JP5452057B2 - Oral composition - Google Patents
Oral composition Download PDFInfo
- Publication number
- JP5452057B2 JP5452057B2 JP2009086919A JP2009086919A JP5452057B2 JP 5452057 B2 JP5452057 B2 JP 5452057B2 JP 2009086919 A JP2009086919 A JP 2009086919A JP 2009086919 A JP2009086919 A JP 2009086919A JP 5452057 B2 JP5452057 B2 JP 5452057B2
- Authority
- JP
- Japan
- Prior art keywords
- present
- adsorbent
- laxative
- oral
- ester
- 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.)
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Description
本発明は、吸着剤を含有する経口用組成物に関する。 The present invention relates to an oral composition containing an adsorbent.
人体に有害な影響を及ぼす化学物質などの有害物質や老廃物の体内への蓄積を回避することは難しく、我々はそれらによる悪影響を少なからず受けている。例えば、これらの蓄積は、肝機能や腎機能の低下などを生じさせ得る。そこで、これらの有害物質や老廃物を体内から排除し、健康状態を取り戻す方法が種々試みられている。 It is difficult to avoid the accumulation of harmful substances such as chemicals that have a harmful effect on the human body and waste products in the body, and we are affected by many of them. For example, these accumulations can cause a decrease in liver function or kidney function. Therefore, various methods have been tried to remove these harmful substances and waste products from the body and restore their health.
このような方法として、例えば食物繊維の摂取による排泄能の向上などによる対処法が知られている。しかしながら、該対処法は即効性に欠け、食生活の改善から長期的スパンで望まなければならないという欠点がある。また、吸着剤の服用による解毒療法が知られている。より具体的には、例えば吸着剤として薬用炭などの活性炭を服用することによる解毒療法が知られている。しかしながら、該療法には同時に投与した他の有用物質や体内に存在する有用物質を吸着剤が非特異的に吸着してしまうなどの問題がある。また、該療法には便秘などの消化不良を起こすなどの問題がある（特許文献１）。そこで、該便秘を解消するための方法として、活性炭の摂取後に下剤等の瀉下作用を有する物質を別途服用する方法が知られているが、これは瀉下作用を有する物質が活性炭に吸着されないよう、活性炭と瀉下作用を有する物質とを相当の時間的間隔をおいて別々に服用する必要があり手間を要する。 As such a method, for example, a countermeasure by improving the excretion ability by ingesting dietary fiber is known. However, this countermeasure has a drawback that it lacks immediate effect and must be desired over a long period of time from the improvement of eating habits. In addition, detoxification therapy by taking an adsorbent is known. More specifically, for example, detoxification therapy by taking activated carbon such as medicinal charcoal as an adsorbent is known. However, this therapy has a problem that the adsorbent non-specifically adsorbs other useful substances administered simultaneously or useful substances present in the body. In addition, the therapy has problems such as indigestion such as constipation (Patent Document 1). Therefore, as a method for relieving the constipation, a method of separately taking a substance having a laxative action such as laxative after ingestion of activated carbon is known, but this prevents the substance having a laxative action from being adsorbed on the activated carbon. It is necessary to take the activated carbon and the substance having an armpit action separately at a considerable time interval, which is troublesome.
このため、生体内において蓄積、発生する有害物質や老廃物の量を、有用物質量の低減を防ぎつつ、簡便かつ短時間で低減できる技術が求められている。 For this reason, there is a need for a technique that can easily and quickly reduce the amount of harmful substances and waste products accumulated and generated in a living body while preventing the amount of useful substances from being reduced.
本発明は、生体内において蓄積、発生する有害物質や老廃物の量を、有用物質量の低減を防ぎつつ、簡便かつ短時間で低減できる経口用組成物を提供することを目的とする。 An object of the present invention is to provide an oral composition that can easily and quickly reduce the amount of harmful substances and waste products accumulated and generated in a living body while preventing the amount of useful substances from being reduced.
吸着剤は、フェノール系物質をはじめとする種々の物質を吸着する性質を有する。このことから、吸着剤はそのまま投与すると体内の有用物質を吸着してしまう。また、吸着剤と瀉下剤とを同時に投与した場合には、瀉下剤が吸着剤に吸着されて便秘等の問題が解消されず、したがって有害物質や老廃物を効果的に生体内から効率よく排除できない。 The adsorbent has a property of adsorbing various substances including phenolic substances. Therefore, if the adsorbent is administered as it is, it will adsorb useful substances in the body. In addition, when adsorbent and laxative are administered at the same time, the laxative is adsorbed by the adsorbent and problems such as constipation are not eliminated, so harmful substances and waste are effectively eliminated from the living body effectively. Can not.
本発明者らが前記課題を解決するべく鋭意検討を重ねたところ、吸着剤、及び炭素数10〜40の長鎖脂肪酸とグリセロールとのエステルを組み合わせて用いることにより、生体内において蓄積、発生する有害物質や老廃物を簡便かつ短時間で排除できる優れた組成物が得られることを見出した。本発明は前記知見に基づきさらに検討を重ねた結果完成されたものであり、下記に掲げるものである。
項１．吸着剤、及び炭素数10〜40の長鎖脂肪酸とグリセロールとのエステルを含有する経口用組成物。
項２．吸着剤が多孔体である、項１に記載の経口用組成物。
項３．多孔体が薬用炭、活性炭、球状炭、カオリン、及び天然ケイ酸アルミニウムからなる群より選択される少なくとも1種である、項２に記載の経口用組成物。
項４．エステルが炭素数10〜40の長鎖脂肪酸三分子とグリセロールとのトリエステルである、項１〜３のいずれかに記載の経口用組成物。
項５．吸着剤１重量部に対してエステル0.5〜12.5重量部を含有する、項１〜４のいずれかに記載の経口用組成物
項６．さらに、瀉下剤を含有する、項１〜５のいずれかに記載の経口用組成物。
項７．瀉下剤が大腸刺激性下剤である、項６に記載の経口用組成物。
項８．大腸刺激性下剤がジフェニルメタン系下剤、アントラキノン系下剤、フェノールフタレイン系下剤、及び生薬系下剤からなる群より選択される少なくとも1種である、項７に記載の経口用組成物。
項９．経口薬又は食品である、項１〜８のいずれかに記載の経口用組成物。
As a result of extensive studies by the present inventors to solve the above-mentioned problems, it is accumulated and generated in a living body by using an adsorbent and a combination of a long-chain fatty acid having 10 to 40 carbon atoms and glycerol. It has been found that an excellent composition capable of easily removing harmful substances and waste products in a short time can be obtained. The present invention has been completed as a result of further studies based on the above findings, and is described below.
Item 1. An oral composition comprising an adsorbent and an ester of a long-chain fatty acid having 10 to 40 carbon atoms and glycerol.
Item 2. Item 2. The oral composition according to Item 1, wherein the adsorbent is a porous material.
Item 3. Item 3. The oral composition according to Item 2, wherein the porous material is at least one selected from the group consisting of medicinal charcoal, activated carbon, spherical charcoal, kaolin, and natural aluminum silicate.
Item 4. Item 4. The oral composition according to any one of Items 1 to 3, wherein the ester is a triester of three long-chain fatty acid molecules having 10 to 40 carbon atoms and glycerol.
Item 5. Item 5. The oral composition according to any one of Items 1 to 4, comprising 0.5 to 12.5 parts by weight of an ester with respect to 1 part by weight of the adsorbent. Item 6. The oral composition according to any one of Items 1 to 5, further comprising a laxative.
Item 7. Item 7. The oral composition according to Item 6, wherein the laxative is a colon-irritating laxative.
Item 8. Item 8. The oral composition according to Item 7, wherein the colonic stimulant laxative is at least one selected from the group consisting of a diphenylmethane laxative, an anthraquinone laxative, a phenolphthalein laxative, and a herbal medicinal laxative.
Item 9. Item 9. The oral composition according to any one of Items 1 to 8, which is an oral drug or food.
本発明の経口用組成物によれば、有用物質量の低減を防ぎつつ、有害物質や老廃物の量を簡便かつ短時間で低減できる。 According to the oral composition of the present invention, it is possible to reduce the amount of harmful substances and waste products easily and in a short time while preventing the amount of useful substances from being reduced.
また、本発明の経口用組成物によれば、有害物質や老廃物の生体内量を効果的に低減できることから、高尿酸血症、腎不全、肝疾患、さらには尿毒症、意識障害等の脳症等の疾患の症状や有害物質・老廃物の影響による肝臓、腎臓、消化器官等の機能低下、それに伴う抜け毛、肌荒れ、乾燥肌、疲労感、頭痛、精神不安等を軽減することができる。 In addition, according to the oral composition of the present invention, since the in vivo amount of harmful substances and waste products can be effectively reduced, hyperuricemia, renal failure, liver disease, uremia, consciousness disorder, etc. It is possible to reduce the deterioration of the liver, kidney, digestive organs, etc. due to the symptoms of diseases such as encephalopathy and the effects of harmful substances and waste products, and associated hair loss, rough skin, dry skin, fatigue, headache, mental anxiety and the like.
特に本発明の経口用組成物がさらに瀉下剤を含む場合には、吸着剤及び瀉下剤を同時に又は逐次に投与しているにもかかわらず、瀉下剤が従来のように過剰に吸着剤に吸着されることなく、吸着剤及び瀉下剤をともに作用させることができる。より詳細には、吸着剤の作用により、生体内の有害物質及び老廃物の量を低減させることができる。また、瀉下剤の作用により、吸着剤に起因する便秘等の消化不良を回避しつつ吸着剤を体外に排出することができる。 In particular, when the oral composition of the present invention further contains a laxative, the laxative is adsorbed excessively on the adsorbent as in the past even though the adsorbent and the laxative are administered simultaneously or sequentially. The adsorbent and the laxative can act together without being treated. More specifically, the amount of harmful substances and waste products in the living body can be reduced by the action of the adsorbent. In addition, the action of the laxative can discharge the adsorbent out of the body while avoiding indigestion such as constipation due to the adsorbent.
１．本発明の経口用組成物
本発明の経口用組成物は、吸着剤、及び炭素数10〜40の長鎖脂肪酸とグリセロールとのエステルを含有することを主な特徴とする。また、本発明の経口用組成物は必要に応じてさらに瀉下剤を含んでいてもよい。以下、本発明の構成について詳細に説明する。
1. Oral composition of the present invention The oral composition of the present invention is mainly characterized by containing an adsorbent and an ester of a long-chain fatty acid having 10 to 40 carbon atoms and glycerol. The oral composition of the present invention may further contain a laxative as necessary. Hereinafter, the configuration of the present invention will be described in detail.
（１）吸着剤
吸着剤は、その表面に他の物質を付着させる性質を有するものである。吸着剤は、経口投与可能であり、かつ生体内で有害物質や老廃物を吸着するものであればよく、特に限定されない。例えば、各種の多孔体が挙げられる。
(1) Adsorbent Adsorbent has the property of adhering other substances to its surface. The adsorbent is not particularly limited as long as it can be administered orally and adsorbs harmful substances and wastes in vivo. For example, various porous bodies are mentioned.
本発明において多孔体とは内部及び表面に、又は内部若しくは表面のいずれかに微細な空隙が多数存在する物質を意味する。多孔体としては、例えば、各種の炭類、カオリン、及び天然ケイ酸アルミニウム等が好ましく用いられる。炭類としては活性炭、薬用炭、及び球状炭等が例示される。なかでも、有害物質や老廃物の吸着能、及び安全性等の点から薬用炭が好ましい。薬用炭は日本薬局方における規定に従い、各種木炭、おがくず、石炭、食物繊維質など含炭素物質を原料とする。これらは単独で使用してもよく、２種以上を組み合わせて使用してもよい。 In the present invention, the porous body means a substance having a large number of fine voids inside and on the surface, or inside or on the surface. As the porous body, for example, various charcoal, kaolin, natural aluminum silicate, and the like are preferably used. Examples of the charcoal include activated carbon, medicinal charcoal, and spherical charcoal. Of these, medicinal charcoal is preferred from the standpoints of adsorbability and safety of harmful substances and waste products. Medicinal charcoal is based on carbon-containing substances such as various charcoal, sawdust, coal, and dietary fiber, in accordance with Japanese Pharmacopoeia regulations. These may be used alone or in combination of two or more.
吸着剤の形状は、本発明の効果を妨げない限り制限されないが、粉状、粒状、球状が例示される。吸着剤の形状は、後述する常温液状油及び水溶性高分子等との相性等の点から、好ましくは粉状、又は粒状であり、より好ましくは粉状である。 The shape of the adsorbent is not limited as long as the effect of the present invention is not hindered, but examples thereof include powder, granule, and sphere. The shape of the adsorbent is preferably powdery or granular, more preferably powdery, from the viewpoint of compatibility with room temperature liquid oil and a water-soluble polymer described later.
また、吸着剤の大きさ（平均粒子径）も、本発明の効果を妨げない限り制限されない。例えば、吸着剤の大きさは好ましくは０．０１〜２０００μｍ、好ましくは０．１〜１０００μｍ、より好ましくは１〜２００μｍが例示される。 Moreover, the magnitude | size (average particle diameter) of adsorption agent is not restrict | limited, unless the effect of this invention is prevented. For example, the size of the adsorbent is preferably 0.01 to 2000 μm, preferably 0.1 to 1000 μm, more preferably 1 to 200 μm.
なお、本発明において、大きさ（平均粒子径）とはコールターカウンター法により測定されたものをいう。コールターカウンター法による測定機器としては、ベックマン・コールター株式会社製「Multisizer 3」又はそれに準ずる機器を使用する。 In the present invention, the size (average particle diameter) means that measured by the Coulter counter method. As a measuring device by the Coulter counter method, “Multisizer 3” manufactured by Beckman Coulter, Inc. or an equivalent device is used.
薬用炭以外の吸着剤、又は複数の吸着剤を組み合わせて利用する場合には、その形状及び大きさは、前記薬用炭の形状及び大きさ並びに有害物質や老廃物の排出効果の関係に基づき適宜設定される。 When using an adsorbent other than medicinal charcoal, or a combination of adsorbents, the shape and size of the adsorbent are appropriately determined based on the relationship between the shape and size of the medicinal charcoal and the effect of discharging harmful substances and waste products. Is set.
なお、ここで有害物質及び老廃物とは、腸管内で産生されたり消化管で分泌されるなど生体内で発生する物質や、経口的に摂取される飲食品等に含まれる種々の物質や微生物、また薬物などを含み、生体内に吸収又は蓄積されることにより疾患をもたらし得るものを指す。疾患としては、特に限定されないが、例えば、肝機能や腎機能の低下、高尿酸血症、尿毒症、意識障害等の脳症等が挙げられる。具体的には例えば、肝機能障害、腎機能障害
等が挙げられ、その自覚症状としては抜け毛、肌荒れ、乾燥肌、疲労感、頭痛、精神不安など様々である。
Here, harmful substances and waste products are substances generated in the living body such as produced in the intestinal tract and secreted in the digestive tract, and various substances and microorganisms contained in food and drink taken orally. In addition, it means a substance that contains a drug or the like and can cause a disease by being absorbed or accumulated in a living body. Although it does not specifically limit as a disease, For example, encephalopathy, such as a fall of a liver function and a renal function, hyperuricemia, uremia, and consciousness disorder, etc. are mentioned. Specific examples include liver dysfunction, renal dysfunction, and the like, and various subjective symptoms include hair loss, rough skin, dry skin, fatigue, headache, and mental anxiety.
（２）炭素数10〜40の長鎖脂肪酸とグリセロールとのエステル
炭素数10〜40の長鎖脂肪酸とグリセロールとのエステルは、本発明の効果を妨げない限り制限されない。なお、本明細書においては、炭素数10〜40の長鎖脂肪酸とグリセロールとのエステルのことを単に「エステル」と表記することもある。
(2) Ester of long-chain fatty acid having 10 to 40 carbon atoms and glycerol The ester of long-chain fatty acid having 10 to 40 carbon atoms and glycerol is not limited as long as the effect of the present invention is not hindered. In the present specification, an ester of a long-chain fatty acid having 10 to 40 carbon atoms and glycerol may be simply referred to as “ester”.
（２−１）長鎖脂肪酸
本発明の効果をより顕著に奏することから、炭素数10〜40の長鎖脂肪酸の中でも、炭素数10〜30の長鎖脂肪酸が好ましく、炭素数10〜20の長鎖脂肪酸がより好ましい。
(2-1) Long chain fatty acid Since the effects of the present invention are more remarkably exhibited, among long chain fatty acids having 10 to 40 carbon atoms, long chain fatty acids having 10 to 30 carbon atoms are preferable, and those having 10 to 20 carbon atoms are preferred. Long chain fatty acids are more preferred.
例えば、炭素数10〜40の長鎖脂肪酸としては、本発明の効果を妨げない限り、直鎖飽和脂肪酸、直鎖不飽和脂肪酸、分岐飽和脂肪酸、分岐不飽和脂肪酸、環状脂肪酸、含酸素脂肪酸、又はヒドロキシ脂肪酸であってもよい。中でも、直鎖飽和脂肪酸または直鎖不飽和脂肪酸が好ましく、直鎖飽和脂肪酸としては、例えばミリスチン酸、ペンタデシル酸、パルミチン酸、ヘプタデシル酸、ステアリン酸、ノナデカン酸、アラキン酸、ベヘン酸、リグノセリン酸、セロチン酸、ヘプタコサン酸、モンタン酸、メリシン酸、ラクセル酸等を挙げることができ、直鎖不飽和脂肪酸としては、例えばオレイン酸、リノール酸、リノレン酸等を挙げることができる。中でも、本発明の効果をより顕著に奏することから、ミリスチン酸、パルミチン酸、ステアリン酸、オレイン酸、リノール酸、及びリノレン酸からなる群より選択される少なくとも１種がより好ましい。 For example, as long-chain fatty acids having 10 to 40 carbon atoms, straight saturated fatty acids, linear unsaturated fatty acids, branched saturated fatty acids, branched unsaturated fatty acids, cyclic fatty acids, oxygenated fatty acids, as long as the effects of the present invention are not hindered. Alternatively, it may be a hydroxy fatty acid. Among these, linear saturated fatty acids or linear unsaturated fatty acids are preferred, and examples of the linear saturated fatty acids include myristic acid, pentadecylic acid, palmitic acid, heptadecylic acid, stearic acid, nonadecanoic acid, arachidic acid, behenic acid, lignoceric acid, Examples include serotic acid, heptacosanoic acid, montanic acid, melicic acid, and laccelic acid. Examples of the linear unsaturated fatty acid include oleic acid, linoleic acid, and linolenic acid. Among them, at least one selected from the group consisting of myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, and linolenic acid is more preferable because the effects of the present invention are more remarkably exhibited.
（２−２）エステル
炭素数10〜40の長鎖脂肪酸とグリセロールとのエステルは、モノエステルであってもよく、ジエステルであってもよく、またトリエステルであってもよい。本発明の効果をより顕著に奏することからトリエステルが好ましい。ジエステル又はトリエステルは、上で説明した長鎖脂肪酸のいずれか1種とグリセロールとのエステルであってもよく、いずれか２種以上とグリセロールとのエステルであってもよい。
(2-2) The ester of a long-chain fatty acid having 10 to 40 ester carbon atoms and glycerol may be a monoester, a diester, or a triester. A triester is preferable because the effects of the present invention are more remarkably exhibited. The diester or triester may be an ester of any one of the long-chain fatty acids described above with glycerol, or may be an ester of any two or more with glycerol.
炭素数10〜40の長鎖脂肪酸とグリセロールとのエステルは、例えば、グリセリン脂肪酸エステル、硬化油、サフラワー油、キャノーラ油、パーム油、ヤシ油、ゴマ油、硬化油（例えば、ナタネ由来、ゴマ由来）、オリブ油、大豆油、ひまし油、コーン油、綿実油、ラード、ヘット、魚油、及びミリスチン酸イソプロピル等を挙げることができる。これらは単独で使用してもよく、２種以上を組み合わせて使用してもよい。中でも、本発明の効果をより顕著に奏することから、サフラワー油、キャノーラ油、ゴマ油、硬化油（例えば、ナタネ由来、ゴマ由来）、及びラードからなる群より選択される少なくとも１種が好ましい。 Esters of long chain fatty acids having 10 to 40 carbon atoms and glycerol are, for example, glycerin fatty acid ester, hydrogenated oil, safflower oil, canola oil, palm oil, coconut oil, sesame oil, hydrogenated oil (for example, rapeseed, sesame ), Olive oil, soybean oil, castor oil, corn oil, cottonseed oil, lard, head, fish oil, and isopropyl myristate. These may be used alone or in combination of two or more. Among these, at least one selected from the group consisting of safflower oil, canola oil, sesame oil, hardened oil (eg, rapeseed-derived, sesame-derived), and lard is preferable because the effects of the present invention are more remarkably exhibited.
（３）瀉下剤
本発明の経口用組成物に配合される瀉下剤としては、瀉下作用を有するものであればよく、本発明の効果を妨げない限り制限されない。例えば、一般に薬の成分として用いられるものを用いることができる。そのような瀉下剤としては、例えば、一般に大腸刺激性下剤として用いられるもの等が挙げられる。大腸刺激性下剤は、大腸の粘膜に直接作用することにより瀉下作用を有する下剤であり、ジフェニルメタン系、アントラキノン系、フェノールフタレイン系、及び生薬系に分類される。
(3) Laxative agent The laxative compounded in the oral composition of the present invention is not limited as long as it has a laxative action and does not interfere with the effects of the present invention. For example, what is generally used as a medicine component can be used. Examples of such laxatives include those generally used as colonic stimulating laxatives. Colonic stimulant laxatives are laxatives that have a laxative action by acting directly on the mucosa of the large intestine, and are classified into diphenylmethane, anthraquinone, phenolphthalein, and herbal medicines.
ジフェニルメタン系の下剤としては、ピコスルファートナトリウム、ビサコジル等が例示される。 Examples of the diphenylmethane laxative include picosulfate sodium and bisacodyl.
また、アントラキノン系の下剤としては、センノシド、センノシドＡ・Ｂ、これらのカルシウム塩、アロイン等が例示される。 Examples of anthraquinone laxatives include sennoside, sennoside A / B, calcium salts thereof, and aloin.
また、フェノールフタレイン系の下剤としては、フェノールフタレイン及びフェノバリン等が例示される。 Examples of the phenolphthalein laxative include phenolphthalein and phenovaline.
また、生薬系の下剤としては、アロエ、アカメガシワ、ダイオウ、ゲンノショウコ、ケツメイシ、アセンヤク、ウバイ、エイジツ、カスカラサグラダ、ケンゴシ、センナ及びこれらのエキス等が例示される。 Moreover, examples of herbal physic laxatives include aloe, red-crowned wrinkles, daiou, geno shoko, katsumeshi, asenyaku, ubai, ages, kasara sagrada, kengoshi, senna, and extracts thereof.
これらは単独で使用してもよく、２種以上を組み合わせて使用してもよい。 These may be used alone or in combination of two or more.
（４）経口用組成物
本発明の経口用組成物は、吸着剤、及び炭素数10〜40の長鎖脂肪酸とグリセロールとのエステルを含有する。また、本発明の経口用組成物は必要に応じてさらに瀉下剤を含んでいてもよい。
(4) Oral Composition The oral composition of the present invention contains an adsorbent and an ester of glycerol and a long-chain fatty acid having 10 to 40 carbon atoms. The oral composition of the present invention may further contain a laxative as necessary.
本発明の経口用組成物においては、吸着剤とエステルとは、単に混合されていればよい。混合の方法としては、例えば、液状のエステルに吸着剤を加え、両者を撹拌により混合してもよい。 In the oral composition of the present invention, the adsorbent and the ester need only be mixed. As a mixing method, for example, an adsorbent may be added to a liquid ester, and both may be mixed by stirring.
本発明の経口用組成物がさらに瀉下剤を含む場合、瀉下剤は同様に吸着剤及びエステルと混合されていてもよいし、あるいは同一製剤中において吸着剤及びエステルとは異なる区画に瀉下剤が配置されていてもよい。 When the oral composition of the present invention further contains a laxative, the laxative may be mixed with the adsorbent and the ester, or the laxative is in a different compartment from the adsorbent and the ester in the same preparation. It may be arranged.
本発明の経口用組成物は、経口薬又は食品である。 The oral composition of the present invention is an oral drug or food.
（４−１）経口薬
本発明の経口薬の形態としては、錠剤、顆粒剤、カプセル剤（ソフトカプセルを含む）等の固形製剤が例示される。例えば、錠剤は、必要に応じ通常の剤皮を施したもの、例えば糖衣錠、ゼラチン被包錠、腸溶被錠、フィルムコーティング錠あるいは二重錠、多層錠とすることができる。このほかの固形製剤についても、必要に応じて、同様に剤皮を施すことができる。
(4-1) Oral Drug Examples of the oral drug form of the present invention include solid preparations such as tablets, granules, and capsules (including soft capsules). For example, the tablet can be a tablet with a usual coating as required, for example, a sugar-coated tablet, a gelatin-encapsulated tablet, an enteric-coated tablet, a film-coated tablet, a double tablet, or a multilayer tablet. For other solid preparations, a coating can be similarly applied as necessary.
このような本発明の経口薬には、薬学的に許容される賦形剤、担体等を更に添加することができる。 To such an oral drug of the present invention, pharmaceutically acceptable excipients, carriers and the like can be further added.
本発明の経口薬を錠剤とする場合には、担体として当該分野で従来公知のものを広く使用することができる。このような担体としては、例えば乳糖、白糖、塩化ナトリウム、ブドウ糖、尿素、デンプン、炭酸カルシウム、カオリン、ケイ酸等の賦形剤；水、エタノール、プロパノール、単シロップ、ブドウ糖液、デンプン液、ゼラチン溶液、Ｄ−ソルビトール液、セラック、メチルセルロース、リン酸カリウム、ポリビニルピロリドン、結晶セルロース、ヒドロキシプロピルセルロース、ヒプロメロース、アルギン酸ナトリウム等の結合剤；メタクリル酸コポリマーL（デグサ社製、商品名オイドラギッドL100）、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、酢酸フタル酸セルロース等のコーティング剤；乾燥デンプン、カンテン末、ラミナラン末、炭酸水素ナトリウム、ポリオキシエチレンソルビタン脂肪酸エステル類、ラウリル硫酸ナトリウム、ステアリン酸モノグリセリド、デンプン、クロスポビドン、ポビドン等の崩壊剤；ステアリン、カカオバター、水素添加油等の崩壊抑制剤；第４級アンモニウム塩、ラウリル硫酸ナトリウム等の吸収促進剤；グリセリン等保湿剤；デンプン、乳糖、カオリン、ベントナイト、コロイド状ケイ酸等の吸着剤；精製タルク、ステアリン酸塩、ホウ酸末、ポリエチレングリコール等の滑沢剤；ステビア、ソルビトール、マルチトール、キシリトール、アスパルテーム等の甘味剤等を使用できる。 When the oral medicine of the present invention is used as a tablet, a wide variety of carriers conventionally known in the art can be used as a carrier. Examples of such carriers include excipients such as lactose, sucrose, sodium chloride, glucose, urea, starch, calcium carbonate, kaolin, silicic acid; water, ethanol, propanol, simple syrup, glucose solution, starch solution, gelatin Binders such as solution, D-sorbitol solution, shellac, methylcellulose, potassium phosphate, polyvinylpyrrolidone, crystalline cellulose, hydroxypropylcellulose, hypromellose, sodium alginate; methacrylic acid copolymer L (trade name Eudragit L100, manufactured by Degussa), hydroxy Coating agents such as propylmethylcellulose acetate succinate and cellulose acetate phthalate; dry starch, agar powder, laminaran powder, sodium bicarbonate, polyoxyethylene sorbitan fatty acid esters, lauryl Disintegrating agents such as sodium acid, stearic acid monoglyceride, starch, crospovidone and povidone; disintegration inhibitors such as stearin, cocoa butter and hydrogenated oil; absorption promoters such as quaternary ammonium salts and sodium lauryl sulfate; Agents: Adsorbents such as starch, lactose, kaolin, bentonite, colloidal silicic acid; Lubricants such as purified talc, stearate, boric acid powder, polyethylene glycol; Stevia, sorbitol, maltitol, xylitol, aspartame, etc. Sweeteners can be used.
本発明の経口薬を錠剤とする場合には、例えば吸着物及びエステルを含む内層を、直接又は瀉下剤を含有しないフィルム層を挟んで、瀉下剤を含有するフィルムで被覆することができる。これは例えば、顆粒等の状態にした前記内層に対して、瀉下剤及び高分子等を含む溶液を噴霧、乾燥させることにより製造することができる。 When the oral medicine of the present invention is used as a tablet, for example, an inner layer containing an adsorbate and an ester can be covered with a film containing a laxative agent directly or sandwiching a film layer not containing a laxative agent. This can be produced, for example, by spraying and drying a solution containing a laxative and a polymer on the inner layer in a granular state.
本発明の経口薬をカプセル剤とする場合には、前記活性炭、水膨潤性物質及び大腸刺激性下剤、ならびに必要に応じて添加される薬学的に許容される賦形剤や担体等を、ゼラチン、プルラン、デンプン、アラビアガム等を原料とする従来公知のカプセルに充填することによりカプセル剤としてもよい。 When the oral drug of the present invention is used as a capsule, the activated carbon, the water-swellable substance and the colon-irritating laxative, and pharmaceutically acceptable excipients and carriers added as necessary, Capsules may be prepared by filling conventionally known capsules made from pullulan, starch, gum arabic and the like.
また、本発明の経口薬を丸剤とする場合には、担体として当該分野で従来公知のものを広く使用することができ、ブドウ糖、乳糖、デンプン、カカオ脂、硬化植物油、カオリン、タルク等の賦形剤、アラビアゴム末、トラガント末、ゼラチン、エタノール等の結合材、ラミナラン、カンテン等の崩壊剤等を使用できる。 In addition, when the oral medicine of the present invention is used as a pill, conventionally known carriers can be widely used as carriers, such as glucose, lactose, starch, cocoa butter, hydrogenated vegetable oil, kaolin, talc and the like. Excipients, gum arabic powder, tragacanth powder, binders such as gelatin and ethanol, disintegrants such as laminaran and agar can be used.
前記以外に、添加剤として、例えば界面活性剤、吸収促進剤、吸着剤、充填剤、防腐剤、安定剤、乳化剤、可溶化剤、浸透圧を調節する塩を、製剤の投与単位形態に応じて適宜選択し使用できる。 In addition to the above, as additives, for example, surfactants, absorption accelerators, adsorbents, fillers, preservatives, stabilizers, emulsifiers, solubilizers, salts that regulate osmotic pressure, depending on the dosage unit form of the preparation Can be selected and used as appropriate.
また、アミノ酸、ビタミン類、無機塩類、生薬類、植物類、植物由来油、整腸生菌等の他の活性成分を含有させてもよい。他の活性成分としては、例えば、バリン、ロイシン、イソロイシン、トレオニン、メチオニン、フェニルアラニン、トリプトファン、リジン、グリシン、アラニン、アスパラギン、グルタミン、セリン、システイン、シスチン、チロシン、プロリン、ヒドロキシプロリン、アスパラギン酸、グルタミン酸、ヒドロキシリジン、アルギニン、オルニチン、ヒスチジン等のアミノ酸；ビタミンＡ１、ビタミンＡ２、カロチン、リコピン（プロビタミンＡ）、ビタミンＢ６、ビタミンＢ１、ビタミンＢ２、アスコルビン酸、ニコチン酸アミド、ビオチン等のビタミン類；塩化ナトリウム、塩化カリウム、酸化マグネシウム等の金属塩や、クエン酸塩、酢酸塩、リン酸塩等の無機塩類；アロエ、ゲンノショウコ、マオウ、アカメガシワ、ダイオウ及びこれらのエキスを含む生薬類；プランタゴ・オバタなどの植物類；植物油等；乳酸菌等の整腸生菌等が例示される。 In addition, other active ingredients such as amino acids, vitamins, inorganic salts, herbal medicines, plants, plant-derived oils, live intestinal fungi may be contained. Examples of other active ingredients include valine, leucine, isoleucine, threonine, methionine, phenylalanine, tryptophan, lysine, glycine, alanine, asparagine, glutamine, serine, cysteine, cystine, tyrosine, proline, hydroxyproline, aspartic acid, glutamic acid , Amino acids such as hydroxylysine, arginine, ornithine, histidine; vitamins such as vitamin A1, vitamin A2, carotene, lycopene (provitamin A), vitamin B6, vitamin B1, vitamin B2, ascorbic acid, nicotinamide, biotin; Metal salts such as sodium chloride, potassium chloride, magnesium oxide, and inorganic salts such as citrate, acetate, phosphate, etc .; aloe, ganoderma, mao, akamegasiwa, diou and Herbal such containing these extracts; plants such as Plantago Obata; vegetable oil; intestinal bacteria such as lactic acid are exemplified.
本発明の経口薬が前記錠剤、カプセル剤以外の固形製剤の形態であっても、必要に応じて前記賦形剤、担体等を添加することができる。 Even if the oral medicine of the present invention is in the form of a solid preparation other than the tablet and capsule, the excipient, carrier and the like can be added as necessary.
本発明の経口薬における吸着剤の配合割合は、本発明の効果を妨げない限り制限されないが、本発明の効果をより顕著に奏することから、本発明の経口薬における吸着剤の配合割合は、例えば３〜７５重量％が好ましい。 The blending ratio of the adsorbent in the oral drug of the present invention is not limited as long as it does not interfere with the effects of the present invention, but since the effects of the present invention are more prominent, the blending ratio of the adsorbent in the oral drug of the present invention is: For example, 3 to 75% by weight is preferable.
炭素数10〜40の長鎖脂肪酸とグリセロールとのエステルの経口用組成物における配合割合は、本発明の効果を妨げない限り制限されないが、本発明の効果をより顕著に奏することから、本発明の経口薬におけるエステルの配合割合は、例えば３〜６０重量％が好ましい。 The blending ratio in the oral composition of an ester of a long-chain fatty acid having 10 to 40 carbon atoms and glycerol is not limited as long as the effect of the present invention is not hindered, but the effect of the present invention is more prominent. The blending ratio of the ester in the oral medicine is preferably 3 to 60% by weight, for example.
また、エステルの吸着剤に対する配合比率は、本発明の効果を妨げない限り制限されないが、本発明の効果をより顕著に奏することから、これらエステルの吸着剤に対する配合比率は、吸着剤1重量部に対して0.5重量部〜12.5重量部が好ましい。 Further, the blending ratio of the ester to the adsorbent is not limited as long as the effect of the present invention is not hindered, but the blending ratio of these esters to the adsorbent is 1 part by weight of the adsorbent because the effects of the present invention are more prominent. 0.5 parts by weight to 12.5 parts by weight is preferable.
本発明の経口薬における瀉下剤の配合割合は、本発明の効果を妨げない限り制限されないが、本発明の効果をより顕著に奏することから、本発明の経口薬における瀉下剤の配合割合は、例えば０．１〜８０重量％が好ましい。 The blending ratio of the laxative in the oral medicine of the present invention is not limited as long as it does not interfere with the effect of the present invention, but since the effect of the present invention is more prominent, the blending ratio of the laxative in the oral drug of the present invention is For example, 0.1 to 80% by weight is preferable.
瀉下剤の吸着剤に対する配合比率は、発明の効果を妨げない限り制限されないが、本発明の効果をより顕著に奏することから、瀉下剤の吸着剤に対する配合比率は、例えば、吸着剤１００重量部に対して０．２５〜１３５０重量部が好ましい。 The blending ratio of the laxative to the adsorbent is not limited as long as it does not interfere with the effects of the invention. However, the blending ratio of the laxative to the adsorbent is, for example, 100 parts by weight of the adsorbent. The amount is preferably 0.25 to 1350 parts by weight.
本発明の経口薬を各種製剤に調製した場合の１日摂取量は、投与対象の状態や症状の程度に応じて適宜変更され得るが、大人１人（体重６０ｋｇ）に対する１日あたりの投与量は経口薬中の活性炭量として通常１００〜４０００ｍｇ、好ましくは１５０〜２０００ｍｇ、より好ましくは２００〜１０００ｍｇである。また、本発明の経口薬は、通常１日１〜３回に分けて経口投与の形態で用いられる。服用時刻は特に限定されないが、食後が好ましい。 The daily intake when the oral preparation of the present invention is prepared into various preparations can be appropriately changed according to the condition of the administration subject and the degree of symptoms, but the daily dose for one adult (body weight 60 kg) Is usually 100 to 4000 mg, preferably 150 to 2000 mg, more preferably 200 to 1000 mg as the amount of activated carbon in the oral medicine. In addition, the oral medicine of the present invention is usually used in the form of oral administration divided into 1 to 3 times a day. The dose time is not particularly limited, but is preferably after meals.
（４−２）食品
本発明の食品の形態は発明の効果を妨げない限り制限されない。
(4-2) Food The form of the food of the present invention is not limited as long as the effects of the invention are not hindered.
本発明の食品の形態には、本発明の経口薬において説明したような固形製剤も含まれる。本発明の食品のうち固形製剤については、本発明の経口薬における説明に準じて、当該分野において通常行われるところに従って製造することができる。 The form of the food of the present invention includes a solid preparation as described in the oral medicine of the present invention. Among the foods of the present invention, the solid preparation can be produced according to the description in the oral medicine of the present invention according to the usual practice in the field.
また、本発明の食品の形態には一般食品も含まれる。 Moreover, general food is also contained in the form of the foodstuff of this invention.
本発明の食品の形態のうち一般食品としては、例えば小麦粉、デンプン粉、乳製品、及びクリーム等；豆腐、蒲鉾、ハム、及びソーセージ等；並びにドレッシング又はルウのような各種調味料が挙げられる。 Among the food forms of the present invention, examples of the general food include wheat flour, starch powder, dairy products, and creams; tofu, rice cake, ham, sausage, and the like; and various seasonings such as dressing or roux.
本発明の食品には、必要に応じて、発明の効果を妨げない範囲で、当該分野において通常用いられる添加物をさらに配合することができる。 If necessary, the food of the present invention may further contain additives commonly used in the art as long as the effects of the invention are not hindered.
添加物としては、食品に一般的に使用される、賦形剤、滑沢剤、結合剤、防腐剤、粘稠剤、ｐＨ調整剤、甘味料、酸味料、着色料、香料、などが挙げられる。 Examples of additives include excipients, lubricants, binders, preservatives, thickeners, pH adjusters, sweeteners, acidulants, colorants, flavors and the like commonly used in foods. It is done.
本発明の食品を調製するに際しては、吸着剤、エステル、及び必要に応じて瀉下剤、並びに必要に応じて添加物を、任意の順番で配合することができる。全て同時に配合してもよいし、順次配合してもよい。また、添加物のみを他の配合成分とは独立して別個に配合してもよい。 In preparing the food of the present invention, an adsorbent, an ester, an optional laxative, and an additive as required can be blended in any order. You may mix | blend all at the same time and may mix | blend sequentially. Moreover, you may mix | blend only an additive independently independently of another compounding component.
本発明の食品における、吸着剤、エステル、及び必要に応じて配合される瀉下剤の含量については、本発明の経口薬で説明した摂取量に基づき適宜設定される。 About the content of the adsorbent, ester, and the laxative mix | blended as needed in the foodstuff of this invention, it sets suitably based on the intake demonstrated with the oral medicine of this invention.
本発明の食品は、例えば食品に対して吸着剤、エステル、及び必要に応じて配合される瀉下剤を練り込むことにより製造することができる。 The food of the present invention can be produced, for example, by kneading an adsorbent, an ester, and a laxative blended as necessary with the food.
本発明の食品を摂取することにより、有用物質量の低減を防ぎつつ、有害物質や老廃物の量を簡便かつ短時間で低減できる。このことにより、普段の食事によって健康増進を図ることができる。 By ingesting the food of the present invention, it is possible to reduce the amount of harmful substances and waste products easily and in a short time while preventing the amount of useful substances from being reduced. As a result, health promotion can be promoted by a normal meal.
本発明の食品を摂取量は、本発明の経口薬において説明した摂取量に基づき適宜設定される。 The intake of the food of the present invention is appropriately set based on the intake described in the oral medicine of the present invention.
以下に実施例、比較例及び試験例により本発明をさらに詳細に説明するが、本発明は以下の例にのみ限定されるものではない。 The present invention will be described in more detail with reference to the following examples, comparative examples, and test examples, but the present invention is not limited to the following examples.
１．実施例：本発明の経口用組成物の製造
表１及び２の通り実施例毎に各成分を秤量した上で混合することにより、本発明の経口用組成物を得た。
1. Example: Production of oral composition of the present invention As shown in Tables 1 and 2, each component was weighed for each example and mixed to obtain an oral composition of the present invention.
２．比較例：比較対照造粒物の製造
表３の通り比較例毎に各成分を用い、実施例と同様に経口用組成物を得た。これらを以下の試験例において、実施例の経口用組成物に対する比較対照として用いた。
2. Comparative Example: Production of Comparative Granules As shown in Table 3, each component was used for each comparative example, and an oral composition was obtained in the same manner as in the examples. These were used as comparative controls for the oral compositions of the Examples in the following test examples.
３．試験例：吸着抑制試験
本試験例は、食用に用いられるものに含まれる機能成分であって、かつ吸着剤に吸着されることが既知である成分の中から瀉下作用の知られるバルバロインを代表として採用し、それに対する吸着能が、実施例の組成物及び比較例の組成物の間で異なるか否かを検証することを目的とするものである。今回、バルバロインを含有する天然物としてアロエ末を採用した。
3. Test example: Adsorption suppression test This test example is representative of barbaroin, which is a functional ingredient contained in foods and is known to be adsorbed by adsorbents. The purpose is to verify whether or not the adsorptive capacity with respect to the composition of the example and the composition of the comparative example are different. This time, aloe powder was adopted as a natural product containing barbaroin.
実施例１〜１６及び比較例１〜８で製造した経口用組成物をそれぞれ薬用炭として400mgとなるようにとり、アロエ末150mgとともに抽出溶媒（THFメタノール混液(1:1)）30mL中に分散させた。続いてこの溶液を40℃で30分間加温し、15分間超音波照射し（３５ｋＨｚ）懸濁させた。その後、上澄み液をとり、新たに抽出溶媒を３０ｍＬ加え、以後同様の操作を繰り返した。合計3回の抽出操作を行なった。なお、この抽出操作は、アロエ末からバルバロインを抽出するための操作であり、バルバロインがアロエ末から高効率で抽出される。 The oral compositions prepared in Examples 1 to 16 and Comparative Examples 1 to 8 were each taken as 400 mg of medicinal charcoal and dispersed in 30 mL of extraction solvent (THF methanol mixture (1: 1)) together with 150 mg of aloe powder. It was. Subsequently, this solution was heated at 40 ° C. for 30 minutes, and subjected to ultrasonic irradiation for 15 minutes (35 kHz) to be suspended. Thereafter, the supernatant was taken, 30 mL of extraction solvent was newly added, and the same operation was repeated thereafter. A total of three extraction operations were performed. This extraction operation is an operation for extracting barbaroin from the aloe powder. Barbaroin is extracted from the aloe powder with high efficiency.
この3回分の抽出液を孔径0.45μｍの樹脂製フィルター（Ｐａｌｌ社製）を用いて濾過した。得られた濾液中に含まれているバルバロイン量を、第十五改正日本薬局方解説書（生薬等）D-22−D-26頁「アロエ」の定量法に従い定量した。 The extract for three times was filtered using a resin filter (Pall) having a pore size of 0.45 μm. The amount of barbaroin contained in the obtained filtrate was quantified according to the quantification method of “Aloe” on pages D-22 to D-26 of the 15th revised Japanese Pharmacopoeia Manual (herbal medicine, etc.).
カラムはＣＯＳＭＯＳＩＬ「５Ｃ１８−ＭＳ−II」（内径４．６×１５０ｍｍ）（ナカライテスク社製）を、カラム温度は３０度にて、移動相に水／アセトニトリル／酢酸（74／26／１）混液を用い、紫外吸光光度計（株式会社島津製作所製）にて３６０ｎｍの吸光度を測定した。 The column is COSMOSIL “5C18-MS-II” (inner diameter 4.6 × 150 mm) (manufactured by Nacalai Tesque), the column temperature is 30 degrees, and the mobile phase is a mixture of water / acetonitrile / acetic acid (74/26/1). The absorbance at 360 nm was measured with an ultraviolet absorptiometer (manufactured by Shimadzu Corporation).
アロエ末のみを同様に超音波懸濁させた場合の濾液中のバルバロイン量に対する、各実施例及び各比較例の組成物を懸濁させたときのバルバロイン量の比率を残存率（％）として算出した。この残存率がより高いものほど、バルバロインに対する吸着能がより抑制されているものと評価した。また、残存率が95%以上のものを◎、90〜95%のものを○、及び90％未満のものを×と評価した。 Similarly, the ratio of the amount of barbaroin when the composition of each example and each comparative example was suspended to the amount of barbaroin in the filtrate when only aloe powder was ultrasonically suspended was the residual rate (%). Calculated as It was evaluated that the higher the residual rate, the more the ability to adsorb to barbaroin was suppressed. Further, those having a residual rate of 95% or more were evaluated as ◎, those having 90 to 95% as ○, and those having less than 90% as ×.
結果を表１〜３にそれぞれ示す。 The results are shown in Tables 1 to 3, respectively.
実施例１〜１６の経口用組成物はいずれも残存率が90％を上回っており、軒並み高い値を示したのに対して、比較例１〜８の経口用組成物はいずれも残存率が90％未満であり低い値に止まることが明らかになった。 The oral compositions of Examples 1 to 16 all had a survival rate exceeding 90%, and showed high values across the board, whereas the oral compositions of Comparative Examples 1 to 8 all had a residual ratio. It became clear that it was less than 90% and remained low.
なお、実施例は脂肪酸とグリセロールとのエステルを用いるものであるのに対して、比較例８は、エステルを含まないものである。比較例１〜３はエステルの代わりに単なる脂肪酸を用いるものである。比較例５〜７は、エステルの代わりにそれぞれβ−シクロデキストリン、グリセリン、及びリドカインを用いるものである。 The examples use esters of fatty acids and glycerol, while Comparative Example 8 does not contain esters. Comparative Examples 1 to 3 use simple fatty acids instead of esters. In Comparative Examples 5 to 7, β-cyclodextrin, glycerin, and lidocaine are used instead of esters, respectively.
また、実施例は炭素数が12以上の脂肪酸とグリセロールとのエステルを用いるものであるのに対して、比較例４は、炭素数が10以下の脂肪酸とグリセロールとのエステルを用いるものである。これにより、瀉下剤をはじめとする有用物質に対する吸着能を低減させるという点でより優れているのは、脂肪酸とグリセロールとのエステルであって、脂肪酸が少なくとも炭素数が10を超える脂肪酸、又は好ましくは炭素数が12以上の脂肪酸である経口用組成物だということが確認された。 In addition, while the examples use esters of fatty acids having 12 or more carbon atoms and glycerol, Comparative Example 4 uses esters of fatty acids having 10 or less carbon atoms and glycerol. As a result, an ester of a fatty acid and glycerol is superior in that it reduces the adsorptive capacity for a useful substance such as a laxative, and the fatty acid has at least 10 carbon atoms, or preferably Was confirmed to be an oral composition of 12 or more fatty acids.
さらに、脂肪酸とグリセロールとのエステルがモノ又はジエステルである実施例１２〜１６の経口用組成物はいずれも残存率が95％を下回っているのに対して、脂肪酸とグリセロールとのエステルがトリエステルである実施例１〜１１の経口用組成物がいずれも95％を超える残存率を示すことが明らかになった。これにより、瀉下剤をはじめとする有用物質に対する吸着能を低減させるという点でより優れているのは、脂肪酸とグリセロールとのエステルがトリエステルである本発明の経口用組成物だということが確認された。 Furthermore, in the oral compositions of Examples 12 to 16 where the ester of fatty acid and glycerol is a mono- or diester, the residual rate is less than 95%, whereas the ester of fatty acid and glycerol is a triester. It was revealed that all of the oral compositions of Examples 1 to 11 exhibit a residual rate exceeding 95%. As a result, it is confirmed that the oral composition of the present invention, in which the ester of fatty acid and glycerol is a triester, is superior in that it reduces the adsorptive ability to useful substances such as laxatives. It was done.
さらに、実施例８〜１１から、吸着剤１重量部に対して脂肪酸とグリセロールとのエステルが0.5重量部以上含まれていればよく、その含有量が増えるほど、残存率が向上することが明らかになった。これにより、瀉下作用などの機能性を有する物質に対する吸着能を抑制させるという点でより優れているのは、エステル含量のより高い本発明の経口用組成物だということが確認された。 Furthermore, from Examples 8 to 11, it is sufficient that the ester of fatty acid and glycerol is contained in an amount of 0.5 parts by weight or more with respect to 1 part by weight of the adsorbent, and the residual rate improves as the content increases. Became. Thus, it was confirmed that the oral composition of the present invention having a higher ester content is superior in that it suppresses the adsorptive ability to a substance having a function such as an armpit action.
また、実施例１〜７で製造した組成物について、抽出溶媒を人工胃液（日本薬局方崩壊試験法の第1液）に代えて３７℃、ｐＨ１．２で３０分間振とうさせたところ、実施例と同様にバルバロイン残存率に優れていた。一方、抽出溶媒を人工腸液（日本薬局方崩壊試験法の第2液）に代えて３７℃、ｐＨ６．８で１８０分間振とうさせたところ、バルバロインの残存率が４０％を下回った。この結果は、本発明の組成物が胃内においては吸着能が抑制されているのに対して、腸内においては胃内とは対照的に、吸着剤の本来の機能である吸着能がある程度回復していることを示すものである。このため、本発明の組成物であれば、少なくとも胃内では瀉下剤を吸着することがない一方で、腸内では有害物質や老廃物を吸着することができる。 Moreover, about the composition manufactured in Examples 1-7, it replaced with artificial gastric juice (The 1st liquid of the Japanese Pharmacopoeia disintegration test method), and when it was made to shake for 30 minutes at 37 degreeC and pH1.2, it implemented. The barbaroin residual rate was excellent as in the example. On the other hand, when the extraction solvent was shaken for 180 minutes at 37 ° C. and pH 6.8 instead of artificial intestinal fluid (second solution of the Japanese Pharmacopoeia Disintegration Test Method), the residual rate of barbaroin was less than 40%. As a result, the adsorbing ability of the composition of the present invention is suppressed in the stomach, whereas in the intestine, the adsorbing ability, which is the original function of the adsorbent, is somewhat. It shows that it is recovering. For this reason, if it is a composition of this invention, while a laxative is not adsorbed at least in the stomach, a harmful substance and a waste product can be adsorbed in the intestine.
４．製剤例
製剤例１〜７２に従い、吸着剤、及び炭素数10〜40の長鎖脂肪酸とグリセロールとのエステルを含有する経口用組成物を製造した。また、必要に応じてさらに瀉下剤を含ませた経口用組成物を製造した。
4). Formulation Example According to Formulation Examples 1 to 72, an oral composition containing an adsorbent and an ester of a long-chain fatty acid having 10 to 40 carbon atoms and glycerol was produced. Moreover, the composition for oral use which further included the laxative as needed was manufactured.
なお、以下のカプセル剤又はソフトカプセル剤は、日本薬局方 製剤総則６．カプセル剤の製法に従って製造できる。なお、瀉下剤を含ませる場合は、吸着剤を含む構成と瀉下剤を含む構成とに別け、各々造粒したものをカプセルに充てんすることが望ましい。 The following capsules or soft capsules are listed in the Japanese Pharmacopoeia General Rules for Preparations 6. It can be produced according to a capsule manufacturing method. In addition, when the laxative is included, it is desirable that the granulated product is filled in a capsule separately from the configuration including the adsorbent and the configuration including the laxative.
また、以下の顆粒剤は日本薬局方 製剤総則７．顆粒剤の製法に従って製造できる。なお、瀉下剤を含ませる場合は、吸着剤を含む構成と瀉下剤を含む構成とに別け、各々造粒したものを包装することが望ましい。 In addition, the following granules are listed in Japanese Pharmacopoeia General Rules for Preparations 7. It can be produced according to a granule production method. In addition, when a laxative is included, it is desirable to wrap each granulated product separately into a configuration including an adsorbent and a configuration including a laxative.
錠剤については日本薬局方 製剤総則１５．錠剤の製法に従って製造できる。なお、瀉下剤を含ませる場合は、吸着剤を含む構成を造粒した後、瀉下剤を含む構成と共に打錠することが望ましい。 For tablets, General Rules for Preparations of Japanese Pharmacopoeia15. It can be produced according to the tablet manufacturing method. In addition, when including a laxative, it is desirable to granulate the composition containing the adsorbent and then compress the tablet together with the composition containing the laxative.
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