JP2019205371A - Oral alleviating agent against ultraviolet skin damage or skin state improving agent - Google Patents
Oral alleviating agent against ultraviolet skin damage or skin state improving agent Download PDFInfo
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Abstract
Description
本発明は、乳児腸内由来のラクトバチルス属ガセリ種の乳酸菌を有効成分として含有する紫外線ダメージ軽減剤又は皮膚状態改善剤、当該紫外線ダメージ軽減剤又は皮膚状態改善剤を有効成分として含む皮膚用医薬品、および皮膚用飲食品を提供する。 The present invention relates to an ultraviolet damage reducing agent or a skin condition improving agent containing, as an active ingredient, an Lactobacillus genus Lactobacillus derived from the intestine of an infant as an active ingredient, and a skin drug containing the ultraviolet damage reducing agent or a skin condition improving agent as an active ingredient And food and drink for skin.
近年、皮膚の老化防止に関する研究が盛んに行われてきており、皮膚においては加齢による老化よりもむしろ紫外線による光老化の影響が支配的であるとも言われている。皮膚が紫外線に曝露されると炎症が誘導され、細胞およびDNAさらには細胞外マトリックスに障害が生じ、皮膚の肥厚化や色素沈着などに起因するシワやシミ、いわゆる光老化が引き起される(非特許文献1)。慢性的な紫外線の曝露ではDNAの損傷が完全に修復できず皮膚がんのリスクも増大する(非特許文献2)。したがって、皮膚の老化防止の観点では紫外線の影響をいかに軽減するかが重要であると言える。 In recent years, research on the prevention of skin aging has been actively conducted, and it is said that the influence of photoaging by ultraviolet rays rather than aging by aging is dominant in the skin. When the skin is exposed to ultraviolet light, inflammation is induced, causing damage to cells and DNA, as well as the extracellular matrix, causing wrinkles and spots due to skin thickening and pigmentation, so-called photoaging ( Non-patent document 1). Chronic UV exposure cannot completely repair DNA damage and increases the risk of skin cancer (Non-patent Document 2). Therefore, it can be said that how to reduce the influence of ultraviolet rays is important in terms of preventing skin aging.
紫外線ダメージの分かりやすい例として日焼けがある。日焼けは地表に降り注ぐ紫外線の中でも主として高エネルギーのUVBに皮膚が曝露されることによって生じる。多くの日本人では炎症によるサンバーンを経て、色素沈着によるサンタンを生じるが、皮膚の紫外線抵抗性は個々人によって異なり、その応答には個人差があることも知られている。従って、紫外線ダメージの軽減には紫外線に対する抵抗力を高めることや、紫外線による炎症を抑制することが有効であると言える。また、紫外線による炎症を抑制することで結果的に色素沈着も抑制されるものと考えられる。 An easy-to-understand example of UV damage is sunburn. Sunburn is mainly caused by exposure of the skin to high-energy UVB in the ultraviolet rays that fall on the earth's surface. Many Japanese people undergo sunburn due to inflammation and produce suntan due to pigmentation, but the UV resistance of the skin varies from individual to individual, and it is also known that the response varies among individuals. Therefore, it can be said that increasing the resistance to ultraviolet rays and suppressing inflammation caused by ultraviolet rays are effective in reducing ultraviolet ray damage. Moreover, it is thought that pigmentation is also suppressed by suppressing the inflammation by ultraviolet rays.
紫外線の影響を少なくする手段としてはサンスクリーン剤による紫外線の遮断や、化粧品類によるシミ・そばかす対策など、皮膚に直接塗布する方法が主流である。食品や飲料などにより経口摂取で紫外線の影響を軽減する手段は増加しているもののまだ発展途上にある。 As a means for reducing the influence of ultraviolet rays, methods of applying directly to the skin, such as blocking ultraviolet rays with a sunscreen agent and measures against stains and freckles with cosmetics, are the mainstream. Although the means for reducing the effects of ultraviolet rays by ingesting foods and beverages is increasing, it is still developing.
一方で乳酸菌の摂取による健康効果は古くから研究されてきたが、近年では整腸作用に留まらず全身や腸管以外の臓器への有効性も次々と明らかになってきている(非特許文献3)。しかし、人体最大の臓器とも言える皮膚への効果についての有効な報告は他の臓器に比べるとまだ少なく、特に皮膚への紫外線ダメージへの効果についてはほとんど報告がない。 On the other hand, although the health effect by ingestion of lactic acid bacteria has been studied for a long time, in recent years, not only the intestinal regulating action but also the effectiveness to the whole body and organs other than the intestinal tract has been clarified one after another (Non-Patent Document 3). . However, there are still few effective reports on the effect on the skin, which can be said to be the largest organ of the human body, compared to other organs, and there is almost no report on the effect on the UV damage to the skin.
本発明は、乳児腸内由来のラクトバチルス属ガセリ種の乳酸菌を有効成分として含有する紫外線ダメージ軽減剤又は皮膚状態改善剤、当該紫外線ダメージ軽減剤又は皮膚状態改善剤を有効成分として含む皮膚用医薬品、および皮膚用飲食品を提供することを目的とする。 The present invention relates to an ultraviolet damage reducing agent or a skin condition improving agent containing, as an active ingredient, an Lactobacillus genus Lactobacillus derived from the intestine of an infant as an active ingredient, and a skin drug containing the ultraviolet damage reducing agent or a skin condition improving agent as an active ingredient And it aims at providing food-drinks for skin.
本発明者らは、皮膚の保湿力向上にはヒアルロン酸が必要不可欠である点に着目し、多数の乳酸菌についてスクリーニングを行った結果、乳児腸内由来のラクトバチルス属ガセリ種の乳酸菌、特にラクトバチルス・ガセリN320株(NITE BP-02287)には高いヒアルロン酸産生促進能力があり、例えば、乾燥による、皮膚の水分量の低下、頬や背中、頸の乾燥状態の悪化、洗顔後のつっぱり感、皮膚のつやの低下を含む、皮膚状態の改善に有効であることをこれまでに見出している。
さらに、本菌株について皮膚に対する新たな機能を探索し、例えば、紫外線曝露部位の紫外線抵抗性向上、皮膚の赤み軽減、皮膚の色素沈着軽減を含む紫外線ダメージ軽減や、顔の肌色・くすみ改善、顔のべとつき・油感改善を含む皮膚状態の改善に有効であることを見出し、本発明を完成するに至った。
The present inventors paid attention to the point that hyaluronic acid is indispensable for improving the moisture retention of the skin, and as a result of screening for a large number of lactic acid bacteria, lactic acid bacteria of the Lactobacillus sp. Bacillus gasseri N320 strain (NITE BP-02287) has a high ability to promote hyaluronic acid production. For example, the moisture content of the skin decreases due to dryness, the dryness of the cheeks, back, and neck deteriorates. So far, it has been found to be effective in improving skin conditions, including the reduction of skin gloss.
In addition, new strains of this strain will be searched for, for example, improved UV resistance at exposed sites, reduced redness of skin, reduced skin pigmentation, reduced skin color and dullness, facial It has been found that it is effective in improving the skin condition including stickiness and oiliness improvement, and the present invention has been completed.
すなわち、本願第一の発明は、ラクトバチルス属ガセリ種の乳酸菌又は当該乳酸菌の発酵物を有効成分とする、経口投与可能な紫外線ダメージ軽減剤又は皮膚状態改善剤であり、本願第二の発明は、紫外線照射部位の紫外線抵抗性向上、皮膚の赤み軽減又は皮膚の色素沈着軽減のいずれかの効果を含む紫外線ダメージ軽減や、顔の肌色、くすみ改善、顔のべとつき又は油感改善のいずれかの効果を含む本願第一の発明に記載の紫外線ダメージ軽減剤又は皮膚状態改善剤であり、本願第三の発明は、乳酸菌が、ラクトバチルス・ガセリN320株(NITE BP-02287)である、本願第一の発明または本願第二の発明に記載の紫外線ダメージ軽減剤又は皮膚状態改善剤である。さらに、本出願人は、当該ラクトバチルス属ガセリ種の乳酸菌を含む紫外線ダメージ軽減又は皮膚状態を改善するための皮膚用医薬品、皮膚用飲食品も意図している。 That is, the first invention of the present application is an orally administrable ultraviolet damage reducing agent or skin condition improving agent comprising, as an active ingredient, a lactic acid bacterium of Lactobacillus gasseri species or a fermented product of the lactic acid bacterium. , UV damage reduction including any of the effects of improving UV resistance at the site of UV irradiation, reducing redness of the skin or reducing pigmentation of the skin, improving skin color, dullness, stickiness of the face or oiliness The ultraviolet damage reducing agent or skin condition improving agent according to the first invention of the present application including effects, and the third invention of the present application is that the lactic acid bacterium is Lactobacillus gaselli N320 strain (NITE BP-02287). The ultraviolet damage reducing agent or skin condition improving agent according to one invention or the second invention of the present application. Furthermore, the present applicant also contemplates a skin drug and a skin food or drink for reducing UV damage or improving the skin condition, which contain the Lactobacillus gasseri lactic acid bacteria.
本発明によれば、日常的に経口摂取して皮膚の乾燥を改善することが可能な紫外線ダメージ軽減剤、皮膚状態改善剤、前記紫外線ダメージ軽減剤又は皮膚状態改善剤を有効成分とする皮膚用医薬品、又は皮膚用飲食品が提供される。 According to the present invention, an ultraviolet damage reducing agent that can be taken orally on a daily basis to improve skin dryness, a skin condition improving agent, and the skin damage containing the ultraviolet damage reducing agent or skin condition improving agent as an active ingredient. A pharmaceutical product or food or drink for skin is provided.
以下、本発明を詳細に説明する。
1.ラクトバチルス・ガセリN320株(NITE BP-02287)
本発明において利用する乳酸菌は、ラクトバチルス・ガセリ(Lactobacillus gasseri)である。特にラクトバチルス・ガセリに属する乳酸菌のうち、ラクトバチルス・ガセリN320株(NITE BP-02287)である。本発明にいうN320の記号は日清食品ホールディングス株式会社で独自に菌株に付与した番号であり、本ラクトバチルス・ガセリN320株は本発明者によって初めて分離されたものである。
Hereinafter, the present invention will be described in detail.
1. Lactobacillus gaselli N320 strain (NITE BP-02287)
The lactic acid bacterium used in the present invention is Lactobacillus gasseri. Among the lactic acid bacteria belonging to Lactobacillus gasseri, in particular, Lactobacillus gasseri strain N320 (NITE BP-02287). The symbol N320 referred to in the present invention is a number uniquely assigned to the strain by Nissin Foods Holdings Co., Ltd., and the present Lactobacillus gasseri N320 strain was first isolated by the present inventor.
本発明のラクトバチルス・ガセリN320株は、下記条件で寄託されている。
(1)寄託機関名:独立行政法人製品技術基盤機構 特許微生物寄託センター
(2)連絡先:〒292-0818 千葉県木更津市かずさ鎌足2-5-8 122号室
(3)受託番号:NITE BP-02287
(4)識別のための表示:N320
(5)原寄託日:2016年6月14日
(6)ブダペスト条約に基づく寄託への移管日:2017年4月10日
本発明において利用するラクトバチルス・ガセリN320株の菌学的性質は、以下の表1及び2に示す通りである。本菌学的性質は、Bergey’s manual of systematic bacteriology Vol.2(1986)に記載の方法による。表1は本菌株に関する形状等を、表2はアピ50CH及びアピCHL(ビオメリュー製)により、糖資化性を試験した結果を示す。表2において、「+」は発酵性あり、「-」は発酵性なしを示す。
The Lactobacillus gasseri N320 strain of the present invention is deposited under the following conditions.
(1) Depositary Institution: National Institute of Technology and Technology Patent Microorganisms Deposit Center (2) Contact: Room 2-5-8 Kazusa Kamashi, Kisarazu City, Chiba 292-0818 (3) Deposit Number: NITE BP -02287
(4) Display for identification: N320
(5) Date of original deposit: June 14, 2016 (6) Date of transfer to deposit under the Budapest Treaty: April 10, 2017 The bacteriological properties of the Lactobacillus gasseri N320 strain used in the Japanese invention are as follows: As shown in Tables 1 and 2. This bacteriological property is determined by the method described in Bergey's manual of systematic bacteriology Vol. 2 (1986). Table 1 shows the shape and the like related to this strain, and Table 2 shows the results of the sugar assimilation test using API 50CH and API CHL (manufactured by Biomelieu). In Table 2, “+” indicates fermentability, and “−” indicates no fermentability.
2.スキムミルク培地での増殖性試験
<スキムミルク培地増殖性試験>
前培養液を10%スキムミルク培地に接種し、これを37℃ ・24時間培養した上で、乳酸菌生菌数によってミルク培地での増殖性を評価した。
2. Proliferation test on skim milk medium <Skim milk medium growth test>
The preculture was inoculated into a 10% skim milk medium, which was cultured at 37 ° C. for 24 hours, and then the growth in the milk medium was evaluated by the number of living lactic acid bacteria.
3.紫外線ダメージ軽減剤
本発明においては、前記ラクトバチルス属ガセリ種の乳酸菌を有効成分とする紫外線ダメージ軽減剤とすることができる。ここで、本発明にいう紫外線ダメージ軽減とは紫外線照射部位の紫外線抵抗性向上、皮膚の赤み軽減又は皮膚の色素沈着軽減のいずれかの効果を奏するものをいう。
当該紫外線ダメージ軽減剤は、前記乳酸菌を発酵後の乳酸菌の菌体そのものであってもよいし、当該乳酸菌を発酵後に濃縮や分離等でエキス化及び粉末化したものであってもよい。さらに、前記乳酸菌菌体に他の成分(例えば、糖類、タンパク質、アミノ酸、脂質、水分、ビタミン、ミネラル等)を含んでいてもよい。さらに、当該紫外線ダメージ軽減剤は、含水形態であっても乾燥形態であっても良いことは勿論である。
3. Ultraviolet ray damage reducing agent In the present invention, an ultraviolet ray damage reducing agent comprising the lactic acid bacteria of the Lactobacillus sp. Here, the term “reducing ultraviolet damage” as used in the present invention refers to a substance that exhibits any of the effects of improving the ultraviolet resistance at the site irradiated with ultraviolet light, reducing redness of the skin, or reducing pigmentation of the skin.
The ultraviolet damage reducing agent may be the lactic acid bacterium itself after fermentation of the lactic acid bacterium, or may be extracted and powdered by concentration, separation, or the like after fermentation. Furthermore, the lactic acid bacterium may contain other components (for example, sugars, proteins, amino acids, lipids, moisture, vitamins, minerals, etc.). Further, it goes without saying that the ultraviolet damage reducing agent may be in a water-containing form or a dry form.
4.皮膚状態改善剤
本発明においては、前記ラクトバチルス属ガセリ種の乳酸菌を有効成分とする皮膚状態改善剤とすることができる。ここで、本発明にいう皮膚状態改善とは顔の肌色、くすみ改善、顔のべとつき又は油感改善のいずれかの効果を奏するものをいう。
当該皮膚状態改善剤は、前記乳酸菌を発酵後の乳酸菌の菌体そのものであってもよいし、当該乳酸菌を発酵後に濃縮や分離等でエキス化及び粉末化したものであってもよい。さらに、前記乳酸菌菌体に他の成分(例えば、糖類、タンパク質、アミノ酸、脂質、水分、ビタミン、ミネラル等)を含んでいてもよい。
さらに、当該皮膚状態改善剤は、含水形態であっても乾燥形態であっても良いことは勿論である。
4). Skin condition-improving agent In the present invention, a skin condition-improving agent comprising the lactic acid bacteria of the Lactobacillus sp. Here, the improvement of the skin condition referred to in the present invention means an effect that exhibits any of the following effects: facial skin color, dullness improvement, stickiness of the face, or oiliness improvement.
The skin condition-improving agent may be the lactic acid bacterium itself after fermentation of the lactic acid bacterium, or may be extracted and powdered by concentration, separation, or the like after fermentation. Furthermore, the lactic acid bacterium may contain other components (for example, sugars, proteins, amino acids, lipids, moisture, vitamins, minerals, etc.).
Furthermore, it goes without saying that the skin condition improving agent may be in a water-containing form or a dry form.
5.皮膚用飲食品
本発明の紫外線ダメージ軽減剤又は皮膚状態改善剤は飲食品に含有せしめて皮膚用飲食品として使用することができる。本発明の紫外線ダメージ軽減剤又は皮膚状態改善剤は特に乳製品に好適に用いることができるが、例えば、乳酸菌入り発酵乳及び乳酸菌入り乳酸菌飲料が考えられる。現行の乳及び乳製品の成分規格等に関する省令では、成分規格として乳酸菌数は特に規定はされていないが、発酵乳(無脂乳固形分8.0%以上のもの)や乳酸菌飲料(無脂乳固形分3.0%以上のもの)であれば1.0×107 cfu/ml以上、乳酸菌飲料(無脂乳固形分3.0%未満のもの)であれば1.0×106 cfu/ml以上が好ましく、乳などで増殖させたり、最終製品の形態で増殖させたりすることによって上記の菌数を実現することができる。
また、乳酸菌入り発酵乳及び乳酸菌入り乳酸菌飲料以外にも、バター等の乳製品、マヨネーズ等の卵加工品、バターケーキ等の菓子パン類等にも利用することができる。また、即席麺やクッキー等の加工食品にも好適に利用することができる。上記の他、本発明の食品は、前記乳酸菌と共に、必要に応じて適当な担体及び添加剤を添加して製剤化された形態(例えば、粉末、顆粒、カプセル、錠剤等)であってもよい。
5. Food and drink for skin The UV damage reducing agent or skin condition improving agent of the present invention can be used as a food and drink for skin by containing it in a food or drink. The UV damage reducing agent or skin condition improving agent of the present invention can be particularly suitably used for dairy products. For example, fermented milk containing lactic acid bacteria and lactic acid bacteria-containing beverages containing lactic acid bacteria can be considered. The current ministerial ordinance on milk and dairy product component specifications does not specify the number of lactic acid bacteria as a component standard, but fermented milk (non-fat milk solid content of 8.0% or more) and lactic acid bacteria beverage (non-fat milk solids) 1.0 × 10 7 cfu / ml or more if it ’s 3.0% or more), and 1.0 × 10 6 cfu / ml or more if it ’s a lactic acid bacteria beverage (non-fat milk solid content less than 3.0%). The above-mentioned number of bacteria can be realized by growing or growing in the form of a final product.
In addition to fermented milk containing lactic acid bacteria and lactic acid bacteria beverages containing lactic acid bacteria, it can also be used for dairy products such as butter, processed egg products such as mayonnaise, and confectionery breads such as butter cake. Moreover, it can utilize suitably also for processed foods, such as instant noodles and a cookie. In addition to the above, the food of the present invention may be in the form of a formulation (for example, powder, granule, capsule, tablet, etc.) by adding an appropriate carrier and additives as necessary together with the lactic acid bacteria. .
本発明において利用する乳酸菌は、一般の飲料や食品以外にも特定保健用食品、栄養補助食品等に含有させることも有用である。 The lactic acid bacteria used in the present invention are also useful for inclusion in foods for specified health use, dietary supplements, etc. in addition to general beverages and foods.
また、本発明の皮膚用飲食品は本発明の紫外線ダメージ軽減剤又は皮膚状態改善剤を有効成分して含有していればよく、当該紫外線ダメージ軽減剤又は皮膚状態改善剤以外に他の成分(例えば、糖類、タンパク質、アミノ酸、脂質、水分、ビタミン、ミネラル等)を含有していても良いことは勿論である。 The skin food or drink of the present invention only needs to contain the ultraviolet damage reducing agent or skin condition improving agent of the present invention as an active ingredient, and other components (in addition to the ultraviolet damage reducing agent or skin condition improving agent) ( For example, saccharides, proteins, amino acids, lipids, moisture, vitamins, minerals, etc.) may be included.
6.皮膚用医薬品
本発明の紫外線ダメージ軽減剤又は皮膚状態改善剤は、発酵後に濃縮や分離等でエキス化及び粉末化して調製した後に、当該紫外線ダメージ軽減剤又は皮膚状態改善剤を有効成分とする皮膚用医薬品として使用することができる。例えば、エキス化したものを瓶等に詰めたものや、発酵液乾燥粉末を賦形剤なども用いて顆粒やカプセル化、打錠し錠剤の形態として提供が可能である。
また、本発明の皮膚用医薬品は本発明の紫外線ダメージ軽減剤又は皮膚状態改善剤を有効成分して含有していればよく、当該紫外線ダメージ軽減剤又は皮膚状態改善剤以外に他の成分(例えば、糖類、タンパク質、アミノ酸、脂質、水分、ビタミン、ミネラル等)を含有していても良いことは勿論である。
6). Skin care pharmaceuticals The ultraviolet damage reducing agent or skin condition improving agent of the present invention is prepared by extracting and pulverizing after fermentation by concentration, separation or the like, and then using the ultraviolet damage reducing agent or skin condition improving agent as an active ingredient. It can be used as a medicinal product. For example, it can be provided in the form of a tablet obtained by granulating, encapsulating, or compressing a product obtained by filling an extract into a bottle or using a fermented liquid dry powder with excipients.
In addition, the dermatological drug of the present invention only needs to contain the ultraviolet damage reducing agent or skin condition improving agent of the present invention as an active ingredient, and other components (for example, the ultraviolet damage reducing agent or skin condition improving agent (for example, Of course, saccharides, proteins, amino acids, lipids, moisture, vitamins, minerals, etc.) may be contained.
本発明に利用する乳酸菌(ラクトバチルス・ガセリN320株)は当該乳酸菌を有効成分として含有する紫外線ダメージ軽減剤又は皮膚状態改善剤として利用することができる。また、当該紫外線ダメージ軽減剤又は皮膚状態改善剤を有効成分とする皮膚用医薬品、又は皮膚用飲食品を日常的に摂取することで、例えば、紫外線曝露部位の紫外線抵抗性向上、皮膚の赤み軽減、皮膚の色素沈着軽減を含む紫外線ダメージの軽減や、顔の肌色・くすみ改善、顔のべとつき・油感改善を含む皮膚状態を改善することができる。
The lactic acid bacteria (Lactobacillus gasseri N320 strain) used in the present invention can be used as an ultraviolet damage reducing agent or a skin condition improving agent containing the lactic acid bacteria as an active ingredient. In addition, daily ingestion of dermatological drugs or skin foods and drinks containing the UV damage-reducing agent or skin condition-improving agent as an active ingredient, for example, improving UV resistance at UV-exposed sites and reducing skin redness It is possible to reduce UV damage including reduction of skin pigmentation, improve skin color and dullness of the face, and improve skin condition including improvement of stickiness and oiliness of the face.
<試験例1>スキムミルク培地増殖性試験
本発明のラクトバチルス・ガセリN320株と、自社保有の3つのラクトバチルス・ガセリ比較菌株(N219、N220、N313)について、スキムミルク培地増殖性試験を実施した。
Test Example 1 Skim Milk Medium Proliferation Test A Lactobacillus gasseri N320 strain of the present invention and three Lactobacillus gasseri comparative strains (N219, N220, N313) owned by the company were subjected to a skim milk medium growth test.
10%スキムミルク培地に各菌株を接種し、これを37℃ ・24時間培養した上で、乳酸菌の生菌数を測定することによってスキムミルク培地での増殖性を評価した。 Each strain was inoculated into a 10% skim milk medium and cultured at 37 ° C. for 24 hours, and then the viability of the lactic acid bacteria was measured to evaluate the growth on the skim milk medium.
結果を表3及び図1に示す。 The results are shown in Table 3 and FIG.
本発明の菌株(ラクトバチルス・ガセリN320株)の生菌数は22×107 cfu/mlであり、他の比較菌株と比べて増殖性が高く、乳酸菌入り発酵乳及び乳酸菌入り乳酸菌飲料を生産する上で問題のないレベルであった。 The viable count of the strain of the present invention (Lactobacillus gaselli N320 strain) is 22 × 10 7 cfu / ml, which is highly proliferative compared to other comparative strains, producing fermented milk containing lactic acid bacteria and lactic acid bacteria-containing beverages containing lactic acid bacteria It was a level with no problem.
<試験例2>ヒト被験者に対する有効性評価試験
被験者として年齢30歳以上49歳以下で日本人の主要な肌タイプであるフィッツパトリックスキンタイプIIあるいはIIIに属する各群35名、合計70名を選抜し有効性評価試験を行った。スクリーニング時に性別、年齢、最小紅斑量(MED)、肌の明るさ(L*値)、肌の赤み(a*値)などが各群間でできるだけ同一になるように乱数を用いて割り付けを行った。
<Test Example 2> Efficacy evaluation test for human subjects
A total of 70 subjects were selected from 35 groups belonging to Fitzpatrick Skin Type II or III who are 30 to 49 years of age and belong to the major Japanese skin types, and an efficacy evaluation test was conducted. When screening, random numbers are used to assign gender, age, minimum erythema amount (MED), skin brightness (L * value), skin redness (a * value) as much as possible between groups. It was.
尚、フィッツパトリックスキンタイプとは、皮膚色のタイプの分類をいい、特にタイプIIは日光(紫外線)に当った場合、皮膚が紅くなる反応を示す(サンバーン)と共に、しばらくして黒くなる反応を時々示す(サンタン)皮膚タイプをいう。また、タイプIIIは日光(紫外線)に当った場合、皮膚が紅くなる反応を示すと共にしばらくして黒くなる反応を示す皮膚タイプをいう。 In addition, Fitzpatrick skin type refers to the classification of skin color type, especially type II shows a reaction that the skin turns red (sunburn) when exposed to sunlight (ultraviolet rays) and a reaction that turns black after a while. Sometimes referred to as (Santan) skin type. Type III refers to a skin type that exhibits a reaction that makes the skin red when exposed to sunlight (ultraviolet rays) and a reaction that becomes black after a while.
<試験食の作製>
試験食としてラクトバチルス・ガセリN320株を1日当たり20 mg含有するハードカプセルと、プラセボ食として、賦形剤のみを含有するハードカプセルを作製した。なお、試験食が含有する本菌株は死菌体である。
<Preparation of test meal>
A hard capsule containing 20 mg of Lactobacillus gasseri N320 strain per day as a test meal and a hard capsule containing only excipients as a placebo meal were prepared. In addition, this strain contained in the test meal is dead cells.
<試験方法>
上記被験者を対象にプラセボ対照ランダム化二重盲検並行群間比較試験を実施した。各被験者には、1日に1回、被験食あるいはプラセボ食を8週間摂取後、検査期間1週間を含む計9週間(63日間)摂取させた。試験期間中の被験者には下記の制限事項を守るよう指導した。なお、被験者には倫理的配慮のもと同意を得た上で実施した。
(1)試験期間中は、日常生活を越えて過度に紫外線を浴びないように注意する。外出する際、紫外線照射評価部位が露出しないような衣服を着用する。
(2)試験期間中は、試験参加前から食事、運動、飲酒、睡眠時間等の生活習慣を変えずに維持する。(制限事項)
(3)試験期間中は、日常範囲を大きく逸脱する過度な運動、睡眠不足、ダイエットおよび暴飲暴食(宴会、食べ放題、バイキング等)を避ける。(制限事項)
(4)試験期間中は、やむを得ない場合を除き、医薬品を摂取しない。医薬品を摂取する場合は日誌に医薬品名と摂取量を記録する。(制限事項)
(5)試験期間中は、美容医療や特別なスキンケア施術(エステなど)を受けることを禁止する。(禁止事項)
(6)評価部位に対して、本試験で検討する有効性と同様もしくは関連する効果効能(美白・美肌効果)を標榜あるいは強調した化粧品(スキンケア製品を含む)、医薬部外品(薬用化粧品を含む)あるいは健康食品(特にヨーグルト、乳酸菌製剤、ビタミン類、ポリフェノール類などを含むもの)などの摂取を禁止する。(禁止事項)
(7)検査日前3日間は夜更かし、徹夜および激しい運動(息が上がるようなランニング、水泳、登山など)を禁止する。(禁止事項)
(8)検査日前日は就寝前までに入浴し、検査当日は、起床後から検査終了まで入浴(シャワーを含む)を禁止する。(禁止事項)
(9)検査日前日は禁酒とし、十分に睡眠をとり、体調を整える。
<Test method>
A placebo-controlled, randomized, double-blind, parallel group comparison study was performed on these subjects. Each subject was ingested once a day for a total of 9 weeks (63 days), including a test week or a placebo diet for 8 weeks, including a test period of 1 week. Subjects were instructed to observe the following restrictions during the study period. The test was conducted after obtaining consent from the ethical considerations.
(1) During the test period, be careful not to be exposed to excessive UV rays beyond daily life. When going out, wear clothing that does not expose the UV irradiation site.
(2) During the test period, maintain lifestyles such as eating, exercising, drinking, and sleeping hours before changing the test. (Limitations)
(3) During the test period, avoid excessive exercise, sleep deprivation, dieting and heavy eating and drinking (banquets, all-you-can-eat, buffet, etc.) that greatly deviate from the daily range. (Limitations)
(4) Do not take medicines during the test period unless it is unavoidable. When taking medicines, record the name of the medicine and the amount taken. (Limitations)
(5) During the test period, it is prohibited to receive aesthetic medicine and special skin care treatments (esthetics, etc.). (Prohibited matter)
(6) Cosmetics (including skin care products) and quasi-drugs (medicinal cosmetics) that have the same or related effects (whitening / skin-beautifying effects) as or related to the efficacy studied in this study. Including) or health foods (especially those containing yogurt, lactic acid bacteria preparations, vitamins, polyphenols, etc.). (Prohibited matter)
(7) Stay up late for 3 days before the test date, and all night and intense exercise (breathing running, swimming, climbing, etc.) are prohibited. (Prohibited matter)
(8) Bath on the day before the test day before going to bed, and on the day of the test, bathing (including a shower) is prohibited from getting up to the end of the test. (Prohibited matter)
(9) Prohibit drinking the day before the test date, sleep well, and maintain physical condition.
なお、上記被験者管理事項については遵守することを原則とするが、医療上の必要、その他生命身体の安全に危険を及ぼす場合はこの限りではないものとした。被験者管理事項に反する事項が生じた場合には、被験者は試験実施機関へ直ちに連絡をすることとした。被験者は、摂取前、摂取後8〜9週目に、紫外線照射部位のMED、L*値、a*値を評価した。また、摂取0週目、摂取4週目、摂取9週目に使用感アンケートを実施した。 As a general rule, the subject management items described above must be observed, but this does not apply to cases where there is a medical need or other danger to life or physical safety. In the event that a matter that contradicts subject management matters occurs, the subject will immediately contact the study site. The subjects evaluated the MED, L * value, and a * value of the ultraviolet irradiation site before ingestion and 8-9 weeks after ingestion. In addition, a usability questionnaire was conducted at 0 weeks of intake, 4 weeks of intake, and 9 weeks of intake.
MEDは、被験者背部に6段階公比1.2のエネルギー量の紫外線を照射し、1日後に照射部位を観察して紅班を生じた最も小さいエネルギー量と判定した。MEDが大きいほど紫外線への抵抗性が高いことを示している。 MED was determined to be the smallest amount of energy that caused erythema by irradiating the back of the subject with ultraviolet rays having an energy amount of 1.2 in 6 steps and observing the irradiated site one day later. The larger the MED, the higher the resistance to ultraviolet light.
L*値およびa*値は、摂取前検査で判定されたMEDの1.5倍量の紫外線を被験者背部に照射し、照射1日後、照射7日後の照射部位について分光測色計で評価した。L*値が大きいほど色素沈着が抑えられ、a*値が小さいほど炎症が抑えられていることを示している。 The L * value and the a * value were evaluated with a spectrocolorimeter for the irradiated part 1 day after irradiation and 7 days after irradiation with 1.5 times the amount of MED determined in the pre-intake examination. It shows that pigmentation is suppressed as the L * value increases, and inflammation is suppressed as the a * value decreases.
使用感アンケートは、被験者の肌状態あるいはトラブルについて、1:非常に気になる、2:少し気になる、3:どちらとも言えない、4:あまり気にならない、5:まったく気にならない、の5段階のスコアとして評価した。 The usability questionnaire is about the subject's skin condition or trouble, 1: very concerned, 2: a little worried, 3: not say either, 4: not much, 5: not at all It was evaluated as a 5-point score.
<結果>
試験期間中の脱落者を除く、被験食群33名、プラセボ群32名を解析に用いた。
紫外線への感受性が高い(紫外線による色素沈着の程度が被験者平均よりも大きい)被験者について解析を行ったところ、図2に示すように、試験食摂取前後のMED変化量が有意に増加した。プラセボ群では有意差はなかった。
<Result>
Excluding those who dropped out during the study period, 33 test food groups and 32 placebo groups were used in the analysis.
When analysis was performed on subjects with high sensitivity to ultraviolet rays (the degree of pigmentation due to ultraviolet rays was greater than the average of subjects), as shown in FIG. 2, the amount of change in MED before and after intake of the test meal increased significantly. There was no significant difference in the placebo group.
また、同じく紫外線への感受性が高い被験者について解析を行ったところ、図3、図4に示すように、被験食群でプラセボ群に比較して、紫外線照射7日後のL*値変化量が有意傾向で上昇し、a*値変化量が有意に抑制された。 In addition, analysis was performed on subjects who were also highly sensitive to ultraviolet rays. As shown in FIGS. 3 and 4, the L * value change amount after 7 days of ultraviolet irradiation was significant in the test food group compared to the placebo group. The tendency increased and the a * value change was significantly suppressed.
使用感アンケートを解析したところ、図5、図6に示すように、「顔の肌色・くすみ」「顔のべとつき・油感」の項目においてスコアの変化量で、摂取0週目と比較して摂取4週目、9週目ともに被験食群で有意なスコア改善が見られた。プラセボ群では有意差はなかった。 As shown in FIGS. 5 and 6, the usability questionnaire was analyzed. As shown in FIG. 5 and FIG. 6, the amount of change in score in the items of “skin color / dullness” and “stickiness / oiliness” of the face, Significant improvement in scores was observed in the test food group at 4 and 9 weeks of ingestion. There was no significant difference in the placebo group.
プラセボ対照ランダム化二重盲検並行群間比較試験の結果、ラクトバチルス属ガセリ種の乳酸菌を主成分とする紫外線ダメージ軽減剤および皮膚状態改善組成物には、紫外線への感受性が高い被験者において、紫外線抵抗性の向上、紫外線照射部位の炎症および色素沈着の抑制、顔の肌色・くすみの改善効果、顔のべとつき・油感の改善効果があることが確認された。 As a result of a placebo-controlled randomized double-blind parallel group comparison test, the UV damage-reducing agent and skin condition-improving composition based on lactic acid bacteria of the Lactobacillus gasseri species are highly sensitive to UV rays, It was confirmed that there was an improvement in UV resistance, suppression of inflammation and pigmentation at the UV-irradiated site, improvement of facial skin color and dullness, improvement of facial stickiness and oiliness.
Claims (5)
An orally administrable skin UV damage-reducing agent or skin condition improving agent comprising a lactobacillus species of Lactobacillus gasseri as an active ingredient.
The UV damage reduction of the skin includes any of the effects of improving the UV resistance of the UV irradiation site, reducing the redness of the skin or reducing the pigmentation of the skin, and improving the skin condition includes improving the skin color of the face, dullness, The ultraviolet damage reducing agent or skin condition improving agent according to claim 1, comprising any effect of improving the stickiness of the face or oiliness.
The said lactic acid bacteria is a Lactobacillus gasseri N320 strain | stump | stock (NITE BP-02287), The ultraviolet damage reduction agent or skin condition improvement agent of Claim 1 or 2.
A skin food or drink comprising the ultraviolet damage reducing agent or the skin condition improving agent according to any one of claims 1 to 3 as an active ingredient.
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KR20140128675A (en) * | 2013-04-29 | 2014-11-06 | 주식회사한국야쿠르트 | Probiotics of Lactobacillus gasseri HY7025 for skin wrinkle inhibitory and moisturizing effects and use of thereof as skin anti-wrinkle or moisturizing products |
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JP2019119689A (en) * | 2017-12-28 | 2019-07-22 | 日清食品ホールディングス株式会社 | Skin condition improving agent |
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