JP4156234B2 - Soft capsule - Google Patents
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- JP4156234B2 JP4156234B2 JP2001396643A JP2001396643A JP4156234B2 JP 4156234 B2 JP4156234 B2 JP 4156234B2 JP 2001396643 A JP2001396643 A JP 2001396643A JP 2001396643 A JP2001396643 A JP 2001396643A JP 4156234 B2 JP4156234 B2 JP 4156234B2
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Description
【発明が属する技術分野】
【０００１】
本発明は、内容液に天然物から得られた濃縮物の親水性粉末とポリグリセリン縮合リシノール酸エステルを含有する食品、医薬品、化粧品等に利用されるゼラチンを皮膜とする軟カプセルに関する。
【従来の技術】
【０００２】
軟カプセルは、一般に油脂、脂溶性成分等を内容液とし、ゼラチンを皮膜とするカプセル製剤で、食品、医薬品、化粧品等の分野で広く用いられている。これは、軟カプセルが一定量の成分を簡便に配合でき、内容成分を安定に保つことができる為である。最近では、親水性粉末を界面活性剤、安定剤等で油相に分散せしめた内容液を充填する方法が開発され、軟カプセルの汎用性がさらに高まっている。
【発明が解決しようとする課題】
【０００３】
しかし、親水性粉末の配合量が多くなると、内容液の充填時にゼラチン皮膜の接合部分に当該親水性粉末が付着して接合部分が脆くなり、温度変化、経時等により内容液が漏れるという問題がある。係る問題に対処するには、ゼラチン皮膜を厚くする方法があるが、軟カプセルの崩壊時間が著しく遅延するという重大な欠点がある。
【０００４】
又、一般に天然物から得られた濃縮物の親水性粉末にはアルデヒド類、ケトース、酸化物等が含まれる。この為、当該親水性粉末を含む内容液を軟カプセルに充填すると、ゼラチンのリジン残基とアルデヒド類やケトースの反応、或いはリジン残基の酸化によるアルデヒド化でゼラチンが不溶化し、軟カプセルの崩壊時間が経時的に遅延するという問題がある。崩壊時間が遅延すると、カプセルが消化器系で溶解されず、カプセルの内容成分が人体に吸収されない等の問題が生じる。
【０００５】
係る問題に対処すべく、特開平８−２４５３７２号には皮膜に酸処理ゼラチン、還元剤等を配合した軟カプセルが、特開２０００−４４４６５号には皮膜に化学修飾ゼラチン及びポリグルコースを配合した軟カプセルが開示されているが、これらは崩壊時間の経時的遅延は防止されるものの、当初から崩壊性そのものが悪く、根本的な解決には至っていないのが現状である。
【０００６】
この様な事情に鑑み本発明者らが鋭意検討した結果、軟カプセルの内容液に天然物から得られた濃縮物の親水性粉末を多量に配合しても、所定のポリグリセリン縮合リシノール酸エステルを含有せしめることで、軟カプセルの経時的な液漏れ、崩壊時間の遅延等を防止できることを見出し、本発明を完成するに至った。
【課題を解決するための手段】
【０００７】
即ち、本発明は、内容液に天然物から得られた濃縮物の親水性粉末を２０〜５０％配合した場合において、ポリグリセリン縮合リシノール酸エステル（グリセリン単位２〜１０及びリシノール酸単位２〜１０）を０．１〜３０％含有せしめることで、経時的な液漏れ、崩壊時間の遅延等を防止するゼラチンを皮膜とする軟カプセルである。
【０００８】
本発明に係る天然物から得られた濃縮物の親水性粉末とは、天然物の抽出液、搾汁、或は天然物自体等を濃縮した親水性の粉末をいう。例えば、抽出液の濃縮物の親水性粉末としては、高麗人参、エゾウコギ、アガリクス、霊芝、メシマコブ、ギムネマ、アロエ、ウコン、イチョウ葉、桑の葉、くま笹等の生薬、大豆、米、小麦等の穀物、緑茶、ウーロン茶、紅茶等の茶、人参、カボチャ、ほうれん草、キャベツ等の野菜、ブルーベリー、ぶどう、オレンジ、りんご、みかん、レモン等の果物、牛乳、山羊乳、羊乳等の乳、鰯、鰹、牡蠣、イカ等の魚介、鶏肉、豚肉、牛肉等の獣肉、プロポリス、ローヤルゼリー等の冷水、熱水、アルコール、含水アルコール等の抽出液を濃縮した粉末が挙げられる。搾汁の濃縮物の親水性粉末としては、上述の生薬、野菜、果物等の搾汁を濃縮した粉末が挙げられる。又、天然物自体の濃縮物の親水性粉末としては、上述の生薬、穀物、茶、野菜、果物、乳、魚介、獣肉、プロポリス、ローヤルゼリー等を乾燥、濃縮、粉砕等した粉末が挙げられる。これらの天然物から得られた濃縮物の親水性粉末は、必要に応じて酵素、加水分解、精製等の処理がされたものを用いることができる。又、天然物から得られた濃縮物の親水性粉末は単独又は２種以上を組み合わせて用いることができる。
【０００９】
粉末の粒度は特に限定されないが、６０メッシュ以下がよく、好ましくは８０メッシュ以下、さらに好ましくは１００メッシュ以下である。又、粉末の水分量は、７％以下が好ましく、さらに好ましくは５％以下である。
【００１０】
ポリグリセリン縮合リシノール酸エステルは、通常、グリセリンを脱水縮合したポリグリセリンと、ヒマシ油脂肪酸に触媒を添加して窒素ガス気流下で１８０〜２１０℃に加熱して得られた縮合リシノール酸を、窒素ガス気流下で１８０〜２１０℃でエステル化して得られるものである。ポリグリセリン縮合リシノール酸エステルは食品、医薬品、化粧品等に広く用いられており、市販品を用いることができる。本発明のポリグリセリン縮合リシノール酸エステルはグリセリン単位が２〜１０、リシノール酸単位が２〜１０のものを用いる。より好ましくは、グリセリン単位が４〜６、リシノール酸単位が４〜６のものである。尚、特開平９−１６３９６３号には、乳化物である内容液にグリセリン単位が１〜１５のポリグリセリンとポリヒドロキシカルボン酸からなるエステルを用いた軟カプセルが開示されているが、当該発明は乳化物の安定性と熱水溶解性を高めたものであり、本発明に係る軟カプセルを示唆するものでは無い。
【００１１】
本発明の内容液に天然物から得られた濃縮物の親水性粉末とポリグリセリン縮合リシノール酸エステルを含有するゼラチンを皮膜とした軟カプセルは、内容液にレシチンを配合することにより更に効果を高めることができる。レシチンは、大豆、卵黄等から得られるホスファチジルコリン、ホスファチジルエタノールアミン、ホスファチジルイノシトール等を含むリン脂質である。レシチンは、天然の両性イオン系界面活性剤で、食品、医薬品、化粧品等に広く用いられており、市販品を用いることができる。レシチンとしては大豆レシチン、卵黄レシチンの他に、これらをアセトンで脱脂濃縮した粉末レシチン、エタノールで分画濃縮した分画レシチン、酵素的に加水分解した酵素分解レシチン等が挙げられ、これらは単独又は２種以上を組み合せて用いることができる。
【００１２】
本発明に係る天然物から得られた濃縮物の親水性粉末の内容液への配合量は、２０〜５０％である。ポリグリセリン縮合リシノール酸エステルの配合量は、０．１〜３０％、より好ましくは０．１〜１０％である。又、レシチンを配合する場合は、０.１〜５％配合するとよい。
【００１３】
本発明の軟カプセルの内容液として、シソ油、米胚芽油、小麦胚芽油、大豆油、ナタネ油、コーン油、サフラワー油、ゴマ油、綿実油、パーム油等の植物油脂、魚油、イカ油、鯨油、牛脂、豚脂等の動物油脂、スクワラン、パラフィン等の炭化水素、ミツロウ、米糠ロウ、カルナウバロウ等のワックス、ビタミン、ミネラル、アミノ酸等の栄養強化剤、グリセリン脂肪酸エステル、ショ糖脂肪酸エステル等の界面活性剤、ビタミンＥ、ヒドロキシトルエン、ヒドロキシアニソール等の酸化防止剤、高級アルコール等の食品、医薬品、化粧品等に用いられているものを適宜配合することができる。
【００１４】
本発明に係るゼラチン皮膜は、ゼラチンにグリセリン、ソルビット等の可塑剤を配合したものを基剤とする。ゼラチン、可塑剤の種類及び配合比は、目的とする軟カプセルの大きさ、形状等を考慮して適宜選択する。又、必要に応じて色素等の添加剤を配合することができる。ゼラチンは、アルカリ処理ゼラチン、酸処理ゼラチン、酵素処理ゼラチン、化学修飾ゼラチン等の食品、医薬品、化粧品等で用いられているものを適宜選択して用いることができる。
【００１５】
本発明に係る内容液の調製は、一般的な方法に従えばよい。例えば、油脂、ポリグリセリン縮合リシノール酸エステル、ワックス等を６０〜８０℃で加熱溶解して３０〜５０℃まで冷却する。これに天然物から得られた濃縮物の親水性粉末、レシチン、酸化防止剤等を添加してホモミキサー等の高速攪拌機で均一に混合した後、マイコロイダー等の粉砕機で粉砕して篩過し、減圧下で脱泡して内容液を得る。
【００１６】
軟カプセルの成形は、ロータリー法、平板法、２重ノズル法等の一般的な方法に従えばよいが、特にロータリー法及び平板法による軟カプセルにおいて本発明の効果が発揮される。ロータリー法による軟カプセルの成形は、例えば、内容液を送る定量ポンプ、ゼラチンシートを送るローラー、打ち抜き型等を装備したロータリー式カプセル成形機を用い、内容液の充填、ゼラチンシートの圧着接合及びカプセル成形を同時に行う。その後、回転ドラム式乾燥機で皮膜水分を１０％以下になるまで乾燥し、軟カプセルを得る。
【実施例】
【００１７】
次に本発明を詳細に説明するために代表的な実施例を挙げるが、本発明はこれに限定されるものではない。実施例に示す配合量は重量％を示す。
【００１８】
実施例１
＜処方＞ 配合量（％）
１．シソ油 ５１．０
２．ポリグリセリン縮合リシノール酸エステル ３．０
（グリセリン単位６、リシノール酸単位５．５）
３．ミツロウ １２．０
４．ビタミンＥ ３．０
５．大豆レシチン １．０
６．霊芝の熱水抽出物の粉末（粒度８０メッシュ以下、水分４．５％）３０．０
＜製法＞
成分１〜３を７０℃で加熱溶解して４０℃まで冷却した後、成分４〜６を添加してホモミキサー（２０００ｒｐｍ）で３０分間混合し、マイコロイダーで粉砕して８３メッシュ（目開き１８０μｍ）で篩過する。さらに７２０ｍｍＨｇ減圧下で脱泡したものを内容液とした。皮膜液は、ゼラチン１００部、グリセリン３５部及び精製水８０部を加熱溶解したものを使用し、ロータリー式カプセル成形機にて内容液を充填して成形し、回転ドラム式乾燥機で皮膜水分が７％になるまで乾燥し、全重量５５０ｍｇ、内容液量３６０ｍｇの楕円形軟カプセルを得た。
【００１９】
実施例１のポリグリセリン縮合リシノール酸エステル（グリセリン単位６及びリシノール酸単位５．５）のグリセリン単位或いはリシノール酸単位を表１の重合単位のものに置き換えて得た軟カプセルを実施例２〜４、比較例１〜３とした。
【００２０】
【表１】
実施例１のポリグリセリン縮合リシノール酸エステルの配合量を表２の通りに変えて、全体量をシソ油で調整して得た軟カプセルを実施例５〜７及び比較例４とした。
【００２２】
【表２】
ポリグリセリン縮合リシノール酸エステルを、表３のグリセリンモノ脂肪酸エステル或いは脂肪酸が縮合リシノール酸以外の脂肪酸であるポリグリセリン脂肪酸エステルに置き換えて得た軟カプセルを比較例５〜１０とした。
【００２４】
【表３】
実施例８
実施例１において、大豆レシチンをシソ油に置き換えたものを実施例８とした。
【００２６】
実施例９
＜処方＞ 配合量（％）
１．米胚芽油 ５０．０
２．ポリグリセリン縮合リシノール酸エステル ２．０
（グリセリン単位６、リシノール酸単位５．５）
３．ミツロウ ４．５
４．ビタミンＥ ３．０
５．大豆レシチン ０．５
６．ブルーベリー果汁の含水アルコール抽出物の粉末 ４０．０
（粒度８０メッシュ以下、水分３．４％）
＜製法＞
成分１〜３を７０℃で加熱溶解して４０℃まで冷却した後、成分４〜６を添加してホモミキサー（２０００ｒｐｍ）で３０分間混合した後、マイコロイダーで粉砕して８３メッシュ（目開き１８０μｍ）で篩過する。さらに７２０ｍｍＨｇ減圧下で脱泡したものを内容液とした。皮膜液は、ゼラチン１００部、グリセリン３５部及び精製水８０部を加熱溶解したものを使用し、ロータリー式カプセル成形機にて内容液を充填して成形し、回転ドラム式乾燥機で皮膜水分が８％になるまで乾燥し、全重量５５０ｍｇ、内容液量３６０ｍｇの楕円形軟カプセルを得た。
【００２７】
実施例１０
＜処方＞ 配合量（％）
１．コーン油 ５３．０
２．ポリグリセリン縮合リシノール酸エステル １．５
（グリセリン単位６、リシノール酸単位５．５）
３．ミツロウ ７．０
４．ビタミンＥ ３．０
５．大豆レシチン ０．５
６．アガリクスの熱水抽出物の粉末 ３５．０
(粒度８０メッシュ以下、水分４．３％)
＜製法＞
成分１〜３を７０℃で加熱溶解して４０℃まで冷却した後、成分４〜６を添加してホモミキサー（２０００ｒｐｍ）で３０分間混合した後、マイコロイダーで粉砕して８３メッシュ（目開き１８０μｍ）で篩過する。さらに７２０ｍｍＨｇ減圧下で脱泡したものを内容液とした。皮膜液は、ゼラチン１００部、グリセリン３５部及び精製水８０部を加熱溶解したものを使用し、ロータリー式カプセル成形機にて内容液を充填して成形し、回転ドラム式乾燥機で皮膜水分が７％になるまで乾燥し、全重量４８０ｍｇ、内容液量２５０ｍｇの楕円形軟カプセルを得た。
【発明の効果】
【００２８】
以下の実験例にて、本発明の効果を詳細に説明する。実施例１〜８及び比較例１〜１０の軟カプセルを夫々１０００粒づつガラスの密閉容器に入れ、４０℃で２ヶ月保存後の軟カプセルの液漏れ、割れ、崩壊時間を観察した。尚、液漏れ及び割れは目視で、崩壊時間は日本薬局方の崩壊試験法（試験液は精製水、ｎ＝６、補助盤使用）に準じて行った。
【００２９】
経時的な液漏れ及び割れの発生数、崩壊時間を表４に示す。本発明に係る実施例１〜８の軟カプセルは、何れも経時的な液漏れ及び割れを生じず、又、崩壊時間の遅延が防止されている。特にグリセリン単位が４〜６及びリシノール酸単位が４〜６のポリグリセリン縮合リシノール酸エステルと大豆レシチンを併用した実施例において、優れた崩壊時間の遅延防止効果が得られている。一方、他の界面活性剤を用いた軟カプセルは経時的な液漏れ或いは割れを生じ、崩壊時間が遅延しているのがわかる。尚、表４中のＥは天然物から得られた濃縮物の親水性粉末、Ｒはポリグリセリン縮合リシノール酸エステル、Ｄは大豆レシチンを示す。
【００３０】
【表４】
以上の結果から、内容液に天然物から得られた濃縮物の親水性粉末を２０〜５０％、ポリグリセリン縮合リシノール酸エステル（グリセリン単位２〜１０及びリシノール酸単位２〜１０）を０．１〜３０％含有することを特徴とするゼラチンを皮膜とする軟カプセルは、経時的に液漏れ及び割れを生じず、崩壊時間が遅延しにくいことが証明された。又、当該構成にレシチンを０．１〜５％配合することによりさらに優れた効果が得られることが明らかとなった。[Technical field to which the invention belongs]
[0001]
The present invention relates to a soft capsule containing gelatin as a film for use in foods, pharmaceuticals, cosmetics and the like containing a hydrophilic powder of a concentrate obtained from a natural product and a polyglycerin condensed ricinoleic acid ester in a content liquid.
[Prior art]
[0002]
Soft capsules are generally capsule preparations containing oils and fats, fat-soluble components and the like as content liquids and gelatin as a film, and are widely used in the fields of foods, pharmaceuticals, cosmetics and the like. This is because soft capsules can easily add a certain amount of components and keep the content components stable. Recently, a method of filling a content liquid in which hydrophilic powder is dispersed in an oil phase with a surfactant, a stabilizer or the like has been developed, and the versatility of soft capsules is further increased.
[Problems to be solved by the invention]
[0003]
However, when the amount of the hydrophilic powder is increased, the hydrophilic powder adheres to the joint portion of the gelatin film when the content liquid is filled, the joint portion becomes brittle, and the content liquid leaks due to temperature change, aging, etc. is there. To deal with such a problem, there is a method of thickening the gelatin film, but there is a serious disadvantage that the disintegration time of the soft capsule is significantly delayed.
[0004]
In general, hydrophilic powders of concentrates obtained from natural products include aldehydes, ketoses, oxides and the like. Therefore, when a soft capsule is filled with the content liquid containing the hydrophilic powder, gelatin becomes insoluble due to the reaction of lysine residue of gelatin with aldehydes and ketose, or aldehyde formation by oxidation of lysine residue, and the soft capsule collapses. There is a problem that time is delayed over time. If the disintegration time is delayed, the capsule is not dissolved in the digestive system, and the content of the capsule is not absorbed by the human body.
[0005]
In order to deal with such problems, Japanese Patent Application Laid-Open No. 8-245372 has soft capsules containing acid-treated gelatin and a reducing agent in the film, and Japanese Patent Application No. 2000-44465 has chemically modified gelatin and polyglucose in the film. Although soft capsules have been disclosed, the disintegration time is prevented from being delayed over time, but the disintegration itself is poor from the beginning, and the fundamental solution has not been reached.
[0006]
As a result of intensive studies by the present inventors in view of such circumstances, even if a large amount of a hydrophilic hydrophilic powder obtained from a natural product is blended in the soft capsule content liquid, a predetermined polyglycerin condensed ricinoleic acid ester It has been found that the inclusion of can prevent the liquid leakage of the soft capsule over time, the delay of the disintegration time, and the like, and the present invention has been completed.
[Means for Solving the Problems]
[0007]
That is, when 20-50% of the concentrated hydrophilic powder obtained from a natural product is blended in the content liquid, the present invention provides a polyglycerin condensed ricinoleic acid ester (glycerin units 2 to 10 and ricinoleic acid units 2 to 10). ) Is contained in 0.1 to 30%, it is a soft capsule having a gelatin coating that prevents liquid leakage with time, delay in disintegration time, and the like.
[0008]
The hydrophilic powder of the concentrate obtained from the natural product according to the present invention refers to a hydrophilic powder obtained by concentrating a natural product extract, juice or natural product itself. For example, as the hydrophilic powder of the extract concentrate, herbal medicines such as ginseng, Ezocogi, agaricus, ganoderma, Meshimakobu, Gymnema, aloe, turmeric, ginkgo biloba, mulberry leaves, bear cocoon, soy, rice, wheat Cereals such as green tea, oolong tea, tea etc., vegetables such as carrots, pumpkins, spinach, cabbage, fruits such as blueberries, grapes, oranges, apples, tangerines, lemons, milk such as milk, goat milk, sheep milk, Examples thereof include powders obtained by concentrating extracts such as seafood such as salmon, salmon, oysters, squid, animal meat such as chicken, pork and beef, cold water such as propolis and royal jelly, hot water, alcohol and hydrous alcohol. Examples of the hydrophilic powder of the juice concentrate include a powder obtained by concentrating the juice of the above-mentioned crude drugs, vegetables, fruits and the like. Examples of the hydrophilic powder of the concentrate of the natural product itself include powders obtained by drying, concentrating, and pulverizing the above-described crude drugs, grains, tea, vegetables, fruits, milk, seafood, animal meat, propolis, royal jelly and the like. As the hydrophilic powder of the concentrate obtained from these natural products, those subjected to treatment such as enzyme, hydrolysis, purification, etc. can be used as necessary. Moreover, the hydrophilic powder of the concentrate obtained from the natural product can be used individually or in combination of 2 or more types.
[0009]
The particle size of the powder is not particularly limited, but is preferably 60 mesh or less, preferably 80 mesh or less, and more preferably 100 mesh or less. The moisture content of the powder is preferably 7% or less, more preferably 5% or less.
[0010]
Polyglycerin-condensed ricinoleic acid ester is usually obtained by adding polyglycerin obtained by dehydration condensation of glycerin and condensed ricinoleic acid obtained by adding a catalyst to castor oil fatty acid and heating to 180 to 210 ° C. under a nitrogen gas stream. It is obtained by esterification at 180 to 210 ° C. under a gas stream. Polyglycerin condensed ricinoleic acid esters are widely used in foods, pharmaceuticals, cosmetics, and the like, and commercially available products can be used. As the polyglycerin condensed ricinoleic acid ester of the present invention, those having 2 to 10 glycerin units and 2 to 10 ricinoleic acid units are used. More preferably, the glycerin unit is 4-6 and the ricinoleic acid unit is 4-6. JP-A-9-163963 discloses a soft capsule using an ester composed of polyglycerin having 1 to 15 glycerin units and polyhydroxycarboxylic acid in the content liquid which is an emulsion. The stability of the emulsion and the hot water solubility are improved, and the soft capsule according to the present invention is not suggested.
[0011]
The soft capsules in which the hydrophilic liquid of the concentrate obtained from the natural product and the gelatin containing the polyglycerin condensed ricinoleate are coated in the content liquid of the present invention are further enhanced by adding lecithin to the content liquid. be able to. Lecithin is a phospholipid containing phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol and the like obtained from soybean, egg yolk and the like. Lecithin is a natural zwitterionic surfactant and is widely used in foods, pharmaceuticals, cosmetics and the like, and commercially available products can be used. Examples of lecithin include soy lecithin, egg yolk lecithin, powdered lecithin degreased and concentrated with acetone, fractionated lecithin fractionated and concentrated with ethanol, enzymatically hydrolyzed enzymatically decomposed lecithin, and the like. Two or more types can be used in combination.
[0012]
The amount of the concentrate obtained from the natural product according to the present invention to the content liquid of the hydrophilic powder is 20 to 50%. The compounding quantity of polyglycerol condensed ricinoleic acid ester is 0.1 to 30%, More preferably, it is 0.1 to 10%. Moreover, when mix | blending lecithin, it is good to mix | blend 0.1 to 5%.
[0013]
As a soft capsule content liquid of the present invention, perilla oil, rice germ oil, wheat germ oil, soybean oil, rapeseed oil, corn oil, safflower oil, sesame oil, cottonseed oil, palm oil and other vegetable oils, fish oil, squid oil, Animal oils and fats such as whale oil, beef tallow and pork fat, hydrocarbons such as squalane and paraffin, waxes such as beeswax, rice bran wax and carnauba wax, nutrition enhancers such as vitamins, minerals and amino acids, glycerin fatty acid esters and sucrose fatty acid esters Surfactants, antioxidants such as vitamin E, hydroxytoluene, hydroxyanisole, and the like, foods such as higher alcohols, pharmaceuticals, cosmetics and the like can be appropriately blended.
[0014]
The gelatin film according to the present invention is based on gelatin containing a plasticizer such as glycerin or sorbit. The kind and blending ratio of gelatin and plasticizer are appropriately selected in consideration of the size and shape of the intended soft capsule. Moreover, additives, such as a pigment | dye, can be mix | blended as needed. As the gelatin, those used in foods such as alkali-treated gelatin, acid-treated gelatin, enzyme-treated gelatin, chemically modified gelatin and the like, pharmaceuticals, cosmetics and the like can be appropriately selected and used.
[0015]
The content liquid according to the present invention may be prepared according to a general method. For example, fats and oils, polyglycerin condensed ricinoleic acid ester, wax and the like are heated and dissolved at 60 to 80 ° C. and cooled to 30 to 50 ° C. To this, a hydrophilic powder of a concentrate obtained from a natural product, lecithin, antioxidant, etc. are added and mixed uniformly with a high-speed stirrer such as a homomixer. And defoaming under reduced pressure to obtain the content liquid.
[0016]
The soft capsule may be formed by a general method such as a rotary method, a flat plate method, or a double nozzle method, but the effect of the present invention is exhibited particularly in a soft capsule by the rotary method and the flat plate method. Soft capsule molding by the rotary method uses, for example, a rotary capsule molding machine equipped with a metering pump for feeding the content liquid, a roller for feeding the gelatin sheet, a punching die, etc. Forming at the same time. Thereafter, the film moisture is dried to 10% or less with a rotary drum dryer to obtain soft capsules.
【Example】
[0017]
Next, representative examples will be given to describe the present invention in detail, but the present invention is not limited thereto. The compounding amount shown in the examples indicates% by weight.
[0018]
Example 1
<Prescription> Compounding amount (%)
1. Perilla oil 51.0
2. Polyglycerin condensed ricinoleic acid ester 3.0
(Glycerin unit 6, ricinoleic acid unit 5.5)
3. Beeswax 12.0
4). Vitamin E 3.0
5. Soy lecithin 1.0
6). Ganoderma hot water extract powder (particle size 80 mesh or less, moisture 4.5%) 30.0
<Production method>
Components 1 to 3 were heated and dissolved at 70 ° C. and cooled to 40 ° C., then components 4 to 6 were added, mixed with a homomixer (2000 rpm) for 30 minutes, and pulverized with a mycolloider to obtain 83 mesh (opening 180 μm). ). Furthermore, what was degassed under reduced pressure of 720 mmHg was used as the content liquid. The coating solution is prepared by heating and dissolving 100 parts of gelatin, 35 parts of glycerin and 80 parts of purified water, filling the content liquid with a rotary capsule molding machine, and forming the film moisture with a rotary drum dryer. The resultant was dried to 7% to obtain an elliptical soft capsule having a total weight of 550 mg and a content liquid amount of 360 mg.
[0019]
Soft capsules obtained by substituting the glycerin units or ricinoleic acid units of the polyglycerin condensed ricinoleic acid ester (glycerin unit 6 and ricinoleic acid unit 5.5) of Example 1 with those of the polymerized units of Table 1 in Examples 2 to 4 Comparative Examples 1 to 3 were used.
[0020]
[Table 1]
Soft capsules obtained by changing the blending amount of the polyglycerin condensed ricinoleic acid ester of Example 1 as shown in Table 2 and adjusting the total amount with perilla oil were designated as Examples 5 to 7 and Comparative Example 4.
[0022]
[Table 2]
The soft capsules obtained by replacing the polyglycerin condensed ricinoleic acid ester with the glycerin mono fatty acid ester in Table 3 or a polyglycerin fatty acid ester in which the fatty acid is a fatty acid other than condensed ricinoleic acid were used as Comparative Examples 5 to 10.
[0024]
[Table 3]
Example 8
In Example 1, the soybean lecithin was replaced with perilla oil to give Example 8.
[0026]
Example 9
<Prescription> Compounding amount (%)
1. Rice germ oil 50.0
2. Polyglycerin condensed ricinoleic acid ester 2.0
(Glycerin unit 6, ricinoleic acid unit 5.5)
3. Beeslow 4.5
4). Vitamin E 3.0
5. Soy lecithin 0.5
6). Blueberry juice hydroalcoholic powder 40.0
(Grain size 80 mesh or less, moisture 3.4%)
<Production method>
Ingredients 1 to 3 were heated and melted at 70 ° C. and cooled to 40 ° C., then ingredients 4 to 6 were added and mixed for 30 minutes with a homomixer (2000 rpm), then pulverized with Mycoloyder and 83 mesh (opening) Sieving at 180 μm). Furthermore, what was degassed under reduced pressure of 720 mmHg was used as the content liquid. The coating solution is prepared by heating and dissolving 100 parts of gelatin, 35 parts of glycerin and 80 parts of purified water, filling the content liquid with a rotary capsule molding machine, and forming the film moisture with a rotary drum dryer. It was dried to 8% to obtain an elliptical soft capsule having a total weight of 550 mg and a content liquid amount of 360 mg.
[0027]
Example 10
<Prescription> Compounding amount (%)
1. Corn oil 53.0
2. Polyglycerin condensed ricinoleic acid ester 1.5
(Glycerin unit 6, ricinoleic acid unit 5.5)
3. Beeswah 7.0
4). Vitamin E 3.0
5. Soy lecithin 0.5
6). Agaricus hot water extract powder 35.0
(Granularity 80 mesh or less, moisture 4.3%)
<Production method>
Ingredients 1 to 3 were heated and melted at 70 ° C. and cooled to 40 ° C., then ingredients 4 to 6 were added and mixed for 30 minutes with a homomixer (2000 rpm), then pulverized with Mycoloyder and 83 mesh (opening) 180 μm). Furthermore, what was degassed under reduced pressure of 720 mmHg was used as the content liquid. The coating solution is prepared by heating and dissolving 100 parts of gelatin, 35 parts of glycerin and 80 parts of purified water, filling the content liquid with a rotary capsule molding machine, and forming the film moisture with a rotary drum dryer. It was dried to 7% to obtain an elliptical soft capsule having a total weight of 480 mg and a content liquid amount of 250 mg.
【The invention's effect】
[0028]
The effects of the present invention will be described in detail in the following experimental examples. Each of the soft capsules of Examples 1 to 8 and Comparative Examples 1 to 10 was put into a glass sealed container of 1000 grains, and the liquid leakage, cracking, and disintegration time of the soft capsules after storage at 40 ° C. for 2 months were observed. Liquid leakage and cracking were visually observed, and the disintegration time was determined according to the Japanese Pharmacopoeia disintegration test method (the test solution was purified water, n = 6, using an auxiliary panel).
[0029]
Table 4 shows the number of liquid leaks and cracks with time, and the disintegration time. All of the soft capsules of Examples 1 to 8 according to the present invention do not cause liquid leakage and cracking over time, and the disintegration time is prevented from being delayed. In particular, in an example in which a polyglycerin-condensed ricinoleic acid ester having 4 to 6 glycerin units and 4 to 6 ricinoleic acid units and soybean lecithin are used in combination, an excellent effect of preventing delay of disintegration time is obtained. On the other hand, it can be seen that soft capsules using other surfactants cause liquid leakage or cracking over time, and the disintegration time is delayed. In Table 4, E is a hydrophilic powder of a concentrate obtained from a natural product, R is a polyglycerol condensed ricinoleic acid ester, and D is soybean lecithin.
[0030]
[Table 4]
From the above results, 20-50% of the concentrated hydrophilic powder obtained from the natural product is contained in the content liquid, and 0.1% of the polyglycerin condensed ricinoleic acid ester (glycerin units 2-10 and ricinoleic acid units 2-10) is 0.1. It was proved that the soft capsule having gelatin as a film characterized by containing ˜30% does not cause liquid leakage and cracking over time, and the disintegration time is hardly delayed. Moreover, it became clear that the further excellent effect is acquired by mix | blending lecithin 0.1-5% with the said structure.
Claims (3)
Priority Applications (1)
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| JP2001396643A JP4156234B2 (en) | 2001-12-27 | 2001-12-27 | Soft capsule |
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|---|---|---|---|
| JP2001396643A JP4156234B2 (en) | 2001-12-27 | 2001-12-27 | Soft capsule |
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| JP4156234B2 true JP4156234B2 (en) | 2008-09-24 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2012051945A (en) * | 2003-11-21 | 2012-03-15 | Wakunaga Pharmaceut Co Ltd | Capsule, method for manufacturing the same, and capsule wall |
| JP4913340B2 (en) * | 2003-11-21 | 2012-04-11 | 湧永製薬株式会社 | Capsule |
| CN100553680C (en) | 2004-02-17 | 2009-10-28 | 卫材R&D管理有限公司 | Soft capsule |
| TWI309984B (en) * | 2004-07-30 | 2009-05-21 | Wakunaga Pharma Co Ltd | Composition for capsule coating, capsule coating, and capsule agent |
| JP4943112B2 (en) * | 2006-10-16 | 2012-05-30 | 花王株式会社 | Process for producing polyglycerin condensed ricinoleic acid ester |
| JP5405242B2 (en) * | 2009-09-07 | 2014-02-05 | 理研ビタミン株式会社 | Liquid composition for soft capsule filling |
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| JPS6112632A (en) * | 1984-06-27 | 1986-01-21 | Eisai Co Ltd | Composition containing fat-soluble drug |
| DE3629386A1 (en) * | 1986-08-29 | 1988-03-03 | Scherer Gmbh R P | GELATINE CAPSULES AND METHOD FOR THEIR PRODUCTION |
| JPH0353873A (en) * | 1989-07-19 | 1991-03-07 | Kotobuki Akad:Kk | Soft capsule |
| JP3493563B2 (en) * | 1995-03-13 | 2004-02-03 | 富士カプセル株式会社 | Capsule |
| JPH10174861A (en) * | 1996-12-19 | 1998-06-30 | Lion Corp | Microcapsule and production of microcapsule |
| JPH10230158A (en) * | 1997-02-21 | 1998-09-02 | Lion Corp | Manufacture of microcapsule |
| JP2000044465A (en) * | 1998-05-28 | 2000-02-15 | Fuji Capsule Kk | Soft capsule agent |
| JP2000079337A (en) * | 1998-09-07 | 2000-03-21 | Lion Corp | Microcapsule and its manufacture |
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