JPH06321790A - Fast-disintegrating galenical preparation - Google Patents
Fast-disintegrating galenical preparationInfo
- Publication number
- JPH06321790A JPH06321790A JP5135422A JP13542293A JPH06321790A JP H06321790 A JPH06321790 A JP H06321790A JP 5135422 A JP5135422 A JP 5135422A JP 13542293 A JP13542293 A JP 13542293A JP H06321790 A JPH06321790 A JP H06321790A
- Authority
- JP
- Japan
- Prior art keywords
- disintegration
- disintegrating
- galenical
- polyethylene glycol
- fast
- 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
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は速崩壊性生薬製剤に関す
る。TECHNICAL FIELD The present invention relates to a rapidly disintegrating crude drug preparation.
【０００２】[0002]
【従来の技術】生薬を配合する薬剤は生薬特有の苦味、
辛味または収斂味など不快な味を有することが多く、ま
た生薬中の成分の安定性等の点から液剤より固形剤が汎
用されている。固形剤の場合、充填、包装および輸送な
ど通常の取扱い過程において壊れない程度の錠剤硬度あ
るいは顆粒強度が要求される。また、通常、日本薬局方
に定められた崩壊試験の規定に適合しなければならない
が、薬剤の速効性を期待する場合、崩壊性を良好なもの
にする必要がある。一方、多くの生薬には植物ゴム質、
ヘミセルロースあるいは植物粘質物等を含んでいるた
め、これらの物質が水中で膨潤し、ゲル化等を起こし崩
壊を妨げている。そのため、生薬を含有する固形製剤を
調製する場合、錠剤硬度や顆粒強度を良好なものにする
と崩壊性が低下する。その逆に、崩壊性を高めると、錠
剤硬度や顆粒強度が不十分なものになるという問題点が
あった。2. Description of the Prior Art Drugs containing crude drugs are bitterness peculiar to crude drugs,
In many cases, it has an unpleasant taste such as a pungent or astringent taste, and solid agents are generally used rather than liquid agents from the viewpoint of the stability of components in crude drugs. In the case of a solid formulation, tablet hardness or granule strength is required so that it does not break during normal handling processes such as filling, packaging and transportation. In addition, normally, it is necessary to comply with the regulations of the disintegration test provided in the Japanese Pharmacopoeia, but in the case of expecting a fast-acting drug, it is necessary to make the disintegration good. On the other hand, many herbal medicines contain vegetable gums,
Since they contain hemicellulose or plant mucilage, these substances swell in water and cause gelation, etc., which prevents disintegration. Therefore, in the case of preparing a solid preparation containing a crude drug, if the tablet hardness and the granule strength are made to be good, the disintegration property decreases. On the contrary, if the disintegration is increased, there is a problem that the tablet hardness and the granule strength become insufficient.
【０００３】[0003]
【発明が解決しようとする課題】このように服用しにく
い生薬を固形剤にして飲みやすくし、また、その固形剤
は十分な錠剤硬度あるいは顆粒強度を有し、しかも崩壊
性にも優れたものが望まれていた。Thus, a crude drug which is difficult to take is made into a solid formulation to make it easy to drink, and the solid formulation has sufficient tablet hardness or granule strength and is also excellent in disintegration. Was desired.
【０００４】[0004]
【課題を解決するための手段】そこで本発明者らは鋭意
検討した結果、生薬を主剤とする錠剤または顆粒などの
固形剤を調製する場合、ポリエチレングリコール、およ
びカルボキシメチル基を有するセルロース類またはスタ
ーチ類を用いることにより、十分な錠剤硬度あるいは顆
粒強度を有し、しかも崩壊性にも優れたものとなること
を見い出した。Therefore, as a result of intensive investigations by the present inventors, when preparing solid preparations such as tablets or granules containing a crude drug as a main ingredient, polyethylene glycol and celluloses or starches having a carboxymethyl group are used. It has been found that the use of these compounds has sufficient tablet hardness or granule strength and is also excellent in disintegration.
【０００５】本発明に用いられる生薬はアロエ、エイジ
ツ、オウゴン、オウレン、オウバク、カスカラサグラ
ダ、カンゾウ、ケイヒ、ケツメイシ、ケンゴシ、コウジ
ン、シャクヤク、ジリュウ、セネガ、センナ、ダイオ
ウ、チンピ、ニンジン、ハンゲ、プランタゴオバタ種
皮、マシニンおよびヨクイニンからなる群から選ばれる
少なくとも１種以上の生薬末、あるいは乾燥エキス、軟
稠エキスなどの抽出物が挙げられるが、その他、一般的
に汎用されている生薬であれば、いかなるものでもよ
い。The herbal medicines used in the present invention are aloe, ages, sardines, lauren, sage, cascara sacralda, licorice, keihi, ketsumeishi, kengoshi, koujin, peony, diryu, senega, senna, rhododendron, chinpi, carrot, hange, At least one or more kinds of crude drug powder selected from the group consisting of plantago ovata seed coat, machinin and yokuinin, or extracts such as dried extract and soft extract can be mentioned. , Any.
【０００６】本発明に用いられるポリエチレングリコー
ルとしてはポリエチレングリコール４０００、ポリエチ
レングリコール６０００などが挙げられるが、ポリエチ
レングリコール６０００が錠剤硬度あるいは顆粒強度、
および崩壊性の点で最も優れている。その配合量は１〜
１０重量％である。１重量％以下では、十分な錠剤硬度
あるいは顆粒強度と崩壊性を得ることができず、１０重
量％を越えてもそれ以上、崩壊性は上がらない。Examples of the polyethylene glycol used in the present invention include polyethylene glycol 4000 and polyethylene glycol 6000. Among them, polyethylene glycol 6000 has tablet hardness or granule strength,
And the best in terms of disintegration. The blending amount is 1
It is 10% by weight. If it is 1% by weight or less, sufficient tablet hardness or granule strength and disintegration cannot be obtained, and if it exceeds 10% by weight, the disintegration does not further increase.
【０００７】本発明に用いられるカルボキシメチル基を
有するセルロース類またはスターチ類としてはカルメロ
ース、カルメロースナトリウム、カルメロースカルシウ
ム、クロスカルメロースナトリウムおよびカルボキシメ
チルスターチナトリウムが挙げられるが、クロスカルメ
ロースナトリウムおよびカルボキシメチルスターチナト
リウムが錠剤硬度あるいは顆粒強度、および崩壊性の点
で最も優れている。その配合量は１〜２０重量％であ
る。１重量％以下では、十分な錠剤硬度あるいは顆粒強
度と崩壊性を得ることができず、２０重量％を越えても
それ以上、崩壊性は上がらない。カルボキシメチル基を
有するセルロース類またはスターチ類とポリエチレング
リコールの配合割合は、重量比で５：１〜１：１、好ま
しくは４：１〜２：１が崩壊性の点で優れている。Examples of celluloses or starches having a carboxymethyl group used in the present invention include carmellose, carmellose sodium, carmellose calcium, croscarmellose sodium and carboxymethyl starch sodium, and croscarmellose sodium and carboxy. Methylstarch sodium is the best in terms of tablet hardness or granule strength and disintegration. The blending amount is 1 to 20% by weight. If it is 1% by weight or less, sufficient tablet hardness or granule strength and disintegration cannot be obtained, and if it exceeds 20% by weight, the disintegration does not further increase. The weight ratio of the cellulose or starch having a carboxymethyl group to the polyethylene glycol is 5: 1 to 1: 1, preferably 4: 1 to 2: 1 because of its excellent disintegrating property.
【０００８】その他、賦形剤としては、デンプン、ヒド
ロキシプロピルスターチなどのスターチ系、乳糖、粉末
白糖などの糖系、結晶性セルロースなどのセルロース
系、含水二酸化ケイ素、軽質無水ケイ酸、合成ケイ酸ア
ルミニウム、リン酸水素カルシウムなどの無機物系が挙
げられる。また、粉末粒子間の粘着性を増加するための
結合剤としては、デンプン、アルファー化デンプン、マ
ルトース、アラビアゴム、メチルセルロース、カルボキ
シメチルセルロース、ヒドロキシプロピルセルロース、
微結晶性セルロース、ゼラチン、カンテンなどが挙げら
れる。粉末原料が打錠機の臼に流れ込み易く、また粉末
原料が杵や臼に粘着するのを防ぎ、また錠剤に光沢を与
えるための滑沢剤としては、タルク、ステアリン酸マグ
ネシウム、ステアリン酸カルシウムなどが挙げられる。
また、その他の添加剤として着色剤、着香剤などを適
宜、配合する。Other excipients include starch, starch such as hydroxypropyl starch, sugars such as lactose and powdered sucrose, cellulose such as crystalline cellulose, hydrous silicon dioxide, light anhydrous silicic acid, synthetic silicic acid. Inorganic materials such as aluminum and calcium hydrogen phosphate can be used. Further, as a binder for increasing the adhesiveness between powder particles, starch, pregelatinized starch, maltose, gum arabic, methyl cellulose, carboxymethyl cellulose, hydroxypropyl cellulose,
Microcrystalline cellulose, gelatin, agar and the like can be mentioned. The powder raw material easily flows into the die of the tabletting machine, and the lubricant for preventing the powder raw material from sticking to the punches and dies, and as a lubricant for giving the tablet gloss, talc, magnesium stearate, calcium stearate, etc. Can be mentioned.
Further, as other additives, coloring agents, flavoring agents and the like are appropriately added.
【０００９】[0009]
【作用】本発明の速崩壊性生薬製剤を服用すると、消化
管内において薬剤表面に生成した粘質ゲルをポリエチレ
ングリコール、およびカルボキシメチル基を有するセル
ロース類またはスターチ類がコロイドに分散させること
により、薬剤内部へ水分の浸透性を高め、崩壊性を高め
ることができる。When the rapidly disintegrating crude drug preparation of the present invention is taken, the viscous gel formed on the surface of the drug in the digestive tract is dispersed in a colloid of polyethylene glycol and celluloses or starches having a carboxymethyl group to give a drug. The permeability of water to the inside can be enhanced, and the disintegration can be enhanced.
【００１０】[0010]
実施例１ 表１の実施例１は、先ず、主薬のフェノバリン４００
ｇ、センナ末７５０ｇおよびヨクイニン末１００ｇと軽
質無水ケイ酸４０ｇを４８メッシュの篩に通して、混合
機で混合する。次にクロスカルメロースナトリウム２０
０ｇ、ポリエチレングリコール６０００５０ｇおよび乳
糖２５０ｇを添加し、乾式造粒機にて造粒する。それに
ステアリン酸カルシウム１０ｇを加えて打錠して瀉下剤
を得た。錠剤の硬度は５ｋｇ／ｃｍ2（モンサント型錠
剤用硬度計を用いて測定した。）になるように打錠し
た。更に比較例１〜３も同様に調製した。Example 1 In Example 1 of Table 1, first, the main drug phenovaline 400 was used.
g, 750 g of senna powder, 100 g of yokuinin powder and 40 g of light anhydrous silicic acid are passed through a 48-mesh sieve and mixed with a mixer. Next, croscarmellose sodium 20
0 g, polyethylene glycol 600050 g and lactose 250 g are added and granulated by a dry granulator. 10 g of calcium stearate was added thereto and tabletted to obtain a cathartic. Tablets were tabletted to have a hardness of 5 kg / cm 2 (measured with a Monsanto type tablet hardness meter). Further, Comparative Examples 1 to 3 were similarly prepared.
【００１１】以上のように調製した実施例１および比較
例１〜３の錠剤の崩壊試験を日本薬局方に準拠した方法
で行った。すなわち、試験液に水を用い、上下運動を行
なった後、観察するとき、試料の残留物をガラス管内に
認めないか、又は認めても海綿状の物質であるか、若し
くは軟質の物質若しくは泥状の物質がわずかのときを適
合としている。従って、崩壊試験の結果、適合と判断で
きるまでに要した時間を崩壊時間として表１に示した。Disintegration tests of the tablets of Example 1 and Comparative Examples 1 to 3 prepared as described above were carried out by a method according to the Japanese Pharmacopoeia. That is, when water is used as the test solution and vertical movement is performed, the residue of the sample is not observed in the glass tube, or even if it is observed, it is a spongy substance, or a soft substance or mud. Conformity is defined when the amount of substance is small. Therefore, the time required until the result of the disintegration test was judged to be suitable is shown in Table 1 as the disintegration time.
【００１２】[0012]
【表１】 実施例１は比較例１〜３と比較して崩壊性が優れている
ことがわかる。また、実施例１の錠剤の打錠圧を変えて
硬度４〜６としたものの崩壊試験を行い、その崩壊時間
を表２に示した。[Table 1] It can be seen that Example 1 has better disintegration than Comparative Examples 1 to 3. Further, the tablet of Example 1 was subjected to a disintegration test by changing the tableting pressure to have a hardness of 4 to 6, and the disintegration time is shown in Table 2.
【００１３】[0013]
【表２】 いずれも日本薬局方の基準である３０分以内であった。[Table 2] All were within 30 minutes, which is the standard of the Japanese Pharmacopoeia.
【００１４】実施例２ 表３の実施例２は、先ず、ケイヒ末、オウバク末、カン
ゾウ末およびバレイショデンプンを４８メッシュの篩に
通し、その粉末とその他の成分と混合する。これに適量
のエタノールを添加し、練合した後、押し出し造粒機で
造粒する。この顆粒を乾燥させて胃腸薬を得た。更に比
較例４も同様に調製した。Example 2 In Example 2 of Table 3, firstly, cinnamon powder, oat powder, licorice powder and potato starch are passed through a 48-mesh sieve, and the powder and other components are mixed. An appropriate amount of ethanol is added to this, and after kneading, it is granulated by an extrusion granulator. The granules were dried to obtain a gastrointestinal drug. Further, Comparative Example 4 was similarly prepared.
【００１５】以上のように調製した実施例２および比較
例４の顆粒の崩壊試験を実施例１と同様に行い、適合と
判断できるまでに要した時間を崩壊時間として表２に示
した。また、押し出し造粒機で造粒する際の顆粒の目詰
まりの具合いを造粒性として、表２に示した。The disintegration test of the granules of Example 2 and Comparative Example 4 prepared as described above was carried out in the same manner as in Example 1, and the time required until it was judged as conforming is shown in Table 2 as the disintegration time. Further, the degree of granule clogging when granulating with an extrusion granulator is shown in Table 2 as granulating property.
【００１６】[0016]
【表３】 実施例２は比較例４と比較して崩壊性が優れていること
がわかる。また、比較例４は押し出し造粒機に目詰まり
するなど造粒性に問題があるが、本発明による実施例２
にはそのような問題はない。[Table 3] It can be seen that Example 2 has better disintegration than Comparative Example 4. Further, Comparative Example 4 has a problem in granulation such as clogging of the extrusion granulator, but Example 2 according to the present invention
Has no such problem.
【００１７】 実施例３ ｇ アセトアミノフェン ４５０ エテンザミド ４５０ ｄｌ−塩酸メチルエフェドリン ３０ 地竜エキス ２００ カンゾウエキス ２００ オウバクエキス ３００ 直打用乳糖 ３３０ 軽質無水ケイ酸 ５０ クロスカルメロースナトリウム １８０ ポリエチレングリコール６０００ ９０ ステアリン酸カルシウム ２０ 合計 ２３００ アセトアミノフェン、エテンザミド、ｄｌ−塩酸メチル
エフェドリン、地竜エキス、カンゾウエキス、オウバク
エキスおよび軽質無水ケイ酸を４８メッシュの篩に通
し、その粉末に直打用乳糖、クロスカルメロースナトリ
ウムおよびポリエチレングリコール６０００を混合す
る。更にステアリン酸カルシウムを添加し、直打にて打
錠し風邪薬を得た。実施例１と同様に錠剤として十分な
硬度である５ｋｇ／ｃｍ2とした。また実施例１と同様
の崩壊試験によると崩壊時間は５分であり、崩壊性にも
優れたものである。Example 3 g Acetaminophen 450 Ethenzamide 450 dl-Methylephedrine hydrochloride 30 Chiryu extract 200 Licorice extract 200 Oat extract 300 Lactose for direct hitting 330 Light anhydrous silicic acid 50 Croscarmellose sodium 180 Polyethylene glycol 6000 90 Calcium stearate 20 Total 2300 Acetaminophen, ethenzamid, dl-methylephedrine hydrochloride, Chiryu extract, licorice extract, Oat extract and light anhydrous silicic acid are passed through a 48-mesh sieve, and the powder is directly lactose, croscarmellose sodium and Mix polyethylene glycol 6000. Further, calcium stearate was added, and the mixture was directly compressed to give a cold medicine. As in Example 1, the tablet had a sufficient hardness of 5 kg / cm 2 . According to the same disintegration test as in Example 1, the disintegration time was 5 minutes and the disintegration property was excellent.
【００１８】[0018]
【発明の効果】本発明の速崩壊性生薬製剤は、苦味等の
不快な味を有する生薬を固形剤にして飲みやすくし、ま
た、その固形剤は十分な錠剤硬度あるいは顆粒強度を有
し、しかも崩壊性にも優れたものである。The rapidly disintegrating galenical preparation of the present invention makes a crude drug having an unpleasant taste such as bitterness into a solid agent and makes it easy to drink, and the solid agent has sufficient tablet hardness or granule strength. Moreover, it is also excellent in disintegration.
───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.5 識別記号 庁内整理番号 ＦＩ 技術表示箇所 Ａ６１Ｋ 47/36 Ｂ 7433−4Ｃ Ｚ 7433−4Ｃ 47/38 Ｂ 7433−4Ｃ Ｚ 7433−4Ｃ ─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. 5 Identification code Internal reference number FI Technical display location A61K 47/36 B 7433-4C Z 7433-4C 47/38 B 7433-4C Z 7433-4C
Claims (1)
カルボキシメチル基を有するセルロース類またはスター
チ類からなることを特徴とする速崩壊性生薬製剤。1. A rapidly disintegrating crude drug formulation comprising a crude drug, polyethylene glycol, and celluloses or starches having a carboxymethyl group.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP13542293A JP3319625B2 (en) | 1993-05-12 | 1993-05-12 | Fast-disintegrating crude drug formulation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP13542293A JP3319625B2 (en) | 1993-05-12 | 1993-05-12 | Fast-disintegrating crude drug formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH06321790A true JPH06321790A (en) | 1994-11-22 |
| JP3319625B2 JP3319625B2 (en) | 2002-09-03 |
Family
ID=15151368
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP13542293A Expired - Fee Related JP3319625B2 (en) | 1993-05-12 | 1993-05-12 | Fast-disintegrating crude drug formulation |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3319625B2 (en) |
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1998008517A3 (en) * | 1996-08-26 | 1998-05-07 | Takeda Chemical Industries Ltd | Pharmaceutical composition containing osteogenesis-promoting substance and a polyethylene glycol |
| WO2006068166A1 (en) * | 2004-12-21 | 2006-06-29 | Eisai R & D Management Co., Ltd. | Dry granulated substance and process for producing the same |
| JP2009084234A (en) * | 2007-10-01 | 2009-04-23 | Suntory Ltd | Production method of quickly disintegrative granule containing unfavorable taste ingredient |
| JP2009173604A (en) * | 2008-01-25 | 2009-08-06 | Kobayashi Pharmaceut Co Ltd | Tablet containing processed vegetable and pantethines |
| JP2014210772A (en) * | 2013-04-04 | 2014-11-13 | 沢井製薬株式会社 | Telmisartan-containing tablet |
| US8945618B2 (en) | 1996-06-14 | 2015-02-03 | Kyowa Hakko Kirin Co., Ltd. | Intrabuccally rapidly disintegrating tablet and a production method of the tablets |
| JP2015024987A (en) * | 2013-06-20 | 2015-02-05 | 大正製薬株式会社 | Tablet |
| US9040086B2 (en) | 2001-10-04 | 2015-05-26 | Aptalis Pharmatech, Inc. | Timed, sustained release systems for propranolol |
| US9161918B2 (en) | 2005-05-02 | 2015-10-20 | Adare Pharmaceuticals, Inc. | Timed, pulsatile release systems |
| US9233105B2 (en) | 2009-12-02 | 2016-01-12 | Adare Pharmaceuticals S.R.L. | Fexofenadine microcapsules and compositions containing them |
| US9884014B2 (en) | 2004-10-12 | 2018-02-06 | Adare Pharmaceuticals, Inc. | Taste-masked pharmaceutical compositions |
| US10471017B2 (en) | 2004-10-21 | 2019-11-12 | Adare Pharmaceuticals, Inc. | Taste-masked pharmaceutical compositions with gastrosoluble pore-formers |
-
1993
- 1993-05-12 JP JP13542293A patent/JP3319625B2/en not_active Expired - Fee Related
Cited By (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6190695B1 (en) | 1919-04-09 | 2001-02-20 | Takeda Chemical Industries, Ltd. | Pharmaceutical composition containing osteogenesis-promoting substance |
| US8945618B2 (en) | 1996-06-14 | 2015-02-03 | Kyowa Hakko Kirin Co., Ltd. | Intrabuccally rapidly disintegrating tablet and a production method of the tablets |
| US8956650B2 (en) | 1996-06-14 | 2015-02-17 | Kyowa Hakko Kirin Co., Ltd. | Intrabuccally rapidly disintegrating tablet and a production method of the tablets |
| WO1998008517A3 (en) * | 1996-08-26 | 1998-05-07 | Takeda Chemical Industries Ltd | Pharmaceutical composition containing osteogenesis-promoting substance and a polyethylene glycol |
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