TW201813633A - 包衣組成物和包衣製劑及其製造方法 - Google Patents
包衣組成物和包衣製劑及其製造方法 Download PDFInfo
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Abstract
本發明提供一種提高酸性下的耐溶解性（胃環境下的不溶性）且進而可實現優異的腸溶性的包衣組成物、使用所述包衣組成物的製劑及其製造方法。一種包衣組成物，其含有（A）酯化度為3%～40%的果膠、（B）選自鈣鹽及鎂鹽中的一種以上、（C）被膜形成成分，鈣及鎂/（A）所表示的質量比為0.002～0.1，（C）/（A）所表示的（A）成分與（C）成分的質量比為0.2～3。
Description
本發明是有關於一種包衣組成物和包衣製劑及其製造方法。
存在如乳酸菌或酵素等蛋白質的功能成分般，藉由防止在胃中的分解，維持結構並到達腸道內而發揮高功能性的成分，為此需要一種在胃中不溶解而在腸道中溶解的腸溶性製劑。
作為用以使有效成分到達腸道的保護膜，需要在胃中的pH條件（酸性）下不溶解而在小腸的pH條件（中性）下溶解的成分，於醫藥品中通常使用甲基丙烯酸系高分子化合物，於食品中通常使用蟲膠及玉米膠蛋白，但進而需要可實現優異的腸溶性的包衣組成物。 [現有技術文獻] [專利文獻]
[專利文獻1]日本專利特開2005-027651號公報
[發明所欲解決之課題] 本發明是鑒於所述情況而成者，其目的在於提供一種提高酸性下的耐溶解性（胃環境下的不溶性）且進而可實現優異的腸溶性的包衣組成物、使用所述包衣組成物的製劑及其製造方法。 [解決課題之手段]
本發明者等人為了達成所述目的而進行了努力研究，結果發現於使用果膠的情況下可獲得一定的腸溶性的可能性。然而，利用果膠而製備的膜雖於酸性下（pH為1.2）不會溶解，但出現脆而易損壞的問題。對此，發現藉由在與被膜形成成分組合的基礎上，選定果膠中甲氧基化程度低、酯化度為3%～40%且具有大量的陰離子性基的果膠，提高酸性下的耐溶解性，進而併用鈣鹽或鎂鹽來對果膠進行交聯，而可強化酸性下的耐溶解性，並可獲得高的腸溶性能，從而完成了本發明。
因此，本發明提供下述發明。 [1].一種包衣組成物，其含有（A）酯化度為3%～40%的果膠、（B）選自鈣鹽及鎂鹽中的一種以上、（C）被膜形成成分，鈣及鎂/（A）所表示的質量比為0.002～0.1，（C）/（A）所表示的（A）成分與（C）成分的質量比為0.2～3。 [2].如[1]所述的包衣組成物，其中（C）成分為選自羥丙基甲基纖維素、聚乙烯醇、阿拉伯膠、羥丙基纖維素、普魯蘭多糖及卡特蘭多醣中的一種以上。 [3].如[1]或[2]所述的包衣組成物，其中（A）成分是藉由（B）成分而進行交聯的果膠。 [4].一種包衣製劑，其於被包衣物的表面形成有包含如[1]～[3]中任一項所述的包衣組成物的包衣層。 [5].如[4]所述的包衣製劑，其於被包衣物與包衣層之間具有中間層，所述中間層含有（D）6質量%水溶液於25℃下的黏度未滿300 mPa·s的高分子化合物。 [6].一種製造方法，其製造如[4]或[5]所述的包衣製劑，且所述製造方法包括對被包衣物或具有中間層的被包衣物噴霧包衣如[1]～[3]中任一項所述的包衣組成物的步驟。 [發明的效果]
根據本發明，可提供一種可強化酸性下的耐溶解性且可獲得高的腸溶性能的包衣組成物、使用所述包衣組成物的製劑及其製造方法。
以下，對本發明進行詳細說明。 （A）酯化度為3%～40%的果膠 本發明的果膠是酯化度（甲氧基）為3%～40%的果膠。就初始及保存後的耐胃性、腸環境下的溶解性的方面而言，酯化度較佳為22%～35%，更佳為22%～30%。若酯化度超過40%，則利用鈣或鎂的交聯不充分，無法充分實現酸性下的耐溶解性、胃環境下的不溶性（以下，概括記載為耐胃性）功能。若酯化度未滿3%，則分子量小，無法充分發揮耐胃性功能。再者，酯化度可利用依照美國食品化學品法典（Food Chemicals Codex，FCC）及聯合國糧食農業組織（Food and Agriculture Organization，FAO）/世界衛生組織（World Health Organization，WHO）中的測定方法的適定法進行測定。另外，果膠根據脫脂化的方法的不同而大致分為酸處理類型與鹼處理類型（醯胺果膠），並無特別限定，但就包衣液中的溶解性及凝膠化狀態的方面而言，較佳為酸處理類型。
（A）成分的含量於組成物中較佳為2質量%～10質量%（固體成分），更佳為3質量%～5質量%（固體成分）。另外，於包衣層中較佳為30質量%～55質量%，更佳為35質量%～50質量%。
（B）選自鈣鹽及鎂鹽中的一種以上 作為鈣鹽，可列舉氯化鈣、乳酸鈣、糖精鈣等水溶性鈣鹽，作為鎂鹽，可列舉氯化鎂等水溶性鎂鹽。就於水中的溶解性高的方面而言，較佳為氯化鈣、乳酸鈣、氯化鎂。
（B）成分的含量於組成物中較佳為0.02質量%～0.5質量%（固體成分），更佳為0.04質量%～0.2質量%（固體成分）。另外，於包衣層中較佳為0.2質量%～6質量%，更佳為0.5質量%～3質量%。
另外，鈣及鎂/（A）所表示的質量比為0.002～0.1，就初始及保存後的耐胃性、腸環境下的溶解性的方面而言，較佳為0.005～0.05，更佳為0.005～0.02。再者，「鈣及鎂」量並非（B）成分的鹽量，而是鈣量及鎂量的總量，於單獨為鈣的情況下為鈣量，於單獨為鎂的情況下為鎂量。若所述質量比超過0.1，則包衣組成物發生凝膠化，初始及保存後的耐胃性、腸環境下的溶解性變差，若未滿0.002，則無法充分發揮耐胃性功能。
（C）被膜形成成分 作為被膜形成成分，可列舉黏度低的皮膜形成成分，例如羥丙基甲基纖維素（Hydroxy Propyl Methyl Cellulose，HPMC）、聚乙烯醇（Polyvinyl Alcohol，PVA）、阿拉伯膠、羥丙基纖維素（Hydroxy Propyl Cellulose，HPC）、普魯蘭多糖、卡特蘭多醣等，可單獨使用一種或者適宜組合使用兩種以上。其中，較佳為羥丙基甲基纖維素、聚乙烯醇、普魯蘭多糖，更佳為羥丙基甲基纖維素。
（C）成分的含量於組成物中較佳為0.5質量%～5質量%（固體成分），更佳為0.5質量%～2質量%（固體成分）。另外，於包衣層中較佳為5質量%～45質量%，更佳為10質量%～30質量%。
（C）/（A）所表示的（A）成分與（C）成分的質量比為0.2～3，就初始及保存後的耐胃性、腸環境下的溶解性的方面而言，較佳為0.2～0.8，更佳為0.3～0.5。若所述比率超過3，則無法充分發揮耐胃性功能。另外，若未滿0.2，則膜的形成性下降，無法充分發揮耐胃性功能。
可於不妨礙本發明的效果的範圍內於本發明的包衣組成物中調配任意成分。作為所述成分，可列舉：塑化劑、防附著劑、潤滑劑、消泡劑、著色劑等。
作為塑化劑，可列舉：蔗糖脂肪酸酯、甘油脂肪酸酯、單甘油脂肪酸酯、聚氧乙烯山梨糖醇酐脂肪酸酯等界面活性劑；甘油、丙二醇、聚乙二醇等多元醇；葡萄糖、果葡糖漿、蔗糖等糖；山梨糖醇、麥芽糖醇、甘露糖醇、赤藻糖醇、木糖醇等糖醇；十二烷醇、十三烷醇、十四烷醇、十五烷醇、十六烷醇、十七烷醇、十八烷醇、十六醇、異硬脂醇、2-辛基十二烷醇等（較佳為碳數6～22）的高級醇；中鏈脂肪酸酯（較佳為碳數6～12）等油脂。該些可單獨使用一種或者適宜組合使用兩種以上。其中，就包衣膜的塑化效果的方面而言，較佳為甘油，就腸溶性的方面而言，較佳為界面活性劑，更佳為甘油及/或蔗糖脂肪酸酯。相對於包衣組成物，塑化劑的含量較佳為0.2質量%～5質量%（固體成分），更佳為0.5質量%～2質量%（固體成分）。另外，於包衣層中較佳為2質量%～25質量%，更佳為5質量%～20質量%。
作為防附著劑及潤滑劑，可列舉滑石、硬脂酸鈣、二氧化矽等，可單獨使用一種或者適宜組合使用兩種以上。微粒子的粒徑為0.01 μm～50 μm，較佳為0.1 μm～20 μm。再者，粒徑的測定利用雷射繞射式粒度分佈測定裝置進行。相對於包衣組成物，防附著劑及潤滑劑的含量較佳為0.1質量%～2質量%（固體成分），更佳為0.2質量%～1.5質量%（固體成分）。另外，於包衣層中較佳為1質量%～20質量%，更佳為5質量%～15質量%。
作為消泡劑，例如可列舉：甘油脂肪酸酯、二甲基聚矽氧烷、二甲基聚矽氧烷·二氧化矽混合物、含水二氧化矽、二氧化矽等，可單獨使用一種或者適宜組合使用兩種以上。
作為著色劑，例如可列舉：兒茶鞣酸粉末、薑黃萃取液、黃色三二氧化鐵、柑橙精華液、褐色氧化鐵、炭黑、焦糖、洋紅、胡蘿蔔素液、β-胡蘿蔔素、甘草提取物、金箔、黑色氧化鐵、輕質矽酸酐、氧化鈦、三二氧化鐵、食用藍色1號、食用黃色4號、食用黃色4號鋁色澱、食用黃色5號、食用紅色2號、食用紅色3號、食用紅色102號、氫氧化鈉、葉綠酸銅鈉、葉綠素銅、青稞綠葉提取物、藥用炭、核黃素丁酸酯、核黃素、綠茶粉末、核黃素磷酸鈉等。
[包衣組成物] （A）酯化度為3%～40%的果膠藉由（B）選自鈣鹽及鎂鹽中的一種以上而進行交聯，耐胃性功能進一步得到發揮。包衣組成物中的水分量並無特別限定，自50質量%～98質量%中適宜選定。
[包衣製劑] 使用所述包衣組成物，可製成於被包衣物的表面形成有包含包衣組成物的包衣層的包衣製劑。
本發明的包衣組成物及由所述包衣組成物形成的包衣膜具有腸溶性、即「在胃中不溶解而在腸道中溶解，且可使被包衣物到達腸道中」的性質。
本發明中，所謂「腸溶性」是指依照日本藥典的溶出試驗法，在相當於胃液的溶出試驗液（pH為1.2）中2小時溶出率為20%以下，在相當於腸液的溶出試驗液（pH為6.8）中2小時溶出率為70%以上。
包衣膜的厚度並無特別限定，較佳為5 μm～1 mm，更佳為10 μm～500 μm。另外，相對於包衣製劑，較佳為將包衣膜設為0.5質量%～30質量%，更佳為1質量%～25質量%。
相對於包衣膜，包衣膜的水分量較佳為10質量%～30質量%，更佳為15質量%～25質量%。
作為被包衣物，並無特別限定，可列舉食品、醫藥品等的有效成分等。例如可列舉：乳酸菌、胱胺酸、鐵、抗體或乳鐵蛋白等蛋白質、肽、三磷酸腺苷（Adenosine Triphosphate，ATP）-2Na等，該些可單獨使用一種或者適宜組合使用兩種以上。其中，較佳為蛋白質等高分子量成分或水不溶性成分。就包衣片的外觀性及腸環境下的溶出性的方面而言，較佳為結晶纖維素40 mg～100 mg（1片中）、麥芽糖醇40 mg～80 mg（1片中）。
被包衣物的形狀或劑型並無特別限定，不特別限定於片劑、散劑、細粒劑、顆粒劑等。片劑可為單層亦可為兩層以上。其中，就進一步發揮腸溶性的方面而言，較佳為設為片劑。片劑的尺寸並無特別限定，就片劑的處理容易性與咽下性的觀點而言，作為片劑的直徑，較佳為5 mmf～14 mmf，更佳為7 mmf～12 mmf。另外，作為每1片的片劑質量，適當的是150 mg～700 mg左右，作為片劑的形狀，並無特別限定，有圓形（R片、2段R片、多棱角平片等）、三角形、四邊形、六邊形、八邊形、橢圓形、橄欖球形等，較佳為圓形的R片、2段R片。
本發明的包衣製劑較佳為於被包衣物與包衣層之間具有中間層，所述中間層含有（D）6質量%水溶液於25℃下的黏度未滿300 mPa·s的高分子化合物。藉由設置所述中間層，耐胃性功能進一步提高。作為6質量%水溶液於25℃下的黏度未滿300 mPa·s的高分子化合物，可列舉黏度低的皮膜形成成分，例如羥丙基甲基纖維素（HPMC）、聚乙烯醇（PVA）、阿拉伯膠、羥丙基纖維素（HPC）、普魯蘭多糖、卡特蘭多醣等，可單獨使用一種或者適宜組合使用兩種以上。其中，較佳為羥丙基甲基纖維素（HPMC）、聚乙烯醇（PVA）、羥丙基纖維素（HPC），更佳為羥丙基甲基纖維素（HPMC）。相對於形成中間層的包衣組成物，（C）成分的含量較佳為1質量%～20質量%（固體成分），更佳為2質量%～10質量%（固體成分）。另外，於中間層中較佳為20質量%～80質量%，更佳為30質量%～70質量%。
於中間層中除了（D）成分以外亦可含有甘油、蔗糖脂肪酸酯等成分。相對於形成中間層的包衣組成物，該些成分的含量較佳為0.1質量%～10質量%（固體成分），更佳為0.5質量%～5質量%（固體成分），於中間層中較佳為1質量%～40質量%，更佳為5質量%～30質量%。
相對於包衣層的量，中間層的量較佳為5質量%～50質量%，更佳為10質量%～50質量%。藉由設為5質量%以上，可獲得經時的充分的耐胃性。另外，可獲得平滑的包衣片。另外，藉由設為50質量%以下，於腸環境下的溶出性變得良好。另外，（D）成分的包衣中間層中的含量較佳為10質量%～80質量%，更佳為20質量%～70質量%。
相對於中間層，中間層的水分量較佳為5質量%～40質量%，更佳為10質量%～30質量%。
[包衣製劑的製造方法] 包衣組成物可藉由混合所述必須成分而獲得，包衣製劑可藉由如下方式獲得：藉由對被包衣物直接噴霧包衣組成物、或者噴霧添加了水的包衣溶液並進行乾燥而於被包衣物的表面形成包衣膜。本發明的包衣組成物為水性，因此可進行使用了水的包衣，而形成水溶性膜。
包衣溶液包含包衣組成物及水，包衣溶液的水分量較佳為50質量%～98質量%，更佳為70質量%～96質量%。另外，亦可於不損及本發明的效果的範圍內調配乙醇等有機溶劑。
包衣機並無特別限定，可使用鍋式包衣機、流動層包衣機、轉動包衣機等。
包衣方法並無特別限定，例如可列舉如下方法：對被包衣物噴霧包衣溶液，並藉由加溫而進行乾燥，藉此於被包衣的表面進行膜化。包衣溶液可適當加溫，溫度較佳為30℃～80℃，乾燥溫度較佳為40℃～80℃。包衣溶液的添加速度相對於乾燥風量1 m3
/min而言較佳為1 g/min～5 g/min。除此以外，亦可採取於包衣溶液中浸漬被包衣物並使其乾燥的浸漬包衣的方法。乾燥較佳為乾燥至包衣製劑中的水分量成為所述較佳範圍為止。
於設置中間層的情況下，只要於進行所述包衣之前，製備（D）6質量%水溶液於25℃下的黏度未滿300 mPa·s的高分子化合物溶液，並利用與所述相同的方法進行包衣即可。中間層溶液的水分量較佳為50質量%～99質量%，更佳為80質量%～99質量%。 [實施例]
以下示出實施例及比較例來對本發明進行具體的說明，但本發明並不限制於下述實施例。再者，下述例子中，於未特別標明的情況下，組成的「%」表示質量%，比率表示質量比。
[實施例、比較例] 將下述原料混合，使用壓片機進行壓片以形成片劑（300 mg、f9.0 mm、厚度5.3 mm、2段R片（R1=3.6 mm、R2=10.5 mm、H=1.5 mm）），而製備素片。製備下述表1～表4中所示的組成的包衣溶液、下述表1中所示的中間層溶液並利用下述方法對素片進行包衣，而製備包衣片（表2～表4無中間層）。對所得的包衣片進行下述評價。將結果一併記載於表中。 [素片] 每1片的質量 乳鐵蛋白：110 mg 蓽拔提取物粉末：50 mg 麥芽糖醇：50 mg 結晶纖維素：80.5 mg 羧甲基纖維素鈣（CMC-Ca）：6.0 mg 硬脂酸鈣0.5 mg 二氧化矽微粒：3.0 mg
[中間層（第1層）] ﹤中間層包衣液的製備﹥ ＜包衣液的製備＞ 將所有原料混合攪拌並溶解而獲得中間層包衣液。 ＜包衣＞ 使用包衣機（弗羅因德（FREUND）產業（股）製造、海克特（HICOATER）FZ-Lab），對200 g素片噴霧45 g中間層包衣液，以水分殘存量成為約20 g的方式進行乾燥，而獲得包衣片。
[包衣層（第2層）] ＜包衣液的製備＞ 將（A）成分與（B）成分分散於一部分水中，加熱為80℃並加以溶解。將其他原料分散於剩下的水中，與所述溶液混合而獲得包衣液。 ＜包衣＞ 使用包衣機（弗羅因德（FREUND）產業（股）製造、海克特（HICOATER）FZ-Lab），對200 g素片噴霧300 g包衣液，以水分殘存量成為15%～20%的方式進行乾燥，而獲得包衣片。
＜溶出性試驗＞ 利用乳鐵蛋白的溶出性來評價包衣膜的溶解性。 評價剛包衣後的包衣片、包衣後於40℃75%RH下保管4個月後的樣品。
＜試樣溶液的製備＞ 使用日本藥局1液（pH為1.2），進行依照日本藥局一般試驗法的溶出試驗。 使用日本藥局2液（pH為6.8），進行依照日本藥局一般試驗法的溶出試驗。 ＜乳鐵蛋白定量＞ 乳鐵蛋白的定量法依照第9版食品添加物公定書的方法。 ＜定量＞ 將所述溶出試驗的2小時後的取樣溶液作為試樣溶液。分別各量取20 μL試樣溶液及3濃度的標準溶液，利用以下操作條件進行液相層析。測定各標準液的乳鐵蛋白峰值面積，並製成校準曲線。根據所述校準曲線與試樣溶液的乳鐵蛋白面積求出試樣溶液中的乳鐵蛋白濃度，並藉由下式求出對於乳鐵蛋白100 mg/片的乳鐵蛋白溶出率。 乳鐵蛋白溶出率（%）=試樣溶液中的乳鐵蛋白濃度（mg/mL）×900（mL）×定量用乳鐵蛋白的純度（%）×1/100×1/100（mg）×100
層析條件 檢測器：紫外吸光光度計（測定波長：280 nm） 管柱填充劑：5 μm的液相層析用丁基化聚乙烯醇聚合物凝膠（索得克斯艾薩海帕克（Shodex Asahipak）C4P-50 4D） 管柱管：內徑為4.6 mm、長度為15 cm的不鏽鋼管 保護管柱：索得克斯艾薩海帕克（Shodex Asahipak）C4P-50G 4A 管柱溫度：35℃ 移動相A 0.03 w/v%含三氟乙酸的乙腈/氯化鈉溶液（3→100）混合液（10：90） 移動相B 0.03 w/v%含三氟乙酸的乙腈/氯化鈉溶液（3→100）混合液（50：50） 濃度梯度 進行25分鐘自A：B（50：50）至（0：100）為止的直線濃度梯度。 流量：0.8 mL/分鐘 定量用乳鐵蛋白：和光純藥工業（股）製造 生化學用「乳鐵蛋白、源自牛乳」 定量用乳鐵蛋白的純度（%）：使用和光純藥工業（股）檢查成績書的含量（高效液相層析法（High Performance Liquid Chromatography，HPLC））的數值
根據溶出率，並利用下述基準來表示結果。 日本藥局1液（pH為1.2）： 2小時溶出性為5%以下：◎ 2小時溶出性超過5%且為10%以下：○ 2小時溶出性超過10%且為20%以下：● 2小時溶出性超過20%：× 日本藥局2液（pH為6.8）： 2小時溶出性為90%以上：◎ 2小時溶出性為70%以上且未滿90%：○ 2小時溶出性為30%以上且未滿70%：△ 2小時溶出性未滿30%：× 將於日本藥局1液的試驗中為◎、○、●且於日本藥局2液的試驗中為◎、○的情況設為腸溶性。
[表1]
[表2]
[表3]
[表4]
以下示出製備實施例及比較例時使用的原料。再者，表中的量為純度換算量。 [表5]
無
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Claims (6)
- 一種包衣組成物，其含有（A）酯化度為3%～40%的果膠、（B）選自鈣鹽及鎂鹽中的一種以上、（C）被膜形成成分，其中所述鈣及鎂/所述（A）所表示的質量比為0.002～0.1，所述（C）/所述（A）所表示的（A）成分與（C）成分的質量比為0.2～3。
- 如申請專利範圍第1項所述的包衣組成物，其中所述（C）成分為選自羥丙基甲基纖維素、聚乙烯醇、阿拉伯膠、羥丙基纖維素、普魯蘭多糖及卡特蘭多醣中的一種以上。
- 如申請專利範圍第1項或第2項所述的包衣組成物，其中所述（A）成分是藉由所述（B）成分而進行交聯的果膠。
- 一種包衣製劑，其於被包衣物的表面形成有包含如申請專利範圍第1項至第3項中任一項所述的包衣組成物的包衣層。
- 如申請專利範圍第4項所述的包衣製劑，其於被包衣物與包衣層之間具有中間層，所述中間層含有（D）6質量%水溶液於25℃下的黏度未滿300 mPa·s的高分子化合物。
- 一種製造方法，其製造如申請專利範圍第4項或第5項所述的包衣製劑，且所述製造方法包括對被包衣物或具有中間層的被包衣物噴霧包衣如申請專利範圍第1項至第3項中任一項所述的包衣組成物的步驟。
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