JP5005750B2 - Soft capsule filling composition - Google Patents
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- JP5005750B2 JP5005750B2 JP2009235697A JP2009235697A JP5005750B2 JP 5005750 B2 JP5005750 B2 JP 5005750B2 JP 2009235697 A JP2009235697 A JP 2009235697A JP 2009235697 A JP2009235697 A JP 2009235697A JP 5005750 B2 JP5005750 B2 JP 5005750B2
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Description
本発明は、医薬品、食品、化粧品、医薬部外品等で用いられる軟カプセル剤の皮膜内に充填される軟カプセル剤充填用組成物に関する。 The present invention relates to a soft capsule filling composition filled in a soft capsule film used in pharmaceuticals, foods, cosmetics, quasi drugs and the like.
軟カプセル剤は通常、疎水性の液体を、ゼラチンを主体とする皮膜で包むことによって製造される。軟カプセル剤にカプセル化対象物として粉末成分又は水溶性成分を充填する場合、油液の中に粉末成分又は水溶性成分を懸濁（分散）させるが、懸濁が不十分だと、カプセル製造工程中−即ち、カプセル充填工程や乾燥工程−又は製品化後の保存中に粉末成分又は水溶性成分が油液から分離して問題となる。カプセル充填工程中にこの分離が発生すると、カプセル内容物の均一性が担保できなくなり、好ましくない。乾燥工程や製品化後のこの分離は、外観上の不具合になる。 Soft capsules are usually produced by wrapping a hydrophobic liquid with a film mainly composed of gelatin. When filling a soft capsule with a powder component or a water-soluble component as an object to be encapsulated, the powder component or the water-soluble component is suspended (dispersed) in the oil solution. During the process—that is, the capsule filling process or the drying process—or during storage after commercialization, the powder component or the water-soluble component separates from the oil liquid and becomes a problem. If this separation occurs during the capsule filling process, the uniformity of the capsule contents cannot be secured, which is not preferable. This separation after the drying process or commercialization becomes an appearance defect.
従来技術としては、粉末成分や水溶性成分のための懸濁剤としてミツロウが一般的に使用されている。ミツロウを用いた軟カプセル剤充填用組成物の調製手順の概略を以下に示す。 In the prior art, beeswax is generally used as a suspending agent for powder components and water-soluble components. An outline of the procedure for preparing a soft capsule filling composition using beeswax is shown below.
(1)各種植物油などの適当な油（基剤油）に、動物由来の懸濁剤であるミツロウを加える。必要に応じて合成懸濁剤であるグリセリン脂肪酸エステルを更に加えることもある。 (1) Add beeswax, a suspension derived from animals, to an appropriate oil (base oil) such as various vegetable oils. If necessary, a glycerin fatty acid ester which is a synthetic suspension may be further added.
(2)(1)の混合物を液状化するまで加温し、ミツロウを溶解する。 (2) Warm the mixture of (1) until liquefied and dissolve beeswax.
(3)(2)の溶液を、攪拌しながら冷却して、ペースト状液とする。 (3) The solution of (2) is cooled with stirring to obtain a paste-like liquid.
(4)(3)のペースト状液に粉末成分又は水溶性成分を加えて攪拌混合し、粉末成分又は水溶性成分をペースト状液の中に均一に分散し、軟カプセル剤充填用組成物を得る。 (4) A powder component or a water-soluble component is added to the paste-like liquid of (3) and mixed by stirring, and the powder component or the water-soluble component is uniformly dispersed in the paste-like liquid to obtain a soft capsule filling composition. obtain.
従来技術では、軟カプセル剤充填用組成物の粉末成分や水溶性成分のための懸濁剤として、動物由来のミツロウや合成懸濁剤のグリセリン脂肪酸エステルを用いているため、以下の問題点がある。 In the prior art, animal-derived beeswax and glycerin fatty acid esters of synthetic suspensions are used as suspending agents for powder components and water-soluble components of soft capsule filling compositions. is there.
(a)粉末成分や水溶性成分の充填物に対して12〜25％という比較的多量の懸濁剤が必要とされる。懸濁剤が多い分、他の有効成分（粉末成分や水溶性成分）の量を少なくするか、カプセルを大型化せざるを得ない。 (a) A relatively large amount of suspending agent of 12 to 25% with respect to the packing of the powder component and water-soluble component is required. Since the amount of the suspending agent is large, the amount of other active ingredients (powder ingredient and water-soluble ingredient) must be reduced or the capsule must be enlarged.
(b)配合する粉末成分や水溶性成分によっては、粘度のわりに粉末成分や水溶性成分の分散性が十分でなく、沈殿が生じる場合がある。また、軟カプセル剤充填用組成物の粘度が高く、皮膜への充填性が悪い。 (b) Depending on the powder component and water-soluble component to be blended, the dispersibility of the powder component and water-soluble component may not be sufficient instead of viscosity, and precipitation may occur. In addition, the soft capsule filling composition has a high viscosity, and the filling property to the film is poor.
(c)近年、天然志向・健康志向が進み、天然素材（特に植物性成分）が好まれる傾向にあるが、動物由来の懸濁剤であるミツロウや合成懸濁剤であるグリセリン脂肪酸エステルはこの傾向に沿わない。 (c) In recent years, natural and health-oriented products have been promoted, and natural materials (especially plant components) tend to be preferred. Beeswax, an animal-derived suspension, and glycerin fatty acid ester, a synthetic suspension, are Does not follow the trend.
発明の課題は、軟カプセル剤充填用組成物に用いられる粉末成分や水溶性成分のための懸濁剤の添加量を少なくしながら粉末成分や水溶性成分に十分な分散性を確保し、軟カプセル剤充填用組成物の粘度を低くし、軟カプセル剤充填用組成物の天然志向、健康志向にも対応することにある。 The problem of the invention is to ensure sufficient dispersibility in the powder component and water-soluble component while reducing the amount of the suspension for the powder component and water-soluble component used in the soft capsule filling composition. The purpose is to reduce the viscosity of the capsule filling composition and to cope with the natural orientation and health orientation of the soft capsule filling composition.
請求項１の発明は、油性溶剤に植物由来のワックス類を含有してなる基剤に、粉末成分又は水溶性成分を均一に含有してなり、前記油性溶剤が植物油で、前記植物由来のワックス類が、キャンデリラロウ又はモクロウであり、前記粉末成分又は水溶性成分のための分散性を得るとともに沈澱を抑えられているようにしたものである。 The invention of claim 1 is a base comprising a plant-derived wax in an oily solvent, and uniformly containing a powder component or a water-soluble component, wherein the oily solvent is vegetable oil, and the plant-derived wax The class is candelilla wax or mollusc, which is capable of obtaining dispersibility for the powder component or water-soluble component and suppressing precipitation.
請求項２の発明は、油性溶剤に植物由来のワックス類を含有してなる基剤に、粉末成分又は水溶性成分を均一に含有してなり、前記油性溶剤が大豆油またはサフラワー油で、前記植物由来のワックス類が、キャンデリラロウ又はモクロウであり、前記粉末成分又は水溶性成分のための分散性を得るとともに沈殿を抑えられているようにしたものである。 The invention of claim 2 is a base comprising a plant-derived wax in an oily solvent, uniformly containing a powder component or a water-soluble component, and the oily solvent is soybean oil or safflower oil, The plant-derived waxes are candelilla wax or mollusc, and are intended to obtain dispersibility for the powder component or water-soluble component and to suppress precipitation.
請求項３の発明は、油性溶剤に植物由来のワックス類を含有してなる基剤に、粉末成分又は水溶性成分を均一に含有してなり、前記油性溶剤が小麦胚芽油で、前記植物由来のワックス類が、キャンデリラロウ又はモクロウであり、前記粉末成分又は水溶性成分のための分散性を得るとともに沈殿を抑えられているようにしたものである。 The invention according to claim 3 is a base comprising a plant-derived wax in an oily solvent, and uniformly containing a powder component or a water-soluble component, wherein the oily solvent is wheat germ oil and is derived from the plant These waxes are candelilla wax or molasses, and are intended to obtain dispersibility for the powder component or water-soluble component and to suppress precipitation.
請求項４の発明は、請求項１〜３のいずれかの発明において更に、大豆レシチンを含むようにしたものである。 The invention of claim 4 further includes soybean lecithin in the invention of any one of claims 1 to 3 .
本発明によれば、軟カプセル剤充填用組成物に用いられる粉末成分や水溶性成分のための懸濁剤の添加量を少なくしながら粉末成分や水溶性成分に十分な分散性を確保し、軟カプセル剤充填用組成物の粘度を低くし、軟カプセル剤充填用組成物の天然志向、健康志向にも対応することができる。According to the present invention, while ensuring a sufficient dispersibility in the powder component and the water-soluble component while reducing the amount of the suspension for the powder component and the water-soluble component used in the soft capsule filling composition, The viscosity of the composition for filling soft capsules can be lowered, and the composition for filling soft capsules can be adapted to the natural orientation and health orientation.
［テスト（模擬粉体による製剤性の検討）］
模擬粉体としてトウモロコシデンプンを用い、基剤油に小麦胚芽油を使用する。各懸濁剤について、トウモロコシデンプンの沈殿を抑制し得る懸濁剤の最少添加量（重量％）を実験により求めた。本実験系の処方を表１に示す。液温25℃における粘度及び遠心分離テストの結果を表２に示す。表２において、分離2,000rpm×5分は、遠心分離機を2,000rpm、5分運転したときのトウモロコシデンプンの分離の有無を示し、分離3,000rpm×5分は、遠心分離機を3,000rpm、5分運転したときのトウモロコシデンプンの分離の有無を示す。また、表２において、15％沈殿は、検体容積100％に対し沈殿物が占める容積が15％であることを示す。
[Test (examination of drug formulation by simulated powder)]
Corn starch is used as a simulated powder, and wheat germ oil is used as the base oil. For each suspension, the minimum addition amount (% by weight) of the suspension that can suppress the precipitation of corn starch was determined by experiment. Table 1 shows the formulation of this experimental system. Table 2 shows the viscosity at a liquid temperature of 25 ° C. and the results of the centrifugation test. In Table 2, separation 2,000 rpm × 5 minutes indicates the presence or absence of separation of corn starch when the centrifuge is operated at 2,000 rpm for 5 minutes, and separation 3,000 rpm × 5 minutes indicates that the centrifuge is 3,000 rpm, 5 minutes It shows the presence or absence of separation of corn starch when run for minutes. In Table 2, 15% precipitation indicates that the volume occupied by the precipitate is 15% with respect to the sample volume of 100%.
尚、粘度計として東京計器社製「ＢＭ型粘度計」（ローターNo.４）を用い、遠心分離機としてクボタ社製遠心分離機「ＫＮ−７０」を用い、10mL遠沈管に各検体を入れ、2,000rpm・3,000rpmで各５分間回転させ、分離状況を観察した。 Each sample is put into a 10 mL centrifuge tube using a “BM type viscometer” (rotor No. 4) manufactured by Tokyo Keiki Co., Ltd. as a viscometer and a centrifuge “KN-70” manufactured by Kubota Corporation as a centrifuge. The sample was rotated at 2,000 rpm and 3,000 rpm for 5 minutes, and the state of separation was observed.
［実験結果］
従来から用いられている対照「ミツロウ＋グリセリン脂肪酸エステル」の添加量12％と比較して、Ａ、Ｂ「キャンデリラロウ」は約10％、Ｃ、Ｄ「モクロウ」は7〜8％の添加量で［同等の分散性］を示し、なおかつ［より低い粘度］になる結果が得られた。この結果から、キャンデリラロウ及びモクロウは、従来の懸濁剤よりも優れた粉末分散性を有することが示唆された。
[Experimental result]
Compared to 12% of the conventional addition of beeswax + glycerin fatty acid ester, A and B "Candelilla wax" is about 10%, and C and D "Mokuro" are 7 to 8%. The result showed [equivalent dispersibility] in quantity and [lower viscosity]. From these results, it was suggested that candelilla wax and molefish have better powder dispersibility than conventional suspensions.
［比較例１］
軟カプセル剤に充填する内容物として、以下の比較例１を処方した。懸濁剤としては「ミツロウ＋グリセリン脂肪酸エステル」を用い、適正な粘度及び分離テストの結果が得られるように懸濁剤の配合量を調整した。懸濁剤の割合は18％（重量％）であった。尚、比較例１では、ニンニクエキス粉末を粉末成分とし、大豆油を油性溶剤とし、大豆レシチンを栄養成分、かつ大豆油に溶解させて懸濁剤としても機能せしめるものである。
[Comparative Example 1]
The following Comparative Example 1 was formulated as the content to be filled in the soft capsule. “Beeswax + glycerin fatty acid ester” was used as the suspending agent, and the blending amount of the suspending agent was adjusted so that the proper viscosity and the result of the separation test were obtained. The proportion of the suspension was 18% (% by weight). In Comparative Example 1, garlic extract powder is used as a powder component, soybean oil is used as an oily solvent, soybean lecithin is dissolved in nutrient components and soybean oil, and functions as a suspending agent.
得られたものの粘度は25℃において14,000cPで、2,000rpm及び3,000rpmにおける遠心分離テストの結果は分離なしだった。 The viscosity of the obtained product was 14,000 cP at 25 ° C., and the results of the centrifugation test at 2,000 rpm and 3,000 rpm were no separation.
［実施例１］
軟カプセル剤に充填する内容物として、以下の実施例１を処方した。比較例１との相違点は、懸濁剤を「ミツロウ＋グリセリン脂肪酸エステル」から「モクロウ」にかえて、粘度及び遠心分離テストが適正になるように懸濁剤の配合量を調整した。懸濁剤の割合は10％（重量％）であった。尚、比較例１では、ニンニクエキス粉末を粉末成分とし、大豆油を油性溶剤とし、大豆レシチンを栄養成分、かつ大豆油に溶解させて懸濁剤としても機能せしめるものである。
[Example 1]
The following Example 1 was formulated as the contents to be filled in the soft capsule. The difference from Comparative Example 1 was that the amount of the suspension was adjusted so that the viscosity and the centrifuge test were appropriate by changing the suspension from “honey bee + glycerin fatty acid ester” to “marrow”. The proportion of the suspension was 10% (% by weight). In Comparative Example 1, garlic extract powder is used as a powder component, soybean oil is used as an oily solvent, soybean lecithin is dissolved in nutrient components and soybean oil, and functions as a suspending agent.
得られたものの粘度は25℃において13,000cPで、2,000rpm及び3,000rpmでの遠心分離テストの結果は分離なしだった。比較例と比べて低粘度にし、かつ懸濁剤の割合を約半分にすることができた。 The viscosity of the obtained product was 13,000 cP at 25 ° C., and the results of the centrifugation test at 2,000 rpm and 3,000 rpm were no separation. Compared with the comparative example, the viscosity was reduced, and the ratio of the suspending agent could be reduced to about half.
［実施例２］
軟カプセル剤に充填する内容物として、以下の実施例２を処方した。尚、実施例２では、Ｌ−アスコルビン酸、塩酸ピリドキシン、リボフラビン、及びニコチン酸アミドを粉末成分とし、サフラワー油を油性溶剤とし、キャンデリラロウを懸濁剤としたものである。
[Example 2]
The following Example 2 was formulated as the content to be filled in the soft capsule. In Example 2, L-ascorbic acid, pyridoxine hydrochloride, riboflavin, and nicotinamide are used as powder components, safflower oil is used as an oily solvent, and candelilla wax is used as a suspending agent.
得られたものの粘度は25℃において15,000cPで、2,000rpm及び3,000rpmでの遠心分離テストの結果は分離なしだった。 The viscosity of the obtained product was 15,000 cP at 25 ° C., and the results of the centrifugation test at 2,000 rpm and 3,000 rpm were no separation.
［カプセル製造時及び保存中の経時的安定性］
比較例１、実施例１、２で得られた組成物を、それぞれＯＶＡＬ型のカプセル皮膜に充填して軟カプセル剤とした。カプセル皮膜の組成としては、ゼラチン100重量部、グリセリン35重量部とした。これらの軟カプセル剤は、いずれも製造時及び保存中の安定性の問題を生じないものであった。
[Stability over time during capsule production and storage]
The compositions obtained in Comparative Example 1 and Examples 1 and 2 were each filled into an OVAL type capsule film to prepare soft capsules. The composition of the capsule film was 100 parts by weight of gelatin and 35 parts by weight of glycerin. None of these soft capsules caused stability problems during production and storage.
以上、本発明の実施の形態を詳述したが、本発明の具体的な構成はこの実施の形態に限られるものではなく、本発明の要旨を逸脱しない範囲の変更等があっても本発明に含まれる。 Although the embodiment of the present invention has been described in detail above, the specific configuration of the present invention is not limited to this embodiment, and the present invention is not limited to the scope of the present invention. Included .
以上のように本発明によれば、軟カプセル剤充填用組成物に用いられる粉末成分や水溶性成分のための懸濁剤の添加量を少なくしながら粉末成分や水溶性成分に十分な分散性を確保し、軟カプセル剤充填用組成物の粘度を低くし、軟カプセル剤充填用組成物の天然志向、健康志向にも対応することできる。 As described above, according to the present invention, the dispersibility sufficient for the powder component and the water-soluble component while reducing the addition amount of the suspending agent for the powder component and the water-soluble component used in the soft capsule filling composition. Can be ensured, the viscosity of the soft capsule filling composition can be lowered, and the natural or health orientation of the soft capsule filling composition can be dealt with.
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| Application Number | Priority Date | Filing Date | Title |
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| JP2009235697A JP5005750B2 (en) | 2009-10-09 | 2009-10-09 | Soft capsule filling composition |
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| JP2009235697A JP5005750B2 (en) | 2009-10-09 | 2009-10-09 | Soft capsule filling composition |
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| JP2000361840A Division JP2002161029A (en) | 2000-11-28 | 2000-11-28 | Composition for filling soft capsule |
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| JP2010024234A JP2010024234A (en) | 2010-02-04 |
| JP5005750B2 true JP5005750B2 (en) | 2012-08-22 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6277320A (en) * | 1985-09-28 | 1987-04-09 | Kyowa Hakko Kogyo Co Ltd | L-ascorbic acid pharmaceutical and production thereof |
| JPH07549B2 (en) * | 1986-07-03 | 1995-01-11 | ゼリア新薬工業株式会社 | Composition for filling soft capsules |
| JPS63280017A (en) * | 1987-05-13 | 1988-11-17 | R P Shiila- Kk | Coating composition for soft capsule |
| JP3157233B2 (en) * | 1991-11-22 | 2001-04-16 | エーザイ株式会社 | Soft capsule containing water-soluble drug |
| JPH07242536A (en) * | 1994-03-01 | 1995-09-19 | Toyo Capsule Kk | Gelatin capsule agent containing essential oil component in skin |
| JP3364544B2 (en) * | 1994-11-25 | 2003-01-08 | キユーピー株式会社 | How to prevent browning of dietary supplements |
| JP2000083599A (en) * | 1998-09-11 | 2000-03-28 | Sankyo:Kk | Soft capsule agent superior in emulsion stability including high concentration of powders and extracts and its production |
| JP2000095676A (en) * | 1998-09-21 | 2000-04-04 | Tokai Capsule Kk | Soft capsule including vitamin b12 |
| JP3253948B2 (en) * | 1999-03-24 | 2002-02-04 | 富士カプセル株式会社 | Capsule |
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