TW201427715A - 內服液體組成物 - Google Patents
內服液體組成物 Download PDFInfo
- Publication number
- TW201427715A TW201427715A TW102134785A TW102134785A TW201427715A TW 201427715 A TW201427715 A TW 201427715A TW 102134785 A TW102134785 A TW 102134785A TW 102134785 A TW102134785 A TW 102134785A TW 201427715 A TW201427715 A TW 201427715A
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- Prior art keywords
- liquid composition
- polyoxyethylene
- water
- vitamin
- examples
- Prior art date
Links
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Classifications
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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Abstract
本發明係提供一種內服液體組成物,其特徵為含有a)難溶於水的維他命、油成分、或生藥萃取物、b)選自聚氧乙烯月桂基醚、聚氧乙烯植物固醇以及聚氧乙烯植物甾烷醇中之一種以上、以及c)多元醇類,且此內服液體組成物為即使於低pH值,亦不會產生混濁、沈澱,且可使難溶於水的維他命、油成分,或生藥萃取物長時間安定地溶解之內服液體組成物。
Description
本發明係有關使難溶於水的維他命、油成分,或生藥萃取物於液體組成物中長時間安定地溶解之內服液體組成物。
將難溶於水的維他命、油成分等難溶於水的成份與生藥萃取物,於低pH下摻混於飲料劑等飲料時,必需要有可溶化劑。難溶於水的成份需要可溶化劑是理所當然,且在生藥萃取物中,因水解而產生長期性的混濁與沈澱,也必須有可溶化劑。且,飲料劑等飲料以防腐性與風味等觀點來看,低pH為適合。
然而,摻混於食品與醫藥品等可經口的可溶化劑,較多在低pH範圍中長期保存時,會發生來自可溶化劑的混濁與沈澱之課題(專利文件1)。
〔專利文件1〕日本特開2002-128703
因此,本發明之課題為:提供一種即使於低pH值,亦不會產生混濁、沈澱,且可使難溶於水的維他命、油成分、或生藥萃取物長時間安定地溶解之內服液體組成物。
本發明者們為解決相關課題重複進行專心檢討後,發現使用選自聚氧乙烯月桂基醚、聚氧乙烯植物固醇以及聚氧乙烯植物甾烷醇中之1種以上作為可溶化劑,進而藉由摻混多元醇類,可使難溶於水的維他命、油成分、或生藥萃取物長時間安定地溶解。
以相關知識為基礎而完成之本發明之實施方式係:
(1)一種內服液體組成物,其特徵係含有a)選自難溶於水的維他命、油成分、以及生藥萃取物中之一種以上、b)選自聚氧乙烯月桂基醚、聚氧乙烯植物固醇以及聚氧乙烯植物甾烷醇中之一種以上、以及c)多元醇類。
(2)如(1)之內服液體組成物,其pH值係2.0~4.0。
(3)如(1)或(2)項之內服液體組成物,其中多元醇類係含有選自甘油、以及山梨糖醇中之一種以上。
(4)如(1)~(3)項中任一項之內服液體組成物,其中b)及c)成分之摻混量,相對於1質量份之a)
成分之摻混量,為0.02~500質量份。
利用本發明,可獲得使難溶於水的維他命、油成分、或生藥萃取物長時間安定地溶解之透明的內服液體組成物。
本發明中使用的難溶於水的維他命係指:可內服的難溶於水的維他命,例如可舉出維他命E、維他命E脂肪酸酯等維他命E衍生物(例如乙酸生育酚)、維他命A、維他命D、維他命K。油成分係指:具有生理活性的脂溶性物質與香料(合成香料、天然香料)、精油類等可內服者,具有生理活性的脂溶性物質可舉出例如γ-榖維素、γ-亞麻油酸、葉黃素、甘蔗原素(polycosanol)、CoQ10、神經醯胺、白藜蘆醇、蝦紅素、亞麻仁油、EPA、辣椒萃取物以及胡椒萃取物等,香料(合成香料、天然香料)、精油類則可舉出例如檸檬醛、檸檬烯等合成或來自天然的香料或精油類。難溶於水的維他命、油成分係可單獨摻混,亦可組合2種以上而進行摻混。並未特別限定於內服液體組成物中該等物質之摻混量,較佳係0.0001至1質量%,更佳係0.001至0.5質量%,最佳係0.002至0.05質量%。
本發明中使用之生藥萃取物係萃取末、萃取萃取物、
流浸膏劑等,只要是可內服者則無特別限制,生藥可舉出例如人參、黃耆、黃精、甘草、紅棗、陳皮、白朮、山藥、茯苓、砂仁、地黃、當歸、枸杞、何首烏、龍眼肉、芍藥、川芎、肉蓯蓉、蛇床子、菟絲子、杜仲、鹿茸、淫羊藿、海狗腎、冬蟲夏草、海馬、遠志、薏苡仁、山茱萸、五味子、生薑、柴胡、桂皮、反鼻、晃晃木(Muira Puama)、麥門冬、牛黃、女貞子等。該等中藥可單獨摻混,亦可組合2種以上而進行摻混。並未特別限定於內服液體組成物中該等之摻混量,較佳係0.0001至1質量%,更佳係0.001至0.5質量%,最佳係0.002至0.05質量%。
本發明中使用之聚氧乙烯月桂基醚係聚氧乙烯的附加莫耳數為5~50莫耳,且聚氧乙烯植物固醇、聚氧乙烯植物甾烷醇係聚氧乙烯的附加莫耳數為5~50莫耳之聚氧乙烯植物固醇。具體而言,可舉出聚氧乙烯(25莫耳)月桂基醚、聚氧乙烯(5莫耳)植物固醇、聚氧乙烯(10莫耳)植物固醇、聚氧乙烯(20莫耳)植物固醇、聚氧乙烯(30莫耳)植物固醇、聚氧乙烯(25莫耳)植物甾烷醇等,該等可單獨摻混,亦可組合2種以上而摻混。
選自聚氧乙烯月桂基醚、聚氧乙烯植物固醇以及聚氧乙烯植物甾烷醇之1種以上的摻混量係無特別限制,相對於選自難溶於水的維他命、油成分以及生藥萃取物之1種以上的1質量分,一般以0.02~500質量分為佳,更佳係0.05~200質量分,最佳係0.5~100質量分。聚氧乙烯月
桂基醚、聚氧乙烯植物固醇以及聚氧乙烯植物甾烷醇的摻混量少時,生成混濁與沈澱,無法獲得商品性佳且安定的液體組成物。
本發明中使用的多元醇類可舉出例如選自乙二醇、丙二醇、1,3-丁二醇、二丙二醇、異戊二醇、聚乙二醇、甘油、聚甘油、二甘油以及山梨糖醇之1種以上。該等多元醇類中以選自甘油以及山梨糖醇之1種以上為佳,多元醇類的摻混量係無特別限制,相對於選自難溶於水的維他命、油成分以及生藥萃取物之1種以上的1質量分,一般以0.02~500質量分為佳,更佳係0.05~200質量分,最佳係1~100質量分。
本發明之內服液體組成物於長時間保存後亦為透明的狀態,進而即使於長時間保存後的低溫環境下亦不會產生沈澱,而維持於透明的狀態。此處,低溫係意指較佳係10℃以下,進而更佳係5℃以下。
本發明之內服液體組成物的pH,自風味之觀點以及防腐性之觀點,以2.0~4.0為佳。pH的調整係可使用例如檸檬酸、蘋果酸、富馬酸、酒石酸、乳酸以及琥珀酸等有機酸,或該等有機酸之鹽、磷酸、鹽酸等無機酸、氫氧化鈉等無機鹽基。本發明之內服液體組成物除了醫藥品以及準醫藥品之外,係可利用為營養功能性食品、特定保健用食品等食品領域內之內服液劑。
本發明之內服液體組成物中,可在不損及本發明效果的範圍內適當地摻混水溶性維他命類、礦物質類、胺基酸
類、蜂王漿、咖啡因等。另外亦可因應需要在不損及本發明效果的範圍內適當地摻混抗氧化劑、著色劑、香料、矯味劑、界面活性劑、溶解輔助劑、保存劑、甜味料等添加物。
並未特別限制本發明之內服液體組成物之製造方法。一般係將聚氧乙烯月桂基醚、聚氧乙烯植物固醇或聚氧乙烯植物甾烷醇、與難溶於水的維他命、油成分或生藥萃取物以及多元醇類等各成分,溶解於適量的純化水之後,調整pH,進而再加入純化水調整容量,因應需要能夠藉由施以過濾、滅菌處理,而進行製造。
以下,舉實施例、比較例以及試驗例,進而詳細說明本發明。
製造表1所示配方之內服液體組成物。首先,將聚氧乙烯月桂基醚、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例1~4。
製造表2所示配方之內服液體組成物。首先,將聚氧
乙烯植物固醇、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例5~10。
製造表3所示配方之內服液體組成物。首先,將聚氧乙烯植物甾烷醇、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例11~18。
製造表4所示配方之內服液體組成物。首先,將a)聚氧乙烯月桂基醚、b)維他命D、維他命K、乙酸生育酚、γ-榖維素中之1種或2種、c)甘油或山梨糖醇,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例19~22。
製造表5所示配方之內服液體組成物。首先,將a)聚氧乙烯植物固醇、b)維他命D、維他命K、乙酸生育酚、γ-榖維素中之1種或2種、c)甘油或山梨糖醇,於
90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例23~26。
製造表6所示配方之內服液體組成物。首先,將a)聚氧乙烯植物甾烷醇、b)維他命D、維他命K、乙酸生育酚、γ-榖維素中之1種或2種、c)甘油或山梨糖醇,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例27~31。
製造表7所示配方之內服液體組成物。首先,將聚氧乙烯月桂基醚、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解,其次摻混人參萃取物、甘草萃取物、陳皮萃取物之任1種與檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例32~34。
製造表8所示配方之內服液體組成物。首先,將聚氧乙烯植物固醇、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混人參萃取物、甘草萃取
物、陳皮萃取物之任1種與檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例35~37。
製造表9所示配方之內服液體組成物。首先,將聚氧乙烯植物甾烷醇、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混人參萃取物、甘草萃取物、陳皮萃取物之任1種與檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例38~40。
製造表10所示配方之內服液體組成物。首先,將聚氧乙烯月桂基醚、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液或1mol/L的鹽酸調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例41、42。
製造表11所示配方之內服液體組成物。首先,將聚氧乙烯植物固醇、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液或1mol/L的鹽酸調整pH。將該等填充
於玻璃瓶,施加蓋子,作為實施例43、44。
製造表12所示配方之內服液體組成物。首先,將聚氧乙烯植物甾烷醇、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液或1mol/L的鹽酸調整pH。將該等填充於玻璃瓶,施加蓋子,作為實施例45、46。
製造表13所示配方之內服液體組成物。首先,將聚氧乙烯氫化蓖麻油、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為比較例1~2。
製造表13所示配方之內服液體組成物。首先,將聚氧乙烯十六烷基醚(POE(30))、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為比較例3~4。
製造表13所示配方之內服液體組成物。首先,將聚氧乙烯十六烷基醚(POE(40))、乙酸生育酚、甘油,於90℃加溫混合後,以常溫的水溶解。其次摻混檸檬酸,以4mol/L的氫氧化鈉水溶液調整pH。將該等填充於玻璃瓶,施加蓋子,作為比較例5~6。
將實施例1~46、以及比較例1~6置於65℃的恆溫槽中保存4周後,於5℃下冷卻1天(表中係簡記作65℃-4W+5℃-1D),以目視觀察內服液體組成物中之沈澱以及浮游物。結果示於表1~13。且,沈澱以及浮游物的程度係以下述標準而判定。
性狀的觀察標準
無不溶物:-
有少量不溶物:+
有大量的不溶物:++
根據上述結果,藉由摻混選自聚氧乙烯月桂基醚、聚氧乙烯植物固醇、以及聚氧乙烯植物甾烷醇中之一種以上,可使難溶於水的維他命長時間安定地溶解,且確認於長期保存亦不會生成混濁與沈澱。
根據本發明,可期待提供一種內服液劑,其於醫藥品、準醫藥品或食品的領域中,作為含有難溶於水的維他命、油成分,或生藥萃取物之內服液劑。
Claims (4)
- 一種內服液體組成物,其特徵係含有a)選自難溶於水的維他命、油成分,以及生藥萃取物中之一種以上、b)選自聚氧乙烯月桂基醚、聚氧乙烯植物固醇以及聚氧乙烯植物甾烷醇中之一種以上、以及c)多元醇類。
- 如請求項1之內服液體組成物,其pH值係2.0~4.0。
- 如請求項1或2項之內服液體組成物,其中多元醇類係含有選自甘油、以及山梨糖醇中之一種以上。
- 如請求項1~3項中任一項之內服液體組成物,其中b)及c)成分之摻混量,相對於1質量份之a)成分之摻混量,為0.02~500質量份。
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