JP5819951B2 - セクシャルウェルネスを改善するための組成物 - Google Patents
セクシャルウェルネスを改善するための組成物 Download PDFInfo
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- JP5819951B2 JP5819951B2 JP2013516025A JP2013516025A JP5819951B2 JP 5819951 B2 JP5819951 B2 JP 5819951B2 JP 2013516025 A JP2013516025 A JP 2013516025A JP 2013516025 A JP2013516025 A JP 2013516025A JP 5819951 B2 JP5819951 B2 JP 5819951B2
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- 238000003809 water extraction Methods 0.000 description 1
- 230000037221 weight management Effects 0.000 description 1
- 230000036642 wellbeing Effects 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- 239000002023 wood Substances 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical class [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/738—Rosa (rose)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/49—Fagaceae (Beech family), e.g. oak or chestnut
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
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- Natural Medicines & Medicinal Plants (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
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- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Mycology (AREA)
- Botany (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Alternative & Traditional Medicine (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Medicines Containing Plant Substances (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Description
−プロアントシアニジン源と、
−アルギニン源と、
−ローズヒップおよび/もしくはその抽出物またはQuercus roburおよび/もしくはその抽出物あるいはそれらの混合物と、好適な賦形剤
との組み合わせで存在する。
(目的:Prelox(登録商標)Ladyの単一施設ランダム化プラセボ対照研究は、40〜50歳の閉経前の女性において情動的身体的健康および性機能に影響する)
40〜50歳の合計80人の女性をこの研究に登録した。乱数発生器を使用して、参加者を2つの等しい群(各々40人を含む)にランダム化した。群Aの患者をPrelox(登録商標)Ladyで処置し、群Bの患者にはプラセボを投与した。
すべての統計的検定を、SPSS17.0.1.コンピュータソフトウェアによって行った。0.05の確率が、帰無仮説を棄却し、有意であるとみなされた。以下の統計学的方法を用いた:
1.記述的解析
2.グラフ解析
3.変量解析
4.分布のタイプに対するシャピロ・ウイルク検定
5.2つの独立したサンプルに対するスチューデントのt検定
6.2つの独立したサンプルに対するノンパラメトリックマン・ホイットニー検定
7.反復測定ANOVA
8.2つの従属サンプルに対するスチューデントのt検定
9.いくつかの従属サンプルに対するノンパラメトリックフリードマン検定
10.2つの従属サンプルに対するノンパラメトリックウィルコクソン検定
全参加者の平均年齢は、45,41±2,37歳(40〜50歳の範囲)だった。表1に記載されるように、処置を受けた患者およびコントロールは、年齢について調整され、身長および体重に有意差はなかった。群Bに比べて群Aの女性は、有意に低いBMIスコア、ならびに収縮期血圧および拡張期血圧(SBPおよびDBP)の高い値を有したことに注目すべきである。それにもかかわらず、これらの測定値を絶対値とみなすと、2群間の差は、それほど明らかでなかった。
プラセボ群の女性は、治療に対して、処置群の女性よりも低い応答パーセントを有した。興味深いことに、プラセボの投与によって最も影響された症状は、疼痛だった。性的興奮および性的欲求の領域は、群Bにおいて最も小さくしか改善されなかった。群Aにおける処置は、オルガスムおよび満足のパラメータに対して最も正の影響を有した一方で、性的欲求および疼痛は、最も小さくしか影響されなかった。
本発明者らの知見は、両群の女性で最も多い愁訴は、のぼせ、寝汗、睡眠障害および短気であることを示した。これらは、処置群だけで改善された症状でもある。総スコアによると、更年期症状の緩和は、群Aにおいてより著しかった。群Bで報告された症状の重症度は、検査の全期間にわたって永続的なレベルを維持したが、処置群の参加者は、症状の著しい改善を経験し、それは、本研究が終わる前には十分に明らかだった。血圧、BMI、脂質プロファイルおよびTACが、群Aにおいて有意に改善された。Prelox(登録商標)Ladyを投与した後、ヘモグロビン濃度、赤血球、Hct、血小板、プロラクチンエストラジオールおよびテストステロンの有意な増加、ならびに白血球、空腹時血糖およびFSHの減少が観察された。LHおよびプロゲステロンレベルだけが、変化しないままだった。さらに、更年期症状をWomen’s Health Questionnaire(WHQ)によって評価した。観察期間(来診2および3)において、まったくすべてのWHQ症状が、群Bと比べて群Aにおいてより著しく低く評定された。Prelox(登録商標)Ladyは、集中力、不安/恐怖および身体症状の改善に対して有意な効果を有したが、うつを阻止しなかった。また、プラセボ群においてそれほど減少しなかった症状のうちの1つが、抑うつ気分だった。興味深いことに、プラセボの投与によって最も影響された症状は、自分が感じる魅力だった。Female Sexual Function Index(FSFI)を用いて、女性の性機能を評価した。1つの興味深い現象が明確になり、すなわち、疼痛は、真の医薬よってそれほど軽減されない領域であり、プラセボの投与によって最も影響される領域だった。群Aにおける処置は、オルガスムおよび満足のパラメータに対して最も正の影響を有した一方で、性的欲求および疼痛は、最も小さくしか影響されなかった。
本研究の目的は、健常な血行を有する閉経後女性における性機能障害(SD)を改善するため/制御するためのPrelox Lady(登録商標)の有効性を評価することだった。
方法:Prelox Lady(登録商標)群とコントロール群とは、Female Sexual Function Index(FSFI)スコアに関して参加時に同程度であり、それぞれ36人の女性(50.1±3.1歳)および39人の女性(51.2±2.3歳)を含んだ。
結論:本研究は、性機能の問題に苦しむ女性に対して興味深い見通しを開き、有望な新しい処置の選択肢を提案する。より多くの研究が必要であり、閉経前および閉経期前後の女性も調査されるべきである。
本研究には、45〜55歳の範囲の年齢の健常な閉経後女性が含められた。最近のプロトコルに従って、使用した評価方法は、女性の性機能を評価するための多次元尺度の検証済みの質問票(表16)であるFSFIだった。SDを有する正常な女性を、心臓血管の問題について予めスクリーニングされた健常女性に対する規定のスクリーニングプログラムを用いて評価した。
登録の目的は、80人の女性の群(その半数が、活性なPrelox Lady(登録商標)を少なくとも8週間使用した)からのデータを解析することだった。その結果を、分散分析(ボンフェローニの補正を行うANOVA)およびノンパラメトリックのマンホイットニーのU検定を用いて評価した。
FSFIスコアシステムの最初の評価では、主成分分析(main component analysis)(バリマックス回転を用いる)を、その質問票の因子構造を調査するために行った。FSFI項目は、1つの因子に対する高い/中等度の負荷量、低い因子間負荷量(crossfactor loading)、高い/中等度の試験・再試験信頼性およびFSADとコントロールサンプルとの良好な識別の中から、項目包含に対する統計的基準に基づいて選択された。本研究の基礎であるRosenの原報では、項目が、予測形式で大まかにクラスター化され、相対的に高い因子負荷量を有したことから、この最終的な質問票の全体的な因子妥当性が裏付けられた。それらの項目は、バランスがとれたものであり、種々の社会的環境において使用され得る。しかしながら、地域文化的変動および集団因子が、なおも予測不可能な値を有し得る。
結果:
FSFI質問票は、女性における性機能の重要な範囲を評価するために、自己申告式の多次元の道具として開発された。この質問票は、心理測定的に妥当であると考えられている;完成させやすく、SDを有する臨床集団および非臨床集団にとって価値があると示されている。この質問票は、いくつかの臨床試験または疫学的研究において、女性の性機能および生活の質の評価について確証されている。閉経後女性では、膣の灌流ならびに子宮頸部および膣の粘液の産生の変化が、性機能障害において重要な因子であり得る。これは、しばしば腟乾燥を訴える糖尿病の女性においてより明らかである。本研究の処置群では、粘膜の乾燥が改善され、おそらくそれにより、自然な***が促される。ヒトの子宮頸部/膣の粘液由来の粘液性グリコール−タンパク質(ムチン)は、いくつかの高分子(すなわち、セリン、トレオニン、プロリン、糖、例えば、N−アセチルグルコサミン、N−アセチルガラクトサミン、ガラクトース、シアル酸およびフルクトース)を含む。この組成は、閉経後の特に糖尿病の女性において大きく変化し得る。粘液産生を伴う刺激に対する応答は、変化し得るかまたは遅延し得、粘膜の表面をより乾燥させ得る。これにより、***中の問題点が大きくなり得、また、女性が無症候性感染に曝され得る。糖尿病の女性における微小循環の変化が、報告されており、定量化されている。これらの重要な変化(血管運動反応の変化を含む)は、女性における性機能障害と強い関連があり得る可能性がある。しかしながら、糖尿病でない女性においても、粘膜の加齢とホルモンレベルの低下との複合効果が、かなり低いレベルの徴候および症状をもたらし得る。性機能障害は、女性にとってよくある問題であるが、めったに報告されないし、議論されない。いくつかの生理学的作用が関わり、非常に重要な心理学的要素が存在する。女性のSDに対する薬学的処置は、現時点では利用可能でない。閉経後女性におけるSDをシルデナフィルで処置する試みは、有効でなかった。また、ホルモン処置は、重大な副作用を引き起こし得る。本研究は、Prelox Lady(登録商標)を用いることにより、不快感および疼痛の減少とともに乾燥の有意な改善を得ることができることを示唆する。これは順に、***の頻度の上昇およびより満足できる関係性に関係し得る。これらの観察結果は、閉経前および閉経期の女性で現在進行中のPrelox Lady(登録商標)を用いたより大きな研究において確証される可能性がある。
FSFI質問票(Rosen’s Female Sexual Function Index)
性的欲求または性的関心は、性体験をもちたいことを含む感覚、パートナーによる性行為の開始を受け入れる感覚、および***することについて考えることまたは空想することである。
1.どのくらいの頻度で性的欲求または性的関心を感じましたか?
ほぼ常にまたは常に
かなり頻繁に(半分より多く)
時々(半分くらい)
何回か(半分より少なく)
ほとんどないまたはない
2.あなたの性的欲求または性的関心のレベル(程度)はどれくらいでしたか?
非常に高い
高い
中程度
低い
非常に低いまたはまったくない
性的興奮は、身体的および精神的な局面の性的興奮を含む。それは、生殖器の温感または刺痛の感覚、潤滑(濡れ)または筋収縮を含み得る。
3.どのくらいの頻度で性行為中または***中に性的興奮(「性的興味」)を感じましたか?
性行為なし
ほぼ常にまたは常に
かなり頻繁に(半分より多く)
時々(半分くらい)
何回か(半分より少なく)
ほとんどないまたはまったくない
4.性行為中または***中のあなたの性的興奮(「性的興味」)のレベルはどれくらいでしたか?
性行為なし
非常に高い
高い
中程度
低い
非常に低いまたはまったくない
5.どれくらい確信を持って性行為中または***中に性的に興奮したといえますか?
性行為なし
非常に高い確信
高い確信
中程度の確信
低い確信
非常に低い確信または確信なし
6.どのくらいの頻度で性行為中または***中の性的興奮(刺激)に満足しましたか?
性行為なし
ほぼ常にまたは常に
かなり頻繁に(半分より多く)
時々(半分くらい)
何回か(半分より少なく)
ほとんどないまたはまったくない
7.どのくらいの頻度で性行為中または***中に潤い(「濡れ」)ましたか?
性行為なし
ほぼ常にまたは常に
かなり頻繁に(半分より多く)
時々(半分くらい)
何回か(半分より少なく)
ほとんどないまたはまったくない
8.性行為中または***中に潤う(「濡れる」)のはどれくらい難しかったですか?
性行為なし
極度に困難または不可能
非常に困難
困難
わずかに困難
困難ではなかった
9.どのくらいの頻度で性行為または***が終わるまで潤い(「濡れ」)を維持しましたか?
性行為なし
ほぼ常にまたは常に
かなり頻繁に(半分より多く)
時々(半分くらい)
何回か(半分より少なく)
ほとんどないまたはまったくない
10.性行為または***が終わるまで潤い(「濡れ」)を維持するのはどれくらい難しかったですか?
性行為なし
極度に困難または不可能
非常に困難
困難
わずかに困難
困難ではなかった
11.性的刺激または***があったとき、どれくらいの頻度でオルガスム(絶頂)に達しましたか?
性行為なし
ほぼ常にまたは常に
かなり頻繁に(半分より多く)
時々(半分くらい)
何回か(半分より少なく)
ほとんどないまたはまったくない
12.性的刺激または***があったとき、オルガスム(絶頂)に達するのはどれくらい難しかったですか?
性行為なし
極度に困難または不可能
非常に困難
困難
わずかに困難
困難ではなかった
13.性行為中または***中にオルガスム(絶頂)に達することができることにどれくらい満足しましたか?
性行為なし
非常に満足した
中程度に満足した
満足と不満足がほぼ等しい
中程度に不満足
非常に不満足
14.性行為中のあなたとパートナーとの間の心理的一体感にどれくらい満足しましたか?
性行為なし
非常に満足した
中程度に満足した
満足と不満足がほぼ等しい
中程度に不満足
非常に不満足
15.パートナーとの性的関係性にどれくらい満足しましたか?
非常に満足した
中程度に満足した
満足と不満足がほぼ等しい
中程度に不満足
非常に不満足
16.性生活全体にどれくらい満足しましたか?
非常に満足した
中程度に満足した
満足と不満足がほぼ等しい
中程度に不満足
非常に不満足
17.どのくらいの頻度で膣への挿入中に不快感または疼痛を感じましたか?
***を試みなかった
ほぼ常にまたは常に
かなり頻繁に(半分より多く)
時々(半分くらい)
何回か(半分より少なく)
ほとんどないまたはまったくない
18.どのくらいの頻度で膣への挿入後に不快感または疼痛を感じましたか?
***を試みなかった
ほぼ常にまたは常に
かなり頻繁に(半分より多く)
時々(半分くらい)
何回か(半分より少なく)
ほとんどないまたはまったくない
19.膣への挿入中または挿入後の不快感または疼痛のレベル(程度)はどれくらいでしたか?
***を試みなかった
非常に高い
高い
中程度
低い
非常に低いまたはまったくない
性的欲求 1.2〜6
性的興奮 0〜6
潤滑 0〜6
満足 0.8〜6
疼痛 0〜6
5つすべての領域について最高6点のうち4点未満のスコアを示した全年齢の成人女性を調査した。その調査は、表に詳述されるような介入に対する、処置の4週間後の反応者(5つすべての領域について4点以上のスコアを有する)の数を表す。
Rosen R,Brown C,Heiman J,Leiblum S,Meston C,Shabsigh R,Ferguson D,D’Agostino R Jr.The Female Sexual Function Index(FSFI):a multidimensional self−report instrument for the assessment of female sexual function.J Sex Marital Ther 26:191−208,2000.
スコア 解釈
0〜6 重篤な機能不全
7〜12 中等度の機能不全
13〜18 軽度から中等度の機能不全
19〜24 軽度の機能不全
25〜30 機能不全なし
上に説明されたような改善の応答をした男性。
Claims (12)
- マツの樹皮、ブドウの種子、ラズベリー、スグリ(クロスグリ)、ブルーベリー、チャ、カカオノキの抽出物またはそれらの組み合わせから選択されるプロアントシアニジン類含有植物抽出物源と、
アルギニン源であって、該アルギニン源が、アルギニンまたはシトルリンである、アルギニン源と、
ヨーロッパナラおよび/もしくはその抽出物と、好適な賦形剤
との組み合わせで存在する、男女の性的適応度もしくはセクシャルウェルネス、または性的増強の改善において使用するための、調製物。 - マツの樹皮、ブドウの種子、ラズベリー、スグリ(クロスグリ)、ブルーベリー、チャ、カカオノキの抽出物またはそれらの組み合わせから選択されるプロアントシアニジン類含有植物抽出物源と、
アルギニン源であって、該アルギニン源が、アルギニンまたはシトルリンである、アルギニン源と、
ヨーロッパナラおよび/もしくはその抽出物と、好適な賦形剤
との組み合わせで存在する、男女の性機能障害の処置または予防において使用するための、調製物。 - さらに、ローズヒップおよび/またはその抽出物を含む、請求項1または2記載の使用のための調製物。
- 前記アルギニン源が、アスパラギン酸アルギニンである、請求項1〜3のいずれかに記載の使用のための調製物。
- 前記植物抽出物が、マツの樹皮を起源とする、請求項1〜4のいずれかに記載の使用のための調製物。
- 前記マツの樹皮が、フランスカイガンショウの樹皮を起源とする、請求項5記載の使用のための調製物。
- ローズヒップおよび/またはその抽出物が、カロテノイド類、トコフェロール類、トコトリエノール類、ビタミンC、ポリフェノール類、およびモノ−またはジ−またはトリアシルグリセロール化合物のグリコシド類を含む、請求項3記載の使用のための調製物。
- ローズヒップおよび/またはその抽出物が、ロサカニーナからなる、請求項3記載の使用のための調製物。
- 前記好適な賦形剤が、薬学的に許容可能な賦形剤である、請求項1〜8のいずれかに記載の使用のための調製物。
- 食品調製物、食事性補給物、栄養補助食品または飲料の形態にある、請求項1〜9のいずれかに記載の使用のための調製物。
- 医薬としての、請求項1〜9のいずれかに記載の使用のための調製物。
- 前記調製物が、1日あたり5mg〜1日あたり2000mgの投与量で投与されることを特徴とする、請求項1〜11のいずれかに記載の使用のための調製物。
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PCT/IB2011/052788 WO2011161655A1 (en) | 2010-06-25 | 2011-06-24 | Composition for improving sexual wellness |
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CN103392853B (zh) * | 2013-07-08 | 2014-12-24 | 广西壮族自治区农业科学院蔬菜研究所 | 一种***保健芥蓝茶及其制备方法 |
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