JPH05155761A - Soft capsule agent - Google Patents
Soft capsule agentInfo
- Publication number
- JPH05155761A JPH05155761A JP34850091A JP34850091A JPH05155761A JP H05155761 A JPH05155761 A JP H05155761A JP 34850091 A JP34850091 A JP 34850091A JP 34850091 A JP34850091 A JP 34850091A JP H05155761 A JPH05155761 A JP H05155761A
- Authority
- JP
- Japan
- Prior art keywords
- drug
- soft capsule
- contained
- oily
- film
- 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
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は、皮膜中に薬物を含有し
た軟カプセル剤に関する。TECHNICAL FIELD The present invention relates to a soft capsule containing a drug in a film.
【０００２】[0002]
【従来の技術】油性の液状または半固体状の薬物や、油
性溶媒に溶解もしくは懸濁した薬物を製剤化する場合
は、軟カプセル剤とする場合が多い。従来、軟カプセル
剤は、ゼラチンにグリセリン等を混合したもの皮膜と
し、薬物等の生理活性物質及びそれらを溶解あるいは混
合する油性溶剤を内容物としている。一方、水溶性薬物
を軟カプセル剤とする場合には、皮膜中に溶解する技術
が知られている。2. Description of the Related Art When an oily liquid or semi-solid drug or a drug dissolved or suspended in an oily solvent is formulated, a soft capsule is often used. Conventionally, soft capsules are formed by coating gelatin with glycerin or the like, and contain a physiologically active substance such as a drug and an oily solvent for dissolving or mixing them. On the other hand, when a water-soluble drug is used as a soft capsule, a technique of dissolving it in a film is known.
【０００３】[0003]
【発明が解決しようとする課題】軟カプセル剤を製造す
るには、内容物が充填に適した諸物性を有した液体であ
ることが必要である。したがって、常温で固体の脂溶性
薬物を溶解または懸濁すると、粘度の上昇や固化等を起
こし、軟カプセル剤とすることが困難であった。一方、
軟カプセル剤の皮膜は水溶性であるため、脂溶性薬物を
含有させることは困難であると考えられ、試みられてい
なかった。本発明者らは、上記課題を解決すべく鋭意検
討を行ったところ、次に示す手段により、課題を解決で
きることを見いだし本発明を完成した。In order to manufacture a soft capsule, it is necessary that the content be a liquid having physical properties suitable for filling. Therefore, when a solid lipophilic drug is dissolved or suspended at room temperature, the viscosity increases or solidification occurs, making it difficult to obtain a soft capsule. on the other hand,
Since the film of the soft capsule is water-soluble, it was considered difficult to incorporate the fat-soluble drug, and it has not been attempted. The present inventors have conducted extensive studies to solve the above problems, and have found that the problems can be solved by the means shown below, and have completed the present invention.
【０００４】[0004]
【課題を解決するための手段】すなわち、本発明は軟カ
プセル剤において、１種または２種以上の薬物を皮膜中
に含有し、残余の薬物を内容物中に含有することを特徴
とする軟カプセル剤である。本発明において、皮膜中に
含有する薬物とは、常温において固体である脂溶性薬物
である。内容物中に含有するのは通常は、常温で液体の
油状薬物、常温で半固体の油状薬物、微細な粒子が懸濁
した油状薬物または油性溶媒に溶解もしくは懸濁した薬
物である。Means for Solving the Problems That is, the present invention provides a soft capsule, characterized in that one or more drugs are contained in a film and the remaining drug is contained in the contents. It is a capsule. In the present invention, the drug contained in the film is a fat-soluble drug that is solid at room temperature. The content usually contains an oily drug that is liquid at room temperature, an oily drug that is semi-solid at room temperature, an oily drug in which fine particles are suspended, or a drug dissolved or suspended in an oil solvent.
【０００５】皮膜中に含有する常温において固体である
薬物としては、例えばガンマ−オリザノ−ル、フィトス
テロ−ル等を挙げることができ、内容物とする常温で液
体の油状物質としては、トコフェロ−ル類、綿実油、落
下生油、または中鎖脂肪酸のグリセライド等の合成油な
どを挙げることができ、油に溶解する薬物を溶解したも
のでも良い。また、内容物はオレイン酸モノグリセライ
ド等のグリセリンの高級脂肪酸エステルもしくはプロピ
レングリコ−ルの高級脂肪酸エステル等の常温で半固体
の油状物質または油に溶解しない薬物もしくは軽質無水
ケイ酸等の生理的に不活性な物質を懸濁した油状物質と
することもできる。皮膜中に含有する薬物は、その物理
化学的性質や、使用量によっては内容物中に含有するこ
ともでき、逆に、通常は内容物とする物質でも皮膜中に
含有することができるため、実際の使用目的や製造条件
に応じてどちらに含有するかを適宜選択することが可能
である。Examples of the drug contained in the film and solid at room temperature include gamma-oryzanol and phytosterol. As an oily substance which is liquid at room temperature, tocopherol is used. Examples thereof include cottonseed oil, cottonseed oil, raw falling oil, and synthetic oil such as glyceride of medium-chain fatty acid, and a drug in which an oil-soluble drug is dissolved may be used. In addition, the content is a semi-solid oily substance at room temperature such as higher fatty acid ester of glycerin such as oleic acid monoglyceride or higher fatty acid ester of propylene glycol, or a drug that is not soluble in oil or physiologically non-soluble such as light anhydrous silicic acid. It can also be an oily substance in which the active substance is suspended. The drug contained in the film can be contained in the content depending on its physicochemical properties and the amount used, and conversely, since the substance that is the content can also be contained in the film, It is possible to appropriately select which to contain depending on the actual purpose of use and manufacturing conditions.
【０００６】皮膜に含有する薬物の量はその種類や性質
などにより異なるため、特に限定されないが、ガンマ−
オリザノ−ルの場合には、皮膜重量に対して通常０．０
５〜５０重量％、好ましくは０．１〜１５重量％、更に
好ましくは０．５〜７重量％である。[0006] The amount of the drug contained in the film is not particularly limited because it depends on the type and properties of the drug.
In the case of oryzanol, it is usually 0.0 with respect to the coating weight.
It is 5 to 50% by weight, preferably 0.1 to 15% by weight, and more preferably 0.5 to 7% by weight.
【０００７】本発明にかかる軟カプセル剤を製造するに
は、ロ−タリ−式自動充填機を用い通常用いられる方法
によることができる。すなわち、ゼラチン、グリセリ
ン、パラベン類及び皮膜に配合する薬物に精製水を加
え、加温溶解して皮膜液を得ることができる。また、内
容物は薬物と溶剤を混合し、加温溶解して得ることがで
きる。このようにして得た皮膜液及び内容物を用いて常
法により軟カプセル剤を製造することができる。The soft capsules according to the present invention can be produced by a commonly used method using a rotary type automatic filling machine. That is, purified water can be added to gelatin, glycerin, parabens, and the drug to be added to the film, and dissolved by heating to obtain a film solution. Further, the content can be obtained by mixing a drug and a solvent and heating and dissolving. A soft capsule can be manufactured by a conventional method using the coating solution and the contents thus obtained.
【０００８】[0008]
【作用】軟カプセル剤に内容物を充填するには、一般に
内容物の粘度が５００００ミリパスカル以下であること
が必要である。常温で固体である物質を溶解もしくは分
散すると粘度が著しく高くなり、軟カプセルに充填でき
なくなることがある。本発明においては、内容物の粘度
を増加して充填不可能にする物質が皮膜部分に含有され
るため、内容物の粘度が増加することがなく、軟カプセ
ル剤を製造することができる。In order to fill the contents into the soft capsule, it is generally necessary that the viscosity of the contents is 50,000 millipascals or less. When a substance that is solid at room temperature is dissolved or dispersed, the viscosity becomes extremely high and it may not be possible to fill the soft capsule. In the present invention, the substance that increases the viscosity of the content to make it unfillable is contained in the film portion, so that the soft capsule can be produced without increasing the viscosity of the content.
【０００９】[0009]
【実施例】以下に実施例を挙げて本発明を更に詳細に説
明するが、本発明はこれらに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 thereto.
【００１０】実施例１ 皮膜の調製は、ゼラチン７１％、濃グリセリン２１．７
％、エチルパラベン０．２％、プロピルパラベン０．１
％に精製水を適量加えて加温溶解し、更にガンマオリザ
ノ−ル７％を加え、同温度で均一に分散して得た。ま
た、内容物の調製は、大豆不けん化物４３％、ｄ−α−
トコフェロ−ル７％、オクチルデシルトリグリセライド
５０％をとり、加温して均一になるまで撹拌したものを
内容物とした。このようにして得た皮膜及び内容物を用
いて、ロ−タリ−式自動充填機により軟カプセル剤と
し、３０℃（湿度２０％）で２４時間乾燥した。水分率
は約１０％であった。Example 1 A film was prepared by using gelatin 71% and concentrated glycerin 21.7.
%, Ethylparaben 0.2%, propylparaben 0.1
%, Purified water was added and dissolved under heating, 7% of gamma oryzanol was further added, and the mixture was uniformly dispersed at the same temperature. In addition, the content was prepared by soybean unsaponifiables 43%, d-α-
Tocopherol (7%) and octyldecyl triglyceride (50%) were taken, heated and stirred until the contents became uniform. The film and contents thus obtained were used as a soft capsule by a rotary type automatic filling machine, and dried at 30 ° C. (humidity 20%) for 24 hours. The water content was about 10%.
【００１１】比較例 大豆不けん化物４３％、ｄ−α−トコフェロ−ル７％、
オクチルデシルトリグリセライド４７．５％、ガンマオ
リザノ−ル３．２％をとり、加温しながら撹拌し内溶液
を調製しようと試みた。しかし、内溶液は固化し、軟カ
プセルに充填は不可能であった。Comparative Example Soybean unsaponifiables 43%, d-α-tocopherol 7%,
An attempt was made to prepare an internal solution by taking 47.5% octyldecyl triglyceride and 3.2% gamma oryzanol and stirring them while heating. However, the inner solution solidified and it was impossible to fill the soft capsule.
Claims (3)
上の薬物を皮膜に含有し、残余の薬物を内容物中に含有
することを特徴とする軟カプセル剤。1. A soft capsule, wherein one or more drugs are contained in a film and the remaining drug is contained in the content.
性薬物を皮膜に含有し、常温で液体の油状薬物、常温で
半固体の油状薬物、微細な粒子が懸濁した油状薬物また
は油性溶媒に溶解もしくは懸濁した薬物を内容物として
含有することを特徴とする軟カプセル剤。2. A soft capsule, which contains a lipid-soluble drug which is solid at room temperature in a film and is an oily drug which is liquid at room temperature, a semi-solid oily drug at room temperature, an oily drug in which fine particles are suspended or an oily solvent A soft capsule which comprises a drug dissolved or suspended in as a content.
−ルを皮膜に含有し、トコフェロ−ル類及び大豆不けん
化物を内容物中に含有することを特徴とする軟カプセル
剤。3. A soft capsule, characterized in that gamma-oryzanol is contained in the film, and tocopherols and soybean unsaponifiable matter are contained in the contents.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP34850091A JP3144865B2 (en) | 1991-12-06 | 1991-12-06 | Soft capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP34850091A JP3144865B2 (en) | 1991-12-06 | 1991-12-06 | Soft capsule |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH05155761A true JPH05155761A (en) | 1993-06-22 |
| JP3144865B2 JP3144865B2 (en) | 2001-03-12 |
Family
ID=18397431
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP34850091A Expired - Lifetime JP3144865B2 (en) | 1991-12-06 | 1991-12-06 | Soft capsule |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3144865B2 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009087938A1 (en) * | 2008-01-10 | 2009-07-16 | Takeda Pharmaceutical Company Limited | Capsule formulation |
-
1991
- 1991-12-06 JP JP34850091A patent/JP3144865B2/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009087938A1 (en) * | 2008-01-10 | 2009-07-16 | Takeda Pharmaceutical Company Limited | Capsule formulation |
| JP5421126B2 (en) * | 2008-01-10 | 2014-02-19 | 武田薬品工業株式会社 | Capsule formulation |
Also Published As
| Publication number | Publication date |
|---|---|
| JP3144865B2 (en) | 2001-03-12 |
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