JP6936908B2 - Oral composition - Google Patents
Oral composition Download PDFInfo
- Publication number
- JP6936908B2 JP6936908B2 JP2020132287A JP2020132287A JP6936908B2 JP 6936908 B2 JP6936908 B2 JP 6936908B2 JP 2020132287 A JP2020132287 A JP 2020132287A JP 2020132287 A JP2020132287 A JP 2020132287A JP 6936908 B2 JP6936908 B2 JP 6936908B2
- Authority
- JP
- Japan
- Prior art keywords
- extract
- mass
- crude drug
- ondi
- stearate
- 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.)
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Landscapes
- Medicinal Preparation (AREA)
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Description
本発明は、変質・変色等の経時的劣化が効果的に防止され、長期間にわたって優れた薬効が安定に保たれる、オンジ生薬単味エキス含有内服組成物に関するものである。 The present invention relates to an internal composition containing an ondi crude drug simple extract, which effectively prevents deterioration over time such as alteration and discoloration, and maintains excellent medicinal properties stably for a long period of time.
生薬を配合した製剤には、生薬そのもの(原生薬)を配合した製剤と、生薬を水等で煎じて調製した生薬抽出エキスを配合した製剤とが存在している。そして、原生薬を配合するとかさ高になるため、生薬抽出エキスを配合するものが多くみられる。しかし、生薬抽出エキスを使用した製剤は、変質・変色等が起こりやすく、保管や取扱いが難しいという問題がある。 As the preparation containing the crude drug, there are a preparation containing the crude drug itself (herbal medicine) and a preparation containing the crude drug extract prepared by decocting the crude drug with water or the like. And, since it becomes bulky when the crude drug is mixed, many of them are mixed with the crude drug extract. However, the preparation using the crude drug extract has a problem that it is easily deteriorated and discolored, and it is difficult to store and handle it.
したがって、このような生薬抽出エキス含有製剤において、その変質・変色等を防止するために、様々な提案がなされている。例えば、特許文献1には、原生薬から水等を用いてエキスを抽出し、この抽出液に特定の吸着能を有する吸着剤を2種類配合して粉末化した生薬抽出エキスを配合する製剤が提案されている。この生薬抽出エキス粉末を用いると、製剤のケーキング(固化)および経時的な変色を有効に抑制できるとされる。 Therefore, various proposals have been made in order to prevent alteration, discoloration, etc. of such a crude drug extract-containing preparation. For example, Patent Document 1 describes a formulation in which an extract is extracted from a crude drug using water or the like, and the extract is mixed with two types of adsorbents having a specific adsorbing ability to form a powdered crude drug extract. Proposed. It is said that the use of this crude drug extract powder can effectively suppress the cakeing (solidification) and discoloration of the preparation over time.
しかしながら、このものは、生薬抽出エキスを、抽出液に2種類の異なる吸着剤を配合して粉末化するという特殊で大掛かりな手法によって調製することが必要であり、より簡便な方法が求められている。 However, it is necessary to prepare the crude drug extract by a special and large-scale method of mixing two different types of adsorbents in the extract and pulverizing it, and a simpler method is required. There is.
本発明は、このような事情に鑑みなされたもので、変質・変色等の経時的劣化が効果的に防止され、簡便な手法によって製造することができる、生薬としてオンジのみが配合された内服組成物の提供をその目的とする。 The present invention has been made in view of such circumstances, and has an internal composition containing only Onji as a crude drug, which can be produced by a simple method by effectively preventing deterioration over time such as alteration and discoloration. Its purpose is to provide goods.
上記目的を達成するため、本発明は、その要旨とするオンジ抽出物とステアリン酸塩とを含有し、生薬としてオンジのみが配合されることを特徴とする内服組成物。。 In order to achieve the above object, the present invention is an internal composition containing ondi extract and stearate, which is the gist of the present invention, and containing only ondi as a crude drug. ..
すなわち、本発明者らは、生薬としてオンジのみが配合された内服組成物を製造するに際し、オンジ抽出物に由来する成分の経時的劣化を防止するため、種々の検討を重ねた。その結果、オンジ生薬そのもの(原生薬)ではなく、生薬を水等で煎じて調製した抽出液由来のオンジ抽出物を用いることを選択し、さらに、そのオンジ抽出物とステアリン酸塩とを併用すると、意外なことに、その色、形状の変化を、長期間にわたって抑制できること、さらに製造直後からオンジ生薬特有のにおいを軽減することができることを見い出し、本発明に到達した。 That is, the present inventors have conducted various studies in order to prevent the components derived from the Onji extract from deteriorating over time in producing an internal composition containing only Onji as a crude drug. As a result, instead of using the crude drug itself (herbal medicine), it was selected to use the ondi extract derived from the extract prepared by decocting the crude drug with water or the like, and further, when the ondi extract and stearate are used in combination. Surprisingly, we have found that the change in color and shape can be suppressed for a long period of time, and that the odor peculiar to Onji crude drugs can be reduced immediately after production, and the present invention has been reached.
なお、本発明において、「生薬としてオンジのみが配合される」とは、単味生薬(生薬を複数組み合わせた漢方薬等としての利用ではなく、単独で利用される場合の生薬)としてオンジが配合される、の意味である。 In the present invention, "only Onji is blended as a crude drug" means that Onji is blended as a simple crude drug (a crude drug when used alone, not as a herbal medicine in which a plurality of crude drugs are combined). It means "ru".
このように、本発明の内服組成物は、長期間保存後においても、その色、形状、においの変化が抑制され、品質の安定化が図られている。また、この内服組成物は、製造直後から、オンジ生薬に由来する特有のにおいが軽減されているため、生薬特有のにおいが苦手な人でも容易に服用することができる。本発明の内服組成物は、生薬としてオンジが配合されるため、特に脳機能の改善剤や高齢者用の記憶改善剤として供することができる。 As described above, the internal composition of the present invention suppresses changes in its color, shape, and odor even after long-term storage, and its quality is stabilized. In addition, since the peculiar odor derived from the herbal medicine is reduced immediately after the production of this oral composition, even a person who is not good at the odor peculiar to the herbal medicine can easily take it. Since the oral composition of the present invention contains Onji as a crude drug, it can be provided as an agent for improving brain function or a memory improving agent for the elderly.
つぎに、本発明を実施するための形態について説明する。 Next, a mode for carrying out the present invention will be described.
本発明の内服組成物は、オンジ抽出物を、ステアリン酸塩とともに含有しているが、他の生薬の抽出物を含有していない。このため、オンジ生薬由来の成分を含有しながらも長期保存安定性に優れ、しかも、そのオンジ生薬に由来する特有のにおいが軽減されるという、オンジ抽出物配合の内服組成物にとって極めて優れた効果を奏する。 The oral composition of the present invention contains an ondi extract together with stearate, but does not contain extracts of other crude drugs. For this reason, it has an extremely excellent effect on the oral composition containing the Onji extract, that is, it is excellent in long-term storage stability while containing the ingredients derived from the Onji crude drug, and the peculiar odor derived from the Onji crude drug is reduced. Play.
本発明において、オンジ抽出物とは、オンジ原生薬(刻みまたは粉末)から水、エタノール等の有機溶媒またはその混合物を用いて抽出した、抽出液由来のもの全般を意味し、抽出液、それを濃縮した軟エキス、抽出液または軟エキスを乾燥させたエキス粉末等の、いずれの形態をも含む趣旨である。本発明のオンジ抽出物には、処方の小型化および取扱いの点から、エキス粉末を用いることが好ましい。 In the present invention, the Onji extract means all the extracts derived from the Onji original drug (chopped or powder) using an organic solvent such as water or ethanol or a mixture thereof, and the extract. The purpose is to include any form such as a concentrated soft extract, an extract, or an extract powder obtained by drying the soft extract. For the ondi extract of the present invention, it is preferable to use an extract powder from the viewpoint of miniaturization and handling of the formulation.
本発明の内服組成物において、オンジ抽出物の含有量は特に制限されるものではない。しかし、その収率にもよるが、本発明の効果を奏する観点から、内服組成物全体に対し、通常1質量%以上含有するものであり、5〜99質量%含有することが好ましく、より好ましくは8〜95質量%、特に好ましくは15〜90質量%、さらに好ましくは20〜75質量%、一層好ましくは25〜50質量%、特に好ましくは25〜40質量%、最も好ましくは30〜40質量%含有するものである。また、1日の服用量として、200〜2000mg含有することが好ましく、より好ましくは300〜1000mg、一層好ましくは400〜1000mg、特に好ましくは500〜600mgである。すなわち、オンジ抽出物が少なすぎるとオンジ生薬由来の薬効成分を充分に配合することができない傾向がみられるうえに、本発明における課題が発生しない場合がある。一方で、オンジ抽出物が多すぎると上記薬効成分が過剰に配合され、固化や着色が抑制されない等、本発明の効果を奏しないおそれがあるためである。 In the internal composition of the present invention, the content of the ondi extract is not particularly limited. However, although it depends on the yield, from the viewpoint of exerting the effect of the present invention, it is usually contained in an amount of 1% by mass or more, preferably 5 to 99% by mass, more preferably, based on the entire internal composition. Is 8 to 95% by mass, particularly preferably 15 to 90% by mass, still more preferably 20 to 75% by mass, still more preferably 25 to 50% by mass, particularly preferably 25 to 40% by mass, and most preferably 30 to 40% by mass. % Is contained. The daily dose is preferably 200 to 2000 mg, more preferably 300 to 1000 mg, still more preferably 400 to 1000 mg, and particularly preferably 500 to 600 mg. That is, if the amount of the ondi extract is too small, there is a tendency that the medicinal ingredient derived from the ondi crude drug cannot be sufficiently blended, and the problem in the present invention may not occur. On the other hand, if the amount of the ondi extract is too large, the above-mentioned medicinal ingredients are excessively blended, and solidification and coloring may not be suppressed, so that the effects of the present invention may not be exhibited.
さらに、オンジ抽出物は、一日の服用量としてオンジ原生薬1〜10g、好ましくは3〜10g、さらに好ましくは3〜5g、特に好ましくは3gを、4〜200倍量、好ましくは10〜120倍量、とりわけ、120倍量の水およびエタノールの少なくとも一方をもって煮て得られた抽出液から得られるものであることが好ましい。また、本発明の内服組成物に用いられるオンジ抽出物としては、原生薬からの収率が3〜50質量%、好ましくは5〜30質量%、特に好ましくは10〜20質量%のものを用いることが好ましい。この収率が低すぎると不純物が多くオンジ生薬由来の薬効成分を充分に配合することができない傾向がみられ、高すぎると上記薬効成分が過剰に配合され、さらには固化や着色の抑制等、本発明の効果を奏しないおそれがあるためである。 Further, the Ondi extract is a daily dose of 1 to 10 g of Ondi crude drug, preferably 3 to 10 g, more preferably 3 to 5 g, particularly preferably 3 g, 4 to 200 times, preferably 10 to 120. It is preferably obtained from an extract obtained by boiling in at least a double amount, particularly 120 times the amount of water and ethanol. Further, as the ondi extract used in the internal composition of the present invention, one having a yield from the crude drug of 3 to 50% by mass, preferably 5 to 30% by mass, particularly preferably 10 to 20% by mass is used. Is preferable. If this yield is too low, there are many impurities and there is a tendency that the medicinal ingredients derived from Onji crude drugs cannot be sufficiently blended. This is because the effect of the present invention may not be achieved.
内服組成物に用いられるステアリン酸塩は、一般的には、圧縮錠剤(Compressed Tablet)製造時の滑沢剤(Lubricant)として使用されるものであるが、本発明では、内服組成物を圧縮錠剤の形状としない場合にも使用する。ステアリン酸塩としては、例えば、ステアリン酸マグネシウム、ステアリン酸カルシウム、ステアリン酸カリウム、ステアリン酸ナトリウム、ステアリン酸亜鉛が挙げられる。これらはいずれも白色の微差なかさ高い粉末であり、わずかなにおいが生じることがあり、また、水やエタノールに溶けにくいなど共通の物性を有する。このようなステアリン酸塩のうち、本発明の内服組成物に好ましく用いられるのは、ステアリン酸マグネシウム、ステアリン酸カルシウム、ステアリン酸カリウムであり、特に好ましくはステアリン酸マグネシウムである。 The stearate used in the internal composition is generally used as a lubricant during the production of compressed tablets, but in the present invention, the internal composition is used as a compressed tablet. It is also used when the shape is not. Examples of stearate include magnesium stearate, calcium stearate, potassium stearate, sodium stearate, and zinc stearate. All of these are white powders with a slight difference, which may give off a slight odor, and have common physical characteristics such as being difficult to dissolve in water or ethanol. Among such stearate, magnesium stearate, calcium stearate, and potassium stearate are preferably used in the internal composition of the present invention, and magnesium stearate is particularly preferable.
本発明の内服組成物において、ステアリン酸塩の含有量は特に制限されないが、本発明の効果を奏する観点から、内服組成物全体に対し、0.1〜90質量%含有することが好ましく、より好ましくは0.3〜50質量%、一層好ましくは0.5〜10質量%、特に好ましくは1〜5質量%である。 In the internal composition of the present invention, the content of stearate is not particularly limited, but from the viewpoint of exerting the effect of the present invention, it is preferably contained in an amount of 0.1 to 90% by mass based on the entire internal composition. It is preferably 0.3 to 50% by mass, more preferably 0.5 to 10% by mass, and particularly preferably 1 to 5% by mass.
また、ステアリン酸塩の含有量は、オンジ抽出物1質量部に対し、0.01〜100質量部の範囲に設定されることが好ましく、より好ましくは、0.01〜50質量部の範囲に設定され、一層好ましくは、0.03〜10質量部の範囲に設定され、特に好ましくは、1〜10質量部の範囲に設定されることである。オンジ抽出物に対するステアリン酸塩の比率が少なすぎると、製剤の形状、におい、色の変化の抑制効果が薄れる傾向が見られ、逆に、多すぎると、製剤が大型化するだけで、所定以上の効果は得られないためである。上記の範囲に設定されていると、製剤の小型化と、製剤の色、形状、においの変化の抑制の効果をバランス良く両立するものとなる。 The stearate content is preferably set in the range of 0.01 to 100 parts by mass, more preferably in the range of 0.01 to 50 parts by mass with respect to 1 part by mass of the ondi extract. It is set, more preferably set in the range of 0.03 to 10 parts by mass, and particularly preferably set in the range of 1 to 10 parts by mass. If the ratio of stearate to the ondi extract is too small, the effect of suppressing changes in the shape, odor, and color of the formulation tends to be diminished. This is because the effect of When it is set in the above range, the miniaturization of the formulation and the effect of suppressing changes in the color, shape, and odor of the formulation are compatible with each other in a well-balanced manner.
さらに、本発明の内服組成物は、生薬としてオンジのみが配合されることを特徴とするものであり、オンジ抽出物以外の原生薬および原生薬から得られた抽出物を含有しない。換言すると、本発明の内服組成物には、構成生薬の一つとしてオンジ抽出物を含有する漢方薬等の複数の生薬を組み合わせた内服組成物は該当しない。これは、オンジ抽出物以外の原生薬および原生薬抽出物を含有すると、着色、固化もしくは異臭等の性状変化が起き易くなり、本発明の効果を奏しない傾向がみられるためである。ただし、グリチルリチン酸二カリウムのように、原生薬であるカンゾウから抽出され、一化合物として精製されたものは、原生薬から得られた抽出物に該当せず、本発明の内服組成物に含有することができる。 Furthermore, the oral composition of the present invention is characterized in that only Onji is blended as a crude drug, and does not contain a crude drug other than the Ondi extract and an extract obtained from the crude drug. In other words, the internal composition of the present invention does not correspond to an internal composition in which a plurality of crude drugs such as Chinese herbal medicine containing an ondi extract are combined as one of the constituent crude drugs. This is because when a crude drug other than the ondi extract and a crude drug extract are contained, property changes such as coloring, solidification or offensive odor are likely to occur, and the effect of the present invention tends not to be exhibited. However, a compound extracted from licorice, which is a crude drug, and purified as one compound, such as dipotassium glycyrrhizinate, does not fall under the extract obtained from the crude drug and is contained in the internal composition of the present invention. be able to.
そして、本発明の内服組成物は、オンジ抽出物およびステアリン酸塩以外の他の材料を含んでいてもよい。すなわち、本発明の内服組成物は、一般に製剤学的に利用可能な製剤添加物、例えば、安定化剤、安定剤、界面活性剤、滑沢化剤、滑沢剤、可溶(化)剤、緩衝剤、甘味剤、基剤、吸着剤、矯味剤、結合剤、懸濁(化)剤、硬化剤、抗酸化剤、光沢化剤、香料、コーティング剤、剤皮、湿潤剤、湿潤調整剤、充填剤、消泡剤、清涼(化)剤、咀嚼剤、静電防止剤、着香剤・香料、着色剤、糖衣剤、等張化剤、軟化剤、乳化剤、粘着剤、粘着増強剤、粘調(化)剤、発泡剤、pH調整剤、pH調節剤、賦形剤、分散剤、崩壊剤、崩壊補助剤、芳香剤、防湿剤、防腐剤、保存剤、溶解剤、溶解補助剤、溶剤、流動化剤を必要に応じて含有することができる。 The oral composition of the present invention may contain materials other than the ondi extract and stearate. That is, the oral composition of the present invention is generally a pharmaceutical additive that is commercially available, such as a stabilizer, a stabilizer, a surfactant, a smoothing agent, a smoothing agent, and a solubilizing agent. , Buffers, sweeteners, bases, adsorbents, flavoring agents, binders, suspending agents, hardeners, antioxidants, brighteners, fragrances, coating agents, skins, wetting agents, wetting adjustments Agents, fillers, defoaming agents, cooling agents, chewing agents, antistatic agents, flavoring agents / fragrances, coloring agents, sugar coating agents, isotonic agents, softening agents, emulsifiers, adhesives, adhesive enhancement Agents, viscous agents, foaming agents, pH regulators, pH regulators, excipients, dispersants, disintegrants, disintegrant aids, fragrances, moisture barriers, preservatives, preservatives, solubilizers, dissolves Auxiliary agents, solvents and fluidizing agents can be contained as required.
このような製剤添加物の具体例としては、精製白糖、ブドウ糖、トレハロース、乳糖、マルトース、マンニトール、ソルビトール、キシリトール、エリスリトール、サッカリンナトリウム、アスパルテーム、アセスルファムカリウム、スクラロース、カンゾウ抽出物、ステビア抽出物、ラカンカ抽出物、トウモロコシデンプン、バレイショデンプン、コムギデンプン、炭酸水素ナトリウム、塩化ナトリウム、結晶セルロース、メチルセルロース、エチルセルロース、ヒプロメロース、ヒドロキシプロピルセルロース、カルボキシメチルセルロース、カルボキシメチルセルロースナトリウム、カルボキシメチルセルロースカルシウム、カルメロースカルシウム、ヒプロメロースフタル酸エステル、セルロースアセテートフタレート、デキストリン、α化デンプン、アラビアゴム、ゼラチン、アルギン酸ナトリウム、ポリビニルピロリドン、ポリビニルアルコール、カゼイン、カゼインナトリウム、カルボキシビニルポリマー、タルク、水素添加植物油、マクロゴール、シリコーン油、寒天、炭酸水素ナトリウム、アルギン酸ナトリウム、セラック、グリセリン、芳香性精油類、水溶性食用色素、黄酸化鉄、黄色三二酸化鉄、三二酸化鉄、褐色酸化鉄、黒酸化鉄、二酸化チタン、レーキ色素、安息香酸、安息香酸ナトリウム、パラオキシ安息香酸、ポリソルベート80、グリセリン脂肪酸エステル、サラシミツロウ、中鎖脂肪酸トリグリセリド、アスコルビン酸、トコフェロール、チオ硫酸ナトリウム、エデト酸ナトリウム、オレンジやレモン等の柑橘系香料やコーヒー系香料、チョコレート系香料、ヨーグルト系香料、ミルク系香料やレモン油、ペパーミント油、スペアミント油、スパイス油などの植物精油などを挙げることができる。なお、本発明の内服組成物に使用できる製剤添加剤は、上記列挙したものに限定されず、製剤学上利用可能なものであれば特に限定されない。 Specific examples of such pharmaceutical additives include purified sucrose, glucose, trehalose, lactose, maltose, mannitol, sorbitol, xylitol, erythritol, sodium saccharin, aspartame, acesulfam potassium, sclarose, kanzo extract, stevia extract, and lacanca extract. Foods, corn starch, potato starch, wheat starch, sodium hydrogen carbonate, sodium chloride, crystalline cellulose, methyl cellulose, ethyl cellulose, hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, carboxymethyl cellulose calcium, carmellose calcium, hypromellose phthal. Acid ester, cellulose acetate phthalate, dextrin, pregelatinized starch, gum arabic, gelatin, sodium alginate, polyvinylpyrrolidone, polyvinyl alcohol, casein, sodium caseinate, carboxyvinyl polymer, talc, hydrogenated vegetable oil, macrogol, silicone oil, agar, Sodium hydrogen carbonate, sodium alginate, cellac, glycerin, aromatic essential oils, water-soluble edible pigments, iron yellow oxide, yellow iron sesquioxide, iron sesquioxide, brown iron oxide, black iron oxide, titanium dioxide, lake pigment, benzoic acid , Sodium benzoate, paraoxybenzoic acid, polysorbate 80, glycerin fatty acid ester, salashimitsurou, medium chain fatty acid triglyceride, ascorbic acid, tocopherol, sodium thiosulfate, sodium edetate, citrus fragrances such as orange and lemon, and coffee fragrances. Examples thereof include chocolate-based fragrances, yogurt-based fragrances, milk-based fragrances, lemon oil, peppermint oil, spare mint oil, and vegetable essential oils such as spice oil. The pharmaceutical additives that can be used in the oral composition of the present invention are not limited to those listed above, and are not particularly limited as long as they can be used in pharmaceutics.
これらの中でも、本発明の内服組成物には、オンジ抽出物の着色やにおいを抑制する観点から、結合剤を添加することが好適である。結合剤としては、例えば、精製白糖、ブドウ糖、トレハロース、乳糖、マルトース、サッカリンナトリウム、アスパルテーム、アセスルファムカリウム等の多糖、トウモロコシデンプン、バレイショデンプン、コムギデンプンおよびこれらのα化デンプン、マンニトール、ソルビトール、キシリトール、エリスリトール、スクラロース等の糖アルコール、結晶セルロース、メチルセルロース、エチルセルロース、ヒプロメロース、ヒドロキシプロピルセルロース、カルボキシメチルセルロース、カルボキシメチルセルロースナトリウム、カルボキシメチルセルロースカルシウム、カルメロースカルシウム、ヒプロメロースフタル酸エステル、セルロースアセテートフタレート等のセルロース系高分子があげられる。特に好ましい結合剤としては、結晶セルロース、バレイショデンプン、マンニトール、乳糖があげられる。 Among these, it is preferable to add a binder to the internal composition of the present invention from the viewpoint of suppressing the coloring and odor of the ondi extract. Examples of the binder include purified sucrose, glucose, trehalose, lactose, maltose, sodium saccharin, aspartame, polysaccharides such as acesulfam potassium, corn starch, potato starch, wheat starch and their pregelatinized starch, mannitol, sorbitol, xylitol and erythritol. , Sugar alcohols such as sucralose, crystalline cellulose, methyl cellulose, ethyl cellulose, hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, carboxymethyl cellulose calcium, carmellose calcium, hypromellose phthalate ester, cellulose acetate phthalate and other cellulosic highs The molecule can be mentioned. Particularly preferred binders include crystalline cellulose, potato starch, mannitol and lactose.
本発明の内服組成物において、結合剤の含有量は特に制限されるものではないが、本発明の効果をより奏する観点から、内服組成物全体に対し、通常5〜95質量%含有することが好ましく、より好ましくは20〜90質量%、特に好ましくは30〜85質量%、さらに好ましくは40〜80質量%である。 In the internal composition of the present invention, the content of the binder is not particularly limited, but from the viewpoint of more exerting the effect of the present invention, it is usually contained in an amount of 5 to 95% by mass with respect to the entire internal composition. It is preferably more preferably 20 to 90% by mass, particularly preferably 30 to 85% by mass, and even more preferably 40 to 80% by mass.
そして、本発明の内服組成物は、オンジ抽出物、ステアリン酸塩および必要であればその他の材料を、慣用の方法で混合することによって得ることができる。すなわち、まず、オンジ抽出物とステアリン酸塩とを混合し、この混合物にその他の材料を混ぜ合わせるようにしてもよいし、オンジ抽出物、ステアリン酸マグネシウムを含む全ての材料を一度に混ぜ合わせるようにしてもよい。しかし、オンジ生薬由来のにおいがより抑制され、形状安定性が高まる点から、まず、オンジ抽出物とステアリン酸塩とを混合し、この混合物にその他の材料を混ぜ合わせることが好ましい。得られた内服組成物は、多くの場合、乾燥および整粒され、固形組成物となる。 The oral composition of the present invention can then be obtained by mixing the ondi extract, stearate and, if necessary, other materials in a conventional manner. That is, the ondi extract and stearate may be mixed first, and other ingredients may be mixed with this mixture, or all the ingredients including ondi extract and magnesium stearate may be mixed at once. It may be. However, it is preferable to first mix the ondi extract and stearate, and then mix other materials with this mixture, from the viewpoint that the odor derived from the ondy crude drug is further suppressed and the shape stability is enhanced. The obtained oral composition is often dried and sized to become a solid composition.
本発明の内服組成物を、錠剤、顆粒剤、細粒剤、散剤、丸剤、ドライシロップ剤等とするため、すなわち、内服組成物の形状を調整する必要がある場合には、一般に利用される造粒法、例えば、噴霧造粒法、撹拌造粒法、流動造粒法、転動造粒法、転動流動造粒法等の湿式造粒法、圧密造粒法などの乾式造粒法を用いることができる。また、錠剤、顆粒剤等に成形された内服組成物は、小分けして充填し、分包とすることもできる。錠剤は、内服組成物、粉末剤、細粒剤、顆粒剤、丸剤等と製剤添加物を混合し、圧縮成型することにより製造することができる。糖衣錠、フィルムコーティング錠、コーティング顆粒などのコーティング製剤は、パンコーティング法、流動コーティング法、転動コーティング法、および、これらの組み合わせなどの常法により製造することができる。 It is generally used to make the internal composition of the present invention into tablets, granules, fine granules, powders, rounds, dry syrups, etc., that is, when it is necessary to adjust the shape of the internal composition. Granulation methods such as spray granulation method, stirring granulation method, flow granulation method, rolling granulation method, wet granulation method such as rolling flow granulation method, and dry granulation method such as compaction granulation method. Can be used. In addition, the internal composition molded into tablets, granules, etc. can be divided into small portions and filled into separate packages. Tablets can be produced by mixing an internal composition, a powder, fine granules, granules, pills and the like with a pharmaceutical additive and compression molding. Coated formulations such as sugar-coated tablets, film-coated tablets, and coated granules can be produced by a conventional method such as a pan coating method, a fluid coating method, a rolling coating method, and a combination thereof.
そして、本発明の内服組成物は、錠剤、散剤、顆粒剤、丸剤、カプセル剤、チュアブル錠、糖衣剤、フィルムコーティング剤、発泡製剤、口腔内崩壊製剤、マトリックス製剤、ドリンク剤、ゼリー剤、シロップ剤等、どのような形状であってもよいが、本発明の効果を顕著に奏するという点から、錠剤、散剤、顆粒剤、丸剤、チュアブル錠等の固形組成物が好ましく、簡易な組成で、服用が容易になる点から、錠剤または顆粒剤がより好ましく用いられる。 The oral composition of the present invention includes tablets, powders, granules, pills, capsules, chewable tablets, sugar coatings, film coatings, effervescent preparations, orally disintegrating preparations, matrix preparations, drinks, jelly preparations, etc. Although it may have any shape such as a syrup, a solid composition such as a tablet, a powder, a granule, a pill, or a chewable tablet is preferable and has a simple composition from the viewpoint that the effect of the present invention is remarkably exhibited. Therefore, tablets or granules are more preferably used because they are easy to take.
また、本発明の内服組成物は、変質・変色等の経時的劣化が効果的に防止され、長期間にわたって優れた薬効が安定に保たれる。このため、1日に服用する錠数や包数が多い場合にも少ない場合にも有用となる。単味生薬としてエキス粉末が配合された固形組成物の1日に服用する錠数や包数は、錠剤であれば、通常1〜30錠、好ましくは2〜25錠程度であり、散剤、顆粒剤であれば、2〜5包程度である。その場合、1錠(包)あたりの質量は通常、50〜1000mg、好ましくは200〜600mg程度となる。 In addition, the oral composition of the present invention effectively prevents deterioration over time such as deterioration and discoloration, and excellent medicinal effect is stably maintained for a long period of time. Therefore, it is useful regardless of whether the number of tablets or packets taken per day is large or small. The number of tablets and the number of packets of the solid composition containing the extract powder as a simple crude drug per day are usually 1 to 30 tablets, preferably about 2 to 25 tablets, and powders and granules. If it is an agent, it is about 2 to 5 packets. In that case, the mass per tablet (packet) is usually about 50 to 1000 mg, preferably about 200 to 600 mg.
さらに、本発明の内服組成物には、製剤添加物などを用い、薬効成分の安定化、徐放化、持続化、速崩化、速溶化、溶解性の改善、服用感の改善などの機能を付加してもよい。これらの機能の付加は、一般に使用する方法で行うことができ、例えば、薬効成分を別々の顆粒に配合する、多層の顆粒にする、多層錠や有核錠にする、別々の顆粒にして打錠する、マイクロカプセルとする、糖衣錠、フィルムコーティング錠、コーティング顆粒などのコーティング製剤とする、発泡製剤とする、チュアブル製剤とする、口腔内崩壊製剤とする、マトッリックス製剤とする、共粉砕する、固溶体とする、甘味剤や清涼化剤を添加する、抗酸化剤や安定(化)剤を添加する、特定のpH・粘度・浸透圧・塩濃度に調整する、という手法を挙げることができ、これらの方法を組み合わせても良い。 Further, the oral composition of the present invention uses a pharmaceutical additive or the like to have functions such as stabilizing, sustained-release, sustaining, rapid-disintegrating, rapid-dissolving, improving solubility, and improving the feeling of ingestion of the medicinal ingredient. May be added. The addition of these functions can be carried out by a commonly used method, for example, the medicinal ingredient is blended into separate granules, multi-layer granules, multi-layer tablets or nucleated tablets, and striking in separate granules. Tablets, microcapsules, sugar-coated tablets, film-coated tablets, coated granules and other coating products, effervescent products, chewable products, orally disintegrating products, matrix products, co-crushing, Methods such as adding a solid solution, adding a sweetener or a cooling agent, adding an antioxidant or a stabilizing agent, and adjusting to a specific pH, viscosity, osmotic pressure, and salt concentration can be mentioned. These methods may be combined.
つぎに、実施例について、比較例と併せて説明する。ただし、本発明はこれに限定されるものではない。なお、以下に示す成分組成は、特に記載がない限り、すべて質量基準(質量部)で示している。 Next, Examples will be described together with Comparative Examples. However, the present invention is not limited to this. Unless otherwise specified, all the component compositions shown below are shown on a mass basis (parts by mass).
〔実施例1〜9、比較例1〜13〕
後記の表1〜6に示す組成の通り、内服組成物(実施例1〜9、比較例1〜13)を調製した。すなわち、各材料を準備し、これらを一度に混合して、粉末状の内服組成物を調製した。なお、各生薬の抽出物に関しては、下記のものを使用し、その他の材料は日本薬局方の収載品を用いた。
[Examples 1 to 9, Comparative Examples 1 to 13]
Oral compositions (Examples 1 to 9 and Comparative Examples 1 to 13) were prepared according to the compositions shown in Tables 1 to 6 below. That is, each material was prepared and mixed at once to prepare a powdery oral composition. The following extracts were used for each crude drug, and the other materials listed in the Japanese Pharmacopoeia were used.
オンジ抽出物:刻まれたオンジ原生薬を、10倍量の水をもって煮て(約100℃)、30分間抽出を行った。得られた抽出液を100メッシュの篩でろ過し、ろ液を70℃以下で濃縮した。濃縮液は加熱殺菌し、噴霧乾燥して粉末状のオンジ抽出物を得た。この方法では、オンジ原生薬5gから約0.55gのオンジ抽出物が得られた(収率11質量%)。
カンゾウ抽出物:カンゾウエキス末(日本粉末薬品社)
ニンジン抽出物:人参乾燥エキス(日本粉末薬品社)
Onji extract: The chopped Onji crude drug was boiled in 10 times the amount of water (about 100 ° C.) and extracted for 30 minutes. The obtained extract was filtered through a 100-mesh sieve, and the filtrate was concentrated at 70 ° C. or lower. The concentrate was sterilized by heating and spray-dried to obtain a powdered Onji extract. By this method, about 0.55 g of Ondi extract was obtained from 5 g of Ondi crude drug (yield 11% by mass).
Licorice extract: Licorice extract powder (Nippon Powder Pharmaceutical Co., Ltd.)
Carrot extract: dried carrot extract (Nippon Powder Pharmaceutical Co., Ltd.)
各実施例および各比較例の内服組成物について、(1)色差抑制率1、(2)質量変化抑制率、(3)固化の有無、(4)においの抑制、(5)においの変化、(6)色差抑制率2、の6項目について評価を行った。各項目の評価方法は、以下に示すとおりである。なお、各実施例および各比較例における上記6項目の各評価は、オンジ抽出物として収率11質量%のものを同量用いれば同じものとなる。すなわち、オンジ原生薬5gから得られた約0.55gのオンジ抽出物に代えて、オンジ原生薬3gから得た約0.33gのオンジ抽出物を同量用いた場合であっても、各実施例および各比較例における上記6項目の各評価はかわることはない。 For the internal composition of each Example and each Comparative Example, (1) color difference suppression rate 1, (2) mass change suppression rate, (3) presence / absence of solidification, (4) odor suppression, (5) odor change, (6) Six items of color difference suppression rate 2 were evaluated. The evaluation method for each item is as shown below. In addition, each evaluation of the above 6 items in each Example and each comparative example becomes the same when the same amount of the ondi extract with a yield of 11% by mass is used. That is, even when the same amount of about 0.33 g of Onji extract obtained from 3 g of Onji crude drug was used in place of about 0.55 g of Onji extract obtained from 5 g of Onji crude drug, each implementation was carried out. Each evaluation of the above six items in the example and each comparative example does not change.
(1)色差抑制率1
表1および表2に示す組成の通り調製した内服組成物0.5gをプラスチック製シャーレに入れ、40℃、湿度75%RHで10分間保存後の内服組成物の色の変化を、色差計(コニカミノルタ社製、品番:CR−400)を用いて測定し、調製直後の内服組成物の色をスタンダードとし、下記の式1を用いて保管前後における色差(ΔE*ab)を求めた。さらに、オンジ抽出物のみが配合された内服組成物(比較例1)の色の経時変化(ΔE*ab)を基準とし、経時による色の変化をどの程度抑制できたか(色差抑制率%)を式2により算出した。色差抑制率が高いほど、高温高湿度保存下での変色が抑制されたことを意味する。表1および表2に併せて結果を示す。
式1:色差(ΔE*ab)=[(Δa*)2+(Δb*)2+(ΔL*)2]1/2
Δa*:保存後の錠剤のa値−保存前の錠剤のa値
Δb*:保存後の錠剤のb値−保存前の錠剤のb値
ΔL*:保存後の錠剤のL値−保存前の錠剤のL値
式2:色差抑制率(%)=((比較例1の色差−各組成物の色差)/比較例1の色差)×100
(1) Color difference suppression rate 1
0.5 g of the internal composition prepared according to the compositions shown in Tables 1 and 2 was placed in a plastic petri dish, and the color change of the internal composition after storage at 40 ° C. and 75% humidity RH for 10 minutes was measured by a color difference meter (color difference meter). Measurement was performed using Konica Minolta Co., Ltd., product number: CR-400), and the color difference (ΔE * ab) before and after storage was determined using the following formula 1 using the color of the internal composition immediately after preparation as a standard. Furthermore, based on the time-dependent change (ΔE * ab) of the color of the oral composition (Comparative Example 1) containing only the Ondi extract, how much the color change with time could be suppressed (color difference suppression rate%). Calculated by Equation 2. The higher the color difference suppression rate, the more the discoloration under high temperature and high humidity storage is suppressed. The results are also shown in Tables 1 and 2.
Equation 1: Color difference (ΔE * ab) = [(Δa * ) 2 + (Δb * ) 2 + (ΔL * ) 2 ] 1/2
Δa * : A value of the tablet after storage-a value of the tablet before storage Δb * : b value of the tablet after storage-b value of the tablet before storage ΔL * : L value of the tablet after storage-before storage Tablet L value formula 2: Color difference suppression rate (%) = ((Color difference of Comparative Example 1-Color difference of each composition) / Color difference of Comparative Example 1) × 100
上記表1および表2に示されたように、オンジ抽出物とステアリン酸マグネシウムとを含有し、生薬としてオンジのみが配合される実施例1〜5のすべてにおいて、高温高湿下での経時的な変色が抑制されており、品質が安定していることが確認された。一方で、オンジ抽出物以外に、生薬としてカンゾウ抽出物もしくはニンジン抽出物を含有する比較例2、3においては、変色が抑制されておらず、むしろ一層変色していた。また、ステアリン酸マグネシウムに換えて、結晶セルロース、バレイショデンプン、もしくはマンニトールを用いた比較例4〜6においても、変色が抑制されず、むしろ一層変色していた。 As shown in Tables 1 and 2 above, in all of Examples 1 to 5 containing the ondi extract and magnesium stearate and containing only ondi as a crude drug, over time under high temperature and high humidity. It was confirmed that the discoloration was suppressed and the quality was stable. On the other hand, in Comparative Examples 2 and 3 containing the licorice extract or the carrot extract as a crude drug in addition to the ondi extract, the discoloration was not suppressed, but rather the discoloration was further increased. Further, in Comparative Examples 4 to 6 in which crystalline cellulose, potato starch, or mannitol was used instead of magnesium stearate, discoloration was not suppressed, but rather discoloration was further observed.
(2)質量変化抑制率
下記の表3に示す組成の通り調製した内服組成物0.5gをプラスチック製シャーレに入れ、40℃,湿度75%RHで10分間保存後の内服組成物の吸湿による質量の変化を、調製直後の内服組成物の質量をスタンダードとし、下記の式3に示すとおり、質量変化率(%)として算出した。さらに、オンジ抽出物のみが配合された内服組成物(比較例1)の質量変化率(%)を基準とし、経時による質量の変化をどの程度抑制できたか(質量変化抑制率(%))を下記の式4を用いて算出した。質量変化抑制率が高いほど、高温高湿度保存下での吸湿による質量変化が抑制されたことを意味する。表3に併せて結果を示す。
式3:質量変化率(%)=〔(保存後の質量−保存前の質量)/保存前質量〕×100
式4:質量変化抑制率(%)=〔(比較例1の質量変化率−各組成物の質量変化率)/比較例1の質量変化率〕×100
(2) Inhibition rate of mass change 0.5 g of the internal composition prepared according to the composition shown in Table 3 below is placed in a plastic petri dish and stored at 40 ° C. and 75% humidity for 10 minutes by moisture absorption of the internal composition. The change in mass was calculated as the rate of change in mass (%) as shown in Formula 3 below, using the mass of the oral composition immediately after preparation as a standard. Furthermore, based on the mass change rate (%) of the oral composition (Comparative Example 1) containing only the Ondi extract, how much the mass change with time could be suppressed (mass change suppression rate (%)). It was calculated using the following formula 4. The higher the mass change suppression rate, the more the mass change due to moisture absorption under high temperature and high humidity storage is suppressed. The results are also shown in Table 3.
Equation 3: Mass change rate (%) = [(mass after storage-mass before storage) / mass before storage] x 100
Equation 4: Mass change suppression rate (%) = [(Mass change rate of Comparative Example 1-Mass change rate of each composition) / Mass change rate of Comparative Example 1] × 100
上記表3に示されたように、オンジ抽出物とステアリン酸マグネシウムとを含有し、生薬としてオンジのみが配合される実施例1〜5のすべてにおいて、高温高湿下での経時的な変色が抑制されており、品質が安定していることが確認された。 As shown in Table 3 above, in all of Examples 1 to 5 containing the ondi extract and magnesium stearate and containing only ondi as a crude drug, discoloration over time under high temperature and high humidity was observed. It was confirmed that it was suppressed and the quality was stable.
(3)固化の有無
下記の表4および表5に示す組成の通り調製した内服組成物10gをプラスチック製シャーレに入れ、40℃、湿度75%RHで1時間保存後の外観を目視により観察し、下記の基準に基づいて内服組成物の固化の有無を評価した。表4および表5に併せて結果を示す。
◎:固化は生じなかった。
○:固化がごくわずかに認められたが、問題とならない程度のものであった。
△:部分的に固化が生じた。
×:全体が固化した。
(3) Presence or absence of solidification 10 g of the internal composition prepared according to the compositions shown in Tables 4 and 5 below is placed in a plastic petri dish, and the appearance after storage at 40 ° C. and 75% humidity RH for 1 hour is visually observed. , The presence or absence of solidification of the oral composition was evaluated based on the following criteria. The results are also shown in Tables 4 and 5.
⊚: Solidification did not occur.
◯: Very slight solidification was observed, but it was not a problem.
Δ: Solidification occurred partially.
X: The whole was solidified.
上記表4および表5に示されたように、オンジ抽出物のみを含有する比較例7が高温高湿下で固化したのに対して、オンジ抽出物とステアリン酸マグネシウムとを含有し、生薬としてオンジのみが配合される実施例6〜9のすべてにおいて、経時的な固化が抑制されており、品質が安定していることが確認された。一方で、オンジ抽出物以外に、生薬としてカンゾウ抽出物、ニンジン抽出物、もしくはショウキョウ抽出物を含有する比較例8〜10においては、固化が抑制されていなかった。また、ステアリン酸マグネシウムに換えて、結晶セルロース、バレイショデンプン、もしくはマンニトールを用いた比較例11〜13においても、固化が抑制されていなかった。 As shown in Tables 4 and 5, Comparative Example 7 containing only the ondi extract solidified under high temperature and high humidity, whereas the ondi extract and magnesium stearate were contained as crude drugs. It was confirmed that in all of Examples 6 to 9 in which only Onji was blended, solidification over time was suppressed and the quality was stable. On the other hand, in Comparative Examples 8 to 10 containing licorice extract, carrot extract, or ginger extract as crude drugs in addition to the ondi extract, solidification was not suppressed. Further, in Comparative Examples 11 to 13 in which crystalline cellulose, potato starch, or mannitol was used instead of magnesium stearate, solidification was not suppressed.
(4)においの抑制
下記の表6に示す組成比の通り調製した調製直後の内服組成物について、10cm離れたところからそのにおいを嗅ぎ、下記の基準に基づいて評価した。評価を表6に併せて示す。
〇:オンジ生薬由来のにおいが抑制されたように感じた。
×:オンジ生薬由来のにおいの抑制は感じられなかった。
(4) Smell suppression The oral composition immediately after preparation prepared according to the composition ratio shown in Table 6 below was smelled from a distance of 10 cm and evaluated based on the following criteria. The evaluation is also shown in Table 6.
〇: I felt that the odor derived from Onji herbal medicine was suppressed.
X: No suppression of odor derived from Onji crude drug was felt.
(5)においの変化
下記の表6に示す組成比の通り調製した内服組成物10gをプラスチック製シャーレに入れ、40℃、湿度75%RHで1時間保存した。調製直後の内服組成物のにおいと、保存後の内服組成物のにおいを対比し、下記の基準に基づいて内服組成物のにおいの変化を評価した。評価を表6に併せて示す。
〇:においの変化は感じられなかった。
×:においが悪化した(不快なにおいが強くなった)。
(5) Change in odor 10 g of the internal composition prepared according to the composition ratio shown in Table 6 below was placed in a plastic petri dish and stored at 40 ° C. and 75% RH for 1 hour. The odor of the internal composition immediately after preparation was compared with the odor of the internal composition after storage, and the change in the odor of the internal composition was evaluated based on the following criteria. The evaluation is also shown in Table 6.
〇: No change in odor was felt.
X: The odor worsened (the unpleasant odor became stronger).
上記表6に示されたように、オンジ抽出物のみを含有する比較例7が生薬特有のにおいを発し、高温高湿下でにおいが悪化したのに対して、オンジ抽出物とステアリン酸マグネシウムとを含有し、生薬としてオンジのみが配合される実施例8、9のすべてにおいて、調製直後のにおいが改善され、また経時的なにおいの悪化が抑制されており、品質が安定していることが確認された。一方で、ステアリン酸マグネシウムに換えて、結晶セルロース、バレイショデンプン、もしくはマンニトールを用いた比較例11〜13においては、においが改善されず、においの悪化が抑制されていなかった。 As shown in Table 6 above, Comparative Example 7 containing only the Ondi extract emitted an odor peculiar to crude drugs, and the odor worsened under high temperature and high humidity, whereas the Ondi extract and magnesium stearate In all of Examples 8 and 9 in which only Onji is blended as a crude drug, the odor immediately after preparation is improved, the deterioration of the odor over time is suppressed, and the quality is stable. confirmed. On the other hand, in Comparative Examples 11 to 13 in which crystalline cellulose, potato starch, or mannitol was used instead of magnesium stearate, the odor was not improved and the deterioration of the odor was not suppressed.
(6)色差抑制率2
下記の表7〜10に示す組成の通り調製した内服組成物における、40℃、湿度75%RHで10分間保存後の保管前後の色差を求めた。色差および色差抑制率は、前記「色差抑制率1」試験と同様の方法で測定、算出した。なお、実施例10については比較例1の代わりに比較例14を、実施例11については比較例1の代わりに比較例15を、実施例12については比較例1の代わりに比較例16を、実施例13については比較例1の代わりに比較例17を用いた。表7〜10に併せて結果を示す。
(6) Color difference suppression rate 2
The color difference before and after storage after storage at 40 ° C. and 75% RH for 10 minutes in the internal composition prepared according to the compositions shown in Tables 7 to 10 below was determined. The color difference and the color difference suppression rate were measured and calculated by the same method as in the above-mentioned "color difference suppression rate 1" test. In addition, about Example 10, Comparative Example 14 instead of Comparative Example 1, Comparative Example 15 instead of Comparative Example 1 for Example 11, and Comparative Example 16 instead of Comparative Example 1 for Example 12. For Example 13, Comparative Example 17 was used instead of Comparative Example 1. The results are shown in Tables 7 to 10.
上記表7〜表10に示されたように、ステアリン酸マグネシウムを含有しない比較例14〜17に対して、オンジ抽出物とステアリン酸マグネシウムが配合される実施例10〜13のすべてにおいて、高温高湿下での経時的な変色が抑制されており、品質が安定していることが確認された。 As shown in Tables 7 to 10 above, in all of Examples 10 to 13 in which the ondi extract and magnesium stearate are blended, the temperature is high and high, as opposed to Comparative Examples 14 to 17 which do not contain magnesium stearate. It was confirmed that the discoloration over time under wet conditions was suppressed and the quality was stable.
〔製剤例〕
下記の表11〜16に示す材料を用いて、本発明の内服組成物(製剤例1〜28)を調製した。なお、製剤例1〜28の材料としては、オンジ抽出物については、実施例1〜13で用いたもの、およびそれに準じる方法により得られたものを用い、その他の材料は日本薬局方の収載品を用いた。また、表中、錠剤(素錠)とはコーティングされていない錠剤を意味し、錠剤(フィルム)とはフィルムコーティングされた錠剤を意味している。
[Formulation example]
The oral compositions (formulation examples 1-28) of the present invention were prepared using the materials shown in Tables 11 to 16 below. As the material of the pharmaceutical examples 1 to 28, the ondi extract used in Examples 1 to 13 and the material obtained by a method similar thereto are used, and the other materials are listed in the Japanese Pharmacopoeia. Was used. Further, in the table, a tablet (uncoated tablet) means an uncoated tablet, and a tablet (film) means a film-coated tablet.
上記表11〜16に示す製剤例1〜28について、実施例と同様の方法により、固化の有無、においの抑制、においの変化の3項目の評価を行った。その結果、オンジ抽出物とステアリン酸塩とを含有し、生薬としてオンジのみが配合される製剤例1〜28のすべてにおいて、経時的な固化が抑制されており、調製直後のにおいが改善されていた。また、経時的なにおいの悪化が抑制されており、品質が安定していることが確認された。 With respect to the pharmaceutical examples 1 to 28 shown in Tables 11 to 16 above, the presence or absence of solidification, the suppression of odor, and the change in odor were evaluated by the same method as in the examples. As a result, in all of Pharmaceutical Examples 1-28 containing the ondi extract and stearate and containing only ondi as a crude drug, solidification over time was suppressed and the odor immediately after preparation was improved. rice field. In addition, it was confirmed that the deterioration of the odor over time was suppressed and the quality was stable.
本発明は、長期保存性に優れるオンジ単味生薬エキス含有の内服組成物であり、服用により、高齢者の記憶力の改善効果が期待できる。 INDUSTRIAL APPLICABILITY The present invention is an internal composition containing an ondi simple crude drug extract having excellent long-term storage stability, and its administration can be expected to have an effect of improving the memory of the elderly.
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