WO2017057032A1 - Non-steroidal preparation for external use comprising silver ion and aphanothece sacrum polysaccharide - Google Patents

Non-steroidal preparation for external use comprising silver ion and aphanothece sacrum polysaccharide Download PDF

Info

Publication number
WO2017057032A1
WO2017057032A1 PCT/JP2016/077351 JP2016077351W WO2017057032A1 WO 2017057032 A1 WO2017057032 A1 WO 2017057032A1 JP 2016077351 W JP2016077351 W JP 2016077351W WO 2017057032 A1 WO2017057032 A1 WO 2017057032A1
Authority
WO
WIPO (PCT)
Prior art keywords
effect
silver ion
external use
cases
effective
Prior art date
Application number
PCT/JP2016/077351
Other languages
French (fr)
Japanese (ja)
Inventor
稲葉 葉一
稲葉 千歳
Original Assignee
稲葉 葉一
大鳥居 裕明
尊田 京子
稲葉 千歳
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by 稲葉 葉一, 大鳥居 裕明, 尊田 京子, 稲葉 千歳 filed Critical 稲葉 葉一
Priority to JP2017543128A priority Critical patent/JPWO2017057032A1/en
Publication of WO2017057032A1 publication Critical patent/WO2017057032A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/38Silver; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/02Algae
    • A61K36/04Rhodophycota or rhodophyta (red algae), e.g. Porphyra

Definitions

  • the present invention is an invention of a new non-steroidal external preparation for the purpose of antipruritic effect, anti-inflammatory effect and antibacterial effect containing silver ion and suizendinori polysaccharide.
  • Steroids are most commonly used as external preparations for chronic eczema, as typified by atopic dermatitis, but there are other nonsteroidal external preparations that contain anti-inflammatory analgesics and antihistamines as the main drug.
  • Non-steroidal topical preparations are problematic in terms of effectiveness compared to steroidal topical preparations, but are used in cases where safety is a priority, particularly infants.
  • the mechanism of exacerbation of eczema is that the patient is scratching the lesion site due to itching, and it is stimulated and the itch substance is released, thereby repeatedly scratching the vicious circle. This is a well-known fact.
  • Steroid external preparations have been confirmed to have various effects, but also have a strong antipruritic effect, and can be said to be the most effective external preparation that breaks this itch-scratch chain.
  • the present inventor paid attention to the bactericidal effect of silver ions that have been reported so far (described later), and in cases where silver ion water was used to disinfect the scratches of atopic dermatitis patients, The phenomenon of lightening was frequently observed.
  • the antistatic effect of silver ions is related not only to the above-mentioned inhibitory action on the production of skin irritants by antibacterial action, but also to the sedative action of free nerve endings of C fibers.
  • Suizendinori polysaccharides have been reported to have an anti-inflammatory action (described later), and it is estimated that the effects are higher. it can.
  • silver ion is used as the main agent of external preparations for the purpose of developing external preparations that have powerful effects on healing eczema (antipruritic effects, anti-inflammatory effects, cell growth inhibitory effects, etc.) comparable to steroid external preparations. And Suizenjinori polysaccharide.
  • ionized silver atoms have been known to have antibacterial activity, but many silver ion waters have problems such as low ionization rate and poor stability and long-term storage.
  • silver ion water when silver ion water is used for chronic eczema such as atopic dermatitis, the erythema and pruritus sensation at the site can be improved relatively early. In addition to this, it was because there were several cases of itch pruritus, which are common in the elderly, where itching stopped from that day just by applying silver ion water.
  • the present inventor applied a strong moisturizing agent to the eczema site to completely block the affected area from external stimuli, so that itching is gradually suppressed without containing a powerful drug such as steroid, and eczema gradually
  • a strong moisturizing agent to the eczema site to completely block the affected area from external stimuli, so that itching is gradually suppressed without containing a powerful drug such as steroid, and eczema gradually
  • the phenomenon of remission is experienced in daily medical care, and in this case, the effect was particularly remarkable for lichenoid eczema lesions.
  • silver ions used as the main drug are especially against inflammatory erythema and pruritus in the acutely stimulated state, while suizendinori polysaccharides block external stimuli and have anti-inflammatory effects in the chronically stimulated state due to the strong moisturizing effect.
  • suizendinori polysaccharides block external stimuli and have anti-inflammatory effects in the chronically stimulated state due to the strong moisturizing effect.
  • the base of the external preparation is selected from vaseline-based ointment or lotion dissolved in purified water, and silver ion water is made by TSS Aqua Co., Ltd., which has high stability, and the concentration kills fungi and bacteria as shown below.
  • concentration kills fungi and bacteria as shown below.
  • 2 ppm or more, and Suizendinori polysaccharides are blended around 0.5% in order to exert sufficient moisturizing power and anti-inflammatory action.
  • the present invention has a bactericidal action inherent to silver ions in addition to the effects of remedying eczema as powerfully as a steroid topical preparation (antipruritic effect, anti-inflammatory effect, cell growth inhibitory effect, etc.), and is a disadvantage of a steroid external preparation.
  • the infectivity problem can be solved, and it is not necessary to add a preservative, which is advantageous in terms of safety.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Biotechnology (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

In recent years, steroidal preparations for external use, which induce the problem of side effects when used over a long time, have been avoided by patients. Thus, it is hard for doctors to prescribe such preparations, which makes it difficult to treat chronic eczema. To solve this problem, provided is a preparation for external use which comprises a polysaccharide derived from Aphanothece sacrum having a potent moisture retaining effect and silver ion water having antimicrobial and anti-inflammatory actions. Due to this composition, the preparation for external use exhibits therapeutic effects on eczema (an antipruritic effect, anti-inflammatory effect, cell proliferation-inhibiting effect, etc.) comparable to steroidal preparations for external use as well as an antimicrobial effect.

Description

銀イオン及びスイゼンジノリ多糖体配合非ステロイド外用剤Non-steroidal external preparation containing silver ion and suizendinori polysaccharide
 本発明は、銀イオンおよびスイゼンジノリ多糖体を配合した止痒効果、抗炎症効果および抗菌効果を目的とした新しい非ステロイドの外用剤の発明である。 The present invention is an invention of a new non-steroidal external preparation for the purpose of antipruritic effect, anti-inflammatory effect and antibacterial effect containing silver ion and suizendinori polysaccharide.
 アトピー性皮膚炎に代表される慢性の湿疹に対する外用剤はステロイドが最も使用されているが、その他には主薬に消炎鎮痛薬や抗ヒスタミン薬を配合した非ステロイド外用剤もある。 Steroids are most commonly used as external preparations for chronic eczema, as typified by atopic dermatitis, but there are other nonsteroidal external preparations that contain anti-inflammatory analgesics and antihistamines as the main drug.
 近年ステロイド外用剤は、長期使用による副作用の問題で患者からは敬遠されているため、医者も処方をなるべく控える傾向にある。 In recent years, topical steroids have been avoided by patients due to side effects caused by long-term use, and doctors tend to refrain from prescribing as much as possible.
 非ステロイド外用剤は、ステロイド外用剤に比べ効果の面で問題があるが、安全性を重視する症例、特に乳幼児では使用されている。 Non-steroidal topical preparations are problematic in terms of effectiveness compared to steroidal topical preparations, but are used in cases where safety is a priority, particularly infants.
 非ステロイド外用剤の様に副作用が少なく、ステロイド外用剤の様に強力に湿疹を治す効果(止痒効果、抗炎症効果および細胞増殖抑制効果など)がある外用剤を開発することである。 Develop external preparations that have few side effects like non-steroidal preparations, and have powerful effects on healing eczema (antipruritic effect, anti-inflammatory effect, cell growth inhibitory effect, etc.) like steroid external preparations.
 湿疹が増悪する機序は、患者は痒みのため病変部位を掻破し、それが刺激となり痒み物質が放出され、それによってまた掻いてしまうと言う悪循環を繰り返す事が一番の原因である事は周知の事実である。 The mechanism of exacerbation of eczema is that the patient is scratching the lesion site due to itching, and it is stimulated and the itch substance is released, thereby repeatedly scratching the vicious circle. This is a well-known fact.
 ステロイド外用剤は種々の効果が確認されているが、止痒効果も強力であり、この痒み‐掻破の連鎖を断ち切る最も有効な外用剤と言える。 Steroid external preparations have been confirmed to have various effects, but also have a strong antipruritic effect, and can be said to be the most effective external preparation that breaks this itch-scratch chain.
 本発明者は従来から報告されている銀イオンの殺菌効果(後述)に注目し、アトピー性皮膚炎患者の掻き傷の消毒に銀イオン水を使用していた症例で、痒みが治まり湿疹病変が軽快すると言う現象が頻繁に認められた。 The present inventor paid attention to the bactericidal effect of silver ions that have been reported so far (described later), and in cases where silver ion water was used to disinfect the scratches of atopic dermatitis patients, The phenomenon of lightening was frequently observed.
 しかし銀イオンは抗菌作用が強力で細菌、真菌、ウイルスを問わず多くの微生物に対して抗菌力があることは周知の事実であり、また外傷や火傷の疼痛を惹起する炎症を抑える抗炎症作用の報告もあるが、この様な痒みや紅斑、湿疹を軽快させうる作用は今まで報告がない。 However, it is a well-known fact that silver ion has a strong antibacterial action and has an antibacterial action against many microorganisms regardless of bacteria, fungi, and viruses, and also has an anti-inflammatory action to suppress inflammation that causes pain of trauma and burns. However, there has been no report on the effect that can relieve itching, erythema and eczema.
 これは銀イオンが湿疹部位で過剰増殖している皮膚常在菌を抑える事により、それら菌による皮脂の分解産物としてのパルミチン酸・ステアリン酸・オレイン酸などの皮膚刺激物の産生が抑えられる事による二次的な効果が一因と考えられるが、それだけでは説明がつかない。 This suppresses the production of skin irritants such as palmitic acid, stearic acid, and oleic acid as degradation products of sebum by these bacteria, by suppressing the resident skin bacteria in which silver ions are excessively proliferating at the site of eczema. The secondary effects of can be thought to be a factor, but that alone cannot explain.
 また高齢者に多い皮膚掻痒症に罹患している患者に銀イオン水を塗布すると、それまでは痒みでなかなか寝付けない状態が続いていたにもかかわらず、その日から痒みが止まって眠れるようになると言う症例を数例経験した(後述症例13,14,15)。 In addition, when silver ion water is applied to patients suffering from skin pruritus, which is common in the elderly, it has been difficult to sleep due to itching until then, and itching stops and sleeps from that day. Several cases were said (cases 13, 14, and 15 described later).
 これは抗炎症効果とは直接関係無く、痒みの神経である表皮−真皮境界部に分布しているC線維の自由神経終末における鎮静作用が考えられる。 This is not directly related to the anti-inflammatory effect, and is considered to be a sedative action at the free nerve endings of C fibers distributed in the epidermis-dermis boundary, which is the itch nerve.
 つまり銀イオンの止痒効果は、前述した抗菌作用による皮膚刺激物の産生抑制作用だけではなく、C線維の自由神経終末の鎮静作用も関係していると推測される。 In other words, it is speculated that the antistatic effect of silver ions is related not only to the above-mentioned inhibitory action on the production of skin irritants by antibacterial action, but also to the sedative action of free nerve endings of C fibers.
 また本発明者は以前から湿疹部位に強力な保湿剤を塗布し患部を外部刺激から完全に遮断すると、ステロイドの様な抗炎症作用のある薬剤を含有させなくとも痒みが抑えられ、湿疹も徐々に軽快すると言う現象を経験し、日々の診療に応用している。 In addition, when the present inventor has applied a strong moisturizing agent to the site of eczema for a long time and completely blocks the affected area from external irritation, itching can be suppressed without containing an anti-inflammatory drug such as steroid, and eczema gradually Experience the phenomenon of lightening, and applied to daily medical care.
 特に苔癬化した慢性の湿疹に対してその効果が高く、外部刺激は苔癬化、つまり表皮細胞の増殖を加速させる働きがあると推測できる。 Especially, it is highly effective against lichenified chronic eczema, and it can be inferred that external stimulation has the effect of lichenification, that is, the acceleration of epidermal cell proliferation.
 この様な現象はスイゼンジノリ多糖体やリピジュアなどの高保湿成分特有の効果として報告されているが、その中でもスイゼンジノリ多糖体には抗炎症作用の報告があり(後述)、よりその効果が高いと推測できる。 Such a phenomenon has been reported as an effect peculiar to highly moisturizing ingredients such as Suizendinori polysaccharides and lipids. Among them, Suizendinori polysaccharides have been reported to have an anti-inflammatory action (described later), and it is estimated that the effects are higher. it can.
 これらの事を踏まえ、ステロイド外用剤に匹敵する強力に湿疹を治す効果(止痒効果、抗炎症効果および細胞増殖抑制効果など)を持つ外用剤を開発する目的で、外用剤の主薬に銀イオンとスイゼンジノリ多糖体を配合させた。 Based on these facts, silver ion is used as the main agent of external preparations for the purpose of developing external preparations that have powerful effects on healing eczema (antipruritic effects, anti-inflammatory effects, cell growth inhibitory effects, etc.) comparable to steroid external preparations. And Suizenjinori polysaccharide.
 従来からイオン化した銀原子は抗菌作用があることは知られていたが、多くの銀イオン水はイオン化率が低くかつ安定性が悪く長期保存が出来ないなどの問題があったが、今回は株式会社TSSアクアが電気分解によって作成した1000ppmと非常に高濃度で、長期安定性がある銀イオン水を使用した。 Traditionally, ionized silver atoms have been known to have antibacterial activity, but many silver ion waters have problems such as low ionization rate and poor stability and long-term storage. Silver ion water with a very high concentration and long-term stability of 1000 ppm produced by electrolysis by TSS Aqua was used.
 本発明で銀イオン水を用いる根拠であるが、前述した様にアトピー性皮膚炎など慢性の湿疹に対して銀イオン水を使用すると、その部位の紅斑や掻痒感が比較的早期に改善する事に加え、高齢者に多い皮膚掻痒症の患者で、銀イオン水を塗布するだけでその日から痒みが止まると言う症例を数例経験したからである。 Although it is the basis for using silver ion water in the present invention, as described above, when silver ion water is used for chronic eczema such as atopic dermatitis, the erythema and pruritus sensation at the site can be improved relatively early. In addition to this, it was because there were several cases of itch pruritus, which are common in the elderly, where itching stopped from that day just by applying silver ion water.
 また前述した様に、本発明者は湿疹部位に強力な保湿剤を塗布し患部を外部刺激から完全に遮断すると、ステロイドの様な強力な薬剤を含有させなくとも痒みが抑えられ湿疹も徐々に軽快すると言う現象を日々の診療で経験しているが、この場合は特に苔癬化した湿疹病変に効果が顕著であった。 In addition, as described above, the present inventor applied a strong moisturizing agent to the eczema site to completely block the affected area from external stimuli, so that itching is gradually suppressed without containing a powerful drug such as steroid, and eczema gradually The phenomenon of remission is experienced in daily medical care, and in this case, the effect was particularly remarkable for lichenoid eczema lesions.
 これらの現象を踏まえ、主薬に用いる銀イオンは特に急性刺激状態における炎症性紅斑や掻痒感に対して、スイゼンジノリ多糖体は、強力な保湿剤効果による慢性刺激状態における外的刺激遮断および抗炎症作用の目的で配合した。 Based on these phenomena, silver ions used as the main drug are especially against inflammatory erythema and pruritus in the acutely stimulated state, while suizendinori polysaccharides block external stimuli and have anti-inflammatory effects in the chronically stimulated state due to the strong moisturizing effect. For the purpose of.
 外用剤の基剤はワセリン主体の軟膏あるいは精製水に溶かしたローションを選択し、銀イオン水は安定性の高い株式会社TSSアクア製を用い、濃度は以下に示した様に真菌や細菌を死滅される濃度に合わせる為2ppm以上、またスイゼンジノリ多糖体は十分な保湿力と抗炎症作用を発揮させるため0.5%前後配合する。 The base of the external preparation is selected from vaseline-based ointment or lotion dissolved in purified water, and silver ion water is made by TSS Aqua Co., Ltd., which has high stability, and the concentration kills fungi and bacteria as shown below. In order to adjust to the concentration to be achieved, 2 ppm or more, and Suizendinori polysaccharides are blended around 0.5% in order to exert sufficient moisturizing power and anti-inflammatory action.
 銀イオンの抗菌効果の報告
1.高山正彦:J.Antibact.Antifung.Agents 24(8),561−567(1996).
 その他
 食環境衛生研究所における検証の結果
 試験番号:14121700
 レジオネラ菌 Ag水 1ppm6分、10ppm2分で除菌
 試験番号:14040119
 ネコカリシウイルス Ag水 10ppm 30秒で98.7%減少
 その他にも一般細菌:大腸菌群、ブドウ球菌群、緑膿菌、ピロリ菌、真菌などに同程度の低濃度で強い殺菌力あるとの多数の報告あり。
Report of antibacterial effect of silver ion Masahiko Takayama: J. Antibact. Antifung. Agents 24 (8), 561-567 (1996).
Other Results of verification at the National Institute of Food and Environmental Health Test number: 14121700
Legionella bacteria Ag water 1 ppm 6 minutes, 10 ppm 2 minutes to disinfect test number: 14040119
Feline calicivirus Ag water 10ppm Decrease of 98.7% in 30 seconds Other common bacteria: Escherichia coli, Staphylococcus, Pseudomonas aeruginosa, Helicobacter pylori, fungi, etc. Reported.
 サクラン(スイゼンジノリ多糖体)の抗炎症効果などに関する報告
1. Anti−inflammatory effects of sacran,a novel polysaccharide from Aphanothece sacrum,on 2,4,6−trinitrochlorobenzene−induced aller−gic dermatitis in vivo.Ngatu,N.R.,M.K.Okajima,M.Yokogawa,R.Hirota,M.Eitoku,B.A.Muzembo,N.Dumavibhat,M.Takaishi,S.Sano,T.Kaneko,T.Tanaka,H.Nakamura and N.Suganuma.Ann Allergy Asthma Immunol 108(2):117−122(2012).
2. Sacran,a natural skin barrier enhancer,improves atopic and contact eczema:Case report.Nlandu Roger Ngatu,Ryoji Hirota,Maiko Kaneko Okajima,Tetsuo Kaneko,Kaj Francoise Malonga,Narufumi Suganuma.Annals of Phytomedicine 4(1):111−113(2015).
Report on the anti-inflammatory effect of cherry (Suizendinori polysaccharide) Anti-inflammatory effects of sacran, a novel polysaccharide from Aphanothacea sacrum, on 2,4,6-trinitrochlorobenzene-induced allervidic dermatitis. Ngatu, N .; R. , M.M. K. Okajima, M .; Yokogawa, R .; Hirota, M .; Eitoku, B .; A. Muzembo, N.M. Dumavivhat, M.M. Takashi, S .; Sano, T .; Kaneko, T .; Tanaka, H .; Nakamura and N.K. Suganuma. Ann Allergy Asthma Immunol 108 (2): 117-122 (2012).
2. Sacran, a natural skin barrier enhancer, improve atomic and contact eczema: Case report. Nlandu Roger Ngatu, Ryoji Hirota, Maiko Kaneko Okajima, Tetsuo Kaneko, Kaj Francoise Malonga, Narufumi Suganuma. Anals of Phytomedicine 4 (1): 111-113 (2015).
 以下に本発明を含めた試作外用剤の臨床試験結果を記載する。
1.スイゼンジノリ多糖体単独配合軟膏、銀イオン水単独配合軟膏及び本発明との比較実験
対象:アトピー性皮膚炎患者
基剤:ワセリン、観察期間1ヶ月間
観察部位:紅斑および苔癬化部位、1日2回病変部に塗布
▲1▼スイゼンジノリ多糖体単独配合軟膏:スイゼンジノリ多糖体(0.5%)配合
     年齢   部位と苔癬化 痒み  紅斑  苔癬化 総合的効果
症例1  16歳 女性 顔面   少し軽快 少し軽快 −(*) やや有効
症例2   8歳 男児 肘部/苔癬化 不変  不変  少し軽快 やや有効
症例3  38歳 女性 顔面   少し軽快 少し軽快 −    やや有効
症例4   5歳 男児 大腿/苔癬化 不変 少し軽快 少し軽快   有効
症例5   3歳 女児 肩      不変  不変  −      無効
▲2▼銀イオン水単独配合軟膏(20ppm)
    年齢   部位と苔癬化  痒み  紅斑  苔癬化 総合的効果
症例1  16歳 女性 顔面     軽快 少し軽快 −    有効
症例2   8歳 男児 肘部/苔癬化 不変  不変  不変   無効
症例3  38歳 女性 顔面     軽快 少し軽快  −   有効
症例6   2歳 女児 陰部     軽快  軽快  −    著効
症例7  15歳 男性 膝窩   少し軽快 少し軽快 −  やや有効
症例8  11歳 女児 肘窩/苔癬化 不変 少し軽快 不変 やや有効
▲3▼本発明:銀イオン水(20ppm)、スイゼンジノリ多糖体(0.5%)配合
    年齢    部位と苔癬化  痒み   紅斑 苔癬化 総合的効果
症例1  16歳 女性 顔面     軽快   軽快   −     著効
症例2   8歳 男児 肘部/苔癬化 少し軽快 不変  少し軽快   有効
症例3 38歳 女性 顔面      軽快   軽快   −     著効
症例9  12歳 女児 膝窩     少し軽快 少し軽快 −   やや有効
症例10 10歳 男児 臀部/苔癬化 少し軽快 少し軽快     やや有効
症例11  2歳 女児 頚部     軽快   軽快   −     著効
症例12  2歳 女児 陰部     軽快   軽快   −     著効
*苔癬化の欄で(−)は苔癬化傾向が殆ど無い状態
The clinical trial results of the external preparation for trial production including the present invention are described below.
1. Comparison experiment with suizendinori polysaccharides alone ointment, silver ion water alone ointment and the present invention: Atopic dermatitis patient base: petrolatum, observation period 1 month observation site: erythema and lichenification site, 1 day 2 Applied to ileal lesions (1) ointment with suizendinori polysaccharide alone: suizendinori polysaccharide (0.5%) age age and lichenification itchiness erythema lichenification Overall effect case 1 16 years old female face a little light little a little- (*) Slightly effective case 2 8-year-old boy Elbow / Lossification unchanged No change Slightly effective case 3 38-year-old female Face A little improvement slightly improvement-Slightly effective case 4 5-year-old boy Thigh / lichenification No change Slight improvement Effective case 5 3-year-old girl Shoulder invariant Invariant-Ineffective ▲ 2 ▼ Ointment with silver ion water alone (20 ppm)
Age site and lichenification itching erythema lichenification Overall effect case 1 16 years old Female face slight improvement-effective case 2 8 years old boy Elbow / lichenification unchanged unchanged unchanged invalid 3 38 years old female facial improvement slightly improved- Effective case 6 2-year-old girl Genital remission Light-remarkable case 7 15-year-old male Poplite slightly relieved slightly relieved-Slightly effective case 8 11-year-old girl Elbow fossa / mossification Invariant slightly relieved Unchanged slightly effective (3) Present invention: Silver Ionized water (20ppm), Suizendinori polysaccharide (0.5%) combination Age site and lichenification Itching Erythema Lichenification Overall effect case 1 16 years Female Face light remission-Remarkable case 2 8 years old Male elbow / moss Slight amelioration Slight amelioration Slight amelioration Effective case 3 38-year-old female Face amelioration Relief-Remarkable case 9 12-year-old girl Poplite A little amelioration A little Pleasant-Slightly effective case 10 10-year-old boy Ridge / lichenization Slightly relieved Slightly relieved Slightly effective case 11 2-year-old girl Neck irritated Relief-Remarkable case 12 2-year-old girl -) Is almost no lichenification tendency
2.銀イオン水単独配合水の止痒効果の臨床試験
対象:老人性皮膚掻痒症
観察部位:皮疹が無く痒みがある部位、1日1回病変部に塗布
▲4▼銀イオン水(20ppm)
     年齢     部位   痒み          総合的効果
症例13 71歳 男性 体幹   軽快             有効
症例14 75歳 女性 背部   消失             著効
症例15 80歳 男性 体幹   軽快             有効
2. Clinical trial of antipruritic effect of water containing silver ion water alone: Senile skin pruritus Observation site: Site without rash and itching, applied once to the affected area (4) Silver ion water (20 ppm)
Age Site Itching Total effect case 13 71 years old Male trunk remission Effective case 14 75 years old Female Back disappearance Effective case 15 80 years old Male trunk remission effective
3.本発明についての使用後調査(2015年10月9日現在)
対象:乳幼児アトピー性皮膚炎の1歳から3歳までの乳幼児79例
試用期間:1ヶ月間
方法:患児の観察部位の皮疹に1日2回単純塗布させ、治療開始から1ヶ月間での有効性を患児の母親のアンケートを通して検討した。
それと平行して、患児に通常使用しているステロイド軟膏(*)と効果に関して同様な方法で比較検討した。
結果
  症例数    79例
1.著効     27例   34.2%
2.非常に有効  24例   30.3%
3.有効      9例   11.3%
4.やや有効    8例   10.1%
5.効果なし   10例   12.7%
6.悪化      1例    1.3%
有効以上 79例中60例   75.9%
ステロイド軟膏との比較
1. 本発明が対象ステロイド軟膏より強いと感じた人:14例 17.7%
2. 本発明が対象ステロイド軟膏と同程度と感じた人:31例 39.2%
3. 1+2→本発明が対象ステロイド軟膏と同等以上と感じた人:
                      79例中45例 57.0%
*対象ステロイド軟膏(クロベタゾン酪酸エステル0.05%軟膏とワセリンを1:1に混合した軟膏)
3. Post-use survey for the present invention (as of October 9, 2015)
Subjects: 79 infants aged 1 to 3 years with infantile atopic dermatitis Trial period: 1 month Method: Simple application twice a day to the skin rash on the patient's observation site, effective for 1 month from the start of treatment Sex was examined through questionnaires of mothers of children.
In parallel with this, the same method was used for comparison with the steroid ointment (*) normally used for children.
Results Number of cases 79 cases Excellent effect 27 cases 34.2%
2. Very effective 24 cases 30.3%
3. Effective 9 cases 11.3%
4). Slightly effective 8 cases 10.1%
5). No effect 10 cases 12.7%
6). Deterioration 1 case 1.3%
More than effective 60 out of 79 cases 75.9%
Comparison with steroid ointment Persons who felt that the present invention was stronger than the target steroid ointment: 14 cases 17.7%
2. People who felt that the present invention was comparable to the target steroid ointment: 31 cases 39.2%
3. 1 + 2 → Person who feels the present invention is equal to or better than the target steroid ointment:
45 of 79 cases 57.0%
* Target steroid ointment (clobetasone butyrate 0.05% ointment and vaseline mixed 1: 1)
臨床試験のまとめ
 ▲1▼のスイゼンジノリ多糖体単独配合軟膏と▲2▼の銀イオン水単独配合軟膏との比較では、苔癬化部位に関しては▲1▼の方がやや効果的であり、急性刺激状態にある部位に関しては▲2▼の方がやや効果的であった。
 それに対して▲3▼の本発明は、それぞれの軟膏の単独効果より有効性が高く、総合評価では有効以上が75.9%と非常に高評価であった。
 また本発明は、対象ステロイド軟膏との直接比較で、同程度以上の強さとの評価が57.0%であった。
 また皮膚掻痒症の痒みに対して銀イオン水は非常に効果的であった。
 なお本発明は第115回皮膚科学会総会にて発表した。
Summary of clinical trials In comparison of (1) ointment containing suizendinori polysaccharide alone and (2) ointment containing silver ion water alone, (1) is slightly more effective for the lichenification site, and acute irritation Regarding the part in the state, (2) was slightly more effective.
On the other hand, the present invention (3) was more effective than the single effect of each ointment, and the overall evaluation was very high with 75.9% or more effective.
In the present invention, the evaluation of the same or higher strength was 57.0% in direct comparison with the subject steroid ointment.
Silver ion water was very effective against pruritus pruritus.
The present invention was announced at the 115th General Meeting of Dermatological Association.
 また水素は細胞の酸化を食い止める抗炎症作用、抗酸化作用があることが報告されているが、本発明の湿疹・皮膚炎に対する臨床効果を高めるために水素を加えたものと加えないものとで比較試験を実施したところ、以下の様に有意な差が認められた。この結果は第67回日本皮膚科学会中部支部学術大で発表する予定である。
1.水素水を加えない本発明の湿疹・皮膚炎に対する試用結果
    症例数   80症例
    1.著効     19例   23.7%
    2.非常に有効  41例   51.3%
    3.有効      7例    8.8%
    4.やや有効    5例    6.2%
    5.不変      8例   10.0%
    6.悪化      0例      0%
    有効以上 67例/80例   83.8%
2.水素水を加えた本発明の湿疹・皮膚炎に対する試用結果
    症例数   39症例
    1.著効      8例   20.5%
    2.非常に有効  26例   66.6%
    3.有効      3例    7.7%
    4.やや有効    1例    2.6%
    5.不変      1例    2.6%
    6.悪化      0例      0%
    有効以上 37例/39例   94.9%
In addition, hydrogen has been reported to have anti-inflammatory and anti-oxidant effects that inhibit cell oxidation, but with or without hydrogen added to enhance the clinical effect on eczema / dermatitis of the present invention. When a comparative test was conducted, the following significant differences were observed. The results will be presented at the 67th Japan Dermatological Association Chubu Branch Academic University.
1. Trial results for eczema / dermatitis of the present invention without adding hydrogen water Number of cases 80 cases Excellent effect 19 cases 23.7%
2. Very effective 41 cases 51.3%
3. Effective 7 cases 8.8%
4). Slightly effective 5 cases 6.2%
5). Unchanged 8 cases 10.0%
6). 0 cases 0%
More than effective 67 cases / 80 cases 83.8%
2. Trial results for eczema / dermatitis of the present invention to which hydrogen water was added Number of cases 39 cases 8 cases 20.5%
2. Very effective 26 cases 66.6%
3. Effective 3 cases 7.7%
4). Slightly effective 1 case 2.6%
5). Unchanged 1 example 2.6%
6). 0 cases 0%
More than effective 37/39 94.9%
 本発明はステロイド外用剤の様な強力に湿疹を治す効果(止痒効果、抗炎症効果および細胞増殖抑制効果など)の他に銀イオン本来の殺菌作用があり、ステロイド外用剤の欠点である易感染性の問題も解決出来、また防腐剤を添加する必要が無いため安全性の面で有利であるなどステロイド外用剤より有用性が高いと考えられる。 The present invention has a bactericidal action inherent to silver ions in addition to the effects of remedying eczema as powerfully as a steroid topical preparation (antipruritic effect, anti-inflammatory effect, cell growth inhibitory effect, etc.), and is a disadvantage of a steroid external preparation. The infectivity problem can be solved, and it is not necessary to add a preservative, which is advantageous in terms of safety.
 特に湿疹病変と皮膚感染症が併発した様な状態、伝染性膿痂疹や寄生菌性紅斑、脂漏性皮膚炎など、ステロイド外用剤や抗菌剤の単独使用ではなかなかコントロールできない皮膚疾患にも、本発明だけで軽快させることが出来、その点においてもステロイド外用剤より有用であると言える。 Especially for skin diseases that are difficult to control with the use of topical steroids or antibacterial agents alone such as eczema lesions and skin infections, infectious impetigo, parasitic erythema, seborrheic dermatitis, It can be ameliorated only by the present invention, and in that respect, it can be said that it is more useful than a steroid external preparation.
 ステロイド外用剤の副作用の問題により消費が低迷している医療業界にあって、この副作用がなくステロイド外用剤と同等以上の効果がある外用剤が製品化されれば、患者も処方する医者も安心して使うことが出来るため、皮膚科を中心に湿疹の治療を行っている医療機関にとっては大きな消費が生まれ収入増が見込まれる。 In the medical industry, where consumption is sluggish due to the side effects of topical steroids, patients and prescribing doctors will be safe if an external preparation that does not have these side effects and is at least as effective as steroids. Because it can be used with heart, medical institutions that treat eczema, mainly in dermatology, will generate significant consumption and increase income.

Claims (3)

  1.  主薬に銀イオン水及び保湿成分を配合した非ステロイド外用剤の発明。 Invention of a non-steroidal external preparation that contains silver ion water and a moisturizing ingredient in the active ingredient.
  2.  主薬の保湿成分にスイゼンジノリ多糖体を配合した請求項1の発明。 The invention of claim 1, wherein a suizendinori polysaccharide is blended in the moisturizing component of the active ingredient.
  3.  主薬に水素水を配合した請求項1,2の発明。 The inventions of claims 1 and 2, wherein the active ingredient is mixed with hydrogen water.
PCT/JP2016/077351 2015-09-30 2016-09-01 Non-steroidal preparation for external use comprising silver ion and aphanothece sacrum polysaccharide WO2017057032A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2017543128A JPWO2017057032A1 (en) 2015-09-30 2016-09-01 Non-steroidal external preparation containing silver ion and suizendinori polysaccharide

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2015206736 2015-09-30
JP2015-206736 2015-09-30

Publications (1)

Publication Number Publication Date
WO2017057032A1 true WO2017057032A1 (en) 2017-04-06

Family

ID=58427703

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2016/077351 WO2017057032A1 (en) 2015-09-30 2016-09-01 Non-steroidal preparation for external use comprising silver ion and aphanothece sacrum polysaccharide

Country Status (2)

Country Link
JP (1) JPWO2017057032A1 (en)
WO (1) WO2017057032A1 (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1685824A1 (en) * 2005-01-30 2006-08-02 Or-Le-Or Ltd. Cosmetic composition
JP2009007266A (en) * 2007-06-27 2009-01-15 Shin-Ei Chemical Co Ltd Silver ion water for cosmetic and low-irritant cosmetic using the same
JP2010275241A (en) * 2009-05-29 2010-12-09 Blue Mercury Co Ltd Therapeutic agent or prophylactic agent for allergic disease
WO2015076244A1 (en) * 2013-11-19 2015-05-28 国立大学法人熊本大学 Anti-inflammatory agent using low-molecular-weight polysaccharide from aphanothece sacrum

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1685824A1 (en) * 2005-01-30 2006-08-02 Or-Le-Or Ltd. Cosmetic composition
JP2009007266A (en) * 2007-06-27 2009-01-15 Shin-Ei Chemical Co Ltd Silver ion water for cosmetic and low-irritant cosmetic using the same
JP2010275241A (en) * 2009-05-29 2010-12-09 Blue Mercury Co Ltd Therapeutic agent or prophylactic agent for allergic disease
WO2015076244A1 (en) * 2013-11-19 2015-05-28 国立大学法人熊本大学 Anti-inflammatory agent using low-molecular-weight polysaccharide from aphanothece sacrum

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
FLUHR, J.W. ET AL.: "Silver-loaded seaweed-based cellulosic fiber improves epidermal skin physiology in atopic dermatitis: safety assessment, mode of action and controlled, randomized single-blinded exploratory in vivo study", EXP. DERMATOL., vol. 19, no. 8, 2010, pages e9 - e15, XP055189157, ISSN: 0906-6705 *
KECK, C.M. ET AL.: "Silver-nanolipid complex for application to atopic dermatitis skin: rheological characterization, in vivo efficiency and theory of action", J. BIOMED. NANOTECHNOL., vol. 5, no. 4, 2009, pages 428 - 436, ISSN: 1550-7033 *
TASKAPAN, M.O. ET AL.: "Role of staphylococcal superantigens in atopic dermatitis: from colonization to inflammation", ANN. ALLERGY ASTHMA IMMUNOL., vol. 84, no. 1, 2000, pages 3 - 10, XP026957967, ISSN: 1081-1206 *

Also Published As

Publication number Publication date
JPWO2017057032A1 (en) 2018-07-12

Similar Documents

Publication Publication Date Title
US6911196B2 (en) Topical medicament for treating nappy rash
CN108853312A (en) Lauromacrogol external-use gel and preparation method thereof
EA032439B1 (en) Compositions and methods for treating surface wounds
JP2011522831A (en) Acne treatment composition containing nanosilver and use thereof
US20100284951A1 (en) Novel compositions for the treatment of wounds and skin care
WO2008104076A1 (en) Electrocolloidal silver and echinacea root antimicrobial formulation
US20190216871A1 (en) Diabetic foot cream
US20140271920A1 (en) Skin ointment formulation
US6399108B1 (en) Compositions and methods for the treatment of skin disorders
US20110165276A1 (en) Composition for burn treatment
WO2017057032A1 (en) Non-steroidal preparation for external use comprising silver ion and aphanothece sacrum polysaccharide
US20060105064A1 (en) Composition for treating skin ulcers
US10702569B2 (en) Compositions and methods for treatment of pain
WO2017020036A1 (en) Composition and related methods for treatment of pilosebaceous diseases
US20030092682A1 (en) Use of doxycycline for treatment of certain skin and mouth ailments
EP2883541B1 (en) Composition for topical use comprising hyaluronic acid
WO2019175902A1 (en) A topical preparation for various skin ailments
Jayapal et al. Evaluation of skin-irritancy potential of a skin ointment containing the essential oil of ocimum sanctum l (Basil/Thulasi) leaves in Wistar albino rats
Mansour et al. A botanical nano ozonated composition with maximum bioavailability for burns
CN1124849C (en) Nail health disinfecting liquid
RU2416403C2 (en) Method of acne vulgaris treatment
US20220175703A1 (en) Compositions and Methods of Achieving Pain Relief
US20190117559A1 (en) Method of treating inflammation and promoting wound healing
Clyman Comparative effects of hydrocortisone and hydrocortisone-coal tar extract creams in cases of atopic dermatitis
GR1009906B (en) Paste for the prevention and therapy of bedsores and decubitus ulcers - production method thereof

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16851206

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2017543128

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16851206

Country of ref document: EP

Kind code of ref document: A1