JP3063438B2 - Dopamine derivative-containing formulation for oral administration - Google Patents
Dopamine derivative-containing formulation for oral administrationInfo
- Publication number
- JP3063438B2 JP3063438B2 JP4344026A JP34402692A JP3063438B2 JP 3063438 B2 JP3063438 B2 JP 3063438B2 JP 4344026 A JP4344026 A JP 4344026A JP 34402692 A JP34402692 A JP 34402692A JP 3063438 B2 JP3063438 B2 JP 3063438B2
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- JP
- Japan
- Prior art keywords
- preparation
- substance
- water
- docarpamine
- oral administration
- 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
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
【０００１】[0001]
【産業上の利用分野】本発明は、ドパミン誘導体である
ドカルパミンの経口投与用製剤に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a preparation for oral administration of docarpamine which is a dopamine derivative.
【０００２】[0002]
【従来の技術】ドパミン誘導体であるドカルパミン〔化
学名：（−）−（Ｓ）−２−アセタミド−Ｎ−［３，４
−ビス（エトキシカルボニルオキシ）フェネチル］−４
−（メチルチオ）ブチルアミド〕は、経口投与で優れた
心収縮力増加作用、腎血流量増加作用を示し、循環不全
に伴う諸症状の改善・治療薬として優れた薬物である。2. Description of the Related Art Docarpamine, a dopamine derivative [chemical name: (-)-(S) -2-acetamide-N- [3,4
-Bis (ethoxycarbonyloxy) phenethyl] -4
-(Methylthio) butyramide] has an excellent effect of increasing cardiac contractility and renal blood flow upon oral administration, and is an excellent drug for improving and treating various symptoms associated with circulatory insufficiency.
【０００３】ドカルパミンは、有効血中濃度が高いので
高含量の製剤とすることが望まれるものの、水溶性が低
いため、ドカルパミンを高含量とした場合、常用される
賦形剤、崩壊剤等を配合しただけでは、崩壊性が低く、
生物学的利用能が低下するという問題があった。[0003] Docarpamine has a high effective blood concentration and is therefore desirably formulated into a high content. However, since its water solubility is low, when docalpamine is used in a high content, excipients, disintegrants and the like which are commonly used are not used. By simply blending, the disintegration is low,
There was the problem that bioavailability was reduced.
【０００４】[0004]
【発明が解決しようとする課題】本発明は、ドカルパミ
ンを高含量で配合した場合にも優れた崩壊性を示す経口
投与用製剤を提供しようとするものである。SUMMARY OF THE INVENTION An object of the present invention is to provide a preparation for oral administration which shows excellent disintegration properties even when docarpamine is incorporated at a high content.
【０００５】[0005]
【課題を解決するための手段】本発明は、ドカルパミン
に水易溶性物質、膨潤性物質およびヒドロキシプロピル
メチルセルロース（以下、ＨＰＭＣと称する。）を配合
することを特徴とする経口投与用製剤である。Means for Solving the Problems The present invention is a preparation for oral administration characterized by blending docarpamine with a water-soluble substance, a swelling substance and hydroxypropylmethylcellulose (hereinafter referred to as HPMC).
【０００６】ドカルパミンに水易溶性物質、膨潤性物質
を配合しただけの製剤では、崩壊性は改善されないが、
本発明の製剤はこれに更にヒドロキシプロピルメチルセ
ルロースを配合したものであり、これにより意外にも、
ドカルパミンを高含量で配合しても崩壊性に優れ、速や
かに有効血中濃度に達するという優れた作用効果を奏す
るものである。[0006] In a preparation containing only a water-soluble substance and a swelling substance mixed with docarpamine, disintegration is not improved,
The formulation of the present invention is further blended with hydroxypropyl methylcellulose, thereby surprisingly,
Even when docarpamine is incorporated in a high content, it has excellent disintegration properties and an excellent effect of quickly reaching an effective blood concentration.
【０００７】本発明の製剤に用いられる水易溶性物質と
しては、２０℃の水に１０ｗ／ｖ％以上溶解する物質で
あればよく、かかる物質としては例えば、シュクロー
ス、マンニット、乳糖、グルコース等が挙げられ、この
うちシュクロースまたはマンニットがとりわけ好まし
い。[0007] The easily water-soluble substance used in the preparation of the present invention may be any substance that is soluble in water at 20 ° C at a concentration of 10 w / v% or more. Examples of such substances include sucrose, mannitol, lactose, and glucose. And the like. Among them, sucrose or mannitol is particularly preferred.
【０００８】膨潤性物質としては、通常内服用固形製剤
に崩壊剤として用いられる物質であればよく、例えばカ
ルボキシメチルセルロースカルシウム、低置換度ヒドロ
キシプロピルセルロース、内部架橋カルボキシメチルセ
ルロースナトリウム、カルボキシメチルスターチ、カル
ボキシメチルセルロース、トウモロコシデンプン、小麦
デンプン、バレイショデンプンなどが挙げられる。この
うち、カルボキシメチルセルロースカルシウム、低置換
度ヒドロキシプロピルセルロース、内部架橋カルボキシ
メチルセルロースナトリウム又はカルボキシメチルスタ
ーチが好ましく、とりわけカルボキシメチルセルロース
カルシウムが好ましい。The swellable substance may be any substance which is usually used as a disintegrant in a solid preparation for internal use, such as carboxymethylcellulose calcium, low-substituted hydroxypropylcellulose, internally crosslinked sodium carboxymethylcellulose, carboxymethylstarch, carboxymethylcellulose. , Corn starch, wheat starch, potato starch and the like. Of these, carboxymethylcellulose calcium, low-substituted hydroxypropylcellulose, internally crosslinked sodium carboxymethylcellulose and carboxymethylstarch are preferable, and carboxymethylcellulose calcium is particularly preferable.
【０００９】上記の水易溶性物質および膨潤性物質は、
いずれも１種類に限られることなく、２種以上を適宜組
み合せて使用することも可能である。[0009] The water-soluble substance and the swellable substance described above include:
Each of them is not limited to one type, and two or more types can be used in appropriate combination.
【００１０】また、ＨＰＭＣとしては、白色〜帯黄白色
の繊維状の粉末又は粒で、水に溶解した時の粘度が、５
０ｃｐｓ（２％、２０℃）以下のものであればよく、か
かるＨＰＭＣとしては例えば、ＴＣ−５（信越化学社
製）、メトローズ（信越化学社製）、メトセル（ダウケ
ミカル社製）などが挙げられる。本発明においては、で
きるだけ低粘度のものが好ましい。The HPMC is a white to yellowish-white fibrous powder or granules having a viscosity of 5 when dissolved in water.
The HPMC may be 0 cps (2%, 20 ° C.) or less. Examples of such HPMC include TC-5 (manufactured by Shin-Etsu Chemical Co., Ltd.), Metro's (manufactured by Shin-Etsu Chemical Co., Ltd.), and Methocel (manufactured by Dow Chemical Company). Can be In the present invention, those having the lowest possible viscosity are preferred.
【００１１】本発明の製剤中における上記各成分の配合
量は、主薬であるドカルパミンが、約６５ｗ／ｗ％以
上、とりわけ７０〜９０ｗ／ｗ％、水易溶性物質が約４
〜８ｗ／ｗ％、とりわけ５〜７ｗ／ｗ％、膨潤性物質
が、約４〜１２ｗ／ｗ％、とりわけ６〜１０ｗ／ｗ％、
ＨＰＭＣが、約２〜６ｗ／ｗ％、とりわけ３〜５ｗ／ｗ
％であるのが好ましい。The compounding amount of each of the above components in the preparation of the present invention is such that docarpamine as the main drug is about 65 w / w% or more, especially 70 to 90 w / w%, and the water-soluble substance is about 4 w / w%.
-8% w / w, especially 5-7% w / w, the swelling substance is about 4-12% w / w, especially 6-10% w / w,
HPMC is about 2-6 w / w%, especially 3-5 w / w
%.
【００１２】本発明の製剤の剤形は、錠剤、顆粒剤、細
粒、散剤、カプセル剤等経口投与用製剤であればいずれ
の形態でもよいが、とりわけ顆粒剤、細粒が好ましい。The dosage form of the preparation of the present invention may be any form as long as it is a preparation for oral administration such as tablets, granules, fine granules, powders, capsules, etc., and granules and fine granules are particularly preferable.
【００１３】本発明の製剤は、いずれも常法により製造
することができる。例えば、本発明の製剤が顆粒剤であ
れば、ドカルパミン、水易溶性物質、膨潤性物質および
ＨＰＭＣ、要すれば各種の賦形剤を配合し、湿式造粒法
や乾式造粒法により顆粒とすればよく、更に所望によ
り、流動化剤の存在もしくは非存在下に皮膜剤をコーテ
ィングして製することができる。また、錠剤の場合に
は、上記各成分を混合したのち常法により打錠して錠剤
とし、要すればこれに上記と同様皮膜剤をコーティング
することにより容易に製することができる。本発明の製
剤は、上記各成分に加えて、所望により、この技術分野
で通常賦形剤として用いられる成分、例えばソルビッ
ト、結晶セルロース、第二リン酸カルシウム、硫酸カル
シウム等を併用することもできる。これらは、経口投与
用製剤に通常用いられるものであればいずれも使用する
ことができる。All of the preparations of the present invention can be produced by a conventional method. For example, if the preparation of the present invention is a granule, docarpamine, a water-soluble substance, a swelling substance and HPMC, and various excipients are blended if necessary, and the granules are formed by wet granulation or dry granulation. It can be produced by coating a film agent in the presence or absence of a fluidizing agent, if desired. In the case of tablets, they can be easily produced by mixing the above-mentioned components, tableting the mixture by a conventional method to give tablets, and, if necessary, coating the same with a film agent as described above. In the preparation of the present invention, in addition to the above-mentioned components, if necessary, components commonly used as excipients in this technical field, for example, sorbitol, crystalline cellulose, dibasic calcium phosphate, calcium sulfate and the like can also be used in combination. Any of these can be used as long as they are usually used for a formulation for oral administration.
【００１４】また、本発明の製剤は、所望に応じて皮膜
形成性物質で被覆されていてもよく、かかる皮膜形成性
物質としては、皮膜剤として製剤に通常用いられるもの
のうち水性の溶媒に溶解するものであれば特に限定され
ないが、投与後速やかにドカルパミンが溶出するよう、
水溶性、胃溶性ないし腸溶性のものが好ましい。かかる
皮膜形成性物質としては、例えばＨＰＭＣ、ヒドロキシ
プロピルセルロース、ヒドロキシプロピルメチルセルロ
ースフタレート、ポリビニルアセタールジエチルアミノ
アセテート、ヒドロキシプロピルメチルセルロースアセ
テートサクシネート、メタクリル酸コポリマー（商品
名：オイドラギットＥ、オイドラギットＬ、ロームアン
ドファーマ社製）等が挙げられる。The preparation of the present invention may be coated with a film-forming substance, if desired. Such a film-forming substance may be dissolved in an aqueous solvent among those usually used in preparations as a film agent. It is not particularly limited as long as docarpamine is eluted immediately after administration,
Water-soluble, gastric-soluble or enteric-soluble ones are preferred. Examples of such a film-forming substance include HPMC, hydroxypropylcellulose, hydroxypropylmethylcellulose phthalate, polyvinyl acetal diethylaminoacetate, hydroxypropylmethylcellulose acetate succinate, and methacrylic acid copolymer (trade names: Eudragit E, Eudragit L, manufactured by Rohm and Pharma Co., Ltd.) ) And the like.
【００１５】皮膜形成性物質は、製剤に対して約４〜１
０ｗ／ｗ％、とりわけ５．５〜８．５ｗ／ｗ％程度とな
る量を使用するのが好ましい。The film-forming substance is used in an amount of about 4-1 to the preparation.
It is preferable to use an amount of 0 w / w%, especially about 5.5 to 8.5 w / w%.
【００１６】また、皮膜形成性物質とともに流動化剤を
併用してもよく、このような流動化剤は、製剤に通常用
いられるものであれば良く、特に限定されないが、含水
二酸化ケイ素、無水ケイ酸、ステアリン酸、ステアリン
酸カルシウム、ステアリン酸マグネシウム、タルク等を
好適に用いることができる。Further, a fluidizing agent may be used in combination with the film-forming substance. Such a fluidizing agent may be any of those usually used in pharmaceutical preparations, and is not particularly limited. Acid, stearic acid, calcium stearate, magnesium stearate, talc and the like can be suitably used.
【００１７】以下に、実施例、実験例をあげて更に本発
明を説明する。Hereinafter, the present invention will be further described with reference to Examples and Experimental Examples.
【００１８】[0018]
実施例 ドカルパミン７５重量部、シュクロース６重量部、ＣＭ
Ｃ−Ｃａ（化学名：カルボキシメチルセルロースカルシ
ウム）９重量部を混合し、攪拌造粒機（品川式混合機）
に入れ、これにＨＰＭＣ５重量部を水に溶解させて加
え、約２０分間練合する。練合物を、ロータリー製粒機
（スクリーン ０．８ｍｍΦ）で押し出し造粒する。押
し出し造粒した顆粒を１０メッシュ篩で篩過し、乾燥し
て素顆粒を得る。素顆粒９５重量部を流動層コーティン
グ機に入れ、ＨＰＭＣ−ＡＳ（化学名：ヒドロキシプロ
ピルメチルセルロースアセテートサクシネート）５重量
部を水アルコール混液（４０：６０）に溶解させた液を
スプレーしてフィルムコーティングし、含水二酸化ケイ
素０．２重量部を加えて混合することにより、ドカルパ
ミン含有フィルムコーティング顆粒を得る。Example 75 parts by weight of docarpamine, 6 parts by weight of sucrose, CM
9 parts by weight of C-Ca (chemical name: carboxymethylcellulose calcium) are mixed and agitated granulator (Shinagawa type mixer)
And 5 parts by weight of HPMC dissolved in water are added thereto, and kneaded for about 20 minutes. The kneaded product is extruded and granulated by a rotary granulator (screen 0.8 mmΦ). The extruded granules are sieved through a 10-mesh sieve and dried to obtain elementary granules. 95 parts by weight of elementary granules are put into a fluidized bed coating machine, and a liquid obtained by dissolving 5 parts by weight of HPMC-AS (chemical name: hydroxypropylmethylcellulose acetate succinate) in a water-alcohol mixture (40:60) is sprayed to form a film coating. Then, docarpamine-containing film-coated granules are obtained by adding and mixing 0.2 parts by weight of hydrous silicon dioxide.
【００１９】実験例 実施例で得られた本発明の製剤と下記方法で得られる対
照製剤につき、崩壊性および保存安定性を調べた。 （１）対照製剤の調製 ドカルパミン７５重量部、乳糖６重量部、トウモロコシ
デンプン９重量部を混合し、攪拌造粒機（品川式混合
機）に入れ、これにポリビニルピロリドン５重量部を水
に溶解させて加え、約２０分間練合する。練合物を、ロ
ータリー製粒機（スクリーン ０．８ｍｍΦ）で押し出
し造粒する。押し出し造粒した顆粒を１０メッシュ篩で
篩過し、乾燥して素顆粒を得る。素顆粒９５重量部を流
動層コーティング機に入れ、ＨＰＭＣ５重量部を水アル
コール混液（５０：５０）に溶解させた液をスプレーし
てフィルムコーティングし、含水二酸化ケイ素 ０．２
重量部を加えて混合することにより、ドカルパミン含有
フィルムコーティング顆粒を得る。Experimental Example The disintegration and storage stability of the preparation of the present invention obtained in the examples and the control preparation obtained by the following method were examined. (1) Preparation of control preparation 75 parts by weight of docarpamine, 6 parts by weight of lactose, and 9 parts by weight of corn starch are mixed and put into a stirring granulator (Shinagawa mixer), and 5 parts by weight of polyvinylpyrrolidone is dissolved in water. And knead for about 20 minutes. The kneaded product is extruded and granulated by a rotary granulator (screen 0.8 mmΦ). The extruded granules are sieved through a 10-mesh sieve and dried to obtain elementary granules. 95 parts by weight of the raw granules are put into a fluid bed coating machine, and a solution obtained by dissolving 5 parts by weight of HPMC in a 50:50 mixture of water and alcohol is spray-coated to form a film.
By adding and mixing the parts by weight, docarpamine-containing film-coated granules are obtained.
【００２０】（２）崩壊性試験 日本薬局方（第１２改正）崩壊試験法（第２液使用）に
基づいて崩壊性試験を行った。(2) Disintegration Test A disintegration test was performed based on the Japanese Pharmacopoeia (12th revision) disintegration test method (using the second liquid).
【００２１】（３）保存安定性試験 ５０℃、１箇月間保存後の製剤について、薄層クロマト
グラフィー（ＴＬＣ）による成分分析および肉眼による
外観観察を行った。(3) Storage stability test The preparation after storage at 50 ° C. for one month was subjected to component analysis by thin layer chromatography (TLC) and visual observation with the naked eye.
【００２２】（４）結果 結果は表１に示す通りである。(4) Results The results are as shown in Table 1.
【００２３】[0023]
【表１】 [Table 1]
【００２４】[0024]
【発明の効果】本発明の製剤は、水易溶性物質、膨潤性
物質およびＨＰＭＣの３成分を配合することにより、水
溶性の低いドカルパミンを高含量で配合した場合にも、
優れた崩壊性を有するという特長をもつ。また、これら
３成分を使用することにより、主薬であるドカルパミン
の保存安定性が高いという効果も併せ有する。EFFECT OF THE INVENTION The preparation of the present invention can be prepared by blending three components of a water-soluble substance, a swellable substance and HPMC so that a low water-soluble docarpamine is blended in a high content.
It has the feature of having excellent disintegration properties. The use of these three components also has an effect that the storage stability of docarpamine, which is the main drug, is high.
フロントページの続き (51)Int.Cl.7 識別記号 ＦＩ Ａ６１Ｋ 47/36 Ａ６１Ｋ 47/36 47/38 47/38 Ａ６１Ｐ 9/04 Ａ６１Ｐ 9/04 (72)発明者 松原 孝次 兵庫県神戸市中央区大日通３丁目４番６ 号 (58)調査した分野(Int.Cl.7，ＤＢ名) A61K 31/222 A61K 9/16 A61K 9/20 A61K 9/50 A61K 47/26 A61K 47/36 A61K 47/38 A61P 9/04 ＣＡ（ＳＴＮ) ＥＭＢＡＳＥ（ＳＴＮ) ＭＥＤＬＩＮＥ（ＳＴＮ)Continued on the front page (51) Int.Cl. 7 Identification code FI A61K 47/36 A61K 47/36 47/38 47/38 A61P 9/04 A61P 9/04 (72) Inventor Koji Matsubara Chuo-ku, Kobe-shi, Hyogo 3-4-6 Dainichitsu (58) Field surveyed (Int.Cl. 7 , DB name) A61K 31/222 A61K 9/16 A61K 9/20 A61K 9/50 A61K 47/26 A61K 47/36 A61K 47/38 A61P 9/04 CA (STN) EMBASE (STN) MEDLINE (STN)
Claims (4)
質およびヒドロキシプロピルメチルセルロースを配合す
ることを特徴とする経口投与用製剤。1. A preparation for oral administration characterized by mixing a water-soluble substance, a swelling substance and hydroxypropylmethylcellulose with docarpamine.
％、膨潤性物質を４〜１２ｗ／ｗ％、ヒドロキシプロピ
ルメチルセルロースを２〜６ｗ／ｗ％配合してなる請求
項１記載の製剤。2. A preparation containing 4-8 w / w of a water-soluble substance in a preparation.
%, A swelling substance of 4 to 12 w / w%, and hydroxypropyl methylcellulose of 2 to 6 w / w%.
ニットの少なくともいずれか一種であり、膨潤性物質が
カルボキシメチルセルロースカルシウム、低置換度ヒド
ロキシプロピルセルロース、内部架橋カルボキシメチル
セルロースナトリウム又はカルボキシメチルスターチか
ら選ばれる少なくとも１種である請求項１又は２記載の
製剤。3. The water-soluble substance is at least one of sucrose and mannitol, and the swellable substance is selected from carboxymethylcellulose calcium, low-substituted hydroxypropylcellulose, internally cross-linked sodium carboxymethylcellulose, and carboxymethyl starch. 3. The preparation according to claim 1, which is at least one kind.
る請求項１、２又は３記載の製剤。4. The preparation according to claim 1, wherein the preparation surface is coated with a film-forming substance.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP4344026A JP3063438B2 (en) | 1992-12-24 | 1992-12-24 | Dopamine derivative-containing formulation for oral administration |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP4344026A JP3063438B2 (en) | 1992-12-24 | 1992-12-24 | Dopamine derivative-containing formulation for oral administration |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH06183964A JPH06183964A (en) | 1994-07-05 |
| JP3063438B2 true JP3063438B2 (en) | 2000-07-12 |
Family
ID=18366088
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP4344026A Expired - Lifetime JP3063438B2 (en) | 1992-12-24 | 1992-12-24 | Dopamine derivative-containing formulation for oral administration |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3063438B2 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2173420T3 (en) * | 1996-02-29 | 2002-10-16 | Fujisawa Pharmaceutical Co | TABLETS CONTAINING AN ANTIBIOTIC BETA-LACTAMIC AND PROCEDURE FOR PRODUCTION. |
| TW527195B (en) | 1997-10-09 | 2003-04-11 | Ssp Co Ltd | Fast-soluble solid pharmaceutical combinations |
-
1992
- 1992-12-24 JP JP4344026A patent/JP3063438B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JPH06183964A (en) | 1994-07-05 |
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