CN107106603A - 口服产品 - Google Patents

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Publication number
CN107106603A
CN107106603A CN201680004741.4A CN201680004741A CN107106603A CN 107106603 A CN107106603 A CN 107106603A CN 201680004741 A CN201680004741 A CN 201680004741A CN 107106603 A CN107106603 A CN 107106603A
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CN
China
Prior art keywords
vitamin
composition
peppermint
zinc
acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201680004741.4A
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English (en)
Inventor
M·A·古德
A·R·福尔克
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PF Consumer Healthcare 1 LLC
Original Assignee
SmithKline Beecham Ltd
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Filing date
Publication date
Application filed by SmithKline Beecham Ltd filed Critical SmithKline Beecham Ltd
Publication of CN107106603A publication Critical patent/CN107106603A/zh
Pending legal-status Critical Current

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    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/32—Manganese; Compounds thereof
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    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/362—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing inorganic compounds
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/364—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • A23G3/368—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins containing vitamins, antibiotics
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Abstract

本发明提供一种营养补充组合物，其可在任何时间或任何地点，不用吞咽片剂通常需要的水或其他液体来服用。本发明为一种营养补充组合物，其为一种便利、有香味且令人愉快的维生素薄荷糖，它可无水服用。

Description

口服产品
发明领域
本发明涉及营养补充组合物。更特定言之，本发明提供一种营养补充组合物，其可在任何时间或任何地点，不使用吞咽片剂通常需要的水或其他液体来服用。本发明为一种营养补充组合物，其为一种便利、有香味且令人愉快的维生素薄荷糖，可无水服用。消费者可有效地将维生素薄荷糖溶解在他或她的口腔中，或消费者可咀嚼且吞咽该薄荷糖；消费该维生素薄荷糖不需要水。
发明背景
长期以来已确立，许多通常称为维生素及矿物质的化合物为维持个体处于健康状态及/或治疗特定医学病状提供重要价值，即使以相对小的量供应时。人体无法合成大部分对维持人体健康而言不可或缺的维生素及矿物质。因此，维生素及矿物质必须自外部来源获得。两个最常见外部来源为食物及营养补充剂。因为大部分人不吃一致提供每天必需量的维生素及矿物质的食物，所以维生素及矿物质营养补充已变成一种被认可的符合公认医学及健康标准的方法。
微量营养物为元素或化合物，它们少量或痕量存在于食物中且包括维生素、矿物质或在食物中发现的其他元素及化合物，它们中的许多尚未限定推荐每日摄取量(RDA)。常量营养物由碳水化合物、脂肪及蛋白质组成，其供应营养物及热量且大部分经由食物及膳食摄入来消耗。一些微量营养物例如钙、钠、钾、氯化物及磷以相对大的量被消耗，而许多其他微量营养物例如铁、碘及锌被消耗的量小。维生素例如B12及叶酸及矿物质例如硒消耗极少量或痕量。由于人体不合成许多对于人体而言不可或缺的化合物，这些特定的维生素及矿物质可仅仅自两个来源获得：食物及补充剂。
可服用维生素及矿物质制剂来治疗特定医学病状或将其作为一般营养补充剂。因为需要许复合维生素及矿物质且每日需要量相对小，所以宜服用呈片剂或胶囊形式的维生素与矿物质的混合物作为一般补充剂。市售复合维生素及矿物质补充剂的典型日剂量为每天一或两个片剂或胶囊。除制备剂型所需的赋形剂以外，通常此类组合物亦包括两打或更多种营养物。
成人中出现的营养缺乏症很多且根据个体的地理环境及社会经济地位而变化。所有营养物的主要来源为食物；然而，许多成人经由摄食无法满足必需微量营养物的RDA。因此，维生素及矿物质补充已成为一种被认可的符合公认医学及健康标准的方法。为对抗这些亚适维生素水平，有多种多样的营养补充剂可为公众利用。
消费者对除片剂以外的剂型的复合维生素及矿物质营养补充剂有兴趣，因为一些片剂大且可能难以吞咽。另外，需要水或另一液体来服用营养补充片剂。营养补充剂的替代性剂型包括咀嚼片剂；然而，许多消费者不喜欢咀嚼片剂的硬度且咀嚼它们的难度。此外，消费者不喜欢一些咀嚼片剂的白垩质或砂质质地。粉末状饮料混合物为营养补充剂的另一剂型；然而，饮料混合物需要水。显然，需要一种新的营养补充剂剂型，其提供一种可在任何时间及任何地点而不需要吞咽片剂或制备粉末状饮料混合物所需要的水或其他液体即可服用的便利形式。因此，本发明人意图提供本发明的营养补充组合物，其为一种便利、有香味且令人愉快的维生素薄荷糖，它可以无水服用。消费者可将该薄荷糖有效地溶解在他或她的口腔中，或消费者可咀嚼且吞咽该薄荷糖。服用所述维生素薄荷糖营养补充组合物不需要水。
发明概述
在本发明的一方面，提供一种经口递送给服用者的组合物，其包含维生素及矿物质，其中该组合物可溶解在该服用者的口中或可被该服用者咀嚼及吞咽。
在本发明的另一方面，提供一种组合物，其中所述维生素选自维生素A、β-胡萝卜素、维生素D、维生素E、维生素K、硫胺素、核黄素、烟酸、维生素B6、叶酸、维生素B12、生物素及泛酸。
在本发明的又一方面，提供一种组合物，其中所述矿物质选自钙、铁、磷、碘、镁、锌、硒、铜、锰、铬、钼、氯化物、钾、硼、镍、硅、锡及钒。
发明的详细说明
本申请中描述的复合维生素及矿物质剂型意欲用于想要一种可不用水服用的便利、有香味且令人愉快的营养补充薄荷糖的消费者。消费者可使该薄荷糖溶解在他或她的口中或消费者可咀嚼及吞咽该薄荷糖。服用所述维生素薄荷糖营养补充组合物不需要水。目前尚无市售的可被允许溶解在消费者口中或可被咀嚼及吞咽的呈薄荷糖形式的营养补充剂。
本发明的营养补充剂被设计用于补给身体每日基础上损失的维生素及矿物质且为身体提供对最佳功能所需要的全范围的营养物。那些维生素及矿物质可包括维生素A、β-胡萝卜素、维生素D、维生素E、维生素K、硫胺素、核黄素、烟酸、维生素B6、叶酸、维生素B12、生物素、泛酸、钙、铁、磷、碘、镁、锌、硒、铜、锰、铬、钼、氯化物、钾、硼、镍、硅、锡及钒。
亦称为维生素B9的叶酸或叶酸盐(阴离子形式)为产生及维持新细胞所必需。这在快速细胞分裂及生长期例如婴儿期及妊娠期期间尤其重要。需要叶酸盐来合成DNA复制所需的DNA碱基(最特别的是胸腺嘧啶，以及嘌呤碱基)。因此，叶酸盐缺乏症阻碍DNA合成及细胞分裂，最特别影响均参与快速细胞分裂的骨髓及癌症。因为叶酸盐缺乏症限制细胞分裂，所以阻碍红细胞生成，即红血细胞(RBC)的产生且可引起贫血。
维生素B1亦称为硫胺素，为一种具有通过亚甲基桥接合的噻唑环及嘧啶环的水溶性物质，且体内生物半衰期为约15天。硫胺素对神经功能及碳水化合物代谢是必需的且以药学上可接受的维生素B1化合物的形式给与。如本申请中所使用，“药学上可接受的”为适合用于人类中，无过度副作用，例如刺激、毒性及过敏性反应的组分。适用的药学上可接受的维生素B1化合物包括(但不限于)氯化硫胺素盐酸盐。
烟酸为细胞呼吸所需要，有助于碳水化合物、脂肪及蛋白质的能量释放及代谢、适当循环及健康皮肤、神经系统发挥功能以及胆汁及胃液的正常分泌。其用于合成性激素，治疗精神分裂症及其他精神疾病，且是记忆增强剂。药物剂型中给与的烟酸改善血液胆固醇型态，且已用于清除身体的有机毒物，例如某些杀虫剂。烟酸的一种优选形式为烟酰胺。
维生素B6或吡哆醇与人体中RNA及DNA的产生以及许多其他生物反应有关。吡哆醛磷酸酯(维生素B6的代谢活性形式)与常量营养物代谢、神经递质合成、组胺合成、血红蛋白合成及功能以及基因表现的许多方面有关。适用的药学上可接受的维生素B6化合物包括(但不限于)吡哆醇、吡哆醛及吡哆胺或其盐，包括(但不限于)吡哆醇盐酸盐。磷酸酯衍生物吡哆醛磷酸酯一般充当许多反应的辅酶且可帮助促进去羧基、转胺基作用、外消旋化、消除、置换及β基相互转化反应。过度剂量的吡哆醇可引起某些神经例如本体感受器神经的暂时性死亡，引起本体感受丧失所常见的脱离身体的感觉。当中止补充时，此病状为可逆的。
维生素B12或钴胺素为整个代谢、神经系统功能、叶酸代谢、高半胱胺酸还原及红血细胞产生所必需。钴胺素存在至少三种活性形式：氰钴胺、羟钴胺及硝钴胺。
生物素为碳水化合物、蛋白质及脂肪代谢所必需且为健康皮肤及头发所需要。
泛酸亦称作维生素B5，为一种维持生命所需的水溶性维生素。泛酸为形成辅酶-A(CoA)所需，且在碳水化合物、蛋白质及脂肪的代谢及合成中至关重要。泛酸的衍生物泛醇为该维生素的一种更稳定形式且常常用作多复合维生素补充剂中该维生素的来源。该维生素的另一常见补充形式为泛酸钙。泛酸钙常常用于膳食补充剂中，因为作为一种盐，其在消化道中比泛酸更稳定，从而允许更好地吸收。泛酸钙亦可降低类风湿性关节炎患者中晨起僵硬的持续时间、残疾程度及疼痛严重程度。泛酸的一种优选形式为泛酸钙。
维生素E为一种脂溶性维生素，为涉及所有细胞代谢的抗氧化维生素。其保护维生素A及必需脂肪酸免于在身体细胞内氧化且防止身体组织分解。维生素E为一组相关物质的通用术语，该组物质包括α-生育酚、β-生育酚、γ-生育酚及δ-生育酚。另外，此四种化合物各具有“d”形式(其为天然形式)和“d1”形式(它是合成形式)。优选地，在本发明的营养补充剂中，维生素E呈天然形式。
维生素C亦称为抗坏血酸，为一种水溶性抗氧化维生素。其在形成胶原蛋白中是重要的，胶原蛋白为一种为骨骼、软骨、肌肉及血管提供结构的蛋白质。维生素C亦有助于铁吸收，且帮助维持毛细血管、骨骼及牙齿。作为水溶性抗氧化剂，维生素C在水性过氧基自由基有机会破坏脂质之前清除这些破坏性物质方面处于独特的位置。它与维生素E(一种脂溶性抗氧化剂)及酶谷胱甘肽过氧化酶一起发挥作用，中止自由基链反应。
维生素C可增强身体对一类疾病(包括感染性病症及许多类型癌症)的抵抗力。其通过刺激抗体及免疫系统细胞例如吞噬细胞及嗜中性白细胞的的活性，加强及保护免疫系统。维生素C有助于多种其他生物化学功能。这些功能包括氨基酸肉碱及调节神经系统的儿茶酚胺的生物合成。其亦帮助身体吸收铁及分解组胺。虽然在每个细胞中均发现维生素C，但其尤其适用于身体的关键部位。这些部位包括血液、皮肤、神经系统、牙齿及骨骼以及腺体，例如胸腺、肾上腺及甲状腺。
维生素D为一组脂溶性激素原，其两种主要形式为维生素D2(或麦角钙化醇)及维生素D3(或胆钙化醇)。如本申请中所使用，术语维生素D亦指这些物质的代谢物及其他类似物。维生素D3在暴露于日光，特别是紫外线B辐射的皮肤中产生。
维生素D在器官系统的维持中起重要作用。已显示其通过在肠中促进钙及磷从食物中的吸收，且通过促进肾中钙的再吸收而调节血液中钙及磷含量，使得骨骼矿化正常。其亦为骨骼生长及骨骼重塑所需。亦暗示维生素D通过促进吞噬作用、抗肿瘤活性及免疫调节功能而影响免疫系统。
维生素D缺乏症可由以下因素引起：摄入不足联合日光暴露不足；限制其吸收的病症；损害维生素D至活性代谢物的转化的病状，例如肝或肾病症；或很少地，由许多遗传病症引起。缺乏症引起骨骼矿化受损且导致骨骼软化疾病、儿童中佝偻病及成人中骨软化症，且可能促进骨质疏松。然而，为避免缺乏而进行日光暴露带有其他风险，包括皮肤癌；经由饮食或以膳食补充剂形式进行膳食吸收来避免此风险。
锌为一种必需矿物质，其天然存在于一些食物中，添加至其他物质中且可用作膳食补充剂。锌与细胞代谢的多个方面有关。其为大约100种酶的催化活性所需且其在免疫功能、蛋白质合成、伤口愈合、DNA合成及细胞分裂中起作用。需要每日摄入锌以维持稳态，因为身体无专门储锌系统。锌缺乏症的特征为生长延迟、食欲丧失及免疫功能受损。在更严重情况下，锌缺乏症造成脱发、腹泻、性成熟延迟、阳萎、男性性腺机能减退以及眼睛及皮肤病变。亦可能发生体重减轻、创伤愈合延迟、味觉异常及精神不振。
严重锌缺乏症亦可抑制免疫功能，甚至轻度至中度的锌缺乏症亦可损害巨噬细胞及嗜中性白细胞功能、自然杀手细胞活性及补体活性。身体需要锌来使T-淋巴细胞发育及活化。锌含量低的个体已显示对促分裂原的淋巴细胞增殖反应降低及可通过补充锌来校正的免疫性的其他有害改变。免疫功能的这些改变可能解释低锌状态与对肺炎及其他感染的敏感性增加相关的原因。锌的几种形式，包括葡萄糖酸锌、硫酸锌、氧化锌及乙酸锌可用于本申请中描述的营养补充剂中。锌的优选形式为氧化锌。
硒为一种必需痕量元素，其充当与抗氧化保护及甲状腺激素代谢有关的酶的组分。硒具有抗氧化特性且已显示降低心脏病发作及心脏病的风险。尚未描述人类中硒缺乏症的特征性征象，但极低硒状态为在中国硒缺乏地区中发生的青少年心肌病(克山病)及软骨营养障碍(卡斯钦-贝克(Kashin-Beck)病)的病因学中的因素。
维生素A为一种由碳与氢之间的双极性共价键形成的双极性分子，其与类似形状的分子的家族(类视黄醇)关联。其重要部分为视黄基，可以几种形式发现。维生素A可以酯形式发现，主要为棕榈酸视黄酯(在食物中发现且在小肠中转化成视黄醇)。维生素A亦可以作为视黄醛或视黄酸存在。该维生素的前体作为类胡萝卜素家族化合物的的一些成员存在于植物来源的食物中。在来自植物的食物中发现的常见原维生素A类胡萝卜素为β胡罗卜素、α胡罗卜素及β隐黄素。在这些物质中，β-胡萝卜素最有效形成视黄醇。α胡罗卜素及β隐黄素亦转化成维生素A，但效率仅为β胡罗卜素的一半。
维生素A在整个身体中多种功能中起作用，例如：视觉、基因转录、免疫功能、胚胎发育及再生、骨骼代谢、造血、皮肤健康、降低心脏病风险及抗氧化活性。维生素A缺乏症可作为原发性或继发性缺乏症发生。原发性维生素A缺乏症发生在未足够摄入黄色及绿色蔬菜、水果及食用肝的儿童及成人中间。继发性维生素A缺乏症与脂质慢性吸收障碍、胆汁产生及释放减弱、低脂膳食及长期暴露于氧化剂(例如香烟烟雾)相关。维生素A为一种脂溶性维生素且对于分散至小肠中而言依赖于微团溶解，因此低脂膳食引起维生素A的利用差。锌缺乏症亦可削弱维生素A的吸收、转运及代谢，因为其对于维生素A转运蛋白的合成及视黄醇氧化成视黄醛而言是必需的。
维生素K表示一组亲脂性、疏水性维生素，它们为某些蛋白质转译后修饰所需。化学上，它们为2-甲基-1,4-萘醌衍生物。维生素K组的维生素的所有成员都含有甲基化萘醌环结构且在附接在3-位置的脂族侧链上有变化。叶绿醌(亦称为维生素K1)在其侧链中一律含有四个类异戊二烯残基，其中的一个是不饱和的。
公认萘醌为官能基，以至于所有K-维生素的作用机制类似。然而，在肠吸收、转运、组织分布及生物利用度方面，可预期实质差异。这些差异由各种侧链的不同亲脂性及其中所存在的不同食物基质引起。维生素K缺乏症极稀少。在身体无法自肠道适当地吸收该维生素时，发生维生素K缺乏症。维生素K缺乏症亦可发生在长期用抗生素治疗之后。患有维生素K缺乏症的个体通常更可能具有瘀伤及出血。维生素K为一种活性血液凝固剂且有助于骨骼形成。优选地，维生素K呈维生素K1形式。
其他微量营养物包括(但不限于)磷、氯化物、铬、碘、镁、锰、钼及钾。
铬有助于调节葡萄糖代谢，用于合成脂肪酸及胆固醇，有助于转运蛋白质，降低LDL血液含量，且升高高密度脂蛋白血液含量。在营养补充剂中，铬以药学上可接受的铬化合物给与。适用的药学上可接受的铬化合物包括(但不限于)氯化铬、酵母结合的铬、吡啶甲酸盐、烟酸结合的铬以及它们的组合。
碘有助于代谢脂肪且为适当甲状腺功能所必需，且有助于减少纤维囊性乳房病状。在本发明的营养补充剂中，碘以碘的药学上可接受的形式施用，其包括(但不限于)碘化钾、碘化钠及其组合。在一个优选实施方案中，碘呈碘化钾形式。
钼可促进脂肪、碳水化合物及铁适当代谢且可保护免患某些癌症。药学上可接受的钼化合物包括(但不限于)钼酸钠、钼氨基酸螯合物及其组合。
体内锰含量低可能与糖尿病相关。因此，锰似乎在控制血糖含量中起作用。锰亦可能在氨基酸及某些维生素的代谢中起作用。药学上可接受的锰化合物包括(但不限于)氯化锰、硫酸锰及其组合。
如本申请中所使用，术语“薄荷糖”描述一种可在任何时间或任何地点，不使用水或其他液体即可摄取的口服剂型。消费者可使该薄荷糖溶解在他或她的口中或消费者可咀嚼及吞咽该薄荷糖；消费该维生素薄荷糖不需要水。
此外，可使用本领域中已知的常规设备及技术制备这些组合物。当制备内含本发明组合物的剂型时，营养组分通常与例如以下的常规赋形剂掺合：粘合剂，包括明胶、预糊化淀粉及类似物；润滑剂，例如氢化植物油、硬脂酸及类似物；稀释剂，例如乳糖、甘露糖及蔗糖；崩解剂，例如羧甲基纤维素及羟基乙酸淀粉钠；悬浮剂，例如聚维酮、聚乙烯醇及类似物；吸附剂，例如二氧化硅；以及着色剂，例如F.D.&C染料及类似物。在本发明中，粘合剂可包括糖醇，例如山梨糖醇、木糖醇、甘露糖醇、乳糖醇、麦芽糖醇、赤藓糖醇及异麦芽糖。糖醇因它们的低水活性以及它们的低含热量而用于优选实施方案中。因为它们的含热量低，所以糖醇比其他粘合剂较不会促进龋齿。本发明中使用的矫味剂可以是喷雾干燥的或囊封的。所述口服剂型可进一步含有甜味剂及/或矫味剂及/或着色剂。
此外，除本申请中描述的无活性成分以外，组合物优选包含另外的微量营养物以补充那些微量营养物的每日膳食摄入。那些维生素及矿物质可包括维生素A、β-胡萝卜素、维生素D、维生素E、维生素K、硫胺素、核黄素、烟酸、维生素B6、叶酸、维生素B12、生物素、泛酸、钙、铁、磷、碘、镁、锌、硒、铜、锰、铬、钼、氯化物、钾、硼、镍、硅、锡及钒。
虽然已用某些特定实施方案描述了本发明，但将了解的是本领域技术人员可在不背离本发明下进行许多修改及改变。因此，意欲所附权利要求涵盖可能落入本发明的真实精神及范围内的所有此类修改及改变。
实施例
实施例1：清凉薄荷味制剂的制备
通过将下表中列出的成分以及赋形剂、矫味剂、甜味剂及着色剂组合制备了清凉薄荷制剂。接着将混合物压缩且压纹以形成本发明的清凉薄荷味营养补充剂。
表1
营养物 量/薄荷糖 量/2个薄荷糖
维生素C 30mg 60mg
维生素E 16IU 30IU
叶酸 200mcg 400mcg
维生素K 32.5mcg 65mcg
生物素 30mcg 60mcg
维生素D 500.000IU 1000IU
β-胡萝卜素 362.5IU 725IU
维生素A 887.5IU 1775IU
烟酸 1mg 2mg
维生素B1 0.6mg 1.2mg
维生素B6 1mg 2mg
维生素B12 2.5mcg 5mcg
泛酸 2.5mg 5mg
锌 .75mg 1.5mg
锰 1.15mg 2.3mg
碘 75mcg 150mcg
硒 10mcg 20mcg
钼 20mcg 40mcg
铬 17.5mcg 35mcg
实施例2：冬青味制剂的制备
通过将下表中列出的成分以及赋形剂、矫味剂、甜味剂及着色剂组合制备了冬青制剂。接着将混合物压缩且压纹以形成本发明的冬青味营养补充剂。
表2
营养物 量/薄荷糖 量/2个薄荷糖
维生素C 30mg 60mg
维生素E 16IU 30IU
叶酸 200mcg 400mcg
维生素K 32.5mcg 65mcg
生物素 30mcg 60mcg
维生素D 500.000IU 1000IU
β-胡萝卜素 362.5IU 725IU
维生素A 887.5IU 1775IU
烟酸 1mg 2mg
维生素B1 0.6mg 1.2mg
维生素B6 1mg 2mg
维生素B12 2.5mcg 5mcg
泛酸 2.5mg 5mg
锌 .75mg 1.5mg
锰 1.15mg 2.3mg
碘 75mcg 150mcg
硒 10mcg 20mcg
钼 20mcg 40mcg
铬 17.5mcg 35mcg
实施例3：柠檬味制剂的制备
通过将下表中列出的成分以及赋形剂、矫味剂、甜味剂及着色剂组合制备了柠檬制剂。接着将混合物压缩且压纹以形成本发明的柠檬味营养补充剂。
表3
营养物 量/薄荷糖 量/2个薄荷糖
维生素C 30mg 60mg
维生素E 16IU 30IU
叶酸 200mcg 400mcg
维生素K 32.5mcg 65mcg
生物素 30mcg 60mcg
维生素D 500.000IU 1000IU
β-胡萝卜素 362.5IU 725IU
维生素A 887.5IU 1775IU
烟酸 1mg 2mg
维生素B1 0.6mg 1.2mg
维生素B6 1mg 2mg
维生素B12 2.5mcg 5mcg
泛酸 2.5mg 5mg
锌 .75mg 1.5mg
锰 1.15mg 2.3mg
碘 75mcg 150mcg
硒 10mcg 20mcg
钼 20mcg 40mcg
铬 17.5mcg 35mcg
实施例4：覆盆子味制剂的制备
通过将下表中列出的成分以及赋形剂、矫味剂、甜味剂及着色剂组合制备了覆盆子制剂。接着将混合物压缩且压纹以形成本发明的覆盆子营养补充剂。
营养物 量/薄荷糖 量/2个薄荷糖
维生素C 30mg 60mg
维生素E 16IU 30IU
叶酸 200mcg 400mcg
维生素K 32.5mcg 65mcg
生物素 30mcg 60mcg
维生素D 500.000IU 1000IU
β-胡萝卜素 362.5IU 725IU
维生素A 887.5IU 1775IU
烟酸 1mg 2mg
维生素B1 0.6mg 1.2mg
维生素B6 1mg 2mg
维生素B12 2.5mcg 5mcg
泛酸 2.5mg 5mg
锌 .75mg 1.5mg
锰 1.15mg 2.3mg
碘 75mcg 150mcg
硒 10mcg 20mcg
钼 20mcg 40mcg
铬 17.5mcg 35mcg
实施例5：维生素薄荷糖硬度的优化
测试了本发明的维生素薄荷糖的硬度以确定薄荷糖使消费者让薄荷糖溶解在他或她的口中或咀嚼及吞咽该维生素薄荷糖的体验最大化的最佳硬度。
阶段1：在第一阶段，测量美国市售产品的整体硬度。表5中给出了此研究的结果。
表5：美国市售产品的硬度
基于美国市售产品的硬度测量值，进行了一项直接内部感觉消费者研究以确定本发明的维生素薄荷糖的最佳硬度。
阶段2：在此阶段，制备了从13kP至30kP一系列硬度的维生素薄荷糖且测量了消费者对该维生素薄荷糖硬度的反应。将消费者体验的等级量表标题为“刚刚好硬度等级量表”，以测量全部范围的消费者关于维生素薄荷糖的硬度的观点，包括(a)“太过软”，(b)“刚刚好”，及(c)“太过硬”。表6显示了与所述清凉薄荷味维生素薄荷糖硬度相关的消费者测试的结果。
表6
片剂硬度范围 1-(太过软) 2 3-(刚刚好) 4 5-(太过硬)
13-15kP 5 20 69 6 0
20-25kP 2 12 68 18 0
30Kp 0 6 57 31 6
基于消费者测试的结果，确定了以下维生素薄荷糖硬度范围。可接受的维生素薄荷糖硬度范围为17千克力(kP)至28kP。所提议的维生素硬度范围为17至28kP且所提议的维生素薄荷糖硬度目标为23kP。本发明人相信，不束缚于任何理论，他们已获得了将改善消费者体验的维生素薄荷糖的最佳硬度。此研究的结果有力支持了消费者在通过让维生素薄荷糖溶解在他或她的口中或咀嚼且吞咽该维生素薄荷糖来摄取本发明的维生素薄荷糖中的享受。
实施例6：消费者测试
对本发明的清凉薄荷味维生素薄荷糖的多个属性进行消费者测试。表7列出了来自消费者测试的资料。测试的属性包括(1)芳香、(2)整体喜爱程度、(3)整体香味喜爱程度、(4)香味强度喜爱程度、(5)甜度、(6)硬度、(7)整体质地及(8)清凉效果。喜爱程度量表范围为表示“极不喜欢”的1至表示“极其喜爱”的9。消费者测试的成功标准为整体喜爱程度为6或更高的等级。表7中给出的所测试的属性的等级证实，每个属性均达到了成功标准。
表7
进行了与以下属性相关的另外的消费者测试：(1)芳香、(2)砂质程度、(3)白垩质程度、(4)硬度、(5)清凉效果及(6)香味强度。表8中给出了结果。用于此测试中的量表为“刚刚好量表”，其以百分比形式给出。等级范围从“太少”等级1至“太多”等级5。表8中给出的值仅仅显示等级3(其为“刚刚好”等级)的结果。结果显示大部分时间，所测试的所有属性均达到“刚刚好等级”。
表8
实施例7：崩解研究
与其他当前市售复合维生素及矿物质产品相比，对本发明的维生素薄荷糖进行了崩解研究。使用美国药典(USP)标题为“DISINTEGRATION AND DISSOLUATION OF DIETARYSUPPLEMENTS”的第2040章中的程序进行了崩解研究。表9提供了以秒计的平均值的崩解数据。Centrum Adults Chewable(橙味)及Centrum Kids Chewable(橙味)具有大约1200至1300秒的平均崩解时间。本发明的维生素薄荷糖具有大约350至362秒的平均崩解时间。本发明的维生素薄荷糖的平均崩解时间比市售复合维生素及矿物质产品的平均崩解时间低得多。该崩解数据显示，本发明的维生素薄荷糖可有效地溶解于消费者的口中。此数据证实了本发明的维生素薄荷糖有效地溶解于消费者的口中的特性。
表9
产品名称 平均崩解时间(秒)
Centrum Adult Chewable(橙味) 1284
Centrum Kids Chewable(橙味) 1308
清凉薄荷维生素薄荷糖 362
冬青维生素薄荷糖 350
实施例8：含热量
表10列出了与本发明的维生素薄荷糖相比，多个市售产品的含热量数据。市售产品的含热量从产品标签获得，且测量了本发明的清凉薄荷味维生素薄荷糖的含热量。
表10
表10中给出的含热量数据证实，本发明的维生素薄荷糖的含热量低于一些市售产品，例如Brach Star Brite Peppermint Mint、Bob's Sweet Stripe Soft Min、LifesaveWint O Green及Certs CoolMint Drops。尤其，本发明的维生素薄荷糖的含热量与CentrumAdult Chewable(橙味)及Centrum Silver Chewable相当。

Claims (10)

1.一种供消费对象口服的组合物，其包含维生素及矿物质，其中该组合物可溶解在该消费对象的口中或可被该消费对象咀嚼及吞咽。
2.前述权利要求中任一项的组合物，其中所述维生素选自维生素A、β-胡萝卜素、维生素D、维生素E、维生素K、硫胺素、核黄素、烟酸、维生素B6、叶酸、维生素B12、生物素及泛酸。
3.前述权利要求中任一项的组合物，其中所述矿物质选自钙、铁、磷、碘、镁、锌、硒、铜、锰、铬、钼、氯化物、钾、硼、镍、硅、锡及钒。
4.前述权利要求中任一项的组合物，其中所述维生素选自维生素C、维生素E、叶酸、维生素K、生物素、维生素D、β胡罗卜素、维生素A、烟酸、维生素B1、维生素B6、维生素B12及泛酸。
5.前述权利要求中任一项的组合物，其中所述矿物质选自锌、锰、碘、硒、钼及铬。
6.前述权利要求中任一项的组合物，其中该组合物的含热量为约5卡路里。
7.前述权利要求中任一项的组合物，其中该组合物的硬度为17Kp至28kP。
8.前述权利要求中任一项的组合物，其中所述矫味剂可以是喷雾干燥的矫味剂或囊封的矫味剂。
9.前述权利要求中任一项的组合物，其中该组合物的平均崩解速率为大约5至10分钟。
10.前述权利要求中任一项的组合物，其中该组合物的平均崩解速率为大约350至362秒。
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