JPS63203611A - Gradually collapsing capsule - Google Patents
Gradually collapsing capsuleInfo
- Publication number
- JPS63203611A JPS63203611A JP3722587A JP3722587A JPS63203611A JP S63203611 A JPS63203611 A JP S63203611A JP 3722587 A JP3722587 A JP 3722587A JP 3722587 A JP3722587 A JP 3722587A JP S63203611 A JPS63203611 A JP S63203611A
- Authority
- JP
- Japan
- Prior art keywords
- substance
- gastric juice
- gradually
- gelatin
- capsule
- 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.)
- Pending
Links
- 239000002775 capsule Substances 0.000 title claims abstract description 21
- 239000000126 substance Substances 0.000 claims abstract description 12
- 108010010803 Gelatin Proteins 0.000 claims abstract description 10
- 229920000159 gelatin Polymers 0.000 claims abstract description 10
- 239000008273 gelatin Substances 0.000 claims abstract description 10
- 235000019322 gelatine Nutrition 0.000 claims abstract description 10
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 10
- 210000004051 gastric juice Anatomy 0.000 claims abstract description 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 abstract description 8
- 239000003814 drug Substances 0.000 abstract description 4
- 235000019359 magnesium stearate Nutrition 0.000 abstract description 4
- 238000000034 method Methods 0.000 abstract description 4
- 239000000203 mixture Substances 0.000 abstract description 3
- 239000000546 pharmaceutical excipient Substances 0.000 abstract description 3
- 235000021355 Stearic acid Nutrition 0.000 abstract description 2
- YKTSYUJCYHOUJP-UHFFFAOYSA-N [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] Chemical compound [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] YKTSYUJCYHOUJP-UHFFFAOYSA-N 0.000 abstract description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 abstract description 2
- 239000008116 calcium stearate Substances 0.000 abstract description 2
- 235000013539 calcium stearate Nutrition 0.000 abstract description 2
- 229940079593 drug Drugs 0.000 abstract description 2
- 238000000465 moulding Methods 0.000 abstract description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 abstract description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 abstract description 2
- 239000002994 raw material Substances 0.000 abstract description 2
- 239000008117 stearic acid Substances 0.000 abstract description 2
- 239000003795 chemical substances by application Substances 0.000 abstract 3
- 238000012856 packing Methods 0.000 abstract 1
- 239000007902 hard capsule Substances 0.000 description 4
- 239000001913 cellulose Substances 0.000 description 3
- 229920002678 cellulose Polymers 0.000 description 3
- 238000007922 dissolution test Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000000576 coating method Methods 0.000 description 2
- 238000007796 conventional method Methods 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 238000013268 sustained release Methods 0.000 description 2
- 239000012730 sustained-release form Substances 0.000 description 2
- 239000000654 additive Substances 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000001754 anti-pyretic effect Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 239000002221 antipyretic Substances 0.000 description 1
- 229940125716 antipyretic agent Drugs 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 229920001592 potato starch Polymers 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
【発明の詳細な説明】
〔産業上の利用分野〕
本発明は徐崩壊性カシセル、更に詳細には医薬品等の内
服用カプセル剤皮膜として用いられる徐崩壊性カプセル
に関する。DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to slowly disintegrating capsules, and more particularly to slowly disintegrating capsules used as capsule coatings for internal use such as pharmaceuticals.
従来、カプセルは一般にゼラチンを主体として製造せら
れていた。而して、従来カプセルはこれを服用した場合
、その崩壊性はほぼ一定しているため、胃内で徐放性を
与えたい抗生物質、解熱剤等の医薬品等を内容物として
収容せんとするときは、当該内容物自体に各種属さの被
膜をコーティング形成せしめていたのが実状であった。In the past, capsules were generally made mainly from gelatin. Therefore, when conventional capsules are taken, their disintegration is almost constant, so when the contents are intended to contain pharmaceuticals such as antibiotics and antipyretics that need to be released slowly in the stomach. The actual situation was that the contents themselves were coated with various kinds of films.
然しなから、斯かる内容物に被膜を形成する方法は、製
造工程としても慎重とならざるを得す、自ずと工業的不
利なるを免れ得なかった。However, the method of forming a film on such contents requires careful manufacturing process, which inevitably leads to industrial disadvantages.
そこで、本発明者は斯かる従来の欠点を解消すべく種々
検討を重ねた結果、内容物ではすく、カプセル自体に徐
崩壊性を付与せしめた本発明を完成したものである。Therefore, the inventors of the present invention have made various studies to overcome these conventional drawbacks, and as a result have completed the present invention, in which the capsule itself has gradual disintegration properties rather than the contents.
すなわち、本発明は対胃液難溶性物質をゼラチン中に分
散せしめて成型したことを特徴とする徐崩壊性カプセル
である。That is, the present invention is a slowly disintegrating capsule characterized by being formed by dispersing a substance poorly soluble in gastric fluid in gelatin.
ここに対胃液難溶性物質としては、服用しても人体に悪
影響を与えない物質、特に医薬品添加物として認められ
ているステアリン酸、ステアリン酸マグネシウム、ステ
アリン酸カルシウム、合成ケイ酸アルミニウム等が好ま
しいものとして挙げられ、これらは適宜単独又は混合し
て用いることができる。Here, as substances poorly soluble in gastric juice, substances that do not have a negative effect on the human body even if taken, especially stearic acid, magnesium stearate, calcium stearate, synthetic aluminum silicate, etc., which are approved as pharmaceutical additives, are preferred. These can be used alone or in combination as appropriate.
対胃液難溶性物質の配合量としては、目的とする徐崩壊
性の程度に応じて適宜選定されるが、通常主原料たるゼ
ラチンに対し１０〜３０重量慢配合するのが好ましい。The amount of the substance poorly soluble in gastric fluid is appropriately selected depending on the desired degree of gradual disintegration, but it is usually preferable to add 10 to 30% by weight relative to gelatin, which is the main raw material.
尚、必要に応じて結晶セルロース等の賦型剤等の添加剤
を適宜配合することができる。Incidentally, additives such as excipients such as crystalline cellulose may be appropriately blended as necessary.
本発明のカプセルを製造するには、一般的な処方に従っ
て調製されたゼラチン溶液中に、適当量の対胃液難溶性
物質を添加混合して均一に分散せしめ、以下常法に従い
成型加工すれば良い。To manufacture the capsules of the present invention, an appropriate amount of a substance that is poorly soluble in gastric juices is added and mixed into a gelatin solution prepared according to a general recipe, and then uniformly dispersed, followed by molding according to a conventional method. .
本発明カプセルは以上の如く構成されているため、これ
を服用すると胃液による崩壊がゼラチン部に於て速く、
対胃液難溶性物質部に於て遅く生じる結果、全体として
徐々に崩壊が進行する。Since the capsule of the present invention is constructed as described above, when taken, the gelatin part disintegrates quickly due to gastric juice,
As a result of slow formation in the part of the substance that is poorly soluble in gastric juice, disintegration progresses gradually as a whole.
以上従って、本発明カプセルはそれ自体徐崩壊性を有す
るため、これを用いれば、医薬品等の内容物に格別コー
ティング処理することなくそのまま充填収容するだけで
、胃内に於て当該内容物が徐々に放出される所謂徐放性
カプセル剤を得ることができるので、従来に比し工業的
に有利な徐放性カプセル剤の製造が可能となる。Therefore, since the capsule of the present invention itself has a slow disintegrating property, if it is used, the contents of medicines etc. can be simply filled and accommodated without any special coating treatment, and the contents will gradually disintegrate in the stomach. Since it is possible to obtain so-called sustained-release capsules that are released in a timely manner, it becomes possible to produce sustained-release capsules that are industrially more advantageous than conventional methods.
以下実施例及び試験例を挙げて本発明金更に説明する。 The present invention will be further explained below with reference to Examples and Test Examples.
実施例
ゼラチン５ Ｋｙを蒸留水ｌＯｌ！に膨潤させ、攪拌下
６０℃に加熱して完全に溶解させた。Example gelatin 5 Ky in distilled water lOl! The mixture was swollen and heated to 60° C. with stirring to completely dissolve.
この溶液にステアリン酸マグネシウム７５０を及び結晶
セルロース２５０ｔを添加混合して均一に分散せしめた
。次いで、この溶液をカプセル製造装置に仕込み、サイ
ズ１号の硬カシセルを成型した。750 tons of magnesium stearate and 250 tons of crystalline cellulose were added and mixed to this solution and uniformly dispersed. Next, this solution was charged into a capsule manufacturing apparatus, and a size 1 hard capsule was molded.
試験例
実施例で得られた硬カプセルに、アセトアミノフェノン
と馬鈴薯澱粉の混合物（混合比１：４）ｔ−３００１１
Ｆ充填収容してカプセル剤を得、本発明サンプルとした
。Test Examples A mixture of acetaminophone and potato starch (mixing ratio 1:4) t-30011 was added to the hard capsules obtained in the examples.
Capsules were obtained by filling with F and used as samples of the present invention.
ステアリン酸マグネシウム及び結晶セルロースを添加混
合しない以外は実施例と同様にして得られた硬カプセル
に、前記本考案サンプルと同一の内容物を充填収容して
カプセル剤を得、比較サンプルとした。Hard capsules obtained in the same manner as in the example except that magnesium stearate and crystalline cellulose were not added and mixed were filled with the same contents as the sample of the present invention to obtain capsules, which were used as comparative samples.
両サンプルを日本薬局方の溶出試験第１法に基づき、ア
セトアミノフェノンの溶出試験を行なった。Both samples were subjected to a dissolution test for acetaminophone based on Dissolution Test Method 1 of the Japanese Pharmacopoeia.
その結果は第２図の通りであった。The results were as shown in Figure 2.
第１図は本発明硬カプセルの断面説明図、Ｉｓ２図はア
セトアミノフェノンの溶出試験の結果を示すグラフであ
る。
以上FIG. 1 is an explanatory cross-sectional view of the hard capsule of the present invention, and FIG. Is2 is a graph showing the results of an acetaminophenone dissolution test. that's all
Claims (1)
ことを特徴とする徐崩壊性カプセル。A slowly disintegrating capsule characterized by being formed by dispersing a substance poorly soluble in gastric juice in gelatin.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3722587A JPS63203611A (en) | 1987-02-20 | 1987-02-20 | Gradually collapsing capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3722587A JPS63203611A (en) | 1987-02-20 | 1987-02-20 | Gradually collapsing capsule |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPS63203611A true JPS63203611A (en) | 1988-08-23 |
Family
ID=12491653
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP3722587A Pending JPS63203611A (en) | 1987-02-20 | 1987-02-20 | Gradually collapsing capsule |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS63203611A (en) |
-
1987
- 1987-02-20 JP JP3722587A patent/JPS63203611A/en active Pending
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