ES2562985B1 - Pharmaceutical composition for the treatment of skin lesions - Google Patents
Pharmaceutical composition for the treatment of skin lesions Download PDFInfo
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- ES2562985B1 ES2562985B1 ES201531954A ES201531954A ES2562985B1 ES 2562985 B1 ES2562985 B1 ES 2562985B1 ES 201531954 A ES201531954 A ES 201531954A ES 201531954 A ES201531954 A ES 201531954A ES 2562985 B1 ES2562985 B1 ES 2562985B1
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- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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- 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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- 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
- A61K31/41—Heterocyclic 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
- A61K31/4164—1,3-Diazoles
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- 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
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- Pharmacology & Pharmacy (AREA)
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- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
El objeto de esta patente de invención es una composición farmacéutica para el tratamiento de lesiones de la piel que contiene una combinación de 4 sustancias activas, en concreto Diclofenaco sódico, Clotrimazol, Sulfanilamida y Alcohol bencílico, todas ellas en una formulación de administración por vía tópica en la piel, de consistencia semisólida en una estructura de gel hidrófilo, con una textura viscosa y translúcida, fácilmente aplicable sobre la piel y susceptible de ser aplicada de forma uniforme. La formulación contiene por 1 gramo (1.000 mg.) Diclofenaco sódico en una proporción de entre 10 mg. y 60 mg.; Clotrimazol en una proporción de entre 10 mg. y 60 mg.; Sulfanilamida en una proporción de entre 50 mg. y 150 mg. y Alcohol bencílico en una proporción de entre 10 mg. y 80 mg., contenidos en una misma formulación.The object of this invention patent is a pharmaceutical composition for the treatment of skin lesions containing a combination of 4 active substances, in particular Sodium Diclofenac, Clotrimazole, Sulfanilamide and Benzyl Alcohol, all of them in a topical administration formulation. on the skin, of semi-solid consistency in a hydrophilic gel structure, with a viscous and translucent texture, easily applicable on the skin and capable of being applied uniformly. The formulation contains per 1 gram (1,000 mg.) Diclofenac sodium in a proportion of between 10 mg. and 60 mg .; Clotrimazole in a proportion between 10 mg. and 60 mg .; Sulfanilamide in a proportion between 50 mg. and 150 mg. and Benzyl alcohol in a proportion of between 10 mg. and 80 mg., contained in the same formulation.
Description
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ES 2 562 985 A1ES 2 562 985 A1
DESCRIPCIONDESCRIPTION
La presente invention se refiere a una composition farmaceutica para el tratamiento de lesiones de la piel.The present invention relates to a pharmaceutical composition for the treatment of skin lesions.
Antecedentes de la invencionBackground of the invention
La piel, considerado el mayor organo del cuerpo humano, es tambien posiblemente uno de los que sufre un mayor desgaste, renovandose de forma continuada con la formation de nuevas celulas que sustituyen a las celulas muertas y propenso a padecer lesiones. En realidad, la piel actua como una defensa efectiva que cubre todo el organismo, aislandolo de todo aquello que lo rodea y espedficamente de cualquier agresion externa. Estructuralmente, la piel no es uniforme en todo el cuerpo, su grosor varia en funcion de las necesidades de protection y de su relation con el medio ambiente, siendo mas gruesa donde existe mayor contacto y/o roce y por tanto requiere una mayor resistencia, por ejemplo los pies y en particular los talones, y siendo mas fina en otras zonas, como los parpados o la cara, comprendiendo la estructura de la piel tres partes o capas: epidermis, dermis e hipodermis, siendo la epidermis la mas superficial y la hipodermis o tejido subcutaneo, la mas profunda.The skin, considered the largest organ of the human body, is also possibly one of the ones that suffers the most wear, continually renewing itself with the formation of new cells that replace dead cells and prone to suffer injuries. In reality, the skin acts as an effective defense that covers the entire organism, isolating it from everything that surrounds it and specifically from any external aggression. Structurally, the skin is not uniform throughout the body, its thickness varies depending on the needs of protection and its relationship with the environment, being thicker where there is greater contact and / or rubbing and therefore requires greater resistance, for example the feet and in particular the heels, and being thinner in other areas, such as the eyelids or the face, the skin structure comprising three parts or layers: epidermis, dermis and hypodermis, the epidermis being the most superficial and the hypodermis or subcutaneous tissue, the deepest.
Logicamente, al ser la piel el organo protector que recubre todo el cuerpo humano esta continuamente expuesta a multiples lesiones, producto de circunstancias accidentales como golpes, roces, quemaduras, etc. y tambien afectaciones que pueden ser consecuencias de otras enfermedades como las ulceras derivadas de la diabetes, enfermedades vasculares o infecciones. En todo caso, una agresion en la piel que altere su estructura debe ser considerada como una lesion que requiere un tratamiento medico adecuado puesto que cualquier lesion de la piel o en la membrana mucosa con perdida de sustancia, es decir, una ulcera, conlleva unos riesgos de infection considerables susceptibles de afectar a otros organos internos y/o de no cicatrizar y pasar a ser cronicas.Logically, being the skin the protective organ that covers the entire human body is continually exposed to multiple injuries, due to accidental circumstances such as bumps, friction, burns, etc. and also effects that may be consequences of other diseases such as ulcers derived from diabetes, vascular diseases or infections. In any case, an aggression in the skin that alters its structure should be considered as an injury that requires adequate medical treatment since any lesion of the skin or mucous membrane with loss of substance, that is, an ulcer, involves Considerable infection risks likely to affect other internal organs and / or not to heal and become chronic.
Ademas de ulceraciones, la piel es susceptible de sufrir multiples alteraciones de su estructura, como queratosis producidas por exposition al sol, tumores epidermicos, acne, psoriasis, verrugas o pustulas.In addition to ulcerations, the skin is susceptible to multiple alterations in its structure, such as keratosis caused by sun exposure, epidermal tumors, acne, psoriasis, warts or pustules.
Cualquier lesion de la piel requiere tratamiento medico para aliviar y tratar su sintomatologia y recuperar su estructura. Existen para ello tratamientos quirurgicos,Any skin lesion requires medical treatment to relieve and treat its symptoms and recover its structure. There are surgical treatments,
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adecuados para patologias de la piel especialmente significativas como pueden ser tumores o quemaduras que requieren una intervencion directa para limpiar y tratar la zona afectada, pero la mayoria de procedimientos son de caracter no quirurgico con un tratamiento de menor agresividad basado en la utilization de pomadas, unguentos, geles o similares de aplicacion directa sobre la piel para aliviar y tratar los smtomas que puedan producirse.suitable for especially significant skin pathologies such as tumors or burns that require direct intervention to clean and treat the affected area, but most procedures are non-surgical with a treatment of less aggressiveness based on the use of ointments, Ointments, gels or the like of direct application on the skin to relieve and treat the symptoms that may occur.
Una de las composiciones farmaceuticas mas dispensadas es la combination de neomicina, polimixina y bacitracina, especialmente adecuada para quemaduras, raspaduras o cortes que derivan en una infection, siendo altamente eficaces por su contenido en antibioticos que trabajan para detener el crecimiento de bacterias. Tambien el diclofenaco topico, del tipo antiinflamatorios no esteroides, es de uso eficaz para tratar la queratosis actmica y la osteoartritis pero resulta escasamente eficaz, por si mismo, en otro tipo de lesiones de la piel al no tener propiedades antibacterianas.One of the most dispensed pharmaceutical compositions is the combination of neomycin, polymyxin and bacitracin, especially suitable for burns, scrapes or cuts that result in an infection, being highly effective because of its content in antibiotics that work to stop the growth of bacteria. Also, diclofenac topic, of the non-steroidal anti-inflammatory type, is of effective use to treat actmic keratosis and osteoarthritis but is scarcely effective, in itself, in other types of skin lesions as they do not have antibacterial properties.
A nivel de propiedad industrial son muchas las patentes farmaceuticas que presentan formulaciones y composiciones destinadas al tratamiento de afecciones de la piel como por ejemplo la patente US2010221245 para el tratamiento del acne y que contiene un agente antibacteriano, por ejemplo, bacitracina, un agente antiinflamatorio, por ejemplo, peroxido de benzoilo y un agente antioxidante, por ejemplo, omeprazol y pantoprazol sodico. Por su parte, la patente WO2009158687 desarrolla una formulation que cubre un amplio aspectro de afectaciones de la piel, como la psoriasis, infeccion cutanea, queratosis actmica, dermatitis eccematosa, los smtomas del fenomeno de Raynaud, smtoma de lupus eritematoso y cancer de piel, la cual incluye principios activos antiseborreicos, dermatologico, antipsoriasicos, queratolrticos y vasotropicos.At the industrial property level there are many pharmaceutical patents that have formulations and compositions intended for the treatment of skin conditions such as for example US2010221245 for the treatment of acne and containing an antibacterial agent, for example, bacitracin, an anti-inflammatory agent, for example, benzoyl peroxide and an antioxidant agent, for example, omeprazole and sodium pantoprazole. For its part, WO2009158687 develops a formulation that covers a wide range of skin effects, such as psoriasis, skin infection, actic keratosis, eczematous dermatitis, Raynaud's phenomenon symptoms, lupus erythematosus smtoma and skin cancer, which includes active anti-seborrheic, dermatological, antipsoriasic, keratolrtic and vasotropic principles.
En cuanto a tratamientos alternativos, se aconseja aplicar sobre la piel, sea en formato gel o crema o mediante compresas en caso de ser lesiones abiertas, ciertas combinaciones de hierbas, vitaminas y aminoacidos, cremas con corticoides, antihistammicos (antialergicos) orales en circunstancias esporadicas, lociones y cremas hidratantes etc. Entre estos remedios naturales, citar el Aloe Vera en formato gel especialmente efectivo para las ulceras por presion; la combinacion de raiz de curcuma y Hazel, la Agrimonia (Agrimonia eupatoria) tambien conocida popularmente como Hierba de san Guillermo, el hiperico (Hypericum perforatum), la Milenrama (Achillea millefolium) o aquilea o la combinacion de azucar y miel.As for alternative treatments, it is advisable to apply on the skin, either in gel or cream format or by compresses in case of open lesions, certain combinations of herbs, vitamins and amino acids, corticosteroid creams, oral antihistammics (allergy) in sporadic circumstances , lotions and moisturizers etc. Among these natural remedies, cite Aloe Vera in gel format especially effective for pressure ulcers; the combination of curcuma root and Hazel, Agrimony (Agrimonia eupatoria) also popularly known as St. William's Wort, hypericum (Hypericum perforatum), Yarrow (Achillea millefolium) or aquilea or the combination of sugar and honey.
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Objeto de la inventionObject of the invention
La presente invencion se refiere a una composition farmaceutica para el tratamiento de lesiones de la piel que se presenta principalmente en formato gel, pomada o unguento.The present invention relates to a pharmaceutical composition for the treatment of skin lesions that occurs mainly in gel, ointment or ointment format.
En particular, la composicion que se reivindica esta especialmente formulada para actuar ante la queratosis producidas por exposition al sol, tumores epidermicos de amplio espectro, acne, verrugas y pustulas, siendo igualmente efectiva para aliviar ulceras y heridas abiertas de la piel puesto que actua para inhibir de la division y proliferation de hongos y microorganismos, reduciendo la inflamacion, la esclerosis y el endurecimiento de la ulceracion, dejando, tras una aplicacion continuada y correctamente dosificada, una costra que por su desecacion se suelta de la piel y se cae por si sola.In particular, the composition claimed is specially formulated to act against keratosis caused by sun exposure, wide-spectrum epidermal tumors, acne, warts and pustules, being equally effective in relieving ulcers and open skin wounds since it acts to inhibit the division and proliferation of fungi and microorganisms, reducing inflammation, sclerosis and hardening of the ulcer, leaving, after a continuous and correctly dosed application, a crust that by its desiccation is released from the skin and falls on its own alone.
En general, resulta obvio que cualquier formulation que pretenda tener resultado eficaz ante afectaciones de la piel debe combinar diversos principios activos que reunan principalmente propiedades antibacterianas y antiinflamatorias capaces de actuar ante los germenes, bacterias, hongos o similares que proliferan especialmente en heridas abiertas en la piel y propiedades analgesicas que reduzcan y alivien el dolor.In general, it is obvious that any formulation that claims to have an effective result against skin disorders must combine various active ingredients that mainly combine antibacterial and anti-inflammatory properties capable of acting against germs, bacteria, fungi or the like that proliferate especially in open wounds in the skin. skin and analgesic properties that reduce and relieve pain.
La composicion que se reivindica contiene una combination de cuatro sustancias activas que responden a las necesidades descritas, en concreto Diclofenaco sodico, Clotrimazol, Sulfanilamida y Alcohol bencflico, todas ellas en una formulacion de administration por via topica en la piel, de consistencia semisolida en una estructura de gel hidrofilo, con una textura viscosa y translucida, facilmente aplicable sobre la piel y susceptible de ser aplicada de forma uniforme.The claimed composition contains a combination of four active substances that meet the needs described, namely Diclofenac sodium, Clotrimazole, Sulfanilamide and Benzyl Alcohol, all of them in a topically administered administration formulation in the skin, of semi-solid consistency in a Hydrophilic gel structure, with a viscous and translucent texture, easily applicable to the skin and capable of being applied uniformly.
La formulacion contiene por 1 gramo (1.000 mg.) Diclofenaco sodico en una proportion de entre 10 mg. y 60 mg.; Clotrimazol en una proporcion de entre 10 mg. y 60 mg.; Sulfanilamida en una proporcion de entre 50 mg. y 150 mg. y Alcohol bencflico en una proporcion de entre 10 mg. y 80 mg., contenidos en una misma formulacion.The formulation contains per 1 gram (1,000 mg.) Diclofenac sodium in a proportion of between 10 mg. and 60 mg .; Clotrimazole in a proportion between 10 mg. and 60 mg .; Sulfanilamide in a proportion between 50 mg. and 150 mg. and benzyl alcohol in a proportion of between 10 mg. and 80 mg., contained in the same formulation.
Las cuatro sustancias activas citadas tienen, cada una en particular, distintas propiedades que, sumadas, actuan de una forma eficaz ante las lesiones de la piel citadas.The four aforementioned active substances have, in particular, different properties that, added together, act in an effective manner against the aforementioned skin lesions.
El Diclofenaco sodico es un medicamento que pertenece a la familia de los antiinflamatorios no esteroideos (AINE), por lo tanto con propiedades que actuan contra laDiclofenac sodium is a medicine that belongs to the family of non-steroidal anti-inflammatory drugs (NSAIDs), therefore with properties that act against
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inflamacion y tambien de caracter analgesico, a las que se anaden propiedades miorrelajantes que alivian espasmos musculares.inflammation and also of an analgesic nature, to which are added muscle relaxant properties that relieve muscle spasms.
El Clotrimazol es un medicamento antomicomico o antifungico, es dedr, capaz de actuar contra ciertos hongos, evitando su crecimiento o destruyendolos.Clotrimazole is an antomicomic or antifungal drug, it is dedr, capable of acting against certain fungi, preventing their growth or destroying them.
La Sulfanilamida es un antibiotico que pertenece al grupo de las sulfamidas, eficaz en infecciones superficiales de la piel de origen bacteriano, actuando sobre la pared de las bacterias, eliminandolas y evitando por tanto que la infeccion se propague.Sulfanilamide is an antibiotic that belongs to the group of sulfa drugs, effective in superficial infections of the skin of bacterial origin, acting on the wall of the bacteria, eliminating them and thus preventing the infection from spreading.
El Alcohol bendlico es un preservante antimicrobiano con ciertas propiedades desinfectantes y anestesicas en una aplicacion local.Bendic Alcohol is an antimicrobial preservative with certain disinfectant and anesthetic properties in a local application.
La suma de estas sustancias refuerza las propiedades positivas de cada una de ellas, lo que se traduce en una alta efectividad en los procesos que comportan lesiones en la piel al actuar conjuntamente con propiedades antibacterianas, antiinflamatorias y analgesicas/ anestesicas.The sum of these substances reinforces the positive properties of each of them, which translates into a high effectiveness in the processes that involve skin lesions when acting together with antibacterial, anti-inflammatory and analgesic / anesthetic properties.
La composicion farmaceutica contiene al menos uno de los excipientes siguientes: Aceite de coco, Alcohol isopropflico, Parafina, Propilenglicol, Carbitol, Estearatos y Agua en cantidad suficienteThe pharmaceutical composition contains at least one of the following excipients: Coconut oil, Isopropyl Alcohol, Paraffin, Propylene Glycol, Carbitol, Stearates and Water in sufficient quantity
Segun el porcentaje de agua, la formulacion farmaceutica desarrollada tiene estructura de crema o unguento.Depending on the percentage of water, the developed pharmaceutical formulation has a cream or ointment structure.
La posologia preferente es de una aplicacion sobre la piel danada cada 24 horas.The preferred dosage is one application on the damaged skin every 24 hours.
La pauta de aplicacion es la siguiente:The application guideline is as follows:
1. Aplicar una pequena cantidad de gel cubriendo la zona a tratar.1. Apply a small amount of gel covering the area to be treated.
2. Cubrir la zona para evitar la evaporacion y sequedad del gel. Mantener cubierto durante 12 horas.2. Cover the area to prevent evaporation and dryness of the gel. Keep covered for 12 hours.
a) Normalmente es suficiente aplicar una pequena lamina de plastico suave (polietileno o similar) oa) It is usually sufficient to apply a small sheet of soft plastic (polyethylene or similar) or
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b) En caso de heridas abiertas o llagas supurantes, aplicar una gasa en lugar de la lamina de plastico.b) In case of open wounds or suppurating sores, apply a gauze instead of the plastic sheet.
3. A las 12 horas, descubrir y lavar con agua y jabon en pastilla, especialmente neutro.3. At 12 hours, discover and wash with water and soap in a tablet, especially neutral.
4. Mantener la zona a tratar sin cubrir, secandola al aire libre durante 12 horas.4. Keep the area to be treated without covering, drying it in the open air for 12 hours.
5. A las 12 horas, iniciar una nueva pauta de aplicacion, es decir, aplicar una pequena cantidad de gel cubriendo la zona a tratar.5. At 12 o'clock, start a new application schedule, that is, apply a small amount of gel covering the area to be treated.
No se considera necesario hacer mas extensa esta description para que cualquier experto en la materia comprenda el alcance de la invention y las ventajas que de esta composition se derivan. Los terminos en que se ha redactado esta memoria deberan ser tomados siempre en sentido amplio y no limitativo.It is not considered necessary to make this description more extensive so that any person skilled in the art understands the scope of the invention and the advantages derived from this composition. The terms in which this report has been written should always be taken in a broad and non-limiting sense.
Claims (5)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES201531954A ES2562985B1 (en) | 2015-12-31 | 2015-12-31 | Pharmaceutical composition for the treatment of skin lesions |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES201531954A ES2562985B1 (en) | 2015-12-31 | 2015-12-31 | Pharmaceutical composition for the treatment of skin lesions |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| ES2562985A1 ES2562985A1 (en) | 2016-03-09 |
| ES2562985B1 true ES2562985B1 (en) | 2016-09-14 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES201531954A Expired - Fee Related ES2562985B1 (en) | 2015-12-31 | 2015-12-31 | Pharmaceutical composition for the treatment of skin lesions |
Country Status (1)
| Country | Link |
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| ES (1) | ES2562985B1 (en) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0108082D0 (en) * | 2001-03-30 | 2001-05-23 | Novartis Consumer Health Sa | Topical composition |
| US20050014729A1 (en) * | 2003-07-16 | 2005-01-20 | Pharmacia Corporation | Method for the treatment or prevention of dermatological disorders with a cyclooxygenase-2 inhibitor alone and in combination with a dermatological treatment agent and compositions therewith |
| US20050147570A1 (en) * | 2004-01-06 | 2005-07-07 | Nordsiek Michael T. | Methods of administering diclofenac compositions for treating photodamaged skin, rosacea and/or acne |
| US8784852B2 (en) * | 2009-02-27 | 2014-07-22 | Audrey Kunin | Topical skin care composition |
| CN104800148A (en) * | 2015-04-20 | 2015-07-29 | 程伟智 | Clotrimazole emulsifiable paste and preparation method thereof |
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| Publication number | Publication date |
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| ES2562985A1 (en) | 2016-03-09 |
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