JP7388718B2 - 軟カプセル皮膜組成物 - Google Patents
軟カプセル皮膜組成物 Download PDFInfo
- Publication number
- JP7388718B2 JP7388718B2 JP2020515544A JP2020515544A JP7388718B2 JP 7388718 B2 JP7388718 B2 JP 7388718B2 JP 2020515544 A JP2020515544 A JP 2020515544A JP 2020515544 A JP2020515544 A JP 2020515544A JP 7388718 B2 JP7388718 B2 JP 7388718B2
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- JP
- Japan
- Prior art keywords
- starch
- soft capsule
- gellan gum
- acid
- coating composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- A—HUMAN NECESSITIES
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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Description
また、軟カプセル皮膜を製造する際には多種多様な澱粉類が使用されている。これまでに、天然澱粉や種々の加工澱粉が用いられており、天然澱粉としては、馬鈴薯澱粉、タピオカ澱粉、サゴ澱粉、甘藷澱粉、緑豆澱粉、小麦澱粉、とうもろこし澱粉、米澱粉,ワキシーコーン澱粉、ワキシーポテト澱粉、ワキシー小麦澱粉、もち米澱粉等が挙げられ、加工澱粉としては、上記の天然澱粉をアセチル化、ヒドロキシプロピル化、オクテニルコハク酸化、リン酸化、架橋、酸処理、湿熱処理、超音波処理等を施した澱粉が挙げられる(特に特許文献13~14)。
しかしながら、ジェランガムを用いた軟カプセル皮膜組成物及びその軟カプセル剤製造においては、以下の課題が残されている。
(1)(A)ネイティブジェランガム、(B)一種若しくは二種以上の親水性多糖類、(C)澱粉又は加工澱粉、(D)可塑剤、及び(E)水を含有し、(A)ネイティブジェランガム及び(B)一種若しくは二種以上の親水性多糖類以外のゲル化剤を必須成分としないことを特徴とする軟カプセル皮膜組成物。
(2)(C)澱粉又は加工澱粉が、天然澱粉、酸化澱粉、ヒドロキシプロピル化澱粉、アセチル化澱粉、アセチル化、ヒドロキシプロピル化、オクテニルコハク酸化、リン酸化、架橋、酸処理、塩の存在下で湿熱処理がされてなる澱粉、又は澱粉糊液に超音波処理がされてなる澱粉分散物から選ばれる一種又は二種以上であることを特徴とする、(1)の軟カプセル皮膜組成物。
(3)(C)澱粉又は加工澱粉が、サゴ澱粉、甘藷澱粉、緑豆澱粉、小麦澱粉、とうもろこし澱粉、米澱粉,ワキシーコーン澱粉、ワキシーポテト澱粉、ワキシー小麦澱粉、もしくはもち米澱粉、又はこれらから得られる加工澱粉、から選ばれる一種又は二種以上であることを特徴とする、(1)又は(2)の軟カプセル皮膜組成物。
(4)(C)澱粉又は加工澱粉が、ワキシーポテト澱粉、酸化澱粉、塩の存在下で湿熱処理がされてなる澱粉、又は澱粉糊液に超音波処理がされてなる澱粉分散物から選ばれる一種又は二種以上であることを特徴とする、(1)~(3)のいずれかの軟カプセル皮膜組成物。
(5)(A)ネイティブジェランガムと(B)一種若しくは二種以上の親水性多糖類の含有質量比[(A):(B)]が1:1~1:0.01である(1)~(4)のいずれかの軟カプセル皮膜組成物。
(6)澱粉糊液に超音波処理がされてなる澱粉分散物が、ワキシーコーン澱粉に由来する澱粉分散物である(1)~(5)のいずれかの軟カプセル皮膜組成物。
(7)澱粉糊液に超音波処理がされてなる澱粉分散物に用いられるワキシーコーン澱粉が未加工の天然澱粉である(6)の軟カプセル皮膜組成物。
(8)(C)澱粉又は加工澱粉が、塩の存在下で湿熱処理がされてなるワキシーコーン澱粉である(1)~(5)のいずれかの軟カプセル皮膜組成物。
(9)(1)~(8)のいずれかの軟カプセル皮膜組成物を用いて得られる軟カプセル皮膜。
(10)(1)~(8)のいずれかの軟カプセル皮膜組成物を用いて得られる軟カプセル。
なお、本明細書でいう「ゲル化剤」とは、液状ゾルのゲル化を起こさせる化学物質を意味する。また、「ゲル化」とは、液状ゾルがゼリー状に固化する現象を意味する。例えば寒天、ゼラチン等のように冷却によりゲル化するゲル化剤や、アルギン酸塩等のように特定のイオンの存在によってゲル化するゲル化剤などがある。
本明細書でいうネイティブジェランガムとは、すべての反復ユニットのグルコースにアセチル基とグリセリル基とが結合している必要はなく、ジェランガム全体の中にアシル化された基が存在しているジェランガムはすべて本発明でいうネイティブジェランガムに包含される。換言すると、「アシル化度:0」のジェランガムが「脱アシル化ジェランガム」、それ以外の(アシル化度が0ではない)ジェランガムはすべて「ネイティブジェランガム」である。本明細書でいうネイティブジェランガムとは、アシル化度が0ではないジェランガムを意味する。ここで、「アシル化度」は1HNMR測定により、Bruker Avance DRX-400(Bruker)を用い1.3ppm付近に現れるラムノースのメチル基由来のピークと2.1ppm付近に現れるβグルコースの6位のヒドロキシル基に結合したアセチル基のピークの信号強度比により測定できる。(安藤暢毅、「ネイティブジェランのゲル化機構に関する基礎研究」東京海洋大、2009年9月)
本発明において使用するジェランガムとしてネイティブジェランガムを採用した理由は以下の通りである。
(1)脱アシル化ジェランガムを軟カプセルの製造に顕著に使用すると、ゲルが硬いため、品質の低下につながる。
(2)ネイティブジェランガムはゲルが柔軟性を有し、軟カプセルの製造に好適である。
低メトキシペクチン(LMペクチン)は、エステル化度(DE)が50%未満のペクチンを意味し、高メトキシペクチンは、エステル化度(DE)が50%以上のペクチンを意味する。なお、エステル化度とは、総ガラクツロン酸中、メチルエステル化されているものの割合を意味し、メチルエステル化されたガラクツロン酸数を総ガラクツロン酸数で割って100を乗じた値(%)として求めることができる。
なお、本発明において、「固形成分」とは、皮膜組成物の中から、水を除いた物のことである。
本発明において、加工澱粉とは、澱粉に必要に応じて水、化学薬品(種々の塩類、アジピン酸、次亜塩素酸ナトリウム、酢酸ビニル、リン酸化合物、等)を加え、加熱処理、超音波処理、若しくはその他の処理を行って得られる澱粉を意味する。加工澱粉として、例えば、以下で言及するワキシーコーン澱粉(ワキシーコーンスターチ)が挙げられる。
塩の存在下で湿熱処理がされてなるワキシーコーン澱粉は、ワキシーコーン澱粉を、塩の存在下、湿潤状態で加熱を行った澱粉である。湿熱処理後、乾燥、必要に応じて粉砕することにより製造することができる。
このような澱粉は公知であり、例えば、ワキシーコーン澱粉から特許第4608051号公報に記載の方法又はこれに準じた方法により製造される。
なお、澱粉糊液の調製に用いられる澱粉は、未加工、すなわち、酸処理、アルファ化、エーテル化、アセチル化等の加工を行っていないものが好ましい。
超音波処理により、澱粉糊液の粘度は低下し、澱粉分散物が得られる。超音波処理後の澱粉分散物の粘度(B型粘度計、澱粉の含有量20質量%、液温80℃)は、澱粉の種類によって相違するものの、350mPa・s以下が好ましく、10~350mPa・sがより好ましい。
本発明において、澱粉糊液に超音波処理がされてなる澱粉分散物は市販品を使用することもできる。
塩の存在下で湿熱処理がされてなるワキシーコーン澱粉及び澱粉糊液に超音波処理がされてなる澱粉分散物以外の澱粉類の含有量は、皮膜シート強度、接着力及び乾燥後の弾力性の点から、固形成分の合計量中、50質量%以下が好ましく、40質量%以下がより好ましく、30質量%以下が更に好ましく、10質量%以下が更により好ましい。下限値は0質量%である。
そのような澱粉の種類としては、例えば、馬鈴薯澱粉、タピオカ澱粉、サゴ澱粉、甘藷澱粉、緑豆澱粉、小麦澱粉、とうもろこし澱粉、米澱粉,ワキシーコーン澱粉、ワキシーポテト澱粉、ワキシー小麦澱粉、もち米澱粉等が挙げられる。これらは一種又は二種以上を組み合わせて用いることができる。
本発明の軟カプセル皮膜組成物における可塑剤の含有量は、柔軟性の点から、固形成分の合計量中、20質量部以上が好ましく、30質量部以上がより好ましい。また、付着性の点から、固形成分の合計量100質量部に対して、60質量部以下が好ましく、50質量部以下がより好ましい。
(A)ネイティブジェランガム、(B)一種若しくは二種以上の親水性多糖類、(C)澱粉又は加工澱粉、(D)可塑剤、及び(E)水を含有し、(A)ネイティブジェランガム及び(B)一種若しくは二種以上の親水性多糖類以外のゲル化剤を必須成分としないことを特徴とする、本発明の軟カプセル皮膜組成物の処方を以下に例示する。
処方例1
(A)ネイティブジェランガム
(B)低メトキシペクチン
(C)ワキシーポテト澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(D)グリセリン
(E)精製水
処方例2
(A)ネイティブジェランガム
(B)低メトキシペクチン
(C)ワキシーポテト澱粉
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(D)グリセリン
(E)精製水
処方例3
(A)ネイティブジェランガム
(B)低メトキシペクチン
(C)ワキシーポテト澱粉
(C)酸化澱粉
(D)グリセリン
(E)精製水
処方例4
(A)ネイティブジェランガム
(B)低メトキシペクチン
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(D)グリセリン
(E)精製水
処方例5
(A)ネイティブジェランガム
(B)ローカストビーンガム
(C)ワキシーポテト澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(D)グリセリン
(E)精製水
処方例6
(A)ネイティブジェランガム
(B)ローカストビーンガム
(C)ワキシーポテト澱粉
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(D)グリセリン
(E)精製水
処方例7
(A)ネイティブジェランガム
(B)ローカストビーンガム
(C)ワキシーポテト澱粉
(C)酸化澱粉
(D)グリセリン
(E)精製水
処方例8
(A)ネイティブジェランガム
(B)ローカストビーンガム
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(D)グリセリン
(E)精製水
処方例9
(A)ネイティブジェランガム
(B)キサンタンガム
(C)ワキシーポテト澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(D)グリセリン
(E)精製水
処方例10
(A)ネイティブジェランガム
(B)キサンタンガム
(C)ワキシーポテト澱粉
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(D)グリセリン
(E)精製水
処方例11
(A)ネイティブジェランガム
(B)キサンタンガム
(C)ワキシーポテト澱粉
(C)酸化澱粉
(D)グリセリン
(E)精製水
処方例12
(A)ネイティブジェランガム
(B)キサンタンガム
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(D)グリセリン
(E)精製水
処方例13
(A)ネイティブジェランガム
(B)低メトキシペクチン
(B)ローカストビーンガム
(C)ワキシーポテト澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(D)グリセリン
(E)精製水
処方例14
(A)ネイティブジェランガム
(B)低メトキシペクチン
(B)ローカストビーンガム
(C)ワキシーポテト澱粉
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(D)グリセリン
(E)精製水
処方例15
(A)ネイティブジェランガム
(B)低メトキシペクチン
(B)ローカストビーンガム
(C)ワキシーポテト澱粉
(C)酸化澱粉
(D)グリセリン
(E)精製水
処方例16
(A)ネイティブジェランガム
(B)低メトキシペクチン
(B)ローカストビーンガム
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(D)グリセリン
(E)精製水
処方例17
(A)ネイティブジェランガム
(B)低メトキシペクチン
(B)キサンタンガム
(B)ローカストビーンガム
(C)ワキシーポテト澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(D)グリセリン
(E)精製水
処方例18
(A)ネイティブジェランガム
(B)低メトキシペクチン
(B)キサンタンガム
(B)ローカストビーンガム
(C)ワキシーポテト澱粉
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(D)グリセリン
(E)精製水
処方例19
(A)ネイティブジェランガム
(B)低メトキシペクチン
(B)キサンタンガム
(B)ローカストビーンガム
(C)ワキシーポテト澱粉
(C)酸化澱粉
(D)グリセリン
(E)精製水
処方例20
(A)ネイティブジェランガム
(B)低メトキシペクチン
(B)キサンタンガム
(B)ローカストビーンガム
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(D)グリセリン
(E)精製水
処方例21
(A)ネイティブジェランガム
(B)低メトキシペクチン
(C)ワキシーポテト澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(D)グリセリン
(E)精製水
処方例22
(A)ネイティブジェランガム
(B)低メトキシペクチン
(C)ワキシーポテト澱粉
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(C)酸化澱粉
(D)グリセリン
(E)精製水
処方例23
(A)ネイティブジェランガム
(B)低メトキシペクチン
(C)ワキシーポテト澱粉
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(C)酸化澱粉
(D)グリセリン
(E)精製水
処方例24
(A)ネイティブジェランガム
(B)低メトキシペクチン
(C)澱粉糊液に超音波処理がされてなる澱粉分散物
(C)塩の存在下で湿熱処理がされてなるワキシーコーン澱粉
(C)酸化澱粉
(D)グリセリン
(E)精製水
以下に、カプセルに含有し得るものを例示する。これら各成分は、カプセル剤中のいかなる部分にも含有しうる。
ネイティブジェランガム:ケルコゲルHM(登録商標)(CP Kelco社製)
低メトキシペクチン:NEW GELIN(登録商標) LP-4(三菱商事フードテック社製)
塩の存在下で湿熱処理がされてなるワキシーコーン澱粉:ソフトスターチSF-930(三和澱粉工業社製)
澱粉糊液に超音波処理がされてなる澱粉分散物:エフスマッシュ(登録商標)(フタムラ化学社製)(ワキシーコーン澱粉に由来)
ワキシーポテト澱粉:エリアンGEL 100(松谷化学工業社製)
グリセリン:食品添加物グレード(阪本薬品工業社製)
水:精製水
(1)表1に示した量(質量部)のネイティブジェランガム、低メトキシペクチン、塩の存在下で湿熱処理がされてなるワキシーコーン澱粉、澱粉糊液に超音波処理がされてなる澱粉分散物、ワキシーポテト澱粉、グリセリンをそれぞれ水に攪拌・分散させた後、90~98℃で攪拌しながら溶解させ、真空脱泡した。この皮膜液から、ロータリーダイ式軟カプセル充填機を用いてシート及び軟カプセルを製造した。
先ず、皮膜液をキャスティング装置により、回転ドラム上に展延して皮膜シートを調製した。この段階で、下記〔a.皮膜シート強度の評価〕、〔b.皮膜シートの伸びの評価〕及び〔c.皮膜シートのべたつきの評価〕を行った。
結果を表1に示す。
専門パネル5名の感覚により、以下に示す評価基準に従って、皮膜シートの強さを評価した。
5:とても強い
4:強い
3:やや弱い
2:弱い
1:とても弱い。
専門パネル5名の感覚により、皮膜シートの強度の評価時に同時に、以下に示す評価基準に従って、皮膜シートの伸びを評価した。
5:とても伸びて、弾力性がある
4:伸びて、弾力性がある
3:伸びはあるが、弾力性がやや弱い
2:ほとんど伸びがなく、弾力性が弱い
1:伸びがなく、弾力性がない
専門パネル5名の感覚により、皮膜シートの強度の評価時に同時に、以下に示す評価基準に従って、皮膜シートの伸びを評価した。
5:べたつきがない
4:べたつきが少ない
3:べたつきがややある
2:べたつきが多い
1:べたつきが非常に多い
専門パネル5名で乾燥前のカプセルを指で押しつぶして、以下に示す評価基準に従って、カプセル成形直後の皮膜シートの接着性を評価した。
5:強く押しても内容液が全く漏れ出さないし、24時間静置してもすべてのカプセルに浸出が発生しない
4:強く押しても内容液は漏れ出さないが、24時間静置すると一部のカプセルに浸出が発生する
3:強く押すとごく少量の内容液が漏れてしまう
2:弱く押しても少量の内容液が漏れてしまう
1:弱く押しても内容液が漏れてしまう
上記a~dの評価を元に、以下に示す評価基準に従って、カプセル充填機での製造性を評価した。
○:従来の設備を使用し、カプセル充填機での製造が可能である。
△:カプセル充填機での製造は可能であるが、従来の設備からの変更が必要である。
×:皮膜シートの物性から、カプセル充填機での製造は不可能である。
一方、本発明に係る実施例1及び実施例2では、皮膜シートの物性が良好であり、いずれもカプセル充填機での製造が容易であった。
(1)表2に示した量(質量部)のネイティブジェランガム、低メトキシペクチン、ローカストビーンガム、キサンタンガム、超音波処理ワキシーコーンスターチ、ワキシーポテトスターチ、グリセリンをそれぞれ水に攪拌・分散させた後、90~98℃で攪拌しながら溶解させ、真空脱泡した。この皮膜液から、ロータリーダイ式軟カプセル充填機を用いてシート及び軟カプセルを製造した。
先ず、皮膜液をキャスティング装置により、回転ドラム上に展延して皮膜シートを調製した。この段階で、下記〔a.皮膜シート強度の評価〕、〔b.皮膜シートの伸びの評価〕及び〔c.皮膜シートのべたつきの評価〕を行った。
結果を表2に示す。
表2における評価の基準は、前記「実施例1~2、比較例1~2:ロータリーダイ式軟カプセル充填機による軟カプセルの製造」の表1における評価基準と同一である。
本発明に係る軟カプセル皮膜組成物を用いて製造された軟カプセルは、医薬品、医薬部外品、化粧品、食品等種々の用途に利用することができる。
11 タンク
12 キャスティング装置
13 回転ドラム
14 潤滑ローラー
15 デフレクトロール
16 金型
16A 金型の凹部
17 セグメント
18 ポンプ
18A ピストン
A 皮膜シート
B 内容物
C カプセル
Claims (9)
- (A)ネイティブジェランガム、(B)低メトキシペクチン、ローカストビーンガム、及びキサンタンガムから選ばれる一種若しくは二種以上の親水性多糖類、(C)澱粉糊液に超音波処理がされてなる澱粉分散物、(D)可塑剤、及び(E)水を含有し、(A)ネイティブジェランガム及び(B)低メトキシペクチン、ローカストビーンガム、及びキサンタンガムから選ばれる一種若しくは二種以上の親水性多糖類以外のゲル化剤を含まないことを特徴とする軟カプセル皮膜組成物。
- 澱粉糊液に超音波処理がされてなる澱粉分散物が、ワキシーコーン澱粉に由来する澱粉分散物である請求項1記載の軟カプセル皮膜組成物。
- 澱粉糊液に超音波処理がされてなる澱粉分散物に用いられるワキシーコーン澱粉が未加工の天然澱粉である請求項2に記載の軟カプセル皮膜組成物。
- さらに、天然澱粉、酸化澱粉、ヒドロキシプロピル化澱粉、アセチル化澱粉、アセチル化、ヒドロキシプロピル化、オクテニルコハク酸化、リン酸化、架橋、酸処理、塩の存在下で湿熱処理がされてなる澱粉から選ばれる一種又は二種以上を含むことを特徴とする、請求項1~3いずれか記載の軟カプセル皮膜組成物。
- (C)塩の存在下で湿熱処理がされてなる澱粉が、塩の存在下で湿熱処理がされてなるワキシーコーン澱粉である請求項4記載の軟カプセル皮膜組成物。
- (C)澱粉の由来が、サゴ澱粉、甘藷澱粉、緑豆澱粉、小麦澱粉、とうもろこし澱粉、米澱粉,ワキシーコーン澱粉、ワキシーポテト澱粉、ワキシー小麦澱粉、もしくはもち米澱粉であることを特徴とする、請求項4記載の軟カプセル皮膜組成物。
- (A)ネイティブジェランガムと(B)低メトキシペクチン、ローカストビーンガム、及びキサンタンガムから選ばれる一種若しくは二種以上の親水性多糖類の含有質量比[(A):(B)]が1:1~1:0.01である請求項1~6のいずれか1項記載の軟カプセル皮膜組成物。
- 請求項1~7のいずれか1項記載の軟カプセル皮膜組成物を用いて得られる軟カプセル皮膜。
- 請求項1~7のいずれか1項記載の軟カプセル皮膜組成物を用いて得られる軟カプセル。
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JP7411990B2 (ja) | 2019-12-24 | 2024-01-12 | 中日本カプセル 株式会社 | ソフトカプセル皮膜、ソフトカプセル、及び、ソフトカプセルの製造方法 |
CN113115930B (zh) * | 2019-12-30 | 2023-06-13 | 仙乐健康科技股份有限公司 | 含结冷胶和淀粉的成膜组合物及在软胶囊中应用 |
WO2021157745A1 (ja) * | 2020-02-06 | 2021-08-12 | 株式会社オーアンドケー | ヘミモルファイト含有の潤滑皮膜を形成させるための潤滑剤組成物および金属加工材の表面に該潤滑皮膜を形成する方法と、該潤滑皮膜を備えた金属加工材 |
KR102294072B1 (ko) * | 2020-11-19 | 2021-08-26 | (주)알피바이오 | 식물성 츄어블 연질캡슐용 조성물 및 이를 통해 형성된 식물성 츄어블 연질캡슐 |
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