JPH0774149B2 - Hard gelatin capsule - Google Patents
Hard gelatin capsuleInfo
- Publication number
- JPH0774149B2 JPH0774149B2 JP3361432A JP36143291A JPH0774149B2 JP H0774149 B2 JPH0774149 B2 JP H0774149B2 JP 3361432 A JP3361432 A JP 3361432A JP 36143291 A JP36143291 A JP 36143291A JP H0774149 B2 JPH0774149 B2 JP H0774149B2
- Authority
- JP
- Japan
- Prior art keywords
- capsule
- cap
- hard
- circumferential
- hard gelatin
- 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.)
- Expired - Lifetime
Links
Description
【０００１】[0001]
【産業上の利用分野】本発明は、油性液状物の充填用カ
プセルとして液漏れのないカプセル剤を製造することが
できる硬ゼラチンカプセルに関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a hard gelatin capsule which can be used as a capsule for filling an oily liquid to produce a capsule which does not leak.
【０００２】[0002]
【従来の技術】カプセル剤の製造に使用されるカプセル
は、軟ゼラチンカプセル（以下、「軟カプセル」）と、
硬ゼラチンカプセル（以下、「硬カプセル」）に大別さ
れる。油性液状物の充填には専ら軟カプセルが使用さ
れ、硬カプセルは主として、粉状ないし塊状等の固形の
充填物に対して使用されている。2. Description of the Related Art Capsules used for producing capsules are soft gelatin capsules (hereinafter, "soft capsules"),
It is roughly classified into hard gelatin capsules (hereinafter, "hard capsules"). Soft capsules are exclusively used for filling oily liquids, and hard capsules are mainly used for solid fillings such as powder or lumps.
【０００３】硬カプセルは、図２に示すようにカプセル
キヤツプ１とカプセルボディ２とからなる。医薬品に
は、００号〜５号（号数字が大きい程、カプセルサイズ
は小さい）の７種のサイズのものが使用されている。そ
の硬カプセルは、キヤツプ１とボディ２との嵌合部の離
脱防止のためのロツク機構として、キヤツプ１の嵌合部
周面に、直径方向に向い合う２個所に微小円形状のノツ
チ３1,３1 が形成されている。なお、キヤツプ１とボデ
ィ２の嵌め合い深さを規定し両者のずれを防止するため
に、キヤツプ１には内側に突出する円周突起４が、ボデ
ィ２にはそれに対応する円周溝５がそれぞれ所定位置に
形成されている。硬カプセルは、粉状・塊状等の固形物
の充填のほか、油性液状物の充填に使用することもむろ
ん可能ではあるが、その場合は、嵌合部からの液漏れを
防止するために、上記のノツチに代え、そのシール手段
として嵌合部の外周にゼラチン粘稠液が塗布される。The hard capsule comprises a capsule cap 1 and a capsule body 2 as shown in FIG. There are seven types of medicines, No. 00 to No. 5 (the larger the number, the smaller the capsule size). The hard capsule serves as a locking mechanism for preventing disengagement of the fitting portion between the cap 1 and the body 2, and a minute circular notch 3 1 on the fitting portion peripheral surface of the cap 1 at two points facing each other in the diameter direction. , 3 1 are formed. Incidentally, in order to define the fitting depth of the cap 1 and the body 2 and prevent the displacement between the two, the cap 1 is provided with a circumferential projection 4 protruding inward, and the body 2 is provided with a circumferential groove 5 corresponding thereto. Each is formed at a predetermined position. Hard capsules can be used not only for filling solid substances such as powder and lumps, but also for filling oily liquid substances, but in that case, in order to prevent liquid leakage from the fitting part, Instead of the above-mentioned notch, a viscous gelatin liquid is applied to the outer periphery of the fitting portion as a sealing means.
【０００４】[0004]
【発明が解決しようとする課題】軟カプセルは、油性液
状物を完全な密封状態に充填することができるが、硬カ
プセルに比べ、充填量の偏差が大きい、充填速度、濃度
（粘度）、液温度の影響を受け易い、製品同士が癒着し
易い、等の難点があり、またその充填には特殊な技術と
高価な機器装置を必要とする。他方、硬カプセルは、取
扱いが容易であり、そのカプセル剤の製造には、軟カプ
セルを使用する場合のような特殊な技術や設備を必要と
しないが、油性液状物を充填する場合には、カプセルの
１個ずつにその嵌合部の液漏れ防止としてゼラチン粘稠
液を塗布するという煩瑣なシール工程が必要となり、工
業的生産に不向きである。そこで、本発明は、油性液状
物の充填に硬カプセルを使用し、嵌合部にゼラチン粘稠
液を塗布するシール工程を必要とすることなく、液漏れ
をほゞ完全に防止することができる改良された硬カプセ
ルを提供するものである。A soft capsule can be filled with an oily liquid in a completely sealed state, but has a larger deviation in filling amount than a hard capsule, a filling speed, a concentration (viscosity), and a liquid. There are drawbacks such as being easily affected by temperature and being easily adhered to each other, and the filling requires special technology and expensive equipment. On the other hand, hard capsules are easy to handle, and the production of capsules does not require special techniques or equipment as in the case of using soft capsules, but when filling an oily liquid, A complicated sealing process of applying a viscous gelatin liquid to each of the capsules to prevent liquid leakage at the fitting portion is required, which is not suitable for industrial production. Therefore, in the present invention, a hard capsule is used for filling the oily liquid material, and liquid leakage can be almost completely prevented without requiring a sealing step of applying a gelatin viscous liquid to the fitting portion. The present invention provides an improved hard capsule.
【０００５】[0005]
【課題を解決するための手段】本発明は、硬ゼラチンの
キャップ１とボディ２のそれぞれの開端側を嵌合部とし
て嵌め合わせられる硬ゼラチンカプセルにおいて、嵌合
部のロック機構として、キャップ１の嵌合部内周面に
は、周方向に延在する円周突起４、およびその円周突起
４と開端縁との間の円周方向にほぼ等間隔をなす少なく
とも６個の凸状ノッチ３1 が形成され、ボディ２の嵌合
部外周面には、その周方向に延在して前記キャップ１の
円周突起４と係合する円周溝５、および前記凸状ノッチ
３1 と係合するそれと同じ個数の円周方向にほぼ等間隔
をなす凹状ノッチ３2 が形成されていることを特徴とし
ている。The present invention provides a hard gelatin capsule in which the open end sides of a hard gelatin cap 1 and a body 2 are fitted as fitting parts, and a locking mechanism of the fitting part is used as a locking mechanism of the cap 1. On the inner peripheral surface of the fitting portion, there are circumferential projections 4 extending in the circumferential direction, and at least six convex notches 3 1 arranged at substantially equal intervals in the circumferential direction between the circumferential projections 4 and the open end edges. Is formed on the outer peripheral surface of the fitting portion of the body 2, the circumferential groove 5 extending in the circumferential direction and engaging with the circumferential projection 4 of the cap 1, and the convex notch 3 1. It is characterized in that the same number of concave notches 3 2 are formed at substantially equal intervals in the circumferential direction.
【０００６】[0006]
【作用】本発明の硬ゼラチンカプセルのキャップ１は、
ボディ２と嵌め合わせられる嵌合部に、円周方向にほぼ
等間隔をなす少なくとも６個の内側に突出した凸状ノッ
チ３1 が形成されていることにより、嵌合部の剛性およ
び真円度が高められ、同じようにボディ２も、前記凸状
ノッチ３1 に対応してその嵌合部に形成された円周方向
に等間隔をなす内側へ凹陥した凹状ノッチ３2 により、
その嵌合部の剛性および真円度が高められる。このカプ
セル部品の嵌合部の剛性および真円度向上効果として、
これに例えば中鎖の直鎖脂肪酸であるトリグリセライド
等の油性液状物を充填する場合にも、ゼラチン粘稠液の
シールを施すことなく、充填物の液洩れをほぼ完全に防
止し得る信頼性のある密着嵌合状態が形成される。な
お、本発明の硬ゼラチンカプセルを薬剤充填工程に供す
る場合には、キャップ１の凸状ノッチ３1 （内向きに突
出の突起４）と、ボディ２の円周溝５と係合させるハー
フロック（これは第２図に示した従来タイプのカプセル
におけるキャップ１の凸状ノッチ３1 をボディ２の円周
溝５に係合させた状態に対応する）の仮結合状態として
薬剤充填工程に供すれば、カプセル部品の不時の分離
（二重キャップ等の発生原因となる）や、カプセル部品
の分離不能（空カプセル発生の原因となる）等が回避さ
れ充填操業は円滑に遂行される。The cap 1 of the hard gelatin capsule of the present invention is
The fitting portion to be fitted with the body 2 is formed with at least six convex notches 3 1 projecting inward at substantially equal intervals in the circumferential direction, so that the rigidity and roundness of the fitting portion are improved. Similarly, the body 2 is also provided with concave notches 3 2 formed in the fitting portion corresponding to the convex notches 3 1 which are recessed inward at equal intervals in the circumferential direction.
The rigidity and roundness of the fitting portion are improved. As the effect of improving the rigidity and roundness of the fitting part of this capsule part,
Even when an oily liquid such as triglyceride, which is a medium-chain straight-chain fatty acid, is filled in this liquid, it is possible to prevent leakage of the filled liquid almost completely without sealing the gelatin viscous liquid. A tight fit condition is formed. When the hard gelatin capsule of the present invention is subjected to a drug filling step, a half lock that engages with the convex notch 3 1 (protrusion 4 protruding inward) of the cap 1 and the circumferential groove 5 of the body 2. (This corresponds to the state in which the convex notch 3 1 of the cap 1 in the conventional type capsule shown in FIG. 2 is engaged with the circumferential groove 5 of the body 2) is used in the temporary filling state for the drug filling step. By doing so, the accidental separation of the capsule parts (which causes a double cap, etc.) and the inseparability of the capsule parts (which causes an empty capsule) are avoided, and the filling operation is smoothly performed.
【０００７】図１は本発明の硬カプセルの実施例を示し
ている。キヤツプ１は、ボディ２との嵌合部に、凸状ノ
ツチ（内側に突出）３1,３1,…が円周方向にほゞ等間隔
をなす６個所に形成され、ボディ２の開端側には、キヤ
ツプ１の６個の３1,３1,…に対応する凹状ノツチ３2,３
2,…が円周方向にほゞ等間隔をおいて６個形成されてい
る。本発明の硬カプセルは、そのキヤツプ１とボディ２
との嵌合部に６個以上のノツチが形成されている点を除
き、その材質、形状・サイズ、肉厚、キヤツプとボディ
の嵌合部クリアランス、あるいはキヤツプの円周突起
４，ボディの円周溝５の形設態様等は、従来より粉末な
いし塊状物等の充填に使用されている２ノツチ型硬カプ
セルのそれと何ら異ならず、また改変を加える必要もな
い。本発明の硬カプセルにおけるキヤツプおよびボディ
のノツチ形設態様も、そのノツチ個数が６個以上である
点を除けば、従来の２ノツチ型硬カプセルと異ならず、
そのサイズはカプセルの大きさに応じて適宜設定すれば
よく、ノツチの直径は約1.２〜2.２mm程度、深さ（高
さ）は約0.２〜0.４mm程度としてよい。FIG. 1 shows an embodiment of the hard capsule of the present invention. The cap 1 has six convex notches (protruding inward) 3 1, 3 1, ... Formed in the fitting portion with the body 2 at substantially even intervals in the circumferential direction. The concave notches 3 2, 3 corresponding to the 6 3 1, 3 1, ... Of the cap 1.
2, ... it is formed six at a ho Isuzu equal intervals in the circumferential direction. The hard capsule of the present invention comprises a cap 1 and a body 2.
Except that 6 or more notches are formed in the fitting part with, the material, shape / size, wall thickness, clearance of the fitting part between the cap and the body, or the circumferential projection 4 of the cap, the circle of the body The shape of the circumferential groove 5 is not different from that of the 2-notch type hard capsule conventionally used for filling powders or lumps, and it need not be modified. The notch-shaped aspect of the cap and body in the hard capsule of the present invention is not different from the conventional 2-notch type hard capsule except that the number of notches is 6 or more,
The size may be appropriately set according to the size of the capsule, and the notch may have a diameter of about 1.2 to 2.2 mm and a depth (height) of about 0.2 to 0.4 mm.
【０００８】本発明の硬カプセルのサイズを、医薬品の
充填に使用されている各種号サイズ（００号〜５号）の
うち、例えば００号サイズとし、これに６個のノツチを
形成する場合、キヤツプにおける隣り合うノツチの中心
点間距離（周面上）は約4.６mm，ボディにおける隣り合
うノツチの中心点間距離は約4.５mm、１号サイズのカプ
セルでは、キヤツプのノツチ中心点間距離は約4.０mm、
ボディのノツチ中心点間距離は約3.９mmであり、また５
号サイズのカプセルでは、キヤツプのノツチ中心点間距
離は約2.７mmで、ボディのノツチ中心点間距離は約2.６
mmとなる。The size of the hard capsule of the present invention is, for example, size 00 among various sizes (sizes No. 00 to No. 5) used for filling pharmaceuticals, and when 6 notches are formed in this size, The distance between the center points of the adjacent notches in the cap (on the peripheral surface) is about 4.6 mm, the distance between the center points of the adjacent notches in the body is about 4.5 mm, and between the center points of the notches of the cap in the No. 1 size capsule. Distance is about 4.0mm,
The distance between the notch center points of the body is about 3.9 mm, and 5
For the No. size capsule, the distance between the notch centers of the cap is about 2.7 mm, and the distance between the notch center points of the body is about 2.6.
mm.
【０００９】本発明の硬カプセルのキャップ１およびボ
ディ２を製造するには、その成形原型として、円周方向
にほぼ等間隔をなす６個以上のノツチ形成部分を設けた
ものを使用する点を除いて、従来の２ノツチ型硬カプセ
ルの製造装置をそのまゝ使用すればよく、特別の機器の
使用や工程の付加を必要とせず、２ノツチ型の硬カプセ
ルと全く同様に連続的に製造することができる。また、
本発明の硬カプセルの保管および内容物の充填時の取扱
い等に何ら特別の処置は必要としない。In order to manufacture the hard capsule cap 1 and the body 2 of the present invention, as a molding prototype thereof, one having six or more notch forming portions at substantially equal intervals in the circumferential direction is used. Except for the above, the conventional 2 notch type hard capsule manufacturing device can be used as it is, and it does not require the use of special equipment or additional process, and continuously manufactures just like the 2 notch type hard capsule. can do. Also,
No special treatment is required for the storage of the hard capsule of the present invention and the handling when filling the contents.
【００１０】[0010]
トリグリセライドに微量の親油性薬剤を添加して調製し
た油性液状組成物。An oily liquid composition prepared by adding a trace amount of a lipophilic drug to triglyceride.
【００１１】上記硬ゼラチンカプセルに上記油性液状組
成物２００mgを充填して硬ゼラチンカプセル剤（カプセ
ル剤Ａ）を製剤した。また、対照として、第２図の２ノ
ツチ型硬ゼラチンカプセル（カプセルサイズおよびノツ
チサイズは上記と同じ）を使用して上記油性液状組成物
２００mgを充填した硬ゼラチンカプセル剤（カプセル剤
Ｂ）、およびノツチを有しない硬ゼラチンカプセル
（カプセルサイズは上記と同じ）を使用し上記油性液状
組成物２００mgを充填したうえ、嵌合部外周をゼラチン
粘稠液でシールしたカプセル剤（カプセル剤Ｃ）を、そ
れぞれ製剤した。The above hard gelatin capsule was filled with 200 mg of the above oily liquid composition to prepare a hard gelatin capsule (capsule A). In addition, as a control, a hard gelatin capsule (capsule B) filled with 200 mg of the above oily liquid composition using 2 notch type hard gelatin capsules (capsule size and notch size are the same as above) of FIG. 2 and notch Hard gelatin capsule without
(Capsule size is the same as above), 200 mg of the above oily liquid composition was filled, and capsules (capsule C) in which the outer periphery of the fitting part was sealed with a gelatin viscous liquid were prepared.
【００１２】上記各供試カプセル剤Ａ，Ｂ，Ｃの嵌合部
からの液漏れ発生率を下表に示す。 カプセル剤 液漏れ発生率 Ａ（発明例） 0.１個／10000 個 Ｂ（２ノツチ型カプセル） ５個／10000 個 Ｃ（ゼラチン粘稠液シール） ２個／10000 個The following table shows the liquid leakage occurrence rates from the fitting portions of the respective test capsules A, B and C. Capsule liquid leakage rate A (Invention example) 0.1 / 10,000 B (2 notch type capsule) 5 / 10,000 C (Gelatin viscous liquid seal) 2 / 10,000
【００１３】[0013]
【発明の効果】本発明の硬ゼラチンカプセルは、油性液
状物の充填に使用して嵌合部からの液漏れがほゞ完全に
防止されたカプセル剤を製造することができる。本発明
の硬ゼラチンカプセルは、その成形原型として少なくと
も６個所のノツチ形成部分を設けたものを使用する以外
は、従来の２ノツチ型硬ゼラチンカプセルと同様の機器
および工程により安価に連続生産することができ、また
油性液状物の充填工程では、嵌合部にゼラチン粘稠液を
塗布する煩瑣なシール工程を必要とせず、油性液状物充
填カプセル剤を効率よく製剤することができる。硬ゼラ
チンカプセルは、軟ゼラチンカプセルに比べ取扱い性が
良く、かつそのカプセル剤の製造に特殊な技術や機器装
置を必要とせず、コスト的にも極めて有利である。また
油性液状物充填用カプセルとして軟ゼラチンカプセルに
代え、本発明の硬ゼラチンカプセルを使用することによ
り、軟ゼラチンカプセルを使用する場合の種々の不利を
回避することができる。なお、本発明の硬ゼラチンカプ
セルは、その卓越した密封性により、油性液状物のほか
にも、例えば酸化を受けやすく、空気との接触を避ける
ことが望まれる固形状物（粉末，顆粒等）の充填にも適
している。INDUSTRIAL APPLICABILITY The hard gelatin capsule of the present invention can be used for filling oily liquids to produce capsules in which liquid leakage from the fitting portion is almost completely prevented. The hard gelatin capsule of the present invention can be continuously produced inexpensively by the same equipment and process as the conventional 2-notch hard gelatin capsule, except that a mold forming mold having at least 6 notch forming portions is used. In addition, in the step of filling the oily liquid, a complicated sealing step of applying the gelatin viscous liquid to the fitting portion is not required, and the oily liquid-filled capsule can be efficiently prepared. Hard gelatin capsules are easier to handle than soft gelatin capsules, and do not require special techniques or equipment to manufacture the capsules, and are extremely advantageous in terms of cost. By using the hard gelatin capsule of the present invention instead of the soft gelatin capsule as the oily liquid filling capsule, various disadvantages when using the soft gelatin capsule can be avoided. The hard gelatin capsule of the present invention, due to its excellent hermeticity, is a solid substance (powder, granules, etc.) which is liable to be oxidized, for example, and which is desired to avoid contact with air, in addition to an oily liquid substance. It is also suitable for filling.
【図１】本発明の硬ゼラチンカプセルの実施例を示す斜
視図である。FIG. 1 is a perspective view showing an embodiment of a hard gelatin capsule of the present invention.
【図２】従来の硬ゼラチンカプセルの例を示す斜視図で
ある。FIG. 2 is a perspective view showing an example of a conventional hard gelatin capsule.
１：カプセルキヤツプ，２：カプセルボディ，３1 ：凸
状ノッチ，３2 ：凹状ノッチ, ４：円周突起，５：円周
溝。1: Capsule cap, 2: Capsule body, 3 1 : Convex notch, 3 2 : Concave notch , 4: Circumferential protrusion, 5: Circumferential groove.
Claims (1)
れぞれの開端側を嵌合部として嵌め合わせられる硬ゼラ
チンカプセルにおいて、 嵌合部のロック機構として、キャップ１の嵌合部内周面
には、周方向に延在する円周突起４、およびその円周突
起４と開端縁との間の円周方向にほぼ等間隔をなす少な
くとも６個の凸状ノッチ３ 1 が形成され、ボディ２の嵌
合部外周面には、その周方向に延在して前記キャップ１
の円周突起４と係合する円周溝５、および前記凸状ノッ
チ３ 1 と係合するそれと同じ個数の円周方向にほぼ等間
隔をな す凹状ノッチ３ 2 が形成されていることを特徴と
する硬ゼラチンカプセル。 1. A hard gelatin cap 1 and a body 2 sleeve.
Hard gel that can be fitted with each open end side as a fitting part
In the chin capsule, the inner peripheral surface of the fitting portion of the cap 1 serves as a locking mechanism of the fitting portion.
Includes a circumferential protrusion 4 extending in the circumferential direction and the circumferential protrusion.
A small number of equal intervals are provided in the circumferential direction between the origin 4 and the open end edge.
At least 6 convex notches 3 1 are formed to fit the body 2
On the outer peripheral surface of the joint, the cap 1 extends in the circumferential direction.
Circumferential groove 5 that engages with the circumferential projection 4 of the
Approximately the same number of circumferentially equal distances that engage with 3 1
And characterized in that to the concave notch 3 2, such a septum is formed
Hard gelatin capsules.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3361432A JPH0774149B2 (en) | 1991-12-27 | 1991-12-27 | Hard gelatin capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3361432A JPH0774149B2 (en) | 1991-12-27 | 1991-12-27 | Hard gelatin capsule |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP19808484A Division JPS6176416A (en) | 1984-09-20 | 1984-09-20 | Activated type vitamin d3 derivative composition for encapsulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH05271055A JPH05271055A (en) | 1993-10-19 |
| JPH0774149B2 true JPH0774149B2 (en) | 1995-08-09 |
Family
ID=18473555
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP3361432A Expired - Lifetime JPH0774149B2 (en) | 1991-12-27 | 1991-12-27 | Hard gelatin capsule |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH0774149B2 (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19835346A1 (en) | 1998-08-05 | 2000-02-10 | Boehringer Ingelheim Pharma | Two-part capsule for pharmaceutical preparations for powder inhalers |
| DE102005001332A1 (en) | 2005-01-11 | 2006-07-20 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Two-piece capsule with pre-closure for holding pharmaceutical preparations for powder inhalers |
| ATE555768T1 (en) | 2007-10-19 | 2012-05-15 | Capsugel Belgium Nv | CONTAINER WITH MULTIPLE COMPARTMENTS |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2428397C3 (en) * | 1974-06-12 | 1978-05-18 | Scherer Hartkapsel Gmbh, 6930 Eberbach | Two-part capsule made of hard gelatine |
| IE58468B1 (en) * | 1984-10-25 | 1993-09-22 | Warner Lambert Co | Method for sealing capsules and capsule |
-
1991
- 1991-12-27 JP JP3361432A patent/JPH0774149B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JPH05271055A (en) | 1993-10-19 |
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