Classifications

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Definitions

• the present invention relates to a novel agent or composition for use as a muscle-strengthening drug, an anti-inflammatory drug, an antiasthmatic, an antidiarrheal, an antidepressant, or a drug for the treatment of secondary diseases following cerebral infarction (human stroke sequelae, secondary stroke damages or sequelae of brain infarction), motor paralysis, diminution of vision, hepatitis, inflammatory intestinal syndrome, functional enteropathy, functional cardiopathy, functional hepatopathy, functional nephropathy, dementia, climacteric symptoms, senile dementia and/or Alzheimer disease, and to an agent or composition to be applied to the skin.
• cerebral infarction human stroke sequelae, secondary stroke damages or sequelae of brain infarction
• motor paralysis diminution of vision, hepatitis, inflammatory intestinal syndrome, functional enteropathy, functional cardiopathy, functional hepatopathy, functional nephropathy, dementia, climacteric symptoms, senile dementia and/or Alzheimer disease
• Serotonin and noradrenaline referred to as brain hormones control satisfaction of the will, and in turn, spiritual satisfaction.
• voluntary muscles are activated by adrenaline, an adrenal medullary hormone, secreted from adrenal medulla and chromaffin cells on nerve muscles.
• Serotonin, noradrenaline and adrenaline are also referred to as biogenic monoamines, and are oxidatively decomposed by an enzyme called monoamine oxidase within as long as 3 hours or reabsorbed into nerve tissues and so forth, resulting in the extinction of most effects of secreted monoamines.
• KI in Japanese; vital energy refers to all the functions of the human body. Such body's functions are generically classified into 2 types. One function is controlled by autonomic nerves, which are found in various organs, hormone secretions and blood vessels. The other one works for voluntary muscles which act according to commands released from brain thought functions and thought patterns.
• KI as represented by “HOKI” (in Japanese; complementing energy) and “RIKI” (in Japanese; circulating energy) in Chinese medicine, indicates only the former functions controlled by autonomic nerves.
• the commands for “which functions will be activated” and “how they will be exerted” are released from the medulla oblongata located at the lower part of the brain.
• HOKIYAKU in Japanese; drug for complementing “KI” activates all functions controlled by autonomic nerves, instead of only activating certain organs and tissues, it is likely that the target point on which the “HOKIYAKU” acts may be medulla oblongata (a source of commands) rather than each organ or tissue. That is, it is concluded that the actions of “HOKIYAKU” are for enhancing and facilitating the emission and transmission of commands from the medulla oblongata.
• the “HOKIYAKU” localizes body blood to various organs. This might be aimed at achieving such a blood localization via, as a result of the blood vessel-dilating and constricting action (one of the important actions of medulla oblongata), not only dilating blood vessels directed to the autonomic nervous control system but also constricting blood vessels directed to the brain and brain-controlled organs whereby more nutrient elements will be delivered to required parts as a secondary action of the “HOKIYAKU”.
• the onset of depressive syndrome is caused by retention of a depressive condition when deprived of satisfaction of will and spirit due to a decrease in the secretory capability of biogenic monoamines, whereby the spirit is, on occasion, extremely lowered leading to strong suicidal tendencies.
• this therapy is not a fundamental therapy the aim of which is to eliminate the cause of depression, that is, to cure the decreased secretory ability of biogenic monoamines.
• it is a therapy in expectation of only naturally recovering the secretion capacity of monoamines over a long period of therapy.
• the present invention has been made to develop pharmaceutical drugs and compositions based on this novel medical theory.
• An object of the present invention is to provide very effective pharmaceutical drugs and therapeutic compositions having a muscle-strengthening, antiinflammatory, anti-cerebral infarction sequela, anti-motor paralysis, antiasthmatic, anti-vision diminution, antihepatitis, anti-inflammatory intestinal syndrome, anti-functional enteropahy, and/or anti-dementia activity.
• the present invention has been made to develop pharmaceutical drugs and compositions based on such novel medical theory.
• An object of the present invention is to provide pharmaceutical compositions and therapeutic drugs very effective in the treatment of depression, climacteric disturbance, senile dementia and/or Alzheimer's disease.
• a further object of the invention is to provide dermatological agents and compositions, in particular dermatological agents and compositions for external use, which do not directly act on the skin but releases a monosaccharide in vivo after once absorbed into the body and which thus heal a skin injury, prevent skin deterioration or weakening, or restore healthy skin.
• the present invention relates to a muscle-strengthening drug or anti-inflammatory drug-containing muscle strengthening drug which comprises isoflavone and/or an isoflavone glycoside, and/or a pungent, bitter or sour substance, and/or cholic acid, and/or scymnol and/or a scymnol ester.
• muscle-strengthening drug used herein refers to an agent acting for reducing muscle fatigue, or increasing muscle strength, for instance.
• anti-inflammatory drug used herein refers to an agent for the treatment of inflammation, in particular a therapeutic or prophylactic agent for arthritis, neuralgia or rheumatism, among others.
• the present invention relates to a pharmaceutical agent or composition useful as an antiasthmatic, an antidiarrheal, an antidepressant, a drug for the treatment of secondary diseases following cerebral infarction, or a drug for the treatment of motor paralysis, diminution of vision, hepatitis, inflammatory intestinal syndrome, functional enteropathy, functional cardiopathy, functional hepatopathy, functional nephropathy, dementia, climacteric symptoms, senile dementia and/or Alzheimer disease, and to an agent or composition to be applied to the skin.
• the drug for inflammatory intestinal syndrome as used herein includes agents for Crohn disease and ulcerative colitis.
• the anti-functional enteropathy, anti-functional cardiopathy, anti-functional hepatopathy, anti-functional nephropathy and/or antidiarrheal drug as used herein includes anti-irritable bowel syndrome agents.
• the antiasthmatic, antidiarrheal, antidepressant, drugs for the treatment of secondary diseases following cerebral infarction, motor paralysis, diminution of vision, hepatitis, inflammatory intestinal syndrome, functional enteropathy, functional cardiopathy, functional hepatopathy, functional nephropathy, dementia, climacteric symptoms, senile dementia and/or Alzheimer disease, and agents or compositions to be applied to the skin as used herein, refer to drugs, agents or compositions/preparations for the prophylaxis and/or treatment of a disease.
• the pharmaceutical product (or drug) contains a pungent substance, a bitter substance, and/or a sour substance. It is more preferable that the pharmaceutical product is in admixture with one or more members selected from the group consisting of isoflavones and isoflavone glycosides.
• the particularly preferable isoflavone includes soybean isoflavones comprised in soybean.
• the particularly preferable isoflavone glycoside includes soybean isoflavone glycosides comprised in soybean.
• the pharmaceutical product is in admixture with one or more members selected from the group consisting of cholic acid, scymnol and scymnol esters.
• the daily dose of isoflavone and isoflavone glycoside is preferably 1 to 500 mg, more preferably 5 to 200 mg, and most preferably 10 to 100 mg.
• a most preferable pharmaceutical product comprises at least a pungent substance therein.
• the pungent substance as used herein includes preferably curcumin
• the bitter substance as used herein includes preferably swertiamarin, gentiopicrin, loganin, etc.
• the sour substance as used herein includes preferably citric acid, lactic acid, etc.
• the daily dose of the pungent substance is preferably 1 to 1000 mg, more preferably 5 to 300 mg, and most preferably 10 to 70 mg. When it is administered alone, its daily dose is preferably 100 to 800 mg, and most preferably 300 to 500 mg. When it is administered in combination with “KAMPO” pharmaceutical preparations or drugs (“KAMPO”, Japan's traditional herbal medicine) having the efficacy of “FUSEI” (as pronounced in Japanese: aid for keeping the body normal), such as JUZEN-TAIHO-TO (as pronounced in Japanese), its daily dose is preferably 100 to 200 mg.
• the daily dose of the pungent substance is preferably 1 to 1000 mg, more preferably 10 to 300 mg, and most preferably 20 to 70 mg. When it is administered alone, its daily dose is preferably 100 to 800 mg, and most preferably 300 to 500 mg. When it is administered in combination with “KAMPO” pharmaceutical preparations or drugs having the efficacy of “FUSEI”, such as JUZEN-TAIHO-TO (as pronounced in Japanese), its daily dose is preferably 100 to 200 mg.
• the daily dose of cholic acid is preferably 1 to 1000 mg, more preferably 2 to 300 mg, and most preferably 10 to 100 mg.
• the daily dose of scymnol and scymnol esters is preferably 0.1 to 100 mg, more preferably 0.1 to 50 mg, and most preferably 0.3 to 10 mg.
• a preparation to be applied to the skin it preferably contains a monosaccharide.
• the monosaccharide is preferably glucose or galactose, and galactose is more preferred.
• the sugar may be a sugar or a sugar acyl ester, and an acyl ester is preferred.
• the acyl is preferably a fatty acid acyl, and one to all alcohol moieties may be esterified by an alcohol.
• the content of galactose is preferably 0.1% to 30%, more preferably 1% to 5%.
• the daily dose of galactose is preferably 0.5 to 500 mg, more preferably 1 to 100 mg.
• the content of acetylgalactose is preferably 0.1% to 30%, more preferably 1% to 5%.
• the daily dose of acetylgalactose is preferably 0.5 to 500 mg, more preferably 1 to 100 mg.
• the pharmaceutical product is in admixture with other ingredients including not only generic pharmaceutical drugs but also vitamins, anibiotics, anti-cancer drugs, heme Fe, prune extracts (Prunus Domestica fruit extracts), crude drugs (herbal and animal drugs, or galenical preparations; “SHOUYAKU” as pronounced in Japanese), and the like.
• the “SHOUYAKU” includes preferably those having the efficacy of “FUSEI”, for example those capable of activating or stimulating the functions of organs, glands and blood vessels, all controlled by autonomic nerves, those capable of aiding digestion, and others.
• the galenical preparations (or crude drugs) of 10 or more kinds have been known as those capable of activating or stimulating the functions of organs, glands and blood vessels, all controlled by autonomic nerves.
• Examples of such galenical preparations are ginseng (Ginseng Radix, Panax Ginseng), etc. Some of active elements have been revealed for not only ginseng but also such galenical preparations.
• such active elements can be preferably admixed therewith.
• the admixture of such active elements will lead to achievement of activating body-functions.
• the particularly preferable galenical preparation include Ginseng (Panax Ginseng or Ginseng Radix), Codonopsitis Radix, Psuodostellariae Radix, American Ginseng, Astragali Radix, Attractylodis Rhizoma, Dioscoreae Rhizoma, Glycyrrhia (Glycyrrhizae Radix), Jujube Fruit (Zizyphi Fructus, Zizyphus vulgaris ), Dulcium (malt sugar derived from Oryza seed), Polygonati Rhizoma, Codonopsis lanceolata Benth. et Hock. fil. (“SHIYOUJIN” in Japanese; Oryza sativa L. ), etc.
• Ginseng Panax Ginseng or Ginseng Radix
• Codonopsitis Radix Psuodostellariae Radix
• American Ginseng Astragali Radix
• Galenical preparations capable of aiding digestion can be preferably admixed therewith.
• the particularly preferable galenical preparations capable of aiding digestion include Crataegi Fructus, Massa Medicata Fermentat, Raphani Semen, Fructus Hordei Germiniatus, Fructus Oryzae Germinatus (“KOKUGA” in Japanese; Oryza sativa L. ), Galli Stomachichum Corium, Asa Foetida, etc.
• galenical preparations capable of producing a monosaccharide having a body fluid producing activity (so-called “TSUEKI SAYOU” as pronounced in Japanese) or an antianemic or blood activating activity (so-called “HOKETSU KAKKETSU SAYOU” as pronounced in Japanese) is preferably added.
• the galenical preparation having body fluid producing activity includes Hoelen (Poria, “BUKURYO” in Japanese; Poria cocus WOLF ( Pachyma hoelen RUMPHIUS)), “SEKIBUKURYO” (in Japanese; pale red portion of Poria cocus ), “BUKUSHIN” (in Japanese; particular grade of Poria cocus ), “BUKURYOHI” (in Japanese; cortical portion of Poria cocus ), etc.
• the galenical preparation having antianemic or blood-activating activity includes Cnidii Rhizoma (“SENKYU in Japanese; Cnidium officinale MAKINO), Salviae Militiorrhiziae Radix (“TANJIN” in Japanese; Salvia miltiorrhiza BUNGE”), Mucunae Caulis (Mucuna birdwoodiana, “KEIKETTO” in Japanese; Mucuna birdwoodiana TUTCHER, stem of Millettia reticulata ), “MOUTOUSEI” (in Japanese; root of Ilex pubescens ), among others.
• Scymnol and/or scymnol esters are comprised in biles of shark.
• Scymnol has the following formula:
• Sodium scymnol sulfate has the following formula:
• the active elements contained in soybean are several species of isoflavone glycosides including daidzin, glycitin, genistin, etc. and aglycons thereof, i.e., several species of isoflavones including daidzein, glycitein, genistein, etc.
• soybean is a starting material for producing soybean oil.
• soybean cakes are used as sources for preparing soybean proteins, etc. which are starting materials for food products.
• the soybean cake is mainly used for a fertilizer or feed for livestock and its price is therefore extremely low.
• the soybean cakes which are almost industrial wastes can be used as starting materials to produce inexpensively soybean isoflavones and soybean isoflavone glycosides with high purity.
• inosic acid is added to the agent or composition of the invention.
• a fatty acid having an odd number of carbon atoms (“odd-numbered fatty acid”) is added to the agent or composition of the invention.
• Preferred as the odd-numbered fatty acid are tridecanoic acid, pentadecanoic acid, heptadecanoic acid and nonadecanoic acid. Among them, pentadecanoic acid and heptadecanoic acid are more preferred.
• the dosage form of the pharmaceutical agents or composition for use as a muscle-strengthening drug, an anti-inflammatory drug, an antiasthmatic, an antidiarrheal, an antidepressant, or a drug for the treatment of secondary diseases following cerebral infarction, of motor paralysis, diminution of vision, hepatitis, inflammatory intestinal syndrome, functional enteropathy, functional cardiopathy, functional hepatopathy, functional nephropathy, dementia, climacteric symptoms, senile dementia and/or Alzheimer disease, and the agents or compositions to be applied to the skin according to the invention is not particularly limited but may be administered, for example, in the form of such preparations for internal administration or oral route, as tablets, powders, solid preparations or solutions, suppositories or injectable solutions.
• An excipient such as lactose or starch, a vegetable oil or the like may also be used.
• the dermatological agent or composition according to the invention may be administered in the form of a preparation suitable for external use, and the dosage form thereof is not particularly limited but preferably used in the form of a cream, emulsion, solution or ointment.
• ingredients to be used in the products may be ordinary ones used in conventional creams, emulsions, solutions, or ointments.
• Soybean isoflavones and soybean isoflavone glycosides as used in examples are set to be 40% in purity.
• Cholic acid as used in examples is set to be 90% in purity except for pure cholic acid.
• soybean isoflavone was replaced with soybean isoflavone glycoside was blended to afford powders in the same fashion as above.
• soybean isoflavone glycoside was granulated to afford granules in the same fashion as above.
• Curcumin 30 mg Sodium scymnol sulfate 1 mg Soybean isoflavone 125 mg Crystalline cellulose qs Lactose 140 mg Magnesium stearate 6 mg Talc 3 mg Total 1120 mg
• soybean isoflavone glycoside was blended and packed to afford hard capsules in the same fashion as above.
• Curcumin 25 mg Sodium scymnol sulfate 1 mg Soybean isoflavone 125 mg Cod liver oil 80 mg Tocopherol acetate 5 mg Ginseng extract 200 mg Yellow beeswax 55 mg Edible oil qs Total 1200 mg
• soybean isoflavone glycoside was blended and packed to afford soft capsules in the same fashion as above.
• Curcumin 25 mg Sodium scymnol sulfate 1 mg Soybean isoflavone 125 mg Thiamin hydrochloride 25 mg Pyridoxine hydrochloride 10 mg Riboflavin 10 mg Cyanocobalamin 12 mg Nicotinamide 20 mg Calcium pantothenate 20 mg Ascorbic acid 60 mg L-cysteine 10 mg Lactose 263 mg Magnesium stearate 6 mg Cornstarch qs Total 1150 mg
• soybean isoflavone glycoside was blended and packed to afford hard capsules in the same fashion as above.
• the mix was adjusted with 10% sodium hydroxide as a pH regulator to pH 7. Next, distilled water for injection was added to the mix to make the total volume 5 ml. The resultant mix was dispensed into each ampule which was then melt-sealed, and sterilized.
• soybean isoflavone was replaced with soybean isoflavone glycoside was blended to afford injections in the same fashion as above.
• soybean isoflavone glycoside was replaced with soybean isoflavone was blended to afford powders in the same fashion as above.
• soybean isoflavone glycoside was replaced with soybean isoflavone was granulated to afford granules in the same fashion as above.
• soybean isoflavone glycoside was replaced with soybean isoflavone was granulated to afford spherical granules in the same fashion as above.
• Curcumin 30 mg Cholic acid 140 mg Soybean isoflavone glycoside 280 mg Lactose 4000 mg Carboxymethylcellulose calcium 320 mg Hydroxypropylcellulose 74 mg Crystalline cellulose qs CARPLEX 30 mg Magnesium stearate 10 mg Total 5484 mg
• soybean isoflavone glycoside was replaced with soybean isoflavone was blended and packed to afford hard capsules in the same fashion as above.
• soybean isoflavone glycoside was replaced with soybean isoflavone was blended and packed to afford soft capsules in the same fashion as above.
• soybean isoflavone glycoside was replaced with soybean isoflavone was blended to afford injections in the same fashion as above.
• soybean isoflavone glycoside was replaced with soybean isoflavone was mixed to afford drinks in the same fashion as above.
• soybean isoflavone glycoside was replaced with soybean isoflavone was granulated to afford granules in the same fashion as above.
• soybean isoflavone glycoside was replaced with soybean isoflavone was blended and packed to afford capsules in the same fashion as above.
• soybean isoflavone glycoside was replaced with soybean isoflavone was blended and packed to afford capsules in the same fashion as above.
• soybean isoflavone glycoside was replaced with soybean isoflavone was blended and packed to afford soft capsules in the same fashion as above.
• soybean isoflavone was replaced with soybean isoflavone glycoside was blended to afford powders in the same fashion as above.
• soybean isoflavone glycoside was granulated to afford granules in the same fashion as above.
• the pH is adjusted to 7 with 10% sodium hydroxide for pH adjustment, distilled water for injection is added to make the total amount 5 mL, and an ampoule filled therewith is sealed and sterilized.
• Tablets of Example 4 were administered once a day.
• Curcumin is readily available. For instance, highly pure curcumin is on the market.
• Capsaicine (30 mg) instead of curcumin preparations of Example 1 was administered to elderly patients between the ages of 76 and 83 once daily. Several days later, its effects were dramatic. It has been proved that the drug is effective for muscular degeneration, arthritis and rheumatism after one week. Capsaicine is a powerful irritant with burning aftertaste.
• the treated conditions were markedly ameliorated after the pharmaceutical preparation was administered for 8 weeks.
• the conditions were alleviated after the pharmaceutical preparation was administered for 6 weeks.
• the symptoms were significantly ameliorated after the pharmaceutical preparation was administered for 4 weeks.
• the treated condition was cured after the drug was administered for 4 weeks.
• the condition was ameliorated after administration over 4 weeks.
• the treated conditions were cured after administration for 2 weeks.
• the treated condition was cured after administration for 4 weeks.
• the disease was cured after administration for 1 week.
• the conditions were cured after administration for 8 weeks.
• the symptoms were cured.
• the disease was cured after administration for 3 weeks.
• the drug was administered to a 48-year-old man with hepatitis for 2 weeks, the disease was cured.
• the diseases were markedly alleviated after administration for 6 weeks.
• the treated condition was ameliorated after administration over 16 weeks.
• the conditions were cured after administration for 6 weeks.
• the treated conditions were ameliorated after administration for 6 weeks.
• the diseases were markedly alleviated after administration for 12 weeks.
• the symptoms were obviated after administration for 6 weeks.
• the diseases were alleviated in 6 weeks.
• the symptom was alleviated after administration for 6 weeks.
• the conditions were alleviated after administration for 17 weeks.
• the treated condition was relieved after administration for 6 weeks.
• the treated symptom was cured after the preparation was administered for 8 weeks.
• the conditions were ameliorated after the preparation was administered for 9 weeks.
• the disease was cured after the preparation was administered for 9 weeks.
• the disease was alleviated after administration for 4 weeks.
• the treated condition was cured after the preparation was administered for 12 weeks.
• Example 6 After the capsule preparation of Example 6 was administered over a period of 16 weeks, the following effects were produced as for hair, for instance.
• the instant products have skin beautifying actions and pharmacological actions such as therapeutic or prophylactic actions against atopic dermatitis, various types of dermatitis, dermatomycosis, verrucosis, pigmentation, vulgar psoriasis, senile xeroderma, senile keratoma, and skin injuries, and hair-restoring, peptic juice secretion promoting, perspiration promoting, lapactic, diuretic and other actions.
• the drug is effective in 90% of the cases and the significantly effective case equals 60%.
• Examples 2 and 11 were administered to 12 and 14 females with menopausal disorders including broodiness, depression and dizziness, etc., respectively, at 45 mg of curcumin per day. Five days after the dosing, the broodiness, depression and dizziness were mitigated in five and six individuals, respectively. Three weeks later, improvements were seen in 11 and 12 individuals, respectively.
• Example 2 When granules of Example 2 were administered to 10 elderly patients in the preliminary stages of senile dementia, memory loss was ameliorated in 7 individuals. When granules of Example 11 were administered, similar results were obtained. Such products are also effective for Alzheimer's disease.
• Example 7 After the preparation of Example 7 was administered to a 51-year-old man with a tendency toward depression, weariness and enervation over a period of 16 weeks, the treated states were alleviated. In a 38-year-old woman with autonomic nervous system excitement, enervation and poor physical strength, the treated conditions were alleviated after administration for 2 weeks. After the preparation was administered to a 59-year-old woman with sever emaciation following hysterectomy for 6 weeks, the treated conditions were alleviated significantly. After the preparation was administered to a 46-year-old woman with anemia and hemorrhoid, for 8 weeks, the treated symptoms were remarkably alleviated. When the inventive preparation was administered to a 71-year-old man with sequela of cerebral infarction and with senile dementia for 10 weeks, the treated conditions were significantly relieved.
• Curcumin is readily available. For instance, highly pure curcumin is on the market.
• Capsules wherein powders produced by admixture of capsaicine (50 mg) with lactose were packed in combination with isoflavone glycoside and cholic acid were administered to patients with depression once daily. Several days later, effects were dramatic. The patient were nearly completely recovered from depression after a week. Capsaicine is a powerful irritant with burning aftertaste.
• the present invention is very effective and advantageous in that it can provide pharmaceutical agents or compositions useful as muscle-strengthening drugs, anti-inflammatory drugs, antiasthmatics, antidiarrheals, antidepressants, or drugs for the treatment of secondary diseases following cerebral infarction, motor paralysis, diminution of vision, hepatitis, inflammatory intestinal syndrome, functional enteropathy, functional cardiopathy, functional hepatopathy, functional nephropathy, dementia, climacteric symptoms, senile dementia and/or Alzheimer disease, and dermatological agents or compositions suitable for skin applications, which can treat or prevent muscle weakening and inflammation, in particular arthritis and rheumatism, by the synergistic action resulting from administration of isoflavone, cholic acid or scymnol, and a pungent, bitter or sour substance, in particular a pungent substance.
• the composition can produce good cosmetic effects such as whitening, blotch-removing, wrinkle-removing, trichogenous and/or hair-restoring effects, as well as skin beautifying effects and pharmacological effects such as therapeutic effects against atopic dermatitis, various types of dermatitis, dermatomycosis, verrucosis, pigmentation, vulgar psoriasis, senile xeroderma, senile keratoma, and skin injuries, and hair-restoring, peptic juice secretion promoting, perspiration promoting, lapactic, diuretic and other effects.
• good cosmetic effects such as whitening, blotch-removing, wrinkle-removing, trichogenous and/or hair-restoring effects
• skin beautifying effects and pharmacological effects such as therapeutic effects against atopic dermatitis, various types of dermatitis, dermatomycosis, verrucosis, pigmentation, vulgar psoriasis, senile xeroderma
• the agent or composition is also advantageously effective in preventing adverse effects of anticancer drugs, namely depilation, internal hemorrhage, diarrhea, and disorders of heart, liver, kidney, etc. Therefore, when used in combination with an anticancer drug, it can suppress those side effects otherwise produced by such drugs.

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