲水组分选自聚合物、明胶、阿拉伯树胶、淀粉、改性淀粉、麦芽糖糊精、玉米糖浆固体、水解胶体、角叉胶和丙烯酸盐。
20、按权利要求17的压片剂,其中所述亲水组分与填充剂混合。
21、按权利要求17的压片剂,其中所述生物粘合剂选自支链淀粉、羧甲基纤维素、羟乙基纤维素、丙烯酸酯、明胶、古尔胶、刺梧酮胶、黄蓍胶、琼脂、藻酸、葡聚糖、甲基纤维素、果胶、聚乙二醇、聚乙烯吡咯烷酮和它们的混合物。
22、按权利要求21的压片剂,其中所述生物粘合剂的量为所述片剂重量的0.5%至30%。
23、按权利要求21的压片剂,其中所述生物粘合剂的量为所述片剂重量的7%至25%。
24、按权利要求21的压片剂,其中所述生物粘合剂的量为所述片剂重量的18%至22%。
25、按权利要求21的压片剂,进一步包括所述生物粘合剂与生物效应剂均匀混合。
26、按权利要求25的压片剂,其中所述生物效应剂选自瞬间新鲜剂、瞬间除臭剂、抗龈炎剂和它们的混合物。
27、按权利要求26的压片剂,其中所述瞬间新鲜剂选自α紫罗酮、甲基紫罗酮、薄荷醇、甘草、玖瑰油、堇菜叶、水杨酸盐、仙客来、茉莉油、榄香油、丁香油、小豆蔻油、茴香油、没药树脂和它们的混合物。
28、按权利要求26的压片剂,其中所述瞬间除臭剂是葡萄糖酸铜。
29、按权利要求26的压片剂,其中所述抗龈炎化合物选自洗必太、百里酚、薄荷醇、水杨酸甲酯、桉树脑和它们的混合物。
30、按权利要求17的压片剂,其中所述第一和第二香味成分是相同的。
31、按权利要求17的压片剂,其中所述第一和第二香味成分是不同的。
32、按权利要求18的压片剂,其中所述第一和第二香味剂选自绿薄荷油、樟油、冬青油(水杨酸甲酯)、胡椒薄荷油、柠檬油、橙油、葡萄油、酸橙油、葡萄柚油、苹果香精、草莓香精、樱桃香精、菠萝香精,香蕉油和它们的混合物。
33、按权利要求32的压片剂,其中所述香味剂的量为所述片剂总重量的0.1%至0.5%
34、按权利要求32的压片剂,其中所述香味剂的量为所述片剂重量的0.15%至0.35%
35、按权利要求17的压片剂,其中所述第一相基本上包封所述第二相。
36、按权利要求18的压片剂,其中所述第一和第二香味成分均混入所述第一相内,所述第二香味成分混入所述第二相内。
37、按权利要求17的压片剂,其中所述第二香味成分混入所述第一相内,所述第二香味成分混入所述第二相内。
38、按权利要求17的压片剂,其中所述第一和第二香味成分均混入所述第一相内,所述第一和第二香味成分均混入所述第二相内。
39、按权利要求17的压片剂,其中所述第一香味成分混入所述第一相内,所述第一和第二香味成分均混入所述第二相内。
40、按权利要求17的压片剂,其中所述第二香味成分混入所述第一相内,所述第一和第二香味成分均混入所述第二相内。
41、按权利要求17的压片剂,其中所述第一和第二香味成分均匀分散于所述片剂中。
42、按权利要求18的压片剂,其中所述增甜剂选自基于氨基酸的增甜剂、二肽增甜剂、甘草甜、糖精及其盐、双氧噁噻嗪盐、环己氨磺酸盐、卡哈苡苷、talin、蔗糖的氯衍生物、二氢查耳酮化合物和它们的混合物。
43、按权利要求18的压片剂,其中所述增甜剂的量为5000ppm以下。
44、按权利要求17的压片剂,其中所述憎水组分的量为所述片剂重量的0.1%至18%。
45、按权利要求17的压片剂,其中所述憎水组分的量为4%至14%。
46、按权利要求17的压片剂,其中所述憎水组分的量为6%至10%。
47、按权利要求17的压片剂,其中所述片剂第一相的量为所述片剂重量的84%至100%。
48、按权利要求17的压片剂,其中所述片剂第一相的量为所述片剂重量的86%至94%。
49、按权利要求17的压片剂,其中所述片剂第一相的量为所述片剂重量的88%至90%。
50、按权利要求17的压片剂,其中所述憎水组合物与稀释剂混合。
51、按权利要求50的压片剂,其中所述稀释剂选自碳酸钙、磷酸二钙、麦芽糖糊精、山梨醇、甘露糖醇、微晶纤维素、聚右旋糖、糖、糖醇和它们的混合物。
52、按权利要求17的压片剂,进一步包含润滑剂。
53、按权利要求52的压片剂,其中所述润滑剂选自硬脂酸金属盐、硬脂酸、氢化植物油、滑石粉、玉米淀粉、聚乙二醇、苯甲酸钠和乙酸钠。
54、按权利要求17的压片剂,进一步包含防结块剂。
55、按权利要求54的压片剂,其中所述防结块剂选自磷酸钙、硅酸钙、硬脂酸钙、纤维素、高蛉土、碳酸镁、硫酸镁、硅酸镁(滑石粉)、二氧化硅、亚铁氰化钠、硅铝酸钠、蔗糖酯、硅酸钙铝和它们的混合物。
56、按权利要求17的压片剂,其中所述憎水组合物选自脂肪、蜡、树脂和它们的混合物。
57、按权利要求56的压片剂,其中所述脂肪选自氢化的和部分氢化油。
58、按权利要求57的压片剂,其中所述氢化的和部分氢化油选自棕榈油、棕榈核油、豆油、棉籽油、花生油、菜油、米糠油、葵花籽油、红花油和它们的混合物。
59、按权利要求56的压片剂,其中所述脂肪选自甘油-酸酯、甘油二酸酯、甘油三酸酯、聚甘油酯、山梨醇酯和它们的混合物。
60、制备趋向粘附于口腔分泌物区并将其中所混合的香味成分向口腔控制释放的糖膏压片剂的方法,该方法包括下述步骤:
(a)将香味成分与生物粘合组合物均匀混合;
(b)从步骤(a)得到的混合物压制成压片剂。
61、制备具有趋向粘附于口腔分泌物区并将其中所混合的香味成分向口腔控制释放的糖膏压片剂的方法,该方法包括下述步骤:
(a)制备第一香味成分,该成分均匀混入憎水组合物中,以便向口腔瞬时释放所述第一成分;
(b)制备第二香味成分;
(c)制备在结构上支持所述片剂的第一相,该相中包含从步骤(a)和(b)得到的香味组合物之一或(a)和(b)两个步骤得到的香味组合物;
(d)制备提供生物粘合剂使所述片剂粘附于口腔粘膜的第二相或多相,所述第二相包含从步骤(a)和(b)得到的香味组合物之一或(a)和(b)两个步骤得到的香味组合物;
(e)从步骤(d)得到的混合物压制成压片剂。
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US07/502,464 US5284659A (en) | 1990-03-30 | 1990-03-30 | Encapsulated flavor with bioadhesive character in pressed mints and confections |
US502,464 | 1990-03-30 |
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-
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- 1990-03-30 US US07/502,464 patent/US5284659A/en not_active Expired - Fee Related
-
1991
- 1991-03-25 EP EP91810213A patent/EP0449782A1/en not_active Withdrawn
- 1991-03-27 AU AU73873/91A patent/AU7387391A/en not_active Abandoned
- 1991-03-27 FI FI911499A patent/FI911499A/fi not_active Application Discontinuation
- 1991-03-27 CA CA002039250A patent/CA2039250A1/en not_active Abandoned
- 1991-03-27 PT PT97168A patent/PT97168A/pt not_active Application Discontinuation
- 1991-03-27 FI FI911498A patent/FI911498A/fi not_active Application Discontinuation
- 1991-03-27 NO NO91911259A patent/NO911259L/no unknown
- 1991-03-28 IE IE106591A patent/IE911065A1/en unknown
- 1991-03-28 CN CN91102016A patent/CN1055292A/zh active Pending
- 1991-03-28 ZA ZA912403A patent/ZA912403B/xx unknown
- 1991-03-29 JP JP3089176A patent/JPH04222555A/ja active Pending
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN103281913A (zh) * | 2010-12-29 | 2013-09-04 | 雀巢产品技术援助有限公司 | 包含团聚的油粉的糖果产品 |
CN102771618A (zh) * | 2012-08-09 | 2012-11-14 | 上海应用技术学院 | 一种含有直链淀粉-薄荷酮微胶囊的口香糖及其制备方法 |
CN106794153A (zh) * | 2014-09-16 | 2017-05-31 | Wm.雷格利 Jr.公司 | 含有新型香料组合物的产品 |
CN108366576A (zh) * | 2015-11-30 | 2018-08-03 | Wm.雷格利Jr.公司 | 具有表面特征的口香糖和压制薄荷糖 |
Also Published As
Publication number | Publication date |
---|---|
EP0449782A1 (en) | 1991-10-02 |
NO911259D0 (no) | 1991-03-27 |
JPH04222555A (ja) | 1992-08-12 |
CA2039250A1 (en) | 1991-10-01 |
FI911498A0 (fi) | 1991-03-27 |
FI911498A (fi) | 1991-10-01 |
ZA912403B (en) | 1992-01-29 |
FI911499A0 (fi) | 1991-03-27 |
US5284659A (en) | 1994-02-08 |
FI911499A (fi) | 1991-10-01 |
PT97168A (pt) | 1991-11-29 |
NO911259L (no) | 1991-10-01 |
IE911065A1 (en) | 1991-10-09 |
AU7387391A (en) | 1991-10-03 |
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