WO2018203380A1 - Brown algae extract-containing composition, and brown algae extract-containing hemorrhoid treatment and prevention liquid - Google Patents

Brown algae extract-containing composition, and brown algae extract-containing hemorrhoid treatment and prevention liquid Download PDF

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Publication number
WO2018203380A1
WO2018203380A1 PCT/JP2017/017208 JP2017017208W WO2018203380A1 WO 2018203380 A1 WO2018203380 A1 WO 2018203380A1 JP 2017017208 W JP2017017208 W JP 2017017208W WO 2018203380 A1 WO2018203380 A1 WO 2018203380A1
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brown algae
weight
extract
algae extract
containing composition
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PCT/JP2017/017208
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French (fr)
Japanese (ja)
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増村光一郎
黒部耕司
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ラムズ・マークス株式会社
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Priority to PCT/JP2017/017208 priority Critical patent/WO2018203380A1/en
Publication of WO2018203380A1 publication Critical patent/WO2018203380A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41661,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • 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
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • 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
    • A61K36/03Phaeophycota or phaeophyta (brown algae), e.g. Fucus
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/886Aloeaceae (Aloe family), e.g. aloe vera
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/01Hydrolysed proteins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/14Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Definitions

  • the present invention relates to a gel-like or liquid brown algae extract-containing composition containing a brown algae extract as a main component, and a brown algae extract-containing acupuncture prevention liquid.
  • When a manic disease develops, it is generally embarrassed to go to the hospital because the diseased part is the anus, and it is common to deal with a commercially available medicine for manic diseases.
  • an external medicine for treating hemorrhoid disease for example, (a) 0.01 to 0.3% by mass of a refreshing agent, (b) 0.1 to 10% by mass of a gelling agent, and (c) 1 alcohol.
  • An agent for treating gel-like hemorrhoids containing 10 to 10% by mass, (d) 50 to 98% by mass of water, and (e) 3% by mass or less of a local anesthetic is disclosed (see Patent Document 1).
  • drugs for treating hemorrhoids include local anesthetic components such as lidocaine and dibucaine as described in Patent Document 1, and those that temporarily relieve pain, and refresher components such as menthol and camphor. There are those that have the effect of temporarily relieving itching of manic diseases.
  • a local anesthetic component or a refreshing agent component temporarily removes discomfort of a manic disease such as pain and itch, but cannot be an active ingredient for preventing or treating manic disease. Therefore, these drugs for treating hemorrhoids are only used as coping therapy drugs, and eventually, when the hemorrhoids worsen, there is a current situation in which surgical treatment is unavoidable by anal surgery or the like.
  • the present invention was devised in view of the above circumstances, and contains a brown alga extract-containing composition containing at least a brown algae extract as an active ingredient in order to prevent the induction of an epilepsy disease or to improve an epilepsy disease, and
  • the purpose is to provide a brown algae extract-containing acupuncture prevention liquid.
  • the brown algae extract-containing composition according to the present invention comprises a brown algae extract having a solid content of 0.10 to 10.00% by weight excluding moisture as a main component, and is medically acceptable as a remaining component. It is characterized by containing various components. Brown algae extract contains fucoidan, amino acid, diastase, alginic acid, and abundant minerals, and has been reported to have external effects such as moisturizing action and skin regenerating action. Therefore, the reason why the brown algae extract is a main component is that external effects such as a moisturizing action and a skin regenerating action are active ingredients for leprosy.
  • the remaining components include water, ethanol and the like and are medically acceptable components.
  • the brown algae extract is contained in a solid content of 0.10% by weight or more is that if it is less than 0.10%, a sufficient effect as an active ingredient of a manic disease cannot be obtained.
  • the brown algae extract is contained in an amount of 10.00% by weight or less as the solid content because if it exceeds 10.00% by weight, it is difficult to adjust the remaining components.
  • the solid content of the brown algae extract is preferably 0.10 to 3.00% by weight.
  • the reason why the solid content of the brown algae extract is set in the range of 0.10 to 3.00% by weight is that a particularly effective effect is obtained in this range.
  • the remaining component comprises at least 0.10 to 10.00% by weight of anti-inflammatory agent, 0.20 to 10.00% by weight of aloe extract, and 0.10 to 5.00% by weight of soluble protein component. It is preferable to contain.
  • the reason for containing the anti-inflammatory agent is to suppress inflammation of the manic disease.
  • the reason for containing 0.10% by weight or more of the anti-inflammatory agent is that if it is less than 0.10% by weight, it is difficult to obtain anti-inflammatory effects.
  • the reason why the anti-inflammatory agent is contained in an amount of 10.00% by weight or less is that when the amount exceeds 10.00% by weight, no difference is observed in the anti-inflammatory effect.
  • Aloe extract contains plant phenolic components such as aloin, polysaccharides components such as aloe mannan and gluconic acid, and other components such as aloetin, and also contains brown algal extract. It is because it can become an active ingredient.
  • Plant phenolic components have been reported to have external effects such as sedation and analgesia, bacterial growth inhibition, and enzyme activity suppression.
  • external effects such as skin beautification, wound healing, anti-inflammatory and sterilization have been reported for polysaccharide components.
  • aloetin has a strong antibacterial and antifungal effect for external use.
  • the reason why the aloe extract is contained by 0.20% by weight or more is that if it is less than 0.20% by weight, it is difficult to obtain an effect as an active ingredient.
  • the reason why Aloe extract is contained in an amount of 10.00% by weight or less is that no difference is observed in the efficacy as an active ingredient even if the amount exceeding 10.00% by weight is added.
  • the reason why the soluble protein component is contained is to promote the penetration into the skin.
  • the reason why the soluble protein component is contained in an amount of 0.10% by weight or more is that the permeability to the skin is inferior when the content is less than 0.10% by weight.
  • the reason why the soluble protein component is contained at 5.00% by weight or less is that no difference is observed in the permeability to the skin even if an amount exceeding 5.00% by weight is added.
  • the anti-inflammatory agent preferably contains at least one of glycyrrhizic acid 2K and allantoin.
  • the reason why the anti-inflammatory agent contains at least one kind of glycyrrhizic acid 2K and allantoin is that an anti-inflammatory effect can be obtained by including any of these components.
  • the aloe extract preferably contains at least one kind of aloe vera mesophyll, kidachi aloe mesophyll, cape aloe mesophyll, aloe vera leaf extract, kidachi aloe leaf extract, cape aloe leaf extract.
  • the aloe extract contains at least one of aloe vera mesophyll, kidachi aloe mesophyll, cape aloe mesophyll, aloe vera leaf extract, kidachi aloe leaf extract, cape aloe leaf extract. It is because the effect as is obtained. In order to increase the efficacy as an active ingredient, it is preferable to use a combination of a plurality of ingredients.
  • the soluble protein component is preferably hydrolyzed silk.
  • hydrolyzed silk By using hydrolyzed silk as the soluble protein component, good permeability to the skin can be ensured.
  • the brown algae extract-containing acupuncture prevention liquid according to the present invention is characterized in that the brown algae extract-containing composition according to any one of the above is used as a treatment prevention liquid for an epilepsy disease.
  • the brown algae extract-containing composition according to any of the above is used as a treatment / prevention solution for hemorrhoid disease.
  • the brown algae extract-containing composition according to the present invention, it contains at least a brown algae extract as an active ingredient, and can prevent the induction of epilepsy disease or promote improvement even if it has developed epilepsy disease. Demonstrate the excellent effect of being able to.
  • the brown algae extract according to the present embodiment is an extract extracted from brown algae such as mozuku, wakame and kelp. Seaweeds include green algae, brown algae, and red algae. In this embodiment, it is particularly preferable to use an extract of brown algae.
  • the extraction method of the brown algae extract is not limited, but it is preferable to remove harmful low-molecular substances such as arsenic. Therefore, although it is preferable to use a high molecular weight extract as the brown algae extract, it is not limited to this.
  • Brown algae extract contains fucoidan, amino acid, diastase, alginic acid, and abundant minerals, and has been reported to have external effects such as moisturizing action and skin regenerating action.
  • fucoidan a sulfated polysaccharide composed mainly of full-course sugar, has antitumor, anti-gastric ulcer, antiviral, anti-inflammatory, anticoagulant, immune enhancement, anti-type I allergy, antihyperlipidemia, etc. It has been reported to have various pharmacological actions (JP 2002-220402 A). Fucoidan is also used as a moisturizing ingredient in cosmetics and the like. Therefore, the brown algae extract-containing composition according to the present embodiment has the brown algae extract as a main component because external effects such as a moisturizing action and a skin regenerating action are effective ingredients for leprosy.
  • the brown algae extract-containing composition according to the present invention comprises a brown algae extract having a solid content of 0.10 to 10.00% by weight excluding moisture as a main component, and a medically acceptable component such as water or ethanol as a remaining component. contains.
  • the remaining components include at least 0.10 to 10.00% by weight of anti-inflammatory agent, 0.20 to 10.00% by weight of aloe extract (aloe leaf meat powder and / or aloe leaf extract), and 0 It is preferable to contain 10 to 5.00% by weight of a soluble protein component.
  • the solid content of the brown alga extract is preferably 0.10 to 3.00% by weight.
  • FIG. 1 shows the results of efficacy confirmation tests of Examples 1 to 5 and Comparative Examples 1 to 3.
  • the solid content of the brown algae extract as the main component is changed in the range of 0.5 to 15.0% by weight, and the remaining amount contains purified water and absolute ethanol.
  • the composition of the brown algae extract-containing composition of Example 1 is as follows.
  • the composition of the brown algae extract-containing composition of Example 2 is as follows. (Example 2) Solid content of brown algae extract: 3.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 3 is as follows. (Example 3) Solid content of brown algae extract: 5.0% by weight Purified water and absolute ethanol: remaining
  • Example 4 Solid content of brown algae extract: 10.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 5 is as follows. (Example 5) Solid content of brown algae extract: 15.0% by weight Purified water and absolute ethanol: remaining
  • composition of the brown algae extract-containing composition of Comparative Example 1 is as follows. (Comparative Example 1) Solid content of brown algae extract: 0.05% by weight Purified water and absolute ethanol: remaining
  • composition of the brown algae extract-containing composition of Comparative Example 2 is as follows. (Comparative Example 2) Solid content of brown algae extract: 0.08% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Comparative Example 3 is as follows. (Comparative Example 3) Solid content of brown algae extract: 0.09 wt% Purified water and absolute ethanol: remaining
  • the brown algae extract-containing compositions of practical examples 1 to 5 by containing the solid content of the brown algae extract as the main component in the range of 0.10 to 15.00% by weight, the effect of improving the hemorrhoid disease was confirmed. Further, it was confirmed that the solid content of the brown algae extract is more preferably in the range of 0.10 to 3.00% by weight. However, the solid content of the brown algae extract is preferably set to 10.00 weight or less. Even if the solid content of the brown algae extract as the main component exceeds 10.00% by weight, there is no difference in the efficacy of the active ingredient, and if it exceeds 10.00% by weight, it will be difficult to adjust the remaining components described later. is there.
  • the solid content of the brown algae extract as the main component is appropriately set in the range of 0.05 wt% to 10.0 wt%, and the anti-inflammatory agent, aloe extract, and soluble protein component as the remaining components The content was examined.
  • FIG. 2 shows the results of the efficacy confirmation tests of Examples 6 to 11 and Comparative Examples 4 to 6.
  • the solid content of the brown algae extract as the main component is appropriately set in the range of 0.05 to 10.0% by weight, and the anti-inflammatory agent is in the range of 0.05 to 15.0% by weight.
  • the content is changed, and the remaining amount contains purified water and absolute ethanol.
  • the amount of aloe extract is set to 0% or 5.0% by weight
  • the amount of soluble protein is set to 0% or 3.0% by weight.
  • the composition of the brown algae extract-containing composition of Example 6 is as follows. (Example 6) Solid content of brown algae extract: 0.10% by weight Anti-inflammatory agent: 0.10% by weight Aloe extract: 5.0% by weight Soluble protein: 3.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 7 is as follows. (Example 7) Solid content of brown algae extract: 3.0% by weight Anti-inflammatory agent: 0.50% by weight Aloe extract: 0% by weight Soluble protein: 0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 8 is as follows. (Example 8) Solid content of brown algae extract: 5.0% by weight Anti-inflammatory agent: 5.0% by weight Aloe extract: 5.0% by weight Soluble protein: 3.0% by weight Purified water and absolute ethanol: remaining
  • Example 9 Solid content of brown algae extract: 10.0% by weight Anti-inflammatory agent: 10.0% by weight Aloe extract: 0% by weight Soluble protein: 0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 10 is as follows. (Example 10) Solid content of brown algae extract: 10.0% by weight Anti-inflammatory agent: 15.0% by weight Aloe extract: 5.0% by weight Soluble protein: 3.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Comparative Example 4 is as follows. (Comparative Example 4) Solid content of brown algae extract: 0.05% by weight Anti-inflammatory agent: 0.05% by weight Aloe extract: 0% by weight Soluble protein: 0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Comparative Example 5 is as follows. (Comparative Example 5) Solid content of brown algae extract: 0.08% by weight Anti-inflammatory agent: 0.08% by weight Aloe extract: 5.0% by weight Soluble protein: 3.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Comparative Example 6 is as follows. (Comparative Example 6) Solid content of brown algae extract: 0.09 wt% Anti-inflammatory agent: 0.09% by weight Aloe extract: 0% by weight Soluble protein: 0% by weight Purified water and absolute ethanol: remaining
  • an anti-inflammatory agent contained in the range of 0.10 to 15.0% by weight was effective in improving hemorrhoid disease.
  • the anti-inflammatory agent should be set in the range of 0.10 to 10.0% by weight. Is preferred.
  • an anti-inflammatory agent contains at least 1 sort (s) of glycyrrhizic acid 2K and allantoin, for example.
  • anti-inflammatory agents examples include glycyrrhizic acid 2K and allantoin, but are not limited to these exemplified agents, and are not intended to exclude other anti-inflammatory agents such as aminosalicylic acid and difuranisal.
  • FIG. 3 shows the results of efficacy confirmation tests of Examples 11 to 15 and Comparative Examples 7 to 9.
  • the solid content of the brown algae extract as the main component is appropriately set in the range of 0.05 wt% to 10.0 wt%, and the aloe extract is set in the range of 0.05 to 15.0 wt%.
  • the content is changed, and the remaining amount contains purified water and absolute ethanol.
  • the compounding amount is set to 0% or 5.0% by weight for the anti-inflammatory agent and 0% or 3.0% by weight for the soluble protein.
  • the composition of the brown algae extract-containing composition of Example 11 is as follows. (Example 11) Solid content of brown algae extract: 0.10% by weight Anti-inflammatory agent: 5.0% by weight Aloe extract: 0.20% by weight Soluble protein: 3.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 12 is as follows. (Example 12) Solid content of brown algae extract: 3.0% by weight Anti-inflammatory agent: 0% by weight Aloe extract: 3.0% by weight Soluble protein: 0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 13 is as follows. (Example 13) Solid content of brown algae extract: 5.0% by weight Anti-inflammatory agent: 5.0% by weight Aloe extract: 5.0% by weight Soluble protein: 3.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 14 is as follows. (Example 14) Solid content of brown algae extract: 10.0% by weight Anti-inflammatory agent: 0% by weight Aloe extract: 10.0% by weight Soluble protein: 0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 15 is as follows. (Example 15) Solid content of brown algae extract: 10.0% by weight Anti-inflammatory agent: 5.0% by weight Aloe extract: 15.0% by weight Soluble protein: 3.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Comparative Example 7 is as follows. (Comparative Example 7) Solid content of brown algae extract: 0.05% by weight Anti-inflammatory agent: 0% by weight Aloe extract: 0.05% by weight Soluble protein: 0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Comparative Example 8 is as follows. (Comparative Example 8) Solid content of brown algae extract: 0.08% by weight Anti-inflammatory agent: 5.0% by weight Aloe extract: 0.08% by weight Soluble protein: 3.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Comparative Example 9 is as follows. (Comparative Example 9) Solid content of brown algae extract: 0.09 wt% Anti-inflammatory agent: 0% by weight Aloe extract: 0.10% by weight Soluble protein: 0% by weight Purified water and absolute ethanol: remaining
  • an aloe extract contains at least 1 sort (s), for example, an aloe vera mesophyll powder, Kidachi aloe mesophyll powder, a cape aloe mesophyll powder, an aloe vera leaf extract, a Kidachi aloe leaf extract, and a cape aloe leaf extract.
  • s for example, an aloe vera mesophyll powder, Kidachi aloe mesophyll powder, a cape aloe mesophyll powder, an aloe vera leaf extract, a Kidachi aloe leaf extract, and a cape aloe leaf extract.
  • a combination of a plurality of aloe extract components in the range of 0.20 to 10.00% by weight.
  • FIG. 4 shows the results of the efficacy confirmation test of Examples 16 to 20 and Comparative Examples 10 to 12.
  • the solid content of the brown alga extract as the main component is appropriately set in the range of 0.05% to 10.0% by weight, and the soluble protein is contained in the range of 0.05 to 10.0% by weight.
  • the amount is varied and the remaining amount contains purified water and absolute ethanol.
  • the compounding amount is set to 0% by weight or 5.0% by weight for the anti-inflammatory agent and 0% by weight or 5.0% by weight for the aloe extract.
  • the composition of the brown algae extract-containing composition of Example 16 is as follows. (Example 16) Solid content of brown algae extract: 0.10% by weight Anti-inflammatory agent: 5.0% by weight Aloe extract: 5.0% by weight Soluble protein: 0.10% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 17 is as follows. (Example 17) Solid content of brown algae extract: 3.0% by weight Anti-inflammatory agent: 0% by weight Aloe extract: 0% by weight Soluble protein: 3.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 18 is as follows. (Example 18) Solid content of brown algae extract: 5.0% by weight Anti-inflammatory agent: 5.0% by weight Aloe extract: 5.0% by weight Soluble protein: 5.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 19 is as follows. (Example 19) Solid content of brown algae extract: 10.0% by weight Anti-inflammatory agent: 0% by weight Aloe extract: 0% by weight Soluble protein: 6.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Example 20 is as follows. (Example 20) Solid content of brown algae extract: 10.0% by weight Anti-inflammatory agent: 5.0% by weight Aloe extract: 5.0% by weight Soluble protein: 10.0% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Comparative Example 10 is as follows. (Comparative Example 10) Solid content of brown algae extract: 0.05% by weight Anti-inflammatory agent: 0% by weight Aloe extract: 0% by weight Soluble protein: 0.05% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Comparative Example 11 is as follows. (Comparative Example 11) Solid content of brown algae extract: 0.08% by weight Anti-inflammatory agent: 5.0% by weight Aloe extract: 5.0% by weight Soluble protein: 0.08% by weight Purified water and absolute ethanol: remaining
  • the composition of the brown algae extract-containing composition of Comparative Example 12 is as follows. (Comparative Example 12) Solid content of brown algae extract: 0.09 wt% Anti-inflammatory agent: 0% by weight Aloe extract: 0% by weight Soluble protein: 0.09% by weight Purified water and absolute ethanol: remaining
  • the soluble protein contained in the range of 0.10 to 10.00% by weight was effective in improving manic diseases.
  • the soluble protein is preferably set in the range of 0.10 to 5.0% by weight.
  • a soluble protein is a hydrolysis silk, for example, it is not the meaning which excludes soluble proteins other than the illustrated hydrolysis silk.
  • the brown algae extract-containing composition according to the present embodiment can be used as a treatment / prevention solution for hemorrhoid diseases by applying it to the anus.
  • an efficacy test was performed on 50 subjects. Although the number of subjects is as small as 50, since the hemorrhoid disease is a disease that develops in the anus, there is a current situation that subjects are difficult to gather due to the nature of the disease.
  • FIG. 5 shows a state outside the anus of the subject.
  • 1 is an anus
  • 2 is wart
  • 3 is cut
  • 4 is itchy
  • 5 is a symptom of swelling.
  • FIG. 5 when classified according to the symptoms of the anal region, there are 3 injuries, 18 in one wart, 5 in 2 warts, 4 in warts, 4 in many warts, cuts / swells / itchiness There were 29 people.
  • the test subject who has a symptom of cutting, swelling, and itch partially overlaps with a test subject having other symptoms.
  • FIG. 6 shows the state of the anus of the subject before using the brown algae extract-containing composition as a treatment / prevention solution for hemorrhoid diseases.
  • 11 were less than 1 year ago, 18 were less than 1-5 years ago, 11 were less than 6-19 years ago, and 10 were more than 20 years ago. It was a person.
  • the test subject who has a symptom of cutting, swelling, and itch partially overlaps with a test subject having other symptoms.
  • FIG. 7 shows the usage frequency of the subject. As shown in FIG. 7, when classified according to frequency of use, 38 people once a day, 10 people twice a day, 0 people more than 3 times a day, 1 person every 2 to 3 days, 4 One person per day or more.
  • FIG. 8 shows the usage period of the subject. As shown in FIG. 8, when classified according to the period of use, 1 to 3 days are 0 people, 4 to 10 days are 15 people, 11 to 20 days are 27 people, 21 to 30 days are 4 people, 30 There were four people over the day.
  • FIG. 9 shows the state of the anus of the subject after using the brown algae extract-containing composition as a treatment / prevention solution for hemorrhoid diseases.
  • the brown algae extract-containing acupuncture prevention liquid As shown in FIG. 9, when classified according to the state of the anus after using the brown algae extract-containing acupuncture prevention liquid, there were 11 people who were considerably swollen, 12 people who were slightly swollen, and bleeding stopped There were 10 people, 9 people who stopped itching, 6 people who did not change much, and 2 people who did not change or deteriorated. Therefore, 42 of 50 test subjects, that is, 84%, had an improvement effect on epilepsy.
  • the brown algae extract-containing composition according to the present embodiment is mainly composed of a brown algae extract having a solid content of 0.10 to 10.00% by weight excluding moisture, and the remaining components are at least 0.10 to Contains 10.00 wt% anti-inflammatory agent, 0.20-10.00 wt% aloe extract, and 0.10-5.00 wt% soluble protein component.
  • the brown algae extract-containing composition according to the present embodiment by using it as a treatment / prevention solution for hemorrhoid disease, induction of hemorrhoid disease can be prevented and improvement is promoted even when epilepsy disease has developed. Can do.
  • the brown algae extract-containing composition according to the present embodiment contains a brown algae extract as an active ingredient as a main component, and contains at least an anti-inflammatory agent, an aloe extract, and a soluble protein component as the remaining components.
  • the above remaining components include water, ethanol and the like and are medically acceptable components, but may contain a preservative such as phenoxyethanol, for example. By containing a preservative, it is possible to prevent mold from occurring in the composition.
  • a preservative is not limited to the illustrated chemical
  • the brown alga extract containing composition which concerns on this embodiment may contain gelling agents, such as a suntan gum, for example.
  • gelling agents such as a suntan gum
  • the gelling agent is not limited to the exemplified drugs, and other gelling agents such as gellan gum may be used.
  • the present invention can be implemented in various modes different from the above-described embodiments without departing from the gist thereof.
  • the brown algae extract-containing composition and the brown algae extract-containing acupuncture preventive solution according to the present invention can prevent the induction of hemorrhoid disease or can promote improvement even if it has developed an epilepsy disease. Is expected to be widely applied as a composition that meets the standards for pharmaceuticals and quasi drugs in the Pharmaceutical Affairs Law.

Abstract

The present invention realizes a brown algae extract-containing composition that at least contains a brown algae extract as an active ingredient and that is able to prevent induction of a hemorrhoid disease and promote improvement in a case where a hemorrhoid disease develops. The brown algae extract-containing composition includes, as a main ingredient, a brown algae extract in which the solid content excluding the moisture content accounts for 0.10-10.00 wt%, and includes, as the remaining ingredients, water, ethanol, and the like, and contains medically allowable ingredients. The remaining ingredients at least contain 0.10-10.00 wt% of an anti-inflammatory agent, 0.20-10.00 wt% of an aloe extract, and 0.10-5.00 wt% of a soluble protein component.

Description

褐藻エキス含有組成物、および褐藻エキス含有痔治療予防液Brown algae extract-containing composition and brown algae extract-containing acupuncture prevention liquid
 本発明は、褐藻エキスを主成分として含有するゲル状もしくは液状の褐藻エキス含有組成物、および褐藻エキス含有痔治療予防液に関する。 The present invention relates to a gel-like or liquid brown algae extract-containing composition containing a brown algae extract as a main component, and a brown algae extract-containing acupuncture prevention liquid.
 近年の温水洗浄機能付き便座や便器の普及は、痔疾患の予防や改善に貢献している。ちり紙やトイレットペーパーによる便の除去は、肛門周辺部や患部への摩擦を伴うため、痔疾患の誘発原因となったり、痔疾患を悪化させるからである。 The recent widespread use of toilet seats and toilets with a hot water washing function has contributed to the prevention and improvement of manic diseases. This is because removal of stool with dust paper or toilet paper is accompanied by friction on the perianal area and the affected area, which may cause a manic disease or worsen the manic disease.
 痔疾患を発症した場合には、疾患部位が肛門部であるがゆえに通院が恥ずかしく、市販の痔疾患治療薬剤を用いて対処するのが一般的である。痔疾患を治療する外用薬剤としては、例えば、(a)清涼化剤を0.01~0.3質量%、(b)ゲル化剤を0.1~10質量%、(c)アルコールを1~10質量%、(d)水を50~98質量%、(e)局所麻酔剤を3質量%以下で含有するゲル状痔疾治療用剤が開示されている(特許文献1参照)。 痔 When a manic disease develops, it is generally embarrassed to go to the hospital because the diseased part is the anus, and it is common to deal with a commercially available medicine for manic diseases. As an external medicine for treating hemorrhoid disease, for example, (a) 0.01 to 0.3% by mass of a refreshing agent, (b) 0.1 to 10% by mass of a gelling agent, and (c) 1 alcohol. An agent for treating gel-like hemorrhoids containing 10 to 10% by mass, (d) 50 to 98% by mass of water, and (e) 3% by mass or less of a local anesthetic is disclosed (see Patent Document 1).
特開2012-25771号公報JP 2012-25771 A
 ところで、市販の痔疾患治療薬剤には、特許文献1のように、リドカインやジブカイン等の局所麻酔成分を含有して一時的に痛みを和らげるものや、メントールやカンフル等の清涼剤成分を含有して痔疾患の痒みを一時的に和らげる効能を有するものが存在する。 By the way, commercially available drugs for treating hemorrhoids include local anesthetic components such as lidocaine and dibucaine as described in Patent Document 1, and those that temporarily relieve pain, and refresher components such as menthol and camphor. There are those that have the effect of temporarily relieving itching of manic diseases.
 しかしながら、局所麻酔成分や清涼剤成分は、痛みや痒みなどの痔疾患の不快感を一時的に除去するが、痔疾患を予防・治療する有効成分とはなり得ない。したがって、これらの痔疾患治療薬剤は対処療法的な薬剤として用いられるに過ぎず、結局、痔疾患が悪化した場合には、肛門外科等で外科的治療を受けざるを得ないという現状がある。 However, a local anesthetic component or a refreshing agent component temporarily removes discomfort of a manic disease such as pain and itch, but cannot be an active ingredient for preventing or treating manic disease. Therefore, these drugs for treating hemorrhoids are only used as coping therapy drugs, and eventually, when the hemorrhoids worsen, there is a current situation in which surgical treatment is unavoidable by anal surgery or the like.
 本発明は、上記の事情に鑑みて創案されたものであり、痔疾患の誘発を予防したり、痔疾患を改善するために、少なくとも有効成分として褐藻エキスを含有する褐藻エキス含有組成物、および褐藻エキス含有痔治療予防液の提供を目的とする。 The present invention was devised in view of the above circumstances, and contains a brown alga extract-containing composition containing at least a brown algae extract as an active ingredient in order to prevent the induction of an epilepsy disease or to improve an epilepsy disease, and The purpose is to provide a brown algae extract-containing acupuncture prevention liquid.
 上記目的を達成するために、本発明に係る褐藻エキス含有組成物は、水分を除く固形分0.10~10.00重量%の褐藻エキスを主成分とし、残成分として、医学的に許容可能な成分を含有することを特徴とする。褐藻エキスには、フコイダン、アミノ酸、ジアスターゼ、アルギン酸、および豊富なミネラルが含まれ、保湿作用や皮膚再生作用などの外用効能があることが報告されている。したがって、褐藻エキスを主成分とするのは、保湿作用や皮膚再生作用などの外用効能が痔疾患の有効成分となるからである。残成分は水やエタノール等を含み、医学的に許容可能な成分である。 In order to achieve the above object, the brown algae extract-containing composition according to the present invention comprises a brown algae extract having a solid content of 0.10 to 10.00% by weight excluding moisture as a main component, and is medically acceptable as a remaining component. It is characterized by containing various components. Brown algae extract contains fucoidan, amino acid, diastase, alginic acid, and abundant minerals, and has been reported to have external effects such as moisturizing action and skin regenerating action. Therefore, the reason why the brown algae extract is a main component is that external effects such as a moisturizing action and a skin regenerating action are active ingredients for leprosy. The remaining components include water, ethanol and the like and are medically acceptable components.
 褐藻エキスを固形分として0.10重量%以上含有するのは、0.10重量未満では痔疾患の有効成分としての十分な効能が得られないからである。他方、褐藻エキスを固形分として10.00重量以下含有するのは、10.00重量%を超えると残成分の調整が困難となるからである。 The reason why the brown algae extract is contained in a solid content of 0.10% by weight or more is that if it is less than 0.10%, a sufficient effect as an active ingredient of a manic disease cannot be obtained. On the other hand, the brown algae extract is contained in an amount of 10.00% by weight or less as the solid content because if it exceeds 10.00% by weight, it is difficult to adjust the remaining components.
 上記褐藻エキスの固形分含有量は、さらに0.10~3.00重量%であることが好ましい。褐藻エキスの固形分含有量を0.10~3.00重量%の範囲に設定するのは、この範囲において特に有効な効能が得られるからである。 The solid content of the brown algae extract is preferably 0.10 to 3.00% by weight. The reason why the solid content of the brown algae extract is set in the range of 0.10 to 3.00% by weight is that a particularly effective effect is obtained in this range.
 上記残成分は、少なくとも、0.10~10.00重量%の抗炎症剤、0.20~10.00重量%のアロエ抽出物、および0.10~5.00重量%の可溶性タンパク質成分を含有することが好ましい。抗炎症剤を含有するのは、痔疾患の炎症を抑制するためである。抗炎症剤を0.10重量%以上含有するのは、0.10重量%未満であると抗炎症性の効能が得られ難いからである。抗炎症剤を10.00重量%以下含有するのは、10.00重量%を超えると抗炎症性の効能に差が観られないからである。 The remaining component comprises at least 0.10 to 10.00% by weight of anti-inflammatory agent, 0.20 to 10.00% by weight of aloe extract, and 0.10 to 5.00% by weight of soluble protein component. It is preferable to contain. The reason for containing the anti-inflammatory agent is to suppress inflammation of the manic disease. The reason for containing 0.10% by weight or more of the anti-inflammatory agent is that if it is less than 0.10% by weight, it is difficult to obtain anti-inflammatory effects. The reason why the anti-inflammatory agent is contained in an amount of 10.00% by weight or less is that when the amount exceeds 10.00% by weight, no difference is observed in the anti-inflammatory effect.
 アロエ抽出物を含有するのは、アロエ抽出物にはアロインなどの植物フェノール系成分、アロエマンナン、グルコン酸などの多糖類系成分、およびアロエチンなどのその他の成分が含まれ、褐藻エキスとともに痔疾患の有効成分となり得るからである。 Aloe extract contains plant phenolic components such as aloin, polysaccharides components such as aloe mannan and gluconic acid, and other components such as aloetin, and also contains brown algal extract. It is because it can become an active ingredient.
 植物フェノール系成分には、鎮静鎮痛、細菌繁殖阻止、および酵素活性抑制などの外用効能が報告されている。また、多糖類系成分には、美肌、傷の治癒、消炎、および殺菌などの外用効能が報告されている。さらに、その他の成分として、アロエチンには強い抗菌、抗カビ作用の外用効能があることが報告されておいる。 Plant phenolic components have been reported to have external effects such as sedation and analgesia, bacterial growth inhibition, and enzyme activity suppression. In addition, external effects such as skin beautification, wound healing, anti-inflammatory and sterilization have been reported for polysaccharide components. Furthermore, as other ingredients, it has been reported that aloetin has a strong antibacterial and antifungal effect for external use.
 アロエ抽出物を0.20重量%以上含有するのは、0.20重量%未満であると有効成分としての効能が得られ難いからである。アロエ抽出物を10.00重量%以下含有するのは、10.00重量%を超える量を加えても有効成分としての効能に差が観られないからである。 The reason why the aloe extract is contained by 0.20% by weight or more is that if it is less than 0.20% by weight, it is difficult to obtain an effect as an active ingredient. The reason why Aloe extract is contained in an amount of 10.00% by weight or less is that no difference is observed in the efficacy as an active ingredient even if the amount exceeding 10.00% by weight is added.
 可溶性タンパク質成分を含有するのは、肌への浸透性を促進するからである。可溶性タンパク質成分を0.10重量%以上含有するのは、0.10重量%未満であると肌への浸透性に劣るからである。他方、可溶性タンパク質成分を5.00重量%以下含有するのは、5.00重量%を超える量を加えても肌への浸透性に差が観られないからである。 The reason why the soluble protein component is contained is to promote the penetration into the skin. The reason why the soluble protein component is contained in an amount of 0.10% by weight or more is that the permeability to the skin is inferior when the content is less than 0.10% by weight. On the other hand, the reason why the soluble protein component is contained at 5.00% by weight or less is that no difference is observed in the permeability to the skin even if an amount exceeding 5.00% by weight is added.
 上記抗炎症剤は、グリチルリチン酸2K、アラントインの少なくとも一種類を含むことが好ましい。抗炎症剤がグリチルリチン酸2K、アラントインの少なくとも一種類を含むのは、これらの成分のいずれかの含有によって、抗炎症の効能が得られるからである。抗炎症の効能を高めるには、複数の成分を組み合わせて使用することが好ましい。 The anti-inflammatory agent preferably contains at least one of glycyrrhizic acid 2K and allantoin. The reason why the anti-inflammatory agent contains at least one kind of glycyrrhizic acid 2K and allantoin is that an anti-inflammatory effect can be obtained by including any of these components. In order to enhance the efficacy of anti-inflammatory, it is preferable to use a combination of a plurality of components.
 上記アロエ抽出物は、アロエベラ葉肉末、キダチアロエ葉肉末、ケープアロエ葉肉末、アロエベラ葉エキス、キダチアロエ葉エキス、ケープアロエ葉エキスの少なくとも一種類を含むことが好ましい。アロエ抽出物がアロエベラ葉肉末、キダチアロエ葉肉末、ケープアロエ葉肉末、アロエベラ葉エキス、キダチアロエ葉エキス、ケープアロエ葉エキスの少なくとも一種類を含むのは、これらの成分のいずれかの含有によって、有効成分としての効能が得られるからである。有効成分としての効能を高めるには、複数の成分を組み合わせて使用することが好ましい。 The aloe extract preferably contains at least one kind of aloe vera mesophyll, kidachi aloe mesophyll, cape aloe mesophyll, aloe vera leaf extract, kidachi aloe leaf extract, cape aloe leaf extract. The aloe extract contains at least one of aloe vera mesophyll, kidachi aloe mesophyll, cape aloe mesophyll, aloe vera leaf extract, kidachi aloe leaf extract, cape aloe leaf extract. It is because the effect as is obtained. In order to increase the efficacy as an active ingredient, it is preferable to use a combination of a plurality of ingredients.
 上記可溶性タンパク質成分は、加水分解シルクであることが好ましい。可溶性タンパク質成分として加水分解シルクを用いることにより、肌への良好な浸透性を確保することができる。 The soluble protein component is preferably hydrolyzed silk. By using hydrolyzed silk as the soluble protein component, good permeability to the skin can be ensured.
 また、本発明に係る褐藻エキス含有痔治療予防液は、上記のいずれかに記載の褐藻エキス含有組成物が痔疾患の治療予防液として用いられることを特徴とする。上記のいずれかに記載の褐藻エキス含有組成物を痔疾患の治療予防液として用いることにより、痔疾患の誘発を防止することができ、痔疾患を発症してしまった場合にも改善を促すことができる。 The brown algae extract-containing acupuncture prevention liquid according to the present invention is characterized in that the brown algae extract-containing composition according to any one of the above is used as a treatment prevention liquid for an epilepsy disease. By using the brown algae extract-containing composition according to any of the above as a treatment / prevention solution for hemorrhoid disease, induction of hemorrhoid disease can be prevented, and improvement is promoted even when epilepsy disease has developed. Can do.
 本発明に係る褐藻エキス含有組成物によれば、少なくとも有効成分として褐藻エキスを含有しており、痔疾患の誘発を予防したり、痔疾患を発症してしまった場合にも改善を促すことができるという優れた効果を発揮する。 According to the brown algae extract-containing composition according to the present invention, it contains at least a brown algae extract as an active ingredient, and can prevent the induction of epilepsy disease or promote improvement even if it has developed epilepsy disease. Demonstrate the excellent effect of being able to.
実施例1~5および比較例1~3の効能確認試験の結果を示す説明図である。It is explanatory drawing which shows the result of the efficacy confirmation test of Examples 1-5 and Comparative Examples 1-3. 実施例6~10および比較例4~6の効能確認試験の結果を示す説明図である。It is explanatory drawing which shows the result of the efficacy confirmation test of Examples 6-10 and Comparative Examples 4-6. 実施例11~15および比較例7~9の効能確認試験の結果を示す説明図である。It is explanatory drawing which shows the result of the efficacy confirmation test of Examples 11-15 and Comparative Examples 7-9. 実施例16~20および比較例10~12の効能確認試験の結果を示す説明図である。It is explanatory drawing which shows the result of the efficacy confirmation test of Examples 16-20 and Comparative Examples 10-12. 被験者の肛門部の外側の状態の模式図である。It is a schematic diagram of the state outside a test subject's anal part. 治療予防液使用前の被験者の肛門部の状態の分類図である。It is a classification | category figure of the state of the anal part of a test subject before treatment prevention liquid use. 被験者の使用頻度の分類図である。It is a classification figure of a test subject's use frequency. 被験者の使用期間の分類図である。It is a classification diagram of a test subject's use period. 治療予防液使用後の被験者の肛門部の状態の分類図である。It is a classification | category figure of the state of the anal part of a test subject after treatment prevention liquid use.
 以下、本実施形態に係る褐藻エキス含有組成物および褐藻エキス含有痔治癒予防液について、実施例を挙げて説明する。なお、以下の説明において、図面は模式的に図示している。
〔褐藻エキス含有組成物〕
Hereinafter, the brown algae extract-containing composition and the brown algae extract-containing wrinkle healing preventing liquid according to the present embodiment will be described with reference to examples. In the following description, the drawings are schematically shown.
[Brown algae extract-containing composition]
 本実施形態に係る褐藻エキスは、もずくやワカメ、昆布などの褐藻類から抽出されるエキスである。海藻類には緑藻、褐藻、および紅藻が含まれ、本実施形態では特に褐藻類のエキスを用いることが好ましい。褐藻エキスの抽出方法は問わないが、ヒ素等の有害な低分子物質を除去することが好ましい。したがって、褐藻エキスとしては、高分子量のエキスを用いることが好ましいが、これに限定されない。 The brown algae extract according to the present embodiment is an extract extracted from brown algae such as mozuku, wakame and kelp. Seaweeds include green algae, brown algae, and red algae. In this embodiment, it is particularly preferable to use an extract of brown algae. The extraction method of the brown algae extract is not limited, but it is preferable to remove harmful low-molecular substances such as arsenic. Therefore, although it is preferable to use a high molecular weight extract as the brown algae extract, it is not limited to this.
 褐藻エキスには、フコイダン、アミノ酸、ジアスターゼ、アルギン酸、および豊富なミネラルが含まれ、保湿作用や皮膚再生作用などの外用効能があることが報告されている。特に、フルコースを主構成糖とする硫酸化多糖類であるフコイダンは、抗腫瘍、抗胃潰瘍、抗ウイルス、抗炎症、抗血液凝固、免疫増強、抗I型アレルギー、抗高脂血症などの種々の薬理的作用を有することが報告されている(特開2002-220402号公報)。また、フコイダンは、化粧料等において保湿成分剤としても用いられている。したがって、本実施形態に係る褐藻エキス含有組成物が褐藻エキスを主成分とするのは、保湿作用や皮膚再生作用などの外用効能が痔疾患の有効成分となるからである。 Brown algae extract contains fucoidan, amino acid, diastase, alginic acid, and abundant minerals, and has been reported to have external effects such as moisturizing action and skin regenerating action. In particular, fucoidan, a sulfated polysaccharide composed mainly of full-course sugar, has antitumor, anti-gastric ulcer, antiviral, anti-inflammatory, anticoagulant, immune enhancement, anti-type I allergy, antihyperlipidemia, etc. It has been reported to have various pharmacological actions (JP 2002-220402 A). Fucoidan is also used as a moisturizing ingredient in cosmetics and the like. Therefore, the brown algae extract-containing composition according to the present embodiment has the brown algae extract as a main component because external effects such as a moisturizing action and a skin regenerating action are effective ingredients for leprosy.
 本発明に係る褐藻エキス含有組成物は、水分を除く固形分0.10~10.00重量%の褐藻エキスを主成分とし、残成分として、水やエタノール等の医学的に許容可能な成分を含有する。また、残成分としては、少なくとも、0.10~10.00重量%の抗炎症剤、0.20~10.00重量%のアロエ抽出物(アロエ葉肉末または/およびアロエ葉エキス)、および0.10~5.00重量%の可溶性タンパク質成分を含有することが好ましい。褐藻エキスの固形分含有量は、さらに0.10~3.00重量%であることが好ましい。 The brown algae extract-containing composition according to the present invention comprises a brown algae extract having a solid content of 0.10 to 10.00% by weight excluding moisture as a main component, and a medically acceptable component such as water or ethanol as a remaining component. contains. The remaining components include at least 0.10 to 10.00% by weight of anti-inflammatory agent, 0.20 to 10.00% by weight of aloe extract (aloe leaf meat powder and / or aloe leaf extract), and 0 It is preferable to contain 10 to 5.00% by weight of a soluble protein component. The solid content of the brown alga extract is preferably 0.10 to 3.00% by weight.
 本実施形態に係る褐藻エキス含有組成物を組成する褐藻エキスの固形分、抗炎症剤、アロエ抽出物、および可溶性タンパク質成分の最適な含有量を検討するため、以下の実施例1~20、比較例1~12の含有量の組み合わせで効能の確認試験を行った。 In order to examine the optimal content of the solid content of the brown algae extract, the anti-inflammatory agent, the aloe extract, and the soluble protein component constituting the brown algae extract-containing composition according to the present embodiment, the following Examples 1 to 20, comparison Efficacy confirmation tests were conducted with combinations of the contents of Examples 1-12.
 実施例1~20、比較例1~12において、効能確認試験の効能は、複数人(同数)の被験者の肛門部に1日1回塗布し、痔疾患の症状に対する褐藻エキス含有組成物の使用感を基準に判定を行った。なお、実施例1~20、比較例1~12においては、褐藻エキスの固形分、抗炎症剤、アロエ抽出物、および可溶性タンパク質成分の最適含有量の検討のため、使用感の確認のみを行っており、痔疾患の症状別(イボ、切れ、痛み、痒み、および出血など)についての改善効果の確認は行っていない。
 全ての症状の改善:     ◎
 いずれかの症状の改善:   ○
 痔疾患の不快感の消失:   △
 痔疾患の症状の継続:    ×
In Examples 1 to 20 and Comparative Examples 1 to 12, the efficacy confirmation test was performed once a day on the anus of multiple (same number) subjects, and the use of a brown alga extract-containing composition for symptoms of hemorrhoid disease Judgment was made based on feeling. In Examples 1 to 20 and Comparative Examples 1 to 12, only the feeling of use was confirmed in order to examine the optimum content of the solid content of the brown algae extract, the anti-inflammatory agent, the aloe extract, and the soluble protein component. We have not confirmed the improvement effect for the symptoms of hemorrhoid diseases (warts, cuts, pain, itching, bleeding, etc.).
Improvement of all symptoms: ◎
Improvement of any of the symptoms: ○
消失 Disappearance of disease discomfort: △
Continuation of symptoms of hemorrhoid disease: ×
 まず、褐藻エキスの最適な含有量を検討するため、実施例1~5、比較例1~3の含有量の組み合わせで効能の確認試験を行った。図1は、実施例1~5および比較例1~3の効能確認試験の結果を示している。 First, in order to examine the optimal content of brown algae extract, efficacy confirmation tests were performed using combinations of the contents of Examples 1 to 5 and Comparative Examples 1 to 3. FIG. 1 shows the results of efficacy confirmation tests of Examples 1 to 5 and Comparative Examples 1 to 3.
 図1において、主成分としての褐藻エキスの固形分は0.5~15.0重量%の範囲で含有量を変化させ、残量は精製水および無水エタノールを含有している。実施例1の褐藻エキス含有組成物の組成は次のとおりである。
(実施例1)
褐藻エキスの固形分:0.10重量%
精製水および無水エタノール:残量
In FIG. 1, the solid content of the brown algae extract as the main component is changed in the range of 0.5 to 15.0% by weight, and the remaining amount contains purified water and absolute ethanol. The composition of the brown algae extract-containing composition of Example 1 is as follows.
Example 1
Solid content of brown algae extract: 0.10% by weight
Purified water and absolute ethanol: remaining
 図1において、実施例2の褐藻エキス含有組成物の組成は次のとおりである。
(実施例2)
褐藻エキスの固形分:3.0重量%
精製水および無水エタノール:残量
In FIG. 1, the composition of the brown algae extract-containing composition of Example 2 is as follows.
(Example 2)
Solid content of brown algae extract: 3.0% by weight
Purified water and absolute ethanol: remaining
 図1において、実施例3の褐藻エキス含有組成物の組成は次のとおりである。
(実施例3)
褐藻エキスの固形分:5.0重量%
精製水および無水エタノール:残量
In FIG. 1, the composition of the brown algae extract-containing composition of Example 3 is as follows.
(Example 3)
Solid content of brown algae extract: 5.0% by weight
Purified water and absolute ethanol: remaining
 図1において、実施例4の褐藻エキス含有組成物の組成は次のとおりである。
(実施例4)
褐藻エキスの固形分:10.0重量%
精製水および無水エタノール:残量
In FIG. 1, the composition of the brown algae extract-containing composition of Example 4 is as follows.
Example 4
Solid content of brown algae extract: 10.0% by weight
Purified water and absolute ethanol: remaining
 図1において、実施例5の褐藻エキス含有組成物の組成は次のとおりである。
(実施例5)
褐藻エキスの固形分:15.0重量%
精製水および無水エタノール:残量
In FIG. 1, the composition of the brown algae extract-containing composition of Example 5 is as follows.
(Example 5)
Solid content of brown algae extract: 15.0% by weight
Purified water and absolute ethanol: remaining
 図1において、比較例1の褐藻エキス含有組成物の組成は次のとおりである。
(比較例1)
褐藻エキスの固形分:0.05重量%
精製水および無水エタノール:残量
In FIG. 1, the composition of the brown algae extract-containing composition of Comparative Example 1 is as follows.
(Comparative Example 1)
Solid content of brown algae extract: 0.05% by weight
Purified water and absolute ethanol: remaining
 図1において、比較例2の褐藻エキス含有組成物の組成は次のとおりである。
(比較例2)
褐藻エキスの固形分:0.08重量%
精製水および無水エタノール:残量
In FIG. 1, the composition of the brown algae extract-containing composition of Comparative Example 2 is as follows.
(Comparative Example 2)
Solid content of brown algae extract: 0.08% by weight
Purified water and absolute ethanol: remaining
 図1において、比較例3の褐藻エキス含有組成物の組成は次のとおりである。
(比較例3)
褐藻エキスの固形分:0.09重量%
精製水および無水エタノール:残量
In FIG. 1, the composition of the brown algae extract-containing composition of Comparative Example 3 is as follows.
(Comparative Example 3)
Solid content of brown algae extract: 0.09 wt%
Purified water and absolute ethanol: remaining
 図1に示すように、実施例1および2において、全ての症状の改善:◎の結果が得られた。また、実施例3~5においても、いずれかの症状の改善:○の結果が得られた。しかしながら、比較例3および比較例2においては痔疾患の不快感の消失:△の結果が見られたものの、比較例1においては痔疾患の症状の継続:×の結果であった。 As shown in FIG. 1, in Examples 1 and 2, all the symptoms were improved: ◎ results were obtained. Also in Examples 3 to 5, the improvement of any of the symptoms: results of ◯ were obtained. However, in Comparative Example 3 and Comparative Example 2, the result of disappearance of the discomfort of the hemorrhoid disease: Δ was observed, but in Comparative Example 1, the continuation of symptoms of the hemorrhoid disease: the result of x.
 すなわち、実地例1~5の褐藻エキス含有組成物によれば、主成分としての褐藻エキスの固形分を0.10~15.00重量%の範囲で含有することにより、痔疾患の改善の効能が確認された。また褐藻エキスの固形分含有量は、さらに0.10~3.00重量%の範囲がより好ましいことが確認された。しかしながら、褐藻エキスの固形分含有量は、10.00重量以下に設定することが好ましい。主成分としての褐藻エキスの固形分含有量が10.00重量%を超えても有効成分の効能に差はなく、10.00重量%を超えると後述する残成分の調整が困難となるからである。 That is, according to the brown algae extract-containing compositions of practical examples 1 to 5, by containing the solid content of the brown algae extract as the main component in the range of 0.10 to 15.00% by weight, the effect of improving the hemorrhoid disease Was confirmed. Further, it was confirmed that the solid content of the brown algae extract is more preferably in the range of 0.10 to 3.00% by weight. However, the solid content of the brown algae extract is preferably set to 10.00 weight or less. Even if the solid content of the brown algae extract as the main component exceeds 10.00% by weight, there is no difference in the efficacy of the active ingredient, and if it exceeds 10.00% by weight, it will be difficult to adjust the remaining components described later. is there.
 次に、主成分としての褐藻エキスの固形分含有量を0.05重量%~10.0重量%の範囲で適宜設定して、残成分としての抗炎症剤、アロエ抽出物、および可溶性タンパク質成分を含有量について検討した。 Next, the solid content of the brown algae extract as the main component is appropriately set in the range of 0.05 wt% to 10.0 wt%, and the anti-inflammatory agent, aloe extract, and soluble protein component as the remaining components The content was examined.
 第1に抗炎症剤の最適な含有量を検討するため、実施例6~10、比較例4~6の含有量の組み合わせで効能の確認試験を行った。図2は、実施例6~11および比較例4~6の効能確認試験の結果を示している。 First, in order to examine the optimum content of the anti-inflammatory agent, efficacy confirmation tests were conducted using combinations of the contents of Examples 6 to 10 and Comparative Examples 4 to 6. FIG. 2 shows the results of the efficacy confirmation tests of Examples 6 to 11 and Comparative Examples 4 to 6.
 図2において、主成分としての褐藻エキスの固形分含有量を0.05重量%~10.0重量%の範囲で適宜設定し、抗炎症剤を0.05~15.0重量%の範囲で含有量を変化させ、残量は精製水および無水エタノールを含有している。また、アロエ抽出物は0重量%もしくは5.0重量%、可溶性タンパク質は0重量%もしくは3.0重量%で配合量を設定している。実施例6の褐藻エキス含有組成物の組成は次のとおりである。
(実施例6)
褐藻エキスの固形分:0.10重量%
抗炎症剤:0.10重量%
アロエ抽出物:5.0重量%
可溶性タンパク質:3.0重量%
精製水および無水エタノール:残量
In FIG. 2, the solid content of the brown algae extract as the main component is appropriately set in the range of 0.05 to 10.0% by weight, and the anti-inflammatory agent is in the range of 0.05 to 15.0% by weight. The content is changed, and the remaining amount contains purified water and absolute ethanol. Further, the amount of aloe extract is set to 0% or 5.0% by weight, and the amount of soluble protein is set to 0% or 3.0% by weight. The composition of the brown algae extract-containing composition of Example 6 is as follows.
(Example 6)
Solid content of brown algae extract: 0.10% by weight
Anti-inflammatory agent: 0.10% by weight
Aloe extract: 5.0% by weight
Soluble protein: 3.0% by weight
Purified water and absolute ethanol: remaining
 図2において、実施例7の褐藻エキス含有組成物の組成は次のとおりである。
(実施例7)
褐藻エキスの固形分:3.0重量%
抗炎症剤:0.50重量%
アロエ抽出物:0重量%
可溶性タンパク質:0重量%
精製水および無水エタノール:残量
In FIG. 2, the composition of the brown algae extract-containing composition of Example 7 is as follows.
(Example 7)
Solid content of brown algae extract: 3.0% by weight
Anti-inflammatory agent: 0.50% by weight
Aloe extract: 0% by weight
Soluble protein: 0% by weight
Purified water and absolute ethanol: remaining
 図2において、実施例8の褐藻エキス含有組成物の組成は次のとおりである。
(実施例8)
褐藻エキスの固形分:5.0重量%
抗炎症剤:5.0重量%
アロエ抽出物:5.0重量%
可溶性タンパク質:3.0重量%
精製水および無水エタノール:残量
In FIG. 2, the composition of the brown algae extract-containing composition of Example 8 is as follows.
(Example 8)
Solid content of brown algae extract: 5.0% by weight
Anti-inflammatory agent: 5.0% by weight
Aloe extract: 5.0% by weight
Soluble protein: 3.0% by weight
Purified water and absolute ethanol: remaining
 図2において、実施例9の褐藻エキス含有組成物の組成は次のとおりである。
(実施例9)
褐藻エキスの固形分:10.0重量%
抗炎症剤:10.0重量%
アロエ抽出物:0重量%
可溶性タンパク質:0重量%
精製水および無水エタノール:残量
In FIG. 2, the composition of the brown algae extract-containing composition of Example 9 is as follows.
Example 9
Solid content of brown algae extract: 10.0% by weight
Anti-inflammatory agent: 10.0% by weight
Aloe extract: 0% by weight
Soluble protein: 0% by weight
Purified water and absolute ethanol: remaining
 図2において、実施例10の褐藻エキス含有組成物の組成は次のとおりである。
(実施例10)
褐藻エキスの固形分:10.0重量%
抗炎症剤:15.0重量%
アロエ抽出物:5.0重量%
可溶性タンパク質:3.0重量%
精製水および無水エタノール:残量
In FIG. 2, the composition of the brown algae extract-containing composition of Example 10 is as follows.
(Example 10)
Solid content of brown algae extract: 10.0% by weight
Anti-inflammatory agent: 15.0% by weight
Aloe extract: 5.0% by weight
Soluble protein: 3.0% by weight
Purified water and absolute ethanol: remaining
 図2において、比較例4の褐藻エキス含有組成物の組成は次のとおりである。
(比較例4)
褐藻エキスの固形分:0.05重量%
抗炎症剤:0.05重量%
アロエ抽出物:0重量%
可溶性タンパク質:0重量%
精製水および無水エタノール:残量
In FIG. 2, the composition of the brown algae extract-containing composition of Comparative Example 4 is as follows.
(Comparative Example 4)
Solid content of brown algae extract: 0.05% by weight
Anti-inflammatory agent: 0.05% by weight
Aloe extract: 0% by weight
Soluble protein: 0% by weight
Purified water and absolute ethanol: remaining
 図2において、比較例5の褐藻エキス含有組成物の組成は次のとおりである。
(比較例5)
褐藻エキスの固形分:0.08重量%
抗炎症剤:0.08重量%
アロエ抽出物:5.0重量%
可溶性タンパク質:3.0重量%
精製水および無水エタノール:残量
In FIG. 2, the composition of the brown algae extract-containing composition of Comparative Example 5 is as follows.
(Comparative Example 5)
Solid content of brown algae extract: 0.08% by weight
Anti-inflammatory agent: 0.08% by weight
Aloe extract: 5.0% by weight
Soluble protein: 3.0% by weight
Purified water and absolute ethanol: remaining
 図2において、比較例6の褐藻エキス含有組成物の組成は次のとおりである。
(比較例6)
褐藻エキスの固形分:0.09重量%
抗炎症剤:0.09重量%
アロエ抽出物:0重量%
可溶性タンパク質:0重量%
精製水および無水エタノール:残量
In FIG. 2, the composition of the brown algae extract-containing composition of Comparative Example 6 is as follows.
(Comparative Example 6)
Solid content of brown algae extract: 0.09 wt%
Anti-inflammatory agent: 0.09% by weight
Aloe extract: 0% by weight
Soluble protein: 0% by weight
Purified water and absolute ethanol: remaining
 図2に示すように、実施例6~10において、全ての症状の改善:◎、もしくはいずれかの症状の改善:○の結果が得られた。しかしながら、比較例5,6においては痔疾患の不快感の消失:△の結果が見られたものの、比較例4においては痔疾患の症状の継続:×の結果であった。 As shown in FIG. 2, in Examples 6 to 10, all the symptoms were improved: A, or any of the symptoms was improved: A result was obtained. However, in Comparative Examples 5 and 6, the disappearance of the discomfort of the mania disease: a result of Δ was observed, but in Comparative Example 4, the continuation of symptoms of the mania disease: the result of ×.
 すなわち、抗炎症剤は、0.10~15.0重量%の範囲で含有することにより、痔疾患の改善の効能が確認された。しかしながら、10.0重量%を超える抗炎症剤を含有しても、抗炎症性の効能に差が観られないため、抗炎症剤は0.10~10.0重量%の範囲に設定することが好ましい。なお、抗炎症剤は、例えば、グリチルリチン酸2K、アラントインの少なくとも一種類を含むことが好ましい。抗炎症剤として、グリチルリチン酸2K、アラントインを挙げているが、例示したこれらの薬剤に限定されず、アミノサリチル酸やジフラニサル等の他の抗炎症剤を排除する趣旨ではない。抗炎症の効能を高めるには、0.10~10.00重量%の範囲で複数の成分を組み合わせて使用することが好ましい。 That is, it was confirmed that the anti-inflammatory agent contained in the range of 0.10 to 15.0% by weight was effective in improving hemorrhoid disease. However, even if it contains more than 10.0% by weight of anti-inflammatory agent, there is no difference in anti-inflammatory efficacy, so the anti-inflammatory agent should be set in the range of 0.10 to 10.0% by weight. Is preferred. In addition, it is preferable that an anti-inflammatory agent contains at least 1 sort (s) of glycyrrhizic acid 2K and allantoin, for example. Examples of anti-inflammatory agents include glycyrrhizic acid 2K and allantoin, but are not limited to these exemplified agents, and are not intended to exclude other anti-inflammatory agents such as aminosalicylic acid and difuranisal. In order to increase the efficacy of anti-inflammatory, it is preferable to use a combination of a plurality of components in the range of 0.10 to 10.00% by weight.
 第2にアロエ抽出物の最適な含有量を検討するため、実施例11~15、比較例7~9の含有量の組み合わせで効能の確認試験を行った。図3は、実施例11~15および比較例7~9の効能確認試験の結果を示している。 Secondly, in order to examine the optimal content of the aloe extract, efficacy confirmation tests were conducted using combinations of the contents of Examples 11 to 15 and Comparative Examples 7 to 9. FIG. 3 shows the results of efficacy confirmation tests of Examples 11 to 15 and Comparative Examples 7 to 9.
 図3において、主成分としての褐藻エキスの固形分含有量を0.05重量%~10.0重量%の範囲で適宜設定し、アロエ抽出物を0.05~15.0重量%の範囲で含有量を変化させ、残量は精製水および無水エタノールを含有している。また、抗炎症剤は0重量%もしくは5.0重量%、可溶性タンパク質は0重量%もしくは3.0重量%で配合量を設定している。実施例11の褐藻エキス含有組成物の組成は次のとおりである。
(実施例11)
褐藻エキスの固形分:0.10重量%
抗炎症剤:5.0重量%
アロエ抽出物:0.20重量%
可溶性タンパク質:3.0重量%
精製水および無水エタノール:残量
In FIG. 3, the solid content of the brown algae extract as the main component is appropriately set in the range of 0.05 wt% to 10.0 wt%, and the aloe extract is set in the range of 0.05 to 15.0 wt%. The content is changed, and the remaining amount contains purified water and absolute ethanol. The compounding amount is set to 0% or 5.0% by weight for the anti-inflammatory agent and 0% or 3.0% by weight for the soluble protein. The composition of the brown algae extract-containing composition of Example 11 is as follows.
(Example 11)
Solid content of brown algae extract: 0.10% by weight
Anti-inflammatory agent: 5.0% by weight
Aloe extract: 0.20% by weight
Soluble protein: 3.0% by weight
Purified water and absolute ethanol: remaining
 図3において、実施例12の褐藻エキス含有組成物の組成は次のとおりである。
(実施例12)
褐藻エキスの固形分:3.0重量%
抗炎症剤:0重量%
アロエ抽出物:3.0重量%
可溶性タンパク質:0重量%
精製水および無水エタノール:残量
In FIG. 3, the composition of the brown algae extract-containing composition of Example 12 is as follows.
(Example 12)
Solid content of brown algae extract: 3.0% by weight
Anti-inflammatory agent: 0% by weight
Aloe extract: 3.0% by weight
Soluble protein: 0% by weight
Purified water and absolute ethanol: remaining
 図3において、実施例13の褐藻エキス含有組成物の組成は次のとおりである。
(実施例13)
褐藻エキスの固形分:5.0重量%
抗炎症剤:5.0重量%
アロエ抽出物:5.0重量%
可溶性タンパク質:3.0重量%
精製水および無水エタノール:残量
In FIG. 3, the composition of the brown algae extract-containing composition of Example 13 is as follows.
(Example 13)
Solid content of brown algae extract: 5.0% by weight
Anti-inflammatory agent: 5.0% by weight
Aloe extract: 5.0% by weight
Soluble protein: 3.0% by weight
Purified water and absolute ethanol: remaining
 図3において、実施例14の褐藻エキス含有組成物の組成は次のとおりである。
(実施例14)
褐藻エキスの固形分:10.0重量%
抗炎症剤:0重量%
アロエ抽出物:10.0重量%
可溶性タンパク質:0重量%
精製水および無水エタノール:残量
In FIG. 3, the composition of the brown algae extract-containing composition of Example 14 is as follows.
(Example 14)
Solid content of brown algae extract: 10.0% by weight
Anti-inflammatory agent: 0% by weight
Aloe extract: 10.0% by weight
Soluble protein: 0% by weight
Purified water and absolute ethanol: remaining
 図3において、実施例15の褐藻エキス含有組成物の組成は次のとおりである。
(実施例15)
褐藻エキスの固形分:10.0重量%
抗炎症剤:5.0重量%
アロエ抽出物:15.0重量%
可溶性タンパク質:3.0重量%
精製水および無水エタノール:残量
In FIG. 3, the composition of the brown algae extract-containing composition of Example 15 is as follows.
(Example 15)
Solid content of brown algae extract: 10.0% by weight
Anti-inflammatory agent: 5.0% by weight
Aloe extract: 15.0% by weight
Soluble protein: 3.0% by weight
Purified water and absolute ethanol: remaining
 図3において、比較例7の褐藻エキス含有組成物の組成は次のとおりである。
(比較例7)
褐藻エキスの固形分:0.05重量%
抗炎症剤:0重量%
アロエ抽出物:0.05重量%
可溶性タンパク質:0重量%
精製水および無水エタノール:残量
In FIG. 3, the composition of the brown algae extract-containing composition of Comparative Example 7 is as follows.
(Comparative Example 7)
Solid content of brown algae extract: 0.05% by weight
Anti-inflammatory agent: 0% by weight
Aloe extract: 0.05% by weight
Soluble protein: 0% by weight
Purified water and absolute ethanol: remaining
 図3において、比較例8の褐藻エキス含有組成物の組成は次のとおりである。
(比較例8)
褐藻エキスの固形分:0.08重量%
抗炎症剤:5.0重量%
アロエ抽出物:0.08重量%
可溶性タンパク質:3.0重量%
精製水および無水エタノール:残量
In FIG. 3, the composition of the brown algae extract-containing composition of Comparative Example 8 is as follows.
(Comparative Example 8)
Solid content of brown algae extract: 0.08% by weight
Anti-inflammatory agent: 5.0% by weight
Aloe extract: 0.08% by weight
Soluble protein: 3.0% by weight
Purified water and absolute ethanol: remaining
 図3において、比較例9の褐藻エキス含有組成物の組成は次のとおりである。
(比較例9)
褐藻エキスの固形分:0.09重量%
抗炎症剤:0重量%
アロエ抽出物:0.10重量%
可溶性タンパク質:0重量%
精製水および無水エタノール:残量
In FIG. 3, the composition of the brown algae extract-containing composition of Comparative Example 9 is as follows.
(Comparative Example 9)
Solid content of brown algae extract: 0.09 wt%
Anti-inflammatory agent: 0% by weight
Aloe extract: 0.10% by weight
Soluble protein: 0% by weight
Purified water and absolute ethanol: remaining
 図3に示すように、実施例11~15において、全ての症状の改善:◎、もしくはいずれかの症状の改善:○の結果が得られた。しかしながら、比較例8,9においては痔疾患の不快感の消失:△の結果が見られたものの、比較例7においては痔疾患の症状の継続:×の結果であった。 As shown in FIG. 3, in Examples 11 to 15, the results of improvement of all symptoms: ◎ or improvement of any symptom: ○ were obtained. However, in Comparative Examples 8 and 9, although the result of disappearance of discomfort of epilepsy disease: Δ was seen, in Comparative Example 7, the result of continuation of symptoms of epilepsy disease: x.
 すなわち、アロエ抽出物は、0.20~15.00重量%の範囲で含有することにより、痔疾患の改善の効能が確認された。しかしながら、10.0重量%を超えるアロエ抽出物を含有しても、アロエ抽出物の効能に差が観られないため、アロエ抽出物は0.20~10.0重量%の範囲に設定することが好ましい。なお、アロエ抽出物は、例えば、アロエベラ葉肉末、キダチアロエ葉肉末、ケープアロエ葉肉末、アロエベラ葉エキス、キダチアロエ葉エキス、ケープアロエ葉エキスの少なくとも一種類を含むことが好ましい。有効成分としての効能を高めるには、0.20~10.00重量%の範囲で複数のアロエ抽出物成分を組み合わせて使用することが好ましい。 That is, it was confirmed that the aloe extract contained in the range of 0.20 to 15.00% by weight was effective in improving hemorrhoid disease. However, even if the aloe extract contains more than 10.0% by weight, there is no difference in the efficacy of the aloe extract, so the aloe extract should be set in the range of 0.20 to 10.0% by weight. Is preferred. In addition, it is preferable that an aloe extract contains at least 1 sort (s), for example, an aloe vera mesophyll powder, Kidachi aloe mesophyll powder, a cape aloe mesophyll powder, an aloe vera leaf extract, a Kidachi aloe leaf extract, and a cape aloe leaf extract. In order to increase the efficacy as an active ingredient, it is preferable to use a combination of a plurality of aloe extract components in the range of 0.20 to 10.00% by weight.
 第3に可溶性タンパク質の最適な含有量を検討するため、実施例16~20、比較例10~12の含有量の組み合わせで効能の確認試験を行った。図4は、実施例16~20および比較例10~12の効能確認試験の結果を示している。 Thirdly, in order to examine the optimum content of soluble protein, efficacy confirmation tests were performed with combinations of the contents of Examples 16 to 20 and Comparative Examples 10 to 12. FIG. 4 shows the results of the efficacy confirmation test of Examples 16 to 20 and Comparative Examples 10 to 12.
 図4において、主成分としての褐藻エキスの固形分含有量を0.05重量%~10.0重量%の範囲で適宜設定し、可溶性タンパク質を0.05~10.0重量%の範囲で含有量を変化させ、残量は精製水および無水エタノールを含有している。また、抗炎症剤は0重量%もしくは5.0重量%、アロエ抽出物は0重量%もしくは5.0重量%で配合量を設定している。実施例16の褐藻エキス含有組成物の組成は次のとおりである。
(実施例16)
褐藻エキスの固形分:0.10重量%
抗炎症剤:5.0重量%
アロエ抽出物:5.0重量%
可溶性タンパク質:0.10重量%
精製水および無水エタノール:残量
In FIG. 4, the solid content of the brown alga extract as the main component is appropriately set in the range of 0.05% to 10.0% by weight, and the soluble protein is contained in the range of 0.05 to 10.0% by weight. The amount is varied and the remaining amount contains purified water and absolute ethanol. The compounding amount is set to 0% by weight or 5.0% by weight for the anti-inflammatory agent and 0% by weight or 5.0% by weight for the aloe extract. The composition of the brown algae extract-containing composition of Example 16 is as follows.
(Example 16)
Solid content of brown algae extract: 0.10% by weight
Anti-inflammatory agent: 5.0% by weight
Aloe extract: 5.0% by weight
Soluble protein: 0.10% by weight
Purified water and absolute ethanol: remaining
 図4において、実施例17の褐藻エキス含有組成物の組成は次のとおりである。
(実施例17)
褐藻エキスの固形分:3.0重量%
抗炎症剤:0重量%
アロエ抽出物:0重量%
可溶性タンパク質:3.0重量%
精製水および無水エタノール:残量
In FIG. 4, the composition of the brown algae extract-containing composition of Example 17 is as follows.
(Example 17)
Solid content of brown algae extract: 3.0% by weight
Anti-inflammatory agent: 0% by weight
Aloe extract: 0% by weight
Soluble protein: 3.0% by weight
Purified water and absolute ethanol: remaining
 図4において、実施例18の褐藻エキス含有組成物の組成は次のとおりである。
(実施例18)
褐藻エキスの固形分:5.0重量%
抗炎症剤:5.0重量%
アロエ抽出物:5.0重量%
可溶性タンパク質:5.0重量%
精製水および無水エタノール:残量
In FIG. 4, the composition of the brown algae extract-containing composition of Example 18 is as follows.
(Example 18)
Solid content of brown algae extract: 5.0% by weight
Anti-inflammatory agent: 5.0% by weight
Aloe extract: 5.0% by weight
Soluble protein: 5.0% by weight
Purified water and absolute ethanol: remaining
 図4において、実施例19の褐藻エキス含有組成物の組成は次のとおりである。
(実施例19)
褐藻エキスの固形分:10.0重量%
抗炎症剤:0重量%
アロエ抽出物:0重量%
可溶性タンパク質:6.0重量%
精製水および無水エタノール:残量
In FIG. 4, the composition of the brown algae extract-containing composition of Example 19 is as follows.
(Example 19)
Solid content of brown algae extract: 10.0% by weight
Anti-inflammatory agent: 0% by weight
Aloe extract: 0% by weight
Soluble protein: 6.0% by weight
Purified water and absolute ethanol: remaining
 図4において、実施例20の褐藻エキス含有組成物の組成は次のとおりである。
(実施例20)
褐藻エキスの固形分:10.0重量%
抗炎症剤:5.0重量%
アロエ抽出物:5.0重量%
可溶性タンパク質:10.0重量%
精製水および無水エタノール:残量
In FIG. 4, the composition of the brown algae extract-containing composition of Example 20 is as follows.
(Example 20)
Solid content of brown algae extract: 10.0% by weight
Anti-inflammatory agent: 5.0% by weight
Aloe extract: 5.0% by weight
Soluble protein: 10.0% by weight
Purified water and absolute ethanol: remaining
 図4において、比較例10の褐藻エキス含有組成物の組成は次のとおりである。
(比較例10)
褐藻エキスの固形分:0.05重量%
抗炎症剤:0重量%
アロエ抽出物:0重量%
可溶性タンパク質:0.05重量%
精製水および無水エタノール:残量
In FIG. 4, the composition of the brown algae extract-containing composition of Comparative Example 10 is as follows.
(Comparative Example 10)
Solid content of brown algae extract: 0.05% by weight
Anti-inflammatory agent: 0% by weight
Aloe extract: 0% by weight
Soluble protein: 0.05% by weight
Purified water and absolute ethanol: remaining
 図4において、比較例11の褐藻エキス含有組成物の組成は次のとおりである。
(比較例11)
褐藻エキスの固形分:0.08重量%
抗炎症剤:5.0重量%
アロエ抽出物:5.0重量%
可溶性タンパク質:0.08重量%
精製水および無水エタノール:残量
In FIG. 4, the composition of the brown algae extract-containing composition of Comparative Example 11 is as follows.
(Comparative Example 11)
Solid content of brown algae extract: 0.08% by weight
Anti-inflammatory agent: 5.0% by weight
Aloe extract: 5.0% by weight
Soluble protein: 0.08% by weight
Purified water and absolute ethanol: remaining
 図4において、比較例12の褐藻エキス含有組成物の組成は次のとおりである。
(比較例12)
褐藻エキスの固形分:0.09重量%
抗炎症剤:0重量%
アロエ抽出物:0重量%
可溶性タンパク質:0.09重量%
精製水および無水エタノール:残量
In FIG. 4, the composition of the brown algae extract-containing composition of Comparative Example 12 is as follows.
(Comparative Example 12)
Solid content of brown algae extract: 0.09 wt%
Anti-inflammatory agent: 0% by weight
Aloe extract: 0% by weight
Soluble protein: 0.09% by weight
Purified water and absolute ethanol: remaining
 図4に示すように、実施例16~20において、全ての症状の改善:◎、もしくはいずれかの症状の改善:○の結果が得られた。しかしながら、比較例11,12においては痔疾患の不快感の消失:△の結果が見られたものの、比較例10においては痔疾患の症状の継続:×の結果であった。 As shown in FIG. 4, in Examples 16 to 20, results of improvement of all symptoms: ◎ or improvement of any symptom: ○ were obtained. However, in Comparative Examples 11 and 12, the disappearance of the discomfort of the manic disease was observed as a result of Δ, but in Comparative Example 10, the continuation of symptoms of the manic disease was a result of ×.
 すなわち、可溶性タンパク質は、0.10~10.00重量%の範囲で含有することにより、痔疾患の改善の効能が確認された。しかしながら、5.0重量%を超える可溶性タンパク質を含有しても、可溶性タンパク質の効能に差が観られないため、可溶性タンパク質は0.10~5.0重量%の範囲に設定することが好ましい。なお、可溶性タンパク質は、例えば、加水分解シルクであることが好ましいが、例示した加水分解シルク以外の可溶性タンパク質を排除する趣旨ではない。
〔褐藻エキス含有疾治療予防液〕
That is, it was confirmed that the soluble protein contained in the range of 0.10 to 10.00% by weight was effective in improving manic diseases. However, even if the soluble protein exceeds 5.0% by weight, there is no difference in the efficacy of the soluble protein. Therefore, the soluble protein is preferably set in the range of 0.10 to 5.0% by weight. In addition, although it is preferable that a soluble protein is a hydrolysis silk, for example, it is not the meaning which excludes soluble proteins other than the illustrated hydrolysis silk.
[Brown algae extract-containing disease treatment prevention solution]
 また、本実施形態に係る褐藻エキス含有組成物は、肛門部に塗布することにより、痔疾患の治療予防液として用いることができる。本実施形態の褐藻エキス含有痔治療予防液の有効性をより詳しく確認するため、被験者50人に対して効能試験を行った。なお、被験者の人数が50人と少ないが、痔疾患は肛門部に発症する疾患であるため、疾患の性質上から被験者が集まりにくいという現状がある。 Moreover, the brown algae extract-containing composition according to the present embodiment can be used as a treatment / prevention solution for hemorrhoid diseases by applying it to the anus. In order to confirm in more detail the effectiveness of the brown algae extract-containing acupuncture prevention liquid of this embodiment, an efficacy test was performed on 50 subjects. Although the number of subjects is as small as 50, since the hemorrhoid disease is a disease that develops in the anus, there is a current situation that subjects are difficult to gather due to the nature of the disease.
 図5は、被験者の肛門部の外側の状態を示している。図5において、1は肛門部、2はイボ、3は切れ、4は痒み、5は腫れの症状である。図5に示すように、肛門部の症状によって分類すると、無傷は3人、イボが一つのみは18人、イボが二つは5人、イボが多数は4人、切れ・腫れ・痒みは29人であった。なお、切れ・腫れ・痒みの症状を有する被験者は、他の症状を有する被験者と一部重複している。 FIG. 5 shows a state outside the anus of the subject. In FIG. 5, 1 is an anus, 2 is wart, 3 is cut, 4 is itchy, and 5 is a symptom of swelling. As shown in Fig. 5, when classified according to the symptoms of the anal region, there are 3 injuries, 18 in one wart, 5 in 2 warts, 4 in warts, 4 in many warts, cuts / swells / itchiness There were 29 people. In addition, the test subject who has a symptom of cutting, swelling, and itch partially overlaps with a test subject having other symptoms.
 図6は、褐藻エキス含有組成物を痔疾患の治療予防液として使用する前の被験者の肛門部の状態を示している。図6に示すように、痔疾患の発症時期で分類すると、1年未満前が11人、1~5年未満前が18人、6~19年未満前が11人、20年以上前が10人であった。また、痔疾患の症状で分類すると、内痔核が6人、外痔核・イボ痔が28人、肛門周囲の腫れが12人、出血が24人、痛みが18人、痒みが20人、切れ痔が13人、痔瘻が1人、その他(無償)が3人であった。なお、切れ・腫れ・痒みの症状を有する被験者は、他の症状を有する被験者と一部重複している。 FIG. 6 shows the state of the anus of the subject before using the brown algae extract-containing composition as a treatment / prevention solution for hemorrhoid diseases. As shown in FIG. 6, when classified by the onset of epilepsy disease, 11 were less than 1 year ago, 18 were less than 1-5 years ago, 11 were less than 6-19 years ago, and 10 were more than 20 years ago. It was a person. In addition, when classified according to the symptoms of hemorrhoid disease, there are 6 internal hemorrhoids, 28 external hemorrhoids and wart hemorrhoids, 12 swelling around the anus, 24 bleeding, 18 pains, 20 itch, cuts There were 13 people, 1 niece, and 3 others (free of charge). In addition, the test subject who has a symptom of cutting, swelling, and itch partially overlaps with a test subject having other symptoms.
 図7は、被験者の使用頻度を示している。図7に示すように、使用頻度で分類すると、1日1回が38人、1日2回が10人、1日3回以上が0人、2~3日に1回が1人、4日以上に1回が1人であった。 FIG. 7 shows the usage frequency of the subject. As shown in FIG. 7, when classified according to frequency of use, 38 people once a day, 10 people twice a day, 0 people more than 3 times a day, 1 person every 2 to 3 days, 4 One person per day or more.
 図8は、被験者の使用期間を示している。図8に示すように、使用期間で分類すると、1日~3日が0人、4日~10日が15人、11日~20日が27人、21日~30日が4人、30日以上が4人であった。 FIG. 8 shows the usage period of the subject. As shown in FIG. 8, when classified according to the period of use, 1 to 3 days are 0 people, 4 to 10 days are 15 people, 11 to 20 days are 27 people, 21 to 30 days are 4 people, 30 There were four people over the day.
 図9は、褐藻エキス含有組成物を痔疾患の治療予防液として使用した後の被験者の肛門部の状態を示している。図9に示すように、褐藻エキス含有痔治療予防液の使用後の肛門部の状態で分類すると、かなり腫れが引いた人が11人、少し腫れが引いた人が12人、出血が止まった人が10人、痒みが止まった人が9人、あまり変わらない人が6人、変化なし・悪化した人が2人であった。よって、被験者50人中の42人、すなわち、84%に痔疾患の改善効果が得られた。 FIG. 9 shows the state of the anus of the subject after using the brown algae extract-containing composition as a treatment / prevention solution for hemorrhoid diseases. As shown in FIG. 9, when classified according to the state of the anus after using the brown algae extract-containing acupuncture prevention liquid, there were 11 people who were considerably swollen, 12 people who were slightly swollen, and bleeding stopped There were 10 people, 9 people who stopped itching, 6 people who did not change much, and 2 people who did not change or deteriorated. Therefore, 42 of 50 test subjects, that is, 84%, had an improvement effect on epilepsy.
 以上説明したように、本実施形態に係る褐藻エキス含有組成物は、水分を除く固形分0.10~10.00重量%の褐藻エキスを主成分とし、残成分として、少なくとも、0.10~10.00重量%の抗炎症剤、0.20~10.00重量%のアロエ抽出物、及び0.10~5.00重量%の可溶性タンパク質成分を含有する。本実施形態に係る褐藻エキス含有組成物よれば、痔疾患の治療予防液として用いることにより、痔疾患の誘発を防止することができ、痔疾患を発症してしまった場合にも改善を促すことができる。
〔他の実施形態〕
As explained above, the brown algae extract-containing composition according to the present embodiment is mainly composed of a brown algae extract having a solid content of 0.10 to 10.00% by weight excluding moisture, and the remaining components are at least 0.10 to Contains 10.00 wt% anti-inflammatory agent, 0.20-10.00 wt% aloe extract, and 0.10-5.00 wt% soluble protein component. According to the brown algae extract-containing composition according to the present embodiment, by using it as a treatment / prevention solution for hemorrhoid disease, induction of hemorrhoid disease can be prevented and improvement is promoted even when epilepsy disease has developed. Can do.
[Other Embodiments]
 以上、本発明の好適な実施形態を説明したが、これらは本発明の説明のための例示であり、本発明の範囲をこれらの実施形態にのみ限定する趣旨ではない。本実施形態に係る褐藻エキス含有組成物は、有効成分としての褐藻エキスを主成分とし、残成分として、少なくとも、抗炎症剤、アロエ抽出物、及び可溶性タンパク質成分を含有する。上記の残成分は水やエタノール等を含み、医学的に許容可能な成分であるが、例えば、フェノキシエタノール等の防腐剤を含有していてもよい。防腐剤を含有することにより、組成物にカビが発生するのを防止することができる。なお、防腐剤は、例示の薬剤に限定されず、安息香酸ナトリウム等の他の防腐剤を用いてもよい。 The preferred embodiments of the present invention have been described above, but these are examples for explaining the present invention, and the scope of the present invention is not limited to these embodiments. The brown algae extract-containing composition according to the present embodiment contains a brown algae extract as an active ingredient as a main component, and contains at least an anti-inflammatory agent, an aloe extract, and a soluble protein component as the remaining components. The above remaining components include water, ethanol and the like and are medically acceptable components, but may contain a preservative such as phenoxyethanol, for example. By containing a preservative, it is possible to prevent mold from occurring in the composition. In addition, a preservative is not limited to the illustrated chemical | medical agent, You may use other preservatives, such as sodium benzoate.
 また、本実施形態に係る褐藻エキス含有組成物は、例えば、サンタンガム等のゲル化剤を含有していてもよい。ゲル化剤を含有することにより、治療予防液として肛門部に塗布する際の保持力を高めることができる。なお、ゲル化剤は、例示の薬剤に限定されず、ジェランガム等の他のゲル化剤を用いてもよい。このように本発明は、その要旨を逸脱しない範囲で、上記実施形態とは異なる種々の態様で実施することができる。 Moreover, the brown alga extract containing composition which concerns on this embodiment may contain gelling agents, such as a suntan gum, for example. By containing the gelling agent, it is possible to increase the holding power when applied to the anus as a treatment preventive solution. The gelling agent is not limited to the exemplified drugs, and other gelling agents such as gellan gum may be used. As described above, the present invention can be implemented in various modes different from the above-described embodiments without departing from the gist thereof.
 本発明に係る褐藻エキス含有組成物および褐藻エキス含有痔治療予防液は、痔疾患の誘発を予防したり、痔疾患を発症してしまった場合にも改善を促すことができ、今後、臨床試験を重ねれば、薬事法の医薬品や医薬部外品の基準を満たす組成物として、広く適用することが期待される。 The brown algae extract-containing composition and the brown algae extract-containing acupuncture preventive solution according to the present invention can prevent the induction of hemorrhoid disease or can promote improvement even if it has developed an epilepsy disease. Is expected to be widely applied as a composition that meets the standards for pharmaceuticals and quasi drugs in the Pharmaceutical Affairs Law.
  1  肛門部、
  2  イボ、
  3  切れ、
  4  痒み、
  5  腫れ。
1 anal part,
2 Warts,
3 slices,
4 Itching,
5 Swelling.

Claims (7)

  1.  水分を除く固形分0.10~10.00重量%の褐藻エキスを主成分とし、残成分として、医学的に許容可能な成分を含有することを特徴とする褐藻エキス含有組成物。 A brown algae extract-containing composition comprising a brown algae extract having a solid content of 0.10 to 10.00% by weight excluding moisture as a main component and a medically acceptable component as a remaining component.
  2.  前記褐藻エキスの固形分含有量は、0.10~3.00重量%である請求項1に記載の褐藻エキス含有組成物。 2. The brown algae extract-containing composition according to claim 1, wherein the solid content of the brown algae extract is 0.10 to 3.00% by weight.
  3.  前記残成分は、少なくとも、0.10~10.00重量%の抗炎症剤、0.20~10.00重量%のアロエ抽出物、および0.10~5.00重量%の可溶性タンパク質成分を含有する請求項1または請求項2に記載の褐藻エキス含有組成物。 The remaining component includes at least 0.10 to 10.00% by weight of an anti-inflammatory agent, 0.20 to 10.00% by weight of aloe extract, and 0.10 to 5.00% by weight of soluble protein component. The brown algae extract containing composition of Claim 1 or Claim 2 to contain.
  4.  前記抗炎症剤は、グリチルリチン酸2K、アラントインの少なくとも一種類を含む請求項3に記載の褐藻エキス含有組成物。 The brown alga extract-containing composition according to claim 3, wherein the anti-inflammatory agent contains at least one of glycyrrhizic acid 2K and allantoin.
  5.  前記アロエ抽出物は、アロエベラ葉肉末、キダチアロエ葉肉末、ケープアロエ葉肉末、アロエベラ葉エキス、キダチアロエ葉エキス、ケープアロエ葉エキスの少なくとも一種類を含む請求項3に記載の褐藻エキス含有組成物。 4. The brown alga extract-containing composition according to claim 3, wherein the aloe extract contains at least one of aloe vera mesophyll, kidachi aloe mesophyll, cape aloe mesophyll, aloe vera leaf extract, kidachi aloe leaf extract, cape aloe leaf extract.
  6.  前記可溶性タンパク質成分は、加水分解シルクである請求項3に記載の褐藻エキス含有組成物。 The brown alga extract-containing composition according to claim 3, wherein the soluble protein component is hydrolyzed silk.
  7.  請求項1から6に記載の褐藻エキス含有組成物は、痔疾患の治療予防液として用いられることを特徴とする褐藻エキス含有痔治療予防液。 The brown algae extract-containing composition according to any one of claims 1 to 6, wherein the brown algae extract-containing composition is used as a treatment / prevention liquid for acupuncture diseases.
PCT/JP2017/017208 2017-05-01 2017-05-01 Brown algae extract-containing composition, and brown algae extract-containing hemorrhoid treatment and prevention liquid WO2018203380A1 (en)

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