TWI457079B - 複維生素及礦物質補充劑 - Google Patents
複維生素及礦物質補充劑 Download PDFInfo
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- TWI457079B TWI457079B TW094109559A TW94109559A TWI457079B TW I457079 B TWI457079 B TW I457079B TW 094109559 A TW094109559 A TW 094109559A TW 94109559 A TW94109559 A TW 94109559A TW I457079 B TWI457079 B TW I457079B
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- pharmaceutically acceptable
- compound
- vitamin
- micrograms
- nutritional supplement
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Description
本發明係關於一種營養補充劑。本發明之特徵包含提供複維生素及/或礦物質補充劑之成分以及微量營養素以幫助減少人體中之膽固醇,及/或減少升半胱胺酸,及/或減少低-密度脂蛋白-膽固醇(LDL-C)之氧化作用。尤其,本發明係關於一種複維生素及/或礦物質補充劑,其包含至少一種已知之可減少膽固醇之成分。
長久以來已確立許多化學化合物,一般係指維生素及礦物質,可在維持個體健康狀態及/或治療特殊醫療適應症、甚至在供應相當少量時提供顯著之價值。多年來,已鑑別出許多此種維生素及礦物質。例如,維生素包含維生素A、C、D、E及維生素B群,以及礦物質包含鐵、鋅、鈣及鉻。人體無法合成大部分之此等維持人體健康所需之化合物。因此此等必須維生素與礦物質需要由外部來源獲得。兩種最常見之外部來源係食物及營養補充劑。食物係獲得必須營養素之一般主要來源;然而,多數人未食用一貫地提供維生素與礦物質之必須每日需求量之食物。因此,維生素與礦物質營養補充成為符合公認之醫療以及健康標準之經認可的方法。
儘管某些維生素與礦物質已經顯示為維持個體健康所需者,利用維生素與礦物質營養補充已提供包含微量營養素之可能性,雖然其非維持健康絕對所需,但對維持健康可提供顯著的利益。例如,Cooper等人之美國專利第6,361,800號提供一種複維生素補充品製劑其具有微量營養素之組成物,其目的為降低血漿升半胱胺酸濃度及血漿葡萄糖濃度。
高膽固醇之問題對許多個體來說都是一項顯著的健康考量。儘管許多藥物可治療此問題,大多數之常見藥物需要於醫生監督下使用且相當昂貴。當然在大幅提高或慢性提高膽固醇之情形下,醫生之照顧與此等藥物之使用係非常重要,但該藥物係當膽固醇濃度對健康造成嚴重威脅時才使用。
某些草本/天然維生素及/或礦物質及/或營養組成物含有植物固醇,該等經認為可幫助減少膽固醇之化合物可自商業上購得。然而,此等草本/天然產物組成物其在減少膽固醇方面之功效並不確定,因為每劑一般含有20至50毫克植物固醇。此劑量實質上低於FDA(食品藥物管理局)認可之可減少膽固醇濃度之植物固醇的有效劑量。於2003年2月14日公佈之21 CFR 101.83中,FDA指出:為降低罹患冠心臟病之風險,植物固醇之最低有效攝取量係800毫克/天。
因此,需要一種方便、實用以及價錢相對低廉之方式俾於膽固醇濃度對健康造成嚴重威脅前,幫助減少人體中之膽固醇濃度,及/或減少升半胱胺酸,及/或降低LDL-C之氧化作用。
本發明提供一種營養補充劑,其有助於提供維生素、礦物質及其他微量營養素之足量攝取,以預防疾病、防止營養流失以及因不當的飲食攝取模式及生活型態因素所造成之缺乏,且提供微量營養素以幫助減少人體中之膽固醇,及/或減少升半胱胺酸,及/或減少LDL膽固醇。本發明亦提供一種製備呈實用劑型之有效劑量的營養補充劑之方法以及提供減少人體中之膽固醇濃度及/或LDL膽固醇及/或升半胱胺酸之方法。
於一具體實施例中,本發明提供一種投予人類之營養補充劑,其包括:有效量之至少一種維生素,該維生素係選自由維生素A、維生素C、維生素E、維生素B6
、維生素B2
、葉酸及維生素B1 2
所組成之群組,以及有效量之至少一種降膽固醇劑,該降膽固醇劑係選自由植物固醇、植物甾烷醇(phytostanol)、甘蔗原素(policosanol)、以及司他汀類(statins)所組成之群組。
於一具體實施例中,本發明提供一種投予人類之營養補充劑,其包括:有效量之至少一種礦物質,該礦物質係選自由硒、鉻及鋅所組成之群組,以及有效量之至少一種降膽固醇劑,該降膽固醇劑係選自由植物固醇、植物甾烷醇、甘蔗原素、以及司他汀所組成之群組。
於一具體實施例中,本發明提供一種投予人類之複-維生素及礦物質營養補充劑,其包括至少一種選自由植物固醇、植物甾烷醇、甘蔗原素、以及司他汀所組成群之降膽固醇劑,其含量可有效減少膽固醇,以及包括有效量之維生素A、B2
、B6
、B1 2
、葉酸鹽(葉酸)、及E。該組成物可進一步包括至少一種有效量之茄紅素以及有效量之硒。
於另一具體實施例中,本發明提供一種投予人類之複-維生素及礦物質營養補充劑,其包括醫藥可接受形式之下列物質:至少約800毫克之植物固醇;至少約3500 I.U.之維生素A及/或維生素A前驅物;至少約60毫克之維生素C;至少約400 I.U.之維生素D;至少約30 I.U.之維生素E;至少約25微克之維生素K;約1.5毫克之維生素B1
;至少約1.7毫克之維生素B2
(核黃素);至少約20毫克之菸鹼酸;至少約5毫克之維生素B6
;至少約800微克之葉酸;至少約200微克之維生素B1 2
;至少約30微克之生物素;至少約10毫克之泛酸;至少約6毫克之鐵;約150微克之碘;至少約210毫克之鎂;至少約7.5毫克之鋅;至少約20微克之硒;至少約0.7毫克之銅;至少約2毫克之錳;至少約108毫克之鈣;至少約80毫克之磷;至少約75微克之鉬;至少約320微克之硼;至少約5微克之鎳;至少約2毫克之矽;至少約10微克之錫;至少約10微克之釩;至少約120微克之鉻;至少約64毫克之鉀;至少約78毫克之氯化物;至少約300微克之茄紅素;以及至少約250微克之黃體素。
本發明之另一具體實施例提供一種投予人類之複-維生素及礦物質營養補充劑,其包括醫藥可接受形式之下列物質:至少一種成分以幫助減少膽固醇、至少一種成分以幫助減少升半胱胺酸或幫助減少低-密度脂蛋白-膽固醇(LDL-C)以及約1300 I.U.至約10,000 I.U.之維生素A及/或維生素A前驅物;約200 I.U.至約2000 I.U.之維生素D;約0微克至約50微克之維生素K;約1.2毫克至約4.5毫克之維生素B1
;約5毫克至約40毫克之菸鹼酸;約0毫克至約550毫克之膽鹼;約0微克至約1400微克之葉酸;約0微克至約300微克之生物素;約0毫克至約16毫克之泛酸;約0毫克至約18毫克之鐵;約0微克至約300微克之碘;約0毫克至約100毫克之鎂;約3毫克至約15毫克之鋅;約0毫克至約2毫克之銅;約0毫克至約6毫克之錳;約0至約200毫克之鈣;約0毫克至約750毫克之磷;約0微克至約250微克之鉬;約0微克至約150微克之硼;約0微克至約100微克之鎳;約0毫克至約40毫克之矽;約0微克至約35微克之錫;約0微克至約25微克之釩;約0微克至約300微克之鉻;約0毫克至約125毫克之鉀;約0毫克至約120毫克之氯化物;約0至3克之Omega-3脂肪酸;約0至3克之茄紅素;約0至3克之玉米黃素(zeaxanthin);約0微克至約3克之黃體素。
有助於減少膽固醇之成分包括一或多種下列成分,其含量可有效減少膽固醇:呈游離或酯化形式之植物固醇、植物甾烷醇、或其等同物、甘蔗原素以及司他汀。適合的司他汀包含,例如,阿托發司他汀(atorvastatin)、普伐他汀(provastatin)、辛伐他汀(simvastatin)、洛伐他汀(lovastatin)或否伐他汀(flavastatin)。一般地,該複維生素及礦物質補充劑中係使用約0.8克至約3克之植物固醇、甾烷醇、或其等同物。該複維生素及礦物質補充劑中可使用最高達約200毫克之甘蔗原素。司他汀之用量可最高達80毫克以及其一般用量約為40毫克至約80毫克。更具體地,關於司他汀、普伐他汀以及辛伐他汀其用量較佳為約40毫克,以及、阿托發司他汀、洛伐他汀與否伐他汀其一般用量為約80毫克。
有助於減少升半胱胺酸之成分包括一或多種下列成分:最高達約40毫克之維生素B2
(核黃素);最高達約10毫克之維生素B6
;最高達約1毫克之葉酸;以及最高達約2毫克之維生素B12
。有助於減少升半胱胺酸之成分較佳為包括一或多種下列成分:約1.3毫克至約5.1毫克之維生素B2
(核黃素);最高達約1400微克約800微克之葉酸;約1毫克至約6毫克之維生素B6
;以及約2.4微克至約200微克之維生素B12
。
有助於減少低-密度脂蛋白-膽固醇(LDL-C)氧化之成分包括一或多種下列成分:最高達約2克之維生素C;最高達約800I.U.之維生素E;最高達約6克之茄紅素;以及最高達約350微克之硒。有助於減少低-密度脂蛋白-膽固醇(LDL-C)氧化之成分較佳為包括一或多種下列成分:約45毫克至約250毫克之維生素C;約20I.U.至約200I.U.之維生素E;約0微克至約3克之茄紅素;以及約0微克至約75微克之硒。
本文所述之組成物可進一步包含稀釋劑,例如鈣化合物、鎂化合物、微晶纖維素、澱粉或其組合。
本文所述之組成物亦可包含吸收劑,例如二氧化矽。某些具體實施例中該二氧化矽可經沉澱、煙燻或其組合。
本發明進一步提供一種減少人體中膽固醇濃度、減少升半胱胺酸、以及降低低-密度脂蛋白-膽固醇(LDL-C)氧化之方法,該方法係對人類投予本發明之組成物。
本發明進一步包含一種將具有至少一種植物固醇之營養補充劑錠劑化之方法,該方法包括:提供至少一種植物固醇以及至少一種稀釋劑;於高切變造粒條件下將該植物固醇及至少一種稀釋劑進行造粒,俾形成顆粒;研磨該顆粒;以及於該顆粒中添加吸收劑。
至於濕式造粒法,該方法復包括將該顆粒乾燥,以及較佳為於乾燥後加入吸收劑。流體床乾燥機係適合用於乾燥該顆粒之示範。
該方法包括將該顆粒壓縮成錠劑。該錠劑可以薄膜包覆,該薄膜之實例例如為聚乙烯醇(PVA)。
一具體實施例中營養補充劑之每日有效量包括兩顆錠劑,該兩顆錠劑之各個體積係小於2立方公分。
一具體實施例中營養補充劑之每日有效量包括四顆錠劑或較少,各錠劑之體積小於1.5立方公分。
某些具體實施例中該錠劑為橢圓形、卵形、修飾之卵形、或膠囊形。
或者該營養補充劑之每日有效量包括一或多個膠囊、一或多個可嚼式遞送單位、粉末、或囊袋(sachet)。
本發明提供一種營養補充劑,於一具體實施例中其係一種投予至人類之複維生素及礦物質營養補充劑,該補充劑具有至少一種有助於減少膽固醇之成分。該降膽固醇成分可包含植物固醇及/或甾烷醇、及/或司他汀、及/或甘蔗原素。某些具體實施例中,該營養補充劑進一步包含至少一種用於減少升半胱胺酸及/或減少低-密度脂蛋白-膽固醇(LDL-C)之成分。該複維生素及礦物質補充劑可包括一或多種下列物質:維生素A及/或維生素A前驅物;維生素C;維生素D;維生素E;維生素K;維生素B1
;維生素B2
(核黃素);菸鹼酸;維生素B6
;葉酸;維生素B12
;生物素;泛酸;鐵;碘;鎂;鋅;硒;銅;錳;鈣;磷;鉬;硼;鎳;矽;錫;釩;鉻;鉀;氯化物;膽鹼;茄紅素;以及葉黃素(lutein)。當規律地投予給人類時(例如,每天),本發明之組成物有助於適當攝取維生素及礦物質且提供其他微量營養素,以促進良好健康,其包含於該微量營養素有助於降低人體中之膽固醇濃度、及/或減少升半胱胺酸、及/或降低低-密度脂蛋白-膽固醇(LDL-C)氧化。於其他具體實施例中,該營養補充劑可包含一或多種維生素與至少一種降膽固醇成分之組合,或者包含至少一種礦物質與至少一種降膽固醇成分之組合。「營養補充劑」或「補充劑」係指任何或所有具體實施例(例如,具有至少一種降膽固醇劑之複維生素及礦物質補充劑、包括至少一種維生素及至少一種降膽固醇劑之組成物、或包括至少一種礦物質及至少一種降膽固醇劑之組成物)。於某些具體實施例中,該營養補充劑進一步包括其他可提供營養及/或對健康有益之活性物。本發明之較佳具體實施例係一種具有至少一種降膽固醇劑之複維生素及礦物質補充劑,此等補充劑提供一種簡單的方法,以滿足所缺乏之營養,及促使需要補充營養之個體使用補充劑。
本發明進一步提供一種製備固體劑型之方法,該固體劑型於一單位或符合人類使用方便之單位中包括有效量之營養補充劑成分。(例如,於一劑型中,每日有效量之至少一種維生素及/或礦物質補充劑與至少一種降膽固醇成分及/或礦物質補充劑與至少一種降膽固醇成分係包含於2至4顆錠劑中,該錠劑之大小實際上可讓成人吞入。)對一般補充營養缺乏提供之有效每日劑量所需之維生素及礦物質成分之數目及含量一般係構成實質上之錠劑體積。為了有助於減少膽固醇而於補充劑中提供額外成分,會進一步增加包含於劑型中之物質的體積。
當製備一種於實用劑量單位中含有顯著數目之有效量的維生素及礦物質與植物固醇之固體劑型時,特別具有挑戰性的係,例如,植物固醇之每日最低量須為800毫克才符合FDA之功效標準,而植物固醇係一種低總體密度之蠟狀物質。本發明人已藉由發展出一種製備方法(例如製造程序)而解決這些問題,該方法係採用造粒技術及/或利用稀釋劑及/或利用吸收劑賦型劑來製備一種錠劑劑型,該劑型較佳係於2至4顆錠劑中包含有效之每日所需量之營養補充劑成分,該錠劑之大小適合讓人吞入。
本文所使用之「降膽固醇劑」或「膽固醇減少劑」係指任何化合物、化合物之組合,包含任何萃取物或植物成分,於自然中發現或經處理過者,或合成之化合物,當其以有效量投予時具有降低膽固醇濃度之性質。
除非另行指定,本文具體指明之所有含量係以毫克為主。「I.U.」係代表國際單位。「mcg」係指微克,「mg」係指毫克,以及「g」係指公克。再者,應了解本文揭示之成分的含量係每日劑量而該每日劑量可包括一個劑量單位或多個劑量單位。
營養素之「有效劑量」係由美國食品藥物管理局(FDA)認可之該營養素每日所需之至少最低量,以提供健康或營養益處。吾等進一步注意到:在某些指導方針中,FDA建議應將複維生素及礦物質補充劑之每日劑量分成兩個劑量單位投予,且於一天中間隔一段時間再攝取。一般來說,係與進食或食物一起,例如每日兩次進食。雖然配入的是每日劑量但應了解:該每日劑量可分成多個劑量單位,以及此等單位可同時攝取或於一天中不同時間攝取。
一般來說,衍生自植物來源之固醇類及甾烷醇類係稱為植物固醇類及植物甾烷醇類。植物固醇類及植物甾烷醇類係天然的化合物,其可經常食用而作為健康飲食之一部分。此外,雖然由植物衍生得出之物質係此等化合物較佳之來源,實行本發明時亦可使用等同之合成的甾烷醇類及固醇類,或其他來源之甾烷醇類及固醇類。本文中所提出之任何關於使用植物固醇或植物甾烷醇類應可與其他來源之固醇類或甾烷醇類等同地加以應用。應了解:在討論該組成物之含量方面,固醇類或植物固醇類之含量應相近,反之亦然。應了解:在討論該組成物之含量方面,甾烷醇類或植物甾烷醇類之含量應相近,反之亦然。
多種特定化學物質被分類為植物固醇類,其包含但不限於例如β-轂甾醇、菜油固醇、以及豆甾醇。本發明之營養補充劑可採用單一特定化學種類之植物固醇、或為由多種特定化學種類之植物固醇組成之混合物。例如,具有β-轂甾醇、菜油固醇、以及豆甾醇為主要成分之植物固醇混合物係於實行本發明時適合使用之混合物實例。混合之植物固醇的商業製劑可自供應商購得,例如Cargill及ADM(Archer Daniels Midland)。同樣地,該植物甾烷醇類包含多種特定化學種類之植物甾烷醇類,以及單一特定化學種類之植物甾烷醇類、或多重特定化學種類之植物甾烷醇類之混合物均可用於實行本發明。因此,關於本文所討論之組成物中的植物固醇類或植物甾烷醇類應視為包含單一特定化學種類形式以及混合物。
食物例如水果、蔬菜、麵包及其他全穀類產品,以及多數植物油包含至少一些植物固醇類。然而,一天中難以消耗足量這些食物以得到足夠之植物固醇攝取量,從而獲得降膽固醇的效果。根據飲食中植物固醇之用途的臨床試驗之數據,FDA建議將每日攝取至少0.8克(800毫克)之植物固醇作為飲食之一部分,其可降低飽和脂肪及膽固醇而提供顯著的降膽固醇效果。攝取本發明之營養補充劑係一種確保每日可獲得有效攝取之方式。
咸信,因為其結構與膽固醇類似,經攝取之植物固醇類及甾烷醇類會與膽固醇競爭而降低小腸中膽固醇之吸收以及再吸收,但本發明人不願受限於理論。其重點係,於進食後,當小腸中游離形式之固醇(例如植物固醇)越多,則膽固醇會被吸收及再吸收者越少。再者,被消耗掉之植物固醇類、植物甾烷醇類、及其等同物係不被吸收至任何可察覺到之範圍。因此,咸信植物固醇類可抑制身體攝取膽固醇,以及其會通過身體而未被吸收。一研究顯示,其全面性之效果係可平均減少「壞的」低-密度脂蛋白-膽固醇(例如「LDL-C」)於血液中之濃度達8-15%,而未觀察到或確定有不良作用。(參見“Plant Sterol-Fortified Orange Juice Effectively Lowers Cholesterol Levels In Mildly Hypercholesterolemic Healthy Individuals.”Arterioscler.Thromb.Vasc.Biol.2004 Mar;24(3):e25-8.Epub 2004 Feb 05)較佳地,該複維生素及礦物質補充劑包括最高達約3克之游離形式或酯化形式之植物固醇類,以及更佳係包括至少約800毫克之植物固醇類。最佳地,該補充劑包括約800毫克之游離形式的植物固醇類。於某些具體實施例中,該植物固醇可由植物甾烷醇類取代,或可使用植物固醇類與植物甾烷醇類之組合。
甘蔗原素係長鏈之一級脂肪族飽和醇類之混合物的一般名稱,其可減少血清中總膽固醇以及低-密度脂蛋白-膽固醇(LDL-C)之濃度。甘蔗原素(policosanol)亦稱為polycosanol、policosanal、policosinal、policosinol、polycosanal、polycosinal及polycosinol。這些醇類係衍生自諸如甘蔗(Saccharum officinarium)及山芋類植物(例如Dioscorea opposita)等植物之蠟質。其亦於蜂蠟中發現。甘蔗原素中主要的長鏈醇係28個碳之1-二十八烷醇(1-octanosol),以及第二多的係30個碳之1-三十烷醇。其他長鏈醇類之含量較低,包括:1-二十二烷醇(C2 2
)、1-二十四烷醇(C2 4
)、1-二十六烷醇(C2 6
)、1-二十七烷醇(C2 7
)、1-二十九烷醇(C2 9
)、1-三十二烷醇(C3 2
)以及1-三十四烷醇(C3 4
)。這些長鏈醇類係固態的蠟狀物質且不溶於水。其共稱為脂肪族醇類。
已知甘蔗原素具有降膽固醇活性,但其作用機制未知,而本發明人不欲受限於任何理論。關於甘蔗原素作用方法之數種理論已於文獻中提出,其包含某些得自動物研究之結果,指出甘蔗原素可藉由間接調降HMG-CoA還原酶而於肝臟中抑制膽固醇之合成。(參見“Policosanol Safety Down Regulates HMG-CoA Reductase-Potential As A Component of the Esselstyn Regimen.”Med.Hypotheses. 2002 Sept;59(3):268-79)其他已提出之理論係甘蔗原素可削減在乙酸酯和甲羥戊酸酯產生步驟之間的膽固醇合成及/或增加受體-依賴性之LDL-C處理。(參見“Policosanol:Clinical Pharmacology and Therapeutic Significance of a New Lipid-Lowering Agent.”Am.Heart J. 2002 Feb;143(2):356-65)。其他已提出之理論係甘蔗原素亦可降低脂質之過氧化作用(參見“Effect of Policosanol on In Vitro and In Vivo Rat Liver Microsomal Lipid Peroxidation.”Arch.Med.Res.1997 Autumn;28(3):355-60)。咸信該長鏈醇類可顯露出不同的生物活性,例如二十八烷醇本身不會與甘蔗原素具有相同之活性,以及至少於某些例子中,甘蔗原素中之醇類的所有或某些組合可能具有協同作用。於一具體實施例中,甘蔗原素係包含於該複維生素及礦物質補充劑中。於含有甘蔗原素之複維生素及礦物質補充劑之具體實施例中,甘蔗原素之含量最高達約200毫克,以及較佳係含有約10至約20毫克之甘蔗原素。
司他汀類係包含阿托發司他汀、普伐他汀、辛伐他汀、洛伐他汀、以及否伐他汀,咸信司他汀會與3-羥基-3甲基戊二醯基CoA競爭,後文稱為HMGCoA還原酶抑制劑。因此,咸信司他汀可有效降低膽固醇,以及其不僅可有效預防一再發生之心臟病發作,亦可預防第一次的心臟病發作。在某些例子中,司他汀亦可降低中風之風險。於一具體實施例中,司他汀可包含於該複維生素及礦物質補充劑中。於含有司他汀之營養補充劑之具體實施例中,司他汀或司他汀混合物之含量最高達約80毫克,以及較佳係含有約5至約80毫克之司他汀或司他汀混合物。普伐他汀及辛伐他汀之含量較佳為約40毫克,以及阿托發司他汀、洛伐他汀與否伐他汀之含量較佳為約80毫克。
已知數種維生素及礦物質可有助於降低膽固醇、降低升半胱胺酸、以及降低低密度脂蛋白-膽固醇。藉由於複維生素及營養性礦物質補充劑中提供這些維生素及礦物質中之一種或其組合,本發明提供一種方便、實用及相對較便宜之方式來幫助降低人體中之膽固醇濃度,以及/或降低升半胱胺酸濃度,及/或減少LDL-C之氧化作用。
維生素C,亦已知為抗壞血酸,認為其係合成膠原所必需,以及可作為抗氧化劑。一般認為維生素C可對抗感染、降低發炎、癒合傷口、藉由降低LDL-C之氧化作用而降低心臟疾病之風險、降低膽固醇、降低肺癌、胃癌及食道癌之風險、減少子宮頸上皮細胞異常、抑制N-亞硝胺、以及降低感冒之嚴重性。該營養補充劑可包括最高達約2000毫克之維生素C,較佳為約45毫克至約250毫克,以及最佳為約60毫克之維生素C。
維生素E為維持細胞膜以及神經健康所需。維生素E可減輕熱潮紅、減輕***痛、幫助對抗纖維囊腫性***疾病、減少乳腺腫瘤、降低肺癌之風險、以及藉由減少LDL-C膽固醇之氧化作用而降低心臟病的風險。維生素E係一群相關物質之通稱,其包含α-生育酚、β-生育酚、γ-生育酚、以及δ-生育酚。此外,此四種化合物各具有「d」型(其係天然之形式)以及「d1」型(其係合成的形式)。本文包含維生素E所涵蓋之所有物質的所有形式。該營養補充劑可包括最高達約1500I.U.之維生素E,以及較佳係約15I.U.至
約800I.U.。最佳係該複維生素及礦物質營養補充劑可包括約20I.U.至200I.U.之維生素E。
該營養補充劑可包括一或多種維生素B複合物。營養補充劑中所包含之維生素B可包含硫胺素(維生素B1
)、核黃素(維生素B2
)、菸鹼酸(維生素B3
)、泛酸(維生素B5
)、吡哆醇(維生素B6
)、生物素、葉酸、以及鈷胺(維生素B12
)或其組合。維生素B係水溶性的。此等維生素中,已知B2
、B6
、及B12
(例如,或為鈷胺)可降低升半胱胺酸之濃度。然而,由於維生素B之一般地有益的性質,經思量後都將其用於本發明之一具體實施例中。
維生素B1
或硫胺素可幫助維持富含膠原之結締組織以及黏膜之健康,有助於保持平滑肌,有助於形成血球細胞,以及為適當的神經系統功能所需。該營養補充劑可包括約0.9毫克至約100毫克,較佳約1.2毫克至約4.5毫克以及最佳為約1.5毫克之硫胺素。
維生素B2
或核黃素為健康之頭髮、指甲以及黏膜所需,且涉及紅血球細胞形成,升半胱胺酸之降低,抗體之產生以及整體的生長。本發明之營養補充劑可包括最高達約40毫克之核黃素,較佳係約0.9毫克至約5.1毫克以及最佳係約1.3至1.7毫克之核黃素。
維生素B3
或菸鹼酸有助於生產大多數之性激素,擴張血管以及有助於維持血液循環。菸鹼酸係一群化合物之通稱,其展現菸鹼酸活性以及包含菸鹼醯胺及菸鹼酸。該營養補充劑可包括約5毫克至約500毫克之菸鹼酸,較佳係約
5毫克至約40毫克以及最佳係約20毫克之菸鹼酸如菸鹼醯胺。
維生素B6
或吡哆醇係與核糖核酸(RNA)及去氧核糖核酸(DNA)之產生、升半胱胺酸之減少、以及身體中之許多其他反應有關。吡哆醇係指且包含三種不同之化合物:吡哆醇、吡哆胺、以及吡哆醛。該營養補充劑可包括約1毫克至約10毫克之維生素B6
,較佳係約1毫克至約6毫克,以及最佳係約5毫克之維生素B6
。
葉酸係用於產生紅血球細胞、產生激素、以及合成DNA。該營養補充劑可包括最高達約1000微克之葉酸,較佳約0微克至約800微克之葉酸鹽(葉酸),以及最佳約800微克之葉酸。
維生素B12
(例如鈷胺)係為整體代謝、神經系統功能、葉酸之代謝、升半胱胺酸之減少、以及紅血球細胞之產生所需。鈷胺至少有三種活性形式:氰鈷胺(cyanocobalamin)、羥鈷胺(hydroxocobalamin)、以及硝鈷胺(nitrocobalamin)。該營養補充劑可包括最高達約2000微克之維生素B12
,較佳約2.4微克至約200微克,以及最佳約200微克之維生素B12
。
生物素係碳水化合物、蛋白質、及脂肪之代謝所需,以及為健康之皮膚與頭髮所需。該營養補充劑可包括最高達約900微克之生物素,以及較佳係約0微克至約300微克,以及最佳係約30微克之生物素。
泛酸,亦已知為維生素B5
,在產生腎上腺激素、增加整體能量、以及幫助食物轉換為能量方面係重要的。該營養補充劑可包括最高達約200毫克之泛酸,較佳係約0毫克至約10毫克,以及最佳係約10毫克之泛酸。
維生素A亦係經考慮而用於本發明之複維生素及礦物質補充劑。維生素A可預防夜盲症以及其他眼睛病症,保持皮膚水分以及彈性,維持健康之頭髮、皮膚、以及齒齦,降低乳癌之風險,幫助緩和***痛,降低肺癌之風險,維持細胞結構以及完整性,作為抗氧化劑以預防細胞老化,幫助預防感染,以及消除皮膚皺紋與太陽傷害之影響。維生素A係脂溶性維生素。維生素A係用於包含視黃醇、以及與類視色素有關之其他化學上類似之化合物。
實行本發明時,維生素A可以維生素A之形式、維生素A前驅物類胡蘿蔔素之形式(例如β胡蘿蔔素)、或其混合物之形式來提供。例如,於一般具體實施例中29%之維生素A可以β胡蘿蔔素之形式來提供,其他係以醋酸維生素A之形式來提供。本發明之營養補充劑可包括最高達約10,000I.U.之維生素A(包含維生素A前驅物),較佳係約1300I.U.至約5000I.U以及最佳係約3500I.U.之維生素A形式之維生素A、或維生素A與維生素A前驅物β胡蘿蔔素。
β胡蘿蔔素及其他類胡蘿蔔素係維生素原,亦即,維生素前驅物,且可轉換為身體所需之維生素或類-維生素物質。儘管類胡蘿蔔素包含黄體素、玉米黃素以及茄紅素,
此等成分之含量係於本文中特別指明,且本文列舉之任何含量的維生素A前驅物不應解釋為包含任何相當量之黄體素、玉米黃素以及茄紅素。
維生素D亦為一種必須礦物質,其可協助骨之礦物化作用及鈣化作用,預防兒童之佝僂病、預防成人之軟骨病、維持骨及牙齒之生長、以及降低血壓。維生素D係脂溶性的,以及其較佳形式為膽鈣化醇(cholecalciferol)或D3
。較佳地,該營養補充劑可包括最高達約2000I.U.之維生素D,以及較佳係約200至約400I.U.之維生素D。
維生素K係一種活性血液凝集劑,且可協助骨之生成作用。其亦有助於自動脈硬化斑中移除鈣。葉綠醌或K1
以及甲基萘醌(Menoquinone)或K2
係較佳之形式。該營養補充劑較佳係可包括最高達約1毫克之維生素K,更佳係約0微克至約90微克之維生素K以及最佳係約25微克之維生素K。
膽鹼為神經系統功能及腦功能所需。其對膽囊及肝臟之功能亦為重要。膽鹼有助於維持體內每一細胞周圍之膜的結構完整性,亦可於神經訊息傳導、膽固醇之運送、以及能量代謝中扮演一角色。於該營養補充劑中,膽鹼可以醫藥可接受之膽鹼鹽之形式提供,例如,重酒石酸鹽之形式。該營養補充劑可視需要包括最高達約3500毫克之膽鹼,以及較佳係約50毫克至約550毫克之重酒石酸膽鹼形式之膽鹼。
鐵係用於製造血紅素以及肌紅蛋白。於該營養補充劑中,鐵係以醫藥可接受之鐵化合物的形式配入。如本文所使用者,「醫藥可接受」係一種適用於人類而不會有不適當之副作用的成分,該副作用係例如刺激、毒性、以及過敏反應。有用之醫藥可接受之鐵化合物包含但不限於:反丁烯二酸亞鐵、硫酸亞鐵、羰基鐵、葡萄糖酸亞鐵、氯化亞鐵、乳酸亞鐵、酒石酸亞鐵、琥珀酸亞鐵、麩胺酸亞鐵、檸檬酸亞鐵、焦磷酸亞鐵、膽鹼異檸檬酸亞鐵、碳酸亞鐵、鐵-糖-羧酸複合物、及其組合。該營養補充劑可包括最高達約18毫克之以醫藥可接受之鐵化合物形式配入之鐵,以及較佳係約5毫克至約18毫克之鐵。
碘有助於代謝脂肪,其為適當之甲狀腺功能所需,且可減少***纖維囊腫病症。本發明之營養補充劑中,碘係以醫藥可接受之碘化合物形式配入。可使用之醫藥可接受之碘化合物包含但不限於:碘化鉀、碘化鈉及其組合。該營養補充劑可包括最高達約1100微克之以醫藥可接受之碘化合物形式配入之碘,較佳係最高達約150微克,以及最佳係約150微克之碘。
鎂係用於骨之形成及生長,預防骨質流失、鬆弛冠狀動脈,鎂係用於控制子癇前症(pre-eclampsia)、治療心律不整、以及控制糖尿病。於該營養補充劑中,鎂係以醫藥可接受之鎂化合物形式配入。可使用之醫藥可接受之鎂化合物包含但不限於:硬脂酸鎂、碳酸鎂、氧化鎂、氫氧化鎂、硫酸鎂、及其組合。該營養補充劑可包括最高達約400
毫克之以醫藥可接受之鎂化合物形式配入之鎂,較佳係最高達約350毫克,以及最佳係約100毫克之鎂。
鋅為適當之DNA及RNA形成作用所需,且為女性之生長、免疫力以及性發展所需。於本發明之複維生素及礦物質營養補充劑中,鋅係以醫藥可接受之鋅化合物形式配入。醫藥可接受之鋅化合物包含但不限於:硫酸鋅、氯化鋅、氧化鋅、及其組合。該營養補充劑可包括最高達約3毫克至約40毫克之以醫藥可接受之鋅化合物形式配入之鋅,較佳係約3毫克至約15毫克以及最佳係約15毫克之鋅。
硒可降低心臟病發作與心臟疾病之風險、降低癌症之風險、保護而對抗金屬中毒、且咸信其與維生素E在降低LDL膽固醇氧化作用上具有協同作用。醫藥可接受之硒化合物包含但不限於:硒酸鈉、硒代半胱胺酸、硒代甲硫胺酸或其他胺基酸螯合物、及其組合。該營養補充劑可包括最高達約400微克之硒,較佳係最高達約75微克以及最佳係約15微克至約75微克之硒,其係以醫藥可接受之形式配入之硒。
銅有助於維持血管彈性,為形成彈性蛋白及膠原所需,可作為鐵之氧化劑,以及為適當之維生素C的功能所需。該營養補充劑中,銅係以醫藥可接受之銅化合物形式配入。醫藥可接受之銅化合物包含但不限於:氧化銅、檸檬酸銅、硫酸銅、碳酸銅、葡萄糖酸銅、及其組合。該營養補充劑可包括最高達約10毫克之以醫藥可接受之銅化合
物形式配入之銅,以及較佳係約1.0毫克之以葡萄糖酸銅、硫酸銅或檸檬酸銅形式配入之銅。
鈣為身體建立及維持強壯之骨骼與牙齒、幫助神經傳導以及調節肌肉收縮與心跳所需。鈣會隨著脫落之皮膚、指甲、髮汗、尿及***物而流失。當攝取不足時,身體會自骨中移除鈣以得到該礦物質,其對骨密度有不良影響而使骨較容易受傷。醫藥可接受之鈣化合物包含但不限於:碳酸鈣、磷酸氫鈣、磷酸鈣、葡萄糖酸鈣、乳酸鈣、檸檬酸鈣、及其組合。該營養補充劑可包括最高達約1500毫克之鈣,較佳係最高達約200毫克以及最佳係約100毫克至約162毫克之鈣,其係以醫藥可接受形式配入。
身體中錳的濃度低時可能與糖尿病有關。因此錳在血糖濃度控制上扮演一角色。錳亦涉及胺基酸與某些維生素之代謝。醫藥可接受之錳化合物包含但不限於:氯化錳、硫酸錳、及其組合。該營養補充劑可包括最高達約12毫克之以醫藥可接受之形式配入之錳,較佳係該營養補充劑中可包括約0毫克至約4毫克之錳以及最佳係約1毫克之錳。
咸信矽係用於建立骨及結締組織之膠原。醫藥可接受之矽化合物包含但不限於:矽酸鈉、矽鋁酸鈉、二氧化矽、及其組合。該營養補充劑可包括約0毫克至約500毫克之以醫藥可接受之形式配入之矽,較佳係約0毫克至約60毫克之矽,以及最佳係約2毫克之矽。
鉬可幫助脂肪、碳水化合物及鐵適當地代謝,以及可保護而對抗某些癌症。醫藥可接受之鉬化合物包含但不限
於:鉬酸鈉、鉬胺基酸螯合物、及其組合。該營養補充劑可包括最高達約2000微克之以醫藥可接受之形式配入之鉬。較佳係該營養補充劑可包括約0微克至約75微克,以及最佳係該營養補充劑包括約75微克之鉬。
咸信釩涉及血液中之糖濃度的調節。醫藥可接受之釩化合物包含但不限於:酒石酸銨釩、偏釩酸鈉、硫酸氧釩(vanadyl sulfate)、及其組合。該營養補充劑可包括最高達約1.8毫克之醫藥可接受形式之釩,較佳係約6微克至約18微克之釩以及最佳係約10微克之釩。
硼係涉及礦物質之代謝。醫藥可接受之硼化合物包含但不限於:硼酸鈉、檸檬酸硼、硼胺基酸螯合物、及其組合。該營養補充劑可包括最高達約20毫克之以醫藥可接受之形式配入之硼,較佳係約0微克至約1.35微克之硼,以及最佳係約150微克至約350微克之硼。
鎳可活化或抑制某些酵素或激素之作用。醫藥可接受之鎳化合物包含但不限於:硫酸鎳。該營養補充劑可包括最高達約1.0毫克之以醫藥可接受之形式配入之鎳,較佳係約0微克至約100微克之鎳以及最佳係約5微克之鎳。
已知於人類體內可發現錫。於大鼠中,缺乏錫時可能會抑制生長。醫藥可接受之錫化合物包含但不限於:氯化亞錫。該營養補充劑可包括最高達約200微克之以醫藥可接受之形式配入之錫,較佳係約0微克至約10微克之錫以及最佳係約10微克之錫。
磷為骨骼發展所需,且係所有主要類型之生物化學化合物之成分。呈三磷酸腺苷中之磷酸形式的磷係重要的能量來源,為多數代謝過程所需。醫藥可接受之磷化合物包含但不限於:磷酸鈣、磷酸鈉、磷酸鉀、磷酸銨、磷酸甘油酯、及其組合之形式。該營養補充劑可包括最高達約1250毫克之磷,較佳係約0毫克至約750毫克,以及最佳係約109毫克之磷,其係以醫藥可接受之形式配入。
鉻可協助葡萄糖代謝之調節、用於合成脂肪酸及膽固醇、協助運送蛋白質、降低血液中LDL之濃度、以及提升血液中高密度脂蛋白之濃度。於該營養補充劑中,鉻係以醫藥可接受之鉻化合物之形式配入。有用之醫藥可接受之鉻化合物包含但不限於:氯化鉻、與酵母菌結合之鉻(yeast-bound chromium)、吡啶甲酸鉻、與菸鹼酸結合之鉻、以及其組合。該營養補充劑可包括最高達約10毫克之以醫藥可接受之形式配入之鉻,較佳係約0微克至約150微克之鉻,以及最佳係約120微克之鉻。
鉀為調節水分平衡、酸性程度、血壓及神經肌肉的功能所需。鉀亦為碳水化合物與蛋白質之代謝所需。於該營養補充劑中,鉀係以醫藥可接受之鉀化合物之形式配入。有用之醫藥可接受之鉀化合物包含但不限於:氯化鉀、硫酸鉀、甘油磷酸鉀、檸檬酸鉀、葡萄糖酸鉀、磷酸鉀、及其組合。該營養補充劑可包括最高達約3900毫克之以醫藥可接受之鉀化合物之形式配入之鉀,較佳約0毫克至約80毫克之鉀,以及最佳約50毫克至約80毫克之鉀。
已發現茄紅素可降低癌症之風險,且亦發現其可經由本身之抗氧化能力來減少LDL膽固醇氧化作用。茄紅素主要係於番茄、紅葡萄柚、西瓜、及其他來源中發現,且係一種類胡蘿蔔素。該營養補充劑可包括最高達約6克之茄紅素,較佳係約0微克至約3克之茄紅素以及最佳係約300微克之茄紅素。
黄體素及玉米黃素係類胡蘿蔔素之抗氧化劑,其有助於維持健康之視力,且發現其可降低癌症與心臟疾病之風險。已發現葉黃素可降低黃斑病變之風險且防止黃斑病變發展,該黃斑病變可造成65歲以上之患者失明。黄體素及玉米黃素主要係於黃玉米、蛋黃、菠菜、綠花椰菜及其他綠色葉菜類中發現。該營養補充劑可包括最高達約6克之醫藥可接受形式之葉黃素,較佳係約0微克至約3克之葉黃素以及最佳係約250微克之葉黃素。該營養補充劑可包括最高達約6克之醫藥可接受形式之玉米黃素,較佳係約0微克至約3克之玉米黃素以及最佳係約300微克之玉米黃素。
流行病學及干預試驗已證實:增加Omega-3脂肪酸之濃度對心血管有益。於近年Bucher等人(2002)之整合分析中看到Omega-3脂肪酸在隨機對照試驗中之效用。此分析包含以7951位病患進行11個試驗。Bucher等人之“N-3 Polyunsaturated Fatty Acids in Coronary Heart Disearch:A meta-Analysis of Randomized Control Trials;”Am.J.Med.;Mar.2002,112(4):pp 298-304。該試驗包含Omega-3脂肪酸之飲食及補充來源。在飲食及補充來源兩者中增加Omega-3脂肪酸攝取的族群中證實:其於統計上可顯著降
低30%之心臟猝死。該營養補充劑較佳係包括最高達約6克之Omega-3脂肪酸,較佳係約0克至約3克以及最佳係約1克之Omega-3脂肪酸。
氯化物為幫助體內維持離子與液體之平衡所需,且係胃與腸分泌物中之必需成分。有用之醫藥可接受之氯化物化合物包含不限於:氯化鈉、氯化鉻、氯化亞錫以及氯化鉀。該複維生素及礦物質營養補充劑較佳係包括最高達約100毫克之氯化物,更佳係約0毫克至約80毫克以及最佳係約50毫克至約75毫克之氯化物。
本發明之複維生素及礦物質營養補充劑係用於口服投予,且可以固體形式提供。除了活性物質外,該複維生素及礦物質營養補充劑可進一步包括賦形劑以及製程助劑,例如:吸收劑、稀釋劑、矯味劑、著色劑、安定劑、填充物、黏結劑、崩解劑、潤滑劑、濕潤劑、助滑劑、抗附著劑、糖或薄膜包覆劑、防腐劑、緩衝劑、人工甘味劑、天然甘味劑、分散劑、增稠劑、助溶劑等或其某些組合。
一般來說,本發明之劑型經考慮後係固體。然而,其可包含液體或半固體成分。本發明之適合的固體劑型包含但不限於:錠劑、薄膜衣片(caplet)、膠囊(包含軟凝膠膠囊),可嚼式劑型及囊袋等。每日之劑量可包含於單一遞送單位中、或包含於多個遞送單位中。若使用錠劑,可將每日劑量分配成多個遞送單位,例如,提供具有便於吞嚥之大小之錠劑。若使用多個遞送單位,其可一次投予或視需要於劑量期間(例如一般為一天)內間隔投予。目前FDA之指導方針中建議可將每日劑量進行分配、且於間隔之時間
投予兩劑量單位。然而,吾等注意到目前至少三個臨床研究顯示:每日一劑植物固醇類係有效的。(參見Plat J等人之Effects On Serum Lipids,Lipoproteins and Fat Soluble Antioxidant Concentrations of Consuption Frequency of Margarines and Shortenings Enriched With Plant Sterol Esters.Eur J Clin Nutr 2000,54:671-677;Matvienko OA等人之A Single Daily Dose of Soybean Phytosterols in Ground Beef Decreases Serum Total Cholesterol and LDL Cholesterol in Young Mildly Hypercholesterolemeic Men.Am J Clin Nutr 2002,76:57-64;以及Volpe,R.等人之Effects of Yogurt Enriched With Plant Sterols on Serum Lipids in Patients With Moderate Hypercholesterolemia.British Journal of Nutrition.2001;86:233-39.)
因此應了解:本文所揭示之維生素、礦物質以及降膽固醇劑之含量係每日劑量,且該劑量可以單一遞送單位形式予以遞送、或以多個遞送單位形式予以遞送。於某些具體實施例中,包裝之設計可用於幫助消費者識別該適當的每日劑量。
在含有固醇類(例如植物固醇)之錠劑組成物方面存在著一些挑戰。植物固醇具有蠟狀之天性,係疏水性的,一般於微製化(micronized)形式中不易流動且總體密度低。這些性質造成錠劑製造(製錠)過程中之問題,其包含但不限於:原料之挑選及黏附至壓型(tooling)、於壓縮期間原料黏附至壓製轉盤(press turntable)以及不良之錠劑重量管理。再者,因為植物固醇具有阻塞該研磨篩之傾向,故難以研磨植物固醇,除非進行冷凍-研磨。於本發明之前,含有高量植物固醇之錠劑一般顯示出不良之壓縮性,且一旦經壓縮成形,該錠劑之崩解速率緩慢,對該植物固醇於攝取時之遞送有不利的影響。吾人相信:錠劑及時地崩解在功效方面係重要的。在不欲受限於任何理論的情形下,本發明人認為,植物固醇於消化腔中主要係以顆粒形式來作用。
出人意外地,本發明人發現利用特定之造粒方法可產生於單一錠劑中含有至少二分之一之每日有效劑量之植物固醇、以及至少一種其他維生素或礦物質之錠劑,該錠劑之大小可讓人吞入。再者,本發明之錠劑崩解成原始之顆粒的時間與胃排空時間(gastric emptying time)一致,例如,吾人相信,本發明經壓縮之含植物固醇的錠劑實質上可於抵達胃腸腔前崩解。於一具體實施例中,將至少二分之一之每日有效劑量之植物固醇、以及至少二分之一之每日有效劑量之多種其他維生素與礦物質製錠於單一錠劑中,該錠劑之大小可讓人吞入,且該錠劑崩解之時間與胃排空時間一致。於一具體實施例中,本發明營養補充劑之每日有效劑量係包含於兩個錠劑中,各錠劑之體積較佳係小於約2立方公分。
另一具體實施例中,本發明營養補充劑之每日有效劑量係製錠於四個或以下之錠劑中,各錠劑之大小可讓人吞入。當每日有效劑量係包含於三或四個錠劑中時,各錠劑之體積較佳為約1.5立方公分或以下。
營養補充劑之錠劑的形狀係由數種可改善使用者依從度之因素促成。本發明人在不欲受限於理論的情況下相信:體積為約1.5立方公分或以下之橢圓形、卵形、經修飾之卵形、以及膠囊形狀的壓縮物較例如約1.5立方公分或以下之圓形壓縮物容易讓消費者吞入。某些例子中較易吞入之錠劑可能可改善使用者之依從度以符合服用規定。第1至3圖係顯示錠劑形狀之示範性具體實施例。熟習該項技藝者應了解此形狀係一示範且任何其他形狀皆可適用於實行本發明。
於一具體實施例中,可利用高切變濕式造粒方法來製備錠劑。於一示範性之高切變濕式造粒方法中,植物固醇係以至少一種稀釋劑進行造粒。該稀釋劑可包括一或多種本文所述之無機礦物質營養素,例如,鎂化合物、或鈣化合物、其他活性劑;無活性之稀釋劑例如,纖維素、纖維素衍生物、乳糖或其他糖類,多元醇類、澱粉、澱粉衍生物、其聚合物或混合物。利用一或多種無機礦物質營養素作為稀釋劑或部分稀釋劑時,可具有減少添加賦形劑之優點,且有助於形成較小之錠劑。磷酸氫鈣、以及氧化鎂係特定之鎂及鈣化合物之示例,兩者皆可作為營養素與作為稀釋劑。此等稀釋劑係示例用,且其他為熟習該項技藝者所知悉之稀釋劑及造粒成分或其混合物亦可用於該造粒作用中。可添加熟習該項技藝者所知悉之其他造粒作用賦形劑例如聚維酮、崩解劑、共-崩解劑、超-崩解劑、界面活性劑、助滑劑、潤滑劑及黏結劑。此外,其他活性物質例如低劑量之礦物活性物質可包含於造粒作用混合物中。於造粒作用中包含其他低劑量之活性物質僅可適度地提供該造粒性質,但加入該造粒作用混合物可有助於此等低劑量活性物質之均勻分布。於一示範性具體實施例中,將該混合物進行造粒作用其包括植物固醇、稀釋劑、黏結劑聚乙烯吡咯啶酮(PVP)、賦形劑交聚維酮、以及水。水係緩慢加入至其餘成分中同時於高切變造粒機中混合。
可視需要將該粒狀物乾燥。該乾燥可於例如流體床乾燥機中進行。將粒狀物磨成適當的顆粒大小。於一示範性具體實施例中,係使用0.05之篩子。然而,熟習該項技藝者應了解此係示範性之顆粒大小且可採用其他尺寸。研磨後,將經研磨之粒狀物與吸收劑混合。二氧化矽係適合之吸收劑之實例。熟習該項技藝者所知悉之其他可作為吸收劑之物質亦可用於實行本發明。
其他維生素、礦物質以及降膽固醇劑可與具有吸收劑之經研磨之粒狀物混合,混合順序較佳係當部分吸收劑與該粒狀物結合後再混合其他維生素、礦物質以及降膽固醇劑。此等添加成分可呈單一成分添加、呈混合物添加或其合併物添加。可視需要包含其他賦形劑例如調味劑、著色劑、安定劑、填充物、黏結劑、崩解劑、潤滑劑、研磨劑、助滑劑、抗附著劑、防腐劑、緩衝劑、甘味劑、分散劑、增稠劑、助溶劑等或其組合。
於混合後,該組成物可使用例如壓縮方法,而使該組成物形成錠劑。視需要使用錠劑包覆材料將該錠劑予以包覆,且該包覆方法係諸如熟習該項技藝者所知悉之方法。已發現植物固醇類之蠟狀性質會使薄膜-包覆材料要附著至錠劑核心變得困難。本發明人已發現利用含有聚乙烯醇之水性系薄膜-包覆系統可獲得令人滿意之附著性。再者,本發明人在不欲受限於理論的情況下相信:利用含有聚乙烯醇之薄膜-包覆產生較易吞嚥之錠劑可改善病患的服用順從度。
本發明人在不欲受限於理論的情況下相信:其發現依序混合該植物固醇粒狀物與要包覆或部分包覆該顆粒之吸收物有助於該錠劑之崩解。因此本發明人之發現解決了未處理之蠟狀植物固醇類易形成緊密物而延長崩解時間之不理想的問題。該未處理之緊密物化合物可能於通過胃腸道時若發生崩解的話,僅有少量崩解成原本之顆粒,而吾人相信,對藥效而言,該崩解作用是必須的。
本發明人進一步認為該吸收物顆粒之物理性質及大小可修正該錠劑之崩解速率。例如,本發明人已發現當該吸收物二氧化矽與植物固醇類是以1:8 w/w之比例使用時,可發現使用具有約0.2至0.3微米之顆粒大小且具有約200平方米/克之表面積的煙燻二氧化矽,其崩解速率較具有約7微米之顆粒大小且具有約300平方米/克之表面積的沉澱二氧化矽來得慢。本發明人認為:較佳係使用上述之沉澱二氧化矽作為立即釋放之植物固醇營養補充劑之吸收物,以及可將上述之煙燻二氧化矽作為調節崩解速率之吸收物。於某些具體實施例中顯示:該吸收物之物理性質及大小會影響崩解速率,較佳係使用混合之吸收物類型及/或顆粒大小,俾有助於得到理想之崩解曲線圖。雖然本文中係將二氧化矽作為吸收物,本發明人亦指出該二氧化矽亦可作為吸附劑(例如其可為吸著劑)。為了此揭示之目的,吸收物與吸附劑之區別並不嚴格,且提及吸收物應視為包含吸收物、吸附劑、吸著劑或其組合。
第4及5圖分別顯示本發明組成物於水及酸中崩解之兩實施例之示範性之崩解數據。第4及5圖中所有實例之崩解時間相當於胃腸道中之崩解時間。然而,崩解時間會根據所使用之二氧化矽的形式而改變,如第4及5圖所示。
本文所述之高切變造粒方法係製備本發明組成物之適當方法的範例。本發明人亦指出本文所述之濕式造粒方法不需要昂貴之冷凍-研磨。或者,可使用諸如乾式重擊(dryslugging)、乾式滾筒壓縮或擠壓之方法以製備本發明之組成物。
該營養補充劑可選擇性地以液體及/或半固體製劑來提供。除了該活性物質外,此等液體及/或半固體製劑可包含賦形劑及製程助劑例如:調味劑、著色劑、安定劑、緩衝劑、人工甘味劑、天然甘味劑、鉗合劑及/或螯合劑、分散劑、增稠劑、溶解劑、保濕劑、抗氧化劑、乳化劑、水、乙醇、甘油、丙二醇等或其相同組合。該複維生素製劑之單位劑量中活性物質之含量係根據特定應用以及活性成分之效力而異。
熟習該項技藝者知曉如何決定特定情況下之適當劑量。該複維生素及礦物質營養補充劑可選擇性地出現在控制釋放之配方中。
雖然本發明之組成物較佳係欲投予至人類,應了解該配方亦可用於動物方面之獸醫學應用。
實施例1複維生素及礦物質營養補充劑-表1提供本發明之示範性具體實施例之組成物。此組成物係有代表性且係本發明範疇中之多種組成物之一者,以及所提供之組成物係用於說明之目的。實施例1所例示之複維生素及礦物質營養補充劑係為每日劑量,且一般應投予一或多個劑量單位(例如一至四顆錠劑)。若使用多重劑量單位,一天中應一次服用或間隔時間服用。
實施例2複維生素及礦物質營養補充劑-表2提供本發明另一示範性具體實施例之組成物。此係本發明範疇中之組成物之另一代表性組成物,以及所提供之組成物係用於說明之目的。實施例2所例示之複維生素及礦物質營養補充劑係為每日劑量,且一般應投予一或多個劑量單位(例如一至四顆錠劑)。若使用多重劑量單位,一天中應一次服用或間隔時間服用。
實施例3複維生素及礦物質營養補充劑-表3提供本發明另一示範性具體實施例之組成物。此係本發明範疇中之組成物之另一代表性組成物,以及所提供之組成物係用於說明之目的。實施例3所例示之複維生素及礦物質營養補充劑係為每日劑量,且一般應投予一或多個劑量單位(例如一至四顆錠劑)。若使用多重劑量單位,一天中應一次服用或間隔時間服用。
採用下列濕式造粒方法製備含有多種維生素及礦物質營養補充成分及植物固醇之示範性複維生素及礦物質營養補充劑。
利用配有篩網之低能量震盪系統將植物固醇去團塊化(delumped)。然後將該去團塊化之植物固醇轉移至高切變造粒機並與MgO併合,以及於該造粒碗狀容器中加入磷酸鈣稀釋劑(其亦為活性物質)、ZnO低劑量礦物質活性物質、微晶纖維素、超級崩解劑以及聚乙烯吡咯啶酮黏結劑。造粒作用開始時以低速進行混合,且於混合時逐漸加入水俾形成可接受之顆粒。熟習該項技藝者知曉該可接受之顆粒的外觀及物理特性。
一旦得到可接受之顆粒,將該顆粒利用流體床乾燥機以入口溫度約為90℃之氣流進行乾燥。將該顆粒乾燥至水分含量不超過約1.5% w/w,其係在乾燥平衡時由紅外線損失所測定。
將經乾燥之顆粒冷卻,以及於適中之速度下使用0.050之篩網以刀向前進行研磨。將大約一半之經研磨的顆粒放置於斜面錐形攪拌機,接著以#20篩孔篩選二氧化矽。加入其餘經研磨的顆粒以及攪拌該混合物。
加入其他活性成分及賦形劑包含抗壞血酸以及維生素E醋酸酯、磷酸氫鈣(第二份)、氯化鉻、鉬酸鈉、氯化亞錫、偏釩酸鈉、硫酸亞鎳、硒酸鈉、硫酸錳、生物素、維生素K、核黃素、維生素B1
單硝酸鹽、碘化鉀、菸鹼醯胺、硫酸銅、泛酸鈣、鹽酸吡哆醇、葉酸、氰鈷胺、氯化鉀、反丁烯二酸亞鐵、維生素A醋酸酯、β胡蘿蔔素、維生素D3
、茄紅素、黃體素、交聯羧甲纖維素鈉、交聚維酮、以及微晶纖維素(第二份)且摻混約10分鐘。於組成物中加入經由#20篩網篩選之硬脂酸鎂以及持續摻混約1.5分鐘。
利用熟習該項技藝者所知悉之製錠技術使用卵形之製錠工具將如此所得之顆粒壓縮成錠劑。本發明人認為橢圓形、經修飾之卵形、以及膠囊形狀之壓縮物較類似體積之圓形壓縮物更易讓消費者吞入。此具體實施例中將每日有效劑量之植物固醇及所示之維生素及礦物質製成兩顆錠劑,各錠劑之體積約為1.2 cm3
。
然後使用包括聚乙烯醇之水系薄膜-包覆系統將錠劑包覆。
儘管上述本發明已藉由圖示及實施例之方式予以詳細說明以達清楚明瞭之目的,某些可實行之改變及修飾係顯而易見地包含於隨附之申請專利範圍之範疇中。上述實行本發明之態樣上的修飾對熟習該項技藝者來說係明顯地包含於下列申請專利範圍之範疇中。
第1圖係本發明組成物之示範性具體實施例之錠劑的端視圖;第2圖係本發明組成物之示範性具體實施例之錠劑的俯視圖;第3圖係本發明組成物之示範性具體實施例之錠劑的側視圖;第4圖係一圖表,其顯示本發明組成物之兩種示範性具體實施例之錠劑於水中崩解之數據;以及第5圖係一圖表,其顯示本發明之兩種示範性具體實施例之錠劑於酸中崩解之數據。
Claims (31)
- 一種營養補充劑,其包括:至少一種選自維生素A、維生素C、維生素B6 、維生素B2 、葉酸、維生素B12 、及維生素E之維生素;至少一種選自硒、鉻及鋅之礦物質;以及至少一種植物固醇;,其中該植物固醇之至少部分被二氧化矽包覆,且該植物固醇為游離型。
- 如申請專利範圍第1項之營養補充劑,其中該植物固醇為至少800mg。
- 如申請專利範圍第1項之營養補充劑,其進一步包括茄紅素及硒之至少一者。
- 如申請專利範圍第3項之營養補充劑,其中該植物固醇為至少800mg。
- 一種營養補充劑,該補充劑包括:至少800毫克之植物固醇;至少3500I.U.之維生素A及維生素A前驅物;至少60毫克之維生素C;至少400I.U.之維生素D;至少30I.U.之維生素E;至少25微克之維生素K;至少1.5毫克之維生素B1 ;至少1.7毫克之維生素B2 (核黃素); 至少20毫克之菸鹼酸;至少5毫克之維生素B6 ;至少800微克之葉酸;至少200微克之維生素B12 ;至少30微克之生物素;至少10毫克之泛酸;至少6毫克之以醫藥可接受之鐵化合物形式配入之鐵;至少150微克之以醫藥可接受之碘化合物形式配入之碘;至少40毫克之以醫藥可接受之鎂化合物形式配入之鎂;至少7.5毫克之以醫藥可接受之鋅化合物形式配入之鋅;至少20微克之以醫藥可接受之硒化合物形式配入之硒;至少0.7毫克之以醫藥可接受之銅化合物形式配入之銅;至少2毫克之以醫藥可接受之錳化合物形式配入之錳;至少108毫克之以醫藥可接受之鈣化合物形式配入之鈣;至少80毫克之以醫藥可接受之磷化合物配入之磷; 至少75微克之以醫藥可接受之鉬化合物配入之鉬;至少32微克之以醫藥可接受之硼化合物配入之硼;至少5微克之以醫藥可接受之鎳化合物配入之鎳;至少2毫克之以醫藥可接受之矽化合物配入之矽;至少10微克之以醫藥可接受之錫化合物配入之錫;至少10微克之以醫藥可接受之釩化合物配入之釩;至少120微克之以醫藥可接受之鉻化合物形式配入之鉻;至少64毫克之以醫藥可接受之鉀化合物形式配入之鉀,至少58毫克之以醫藥可接受之氯化物化合物形式配入之氯化物;至少300微克之以醫藥可接受之茄紅素化合物形式配入之茄紅素;以及至少250微克之以醫藥可接受之葉黃素化合物形式配入之葉黃素(lutein);其中該植物固醇之至少部分被二氧化矽包覆;且該植物固醇為游離型。
- 一種營養補充劑,該補充劑包括:800毫克至3克之植物固醇;1300I.U.至12,000I.U.之維生素A;45毫克至250毫克之維生素C;200I.U.至2000I.U.之維生素D; 20I.U.至200I.U.之維生素E;10微克至90微克之維生素K;1.2毫克至4.5毫克之維生素B1 ;1.3毫克至5.1毫克之維生素B2 (核黄素);0毫克至550毫克之膽鹼;5毫克至40毫克之菸鹼酸;1毫克至8毫克之維生素B6 ;0微克至1400微克之葉酸;2.4微克至400微克之維生素B12 ;0微克至300微克之生物素;0毫克至16毫克之泛酸;0毫克至18毫克之以醫藥可接受之鐵化合物形式配入之鐵;0微克至300微克之以醫藥可接受之碘化合物形式配入之碘;0毫克至100毫克之以醫藥可接受之鎂化合物形式配入之鎂;3毫克至15毫克之以醫藥可接受之鋅化合物形式配入之鋅;15微克至75微克之以醫藥可接受之硒化合物形式配入之硒;0毫克至10毫克之以醫藥可接受之銅化合物形式配入之銅; 0毫克至6毫克之以醫藥可接受之錳化合物形式配入之錳;0毫克至200毫克之以醫藥可接受之鈣化合物形式配入之鈣;0毫克至750毫克之以醫藥可接受之磷化合物配入之磷;0微克至250微克之以醫藥可接受之鉬化合物配入之鉬;0毫克至1.35毫克之以醫藥可接受之硼化合物配入之硼;0微克至100微克之以醫藥可接受之鎳化合物配入之鎳;0毫克至40毫克之以醫藥可接受之矽化合物配入之矽;0微克至35微克之以醫藥可接受之錫化合物配入之錫;6微克至25微克之以醫藥可接受之釩化合物配入之釩;0微克至300微克之以醫藥可接受之鉻化合物形式配入之鉻;0毫克至125毫克之以醫藥可接受之鉀化合物形式配入之鉀;0毫克至120毫克之以醫藥可接受之氯化物化合物 形式配入之氯化物;0克至3克之omega-3脂肪酸;0克至3克之以醫藥可接受之茄紅素化合物形式配入之茄紅素;0克至3克之以醫藥可接受之玉米黃素化合物形式配入之玉米黃素;以及0克至3克之以醫藥可接受之葉黃素化合物形式配入之葉黃素;其中該植物固醇之至少部分被二氧化矽包覆;且該植物固醇為游離型。
- 一種營養補充劑,該補充劑包括:最高達3克之植物固醇;最高達20毫克之甘蔗原素;最高達40至80毫克之司他汀類;最高達10,000I.U.之維生素A及維生素A前驅物;最高達2克之維生素C;最高達2000I.U.之維生素D;最高達1500I.U.之維生素E;最高達1毫克之維生素K;最高達100毫克之維生素B1 ;最高達40毫克之維生素B2 (核黄素);最高達500毫克之菸鹼酸;最高達10毫克之維生素B6 ; 最高達1.5毫克之葉酸;最高達2毫克之維生素B12 ;最高達900微克之生物素;最高達200毫克之泛酸;最高達3500毫克之以醫藥可接受之膽鹼化合物形式配入之膽鹼;最高達18毫克之以醫藥可接受之鐵化合物形式配入之鐵;最高達1100微克之以醫藥可接受之碘化合物形式配入之碘;最高達400毫克之以醫藥可接受之鎂化合物形式配入之鎂;最高達40毫克之以醫藥可接受之鋅化合物形式配入之鋅;最高達400微克之以醫藥可接受之硒化合物形式配入之硒;最高達10毫克之以醫藥可接受之銅化合物形式配入之銅;最高達12毫克之以醫藥可接受之錳化合物形式配入之錳;最高達1500毫克之以醫藥可接受之鈣化合物形式配入之鈣;最高達1250毫克之以醫藥可接受之磷化合物配入之 磷;最高達2000微克之以醫藥可接受之鉬化合物配入之鉬;最高達20毫克之以醫藥可接受之硼化合物配入之硼最高達1毫克之以醫藥可接受之鎳化合物配入之鎳;最高達500毫克之以醫藥可接受之矽化合物配入之矽,最高達200微克之以醫藥可接受之錫化合物配入之錫;最高達18毫克之以醫藥可接受之釩化合物配入之釩最高達10毫克之以醫藥可接受之鉻化合物形式配入之鉻;最高達3900毫克之以醫藥可接受之鉀化合物形式配入之鉀;最高達150毫克之以醫藥可接受之氯化物化合物形式配入之氯化物;最高達6克至之omega-3脂肪酸;最高達6克之以醫藥可接受之茄紅素化合物形式配入之茄紅素;最高達6克之以醫藥可接受之玉米黃素化合物形式配入之玉米黃素;以及 最高達6克之以醫藥可接受之葉黃素化合物形式配入之葉黃素;其中該植物固醇之至少部分被二氧化矽包覆;其中該植物固醇為游離型。
- 如申請專利範圍第1至7項中任一項之營養補充劑,其進一步包括稀釋劑。
- 如申請專利範圍第8項之營養補充劑,其中該稀釋劑係選自由鈣化合物、鎂化合物、微晶纖維素、澱粉以及其組合所組成之群組。
- 如申請專利範圍第1至7項中任一項之營養補充劑,其中該植物固醇之至少部分被二氧化矽包覆且係藉由下列步驟製備:提供至少一種游離型之植物固醇以及至少一種稀釋劑;以及於顆粒中添加吸收劑,其中該吸收劑為二氧化矽且該二氧化矽部分地包覆該植物固醇。
- 如申請專利範圍第1至7項中任一項之營養補充劑,其中該二氧化矽係選自由煙燻二氧化矽、沉澱二氧化矽以及其混合物所組成之群組。
- 如申請專利範圍第1至7項中任一項之營養補充劑,其中該補充劑之形式係選自錠劑、薄膜衣片(caplet)、膠囊、可嚼式劑型單位或囊袋(sachet)。
- 如申請專利範圍第12項之營養補充劑,其中該補充劑 係呈錠劑之形式。
- 如申請專利範圍第13項之營養補充劑,其中該錠劑係經包覆。
- 如申請專利範圍第14項之營養補充劑,其中該包覆係薄膜包衣。
- 如申請專利範圍第15項之營養補充劑,其中該薄膜包衣包含聚乙烯醇。
- 如申請專利範圍第1至7項中任一項之營養補充劑,其中每日有效量之營養補充劑包含2片錠劑,其中此2片錠劑之每一者具有少於約2立方公分的體積。
- 如申請專利範圍第1至7項中任一項之營養補充劑,其中每日有效量之營養補充劑包含4片或以下之錠劑,其中各錠劑之每一者具有少於1.5立方公分的體積。
- 如申請專利範圍第17項之營養補充劑,其中該錠劑為長橢圓形、囊狀、經修飾卵形、或卵形。
- 如申請專利範圍第19項之營養補充劑,其中該錠劑經包含聚乙烯醇的薄膜包衣包覆。
- 如申請專利範圍第18項之營養補充劑,其中該錠劑為長橢圓形、囊狀、經修飾卵形、或卵形。
- 如申請專利範圍第21項之營養補充劑,其中該錠劑經包含聚乙烯醇的薄膜包衣包覆。
- 一種製造用於製作如申請專利範圍第1至22項中任一項之營養補充錠劑之顆粒之方法,該營養補充錠劑包括 至少一種植物固醇,該方法包括:提供至少一種游離型之植物固醇以及至少一種稀釋劑;於高切變造粒條件下將該植物固醇以及該至少一種稀釋劑加以造粒,以形成顆粒;研磨該顆粒;以及於該顆粒中添加吸收劑,其中該吸收劑為二氧化矽且該二氧化矽部分地包覆該植物固醇,然後可選擇摻混其他適合的成份於該顆粒;以及壓縮該顆粒以形成錠劑。
- 如申請專利範圍第23項之方法,其進一步包括添加至少一種營養素,該營養素係選自由維生素與礦物質及其混合物所組成之群組。
- 如申請專利範圍第23項之方法,其進一步包括將該顆粒乾燥。
- 如申請專利範圍第25項之方法,其中該乾燥係於流體床乾燥機中進行。
- 如申請專利範圍第23項之方法,其中該稀釋劑包括至少一種礦物質。
- 如申請專利範圍第23項之方法,其中至少部分之稀釋劑係選自鈣化合物、鎂化合物或其組合。
- 如申請專利範圍第23項之方法,其中該二氧化矽係選自由煙燻二氧化矽、沉澱二氧化矽以及其混合物所組成 之群組。
- 如申請專利範圍第23項之方法,其中一旦形成錠劑即予以包覆。
- 如申請專利範圍第30項之方法,其中該錠劑係以薄膜包衣包覆,該薄膜包衣包括聚乙烯醇。
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