WO2013085351A1 - 디아미노디페닐술폰 또는 이의 약학적으로 허용가능한 염을 포함하는 근육 소모 관련 질환의 예방 또는 치료용 약학적 조성물 - Google Patents
디아미노디페닐술폰 또는 이의 약학적으로 허용가능한 염을 포함하는 근육 소모 관련 질환의 예방 또는 치료용 약학적 조성물 Download PDFInfo
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- WO2013085351A1 WO2013085351A1 PCT/KR2012/010647 KR2012010647W WO2013085351A1 WO 2013085351 A1 WO2013085351 A1 WO 2013085351A1 KR 2012010647 W KR2012010647 W KR 2012010647W WO 2013085351 A1 WO2013085351 A1 WO 2013085351A1
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- muscle
- dds
- diaminodiphenylsulfone
- preventing
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Classifications
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/18—Sulfonamides
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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
- A61K31/13—Amines
- A61K31/145—Amines having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2)
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- 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
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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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/136—Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
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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
- A61K31/16—Amides, e.g. hydroxamic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Definitions
- the present invention relates to a pharmaceutical composition comprising diaminodiphenyl sulfone that can be usefully used for the prevention or treatment of muscle wasting-related diseases.
- Muscular dysfunction is a muscle disease in most elderly people, and it appears that muscle mass decreases with age.
- the senile muscular dystrophy causes painful old life due to uncomfortable physical performance, and can also cause various aging-related diseases such as diabetes, obesity, cardiovascular disease, and osteoporosis.
- DDS diaminodiphenylsulfone
- the effects of DDS on muscle diseases have not been disclosed anywhere in previous studies.
- the present inventors have confirmed that the DDS according to the present invention increases muscle mass and effectively restores muscle function, confirming that it can be usefully used for preventing or treating muscle wasting-related diseases and completed the present invention.
- One object of the present invention is to provide diaminodiphenylsulfone for preventing or treating muscle wasting related diseases by increasing muscle mass, preventing muscle loss, and effectively restoring muscle function.
- Diaminodiphenylsulfone according to the present invention increases muscle mass, prevents muscle loss, and effectively improves muscle function, so that the pharmaceutical composition comprising the same prevents muscle wasting-related diseases. Or may be usefully used for treatment.
- 1 is a result of HPLC analysis of DDS concentration in mouse blood, according to an embodiment of the present invention.
- Figure 2 is a bacterial activity test results of DDS, according to an embodiment of the present invention.
- 3 is a result of analyzing the water intake according to the DDS in accordance with an embodiment of the present invention.
- FIG. 4 is a blood CK concentration analysis result of the mouse, according to an embodiment of the present invention.
- 5 is a mouse grip force measurement result according to an embodiment of the present invention.
- the present invention provides a pharmaceutical composition for preventing or treating muscle wasting-related diseases, including diaminodiphenylsulfone or a pharmaceutically acceptable salt thereof.
- diaminodiphenylsulfone refers to a compound represented by the following Chemical Formula 1 and referred to as a generic name, depsone or nickname DDS.
- the diaminodiphenyl sulfone is a white, odorless, crystalline powder, which is a water insoluble compound.
- diaminodiphenylsulfone is taken as 100 mg per day for the treatment of leprosy, and is also used for the treatment of dermatitis, rheumatoid arthritis or malaria.
- the DDS may be purchased commercially, synthesized directly, or may be extracted from natural products, but is not limited thereto.
- the DDS of the present invention can be used by autoclaving after mixing with water in order to further improve the water insoluble properties.
- the autoclave treatment may be performed by a method generally used, and may be preferably performed at 121 ° C. and 151 psi for 15 to 20 minutes.
- the DDS when the DDS was mixed with water and subjected to autoclave treatment, despite the water insolubility of the DDS, it could be dissolved at a necessary concentration, and exhibited an appropriate range of effective blood concentrations when administered to mice. It was confirmed. In addition, it was confirmed through the antimicrobial activity test that the activity of DDS is preserved by autoclaving.
- the term 'pharmaceutically acceptable salt' refers to a formulation of a compound that does not cause serious irritation to the organism to which the compound is administered and does not impair the biological activity and properties of the compound.
- the pharmaceutical salts include acids that form non-toxic acid addition salts containing pharmaceutically acceptable anions, for example inorganic acids such as hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, hydrobromic acid, hydroiodic acid, and the like, tartaric acid, formic acid, Organic carbon acids such as citric acid, acetic acid, trichloroacetic acid, trichloroacetic acid, gluconic acid, benzoic acid, lactic acid, fumaric acid, maleic acid, salicylic acid, etc., such as methanesulfonic acid, ethanesulfonic acid, benzenesulfonic acid, p-toluenesulfonic acid, etc.
- inorganic acids such as hydrochloric acid, sulfur
- Acid addition salts formed by sulfonic acid or the like include metal salts or alkaline earth metal salts formed by lithium, sodium, potassium, calcium, magnesium, amino acid salts such as lysine, arginine, guanidine, dicyclohexylamine, N Organic salts such as -methyl-D-glucamine, tris (hydroxymethyl) methylamine, diethanolamine, choline and triethylamine and the like.
- the term 'muscle wasting related disease' refers to a disease or condition accompanied by symptoms such as gradual loss of muscle mass.
- the muscle wasting is genetic predisposition; Age-related diseases such as hypertension, impaired glucose tolerance, diabetes, obesity, dyslipidemia, atherosclerosis and cardiovascular disease; Diseases such as cancer, autoimmune diseases, infectious diseases, AIDS, chronic inflammatory diseases, arthritis, malnutrition, kidney disease, chronic obstructive pulmonary disease, emphysema, rickets, chronic lower spinal pain, peripheral nerve damage, central nerve damage and chemical damage Chronic diseases such as; Conditions such as organ fixation, conditions such as helplessness such as fractures or traumas, post-operative bed care; And progressive progression of skeletal muscle mass and strength according to the aging process. Muscle wasting related diseases can lead to a weakened physical condition that can lead to deterioration of health status or incapacity of physical performance.
- the composition of the present invention can be used for the prevention or treatment of myopathy.
- the myopathy of the present invention refers to a gradual reduction of skeletal muscle mass due to aging, which directly induces a decrease in muscle strength, and as a result, a condition in which various physical functions may be reduced and impaired.
- the pharmaceutical composition of the present invention is characterized by increasing muscle mass or preventing muscle loss.
- the DDS of the present invention when the DDS of the present invention was administered to the mouse, it was confirmed that the muscle weight of various muscle types (SOL, EDL, GA, TA) increases, spasm and contraction stimulation for SOL and EDL It was confirmed that the reactivity to the increased. In addition, it was confirmed that the decrease in the level of creatine kinase and the grip power in the blood. As a result, it was confirmed that DDS increases muscle mass and prevents muscle loss, thereby effectively restoring and improving muscle function.
- SOL muscle weight of various muscle types
- the term 'prevention' means any action that inhibits or delays the onset of muscle wasting-related diseases by administration of the composition.
- treatment refers to any action that improves or advantageously changes the symptoms caused by muscle wasting-related diseases by administration of the composition.
- the pharmaceutical composition of the present invention may include a pharmaceutically acceptable carrier, excipient or diluent in addition to the DDS or a pharmaceutically acceptable salt thereof for administration.
- the carriers, excipients and diluents include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline Cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.
- compositions of the present invention may be formulated in the form of powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, oral formulations, external preparations, suppositories, or sterile injectable solutions, respectively, according to conventional methods.
- it may be prepared by using diluents or excipients such as fillers, weighting agents, binders, wetting agents, disintegrating agents, and surfactants which are commonly used.
- Solid preparations for oral administration include, but are not limited to, tablets, pills, powders, granules, capsules, and the like.
- Such solid preparations may be prepared by mixing at least one excipient such as starch, calcium carbonate, sucrose, lactose, gelatin and the like.
- excipients such as starch, calcium carbonate, sucrose, lactose, gelatin and the like.
- lubricants such as magnesium stearate, talc can also be used.
- It may be prepared by adding various excipients such as humectants, sweeteners, fragrances, preservatives and the like in addition to liquid oral liquids or liquid paraffin for oral use.
- Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized formulations and suppositories.
- non-aqueous solvent and suspending agent propylene glycol, polyethylene glycol, vegetable oils such as olive oil, injectable esters such as ethyl oleate and the like can be used.
- base of the suppository utopsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin and the like can be used.
- composition of the present invention can be administered orally or parenterally (eg, applied intravenously, subcutaneously, intraperitoneally or topically) according to the desired method, and the dosage is based on the condition and weight of the patient, the extent of the disease, Depending on the drug form, route of administration, and time, it may be appropriately selected by those skilled in the art.
- the present invention also provides a dietary supplement for preventing or ameliorating diseases related to muscle wasting, including diaminodiphenylsulfone or a pharmaceutically acceptable salt thereof. That is, the composition of the present invention may be used simultaneously or separately with a medicament for treating a disease before or after the onset of the muscle wasting-related disease in order to prevent or ameliorate the muscle wasting-related disease.
- composition of the present invention can be used for the prevention or amelioration of myopathy.
- the health functional food composition is characterized by increasing muscle mass or preventing muscle loss.
- the DDS can be used by autoclaving after mixing with water, in order to further improve the water insoluble properties.
- the autoclave treatment may be performed by a method generally used, and may be preferably performed at 121 ° C. and 151 psi for 15 to 20 minutes.
- the term 'improvement' refers to any action that at least reduces the parameters associated with the condition being treated, for example, the extent of symptoms.
- the composition of the present invention when used as a food additive, the composition may be added as it is or used with other food or food ingredients, and may be appropriately used according to a conventional method.
- the compositions of the present invention are added in an amount of up to 15% by weight, preferably up to 10% by weight relative to the raw materials.
- the active ingredient may be used in an amount above the above range.
- Examples of the food to which the substance can be added include dairy products including meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, ice cream, various soups, drinks, tea, drinks, Alcoholic beverages and vitamin complexes, and the like and include all of the health foods in the conventional sense.
- the health beverage composition of the present invention may contain various flavors or natural carbohydrates, etc. as additional components, as in the general beverage.
- the natural carbohydrates described above may be used as monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, and natural sweeteners such as dextrin and cyclodextrin, and synthetic sweeteners such as saccharin and aspartame.
- the proportion of the natural carbohydrate can be appropriately determined by the choice of those skilled in the art.
- the composition of the present invention includes various nutrients, vitamins, electrolytes, flavors, coloring agents, pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, And a carbonation agent used for the carbonated beverage.
- the composition of the present invention may contain a pulp for the production of natural fruit juices, fruit juice drinks and vegetable drinks. These components can be used independently or in combination. The proportion of such additives may also be appropriately selected by those skilled in the art.
- the present invention comprises the steps of administering a composition comprising the diaminodiphenylsulfone (diaminodiphenylsulfone) or a pharmaceutically acceptable salt thereof to a subject having the onset or possibility of developing muscle wasting-related diseases in a pharmaceutically effective amount It provides a method for preventing or treating muscle wasting-related diseases comprising a.
- the method can be achieved through increasing muscle mass or preventing muscle loss.
- the term 'individual' means any animal including a human who has already developed or may develop a muscle wasting disease, and by effectively administering the composition of the present invention to an individual, the disease can be effectively prevented and treated. have.
- composition of the present invention is administered in a pharmaceutically effective amount.
- the term 'pharmaceutically effective amount' refers to an amount sufficient to treat a disease at a reasonable benefit / risk ratio applicable to medical treatment
- an effective dose level refers to an individual type and severity, age, sex, It may be determined according to the type of muscle wasting-related disease, the activity of the drug, the sensitivity to the drug, the time of administration, the route of administration and the rate of release, the duration of treatment, factors including the drug used concurrently and other factors well known in the medical field.
- the compositions of the present invention may be administered as individual therapeutic agents or in combination with other therapeutic agents and may be administered sequentially or simultaneously with conventional therapeutic agents. And single or multiple administrations. Taking all of the above factors into consideration, it is important to administer an amount that can obtain the maximum effect in a minimum amount without side effects, and can be easily determined by those skilled in the art.
- mice C57BL / 6J mouse females and males of 5, 15, 20 and 27 months old were each purchased from Korea Research Institute of Bioscience and Biotechnology. The mice were reared free of food, and had a stabilization period of one week with the temperature maintained at 21 ⁇ 1 ° C. and the humidity at 60%. All animal studies were conducted with the approval of the Animal Research Ethics Committee of Seoul National University.
- DDS Due to the characteristics of DDS, it is insoluble in water, so that it was dissolved at 2 mg / kg, which is the recommended concentration for treating Hansen's disease, by mixing with water and autoclaving, which was administered to female and male mice, respectively. Blood was analyzed by HPLC to determine whether the administered DDS was successfully absorbed into the blood of mice.
- DDS is mixed with water so as to be the recommended concentration of 2 mg / kg and treated with autoclave and then 5 months, 15 months, 20 Months, 27 months of female and male mice, 12 mice each, were fed for three months, once every four days.
- the water intake of the mice was measured under the same conditions except that Clenbuterol was fed, and the results are shown in FIG. 3.
- the amount of creatine kinase in the blood of the mouse was measured to determine if the amount of creatine kinase, known to increase in muscle contraction, muscle damage, and myotropenia due to aging, is regulated by the administration of DDS.
- DDS was mixed with water to the recommended human concentration of 2 mg / kg and autoclaved, followed by 3 months every 4 days for 12 female and male mice of 5, 15, 20, and 27 months.
- the blood of the mouse to measure the amount of creatine kinase was used that was not hemolyzed, and the measurement was performed using the EnzyChromTM Creatine Kinase Assay Kit (ECPK-100, BioAssay Systems).
- the measurement of creatine kinase was calculated by the following equation, and the results are shown in FIG. 4. Blood of untreated mice was used as a negative control, and blood of mice fed Clenbuterol was used as a positive control.
- the grip force was measured to determine the actual effect on muscle function by DDS.
- DDS was mixed with water to the recommended human concentration of 2 mg / kg and autoclaved, followed by 3 months every 4 days for 12 female and male mice of 5, 15, 20, and 27 months.
- Bioseb's grip strength meter was used to measure the grip force of the mouse.
- the grip force of the mouse was the value of the time when the forefoot is grasping the grating and pulled the tail slowly horizontally to fall from the grating, and the average was determined by measuring the maximum value of five times for each mouse and the results are shown in FIG.
- mice treated with nothing were used
- mice fed with Clenbuterol were used.
- DDS was mixed with water to the recommended human concentration of 2 mg / kg and autoclaved, followed by 3 months every 4 days for 12 female and male mice of 5, 15, 20, and 27 months. Fed while.
- SOL sodium pentobarbital
- EDL extensor digitorum longus
- DDS was mixed with water to the recommended human concentration of 2 mg / kg and autoclaved, followed by 3 months every 4 days for 12 female and male mice of 5, 15, 20, and 27 months. Fed while.
- To isolate muscle from the mouse anesthetized by injection with sodium pentobarbital (100 mg / kg body weight).
- G gastrocnemius
- TA tibialis anterior
- Muscle spasms and contractions were controlled by the intensity of the electric field stimulation. Muscles were stabilized in Ringer's solution for 10 minutes and then muscle contraction function test was performed. In order to maximize the function of the muscle, the length of the muscle with the maximum response at 0.2 Hz (100 V), which is a soft stimulation, was measured and designated as Lo . At that time, the muscle contraction force value, mN, was used as the soft axis, and the result is shown in FIG. As a negative control, mouse hind paws without DDS were used, and as a positive control, mouse hind paws fed Clenbuterol were used.
- SOL muscle showed a trend of stabilization of peak plateau formation, that is, muscle contraction graph at 150 Hz, 100 V, and 800 ms.
- EDL muscle showed graph stabilization at 100Hz, 100V and 400ms.
- the mouse used in Example 6 was used. After the soft stimulation, the mice were given sufficient time to rest and the hard stimulation.
- Soleus uses 150 Hz (100 V, stimulation time 800 ms)
- EDL uses 100 Hz (100 V, stimulation time 400 ms). It is called peak isometric force, and it is shown in FIG. 9 by mN value.
- a negative control mouse hind paws without DDS were used, and as a positive control, mouse hind paws fed Clenbuterol were used.
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Abstract
Description
Claims (9)
- 디아미노디페닐술폰(Diaminodiphenylsulfone) 또는 이의 약학적으로 허용가능한 염을 포함하는 근육 소모 관련 질환의 예방 또는 치료용 약학적 조성물.
- 제1항에 있어서, 상기 질환은 근감소증인 것을 특징으로 하는 약학적 조성물.
- 제1항에 있어서, 상기 근육 소모 관련 질환의 예방 또는 치료는 근육량을 증가시키거나, 근육손실을 방지하는 것에 의한 것인 약학적 조성물.
- 제1항에 있어서, 상기 디아미노디페닐술폰은 151 psi에서 고압멸균 처리한 것을 특징으로 하는 약학적 조성물.
- 디아미노디페닐술폰(Diaminodiphenylsulfone) 또는 이의 약학적으로 허용가능한 염을 포함하는 근육 소모 관련 질환의 예방 또는 개선용 건강기능식품 조성물.
- 제5항에 있어서, 상기 질환은 근감소증인 것을 특징으로 하는 건강기능식품 조성물.
- 제5항에 있어서, 상기 근육 소모 관련 질환의 예방 또는 개선은 근육량을 증가시키거나, 근육손실을 방지하는 것에 의한 것인 건강기능식품 조성물.
- 제5항에 있어서, 상기 디아미노디페닐술폰은 151 psi에서 고압멸균 처리한 것을 특징으로 하는 건강기능식품 조성물.
- 제1항 내지 제4항 중 어느 한 항의 조성물을 인간을 제외한 동물에 투여하는 단계를 포함하는 근육 소모 관련 질환의 예방 또는 치료 방법.
Priority Applications (4)
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EP12854700.7A EP2789334B1 (en) | 2011-12-07 | 2012-12-07 | Pharmaceutical composition comprising diaminodiphenylsulfone or the pharmaceutically acceptable salts thereof for preventing or treating diseases associated with muscle atrophy |
JP2014545827A JP6080864B2 (ja) | 2011-12-07 | 2012-12-07 | ジアミノジフェニルスルホンまたはその薬学的に許容可能な塩を含む筋肉消耗性疾患の予防または治療用の医薬組成物 |
CN201280060674.XA CN104023714B (zh) | 2011-12-07 | 2012-12-07 | 包含二氨基二苯砜或其药学上可接受的盐的用于预防或治疗肌肉萎缩相关疾病的药物组合物 |
US14/363,416 US9226905B2 (en) | 2011-12-07 | 2012-12-07 | Pharmaceutical composition for preventing or treating muscle wasting-related disease comprising diaminodiphenylsulfone or pharmaceutically acceptable salt thereof |
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KR10-2011-0130607 | 2011-12-07 | ||
KR1020110130607A KR101875705B1 (ko) | 2011-12-07 | 2011-12-07 | 디아미노디페닐술폰을 포함하는 근육 소모 관련 질환의 예방 또는 치료용 약학적 조성물 |
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JP (1) | JP6080864B2 (ko) |
KR (1) | KR101875705B1 (ko) |
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US9381171B2 (en) | 2013-12-19 | 2016-07-05 | Samsung Electronics Co., Ltd. | Composition including dapsone for preventing or treating side effect of steroid in subject and use of the composition |
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KR20160047318A (ko) * | 2014-10-22 | 2016-05-02 | 삼성전자주식회사 | 다프손을 포함하는, 개체의 부위에서 혈관신생을 자극시키기 위한 조성물 및 그의 용도 |
US20160239921A1 (en) * | 2015-02-16 | 2016-08-18 | Autoclaims Direct Inc. | Apparatus and methods for estimating an extent of property damage |
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CN104023714B (zh) | 2016-03-16 |
EP2789334A1 (en) | 2014-10-15 |
CN104023714A (zh) | 2014-09-03 |
JP6080864B2 (ja) | 2017-02-15 |
EP2789334A4 (en) | 2015-05-20 |
US9226905B2 (en) | 2016-01-05 |
KR101875705B1 (ko) | 2018-07-06 |
US20150031773A1 (en) | 2015-01-29 |
EP2789334B1 (en) | 2016-06-08 |
JP2015501812A (ja) | 2015-01-19 |
KR20130063961A (ko) | 2013-06-17 |
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