TWI715550B - 口服產品 - Google Patents

口服產品 Download PDF

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Publication number
TWI715550B
TWI715550B TW105100690A TW105100690A TWI715550B TW I715550 B TWI715550 B TW I715550B TW 105100690 A TW105100690 A TW 105100690A TW 105100690 A TW105100690 A TW 105100690A TW I715550 B TWI715550 B TW I715550B
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TW
Taiwan
Prior art keywords
vitamin
composition
vitamins
mint
zinc
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TW105100690A
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English (en)
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TW201642767A (zh
Inventor
麥可 古德
安 沃克
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美商Ｐｆ消費者保健第一有限責任公司
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Publication of TW201642767A publication Critical patent/TW201642767A/zh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/32—Manganese; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • 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
    • 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
    • A23G3/364—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
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A23G4/00—Chewing gum
    • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
    • A23G4/064—Chewing gum characterised by the composition containing organic or inorganic compounds containing inorganic compounds
    • A—HUMAN NECESSITIES
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    • A23G4/00—Chewing gum
    • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
    • A23G4/12—Chewing gum characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • A23G4/126—Chewing gum 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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    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
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    • A61K31/07—Retinol compounds, e.g. vitamin A
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    • A61K31/12—Ketones
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
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Abstract

本發明提供一種營養補充組合物，其可在任何時間或任何地點，不使用水或吞咽錠劑通常需要之其他液體來服用。本發明為一種營養補充組合物，其為一種便利、有香味且令人愉快之維生素薄荷糖，可無水服用。

Description

口服產品
本發明係關於營養補充組合物。更特定言之，本發明提供一種營養補充組合物，其可在任何時間或任何地點，不使用水或吞咽錠劑通常需要之其他液體來服用。本發明為一種營養補充組合物，其為一種便利、有香味且令人愉快之維生素薄荷糖，可無水服用。消費者可有效地將維生素薄荷糖溶解在其口腔中，或消費者可咀嚼且吞咽薄荷糖；食用維生素薄荷糖無需水。
長期以來已確立許多通常稱為維生素及礦物質之化合物提供維持個體處於健康狀態及/或治療特定醫學病狀之重要價值，即使以相對較小量供應。人體無法合成大部分對維持人體健康而言不可或缺之維生素及礦物質。因此，維生素及礦物質必須自外部來源獲得。兩個最常見外部來源為食物及營養補充劑。因為大部分人不吃一致提供每天必需量之維生素及礦物質的食物，所以維生素及礦物質營養補充已變成一種認可的符合公認醫學及健康標準之方法。
微量營養素為少量或痕量存在於食物中且包括維生素、礦物質或在食物中發現之其他元素及化合物的元素或化合物，其中多者尚未限定建議每日攝取量(recommended daily allowance，RDA)。大量營養素由碳水化合物、脂肪及蛋白質組成，其供應營養素及熱量且大部分經由食物及膳食攝入來消耗。諸如鈣、鈉、鉀、氯化物及磷之一些 微量營養素消耗相對大量，而諸如鐵、碘及鋅之許多其他微量營養素消耗少量。諸如B12及葉酸之維生素及諸如硒之礦物質消耗極少量或痕量。由於人體不合成許多對於人體而言不可或缺之化合物，所以此等特定維生素及礦物質可僅僅自兩個來源獲得：食物及補充劑。
可投與維生素及礦物製劑來治療特定醫學病狀或其作為一般營養補充劑。因為需要許多維生素及礦物質且每日需要量相對較小，所以宜投與呈錠劑或膠囊形式的維生素與礦物質之混合物作為一般補充劑。市售多維生素及礦物質補充劑之典型日劑量為每天一或兩個錠劑或膠囊。除製備劑型所需之賦形劑之外，此類組合物通常亦包括兩打或更多種營養素。
成人中出現之營養缺乏症很多且根據個體之地理環境及社會經濟地位而變化。所有營養素之主要來源為食物；然而，許多成人經由攝食無法滿足必需微量營養素之RDA。因此，維生素及礦物質補充已變成一種認可的符合公認醫學及健康標準之方法。為對抗此等次佳維生素含量，多種營養補充劑已為公眾可用。
消費者對除錠劑外之劑型的多維生素及礦物質營養補充劑有興趣，因為一些錠劑很大且可能難以吞咽。另外，需要水或另一液體來服用營養補充錠劑。營養補充劑之替代性劑型包括咀嚼錠劑；然而，許多消費者不喜歡咀嚼錠劑之硬度且難以咀嚼其。此外，消費者不喜歡一些咀嚼錠劑之白堊質或砂質紋理。粉末狀飲料混合物為營養補充劑之另一劑型；然而，飲料混合物需要水。顯然，需要一種新營養補充劑型，其提供一種可在任何時間及任何地點，不需要水或吞咽錠劑或製備粉末狀飲料混合物需要之其他液體即可服用之便利形式。因此，本發明人意圖提供本發明之營養補充組合物，其為一種便利、有香味且令人愉快之維生素薄荷糖，可無水服用。消費者可將該薄荷糖有效地溶解在其口腔中，或消費者可咀嚼且吞咽薄荷糖。服用維生素 薄荷糖營養補充組合物無需水。
在本發明之一個態樣中，提供一種組合物，其用於個體口服，其包含維生素及礦物質，其中該組合物可溶解在該個體之口腔中或可由該個體咀嚼及吞咽。
在本發明之另一態樣中，提供一種組合物，其中該等維生素係選自維生素A、β-胡蘿蔔素、維生素D、維生素E、維生素K、硫胺素、核黃素、菸酸、維生素B6、葉酸、維生素B12、生物素及泛酸。
在本發明之又一態樣中，提供一種組合物，其中該等礦物質係選自鈣、鐵、磷、碘、鎂、鋅、硒、銅、錳、鉻、鉬、氯化物、鉀、硼、鎳、矽、錫及釩。
本文中描述之多維生素及礦物質劑型意欲用於想要一種可無水服用的便利、有香味且令人愉快之營養補充薄荷糖的消費者。消費者可使薄荷糖溶解在其口腔中或消費者可咀嚼及吞咽薄荷糖。服用維生素薄荷糖營養補充組合物無需水。目前尚無市售之營養補充劑呈可溶解在消費者口腔中或可咀嚼及吞咽之薄荷糖形式。
本發明之營養補充劑經設計以補給身體每日損失之維生素及礦物質且為身體提供對於理想功能性，其需要之全範圍之營養素。彼等維生素及礦物質可包括維生素A、β-胡蘿蔔素、維生素D、維生素E、維生素K、硫胺素、核黃素、菸酸、維生素B6、葉酸、維生素B12、生物素、泛酸、鈣、鐵、磷、碘、鎂、鋅、硒、銅、錳、鉻、鉬、氯化物、鉀、硼、鎳、矽、錫及釩。
亦稱為維生素B9之葉酸或葉酸鹽(陰離子形式)為產生及維持新細 胞所必需。此在快速細胞分裂及生長期，諸如嬰兒期及妊娠期期間尤其重要。需要葉酸鹽來合成DNA複製所需之DNA鹼基(最尤其為胸腺嘧啶，以及嘌呤鹼基)。因此，葉酸鹽缺乏症阻礙DNA合成及細胞分裂，最特別影響均參與快速細胞分裂之骨髓及癌症。因為葉酸鹽缺乏症限制細胞分裂，所以阻礙紅血球生成，紅血球產生(RBC)且可引起貧血。
維生素B1亦稱為硫胺素，為一種具有噻唑及嘧啶環藉由亞甲基橋接合之水溶性物質，且體內生物半衰期為約15天。硫胺素對神經功能及碳水化合物代謝為至關重要的且呈醫藥學上可接受之維生素B1化合物形式給與。如本文所用，「醫藥學上可接受」為組分適合用於人類中，無過度副作用，諸如刺激、毒性及過敏性反應。適用之醫藥學上可接受之維生素B1化合物包括(但不限於)氯化硫胺素鹽酸鹽。
菸酸為細胞呼吸所需，有助於碳水化合物、脂肪及蛋白質之能量釋放及代謝、適當循環及健康皮膚、神經系統發揮功能以及膽液及胃液之正常分泌。其用於合成性激素，治療精神分裂症及其他精神疾病，以及為記憶強化劑。醫藥劑型中給與之菸酸改善血液膽固醇型態，且已用於清除有機毒物體，諸如某些殺蟲劑。菸酸之一較佳形式為菸鹼醯胺。
維生素B6或吡哆醇與RNA及DNA產生以及人體中許多其他生物反應有關。吡哆醛磷酸酯(維生素B6之代謝活性形式)與大量營養素代謝、神經傳遞質合成、組織胺合成、血紅蛋白合成及功能以及基因表現之許多態樣有關。適用之醫藥學上可接受之維生素B6化合物包括(但不限於)吡哆醇、吡哆醛及吡哆胺或其鹽，包括(但不限於)吡哆醇鹽酸鹽。磷酸酯衍生物吡哆醛磷酸酯一般充當許多反應之輔酶且可幫助促進去羧基、轉胺基作用、外消旋化、消除、置換及β基相互轉化反應。過度劑量之吡哆醇可引起諸如本體感受器神經之某些神經暫時 性死亡，引起本體感受喪失所常見之去身體化感。此病狀當中止補充時為可逆的。
維生素B12或鈷胺素為整個代謝、神經系統功能、葉酸代謝、高半胱胺酸還原及紅血球產生所必需。鈷胺素存在至少三種活性形式：氰鈷胺素、羥鈷胺素及硝鈷胺素。
生物素為碳水化合物、蛋白質及脂肪代謝所必需且為健康皮膚及頭髮所需要。
泛酸亦稱作維生素B5，為一種維持生命所需之水溶性維生素。泛酸為形成輔酶-A(CoA)所需，且在碳水化合物、蛋白質及脂肪之代謝及合成中為至關重要。泛酸之衍生物泛醇為該維生素之一種更穩定形式且常常用作多種維生素補充劑中該維生素之來源。該維生素之另一常見補充形式為泛酸鈣。泛酸鈣常常用於膳食補充劑中，因為呈一種鹽，其在消化道中比泛酸更穩定，從而可更好地吸收。泛酸鈣亦可降低類風濕性關節炎患者中晨起關節僵硬之持續時間、殘疾程度及疼痛嚴重程度。泛酸之一種較佳形式為泛酸鈣。
維生素E為一種脂溶性維生素，為涉及所有細胞代謝之抗氧化維生素。其保護維生素A及必需脂肪酸免於在身體細胞內氧化且防止身體組織分解。維生素E為一群相關物質之通用術語，該等物質包括α-生育酚、β-生育酚、γ-生育酚及δ-生育酚。另外，此四種化合物各具有天然形式「d」形式及合成形式「d1」形式。較佳地，在本發明之營養補充劑中，維生素E呈天然形式。
維生素C亦稱為抗壞血酸，為一種水溶性抗氧化維生素。其對於形成膠原蛋白具有重要性，膠原蛋白為一種為骨骼、軟骨、肌肉及血管提供結構之蛋白質。維生素C亦有助於鐵吸收，且幫助維持毛細血管、骨骼及牙齒。作為水溶性抗氧化劑，維生素C在水性過氧基自由基有機會破壞脂質前獨一無二地清除此等破壞性物質。其與維生素E (一種脂溶性抗氧化劑)及酶麩胱甘肽過氧化酶一起工作，中止自由基鏈反應。
維生素C可增強身體對一類疾病之抗性，包括感染性病症及許多類型癌症。其藉由刺激抗體及諸如吞噬細胞及嗜中性白血球之免疫系統細胞的活性，加強及保護免疫系統。維生素C有助於多種其他生物化學功能。此等功能包括胺基酸肉鹼及調節神經系統之兒茶酚胺之生物合成。其亦幫助身體吸收鐵及分解組織胺。雖然在每個細胞中均發現維生素C，但其尤其適用於身體之關鍵部位。此等部位包括血液、皮膚、神經系統、牙齒及骨骼以及腺體，諸如胸腺、腎上腺及甲狀腺。
維生素D為一群脂溶性前激素，其兩種主要形式為維生素D2(或麥角鈣化醇)及維生素D3(或膽鈣化醇)。如本文所用，術語維生素D亦指此等物質之代謝物及其他類似物。維生素D3在暴露於日光、特別紫外線B放射線之皮膚中產生。
維生素D在器官系統之維持中起重要作用。其已展示藉由促進腸中對鈣及磷自食物之吸收，且藉由促進腎中鈣之再吸收而調節血液中鈣及磷含量，使得骨骼礦化正常。其亦為骨骼生長及骨骼重塑所需。亦已提出維生素D藉由促進吞噬作用、抗腫瘤活性及免疫調節功能而影響免疫系統。
維生素D缺乏症可由以下引起：攝入不足聯合日光暴露不足；限制其吸收之病症；削弱維生素D至活性代謝物之轉化的病狀，諸如肝或腎病症；或很少地，由許多遺傳病症引起。缺乏症引起骨骼礦化減弱且導致骨骼軟化疾病，兒童中佝僂病及成人中骨軟化症，且可能引起骨質疏鬆。然而，為避免缺乏症而進行日光暴露攜有其他風險，包括皮膚癌；經由飲食或以膳食補充劑形式進行膳食吸收來避免此風險。
鋅為一種必需礦物質，其天然存在於一些食物中，添加至其他中且可用作膳食補充劑。鋅與細胞代謝之多個態樣有關。其為大約100種酶之催化活性所需且其在免疫功能、蛋白質合成、傷口癒合、DNA合成及細胞分裂中起作用。需要每日攝入鋅以維持穩態，因為身體無專門儲鋅系統。鋅缺乏症之特徵為生長延遲、食慾不振及免疫功能減弱。在更嚴重情況下，鋅缺乏症造成脫髮、腹瀉、性成熟延遲、陽萎、男性性腺低能症以及眼睛及皮膚病變。亦可能發生重量減輕、創傷癒合延遲、味覺異常及精神不振。
嚴重鋅缺乏症亦可降低免疫功能，且甚至輕度至中度之鋅缺乏症亦可削弱巨噬細胞及嗜中性白血球功能、自然殺手細胞活性及補體活性。身體需要鋅來使T-淋巴細胞發育及活化。鋅含量低之個體已展示對有絲分裂原之淋巴細胞增殖反應降低及可藉由補充鋅來校正的免疫性之其他有害改變。免疫功能之此等改變可解釋低鋅狀態與對肺炎及其他感染之敏感性增加相關的原因。鋅之若干形式，包括葡糖酸鋅、硫酸鋅、氧化鋅及乙酸鋅可用於本文中描述之營養補充劑中。鋅之較佳形式為氧化鋅。
硒為一種必需痕量元素，其充當與抗氧化保護及甲狀腺激素代謝有關之酶的組分。硒具有抗氧化特性且已展示降低心臟病發作及心臟病之風險。尚未描述人類中硒缺乏症之特徵性徵象，但極低硒狀態為在中國硒缺乏地區中發生的幼年型心肌病(克山病(Keshan Disease))及軟骨營養障礙(卡斯欽-貝克病(Kashin-Beck Disease))之病源學中的因素。
維生素A為一種由碳與氫之間的雙極性共價鍵形成的雙極性分子，其連接於類似形狀分子家族，類視黃素。其重要部分為視黃基，可呈若干形式發現。維生素A可呈酯形式發現，主要為棕櫚酸視黃基酯(在食物中發現且在小腸中轉化成視黃醇)。維生素A亦可呈視黃醛 或呈視黃酸存在。該維生素之前驅物作為化合物之胡蘿蔔素家族之一些成員存在於植物來源之食物中。在來自植物之食物中發現之常見原維生素A類胡蘿蔔素為β胡羅蔔素、α胡羅蔔素及β隱黃素。其中，β-胡蘿蔔素最有效形成視黃醇。α胡羅蔔素及β隱黃素亦轉化成維生素A，但有效性僅為β胡羅蔔素一半。
維生素A在整個身體中多種功能中起作用，諸如：視覺、基因轉錄、免疫功能、胚胎發育及再生、骨骼代謝、造血、皮膚健康、降低心臟病風險及抗氧化活性。維生素A缺乏症可作為原發性或繼發性缺乏症發生。原發性維生素A缺乏症發生在未足夠攝入黃色及綠色蔬菜、水果及肝臟之兒童及成人中間。繼發性維生素A缺乏症與脂質慢性吸收障礙、膽液產生及釋放減弱、低脂膳食及長期暴露於氧化劑(諸如香菸煙霧)相關。維生素A為一種脂溶性維生素且視膠束溶解以分散至小腸中而定，因此低脂膳食引起維生素A之利用差。鋅缺乏症亦可削弱維生素A之吸收、輸送及代謝，因為其對維生素A轉運蛋白之合成及視黃醇氧化成視黃醛為至關重要的。
維生素K表示一群親脂性、疏水性維生素，為某些蛋白質轉譯後修飾所需。化學上，其為2-甲基-1,4-萘醌衍生物。維生素之維生素K群之所有成員共享甲基化萘醌環結構且在附接在3-位置之脂族側鏈上變化。葉綠醌(亦稱為K1)在其側鏈中一直含有四個類異戊二烯殘基，其中之一不飽和。
一般公認萘醌為官能基，因而所有K-維生素之作用機制類似。然而，在腸吸收、輸送、組織分佈及生物可用性方面，可預期實質差異。此等差異由各種側鏈之不同親脂性及其所存在之不同食物基質引起。維生素K缺乏症極稀少。其發生在身體無法自腸道適當地吸收該維生素時。維生素K缺乏症亦可發生在長期抗生素治療之後。患有維生素K缺乏症之個體通常更可能瘀傷及出血。維生素K為一種活性血 液凝固劑且幫助骨骼形成。較佳地，維生素K呈維生素K1形式。
其他微量營養素包括(但不限於)磷、氯化物、鉻、碘、鎂、錳、鉬及鉀。
鉻幫助調節葡萄糖代謝，用於合成脂肪酸及膽固醇，幫助傳輸蛋白質，降低LDL血液含量，且升高高密度脂蛋白血液含量。在營養補充劑中，鉻以醫藥學上可接受之鉻化合物給與。適用之醫藥學上可接受之鉻化合物包括(但不限於)氯化鉻、酵母結合之鉻、吡啶甲酸鹽、菸酸結合之鉻及其組合。
碘有助於脂肪代謝且為適當甲狀腺功能所必需，且有助於減少纖維囊性乳房病狀。在本發明之營養補充劑中，碘以碘之醫藥學上可接受之形式投與，包括(但不限於)碘化鉀、碘化鈉及其組合。在一個較佳實施例中，碘呈碘化鉀形式。
鉬可促進脂肪、碳水化合物及鐵適當代謝且可保護免患某些癌症。醫藥學上可接受之鉬化合物包括(但不限於)鉬酸鈉、鉬胺基酸螯合物及其組合。
體內錳含量低可能與糖尿病相關。因此，錳似乎在控制血糖含量中起作用。錳亦可在胺基酸及某些維生素之代謝中起作用。醫藥學上可接受之錳化合物包括(但不限於)氯化錳、硫酸錳及其組合。
如本文所用，術語「薄荷糖」描述一種可在任何時間或任何地點，不使用水或其他液體即可攝取之口服劑型。消費者可使薄荷糖溶解在其口腔中或消費者可咀嚼及吞咽薄荷糖；無需水即可食用維生素薄荷糖。
此外，可使用此項技術中已知之習知設備及技術製備此等組合物。當製備內含本發明組合物的劑型時，營養組分通常與諸如以下之習知賦形劑摻合：黏合劑，包括明膠、預糊化澱粉及其類似物；潤滑劑，諸如氫化植物油、硬脂酸及其類似物；稀釋劑，諸如乳糖、甘露 糖及蔗糖；崩解劑，諸如羧甲基纖維素及羥基乙酸澱粉鈉；懸浮劑，諸如聚維酮、聚乙烯醇及其類似物；吸附劑，諸如二氧化矽；以及著色劑，諸如F.D. & C染料及其類似物。在本發明中，黏合劑可包括糖醇，諸如山梨糖醇、木糖醇、甘露糖醇、乳糖醇、麥芽糖醇、赤藻糖醇及異麥芽糖。糖醇因其低水活性以及其低含熱量而用於較佳實施例中。因為其含熱量低，所以糖醇比其他黏合劑較不會促進齲齒。本發明中使用之調味劑可經噴霧乾燥或囊封。口服劑型可進一步含有甜味劑及/或調味劑及/或著色劑。
此外，除本文中描述之非活性成分之外，組合物較佳包含其他微量營養素以補充彼等微量營養素之每日膳食攝入。彼等維生素及礦物質可包括維生素A、β-胡蘿蔔素、維生素D、維生素E、維生素K、硫胺素、核黃素、菸酸、維生素B6、葉酸、維生素B12、生物素、泛酸、鈣、鐵、磷、碘、鎂、鋅、硒、銅、錳、鉻、鉬、氯化物、鉀、硼、鎳、矽、錫及釩。
雖然已根據某些特定實施例描述本發明，但應瞭解熟習此項技術者可在不背離本發明下進行許多修改及改變。因此，意欲所附申請專利範圍涵蓋所有此類修改及改變在本發明之真實精神及範疇內。
實例 實例1：清涼薄荷味調配物之製備
清涼薄荷調配物藉由將下表中列出之成分以及賦形劑、調味劑、甜味劑及著色劑組合來製備。接著將混合物壓縮且壓紋以形成本發明之清涼薄荷味營養補充劑。
Figure 105100690-A0202-12-0010-3
Figure 105100690-A0202-12-0011-4
實例2：冬青味調配物之製備
冬青調配物藉由將下表中列出之成分以及賦形劑、調味劑、甜味劑及著色劑組合來製備。接著將混合物壓縮且壓紋以形成本發明之冬青味營養補充劑。
Figure 105100690-A0202-12-0011-5
實例3：檸檬味調配物之製備
檸檬調配物藉由將下表中列出之成分以及賦形劑、調味劑、甜味劑及著色劑組合來製備。接著將混合物壓縮且壓紋以形成本發明之檸檬味營養補充劑。
Figure 105100690-A0202-12-0012-6
實例4：樹莓味調配物之製備
樹莓調配物藉由將下表中列出之成分以及賦形劑、調味劑、甜味劑及著色劑組合來製備。接著將混合物壓縮且壓紋以形成本發明之樹莓營養補充劑。
Figure 105100690-A0202-12-0012-16
Figure 105100690-A0202-12-0013-8
實例5：維生素薄荷糖硬度之最佳化
測試本發明之維生素薄荷糖之硬度以確定薄荷糖之最佳硬度以使消費者使薄荷糖溶解在其口腔中或咀嚼及吞咽維生素薄荷糖之體驗達到最大。
階段1：在第一階段，量測美國市售產品之整體硬度。此研究之結果在表5中給出。
Figure 105100690-A0202-12-0013-9
基於美國市售產品之硬度量測結果，進行一項直接內部感覺消費者研究以確定本發明之維生素薄荷糖的最佳硬度。
階段2：在此階段，製備13kP至30kP一系列硬度之維生素薄荷糖且量測消費者對維生素薄荷糖硬度之反應。消費者體驗之等級量表標題為「剛剛好硬度等級量表」，量測全部範圍的消費者關於維生素薄荷糖之硬度之觀點，包括(a)「過軟」，(b)「剛剛好」，及(c)「過硬」。表6展示與清涼薄荷味維生素薄荷糖硬度相關之消費者測試的結 果。
Figure 105100690-A0202-12-0014-10
基於消費者測試之結果，確定以下維生素薄荷糖硬度範圍。可接受之維生素薄荷糖硬度範圍為17千克力(kP)至28kP。所提議之維生素硬度範圍為17至28kP且所提議之維生素薄荷糖硬度目標為23kP。本發明人咸信不束縛於任何理論，其已實現維生素薄荷糖之最佳硬度，此將改善消費者體驗。此研究結果支持藉由使維生素薄荷糖溶解在其口腔中或咀嚼及吞咽維生素薄荷糖，消費者愉快地攝取本發明之維生素薄荷糖。
實例6：消費者測試
對本發明之清涼薄荷味維生素薄荷糖之多個屬性進行消費者測試。表7列出來自消費者測試之資料。測試之屬性包括(1)氣味、(2)整體喜愛程度、(3)整體香味喜愛程度、(4)香味強度喜愛程度、(5)甜味、(6)硬度、(7)整體紋理及(8)清涼作用。喜愛程度量表範圍為「極其討厭」1至「極其喜愛」9。消費者測試之成功標準為整體喜愛程度為6或更高之等級。表7中給出之測試之屬性的等級證實各屬性達到成功標準。
Figure 105100690-A0202-12-0014-11
Figure 105100690-A0202-12-0015-12
進行與以下屬性相關之其他消費者測試：(1)氣味、(2)砂性、(3)白堊性、(4)硬度、(5)清涼作用及(6)香味強度。結果在表8中給出。用於此測試中之量表為「剛剛好量表」，其以百分比形式給出。等級範圍為「過少」等級1至「過多」等級5。表8中給出之值僅僅展示「剛剛好」等級之等級3的結果。結果展示大部分時間，所有測試屬性均達到「剛剛好等級」。
Figure 105100690-A0202-12-0015-13
實例7：崩解研究
與其他當前市售多維生素及礦物質產品相比，對本發明之維生素薄荷糖進行崩解研究。使用USP第2040章標題為「DISINTEGRATION AND DISSOLUATION OF DIETARY SUPPLEMENTS」中的程序進行崩解研究。表9提供呈以秒計之平均值的崩解資料。Centrum Adults Chewable(橙味)及Centrum Kids Chewable(橙香)具有大約1200至1300秒之平均崩解時間。本發明之維生素薄荷糖具有大約350至362秒之平均崩解時間。本發明之維生素薄荷糖的平均崩解時間比市售多維生素及礦物質產品之平均崩解時間低得多。崩解資料展示本發明之維生素薄荷糖可有效地溶解於消費者之口腔中。此資料證實本發明之維生素薄荷糖有效地溶解於消費者之口 腔中的特性。
Figure 105100690-A0202-12-0016-14
實例8：含熱量
表10列出與本發明之維生素薄荷糖相比，多個市售產品之含熱量資料。含熱量自市售產品之產品標籤獲得且對於本發明之清涼薄荷味維生素薄荷糖，進行量測。
Figure 105100690-A0202-12-0016-15
表10中給出之含熱量資料證實本發明之維生素薄荷糖的含熱量低於一些市售產品，諸如Brach Star Brite Peppermint Mint、Bob's Sweet Stripe Soft Min、Lifesave Wint O Green及Certs CoolMint Drops。本發明之維生素薄荷糖的含熱量尤其與Centrum Adult Chewable(橙)及Centrum Silver Chewable相當。

Claims (7)

  1. 一種用於個體口服之組合物，其包含維生素、礦物質及包括糖醇之黏合劑，該糖醇為異麥芽糖，其中該組合物可溶解在該個體之口腔或可由該個體咀嚼及吞咽，且其中該組合物之硬度為17kP至28kP，且該組合物之平均崩解速率為大約350至362秒。
  2. 如請求項1之組合物，其中該等維生素係選自維生素A、β-胡蘿蔔素、維生素D、維生素E、維生素K、硫胺素、核黃素、菸酸、維生素B6、葉酸、維生素B12、生物素及泛酸。
  3. 如請求項1之組合物，其中該等礦物質係選自鈣、鐵、磷、碘、鎂、鋅、硒、銅、錳、鉻、鉬、氯化物、鉀、硼、鎳、矽、錫及釩。
  4. 如請求項1之組合物，其中該等維生素係選自維生素C、維生素E、葉酸、維生素K、生物素、維生素D、β胡羅蔔素、維生素A、菸酸、維生素B1、維生素B6、維生素B12及泛酸。
  5. 如請求項1之組合物，其中該等礦物質係選自鋅、錳、碘、硒、鉬及鉻。
  6. 如請求項1至5中任一項之組合物，其中該組合物之含熱量為約5卡路里。
  7. 如請求項1至5中任一項之組合物，其進一步包含調味劑，其中該調味劑可為噴霧乾燥之調味劑或囊封之調味劑。
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MX2017009197A (es) 2017-12-07
BR112017013886A2 (pt) 2018-01-02
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