JP2009013113A - Functional nutritive food tablet - Google Patents

Functional nutritive food tablet Download PDF

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JP2009013113A
JP2009013113A JP2007176818A JP2007176818A JP2009013113A JP 2009013113 A JP2009013113 A JP 2009013113A JP 2007176818 A JP2007176818 A JP 2007176818A JP 2007176818 A JP2007176818 A JP 2007176818A JP 2009013113 A JP2009013113 A JP 2009013113A
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tablet
magnesium oxide
weight
oligosaccharide
darkening
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JP5160156B2 (en
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Hiroaki Otsuka
大塚博昭
Hiroshi Maeno
前野浩
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Kyowa Chemical Industry Co Ltd
Otsuka Corp
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Kyowa Chemical Industry Co Ltd
Otsuka Corp
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a tablet composed mainly of magnesium oxide and an oligosaccharide as a functional nutritive food free from the occurrence of darkening on its surface. <P>SOLUTION: The tablet for a functional nutritive food is composed mainly of magnesium oxide particles, an oligosaccharide, a brown sugar lump and a sucrose ester, produced by mixing and tableting 10-60 wt.% magnesium oxide particle, 10-60 wt.% oligosaccharide, 5-15 wt.% brown sugar lump and 1-5 wt.% sucrose ester, and effective for preventing the darkening of the tablet surface formed in tableting by the effect of the brown sugar lump. The "darkening" refers to black spots, streaks or areas observable on the surface of the tablet caused by the abrasion of the tablet in contact with a tableting machine. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

本発明は酸化マグネシウム粒子およびオリゴ糖、および黒糖およびショ糖エステルを含有する栄養機能食品用錠剤に関するものであり、より詳しくは、酸化マグネシウム粒子10~60重量%、オリゴ糖10〜60重量%、黒糖5〜15重量%およびショ糖エステル1〜5重量%を混合して打錠することにより、錠剤表面の黒ずみがない錠剤を提供するものである。
ここで、「黒ずみ」とは機械との接触による磨耗性に起因する、錠剤表面の黒色の点、線または面が観察されたものをいう。
The present invention relates to a tablet for nutritional functional food containing magnesium oxide particles and oligosaccharide, and brown sugar and sucrose ester. More specifically, magnesium oxide particles are 10 to 60% by weight, oligosaccharides are 10 to 60% by weight, By mixing and tableting 5 to 15% by weight of brown sugar and 1 to 5% by weight of sucrose ester, a tablet free from darkening on the surface of the tablet is provided.
Here, “darkening” refers to the observation of black spots, lines or surfaces on the tablet surface due to wear due to contact with the machine.

酸化マグネシウム錠剤は、医薬用緩下剤およびミネラル補給剤等として多岐に使用されている。しかしながら、酸化マグネシウム錠剤は錠剤表面に黒ずみが起こりやすい。黒ずみを起こさない方法として、たとえば、粒状の酸化マグネシウム,賦形剤およびタルクならびにステアリンを含有する混合末を圧縮成形する方法(特許文献1)、酸化マグネシウムにポリビニルアルコールおよびステアリン酸マグネシウムを配合する方法(特許文献2)等が考えられたが、かならずしも満足できるものではなかった。
特開2000−1428号公報 特開2004−352633号公報
Magnesium oxide tablets are widely used as pharmaceutical laxatives and mineral supplements. However, magnesium oxide tablets tend to darken on the tablet surface. Examples of methods that do not cause darkening include, for example, a method of compression-molding a mixed powder containing granular magnesium oxide, an excipient and talc and stearin (Patent Document 1), and a method of blending polyvinyl alcohol and magnesium stearate in magnesium oxide. (Patent document 2) etc. were considered, but it was not always satisfactory.
JP 2000-1428 A JP 2004-352633 A

本発明の目的は、黒ずみが発生しない栄養機能食品としての酸化マグネシウムとオリゴ糖を主成分とする錠剤を提供することである。 An object of the present invention is to provide a tablet mainly composed of magnesium oxide and oligosaccharide as a nutritional functional food that does not cause darkening.

本発明者は前記目的を達成するために鋭意研究の結果、黒糖が酸化マグネシウム錠剤の黒ずみの発生防止に有効であることを見出し、前記栄養機能食品としての錠剤製造時に、黒糖を配合することにより黒ずみがない、さらに味がよい錠剤を見出した。
その結果、錠剤1錠中に(1)酸化マグネシウム粒子 10〜60重量% 、(2)オリゴ糖10〜60重量%、(3) 黒糖 5〜15重量% (4)ショ糖エステル 1〜5重量% の割合で混合し、打錠成形することで黒ずみがない錠剤を提供した。
As a result of intensive studies to achieve the above object, the present inventor has found that brown sugar is effective in preventing the occurrence of darkening of magnesium oxide tablets, and by blending brown sugar at the time of tablet production as the nutritional functional food, We found a tablet with better taste and no darkening.
As a result, in one tablet (1) Magnesium oxide particles 10-60% by weight, (2) Oligosaccharide 10-60% by weight, (3) Brown sugar 5-15% by weight (4) Sucrose ester 1-5% by weight %, And tablets were formed by tableting to provide a blackened tablet.

酸化マグネシウム粒子が10重量%以下の場合はミネラルとしてのマグネシウムの1日の必要量を摂取するために錠剤を多く服用する必要があり、また、60重量%以上の場合は
マグネシウムの必用量を摂取するためにオリゴ糖、黒糖等の摂取量が少なくなる。
使用する酸化マグネシウム粒子はいずれの方法で製造したものでもよいが、レーザー回折
散乱法で測定した平均2次粒子径が0.5〜20μm、好ましくは1〜15μmが硬くな
く打錠機を磨耗しない。
If the magnesium oxide particle is 10% by weight or less, it is necessary to take a large amount of tablets to take the daily required amount of magnesium as a mineral, and if it is 60% by weight or more, the necessary dose of magnesium is taken. Therefore, the intake of oligosaccharide, brown sugar, etc. is reduced.
The magnesium oxide particles to be used may be produced by any method, but the average secondary particle diameter measured by the laser diffraction scattering method is 0.5 to 20 μm, preferably 1 to 15 μm, and the tablet press is not worn. .

オリゴ糖は大腸内のビフィズス菌の餌になり、ビフィズス菌を増殖させる作用があるので多いほうがいいが、多すぎると錠剤中の他成分が少なくなり、他成分の効果が抑えられるので、10〜60重量%が好ましい。オリゴ糖は直鎖オリゴ糖、または難消化性オリゴ糖のいずれを使用してもいいが、小腸で吸収されやすい直鎖オリゴ糖より、小腸で吸収されにくい難消化性オリゴ糖が好ましい。 Oligosaccharides are good because it acts as a feed for bifidobacteria in the large intestine and has the effect of growing bifidobacteria, but if it is too much, other components in the tablet will decrease and the effects of other components will be suppressed. 60% by weight is preferred. As the oligosaccharide, either a linear oligosaccharide or an indigestible oligosaccharide may be used, but an indigestible oligosaccharide that is hardly absorbed in the small intestine is preferable to a linear oligosaccharide that is easily absorbed in the small intestine.

黒糖は5〜15重量%が好ましく、5重量%以下では黒ずみ防止の効果がなく、15重量%以上では錠剤が黒くなり、外観がよくない。
ショ糖エステルは滑沢剤として使用し、打錠時に本発明の栄養機能食品が打錠機の杵と臼に付着するのを防止する。
本発明の栄養機能食品用錠剤には上記成分の他、賦形剤、結合剤、崩壊剤および滑沢剤等を必要に応じ添加することが出来る。
The brown sugar is preferably 5 to 15% by weight, and if it is 5% by weight or less, there is no effect of preventing darkening, and if it is 15% by weight or more, the tablet becomes black and the appearance is not good.
The sucrose ester is used as a lubricant to prevent the nutritional functional food of the present invention from adhering to the punch and mortar of the tableting machine during tableting.
In addition to the above components, excipients, binders, disintegrants, lubricants and the like can be added to the nutritional functional food tablet of the present invention as necessary.

本発明の(1)酸化マグネシウム粒子、(2)オリゴ糖、(3)黒糖、(4)ショ糖エステルを使用し、前述の結合剤と崩壊剤等とを組み合わせることによって錠剤中の(1)(2)(3)(4)の合計量が85重量%〜100重量%、好ましくは90重量%〜98重量%の錠剤が得られる。 Using (1) magnesium oxide particles, (2) oligosaccharide, (3) brown sugar, (4) sucrose ester of the present invention, and combining the binder and disintegrant described above (1) in the tablet (2) Tablets with a total amount of (3) and (4) of 85% to 100% by weight, preferably 90% to 98% by weight are obtained.

本発明の栄養機能食品としての錠剤に使用される結合剤としては、カルボキシメチルセルロースナトリウム、低置換度ヒドロキシプロピルセルロース、結晶セルロース、またはデンプン(例えばトウモロコシデンプン)であり、錠剤中1〜10重量%、好ましくは1〜8重量%配合され、また崩壊剤としては、カルボキシメチルセルロースカルシウム、カルメロース、低置換度ヒドロキシプロピルセルロース、クロスカルメロースナトリウム、カルメロースカルシウムまたは、カルボキシスターチナトリウムである。これら崩壊剤は2種以上組み合わせても良い。崩壊剤としては、特に、クロスカルメロースナトリウムまたは、カルボキシスターチナトリウムは、従来の崩壊剤に比べて、極めて少量で崩壊するので、その配合量を減らすことが出来、さらに、経時的変化が非常に少なく、錠剤に配合した場合は、安定性に優れた錠剤を得ることが出来る。最も好ましい崩壊剤はクロスカルメロ-スナトリウムである。崩壊剤は錠剤中1〜10重量%、好ましくは1〜5重量%配合される。 The binder used in the tablet as a nutritional functional food of the present invention is sodium carboxymethylcellulose, low-substituted hydroxypropylcellulose, crystalline cellulose, or starch (eg corn starch), 1 to 10% by weight in the tablet, Preferably, 1 to 8% by weight is blended, and the disintegrant is carboxymethylcellulose calcium, carmellose, low-substituted hydroxypropylcellulose, croscarmellose sodium, carmellose calcium or carboxystarch sodium. Two or more of these disintegrants may be combined. As disintegrants, especially croscarmellose sodium or carboxystarch sodium disintegrates in a very small amount compared to conventional disintegrants, so that the amount of the disintegrant can be reduced and the change with time is very high. When it is blended in a small amount, a tablet having excellent stability can be obtained. The most preferred disintegrant is croscarmellose sodium. The disintegrant is contained in the tablet in an amount of 1 to 10% by weight, preferably 1 to 5% by weight.

本発明の(1)+(2)+(3)+(4)の混合物を打錠化に供するが、(1)+(2)+(3)+(4)の混合物は、粉末状でよく、また顆粒状のいずれでもよいが、顆粒状の方が打錠機の磨耗防止効果、しかもより高含有量の錠剤を得ることができる。
顆粒状粒子の製造方法は公知のいかなる方法でもよいが、流動層造粒が好ましい。流動層造粒は他の造粒方法よりも微粉の発生率が少なく、打錠障害を少なくすることが可能である。流動層造粒装置により造粒する場合、全ての粉体原料に結合剤を混合し、流動層造粒装置に投入する。
混合は(1)酸化マグネシウム粒子10〜60重量%、(2)オリゴ糖10〜60重量%、(3)黒糖5〜15重量%、(4)ショ糖エステル1〜5重量%(5)結合剤1〜10重量%(好ましくは1〜8重量%)とする。この混合物に、崩壊剤1〜10重量%(好ましくは1〜5重量%)を配合してもよく、これらをコンテナー型、V型、あるいはW型などいずれの方法で混合してもよい。
The mixture of (1) + (2) + (3) + (4) of the present invention is subjected to tableting, but the mixture of (1) + (2) + (3) + (4) is in powder form Any of the granules may be used, but the granules are more effective for preventing the wear of the tableting machine, and can provide a tablet with a higher content.
Any known method may be used for producing the granular particles, but fluidized bed granulation is preferred. Fluidized bed granulation produces less fine powder than other granulation methods, and can reduce tableting troubles. When granulating with a fluidized bed granulator, a binder is mixed with all powder raw materials and put into the fluidized bed granulator.
Mixing (1) Magnesium oxide particles 10-60 wt%, (2) Oligosaccharide 10-60 wt%, (3) Brown sugar 5-15 wt%, (4) Sucrose ester 1-5 wt% (5) Binding 1 to 10 wt% (preferably 1 to 8 wt%) of the agent. This mixture may be mixed with 1 to 10% by weight (preferably 1 to 5% by weight) of a disintegrant, and these may be mixed by any method such as container type, V type or W type.

次に本発明の錠剤の製造方法について説明する。
前期顆粒状粒子は、滑沢剤を混合して打錠機に供給される。本発明のショ糖エステルは滑沢剤として配合しているので、他の滑沢剤を配合しなくてもよいし、または配合してもよい。使用される滑沢剤としては、例えばステアリン酸およびその塩(Na,Mg,Ca塩)等がある。好ましくはステアリン酸塩、特にステアリン酸カルシウムおよびステアリン酸マグネシウムであるが、最も有効なものは、ステアリン酸カルシウムである。これら滑沢剤は、多すぎると崩壊遅延となり、少なすぎると杵、臼に付着する。したがって、滑沢剤の添加量は0.2〜2重量%が好ましく、さらに好ましくは0.8〜1.2重量%である。
打錠圧は一錠あたりのパンチ圧として5〜12kNが好ましく、6〜10kNがより好ましい。杵の形状はR面の他、隅角R、隅角平面、隅丸平面等のいずれであってもよい。
Next, the manufacturing method of the tablet of this invention is demonstrated.
Pre-granular particles are mixed with a lubricant and supplied to a tableting machine. Since the sucrose ester of the present invention is blended as a lubricant, other lubricants may not be blended or blended. Examples of the lubricant used include stearic acid and its salts (Na, Mg, Ca salts). Preferred are stearates, especially calcium stearate and magnesium stearate, but the most effective is calcium stearate. When these lubricants are too much, they are delayed in disintegration, and when they are too little, they adhere to the pestle and die. Therefore, the addition amount of the lubricant is preferably 0.2 to 2% by weight, more preferably 0.8 to 1.2% by weight.
The tableting pressure is preferably 5 to 12 kN, more preferably 6 to 10 kN, as a punch pressure per tablet. The shape of the ridge may be any of a corner angle R, a corner plane, a corner-round plane, etc. in addition to the R plane.

実施例において本発明の栄養機能食品を詳細に説明する。
実施例において、酸化マグネシウム粒子の(a)平均2次粒子径、(b)錠剤の黒ずみ数は以下に記載する測定法によって測定された値を意味する。
(a)酸化マグネシウム粒子の平均2次粒子径
MICROTRAC粒度分布計SPAタイプ(LEEDS&NORTHRUP INSTRUMENTS社製)を用いて測定決定する。
資料粉末700mgを70mlの水に加えて、超音波(NISSEI 社製、MODEL US-300,電流300μA)で3分間分散処理した後、その分散液の2-4mlを採って、250mlの脱気水を収容した上記粒度分布計の試料室に加え、分析計を作動させて8分間その懸濁液を循環した後、粒度分布を測定する。合計2回の測定を行い、それぞれの測定について得られた50%累積2次粒子径の算術平均値を算出して、試料の平均2次粒子径とする。
(b)黒ずみ数
目視によりかぞえた。
The nutritional functional food of the present invention will be described in detail in Examples.
In Examples, (a) average secondary particle diameter of magnesium oxide particles and (b) darkening number of tablets mean values measured by the measurement method described below.
(A ) Average secondary particle diameter of magnesium oxide particles
Measurement is determined using a MICROTRAC particle size distribution analyzer SPA type (manufactured by LEEDS & NORTHHRUP INSTRUMENTS).
After adding 700 mg of the material powder to 70 ml of water and dispersing for 3 minutes with ultrasonic waves (NISSEI, MODEL US-300, current 300 μA), take 2-4 ml of the dispersion and add 250 ml of deaerated water. In addition to the sample chamber of the particle size distribution meter containing the above, the analyzer is operated and the suspension is circulated for 8 minutes, and then the particle size distribution is measured. The measurement is performed twice in total, and the arithmetic average value of the 50% cumulative secondary particle diameter obtained for each measurement is calculated to obtain the average secondary particle diameter of the sample.
(B) The number of darkenings was visually observed.

平均2次粒子径が7.0μmの酸化マグネシウム粒子22.0Kg、難消化性オリゴ糖 16.3Kg、黒糖4.4Kg、ショ糖エステル1.3Kg、結晶セルロース1.3Kgをコンテナー型混合器にて混合後、流動層造粒装置にて造粒した成形物を、直径9mm、13R杵を36本装着したロータリー型打錠機にて、打錠圧9kNで製錠し、1錠あたり重量283mg、厚み4.8mmの錠剤をえた。
この錠剤100,000錠を10人で目視にて黒ずみの数をかぞえた。結果を表1に示す。
In a container type mixer, 22.0 kg of magnesium oxide particles having an average secondary particle size of 7.0 μm, 16.3 kg of indigestible oligosaccharide, 4.4 kg of brown sugar, 1.3 kg of sucrose ester, and 1.3 kg of crystalline cellulose After mixing, the molded product granulated with a fluidized bed granulator was tableted with a tableting pressure of 9 kN in a rotary tableting machine equipped with 36 mm diameter and 36 13R punches, and 283 mg in weight per tablet. A tablet with a thickness of 4.8 mm was obtained.
Ten tablets of this 100,000 tablets were visually counted. The results are shown in Table 1.

(比較例1)平均2次粒子径が7.0μmの酸化マグネシウム粒子22.0Kg、難消化性オリゴ糖16.3Kg、ショ糖エステル1.3Kg、結晶セルロース1.3Kgをコンテナー型混合器にて混合後、実施例1と同様に顆粒化し、製剤を行った。1錠あたり288mg、厚み4.8mmの錠剤を得た。
この錠剤100,000錠を10人で目視にて黒ずみの数をかぞえた。結果を表1に示す。


(Comparative Example 1) 22.0 kg of magnesium oxide particles having an average secondary particle size of 7.0 μm, 16.3 kg of indigestible oligosaccharide, 1.3 kg of sucrose ester, and 1.3 kg of crystalline cellulose in a container type mixer After mixing, it was granulated and prepared in the same manner as in Example 1. A tablet having 288 mg and a thickness of 4.8 mm per tablet was obtained.
Ten tablets of this 100,000 tablets were visually counted. The results are shown in Table 1.






































Claims (1)

下記(1)〜(4)を有効成分として85〜100重量%含有する表面に黒ずみがない栄養機能食品用錠剤
(1) 酸化マグネシウム粒子 10〜60重量% 、(2)オリゴ糖10〜60重量%、
(3) 黒糖 5〜15重量% (4)ショ糖エステル 1〜5重量%







































The following (1) to (4) containing 85 to 100% by weight of the active ingredient as an active ingredient and a tablet for nutritional functional foods without darkening on the surface (1) Magnesium oxide particles 10 to 60% by weight, (2) Oligosaccharide 10 to 60% by weight %,
(3) Brown sugar 5-15% (4) Sucrose ester 1-5%







































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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016042831A1 (en) * 2014-09-18 2016-03-24 協和化学工業株式会社 Preparation for treatment purposes for use in test or surgery of large intestine
US10004763B2 (en) 2014-02-25 2018-06-26 Konoshima Chemical Co., Ltd. Magnesium oxide granules for pharmaceutical applications or for use as food additives

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000001428A (en) * 1998-04-16 2000-01-07 Nippon Shinyaku Co Ltd Tablet and its production
JP2004352633A (en) * 2003-05-28 2004-12-16 Kowa Co Magnesium oxide tablet

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000001428A (en) * 1998-04-16 2000-01-07 Nippon Shinyaku Co Ltd Tablet and its production
JP2004352633A (en) * 2003-05-28 2004-12-16 Kowa Co Magnesium oxide tablet

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10004763B2 (en) 2014-02-25 2018-06-26 Konoshima Chemical Co., Ltd. Magnesium oxide granules for pharmaceutical applications or for use as food additives
WO2016042831A1 (en) * 2014-09-18 2016-03-24 協和化学工業株式会社 Preparation for treatment purposes for use in test or surgery of large intestine

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