JP2017105767A - Capsule composition - Google Patents
Capsule composition Download PDFInfo
- Publication number
- JP2017105767A JP2017105767A JP2016230725A JP2016230725A JP2017105767A JP 2017105767 A JP2017105767 A JP 2017105767A JP 2016230725 A JP2016230725 A JP 2016230725A JP 2016230725 A JP2016230725 A JP 2016230725A JP 2017105767 A JP2017105767 A JP 2017105767A
- Authority
- JP
- Japan
- Prior art keywords
- capsule
- olive fruit
- fruit extract
- film
- capsule 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.)
- Granted
Links
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
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Abstract
Description
本発明は、崩壊時間の遅延を防止したオリーブ果実抽出物配合カプセル組成物に関するものである。 The present invention relates to a capsule composition containing an olive fruit extract that prevents a delay in disintegration time.
オリーブはモクセイ科の小さな常緑樹であり、古代ギリシャ時代以来、地中海地方において人々の生活と密接な関わりをもっており、食用・薬用に広く利用されてきた。オリーブの果実にはポリフェノールの一種であるベルバスコシドまたはヒドロキシチロソールと呼ばれる抗酸化物質が含有されていることが知られており、オリーブの果実から得られるオリーブ果実抽出物は、活性酸素除去作用、メラニン生成抑制作用および腫瘍細胞増殖抑制・死滅作用、ヒト白血球エステラーゼ阻害を奏することが報告されている(特許文献1)。 そのため、オリーブ果実抽出物は健康食品素材として注目を集めるようになっている。
一方、カプセルはゼラチン等のタンパク質、デンプン等の多糖類等の溶液を用いて調製した皮膜の内側に、医薬品、健康素材、機能性素材等の有効成分を封入したものであり、主にハードカプセル(硬カプセル)、ソフトカプセル(軟カプセル)がある。食品、医薬品、医薬部外品、化粧品、雑貨等に幅広く用いられている剤形であり、特にソフトカプセルは油状またはペースト状の有効成分も配合可能であるためその用途は広い。ソフトカプセルの皮膜には、製造・保管時の形状安定性や内容物の保存安定性が求められるが、その一方で使用時に速やかに崩壊することが求められている。従って、上記の点を総合的に考慮し、主にゼラチンが皮膜基剤として使用され、ゼラチンに可塑剤等を配合したものがソフトカプセルの皮膜として主に使用されている。
カプセルの崩壊遅延を防止する方法としては、ゼラチン、レシチン、クエン酸をカプセル剤皮中に配合した皮膜を用いる方法(特許文献1)が知られている。
Olives are small evergreens belonging to the family Moleaceae, and have been closely related to people's lives in the Mediterranean region since ancient Greece, and have been widely used for food and medicine. It is known that olive fruit contains an antioxidant called Verbascoside or hydroxytyrosol, a kind of polyphenol. The olive fruit extract obtained from olive fruit has an active oxygen scavenging action, melanin It has been reported that it has a production inhibitory effect, tumor cell growth inhibitory / killing effect, and human leukocyte esterase inhibition (Patent Document 1). Therefore, olive fruit extract has attracted attention as a health food material.
On the other hand, capsules are made by encapsulating active ingredients such as pharmaceuticals, health materials, functional materials, etc. inside a film prepared using a solution such as protein such as gelatin, polysaccharides such as starch, etc. Hard capsules) and soft capsules (soft capsules). The dosage form is widely used in foods, pharmaceuticals, quasi-drugs, cosmetics, miscellaneous goods, etc. Especially, soft capsules have a wide range of uses because they can contain oily or pasty active ingredients. The soft capsule film is required to have shape stability during production and storage and storage stability of the contents, but on the other hand, it is required to rapidly disintegrate during use. Accordingly, in consideration of the above points, gelatin is mainly used as a film base, and gelatin containing a plasticizer or the like is mainly used as a film for soft capsules.
As a method for preventing the capsule disintegration delay, a method using a film in which gelatin, lecithin and citric acid are blended in a capsule skin is known (Patent Document 1).
本発明者らは、オリーブ果実抽出物を配合した製品の提供にあたり、オリーブ果実抽出物を一般的なカプセルに充填し調製を試みたところ、経時的に崩壊時間が遅延する(以下、崩壊遅延という)という課題を見出した。崩壊遅延が起こった場合、当該組成物を摂取した際に、内容物の溶出が遅延することで、内容物中の成分が消化・吸収されず排泄されてしまう懸念がある。
本発明は、上記背景技術に鑑みてなされたものであり、その課題は、崩壊遅延を防止した、オリーブ果実抽出物配合カプセル組成物を提供することにある。
When the present inventors tried to prepare by filling olive fruit extract into a general capsule in providing a product containing olive fruit extract, the disintegration time was delayed over time (hereinafter referred to as disintegration delay). ) Was found. When the decay delay occurs, there is a concern that when the composition is ingested, the elution of the content is delayed and the components in the content are excreted without being digested and absorbed.
This invention is made | formed in view of the said background art, The subject is providing the capsule composition containing an olive fruit extract which prevented the decay | disintegration delay.
本発明者らは、上記課題を解決するため鋭意研究を重ねた結果、カプセル組成物の崩壊遅延の原因が、カプセル皮膜に含まれるゼラチンと、ベルバスコシドを含むオリーブ抽出物との相互作用にあることを突き止め、それによりカプセル皮膜を不溶化することが原因であることを明らかにした。
そこで、カプセル組成物の内容物にベルバスコシドを含むオリーブ果実抽出物を含有せしめる場合、ゼラチンを含まないカプセル皮膜を用いることにより、カプセル皮膜の不溶化を防止し、崩壊遅延を防止できることを見出し、本発明を完成するに至った。
As a result of intensive studies to solve the above-mentioned problems, the present inventors have found that the cause of the delay in disintegration of the capsule composition is the interaction between the gelatin contained in the capsule film and the olive extract containing verbascoside. It was clarified that the cause was insolubilization of the capsule film.
Therefore, when the olive fruit extract containing verbascoside is included in the contents of the capsule composition, it has been found that by using a capsule film that does not contain gelatin, insolubilization of the capsule film can be prevented and disintegration delay can be prevented. It came to complete.
すなわち、本発明は、
(1)内容物としてベルバスコシドを含有するオリーブ果実抽出物を充填したカプセル組成物であって、そのカプセル皮膜はゼラチンを含まないことを特徴とするカプセル組成物、
である。
That is, the present invention
(1) A capsule composition filled with an olive fruit extract containing verbascoside as a content, wherein the capsule film does not contain gelatin,
It is.
本発明により、ベルバスコシドを含むオリーブ果実抽出物を配合し、崩壊遅延を防止でき、崩壊性の良好な、品質の高いカプセル組成物を提供することができる。 According to the present invention, an olive fruit extract containing verbascoside can be blended to prevent disintegration delay and to provide a high-quality capsule composition with good disintegration.
本発明のカプセル皮膜にはゼラチンを含まない。カプセル組成物の種類としては、ハードカプセルとソフトカプセルが挙げられるが、服用し易さ等の点からソフトカプセルが好ましい。本発明のカプセル皮膜を構成する成分としてはゼラチンを含まなければ特に制限はない。カプセル皮膜の主な成分としては、例えば、増粘多糖類、セルロース誘導体、デンプン及びその誘導体が挙げられ、そのほかの成分としては可塑剤、水等通常カプセル皮膜を調製する際に配合し得る成分が挙げられる。上記の増粘多糖類として、カラギーナン(ι、λ、κ)、ローカストビーンガム、サイリウムシードガム、タマリンドシードガム、グルコマンナン、ペクチン、寒天、アルギン酸類、キサンタンガム、ジェランガム、カードラン及びプルラン等を挙げることができる。セルロース誘導体としては、ヒドロキシプロピルメチルセルロース、メチルセルロース等を挙げることができる。上記デンプンとして、トウモロコシデンプン、タピオカデンプン、馬鈴薯デンプン、小麦デンプン等を挙げることができる。またその誘導体としては、ヒドロキシプロピル化、アセチル化、リン酸化、オクテニルコハク酸化等の処理をしたデンプンを挙げることができる。上記可塑剤としては、グリセリン、ポリエチレングリコール、プロピレングリコール、ポリプロピレングリコール、グルコース、フルクトース、ガラクトース、スクロース、マルトース、トレハロース、ラフィノース、プルラン、アラビアガム、アラビノガラクタン、セルロース、ソルビトール、マルチトール、ラクチトール、パラチニット、キシリトール、マンニトール、ガラクチトール等が挙げられる。 The capsule coating of the present invention does not contain gelatin. Examples of the capsule composition include hard capsules and soft capsules, and soft capsules are preferable in terms of ease of taking. The component constituting the capsule film of the present invention is not particularly limited unless it contains gelatin. Examples of the main component of the capsule film include thickening polysaccharides, cellulose derivatives, starch and derivatives thereof, and other components include components that can be blended when preparing a normal capsule film such as plasticizer and water. Can be mentioned. Examples of the thickening polysaccharide include carrageenan (ι, λ, κ), locust bean gum, psyllium seed gum, tamarind seed gum, glucomannan, pectin, agar, alginic acids, xanthan gum, gellan gum, curdlan and pullulan. be able to. Examples of cellulose derivatives include hydroxypropyl methylcellulose and methylcellulose. Examples of the starch include corn starch, tapioca starch, potato starch, and wheat starch. Examples of the derivative include starch that has been treated with hydroxypropylation, acetylation, phosphorylation, octenyl succination and the like. Examples of the plasticizer include glycerin, polyethylene glycol, propylene glycol, polypropylene glycol, glucose, fructose, galactose, sucrose, maltose, trehalose, raffinose, pullulan, gum arabic, arabinogalactan, cellulose, sorbitol, maltitol, lactitol, and palatinit. Xylitol, mannitol, galactitol and the like.
本発明のベルバスコシドを含有するオリーブ果実抽出物は、天然のオリーブ(Olea europaea)から分離される抽出物であり、市販品のOLEASELECT(オリーブ果実より水とエタノールの混合溶媒にて抽出し粉末化したもの、総フェノール量:30質量%以上含有、ベルバスコシド量:5質量%以上含有)、OPEXTAN(オリーブ果実より水とエタノールの混合溶媒にて抽出し粉末化したもの、総フェノール量:10質量%以上含有、ベルバスコシド量2質量%以上含有)等を使用することができる。本発明のオリーブ果実抽出物は、好ましくはベルバスコシドを2質量%以上含有するオリーブ果実抽出物である。 The olive fruit extract containing vervascoside of the present invention is an extract separated from natural olive (Olea europaea), and is commercially available OLEASELECT (extracted from olive fruit with a mixed solvent of water and ethanol and pulverized. , Total phenol content: 30% by mass or more, Verbascoside content: 5% by mass or more), OPEXTAN (pulverized from olive fruit with a mixed solvent of water and ethanol, total phenol content: 10% by mass or more Content, and a Verbascoside content of 2% by mass or more) can be used. The olive fruit extract of the present invention is preferably an olive fruit extract containing 2% by mass or more of Verbascoside.
本発明のオリーブ果実抽出物の配合量は、特に制限されないが、好ましくは本発明のカプセル組成物中1〜50質量%、好ましくは4〜50質量%である。 Although the compounding quantity of the olive fruit extract of this invention is not restrict | limited in particular, Preferably it is 1-50 mass% in the capsule composition of this invention, Preferably it is 4-50 mass%.
本発明のカプセル組成物は、常法に従って製造すればよい。例えば、ソフトカプセルであれば、ロータリーダイ式、シームレス式または平板法などの公知の方法に従って、適宜添加物を用いて製造すればよい。本発明のベルバスコシドを含むオリーブ果実抽出物に、基剤油、乳化剤、所望の有効成分含有粉末等を混合し、常法(例えば特開2015−155384に記載されている方法)に従い調製することができる。また、上記の基剤油としては、特に制限はなく、一般にソフトカプセルの内容物として知られているものが使用可能である。具体的には、例えば、大豆油、ゴマ油、コーン油、綿実油、ヤシ油、パーム油、オリーブ油、落花生油、米糠油、椿油、サフラワー油、シソ油、魚油、EPA、DHA、中鎖脂肪酸トリグリセリド、長鎖脂肪酸トリグリセリド等が挙げられる。上記の乳化剤としては、特に制限はなく、ミツロウ、カルナウバロウ、キャンデリラロウ、コメヌカロウ、レシチン、グリセリン脂肪酸エステル類(酢酸モノグリセリド、乳酸モノグリセリド、クエン酸モノグリセリド、ジアセチル酒石酸モノグリセリド、コハク酸モノグリセリド、ポリグリセリン脂肪酸エステル、ポリグリセリン縮合リノシール酸エステル等)、ショ糖脂肪酸エステル類等が挙げられる。 What is necessary is just to manufacture the capsule composition of this invention in accordance with a conventional method. For example, if it is a soft capsule, according to well-known methods, such as a rotary die type, a seamless type, or a flat plate method, it should just manufacture using an additive suitably. A base oil, an emulsifier, a desired active ingredient-containing powder and the like are mixed with the olive fruit extract containing vervascoside of the present invention, and prepared according to a conventional method (for example, a method described in JP-A-2015-155384). it can. Moreover, there is no restriction | limiting in particular as said base oil, What is generally known as the content of a soft capsule can be used. Specifically, for example, soybean oil, sesame oil, corn oil, cottonseed oil, palm oil, palm oil, olive oil, peanut oil, rice bran oil, camellia oil, safflower oil, perilla oil, fish oil, EPA, DHA, medium chain fatty acid triglyceride Long chain fatty acid triglycerides and the like. The emulsifier is not particularly limited, and beeswax, carnauba wax, candelilla wax, rice bran wax, lecithin, glycerin fatty acid esters (acetic acid monoglyceride, lactic acid monoglyceride, citric acid monoglyceride, diacetyltartaric acid monoglyceride, succinic acid monoglyceride, polyglycerin fatty acid ester , Polyglycerin condensed linosyl acid ester, etc.), sucrose fatty acid esters and the like.
また、ハードカプセルの場合、キャップとボディーを分離して本発明のベルバスコシドを含むオリーブ果実抽出物と適宜添加物を混合したものを充填し、分離したキャップをはめればよい。 In the case of hard capsules, the cap and body may be separated, filled with a mixture of olive fruit extract containing vervascoside of the present invention and appropriate additives, and the separated cap may be fitted.
以下に実施例等を挙げて本発明をさらに詳細に説明するが、本発明はこれら実施例等に何ら限定されるものではない。 The present invention will be described in more detail with reference to the following examples, but the present invention is not limited to these examples.
(カプセル充填用内容物の調製)
加温した基剤油に、乳化剤を溶解させ、室温にて放冷することで内容物基剤を調製した。その内容物基剤中濃度が12.8質量%となるように、テフロン(登録商標)ホモジナイザーを用いて内容物基剤にオリーブ果実抽出物(ベルバスコシド5%含有)を分散させ、カプセル充填用内容物とした。
(Preparation of contents for capsule filling)
The content base was prepared by dissolving the emulsifier in the warmed base oil and allowing to cool at room temperature. Capsule filling content by dispersing olive fruit extract (containing 5% Verbascoside) in the content base using a Teflon (registered trademark) homogenizer so that the concentration in the content base is 12.8% by mass It was a thing.
試験例1:皮膜不溶化防止効果の確認
上記カプセル充填用内容物をネジ口試験管(10mL)に5g量り取った。さらに、ゼラチンを含まない皮膜(主にカラギーナン、デンプンを含む)にて調製され、内容物が充填されていない空カプセルを接合部より上下半分に切り開いたもの(実施例1)及びゼラチンを含む皮膜にて調製され、内容物が充填されていない空カプセルを接合部より上下半分に切り開いたもの(比較例1)を、ネジ口試験管中の内容物に浸漬させるように投入し、栓をした後、40℃75%RHに2週間保管した。また、コントロールとして、上記切り開いたカプセル皮膜を、別の空のネジ口試験管に投入し、栓をした後、40℃75%RHに2週間保管したものを調製した。
保管後、浸漬したソフトカプセル皮膜を取り出し、付着した内容物を拭き取った後、日本薬局方一般試験法「崩壊試験法」(補助盤なし)に準じ、崩壊時間を確認した(n=3)。同時に、空カプセルを切り開いた直後のもの(以下、直後品という)及び上記コントロールの崩壊時間を確認し、比較した。崩壊時間は、残留物をガラス管に認めない時点とした。試験は最大120分まで実施した。結果を表1に示す。
Test Example 1: Confirmation of effect of preventing film insolubilization 5 g of the above-mentioned content for capsule filling was weighed out into a screw test tube (10 mL). Further, a capsule prepared with a gelatin-free coating (mainly containing carrageenan and starch), and an empty capsule not filled with the contents cut into upper and lower halves from the joint (Example 1) and a gelatin-containing coating An empty capsule not filled with the contents, which was cut open in the upper and lower halves from the joint (Comparative Example 1), was poured so as to be immersed in the contents in the screw mouth test tube and capped. Thereafter, it was stored at 40 ° C. and 75% RH for 2 weeks. Moreover, as a control, the capsule capsule opened above was put into another empty screw test tube, capped, and stored at 40 ° C. and 75% RH for 2 weeks.
After storage, the soaked soft capsule film was taken out, the adhered contents were wiped off, and the disintegration time was confirmed according to the Japanese Pharmacopoeia General Test Method “Disintegration Test Method” (without auxiliary board) (n = 3). At the same time, the disintegration times of the one immediately after opening the empty capsule (hereinafter referred to as the immediately after product) and the above control were confirmed and compared. The disintegration time was the time when no residue was found in the glass tube. The test was conducted up to 120 minutes. The results are shown in Table 1.
表1の通り、ゼラチンを含むカプセル皮膜を使用した比較例1では、カプセル充填用内容物に浸漬したことで、カプセル皮膜が溶解せず、顕著な崩壊時間の遅延が認められたのに対し(コントロール2との比較)、ゼラチンを含まないカプセル皮膜である実施例1は、ほとんど崩壊遅延が認められなかった(コントロール1との比較)。
また、40℃75%RH環境下に2週間保管したことによる温湿度及び保管期間による崩壊遅延は軽微であることが示された(実施例1、コントロール1)。本結果から、カプセル皮膜の崩壊遅延の原因が、ベルバスコシドを含むオリーブ果実抽出物とゼラチンとの相互作用にあり、カプセル皮膜を不溶化することが原因であることが分かった。
As shown in Table 1, in Comparative Example 1 using a capsule film containing gelatin, the capsule film was not dissolved by immersing in the capsule filling content, whereas a significant delay in disintegration time was observed ( Comparison with Control 2) In Example 1, which is a capsule film not containing gelatin, almost no disintegration delay was observed (comparison with Control 1).
Further, it was shown that the decay delay due to temperature and humidity and storage period due to storage for 2 weeks in an environment of 40 ° C. and 75% RH was slight (Example 1, Control 1). From these results, it was found that the cause of the delay in the capsule film disintegration was the interaction between the olive fruit extract containing vervascoside and gelatin, and the insolubilization of the capsule film.
(ソフトカプセル組成物の製造)
加温した基剤油に、乳化剤を溶解させ、室温にて放冷することで内容物基剤を調製した。その内容物基剤中濃度が12.8質量%となるように、ホモジナイザーを用いて内容物基剤にベルバスコシド5%以上含有するオリーブ果実抽出物とベルバスコシドを含まないオリーブ果実抽出物を混合して分散させ、懸濁液状のカプセル充填用内容物とした。このカプセル充填用内容物をロータリーダイ式ソフトカプセル充填機にてゼラチンを含まない皮膜(主にカラギーナン、デンプンを含む)に包接し、ソフトカプセル組成物とした(実施例2)。同様に、上記の懸濁液状のカプセル充填用内容物をゼラチンを含む皮膜に包接し、ソフトカプセル組成物とした(比較例2)。
(Manufacture of soft capsule composition)
The content base was prepared by dissolving the emulsifier in the warmed base oil and allowing to cool at room temperature. Using a homogenizer, mix the olive fruit extract containing 5% or more of Verbascoside and the olive fruit extract not containing Verbascoside into the content base using a homogenizer so that the concentration in the content base is 12.8% by mass. Dispersed to obtain a capsule filling content in the form of a suspension. This capsule filling content was wrapped in a gelatin-free film (mainly containing carrageenan and starch) with a rotary die type soft capsule filling machine to give a soft capsule composition (Example 2). Similarly, the above suspension-filled contents for capsule filling were wrapped in a film containing gelatin to obtain a soft capsule composition (Comparative Example 2).
試験例2:ソフトカプセルの崩壊時間の確認(皮膜不溶化防止効果の確認)
製造直後(室温1ヶ月保管、以下製造直後品という)及び40℃75%にてRH2ヶ月保管後(以下、40℃75%RH2ヶ月保管品という)の上記ソフトカプセル組成物(実施例2、比較例2)について、日本薬局方一般試験法「崩壊試験法」(補助盤あり)に準じ、崩壊時間を確認した(製造直後品はn=6、40℃75%RH保管品はn=2で試験を実施)。崩壊時間は、カプセル皮膜が開口して内容物が試験液中に分散し、さらに試料の残留物が原形を留めない状態になった時点とした。試験は最大120分まで実施し、同試料の試験結果において、120分以内に崩壊したものと120分以上崩壊しなかったものがあった場合には、120分以上崩壊しなかったものの崩壊時間を120分として平均値を算出した。結果を表2に示す。
Test Example 2: Confirmation of soft capsule disintegration time (confirmation of film insolubilization prevention effect)
The soft capsule composition (Example 2, Comparative Example) immediately after production (stored at room temperature for 1 month, hereinafter referred to as product immediately after manufacture) and after stored for 2 months in RH at 40 ° C. and 75% (hereinafter referred to as product stored at 40 ° C. and 75% RH for 2 months) For 2), the disintegration time was confirmed according to the Japanese Pharmacopoeia General Test Method “Disintegration Test Method” (with auxiliary panel) (n = 6 for products immediately after production, n = 2 for 40 ° C. 75% RH stored products) Implemented). The disintegration time was defined as the time when the capsule film was opened and the contents were dispersed in the test solution, and the sample residue was not in its original form. The test is conducted for a maximum of 120 minutes, and in the test results of the same sample, when there were those that disintegrated within 120 minutes and those that did not disintegrate for 120 minutes or more, the disintegration time of those that did not disintegrate for 120 minutes or more The average value was calculated as 120 minutes. The results are shown in Table 2.
表2の通り、ゼラチンを含む皮膜を用いたカプセル組成物(比較例2)では顕著に崩壊時間が長く、保存後に崩壊時間の遅延が認められたのに対し、ゼラチンを含まない皮膜を用いたカプセル組成物(実施例2)では、保存後の崩壊遅延はほとんど認められなかった。この結果、カプセル組成物の内容物としてベルバスコシドを含有するオリーブ果実抽出物を含む場合は、ゼラチンを含まないカプセル皮膜を用いることによって相互作用を抑制し、崩壊遅延を防止できることが判明した。 As shown in Table 2, in the capsule composition using the film containing gelatin (Comparative Example 2), the disintegration time was remarkably long and a delay in the disintegration time was observed after storage, whereas the film containing no gelatin was used. In the capsule composition (Example 2), almost no disintegration delay after storage was observed. As a result, it was found that when an olive fruit extract containing verbascoside is included as the contents of the capsule composition, the interaction can be suppressed and the delay of disintegration can be prevented by using a capsule film containing no gelatin.
本発明により、経時的な崩壊遅延を防止したベルバスコシド含有オリーブ果実抽出物配合カプセル組成物を提供することが可能となった。よって、ベルバスコシドを含有するオリーブ果実抽出物を配合した食品(特にサプリメント)、医薬品又は医薬部外品の分野に有益である。 INDUSTRIAL APPLICABILITY According to the present invention, it is possible to provide a capsule composition containing vervascoside-containing olive fruit extract that prevents the decay delay over time. Therefore, it is useful in the field of foods (particularly supplements), pharmaceuticals or quasi-drugs containing an olive fruit extract containing verbascoside.
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