JP5886657B2 - Formulation containing powder derived from wheat bran - Google Patents
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- JP5886657B2 JP5886657B2 JP2012043367A JP2012043367A JP5886657B2 JP 5886657 B2 JP5886657 B2 JP 5886657B2 JP 2012043367 A JP2012043367 A JP 2012043367A JP 2012043367 A JP2012043367 A JP 2012043367A JP 5886657 B2 JP5886657 B2 JP 5886657B2
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- 239000000843 powder Substances 0.000 title claims description 33
- 235000015099 wheat brans Nutrition 0.000 title claims description 20
- 239000000203 mixture Substances 0.000 title description 7
- 238000009472 formulation Methods 0.000 title description 2
- 239000000314 lubricant Substances 0.000 claims description 25
- 239000004480 active ingredient Substances 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 description 16
- 239000002775 capsule Substances 0.000 description 14
- 238000000034 method Methods 0.000 description 10
- 230000000052 comparative effect Effects 0.000 description 9
- 235000009508 confectionery Nutrition 0.000 description 8
- 238000011156 evaluation Methods 0.000 description 8
- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 description 8
- 238000010924 continuous production Methods 0.000 description 7
- 235000013325 dietary fiber Nutrition 0.000 description 7
- 238000004519 manufacturing process Methods 0.000 description 7
- 239000008187 granular material Substances 0.000 description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 6
- 229920002472 Starch Polymers 0.000 description 5
- 235000013312 flour Nutrition 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 239000002994 raw material Substances 0.000 description 5
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 4
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 4
- OVBPIULPVIDEAO-UHFFFAOYSA-N N-Pteroyl-L-glutaminsaeure Natural products C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)NC(CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-UHFFFAOYSA-N 0.000 description 4
- 229930006000 Sucrose Natural products 0.000 description 4
- 229910052791 calcium Inorganic materials 0.000 description 4
- 239000011575 calcium Substances 0.000 description 4
- 235000014113 dietary fatty acids Nutrition 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 239000000194 fatty acid Substances 0.000 description 4
- 229930195729 fatty acid Natural products 0.000 description 4
- 229960000304 folic acid Drugs 0.000 description 4
- 235000019152 folic acid Nutrition 0.000 description 4
- 239000011724 folic acid Substances 0.000 description 4
- 235000013373 food additive Nutrition 0.000 description 4
- 239000002778 food additive Substances 0.000 description 4
- 238000002156 mixing Methods 0.000 description 4
- 239000008107 starch Substances 0.000 description 4
- 235000019698 starch Nutrition 0.000 description 4
- 239000005720 sucrose Substances 0.000 description 4
- -1 sucrose fatty acid ester Chemical class 0.000 description 4
- 244000068988 Glycine max Species 0.000 description 3
- 235000010469 Glycine max Nutrition 0.000 description 3
- 241000209140 Triticum Species 0.000 description 3
- 235000021307 Triticum Nutrition 0.000 description 3
- 239000011230 binding agent Substances 0.000 description 3
- 239000000796 flavoring agent Substances 0.000 description 3
- 235000019634 flavors Nutrition 0.000 description 3
- 238000005469 granulation Methods 0.000 description 3
- 230000003179 granulation Effects 0.000 description 3
- 239000007902 hard capsule Substances 0.000 description 3
- 235000019359 magnesium stearate Nutrition 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 238000010298 pulverizing process Methods 0.000 description 3
- 239000000454 talc Substances 0.000 description 3
- 229910052623 talc Inorganic materials 0.000 description 3
- 229920000881 Modified starch Polymers 0.000 description 2
- 238000000748 compression moulding Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 210000000744 eyelid Anatomy 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 150000004676 glycans Chemical class 0.000 description 2
- 235000013402 health food Nutrition 0.000 description 2
- 229910052742 iron Inorganic materials 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 229920001282 polysaccharide Polymers 0.000 description 2
- 239000005017 polysaccharide Substances 0.000 description 2
- 230000037303 wrinkles Effects 0.000 description 2
- 229920001353 Dextrin Polymers 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- 102000002322 Egg Proteins Human genes 0.000 description 1
- 108010000912 Egg Proteins Proteins 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 244000046052 Phaseolus vulgaris Species 0.000 description 1
- 235000010627 Phaseolus vulgaris Nutrition 0.000 description 1
- 235000008331 Pinus X rigitaeda Nutrition 0.000 description 1
- 235000011613 Pinus brutia Nutrition 0.000 description 1
- 241000018646 Pinus brutia Species 0.000 description 1
- 229930003779 Vitamin B12 Natural products 0.000 description 1
- 244000052616 bacterial pathogen Species 0.000 description 1
- 239000006227 byproduct Substances 0.000 description 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
- 235000013539 calcium stearate Nutrition 0.000 description 1
- 239000007963 capsule composition Substances 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- FDJOLVPMNUYSCM-WZHZPDAFSA-L cobalt(3+);[(2r,3s,4r,5s)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2r)-1-[3-[(1r,2r,3r,4z,7s,9z,12s,13s,14z,17s,18s,19r)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2 Chemical compound [Co+3].N#[C-].N([C@@H]([C@]1(C)[N-]\C([C@H]([C@@]1(CC(N)=O)C)CCC(N)=O)=C(\C)/C1=N/C([C@H]([C@@]1(CC(N)=O)C)CCC(N)=O)=C\C1=N\C([C@H](C1(C)C)CCC(N)=O)=C/1C)[C@@H]2CC(N)=O)=C\1[C@]2(C)CCC(=O)NC[C@@H](C)OP([O-])(=O)O[C@H]1[C@@H](O)[C@@H](N2C3=CC(C)=C(C)C=C3N=C2)O[C@@H]1CO FDJOLVPMNUYSCM-WZHZPDAFSA-L 0.000 description 1
- 238000005238 degreasing Methods 0.000 description 1
- 238000004925 denaturation Methods 0.000 description 1
- 230000036425 denaturation Effects 0.000 description 1
- 235000019425 dextrin Nutrition 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 210000003278 egg shell Anatomy 0.000 description 1
- 210000003038 endothelium Anatomy 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 239000002657 fibrous material Substances 0.000 description 1
- 235000013376 functional food Nutrition 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 150000003278 haem Chemical class 0.000 description 1
- 239000008172 hydrogenated vegetable oil Substances 0.000 description 1
- 235000013336 milk Nutrition 0.000 description 1
- 239000008267 milk Substances 0.000 description 1
- 210000004080 milk Anatomy 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 229930014626 natural product Natural products 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 239000013641 positive control Substances 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
- 235000012222 talc Nutrition 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
- 231100000167 toxic agent Toxicity 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
- 239000011715 vitamin B12 Substances 0.000 description 1
- 235000019163 vitamin B12 Nutrition 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Cereal-Derived Products (AREA)
- General Preparation And Processing Of Foods (AREA)
- Medicinal Preparation (AREA)
Description
本発明は、錠剤、錠菓、カプセル剤に関する。 The present invention relates to tablets, tablet confectionery, and capsules.
錠剤、錠菓は、一般的に原料を粉体のまま若しくは顆粒として打錠機にかけて圧縮成型して製造する。カプセル剤は粉末状態の原料を造粒して、これを顆粒化した後、硬質カプセルに充填する。
錠剤を打錠する際の脱型の工程で錠剤の杵先からの剥離が生じるキャッピング、打錠中に粉末が杵先へ付着し杵離れが悪く、錠剤表面に傷がつくスティッキング、錠剤と臼の摩擦が大きく打錠後の錠剤の離型性が悪くなるバインディングを生じることがあり、品質管理上問題となる。これらがひどくなると打錠を継続して実施できなくなる場合もある。またカプセル剤の場合は充填装置に顆粒が付着することによってスティッキングを起こす。
Tablets and tablet confections are generally produced by compressing and molding raw materials as powders or granules through a tableting machine. The capsule is granulated from a powdered raw material, granulated, and then filled into a hard capsule.
Capping that causes peeling of the tablet from the tip of the tablet during the demolding process when tableting is performed, sticking that causes powder to adhere to the tip of the tablet during tableting, and detachment is bad, and the tablet surface is scratched. There is a case where the friction of the tablet is large, and binding may occur, which causes the tablet release property after tableting to deteriorate, which is a problem in quality control. If these are severe, tableting may not be continued. In the case of capsules, sticking occurs when the granules adhere to the filling device.
錠剤、錠菓を打錠する際の障害となるキャッピング、スティッキング、バインディングおよびカプセル剤のスティッキングの発生を防止するために、結着剤や滑沢剤が使用されている。通常滑沢剤には、従来から、タルク、ステアリン酸カルシウム、ステアリン酸マグネシウム、シュガーエステルなどの食品添加物系のものが使用されている。 Binders and lubricants are used to prevent capping, sticking, binding, and capsule sticking, which are obstacles in tableting tablets and tablet confections. Conventionally, food additives such as talc, calcium stearate, magnesium stearate, sugar ester and the like have been used as lubricants.
しかし、タルクは、食品への使用量に際しては使用基準があり、また滑沢剤としての効果も小さいためあまり用いられないのが現状である。ステアリン酸マグネシウムは、少量の使用で滑沢剤としての効果を発揮することができるが、長い間食品添加物として認められていなかったが現在では、その用途が保健機能食品に限って使用出来る事となったが、用途が限定されるという問題がある。最近の天然物志向の流れからできるだけ合成物質を使用しないようにしてほしいという消費者からの強い要求がある。
このため、また、天然系滑沢剤として食品添加物との製剤品が市販されている。またいくつかの提案がなされている。たとえば卵殻粉末（特許文献１：特開平１０−２２５２８５公報）、豆類や種子の胚芽部の粉砕物（特許文献２：特開２００７−３２０８５６号公報）、植物抽出多糖類（特許文献３：特開２００２−３２６９６１号公報）を挙げることができる。しかし、現状では口解けや風味の面で問題がある。
However, talc is not used so much because there is a use standard for the amount used in foods and the effect as a lubricant is small. Magnesium stearate can exert its effect as a lubricant when used in a small amount, but it has not been recognized as a food additive for a long time, but now it can be used only for health functional foods. However, there is a problem that the application is limited. Due to the recent trend toward natural products, there is a strong demand from consumers to minimize the use of synthetic materials.
For this reason, pharmaceutical products with food additives are also commercially available as natural lubricants. Several proposals have been made. For example, eggshell powder (Patent Document 1: Japanese Patent Laid-Open No. 10-225285), ground product of beans and seed germs (Patent Document 2: Japanese Patent Laid-Open No. 2007-320856), plant extracted polysaccharide (Patent Document 3: Japanese Patent 2002-326961 gazette). However, there are currently problems in terms of prank and flavor.
本発明は、既存の滑沢剤を含有しない錠剤、錠菓であって打錠する際の滑沢性・結着性を高め、キャッピング、スティッキングを抑制した組成の錠剤、錠菓を提供することを課題とする。また、既存の滑沢剤を含有しないカプセル剤であって、スティッキングを抑制したカプセル剤を提供することを課題とする。 The present invention provides a tablet or tablet confectionery that does not contain an existing lubricant and has a composition that enhances the lubricity and binding property when tableting and suppresses capping and sticking. Is an issue. It is another object of the present invention to provide a capsule that does not contain an existing lubricant and that suppresses sticking.
本発明は以下の構成である。
（１）小麦フスマ由来の粉末を有効成分とする滑沢剤。
The present invention has the following configuration.
(1) A lubricant comprising powder derived from wheat bran as an active ingredient.
本発明の実施により滑沢剤を含有しない錠剤、錠菓、カプセル剤が提供される。 By carrying out the present invention, tablets, tablet confections, and capsules containing no lubricant are provided.
本発明における滑沢剤とは、日本薬学会の定義に従うものとする。日本薬学会のホームページの定義は次のとおりである。
錠剤の製造に用いる医薬品添加物の一種。錠剤の原料となる粉末や顆粒に少量（１％以下）加えると、粉体表面に付着し、粉体間の付着力が弱まるため、粉体の流動性が高くなる。また、粉体の装置への付着を防ぐことにより、錠剤の製造をスムースにする。ステアリン酸マグネシウム、タルク、水素添加植物油などが用いられる。
The lubricant in the present invention shall conform to the definition of the Japan Pharmaceutical Association. The definition of the website of the Japan Pharmaceutical Association is as follows.
A type of pharmaceutical additive used in the manufacture of tablets. When a small amount (1% or less) is added to the powder or granule used as the raw material of the tablet, it adheres to the powder surface and the adhesion between the powders is weakened, so that the fluidity of the powder becomes high. In addition, the manufacture of tablets is smoothed by preventing the powder from adhering to the apparatus. Magnesium stearate, talc, hydrogenated vegetable oil, etc. are used.
本発明は、従来の技術とはまったく異なる技術思想の発明である。すなわち従来滑沢剤として公知の食品添加物や医薬品用添加物ではなく、小麦フスマ由来の粉末を製剤を調整する際に一定量配合することで滑沢剤としての機能を付与するものである。小麦フスマは小麦粉を製造する際の廃棄物とされていたが、最近では食用食物繊維として供給されている。食物繊維やセルロースなどの多糖類は製剤技術においては結着剤として使用されることはあったが、滑沢剤としての効果はないものと考えられてきた。逆に繊維性の物質は、製剤技術上は好ましくないとされていた。本発明は、小麦フスマ由来の粉末以外に滑沢剤を使用しなくともスティッキングやキャッピングなどの発生しない製剤を製造することができる。 The present invention is an invention of a technical idea that is completely different from the prior art. That is, a function as a lubricant is imparted by blending a certain amount of powder derived from wheat bran instead of food additives and pharmaceutical additives conventionally known as lubricants when adjusting the preparation. Wheat bran has been considered a waste product in the production of flour, but has recently been supplied as an edible dietary fiber. Polysaccharides such as dietary fiber and cellulose have been used as binders in pharmaceutical technology, but have not been considered effective as a lubricant. On the other hand, fibrous materials have been considered undesirable in terms of pharmaceutical technology. The present invention can produce a preparation that does not cause sticking or capping without using a lubricant other than the powder derived from wheat bran.
本発明においては小麦フスマ由来の粉末であれば使用可能である。この小麦フスマ由来の粉末の粒径は特に限定するものではないが、粒径が大きいと均一に分散せず流動性及び製品の歩留まりが低下するので、好ましくは、粒径が２００μｍ以下、さらに好ましくは１８０μｍ以下である。 In the present invention, any powder derived from wheat bran can be used. The particle size of the wheat bran-derived powder is not particularly limited, but if the particle size is large, the particle size is preferably 200 μm or less, more preferably because it is not uniformly dispersed and fluidity and product yield are reduced. Is 180 μm or less.
本発明に使用する小麦フスマ由来の粉末は、小麦粉を製造する過程で副産物として生産される。小麦粉をローラーで粉砕する工程で小麦顆粒の内皮や胚芽はピューリファイヤーとシフターで分離され、フスマとして除去される。このフスマをさらに粉砕し、得られるものである。フスマを粉砕する場合には、特開平１１−１０３８００号公報に記載され脱脂後焙煎して粉砕する方法や、特開平５−３０４９１５号公報に開示された熱変性を起こさない温度で粉砕する方法など種々の方法が提案されているが、どの方法であっても採用することができる。小麦フスマ由来の粉末は、好ましくはＪＩＳ２４メッシュ篩の通過物であり、さらに好ましくはＪＩＳ３２〜８０メッシュの通過物であることが良い。このようなフスマの粉砕物は食物繊維として市販されているものもある。このような小麦フスマ由来の粉末食物繊維として市販されているものとしては、日本製粉株式会社製「ブランエース」（商品名）、あるいは日清製粉株式会社製「小麦ふすま」などがある。 The wheat bran-derived powder used in the present invention is produced as a by-product in the process of producing wheat flour. In the process of grinding wheat flour with a roller, the endothelium and germ of the wheat granules are separated by a purifier and a shifter and removed as a bran. This bran is obtained by further pulverizing. When pulverizing the bran, the method described in JP-A-11-103800 and roasted and pulverized after degreasing, or the method of pulverizing at a temperature that does not cause thermal denaturation disclosed in JP-A-5-304915 Various methods have been proposed, and any method can be adopted. The wheat bran-derived powder is preferably passed through a JIS 24 mesh sieve, and more preferably passed through a JIS 32-80 mesh. Some of these bran pulverized products are commercially available as dietary fiber. Examples of commercially available powdered dietary fiber derived from wheat bran include “Bran Ace” (trade name) manufactured by Nippon Flour Milling Co., Ltd., and “Wheat Bran” manufactured by Nisshin Flour Milling Co., Ltd.
小麦フスマ由来の粉末を滑沢剤として使用する場合は打錠する成分との関係又はカプセルに充填する成分の口どけや風味を考慮して使用する小麦フスマ由来の粉末を市販品から適宜選択することができる。 When using wheat bran-derived powder as a lubricant, the wheat bran-derived powder to be used is appropriately selected from commercially available products in consideration of the relationship with the components to be tableted or the mouthfeel and flavor of the components to be filled in the capsule. be able to.
本発明において使用する小麦フスマ由来の粉末は、医薬品、健康食品、菓子等に好適に用いられるが、特に、健康食品、菓子等口どけや風味が重要なものにより好適に用いられる。また、食物繊維として有害物質の吸着などの機能も有しており、滑沢剤としてのみでなく、さらに健康に役立つ機能を付加させることができる。 The wheat bran-derived powder used in the present invention is suitably used for pharmaceuticals, health foods, confectionery, and the like, but is particularly preferably used for health foods, confectionery and the like in which mouthfeel and flavor are important. Moreover, it has functions, such as adsorption | suction of a harmful | toxic substance, as a dietary fiber, and can add the function useful for health not only as a lubricant.
本発明の錠剤または錠菓、あるいはカプセル剤の製造の製造過程は、特に限定するものではない。錠剤の場合は、圧縮成型するための粉末または顆粒を製造する造粒プロセスと圧縮成型する打錠プロセスに分けられ、滑沢剤としての機能を発揮させるためには一般に造粒プロセス後に添加されるのが好ましい。添加量は特に限定するものではないが、１．０〜１０．０重量％が好ましい。 The production process for producing the tablet or tablet confectionery or capsule of the present invention is not particularly limited. In the case of tablets, it is divided into a granulation process for producing powder or granules for compression molding and a tableting process for compression molding, and is generally added after the granulation process in order to exert a function as a lubricant. Is preferred. The addition amount is not particularly limited, but is preferably 1.0 to 10.0% by weight.
本発明における打錠製造に用いる打錠機としては、上述したような原料粉体若しくは顆粒を打錠して錠剤を製造できる打錠機であれば特に制限されない。例えば、ロータリー打錠機や単発打錠機が好ましく用いられるがこれらに限られない。カプセル剤の場合も同様である。本発明の実施例、比較例を示し説明するが、本発明はこれらのみに限定されるものではない。 The tableting machine used for tableting production in the present invention is not particularly limited as long as it is a tableting machine capable of producing a tablet by tableting the raw material powder or granule as described above. For example, a rotary tableting machine or a single tableting machine is preferably used, but is not limited thereto. The same applies to capsules. Examples and Comparative Examples of the present invention will be shown and described, but the present invention is not limited to these.
１．葉酸含有製剤の調製と評価（粉体混合後直接打錠による評価）
各種食物繊維ならびに既存の滑沢剤と本発明に用いられる小麦フスマ由来の粉末について滑沢剤としての効果を比較評価した。
葉酸０．２６７重量部、製剤用でんぷん（パーフィラー１０２：フロイント産業製）９９．７７３重量部をミクロ型透視式混合機（筒井理化学機械社）を用いて混合し、これに表１に示す各粉末を添加して混合し、単発打錠機Ｎ−３０Ｅ（岡田精工社）で打錠した。打錠圧は１０００Ｋｇ、錠剤重量を１５０ミリグラムに設定した。
かくして得られた錠剤の外観、錠剤硬度を評価した。また打錠杵への付着状態、打錠下杵／上杵の圧力比、錠剤硬度を測定し評価した。
錠剤硬度はニュースピードチェカーＴＳ−７５Ｎ型（岡田精工社製）を用いて測定した。
1. Preparation and evaluation of folic acid-containing preparation (evaluation by direct tableting after powder mixing)
Various dietary fibers, existing lubricants, and wheat bran-derived powders used in the present invention were comparatively evaluated for their effects as lubricants.
0.267 parts by weight of folic acid and 99.773 parts by weight of starch for preparation (Perfiller 102: manufactured by Freund Sangyo Co., Ltd.) were mixed using a micro-type fluoroscopic mixer (Tsutsui Riken Chemical Co., Ltd.). The powder was added and mixed, and tableted with a single tableting machine N-30E (Okada Seiko Co., Ltd.). The tableting pressure was set to 1000 kg and the tablet weight was set to 150 mg.
The appearance and tablet hardness of the tablets thus obtained were evaluated. Further, the adhesion state to the tablet punch, the pressure ratio of the tablet punch / upper punch, and the tablet hardness were measured and evaluated.
Tablet hardness was measured using New Speed Checker TS-75N (Okada Seiko Co., Ltd.).
上記表１に示すとおり実施例１の小麦フスマ由来の粉末を２％含有する錠剤は、ショ糖脂肪酸エステルや比較例８の大豆粉末のような公知の滑沢剤を配合した場合と同等かそれ以上の製剤適性を示し、杵への付着やスティッキングも発生しなかった。また錠剤の口解けや味覚もなんら問題がなかった。一方、比較例１〜７の他の食物繊維を配合した製剤は打錠適性も不良であり、さらにスティッキング、キャッピングが発生した。 As shown in Table 1 above, the tablet containing 2% of the wheat bran powder of Example 1 is equivalent to the case where a known lubricant such as sucrose fatty acid ester or soybean powder of Comparative Example 8 is blended. The formulation suitability as described above was exhibited, and neither sticking nor sticking occurred. Also, there was no problem with the thawing or taste of the tablets. On the other hand, preparations containing other dietary fibers in Comparative Examples 1 to 7 also had poor tableting suitability, and sticking and capping occurred.
２．葉酸含有製剤の調製と評価（連続打錠による生産性評価）
上記表１で打錠適性が優れていると評価した実施例２、ポジティブコントロールのショ糖脂肪酸エステル、比較例８の大豆粉末の組成、コントロールとして滑沢剤無添加の各組成を実生産装置を用いて連続生産し、生産適性を評価した。なお混合機としてミクロ型透視式混合機Ｓ−３（筒井理化学機械）を用いて１０分間混合し、超小型回転式錠剤機ＶＥＬ２０３１０ＳＷ４ＭＺ（菊水製作所）を用い、打錠圧は１０００Ｋｇ、錠剤重量を１５０ミリグラムに設定して連続生産を行った。
得られた錠剤は上記の１．と同様に下杵の付着、錠剤硬度を測定し評価した。結果を下記表２に示す。
2. Preparation and evaluation of folic acid-containing preparations (productivity evaluation by continuous tableting)
Example 2 evaluated as having excellent tableting suitability in Table 1 above, the composition of the positive control sucrose fatty acid ester, the soybean powder of Comparative Example 8, and each composition with no lubricant added as a control. They were used for continuous production and production suitability was evaluated. In addition, it mixes for 10 minutes using micro type see-through type mixing machine S-3 (Tsutsui RIKEN CHEMICAL CO., LTD) as a mixing machine, and uses ultra-small rotary tablet machine VEL20310SW4MZ (Kikusui Seisakusho), tableting pressure is 1000 kg, and tablet weight is 150. Set to milligrams for continuous production.
The obtained tablets are as described in 1. above. Similarly, the adhesion of the lower eyelid and the tablet hardness were measured and evaluated. The results are shown in Table 2 below.
上記表２に示すとおり、本発明の組成は連続生産に適する製剤であった。一方公知の滑沢剤を使用したショ糖脂肪酸エステル、比較例８は連続生産した場合錠剤硬度が低く、連続生産に適していないことが判明した。 As shown in Table 2 above, the composition of the present invention was a preparation suitable for continuous production. On the other hand, it was found that sucrose fatty acid ester using a known lubricant, Comparative Example 8, had low tablet hardness when continuously produced and was not suitable for continuous production.
３．カルシウム含有製剤の調製と評価（連続打錠による評価）
小麦フスマ由来の粉末ならびに既存の滑沢剤をそれぞれ含有するカルシウム製剤を製造して発明の効果を評価した
カルシウム原料としてミルクカルシウム−２８（ユニオンフーズ）８０重量％、結着剤としてアルファ化モチゴメデンプン（モチールアルファ）２０重量％を流動槽造粒乾燥機（ＦＤ−ＭＰ−０１）を用いて造粒し、これに小麦フスマ由来粉末（ブランエース）１０重量％をミクロ型透視式混合機（筒井理化学機械社）を用いて混合し、超小型回転式錠剤機ＶＥＬ２０３１０ＳＷ４ＭＺ（菊水製作所）を用い、打錠圧は１０００Ｋｇ、錠剤重量を２５０ミリグラムに設定して連続生産を行った。
同様に表３に示すショ糖脂肪酸エステル、部分アルファ化澱粉（ＰＳＣ 旭化成ケミカルズ製、比較例９）、大豆粉末（比較例１０）の公知の滑沢剤を用いて同様に連続生産を行った。得られた錠剤は上記の１．と同様に下杵の付着、錠剤硬度を測定し評価した。結果を下記表３に示す。なお下杵／上杵比は単発打錠機を用いて測定した。
3. Preparation and evaluation of calcium-containing preparations (evaluation by continuous tableting)
Calcium preparations containing wheat bran-derived powder and existing lubricant were manufactured and the effect of the invention was evaluated. Milk calcium-28 (Union Foods) 80% by weight as calcium raw material, pregelatinized mochigome starch as binder 20% by weight of (Motil Alpha) is granulated using a fluidized tank granulator / dryer (FD-MP-01), and 10% by weight of wheat bran-derived powder (Blanace) is added to a micro-type perspective mixer ( Tsutsui Rika Kagaku Co., Ltd.) was used for continuous production using a micro rotary tablet machine VEL20310SW4MZ (Kikusui Seisakusho) with a tableting pressure of 1000 kg and a tablet weight of 250 mg.
Similarly, continuous production was similarly carried out using known lubricants of sucrose fatty acid ester, partially pregelatinized starch (manufactured by PSC Asahi Kasei Chemicals, Comparative Example 9) and soybean powder (Comparative Example 10) shown in Table 3. The obtained tablets are as described in 1. above. Similarly, the adhesion of the lower eyelid and the tablet hardness were measured and evaluated. The results are shown in Table 3 below. The lower wrinkle / upper wrinkle ratio was measured using a single tableting machine.
上記表３に示すとおり、本発明のカルシウム製剤の組成は連続生産に適するものであった。 As shown in Table 3 above, the composition of the calcium preparation of the present invention was suitable for continuous production.
４．鉄ハードカプセル製造の際のスティッキングの発生評価
ヘム鉄９５重量％、澱粉４．６９６重量％、ビタミンＢ１２ １％粉末０．１５２重量％、葉酸０．１５２重量％を流動層造粒乾燥機ＦＤ−ＭＰ−０１型（(株)パウレック）を用いて造粒し、これに小麦フスマ由来粉末（ブランエース）５重量％添加しミクロ形透視式混合機Ｓ−３（筒井理化学器械(株)）を用いて混合した。これをカプセル充填機：ＧＫＦ４００（ＢＯＳＣＨ社(ドイツ)）を用いてハードカプセルに１６０ミリグラム充填し、カプセル製剤を調製した（実施例３）。
同様にデキストリン（パインフロー）５重量％（比較例１１）又は澱粉（モチールアルファ(α化澱粉、上越スターチ(株))）５重量％（比較例１２）を混合し、次いでカプセルに充填してカプセル製剤を調製した。
得られたカプセル製剤の表面を観察してスティッキングの状態を評価した。評価結果を表４に示す。
4). Evaluation of occurrence of sticking in iron hard capsule production Heme iron 95% by weight, starch 4.696% by weight, vitamin B12 1% powder 0.152% by weight, folic acid 0.152% by weight, fluidized bed granulation dryer FD-MP Granulated using -01 type (Paurec Co., Ltd.), added 5% by weight of wheat bran derived powder (Blan Ace), and used micro-type fluoroscopic mixer S-3 (Tsutsui Rikenki Co., Ltd.) And mixed. Using a capsule filling machine: GKF400 (BOSCH (Germany)), 160 mg of hard capsules were filled to prepare a capsule preparation (Example 3).
Similarly, 5% by weight of dextrin (Pine Flow) (Comparative Example 11) or 5% by weight of starch (Motil Alpha (pregelatinized starch, Joetsu Starch Co., Ltd.)) (Comparative Example 12) is mixed and then filled into capsules. A capsule formulation was prepared.
The surface of the obtained capsule preparation was observed to evaluate the sticking state. The evaluation results are shown in Table 4.
上記表４に示すとおり本発明はカプセル製剤のスティッキングを抑制した。 As shown in Table 4 above, the present invention suppressed the sticking of the capsule preparation.
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