JP2021038154A - 経口組成物 - Google Patents
経口組成物 Download PDFInfo
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- JP2021038154A JP2021038154A JP2019158917A JP2019158917A JP2021038154A JP 2021038154 A JP2021038154 A JP 2021038154A JP 2019158917 A JP2019158917 A JP 2019158917A JP 2019158917 A JP2019158917 A JP 2019158917A JP 2021038154 A JP2021038154 A JP 2021038154A
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Abstract
Description
項1. (A)松樹皮抽出物、(B)アルギニン源、並びに、(C)ヒハツ及び/又はその抽出物を含む、経口組成物。
項2. 前記(C)成分がヒハツ抽出物である場合、前記(A)成分及び前記(B)成分の総量1重量部に対し、前記(C)成分を乾燥重量換算で0.004重量部以上を含む、項1に記載の経口組成物。
項3. 前記(C)成分がヒハツである場合、前記(A)成分及び前記(B)成分の総量1重量部に対し、前記(C)成分を0.004重量部以上含む、項1に記載の経口組成物。
項4. 固形状製剤である、項1〜3のいずれかに記載の経口組成物。
項5. 前記固形状製剤が素錠である、項4に記載の経口組成物。
項6. (A)松樹皮抽出物及び(B)アルギニン源を含む経口組成物に、(C)ヒハツ及び/又はその抽出物を配合することを含む、経口組成物の不快味臭低減方法。
本発明の経口組成物は、(A)松樹皮抽出物(以下において、「(A)成分」とも記載する)、(B)アルギニン源(以下において、「(B)成分」とも記載する)、及び(C)ヒハツ及び/又はその抽出物(以下において、「(C)成分」とも記載する)を含むことを特徴とする。以下、本発明の経口組成物について詳述する。
本発明の経口組成物は、(A)成分として松樹皮抽出物を含む。松樹皮抽出物はポリフェノール類の一種であるプロアントシアニジンを含んでおり、プロアントシアニジンの抗酸化作用による、血中脂質改善効果、抗高血圧効果、血糖値上昇抑制効果、血管保護効果、ビタミンCの利用効率向上効果、血液流動性改善効果等の効果を有する公知の成分である。
本発明の経口組成物は、(B)成分としてアルギニン源を含む。アルギニン源は、アルギニン、シトルリン、オルニチン、アスパラギン酸、アスパラギン酸塩及び/又はアスパラギン酸ジペプチドからなる群より選択される成分である。
本発明の経口組成物は、(C)成分としてヒハツ及び/又はその抽出物を含有する。(C)成分は、皮膚表面温度回復作用、血行促進作用、むくみ感改善作用等が知られている公知の成分である。
本発明の経口組成物は、前記(A)〜(C)成分の他に、必要に応じて、他の栄養成分や薬理成分を含有していてもよい。このような栄養成分や薬理成分としては、飲食品や医薬品に使用可能なものであれば特に制限されないが、例えば、ビタミンB1、ビタミンB2、ビタミンB6、ビタミンB12、ビタミンC、ビタミンA、ビタミンD、ビタミンE、ビタミンK、ナイアシン、パントテン酸、葉酸、ビオチン、リコペン等のビタミン類;塩酸ベタイン、塩化カルニチン、塩化ベタネコール等の健胃剤;カルシウム、イオウ、マグネシウム、亜鉛、セレン、鉄等のミネラル類;大豆タンパク、卵白粉末、乳清タンパク等のタンパク質;グリシン、アラニン、シスチン、フェニルアラニン、タウリン、トリプトファン、バリン、ロイシン、イソロイシン等の上記(B)成分以外のアミノ酸;リノール酸、γ−リノレン酸、α−リノレン酸、ドコサヘキサエン酸、エイコサペンタエン酸等の脂肪酸類;カラメル色素、クチナシ色素、アントシアニン色素、アナトー色素、パプリカ色素、紅花色素、紅麹色素、フラボノイド色素、コチニール色素、アマランス、エリスロシン、アルラレッドAC、ニューコクシン、フロキシン、ローズベンガル、アシッドレッド、タートラジン、サンセットイエローFCF、ファストグリーンFCF、ブリリアントブルーFCF、インジゴカルミン等の色素;各種フルーツのフレーバーやエッセンス等の香料;クエン酸及びその塩、リンゴ酸及びその塩、酒石酸及びその塩、酢酸及びその塩、乳酸及びその塩、食塩、グルタミン酸及びその塩、みりん、食酢、天然果汁、上記(A)成分及び(C)成分以外の植物抽出エキス、果実・海産物等の裁断物又は粉末化物等の調味剤;アガリクス、シイタケエキス、レイシ、ヤマブシタケ等のキノコ類又はそのエキス;食物繊維、ローヤルゼリー、プロポリス、ハチミツ、コンドロイチン硫酸、グルコサミン、セラミド、ヒアルロン酸等のその他機能性素材等が挙げられる。これらの添加成分は、1種単独で使用してもよく、また2種以上を組み合わせて使用してもよい。また、これらの添加成分の含有量については、使用する添加成分の種類や経口組成物の用途等に応じて適宜設定される。
本発明の経口組成物の製造方法は、上記の前記(A)〜(C)成分と、必要に応じて配合されるその他の成分とを用いて、各種製剤形態及び性状、並びに使用目的に応じ、従来公知の通常の製剤手順に従えばよい。
本発明の経口組成物の製剤形態については、経口投与が可能であれば特に制限されないが、例えば、散剤、細粒剤、顆粒剤、錠剤、トローチ剤、チュアブル剤、カプセル剤(軟カプセル剤、硬カプセル剤)、丸剤等の固形状製剤;ゼリー剤等の半固形状製剤;液剤、懸濁剤、シロップ剤等の液状製剤が挙げられる。これらの製剤形態の中でも、含有成分の安定性や携帯性等の観点から、好ましくは固形状製剤が挙げられる。また、本発明の経口組成物は、優れた不快味臭低減効果を奏するため、甘味料などの公知のマスキング剤を含まない製剤形態、及びコーティングを含まない製剤形態であっても、効果的に不快味低減効果が奏されるため良好な服用感を得ることができる。このような観点から、製剤形態としては、より好ましくは、散剤、細粒剤、顆粒剤、錠剤、カプセル剤、丸剤が挙げられ、さらに好ましくは、散剤、細粒剤、顆粒剤、錠剤が挙げられ、一層好ましくは錠剤が挙げられ、特に好ましくは素錠が挙げられる。
本発明の経口組成物は、(A)成分、(B)成分、及び/又は(C)成分による公知の効果を得る目的で用いることができる。具体的な用途としては、(A)成分に由来する効能を利用した血中脂質改善剤、抗高血圧剤、血糖値上昇抑制剤、血管保護剤、ビタミンCの利用効率向上剤、血液流動性改善剤等;(B)成分に由来する効能を利用した血管拡張剤、血圧上昇抑剤、筋肉合成剤、創傷治癒竿、アンモニア解毒剤、免疫賦活剤、インスリン分泌剤、ポリアミン合成剤;(C)成分に由来する効能を利用した皮膚表面温度回復剤、血行促進剤、むくみ感改善剤等の少なくともいずれかが挙げられる。
本発明の経口組成物の用量については、投与目的、投与対象者の年齢、性別、体質、症状の程度等に応じて適宜設定されるが、例えば、ヒト1人に対して1日当たり、(A)成分及び(B)成分の総量で300〜1700mg、好ましくは700〜1200mgとなる量で、1日1〜3回、好ましくは2又は3回の頻度で服用することができる。
前述するように、ヒハツ及び/又はその抽出物は、松樹皮抽出物とアルギニン源との両方が配合された極めて強い不快味臭を呈する経口組成物において、当該不快味臭を効果的に低減することができる。従って、本発明は、(A)松樹皮抽出物及び(B)アルギニン源を含む経口組成物に、(C)ヒハツ及び/又はその抽出物を配合することを含む、経口組成物の不快味臭低減方法も提供する。
1.経口組成物の調製
表1の組成を有する経口組成物の散剤を調製した。表1で用いられた各成分の詳細は以下の通りである。
・松樹皮抽出物:フランス松樹皮抽出物Pycnogenol(登録商標)、濃縮率1000倍
・アルギニン源:L−アルギニン
・ヒハツ抽出物:ヒハツ丸善製薬株式会社製「ヒハツエキスパウダーMF」;ヒハツ果穂の水抽出物とデキストリンの混合製剤(混合製剤重量=原生薬換算量)
調製した粉末状製剤240mgを水なしでモニター(訓練された呈味パネラー)が服用し、呈味を評価した。呈味の評価は以下の基準に基づいて行った。結果を表1に示す。
××:苦味があり、木の風味のような不快な臭い及び味が強く、非常に不快な味及び臭いを感じる。
×:苦味があり、木の風味のような不快な臭い及び味がし、不快な味及び臭いを感じる。
△:苦味はあるが、木の風味のような不快な臭い及び味が軽減されており、服用には耐えられる。
○:苦味及び木の風味のような不快な臭い及び味が軽減されており、あまり不快な味及び臭いを感じない。
◎:苦味及び木のような不快な臭い及び味をほとんど感じず、不快な味及び臭いを感じない。
表2に示す組成の経口組成物の素錠を調製した。表2で用いられた松樹皮抽出物、アルギニン源、及びヒハツ抽出物の詳細は、試験例1と同様である。調製した経口組成物の素錠を女性モニター10人が服用し、呈味を評価した。具体的には、表3に示す5段階の判定指標で評価した。結果を表3に示す。
表4及び表5に記載の処方の経口組成物の散剤(1日量)、及び表6に記載の処方の経口組成物の素錠(16錠、1日量)を調製した。表4〜表6で用いられた松樹皮抽出物、アルギニン源、及びヒハツ抽出物の詳細は、試験例1と同様である。いずれの経口組成物も、不快味臭が低減されていた。
Claims (6)
- (A)松樹皮抽出物、(B)アルギニン源、並びに、(C)ヒハツ及び/又はその抽出物を含む、経口組成物。
- 前記(C)成分がヒハツ抽出物である場合、前記(A)成分及び前記(B)成分の総量1重量部に対し、前記(C)成分を原生薬換算で0.004重量部以上を含む、請求項1に記載の経口組成物。
- 前記(C)成分がヒハツである場合、前記(A)成分及び前記(B)成分の総量1重量部に対し、前記(C)成分を0.004重量部以上含む、請求項1に記載の経口組成物。
- 固形状製剤である、請求項1〜3のいずれかに記載の経口組成物。
- 前記固形状製剤が素錠である、請求項4に記載の経口組成物。
- (A)松樹皮抽出物及び(B)アルギニン源を含む経口組成物に、(C)ヒハツ及び/又はその抽出物を配合することを含む、経口組成物の不快味臭低減方法。
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