JP2020029437A - Composition, tablet, and capsule agent containing ampelopsis grossedentata extract - Google Patents
Composition, tablet, and capsule agent containing ampelopsis grossedentata extract Download PDFInfo
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Abstract
Description
本発明は、藤茶抽出物の臭気を抑制した組成物およびそれを含む錠剤又はカプセル剤に関する。 TECHNICAL FIELD The present invention relates to a composition in which the odor of a wisteria tea extract is suppressed, and a tablet or capsule containing the composition.
藤茶は、ブドウ科蛇葡萄属の植物であり、中国名を顕歯蛇葡萄という。学名は、Ａｍｐｅｌｏｐｓｉｓ ｇｒｏｓｓｅｄｅｎｔａｔａである。主には中国の広西、広東、雲南、貴州、湖南、湖北、江西、福建などの省並びに自治区に分布している。中国の広西、湖南などの省や自治区の壮族や瑶族の人々がこの茎および葉から作った飲料を常用しており、風邪、のどの痛みなどにも利用されている。 Wisteria tea is a plant belonging to the genus Snake Grape, and its Chinese name is Dento Snake Grape. The scientific name is Ampelopsis glossedentata. It is mainly distributed in provinces and autonomous regions of China such as Guangxi, Guangdong, Yunnan, Guizhou, Hunan, Hubei, Jiangxi and Fujian. People from provinces such as Guangxi and Hunan in China and people from the tribes and yao in autonomous regions regularly use drinks made from these stems and leaves, and are used for colds and sore throats.
藤茶抽出物には様々な生理活性が見いだされており、藤茶抽出物を含む医薬用途や健康食品用途が提案されている。例えば肝臓疾患の治療用（特許文献１）、リパーゼ阻害用（特許文献２）、マトリックスプロテアーゼ阻害用（特許文献３）、抗菌用（特許文献４）、香料の劣化防止用（特許文献５）、色素の褪色防止用（特許文献６）等の用途が提案されている。 Various physiological activities have been found in the wisteria tea extract, and medical uses and health food applications containing the wisteria tea extract have been proposed. For example, for treatment of liver disease (Patent Document 1), for lipase inhibition (Patent Document 2), for matrix protease inhibition (Patent Document 3), for antibacterial (Patent Document 4), for preventing deterioration of perfume (Patent Document 5), Uses such as for preventing color fading (Patent Document 6) have been proposed.
藤茶抽出物は、上記の様々な作用を担う成分としてフラボノイド化合物であるアンペロプシンが特定されており、これを高含有する抽出物が得られている。これは、乾燥した藤茶茎葉から水又は含水アルコール等の溶媒で抽出され、さらに濃縮したペースト状の濃縮物や噴霧乾燥や凍結乾燥した粉末が市販されている。
藤茶抽出物は、藤茶抽出物を含有するカプセル剤や錠剤化のための製剤化工程で、藤茶抽出物の持つ特有な不快臭（異臭）を生じる事が判明した。特にこの異臭は、長期間保存すると強まるため、必然的に品質保証期間を短くせざるを得なかった。
このため藤茶抽出物を高含有し、長期間保存しても異臭の発生が少なく、飲用しやすい製剤が求められていた。
In the wisteria tea extract, amperopsin, which is a flavonoid compound, is specified as a component responsible for the various actions described above, and an extract containing high levels of this is obtained. It is extracted from dried wisteria tea leaves with a solvent such as water or hydroalcohol, and further concentrated paste-like concentrates and spray-dried or freeze-dried powders are commercially available.
It has been found that wisteria tea extract produces a peculiar unpleasant odor (offensive smell) of wisteria tea extract in a formulation process for capsules and tablets containing wisteria tea extract. In particular, this off-flavor increases when stored for a long period of time, so that the quality assurance period has necessarily been shortened.
For this reason, there has been a demand for a formulation which contains a high amount of wisteria tea extract, generates little off-flavor even when stored for a long time, and is easy to drink.
本発明者らは、上記のような背景技術をもとに研究を行い、藤茶抽出物をさまざまな製剤化条件で検討したところ、キトサン及び藤茶抽出物を含有する組成物を製剤化すると、藤茶抽出物特有の異臭を抑制できることを見出した。本発明はこのような知見に基づくもので、キトサン及び藤茶抽出物を含有する組成物およびこれを含有する錠剤又はカプセル剤を提案するものである。
すなわち、本発明の課題は、藤茶抽出物を高含有しながら、藤茶特有の異臭（悪臭と評価されるような臭気）が抑制された組成物および錠剤又はカプセル剤を提供することにある。
The present inventors have conducted research based on the background art as described above, and examined the wisteria tea extract under various formulation conditions, and found that a composition containing chitosan and wisteria tea extract was formulated. It was found that off-flavor peculiar to wisteria tea extract could be suppressed. The present invention is based on such findings, and proposes a composition containing chitosan and wisteria tea extract, and a tablet or capsule containing the same.
That is, an object of the present invention is to provide a composition and a tablet or a capsule in which wisteria tea extract is contained at a high content while suppressing an unusual odor peculiar to wisteria tea (an odor that is evaluated as an odor). .
本発明の主な構成は以下の通りである。
（１）キトサン及び藤茶抽出物を含有する組成物であって、組成物あたり、キトサンを１０〜３５質量％、アンペロプシンを５〜２２質量％含有し、キトサン／アンペロプシンの質量比が０．６〜３．５である組成物。
（２）（１）に記載の組成物を含む錠剤。
（３）（１）に記載の組成物を含むカプセル剤。
The main configuration of the present invention is as follows.
(1) A composition containing chitosan and wisteria tea extract, wherein the composition contains 10 to 35% by mass of chitosan, 5 to 22% by mass of amperopsin, and the mass ratio of chitosan / amperopsin is 0.6. -3.5.
(2) A tablet comprising the composition according to (1).
(3) A capsule containing the composition according to (1).
本発明により、藤茶抽出物の異臭が抑制された組成物及び錠剤、カプセル剤が提供される。特に本発明によれば、長期間の保存が可能となり、さらに藤茶抽出物由来の異臭発生が抑制されているため、老人や小児であっても抵抗感なく、容易に嚥下できる製剤となる。 According to the present invention, there are provided a composition, a tablet, and a capsule in which an off-flavor of a wisteria tea extract is suppressed. In particular, according to the present invention, the preparation can be stored for a long period of time, and furthermore, the generation of off-flavors derived from the wisteria tea extract is suppressed.
本発明は、キトサン及び藤茶抽出物を含有する組成物、これを含む錠剤又はカプセル剤に係る発明である。 The present invention relates to a composition containing chitosan and wisteria tea extract, and a tablet or capsule containing the same.
本発明組成物の主要な構成成分の一つはキトサンである。キトサンとは、グルコサミンがβ１，４結合によって連結した構造を主に有しており、グルコサミン以外にもＮ−アセチルグルコサミンが構成成分として含まれることがある多糖類である。 One of the main components of the composition of the present invention is chitosan. Chitosan is a polysaccharide mainly having a structure in which glucosamine is linked by β1,4 bonds, and in addition to glucosamine, N-acetylglucosamine may be contained as a component.
本発明で使用されるキトサンの由来については、特に制限されないが、例えば、エビ、カニ等の甲殻類の甲殻；イカの甲等から、カルシウムやタンパク質等を除去することにより得られたキチンを脱アセチル化したものを使用することができる。 The origin of chitosan used in the present invention is not particularly limited. For example, chitin obtained by removing calcium, protein and the like from crustaceans such as shrimp and crab; Acetylated ones can be used.
また、本発明で使用されるキトサンの脱アセチル化度については、特に制限されない。通常は、脱アセチル化度５０〜１００％のものを使用すればよい。なお、キトサンの脱アセチル化度は、コロイド滴定法によって測定される値である。
さらにまた、本発明で使用されるキトサンの平均分子量については、特に制限されない。
本発明に使用されるキトサンは、食品原料として市販されている規格を満たす粉末を使用することが好ましい。
The degree of deacetylation of chitosan used in the present invention is not particularly limited. Normally, one having a degree of deacetylation of 50 to 100% may be used. The degree of deacetylation of chitosan is a value measured by a colloid titration method.
Furthermore, the average molecular weight of chitosan used in the present invention is not particularly limited.
As the chitosan used in the present invention, it is preferable to use a powder that meets a standard that is commercially available as a food material.
藤茶抽出物は、藤茶の葉、茎、花、根のうちいずれか１又は２以上の抽出物を使用することができる。特に茎又は葉の抽出物を利用することが好ましい。
藤茶からの抽出方法は特に限定されるものではない。抽出を行う際には、藤茶をそのまま、あるいは乾燥したものを使用することができるが、乾燥物が抽出効率上好ましい。また顆粒状や粉末状に粉砕して抽出に供した方が、穏和な条件で短時間に高い抽出効率で有効成分の抽出を行うことができる。抽出温度は特に限定されるものではなく、藤茶の粉砕物の粒径や溶媒の種類等に応じて適宜設定すればよい。
溶媒の種類は特に限定されるものではない。水、エタノール等の低級アルコール、又はこれらの混合溶媒が好ましい。抽出は常温で行ってよい。加熱下で（例えば温水や熱水等の加熱した溶媒を用いて）行ってもよい。
As the wisteria tea extract, one or more extracts of wisteria tea leaves, stems, flowers, and roots can be used. In particular, it is preferable to use a stem or leaf extract.
The extraction method from wisteria tea is not particularly limited. When performing extraction, wisteria tea can be used as it is or dried, but a dried product is preferable in terms of extraction efficiency. In addition, when the powder is pulverized into granules or powder and subjected to extraction, the active ingredient can be extracted with high extraction efficiency in a short time under mild conditions. The extraction temperature is not particularly limited, and may be appropriately set according to the particle size of the ground wisteria tea and the type of solvent.
The type of the solvent is not particularly limited. Water, a lower alcohol such as ethanol, or a mixed solvent thereof is preferred. The extraction may be performed at room temperature. It may be performed under heating (for example, using a heated solvent such as hot water or hot water).
このような抽出操作により、藤茶から本発明に係る有効成分が抽出され、溶媒に溶け込む。抽出物を含む溶媒は、そのまま使用してもよい。必要に応じて、滅菌、洗浄、ろ過、脱色、脱臭等の慣用の精製処理を加えてから使用することが好ましい。さらに、溶媒を全て揮発させて固体状（乾燥物）とする。該乾燥物を任意の溶媒に再溶解して、噴霧乾燥するなどの操作で粉末化して使用することができる。本発明にあっては、このような粉末を使用することが好ましい。
なお、藤茶抽出物（エキス）は、丸善製薬株式会社より市販されており、これらを用いることもできる。市販されている藤茶抽出物は、藤茶の葉に多く含まれるフラボノイド化合物の一種であるアンペロプシンを指標として抽出率を管理し規格化されている粉末であり、これを本発明においても利用することができる。
なお藤茶抽出物は、上記の通りカプセル剤化・錠剤化の製剤化工程において極めて特異な好ましくない臭気（異臭）を生じる。
By such an extraction operation, the active ingredient according to the present invention is extracted from the wisteria tea and dissolved in the solvent. The solvent containing the extract may be used as it is. It is preferable to use a conventional purification treatment such as sterilization, washing, filtration, decolorization, or deodorization, if necessary. Further, the solvent is entirely volatilized to a solid (dry product). The dried product can be redissolved in an arbitrary solvent and then powdered by an operation such as spray drying and used. In the present invention, it is preferable to use such a powder.
The wisteria tea extract (extract) is commercially available from Maruzen Pharmaceutical Co., Ltd., and these can also be used. Commercially available wisteria tea extract is a powder that is standardized by controlling the extraction rate using amperopsin, which is a type of flavonoid compound that is abundant in wisteria tea leaves, and is also used in the present invention. be able to.
As described above, the wisteria tea extract produces an extremely peculiar and unpleasant odor (offensive odor) in the process of preparing capsules and tablets.
キトサンと藤茶抽出物を含む組成物、藤茶の臭気を抑制するために、キトサンと藤茶抽出物の粉末を均質に混合する。キトサンと藤茶抽出物の粉末は、その配合量と配合比率が重要である。組成物あたりキトサンを１０〜３５質量％含有させることが好ましい。また、組成物あたりアンペロプシンの濃度が５〜２２質量％となるように藤茶抽出物を含有させることが好ましい。またキトサン／アンペロプシンの質量比が０．６〜３．５となるように配合する。
また、キトサンと藤茶抽出物を含有する組成物は、打錠法によって錠剤とするために各種の賦形剤、例えば糖類やデンプンなどと混合し、必要によっては、造粒操作を行って、顆粒剤とすることができる。この顆粒剤又は粉末を常法にしたがって打錠成形することで藤茶抽出物の異臭の抑制された錠剤を得ることができる。
A composition containing chitosan and wisteria tea extract, and powder of chitosan and wisteria tea extract are mixed homogeneously to suppress the odor of wisteria tea. The amount and ratio of chitosan and wisteria tea extract powders are important. It is preferable to contain 10 to 35% by mass of chitosan per composition. Further, it is preferable to include the wisteria tea extract so that the concentration of amperopsin per composition is 5 to 22% by mass. It is also blended so that the mass ratio of chitosan / amperopsin is 0.6-3.5.
In addition, the composition containing chitosan and wisteria tea extract is mixed with various excipients, such as sugars and starch, to make a tablet by the tableting method, and if necessary, by performing a granulation operation, It can be a granule. By compressing the granules or powder according to a conventional method, tablets having an unpleasant odor of the wisteria tea extract can be obtained.
カプセル剤とする場合には、常法により組成物を硬質カプセルに充填してカプセル剤とする。このとき、カプセル剤とするに際して各種の賦形剤、例えば糖類やデンプンなどと混合し、必要によっては、造粒操作を行って、顆粒剤とすることができる。この顆粒剤又は粉末組成物を常法にしたがって硬質カプセルに充填することで藤茶抽出物の異臭の抑制されたカプセル剤を得ることができる。 When a capsule is to be prepared, the composition is filled into a hard capsule by a conventional method to form a capsule. At this time, a capsule can be prepared by mixing with various excipients, for example, sugars and starch, and, if necessary, performing a granulating operation to obtain a granule. By filling this granule or powder composition into a hard capsule according to a conventional method, a capsule in which the odor of the wisteria tea extract is suppressed can be obtained.
なお製剤化に当たっては、賦形剤として使用することができるものとしては、セルロース、デンプン、乳糖、マルチトール、シクロデキストリン、へミセルロース、グアーガム、コンニャクマンナン、アルギン酸、寒天、カラギーナン、キチン、カルボキシメチルセルロース、ポリデキストロースである。特に好ましくはセルロース又はデンプンである。
また本発明の目的を阻害しなければ、食用油、カルシウム、鉄、ナトリウム、亜鉛、銅、カリウム、リン、マグネシウム、ヨウ素、マンガン、セレンなどのミネラル；ビタミンＡ、ビタミンＣ、ビタミンＤ、ビタミンＥ、ビタミンＫ、ナイアシン、葉酸、パントテン酸などの脂溶性又は水溶性のビタミン群、グリセリン脂肪酸エステル、ショ糖脂肪酸エステル、ソルビタン脂肪酸エステル、プロピレングリコール脂肪酸エステル、リン脂質、アラビアガム、キサンタンガム、トラガカントガム、ローカストビーンガム、保存料・酸化防止剤、風味調整剤や香料、塩化ナトリウム、グルタミン酸ナトリウム、グリシン、コハク酸、乳酸ナトリウムなどの呈味料、クエン酸、クエン酸ナトリウム、酢酸、アジピン酸、フマル酸、リンゴ酸などの酸味料、アスパルテームなどの低カロリー甘味料、着色剤などを配合することもできる。
In the formulation, those that can be used as an excipient include cellulose, starch, lactose, maltitol, cyclodextrin, hemicellulose, guar gum, konjac mannan, alginic acid, agar, carrageenan, chitin, carboxymethyl cellulose. , Polydextrose. Particularly preferred is cellulose or starch.
In addition, minerals such as edible oils, calcium, iron, sodium, zinc, copper, potassium, phosphorus, magnesium, iodine, manganese, and selenium; vitamin A, vitamin C, vitamin D, and vitamin E, as long as the objects of the present invention are not inhibited. , Vitamin K, niacin, folate, pantothenic acid and other fat-soluble or water-soluble vitamins, glycerin fatty acid ester, sucrose fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, phospholipid, gum arabic, xanthan gum, tragacanth gum, locust Bean gum, preservatives / antioxidants, flavor modifiers and flavors, flavoring agents such as sodium chloride, sodium glutamate, glycine, succinic acid, sodium lactate, citric acid, sodium citrate, acetic acid, adipic acid, fumaric acid, Acids such as malic acid Fee, low calorie sweeteners such as aspartame, can also be incorporated, such as coloring agents.
＜錠剤＞
以下に、実施例、比較例の錠剤を用いて行った試験例を示し、本発明の効果を説明する。
１．臭気の評価方法
藤茶抽出物の臭気の本体は、現在特定されていないため官能評価によって数値化することとした。数値化は、専門の熟練した官能評価員が基準品との２点比較によって判断して評点を付した。基準品は次の表１の組成の錠剤を調製し、これを基準品とした。なお評価基準を表の欄外に明示した。基準錠剤は、φ８ｍｍ、２５０ｍｇ／粒の錠剤とし、調製は、原料を混合した後、単発式打錠機（岡田精工社製）を用い打圧１０００ｋｇｆで行った。
<Tablets>
Hereinafter, test examples performed using the tablets of Examples and Comparative Examples are shown, and the effects of the present invention will be described.
1. Evaluation method of odor The main odor of the wisteria tea extract is not specified at present, so it was decided to digitize it by sensory evaluation. The numerical value was evaluated by a skilled and expert sensory evaluator by comparing the two points with a reference product. As a reference product, a tablet having the composition shown in Table 1 below was prepared and used as a reference product. The evaluation criteria are shown outside the table. The reference tablet was a tablet of φ8 mm, 250 mg / grain. After mixing the raw materials, the preparation was performed at a compression pressure of 1000 kgf using a single-shot tableting machine (manufactured by Okada Seiko Co., Ltd.).
なお基準５〜１の臭気の強さは上記表１に記載によるものを基準とするが、官能的に次のような表現に相当する。
基準５：臭気を殆ど感じない。
基準４：わずかに臭気を感じる。
基準３：強い臭気を感じるが飲用には支障がない。
基準２：激しい臭気を感じ、飲用に抵抗を感じる。
基準１：飲用困難な臭気を感じる。
Note that the odor intensities of the standards 5 to 1 are based on those described in Table 1 above, but functionally correspond to the following expressions.
Criterion 5: Almost no odor is felt.
Criterion 4: Slight odor is felt.
Criterion 3: A strong odor is felt, but there is no problem with drinking.
Criterion 2: Feel strong odor and feel resistance to drinking.
Criterion 1: A odor that is difficult to drink is felt.
２．実施例１〜６及び比較例１〜６の錠剤の調製と評価
表２の処方で、原料を混合した後、単発式打錠機(岡田精工社製)にてφ８ｍｍ、２５０ｍｇ／粒の錠剤を作製した。その錠剤２０粒をアルミ袋に入れ、４０℃７５％ＲＨのインキュベータ中にて２週間保存後に開封して発生した臭気を専門の訓練を受けた官能評価員３名で評価した。なお、上記のとおり調製した５つの錠剤を基準品とし、これらと二点比較で同等性を判断した。
評価の判定は、例えば、試験品が基準３と同等の不快な臭いであれば、評点を３とした。なお官能試験結果は、３名の評点の平均値を求めた。結果を表２の最下段に示す。
官能評価平均値４以上のものが不快臭を低減できていると判断した。
2. Preparation and Evaluation of Tablets of Examples 1 to 6 and Comparative Examples 1 to 6 After mixing the raw materials according to the formulation of Table 2, a single-shot tableting machine (manufactured by Okada Seiko Co., Ltd.) was used to prepare tablets of φ8 mm, 250 mg / particle. Produced. Twenty tablets were placed in an aluminum bag, stored in an incubator at 40 ° C. and 75% RH for 2 weeks, opened, and the odor generated was evaluated by three sensory evaluators who received specialized training. In addition, the five tablets prepared as described above were used as reference products, and the two tablets were compared to determine the equivalence.
In the evaluation judgment, for example, if the test article had an unpleasant odor equivalent to the criterion 3, the rating was set to 3. The results of the sensory test were obtained by averaging the scores of three persons. The results are shown at the bottom of Table 2.
Those having a sensory evaluation average value of 4 or more were judged to have reduced the unpleasant odor.
実施例１〜６及び比較例１〜６の錠剤を用いた試験結果から、藤茶抽出物含有錠剤における藤茶抽出物由来の特異臭を抑制するためには、キトサンを配合することが有効であることが判明した。またキトサンと藤茶抽出物を含む打錠前の組成物において、組成物あたりアンペロプシンを５〜２２質量％、キトサンを１０〜３５質量％含有し、キトサン／アンペロプシンの質量比が０．６〜３．５になるように調整すると、藤茶由来の特異臭を感じさせない錠剤を得ることができた。 From the test results using the tablets of Examples 1 to 6 and Comparative Examples 1 to 6, in order to suppress the peculiar odor derived from the wisteria tea extract in the wisteria tea extract-containing tablets, it is effective to mix chitosan. It turned out to be. In addition, the composition before tableting containing chitosan and wisteria tea extract contains 5 to 22% by mass of amperopsin and 10 to 35% by mass of chitosan, and the mass ratio of chitosan / amperopsin is 0.6 to 3. When adjusted to be 5, it was possible to obtain a tablet in which the peculiar smell derived from wisteria tea was not felt.
＜カプセル剤＞
以下に、実施例、比較例のカプセル剤を用いて行った試験例を示し、本発明の効果を説明する。
１．臭気の評価方法
錠剤の試験と同様に専門の熟練した官能評価員が基準品との二点比較によって判断して評点を付した。基準品は次の表３の組成のカプセル剤を調製し、これを基準品とした。なお評価基準を表の欄外に明示した。
また、カプセル剤は、原料を混合した後、ハードカプセル充填機（カプスゲル社製「Ｐｒｏｆｉｌｌ １００」）を使用し、カプセルサイズ２号のハードカプセル（カプセル皮膜はカプスゲル社製）を調製した。
<Capsules>
Hereinafter, test examples performed using the capsules of Examples and Comparative Examples are shown, and the effects of the present invention will be described.
1. Evaluation method of odor As in the case of the tablet test, a specialized and skilled sensory evaluator judged and scored by two-point comparison with the reference product. As a reference product, a capsule having the composition shown in Table 3 below was prepared and used as a reference product. The evaluation criteria are shown outside the table.
The capsules were prepared by mixing the raw materials and using a hard capsule filling machine ("Profill 100" manufactured by Capsugel Co., Ltd.) to prepare hard capsules having a capsule size of 2 (capsule film manufactured by Capsugel Co., Ltd.).
なお基準５〜１の臭気の強さは上記表３に記載によるものを基準とするが、官能的に次のような表現に相当する。
基準５：臭気を殆ど感じない。
基準４：わずかに臭気を感じる。
基準３：強い臭気を感じるが飲用には支障がない。
基準２：激しい臭気を感じ、飲用に抵抗を感じる。
基準１：飲用困難な臭気を感じる。
Note that the odor intensities of the standards 5 to 1 are based on those described in Table 3 above, but functionally correspond to the following expressions.
Criterion 5: Almost no odor is felt.
Criterion 4: Slight odor is felt.
Criterion 3: A strong odor is felt, but there is no problem with drinking.
Criterion 2: Feel strong odor and feel resistance to drinking.
Criterion 1: A odor that is difficult to drink is felt.
２．実施例７〜１２及び比較例７〜１２のカプセル剤の調製と評価
表４の処方で、原料を混合した後、基準品と同様にハードカプセル充填機（カプスゲル社製「Ｐｒｏｆｉｌｌ １００」）を使用し、カプセルサイズ２号のハードカプセル（カプセル皮膜はカプスゲル社製）剤を調製した。その錠剤２０粒をアルミ袋に密閉し、４０℃７５％ＲＨのインキュベータ中にて２週間保存後に開封して発生した臭気を専門の訓練を受けた官能評価員３名で評価した。
なお、上記のとおり調製した５つの基準カプセル剤と二点比較で同等性を判断した。
評価の判定は、例えば、試験品が基準３と同等の不快な臭いであれば、評点を３とした。なお官能試験結果は、３名の評点の平均値を求めた。結果を表４の最下段に示す。
官能評価平均値４以上のものが不快臭を低減できていると判断した。
2. Preparation and Evaluation of Capsules of Examples 7 to 12 and Comparative Examples 7 to 12 After mixing the raw materials according to the formulations shown in Table 4, a hard capsule filling machine (“Profill 100” manufactured by Capsugel) was used in the same manner as the reference product. A capsule No. 2 hard capsule (capsule film manufactured by Capsugel Co., Ltd.) was prepared. Twenty tablets were sealed in an aluminum bag, stored in an incubator at 40 ° C. and 75% RH for 2 weeks, opened, and the odor generated was evaluated by three expertly trained sensory evaluators.
In addition, the equivalence was determined by comparing two points with the five reference capsules prepared as described above.
In the evaluation judgment, for example, if the test article had an unpleasant odor equivalent to the criterion 3, the rating was set to 3. The results of the sensory test were obtained by averaging the scores of three persons. The results are shown at the bottom of Table 4.
Those having a sensory evaluation average value of 4 or more were judged to have reduced the unpleasant odor.
実施例７〜１２及び比較例７〜１２のカプセル剤を用いた試験結果から、藤茶抽出物含有カプセル剤における藤茶抽出物由来の特異臭を抑制するためには、キトサンを配合することが有効であることが判明した。またキトサンと藤茶抽出物を含むカプセル充填前の組成物において、組成物あたりアンペロプシンを５〜２２質量％、キトサンを１０〜３５質量％含有し、キトサン／アンペロプシンの質量比が０．６〜３．５になるように調整すると、藤茶由来の特異臭を感じさせない錠剤を得ることができた。
From the test results using the capsules of Examples 7 to 12 and Comparative Examples 7 to 12, in order to suppress the peculiar odor derived from the wisteria extract in the wisteria extract-containing capsules, it is possible to mix chitosan. It turned out to be effective. The composition before filling the capsule containing chitosan and wisteria tea extract contains 5 to 22% by mass of amperopsin and 10 to 35% by mass of chitosan, and the chitosan / amperopsin has a mass ratio of 0.6 to 3 per composition. When adjusted to be 0.5, tablets could be obtained which did not have a peculiar odor derived from wisteria tea.
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