Classifications

• • 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
  • A61K31/66—Phosphorus compounds
  • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
• • 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
  • A61K31/12—Ketones
  • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
• • 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
  • A61K31/12—Ketones
• • 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
  • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
  • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
  • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
  • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
  • A61K31/355—Tocopherols, e.g. vitamin E
• • 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
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
  • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
  • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
  • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
  • A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
• • 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
  • A61P11/06—Antiasthmatics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system
  • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system
  • A61P9/08—Vasodilators for multiple indications
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system
  • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Definitions

• the present invention relates to a cardiovascular drug. More specifically, the present invention relates to a cardiovascular drug having an excellent action for preventing and / or improving myocardial ischemia.
• Non-patent Document 1 Ischemic heart disease is common to two pathologies of diastolic and systolic dysfunction. It is said that it is important to dilate coronary vessels as quickly as possible during an ischemic heart disease attack and promote adequate blood flow improvement. This is because the longer the myocardial ischemia time, the more irreversible the impairment of cardiac function and coronary vascular function.
• drugs such as nitroglycerin that promote coronary vasodilation during ischemic attacks are administered, but these drugs are often insufficient or ineffective, and in such cases Coronary revascularization (PTCA) and coronary bypass surgery (peripheral artery or vein transplantation) are also performed.
• PTCA Coronary revascularization
• coronary bypass surgery peripheral artery or vein transplantation
• Adenosine 5'-triphosphate (hereinafter sometimes abbreviated as ATP) is a substance that is widely involved in metabolism of carbohydrates, fats, or proteins as a phosphate donor. The energy generated by this is the driving force for energy-requiring reactions in living bodies.
• Drugs containing ATP include improvement of sequelae of head trauma, heart failure, stabilization of regulatory function in regulatory eye strain, chronic gastritis with decreased gastrointestinal function, Meniere's disease and dizziness based on inner ear disorders Efficacy against is recognized.
• ATP pharmacological action
• coronary blood vessels and peripheral blood vessels are dilated in the heart to increase coronary blood flow and cardiac output
• Non-patent Document 3 the crown movement It has been reported that the blood flow in the collateral circulation path of the Inu myocardial infarction model with ligated veins is prevented to prevent the deterioration of the pathological condition.
• Non-patent Document 4 it is known that combined administration by injection of ATP and magnesium chloride is effective for ischemic myocardium and can be used as a therapeutic agent for angina pectoris and myocardial infarction.
• Tubidecarenone is also called Coenzyme Q 10 (CoQ 10 ) and the like and is used in medicine as a metabolic cardiotonic agent due to its special physiological action.
• Myocardial protective effect derived from the antioxidant effect of ubidecarenone, prevention of carcinogenesis, anti-aging effect, blood LD L oxidation suppression, suppression of blood pressure rise, improvement of oxygen utilization efficiency in ischemic myocardium, myocardial mitochondria ATP synthesis activation and cardiac function improvement have been reported.
• the action is taken up by mitochondria in the myocardial cells in the myocardium and acts directly on the ischemic myocardium, improving myocardial energy metabolism in hypoxia and improving oxygen utilization efficiency. It is considered.
• the decrease in cardiac function is suppressed in a myocardial infarction model, and the long-term survival rate is improved with respect to the life prognosis after myocardial infarction (Non-patent Document 5).
• Non-Patent Document 1 F o I i c a .P har mm a c o I .J pn 2004 1 23 23-93
• Non-Patent Document 2 Japanese Pharmaceutical Collection 25th edition, pages 69_70
• Non-Patent Document 3 Basics and Clinical Practice of ATP 1 964 Volume 2 Page 1 37
• Non-Patent Document 4 Chiba Medical Journal 1 985 61 Vol. 3 No. 1 99-209
• Non-Patent Document 5 Japanese Pharmaceutical Collection 25th Edition 2357-2358
• An object of the present invention is to provide a new circulatory organ drug.
• the present invention provides a cardiovascular drug comprising adenosine 5′-triphosphate or a physiologically acceptable salt thereof in combination with ubide force renon.
• the present invention also provides use of adenosine 5'-triphosphate or a physiologically acceptable salt thereof and ubide force renon for the manufacture of a drug for cardiovascular organs.
• the present invention also relates to a method for preventing diseases of the circulatory organ, comprising administering an effective amount of adenosine 5′-triphosphate or a physiologically acceptable salt thereof and ubidecarenone. / Or provide treatment.
• the cardiovascular drug of the present invention is a highly effective prevention and / or myocardial ischemic state due to a synergistic effect of adenosine 5'-triphosphate or a physiologically acceptable salt thereof and ubide force Lennon. It has an improving effect and can be suitably used as a circulatory organ drug.
• a preventive and / or therapeutic agent for ischemic heart disease and also for the prevention and / or treatment of diseases selected from the group consisting of angina pectoris and myocardial infarction.
• it can be suitably used as a therapeutic agent.
• palpitations and / or shortness of breath that appear as symptoms in the ischemic state of the myocardium can be eliminated based on the prevention and / or improvement action of the ischemic state of the myocardium.
• FIG. 1 is a diagram showing ST segment values in ATP 30 mg / kg, ubidecarenone 1 mg / kg, and a combination administration group thereof.
• the cardiovascular drug of the present invention is a combination of adenosine 5'-triphosphate or a physiologically acceptable salt thereof and ubidecarenone. That is, the circulatory organ drug of the present invention administers adenosine 5′-triphosphate or a physiologically acceptable salt thereof and ubidecarenone simultaneously or at different times.
• the cardiovascular drug of the present invention is a combination of a unit dosage form preparation containing adenosine 5'-triphosphate or a physiologically acceptable salt thereof and a unit dosage form preparation containing ubide force renone.
• a unit dosage form preparation containing adenosine 5'-triphosphate or a physiologically acceptable salt thereof and ubidecarenone Provided as (kit) or as a pharmaceutical composition (combination agent) in unit dosage form containing adenosine 5'-triphosphate or a physiologically acceptable salt thereof and ubidecarenone together . More preferably, it is provided as a pharmaceutical composition comprising adenosine 5′-triphosphate or a physiologically acceptable salt thereof together with ubidecarenone.
• Adenosine 5'-triphosphate or a physiologically acceptable salt thereof used in the circulatory organ drug of the present invention is a known substance and can be easily obtained by those skilled in the art.
• the type of physiologically acceptable salt of adenosine 5'-triphosphate is not particularly limited, but examples thereof include alkali metal salts such as sodium salt and force salt; alkalis such as magnesium salt and calcium salt. Examples include earth metal salts.
• alkali metal salts such as sodium salt and force salt
• alkalis such as magnesium salt and calcium salt.
• examples include earth metal salts.
• adenosine 5′-disodium triphosphate is particularly preferred from the viewpoint of preventing and / or improving the ischemic state of the myocardium.
• Formulations containing adenosine 5'-triphosphate or its physiologically acceptable salts are already marketed as oral dosage forms or injections, and adenosine 5'-triphosphate or physiologically acceptable
• a preparation containing the salt alone a commercially available preparation of adenosine 5′-triphosphate or a salt thereof may be used.
• “Adefos” Kelowa Co., Ltd. is commercially available.
• the ubide force lenone used in the circulatory organ drug of the present invention is a known substance and can be easily obtained by those skilled in the art. Preparations containing ubide force Lenone have already been marketed as oral dosage forms. When the circulatory organ drug of the present invention is provided using a preparation containing ubide force Lenone alone, Formulation May be used. For example, “Nyquinone Tablets” (Eisai Co., Ltd.) is commercially available.
• the cardiovascular drug in the present invention is preferably used for preventing and / or improving a state in which the function of the heart is not complete (heart failure). More preferably, it is selected from the group consisting of angina pectoris and myocardial infarction as an agent for preventing and / or treating ischemic heart disease by preventing and / or improving the ischemic state of the myocardium. It is used as a prophylactic and / or therapeutic agent for diseases.
• the circulatory organ drug of the present invention can also be used for the purpose of eliminating symptoms such as palpitation and / or shortness of breath.
• the combination ratio (combination ratio) of adenosine 5'-triphosphate or a physiologically acceptable salt thereof and ubidecarenone in the cardiovascular drug of the present invention is not particularly limited, and is specifically described in Examples below. Those skilled in the art can appropriately select the test method.
• ubide force Lennon is used with respect to 1 part by mass of adenosine 5′-triphosphate or a physiologically acceptable salt thereof. Is preferably used in the range of 0.0001 to 1000 parts by mass, more preferably in the range of 0.001 to 100 parts by mass, and particularly preferably in the range of 0.01 to 10 parts by mass.
• the cardiovascular drug of the present invention has an effect of preventing and / or improving myocardial ischemia.
• vitamin E or a derivative thereof may be further added.
• Such vitamin E or its derivatives include succinic acid d_a-tocopherol, succinic acid dI-a-tocopherol, succinic acid dI-a-tocopherol calcium, acetic acid d-a-tocopherol, acetic acid dI-a ⁇ ⁇ KOFUE GUJI SOLE, d_HII ⁇ KOFUE GUJI ONE OLE, dl _HIICHI
• d-histcopherol acetate is particularly preferred from the viewpoint of synergistic effect of preventing and / or improving myocardial ischemia.
• the combination ratio (combination ratio) of vitamin E or a derivative thereof that can be optionally blended with the cardiovascular drug of the present invention is not limited at all, the ischemic state of the myocardium From the viewpoint of the synergistic effect of the prevention and / or amelioration action of, for example, adenosine 5′-triphosphate or a physiologically acceptable salt thereof, 1 part by mass of vitamin E or its derivative About 1 to 100 parts by mass, preferably about 0.1 1 to 10 parts by mass, particularly preferably about 0.03 to 3 parts by mass.
• the dosage form of the cardiovascular drug of the present invention may be either oral administration or parenteral administration.
• An oral dosage form is preferred.
• a solid, semi-solid, or adenosine 5'-triphosphate or physiologically acceptable salt thereof and ubide force Lenone in one unit dosage form or More preferably, it is provided as a liquid pharmaceutical composition.
• the dosage form is not particularly limited.
• solid pharmaceutical compositions such as powders, granules, tablets, wearable tablets, film-coated tablets, dragees, soft capsules, hard capsules; liquid pharmaceutical compositions such as drinks; jelly agents, etc. Any of the semi-solid pharmaceutical compositions may be used. In the present invention, a solid pharmaceutical composition is particularly preferred.
• the pharmaceutical composition comprising adenosine 5'-triphosphate or a physiologically acceptable salt thereof and ubide force renone together
• the pharmaceutical composition The amount of each component is not particularly limited, and is determined according to the form of the pharmaceutical composition, taking into account the combination ratio as described above as appropriate. For example, when providing as a solid pharmaceutical composition, 10 to 30 O mg of adenosine 5′-triphosphate or a physiologically acceptable salt thereof per unit of pharmaceutical composition, 1 to 10 O mg can be added.
• vitamin E or its derivative is added, for example, vitamin E or its derivative per dosage unit. About 3 to 300 mg can be blended.
• the drug for cardiovascular organs of the present invention includes adenosine 5'-triphosphate or a physiologically acceptable salt thereof, ubidecarenone, and components other than vitamin E or a derivative thereof for the purpose of formulation. It can mix
• Vitamins include thiamine hydrochloride, thiamine nitrate, bisthiamine nitrate, thiamine disulfide, thiamine dicetyl sulfate ester, dicetiamine hydrochloride, fursultiamine hydrochloride, octothiamine, sicothiamine, bisibutiamine, bisbenchamine, full Thiamine, prosultiamine, benfotiamine, flavin adenine dinucleotide sodium, riboflavin, sodium riboflavin phosphate, riboflavin butyrate, pyridoxine hydrochloride, pyridoxal phosphate, hydroxocobalamin hydrochloride, hydroxocobalamin acetate, cyanocobalamin, hydroxocobalamin Ascorbic acid, calcium ascorbate, sodium ascorbate, nicotinic acid, nicotinic acid amide, pante , Calcium pantothenate, sodium
• vitamin-like substances include inositol, inositol hexanicotinate, orotic acid, choline orotate, gamma mono oryzanol, thioctic acid, octanoic acid amide, carnitine chloride, choline bitartrate, rutin and the like.
• caffeine drugs include caffeine, anhydrous caffeine, sodium caffeine benzoate, aminophylline, diprofylline, proxyphylline and the like.
• amino acids examples include L-aspartic acid, L-aspartic acid potassium,
• Herbal medicines include Akiyo, Azanyak, Ikarisou Extract, Ikarisou Dry Extract, Oren, Kashu, Gajutsu, Shinto, Kanzo, Kikuyo, Kiyoukatsu, Kiyonin, Kokushi, Keihi, Gou, Pepper, Kohaku, and Fifty Frost , Psycho, Psycho, Saffron, Sangaku, Ji, Shakanzo, Peonies, Jiakow, Jinko, Shinju, Senso, Animal Bile (Yutan, Beef Bile Extract), Seiha Hawthorn, Senkiyu, Souju, Daiso, Soya Yellow Roll, Taiji , Agar powder, tenma, touki, carrot, park mondo, hange, hampi, beak cucumber, bukkuriyo, pohfu, homika extract, porei, maou, machinin, ryuuno, lyon, antelope kaku, rojiyo And the
• Drugs for liver damage include ursodesoxycholic acid, dehydrocholic acid, glucuronolactone, glucuconic acid, glucuconic acid amide, glycyrrhizic acid, sodium glycyrrhizinate, diisopropylamine dichloroacetate, Examples include methylmethionine sulfone chloride, liver hydrolyzate, and yolk lecithin.
• the cardiovascular drug of the present invention can be appropriately prepared by a technique commonly used in the art.
• one or more kinds of additive for pharmaceuticals usually used in the art may be used.
• pharmaceutical additives include excipients, binders, disintegrants, lubricants, coloring agents, and corrigents. However, it is not limited to these.
• excipients include lactose, starches, crystalline cellulose, sucrose, mannitol, and light anhydrous key acid.
• binder include hydroxypropylmethylcellulose, hydroxypropylcellulose, gelatin, alpha starch, polyvinylpyrrolidone, polyvinyl alcohol, or pullulan.
• disintegrant include carmellose, carmello-carcinum, croscarmellose sodium, crospovidone, corn starch, or low-substituted hydroxypropylcellulose.
• the lubricant include magnesium stearate and talc.
• the colorant include tar pigment and iron sesquioxide.
• corrigent include stevia, aspartame, 1-menthol, d-porneol, and fragrances.
• the dose of the circulatory organ drug of the present invention is not particularly limited, and can be appropriately selected according to various conditions such as the form of the medicine, the degree of the symptom to be applied, or the age of the patient.
• adenosine 5'-triphosphate or its salt should be administered to adults at about 3 to 3 OO Omg / day, especially about 10 to 1 OO Omg / day, and about 30 to 30 Omg / day. That's fine.
• the dose of ubide force renon can be determined by the above-mentioned ratio, but the dose of vitamin E or its derivative can be determined.
• ubidecarenone is about 1 to 10 O Omg / day, especially 3 About 300 mg / day, more preferably about 10 to 10 Omg / day, vitamin E or a derivative thereof about 1 to 100 Omg / day, especially about 3 to 300 mg / day, further 1 About 0 to 10 Omg / day may be administered.
• the method for administering the cardiovascular drug of the present invention is not particularly limited, and adenosine 5'-triphosphate or a physiologically acceptable salt thereof and ubide force renone are administered simultaneously or at different times. be able to.
• adenosine 5′-triphosphate or a physiologically acceptable salt thereof and ubide force lenone are administered at different times, the blood concentration of the active ingredient administered previously exhibits the effect of the present invention. It is desirable to administer the other active ingredient within a time period that does not drop below the concentration.
• adenosine 5′-triphosphate or a physiologically acceptable salt thereof and ubide force lenone are used from the viewpoint of preventing and / or improving myocardial ischemia. It is preferable to administer simultaneously.
• the circulatory organ drug of the present invention has an excellent prevention and / or improvement action against the ischemic state of the myocardium, and is based on the action of preventing and / or improving the ischemic state of the myocardium.
• palpitations and / or shortness of breath that appear as symptoms in the ischemic state of the myocardium can be resolved.
• Test Example 1 Evaluation test for prevention and / or improvement of myocardial ischemia
• Myocardial ischemia is reflected in changes in the ST segment or T wave of the electrocardiogram. Intravenous administration of vasopressin to rats has been reported to cause persistent ST segment depression on the electrocardiogram due to myocardial ischemia (S. Satoh, eta I, Life Science 72 (1): 1 03-1 1 2, 2002). ST segment values were calculated according to the test methods described in the literature, and the effect of preventing and / or improving myocardial ischemia was examined based on whether or not the decrease in ST segment values was suppressed by drug administration. .
• test drug or control drug is orally administered to 7 to 8 male Donryu rats (10 weeks old, Nippon Selichi Co., Ltd.) in each of the test drug administration group and the control drug administration group. 15 minutes later, pentobarbital (50 mg / kg, Nacalai Tesque) Vasopressin under anesthesia ([A rg 8 ]-VASO PRES SIN, manufactured by SI GMA) 0.5 IU / ml L / kg administered intravenously did. Two days later, an electrocardiogram was measured under anesthesia with pentobarbital (50 mg / kg), and the ST segment value was calculated.
• a value obtained by subtracting the average ST segment value of the control drug administration group (0.5% methylcellulose administration group) from the ST segment value of each test drug administration group was evaluated as the “ST segment depression suppression amount”.
• adenosine 5'-disodium triphosphate manufactured by CA LBI OCH EM, hereinafter abbreviated as "ATP” in the examples
• ATP adenosine 5'-disodium triphosphate
• ubidecarenone Co., Ltd.
• a combination of ATP 30 mg / kg and ubidecarenone 1 mg / kg hereinafter abbreviated as “AT P + ubidecarenone” in the Examples
• the test was suspended or dissolved in methylcellulose.
• 0.5% methylcellulose hereinafter abbreviated as “MC” in the examples
• the circulatory organ drug of the present invention is effective for the prevention and / or synergistic prevention of myocardial ischemia by the combination of adenosine 5′-triphosphate or a physiologically acceptable salt thereof and ubidecarenone. It was also found that it has an improving effect.
• This granulated product (4276.8 g) and magnesium stearate (43.2 g) were put into a blender (Asahi Kogyo B2 / 09 model), mixed, and then tableted with a 7 mm diameter and 1 Omm radius of curvature.
• Machine field iron Where: HT—AP 18 SS type
• This sized product 4633. 2 g, stearin 46.8 g of magnesium oxide was put into a blender (Asahi Kogyo B2 / 09 type), mixed, and then a tableting machine with a 7mm diameter and 1 Omm radius of curvature (Hatetsu Station: HT-AP 1 tablet with 1 8 SS type 1 30 mg tablets were obtained.
• This granulated product was dried using a fluid bed dryer (Freund Sangyo: NF LO-5 type) and then sized using a granulator (Sei Okada: N D_ 1 OS type).
• Mixer of this sized product 4 633.2 g and magnesium stearate 46.8 g (Asahi Industries : B 2/1 09 model) and after mixing, 1 tablet 1 with a tableting machine (Hatetsu Works: HT--AP 1 8 SS model) with a 7 mm diameter and 10 mm radius of curvature 30 mg tablets were obtained.
• This granulated product 4455 g and magnesium stearate 45 g are put into a mixing machine (Asahi Kogyo B2 / 09 type) and mixed, and then a tableting machine with a 7.5mm diameter and a curvature radius of 14mm is attached. (Hatabe Works: HT-AP 1 8 SS type) 1 tablet 1 50 mg tablet was obtained.
• Bourec FM-VG-25 type
• This granulated product (41 58 g) and magnesium stearate (42 g) were put into a blender (Asahi Kogyo: B2 / 09 model) and mixed, and then a tableting machine equipped with a punch with a diameter of 8 mm and a radius of curvature of 14 mm ( 1 tablet of 20 Omg was obtained with Hata Iron Works: HT-AP 1 8 SS type.

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