TWI763036B - 可膨脹微膠囊 - Google Patents
可膨脹微膠囊 Download PDFInfo
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- TWI763036B TWI763036B TW109131469A TW109131469A TWI763036B TW I763036 B TWI763036 B TW I763036B TW 109131469 A TW109131469 A TW 109131469A TW 109131469 A TW109131469 A TW 109131469A TW I763036 B TWI763036 B TW I763036B
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Abstract
一種可膨脹微膠囊，具有一核心層，由300重量份的發泡劑、250重量份的高分子吸水材和60重量份的核心層潤滑劑組成，且發泡劑具有可與水反應而產生氣體之特性；以及一包覆層用以包覆於核心層之表面以構成一顆粒狀結構，該包覆層由重量比10%至40%的可食性吸水膠體、5%至40%的功能性健康食品添加物、2%至30%的乳化劑、4%至15%的包覆層潤滑劑及5%至40%的膜衣組成物所組成，且膜衣組成物具有抗胃酸分解而僅可在腸道中被分解之特性。
Description
本發明係一種於食用後可在人體胃中物理性脹大，以增加飽足感的可膨脹微膠囊。
按，「肥胖」通常是指人體異常或過量脂肪累積，依據營養健康調查結果顯示：肥胖會加重身體機能負擔、罹患非傳染性疾病的重大風險因素、並且會導致許多慢性疾病的發生，例如，容易引起動脈硬化、心臟病、中風、心血管疾病、高血壓、高血脂症、糖尿病、惡性腫瘤、脂肪肝、代謝症候群等疾病。
而透過代謝刺激劑、食欲抑制劑、澱粉阻斷劑等藥物，雖可在短期內達到減重的功效，然而長期服用藥物也勢必會對人體造成許多不良的副作用，例如，目前合法的減肥藥品成份羅氏鮮
®(Orlistat
®)，是一種腸胃道胰臟脂肪分解酶的抑制劑，可用以使食物中的部份脂肪在腸胃道中無法被分解及吸收，藉此可減少來自食物當中一部份脂肪的熱量，以達到減肥的效果，但是羅氏鮮
®有極大的副作用，包含干擾脂溶性維生素吸收、油便、胃脹氣、亦可能造成膽結石與肝腎損傷等，因此不適合長期使用；另有以芬他命(phentermine)-妥泰(topiramate)複方及氯卡色林(lorcaserin)作為主要成分的減肥藥品，其作用機轉都在於增加飽足感，以抑制食慾達到減重的目的，但會有頭暈、噁心或失眠、便祕等其他副作用，且這兩項減肥藥品對於心血管疾病產生的風險仍存有疑慮，並不適合有心血管疾病的患者服用。
有鑒於此，故如何解決上述問題，即為本發明所欲解決之首要課題。
本發明之主要目的，在於提供一種可膨脹微膠囊，其具有可於食用後在人體胃中物理性脹大之特點，並藉此即可增加飽足感而抑制食慾，以達到減肥目的，且不會對人體造成有任何藥物的不良副作用。
為達前述之目的，本發明提供一種可膨脹微膠囊，包含有：
一核心層，由300重量份的發泡劑、250重量份的高分子吸水材和60重量份的核心層潤滑劑組成，且該發泡劑具有可與水反應而產生氣體之特性；
一包覆層，包覆於該核心層之表面以構成一顆粒狀結構，該包覆層由重量比10%至40%的可食性吸水膠體、5%至40%的功能性健康食品添加物、2%至30%的乳化劑、4%至15%的包覆層潤滑劑及5%至40%的膜衣組成物所組成，且該膜衣組成物具有抗胃酸分解而僅可在腸道中被分解之特性。
較佳地，食用者除了可直接食用預定量的可膨脹微膠囊，使其可在人體胃中物理性脹大以增加飽足感而抑制食慾，還可依需求將其製成錠狀，或亦可先將預定量的可膨脹微膠囊裝填在由二外型對稱之半囊體所對接組成的中空囊體中，以方便食用者服用。
而本發明之上述目的與優點，不難從下述所選用實施例之詳細說明與附圖中獲得深入了解。
首先，請參閱第1、2圖所示，為本發明所提供一種可膨脹微膠囊10，其主要由一核心層11及一包覆於該核心層11表面之包覆層21所構成，其中：
該核心層11，由300重量份的發泡劑、250重量份的高分子吸水材和60重量份的核心層潤滑劑組成，且該發泡劑具有可與水反應而產生氣體之特性。
該包覆層21，用以相對包覆於該核心層11之表面以構成一顆粒狀結構，該包覆層21由重量比10%至40%的可食性吸水膠體、5%至40%的功能性健康食品添加物、2%至30%的乳化劑、4%至15%的包覆層潤滑劑及5%至40%的膜衣組成物所組成，且該膜衣組成物具有抗胃酸分解而僅可在腸道中被分解之特性。
而在實際製作上，本發明的發泡劑係由100至300重量份的酸性化合物和130至410重量份的鹼性化合物組成，且所述發泡劑在使用前以40°C至80°C條件下乾燥2至4小時，過40至100目篩。所述酸性化合物和鹼性化合物優選為：酸性化合物200重量份、鹼性化合物270重量份；或酸性化合物240重量份、鹼性化合物400重量份；或酸性化合物160重量份、鹼性化合物140重量份。
較佳地，上述的酸性化合物，可以是檸檬酸、酒石酸、富馬酸、己二酸、蘋果酸、抗壞血酸、水溶性氨基酸(例如精氨酸)稀鹽酸、硼酸、酒石酸氫鈉、酒石酸氫鉀、檸檬酸氫鈉、檸檬酸氫鉀、磷酸二氫鉀、磷酸二氫鈉的其中一種或其任意組合。且舉凡是可食用的有機酸、無機酸及其等溶於水後呈酸性的鹽類，均可以作為酸性化合物使用。在酸性化合物中以檸檬酸和/或酒石酸為佳。
較佳地，上述的鹼性化合物，可以是碳酸鈉、碳酸氫鈉、碳酸鉀、碳酸氫鉀、碳酸鈣、甘氨酸碳酸鈉、甘氨酸碳酸鉀的其中一種或其任意組合。且舉凡是可食用的鹼金屬或鹼土金屬的碳酸鹽、過碳酸鹽和碳酸氫鹽以及它們的混合碳酸鹽均可以作為能產生二氧化碳氣體的鹼性化合物，在鹼性化合物中以碳酸鈉、碳酸氫鈉、碳酸鉀、碳酸氫鉀至少其中的一種為佳。另外，在考量一天服用多次含鈉發泡劑，會使不宜多吃鈉的食用者帶來不良後果的情況下，則可考慮少用碳酸鈉、碳酸氫鈉，而改用碳酸氫鉀、碳酸鉀、碳酸鈣、碳酸鋅等不含鈉或含鈉低的二氧化碳源代替。
較佳地，本發明的高分子吸水材為聚丙烯酸鈉，且所述高分子吸水材經超微粉碎達300目以上，在40°C至80°C條件下乾燥2至5小時。
而本發明的核心層潤滑劑主要由20至60重量份的內加潤滑劑和2至6重量份的外加潤滑劑所組成。較佳地，所述內加潤滑劑為聚乙二醇4000或聚乙二醇6000，外加潤滑劑則為硬脂酸鎂、滑石粉或亮氨酸L型或亮氨酸DL型的其中一種或其任意組合，而所述的內加潤滑劑和外加潤滑劑優選為：內加潤滑劑40重量份和外加潤滑劑4重量份，或內加潤滑劑25重量份和外加潤滑劑5重量份，或內加潤滑劑57重量份和外加潤滑劑3重量份。
本發明核心層11的製備方法為：依上述配方比例將發泡劑、高分子吸水材、內加潤滑劑混合，過篩(依產品需求)，混勻，加240重量份的無水乙醇製軟材，經過篩(依產品需求)制粒後，在40°C至80°C條件下乾燥，使混合物顆粒含水率達到3%以下，接著過篩整理(依產品需求)，再添入外加潤滑劑混勻後，即可製得本發明呈顆粒狀之核心層11。
接著，就本發明之包覆層21各組成物說明如下，其中：
該包覆層21主要由重量比10%至40%的可食性吸水膠體、5%至40%的功能性健康食品添加物、2%至30%的乳化劑、4%至15%的包覆層潤滑劑及5%至40%的膜衣組成物所組成。包覆層21中之可食性吸水膠體包括天然產生的材料，例如植物分泌物、種子膠和海藻提取物，或者亦可以是化學改性的材料，例如改性的纖維素、澱粉或天然橡膠衍生物。在可行的實施方案中，可食性吸水膠體可由果膠、蒟蒻粉、阿拉伯膠、卡拉膠、海藻酸鹽、洋菜、關華豆膠、黃原膠、刺槐豆膠、明膠、結蘭膠（gellangum)、半乳甘露聚糖、黃蓍膠、刺梧桐樹膠、可得然膠（curdlan)、殼聚糖、木葡聚糖、β-葡聚糖、帚叉藻膠(furcellaran)、達瓦樹膠（Ghattigum)、圍涎樹膠（tamarin)、細菌膠、海藻酸丙二醇酯、羧甲基洋槐豆膠、低甲氧基果膠、乳化鈣與果膠混合物、改性的微晶纖維素、改性的羧甲基纖維素（CMC)、改性的甲基纖維素（MC)、改性的羥丙基甲基纖維素（HPCM)以及改性的羥丙基纖維素（MPC)的其中一種或其任意組合。
而包覆層21中之功能性健康食品添加物包括但不限於對人體有益的纖維素、益生菌或維生素，以及所有可幫助消化、提高新陳代謝、促進脂肪燃燒、幫助排便順暢、抑制醣類及油脂吸收等對人體有益的添加物。
而包覆層21中之膜衣組成物，經設計可在胃的酸性環境中保持完整不被消化並可吸收胃裡面的水份，但可在腸之較鹼性環境中溶解，此膜衣組成物包含成膜劑、抗黏劑及溶劑。其中，成膜劑可包含但不限於蟲膠甲基纖維素、乙基纖維素、丙基甲基纖維素、羥丙基甲基纖維素鄰苯二甲酸酯(Hydroxypropyl Methyl Cellulose Phthalate；HPMCP)、果膠、海藻膠、海藻酸鈉、羥丙基纖維素、羥丙基甲基纖維素、羥乙基纖維素、聚乙烯吡咯啶酮、聚乙二醇、甲基丙烯酸胺基烷酯共聚物、麥芽糊精及聚葡萄糖的其中一種或其任意組合。優選的，具有胃不溶性的成膜劑為海藻酸鈉。另基於膜衣組成物之使用量為100重量百分比，此膜衣組成物包含1％至25％之成膜劑、0.5％至15％之抗黏劑，以及60％至95％之溶劑。
此外，可進一步在包覆層21中添加乳化劑，可食性吸水膠體與乳化劑的質量比可為7：1，所述乳化劑可特別選自卵磷脂、甘油的脂肪酯、蔗糖或山梨糖醇，以可因應存在高含量的蛋白質或油脂之使用環境。且進一步地，根據生產需要加入便於制粒的包覆層潤滑劑，所述包覆層潤滑劑為聚乙二醇4000、聚乙二醇6000、十二烷基硫酸鈉、十二烷基硫酸鎂、L-亮氨酸、苯甲酸鈉、油酸鈉、氯化鈉、醋酸鈉、硼酸、硬脂酸鎂、滑石粉、微粉矽膠、蔗糖脂肪酸酯和硬脂醯富馬酸鈉、亮氨酸L型或亮氨酸DL型中的一種或其任意組合。
較佳地，本發明包覆層21用以包覆於核心層表面的方法，可藉由習用藥理學技術以製成顆粒狀結構。習用藥理學技術包括例如以下方法中之一者或其組合：(1)乾式混合，(2)直接壓縮，(3)研磨，(4)乾式或非水粒化，(5)濕式粒化，(6)熔融，或(7)擠出／滾圓；其他方法例如常用的溶劑蒸發法(如：噴霧乾燥法、分層或流化床造粒法、旋轉盤、三相乳化技術等)，適合利用溶劑蒸發法的較佳溶劑包括醇類(例如：甲醇、乙醇、正丙醇、異丙醇及丁醇)、酮類(例如：丙酮、甲基乙基酮及甲基異丁基酮)、酯類(例如：乙酸乙酯及乙酸丙酯)及各種不同其他溶劑，如：異丙醚、乙腈、二氯甲烷、氯仿、己烷、甲苯、四氫呋喃、環狀醚類，及1,1,1-三氯乙烷；亦可使用低揮發性溶劑，如：二甲基乙醯胺或二甲亞碸。亦可使用溶劑之混合物，如：20%乙醇與80%丙酮及其與水之混合物。
以上述各組成物所製成之本發明可膨脹微膠囊10，透過在其核心層11中加入高分子吸水材，可及時除去不可避免的酸鹼反應所產生的水，使核心層中發泡劑的顆粒表面可得到隔離，並保持乾燥的狀態，阻止酸鹼反應，從而解決發泡劑存在易吸潮脹氣不穩定的問題，且在實際作用下，更可確保發泡劑吸水後發泡速度快之功效，另一方面透過高分子吸水材吸水後，可以幫助穩定包覆層的膠體形狀，而具有優良的成型效果。
本發明之可膨脹微膠囊10經食用而進入人體胃中時，藉由包覆層21的可食性吸水膠體吸收水份後會軟化，且其核心層11也會因吸收水份脹大，同時因核心層11中的發泡劑與水反應產生二氧化碳，使包覆於核心層11外的包覆層21可受發泡劑持續產生的二氧化碳鼓吹而快速膨脹變大(如第2圖所示)，如此一來，即可達到物理性脹大的效果，並藉此即可大幅增加食用者的飽足感，以進而抑制食慾；另一方面，透過包覆層21中具特定組成之膜衣組成物不會胃酸環境分解崩壞，因此可在胃中保持其膨脹型體，但當其進入腸道較鹼性環境中即會開始崩散，故，當食用者食用本發明可膨脹微膠囊10時，包覆層21中所含有的功能性健康食品添加物可延遲至腸道中始釋放出，而不會被胃酸所分解破壞，進而可提高被人體所吸收之濃度，以提升其功效。透過本發明所提供的可膨脹微膠囊具有可在人體胃中物理性脹大之特點，並藉此即可增加飽足感而抑制食慾，以達到減肥目的，且其不含有任何藥物成分，更可確保不會對人體造成任何不良副作用。
此外，本發明所提供之可膨脹微膠囊在實際應用上，食用者除了可直接食用預定數量的可膨脹微膠囊10，使其可在人體胃中物理性脹大以增加飽足感而抑制食慾，還可依需求將預定數量的可膨脹微膠囊10以前述習用藥理學技術，透過添加適當的黏合劑與有機溶劑製成如第3圖所示之錠狀，以方便食用者服用，其中黏合劑用以賦予將多個可膨脹微膠囊10相互黏結之作用，其包括例如海藻酸及其鹽；纖維素衍生物，例如羧甲基纖維素、甲基纖維素、羥丙基甲基纖維素、羥乙基纖維素、羥丙基纖維素、乙基纖維素(例如，微晶纖維素；微晶右旋糖；直鏈澱粉；矽酸鎂鋁；多糖酸；膨潤土；明膠；聚乙烯基吡咯啶酮/乙酸乙烯酯共聚物；交聯聚維酮；聚維酮；澱粉；預膠凝澱粉；黃蓍膠；糊精；糖，例如，蔗糖、葡萄糖、右旋糖、糖蜜、甘露醇、山梨醇、木糖醇及乳糖；天然或合成樹膠，例如阿拉伯樹膠(acacia)、黃蓍膠、甘地膠(ghatti gum) 聚維酮(povidone)、伊莎貝果殼黏液；聚乙烯基吡咯啶酮、聚甲基丙烯酸酯、松木多糖、聚乙二醇、丙二醇、聚氧化乙烯、蠟、海藻酸鈉亦包括(例如)、洋菜、褐藻酸、卡波姆、卡拉膠、瓜爾豆膠、鄰苯二甲酸乙酸纖維素、硬脂酸、長角豆(ceratonia)、聚維酮(povidone)中的一種或其任意組合。而所述有機溶劑則可選自乙醇、異丙醇、四氫呋喃、異丙醚、丙酮、甲乙酮、二氯甲烷或這些溶劑的混合物。
另如第4圖所示的本發明另一實施態樣，亦可先將預定數量的可膨脹微膠囊10裝填在由二外型對稱之半囊體31、32所對接組成的中空囊體3中，以方便食用者服用，該中空囊體3之成份係包含可由人體吸收之明膠或植物性成份，如甲基纖維素、羥丙基纖維素、丙基甲基纖維素等。
惟，以上實施例之揭示僅用以說明本發明，並非用以限制本發明，故舉凡數值之變更或等效元件之置換仍應隸屬本發明之範疇。
綜上所述，當可使熟知本項技藝者明瞭本發明確可達成前述目的，實已符合專利法之規定，故依法提出申請。
可膨脹微膠囊10
核心層11 包覆層21
半囊體31、32 中空囊體30
第1圖為本發明可膨脹微膠囊之組成結構示意圖。
第2圖為本發明可膨脹微膠囊之物理性脹大示意圖。
第3圖為本發明製成錠狀之組成結構示意圖。
第4圖為本發明另一實施態樣之組成結構示意圖。
可膨脹微膠囊10
核心層11 包覆層21
Claims (9)
- 一種可膨脹微膠囊，包含有：一核心層，由300重量份的發泡劑、250重量份的高分子吸水材和60重量份的核心層潤滑劑組成，且該發泡劑具有可與水反應而產生氣體之特性；一包覆層，包覆於該核心之表面以構成一顆粒狀結構，該包覆層由重量比10%至40%的可食性吸水膠體、5%至40%的功能性健康食品添加物、2%至30%的乳化劑、4%至15%的包覆層潤滑劑及5%至40%的膜衣組成物所組成，且該膜衣組成物具有抗胃酸分解而僅可在腸道中被分解之特性，該可膨脹微膠囊經食用而進入人體胃中時，藉由該核心層中的發泡劑與水反應產生氣體，使包覆於該核心層外的包覆層可受發泡劑持續產生的氣體鼓吹而膨脹變大。
- 如請求項1所述之可膨脹微膠囊，其中，該發泡劑係由100至300重量份的酸性化合物和130至410重量份的鹼性化合物組成，且該酸性化合物由檸檬酸或酒石酸至少其中一種構成，而該鹼性化合物由碳酸鈉、碳酸氫鈉、碳酸鉀、碳酸氫鉀至少其中一種構成。
- 如請求項1所述之可膨脹微膠囊，其中，該高分子吸水材為聚丙烯酸鈉，且該高分子吸水材經超微粉碎達300目以上，在40℃至80℃條件下乾燥至5小時。
- 如請求項1所述之可膨脹微膠囊，其中，該核心層潤滑劑由20至60重量份的內加潤滑劑和2至6重量份的外加潤滑劑所組成， 且該內加潤滑劑由聚乙二醇4000或聚乙二醇6000的其中一種或其組合所構成，而該外加潤滑劑由硬脂酸鎂、滑石粉或亮氨酸L型或亮氨酸DL型的其中一種或其任意組合所構成。
- 如請求項4所述之可膨脹微膠囊，其中，係將發泡劑、高分子吸水材、內加潤滑劑混合，再加240重量份的無水乙醇製軟材，經過篩制粒後，在40℃至80℃條件下乾燥，使混合物顆粒含水率達到3%以下，接著過再添入外加潤滑劑混勻後，以製得該核心層。
- 如請求項1所述之可膨脹微膠囊，其中，該可食性吸水膠體由果膠、蒟蒻粉、阿拉伯膠、卡拉膠、海藻酸鹽、洋菜、關華豆膠、黃原膠、刺槐豆膠、明膠、結蘭膠、半乳甘露聚糖、黃蓍膠、刺梧桐樹膠、可得然膠、殼聚糖、木葡聚糖、β-葡聚糖、帚叉藻膠、達瓦樹膠、圍涎樹膠、細菌膠、海藻酸丙二醇酯、羧甲基洋槐豆膠、低甲氧基果膠、乳化鈣與果膠混合物、改性的微晶纖維素、改性的羧甲基纖維素、改性的甲基纖維素、改性的羥丙基甲基纖維素、改性的羥丙基纖維素的其中一種或其任意組合所構成。
- 如請求項1所述之可膨脹微膠囊，其中，該膜衣組成物由重量百分比1%至25%之成膜劑、0.5%至15%之抗黏劑，以及60%至95%之溶劑所組成，且該成膜劑由蟲膠甲基纖維素、乙基纖維素、丙基甲基纖維素、羥丙基甲基纖維素鄰苯二甲酸酯、果膠、海藻膠、海藻酸鈉、羥丙基纖維素、羥丙基甲基纖維素、羥乙基纖維素、聚乙烯吡咯啶酮、聚乙二醇、甲基丙烯酸胺基烷酯共聚物、麥芽糊精及聚葡萄糖的其中一種或其任意組合所構成。
- 如請求項1所述之可膨脹微膠囊，其中，該乳化劑選自卵磷脂、甘油的脂肪酯、蔗糖或山梨糖醇其中一種。
- 如請求項1所述之可膨脹微膠囊，其中，該包覆層潤滑劑由聚乙二醇4000、聚乙二醇6000、十二烷基硫酸鈉、十二烷基硫酸鎂、L-亮氨酸、苯甲酸鈉、油酸鈉、氯化鈉、醋酸鈉、硼酸、硬脂酸鎂、滑石粉、微粉矽膠、蔗糖脂肪酸酯和硬脂醯富馬酸鈉、亮氨酸L型或亮氨酸DL型中的一種或其任意組合所構成。
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