JP5661994B2 - Composition or internal preparation with anti-stress / fatigue prevention, skin texture improvement or wrinkle improvement / prevention effect - Google Patents

Composition or internal preparation with anti-stress / fatigue prevention, skin texture improvement or wrinkle improvement / prevention effect Download PDF

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JP5661994B2
JP5661994B2 JP2008223166A JP2008223166A JP5661994B2 JP 5661994 B2 JP5661994 B2 JP 5661994B2 JP 2008223166 A JP2008223166 A JP 2008223166A JP 2008223166 A JP2008223166 A JP 2008223166A JP 5661994 B2 JP5661994 B2 JP 5661994B2
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fatigue
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与茂田 敏
敏 与茂田
弘美 小菅
弘美 小菅
日奈 藤田
日奈 藤田
基 樋浦
基 樋浦
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Kracie Pharma Ltd
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Description

本発明は、抗ストレス機能や疲労防止機能を有し、更に外的又は内的要因に起因する肌トラブルや肌老化を抑制して肌のキメ改善又はシワの予防・改善に効果がある、漢方処方に関するものである。   The present invention has an anti-stress function and fatigue prevention function, and is effective in improving skin texture or preventing or improving wrinkles by suppressing skin troubles and skin aging caused by external or internal factors. It is about prescription.

ストレスがさまざまな不調や病気を引き起こす要因になっていることが分かってきたことから、最近の医学では、精神的な要素を重視して、心身両面から健康状態をとらえる医療が注目されている。特に、女性の身体は月経周期的でデリケートなホルモンバランスの上で成り立っており、ストレスの影響を受けやすい。
そのため、疲労感を感じたり、肌トラブルを生じたりして、QOLを妨げ快適な生活に対する影響が大きい。
Since it has been found that stress is a cause of various malfunctions and diseases, in recent medicine, medical care that focuses on mental and physical health by focusing on mental elements has attracted attention. In particular, the female body is based on a menstrual cycle and a delicate hormonal balance, and is susceptible to stress.
For this reason, a feeling of fatigue or a skin trouble is caused, and the influence on the comfortable life is disturbed by preventing QOL.

ストレスを受ければ自律神経系の交感神経の興奮により、血圧と心拍数を上昇させ、胃腸・腎臓・皮膚への血流量を減少させ、骨格筋への血液供給量を増やす。
それに対して副交感神経は、体を休ませ体力を回復し、新たなエネルギーを獲得するために、心拍と血圧を下げて、皮膚と胃腸への血液を増やし、瞳孔と細気管支を収縮させて、唾液腺分泌を刺激して、消化器官の蠕動を活発にする。全身のほとんどの器官は交感神経と副交感神経両方の支配を受け、二つの神経系がバランス良く働くことで適正に保たれているが、交感神経と副交感神経のバランスが崩れると疲労感や多汗などの全身症状が現れる。
When stressed, the sympathetic excitement of the autonomic nervous system increases blood pressure and heart rate, decreases blood flow to the gastrointestinal tract, kidneys and skin, and increases blood supply to skeletal muscle.
The parasympathetic nerve, on the other hand, rests the body, restores physical strength, acquires new energy, lowers heart rate and blood pressure, increases blood to the skin and gastrointestinal tract, contracts the pupil and bronchioles, Stimulates salivary gland secretion and activates peristalsis of the digestive tract. Most organs in the whole body are controlled by both sympathetic and parasympathetic nerves, and the two nervous systems work well in balance, but when the sympathetic and parasympathetic nerves are unbalanced, fatigue and sweating Systemic symptoms such as appear.

また、疲労とは、一般に「過度の肉体的または精神的活動により生じた特有の病的不快感と、休養を求める欲求を伴う身体または精神機能の減退状態」と定義され、肉体的疲労、精神的疲労、慢性疲労性症候群が挙げられる。その中、近年、精神的疲労を自覚する人が急増しているため、その原因解明とともに、予防方法及び治療方法の開発が求められている。また、慢性疲労性症候群は、健康に生活していた人が感冒などを引き金にして、それ以降激しい疲労感、微熱、頭痛、筋肉痛、脱力感、抑うつなどの症状を長期間にわたって訴え、健全な生活ができなくなるという疾患で、その原因は全く解明されていない。   Fatigue is generally defined as “a specific pathological discomfort caused by excessive physical or mental activity and a state of reduced physical or mental function with the desire to rest.” Fatigue and chronic fatigue syndrome. Among them, in recent years, the number of people who are conscious of mental fatigue is increasing rapidly, and the development of preventive and therapeutic methods is required along with elucidating the causes. In addition, chronic fatigue syndrome is triggered by a person living in a healthy manner, and the symptoms such as intense fatigue, slight fever, headache, muscle pain, weakness, depression, etc. are reported over a long period of time. It is a disease that makes life impossible, and its cause has not been elucidated at all.

ストレスが及ぼす皮膚への影響に関しては、ストレスがざ瘡(ニキビ)発症悪化に関係することやアトピー性皮膚炎の要因の一つであることが経験的に指摘されており、また円形脱毛症や慢性蕁麻疹などの皮膚疾患とストレスとの関連が知られている。   Regarding the effect of stress on the skin, it has been empirically pointed out that stress is related to the worsening of acne onset and one of the causes of atopic dermatitis. The relationship between stress and skin diseases such as chronic urticaria is known.

また、皮膚は体全体を被っているものであり、外界からさまざまな刺激を受けている。そのため、皮膚の最も重要な機能はバリアー機能であることは言うまでもない。しかし、紫外線や乾燥などの外的要因、加齢などの内的要因によって皮膚は痛めつけられており、そのダメージ蓄積によって確実に疲労し老化していくのである。肌の老化は、皮膚のキメが粗くなり、ハリがなくなってシワが増え、皮膚の黄色化や色素沈着などが進む。また、女性では月経に伴うホルモンバランスの乱れにより肌の状態が変化し、月経トラブルの有訴者ではニキビ、色素沈着のような肌トラブルを引き起こすことが多い。   The skin covers the entire body and receives various stimuli from the outside world. Therefore, it goes without saying that the most important function of the skin is the barrier function. However, the skin is hurt by external factors such as ultraviolet rays and dryness, and internal factors such as aging, and the accumulated damage will surely fatigue and age. Skin aging results in rough skin, no firmness, increased wrinkles, yellowing of the skin and pigmentation. In addition, in women, the state of the skin changes due to disturbance of hormone balance accompanying menstruation, and in many cases, complainants of menstrual troubles cause skin troubles such as acne and pigmentation.

肌の表面には、皮溝といわれる網目状に走っている細い溝があり、その間に、これに囲まれた大小の四角形、菱形、多角形などの扁平に高まっている部分があり、これを皮丘とよぶ。皮溝が細かく浅い溝からできていて、皮丘も全体として滑らかな表面をつくっているとき、キメの細かい肌という。それに対して、皮溝が深く、広くなって目立ち、皮丘も
個々かたまりが目立っているものは、キメの粗い肌という。小児、若い女性の肌に前者が多く、中年以降の人に後者が多い。また、外界の刺激を多く受けている人ほど、キメの粗い肌が多い。
On the surface of the skin, there are thin grooves running in a mesh shape called skin grooves, and there are large and small squares, rhombuses, polygons, etc. surrounded by this, It is called a barn. When the skin groove is made of fine and shallow grooves, and the skin mound also has a smooth surface as a whole, it is called fine skin. On the other hand, the skin with deep and wide skin grooves and conspicuous clumps is called rough skin. The former is more common in the skin of children and young women, and the latter is more common in people after middle age. In addition, the more the skin is exposed, the more rough the skin.

加齢とともに、肌のキメの細かさがなくなり、シワが増えることは自然の摂理であるが、美容上の問題として、皮膚の老化を防ぎ、いつまでも若い肌でありたいという願望もまた自然である。しかし、このような外観上の問題だけでなく、肌のキメが粗い状態を放置すると、皮膚の機能低下を招き、本来のバリアー機能にまで影響を及ぼすことにもなり、生命維持上重要な機能までダメージを与えることになる。   It is a natural providence that the fineness of the skin disappears and wrinkles increase with aging, but as a cosmetic problem, the desire to prevent skin aging and remain young forever is also natural. . However, in addition to such appearance problems, leaving the texture of the skin rough will cause the skin's function to deteriorate and even affect the original barrier function. Will cause damage.

このような肌のキメやシワを改善して肌の衰えという問題を解決するため、化粧品や食品などの形態で多くの技術が開発されてきた。例えば、スキンケア化粧料を使用して、外的要因に起因する肌荒れを抑え肌のキメを整える場合、その化粧料には肌表皮の新陳代謝の促進に有効な成分、角質層の保護に有効な成分、ヒアルロン酸やコラーゲンの合成を促進する成分や抗酸化剤などが提案されている。このような観点からは、新陳代謝を促進するリノレン酸を安定的に配合した抗老化剤(特許文献1)、ソルビトール及び/又はマンニトールとグリセリン及び/又はジグリセリンを配合したキメ改善化粧料(特許文献2)、皮膚浸透指数が2以上であることを特徴とする油性成分を配合したキメ改善化粧料(特許文献3)、オレイン酸エチルを配合したキメを整える効果に優れた化粧料(特許文献4)、ノニル酸バニリルアミドを含有したキメ、シワやたるみを改善する皮膚外用剤(特許文献5)などが開示されている。   Many techniques have been developed in the form of cosmetics and foods in order to solve the problem of skin deterioration by improving the texture and wrinkles of the skin. For example, when skin care cosmetics are used to suppress rough skin caused by external factors and prepare skin texture, the cosmetics contain ingredients that are effective in promoting metabolism of the skin epidermis and ingredients that are effective in protecting the stratum corneum. In addition, components that promote the synthesis of hyaluronic acid and collagen, antioxidants, and the like have been proposed. From such a point of view, an anti-aging agent that stably contains linolenic acid that promotes metabolism (Patent Document 1), and a texture-improving cosmetic that contains sorbitol and / or mannitol and glycerin and / or diglycerin (Patent Document) 2), a texture-improving cosmetic composition containing an oily component characterized by having a skin penetration index of 2 or more (Patent Document 3), and a cosmetic composition excellent in the effect of preparing a texture containing ethyl oleate (Patent Document 4) ), Skin texture containing nonyl acid vanillylamide, a skin external preparation for improving wrinkles and sagging (Patent Document 5), and the like.

食品としては、肌のキメを細かくする米抽出物よりなる美容飲料(特許文献6)、肌の老化によるシワ、たるみ、くすみ、キメの変化を防止するため2種類のムコ多糖とコラーゲンなどとコエンザイムQ10とを有効成分として配合した経口用皮膚老化予防・改善剤(特許文献7)、レチノイド関連オーファン受容体(ROR)活性化剤を含有する老化防止用組成物(特許文献8)などが開示されている。   As foods, beauty drinks made of rice extract that refines skin texture (Patent Document 6), wrinkles, sagging, dullness, and texture due to skin aging, 2 kinds of mucopolysaccharides and collagen, and coenzyme An oral skin aging preventive / improving agent containing Q10 as an active ingredient (Patent Document 7), an anti-aging composition containing a retinoid-related orphan receptor (ROR) activator (Patent Document 8), and the like are disclosed. Has been.

しかしながら、従来の方法では肌のキメ改善効果において十分に満足するものといえず、紫外線や乾燥などの外的要因、加齢などの内的要因に起因する肌トラブルや肌老化を抑制し、さらには粗くなった肌のキメ改善剤、又はシワ予防若しくはシワ改善剤が求められていた。   However, it cannot be said that the conventional method is sufficiently satisfied with the skin texture improvement effect, and it suppresses skin troubles and skin aging caused by external factors such as ultraviolet rays and drying, and internal factors such as aging, There has been a demand for an agent for improving the texture of rough skin, or an agent for preventing or improving wrinkles.

また、シワの改善目的で、コラーゲン産生促進剤(特許文献9)やヒアルロン酸産生促進剤(特許文献10)などが開示されており、それぞれ桂皮エキスや芍薬エキスなどが有効とされているが、これらは対症療法的な手段であり、根本的な解決にならない。   Further, for the purpose of improving wrinkles, collagen production promoters (Patent Document 9) and hyaluronic acid production promoters (Patent Document 10) have been disclosed, and cinnamon extract and glaze extract are each effective. These are symptomatic measures and do not provide a fundamental solution.

シワ防止のその他の提案として、血管内皮細胞の新生阻害による抗老化剤(特許文献11)としてヨクイニンエキスなどが開示されており、微小循環不全に起因する肌荒れの改善を目的としたヨクイニンのような生薬類を含有するストレス緩和用の経口投与組成物(特許文献12)が開示されているが、シワ防止効果との関連は明確でなく、十分な効果が得られるとは言い難い。   As another proposal for preventing wrinkles, Yokuinin extract and the like have been disclosed as an anti-aging agent (Patent Document 11) by inhibiting neovascularization of vascular endothelial cells, such as Yokuinin for the purpose of improving rough skin caused by microcirculatory failure. Although an oral administration composition for stress relief containing herbal medicines (Patent Document 12) has been disclosed, the relationship with the wrinkle prevention effect is not clear, and it cannot be said that sufficient effects are obtained.

一方、ストレスが原因の種々トラブルに関し、茯苓のような菌類のエッセンスを含有する生体環境快適化組成物(特許文献13)、免疫が低下するようなアポトーシスに対して、桂枝茯苓丸他いくつかの漢方薬を有効成分として含有するアポトーシス抑制剤(特許文献14)、冠元顆粒を有効成分として含有する老化抑制剤及び酸化ストレス抑制剤(特許文献15)が開示されているが、いずれもストレスが原因で生じた生体側の機能低下を改善するものであり、ストレスそのものを根本的に取り除くまでには至っていない。   On the other hand, regarding various troubles caused by stress, biocomfort-enhancing composition containing the essence of fungi such as spider (Patent Document 13) An anti-apoptotic agent containing Japanese herbal medicine as an active ingredient (Patent Document 14), an aging inhibitor containing an anti-progenitor granule as an active ingredient, and an oxidative stress inhibitor (Patent Document 15) are both disclosed. It is intended to improve the deterioration of the function on the living body caused by the cause, and has not yet completely removed the stress itself.

疲労倦怠感に対しては、八味地黄丸や人参栄養湯などの漢方薬がよく知られているが、漢方薬以外に、桂皮、芍薬、茯苓のような生薬類にビタミンやアミノ酸などを組み合わせた新規な疲労改善用の内服剤(特許文献16及び17)が提案されている。ここで生薬類を用いているのは、ビタミンとアミノ酸とによる疲労回復効果を促進するために過ぎないことが示唆され、生薬自体の疲労防止効果は示されていない。   For fatigue fatigue, Chinese medicines such as Hachimijiogan and Ginseng Nutrition are well known, but in addition to herbal medicines, new medicines that combine vitamins, amino acids, etc. with herbal medicines such as cinnamon, glaze, and salmon An internal preparation for improving fatigue (Patent Documents 16 and 17) has been proposed. Here, it is suggested that the use of crude drugs is only to promote the fatigue recovery effect by vitamins and amino acids, and the fatigue prevention effect of the crude drug itself is not shown.

以上のように、従来の方法ではストレスや疲労を根治するものではなく、ストレスや疲労が原因として現われた症状を対症的に改善するものであり、ストレスや疲労の根本治療を期待するには十分に満足するものといえなかった。 As described above, conventional methods do not cure stress and fatigue, but symptomatically improve symptoms caused by stress and fatigue, and are sufficient to expect fundamental treatment for stress and fatigue. Could not be said to be satisfied.

特開2002−80370号公報JP 2002-80370 A 特開2004−51545号公報JP 2004-51545 A 特開2004−51539号公報JP 2004-51539 A 特開2006−273807号公報JP 2006-273807 A 特開2007−261964号公報JP 2007-261964 A 特開2005−177号公報JP-A-2005-177 特開2006−143671号公報JP 2006-143671 A 特開2007−238463号公報JP 2007-238463 A 特開2008−105984号公報JP 2008-105984 A 特開2008−105985号公報JP 2008-105985 A 再公表WO2003/084302号公報Republished WO2003 / 084302 特開2004−83449号公報JP 2004-83449 A 特開2000−119126号公報JP 2000-119126 A 特開平9−30983号公報JP-A-9-30983 特開2006−28155号公報JP 2006-28155 A 特開2007−161675号公報JP 2007-161675 A 特開2007−277207号公報JP 2007-277207 A

本発明は、「抗ストレス・疲労防止作用」を有し、また「肌のキメ改善」「シワの予防又は改善」の効果に優れた組成物又は内服剤を提供することにある。
An object of the present invention is to provide a composition or an internal preparation having an “anti-stress / fatigue-preventing action” and having an excellent effect of “improvement of skin texture” and “prevention or improvement of wrinkles”.

本発明者らは、上記課題を解決するため鋭意研究を行ったところ、桂枝茯苓丸料加ヨクイニンが、抗ストレス・疲労防止作用を有し、肌のキメを改善し、肌の外分泌を促進することにより潤いを与え、シワの予防・改善にも効果が期待できること見出し、本発明を完成させた。   As a result of intensive studies to solve the above-mentioned problems, the inventors of the present invention have the anti-stress / fatigue-preventing effect of Katsushido Karasuma-ryo-yokuinin to improve skin texture and promote skin exocrine secretion. As a result, the present invention was completed by finding that it can be moisturized and can be expected to be effective in preventing and improving wrinkles.

即ち、本発明は、ケイヒ(桂皮)、ブクリョウ(茯苓)、ボタンピ(牡丹皮)、トウニン(桃仁)、シャクヤク(芍薬)、ヨクイニンの混合物からなる肌のキメ改善用又はシワ予防・改善用の組成物或は内服剤である。より具体的には、桂皮2〜5重量部、茯苓2〜5重量部、牡丹皮2〜5重量部、桃仁2〜5重量部、芍薬2〜5重量部、ヨクイニン5〜20重量部である肌のキメ改善用又はシワ予防・改善用の組成物或は内服剤である。さらに具体的には、前記組成物或は内服剤が、桂枝茯苓丸料加ヨクイニンと称される漢方処方である。 That is, the present invention is a composition for skin texture improvement or wrinkle prevention / improvement comprising a mixture of keihi (cinnamon), bukkaku (pepper), button pi (peony skin), tounin (pepper), peonies (glaze), and yakuinin. It is a product or an internal medicine. More specifically, 2 to 5 parts by weight of cinnamon, 2 to 5 parts by weight of peony, 2 to 5 parts by weight of peony, 2 to 5 parts by weight of peony, 2 to 5 parts by weight of glaze, and 5 to 20 parts by weight of yokuinin. A composition for improving skin texture or preventing or improving wrinkles, or an internal preparation. More specifically, the composition or the internal preparation is a Chinese herbal prescription called Keikine Karasuma Yokuinin.

これまで、桂枝茯苓丸料加ヨクイニンが、抗ストレス、疲労防止、肌のキメやシワの改
善などの効果を有することは知られていなかった。また、背景技術にも記載したとおり、桂枝茯苓丸料加ヨクイニンを構成する桂皮、茯苓、芍薬及びヨクイニンなどの生薬には、ストレスや疲労により生じた症状を対症的に改善する効果は開示されているものの、抗ストレス作用や疲労自体を防止する作用は知られていなかった。
So far, it has not been known that Katsushika Testicle Yokainin has effects such as anti-stress, fatigue prevention, and improvement of skin texture and wrinkles. In addition, as described in the background art, herbal medicines such as cinnamon bark, cocoon, glaze, and yokuinin that make up Keishi Karasuma Ryoka Yokuinin have been disclosed to symptomatically improve symptoms caused by stress and fatigue. However, the anti-stress action and the action to prevent fatigue itself have not been known.

本発明の、桂皮、茯苓、牡丹皮、桃仁、芍薬、ヨクイニンの混合物から抽出したエキスを含有する内服剤は、従来より知られていた「月経トラブルに起因するトラブル解消効果」に加え、「抗ストレス・疲労防止作用」「顔面の肌のキメの改善効果」、更には「表皮への水分分泌を活性化し、肌に潤いを与え、シワを予防・改善する効果」を新たに見出した。   The oral preparation containing an extract extracted from a mixture of cinnamon, persimmon, peony skin, peach seed, glaze, and yokuinin of the present invention is known in addition to the conventionally known “problem eliminating effect caused by menstrual trouble” "Stress / fatigue prevention action" "Face skin texture improvement effect", and also "Effects to activate moisture secretion to the skin, moisturize the skin and prevent and improve wrinkles".

以下、本発明についてさらに詳細に説明する。
本発明において使用される生薬は以下のものである。
桂皮は、クスノキ科のケイCinnamomum cassia Blume の樹皮又は周皮の一部を除いたものである。
茯苓は、サルノコシカケ科のマツホドPoria cocos Wolf の菌核で、通例、外層をほとんど除いたものである。
牡丹皮は、ボタン科のボタンPaeonia suffruticosa andrews の根皮である。
桃仁は、バラ科のモモPrunus persica Batsch 又はPrunus persica Batsch var.davidiana Maximowicz の種子である。
芍薬は、ボタン科のシャクヤクPaeonia lactiflora Pallas
の根である。
ヨクイニンは、イネ科のハトムギCoix lacryma-jobi Linne var.mayuen Stapf の種皮を除いた種子である。
Hereinafter, the present invention will be described in more detail.
The crude drugs used in the present invention are as follows.
The cinnamon is obtained by removing a part of the bark or pericyte of Cinnamomum cassia Blue of the camphor family.
The cocoon is a mycorrhiza of the pine moss, Poria cocos Wolf, which is usually removed from the outer layer.
Peony skin is the root bark of the button department button Paeonia suffruticosa andrews.
Taojin is a peach of the Rosaceae, Prunus persica Batsch or Prunus persica Batsch var. It is the seed of davidiana maximowicz.
The glaze is a Peonyia patonia lactiflora Pallas
Is the root of
Yokuinin is a pearl barley of Coix lacryma-jobi Linene var. It is the seed excluding the seed coat of mayuen Stapf.

これら6種類の生薬のうち、桂皮、茯苓、牡丹皮、桃仁及び芍薬の5種類の生薬からなる漢方処方が桂枝茯苓丸である。この桂枝茯苓丸は中国宋時代の医書「金匱要略」に記載されており、月経不順、月経困難症、更年期障害、血の道症、のぼせ症で充血しやすく、足冷え、頭痛、めまい、耳鳴り、肩こりやしみに対して処方される。この桂枝茯苓丸に、民間薬としていぼ取りや皮膚のあれによく使われるヨクイニンを加えた処方、すなわち前述の6種類の生薬からなる漢方処方が桂枝茯苓丸料加ヨクイニンで、お血が原因で起こる皮膚のあれやにきびに用いられる。   Among these six kinds of herbal medicines, Kameda Karasuma is a Kampo prescription consisting of five kinds of herbal medicines such as cinnamon bark, persimmon, peony skin, peach seed and glaze. This katsura testicle is described in a Chinese book of the Chinese era, `` Kin Xin Summary ''. Prescribed for stiff shoulders and spots. This is a prescription that adds Yokuinin, which is often used for wart removal and skin as a folk medicine. Used for skin rashes and acne caused by the cause.

本発明の、桂皮、茯苓、牡丹皮、桃仁、芍薬、ヨクイニンの混合物からなる抗ストレス・疲労防止作用、肌のキメ改善用又はシワ予防・改善用の内服剤は、桂皮2〜5重量部、茯苓2〜5重量部、牡丹皮2〜5重量部、桃仁2〜5重量部、芍薬2〜5重量部、ヨクイニン5〜20重量部からなる混合生薬、または、好ましくは桂皮4重量部、茯苓4重量部、牡丹皮4重量部、桃仁4重量部、芍薬4重量部、ヨクイニン10重量部からなる混合生薬から得られる濃縮エキスまたは乾燥エキス粉末が挙げられる。   An anti-stress / fatigue-preventing action comprising a mixture of cinnamon, cocoon, peony, peony, glaze, and yokuinin of the present invention, 2 to 5 parts by weight of cinnamon for skin texture improvement or wrinkle prevention / improvement, 2 to 5 parts by weight of cocoon, 2 to 5 parts by weight of peony skin, 2 to 5 parts by weight of peach seed, 2 to 5 parts by weight of glaze, 5 to 20 parts by weight of yokuinin, or preferably 4 parts by weight of cinnamon, A concentrated extract or dry extract powder obtained from a mixed herbal medicine consisting of 4 parts by weight, 4 parts by weight of peony skin, 4 parts by weight of peony, 4 parts by weight of glaze, and 10 parts by weight of yokuinin.

これら6種類の生薬の合計重量に対して5〜25倍量、好ましくは8〜20倍量の水を加えて、通常80〜100℃で30分間〜2時間加熱してエキスを煎出する。次に煎出液を熱時濾過して固形成分を除去し、この抽出液を濃縮し生薬抽出液が得られる。さらに、通常の乾燥方法、例えばスプレードライ、減圧濃縮乾燥、凍結乾燥等により乾燥することもできる。このようにして得られたエキス粉末はそのままの形で使用することもできるが
、通常、食品及び/又は医薬品に使用される通常の賦形剤(例えば、結晶セルロース、ショ糖脂肪酸エステル、白糖等)を加え、例えば、乾式造粒法或は湿式造粒法により造粒して製造し、このようにした造粒物をそのまま使用することもできるが、それらをさらに打錠機を用いた圧縮成形物として使用することもできる。
The extract is decocted by adding 5 to 25 times, preferably 8 to 20 times the amount of water with respect to the total weight of these six kinds of herbal medicines, and usually heating at 80 to 100 ° C. for 30 minutes to 2 hours. Next, the decoction is filtered while hot to remove the solid components, and this extract is concentrated to obtain a herbal extract. Furthermore, it can also be dried by ordinary drying methods such as spray drying, vacuum concentration drying, freeze drying and the like. Although the extract powder thus obtained can be used as it is, it is usually used as usual excipients for food and / or pharmaceuticals (for example, crystalline cellulose, sucrose fatty acid ester, sucrose, etc. ), For example, granulated by dry granulation method or wet granulation method, and such granulated products can be used as they are, but they are further compressed using a tableting machine. It can also be used as a molded product.

また、漢方エキスが特有のえぐみを有することから、マスキングした製剤が服用上好ましく、被覆剤で被覆したフィルムコート剤とすることもできる。また、成分の安定性の点や簡単に摂取できる形態として、粉砕したものをそのまままた上記造粒物をハードカプセルやソフトカプセルに充填し摂取してもよい。   In addition, since the Kampo extract has a peculiar taste, a masked preparation is preferable for taking, and a film coating agent coated with a coating agent can also be obtained. In addition, as a component stability point and a form that can be easily ingested, the pulverized product may be used as it is or filled with the above granulated product in a hard capsule or soft capsule.

或いは、各生薬をそれぞれ個別に抽出したエキスを混合して、前述した同様の方法により使用することもできる。   Alternatively, extracts obtained by individually extracting each herbal medicine can be mixed and used by the same method as described above.

また、抽出したエキスに、通常、液状の食品などに使用される甘味料、酸味料、乳化剤、フレーバー、分散助剤などの賦形剤を加えて溶解し、液体の形状として製造することもできる。   In addition, the extracted extract can be dissolved in a liquid form by adding excipients such as sweeteners, acidulants, emulsifiers, flavors, and dispersion aids that are usually used in liquid foods. .

以上のような、内服固形の顆粒、錠剤、散剤、液剤の形態だけではなく、半固形状の形態のもの及び、水や湯などに溶解し液状にして用いることができる粉末状の形態などに加工することもできる。
As described above, not only in the form of internal solid granules, tablets, powders, and liquids, but also in semi-solid forms and powdered forms that can be dissolved and used in water or hot water. It can also be processed.

以下に試験例を挙げて本発明を詳細に説明する。
(試験例1)
女性は月経に伴うホルモンの著しい変化によって、心身に周期性の変化があることが知られている。そこで、キメに対する内服剤効果の確認するため、月経周期変動の影響を考慮し、黄体期に試験方法記載の肌計測を行なった後、月経初日から実施例1の製剤を1回4錠、1日2回の服用を開始し、次の月経期まで各周期に同様の肌計測を行った。
(1)試験方法
22歳から40歳の健常成人女性12名を対象に、肌状態を全顔画像撮影・画像解析システム(ロボスキンアナライザー)(株式会社インフォワード社製)を用いた肌評価により、頬部のキメ、表皮水分の測定、分極電流計による頬部及び額部の真皮水分の測定を行なった。尚、キメの評価は、モノクロ画像における暗部を皮溝、明部を皮丘とし、明部暗部をそれぞれ強調処理して二値化した結果が、一辺0.4mmの正三角形のキメモデルに近ければ近いほど、100点満点中の高い点となるように計測し評価される。
Hereinafter, the present invention will be described in detail with reference to test examples.
(Test Example 1)
It is known that women have periodic changes in mind and body due to significant changes in hormones associated with menstruation. Therefore, in order to confirm the effect of internal use on texture, after taking the skin measurement described in the test method in the luteal phase in consideration of the influence of menstrual cycle variation, 4 tablets of the formulation of Example 1 once from the first day of menstruation, 1 Taking twice a day, the same skin measurement was performed in each cycle until the next menstrual period.
(1) Test method For 12 healthy adult women aged 22 to 40 years old, the skin condition was evaluated by skin evaluation using a full-face image capturing and image analysis system (Robo Skin Analyzer) (manufactured by Inforward Co., Ltd.). The texture of the cheeks and the skin moisture were measured, and the dermis moisture in the cheeks and forehead was measured with a polarization ammeter. Note that the evaluation of the texture is such that the dark part in the monochrome image is a skin groove, the bright part is a skin hill, and the result of binarization by emphasizing the bright part dark part is close to a regular triangle texture model with a side of 0.4 mm. It is measured and evaluated so that the closer it is, the higher the score is out of 100 points.

(2)試験結果
試験結果を表1及び2に示した。実施例1の内服剤の服用により、キメスコアは有意に改善した。また、黄体ホルモンの影響により身体に水分が貯留しやすい黄体期に、内服剤の服用により表皮水分が有意に増加した。加えて、貯留した水分の排泄が損なわれることでトラブルが生じやすい月経期に、真皮水分が有意に低下した。この結果より、真皮層に滞った水分の分泌が活性化され、表皮水分が増加して、肌に潤いが生じたことが示唆された。
(2) Test results The test results are shown in Tables 1 and 2. By taking the internal preparation of Example 1, the texture score was significantly improved. In addition, during the luteal phase, where the body easily retains water due to the effects of luteinizing hormone, epidermal moisture increased significantly by taking the internal preparation. In addition, dermal moisture was significantly reduced during the menstrual period, when the excretion of stored water was impaired and trouble was likely to occur. From this result, it was suggested that the secretion of water stagnated in the dermis layer was activated, the epidermal water increased, and the skin was moistened.

Figure 0005661994
Figure 0005661994

Figure 0005661994
Figure 0005661994

Figure 0005661994
Figure 0005661994

(試験例2)
表皮水分とシワの関連性を確認するため、頬部及び額部の月経周期による変化について評価した。
(Test Example 2)
In order to confirm the relationship between epidermal water and wrinkles, changes in the cheek and forehead due to the menstrual cycle were evaluated.

(1)試験方法
24歳から40歳の健常成人女性13名を対象に、月経周期(卵胞期、排卵期、黄体期、月経期)ごとに、肌状態を全顔画像撮影・画像解析システム(ロボスキンアナライザー)(株式会社インフォワード社製)を用いて、シワ及び表皮水分の測定を行なった。
(1) Test method For all 13 healthy adult women aged 24 to 40 years old, the skin condition of the whole face imaging and image analysis system for each menstrual cycle (follicular phase, ovulation phase, luteal phase, menstrual phase) ( Using a Robo Skin Analyzer (manufactured by Inforward Co., Ltd.), wrinkles and skin moisture were measured.

(2)試験結果
頬部及び額部の表皮水分は、月経周期変化に個体差があったが、平均すると周期による有意な変動は認められなかった。周期ごとに分けで表皮水分と目尻のシワ長の関係を評価した結果、図1〜3に示したように、表皮水分とシワには有意な負の相関が認められ、表皮水分値が高いほどシワが少ないことが確認された。従って、試験例1で示した表皮水分の増加は、シワの予防・改善効果を示唆するものである。
(2) Test results The epidermal water content in the cheeks and forehead had individual differences in menstrual cycle changes, but on average, no significant variation was observed due to the cycle. As a result of evaluating the relationship between the epidermal water content and the wrinkle length of the corners of the eyes divided by period, as shown in FIGS. 1 to 3, a significant negative correlation was observed between the epidermal water content and the wrinkle. It was confirmed that there were few wrinkles. Therefore, the increase in epidermal water shown in Test Example 1 suggests the effect of preventing and improving wrinkles.

(試験例3)
疲労及びストレスに対する内服剤効果確認するため、黄体期に試験方法記載の疲労評価と交感神経の活動レベルの測定を行なった後、月経初日から実施例1の製剤を1回4錠、1日2回の服用を開始し、次の月経期まで各周期に同様の測定を行った。
(Test Example 3)
In order to confirm the effect of internal use on fatigue and stress, after the fatigue evaluation described in the test method and the measurement of the level of sympathetic nerve activity were performed in the luteal phase, 4 tablets of the preparation of Example 1 once a day, 2 times a day The same measurement was performed at each cycle until the next menstrual period.

・ 試験方法
22歳から40歳の健常成人女性12名を対象に、POMS(Profile of Mood Status)を用いた疲労の評価と、分極電流計による額部の皮膚コンダクタンス測定を行なった。
Test Method For 12 healthy adult women aged 22 to 40 years old, fatigue evaluation using POMS (Profile of Mood Status) and skin conductance measurement of the forehead using a polarization ammeter were performed.

(2)試験結果
試験結果を表4及び5に示した。服用前の疲労スコアにより高値群(n=6)と低値群(n=6)で分割し、内服剤の服用による変化を解析したところ、表4に示すように、疲労スコアの高値群では内服剤の服用により、疲労スコアが有意に低下した。また、皮膚コンダクタンスを測定することにより交感神経の活動レベルを示すAP値は、表5に示すように、内服剤の服用により、AP値が有意に低下した。以上のように、実施例1の製剤の服用することで交感神経系の興奮を抑制し、疲労感も軽減することが確認され、この結果は、疲労防止及び抗ストレス効果を示唆するものである。
(2) Test results The test results are shown in Tables 4 and 5. By dividing the high score group (n = 6) and the low score group (n = 6) according to the fatigue score before taking, and analyzing the change due to the internal use, as shown in Table 4, in the high fatigue score group The fatigue score decreased significantly with the internal use. In addition, as shown in Table 5, the AP value indicating the level of sympathetic nerve activity by measuring skin conductance significantly decreased as a result of internal use. As described above, it was confirmed that the sympathetic nervous system excitement was suppressed by taking the preparation of Example 1, and the fatigue feeling was also reduced. This result suggests anti-fatigue and anti-stress effects. .

Figure 0005661994
Figure 0005661994

Figure 0005661994
Figure 0005661994

以下に、実施例および比較例を挙げて本発明をさらに具体的に説明する。 Hereinafter, the present invention will be described more specifically with reference to examples and comparative examples.

(実施例1)
桂枝茯苓丸料加ヨクイニンフィルムコート錠

(素錠部)
桂枝茯苓丸料加ヨクイニンエキス粉末 1800g
結晶セルロース 380g
クロスカルメロースナトリウム 300g
含水二酸化ケイ素 130g
ステアリン酸マグネシウム 30g
小 計 2640g
(剤皮部)
ヒプロメロース 82g
酸化チタン 14g
カルナウバロウ 微量
小 計 96g
合 計 2736g

*桂枝茯苓丸料加ヨクイニンエキス粉末1800mgは、桂皮2g、茯苓2g、牡丹皮2g、桃仁2g、芍薬2g、ヨクイニン5gの混合物から熱水で抽出し乾燥して得られる。
Example 1
Keishi Karasuma Ryoko Yokuinin Film Coat Tablets

(Uncoated part)
Keishi Karasuma Yakuinin Extract Powder * 1800g
380 g of crystalline cellulose
Croscarmellose sodium 300g
Hydrous silicon dioxide 130g
Magnesium stearate 30g
Subtotal 2640g
(Skin part)
Hypromellose 82g
Titanium oxide 14g
Carnauba wax Subtotal 96g
Total 2736g

* 1800 mg of Keishibuchi Karasuma Yokuinin Extract Powder is obtained by extracting with hot water from a mixture of 2 g of cinnamon bark, 2 g of strawberry, 2 g of peony skin, 2 g of peach seed, 2 g of glaze and 5 g of yokuinin and drying.

(製造方法)
「日局」製剤総則、錠剤の項に準じて錠剤を製する。すなわち上表に記載の、桂枝茯苓丸料加ヨクイニンエキス粉末からステアリン酸マグネシウムまでの成分をとり、一錠重量330mgの錠剤を製し、その錠剤に上表の剤皮部ヒプロメロースからカルナウバロウを用いて、コーティングを施し、実施例1のフイルムコーティング錠(一錠重量342mg
桂枝茯苓丸料加ヨクイニンエキス粉末225mg含有)を得た。
(Production method)
Prepare tablets according to “JP” General Rules for Preparations, Tablets. That is, take the ingredients from katsushi testicles added Yokuinin extract powder to magnesium stearate as shown in the table above, and make a tablet with a tablet weight of 330 mg, and use carnauba wax from the skin part hypromellose in the table above The film-coated tablets of Example 1 (one tablet weight 342 mg)
And 225 mg of Yakuinin extract powder).

(実施例2)
桂枝茯苓丸料加ヨクイニン錠

桂枝茯苓丸料加ヨクイニンエキス粉末 1800g
結晶セルロース 380g
クロスカルメロースナトリウム 300g
含水二酸化ケイ素 130g
ステアリン酸マグネシウム 30g
合 計 2640g
(Example 2)
Keishi Karasuma Ryoko Yokuinin Tablet

Katsushika Karasuma Yokuinin Extract Powder 1800g
380 g of crystalline cellulose
Croscarmellose sodium 300g
Hydrous silicon dioxide 130g
Magnesium stearate 30g
Total 2640g

(製造方法)
「日局」製剤総則、錠剤の項に準じて錠剤を製する。すなわち上表に記載の、桂枝茯苓丸料加ヨクイニンエキス粉末からステアリン酸マグネシウムまでの成分をとり錠剤(一錠重量330mg 桂枝茯苓丸料加ヨクイニンエキス粉末225mg含有)を製し、本発明の実施例2の錠剤を得た。
(Production method)
Prepare tablets according to “JP” General Rules for Preparations, Tablets. That is, taking the ingredients from the Katsushido testicles added Yokuinin extract powder to magnesium stearate as shown in the above table to produce a tablet (one tablet weight 330 mg containing Keishibuchi testicles added Yokuinin extract powder 225 mg), The tablet of Example 2 was obtained.

(実施例3)
桂枝茯苓丸料加ヨクイニン錠

(素錠部)
桂枝茯苓丸料エキス粉末* 1150g
ヨクイニンエキス粉末** 390g
結晶セルロース 400g
クロスカルメロースナトリウム 300g
含水二酸化ケイ素 130g
ステアリン酸マグネシウム 30g
合 計 2400g

*桂枝茯苓丸料加ヨクイニンエキス粉末1800mgは、桂皮2g、茯苓2g、牡丹皮2g、桃仁2g、芍薬2gの混合物から熱水で抽出し乾燥して得られる。
**ヨクイニンエキス粉末は、ヨクイニン5gから熱水で抽出し乾燥して得られる。
Example 3
Keishi Karasuma Ryoko Yokuinin Tablet

(Uncoated part)
Keishi Testicle Extract Powder * 1150g
Yokuinin Extract Powder ** 390g
400g of crystalline cellulose
Croscarmellose sodium 300g
Hydrous silicon dioxide 130g
Magnesium stearate 30g
Total 2400g

* Keiseki Karasuma Yakuinin Extract Powder 1800 mg is obtained by extracting with hot water from a mixture of 2 g of cinnamon bark, 2 g of persimmon, 2 g of peony skin, 2 g of peach seed and 2 g of glaze and drying.
** Yokuinin extract powder is obtained by extracting from 5 g of Yokuinin with hot water and drying.

(製造方法)
「日局」製剤総則、錠剤の項に準じて錠剤を製する。すなわち上表に記載の、桂枝茯苓丸料エキス粉末からステアリン酸マグネシウムまでの成分をとり、(一錠重量300mg )を製し、本発明の実施例3の錠剤を得た。
(Production method)
Prepare tablets according to “JP” General Rules for Preparations, Tablets. That is, the ingredients from Katsushido testicle extract powder to magnesium stearate described in the above table were taken to produce (tablet weight 300 mg) to obtain a tablet of Example 3 of the present invention.

(実施例4)
桂枝茯苓丸料加ヨクイニン顆粒剤

桂枝茯苓丸料加ヨクイニンエキス粉末 1800g
乳糖 2550g
ヒドロキシプロピルセルロース 150g
合 計 4500g
Example 4
Keishi Karasuma Ryoko Yokuinin Granules

Katsushika Karasuma Yokuinin Extract Powder 1800g
Lactose 2550g
Hydroxypropylcellulose 150g
Total 4500g

(製造方法)
「日局」製剤総則、錠剤の項に準じて顆粒剤を製する。すなわち上表に記載の、桂枝茯苓丸料加ヨクイニンエキス粉末からヒドロキシプロピルセルロースまでの成分をとり、実施例4の顆粒剤を得た。
(Production method)
Granules are prepared according to the “JP” general rules for preparations and tablets. That is, the ingredients described in the above table, from Katsushika testicle additive Yokuinin extract powder to hydroxypropyl cellulose, were used to obtain granules of Example 4.

卵胞期の右頬表皮水分と目尻のシワスコア(長さ)との関係Relationship between water content of right cheek epidermis in the follicular stage and wrinkle score (length) 排卵期の右頬表皮水分と目尻のシワスコア(長さ)との関係Relationship between water content of right cheek epidermis during ovulation and wrinkle score (length) of eye corner 黄体期の眉間表皮水分と目尻のシワスコア(長さ)との関係The relationship between the water content of the eyebrow during the luteal phase and the wrinkle score (length) of the outer corner of the eye

Claims (5)

桂皮(ケイヒ)、茯苓(ブクリョウ)、牡丹皮(ボタンピ)、桃仁(トウニン)、芍薬(シャクヤク)、ヨクイニンの混合物を含有することを特徴とする月経周期変動による肌のキメの乱れを予防・改善する組成物。Cinnamon (cinnamon),茯苓(Bukuryou), Mudanpi (moutan bark), MomoHitoshi (the person), peony (Paeonia), and preventing the Re turbulence of skin texture by menstrual cycle variations, characterized in that it contains a mixture of Coix Seed Composition to improve. 請求項1記載の組成物が、桂皮2〜5重量部、茯苓2〜5重量部、牡丹皮2〜5重量部、桃仁2〜5重量部、芍薬2〜5重量部、ヨクイニン5〜20重量部である月経周期変動による肌のキメの乱れを予防・改善する組成物。The composition according to claim 1 comprises 2 to 5 parts by weight of cinnamon, 2 to 5 parts by weight of peony, 2 to 5 parts by weight of peony, 2 to 5 parts by weight of peony, 2 to 5 parts by weight of glaze, and 5 to 20 parts by weight of yokuinin. part composition for preventing and improving Re turbulence of skin texture by menstrual cycle fluctuation is. 請求項1又は2記載の組成物が、桂枝茯苓丸料加ヨクイニンである月経周期変動による肌のキメの乱れを予防・改善する組成物。The composition of claim 1 or 2, wherein the, Keishi茯苓Maruryo turbulent Re composition for preventing and improving the skin texture menstrual period fluctuation is pressurized Coix. 請求項1〜3記載の組成物のいずれかを含有する月経周期変動による肌のキメの乱れを予防・改善する剤。Agents for preventing and improving Re turbulence of skin texture by menstrual cycle variations containing any one of claims 1 to 3 composition. 請求項1〜3記載の組成物のいずれかを含有する月経周期変動による肌のキメの乱れを予防・改善する内服剤。Oral agent for preventing and improving Re turbulence of skin texture by menstrual cycle variations containing any one of claims 1 to 3 composition.
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