Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/88—Liliopsida (monocotyledons)
  • A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/15—Vitamins
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
  • A61K31/4415—Pyridoxine, i.e. Vitamin B6
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
  • A61K8/494—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with more than one nitrogen as the only hetero atom
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/67—Vitamins
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
  • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
  • A61K8/9771—Ginkgophyta, e.g. Ginkgoaceae [Ginkgo family]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
  • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
  • A61K8/9783—Angiosperms [Magnoliophyta]
  • A61K8/9789—Magnoliopsida [dicotyledons]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
  • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
  • A61K8/9783—Angiosperms [Magnoliophyta]
  • A61K8/9794—Liliopsida [monocotyledons]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P11/00—Drugs for disorders of the respiratory system
  • A61P11/02—Nasal agents, e.g. decongestants
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
  • A61P17/14—Drugs for dermatological disorders for baldness or alopecia
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P27/00—Drugs for disorders of the senses
  • A61P27/02—Ophthalmic agents
  • A61P27/04—Artificial tears; Irrigation solutions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/02—Nutrients, e.g. vitamins, minerals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/08—Anti-ageing preparations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/58—Metal complex; Coordination compounds

Definitions

• the present invention relates to a composition comprising at least one compound selected from the group consisting of vitamin B6 and salts thereof (hereinafter collectively referred to as “vitamin B6 compound”) and a plant extract.
• vitamin B6 compound a compound selected from the group consisting of vitamin B6 and salts thereof
• the present invention also relates to a method for photostabilizing a vitamin B6 compound in a composition comprising a vitamin B6 compound and a plant extract.
• Vitamin B6 includes pyridoxine, pyridoxal and pyridoxamine.
• Vitamin B6 is a component involved in protein metabolism as a coenzyme for amino acid decarboxylase and aminotransferase in vivo, and is widely used for pharmaceuticals, hair growth, for physical fatigue, eye strain, and nutrition during pregnancy. Used in medicines and health foods.
• Vitamin B6 must be stored protected from light because it degrades over time when exposed to light. For this reason, various compositions that have stabilized vitamin B6 have been studied. For example, eye drops containing flavin adenine dinucleotide, pyridoxine and a specific antioxidant (Patent Document 1), eye drops containing pyridoxine hydrochloride and berberine chloride (Patent Document 2), vitamin B6, oxymetazoline or a salt thereof And eye drops containing a borate buffer (Patent Document 3) are known.
• a light-shielding material (brown container, aluminum container, etc.) is used as the packaging material for storing the preparation, or ultraviolet light is applied to the container.
• a light shielding means such as kneading or coating the absorbent is adopted, or a light shielding means such as storing a container filled with the preparation in a paper box is adopted in the distribution process.
• the active ingredient is easily decomposed by light.
• hair restorers are transparent or semi-transparent that can be used and checked for the amount of use and remaining amount considering the convenience of the user due to the product characteristics of being used continuously for a long period of one to several months every day.
• Container is adopted. For this reason, these products are stored in a dark place or stored in a paper box to maintain the light stability of the active ingredient.
• the transparency of the container can be maintained to some extent, but it cannot be completely shielded from light, and the light stability of the active ingredient is insufficient, or the manufacturing cost of the container increases. There was a problem such as.
• the light shielding means using such a packaging material has a problem that the light stability in the manufacturing process cannot be ensured.
• the conventional light-shielding method is not necessarily an effective method.
• the preparation is taken out from the container and used on application sites such as the scalp, skin, mucous membrane and the like. Therefore, there is a problem that the active ingredient is exposed to light and the active ingredient is easily decomposed at the application site.
• the blending amount of vitamin B6 and the application target are not limited, and it is required to improve the stability of vitamin B6 to light. Yes.
• An object of the present invention is to provide a composition containing vitamin B6 compound in which the stability of the vitamin B6 compound to light is improved.
• Another object of the present invention is to provide a method for photostabilizing a vitamin B6 compound in a composition comprising a vitamin B6 compound and a plant extract.
• chlorophyll contained in a plant extract reduces the photostability of vitamin B6.
• chlorophyll is known as a substance involved in photosynthesis in plants, cyanobacteria, algae, etc., but it is known that chlorophyll co-formulates the light stability of other components such as vitamin B6. It was not done.
• the present invention has been completed on the basis of these findings and found that the concentration of chlorophyll affecting the photostability of the vitamin B6 compound is 0.15 ppm or more. Is included.
• Item 1 A composition comprising at least one compound selected from the group consisting of vitamin B6 and salts thereof, and a plant extract, wherein the content of chlorophyll in the composition is less than 0.15 ppm object.
• the plant extract contains at least one compound selected from the group consisting of vitamin B6 and salts thereof, and the compound is inherent in the plant extract or inherent in the plant extract Item 2.
• Item 3 The plant extract does not contain at least one compound selected from the group consisting of vitamin B6 and salts thereof, and at least one compound selected from the group consisting of vitamin B6 and salts thereof is included in the composition.
• Item 2. The composition according to Item 1, which is externally added.
• Item 4. The composition according to any one of Items 1 to 3, wherein the chlorophyll is at least one chlorophyll selected from the group consisting of chlorophyll a and chlorophyll b.
• Item 5 The composition according to any one of Items 1 to 4, wherein at least one compound selected from the group consisting of vitamin B6 and a salt thereof is pyridoxine hydrochloride.
• Item 6. The composition according to any one of Items 1 to 5, wherein the plant extract is an extract extracted from a plant of a green plant.
• Item 7. The composition according to any one of Items 1 to 6, which is a hair restorer, an eye drop, a nose drop, an eye wash, a nose wash, or a contact lens preparation.
• Item 8 A method for photostabilizing the above compound in a composition comprising at least one compound selected from the group consisting of vitamin B6 and salts thereof and a plant extract, wherein the content of chlorophyll in the composition is less than 0.15 ppm A method for stabilizing light.
• composition containing the vitamin B6 compound of the present invention has improved stability of the vitamin B6 compound to light.
• the stability of the vitamin B6 compound to light can be improved in the composition containing the vitamin B6 compound and the plant extract.
• composition of the present invention contains a vitamin B6 compound and a plant extract, and the content of chlorophyll in the composition is less than 0.15 ppm.
• Vitamin B6 compound means vitamin B6 or a salt thereof.
• examples of vitamin B6 include pyridoxine, pyridoxal, and pyridoxamine. These salts include, but are not particularly limited to, hydrochlorides, sulfates, nitrates, hydrobromides, phosphates, and the like.
• pyridoxine hydrochloride is preferable because it is excellent in the effect of improving eye strain.
• These vitamin B6 compounds can be used alone or in any combination of two or more.
• This vitamin B6 compound does not particularly limit its origin. For example, it may be derived from synthesis or derived from natural products such as plants. Vitamin B6 compounds are commercially available.
• the vitamin B6 compound contained in the composition of the present invention may be an endogenous vitamin B6 compound contained in the plant extract mixed in the composition at the same time, or separately from the plant extract. It may be externally added to the composition (exogenous vitamin B6 compound), or may be both of these (endogenous + exogenous vitamin B6 compound).
• the ratio of the vitamin B6 compound in the composition of the present invention is not particularly limited as long as the effect of the vitamin B6 compound is obtained.
• the action effect of vitamin B6 compound is to help produce energy from protein and maintain the health of skin and mucous membrane, improve skin diseases such as seborrheic dermatitis, eczema, acne, rough skin, skin cell activation action, dandruff and Examples thereof include improvement of itching, improvement of erythema by ultraviolet rays, antiallergic action, improvement of physical fatigue, and improvement of eye strain.
• the blending amount depends on the use of the composition of the present invention (for example, skin preparations such as hair restorers and cosmetics, eye drops, nasal drops, eye wash, nasal wash or contact lens preparations).
• the vitamin B6 compound As a general proportion of the vitamin B6 compound, it is usually about 0.0001 to 1% by weight, preferably about 0.02 to 0.5% by weight, and particularly preferably about 0.05 to 0.2% by weight. Usually about 0.02 to 0.5% by weight, preferably about 0.05 to 0.2% by weight; for cosmetics, usually about 0.0001 to 5% by weight, preferably about 0.05 to 0.2% by weight; usually for eye drops or nasal drops About 0.005 to 0.2% by weight, preferably about 0.01 to 0.1% by weight; In the case of eyewash or nasal rinse, usually about 0.0005 to 0.02% by weight, preferably about 0.001 to 0.01% by weight; Examples are usually about 0.0005 to 1% by weight, preferably about 0.001 to 0.01% by weight.
• composition of the present invention is characterized in that the content of chlorophyll is less than 0.15 ppm.
• Chlorophyll also called chlorophyll, is a porphyrin pigment contained in plants and is a chemical substance involved in photosynthesis.
• chlorophyll contained in plants there are mainly chlorophyll a and b.
• the amount of chlorophyll contained in the composition means the total amount when plural kinds of chlorophyll are contained, and means the amount of chlorophyll blended when only one of them is contained.
• the content of chlorophyll in the composition is preferably less than about 0.1 ppm, particularly preferably less than about 0.05 ppm.
• the composition of the present invention may contain chlorophyll as long as the effects of the present invention are not impaired, and may contain about 0.001 ppm of chlorophyll.
• the plant extract targeted by the present invention does not contain a vitamin B6 compound (non-vitamin B6 compound-containing plant extract) and contains a vitamin B6 compound (vitamin B6 compound) Containing plant extracts).
• the plant extract targeted by the present invention is a product obtained by leaching a plant body in an extraction solvent (water, ethanol, etc.) and then concentrating the liquid (soft extract or dry extract). Therefore, it does not refer to the chemical substance (isolate) itself extracted from the plant body.
• the plant extract is preferably a plant extract extracted from a plant body of a green plant.
• Green plants are phylogenetic groups characterized by having a typical green vegetative body by having chlorophyll (chlorophyll a and / or b) involved in photosynthesis.
• a plant extract extracted from at least one plant selected from the group consisting of aloe, amacha, kiri, mulberry, mugwa, taiso, and dokudami is preferable.
• a plant extract containing a vitamin B6 compound is preferably a plant extract extracted from the leaves or stems of at least one plant selected from the group consisting of ashitaba, licorice, parsley, lettuce, celery and garlic. .
• the plant extract is used in combination with the aforementioned vitamin B6 compound. That is, in this case, the composition of the present invention contains a plant extract containing no vitamin B6 compound and an exogenous vitamin B6 compound.
• the plant extract containing the vitamin B6 compound may be used as it is without adding the aforementioned vitamin B6 compound, Moreover, you may use it in combination with a vitamin B6 compound.
• the composition of the present invention contains a plant extract containing a vitamin B6 compound (containing an endogenous vitamin B6 compound and not containing an exogenous vitamin B6 compound), or a plant extract containing a vitamin B6 compound and an exogenous one. Contains sex vitamin B6 compounds.
• blended with the composition of this invention will not be restrict
• the action effect of the plant extract can include a moisturizing effect, although it varies depending on the type of plant.
• the blending amount depends on the use of the composition of the present invention (for example, skin preparations such as hair restorers and cosmetics, eye drops, nasal drops, eye wash, nasal wash or contact lens preparations). And prepared as appropriate.
• the general proportion of the plant extract is, for example, usually about 0.00001 to 5% by weight, preferably about 0.0001 to 1% by weight, particularly preferably about 0.005 to 0.1% by weight in terms of dry matter weight.
• hair restorer usually about 0.00001 to 5% by weight, preferably about 0.0001 to 1% by weight
• eye drops or nasal drops it is usually about 0.00001 to 1% by weight, preferably about 0.0001 to 0.1% by weight
• an eyewash or nasal rinse it is usually about 0.00001 to 1% by weight, preferably about 0.0001 to 0.1% by weight
• in the case of a contact lens agent it is usually about 0.00001 to 1% by weight, preferably 0.0001 to 0.1% by weight.
• the degree can be mentioned.
• vitamin B6 compound containing plant extract as a plant extract
• the whole plant may be used as it is, or a part of the plant may be used.
• chlorophyll is mainly contained in the leaves and stems of plants, so that the plant extract is a plant extract extracted from the entire plant body including the leaves and stems from the viewpoint of sufficiently exerting the effects of the present invention. Is preferred, and a plant extract extracted from leaves and / or stems is more preferred.
• plant bodies are collectively referred to as “plant bodies”.
• the whole plant for example, a part of the plant, such as leaves, stems, roots, etc.
• in its raw state (undried), dried (dried), or frozen (frozen)
• size can also be used.
• Examples of the method for producing a plant extract include, but are not limited to, a method of combining an extraction step and a separation step, a method of further combining a fractionation step with the above method, and the like.
• the extraction step is a step of extracting necessary components as an extract from the plant using an extraction solvent, and the extraction method and extraction conditions are not particularly limited.
• the type of the extraction solvent is not particularly limited, and examples thereof include water, organic solvents, and mixed solvents thereof.
• examples of the water include water at all temperatures such as cold water, room temperature water, hot water, hot water, and water vapor, and may be sterilized, ion exchanged, osmotic pressure adjusted or buffered.
• the organic solvent is preferably a hydrophilic organic solvent, for example, a monohydric alcohol having 1 to 5 carbon atoms (ethanol, methanol, propanol, isopropanol, etc.), a polyhydric alcohol having 2 to 5 carbon atoms (glycerin, isopropylene glycol, Propylene glycol and 1,3-butylene glycol), esters (methyl acetate, etc.), ketones (acetone, etc.) and the like can be used.
• These hydrophilic organic solvents may use only 1 type and may use 2 or more types together.
• the content of 1,3-butylene glycol in the mixed solution is preferably about 0.1 to 70% by weight, and about 5 to 60% by weight. More preferred is about 10 to 50% by weight.
• the ethanol content in the mixed solution is preferably about 0.1 to 99.5% by weight, more preferably about 5 to 95% by weight, and about 50 to 95% by weight. Is more preferable, and about 60 to 90% by weight is most preferable.
• extraction methods include immersion extraction, stirring extraction, reflux extraction, shaking extraction, and ultrasonic extraction.
• Extraction conditions include room temperature extraction, heat extraction (also called warm extraction), pressure extraction, and supercritical extraction. Among them, room temperature or heating extraction is preferable.
• the extraction time is not particularly limited.
• the pH may be adjusted.
• the extraction operation may be performed once, or may be performed by repeating extraction of the extraction residue obtained after the extraction operation a plurality of times. Furthermore, before and after the extraction step, a treatment such as filtration may be performed as necessary.
• the separation step is a solid-liquid method for separating the insoluble matter that is the extraction residue and the extract from the extract obtained above.
• centrifugation filter press, filtration (pressurization, normal pressure), chromatography
• a method by extraction separation using an adsorbent / absorbent such as graphy.
• the extract collected from the extract may be used as it is, or further purified by fractionation or the like.
• the fractionation step is a method of fractionating necessary components from the extract obtained above and purifying and concentrating.
• activated carbon, anion exchange resin, cation exchange resin, silica gel, chromatography using a polystyrene-based resin that adsorbs an aromatic compound, dialysis, molecular sieve, vacuum concentration Although methods, such as freeze-drying, are mentioned, it is not limited to these. Furthermore, you may perform the process of collect
• a treatment such as filtration may be performed as necessary.
• a gauze, a filtration filter, a commercially available filter, etc. can be used for filtration.
• a sterilization process etc. can be given as needed.
• the plant extract obtained by the above method may be used in a liquid form as it is, but can also be pulverized by a drying process such as spray drying, vacuum drying, freeze drying and the like.
• the composition of the present invention is characterized in that the content of chlorophyll is less than 0.15 ppm.
• the chlorophyll is usually derived from a plant extract, it is preferable to perform a treatment for removing or reducing the amount of chlorophyll during the preparation of the plant extract.
• a treatment for removing or reducing the amount of chlorophyll during the preparation of the plant extract include extraction methods using various extraction solvents (water, ethanol, 1,3-butylene glycol, mixtures thereof, etc.), fractionation methods using a carrier (activated carbon, etc.), centrifugation and filter press, Examples thereof include an extraction separation method using filtration.
• the content of chlorophyll contained in the plant extract can be measured by an absorptiometric method using a spectrophotometer, a high performance liquid chromatography method, an extraction isolation method, a derivative conversion method, or the like.
• composition of the present invention may further contain other components that are usually used in the art as long as they do not impair the pharmacological action and stability of the vitamin B6 compound and plant extract. Can be included. However, this is not the case when it overlaps with the already described components.
• Such other components include, for example, solvents, decongestants, eye conditioning components, anti-inflammatory components, astringent components, antihistamine components, antiallergic components, vitamins, amino acids, antibacterial components, bactericidal components, sugars, Examples thereof include polysaccharides and derivatives thereof, cellulose and derivatives thereof, water-soluble polymers, local anesthetic components, steroid components, glaucoma treatment components, and cataract treatment components. Examples of other components preferable in the present invention include the following.
• Solvent examples of the solvent include water, alcohols, ethers, and mixtures thereof.
• examples of alcohols include at least one selected from the group consisting of polyhydric alcohols and lower alcohols.
• Polyhydric alcohols include propylene glycol, glycerin, diglycerin, triglycerin, ethylene glycol, diethylene glycol, triethylene glycol, polyethylene glycol, propanediol, dipropanediol, tripropanediol, butanediol, dibutanediol, pentanediol, Examples include pentanetriol, hexanediol, cyclohexanetriol, pentaerythritol, trimethylolpropane, sorbitol and mannitol.
• Examples of the lower alcohol include methanol, ethanol, propanol, isopropanol, butanol, isobutanol, amyl alcohol, and isoamyl alcohol.
• propylene glycol, glycerin, ethanol and the like are preferable as alcohols from the viewpoints of safety and stability of vitamin B6 compounds and plant extracts.
• the total content of alcohols in the composition of the present invention is not particularly limited by the type of polyhydric alcohol or lower alcohol, but is preferably about 40% by weight or less, and preferably about 30% by weight or less. More preferably, it is more preferably about 20% by weight or less.
• Decongestant for example, ⁇ -adrenergic agonist, specifically epinephrine, epinephrine hydrochloride, ephedrine hydrochloride, oxymetazoline hydrochloride, tetrahydrozoline hydrochloride, tetrahydrozoline nitrate, naphazoline hydrochloride, naphazoline nitrate, phenylephrine hydrochloride, methylephedrine hydrochloride, hydrogen tartrate Epinephrine and the like.
• ⁇ -adrenergic agonist specifically epinephrine, epinephrine hydrochloride, ephedrine hydrochloride, oxymetazoline hydrochloride, tetrahydrozoline hydrochloride, tetrahydrozoline nitrate, naphazoline hydrochloride, naphazoline nitrate, phenylephrine hydrochloride, methylephedrine hydro
• Eye muscle modulator component For example, cholinesterase inhibitors having an active center similar to acetylcholine, specifically, quaternary ammonium compounds such as neostigmine methyl sulfate and pharmacologically acceptable salts thereof.
• Anti-inflammatory component or astringent component for example, zinc sulfate, zinc lactate, allantoin, ⁇ -aminocaproic acid, indomethacin, lysozyme chloride, silver nitrate, pranoprofen, dipotassium glycyrrhizinate, diclofenac sodium, bromfenac sodium, berberine chloride, Examples include berberine sulfate and methyl salicylate.
• Vitamin For example, at least one vitamin selected from the group consisting of vitamin A, vitamin B (other than the above vitamin B6 compounds), vitamin C, vitamin D, vitamin E, and other vitamins Can be contained.
• vitamins A include retinal, retinol, retinoic acid, carotene, dehydroretinal, lycopene and pharmacologically acceptable salts thereof.
• vitamin B examples include thiamine, thiamine disulfide, dicetiamine, octothiamine, chicotiamine, bisibhiamine, bisbenchamine, prosultiamine, benfotiamine, fursultiamine, riboflavin, flavin adenine dinucleotide, hydroxocobalamin, Cyanocobalamin, methylcobalamin, deoxyadenocobalamin, folic acid, tetrahydrofolic acid, dihydrofolic acid, nicotinic acid, nicotinic acid amide, nicotinic alcohol, pantothenic acid, panthenol, biotin, choline, inositol and their pharmacologically acceptable Examples include salts.
• vitamin C examples include ascorbic acid and derivatives thereof, erythorbic acid and derivatives thereof, and pharmacologically acceptable salts thereof.
• vitamin D examples include ergocalciferol, cholecalciferol, hydroxycholecalciferol, dihydroxycholecalciferol, dihydrotaxosterol and pharmacologically acceptable salts thereof.
• vitamin E examples include tocopherol and its derivatives, ubiquinone derivatives and pharmacologically acceptable salts thereof.
• other vitamins include carnitine, ferulic acid, ⁇ -oryzanol, orotic acid, rutin, eriocitrin, hesperidin and pharmacologically acceptable salts thereof.
• Amino acids examples include aminoethylsulfonic acid (taurine), glutamic acid, creatinine, sodium glutamate, sodium chondroitin sulfate, and the like. These may be d-form, l-form or dl-form.
• Antibacterial component or bactericidal component For example, aminodeoxykanamycin sulfate, kanamycin sulfate, gentamicin sulfate, sisomycin sulfate, streptomycin sulfate, tobramycin, micronomycin sulfate, alkylpolyaminoethylglycine, chloramphenicol, tetracycline hydrochloride, oxytetracycline hydrochloride Ofloxacin, norfloxacin, levofloxacin, lomefloxacin hydrochloride, sulbenicin sodium, cefmenoxime hydrochloride, benzylpenicillin potassium, berberine sulfate, berberine chloride, sodium colistin metasulfonate, erythromycin, erythromycin lactobionate, kitasamycin, spiramycin, fradiomycin sulfate, fradiomycin sul
• Sugars examples include monosaccharides and disaccharides, specifically glucose, trehalose, lactose, fructose and the like.
• Polysaccharides or derivatives thereof examples include sodium hyaluronate and sodium chondroitin sulfate.
• Cellulose or a derivative thereof or a salt thereof examples thereof include sodium carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, methylcellulose and the like.
• Water-soluble polymers other than those mentioned above include, for example, polyvinyl alcohol (completely or partially saponified product), polyvinylpyrrolidone, dextrin, polyethylene glycol and the like.
• Local anesthetic component For example, lidocaine, oxybuprocaine, dibucaine, procaine, ethyl aminobenzoate, meprilucaine, and salts thereof.
• Steroid component examples thereof include hydrocortisone, prednisolone, and salts thereof.
• Glaucoma treatment ingredients for example, levobnolol, timolol, and salts thereof.
• Cataract treatment component For example, pirenoxine and the like.
• the content ratio of these components in the composition is appropriately determined according to the type of the preparation, the type of the contained component, and the like. For example, it is about 0.0001 to 50% by weight, preferably about 0.0001 to 25% by weight, more preferably about 0.001 to 10% by weight, based on the entire preparation.
• the aqueous liquid preparation of the present invention may further contain additives that are usually used in the art as long as they do not impair the pharmacological action and stability of the vitamin B6 compound and plant extract. However, this is not the case when it overlaps with the already described components.
• additives include, for example, preservatives, bactericides or antibacterial agents, thickeners, solubilizers or solubilizers, pH regulators, isotonic agents, fragrances, cooling agents, chelating agents, buffering agents. , Stabilizers, and base materials.
• preferable additives in the present invention include the following additives.
• Preservatives, bactericides or antibacterials for example, alkyldiaminoethylglycine hydrochloride, sodium benzoate, ethanol, chlorobutanol, sorbic acid, potassium sorbate, sodium dehydroacetate, methyl paraoxybenzoate, ethyl paraoxybenzoate, paraoxybenzoic acid
• alkyldiaminoethylglycine hydrochloride sodium benzoate, ethanol, chlorobutanol, sorbic acid, potassium sorbate, sodium dehydroacetate, methyl paraoxybenzoate, ethyl paraoxybenzoate, paraoxybenzoic acid
• Examples include propyl, butyl paraoxybenzoate, oxyquinoline sulfate, phenethyl alcohol, benzyl alcohol, biguanide compounds, and acrinol.
• Thickener For example, sodium carboxymethylcellulose, dextran, polyethylene glycol, carboxyvinyl polymer, hydroxyethylcellulose, hydroxypropylmethylcellulose, methylcellulose, polyvinyl alcohol (completely or partially saponified), polyvinylpyrrolidone, macrogol, sodium chondroitin sulfate, etc. Can be mentioned.
• Solubilizers or solubilizers for example, glycine-type amphoteric surfactants such as alkyldiaminoethylglycine, alkyl ether carboxylates, sulfonates such as sodium tetradecenesulfonate, alkyl sulfates such as sodium lauryl sulfate, N -N-acyl taurine salts such as sodium cocoylmethyl taurine, POE alkyl ether phosphates such as POE (10) sodium lauryl ether phosphate and salts thereof, N-acyl amino acid salts such as sodium lauroylmethylalanine, POE (3) lauryl POE alkyl ether sulfates such as sodium ether sulfate, and anionic surfactants such as ⁇ -olefin sulfonates.
• glycine-type amphoteric surfactants such as alkyldiaminoethylglycine, alkyl
• polyoxyethylene hydrogenated castor oil 60 polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (20) sorbitan tristearate, polyoxyethylene (20 ) Sorbitan oleate, polyoxyl 40 stearate, sucrose stearate, decaglyceryl monostearate, lauryl glucoside, macrogol 4000.
• the numbers in parentheses indicate the number of moles added.
• Examples of the cationic surfactant include quaternary ammonium compounds and biguanide compounds.
• the quaternary ammonium compounds include cetylpyridinium chloride hydrate, decalinium chloride, benzethonium chloride, benzalkonium chloride, alkyldimethylammonium chloride, alkyltrimethylammonium chloride, methylbenzethonium chloride, lauroyl colamino Examples include formylmethylpyridinium chloride.
• Examples of biguanide compounds include chlorhexidine or a salt thereof, preferably chlorhexidine gluconate, chlorhexidine hydrochloride and the like.
• PH adjusting agent For example, hydrochloric acid, aminoethylsulfonic acid, epsilon-aminocaproic acid, acetic acid, sodium hydroxide, sodium bicarbonate, sodium carbonate, triethanolamine, monoethanolamine and the like can be mentioned.
• Isotonizing agents for example, sodium bisulfite, sodium sulfite, potassium chloride, calcium chloride, sodium chloride, magnesium chloride, potassium acetate, sodium acetate, sodium bicarbonate, sodium carbonate, sodium thiosulfate, magnesium sulfate, glycerin, propylene glycol Etc.
• Perfume or refreshing agent For example, terpenes (specifically, anethole, eugenol, camphor, geraniol, cineol, borneol, menthol, limonene, ryuuno, etc. These may be any of d-form, l-form or dl-form. ) Essential oils (specifically, fennel oil, cool mint oil, cinnamon oil, spearmint oil, mint water, mint oil, peppermint oil, bergamot oil, eucalyptus oil, rose oil, etc.).
• Essential oils specifically, fennel oil, cool mint oil, cinnamon oil, spearmint oil, mint water, mint oil, peppermint oil, bergamot oil, eucalyptus oil, rose oil, etc.
• Chelating agent for example, ascorbic acid, tetrasodium edetate, sodium edetate, citric acid and the like.
• Buffering agent For example, citric acid, sodium citrate, acetic acid, potassium acetate, sodium acetate, sodium bicarbonate, sodium carbonate, boric acid, borax and the like can be mentioned.
• Stabilizer For example, cyclodextrin, dibutylhydroxytoluene, trometamol, tocopherol, sodium pyrosulfite, monoethanolamine, aluminum monostearate and the like can be mentioned.
• Base for example, octyldodecanol, olive oil, sesame oil, titanium oxide, potassium bromide, soybean oil, camellia oil, corn oil, rapeseed oil, paraffin, castor oil, plastibase, peanut oil, lanolin, petrolatum and the like.
• the composition of the present invention can be adjusted to an osmotic pressure ratio within a range acceptable for a living body, if necessary.
• the osmotic pressure ratio with respect to physiological saline is usually about 0.3 to 4, preferably about 0.5 to 2, and more preferably about 0.5 to 1.4.
• the osmotic pressure ratio can be adjusted by appropriately using a buffer, an isotonic agent, salts and the like in addition to the pH adjuster.
• composition of the present invention for example, in the liquids for internal use to be described later, is usually preferably pH 2 to 10, more preferably pH 4 to 9, and more preferably pH 6 to 8 in terms of feeling of administration and stability of active ingredients. If it is more preferable.
• the pH is usually 3 to 10, preferably 3 to 9, more preferably 4 to 8 in terms of low irritation to the skin, good usability and stability of the active ingredient. Further preferred.
• the pH is usually 5 to 9.5 in terms of low irritation to mucous membranes and stability of active ingredients.
• the pH is preferably 5.5 to 9, and more preferably 6 to 8.
• Vitamin B6 compounds tend to be unstable and photodecompose easily in compositions having a high water content. Therefore, the composition containing the vitamin B6 compound of the present invention can effectively improve the stability of the vitamin B6 compound to light when it is a composition containing water (water-containing composition).
• the content of water in the composition is preferably about 5% by weight or more, more preferably about 20% by weight or more, further preferably about 50% by weight or more, and 70% by weight or more. Is particularly preferred.
• the upper limit is about 99.9% by weight or less, preferably about 99% by weight or less, more preferably about 95% by weight or less.
• composition of the present invention utilizes a known operation depending on its use (hair preparations, cosmetic preparations and other skin preparations, eye drops, nasal drops, eye wash, nasal wash, contact lens preparations, etc.) However, it can manufacture by mix
• the ingredients are first mixed, and further subjected to filter sterilization treatment if necessary. It can be prepared by filling into a container. More specifically, when the composition is a hair restorer, using distilled water or purified water and additives, dissolve ingredients such as vitamin B6 compounds and plant extracts, and adjust to a predetermined osmotic pressure and pH, It can be manufactured by subjecting it to filtration sterilization in an aseptic environment and aseptically filling a container that has been sterilized by washing.
• composition of the present invention can be used, for example, in the form of internal use or external use depending on the purpose, and can be provided as a topical preparation for various uses.
• Examples of internal dosage forms include various solid preparations such as tablets, pills, capsules (soft capsules, hard capsules), powders (powder) and granules (including dry syrup), or liquids for internal use (liquids) , Including suspensions, syrups, and jelly preparations).
• a skin preparation for example, in the case of a skin preparation, it can be formulated into a liquid agent (lotion, suspension, emulsion, aerosol), ointment, cream, gel (gel), patch, etc. can do.
• a liquid agent liquid agent
• emulsion emulsion
• aerosol ointment
• cream gel
• patch etc.
• it can be used not only as a therapeutic preparation but also as a non-therapeutic preparation such as a contact lens preparation.
• ophthalmic preparations include, for example, eye drops (also referred to as eye drops, including eye drops that can also be used while wearing contact lenses), eye wash (also referred to as eye washes, and eye wash that can be used while wearing contact lenses)
• eye drops also referred to as eye drops, including eye drops that can also be used while wearing contact lenses
• eye wash also referred to as eye washes, and eye wash that can be used while wearing contact lenses
• Contact lens mounting liquid and contact lens preparations (cleaning liquid, preserving liquid, rinsing liquid, disinfecting liquid, multi-purpose solution, etc.) and the like.
• the contact lens means all types of contact lenses such as hard contact lenses (including oxygen permeable hard contact lenses) and soft contact lenses.
• composition of the present invention Since the composition of the present invention has improved stability of vitamin B6 compounds with respect to light, it is preferably applied to a preparation that has conventionally been problematic in that the stability of vitamin B6 compounds with respect to light is problematic.
• preparations in which the low light stability of vitamin B6 compounds is particularly problematic include compositions containing water such as liquids for internal use, skin preparations that are liquid preparations, eyewashes, and contact lens preparations (water-containing compositions) Product). This is because in a composition containing water, the vitamin B6 compound tends to be unstable and easily photodecomposes.
• composition of the present invention is highly stable to light of vitamin B6 compound, it is packaged in a form to be administered multiple times and is continuously used by the user.
• Agent eyewash (eyewash), nasal rinse (nasal rinse), oral medicine (oropharyngeal drug, gargle etc.), ear drops, nasal drops (nasal drops), contact lens agents, It is also useful as a liquid oral medicine (liquid gastrointestinal remedy, liquid cold medicine, etc.), skin external medicine (hair restorer, external analgesic, external antipruritic agent, etc.), cosmetics (skin lotion, milky lotion, cosmetic liquid, etc.) and the like.
• the stability of vitamin B6 compound to light can be improved without depending on the device and packaging.
• the container for packaging the composition of the present invention is not particularly limited. For example, there are cases where it is desired to grasp the internal volume or the remaining amount of the filled composition, such as an ophthalmic preparation, and so on.
• Preferable examples include translucent containers made of polyester resins such as polyethylene resins and polyethylene terephthalate.
• the transmittance in the visible light region is usually 10% or more, preferably 30% or more, more preferably 50% or more, and further preferably 70% or more. It is preferably 80% or more. Further, the upper limit of the transmittance is not particularly limited, but is 99% or less.
• the light stabilization method of the present invention is a method for photostabilization of the above compound in a composition containing a vitamin B6 compound and a plant extract, and contains chlorophyll in the composition. The amount is less than 0.15 ppm.
• the content described in the item of the above composition can be adopted as the content of the vitamin B6 compound and the plant extract contained in the composition.
• the light stabilization method of the present invention is a composition containing a vitamin B6 compound and a plant extract.
• the content of chlorophyll in the composition is preferably less than about 0.1 ppm, particularly preferably less than about 0.05 ppm.
• composition A plant extract was prepared using aloe (Aloe seed: Kidachi aloe) as a plant body.
• Aloe's ethanol extract is pulverized into raw aloe, dried and powdered, and about 10 times the amount of ethanol aqueous solution (80 wt% ethanol, 80% EtOH) is added to the total amount of the dried product. (Aloe EtOH extract). Thereafter, activated carbon was added to remove chlorophyll, whereby an activated carbon-treated extract of aloe was obtained (aloe EtOH extract (after activated carbon treatment)).
• Aloe 1,3-butylene glycol extract is dried after finely chopping raw aloe, and about 30 times the 40% by weight 1,3-butylene glycol aqueous solution is added to the total amount of the dried product at room temperature. Obtained by extracting 5-7 days and nights (Aloe BG extract).
• the solid content of the aloe extract was as follows.
• Aloe 80% EtOH extract Aloe EtOH extract in the table: 2.5% by weight (dry matter weight)
• Aloe 1,3-butylene glycol extract Aloe BG extract in the table: 1% by weight (dry matter weight) Aloe extract after 80% EtOH extraction and activated carbon treatment (In the table, Aloe EtOH extract (after activated carbon treatment)): 1% by weight (dry matter weight)
• each component was dissolved in purified water with the composition shown in Table 1 to make a total amount of 100 g, to prepare a test solution for the composition.
• aloe extract and aloenin which are components of aloe, were contained in each of the prepared aloe extracts (aloe EtOH extract, aloe BG extract and aloe EtOH extract (after activated carbon treatment)). Therefore, these aloe extracts are suitable plant extracts containing the active ingredients of aloe.
• Citric acid and sodium citrate were used for pH adjustment of the test solution.
• the pH of the test solution was pH 5.5.
• chlorophyll chlorophyll
• the content of chlorophyll (chlorophyll) in the test solution was measured by the following procedure using an absorptiometric method using a spectrophotometer. 4 g of a sample was taken, 0.1 g of basic calcium carbonate was added, 5 mL of water and 40 mL of acetone were added, and then the mixture was centrifuged in an ultrasonic cleaner. This process was repeated twice. The operation of adding 50 mL of diethyl ether and 40 mL of water to the supernatant, mixing and allowing to stand, and removing the aqueous layer was repeated 3 times.
• E 660 and E 642.5 are absorbances at 660 nm and 642.5 nm, W is a sampled amount (g), and V is a constant ether volume (mL).
• EtOH represents ethanol and BG represents 1,3-butylene glycol.
• the pyridoxine hydrochloride concentration in the test sample before and after light irradiation was measured by high performance liquid chromatography. From the measured pyridoxine hydrochloride concentration of the test sample, the residual ratio (%) of pyridoxine hydrochloride after light irradiation was calculated according to the following formula.
• Residual rate (%) 100 x pyridoxine hydrochloride concentration after light irradiation (wt%) / Pyridoxine hydrochloride concentration before light irradiation (wt%) (3) Test results Tables 1 and 2 show the photostability test results.
• Examples 1 to 3 which contain pyridoxine hydrochloride (vitamin B6 compound) and aloe extract (plant extract) and have a content of chlorophyll a (chlorophyll) of less than 0.15 ppm, are the residual rate of pyridoxine hydrochloride after the photostability test. Was expensive. Specifically, in Examples 1 to 3, the residual rate of pyridoxine hydrochloride was 90% or more.
• aloe usually contains chlorophyll a and b, but the content of chlorophyll b was smaller than the content of chlorophyll a, and was less than 0.05 ppm in all Examples and Comparative Examples.
• Algae and cyanobacteria also contain chlorophyll.
• chlorophyll contained in algae include chlorophyll b (some green algae), chlorophyll c (brown algae and diatoms), chlorophyll d (red algae), and chlorophyll e (unequal hairy algae).
• Chlorophyll c is an example of chlorophyll contained in cyanobacteria.
• a test solution of a composition such as an extract was prepared in the same manner as in the aloe using algae and cyanobacteria instead of the plant body (aloe).
• These compositions contained pyridoxine hydrochloride (vitamin B6 compound), algal and cyanobacterial extracts, and the like, and the chlorophyll content was less than 0.15 ppm.
• the light stability of vitamin B6 in a composition was evaluated similarly to the said plant body.
• Hair growth agents (Formulation Examples 1 to 9) having the composition shown in Table 3 and having a chlorophyll content of less than 0.15 ppm were prepared. All hair restorers were excellent in the stability of pyridoxine hydrochloride, pyridoxal hydrochloride, and pyridoxamine dihydrochloride.
• Eye Drops Eye drops (Prescription Examples 10 to 18) having the composition shown in Table 4 and having a chlorophyll content of less than 0.15 ppm were prepared. All of the eye drops were excellent in the stability of pyridoxine hydrochloride.
• composition shown in nasal drops Table 5 the content of chlorophyll was prepared nasal agents that it is less than 0.15ppm (the Formulation Example 19).
• the nasal drops were also excellent in the stability of pyridoxine hydrochloride.
• the eyewash was also excellent in the stability of pyridoxine hydrochloride.
• the nasal rinse was also excellent in the stability of pyridoxine hydrochloride.
• Contact lens preparation A contact lens preparation (formulation example 22) having the composition shown in Table 8 and having a chlorophyll content of less than 0.15 ppm was prepared.
• the contact lens agent was also excellent in the stability of pyridoxine hydrochloride.
• the cream was also excellent in the stability of pyridoxine hydrochloride.
• Lotion Toner lotion having a composition shown in Table 10 and having a chlorophyll content of less than 0.15 ppm (Prescription Example 24) was prepared.
• the lotion was also excellent in the stability of pyridoxine hydrochloride.
• Cosmetic liquid with a composition shown in Table 11 having a chlorophyll content of less than 0.15 ppm (Prescription Example 25) was prepared.
• the essence was also excellent in the stability of pyridoxine hydrochloride.
• Drink preparation A drink preparation (formulation example 26) having a composition shown in Table 12 and having a chlorophyll content of less than 0.15 ppm was prepared. The drink was also excellent in the stability of pyridoxine hydrochloride.

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