JP2022136301A - Solid preparation - Google Patents
Solid preparation Download PDFInfo
- Publication number
- JP2022136301A JP2022136301A JP2022121901A JP2022121901A JP2022136301A JP 2022136301 A JP2022136301 A JP 2022136301A JP 2022121901 A JP2022121901 A JP 2022121901A JP 2022121901 A JP2022121901 A JP 2022121901A JP 2022136301 A JP2022136301 A JP 2022136301A
- Authority
- JP
- Japan
- Prior art keywords
- solid preparation
- monascus
- component
- discoloration
- red yeast
- 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
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- 235000021255 galacto-oligosaccharides Nutrition 0.000 description 1
- 150000003271 galactooligosaccharides Chemical class 0.000 description 1
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- 229940055729 papain Drugs 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000419 plant extract Substances 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
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- 239000000737 potassium alginate Substances 0.000 description 1
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- 159000000001 potassium salts Chemical class 0.000 description 1
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- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
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- 159000000000 sodium salts Chemical class 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- General Preparation And Processing Of Foods (AREA)
- Jellies, Jams, And Syrups (AREA)
Abstract
Description
本発明は、紅麹及び/又はその加工物を含む固形製剤でありながら、変色が抑制された
固形製剤に関する。
TECHNICAL FIELD The present invention relates to a solid preparation containing monascus and/or a processed product thereof and having suppressed discoloration.
紅麹は、穀類に紅麹菌を植菌して発酵させた麹であり、中国等で古くから食品材料又は
醸造材料として利用されてきた。また、紅麹に含まれるモナコリンKがコレステロール改
善作用を発現する(非特許文献1,2)ことが報告されており、紅麹は機能性素材として
サプリメントなどの製剤に配合されて利用されている。
Monascus is a fermented rice malt obtained by inoculating and fermenting cereals with monascus, and has long been used as a food material or brewing material in China and other countries. In addition, it has been reported that monacolin K contained in red yeast rice exhibits a cholesterol-improving effect (Non-Patent Documents 1 and 2), and red yeast rice is used as a functional ingredient in formulations such as supplements. .
紅麹を配合した製剤について、その安全性及び機能性を向上させるための改良研究がさ
れている。例えば、毒性物質シトリニンを共産生しない紅麹を産生する技術(特許文献1
)、モナコリンK含量が多い紅麹を生産する技術(特許文献2)、及び紅麹から高濃度の
モナコリンKを含むエキスを得る技術(特許文献3)等が提案されている。
Preparations containing red yeast rice have been studied to improve their safety and functionality. For example, a technique for producing red yeast rice that does not co-produce the toxic substance citrinin (Patent Document 1
), a technique for producing red yeast rice with a high content of monacolin K (Patent Document 2), and a technique for obtaining an extract containing a high concentration of monacolin K from red yeast rice (Patent Document 3).
紅麹は体内で易溶性であるため、固形製剤として製剤化されるのが一般的である。しか
しながら、紅麹を含む固形製剤は製剤安定性が悪く、光及び/又は熱に対して変色を起こ
しやすい。
Since red yeast rice is easily soluble in the body, it is generally formulated as a solid preparation. However, solid formulations containing monascus have poor formulation stability and are prone to discoloration due to light and/or heat.
そこで、本発明の目的は、紅麹及び/又はその加工物を含む固形製剤でありながら、変
色が抑制された固形製剤を提供することである。
Accordingly, it is an object of the present invention to provide a solid preparation containing red yeast rice and/or a processed product thereof and having suppressed discoloration.
本発明者は、鋭意検討を行ったところ、紅麹及び/又はその加工物を含む固形製剤に所
定の添加剤を配合することで、当該固形製剤の変色が抑制されることを見出した。
As a result of intensive studies, the present inventors found that discoloration of solid preparations containing red yeast rice and/or processed products thereof can be suppressed by adding predetermined additives to the solid preparations.
即ち、本発明は、下記に掲げる態様の発明を提供する。
項1. (A)紅麹及び/又はその加工物と、(B)セルロース及びその誘導体、乳タン
パク質及びその消化物、オリゴ糖、糖アルコール、食用加工油脂、増粘多糖類、並びにス
テアリン酸カルシウムからなる群より選択される添加剤とを含有する、固形製剤。
項2. 前記(A)成分の配合量が2重量%以上である、項1に記載の固形製剤。
項3. (A)紅麹及び/又はその加工物を含む固形製剤の変色を抑制する方法であって
、前記固形製剤において、前記(A)成分と共に、(B)セルロース及びその誘導体、乳
タンパク質、オリゴ糖、糖アルコール、食用加工油脂、増粘多糖類、並びにステアリン酸
カルシウムからなる群より選択される添加剤を配合する、変色抑制方法。
That is, the present invention provides inventions in the following aspects.
Section 1. From the group consisting of (A) red yeast rice and/or processed products thereof, and (B) cellulose and derivatives thereof, milk proteins and digests thereof, oligosaccharides, sugar alcohols, edible processed oils and fats, polysaccharide thickeners, and calcium stearate A solid formulation containing selected additives.
Section 2. Item 2. The solid preparation according to Item 1, wherein the amount of component (A) is 2% by weight or more.
Item 3. (A) A method for suppressing discoloration of a solid preparation containing monascus and/or a processed product thereof, wherein in the solid preparation, together with the component (A), (B) cellulose and its derivatives, milk protein, oligosaccharides , sugar alcohols, edible processed oils and fats, polysaccharide thickeners, and calcium stearate.
本発明によれば、紅麹及び/又はその加工物を含む固形製剤でありながら、変色が抑制
された固形製剤が提供される。
According to the present invention, there is provided a solid preparation containing red yeast rice and/or a processed product thereof and having suppressed discoloration.
1.固形製剤
本発明の固形製剤は、(A)紅麹及び/又はその加工物(以下において、「(A)成分
」とも表記する。)と、(B)セルロース及びその誘導体、乳タンパク質及びその消化物
、オリゴ糖、糖アルコール、食用加工油脂、増粘多糖類、並びにステアリン酸カルシウム
からなる群より選択される添加剤(以下において、「(B)成分」又は「所定の添加剤」
とも表記する。)とを含有することを特徴とする。本発明の固形製剤は、変色が抑制され
ている。以下、本発明の固形製剤について詳述する。
1. Solid preparation The solid preparation of the present invention comprises (A) red yeast rice and/or its processed product (hereinafter also referred to as "(A) component"), and (B) cellulose and its derivatives, milk protein and its digestion. oligosaccharides, sugar alcohols, edible processed oils and fats, thickening polysaccharides, and additives selected from the group consisting of calcium stearate (hereinafter referred to as "(B) component" or "predetermined additive"
Also notated. ) and is characterized by containing. Discoloration is suppressed in the solid preparation of the present invention. The solid preparation of the present invention is described in detail below.
(A)紅麹及び/又はその加工物
本発明の固形製剤は、(A)成分として紅麹及び/又はその加工物を含有する。紅麹は
、穀類に紅麹菌を付着させ、発酵させた麹である。
(A) Monascus and/or Processed Products Thereof The solid preparation of the present invention contains monascus and/or processed products thereof as component (A). Red yeast rice is a fermented rice malt made by adhering monascus to cereals.
本発明で使用される紅麹の製造に使用される紅麹菌は、ベニコウジカビ科(Monascacea
e)に属する糸状菌であればよい。ベニコウジカビ科に属する糸状菌としては、例えば、
モナスカス属(Monascus)、及びバシペトスポラ属(Basipetospora)に属する糸状菌が
挙げられ、好ましくはモナスカス属(Monascus)が挙げられる。
The monascus used in the production of the monascus used in the present invention belongs to the Monascaceae family.
Any filamentous fungus belonging to e) may be used. Examples of filamentous fungi belonging to the Aspergillus family include:
Examples include filamentous fungi belonging to the genus Monascus and the genus Basipetospora, preferably the genus Monascus.
モナスカス属に属する糸状菌としては、例えば、モナスカス・ピローサス(M. pilosus
)、モナスカス・パープレウス(M. purpureus)、モナスカス・プビゲレス(M. pubigeru
s)、モナスカス・アンカ(M. anka)、モナスカス・セロルベセンス(M. serorubescens
)、モナスカス・ルベルス(M. rubellus)、モナスカス・カオリアング(M. kaoliang)
、モナスカス・ルビギノサス(M. rubiginosus)、モナスカス・メイジャー(M. major)
、モナスカス・ルバー(M. ruber)、モナスカス・パキシイ(M. paxii)、モナスカス・
フリギノサス(M. fuliginosus)、モナスカス・ビトレウス(M. vitreus)、モナスカス
・バルケリ(M. barkeri)、モナスカス・エスピー(Monascus sp.)、これらの変種又は
変異株が挙げられる。本発明で使用される紅麹は、1種の紅麹菌を使用して製造されたも
のであってもよく、2種以上の紅麹菌を組み合わせて製造されたものであってもよい。こ
れらの紅麹菌の中でも、好ましくはモナスカス・ピローサスが挙げられる。
Examples of filamentous fungi belonging to the genus Monascus include M. pilosus
), Monascus purpureus (M. purpureus), Monascus pubigeru (M. pubigeru
s), M. anka, M. serorubescens
), M. rubellus, M. kaoliang
, Monascus rubiginosus (M. rubiginosus), Monascus major (M. major)
, Monascus ruber (M. ruber), Monascus paxii (M. paxii), Monascus ruber
M. fuliginosus, M. vitreus, M. barkeri, Monascus sp., and variants or mutants thereof. Monascus used in the present invention may be produced using one type of Monascus, or may be produced by combining two or more types of Monascus. Among these monascus, Monascus pyrosus is preferred.
本発明で使用される紅麹の原料として使用される穀類の種類については、可食性があり
、紅麹菌による発酵が可能であることを限度として特に制限されないが、例えば、白米や
玄米等の米類;小麦、大麦、ライ麦、燕麦等の麦類、大豆(白大豆、黒大豆、青大豆等)
、これらの脱脂大豆、これらの胚軸等の豆類等が挙げられる。本発明で使用される紅麹は
、1種の穀類を使用して製造されたものであってもよく、2種以上の穀類を組み合わせて
製造されたものであってもよい。これらの穀類の中でも、好ましくは米類、より好ましく
は白米が挙げられる。
The type of cereal used as a raw material for red yeast rice used in the present invention is not particularly limited as long as it is edible and can be fermented by red yeast rice. Wheat, barley, rye, oats and other barley, soybeans (white soybeans, black soybeans, green soybeans, etc.)
, these defatted soybeans, and beans such as these hypocotyls. The monascus used in the present invention may be produced using one type of grain, or may be produced by combining two or more types of grains. Among these grains, rice is preferred, and polished rice is more preferred.
紅麹は、紅麹菌及び穀類を用いて、慣用の方法によって製造することができる。具体的
には、蒸煮(炊き上げ、蒸し上げ)された穀類に紅麹菌を接種し、20~40℃程度の好
気的条件で静置培養することによって紅麹を製造することができる。また、原料として使
用される穀類は、必要に応じて、蒸煮前又は蒸煮後に細切又は粉砕処理に供していてもよ
い。
Monascus can be produced by a conventional method using monascus and cereals. Specifically, monascus can be produced by inoculating monascus in steamed (cooked or steamed) cereals and statically culturing under aerobic conditions of about 20 to 40°C. In addition, grains used as raw materials may be subjected to chopping or pulverization before or after steaming, if necessary.
本発明では、発酵後の紅麹をそのまま使用してもよく、また、発酵後の紅麹を、加熱、
乾燥、破砕、粉砕、磨砕、抽出等の内1種以上の処理に供された紅麹の加工物を使用して
もよい。
In the present invention, the fermented red yeast rice may be used as it is, or the fermented red yeast rice may be heated and
A processed product of red yeast rice that has been subjected to one or more treatments such as drying, crushing, crushing, grinding, and extraction may be used.
紅麹の加工物としては、具体的には、乾燥紅麹、乾燥紅麹の粉末物、乾燥紅麹の細粒物
、紅麹エキス末等の乾燥物;紅麹のペースト;紅麹エキス(濃縮エキスを含む)等が挙げ
られる。これらの紅麹の加工物の中でも、好ましくは乾燥物、より好ましくは乾燥紅麹の
粉末物、乾燥紅麹の細粒物、更に好ましくは乾燥紅麹の粉末物が挙げられる。また、紅麹
の加工物に含まれる紅麹菌及び酵素は、生菌又は活性を維持した状態であってもよく、ま
た、加熱処理等により失活されていてもよい。
Examples of processed products of monascus include dried monascus, powder of dried monascus, fine granules of dried monascus, and dried monascus extract powder; paste of monascus; including concentrated extracts) and the like. Among these processed products of monascus, preferably dried products, more preferably dried monascus powder, dried monascus granules, and even more preferably dried monascus powder are mentioned. In addition, the monascus and enzymes contained in the processed product of monascus may be viable or in an active state, or may be inactivated by heat treatment or the like.
紅麹の加工物は、商業的に入手したものを使用することもできる。例えば、乾燥米紅麹
の粉末物は、商品名「V.紅麹3P-D」、「V.紅麹3P-D20」(いずれも小林バ
リューサポート株式会社製)として販売されており、本発明ではこれらの市販品を使用す
ることができる。
A commercially available product of red yeast rice can also be used. For example, powdered dried rice red yeast rice is sold under the trade names "V. Red yeast rice 3P-D" and "V. Red yeast rice 3P-D20" (both manufactured by Kobayashi Value Support Co., Ltd.). These commercially available products can be used.
本発明の固形製剤において、(A)成分の含有量としては、例えば2重量%以上が挙げ
られ、より具体的には、5~30重量%、好ましくは10~20重量%が挙げられる。
或いは、本発明の固形製剤における(A)成分の含有量は、例えば40~99重量%又は
45~95重量%であってもよい。
In the solid preparation of the present invention, the content of component (A) is, for example, 2% by weight or more, more specifically 5 to 30% by weight, preferably 10 to 20% by weight.
Alternatively, the content of component (A) in the solid preparation of the present invention may be, for example, 40-99% by weight or 45-95% by weight.
(B)所定の添加剤
本発明の固形製剤は、(B)成分として、セルロース及びその誘導体、乳タンパク質及
びその消化物、オリゴ糖、糖アルコール、食用加工油脂、増粘多糖類、並びにステアリン
酸カルシウムからなる群より選択される添加剤を含む。これらの所定の添加剤を含むこと
により、(A)成分を含む固形製剤の変色が抑制される。
(B) Predetermined Additives The solid preparation of the present invention contains, as components (B), cellulose and its derivatives, milk protein and its digest, oligosaccharides, sugar alcohols, edible processed oils and fats, thickening polysaccharides, and calcium stearate. Contains additives selected from the group consisting of Discoloration of the solid preparation containing component (A) is suppressed by including these predetermined additives.
セルロース及びその誘導体
セルロースとしては、固形製剤における賦形剤としての役割を担うものであれば限定さ
れるものではなく、日本薬局方に記載の種々のセルロースを使用することができる。また
食品添加物として使用されるものを使用することもできる。セルロースの形態も特に問わ
ず、例えば、結晶セルロース(微結晶セルロースを含む)を用いることもできる。また当
該セルロースは、例えば結晶セルロース・カルメロースナトリウム(結晶セルロースとカ
ルメロースナトリウムの混合物)等のように、他成分との混合物の形態で使用されてもよ
い。
Cellulose and its derivative cellulose are not limited as long as they play a role as an excipient in solid preparations, and various celluloses described in the Japanese Pharmacopoeia can be used. Moreover, what is used as a food additive can also be used. The form of cellulose is not particularly limited, and for example, crystalline cellulose (including microcrystalline cellulose) can also be used. The cellulose may also be used in the form of a mixture with other components, such as crystalline cellulose/carmellose sodium (a mixture of crystalline cellulose and carmellose sodium).
セルロースの誘導体としては、メチルセルロース、エチルセルロース、メチルエチルセ
ルロース等のセルロースのアルキル誘導体;ヒドロキシプロピルセルロース(HPC)、
ヒドロキシプロピルメチルセルロース(HPMC)等のヒドロキシプロピル誘導体;カル
ボキシメチルセルロース(CMC、カルメロース)、及びそのカルシウム塩(カルメロー
スカルシウム)、カリウム塩(カルメロースカリウム)、ナトリウム塩(カルメロースナ
トリウム)等が挙げられる。
Cellulose derivatives include alkyl derivatives of cellulose such as methyl cellulose, ethyl cellulose and methyl ethyl cellulose; hydroxypropyl cellulose (HPC);
Hydroxypropyl derivatives such as hydroxypropylmethylcellulose (HPMC); carboxymethylcellulose (CMC, carmellose), and its calcium salts (carmellose calcium), potassium salts (carmellose potassium), sodium salts (carmellose sodium) and the like.
これらのセルロース及びその誘導体は、1種を単独で用いてもよいし、複数種を組み合
わせて用いてもよい。これらのセルロース及びその誘導体の中でも、変色抑制効果をより
一層向上させる観点から、好ましくは結晶セルロース、セルロースのヒドロキシプロピル
誘導体が挙げられる。
One of these celluloses and derivatives thereof may be used alone, or two or more of them may be used in combination. Among these cellulose and derivatives thereof, crystalline cellulose and hydroxypropyl derivatives of cellulose are preferred from the viewpoint of further improving the effect of suppressing discoloration.
乳タンパク質及びその消化物
乳タンパク質としては、乳に由来するタンパク質であれば特に限定されない。乳の由来
生物としても特に限定されないため、乳としては、牛乳、ヤギ乳等が挙げられる。乳タン
パク質の具体例としては、乳清タンパク質及びカゼインが挙げられる。
The milk protein and digested milk protein thereof are not particularly limited as long as they are proteins derived from milk. There are no particular restrictions on the organisms from which milk is derived, and examples of milk include cow's milk and goat's milk. Specific examples of milk proteins include whey protein and casein.
乳タンパク質の消化物としては、上記の乳タンパク質をエンド型プロテアーゼで消化し
たものであれば特に限定されない。エンド型プロテアーゼとしては、例えば、ブロメライ
ン、パパイン、アルカラーゼ、トリプシン等が挙げられる。乳タンパク質の消化物の加水
分解率(加水分解率(%)は、(ホルモール態窒素量/全窒素量)×100により導出さ
れる。)としては特に限定されないが、例えば5~10%が挙げられる。
The milk protein digest is not particularly limited as long as it is obtained by digesting the above milk protein with an endo-type protease. Endo-type proteases include, for example, bromelain, papain, alcalase, trypsin and the like. The hydrolysis rate of the milk protein digest (hydrolysis rate (%) is derived from (formol nitrogen content/total nitrogen content) x 100) is not particularly limited, but may be, for example, 5 to 10%. be done.
これらの乳タンパク質及びその消化物は、1種を単独で用いてもよいし、複数種を組み
合わせて用いてもよい。
One of these milk proteins and digests thereof may be used alone, or two or more of them may be used in combination.
オリゴ糖
オリゴ糖としては、単糖の結合数2~20のものであれば特に限定されない。オリゴ糖
の具体例としては、スクロース、ラクトース 、マルトース、トレハロース、ツラノース
、セロビオース、マルトオリゴ糖、イソマルトオリゴ糖、ゲンチオオリゴ糖、キチンオリ
ゴ糖、キトサンオリゴ糖、直鎖オリゴ糖、分岐オリゴ糖、ラフィノース、ガラクトオリゴ
糖、フラクトオリゴ糖、乳果オリゴ糖、大豆オリゴ糖、ビートオリゴ糖、寒天オリゴ糖(
アガロオリゴ糖)、シアリルオリゴ糖、パラチノースオリゴ糖、キシロオリゴ糖、イヌロ
オリゴ糖、カップリングシュガー、ニゲロオリゴ糖、パノースオリゴ糖、セロオリゴ糖、
ペクチンオリゴ糖、レバンオリゴ糖、マンノオリゴ糖、環状オリゴ糖(シクロデキストリ
ン)、ガラクトシルラクトース等が挙げられる。
The oligosaccharide is not particularly limited as long as it has 2 to 20 monosaccharide bonds. Specific examples of oligosaccharides include sucrose, lactose, maltose, trehalose, turanose, cellobiose, malto-oligosaccharides, iso-malto-oligosaccharides, gentio-oligosaccharides, chitin-oligosaccharides, chitosan-oligosaccharides, straight-chain oligosaccharides, branched-chain oligosaccharides, raffinose, and galacto-oligosaccharides. sugar, fructooligosaccharide, milk oligosaccharide, soybean oligosaccharide, beet oligosaccharide, agar oligosaccharide (
agarooligosaccharide), sialyloligosaccharide, palatinose oligosaccharide, xylooligosaccharide, inulooligosaccharide, coupling sugar, nigerooligosaccharide, panose oligosaccharide, cellooligosaccharide,
pectin oligosaccharide, levan oligosaccharide, mannooligosaccharide, cyclic oligosaccharide (cyclodextrin), galactosyl lactose and the like.
これらのオリゴ糖は、1種を単独で用いてもよいし、複数種を組み合わせて用いてもよ
い。これらのオリゴ糖の中でも、変色抑制効果をより一層向上させる観点から、好ましく
はアガロオリゴ糖及び環状オリゴ糖が挙げられる。
One of these oligosaccharides may be used alone, or two or more of them may be used in combination. Among these oligosaccharides, agarooligosaccharides and cyclic oligosaccharides are preferred from the viewpoint of further improving the effect of suppressing discoloration.
糖アルコール
糖アルコールとしては特に限定されないが、例えば、還元澱粉糖、還元麦芽糖等が挙げ
られる。
Sugar alcohol The sugar alcohol is not particularly limited, but examples thereof include reduced starch sugar, reduced maltose and the like.
これらの糖アルコールは、1種を単独で用いてもよいし、複数種を組み合わせて用いて
もよい。これらの糖アルコールの中でも、変色抑制効果をより一層向上させる観点から、
好ましくは還元麦芽糖が挙げられる。
These sugar alcohols may be used individually by 1 type, and may be used in combination of multiple types. Among these sugar alcohols, from the viewpoint of further improving the effect of suppressing discoloration,
Preferred is reduced maltose.
食用加工油脂
食用加工油脂は、硬化油であれば特に限定されない。硬化油は、油脂に水素添加する方
法により製造された、常温で固形の食用加工油脂である。このような食用加工油脂の材料
となる油脂としては、植物性油脂及び動物性油脂を問わない。植物性油脂としては、大豆
油、菜種油、パーム油、ヤシ油、パーム核油等が挙げられ、動物性油脂としては、鯨油、
魚油、牛脂、豚脂等が挙げられる。
Edible processed oil The edible processed oil is not particularly limited as long as it is a hardened oil. Hydrogenated oil is an edible processed fat that is solid at room temperature and produced by a method of hydrogenating fat. Oils and fats used as materials for such edible processed oils and fats may be either vegetable oils or animal oils and fats. Vegetable oils include soybean oil, rapeseed oil, palm oil, coconut oil, palm kernel oil, etc. Animal oils include whale oil,
fish oil, beef tallow, lard and the like.
これらの食用加工油脂は、1種を単独で用いてもよいし、複数種を組み合わせて用いて
もよい。これらの食用加工油脂の中でも、変色抑制効果をより一層向上させる観点から、
好ましくは水添菜種油が挙げられる。
These edible processed fats and oils may be used singly or in combination of multiple types. Among these edible processed oils and fats, from the viewpoint of further improving the effect of suppressing discoloration,
Hydrogenated rapeseed oil is preferred.
増粘多糖類
増粘多糖類としては特に限定されないが、例えば、アラビアガム、キサンタンガム、カ
ラギナン(例えば、カッパ型カラギナン、イオタ型カラギナン、ラムダ型カラギナン等)
、ガラクトマンナン(例えば、ローカストビーンガム、タラガム、グァガム等)、アルギ
ン酸類(例えば、アルギン酸、アルギン酸塩(例えば、アルギン酸ナトリウム、アルギン
酸カリウム、アルギン酸カルシウム等)、アルギン酸エステル(例えば、アルギン酸プロ
ピレングリコール等)等)、ペクチン(例えば、ローメトキシル(LM)ペクチン、ハイ
メトキシル(HM)ペクチン)、ジェランガム(例えば、脱アシル型ジェランガム、ネイ
ティブ型ジェランガム等)、寒天、ゼラチン、タマリンドシードガム、グルコマンナン、
ウェランガム、サイリウムシードガム、カラヤガム、カードラン、プルラン、澱粉、ファ
ーセレラン等が挙げられる。
Polysaccharide thickener Polysaccharide thickener is not particularly limited, but examples include gum arabic, xanthan gum, carrageenan (e.g., kappa-type carrageenan, iota-type carrageenan, lambda-type carrageenan, etc.)
, galactomannans (e.g., locust bean gum, tara gum, guar gum, etc.), alginic acids (e.g., alginic acid, alginates (e.g., sodium alginate, potassium alginate, calcium alginate, etc.), alginate esters (e.g., propylene glycol alginate, etc.), etc. ), pectin (e.g., low methoxyl (LM) pectin, high methoxyl (HM) pectin), gellan gum (e.g., deacylated gellan gum, native gellan gum, etc.), agar, gelatin, tamarind seed gum, glucomannan,
Welan gum, psyllium seed gum, karaya gum, curdlan, pullulan, starch, furcelleran and the like.
これらの増粘多糖類は、1種を単独で用いてもよいし、複数種を組み合わせて用いても
よい。これらの増粘多糖類の中でも、変色抑制効果をより一層向上させる観点から、好ま
しくはアラビアガム、ジェランガム、プルランが挙げられる。
These polysaccharide thickeners may be used singly or in combination of multiple types. Among these thickening polysaccharides, gum arabic, gellan gum, and pullulan are preferred from the viewpoint of further improving the effect of suppressing discoloration.
ステアリン酸カルシウム
ステアリン酸カルシウムとしては、好ましくは食品添加物公定書に収載されているもの
を用いることができる。
Calcium stearate As the calcium stearate, those listed in the Official Code of Food Additives can be preferably used.
本発明の固形製剤において、(B)成分の含有量としては、総量で、例えば0.1重量
%以上が挙げられ、好ましくは1~70重量%、より好ましくは1.5~60重量%が、
更に好ましくは10~50重量%が挙げられる。
In the solid preparation of the present invention, the total content of component (B) is, for example, 0.1% by weight or more, preferably 1 to 70% by weight, more preferably 1.5 to 60% by weight. ,
More preferably 10 to 50% by weight is mentioned.
本発明の固形製剤において、(A)成分と(B)成分との比率については、各成分の上
記の含有量に応じて定まるが、変色抑制効果をより一層向上させる観点から、(A)成分
1重量部に対する(B)成分の含有量として、好ましくは0.05~7重量部、より好ま
しくは0.1~5重量部、さらに好ましくは0.2~4重量部、一層好ましくは0.5~
3重量部が挙げられる。
In the solid preparation of the present invention, the ratio of the components (A) and (B) is determined according to the above content of each component. The content of component (B) per 1 part by weight is preferably 0.05 to 7 parts by weight, more preferably 0.1 to 5 parts by weight, still more preferably 0.2 to 4 parts by weight, still more preferably 0.2 parts by weight. 5~
3 parts by weight.
その他の成分
本発明の固形製剤は、前記(A)成分及び(B)成分の他に、必要に応じて、他の栄養
成分及び/又は薬理成分を含有していてもよい。このような栄養成分及び薬理成分として
は、飲食品及び/又は医薬品に使用可能なものであれば特に制限されないが、例えば、ビ
タミン、ミネラル、糖質(上記(B)成分以外)、脂肪酸、香料、調味剤、植物エキス(
上記(A)成分以外)、抗酸化剤(上記(A)成分以外)等が挙げられる。これらの成分
は、1種単独で使用してもよく、また2種以上を組み合わせて使用してもよい。また、こ
れらの成分の含有量については、使用する栄養成分及び/又は薬理成分の種類並びに経口
組成物の用途等に応じて適宜設定される。
Other Ingredients The solid preparation of the present invention may contain, if necessary, other nutritional ingredients and/or pharmacological ingredients in addition to the components (A) and (B). Such nutritional ingredients and pharmacological ingredients are not particularly limited as long as they can be used in foods and/or pharmaceuticals. , seasonings, plant extracts (
components other than the above component (A)), antioxidants (other than the above component (A)), and the like. These components may be used singly or in combination of two or more. In addition, the content of these components is appropriately set according to the types of nutritional components and/or pharmacological components to be used, the application of the oral composition, and the like.
更に、本発明の固形製剤は、所望の製剤形態に調製するために、必要に応じて、基剤及
び/又は添加剤等が含まれていてもよい。このような基剤及び添加剤としては、食品及び
/又は医薬品に使用可能なものであれば特に制限されないが、例えば、賦形剤、崩壊剤、
結合剤、滑沢剤等(いずれも上記(B)成分以外)が挙げられる。これらの成分は、1種
単独で使用してもよく、また2種以上を組み合わせて使用してもよい。また、これらの成
分の含有量については、使用する基剤及び/又は添加剤の種類並びに固形製剤の用途等に
応じて適宜設定される。
Furthermore, the solid preparation of the present invention may contain bases and/or additives, etc., if necessary, in order to prepare a desired dosage form. Such bases and additives are not particularly limited as long as they can be used in foods and/or pharmaceuticals. Examples include excipients, disintegrants,
Binders, lubricants and the like (both of which are other than the above component (B)). These components may be used singly or in combination of two or more. In addition, the content of these components is appropriately set according to the type of base and/or additive used, the application of the solid preparation, and the like.
剤型・製剤形態
本発明の固形製剤の剤型については特に限定されないが、例えば、顆粒剤、細粒剤、散
剤、錠剤、カプセル剤(ハードカプセル剤)等が挙げられる。本発明の固形製剤は変色抑
制効果に優れているため、カプセル剤である場合の好適な例として、透光性のカプセルに
収容されたカプセル剤が挙げられる。
Dosage Form/Formulation Form The dosage form of the solid preparation of the present invention is not particularly limited, but examples thereof include granules, fine granules, powders, tablets, capsules (hard capsules) and the like. Since the solid preparation of the present invention is excellent in the effect of suppressing discoloration, a suitable example in the case of a capsule is a capsule contained in a translucent capsule.
本発明の固形製剤は、適宜、任意の容器に収容されることができる。本発明の固形製剤
は変色抑制効果に優れているため、容器の好適な例として、透光性の容器、及び開閉自在
な個包装でない容器(つまり、容器の開閉により、収容した固形製剤が不可避的に容器の
外環境に高頻度で晒される形態のもの)が挙げられる。
The solid preparation of the present invention can be appropriately accommodated in any container. Since the solid preparation of the present invention has an excellent effect of suppressing discoloration, suitable examples of the container include translucent containers and containers that are not individual packages that can be freely opened and closed (that is, opening and closing of the container inevitably causes the stored solid preparation to become unavoidable). type that is frequently exposed to the environment outside the container).
本発明の固形製剤の形態として、具体的には、飲食品及び内服用医薬品(内服用の医薬
部外品を含む)が挙げられる。
Specific examples of the form of the solid preparation of the present invention include foods and beverages and drugs for internal use (including quasi-drugs for internal use).
本発明の固形製剤を食品の製剤形態にする場合、前記(A)成分及び(B)成分を、そ
のままで又は他の食品素材や添加成分と組み合わせて所望の形態に調製すればよい。この
ような食品としては、一般の食品の他、特定保健用食品、栄養補助食品、機能性表示食品
、病者用食品等が挙げられる。これらの飲食品の形態として、特に制限されないが、具体
的には顆粒剤、細粒剤、散剤、錠剤、カプセル剤等のサプリメント等が挙げられる。
When the solid preparation of the present invention is to be in the form of a food preparation, the above components (A) and (B) may be prepared as they are or in combination with other food materials or additives into a desired form. Examples of such foods include general foods, foods for specified health uses, dietary supplements, foods with function claims, foods for the sick, and the like. The form of these foods and drinks is not particularly limited, but specific examples include supplements such as granules, fine granules, powders, tablets and capsules.
本発明の固形製剤を内服用の医薬品の製剤形態にする場合、前記(A)成分及び(B)
成分を、そのままで又は他の添加成分と組み合わせて所望の形態に調製すればよい。この
ような内服用の医薬品としては、具体的には、顆粒剤、細粒剤、散剤、錠剤、カプセル剤
等が挙げられる。
When the solid preparation of the present invention is made into a pharmaceutical formulation for internal use, the above components (A) and (B)
The ingredients may be formulated into the desired form either as such or in combination with other added ingredients. Specific examples of such medicines for internal use include granules, fine granules, powders, tablets, capsules and the like.
2.変色抑制方法
上述のとおり、(B)成分は、(A)成分を含む固形製剤の変色を抑制できる。より具
体的には、(B)成分は、(A)成分を含む固形製剤の、熱及び光の少なくともいずれか
による変色に対する抑制能を有する。従って、本発明は、さらに、(A)紅麹及び/又は
その加工物を含む固形製剤の変色を抑制する方法であって、前記固形製剤において、前記
(A)成分と共に、(B)セルロース及びその誘導体、乳タンパク質、オリゴ糖、糖アル
コール、食用加工油脂、増粘多糖類、並びにステアリン酸カルシウムからなる群より選択
される添加剤を配合する変色抑制方法も提供する。
2. Method for Suppressing Discoloration As described above, component (B) can suppress discoloration of solid preparations containing component (A). More specifically, component (B) has the ability to suppress discoloration of a solid preparation containing component (A) due to at least one of heat and light. Therefore, the present invention further provides (A) a method for suppressing discoloration of a solid preparation containing red yeast rice and/or a processed product thereof, wherein in the solid preparation, (B) cellulose and There is also provided a method for suppressing discoloration by blending an additive selected from the group consisting of derivatives thereof, milk proteins, oligosaccharides, sugar alcohols, edible processed oils and fats, thickening polysaccharides, and calcium stearate.
本発明の変色抑制方法において、使用する成分の種類、使用量等の詳細については、前
記「1.固形製剤」の欄に示す通りである。
In the method for suppressing discoloration of the present invention, details such as the types and amounts of components used are as shown in the section "1. Solid formulation" above.
以下、実施例を挙げて本発明を更に詳細に説明するが、本発明はこれらの実施例に限定
されるものではない。
EXAMPLES The present invention will be described in more detail below with reference to Examples, but the present invention is not limited to these Examples.
試験例
表1及び表2に示す組成の固形製剤を調製した。各表に示した(A)成分及び(B)成
分の詳細は次の通りである。
Solid preparations having the compositions shown in Tables 1 and 2 of Test Examples were prepared. Details of the components (A) and (B) shown in each table are as follows.
(A)成分
紅麹:乾燥米紅麹の粉末物(商品名「3P-D20」、小林バリューサポート株式会社
製、この乾燥米紅麹の粉末物は、モナスカス・ピローサスで白米を発酵させた紅麹の乾燥
粉末物であり、加熱処理により紅麹菌及び酵素は失活した状態になっている。)
(A) Ingredient Red yeast rice: Powdered dried rice red yeast rice (trade name “3P-D20”, manufactured by Kobayashi Value Support Co., Ltd. This dry rice red yeast powder is made by fermenting white rice with Monascus pilosus. It is a dry powder of koji, and red yeast mold and enzymes are inactivated by heat treatment.)
(B)成分
HPMC:メトローズ60SH-4001、信越化学工業株式会社
HPC:NISSO HPC(HPC-SSL)、日本曹達株式会社
結晶セルロース:結晶セルロースFD-302、旭化成株式会社
乳清タンパク質:Wheyco W81 Instant、日本新薬株式会社
アガロオリゴ糖:シオノギアガオリゴ、シオノギヘルスケア株式会社
還元麦芽糖:アマルティMR-51、三菱商事ライフサイエンス株式会社
硬化菜種油:ラブリワックスー102、川研ファインケミカル株式会社
アラビアガム:Instantgum、Nexira
プルラン:食品添加物プルラン、株式会社林原
ステアリン酸Ca:オーラブライトCA-66、日油株式会社
炭酸Ca:ホタテ末、株式会社エヌ・シー・コーポレーション
(B) Component HPMC: Metrose 60SH-4001, Shin-Etsu Chemical Co., Ltd. HPC: NISSO HPC (HPC-SSL), Nippon Soda Co., Ltd. Crystalline cellulose: Crystalline cellulose FD-302, Asahi Kasei Co., Ltd. Whey protein: Wheyco W81 Instant, Nippon Shinyaku Co., Ltd. Agaro-oligosaccharide: Shionogiagaoligo, Shionogi Healthcare Co., Ltd. Reduced maltose: Amalty MR-51, Mitsubishi Corporation Life Sciences Co., Ltd. Hydrogenated rapeseed oil: Lovely wax-102, Kawaken Fine Chemicals Co., Ltd. Gum arabic: Instantgum, Nexira
Pullulan: Food additive pullulan, Hayashibara Co., Ltd. Calcium stearate: Aura Bright CA-66, NOF Corporation Calcium carbonate: Scallop powder, N.C. Corporation
各成分を袋に入れてよく混合させ、100メッシュのふるいにかけた。再度、袋に入れ
て混合することで、固形製剤(散剤)を得た。得られた固形製剤について、以下の変色抑
制試験を行った。
Each component was bagged and mixed well and sieved through a 100 mesh screen. A solid formulation (powder) was obtained by placing the mixture in a bag and mixing again. The following discoloration suppression test was performed on the obtained solid preparation.
<変色抑制試験>
固形製剤30gを、10gずつの3つの試験群(コントロール、温度試験群、及び光試
験群)に分けた。コントロールについては、透明の袋(株式会社セイニチ、ユニパック[
E-4])に入れた後、さらにアルミの外袋(株式会社セイニチ、ラミジップ[AL-1
8])に入れてヒートシールした状態で、4℃に1週間保管した。温度試験群については
、上記の透明の袋に入れ、さらに上記のアルミの外袋に入れて、ヒートシールした状態で
、40℃で1週間保管した。光試験群については、上記の透明の袋に固形製剤を入れて均
一に伸ばし、1週間(2022年3月18日~2022年3月25日、大阪府茨木市)太
陽光が当たる場所で保管した。
<Discoloration suppression test>
30 g of the solid formulation was divided into three test groups of 10 g each (control, temperature test group and light test group). For controls, a transparent bag (Seinichi Co., Ltd., Unipack [
E-4]), and then put it in an aluminum outer bag (Seinichi Co., Ltd., Lamizip [AL-1
8]), heat-sealed, and stored at 4°C for 1 week. The temperature test group was placed in the above transparent bag, further placed in the above aluminum outer bag, heat-sealed, and stored at 40° C. for one week. For the light test group, put the solid formulation in the above transparent bag, stretch it evenly, and store it in a place exposed to sunlight for 1 week (March 18, 2022 to March 25, 2022, Ibaraki City, Osaka Prefecture). did.
各試験群について、色差計を用い、コントロールと温度試験群とにおける色の変化量(
ΔE(温度))及びコントロールと光試験群とにおける色の変化量(ΔE(光))を測定
することで、色の変化を定量的に確認した。結果を表1及び表2に示す。
For each test group, using a color difference meter, the amount of color change between the control and the temperature test group (
Color change was quantitatively confirmed by measuring ΔE (temperature)) and the amount of color change (ΔE (light)) between control and light test groups. The results are shown in Tables 1 and 2.
表1に示される通り、(A)成分からなる固形製剤は熱による変色が確認された(比較
例1)一方で、(A)成分からなる固形製剤に(B)成分を配合することで、固形製剤の
熱による変色が抑制された(各実施例)。また、(B)成分からなる固形製剤では熱によ
る変色の程度が(A)からなる固形製剤に比べて大きいもの、同程度のもの、ある程度小
さいものが認められたが(各参考例)、それらの程度に鑑みても、各実施例による熱によ
る変色抑制効果は顕著であった。なお、(B)成分と同様に固形製剤において賦形剤とし
て用いられる炭酸カルシウムを用いた場合には熱による変色抑制効果が見られず顕著に悪
化した(比較例11-1)ことに鑑みると、各実施例で確認された熱による変色に対する
抑制効果は、(B)成分を配合することによる特有の効果であると認められる。
As shown in Table 1, discoloration due to heat was confirmed in the solid preparation consisting of component (A) (Comparative Example 1). Discoloration of solid preparations due to heat was suppressed (each example). In addition, in the solid preparations consisting of component (B), the degree of discoloration due to heat was found to be greater, the same, or less than that of the solid preparations consisting of (A) (reference examples). In view of the degree of , the effect of suppressing discoloration due to heat in each example was remarkable. In view of the fact that when calcium carbonate, which is used as an excipient in solid preparations as well as the component (B), was used, the effect of suppressing discoloration due to heat was not observed and was significantly deteriorated (Comparative Example 11-1). , The effect of suppressing discoloration due to heat confirmed in each example is recognized as a unique effect by blending the component (B).
表2に示される通り、(A)成分からなる固形製剤は光による変色が確認された(比較
例1)一方で、(A)成分からなる固形製剤に(B)成分を配合することで、固形製剤の
光による変色が抑制された(各実施例)。また、(B)成分からなる固形製剤では光によ
る変色の程度が(A)からなる固形製剤に比べて大きいもの、同程度のもの、ある程度小
さいものが認められたが(各参考例)、それらの程度に鑑みても、各実施例による光によ
る変色抑制効果は顕著であった。なお、(B)成分と同様に固形製剤において賦形剤とし
て用いられる炭酸カルシウムを用いた場合には光による変色抑制効果が見られず顕著に悪
化した(比較例11-1)ことに鑑みると、各実施例で確認された光による変色に対する
抑制効果は、(B)成分を配合することによる特有の効果であると認められる。
As shown in Table 2, discoloration due to light was confirmed in the solid preparation consisting of component (A) (Comparative Example 1). Discoloration of solid preparations due to light was suppressed (each example). In addition, the degree of discoloration due to light in the solid preparations consisting of component (B) was found to be greater, the same, or less than that of the solid preparations consisting of (A) (reference examples). In view of the degree of , the effect of suppressing discoloration due to light in each example was remarkable. Considering that when calcium carbonate, which is used as an excipient in solid preparations as well as component (B), was used, the effect of suppressing discoloration due to light was not observed and was significantly deteriorated (Comparative Example 11-1). , The effect of suppressing discoloration due to light, which was confirmed in each example, is recognized to be a unique effect by blending the component (B).
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