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JP4638927B2 - Soft capsule - Google Patents

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Publication number
JP4638927B2
JP4638927B2 JP2008196951A JP2008196951A JP4638927B2 JP 4638927 B2 JP4638927 B2 JP 4638927B2 JP 2008196951 A JP2008196951 A JP 2008196951A JP 2008196951 A JP2008196951 A JP 2008196951A JP 4638927 B2 JP4638927 B2 JP 4638927B2
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film
gellan gum
soft capsule
capsule
capsules
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JP2009028544A (en
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洋明 長谷川
知徳 小野
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Fuji Capsule Co Ltd
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Fuji Capsule Co Ltd
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Description

本発明は、医薬品、医薬部外品、化粧品、食品等に適用されて好適なソフトカプセルに関する。   The present invention relates to a soft capsule suitable for being applied to pharmaceuticals, quasi drugs, cosmetics, foods, and the like.

従来、ソフトカプセルとして、ゼラチンを皮膜基剤とするソフトカプセルが多用されている。ところが、ゼラチンは水溶性であるため、ゼラチン皮膜からなるソフトカプセルは、水を含む保存液に入れて保存することができなかった。   Conventionally, soft capsules using gelatin as a film base are often used as soft capsules. However, since gelatin is water-soluble, soft capsules made of gelatin film cannot be stored in a storage solution containing water.

そこで、特許文献1に記載の如く、水不溶性の寒天を皮膜基剤とするソフトカプセルが提案されている。寒天皮膜からなるソフトカプセルは、水を含む保存液に入れて保存することができる。
特開平1-193216
Therefore, as described in Patent Document 1 , a soft capsule using water-insoluble agar as a film base has been proposed. Soft capsules made of an agar film can be stored in a preservation solution containing water.
JP-A-1-93216

然しながら、寒天皮膜からなるソフトカプセルにあっては、以下の点での改良が望まれる。
(a)寒天皮膜はゼラチン皮膜(40℃以上で溶解)に比して耐熱性が良いものの、100℃までの耐熱性はない。
However, soft capsules made of an agar film are desired to be improved in the following points.
(a) Although the agar film has better heat resistance than the gelatin film (dissolved at 40 ° C or higher), it does not have heat resistance up to 100 ° C.

(b)寒天皮膜は酸性条件(pH 3)で加熱されると溶解し易く、pH 3.5付近が実用上の限界である。 (b) The agar film is easily dissolved when heated under acidic conditions (pH 3), and the practical limit is around pH 3.5.

(c)透明性が低い。 (c) Low transparency.

本発明の課題は、水不溶性である上に、耐熱性と耐酸性が高く、透明性も良いソフトカプセルを提供することにある。   An object of the present invention is to provide a soft capsule that is insoluble in water, has high heat resistance and acid resistance, and has good transparency.

請求項1に記載の本発明は、皮膜にジェランガムを皮膜基剤として含むソフトカプセルであって、アルギン酸ナトリウム及びアルギン酸プロピレングリコールの両方を皮膜基剤として同時に含むことなく、かつ、マンナンガムを皮膜基剤として含まないことを特徴とする水中に分散させても、溶解することなく安定なソフトカプセルである。 The present invention according to claim 1 is a soft capsule containing gellan gum as a film base in a film , and does not include both sodium alginate and propylene glycol alginate as a film base at the same time, and mannan gum as a film base. be dispersed in water, wherein the free, a stable soft capsule without dissolving.

請求項2に記載の本発明は、皮膜にジェランガムを皮膜基剤として含むソフトカプセルであって、アルギン酸ナトリウムを皮膜基剤として含むことなく、かつ、マンナンガムを皮膜基剤として含まないことを特徴とする水中に分散させても、溶解することなく安定なソフトカプセルである。 The present invention according to claim 2 is a soft capsule containing gellan gum as a film base in a film , wherein sodium alginate is not included as a film base, and mannan gum is not included as a film base. It is a soft capsule that does not dissolve even when dispersed in water.

請求項3に記載の本発明は、請求項1又は2に記載の本発明において更に、皮膜に更に、カラギーナンを皮膜基剤として含むようにしたものである。 The present invention described in claim 3 is the present invention described in claim 1 or 2, further comprising carrageenan as a film base in the film .

請求項4に記載の本発明は、請求項1〜3のいずれかに記載の本発明において更に、皮膜水分量が、95重量%を超えるようにしたものである。 The present invention according to claim 4 is the present invention according to any one of claims 1 to 3, wherein the moisture content of the film exceeds 95% by weight .

作用Action

請求項1〜4に記載の本発明によれば、下記(a)(d)の作用がある。
(a)ジェランガムは水不溶性であり、ジェランガム皮膜からなるソフトカプセル(ジェランガムカプセル)は、水を含む保存液(分散液)に入れて保存することができる。
According to the present invention described in claims 1 to 4, the following effects (a) to (d) are obtained.
(a) Gellan gum is insoluble in water, and soft capsules (gellan gum capsules) made of a gellan gum film can be stored in a storage solution (dispersion) containing water.

(b)ジェランガム皮膜は100℃でも溶解せずに形状維持でき、耐熱性が高い。高温加熱殺菌をしても大丈夫である。 (b) The gellan gum film can maintain its shape without dissolving even at 100 ° C. and has high heat resistance. It is safe to sterilize at high temperature.

(c)ジェランガム皮膜は酸性条件(pH 3)で加熱しても溶解せずに形状維持でき、耐酸性が高い。 (c) Gellan gum film can maintain its shape without dissolving even when heated under acidic conditions (pH 3), and has high acid resistance.

(d)透明性が良い。 (d) Good transparency.

本発明のソフトカプセルは、ジェランガムを皮膜基剤とするものである。ジェランガム(商品名:ケルコゲル)は、ハイドロコロイドと呼ばれる高分子物質の一つである。本発明のソフトカプセルを構成するジェランガム皮膜は、ジェランガムに金属塩(乳酸カルシウム、塩化カルシウム、塩化ナトリウム等)、水を添加して構成することができる。ジェランガム皮膜には、その他、安定化剤、着色剤、香料等を必要に応じて添加できる。尚、ジェランガムは添加する金属塩の種類及び量によって、ゲルの強度をコントロールすることができる。またpH 3.5付近にゲルを調整し、2価の塩と併用することにより、効果的にゲル強度を強くすることもできる。   The soft capsule of the present invention uses gellan gum as a film base. Gellan gum (trade name: Kelcogel) is one of polymer substances called hydrocolloids. The gellan gum film constituting the soft capsule of the present invention can be constituted by adding a metal salt (calcium lactate, calcium chloride, sodium chloride, etc.) and water to gellan gum. In addition, a stabilizer, a coloring agent, a fragrance | flavor, etc. can be added to a gellan gum membrane | film | coat as needed. In addition, gellan gum can control the intensity | strength of a gel with the kind and quantity of the metal salt to add. Moreover, gel strength can also be effectively strengthened by adjusting gel to pH 3.5 vicinity and using together with a bivalent salt.

本発明のソフトカプセルは、一般的なシームレス滴下法により製造される。滴下法は、外側がカプセル皮膜液、内側がカプセル内容液からなる2層性の液流を、一定間隔で切断することにより皮膜液にて内容液を包み、球体(シームレスカプセル)を成形するものである。   The soft capsule of the present invention is produced by a general seamless dropping method. The dripping method is to form a sphere (seamless capsule) by wrapping the content liquid with the film liquid by cutting a two-layered liquid flow consisting of the capsule film liquid on the outside and the capsule content liquid on the inside at regular intervals. It is.

本発明のソフトカプセルには、以下の如くの作用がある。
(a)ジェランガムは水不溶性であり、ジェランガム皮膜からなるソフトカプセル(ジェランガムカプセル)は、水を含む保存液(分散液)に入れて保存することができる。
The soft capsule of the present invention has the following effects.
(a) Gellan gum is insoluble in water, and soft capsules (gellan gum capsules) made of a gellan gum film can be stored in a storage solution (dispersion) containing water.

(b)ジェランガム皮膜は100℃でも溶解せずに形状維持でき、耐熱性が高い。 (b) The gellan gum film can maintain its shape without dissolving even at 100 ° C. and has high heat resistance.

(c)ジェランガム皮膜は酸性条件(pH 3)で加熱しても溶解せずに形状維持でき、耐酸性が高い。 (c) Gellan gum film can maintain its shape without dissolving even when heated under acidic conditions (pH 3), and has high acid resistance.

(d)透明性が良い。 (d) Good transparency.

本発明のソフトカプセルの応用範囲は非常に広く、あらゆる形態の製品に本発明のカプセルを配合することにより様々な目的を達成できる。   The application range of the soft capsule of the present invention is very wide, and various purposes can be achieved by blending the capsule of the present invention into products of all forms.

カプセル皮膜に水を含んだ状態(なまカプセル)では、液・クリーム・ゲル・ペースト状・乳化系等の状態のもの(剤型)に配合し利用できる。   In a state where the capsule film contains water (a raw capsule), it can be used by blending it into a liquid (cream, gel, paste, emulsified system, etc. (form).

カプセル皮膜から水分を除いた状態(乾燥カプセル)では、カプセルをそのまま・粉末・顆粒・錠剤・シート状等の状態のもの(剤型)に配合する等して利用できる。   In a state where moisture is removed from the capsule film (dry capsule), the capsule can be used as it is by mixing it into a powder (granule, tablet, sheet, etc.) (drug form).

以下に、具体的にいくつかの例について説明する。
(1)健康食品用・医療品用ソフトカプセルこの利用形態では、皮膜から水分を除いた乾燥カプセルが望ましい。内容液として、脂溶性成分及び油脂を含有するソフトカプセル。
Hereinafter, some examples will be specifically described.
(1) Soft capsules for health foods and medical products In this form of use, dry capsules obtained by removing moisture from the film are desirable. A soft capsule containing a fat-soluble component and fat as a content liquid.

脂溶性成分の例
ビタミンA類及び誘導体、ビタミンD類、ビタミンE類及び誘導体、ビタミンK類、γ−オリザノール、リノレン酸、カロチン類等
Examples of fat-soluble ingredients Vitamin A and derivatives, vitamin D, vitamin E and derivatives, vitamin K, γ-oryzanol, linolenic acid, carotene, etc.

油脂の例
MCT(中鎖脂肪酸トリグリセリド)、大豆油、小麦胚芽油、とうもろこし油、綿実油、オリブ油、ゴマ油、サフラワー油、ナタネ油等
Examples of oils and fats MCT (medium chain fatty acid triglyceride), soybean oil, wheat germ oil, corn oil, cottonseed oil, olive oil, sesame oil, safflower oil, rapeseed oil, etc.

(2)口内放出性(舌下吸収用)ソフトカプセル
内容物として、ニフェジピン、硝酸イソソルビド等を用い、狭心症発作時にかんで服用すれば速効性が期待できる。更にかむときの力も弱くすることが可能である。
(2) Release in mouth (for sublingual absorption) soft capsule The contents are nifedipine, isosorbide nitrate, etc., and can be expected to be fast-acting if taken with a can during an angina attack. Furthermore, it is possible to weaken the force when biting.

(3)持続性カプセル
ジェランガム皮膜中に、溶出持続性を期待する薬剤(例:塩酸ニカルジピン)を均一に分散させて、滴下により球状物として持続性ソフトカプセルとする。
(3) Sustained capsule Disperse a drug (eg, nicardipine hydrochloride) that is expected to have sustained elution into a gellan gum film, and drop it into a spheroid to form a durable soft capsule.

(4)外用薬ソフトカプセル
スクワランなどの外用薬として用いられる成分をジェランガム皮膜でソフトカプセル化し、用時カプセルをつぶして使用する。このソフトカプセルを皮膜に水分を含んだ状態でガーゼ部分に施した絆創膏を作成すれば、使用時に貼る動作のみで絆創膏の貼付とカプセル内容物の塗布とを同時に行なうことができる。
(4) topical medicine soft capsule The ingredients used as a topical medicine such as squalane are soft-capsulated with gellan gum film, and the capsule is crushed before use. If a bandage is created by applying this soft capsule to the gauze part with moisture contained in the film, the bandage can be applied and the capsule contents can be applied simultaneously by only applying the bandage during use.

本発明のソフトカプセルでは、以下の変形を採用できる。
(1)ジェランガム皮膜への他の多糖類の配合
ジェランガム皮膜に、例えば寒天、κ(カッパ)−タイプもしくはι(イオタ)−タイプ等のカラギーナン、アルギン酸塩、キサンタンガム、ローカストビーンガム、グルコマンナン、ファーセレラン等を配合し、皮膜強度の調整を図ることができる。
The following modifications can be employed in the soft capsule of the present invention.
(1) Formulation of other polysaccharides in gellan gum film For example, agarine, κ (kappa) -type or ι (iota) -type carrageenan, alginate, xanthan gum, locust bean gum, glucomannan, fur celeran, etc. Etc. can be blended to adjust the film strength.

ジェランガム皮膜にκ−カラギーナンを配合したものにあっては、感触がやわらかく、擦っても皮膜の痕跡(カス)が残らない。また、ジェランガム皮膜にι−カラギーナンを配合したものにあっては、κ−カラギーナンを配合したものに比して、感触がよりやわらかく、擦っても皮膜の痕跡(カス)がより残らない。   A gellan gum film blended with κ-carrageenan is soft to the touch and does not leave traces of film even when rubbed. In addition, a gellan gum film blended with ι-carrageenan has a softer feel than a blend of κ-carrageenan and does not leave any traces of film even when rubbed.

(2)ジェランガム皮膜への糖類の添加
ジェランガム皮膜に、例えば蔗糖(砂糖)、白糖、乳糖、ソルビトール等を添加し、皮膜強度の調整を図り、或いは食品、歯磨き剤用カプセルへの適用における食味付与を図ることができる。
(2) Addition of saccharides to gellan gum film Add sucrose, sucrose, lactose, sorbitol, etc. to gellan gum film to adjust the film strength, or to add taste to capsules for foods and dentifrices Can be achieved.

(3)ジェランガムカプセルの保存液(水溶液)への糖類等の配合ジェランガムカプセルのための保存液に、例えばソルビトール、グリセリン、1,3−ブチレングリコール等を配合することにより、皮膜強度の強化、及び腐敗防止等によるカプセルの保存性の向上を図ることができる。   (3) Formulation of saccharides, etc., in gellan gum capsule preservation solution (aqueous solution) Strengthening of film strength by blending, for example, sorbitol, glycerin, 1,3-butylene glycol, etc. in the preservation solution for gellan gum capsules, and It is possible to improve the preservability of the capsule by preventing corruption.

(4)ジェランガムの皮膜強度の調整
以下の手段により、皮膜強度の調整をはかることができる。
皮膜率(皮膜重量/カプセル全体重量)の調整
皮膜の固形分(皮膜中の水以外の成分量/皮膜全体の成分量)の調整
(4) Adjustment of gel strength of gellan gum The strength of the coating can be adjusted by the following means.
Adjustment of film ratio (film weight / total capsule weight) Adjustment of film solids (amount of components other than water in the film / amount of components in the entire film)

(5)乾燥カプセル
ジェランガム皮膜中における固形分(ジェランガム、金属塩等)の濃度を大とすることにより、乾燥カプセルを構成することもできる。
(5) Dry capsule A dry capsule can also be constituted by increasing the concentration of solids (gellan gum, metal salt, etc.) in the gellan gum film.

尚、皮膜に水分を含んだ状態のカプセル(なまカプセル)においては、「皮膜強度が大である事」イコール「良い事」とは必ずしも言えず、ときには破壊されやすいものが望まれる場合もあり、前述のカラギーナンの配合によりそれを達成することもできる。   It should be noted that in capsules with moisture in the film (namely capsules), it is not always possible to say that “the film strength is high” or “good”, and sometimes it is desired to be easily destroyed. It can also be achieved by blending the aforementioned carrageenan.

(1)皮膜処方
ジェランガムを精製水中に投入し、これが完全に溶解してから乳酸カルシウムを投入、溶解せしめ、表1の皮膜液(A)〜(I)、表2の皮膜液(J)〜(N)を得た。
(1) Coating formulation Gellan gum is put into purified water, and after it is completely dissolved, calcium lactate is added and dissolved, and the coating solutions (A) to (I) in Table 1 and the coating solutions (J) in Table 2 (N) was obtained.

Figure 0004638927
Figure 0004638927

(2)シームレスカプセルの形成
上記(1)の皮膜液(A)〜(N)を用いて、従来公知のシームレス滴下法(例えば特公昭36-3700号公報記載の方法)により、中鎖脂肪酸トリグリセリド(MCT:食用油)を内容液とするシームレスカプセル(皮膜率:65%)(直径1mmφのカプセルと直径3mmφのカプセル)の形成充填を行なった。皮膜液(A)〜(N)を用いてのカプセル化の結果は表1、表2の通りであった。
(2) Formation of seamless capsules Medium chain fatty acid triglycerides using the coating liquids (A) to (N) described in (1) above by a conventionally known seamless dropping method (for example, the method described in JP-B 36-3700) Formation and filling of seamless capsules (coating rate: 65%) (capsules with a diameter of 1 mmφ and capsules with a diameter of 3 mmφ) containing (MCT: edible oil) as a content liquid were performed. The results of encapsulation using the coating liquids (A) to (N) are as shown in Tables 1 and 2.

Figure 0004638927
Figure 0004638927

(3)水不溶性の評価
上記(2)で形成したジェランガムカプセルを輸送用保存液としての水中に分散させた結果、水に溶解することなく安定であった。
(3) Evaluation of water insolubility As a result of dispersing the gellan gum capsules formed in the above (2) in water as a transport preservation solution, the capsule was stable without dissolving in water.

(4)透明性の評価
上記(2)で形成したジェランガムカプセルの外観は透明度が高く、美しいものであった。
(4) Evaluation of transparency The appearance of the gellan gum capsules formed in (2) above was highly transparent and beautiful.

(5)耐熱性の評価
方法:保存液中に入れたカプセルを、徐々に加熱してカプセルの割れる温度を測定した。更に加熱を続け、皮膜が完全に溶解するか観察した。
(5) Evaluation of heat resistance Method: The capsule placed in the preservation solution was gradually heated to measure the temperature at which the capsule was broken. Further heating was continued to observe whether the film was completely dissolved.

結果:寒天カプセルは約88℃でカプセルが割れ始め、その後、皮膜は完全に溶解した。ジェランガムカプセルは、約97℃で一部(全体の1/3)の割れを見たが、100℃まで加熱しても溶解しなかった。   Results: The agar capsules began to crack at about 88 ° C, after which the film was completely dissolved. The gellan gum capsules were partially broken (1/3 of the whole) at about 97 ° C, but did not dissolve even when heated to 100 ° C.

(6)耐酸性の評価
方法:カプセルを、これと同重量のpH 1.1の水溶液中に入れて室温、40℃、50℃、80℃に保温した。保温時間は室温、40℃は6日間、50℃は24時間、80℃は4時間まで行なった。
(6) Evaluation of acid resistance Method: Capsules were placed in an aqueous solution having the same weight as pH 1.1 and kept at room temperature, 40 ° C., 50 ° C., and 80 ° C. The incubation time was room temperature, 40 ° C for 6 days, 50 ° C for 24 hours, and 80 ° C for up to 4 hours.

結果:寒天カプセル、ジェランガムカプセルとも、室温、40℃、50℃では変化がなかった。80℃では、寒天カプセルは2時間で2/3、3時間で全て溶解したが、ジェランガムは4時間でも変化しなかった。   Results: Neither agar capsules nor gellan gum capsules changed at room temperature, 40 ° C, or 50 ° C. At 80 ° C, the agar capsules were completely dissolved in 2/3 and 2/3 in 2 hours, but gellan gum did not change in 4 hours.

(7)破壊強度の評価
各皮膜処方の皮膜液(E)、(F)を用いたカプセル(直径 1mmφのカプセル)、皮膜液(A)、(B)を用いたカプセル(直径3mmφのカプセル)(内容物はMCT)を上から押しつぶし、破裂した際に加わる力を測定し表3を得た。尚、表3で比較例として示した寒天カプセルの皮膜処方は、水100重量部に対し寒天1.1重量部であった。
(7) Evaluation of breaking strength Capsules using coating fluids (E) and (F) of each coating formulation (capsules with a diameter of 1 mmφ), capsules using coating fluids (A) and (B) (capsules with a diameter of 3 mmφ) Table 3 was obtained by measuring the force applied when the contents were crushed from the top and ruptured. In addition, the film | membrane prescription of the agar capsule shown as a comparative example in Table 3 was 1.1 weight part of agar with respect to 100 weight part of water.

Figure 0004638927
Figure 0004638927

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. include.

以上のように本発明によれば、水不溶性である上に、耐熱性と耐酸性が高く、透明性も良いソフトカプセルを提供することができる。
As described above, according to the present invention, it is possible to provide a soft capsule that is water-insoluble, has high heat resistance and acid resistance, and has good transparency.

Claims (4)

皮膜にジェランガムを皮膜基剤として含むソフトカプセルであって、
アルギン酸ナトリウム及びアルギン酸プロピレングリコールの両方を皮膜基剤として同時に含むことなく、
かつ、マンナンガムを皮膜基剤として含まないことを特徴とする
水中に分散させても、溶解することなく安定なソフトカプセル。
A soft capsule containing gellan gum as a film base in the film ,
Without simultaneously containing both sodium alginate and propylene glycol alginate as a film base,
Moreover, a stable soft capsule that does not dissolve even when dispersed in water, characterized in that it does not contain mannan gum as a film base .
皮膜にジェランガムを皮膜基剤として含むソフトカプセルであって、
アルギン酸ナトリウムを皮膜基剤として含むことなく、
かつ、マンナンガムを皮膜基剤として含まないことを特徴とする
水中に分散させても、溶解することなく安定なソフトカプセル。
A soft capsule containing gellan gum as a film base in the film ,
Without including sodium alginate as a film base,
In addition, a soft capsule that is stable without being dissolved even when dispersed in water, characterized by not containing mannan gum as a film base .
皮膜に更に、カラギーナンを皮膜基剤として含むことを特徴とする、請求項1又は2に記載のソフトカプセル。 The soft capsule according to claim 1 or 2, wherein the film further contains carrageenan as a film base . 皮膜水分量が、95重量%を超える請求項1〜3のいずれかに記載のソフトカプセル。   The soft capsule according to any one of claims 1 to 3, wherein the moisture content of the film exceeds 95% by weight.
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9742964B2 (en) 2014-01-07 2017-08-22 Samsung Electronics Co., Ltd. Audio/visual device and control method thereof

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Publication number Priority date Publication date Assignee Title
JP2012006872A (en) * 2010-06-25 2012-01-12 Sansho Pharmaceutical Co Ltd Oil-dispersed type composition in water/oil
AU2020361859A1 (en) * 2019-10-11 2022-05-12 Sunsho Pharmaceutical Co., Ltd. Soft capsule
JP7411990B2 (en) * 2019-12-24 2024-01-12 中日本カプセル 株式会社 Soft capsule film, soft capsule, and method for producing soft capsule

Citations (4)

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Publication number Priority date Publication date Assignee Title
JPH0436159A (en) * 1990-05-31 1992-02-06 Fuji Capsule Kk Royal jelly-containing soft capsule
JPH06329833A (en) * 1993-04-27 1994-11-29 Merck & Co Inc Composition and method for producing gelatine-free soft capsule
JPH08175932A (en) * 1994-12-21 1996-07-09 Sansho Kaken Kk Foundation cosmetic
JPH10291928A (en) * 1997-02-24 1998-11-04 Fuji Capsule Kk Soft capsule

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0436159A (en) * 1990-05-31 1992-02-06 Fuji Capsule Kk Royal jelly-containing soft capsule
JPH06329833A (en) * 1993-04-27 1994-11-29 Merck & Co Inc Composition and method for producing gelatine-free soft capsule
JPH08175932A (en) * 1994-12-21 1996-07-09 Sansho Kaken Kk Foundation cosmetic
JPH10291928A (en) * 1997-02-24 1998-11-04 Fuji Capsule Kk Soft capsule

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9742964B2 (en) 2014-01-07 2017-08-22 Samsung Electronics Co., Ltd. Audio/visual device and control method thereof

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