JP6446874B2 - Solid preparation - Google Patents
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- JP6446874B2 JP6446874B2 JP2014144648A JP2014144648A JP6446874B2 JP 6446874 B2 JP6446874 B2 JP 6446874B2 JP 2014144648 A JP2014144648 A JP 2014144648A JP 2014144648 A JP2014144648 A JP 2014144648A JP 6446874 B2 JP6446874 B2 JP 6446874B2
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Images
Description
本発明は、膨潤能を向上した固形製剤に関する。 The present invention relates to a solid preparation having improved swelling ability.
プランタゴ・オバタ種皮（イスパグラ種皮）は水分を吸収すると膨らむ性質があるため、便の量を増やしたり、腸のぜん動運動を促したりすることにより、便通を良くする効果があることから、便秘薬の有効成分として汎用されている（特許文献１参照）。 Plantago / Obata seed coat (Ispagra seed coat) has the property of swelling when it absorbs water, so increasing the amount of stool or promoting peristaltic movement of the intestine has the effect of improving bowel movement. It is widely used as an active ingredient (see Patent Document 1).
製剤化にあたり生薬や賦形剤を配合するとプランタゴ・オバタ種皮の水分吸収による膨潤性が低下する問題があった（特許文献１参照）。
そこで、本発明は、有効成分としてプランタゴ・オバタ種皮を含有し、膨潤能を向上した固形製剤を提供することを課題とする。
When a crude drug or an excipient is blended for formulation, there is a problem that the swelling property of the plantago / Obata seed coat due to water absorption decreases (see Patent Document 1).
Therefore, an object of the present invention is to provide a solid preparation containing plantago obata seed coat as an active ingredient and having improved swelling ability.
本発明者は、プランタゴ・オバタ種皮を配合した固形製剤について、その膨潤能を向上すべく鋭意検討を行った。その結果、キジツ末、コウボク末、マシニン末、ショウキョウ末、カンキョウ末、コショウ末及びダイオウ末の少なくとも１種を配合した場合のみ，膨潤能が向上することを見出した。
かかる知見に基づき完成した本発明の態様は、プランタゴ・オバタ種皮を含有し、キジツ末、コウボク末、マシニン末、ショウキョウ末、カンキョウ末、コショウ末及びダイオウ末から選ばれる１種以上を含有する固形製剤である。
The present inventor has intensively studied to improve the swelling ability of a solid preparation containing plantago obata seed coat. As a result, it was found that the swelling ability was improved only when at least one of pheasant powder, kokuboku powder, machinin powder, ginger powder, citrus powder, pepper powder, and radish powder was blended.
The aspect of the present invention completed based on such findings contains plantago obata seed coat, and contains at least one selected from pheasant powder, koboku powder, machinin powder, ginger powder, citrus powder, pepper powder and dairy powder. It is a solid formulation.
本発明により、プランタゴ・オバタ種皮を配合した、膨潤能の向上したプランタゴ・オバタ種皮含有固形製剤を提供することが可能となった。 According to the present invention, it is possible to provide a plantago / obata seed coat-containing solid preparation with improved swelling ability, which contains plantago / obata seed coat.
本発明は、プランタゴ・オバタ種皮とキジツ末、コウボク末、マシニン末、ショウキョウ末、カンキョウ末、コショウ末及びダイオウ末から選ばれる１種以上を含む固形製剤である。 The present invention is a solid preparation comprising plantago obata seed coat and one or more selected from pheasant powder, mullet powder, machinin powder, ginger powder, citrus powder, pepper powder, and radish powder.
本発明は固形の瀉下用製剤であり、プランタゴ・オバタ種皮を有効成分として含有することを特徴とする。プランタゴ・オバタ種皮の含有量は、有効成分として機能する程度であり、あまりにその含有量が少ないと製剤の１日服用量が膨大となってしまうことから、具体的には製剤全体に対して５０質量％以上、好ましくは６０質量％以上、さらに好ましくは７０質量％以上である。 The present invention is a solid preparation for underarm, characterized in that it contains plantago obata seed coat as an active ingredient. The content of the plantago / Obata seed coat is such that it functions as an active ingredient, and if the content is too small, the daily dose of the preparation becomes enormous. It is at least mass%, preferably at least 60 mass%, more preferably at least 70 mass%.
本発明は、プランタゴ・オバタ種皮を含有する固形製剤を製造するにあたって膨潤能が低下する問題を解決するために、キジツ末、コウボク末、マシニン末、ショウキョウ末、カンキョウ末、コショウ末及びダイオウ末から選ばれる１種以上を加える点に特徴を有する。なお、生薬の粉末は、濡れ性等の粉体物性が大きく異なることから、プランタゴ・オバタ種皮含有製剤の膨潤能を向上するために必要な配合量は各生薬末によって異なる。また、上記生薬のうちキジツ末、コウボク末及びダイオウ末を組み合わせて配合したプランタゴ・オバタ種皮含有製剤は、より高い膨潤能が得られることから好ましい。 In order to solve the problem that the swelling ability is reduced in the production of a solid preparation containing plantago obata seed coat, the present invention provides a powdered powder, a powdered powder, a machinin powder, a pepper powder, a pepper powder, a pepper powder, and a powdered red pepper powder. It is characterized in that one or more selected from the above are added. Since herbal medicine powders have significantly different powder physical properties such as wettability, the blending amount necessary for improving the swelling ability of the plantago / Obata seed coat-containing preparation varies depending on the herbal powder. In addition, a plantago / Obata seed coat-containing preparation containing a combination of pheasant powder, Koboku powder and Daio powder among the above herbal medicines is preferable because higher swelling ability is obtained.
キジツは、ミカン科の常緑高木ミカン、ダイダイ、その他近縁植物の未熟果実をそのまま、または半分に横切りしたものである。キジツ単体を粉砕したものあるいはキジツと賦形剤を共粉砕したものを使用することができる。キジツ末の含有量は、１日あたりの服用量が１００〜１０００ｍｇ、好ましくは２００〜１０００ｍｇとなるようにする。プランタゴ・オバタ種皮含有製剤に配合するキジツ末の含有量としては、プランタゴ・オバタ種皮１質量部に対して、０．０１質量部以上１質量部未満、好ましくは０．０２質量部以上１質量部未満、さらに好ましくは０．０４質量部以上１質量部未満である。
コウボクは、ホウノキの樹皮、ホウノキの近縁種カラホウの樹皮である。コウボク単体を粉砕したものあるいはコウボクと賦形剤を共粉砕したものを使用することができる。コウボク末の含有量は、１日あたりの服用量が５０〜７５０ｍｇ、好ましくは１００〜７５０ｍｇとなるようにする。プランタゴ・オバタ種皮含有製剤に配合するコウボク末の含有量としては、プランタゴ・オバタ種皮１質量部に対して、０．０１質量部以上１質量部未満、好ましくは０．０２質量部以上１質量部未満、さらに好ましくは０．０４質量部以上１質量部未満である。
A pheasant is an evergreen Takagi mandarin of the citrus family, Daidai, and other immature fruits of other related plants, either directly or crossed in half. One obtained by pulverizing a single kid or one obtained by co-grinding a pheasant and an excipient can be used. The content of pheasant powder is such that the daily dose is 100 to 1000 mg, preferably 200 to 1000 mg. The content of pheasant powder blended in the plantago / Obata seed coat-containing preparation is 0.01 parts by mass or more and less than 1 part by mass, preferably 0.02 parts by mass or more and 1 part by mass with respect to 1 part by mass of the plantago / Obata seed coat. Less than, more preferably 0.04 parts by mass or more and less than 1 part by mass.
Koboku is a bark of a cypress bark, a bark of a carahou related species of cypress. One obtained by pulverizing a single body or one obtained by pulverizing a body and an excipient can be used. The content of the mushroom powder is such that the daily dose is 50 to 750 mg, preferably 100 to 750 mg. The content of Komoku powder blended in the plantago / Obata seed coat-containing preparation is 0.01 parts by mass or more and less than 1 part by mass, preferably 0.02 parts by mass or more and 1 part by mass with respect to 1 part by mass of the plantago / Obata seed coat. Less than, more preferably 0.04 parts by mass or more and less than 1 part by mass.
マシニンは、クワ科の１年草アサの雌株の子実である。マシニン単体を粉砕したものあるいはマシニンと賦形剤を共粉砕したものを使用することができる。マシニン末の含有量は、１日あたりの服用量が５０〜５０００ｍｇ、好ましくは１００〜５０００ｍｇとなるようにする。プランタゴ・オバタ種皮含有製剤に配合するマシニン末の含有量としては、プランタゴ・オバタ種皮１質量部に対して、０．０１質量部以上５質量部未満、好ましくは０．０２質量部以上５質量部未満、さらに好ましくは０．０３質量部以上５質量部未満である。 Machinin is the fruit of a female strain of annual grass masa in the mulberry family. A material obtained by pulverizing machinin alone or a material obtained by pulverizing machinin and an excipient can be used. The content of machinin powder is such that the daily dose is 50 to 5000 mg, preferably 100 to 5000 mg. The content of machinin powder blended in the plantago / Obata seed coat-containing preparation is 0.01 parts by mass or more and less than 5 parts by mass, preferably 0.02 parts by mass or more and 5 parts by mass with respect to 1 part by mass of the plantago / Obata seed coat. Less than, more preferably 0.03 parts by mass or more and less than 5 parts by mass.
ショウキョウは、ショウガ科の多年草ショウガの根茎である。ショウキョウ単体を粉砕したものあるいはショウキョウと賦形剤を共粉砕したものを使用することができる。ショウキョウ末の含有量は、１日あたりの服用量が２５〜５００ｍｇ、好ましくは５０〜５００ｍｇとなるようにする。プランタゴ・オバタ種皮含有製剤に配合するショウキョウ末の含有量としては、プランタゴ・オバタ種皮１質量部に対して、０．０１質量部以上３質量部未満、好ましくは０．０２質量部以上３質量部未満、さらに好ましくは０．０４質量部以上３質量部未満である。 Ginger is the rhizome of the ginger family perennial ginger. The thing which grind | pulverized the show simple substance, or the thing which co-ground the show and the excipient | filler can be used. The content of ginger powder is such that the daily dose is 25 to 500 mg, preferably 50 to 500 mg. The content of ginger powder blended in the plantago / Obata seed coat-containing preparation is 0.01 parts by mass or more and less than 3 parts by mass, preferably 0.02 parts by mass or more and 3 parts by mass with respect to 1 part by mass of the plantago / Obata seed coat. Is less than 0.04 parts by mass, more preferably 0.04 parts by mass or more and less than 3 parts by mass.
カンキョウは、ショウガ科の多年草ショウガの外皮を除いた根茎である。カンキョウ単体を粉砕したものあるいはカンキョウと賦形剤を共粉砕したものを使用することができる。カンキョウ末の含有量は、１日あたりの服用量が５０〜１０００ｍｇ、好ましくは１００〜１０００ｍｇとなるようにする。プランタゴ・オバタ種皮含有製剤に配合するカンキョウ末の含有量としては、プランタゴ・オバタ種皮１質量部に対して、０．０１質量部以上１質量部未満、好ましくは０．０２質量部以上１質量部未満、さらに好ましくは０．０４質量部以上１質量部未満である。 Citrus is a rhizome excluding the outer skin of perennial ginger of the ginger family. A pulverized citrus simple substance or a pulverized citrus and excipient can be used. The content of licorice powder is such that the daily dose is 50 to 1000 mg, preferably 100 to 1000 mg. The content of citrus powder blended in the plantago / Obata seed coat-containing preparation is 0.01 parts by mass or more and less than 1 part by mass, preferably 0.02 parts by mass or more and 1 part by mass with respect to 1 part by mass of the plantago / Obata seed coat. Less than, more preferably 0.04 parts by mass or more and less than 1 part by mass.
コショウは、コショウ科コショウの成熟種子を乾燥したものである。コショウ単体を粉砕したものあるいはコショウと賦形剤を共粉砕したものを使用することができる。コショウ末の含有量は、１日あたりの服用量が７５〜１５００ｍｇ、好ましくは１５０〜１５００ｍｇとなるようにする。プランタゴ・オバタ種皮含有製剤に配合するコショウ末の含有量としては、プランタゴ・オバタ種皮１質量部に対して、０．０１質量部以上１．５質量部未満、好ましくは０．０２質量部以上１．５質量部未満、さらに好ましくは０．０４質量部以上１．５質量部未満である。 Pepper is a dried mature seed of a pepper family pepper. Those obtained by pulverizing pepper alone or those obtained by co-pulverizing pepper and excipients can be used. The content of pepper powder is such that the daily dose is 75 to 1500 mg, preferably 150 to 1500 mg. The content of the pepper powder blended in the plantago / Obata seed coat-containing preparation is 0.01 parts by mass or more and less than 1.5 parts by mass, preferably 0.02 parts by mass or more, with respect to 1 part by mass of the plantago / Obata seed coat. Less than 5 parts by mass, more preferably 0.04 parts by mass and less than 1.5 parts by mass.
ダイオウは、タデ科の多年草ダイオウの根茎である。ダイオウ単体を粉砕したものあるいはダイオウと賦形剤を共粉砕したものを使用することができる。ダイオウ末の含有量は、１日あたりの服用量が７５〜３０００ｍｇ、好ましくは１５０〜３０００ｍｇとなるようにする。プランタゴ・オバタ種皮含有製剤に配合するダイオウ末の含有量としては、プランタゴ・オバタ種皮１質量部に対して、０．０１質量部以上３質量部未満、好ましくは０．０２質量部以上３質量部未満、さらに好ましくは０．０４質量部以上３質量部未満である。 Daio is the rhizome of the perennial Daio of the family Tedaceae. A product obtained by pulverizing a single piece of Daio or a product obtained by co-pulverizing Daio and an excipient can be used. The content of Daio powder is such that the daily dose is 75 to 3000 mg, preferably 150 to 3000 mg. The content of Daio powder blended in the plantago / Obata seed coat-containing preparation is 0.01 parts by mass or more and less than 3 parts by mass, preferably 0.02 parts by mass or more and 3 parts by mass with respect to 1 part by mass of the plantago / Obata seed coat. Less than, more preferably 0.04 parts by mass or more and less than 3 parts by mass.
固形製剤を製造するにあたって、プランタゴ・オバタ種皮及びキジツ末、コウボク末、マシニン末、ショウキョウ末、カンキョウ末、コショウ末及びダイオウ末を混合する方法や順序に特に制限はない。例えばプランタゴ・オバタ種皮にキジツ末、コウボク末、マシニン末、ショウキョウ末、カンキョウ末、コショウ末及びダイオウ末を粉末で配合する方法、キジツ末、コウボク末、マシニン末、ショウキョウ末、カンキョウ末、コショウ末及びダイオウ末を溶解した溶液を用いプランタゴ・オバタ種皮に公知の製造方法により噴霧する方法、キジツ末、コウボク末、マシニン末、ショウキョウ末、カンキョウ末、コショウ末及びダイオウ末を溶解した溶液を用いプランタゴ・オバタ種皮に噴霧、造粒する方法、またはプランタゴ・オバタ種皮及びキジツ末、コウボク末、マシニン末、ショウキョウ末、カンキョウ末、コショウ末及びダイオウ末を混合し、公知の造粒方法により粒状製剤を得る方法などがある。また、例えば造粒を行う場合、造粒方法にも特に制限はない。 In producing a solid preparation, there is no particular limitation on the method and order of mixing plantago / Obata seed coat and pheasant powder, Koboku powder, machinin powder, ginger powder, citrus powder, pepper powder and dio powder. For example, a method of blending powdery powder, koboku powder, machinin powder, pepper powder, citrus powder, pepper powder and daiko powder powder into plantago / obata seed coat, A method in which a solution in which pepper powder and radish powder are dissolved is used for spraying to plantago / Obata seed coat by a known production method, a solution in which pheasant powder, mulberry powder, machinin powder, ginger powder, citrus powder, pepper powder and radish powder are dissolved. Spraying and granulating plantago / Obata seed coat using a mixture of plantago / Obata seed coat and pheasant powder, Koboku powder, machinin powder, ginger powder, citrus powder, pepper powder and radish powder, and known granulation methods There is a method of obtaining a granular preparation by, for example. For example, when granulation is performed, the granulation method is not particularly limited.
また、本発明の効果を損なわない範囲で、該固形製剤に他の有効成分及び公知の添加剤を配合することができる。公知の添加剤としては、日本医薬品添加剤協会編「医薬品添加物事典２００７」（２００７年、薬事日報社）に収載されている添加剤等が挙げられる。 In addition, other active ingredients and known additives can be blended with the solid preparation as long as the effects of the present invention are not impaired. Known additives include those listed in “Pharmaceutical Additives Encyclopedia 2007” edited by Japan Pharmaceutical Additives Association (2007, Yakuji Nippo).
本発明の固形製剤は、散剤、用事調製用ドライシロップ剤、又は顆粒剤として提供できる他、これをゼラチンや高分子のハードカプセルに充填し、カプセル剤として提供したり、該製剤粒子を他の賦形剤等と混合し、これを圧縮成形（打錠）することによって、錠剤として提供したりすることも可能である。 The solid preparation of the present invention can be provided as a powder, a dry syrup preparation for business use, or a granule, or it can be filled in gelatin or a polymer hard capsule and provided as a capsule, or the preparation particles can be provided in other shapes. It can also be provided as a tablet by mixing with an agent and the like and compression-molding (tableting) it.
以下に、実施例、比較例及び試験例を挙げ、本発明を更に詳細に説明する。 Hereinafter, the present invention will be described in more detail with reference to Examples, Comparative Examples and Test Examples.
実施例１
プランタゴ・オバタ種皮 ３０．００ｇ
キジツ末 ２．２２ｇ
上記成分を乳鉢で混合した後、水と含水アルコールの混合液を添加して乳鉢で造粒後、２２号篩にて湿粒を全量篩過した後、棚式乾燥機にて乾燥した。乾燥後、６０号篩にて篩過し、篩上品を得た。
Example 1
Plantago obata seed coat 30.00g
Pheasant powder 2.22g
After mixing the said component with a mortar, after adding the liquid mixture of water and a hydrous alcohol and granulating with a mortar, all the wet granules were sieved with No. 22 sieve, Then, it dried with the shelf type dryer. After drying, it was sieved with a No. 60 sieve to obtain a sieved product.
実施例２
プランタゴ・オバタ種皮 ３０．００ｇ
コウボク末 ２．５０ｇ
上記成分を乳鉢で混合した後、水と含水アルコールの混合液を添加して乳鉢で造粒後、２２号篩にて湿粒を全量篩過した後、棚式乾燥機にて乾燥した。乾燥後、６０号篩にて篩過し、篩上品を得た。
Example 2
Plantago obata seed coat 30.00g
KOKUBOKU powder 2.50g
After mixing the said component with a mortar, after adding the liquid mixture of water and a hydrous alcohol and granulating with a mortar, all the wet granules were sieved with No. 22 sieve, Then, it dried with the shelf type dryer. After drying, it was sieved with a No. 60 sieve to obtain a sieved product.
実施例３
プランタゴ・オバタ種皮 ３０．００ｇ
マシニン末 １．７８ｇ
軽質無水ケイ酸 ０．４４ｇ
上記成分を乳鉢で混合した後、水と含水アルコールの混合液を添加して乳鉢で造粒後、２２号篩にて湿粒を全量篩過した後、棚式乾燥機にて乾燥した。乾燥後、６０号篩にて篩過し、篩上品を得た。
Example 3
Plantago obata seed coat 30.00g
Machinin powder 1.78g
Light anhydrous silicic acid 0.44g
After mixing the said component with a mortar, after adding the liquid mixture of water and a hydrous alcohol and granulating with a mortar, all the wet granules were sieved with No. 22 sieve, Then, it dried with the shelf type dryer. After drying, it was sieved with a No. 60 sieve to obtain a sieved product.
実施例４
プランタゴ・オバタ種皮 ３０．００ｇ
ショウキョウ末 ２．２２ｇ
上記成分を乳鉢で混合した後、水と含水アルコールの混合液を添加して乳鉢で造粒後、２２号篩にて湿粒を全量篩過した後、棚式乾燥機にて乾燥した。乾燥後、６０号篩にて篩過し、篩上品を得た。
Example 4
Plantago obata seed coat 30.00g
Showa powder 2.22g
After mixing the said component with a mortar, after adding the liquid mixture of water and a hydrous alcohol and granulating with a mortar, all the wet granules were sieved with No. 22 sieve, Then, it dried with the shelf type dryer. After drying, it was sieved with a No. 60 sieve to obtain a sieved product.
実施例５
プランタゴ・オバタ種皮 ３０．００ｇ
カンキョウ末 ２．２２ｇ
上記成分を乳鉢で混合した後、水と含水アルコールの混合液を添加して乳鉢で造粒後、２２号篩にて湿粒を全量篩過した後、棚式乾燥機にて乾燥した。乾燥後、６０号篩にて篩過し、篩上品を得た。
Example 5
Plantago obata seed coat 30.00g
Sweet potato powder 2.22g
After mixing the said component with a mortar, after adding the liquid mixture of water and a hydrous alcohol and granulating with a mortar, all the wet granules were sieved with No. 22 sieve, Then, it dried with the shelf type dryer. After drying, it was sieved with a No. 60 sieve to obtain a sieved product.
実施例６
プランタゴ・オバタ種皮 ３０．００ｇ
コショウ末 ２．２２ｇ
上記成分を乳鉢で混合した後、水と含水アルコールの混合液を添加して乳鉢で造粒後、２２号篩にて湿粒を全量篩過した後、棚式乾燥機にて乾燥した。乾燥後、６０号篩にて篩過し、篩上品を得た。
Example 6
Plantago obata seed coat 30.00g
Pepper powder 2.22g
After mixing the said component with a mortar, after adding the liquid mixture of water and a hydrous alcohol and granulating with a mortar, all the wet granules were sieved with No. 22 sieve, Then, it dried with the shelf type dryer. After drying, it was sieved with a No. 60 sieve to obtain a sieved product.
実施例７
プランタゴ・オバタ種皮 ３０．００ｇ
ダイオウ末 ５．００ｇ
上記成分を乳鉢で混合した後、水と含水アルコールの混合液を添加して乳鉢で造粒後、２２号篩にて湿粒を全量篩過した後、棚式乾燥機にて乾燥した。乾燥後、６０号篩にて篩過し、篩上品を得た。
Example 7
Plantago obata seed coat 30.00g
Daio powder 5.00g
After mixing the said component with a mortar, after adding the liquid mixture of water and a hydrous alcohol and granulating with a mortar, all the wet granules were sieved with No. 22 sieve, Then, it dried with the shelf type dryer. After drying, it was sieved with a No. 60 sieve to obtain a sieved product.
実施例８
プランタゴ・オバタ種皮 ６００．０ｇ
ダイオウ末 １００．０ｇ
コウボク末 ５０．０ｇ
キジツ末 ４４．４ｇ
ヒドロキシプロピルセルロース ４０．０ｇ
スクラロース ６．０ｇ
上記成分を１２号篩にて篩過した後、混合撹拌機（万能混合撹拌機；品川工業社製）に投入し、水と含水アルコールの混合液を添加して乳鉢で混練し、湿潤混練物を押し出し造粒機（ドームグラン：ダルトン社製）にてスクリーン孔径０．７ｍｍにて造粒した。得られた造粒物を棚式乾燥機にて乾燥した後、１２号篩にて篩過した篩下品を４２号篩にて篩過し、篩上品を得た。
Example 8
Plantago obata seed coat 600.0g
Daio powder 100.0g
KOKUBOKU powder 50.0g
Pheasant powder 44.4g
Hydroxypropylcellulose 40.0g
Sucralose 6.0g
After sieving the above ingredients with a No. 12 sieve, the mixture is put into a mixing stirrer (universal mixing stirrer; manufactured by Shinagawa Kogyo Co., Ltd.), mixed with water and a hydrous alcohol, kneaded in a mortar, and wet kneaded. Was granulated with an extruding granulator (Dome Gran: manufactured by Dalton) with a screen hole diameter of 0.7 mm. The obtained granulated product was dried with a shelf dryer, and the sieved product sieved with a No. 12 sieve was sieved with a No. 42 sieve to obtain a sieved product.
比較例１
プランタゴ・オバタ種皮 ３０．００ｇ
上記成分を乳鉢で混合した後、水と含水アルコールの混合液を添加して乳鉢で造粒後、２２号篩にて湿粒を全量篩過した後、棚式乾燥機にて乾燥した。乾燥後、６０号篩にて篩過し、篩上品を得た。
Comparative Example 1
Plantago obata seed coat 30.00g
After mixing the said component with a mortar, after adding the liquid mixture of water and a hydrous alcohol and granulating with a mortar, all the wet granules were sieved with No. 22 sieve, Then, it dried with the shelf type dryer. After drying, it was sieved with a No. 60 sieve to obtain a sieved product.
比較例２
プランタゴ・オバタ種皮 ３０．００ｇ
ウコン末 ２．２２ｇ
上記成分を乳鉢で混合した後、水と含水アルコールの混合液を添加して乳鉢で造粒後、２２号篩にて湿粒を全量篩過した後、棚式乾燥機にて乾燥した。乾燥後、６０号篩にて篩過し、篩上品を得た。
実施例及び比較例の処方（１日量）を表１に示した。
Comparative Example 2
Plantago obata seed coat 30.00g
Turmeric powder 2.22g
After mixing the said component with a mortar, after adding the liquid mixture of water and a hydrous alcohol and granulating with a mortar, all the wet granules were sieved with No. 22 sieve, Then, it dried with the shelf type dryer. After drying, it was sieved with a No. 60 sieve to obtain a sieved product.
Table 1 shows formulations (daily doses) of Examples and Comparative Examples.
試験例１ 膨潤評価試験
（１）方法
実施例１〜８及び比較例１〜２で調製した固形製剤１．０ｇを１００ｍＬのメスシリンダーに投入し、水を５０ｍＬ投入して軽くかきまぜた後、５分後、６０分後、９０分後、１２０分後における製剤の容積変化をメスシリンダーの目盛りを読み取って測定した。
各測定時間における、製剤の膨潤度を以下の式にて算出した。
Test Example 1 Swelling Evaluation Test (1) Method After putting 1.0 g of the solid preparations prepared in Examples 1 to 8 and Comparative Examples 1 and 2 into a 100 mL graduated cylinder and adding 50 mL of water and gently stirring, 5 Minute, 60 minutes, 90 minutes, and 120 minutes later, the volume change of the preparation was measured by reading the scale of the graduated cylinder.
The swelling degree of the preparation at each measurement time was calculated by the following formula.
膨潤度[％]＝（生薬配合製剤の容積／プランタゴ・オバタ種皮のみ製剤の容積）×１００ Swelling degree [%] = (volume of herbal medicine formulation / volume of plantago / ovabat seed coat only) × 100
結果を図１及び図２に示す。 The results are shown in FIGS.
（２）結果
図１及び図２より、比較例２では膨潤能が低下してしまい、医薬品に用いる組成物としては適当ではないと考えられる。
一方、キジツ末、コウボク末、マシニン末、ショウキョウ末、カンキョウ末、コショウ末及びダイオウ末を配合した実施例１〜７では膨潤能の向上が確認され、さらにキジツ末、コウボク末及びダイオウ末を配合した実施例８ではより優れた膨潤能の向上が確認された。これらは医薬品に用いる組成物として十分に機能することが窺われる。
(2) Results From FIG. 1 and FIG. 2, in Comparative Example 2, the swelling ability is lowered, and it is considered that the composition is not suitable for use in pharmaceuticals.
On the other hand, in Examples 1 to 7 in which pheasant powder, kokuboku powder, machinin powder, ginger powder, citrus powder, pepper powder and radish powder were mixed, improvement in swelling ability was confirmed. In the blended Example 8, a more excellent improvement in swelling ability was confirmed. These appear to function well as compositions for use in pharmaceuticals.
（３）考察
試験例１の結果より、比較例１〜２の組成物に比し、実施例１〜８の組成物では、膨潤能が向上した固形製剤を提供できると考えられる。
(3) Discussion From the results of Test Example 1, it is considered that the compositions of Examples 1 to 8 can provide a solid preparation with improved swelling ability as compared to the compositions of Comparative Examples 1 and 2.
本発明により、膨潤能が向上したプランタゴ・オバタ種皮を含有する固形製剤の提供が可能となり、医薬品産業の発展に寄与することが期待される。 According to the present invention, it is possible to provide a solid preparation containing plantago obata seed coat with improved swelling ability, which is expected to contribute to the development of the pharmaceutical industry.
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