JP2009196958A - Soft capsule highly containing powder and its manufacturing method - Google Patents

Soft capsule highly containing powder and its manufacturing method Download PDF

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JP2009196958A
JP2009196958A JP2008042752A JP2008042752A JP2009196958A JP 2009196958 A JP2009196958 A JP 2009196958A JP 2008042752 A JP2008042752 A JP 2008042752A JP 2008042752 A JP2008042752 A JP 2008042752A JP 2009196958 A JP2009196958 A JP 2009196958A
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powder
soft capsule
capsule
content
weight
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JP5622185B2 (en
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Takashi Kondo
隆 近藤
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Sansho Pharmaceutical Co Ltd
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Abstract

<P>PROBLEM TO BE SOLVED: To solve such a problem that when powder is contained 60% or more as a content, a soft capsule form has not been produced by a conventional manufacturing method. <P>SOLUTION: The soft capsule highly containing powder is the one where the content of the soft capsule is composed of a powder and an oil and fat-based substance, and the weight of the powder is 60-99.9% against the total weight of the content. For example, the soft capsule can be manufactured by utilizing a rotary method equipped with rotary molds 8, supplying the powder in a solid form 3' into a pocket 9 of the one mold 8 by pushing it onto a film sheet 5' from above before the pockets 9 are faced each other, and filling and supplying the oil and fat-based substance 4 between the two film sheets 5', 5' within the faced pockets 9, 9. Because the powder in a solid form 3' is covered with the oil and fat-based substance 4, the content of the soft capsule can be similarly handled as the content for the conventional soft capsule. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

本発明は医薬品、食品等に用いられるカプセルに係り、特に油脂系基材に粉末が高含有されたカプセル内容物が皮膜によって内包されたタイプの軟カプセルに関するものである。   The present invention relates to capsules used in pharmaceuticals, foods, and the like, and more particularly to a soft capsule of a type in which a capsule content containing a high amount of powder in an oily base is encapsulated by a film.

カプセルは硬カプセルと軟カプセルとに大別され、従来からいずれのタイプも利用されているが、なかでも軟カプセルは、その名称の示すとおり、柔軟性に富むので割れ難く、しかも内容物を吸湿、酸化などの化学変化から安定的に保護できることから広く利用されている。
しかしながら、軟カプセルを製造する場合には、通常金型が回転式のロータリー法を利用して、二枚の皮膜シートの間に充填された内容物の粘性を利用して該皮膜シートを外方に押し広げることによりポケット形状に沿って立体成形する。
従って、軟カプセルの内容物は、皮膜シートを極力均等に押し広げることができる粘性を有することが求められている。
そのため、内包したい物質が粉末形態の場合には、適当な油脂系基材に懸濁させた懸濁液として使用しており、内容物全量に占める粉末の相対的な重量はかなり抑えられてしまっていた。
Capsules are broadly divided into hard capsules and soft capsules, and any type has been used. However, as the name implies, soft capsules are flexible and difficult to break, and they absorb moisture. It is widely used because it can be stably protected from chemical changes such as oxidation.
However, when manufacturing a soft capsule, the coating sheet is usually removed by using the rotary method in which the mold is rotated and using the viscosity of the contents filled between the two coating sheets. Three-dimensionally molded along the pocket shape by spreading it.
Therefore, the content of the soft capsule is required to have a viscosity that can spread the film sheet as evenly as possible.
Therefore, when the substance to be encapsulated is in powder form, it is used as a suspension suspended in a suitable oil-based base material, and the relative weight of the powder in the total content is considerably suppressed. It was.

上記のような理由から、粉末の量を増やしたい場合には、通常硬カプセルや粉末を加圧して固めた錠剤として提供されている。
しかしながら、硬カプセルの場合には、キャップとボディとの間にできた隙間を介して内容物が吸湿、酸化などの化学変化を受け易く、しかも経口し難い。
また、錠剤の場合には粉末を固形化するのにある程度の量の賦形剤を添加することが不可欠であり、割れや角の崩れも比較的起こり易い。また、内容物の表面が露出してしまうので、吸湿、酸化などの化学変化を諸に受け易いだけでなく、経口の際には内容物に由来する苦味や臭いの不快さが緩和されない。
For the above reasons, when it is desired to increase the amount of the powder, it is usually provided as a hard capsule or a tablet obtained by pressing and solidifying the powder.
However, in the case of hard capsules, the contents are easily subjected to chemical changes such as moisture absorption and oxidation through a gap formed between the cap and the body, and are difficult to take orally.
In the case of tablets, it is indispensable to add a certain amount of excipient to solidify the powder, and cracks and corners are relatively easy to occur. Moreover, since the surface of the contents is exposed, it is not only susceptible to various chemical changes such as moisture absorption and oxidation, but the bitterness and odor unpleasantness derived from the contents is not alleviated when taken orally.

上記した不都合な点を解消するために、様々な硬カプセルや錠剤の表面を被覆したフィルムコート錠や糖衣錠が提案されているが、被覆のために必要な特別な設備や材料、比較的高度な塗工技術、錠剤加工技術が負担となり、製造コストを押し上げてしまう。   In order to eliminate the above disadvantages, film-coated tablets and sugar-coated tablets covering the surface of various hard capsules and tablets have been proposed, but special equipment and materials necessary for coating, relatively advanced Coating technology and tablet processing technology are burdened and increase manufacturing costs.

登録実用新案第3131917号公報Registered Utility Model No. 3131717 特開2004−250336号公報JP 2004-250336 A

以上より、粉末の相対的含有量を従来より飛躍的に多くできた、新規且つ有用な形態の軟カプセルを提供することを目的とする。
また、上記した軟カプセルの工夫された製造方法を提供することを目的とする。
In view of the above, an object is to provide a new and useful form of soft capsules in which the relative content of powder can be dramatically increased as compared with the prior art.
It is another object of the present invention to provide a method for producing the above-described soft capsule.

本発明者らは、鋭意研究の結果、
(1)軟カプセルの内容物となり得るものは、金型のポケット内で二枚の皮膜シートを外方に押し広げると共に、その押し広げられた空間にすっぽりと入り込めるものであれば良く、固形の芯が有ったとしてもそれが油脂系基材で完全に覆われていれば、従来と同様に軟カプセルの内容物として取り扱えること、
(2)粉末を固形化する際に必要な硬度は加圧成型で十分で、賦形剤などを添加する必要はないこと、
を見出し、粉末を固形化したものを油脂系基材で覆ったものを内容物として軟カプセルを製造してみたところ、
有効成分としての粉末の含有量を飛躍的に高めることに成功し、以下に示す本発明を完成するに至った。
As a result of earnest research, the present inventors have
(1) What can be the contents of a soft capsule is not limited as long as the two coating sheets are spread outwardly in the pocket of the mold, and can completely enter the expanded space. Even if there is a core, if it is completely covered with an oil-based substrate, it can be handled as the contents of a soft capsule as before,
(2) The pressure required for solidifying the powder is sufficient by pressure molding, and it is not necessary to add excipients,
I found a soft capsule as a content of what was solidified powder and covered with an oil-based base material,
The inventors have succeeded in dramatically increasing the content of powder as an active ingredient, and have completed the present invention shown below.

請求項1の発明は、軟カプセルの内容物が粉末と油脂系基材とからなり、粉末重量が内容物の総重量に対して60〜99.9%であることを特徴とする粉末高含有軟カプセルである。
請求項2の発明は、軟カプセルの内容物には有効成分とならない粘度調整剤が含まれていないことを特徴とする請求項1に記載した粉末高含有軟カプセルである。
請求項3の発明は、カプセル皮膜の内側に接触する部分が40℃以下にした場合に固体となる脂質を含む層で構成されていることを特徴とする請求項1または2に記載した粉末高含有軟カプセルである。
請求項4の発明は、二枚の皮膜シートの接合によりカプセル皮膜が形成されており、接合部分は突出していないことを特徴とする請求項1〜3のいずれかに記載した粉末高含有軟カプセルである。
The invention of claim 1 is characterized in that the content of the soft capsule is composed of a powder and an oil-based substrate, and the weight of the powder is 60 to 99.9% with respect to the total weight of the content. Soft capsule.
The invention according to claim 2 is the soft powder high-content capsule according to claim 1, characterized in that the content of the soft capsule does not contain a viscosity modifier that does not become an active ingredient.
Invention of Claim 3 is comprised by the layer containing the lipid which becomes solid when the part which contacts the inside of a capsule membrane | film | coat is 40 degrees C or less, The powder height described in Claim 1 or 2 characterized by the above-mentioned Contains soft capsules.
The invention according to claim 4 is characterized in that the capsule film is formed by joining two film sheets, and the joined part does not protrude, and the soft capsule with high powder content according to any one of claims 1 to 3 It is.

請求項5の発明は、請求項1〜4のいずれかに記載した粉末高含有軟カプセルを、二枚の皮膜シートのシール及び打ち抜きと内容物の充填により製造する方法であって、内容物として粉末を加圧成型してなる固形物とそれを覆う油脂系基材とで構成されたものを使用することを特徴とする粉末高含有軟カプセルの製造方法である。
請求項6の発明は、金型が回転式のロータリー法を利用し、粉末の固形物をポケットが正対する前に一方の金型のポケットに皮膜シート上から押込み供給し、油脂系基材を正対したポケット内の二枚の皮膜シート間に充填供給することを特徴とする請求項5に記載した粉末高含有軟カプセルの製造方法である。
The invention of claim 5 is a method for producing the powder-rich soft capsule according to any one of claims 1 to 4 by sealing and punching two coating sheets and filling the contents, It is a method for producing a soft capsule containing a high amount of powder, characterized in that it is composed of a solid material obtained by pressure-molding a powder and an oil-based base material covering the solid material.
The invention of claim 6 utilizes a rotary method in which the mold is a rotary type, and pushes and supplies the powder solids into the pocket of one mold from the top of the coating sheet before the pocket directly faces, 6. The method for producing a soft capsule with a high content of powder according to claim 5, wherein filling and feeding are performed between two coated sheets in a facing pocket.

本発明の軟カプセルは、従来の軟カプセルより飛躍的に粉末の含有量が高められている。
しかも、上記した軟カプセルを、従来から慣用されているロータリー式軟カプセル製造装置を用いて製造することができる。
In the soft capsule of the present invention, the powder content is dramatically increased as compared with the conventional soft capsule.
And the above-mentioned soft capsule can be manufactured using the rotary type soft capsule manufacturing apparatus conventionally used conventionally.

以下、本発明の粉末高含有軟カプセルを、添付図面に示す実施の形態に基づいて詳細に説明する。
(軟カプセルの形状・構造)
特に形状は限定されないが、ロータリー式軟カプセル製造装置を用いて製造する場合には、それに備えられる金型のポケットの形状による。
図1、図2は本発明の実施の形態に係る軟カプセル1の断面図である。この軟カプセル1は、内容物2とそれを覆うカプセル皮膜5とにより構成されている。カプセル皮膜5は後述する二枚の皮膜シートSの接合・打ち抜きにより立体状に成形されており、境界が若干凹んだ接合部分6が形成されている。
乾燥カプセルの皮膜は接合部分6の近傍が最も厚くなり、その中間部分が最も薄くなるが、いずれの部位の厚さ寸法(d1)も、大部分は0.05〜5.00mmの範囲内に収まっている。
Hereinafter, the soft capsules with high powder content of the present invention will be described in detail based on the embodiments shown in the accompanying drawings.
(Soft capsule shape and structure)
The shape is not particularly limited, but when it is manufactured using a rotary soft capsule manufacturing apparatus, it depends on the shape of a mold pocket provided therein.
1 and 2 are cross-sectional views of a soft capsule 1 according to an embodiment of the present invention. The soft capsule 1 includes a content 2 and a capsule film 5 covering the content 2. The capsule coating 5 is formed into a three-dimensional shape by joining and punching two coating sheets S described later, and a joining portion 6 having a slightly recessed boundary is formed.
The film of the dried capsule is thickest in the vicinity of the joint portion 6 and is thinnest in the middle portion, but most of the thickness dimension (d1) of any portion is in the range of 0.05 to 5.00 mm. It is settled.

(内容物の構造)
内容物2は粉末3と油脂系基材4とから構成されている。
図1に示すように、カプセル皮膜5側には油脂系基材4が比較的優先的に存在し、中心側には粉末3が比較的優先的に存在しているか、図2に示すように、カプセル皮膜5に接する側には油脂系基材4の層が形成されている場合がある。
粉末3の素材としては、従来から軟カプセルの内容物として使用されてきたものに限定されず、従来、硬カプセルや錠剤の形態が選択されている素材においても、用いることができる。
(Structure of contents)
The contents 2 are composed of a powder 3 and an oil base 4.
As shown in FIG. 1, the oil base 4 is relatively preferentially present on the capsule film 5 side, and the powder 3 is relatively preferentially present on the center side, as shown in FIG. In some cases, a layer of the oil-based base material 4 is formed on the side in contact with the capsule film 5.
The material of the powder 3 is not limited to those conventionally used as the contents of soft capsules, and can be used in materials that have conventionally been selected in the form of hard capsules or tablets.

また、40℃以下で固体となる脂質を含む油脂系基材4の場合は、充填供給の際には加熱されて適度な流動性を有した液体となっていれば、使用可能である。前述の油を使用した場合には、図1に示すようになる。一方、40℃以下にした場合に固体となる脂質を含む油脂系基材を使用した場合には、軟カプセルの製造後は温度低下によって固化するので、図2に示すように、軟カプセル1のカプセル皮膜5の直下は固形の脂質層、即ち疎水層4’になる。従って、脂肪を使用することにより、カプセル皮膜5の水分がカプセル内部に移行するのを効果的に阻止できるので、粉末が吸水性の高いものの場合に特に有用である。   Moreover, in the case of the fat-type base material 4 containing the lipid which becomes a solid at 40 ° C. or lower, it can be used as long as it is heated at the time of filling and supplying a liquid having an appropriate fluidity. When the above-mentioned oil is used, it is as shown in FIG. On the other hand, in the case of using an oil-based base material containing a lipid that becomes solid when the temperature is 40 ° C. or lower, the soft capsule is solidified by a temperature drop after the production of the soft capsule. Therefore, as shown in FIG. Immediately below the capsule film 5 is a solid lipid layer, that is, a hydrophobic layer 4 ′. Therefore, by using fat, it is possible to effectively prevent the moisture of the capsule film 5 from moving into the capsule, so that it is particularly useful when the powder has high water absorption.

粉末3と油脂系基材4の重量比は、99.9〜60:1〜40の範囲に設定できるが、粉末3の下限値は、従来の軟カプセルとの区別を明確にするために、従来提供されてきた軟カプセルでは到底内包し得てなかった量としている。   The weight ratio of the powder 3 and the fat-based base material 4 can be set in a range of 99.9 to 60: 1 to 40, but the lower limit value of the powder 3 is to clarify the distinction from the conventional soft capsules. The amount of soft capsules that have been provided so far cannot be included.

カプセル皮膜5の素材としては、ゼラチンに可塑剤としてグリセリンやPVAなどを添加して用いられるが、それに限らずに皮膜形成可能な皮膜基材として、プルラン、寒天、カラギーナン、デンプン、デンプン分解物、アルギン酸やHMC(ヒドロキシメチルセルロース)、HPMC(ヒドロキシプロピルメチルセルロース)、ジェランガム、カードラン等や、これらの酸化・アルカリ化した増粘多糖類も使用できる。
さらに、皮膜成分として、天然色素、食用色素、化学合成色素、二酸化チタン、Ca化合物などの着色剤を含むことも可能である。
As a material of the capsule film 5, glycerin, PVA or the like is added to gelatin as a plasticizer, but is not limited thereto. Alginic acid, HMC (hydroxymethylcellulose), HPMC (hydroxypropylmethylcellulose), gellan gum, curdlan, etc., and these oxidized and alkalized thickening polysaccharides can also be used.
Furthermore, it is also possible to include coloring agents such as natural pigments, food pigments, chemically synthesized pigments, titanium dioxide, and Ca compounds as film components.

(製造装置)
軟カプセルの製造に慣用されているロータリー式軟カプセル製造装置を利用できる。
図3は一例の製造装置7の模式図であり、対向配置されて互いに逆回転する一対の金型8,8の外周面には、カプセル形状を画定するポケット9,9が複数形成されている。符号10はセグメントを示し、このセグメント10を供給路11は上下に貫通して延びており、その下端は一対の金型8、8間に臨んでいる。また、セグメント10には加温するためのヒータ12が備えられている。
符号13は油脂系基材4のための液供給路を示し、この一端は図示しない液タンクに接続し、他端は供給路11に接続されている。液供給路13の途中には、供給ポンプ14が設けられており、この供給ポンプ14の動作状況により液の供給量が決定される。
(Manufacturing equipment)
A rotary soft capsule manufacturing apparatus conventionally used for soft capsule manufacturing can be used.
FIG. 3 is a schematic view of an example of the manufacturing apparatus 7. A plurality of pockets 9, 9 defining a capsule shape are formed on the outer peripheral surfaces of a pair of molds 8, 8 that are arranged opposite to each other and rotate in reverse. . Reference numeral 10 denotes a segment. The supply path 11 extends vertically through the segment 10, and its lower end faces between the pair of molds 8 and 8. Further, the segment 10 is provided with a heater 12 for heating.
Reference numeral 13 denotes a liquid supply path for the oil base 4, one end of which is connected to a liquid tank (not shown) and the other end is connected to the supply path 11. A supply pump 14 is provided in the middle of the liquid supply path 13, and the supply amount of the liquid is determined by the operating state of the supply pump 14.

本発明の軟カプセル1を上手く製造できるように、上記の構造の製造装置7に以下のものが備えられている。
符号15は搬送路を示し、この搬送路15は振動フィーダーで構成されている。搬送路15は傾斜されており、その下端は水平になっている。水平部には落下穴16が形成されている。その落下穴16は粉末固形物3’よりも十分に設計されている。落下穴16の下方には、右側の金型8の最上部のポケット9が臨んでいる。
符号17は押込み器具を示し、この押込み器具17のシャフト18は上下方向に進退動作可能になっており、シャフト18の下端には当接片19が取り付けられているが、その当接片19は搬送路15の落下穴16より十分に小さく設計されている。押込み器具17はセグメント10の右側に配置されており、そのシャフト18が後退したときには、当接片19は搬送路15の落下穴16上に待機しており、シャフト18が進行したときには、当接片19は搬送路15の落下穴16を貫入して金型8のポケット9内に入り込む。
In order to successfully manufacture the soft capsule 1 of the present invention, the manufacturing apparatus 7 having the above structure is provided with the following.
Reference numeral 15 denotes a conveyance path, and the conveyance path 15 is constituted by a vibration feeder. The conveyance path 15 is inclined and its lower end is horizontal. A drop hole 16 is formed in the horizontal portion. The drop hole 16 is designed more fully than the powder solid 3 '. Below the drop hole 16, the uppermost pocket 9 of the right mold 8 faces.
Reference numeral 17 denotes a pushing instrument. A shaft 18 of the pushing instrument 17 can be moved back and forth in the vertical direction. A contact piece 19 is attached to the lower end of the shaft 18. It is designed to be sufficiently smaller than the drop hole 16 of the conveyance path 15. The pushing device 17 is disposed on the right side of the segment 10, and when the shaft 18 is retracted, the contact piece 19 is waiting on the drop hole 16 of the conveyance path 15, and when the shaft 18 is advanced, the contact piece 19 is in contact. The piece 19 penetrates the drop hole 16 of the conveyance path 15 and enters the pocket 9 of the mold 8.

(製造装置7を利用した製造方法)
図3に示すように、左右両側の上方から二枚の皮膜シート5’、5’が回転する金型8,8上に供給される。
同時に、粉末固形物3’も順次搬送路15上を搬送されてくる。そして、図4(1)に示すように、落下穴16から右側の皮膜シート5’上に落下する。さらに、図4(2)に示すように、押込み器具17のシャフト18が進行することにより、その当接片19により押されて粉末固形物3’が金型8のポケット9内に皮膜シート5’の上から押し込まれる。その後は、右側の皮膜シート5’は、左側の皮膜シート5’と共に、セグメント10に相対して適度に温められながら金型8、8の回転により二枚の皮膜シート5’、5’は下方に引き込まれていき、ポケット9、9の正対位置で突き合わされて、熱・圧力の作用により接合され打ち抜かれる。同時に、二枚の皮膜シート5’、5’の間に供給ポンプ14の動作により所定のタイミングで油脂系基材4が充填供給されていき、皮膜シート5’、5’が外方に押し広げられてポケット9、9の形状をした軟カプセルとなる。即ち、皮膜シート5’と粉末固形物3’の間に油脂系基材4が存在する軟カプセルとなる。
(Manufacturing method using manufacturing apparatus 7)
As shown in FIG. 3, two coating sheets 5 ′ and 5 ′ are supplied onto rotating molds 8 and 8 from the upper left and right sides.
At the same time, the powder solid 3 'is also sequentially conveyed on the conveyance path 15. And as shown in FIG. 4 (1), it falls on the film sheet 5 'on the right side from the dropping hole 16. FIG. Further, as shown in FIG. 4 (2), when the shaft 18 of the pushing instrument 17 is advanced, the powder solid material 3 ′ is pushed by the abutting piece 19 into the pocket 9 of the mold 8. 'Push from above. Thereafter, the right coating sheet 5 ′ and the left coating sheet 5 ′ are heated appropriately with respect to the segment 10, and the two coating sheets 5 ′ and 5 ′ are moved downward by rotating the molds 8 and 8. Then, the pockets 9 and 9 are brought into contact with each other at the directly facing positions, joined and punched by the action of heat and pressure. At the same time, the oil base 4 is filled and supplied at a predetermined timing by the operation of the supply pump 14 between the two coating sheets 5 ′ and 5 ′, and the coating sheets 5 ′ and 5 ′ are spread outward. As a result, a soft capsule having the shape of the pockets 9 and 9 is obtained. That is, it becomes a soft capsule in which the oil base 4 is present between the coating sheet 5 ′ and the powder solid 3 ′.

また、皮膜シート5’、5’と粉末固形物3’との間には油脂系基材4が存在するので、得られた軟カプセル1は、図1に示すように、接合部分6は若干凹むことは有っても、不恰好な凸状に突出することはない。   Moreover, since the oil-based base material 4 exists between the coating sheets 5 ′ and 5 ′ and the powder solid 3 ′, the obtained soft capsule 1 has a slightly joined portion 6 as shown in FIG. Even if it dents, it does not protrude into an unpleasant convex shape.

[検体の製造]
(検体1)
皮膜液は、ゼラチン(皮膜基材成分):100重量部、水:90重量部の割合で配合し、65℃の加熱下で真空脱泡しながら60分間撹拌して調製したものを準備した。特に、可塑剤は使用しなかった。粉末固形物は、コンドロイチン硫酸とブルーベリー粉末を20:1の重量比で配合し、V型混合機にて60分間混合させた後、長径12×短径6×厚み3.5mmの楕円形に加圧成型したものを準備した。
皮膜液と粉末固形物の準備終了後、図3に示している製造装置7を利用して、軟カプセルを製造した。油脂系基材としてはMCTを使用し、粉末固形物100重量部に対して2重量部充填した。
得られた軟カプセルのサイズは13×7mmで成形直後の皮膜重量は130mg、内容物重量は200mgで、カプセル総重量は330mgであった。
[Sample preparation]
(Sample 1)
The coating solution was prepared by blending gelatin (coating substrate component): 100 parts by weight and water: 90 parts by weight and stirring for 60 minutes while vacuum degassing under heating at 65 ° C. In particular, no plasticizer was used. The powdered solid was prepared by blending chondroitin sulfate and blueberry powder in a weight ratio of 20: 1, mixing for 60 minutes in a V-type mixer, and then adding an ellipse having a major axis of 12 × minor axis of 6 × thickness of 3.5 mm. A pressure-molded product was prepared.
After completing the preparation of the coating liquid and the powdered solid, soft capsules were manufactured using the manufacturing apparatus 7 shown in FIG. MCT was used as the oil-based substrate, and 2 parts by weight was filled with respect to 100 parts by weight of the powder solid.
The size of the obtained soft capsule was 13 × 7 mm, the film weight immediately after molding was 130 mg, the content weight was 200 mg, and the total capsule weight was 330 mg.

(検体2)
皮膜液は、ゼラチン(皮膜基材成分):90重量部、プルラン(皮膜基材成分):15重量部、水:90重量部の割合で配合し、65℃の加熱下で真空脱泡しながら60分間撹拌して調製したものを準備した。特に、可塑剤は使用しなかった。粉末固形物は、キトサンとブルーベリー粉末を20:3の重量比で配合し、V型混合機にて60分間混合させた後、長径12×短径6×厚み3.5mmの楕円形に、加圧成型したものを準備した。
皮膜液と内容物の準備終了後、図3に示している製造装置7を利用して、軟カプセルを製造した。油脂系基材としてはMCTを使用し、粉末固形物100重量部に対して5重量部充填した。
得られた軟カプセルのサイズは13×7mmで成形直後の皮膜重量は160mg、内容物重量は250mgで、カプセル総重量は410mgであった。
(Sample 2)
The coating solution is blended at a ratio of gelatin (coating substrate component): 90 parts by weight, pullulan (coating substrate component): 15 parts by weight, water: 90 parts by weight, while vacuum degassing under heating at 65 ° C. What was prepared by stirring for 60 minutes was prepared. In particular, no plasticizer was used. The powdered solid was prepared by blending chitosan and blueberry powder in a weight ratio of 20: 3, mixing for 60 minutes in a V-type mixer, and adding to an ellipse having a major axis of 12 × minor axis of 6 × thickness of 3.5 mm. A pressure-molded product was prepared.
After the preparation of the coating solution and contents, soft capsules were manufactured using the manufacturing apparatus 7 shown in FIG. MCT was used as the fat-and-oil base, and 5 parts by weight was filled with respect to 100 parts by weight of the powder solid.
The size of the obtained soft capsule was 13 × 7 mm, the film weight immediately after molding was 160 mg, the content weight was 250 mg, and the total capsule weight was 410 mg.

(検体3)
皮膜液は、ゼラチン(皮膜基材成分):100重量部、グリセリン(可塑剤):30重量部、水:90重量部の割合で配合し、65℃の加熱下で真空脱泡しながら60分間撹拌して調製したものを準備した。粉末固形物は、コンドロイチン硫酸とブルーベリー粉末を20:1の重量比で配合し、V型混合機にて60分間混合させた後、長径12×短径6×厚み3.5mmの楕円形に、加圧成型したものを準備した。
皮膜液と内容物の準備終了後、図3に示している製造装置7を利用して、軟カプセルを製造した。油脂系基材としてはMCTを使用し、粉末固形物100重量部に対して10重量部充填した。
得られた軟カプセルのサイズは13×7mmで成形直後の皮膜重量は130mg、内容物重量は220mgで、カプセル総重量は350mgであった。
(Sample 3)
The coating solution is blended at a ratio of gelatin (coating substrate component): 100 parts by weight, glycerin (plasticizer): 30 parts by weight, water: 90 parts by weight, and heated for 60 minutes while being vacuum degassed under heating at 65 ° C. What was prepared by stirring was prepared. The powdered solid was prepared by blending chondroitin sulfate and blueberry powder in a weight ratio of 20: 1 and mixing for 60 minutes in a V-type mixer, then into an ellipse having a major axis of 12 × minor axis of 6 × thickness of 3.5 mm. A pressure-molded product was prepared.
After the preparation of the coating solution and contents, soft capsules were manufactured using the manufacturing apparatus 7 shown in FIG. MCT was used as the oil-based substrate, and 10 parts by weight was filled with respect to 100 parts by weight of the powder solid.
The size of the obtained soft capsule was 13 × 7 mm, the film weight immediately after molding was 130 mg, the content weight was 220 mg, and the total capsule weight was 350 mg.

(対照品1)
皮膜液は、ゼラチン(皮膜基材成分):100重量部、グリセリン(可塑剤):30重量部、水:90重量部の割合で配合し、65℃の加熱下で真空脱泡しながら60分間撹拌して調製したものを準備した。内容物は、コンドロイチン硫酸とブルーベリー粉末とMCTとグリセリン脂肪酸エステルを18:2:10:5の重量比率で配合したものを準備した。
皮膜と内容物の準備終了後、従来のロータリー式軟カプセル製造装置を利用して、軟カプセルを製造した。
この軟カプセルのサイズは13×7mmで充填直後の皮膜重量は110mg、内容物重量は200mgで、カプセル総重量は310mgであった。
(Control 1)
The coating solution is blended at a ratio of gelatin (coating substrate component): 100 parts by weight, glycerin (plasticizer): 30 parts by weight, water: 90 parts by weight, and heated for 60 minutes while being vacuum degassed under heating at 65 ° C. What was prepared by stirring was prepared. The contents were prepared by blending chondroitin sulfate, blueberry powder, MCT and glycerin fatty acid ester in a weight ratio of 18: 2: 10: 5.
After the preparation of the film and contents, soft capsules were manufactured using a conventional rotary soft capsule manufacturing apparatus.
The size of the soft capsule was 13 × 7 mm, the film weight immediately after filling was 110 mg, the content weight was 200 mg, and the total capsule weight was 310 mg.

(対照品2)
皮膜液は、ゼラチン(皮膜基材成分):100重量部、グリセリン(可塑剤):30重量部、水:90重量部の割合で配合し、65℃の加熱下で真空脱泡しながら60分間撹拌して調製したものを準備した。内容物は、コンドロイチン硫酸とブルーベリー粉末とMCTとグリセリン脂肪酸エステルを18:2:4:2の重量比率で混合したものを準備した。
皮膜と内容物の準備終了後、従来のロータリー式軟カプセル製造装置を利用して、軟カプセルの製造を試みたが、通称メディシンポンプと呼ばれる充填ポンプ内で必要とされる内溶液の流動性が無い為、安定的に供給されない上に、ポンプから押し出された内溶液が樹脂製のチュ−ブ内で詰まってしまい、内容物を充填できなかった。
この軟カプセルのサイズは13×7mm、充填直後の皮膜重量は110mg、内容物重量は200mgで、カプセル総重量は310mg前後を想定していた。
(Control product 2)
The coating solution is blended at a ratio of gelatin (coating substrate component): 100 parts by weight, glycerin (plasticizer): 30 parts by weight, water: 90 parts by weight, and heated for 60 minutes while being vacuum degassed under heating at 65 ° C. What was prepared by stirring was prepared. The contents were prepared by mixing chondroitin sulfate, blueberry powder, MCT and glycerin fatty acid ester in a weight ratio of 18: 2: 4: 2.
After the preparation of the film and contents, we tried to manufacture soft capsules using a conventional rotary soft capsule manufacturing device. However, the fluidity of the inner solution required in a filling pump called a medicine pump is known. Therefore, the inner solution pushed out from the pump was clogged in the resin tube, and the contents could not be filled.
The size of the soft capsule was 13 × 7 mm, the film weight immediately after filling was 110 mg, the content weight was 200 mg, and the total capsule weight was assumed to be around 310 mg.

得られた各検体と対照品1のカプセルは、何れも同様にカプセル皮膜の水分率が10±1%となるまで乾燥させて完成品とした。
得られた各検体、対照品1のカプセルの内容物の粉末と油の重量比と収率は以下の通りであった。
Each of the obtained specimens and the capsules of the control product 1 were similarly dried until the moisture content of the capsule film was 10 ± 1% to obtain a finished product.
The weight ratio and yield of the powder and oil of the contents of the capsules of the obtained specimens and the control product 1 were as follows.

Figure 2009196958
Figure 2009196958

[評価]
〈カプセル高温下試験〉
高温で保管することによりカプセル内溶液の漏れ及び付着の発生を確認する為、以下の手順で試験した。
(1)各検体を20カプセルずつ6号ガラス瓶に入れ、密栓し、+40℃で保存した。
(2)14日(2W)後、28日(4W)後、56日(8W)後、112日(16W)後、の状態を観察した。
結果は、以下の通りであった。
[Evaluation]
<Capsule high temperature test>
In order to confirm the occurrence of leakage and adhesion of the solution in the capsule by storing it at a high temperature, it was tested according to the following procedure.
(1) Twenty capsules were placed in a No. 6 glass bottle, sealed, and stored at + 40 ° C.
(2) After 14 days (2 W), 28 days (4 W), 56 days (8 W), and 112 days (16 W), the states were observed.
The results were as follows.

Figure 2009196958
Figure 2009196958

[評価]
〈カプセル内容液の漏れ比較試験−耐熱・耐寒試験〉
高温又は冷所での保管することで急激な温度変化によるカプセル被膜の膨張・収縮を繰り返させることによりカプセル内溶液の漏れの発生を確認する為、以下の方法で試験した。
(1)検体を20カプセルずつ6号ガラス瓶に入れ、密栓し、−20℃で24時間、続いて+40℃で24時間保存した。
(2)以上を1サイクルとして、これを3サイクル実施し、内容液である油脂系基材の漏れを観察した。
結果は、以下の通りであった。
[Evaluation]
<Capsule content liquid leakage comparison test-heat and cold resistance test>
In order to confirm the occurrence of leakage of the solution in the capsule by repeating the expansion and contraction of the capsule film due to a rapid temperature change by storing in a high temperature or cold place, the following method was used for testing.
(1) Samples of 20 capsules were placed in a No. 6 glass bottle, sealed, and stored at −20 ° C. for 24 hours and then at + 40 ° C. for 24 hours.
(2) The above was made into 1 cycle, this was implemented 3 cycles, and the leakage of the fat-type base material which is a content liquid was observed.
The results were as follows.

Figure 2009196958
[評価]
Figure 2009196958
[Evaluation]

〈カプセル崩解試験〉
本発明カプセルの崩壊性を確認するため、以下の方法で崩壊試験を行った。
本発明カプセル(検体1〜6)を試験機に6個ずつ入れ、これを37℃に保持した精製水に浸漬させ上下運動を行い、カプセルが開口するまでの時間を測定した。この試験内容は日本薬局方(第15改正)崩壊試験法に準ずる。測定は1回につき6カプセルずつ、計三回実施し、その平均値を求めた。結果を表4に示した。なお、対照品として従来のゼラチンカプセルについても同様に開口時間を測定し、その結果を表4に併記した。
結果は、以下の通りであった。
<Capsule disintegration test>
In order to confirm the disintegration property of the capsule of the present invention, a disintegration test was conducted by the following method.
Six capsules of the present invention (samples 1 to 6) were put in a test machine, immersed in purified water maintained at 37 ° C., moved up and down, and the time until the capsule opened was measured. The content of this test conforms to the Japanese Pharmacopoeia (15th revision) disintegration test method. The measurement was performed 6 times, 6 capsules at a time, and the average value was obtained. The results are shown in Table 4. As a control product, the conventional gelatin capsules were similarly measured for the opening time, and the results are also shown in Table 4.
The results were as follows.

Figure 2009196958
Figure 2009196958

〈カプセル衝撃試験〉
カプセルに振動や衝撃を繰り返し与えることにより、内容液の漏れの発生を確認する為、以下の手順で試験した。
(1)各検体を10カプセルずつ6号ガラス瓶に入れ、デシケーター内において24時間減圧乾燥を行い、カプセルの乾燥状態を整えた。
(2)乾燥後、6号ガラス瓶に密栓をして、上下振幅10cmで5回/秒のサイクルにて120秒間振動させた。
(3)以上を1サイクルとして、これを5サイクル実施し、内容液の漏れを観察した。
結果は、以下の通りであった。
<Capsule impact test>
In order to confirm the occurrence of leakage of the content liquid by repeatedly applying vibration and shock to the capsule, the following procedure was used for testing.
(1) Each specimen was placed in a No. 6 glass bottle with 10 capsules and dried under reduced pressure for 24 hours in a desiccator to prepare the dried state of the capsules.
(2) After drying, the No. 6 glass bottle was sealed and oscillated for 120 seconds at a cycle of 5 times / second with a vertical amplitude of 10 cm.
(3) The above was made into 1 cycle, this was implemented 5 cycles, and the leakage of the content liquid was observed.
The results were as follows.

Figure 2009196958
Figure 2009196958

以上のカプセルの安定性試験、カプセル過酷試験、カプセル崩解試験の結果より、本発明の軟カプセルは、内容物の油に対しての粉末率が60%以上となる高含有化をしても、収率と崩壊性に関しては特に影響はなかったことが実証された。
さらに、内容物中の油含有量が少ない条件の場合においては、皮膜中の可塑剤を通常より減らして軟カプセル皮膜の強度を低く設定することができる。その理由として、内容物の固型量が多いので、内容物の温度変化があっても内容物が膨張・収縮し難く、皮膜接着部からの液漏れやカプセルの外圧からの衝撃による割れを防ぐことができる。これにより、従来から問題になっている軟カプセルの欠点であるカプセル皮膜の付着性の改善も図れることが実証された。
From the results of the above-described capsule stability test, capsule severe test, and capsule disintegration test, the soft capsule of the present invention has a high powder content of 60% or more with respect to the oil content. It was demonstrated that there was no particular effect on yield and disintegration.
Furthermore, when the oil content in the contents is low, the plasticizer in the film can be reduced from the usual amount, and the strength of the soft capsule film can be set low. The reason for this is that the content is so solid that it is difficult for the content to expand or contract even if the temperature changes, preventing cracking due to liquid leakage from the film adhesive or impact from the external pressure of the capsule. be able to. As a result, it has been proved that the adhesion of the capsule film, which is a drawback of the soft capsule which has been a problem in the past, can be improved.

[検体の製造]
(検体4)
皮膜液は、ゼラチン(皮膜基材成分):100重量部、グリセリン(可塑剤):30重量部、水:90重量部の割合で配合し、65℃の加熱下で真空脱泡しながら60分間撹拌して調製したものを準備した。粉末固形物は、ドライビタミンA粉末(ビタミンA脂肪酸エステル6%含有)とマルチトールとショ糖脂肪酸エステルを1:20:2の重量比で配合し、V型混合機にて60分間混合させた後、長径12×短径6×厚み3.5mmの楕円形に加圧成型したものを準備した。
皮膜液と内容物の準備終了後、図3に示している製造装置7を利用して、軟カプセルを製造した。油脂系基材としてはMCTを使用し、粉末固形物100重量部に対して2重量部充填した。
得られた軟カプセルのサイズは13×7mmで成形直後の皮膜重量は130mg、内容物重量は210mgで、カプセル総重量は340mgであった。
[Sample preparation]
(Sample 4)
The coating solution is blended at a ratio of gelatin (coating substrate component): 100 parts by weight, glycerin (plasticizer): 30 parts by weight, water: 90 parts by weight, and heated for 60 minutes while being vacuum degassed under heating at 65 ° C. What was prepared by stirring was prepared. The powder solid was prepared by blending dry vitamin A powder (containing 6% vitamin A fatty acid ester), maltitol and sucrose fatty acid ester in a weight ratio of 1: 20: 2, and mixing for 60 minutes in a V-type mixer. Then, what was press-molded into an ellipse having a major axis of 12 × minor axis of 6 × thickness of 3.5 mm was prepared.
After the preparation of the coating solution and contents, soft capsules were manufactured using the manufacturing apparatus 7 shown in FIG. MCT was used as the oil-based substrate, and 2 parts by weight was filled with respect to 100 parts by weight of the powder solid.
The size of the obtained soft capsule was 13 × 7 mm, the film weight immediately after molding was 130 mg, the content weight was 210 mg, and the total capsule weight was 340 mg.

(検体5)
皮膜液は、ゼラチン(皮膜基材成分):100重量部、グリセリン(可塑剤):30重量部、水:90重量部の割合で配合し、65℃の加熱下で真空脱泡しながら60分間撹拌して調製したものを準備した。粉末固形物は、ドライビタミンA粉末(ビタミンA脂肪酸エステル6%含有)とマルチトールとショ糖脂肪酸エステルを1:20:2の重量比で配合し、V型混合機にて60分間混合させた後、長径12×短径6×厚み3.5mmの楕円形に、加圧成型したものを準備した。
皮膜液と内容物の準備終了後、図3に示している製造装置7を利用して、軟カプセルを製造した。油脂系基材としては蜜蝋を使用し、粉末固形物100重量部に対して10重量部充填した。
得られた軟カプセルのサイズは13×7mmで成形直後の皮膜重量は130mg、内容物重量は218mgで、カプセル総重量は348mgであった。
(Sample 5)
The coating solution is blended at a ratio of gelatin (coating substrate component): 100 parts by weight, glycerin (plasticizer): 30 parts by weight, water: 90 parts by weight, and heated for 60 minutes while being vacuum degassed under heating at 65 ° C. What was prepared by stirring was prepared. The powder solid was prepared by blending dry vitamin A powder (containing 6% vitamin A fatty acid ester), maltitol and sucrose fatty acid ester in a weight ratio of 1: 20: 2, and mixing for 60 minutes in a V-type mixer. Thereafter, an ellipse having a major axis of 12 × minor axis of 6 × thickness of 3.5 mm was prepared by pressure molding.
After the preparation of the coating solution and contents, soft capsules were manufactured using the manufacturing apparatus 7 shown in FIG. Beeswax was used as the fat and oil base, and 10 parts by weight was filled per 100 parts by weight of the powdered solid.
The size of the obtained soft capsule was 13 × 7 mm, the coating weight immediately after molding was 130 mg, the content weight was 218 mg, and the total capsule weight was 348 mg.

(対照品3)
ドライビタミンA粉末(ビタミンA脂肪酸エステル6%含有)とマルチトールとショ糖脂肪酸エステルを1:20:2の重量比で配合し、V型混合機にて60分間混合させた後、定法により縦8×横8×高さ4mm、総重量が200mgの円形に加圧成型し、素錠を製造した。
(対照品4)
ドライビタミンA粉末(ビタミンA脂肪酸エステル6%含有)とマルチトールとショ糖脂肪酸エステルを1:20:2の重量比で配合し、V型混合機にて60分間混合させた後、定法により縦8×横8×高さ4mm、総重量が200mgの円形に加圧成型して、粉末固形物とした。
その固形物の表面に3mgのセラックを均一にムラ無く塗布した後、定法によりグラニュ−糖:卵殻Ca:HPMC:炭酸Ca:アラビアガム:ゼラチンを70:20:4:4:1:1で構成される糖衣層を形成させ、糖衣錠を製造した。
得られた糖衣錠のサイズは9.5×6.5mmで総重量は400mgであった。
(Control 3)
Dry vitamin A powder (containing 6% vitamin A fatty acid ester), maltitol and sucrose fatty acid ester are mixed at a weight ratio of 1: 20: 2, mixed for 60 minutes in a V-type mixer, and then vertically An uncoated tablet was manufactured by press-molding into a circle having 8 × width 8 × height 4 mm and a total weight of 200 mg.
(Control 4)
Dry vitamin A powder (containing 6% vitamin A fatty acid ester), maltitol and sucrose fatty acid ester are mixed at a weight ratio of 1: 20: 2, mixed for 60 minutes in a V-type mixer, and then vertically It was press-molded into a circle of 8 × 8 × 4 mm in height and a total weight of 200 mg to obtain a powder solid.
After uniformly coating 3 mg of shellac on the surface of the solid material, the composition of granulated sugar: eggshell Ca: HPMC: Ca carbonate: gum arabic: gelatin is prepared in a ratio of 70: 20: 4: 4: 1: 1 by a conventional method. A sugar-coated layer was formed to produce a sugar-coated tablet.
The size of the resulting sugar-coated tablets was 9.5 × 6.5 mm, and the total weight was 400 mg.

[評価]
〈内容物の酸化比較試験〉
室温で保管した検体4、検体5、対照品3、対照品4の内容物であるビタミンA脂肪酸エステルの残存量を確認する為、以下の手順で試験した。ビタミンA脂肪酸エステルは空気酸化が容易にしやすいので、内容物の酸化度合いの指標とした。
(1)各検体を20カプセルずつ6号ガラス瓶に入れ密栓し、光の影響が無いようにアルミホイルで遮光してから、室温で保存した。
(2)14日(2W)後、28日(4W)後、56日(8W)後、112日(16W)後に、内容物のレチノ−ルをヘキサン抽出したものを、紫外可視吸光度計を用いてレチノ−ル残存量を測定した。
結果は、以下の通りであった。
[Evaluation]
<Oxidation comparison test of contents>
In order to confirm the residual amount of the vitamin A fatty acid ester as the contents of the specimen 4, the specimen 5, the control product 3, and the control product 4 stored at room temperature, the test was performed according to the following procedure. Vitamin A fatty acid esters are easy to oxidize in the air, so they were used as indicators of the degree of oxidation of the contents.
(1) Each specimen was placed in a No. 6 glass bottle with 20 capsules, sealed, shielded with aluminum foil so as not to be affected by light, and stored at room temperature.
(2) After 14 days (2 W), 28 days (4 W), 56 days (8 W), and 112 days (16 W), retanol extracted from the content of hexane was extracted using an ultraviolet-visible spectrophotometer. Thus, the residual amount of retinal was measured.
The results were as follows.

Figure 2009196958
Figure 2009196958

以上の内容物の酸化比較試験の結果より、本発明の軟カプセルは、カプセル皮膜の内側に油層があることで酸化防止効果を有すること、また、油量が相対的に多くなると、酸化防止効果が長く安定的に持続すること、また、皮膜の内側に固形の脂質層を形成させるとさらなる酸化防止効果が実証された。   From the results of the oxidation comparison test of the above contents, the soft capsule of the present invention has an antioxidant effect due to the presence of the oil layer inside the capsule film, and when the oil amount is relatively large, the antioxidant effect Has been demonstrated to have a long and stable persistence, and when a solid lipid layer is formed inside the film, further antioxidant effect has been demonstrated.

健康食品の場合には、単位体積当たりの有効成分の量をできるだけ多くしながら、同時に有効成分を酸化などから保護できることが求められている。1カプセルに封入できる粉末の量が増えれば、経口摂取するカプセル数を減らすことができ、しかも消費者に安全に提供できるからである。
それに対して、本発明の軟カプセルは、1カプセルに封入できる粉末の量を従来に比べて飛躍的に増量でき、しかも、カプセル皮膜の内側には粉末が油脂系基材の層、通常は油層で囲まれた状態で存在しているため空気酸化し難い。さらに、カプセル皮膜の内側に油脂系基材が含まれているので、粉末が脂溶性のものである場合には錠剤や糖衣錠より、体内吸収性を高めることができる。
従って、本発明の軟カプセルは、特に健康食品の需要拡大に寄与し得るものとなる。
In the case of health foods, it is required that the amount of active ingredients per unit volume be as large as possible while simultaneously protecting the active ingredients from oxidation. This is because if the amount of powder that can be encapsulated in one capsule increases, the number of capsules taken orally can be reduced, and it can be safely provided to consumers.
On the other hand, the soft capsule of the present invention can dramatically increase the amount of powder that can be encapsulated in one capsule as compared with the conventional capsule, and the powder is an oil-based substrate layer, usually an oil layer, inside the capsule film. It is difficult to oxidize air because it is surrounded by. Furthermore, since the oil-based base material is contained inside the capsule film, when the powder is fat-soluble, the absorbability in the body can be improved compared to tablets and sugar-coated tablets.
Therefore, the soft capsule of the present invention can contribute particularly to an increase in demand for health foods.

本発明の実施の形態に係る第1の軟カプセルの断面図である。It is sectional drawing of the 1st soft capsule which concerns on embodiment of this invention. 本発明の実施の形態に係る第2の軟カプセルの断面図である。It is sectional drawing of the 2nd soft capsule which concerns on embodiment of this invention. 本発明の実施の形態に係る軟カプセルの製造装置の概略図である。It is the schematic of the manufacturing apparatus of the soft capsule which concerns on embodiment of this invention. 図3の製造装置による一部の工程の説明図である。It is explanatory drawing of the one part process by the manufacturing apparatus of FIG.

符号の説明Explanation of symbols

1 軟カプセル
2 内容物
3 粉末 3’ 粉末固形物
4 油脂系基材 4’ 疎水層
5 カプセル皮膜 5’ 皮膜シート
6 接合部分
7 軟カプセルの製造装置
8 金型
9 ポケット
10 セグメント
11 供給路
12 ヒータ
13 液供給路
14 供給ポンプ
15 搬送路
16 落下穴
17 押込み器具
18 シャフト
19 当接片
DESCRIPTION OF SYMBOLS 1 Soft capsule 2 Contents 3 Powder 3 'Powder solid body 4 Oil base material 4' Hydrophobic layer 5 Capsule film 5 'Film sheet 6 Joining part 7 Soft capsule manufacturing apparatus 8 Mold 9 Pocket 10 Segment 11 Supply path 12 Heater 13 Liquid supply path 14 Supply pump 15 Transport path 16 Drop hole 17 Pushing tool 18 Shaft 19 Contact piece

Claims (6)

軟カプセルの内容物が粉末と油脂系基材とからなり、粉末重量が内容物の総重量に対して60〜99.9%であることを特徴とする粉末高含有軟カプセル。   A soft capsule containing a high amount of powder, characterized in that the content of the soft capsule is composed of a powder and an oil-based substrate, and the weight of the powder is 60 to 99.9% of the total weight of the content. 軟カプセルの内容物には有効成分とならない粘度調整剤が含まれていないことを特徴とする請求項1に記載した粉末高含有軟カプセル。   The soft capsule content-enriched soft capsule according to claim 1, wherein the content of the soft capsule does not contain a viscosity modifier that does not become an active ingredient. カプセル皮膜の内側に接触する部分が40℃以下した場合に固体となる脂質を含む層で構成されていることを特徴とする請求項1または2に記載した粉末高含有軟カプセル。   3. The soft powder-rich capsule according to claim 1, wherein the capsule skin is composed of a layer containing a lipid that becomes a solid when the portion in contact with the inside of the capsule film is 40 ° C. or lower. 二枚の皮膜シートの接合によりカプセル皮膜が形成されており、接合部分は突出していないことを特徴とする請求項1〜3のいずれかに記載した粉末高含有軟カプセル。   The capsule high-content soft capsule according to any one of claims 1 to 3, wherein a capsule film is formed by bonding two film sheets, and a bonded part does not protrude. 請求項1〜4のいずれかに記載した粉末高含有軟カプセルを、二枚の皮膜シートのシール及び打ち抜きと内容物の充填により製造する方法であって、内容物として粉末を加圧成型してなる固形物とそれを覆う油脂系基材とで構成されたものを使用することを特徴とする粉末高含有軟カプセルの製造方法。   A method for producing a soft capsule with high powder content according to any one of claims 1 to 4 by sealing and punching two film sheets and filling the contents, wherein the powder is pressure-molded as the contents What is comprised of the solid substance which becomes and the fat-type base material which covers it is used, The manufacturing method of the powder high content soft capsule characterized by the above-mentioned. 金型が回転式のロータリー法を利用し、粉末の固形物をポケットが正対する前に一方の金型のポケットに皮膜シート上から押込み供給し、油脂系基材を正対したポケット内の二枚の皮膜シート間に充填供給することを特徴とする請求項5に記載した粉末高含有軟カプセルの製造方法。   Using a rotary method where the mold is rotating, powder solids are pushed into the pocket of one mold from the top of the film sheet before the pocket is directly facing the pocket, and the powder in the pocket facing the oil-based substrate is then fed. 6. The method for producing a soft capsule with high powder content according to claim 5, wherein filling and feeding are performed between the two coated sheets.
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WO2020010994A1 (en) * 2018-07-10 2020-01-16 上海现代药物制剂工程研究中心有限公司 Continuous skin packaging and coating apparatus and coating method for tablets
US11896553B2 (en) 2018-07-10 2024-02-13 Shanghai Modern Pharmaceutical Engineering Research Center Co., Ltd. Continuous skin packaging and coating apparatus and coating method for tablets

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