JPH06157915A - Hard coating film composition for capsule - Google Patents
Hard coating film composition for capsuleInfo
- Publication number
- JPH06157915A JPH06157915A JP4319582A JP31958292A JPH06157915A JP H06157915 A JPH06157915 A JP H06157915A JP 4319582 A JP4319582 A JP 4319582A JP 31958292 A JP31958292 A JP 31958292A JP H06157915 A JPH06157915 A JP H06157915A
- Authority
- JP
- Japan
- Prior art keywords
- capsule
- gelatin
- polyvinyl acetal
- polyethylene glycol
- hard coating
- 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
Classifications
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P20/00—Technologies relating to chemical industry
- Y02P20/141—Feedstock
Landscapes
- Medicinal Preparation (AREA)
- Compositions Of Macromolecular Compounds (AREA)
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は、硬ゼラチンカプセルや
そのバンドシールに用いるカプセル硬皮膜組成物に関す
る。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a hard gelatin capsule composition and a capsule hard film composition used for band sealing thereof.
【０００２】[0002]
【従来の技術】硬ゼラチンカプセルは、製剤化が容易で
あり、また服用がし易いことから、広く医薬品分野で用
いられている。しかしながら、従来の硬ゼラチンカプセ
ルは、粉末、顆粒等の吸湿性薬剤を充填すると、カプセ
ル皮膜に含有する水分が薬剤に吸収されてカプセル皮膜
の柔軟性が失われ、ヒビや割れが発生するという問題が
あった。特にカプセルに薬剤を充填した後の包装時や、
服用時にカプセルを包材から取り出すときに、カプセル
が破損し、内容薬剤がカプセルから漏出するという問題
があった。2. Description of the Related Art Hard gelatin capsules are widely used in the pharmaceutical field because they are easy to formulate and easy to take. However, when a conventional hard gelatin capsule is filled with a hygroscopic drug such as powder or granules, moisture contained in the capsule film is absorbed by the drug and the flexibility of the capsule film is lost, causing cracks and cracks. was there. Especially at the time of packaging after filling the capsule with medicine,
When taking the capsule out of the packaging material during administration, there was a problem that the capsule was damaged and the drug in the contents leaked out from the capsule.
【０００３】また、ゼラチンに、グリセリン、ソルビト
ール、ポリエチレングリコール等の可塑剤を添加し、柔
軟性をもたせた硬ゼラチンカプセル硬皮膜組成物が知ら
れている。しかしながら、これらの硬ゼラチンカプセル
は、可塑剤の添加量によりカプセル皮膜が柔らかくなり
過ぎたり、乾燥速度が遅い等、カプセル製造時に問題が
あった。したがって、従来の硬ゼラチンカプセルは、水
分低下によるカプセル皮膜の脆弱化のため、充填する薬
剤が制限されているのが現実である。Further, there is known a hard gelatin capsule hard coating composition in which a plasticizer such as glycerin, sorbitol, polyethylene glycol is added to gelatin to give flexibility. However, these hard gelatin capsules have problems during capsule production, for example, the capsule film becomes too soft depending on the amount of plasticizer added, and the drying speed is slow. Therefore, in the conventional hard gelatin capsule, the drug to be filled is actually limited due to the brittleness of the capsule film due to the decrease in water content.
【０００４】[0004]
【発明が解決しようとする課題】本発明の目的は、吸湿
性の薬剤を充填し、カプセル皮膜の水分量が低下したと
しても脆弱化せず、カプセルにヒビ、欠け等が生じるこ
とが極めて少なく、カプセルの破損による内容薬剤の漏
出を防止することができるカプセル硬皮膜組成物を提供
することにある。The object of the present invention is to fill a hygroscopic drug and not weaken even if the water content of the capsule film is reduced, and the capsule is extremely free from cracks and chips. Another object of the present invention is to provide a capsule hard coating composition capable of preventing leakage of a drug contained in a capsule due to breakage of the capsule.
【０００５】[0005]
【課題を解決するための手段】本発明は、ゼラチンに対
し、ポリビニールアセタールジエチルアミノアセテート
１〜１０重量％及びポリエチレングリコール１〜１０重
量％を含有するカプセル硬皮膜組成物である。The present invention is a capsule hard coating composition containing 1 to 10% by weight of polyvinyl acetal diethylaminoacetate and 1 to 10% by weight of polyethylene glycol with respect to gelatin.
【０００６】以下、本発明を詳細に説明する。本発明に
用いるポリビニールアセタールジエチルアミノアセテー
トは、次式：The present invention will be described in detail below. The polyvinyl acetal diethylaminoacetate used in the present invention has the following formula:
【０００７】[0007]
【化１】 [Chemical 1]
【０００８】で示される構成単位を有する高分子化合物
である。中でも、アセタール化度５８〜６８％、粘度
（１０％メタノール溶液を、２５±０．１℃で測定）が
９．０〜１６．０センチポアズのものが好ましい。市販
品としては、胃溶性錠剤コーティング剤として知られる
ＡＥＡ三共［三共（株）製］を用いることができる。ポ
リビニールアセタールジエチルアミノアセテートの配合
量は、ゼラチンに対し１〜１０重量％である。It is a polymer compound having a structural unit represented by: Among them, those having an acetalization degree of 58 to 68% and a viscosity (measured with a 10% methanol solution at 25 ± 0.1 ° C.) of 9.0 to 16.0 centipoise are preferable. As a commercially available product, AEA Sankyo [manufactured by Sankyo Co., Ltd.] known as a gastric-soluble tablet coating agent can be used. The blending amount of polyvinyl acetal diethylaminoacetate is 1 to 10% by weight with respect to gelatin.
【０００９】本発明に用いるポリエチレングリコールと
しては、日本薬局方又は日本薬局方外医薬品成分規格に
収載されているものであれば特に制限はないが、中でも
好ましいのは、ポリエチレングリコール４０００であ
る。ポリエチレングリコールの配合量は、ゼラチンに対
し１〜１０重量％である。また、ポリビニールアセター
ルジエチルアミノアセテートとポリエチレングリコール
との配合量の組合せは、ゼラチンに対しそれぞれ５重量
％含有するのが最も好ましい。The polyethylene glycol used in the present invention is not particularly limited as long as it is listed in the Japanese Pharmacopoeia or the Japanese Pharmacopoeia Standard for Pharmaceutical Ingredients. Among them, polyethylene glycol 4000 is preferable. The content of polyethylene glycol is 1 to 10% by weight based on gelatin. The combination of polyvinyl acetal diethylaminoacetate and polyethylene glycol is most preferably 5% by weight with respect to gelatin.
【００１０】本発明のカプセル硬皮膜組成物の製造方法
としては、ゼラチンとポリビニールアセタールジエチル
アミノアセテートとポリエチレングリコールとを上記所
定量含有する水溶液を調製した後、これに酸化チタン、
食用色素等の着色剤を添加し、粘度を調整し、カプセル
製造機で成形する方法を挙げることができる。また、ゼ
ラチンとポリビニールアセタールジエチルアミノアセテ
ートとポリエチレングリコールとを含有する水溶液を調
製するに際しては、次の方法によるのが好ましい。As the method for producing the capsule hard coating composition of the present invention, an aqueous solution containing the above predetermined amounts of gelatin, polyvinyl acetal diethylaminoacetate and polyethylene glycol is prepared, and then titanium oxide,
A method of adding a colorant such as an edible dye, adjusting the viscosity, and molding with a capsule manufacturing machine can be mentioned. Further, when preparing an aqueous solution containing gelatin, polyvinyl acetal diethylaminoacetate and polyethylene glycol, the following method is preferable.
【００１１】まず、ポリビニールアセタールジエチルア
ミノアセテートを酸性水溶液に溶解する。ポリビニール
アセタールジエチルアミノアセテートの濃度は、２０〜
３０重量％が好ましい。次に、ポリビニールアセタール
ジエチルアミノアセテート水溶液のｐＨをゼラチンと同
じ弱酸性（ｐＨ５〜６）に調整する。次にゼラチン水溶
液と混合する。この際、ポリビニールアセタールジエチ
ルアミノアセテート水溶液は高温でゲル化する性質があ
るため注意を要する。First, polyvinyl acetal diethylaminoacetate is dissolved in an acidic aqueous solution. The concentration of polyvinyl acetal diethylaminoacetate is 20 ~
30% by weight is preferred. Next, the pH of the polyvinyl acetal diethylaminoacetate aqueous solution is adjusted to the same weak acidity (pH 5 to 6) as that of gelatin. Then mix with an aqueous gelatin solution. At this time, caution is required because the polyvinyl acetal diethylaminoacetate aqueous solution has a property of gelling at high temperature.
【００１２】混合方法としては、例えば、予め比較的低
温でゼラチンとポリビニールアセタールジエチルアミノ
アセテートとの１：１混合液を調製しておき、この混合
液をゼラチン溶液に添加する方法を挙げることができ
る。この混合液は温度を上げてもゲル化しないので、操
作性が向上する。次に、ゼラチンとポリビニールアセタ
ールジエチルアミノアセテートとを混合した溶液に、上
記所定量のポリエチレングリコールを混合し、その他の
所望の添加剤を混合し、粘度を調整してカプセル製造機
に供給する組成物を得る。Examples of the mixing method include a method in which a 1: 1 mixture of gelatin and polyvinyl acetal diethylaminoacetate is prepared in advance at a relatively low temperature, and this mixture is added to a gelatin solution. . Since this mixed solution does not gel even if the temperature is raised, the operability is improved. Next, a composition in which gelatin and polyvinyl acetal diethylaminoacetate are mixed with a predetermined amount of polyethylene glycol described above, and other desired additives are mixed, and the viscosity is adjusted to be supplied to a capsule manufacturing machine. To get
【００１３】[0013]
実施例１ ポリビニールアセタールジエチルアミノアセテート［Ａ
ＥＡ三共、三共（株）製］６００g を酸性溶液に溶解
し、２５重量％ＡＥＡ水溶液を調製した。この溶液に水
酸化ナトリウムを添加して、ｐＨを５．７に調整した
後、冷却して放置し、脱泡した。Example 1 Polyvinyl acetal diethylaminoacetate [A
EA Sankyo, Sankyo Co., Ltd.] 600 g was dissolved in an acidic solution to prepare a 25 wt% AEA aqueous solution. Sodium hydroxide was added to this solution to adjust the pH to 5.7, then cooled and left to stand for defoaming.
【００１４】このＡＥＡ水溶液と同量の３４％重量ゼラ
チン水溶液を混合し、１：１ＡＥＡ−ゼラチン混合液を
調製した。次に、別途調製した３４％重量ゼラチン水溶
液に、上記の１：１ＡＥＡ−ゼラチン混合液を、ゼラチ
ンの総量に対しＡＥＡが５重量％になるように混合し
た。これに、６０℃に加温した６０重量％ポリエチレン
グリコール４０００水溶液を、ゼラチンの総量に対し５
重量％になるように混合した後、酸化チタン及び食用色
素を添加して粘度を調整し、カプセル製造機に供給する
組成物を得た。A 1: 1 AEA-gelatin mixture was prepared by mixing the same amount of this AEA aqueous solution with a 34% weight gelatin aqueous solution. Next, the above-mentioned 1: 1 AEA-gelatin mixed solution was mixed with a separately prepared 34% weight gelatin aqueous solution so that AEA was 5% by weight with respect to the total amount of gelatin. To this, 60% by weight polyethylene glycol 4000 aqueous solution heated to 60 ° C. was added to the total amount of gelatin at 5%.
After mixing so as to have a weight percentage, titanium oxide and an edible pigment were added to adjust the viscosity to obtain a composition to be supplied to a capsule manufacturing machine.
【００１５】この組成物を、カプセル製造機に供給し、
カプセルを製造した。得られたカプセルについて、下記
の空カプセル衝撃試験の結果を表１に、充填カプセル加
圧試験を表２に、崩壊試験を表３に示す。This composition was fed to a capsule making machine,
Capsules were manufactured. With respect to the obtained capsules, the results of the following empty capsule impact test are shown in Table 1, the filled capsule pressure test is shown in Table 2, and the disintegration test is shown in Table 3.
【００１６】空カプセル衝撃試験 得られたカプセルについて、インパクト・テスター（カ
プスゲル社製）を使用し、カプセルの胴部を突破るとき
の、カプセルの厚さ当たりの仕事量（mJ/mm ）を測定
し、耐衝撃性について評価した。 Empty Capsule Impact Test With respect to the obtained capsules, an impact tester (manufactured by Capsugel) is used to measure the work amount per capsule thickness (mJ / mm) when breaking through the body of the capsule. Then, the impact resistance was evaluated.
【００１７】充填カプセル加圧試験 得られたカプセルにコーンスターチを充填し、カプセル
に５kgの荷重をかけたときに、カプセル５０個中破損し
たカプセルの割合（％）で評価した。 Filled Capsule Pressure Test When the obtained capsules were filled with corn starch and a load of 5 kg was applied to the capsules, the percentage (%) of broken capsules in 50 capsules was evaluated.
【００１８】崩壊試験 第十二改正日本薬局方に準拠し、乳糖を充填したカプセ
ルを、３７±２℃の蒸留水に浸漬し、カプセルの開口時
間、内容物の放出完了時間及びカプセルの溶解完了時間
で評価した。また、上記試験については、ゼラチンに対
し５重量％のポリエチレングリコールを含む組成物から
なるカプセル、及び従来品の試験結果を併記した。 Disintegration test According to the 12th revised Japanese Pharmacopoeia, a capsule filled with lactose is immersed in distilled water at 37 ± 2 ° C. to open the capsule, release the content, and dissolve the capsule. Evaluated in time. Regarding the above test, the test results of the capsules made of a composition containing 5% by weight of polyethylene glycol with respect to gelatin and the test results of the conventional product are also shown.
【００１９】[0019]
【表１】 [Table 1]
【００２０】[0020]
【表２】 [Table 2]
【００２１】[0021]
【表３】 [Table 3]
【００２２】表１及び表２から明らかなように、カプセ
ル強度が、特に低水分領域において、従来品及びポリエ
チレングリコール添加品にくらべ優れており、表３から
明らかなように、崩壊性については、従来品と同等であ
り、日本薬局方に適合する。As is clear from Tables 1 and 2, the capsule strength is superior to the conventional product and the polyethylene glycol-added product, especially in the low water content region. It is equivalent to the conventional product and conforms to the Japanese Pharmacopoeia.
【００２３】[0023]
【発明の効果】本発明のカプセル硬皮膜組成物は、吸湿
性の薬剤を充填し、カプセル皮膜の水分量が低下したと
しても脆弱化せず、カプセルにヒビ、欠け等が生じるこ
とが極めて少なく、カプセルの破損による内容薬剤の漏
出を防止することができる。EFFECTS OF THE INVENTION The capsule hard coating composition of the present invention is filled with a hygroscopic agent, does not become brittle even when the water content of the capsule coating is decreased, and the capsule is hardly cracked or chipped. It is possible to prevent leakage of the content drug due to breakage of the capsule.
───────────────────────────────────────────────────── フロントページの続き (72)発明者 清水 豊一 神奈川県相模原市南橋本４−３−36 ワー ナー・ランバート株式会社カプスゲル事業 本部内 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Toyoichi Shimizu 4-3-36 Minamihashimoto, Sagamihara City, Kanagawa Warner Lambert Co., Ltd. Capsugel Business Division
Claims (1)
ルジエチルアミノアセテート１〜１０重量％及びポリエ
チレングリコール１〜１０重量％を含有するカプセル硬
皮膜組成物。1. A capsule hard coating composition containing 1 to 10% by weight of polyvinyl acetal diethylaminoacetate and 1 to 10% by weight of polyethylene glycol with respect to gelatin.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP31958292A JP3320802B2 (en) | 1992-11-30 | 1992-11-30 | Capsule hard film composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP31958292A JP3320802B2 (en) | 1992-11-30 | 1992-11-30 | Capsule hard film composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH06157915A true JPH06157915A (en) | 1994-06-07 |
| JP3320802B2 JP3320802B2 (en) | 2002-09-03 |
Family
ID=18111879
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP31958292A Expired - Fee Related JP3320802B2 (en) | 1992-11-30 | 1992-11-30 | Capsule hard film composition |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3320802B2 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005084649A1 (en) * | 2004-03-04 | 2005-09-15 | Takeda Pharmaceutical Company Limited | Stable capsule preparation |
| WO2008125272A1 (en) * | 2007-04-13 | 2008-10-23 | Sicit Chemitech S.P.A. | Biodegradable blends based on hydrolysed proteins and funtionalised ethylene copolymers |
-
1992
- 1992-11-30 JP JP31958292A patent/JP3320802B2/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005084649A1 (en) * | 2004-03-04 | 2005-09-15 | Takeda Pharmaceutical Company Limited | Stable capsule preparation |
| JPWO2005084649A1 (en) * | 2004-03-04 | 2007-11-29 | 武田薬品工業株式会社 | Stable capsule |
| WO2008125272A1 (en) * | 2007-04-13 | 2008-10-23 | Sicit Chemitech S.P.A. | Biodegradable blends based on hydrolysed proteins and funtionalised ethylene copolymers |
Also Published As
| Publication number | Publication date |
|---|---|
| JP3320802B2 (en) | 2002-09-03 |
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