TW201902464A - 無縫膠囊薄膜用組合物及無縫膠囊 - Google Patents
無縫膠囊薄膜用組合物及無縫膠囊 Download PDFInfo
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- TW201902464A TW201902464A TW107119548A TW107119548A TW201902464A TW 201902464 A TW201902464 A TW 201902464A TW 107119548 A TW107119548 A TW 107119548A TW 107119548 A TW107119548 A TW 107119548A TW 201902464 A TW201902464 A TW 201902464A
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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Abstract
本發明的課題在於提供一種高品質的無縫膠囊,其薄膜厚度的均勻性良好,且於薄膜中幾乎無泡眼。 本發明的薄膜用組合物包含:從洋菜、鹿角菜苷及結蘭膠所組成的群組中選擇的至少一種多糖類,及PVA共聚物;前述PVA共聚物的構成單位包含:(i)聚乙烯醇;(ii)從丙烯酸、甲基丙烯酸、反丁烯二酸及順丁烯二酸所組成的群組中選擇的至少一種不飽和羧酸;以及(iii)從式[I]所示的化合物所組成的群組中選擇的至少一種不飽和羧酸酯; H2C=C(R1)-COOR2[I] (式中,R1表示氫原子或甲基,R2表示具有1至4個碳原子的烷基。)。藉由利用前述薄膜用組合物來製造無縫膠囊,可達成課題。
Description
本發明是關於一種無縫膠囊的薄膜用組合物(以下有時稱為「本件薄膜用組合物」),其包含從洋菜、鹿角菜苷及結蘭膠所組成的群組中選擇的至少一種多糖類(以下有時稱為「洋菜等」),及特定的聚乙烯醇共聚物(PVA共聚物)。
膠囊廣泛利用於藥品、食品、類藥品等領域。膠囊包括軟膠囊(soft capsule)及硬膠囊。無縫膠囊為軟膠囊的一種,利用在油水界面產生的張力及殼體基材的凝膠化特性來製造。無縫膠囊具有粒徑的選擇範圍廣、膠囊薄膜的膜厚或膜硬度的選擇範圍廣、膠囊溶解時間的選擇範圍廣等各種優點。
在無縫膠囊的製造中,為了抑制泡眼(在薄膜中產生的內容物液滴)或厚薄不均(薄膜的厚度依膠囊的部位顯著不同的狀態),以獲得高品質的膠囊,亦將界面張力調整劑或凝膠化促進劑(例如油脂、磷脂質、乙醇等極性有機溶劑)調配於薄膜用組合物或膠囊內容物中。又,明膠在體內的溶解性優異,可迅速崩解而釋出內容物,利用明膠來作為形成無縫膠囊的殼體(薄膜)形成材料(薄膜用組合物)。然而,由於明膠具有胺基,因此當膠囊內容物中,存在有還原糖或巨環內酯類抗生素等包含醛基的物質,或經時性地反應而產生醛的物質時,在保存中,明膠的胺基與內容物中的醛基會進行化學鍵合,引起薄膜變色或不溶化,結果發生導致內容物延遲釋放的問題點。
另,PVA共聚物是以聚乙烯醇(PVA)作為構成單位的共聚物。例如已有報告是將PVA共聚物使用於錠劑或顆粒劑的薄膜包衣劑(專利文獻1)。又,已報告一種以PVA共聚物做為原料的硬膠囊劑(專利文獻2)。又,已報告一種著色膠囊,其包含PVA共聚物、鹿角菜苷等凝膠化劑及有彩色的色素(專利文獻3)。然而,迄今尚未製造以PVA共聚物及洋菜等作為薄膜原料的無縫膠囊,而且亦未知其效果。先行技術文獻 專利文獻
專利文獻1:國際公開2005/019286號小冊 專利文獻2:國際公開2002/017848號小冊 專利文獻3:日本特開2007-91670號公報
發明所欲解決之問題
本發明的課題在於提供一種高品質的無縫膠囊,其薄膜厚度的均勻性良好,且於薄膜中幾乎無泡眼。解決問題之技術手段
本案發明人為了解決上述課題,竭盡全力持續研究。在其過程中,發現若利用包含洋菜等、及特定的PVA共聚物的薄膜用組合物(本件薄膜用組合物),則可製造一種薄膜厚度的均勻性良好,且於薄膜中幾乎無泡眼的高品質的無縫膠囊,終至完成本發明。
亦即,本發明如下。 [1] 一種薄膜用組合物,其為無縫膠囊的薄膜用組合物,包含:至少一種多糖類,從洋菜、鹿角菜苷及結蘭膠所組成的群組中選擇;及聚乙烯醇共聚物; 前述聚乙烯醇共聚物是包含以下(i)、(ii)及(iii)來作為構成單位,其中 (i) 聚乙烯醇; (ii) 從丙烯酸、甲基丙烯酸、反丁烯二酸及順丁烯二酸所組成的群組中選擇的至少一種不飽和羧酸;以及 (iii) 從式[I]所示的化合物所組成的群組中選擇的至少一種不飽和羧酸酯 H2
C=C(R1
)-COOR2
[I] (式中,R1
表示氫原子或甲基,R2
表示具有1至4個碳原子的烷基。)。 [2] 如上述[1]所記載的薄膜用組合物,其中不飽和羧酸為丙烯酸。 [3] 如上述[1]或[2]所記載的薄膜用組合物,其中不飽和羧酸酯為甲基丙烯酸甲酯。 [4] 如上述[1]至[3]中任一項所記載的薄膜用組合物,其中進一步包含一或二種以上的可塑劑。 [5] 如上述[4]所記載的薄膜用組合物,其中一或二種以上的可塑劑是包含甘油及山梨糖醇的可塑劑。 [6] 一種無縫膠囊,其利用如上述[1]至[5]中任一項所記載的薄膜用組合物來獲得。發明之效果
利用本件薄膜用組合物所製造的無縫膠囊為高品質的膠囊,該膠囊的薄膜厚度的均勻性良好,且薄膜中幾乎無泡眼,在食品、藥品、化妝品等領域甚為有用。
用以實施發明之形態
本件薄膜用組合物是為了使用於包覆無縫膠囊的膠囊內容物(亦稱為芯材物質或填充物)的薄膜(殼體)的組合物;前述組合物包含洋菜等及PVA共聚物,而前述PVA共聚物包含以下(i)、(ii)及(iii)來作為構成單位,其中(i)聚乙烯醇;(ii)從丙烯酸、甲基丙烯酸、反丁烯二酸及順丁烯二酸所組成的群組中選擇的至少一種不飽和羧酸;以及(iii)從式[I]H2
C=C(R1
)-COOR2
[I] (式中,R1
表示氫原子或甲基,R2
表示具有1至4個碳原子的烷基。) 所示的化合物所組成的群組中選擇的至少一種不飽和羧酸酯;在此,「構成單位」意味(共)聚合物中之聚合前的單體。
本件薄膜用組合物可大致區別為液體類型與非液體類型。就液體類型的本件薄膜用組合物而言,一般是作為包含洋菜等及本件PVA共聚物的溶劑(例如純水)而構成。又,就非液體類型的本件薄膜用組合物而言,一般是作為粉體等之洋菜等及本件PVA共聚物含有物而構成。若將該非液體類型的本件薄膜用組合物,添加於溶劑(例如純水),藉由混合、攪拌、加溫(一般為85℃至100℃,較宜為85℃至93℃)等予以融解,可調製液體類型的本件薄膜用組合物。
上述洋菜是從石花菜(Amakusa)、真江蘺等紅藻類所獲得的多糖類,以半乳糖作為基本骨架。上述洋菜採用例如按照日本特開2009-225671號公報、日本特開2001-78726號公報、日本特開平5-184331號公報等所記載的方法,從上述紅藻類調製而成之物,或採用市售產品均可。洋菜的市售產品可舉出例如日本藥局方洋菜PS-26、日本藥局方洋菜PS-10、伊那洋菜PC-6F、超寒天AX-30(均為伊那食品工業製)、粉末洋菜JS-1000(朝日公司製)等。
上述鹿角菜苷是藉由鹼,從紅藻類抽取的直鏈狀含硫多糖類的一種,是由D-半乳糖(或3,6-脫水-D-半乳糖)及硫酸所構成的陰離子性高分子化合物。其組成與同樣從紅藻類獲得的洋菜糖(洋菜的主成分)類似,相異點在於含有大量硫酸。依性質特性,鹿角菜苷包括κ型、ι型及λ型三種類型,於本發明,以形成較硬的凝膠的κ型較適宜。
上述結蘭膠是由寄生於水草的微生物Sphingomonas elodea合成的水溶性多糖類,是分類為複合多糖類(雜多糖)的多糖類,是具有由四糖所構成的重複單位的高分子,其中前述四糖是由2個D-葡萄糖殘基、1個L-鼠李糖殘基及1個D-葡醣醛酸殘基所構成。結蘭膠包括2個羥基被乙醯基及甘油基取代的自然型,及已去除該類取代的去醯型兩種類型,於本發明,以去醯型較適宜。 上述洋菜等是水生生物或來自寄生於水生生物的微生物的多糖類,由於分子內具有羧酸殘基,因此於水溶液中,作為顯示酸性的多糖類而具有共通的性質。
上述洋菜等之膠凍強度若在不損及無縫膠囊的成形性的範圍內即可,例如100g/cm2
以上,宜為200g/cm2
以上,更宜為400g/cm2
以上,進而宜為500g/cm2
以上,進而更宜為600g/cm2
以上。又,洋菜等之膠凍強度若過高,唯恐不易以手指擠破無縫膠囊。因此,上述洋菜等之膠凍強度宜為2000g/cm2
以下,更宜為1800g/cm2
以下,進而宜為1600g/cm2
以下,進而更宜為1400g/cm2
以下,尤其宜為1200g/cm2
以下。
於本說明書,「洋菜等之膠凍強度」意味以20℃,將1.5mass%的洋菜等之水溶液放置15小時,藉此凝固而成的洋菜等之凝膠在20℃,該凝膠的表面積每1cm2
耐受20秒的最大質量(g)。洋菜等之凝膠的硬度可利用日寒水式(日本寒天製造水產組合所採用的方式)凝膠強度測定器(木屋製作所製)來測定。
本件薄膜用組合物的洋菜等之濃度並未特別限制,液體類型的本件薄膜用組合物時,例如在1.0至30mass%的範圍內,宜為1.0至10mass%,更宜為1.0至6.0mass%,進而宜為1.0至3.0mass%。又,非液體類型的本件薄膜用組合物時,例如在1.0至60mass%的範圍內,宜為1.0至40mass%,更宜為2.0至20mass%,進而宜為5.0至9.0mass%。
聚乙烯醇一般藉由取代(皂化)反應來製造,該反應是使乙酸乙烯酯在甲醇溶劑中進行自由基聚合,將獲得的聚乙酸乙烯酯置於甲醇溶劑中,使用氫氧化鈉將乙酸基的一部分或全部取代成羥基。因此,聚乙烯醇是依皂化,亦即依聚乙烯醇中羥基相對於乙酸基與羥基的合計數的比率(莫耳%)的差異,一般分類成完全皂化物、中間皂化物及部分皂化物。
上述(i)聚乙烯醇的皂化度並未特別限制,例如在70至99莫耳%的範圍內,宜為75至96莫耳%,較宜為80至94莫耳%,更宜為85至90莫耳%。又,上述(i)聚乙烯醇的平均聚合度並未特別限制,例如為100至4000,宜為300至3000,更宜為400至2000,進而宜為500至1800。又,上述(i)聚乙烯醇可單獨使用一種,或者組合皂化度或平均聚合物不同的二種以上來使用。
關於上述(i)聚乙烯醇,可自行製造具有所需皂化度或平均聚合度的聚乙烯醇,或亦可使用市售產品。聚乙烯醇的市售產品可舉出例如GOHSENOL(註冊商標)EG 05(日本合成化學工業製)、EG 25,EG 40(該等均是日本合成化學工業製)、PVA 203、PVA 204、PVA 205(該等均是KURARAY CO., LTD.製)、JP-04、JP-05(該等均是JAPAN VAM & POVAL CO., LTD.製)。
上述(ii)不飽和羧酸具體而言可舉出:丙烯酸、甲基丙烯酸、反丁烯二酸、或順丁烯二酸一種;丙烯酸與甲基丙烯酸、丙烯酸與反丁烯二酸、丙烯酸與順丁烯二酸、甲基丙烯酸與反丁烯二酸、甲基丙烯酸與順丁烯二酸、或反丁烯二酸與順丁烯二酸二種;丙烯酸與甲基丙烯酸與反丁烯二酸、丙烯酸與甲基丙烯酸與順丁烯二酸、或甲基丙烯酸與反丁烯二酸與順丁烯二酸三種;及丙烯酸與甲基丙烯酸與反丁烯二酸與順丁烯二酸四種;包含丙烯酸的一至四種較適宜,丙烯酸一種更適宜。
具體而言,上述(iii)不飽和羧酸酯是從甲基丙烯酸甲酯、丙烯酸甲酯、甲基丙烯酸乙酯、丙烯酸乙酯、甲基丙烯酸丙酯、丙烯酸丙酯、甲基丙烯酸異丙酯、丙烯酸異丙酯、甲基丙烯酸丁酯、丙烯酸丁酯、甲基丙烯酸異丁酯及丙烯酸異丁酯所組成的群組中選擇的至少一種;從甲基丙烯酸甲酯、丙烯酸甲酯、甲基丙烯酸乙酯及丙烯酸乙酯所組成的群組中選擇的至少一種較適宜,從甲基丙烯酸甲酯及丙烯酸甲酯所組成的群組中選擇的至少一種更適宜,進而宜為甲基丙烯酸甲酯。
本件PVA共聚物所含的(ii)不飽和羧酸與(iii)不飽和羧酸酯的質量比並未特別限制,例如相對於(ii)不飽和羧酸為2至80mass%,(iii)不飽和羧酸酯為20至98mass%;相對於(ii)不飽和羧酸為5至50mass%,(iii)不飽和羧酸酯為50至95mass%較適宜;相對於(ii)不飽和羧酸為10至40mass%,(iii)不飽和羧酸酯為60至90mass%更適宜;相對於(ii)不飽和羧酸為10至30mass%,(iii)不飽和羧酸酯為70至90mass%進而較適宜;相對於(ii)不飽和羧酸為10至20mass%,(iii)不飽和羧酸酯為80至90mass%進而更適宜。換言之,相對於(ii)不飽和羧酸及(iii)不飽和羧酸酯(有時將該等總稱為「聚合性乙烯單體」)的合計量,(ii)不飽和羧酸的質量比為例如2至80mass%,較宜為5至50mass%,更宜為10至40mass%,進而宜為10至30mass%,進而更宜為10至20mass%。又,相對於聚合性乙烯單體的合計量,(iii)不飽和羧酸酯的質量比為例如20至98mass%,較宜為50至95mass%,更宜為60至90mass%,進而宜為70至90mass%,進而更宜為80至90mass%。
上述(ii)不飽和羧酸使用丙烯酸一種,上述(iii)不飽和羧酸酯使用甲基丙烯酸甲酯一種時,(i)聚乙烯醇:(ii)丙烯酸:(iii) 甲基丙烯酸甲酯的質量比宜為60至90mass%:0.5至12mass%:7至38mass%,更宜為70至90mass%:1至5mass%:10至25mass%。
本件薄膜用組合物的本件PVA共聚物的濃度並未特別限制,液體類型的本件薄膜用組合物時,例如在10至70mass%的範圍內,宜為10至60mass%,更宜為10至50mass%,進而宜為20至40mass%。又,非液體類型的本件薄膜用組合物時,例如在40至97mass%的範圍內,宜為50至96mass%,更宜為60至93mass%,進而宜為70至90mass%。
本件PVA共聚物可利用習知的方法來製造。例如於去離子水等之水中,添加(i)聚乙烯醇,藉由加溫(例如90℃至100℃)來使聚乙烯醇溶解後,加入(ii)不飽和羧酸及(iii)不飽和羧酸酯,進行氮氣取代,加入聚合起始劑使其共聚來製造。藉由添加於水的(i)聚乙烯醇、(ii)不飽和羧酸及(iii)不飽和羧酸酯的質量比,來決定本件PVA共聚物中之(i)聚乙烯醇、(ii)不飽和羧酸及(iii)不飽和羧酸酯的質量比。因此,添加於水的各成分的質量比宜與本件PVA共聚物的各成分的質量比相同。
上述聚合起始劑可舉出例如:2,2'-偶氮雙(2-脒基丙烷)鹽酸鹽、AIBN(偶氮異丁腈)等偶氮化合物如;過硫酸鉀、過硫酸鈉、過硫酸銨等過硫酸鹽;叔丁基氫過氧化物等有機過氧化物;及過氧化氫-酒石酸、過氧化氫-酒石酸鈉等氧化還原起始劑等。
本件PVA共聚物具有聚合性乙烯單體之(ii)不飽和羧酸或(iii)不飽和羧酸酯之至少一種,接枝聚合於作為聚乙烯醇的側鏈而存在的-OCOCH3
基的構造。再者,於該接枝聚合,亦可經由「聚合性乙烯單體的至少一種已聚合或共聚的聚合物」,聚乙烯醇彼此鏈結。亦即,聚乙烯醇與聚乙烯醇亦可藉由「聚合性乙烯單體的至少一種已聚合或共聚的聚合物」來架橋。
例如使用(ii)丙烯酸、(iii)甲基丙烯酸甲酯時,本件PVA共聚物具有丙烯酸及甲基丙烯酸甲酯的共聚物,經由聚乙烯醇的-OCOCH3
基而鏈結於聚乙烯醇的構造。 具體而言,該類PVA共聚物(聚乙烯醇‧丙烯酸‧甲基丙烯酸甲酯共聚物)可舉出日本特開2016-008294號公報所記載的PVA共聚物。
本件薄膜用組合物為了藉由成形後的薄膜來賦予柔軟性,宜進一步包含一或二種以上的可塑劑。該可塑劑可舉出例如:甘油、聚乙二醇、丙二醇、聚丙二醇等多價醇;右旋糖、果糖、葡萄糖、半乳糖等單糖類;蔗糖、麥芽糖、海藻糖、耦合糖等二糖;麥芽低聚醣等低聚醣;山梨糖醇、麥芽糖醇、糖醇、帕拉金、木糖醇、甘露糖醇、半乳糖醇等糖醇;聚乙烯醇;甘油三乙酸酯;聚葡萄糖、糊精、麥芽糊精、難消化糊精、環糊精(α、β或γ)等澱粉衍生物;澱粉;羥甲基纖維素(HPMC)、羥丙基纖維素(HPC)、甲基纖維素(MC)、羧甲基纖維素(CMC)等纖維素衍生物等,以包括甘油及山梨糖醇的可塑劑較適宜。
本件薄膜用組合物的可塑劑的濃度並未特別限制,液體類型的本件薄膜用組合物時,例如在1.0至30mass%的範圍內,宜為1.0至20mass%,更宜為1.0至10mass%,進而宜為2.0至5.0mass%。又,非液體類型的本件薄膜用組合物時,例如在1.0至60mass%的範圍內,宜為1.0至40mass%,更宜為2.0至20mass%,進而宜為5.0至9.0mass%。
本件薄膜用組合物亦可包含洋菜以外的凝膠化劑,例如從刺槐豆膠、阿拉伯樹膠、果膠、瓜爾豆膠、海藻酸、普魯蘭多糖、蒟蒻膠、明膠、塔拉膠及葡甘露聚醣所組成的群組中選擇的一或二種以上的凝膠化劑,但宜幾乎(一般為0.1mass%以下,宜為0.01mass%以下,更宜為0.001mass%以下)或完全不含該等凝膠化劑。
本件薄膜用組合物的任意成分可舉出例如:顏料、食用色素、染料等著色劑;氧化鎂、二氧化鈦等遮光劑;十二烷基硫酸鈉、脂肪酸酯類等界面活性劑;香味劑;矯味劑;防腐劑;香料等。於本說明書,「任意成分」意味包含或不包含均可的成分。
於本發明,無縫膠囊可含有的膠囊內容物只要可包於無縫膠囊內,且不侵蝕膠囊薄膜之物均可,並未特別限制,例如油脂類、蠟類、脂肪酸類、維生素類、藥品、食品、濕潤劑、保濕劑、抗氧化劑、防腐劑、收斂劑、美白劑、有機酸、香料等。尤其是藉由含醛基的物質可防止膠囊不溶化,且可減低膠囊內容物氧化,因此該無縫膠囊亦可含有含醛基的物質來作為膠囊內容物。例如從活用無縫膠囊的特長的觀點來看,使含醛基的成分或容易進行氧化反應的成分,溶解於脂肪酸甘油三酯、聚乙二醇而成的填充液尤其適宜。該類含醛基的成分可舉出例如各種還原糖(例如葡萄糖、果糖、乳糖、阿拉伯糖、麥芽糖等)、檸檬醛、香草醛、苯甲醛、戊二醛、鄰溴苯甲醛、丁醛、氯丁醛、糠醛、羥甲基糠醛、戊醛、丙烯醛、醛固酮等。上述膠囊內容物一般為液體類型。
於本發明,無縫膠囊可採用本件薄膜用組合物及膠囊內容物,使用製造無縫膠囊時一般會使用的膠囊製造裝置,例如SPHEREX(Freund Corporation製),或使用無縫膠囊製造裝置(Fuji Capsule製),藉由使用了兩成分(本件薄膜用組合物及膠囊內容物)的多重噴嘴的液中滴下法來製造(調製)。例如利用同心雙重噴嘴,分別以一定速度,於載體液中,從外側噴嘴使液體類型或調製成液體類型的本件薄膜用組合物流出,從內側噴嘴使膠囊內容物流出,以一定間隔阻斷該2層的流液,利用界面張力形成液滴後,藉由冷卻使外側的薄膜層(本件薄膜用組合物)凝膠化,可製造無接縫的無縫膠囊。上述液中滴下法亦稱為液中硬化法或孔口法。又,有時亦使用三重以上的多重噴嘴。由於製造後的無縫膠囊薄膜中的洋菜等或PVA共聚物等各種成分的含有質量比率,與製造前的液體類型或調製成液體類型的本件薄膜用組合物所含的該等成分的含有質量比率相同,因此藉由調整製造前的液體類型或調製成液體類型的本件薄膜用組合物所含的該等成分的含有量,可調整製造後的無縫膠囊薄膜中的各種成分的含有質量比率。
又,藉由適當調整內容物、薄膜用組合物及載體液的噴出速度,可控制膠囊的粒徑。具體而言,以噴出速度0.1至5mL/min噴出內容物,以噴出速度0.1至10mL/min噴出薄膜用組合物,以噴出速度15000至30000mL/min噴出載體液,可製造平均粒徑為900μm以下,例如500至800μm的軟膠囊集合體。
本件薄膜用組合物所製造的無縫膠囊的尺寸(粒徑)可藉由習知的方法適當調整,直徑200μm至10mm的範圍較適宜,直徑400μm至6mm的範圍更適宜,直徑600μm至4mm的範圍更加適宜。
以下藉由實施例來具體說明本發明,但本發明的技術性範圍不限定於該等例示。實施例
實施例1至4 1. 無縫膠囊的製造 藉由混合及攪拌表1(表中的數字若未特別指定,均表示質量部)所示的各原料,一面攪拌一面加溫溶解(實施例1為95℃,實施例2為93℃,實施例3為80℃,實施例4為80℃),來調製4種薄膜用組合物。再者,在剛調製後的80℃條件下,調製成的實施例3的黏度為64mPa‧s。又,在剛調製後的78℃條件下,調製成的實施例1的黏度為22mPa‧s,在剛調製後的82℃條件下,調製成的實施例2的黏度為41mPa‧s。 分別從無縫膠囊製造機(SPHEREX[形成管徑22mm、振動數25Hz、槽溫度80℃、冷卻油設定溫度0℃],Freund Corporation製)的同心雙重噴嘴的內筒,作為芯材物質使由MYRITOL 318(三(辛酸/癸酸)甘油酯,BASF製)100質量部及乙醇5質量部所組成的內容物流下,從外筒,作為包膜物質使上述4種薄膜用組合物流下,製造粒徑(直徑)3或4mm、薄膜率20%的無縫膠囊。
[表1]
*1:日本特開2016-008294號公報所記載的PVA共聚物 *2:參考表2 *3:參考表3 *4:參考表4 *5:Kelcogel(註冊商標)(DSP Gokyo Food & Chemical Co.,Ltd.製)
[表2]
[表3]
[表4]
2. 結果 從實施例1的薄膜用組合物,可製造直徑3mm的無縫膠囊,該膠囊的薄膜厚度的均勻性(厚薄不均≒1:1.5)良好,且未確認到泡眼(殘留於薄膜中的芯材物質的液滴)。又,從實施例2的薄膜用組合物,可製造直徑3mm及4mm的無縫膠囊,該等膠囊的薄膜厚度的均勻性(厚薄不均≒1:1.5及1:1.6)良好,且未確認到泡眼。從實施例3的薄膜用組合物雖可製造直徑3mm的無縫膠囊,但該膠囊的薄膜厚度的均勻性(厚薄不均≒1:2.0)劣於實施例1及2的膠囊,且確認到些許泡眼,惟作為膠囊仍具實用性。從實施例4的薄膜用組合物,可製造直徑4mm的無縫膠囊。 以上結果表示若使用包含本件PVA共聚物及洋菜等之薄膜用組合物,可製造一種薄膜厚度的均勻性良好,且幾乎無(完全無)泡眼的高品質的無縫膠囊。 再者,雖同樣檢討了使用洋菜等以外之其他親水性多糖類,並與PVA共聚物組合,但無法獲得膠囊。具體而言,洋菜以外的其他親水性多糖類可例示刺槐豆膠、黃原膠、Gerumeito(註冊商標)SA(DSP Gokyo Food & Chemical Co., Ltd.製)、Gerumeito(註冊商標)KS(DSP Gokyo Food & Chemical Co., Ltd.製)、GLYLOID(註冊商標)2A(羅望子膠,DSP Gokyo Food & Chemical Co., Ltd.製)、瓜豆膠、果膠及阿拉伯樹膠。再者,於本發明,並不否定該等「洋菜等以外之其他親水性多糖類」與「洋菜等」共存。
實施例5 於對形成管內部的流入速度設為20000mL/min之載體液(中鏈脂肪酸甘油三酯(MCT)),液溫:5℃)中,從無縫膠囊製造機(SPHEREX[內側噴嘴的噴出口的開口部的內徑:0.5mm,外側噴嘴的噴出口的開口部的內徑:1mm,形成管上端的開口部的內徑22mm,振動數25Hz,槽溫度60℃,冷卻油設定溫度5℃],Freund Corporation製)的同心雙重噴嘴的內筒,以噴出速度2.02mL/min,作為芯材物質使由MYRITOL 318(三(辛酸/癸酸)甘油酯,BASF製)100質量部及乙醇5質量部所組成的內容物噴出而滴下,從外筒,以噴出速度5.26mL/min,作為薄膜用組合物使與實施例1相同的薄膜用組合物噴出而滴下,將所獲得的未乾燥膠囊,浸泡於MCT液(液溫:4℃)中5日。回收MCT液中的膠囊,於室溫(20℃)靜置15小時使其乾燥,獲得薄膜率20%的膠囊。 利用粒子圖像分析裝置(裝置名:Morphologi G3、Malvern)來分析所獲得的軟膠囊,可知其為平均粒徑約700μm的膠囊。 又,利用高解析度3DX射線顯微鏡(nano 3DX-J,Rigaku Corporation)及光化學顯微鏡(VHX-D510,Keyence Corporation),來觀察所獲得的膠囊時,可知其為接近真球的球狀軟膠囊。產業上之可利用性
利用本件薄膜用組合物所製造的無縫膠囊為高品質的膠囊,該膠囊的薄膜厚度的均勻性良好,且薄膜中幾乎無泡眼,在食品、藥品、化妝品等領域甚為有用。
Claims (6)
- 一種薄膜用組合物,其為無縫膠囊的薄膜用組合物,包含:至少一種多糖類,從洋菜、鹿角菜苷及結蘭膠所組成的群組中選擇;及一聚乙烯醇共聚物; 前述聚乙烯醇共聚物包含以下(i)、(ii)及(iii)來作為構成單位,其中 (i) 聚乙烯醇; (ii) 從丙烯酸、甲基丙烯酸、反丁烯二酸及順丁烯二酸所組成的群組中選擇的至少一種不飽和羧酸;以及 (iii) 從式[I]所示的化合物所組成的群組中選擇的至少一種不飽和羧酸酯 H2 C=C(R1 )-COOR2 [I] (式中,R1 表示氫原子或甲基,R2 表示具有1~4個碳原子的烷基。)。
- 如申請專利範圍第1項所述之薄膜用組合物,其中不飽和羧酸為丙烯酸。
- 如申請專利範圍第1項或第2項之薄膜用組合物,其中不飽和羧酸酯為甲基丙烯酸甲酯。
- 如申請專利範圍第1項至第3項中任一項所述之薄膜用組合物,其中進一步包含一或二種以上的可塑劑。
- 如申請專利範圍第4項所述之薄膜用組合物,其中一或二種以上的可塑劑是包含甘油及山梨糖醇的可塑劑。
- 一種無縫膠囊,其利用如申請專利範圍第1項至第5項中任一項所述之薄膜用組合物來獲得。
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