Pharmaceutical Composition

Abstract

To provide a pharmaceutical composition containing galenical compositions which includes Touki, Peony, Senkyu, Carrot as non simultaneous extracts of multi galenical materials, in which specific unpleasant odor of the galenical mixture is reduced.SOLUTION: There is provided a pharmaceutical composition containing (A) Touki, Peony, Senkyu, Carrot and / or a single extract thereof, and (B) at least one selected from the group consisting of moutan bark, cahig, bukuro, liquorice, gossip, sandalwood, kobushi, squid, goshyu, hange, rhubarb, rhododendron, magnolia, and a single extract thereof (provided that excepting in the case of bees). The unpleasant odor specific to the component (A) is reduced so as to provide a good feeling of ingestion.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a pharmaceutical composition in which the unpleasant odor of herbal medicines is reduced. [Background technology]

[0002] In modern society, poor blood circulation (blood flow) is often a problem due to various factors such as lack of exercise and autonomic nervous system imbalance caused by stress. This poor blood flow (decreased blood flow) causes various symptoms such as headaches, stiff shoulders, irregular menstruation, sensitivity to cold, swelling, and rough skin, so from a health perspective, measures to increase and improve blood flow are needed.

[0003] To improve physical condition due to poor blood flow, it is desirable to use herbal medicine preparations such as herbal medicines that gradually enhance the body's natural healing power, based on the idea of ​​traditional Oriental medicine. As examples of herbal medicine preparations that improve blood flow, Patent Document 1 describes an oral blood flow promoter containing a crushed product, powder, or extract of Viburnum dilatatum, or a crude or purified product of said extract, and Patent Document 2 describes a blood flow promoter containing, as active ingredients, one or more components selected from the group consisting of ginseng root or an extract thereof, Polygonum multiflorum or an extract thereof, pantothenyl ethyl ether, menthol, and hinokitiol.

[0004] In addition, while herbal preparations generally require long-term continuous administration, they are difficult to swallow due to their distinctive flavors, such as unpleasant odors and bitterness, making them difficult to maintain compliance. For example, a known method for masking the flavor of herbal preparations is to incorporate large amounts of sweeteners such as honey, sucrose, and high-intensity sweeteners. As a masking method using ingredients other than sweeteners, for example, Patent Document 3 describes a method for masking the unpleasant irritation of Kyoseihafue-gan extract in a troche by incorporating gelatin-containing granules, and Patent Document 4 describes a method for reducing the bitterness or odor of Bofutsushosan by combining Bofutsushosan with capsaicin or a capsaicin-containing substance. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2006-347898 [Patent Document 2] Japanese Patent Application Laid-Open No. 2005-213214 [Patent Document 3] Japanese Patent Application Publication No. 05-070359 [Patent Document 4] Japanese Patent Application Laid-Open No. 2009-084213 Summary of the Invention [Problem to be solved by the invention]

[0006] The present inventors have been investigating herbal formulations effective as blood flow improvers, and have come up with the idea of ​​a herbal composition that is not a simultaneous extract of multiple herbal medicines, but contains Angelica acutiloba, Peony root, Cnidium root, and Ginseng. However, they have encountered the problem that this herbal composition has a distinctive unpleasant odor and is very difficult to take.

[0007] The present invention aims to provide a pharmaceutical formulation that reduces the unpleasant odor characteristic of a mixture of herbs in a pharmaceutical composition that contains Angelica acutiloba, Peony Root, Cnidium Root, and Ginseng, and that is not a simultaneous extract of multiple herbs. [Means for solving the problem]

[0008] As a result of extensive research, the present inventors have found that by blending a herbal composition containing Angelica acutiloba, Peony Root, Cnidium Root, and Ginseng, which is not a simultaneous extract of multiple herbal medicines, with a herbal medicine selected from the group consisting of Peony Fruit, Cinnamon Bark, Poria Coccinea, Glycyrrhiza Root, Scutellaria Baicalensis, Atractylodes Rhizome, Magnolia Fruit, Kofuku, Euonymus Root, Pinellia Root, Rhubarb, Atractylodes Rhizome, and Rehmannia Root, the unpleasant odor specific to the herbal medicine composition can be reduced. The present invention was completed based on this finding and through further research.

[0009] That is, the present invention provides the following aspects. Item 1. (A) Angelica acutiloba and / or an extract thereof alone, peony root and / or an extract thereof alone, cnidium root and / or an extract thereof alone, and ginseng root and / or an extract thereof alone, (B) A pharmaceutical composition (excluding the case of honey pills) comprising at least one selected from the group consisting of Peony root and its extract alone, Cinnamon bark and its extract alone, Poria cocos and its extract alone, Licorice root and its extract alone, Gossypium rhizome and its extract alone, Atractylodes rhizome and its extract alone, Magnolia chinensis and its extract alone, Kokka and its extract alone, Euonymus rhizome and its extract alone, Pinellia rhizome and its extract alone, Rhubarb and its extract alone, Atractylodes rhizome and its extract alone, and Rehmannia rhizome and its extract alone. Item 2. The pharmaceutical composition according to claim 1, wherein the content of component (A) in the total herbal ingredients is 30 to 98 wt %. Item 3. The pharmaceutical composition according to Item 1 or 2, wherein the component (A) is Angelica acutiloba, Peony root, Cnidium root, or Ginseng root. Item 4. The pharmaceutical composition according to any one of Items 1 to 3, wherein the component (B) is at least one selected from the group consisting of Peony Fruit, Cinnamon Bark, Poria Coccinea, Glycyrrhiza Root, Atractylodes Rhizome, Magnolia Fruit, Kofu, Euonymus Jujube, Pinellia Root, Rhubarb, Atractylodes Rhizome, and Rehmannia Root. Item 5. The pharmaceutical composition according to any one of Items 1 to 4, which is a blood flow improver. Item 6. A method for reducing an unpleasant odor in a pharmaceutical composition (excluding honey pills) containing (A) Angelica Root and / or a separate extract thereof, Peony Root and / or a separate extract thereof, Cnidium Rhizome and / or a separate extract thereof, and / or a separate extract thereof, the method comprising blending, together with component (A), (B) at least one selected from the group consisting of Peony Fruit and a separate extract thereof, Cinnamon Bark and a separate extract thereof, Poria Coccinea and a separate extract thereof, Licorice Root and a separate extract thereof, Scutellaria Root and a separate extract thereof, Atractylodes Rhizome and a separate extract thereof, Kofuku Root and a separate extract thereof, Euonymus Fruit and a separate extract thereof, Pinellia Root and a separate extract thereof, Rhubarb and a separate extract thereof, Atractylodes Rhizome and a separate extract thereof, and Rehmannia Root and a separate extract thereof. [Effects of the Invention]

[0010] According to the pharmaceutical composition of the present invention, in a pharmaceutical composition containing an herbal composition that is not a simultaneous extract of multiple herbal medicines, including Angelica acutiloba, Peony Root, Cnidium Root, and Ginseng, a formulation is provided that reduces the unpleasant odor characteristic of the herbal mixture, thereby achieving good ease of administration that allows the patient to take the medicine continuously without difficulty. DETAILED DESCRIPTION OF THE INVENTION

[0011] 1. Pharmaceutical Composition The pharmaceutical composition of the present invention is characterized by being a pharmaceutical composition other than honey pills, comprising (A) Angelica acutiloba and / or a separate extract thereof, Peony Root and / or a separate extract thereof, Cnidium Rhizome and / or a separate extract thereof, and / or a separate extract of Ginseng Root and / or a separate extract thereof (hereinafter also referred to as "Component (A)"), and (B) at least one selected from the group consisting of Peony Fruit and a separate extract thereof, Cinnamon Bark and a separate extract thereof, Poria Coccinea and a separate extract thereof, Licorice Root and a separate extract thereof, Gossypium Root and a separate extract thereof, Atractylodes Rhizome and a separate extract thereof, Magnolia Fruit and a separate extract thereof, Celestial Fruit and a separate extract thereof, Euonymus Fruit and a separate extract thereof, Pinellia Root and a separate extract thereof, Rhubarb and a separate extract thereof, Atractylodes Rhizome and a separate extract thereof, and Rehmannia Root and a separate extract thereof (hereinafter also referred to as "Component B"). The pharmaceutical composition of the present invention is described in detail below.

[0012] Component (A) The pharmaceutical composition of the present invention contains, as component (A), Angelica acutiloba and / or an extract thereof alone, Peony root and / or an extract thereof alone, Cnidium root and / or an extract thereof alone, and Ginseng root and / or an extract thereof alone.

[0013] Component (A) may be a mixture of four herbal medicines (Angelica quince, Peony root, Cnidium rhizome, and ginseng), a mixture of individual extracts of each of the four herbal medicines, or a mixture of herbal medicines and individual extracts of the herbal medicines. While such a mixture of four herbal medicines and / or their individual extracts has a distinctive unpleasant odor, the pharmaceutical composition of the present invention can reduce this unpleasant odor. Therefore, even when component (A) contains herbal medicines with a strong unpleasant odor, particularly a mixture of four herbal medicines (Angelica quince, Peony root, Cnidium rhizome, and ginseng), the pharmaceutical composition of the present invention can effectively reduce the unpleasant odor.

[0014] Dong qui (Angelica acutiloba Kitagawa) is the root of the Umbelliferae family (Apiaceae) or other related plants, and is usually blanched. It is used as a herbal medicine (Japanese Pharmacopoeia) in prescriptions for women's medicines, medicines for cold sensitivity, health tonics, medicines for psychoneurotic disorders, and medicines for urinary tract disorders. Dong qui is commercially available from Maruzen Pharmaceutical Co., Ltd., Mikuni Co., Ltd., Ichimaru Pharcos Co., Ltd., etc.

[0015] The sole extract of Dong Quai is known and is listed as Dong Quai extract in the Japanese Pharmacopoeia (JPN) and the Standards for Quasi-drug Raw Materials. Specifically, Dong Quai extract can be obtained by extracting the roots of Dong Quai or other closely related plants with an extraction solvent, optionally removing the n-hexane and / or n-butanol-soluble portion. Examples of extraction solvents used in the Dong Quai sole extract process include polar solvents such as water; lower alcohols such as ethanol and isopropanol; polyhydric alcohols such as 1,3-butylene glycol and propylene glycol; and mixtures thereof. Water, ethanol, 1,3-butylene glycol, propylene glycol, or mixtures thereof are preferred. Dong Quai extract is commercially available from, for example, Maruzen Pharmaceutical Co., Ltd. and Alps Pharmaceutical Co., Ltd.

[0016] Peony (Shakuyaku) is the root of Paeonia lactiflora Pallas or other related plants of the Paeoniaceae family, and is used as a herbal medicine (Japanese Pharmacopoeia) primarily as an analgesic and antispasmodic (gastrointestinal medicine), a women's medicine, a medicine for sensitivity to colds, and a cold remedy. Peony is both the name of the herbal medicine (Japanese Pharmacopoeia) and the name of the plant. Peony is commercially available from Maruzen Pharmaceutical Co., Ltd., Mikuni Co., Ltd., Ichimaru Pharcos Co., Ltd., and others.

[0017] Peony extracts alone are listed as peony extracts in the quasi-drug raw material standards and are known. Specifically, peony extracts alone can be obtained by extracting the roots of peony or other related plants using an extraction solvent. Examples of extraction solvents used in the peony extract process include polar solvents such as water; lower alcohols such as ethanol; polyhydric alcohols such as 1,3-butylene glycol; and mixtures thereof. Water, ethanol, 1,3-butylene glycol, or mixtures thereof are preferred. Peony extracts are commercially available from, for example, Maruzen Pharmaceutical Co., Ltd., Ichimaru Pharcos Co., Ltd., and Alps Pharmaceutical Co., Ltd.

[0018] Cnidium officinale (Cnidium officinale Makino), a plant of the Umbelliferae family, is usually boiled and used as a crude drug (Japanese Pharmacopoeia) primarily for its vasoconstriction and women's medicine purposes. Cnidium is both the name of the crude drug (Japanese Pharmacopoeia) and the name of the plant. Cnidium is commercially available from Nippon Funa Yakuhin Co., Ltd., Tochimoto Tenkaido Co., Ltd., and other companies.

[0019] A sole extract of Cnidium officinale is listed as Cnidium officinale extract in the quasi-drug raw material standards and is publicly known. Specifically, a sole extract of Cnidium officinale can be obtained by extracting the rhizome of Cnidium officinale using an extraction solvent. Examples of extraction solvents used in the sole extraction of Cnidium officinale include water; lower alcohols such as methanol and ethanol; polyhydric alcohols such as propylene glycol and 1,3-butylene glycol; ketones such as acetone; esters such as diethyl ether, dioxane, acetonitrile, and ethyl acetate; xylene; benzene; chloroform; and mixed solvents thereof, with water, ethanol, 1,3-butylene glycol, or mixed solvents thereof being preferred. Cnidium officinale extract is commercially available from, for example, Maruzen Pharmaceutical Co., Ltd. and Alps Pharmaceutical Co., Ltd.

[0020] Ginseng (ninjin) is the root, or lightly blanched root, of the Panax ginseng CA Meyer (Panax schinseng Nees) plant of the Araliaceae family, with the fine rootlets removed. It is used as a herbal medicine (Japanese Pharmacopoeia) primarily as a tonic, a digestive stimulant, antidiarrheal, tranquilizer, hypoglycemic agent, cardiac stimulant, heat retaining agent, and anti-fatigue agent. Ginseng is both the name of the herbal medicine (Japanese Pharmacopoeia) and the name of the plant. Ginseng is commercially available from Nippon Funa Yakuhin Co., Ltd., Tochimoto Tenkaido Co., Ltd., and other companies.

[0021] A carrot extract alone is listed as "carrot extract" in the quasi-drug raw material standards and is known. Specifically, a carrot extract alone can be obtained by extracting carrot rootlets using an extraction solvent. Examples of extraction solvents used in carrot extract alone include polar solvents such as water; lower alcohols such as ethanol; polyhydric alcohols such as 1,3-butylene glycol; and mixtures thereof. Preferred are water, ethanol, 1,3-butylene glycol, or mixtures thereof. Carrot extracts are commercially available from, for example, Matsuura Pharmaceutical Co., Ltd., Alps Pharmaceutical Co., Ltd., and the like.

[0022] In the pharmaceutical composition of the present invention, the content of component (A) in all herbal ingredients is not particularly limited and may be appropriately determined depending on the efficacy to be achieved, but when the total amount is 30 to 98 wt. %, preferably 30 to 85 wt. %, calculated as the crude drug, the effect of component (B) in reducing the unpleasant odor characteristic of component (A) is particularly pronounced. In the pharmaceutical composition of the present invention, component (B) is highly effective in reducing the unpleasant odor characteristic of component (A), so that the unpleasant odor can be effectively reduced even when the amount of component (A) in all herbal ingredients is relatively high. From this perspective, the content of component (A) in all herbal ingredients in the pharmaceutical composition of the present invention is preferably 35 to 85 wt. %, even more preferably 40 to 85 wt. %, and particularly preferably 43 to 85 wt. % calculated as the crude drug.

[0023] The content of all herbal ingredients (the total amount of ingredient (A), ingredient (B), and other herbal ingredients blended as needed) in the entire pharmaceutical composition of the present invention is 30 to 98% by weight, preferably 40 to 95% by weight.

[0024] The proportion of Angelica sinensis and / or its sole extract in component (A) is not particularly limited and may be set appropriately depending on the efficacy to be exerted, etc., but may be, for example, 25 to 35% by weight, preferably 28 to 32% by weight, of the total amount of component (A) in terms of the crude drug.

[0025] The proportion of peony and / or its sole extract in component (A) is not particularly limited and may be set appropriately depending on the efficacy to be exerted, etc., but may be, for example, 25 to 35% by weight, preferably 28 to 32% by weight, of the total amount of component (A) in terms of the crude drug.

[0026] The proportion of Cnidium officinalis and / or its single extract in component (A) is not particularly limited and may be set appropriately depending on the efficacy to be exerted, etc., but for example, the amount may be 15 to 25% by weight, preferably 18 to 22% by weight, of the total amount of component (A) in terms of the crude drug.

[0027] The proportion of ginseng and / or its single extract in component (A) is not particularly limited and may be set appropriately depending on the efficacy to be exerted, etc., but for example, the proportion may be 15 to 25% by weight, preferably 18 to 22% by weight, of the total amount of component (A) in terms of the crude drug.

[0028] (B) Component The pharmaceutical composition of the present invention comprises, as component (B), at least one selected from the group consisting of Peony Fruit and its sole extract, Cinnamon Bark and its sole extract, Poria Coccinea and its sole extract, Licorice Root and its sole extract, Gossypium Root and its sole extract, Atractylodes Rhizome and its sole extract, Magnolia Fruit and its sole extract, Kokka and its sole extract, Euonymus Fruit and its sole extract, Pinellia Root and its sole extract, Rhubarb and its sole extract, Atractylodes Rhizome and its sole extract, and Rehmannia Root and its sole extract.

[0029] In the present invention, component (A) has a unique unpleasant odor, but by blending component (B) with component (A), the unique unpleasant odor of component (A) can be reduced. The masking effect of component (B) is achieved by masking the unique unpleasant odor caused by the composition of component (A) using a specific herbal medicine, and the masking mechanism is due to the offset of the flavors that the specific herbal medicines individually possess. Therefore, the masking effect of component (B), which is a specific herbal medicine, is a unique effect obtained for component (A). Furthermore, because the pharmaceutical composition of the present invention uses a herbal medicine component for masking, the efficacy of the masking component (component (B)) itself can also be expected.

[0030] As component (B), one herbal ingredient from among Moutan Pi and its extract alone, Cinnamon Bark and its extract alone, Poria Coccinea and its extract alone, Glycyrrhiza Root and its extract alone, Gossypium Root and its extract alone, Atractylodes Rhizome and its extract alone, Magnolia Fruit and its extract alone, Kokka and its extract alone, Euonymus Fruit and its extract alone, Pinellia Root and its extract alone, Rhubarb and its extract alone, Atractylodes Rhizome and its extract alone, and Rehmannia Root and its extract alone may be used alone or in combination.

[0031] Furthermore, from the viewpoint of further reducing the unpleasant odor of component (A), component (B) preferably contains one or more species selected from the group consisting of cinnamon bark and an extract thereof, poria cocos and an extract thereof, licorice and an extract thereof, atractylodes rhizome and an extract thereof, magnolia chinensis and an extract thereof, kofta and an extract thereof, echinacea japonica and an extract thereof, pinus sieboldii and an extract thereof, rhubarb and an extract thereof, atractylodes rhizome and an extract thereof, and rehmannia root and an extract thereof; more preferably contains one or more species selected from the group consisting of cinnamon bark and an extract thereof, poria cocos and an extract thereof, licorice and an extract thereof, atractylodes rhizome and an extract thereof, magnolia chinensis and an extract thereof, kofta and an extract thereof, and pinus sieboldii and an extract thereof; and even more preferably contains one or more species selected from the group consisting of cinnamon bark and an extract thereof, poria cocos and an extract thereof, and licorice and an extract thereof.

[0032] Furthermore, from the viewpoint of more efficiently reducing the unpleasant odor of component (A), component (B) is preferably a crude drug itself rather than a single extract. That is, component (B) is preferably one or more selected from the group consisting of Peony Fruit, Cinnamon Bark, Poria Root, Glycyrrhiza Root, Atractylodes Rhizome, Magnolia Fruit, Kofuku, Eggplant, Pinellia Fruit, Rhubarb, Atractylodes Rhizome, and Rehmannia Root; more preferably, it contains one or more selected from the group consisting of cinnamon bark, Poria Root, Glycyrrhiza Root, Atractylodes Rhizome, Kofuku, Eggplant, Pinellia Fruit, Rhubarb, Atractylodes Rhizome, and Rehmannia Root; even more preferably, it contains one or more selected from the group consisting of cinnamon bark, Poria Root, Glycyrrhiza Root, Atractylodes Rhizome, Kofuku, Eggplant, Pinellia Fruit, Rhubarb, Atractylodes Rhizome, and Rehmannia Root; particularly preferably, it contains one or more selected from the group consisting of cinnamon bark, Poria Root, Glycyrrhiza Root, Atractylodes Rhizome, Kofuku, and Pinellia Fruit.

[0033] Peony bark (Moutanpi) is the root bark of the peony (Paeonia suffruticosa Andrews) (Paeonia moutan Sims) of the Paeoniaceae family, and is used as a herbal medicine (Japanese Pharmacopoeia), primarily for women's medicines. Peony bark is commercially available from Tochimoto Tenkaido Co., Ltd., Takasago Pharmaceutical Co., Ltd., and other companies.

[0034] A single extract of Moutan Pi can be obtained by extracting the root bark of Moutan Pi with an extraction solvent. Examples of extraction solvents used for the single extraction of Moutan Pi include polar solvents such as water; lower alcohols such as ethanol and isopropanol; polyhydric alcohols such as 1,3-butylene glycol and propylene glycol; and mixtures thereof. Water, ethanol, 1,3-butylene glycol, propylene glycol, or a mixture thereof is preferred. Single extracts of Moutan Pi are commercially available, for example, from Alps Pharmaceutical Co., Ltd.

[0035] Cinnamon bark is the peeled bark from the thick trunk of Cinnamomum cassia Blum, a member of the Lauraceae family, or other plants of the same genus, and is used as a herbal medicine (Japanese Pharmacopoeia) primarily as an aromatic stomachic. Cinnamon bark is commercially available from Nippon Funa Yakuhin Co., Ltd., Tochimoto Tenkaido Co., Ltd., and other companies.

[0036] Cinnamon bark extracts alone are listed as cinnamon bark extracts in quasi-drug raw material standards and are well known. Specifically, cinnamon bark extracts alone can be obtained by extracting the bark of cinnamon or other plants of the same genus using an extraction solvent. Examples of extraction solvents used in the cinnamon bark extract process include polar solvents such as water; lower alcohols such as ethanol and isopropanol; polyhydric alcohols such as 1,3-butylene glycol and propylene glycol; and mixtures thereof. Water, ethanol, 1,3-butylene glycol, propylene glycol, or mixtures thereof are preferred. Cinnamon bark extracts are commercially available from, for example, Maruzen Pharmaceutical Co., Ltd. and Nippon Funa Yakuhin Co., Ltd.

[0037] Poria cocos (Poria cocos) is the sclerotium of Wolfiporia cocos Ryvarden et Gilbertson (Poria cocos Wolf), a member of the Polyporaceae family. It is usually obtained by removing most of the outer layer, and is used as a herbal medicine (Japanese Pharmacopoeia) primarily as a sedative and diuretic. Poria cocos is commercially available from Takasago Pharmaceutical Co., Ltd., Tochimoto Tenkaido Co., Ltd., and other companies.

[0038] A Poria columbine extract is listed in the quasi-drug raw material standards as a Poria columbine extract and is known. Specifically, a Poria columbine extract can be obtained by extracting the sclerotium of the genus Poria columbine with an extraction solvent. Examples of extraction solvents used in the extraction of Cnidium officinalis include water; lower alcohols such as methanol and ethanol; polyhydric alcohols such as propylene glycol and 1,3-butylene glycol; ketones such as acetone; esters such as diethyl ether, dioxane, acetonitrile, and ethyl acetate; xylene; benzene; chloroform; and mixtures thereof, preferably water, ethanol, 1,3-butylene glycol, or mixtures thereof. Poria columbine extract is commercially available from, for example, Maruzen Pharmaceutical Co., Ltd. and Alps Pharmaceutical Co., Ltd.

[0039] Licorice (Glycyrrhiza uralensis Fischer) or Glycyrrhiza glabra Linne, a plant of the Leguminosae family, is the root and stolons, sometimes with the periderm removed (peeled licorice), and is used as a herbal medicine (Japanese Pharmacopoeia) primarily as an expectorant and anti-gastric ulcer agent. Licorice is commercially available from Nippon Funa Yakuhin Co., Ltd., Takasago Pharmaceutical Co., Ltd., Tochimoto Tenkaido Co., Ltd., and other companies.

[0040] A licorice extract alone is listed as licorice extract in the quasi-drug raw material standards and is known. Specifically, a licorice extract alone can be obtained by extracting the roots or stolons of Glycyrrhiza uralensis Fischer or Glycyrrhiza glabra Linne with an extraction solvent. Examples of extraction solvents used in the licorice extract alone include water; lower alcohols such as methanol and ethanol; polyhydric alcohols such as propylene glycol and 1,3-butylene glycol; ketones such as acetone; esters such as diethyl ether, dioxane, acetonitrile, and ethyl acetate; xylene; benzene; chloroform; and mixed solvents thereof, preferably water, ethanol, 1,3-butylene glycol, or mixed solvents thereof. Licorice extract is commercially available from, for example, Maruzen Pharmaceutical Co., Ltd., Nippon Funa Yakuhin Co., Ltd., and Alps Pharmaceutical Co., Ltd.

[0041] Goshitsu (a Japanese name for Goshitsu) is the root of Achyranthes fauriei Leveille et Vaniot or Achyranthes bidentata Blume, a species of the Amaranthaceae family, and is used as a herbal medicine (Japanese Pharmacopoeia) primarily as a diuretic and for women's health. Goshitsu is commercially available from Nippon Funa Yakuhin Co., Ltd., Mikuni Co., Ltd., Maechu Co., Ltd., and other companies.

[0042] A sole extract of Goshitsu can be obtained by extracting the roots of Achyranthes chinensis using an extraction solvent. Examples of extraction solvents used for the sole extraction of Goshitsu include water; lower alcohols such as methanol and ethanol; polyhydric alcohols such as propylene glycol and 1,3-butylene glycol; ketones such as acetone; esters such as diethyl ether, dioxane, acetonitrile, and ethyl acetate; xylene; benzene; chloroform; and mixtures thereof, preferably water, ethanol, 1,3-butylene glycol, or mixtures thereof. Goshitsu extract is commercially available from, for example, Nippon Funa Yakuhin Co., Ltd. and Maechu Co., Ltd.

[0043] Byakujutsu (White Atractylodes rhizome) is the rhizome of Atractylodes japonica Koidzumi ex Kitamura or Atractylodes ovata De Candolle, both of the Asteraceae family, and is used as a herbal medicine (Japanese Pharmacopoeia) primarily as a stomachic and laxative. Byakujutsu is commercially available from Tochimoto Tenkaido Co., Ltd., Konishi Pharmaceutical Co., Ltd., and other companies.

[0044] A sole extract of Atractylodes rhizome can be obtained by extracting the rhizomes of Atractylodes rhizome or Atractylodes macrocarpa with an extraction solvent. Examples of extraction solvents used for the sole extract of Atractylodes rhizome include polar solvents such as water, lower alcohols such as ethanol, polyhydric alcohols such as 1,3-butylene glycol, and mixtures thereof. Water, ethanol, 1,3-butylene glycol, or a mixture thereof is preferred. A sole extract of Atractylodes rhizome is commercially available, for example, from Alps Pharmaceutical Co., Ltd.

[0045] Kobushi (Cyperus rotundus Linne) is the rhizome of Cyperus rotundus Linne, a plant in the Cyperaceae family, and is used as a herbal medicine (Japanese Pharmacopoeia) primarily as an analgesic. Kobushi is commercially available from Tochimoto Tenkaido Co., Ltd. and other companies.

[0046] A Magnolia kohlrausch extract can be obtained by extracting the rhizomes of Cyperus kohlrausch using an extraction solvent. Examples of extraction solvents used in the Magnolia kohlrausch extract include polar solvents such as water, lower alcohols such as ethanol, polyhydric alcohols such as 1,3-butylene glycol, and mixtures thereof. Water, ethanol, 1,3-butylene glycol, or a mixture thereof is preferred. Magnolia kohlrausch extract is commercially available, for example, from Nippon Funa Pharmaceutical Co., Ltd.

[0047] Safflower (kouka) is the tubular flowers of the safflower (Carthamus tinctorius Linne) of the Asteraceae family (Compositae), either intact or with most of the yellow pigment removed, and is sometimes pressed into sheets. It is used as a crude drug (Japanese Pharmacopoeia), mainly for women's medicines, etc. Kouka is commercially available from Tochimoto Tenkaido Co., Ltd.

[0048] A sole extract of Cerifera tinctorius is listed as safflower extract in the Japanese Pharmacopoeia and is publicly known. Specifically, a sole extract of Cerifera tinctorius can be obtained by extracting safflower tubular flowers or a portion of the safflower tubular flowers from which most of the yellow pigment has been removed using an extraction solvent. Examples of extraction solvents used in the sole extraction of Cerifera tinctorius include water; lower alcohols such as methanol and ethanol; polyhydric alcohols such as propylene glycol and 1,3-butylene glycol; ketones such as acetone; esters such as diethyl ether, dioxane, acetonitrile, and ethyl acetate; xylene; benzene; chloroform; and mixed solvents thereof, with water, ethanol, 1,3-butylene glycol, or mixed solvents thereof being preferred. Safflower extract is commercially available from, for example, Maruzen Pharmaceutical Co., Ltd. and Nippon Funa Yakuhin Co., Ltd.

[0049] Euodia ruticarpa (Euodia rutaecarpa Hooker filius et Thomson) is the fruit of the Euodia ruticarpa (Evodia rutaecarpa Bentham), Euodia officinalis Dode (Evodia officinalis Dode), or Euodia bodinieri Dode (Evodia bodinieri Dode) plant of the Rutaceae family. It is used as a herbal medicine (Japanese Pharmacopoeia) primarily as a painkiller and stomach remedy. Euodia ruticarpa is both the herbal name (Japanese Pharmacopoeia) and the name of the plant. Euodia ruticarpa is commercially available from Nippon Funa Pharmaceutical Co., Ltd.

[0050] A sole extract of Egoshu can be obtained by extracting Egoshu fruit with an extraction solvent. Examples of the extraction solvent used for the sole extraction of Egoshu include water; lower alcohols such as methanol and ethanol; polyhydric alcohols such as propylene glycol and 1,3-butylene glycol; ketones such as acetone; esters such as diethyl ether, dioxane, acetonitrile, and ethyl acetate; xylene; benzene; chloroform; and mixed solvents thereof, with water, ethanol, 1,3-butylene glycol, or mixed solvents being preferred. Egoshu extract is commercially available, for example, from Alps Pharmaceutical Co., Ltd.

[0051] Pinellia ternata Breitenbach is the tuber of the Araceae family (Araceae) with the cork layer removed, and is used as a herbal medicine (Japanese Pharmacopoeia) primarily as an antiemetic and expectorant. Pinellia ternata is commercially available from Tochimoto Tenkaido Co., Ltd.

[0052] A Pinellia ternata extract can be obtained by extracting Pinellia ternata tubers, from which the cork layer has been removed, using an extraction solvent. Examples of extraction solvents used for Pinellia ternata extract include polar solvents such as water, lower alcohols such as ethanol, polyhydric alcohols such as 1,3-butylene glycol, and mixtures thereof. Water, ethanol, 1,3-butylene glycol, or a mixture thereof is preferred. Pinellia ternata extracts are commercially available, for example, from Alps Pharmaceutical Co., Ltd.

[0053] Rhubarb (Daio) is the rhizome of Rheum palmatum L., Rheum tanguticum Maximowicz, Rheum officinale Baillon, Rheum coreanum Nakai, or their interspecific hybrids, which belong to the Polygonaceae family. It is used as a herbal medicine (Japanese Pharmacopoeia) primarily as a stomachic and laxative. Rhubarb is commercially available from Sanwa Shoyaku Co., Ltd., Tochimoto Tenkaido Co., Ltd., and other companies.

[0054] A rhubarb extract can be obtained by extracting the rhizomes of Rheum palmatum L., Rheum tanguticum Maximowicz, Rheum officinale Baillon, Rheum coreanum Nakai, or their interspecific hybrids using an extraction solvent. Examples of extraction solvents used in the rhubarb extract include polar solvents such as water; lower alcohols such as ethanol and isopropanol; polyhydric alcohols such as 1,3-butylene glycol and propylene glycol; and mixtures thereof. Water, ethanol, 1,3-butylene glycol, propylene glycol, or mixtures thereof are preferred. Rhubarb extracts are commercially available, for example, from Alps Pharmaceutical Co., Ltd.

[0055] Atractylodes lancea de candolle (or Atractylodes chinensis Koidzumi) is the rhizome of the narrow-leaved grass Atractylodes lancea de candolle (or Atractylodes chinensis Koidzumi) of the Asteraceae family (Compositae), and is used as a herbal medicine (Japanese Pharmacopoeia) primarily as a stomachic. Atractylodes lancea de candolle is commercially available from Tochimoto Tenkaido Co., Ltd., Yoshimi Pharmaceutical Co., Ltd., and other companies.

[0056] A sole extract of Atractylodes rhizomes can be obtained by extracting the rhizomes of Atractylodes nigra using an extraction solvent. Examples of extraction solvents used for the sole extract of Atractylodes rhizomes include polar solvents such as water; lower alcohols such as ethanol and isopropanol; polyhydric alcohols such as 1,3-butylene glycol and propylene glycol; and mixtures thereof, with water, ethanol, 1,3-butylene glycol, propylene glycol, or mixtures thereof being preferred. Sole extracts of Atractylodes rhizomes are commercially available, for example, from Alps Pharmaceutical Co., Ltd.

[0057] Rehmannia root (Rehmannia Root) is the root (dried rehmannia root) or its steamed preparation (cooked rehmannia root) of Rehmannia glutinosa Liboschitz var. purpurea Makino or Rehmannia glutinosa Liboschitz, a plant of the Scrophulariaceae family. It is used as a herbal medicine (Japanese Pharmacopoeia) primarily as an antidiarrheal and diuretic. Rehmannia root is commercially available from Tochimoto Tenkaido Co., Ltd., Nippon Funa Yakuhin Co., Ltd., and other companies.

[0058] A Rehmannia root extract can be obtained by extracting the roots of Rehmannia root using an extraction solvent. Examples of extraction solvents used for the Rehmannia root extract include polar solvents such as water; lower alcohols such as ethanol and isopropanol; polyhydric alcohols such as 1,3-butylene glycol and propylene glycol; and mixtures thereof. Water, ethanol, 1,3-butylene glycol, propylene glycol, or mixtures thereof are preferred. Rehmannia root extracts are commercially available from, for example, Nippon Funa Yakuhin Co., Ltd.

[0059] In the pharmaceutical composition of the present invention, the content of component (B) in all herbal ingredients is not particularly limited, but may be, for example, 2 to 70% by weight in total, calculated as the amount of the crude drug. Because component (B) exhibits excellent masking effect against the unpleasant odor specific to component (A), the unpleasant odor can be effectively reduced without using a large excess of component (B) as a masking agent relative to the total herbal ingredients. From this perspective, in the pharmaceutical composition of the present invention, the content of component (B) in all herbal ingredients, calculated as the amount of the crude drug, is preferably 2 to 65% by weight, more preferably 2 to 60% by weight, and even more preferably 2 to 57% by weight. Furthermore, from the viewpoint of obtaining a more effective masking effect against the unpleasant odor of component (A), the content is preferably 15 to 57% by weight.

[0060] In the pharmaceutical composition of the present invention, the ratio of component (A) to component (B) is determined based on the amount of each component described above. From the viewpoint of more favorably reducing the unpleasant odor characteristic of component (A), the total amount of component (B) per part by weight of component (A) is preferably 0.02 to 2.3 parts by weight, calculated as the crude drug. Because component (B) exhibits excellent masking effect against the unpleasant odor characteristic of component (A), it can effectively reduce the unpleasant odor without being used in excessive amounts relative to component (A). From this viewpoint, in the pharmaceutical composition of the present invention, the amount of component (B) per part by weight of component (A) is preferably 0.1 to 1.9 parts by weight, more preferably 0.1 to 1.5 parts by weight, and even more preferably 0.1 to 1.3 parts by weight, calculated as the crude drug. Furthermore, from the viewpoint of more favorably masking the unpleasant odor of component (A), the amount is preferably 0.2 to 1.3 parts by weight.

[0061] Other ingredients In addition to the above-described components (A) and (B), the pharmaceutical composition of the present invention may further contain additives and bases appropriate for the formulation. The additives and bases are not particularly limited as long as they are pharmaceutically acceptable, and examples thereof include excipients, binders, disintegrants, lubricants, isotonicity agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, stabilizers, suspending agents, adhesives, coating agents, glossing agents, water, oils and fats, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV protection agents, preservatives, flavoring agents, fragrances, powders, thickeners, dyes, and chelating agents. These additives may be used alone or in combination of two or more. The content of these additives and bases is determined appropriately depending on the type of additives and bases used, the formulation of the pharmaceutical composition of the present invention, and other factors.

[0062] Specific examples of additives and bases include starch, lactose, carmellose calcium, light anhydrous silicic acid, magnesium stearate, synthetic aluminum silicate, magnesium aluminometasilicate, calcium silicate, magnesium silicate, synthetic hydrotalcite, anhydrous calcium hydrogen phosphate, carmellose, croscarmellose sodium, sodium starch glycolate, and crospovidone, with carmellose calcium, light anhydrous silicic acid, magnesium stearate, and synthetic aluminum silicate being preferred. Examples of starches include potato starch and corn starch, with corn starch being preferred. The content of these additives and bases is appropriately determined depending on the types of additives and bases used.

[0063] When the pharmaceutical composition of the present invention further contains additives and bases in addition to the above-mentioned components (A) and (B), the total amount of the additives and bases in the entire pharmaceutical composition is 2 to 70% by weight, preferably 5 to 60% by weight.

[0064] Furthermore, the pharmaceutical composition of the present invention may further contain, as necessary, nutritional components or pharmacological components other than component (A). Such nutritional components and pharmacological components are not particularly limited as long as they are pharmaceutically acceptable, and examples thereof include antacids, stomachic agents, digestive agents, intestinal regulators, antispasmodics, mucosal repair agents, anti-inflammatory agents, antiemetics, antitussives, expectorants, anti-inflammatory enzymes, sedatives, hypnotics, antihistamines, caffeine, cardiac diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, herbal medicines and / or herbal extracts, and vitamins. These nutritional components and pharmacological components may be used alone or in combination of two or more. The content of these components is determined appropriately depending on the type of components used, etc. When herbal medicines and / or herbal extracts are contained as other nutritional or pharmacological ingredients, the total content of the herbal medicine ingredients in the entire pharmaceutical composition, combined with the content of the above-mentioned component (A) and component (B), is formulated to be, for example, 30 to 98% by weight, preferably 40 to 95% by weight, as described above.

[0065] Formulation The dosage form of the pharmaceutical composition of the present invention is not particularly limited, as long as it is orally administrable and not a solid pill. Examples include solid preparations such as powders, fine granules, granules, tablets, lozenges, chewable tablets, capsules (soft capsules, hard capsules), and pills (except in the case of solid pills); semi-solid preparations such as jellies; and liquid preparations such as solutions, suspensions, and syrups. Among these dosage forms, solid preparations are preferred from the viewpoints of the stability and portability of the contained ingredients. Furthermore, since the pharmaceutical composition of the present invention has a reduced unpleasant odor specific to component (A), a good intake experience can be achieved even in a dosage form that does not contain a large amount of a known masking agent such as a sweetener. From this perspective, more preferred dosage forms include powders, fine granules, granules, tablets, capsules, and pills (except in the case of solid pills), and even more preferred are powders, fine granules, granules, and tablets.

[0066] Manufacturing method The pharmaceutical composition of the present invention can be produced by formulating the above-mentioned component (A) and component (B) and other components to be blended as necessary in accordance with a conventional formulation method used in the pharmaceutical field.

[0067] Purpose The pharmaceutical composition of the present invention may be used for any purpose as long as the efficacy of the herbal medicines constituting the above-mentioned component (A) and the above-mentioned component (B) is expected. Preferably, it is used as a blood flow improver due to the efficacy of the herbal medicines constituting the above-mentioned component (A). Since the improvement of blood flow is expected to improve various physical disorders caused by, for example, an imbalance between female hormones and the autonomic nervous system, it is more preferably used as a women's health medicine.

[0068] Dosage / Usage The pharmaceutical composition of the present invention is administered orally. The dosage of the pharmaceutical composition of the present invention is determined appropriately depending on the purpose of administration, the age, sex, constitution, and severity of symptoms of the recipient, but for example, it may be administered in an amount equivalent to 1.5 to 7 g, preferably 2.0 to 6 g, of the total herbal ingredients per day per human, in terms of the amount of raw herbal medicine, 1 to 3 times a day, preferably 2 or 3 times a day. The timing of administration is not particularly limited, and may be before, after, or between meals, but preferably after meals.

[0069] 2. Method for reducing unpleasant odor of pharmaceutical composition As described above, component (B), which is at least one selected from the group consisting of Peony Fruit and an extract thereof, Cinnamon Bark and an extract thereof, Poria Coccinea and an extract thereof, Licorice Root and an extract thereof, Gossypium Root and an extract thereof, Atractylodes Rhizome and an extract thereof, Magnolia Fruit and an extract thereof, Kokka and an extract thereof, Ethospermum Parkii and an extract thereof, Pinellia Root and an extract thereof, Rhubarb and an extract thereof, Atractylodes Rhizome and an extract thereof, and Rehmannia Root and an extract thereof, can reduce the unpleasant odor characteristic of component (A), which is Angelica Root and / or an extract thereof, Peony Root and / or an extract thereof, Cnidium Rhizome and / or an extract thereof, and Ginseng and / or an extract thereof. Therefore, the present invention further provides a method for reducing an unpleasant odor in a pharmaceutical composition (excluding the case of honey pills) containing (A) Angelica Root and / or a single extract thereof, Peony Root and / or a single extract thereof, Cnidium Rhizome and / or a single extract thereof, and / or a single extract thereof, by blending, together with component (A), (B) at least one selected from the group consisting of Peony Fruit and a single extract thereof, Cinnamon Bark and a single extract thereof, Poria Coccinea and a single extract thereof, Licorice Root and a single extract thereof, Scutellaria Root and a single extract thereof, Atractylodes Rhizome and a single extract thereof, Kokka and a single extract thereof, Euonymus Fruit and a single extract thereof, Pinellia Root and a single extract thereof, Rhubarb and a single extract thereof, Atractylodes Rhizome and a single extract thereof, and Rehmannia Root and a single extract thereof.

[0070] In the method for reducing the unpleasant odor of a pharmaceutical composition, the types and amounts of ingredients used, the form of the pharmaceutical composition, etc. are as shown in the section "1. Pharmaceutical composition" above. [Example]

[0071] The present invention will be specifically described below with reference to examples, but the present invention is not limited to these examples.

[0072] Pharmaceutical compositions were prepared having the compositions shown in Tables 1 to 4. The degree of reduction in unpleasant odor in the prepared pharmaceutical compositions was evaluated based on the following criteria.

[0073] 5: Unpleasant odors were significantly reduced 4: Unpleasant odors were significantly reduced 3: Unpleasant odors are reduced 2: Unpleasant odors were slightly reduced 1: Only a slight reduction in unpleasant odor 0: Unpleasant odor is the same as Comparative Example 1 -1: The unpleasant odor increased or another unpleasant taste was added, making it difficult to take

[0074] The results are shown in Tables 1 to 4. As is clear from Tables 1 and 2, the unpleasant odor of a pharmaceutical composition (Comparative Example 1) containing only component (A), which includes Angelica Root powder, Peony Root powder, Cnidium Rhizome powder, and Ginseng powder, was reduced by adding component (B), selected from the group consisting of Peony Fruit Powder, Cinnamon Bark Powder, Poria Coccinea Powder, Licorice Root Powder, Gossypium Root Powder, Atractylodes Rhizome Powder, Magnolia Fruit Powder, Kohka Powder, Euonymus Juice Powder, Pinellia Root Powder, Rhubarb Powder, Atractylodes Rhizome Powder, and Rehmannia Root Powder. Furthermore, as is clear from Table 3, adding component (B) to a pharmaceutical composition containing a herbal ingredient other than component (A) (component (a)) did not produce the effect of reducing the unpleasant odor. In particular, when the (B) component was incorporated into pharmaceutical compositions containing Huangren-Ajiao-Tang, Rhubarb Powder, Scutellaria Baicalensis Powder, or Coptis Rhizome Powder as the (a) component (Comparative Examples 3, 4, 5, 6, 7, 9, and 10), the intake sensation worsened even when the (B) component was incorporated. This indicates that the masking effect of the (B) component is a unique effect exerted on pharmaceutical compositions containing the (A) component. Furthermore, as is clear from Table 4, the incorporation of a herbal ingredient other than the (B) component (component (b)) into the (A) component did not result in the effect of reducing unpleasant odors. In particular, when Forsythia Suspensa Powder, Safflower Root Powder, Ephedra Herb Powder, or Platycodon Grandiflorum Powder was incorporated as the (b) component (Comparative Examples 11, 12, 13, and 15), the intake sensation worsened. This indicates that the masking effect exerted on pharmaceutical compositions containing the (A) component is a unique effect exerted on pharmaceutical compositions containing the (B) component.

[0075] [Table 1]

[0076] [Table 2]

[0077] [Table 3]

[0078] [Table 4]

Claims

1. (A) Angelica acutiloba, peony root, cnidium root, and carrot, (B) at least one selected from the group consisting of Peony root, Cinnamon bark, Poria columbine, Glycyrrhiza, Atractylodes rhizome, Magnolia officinalis, Kobushi, Euonymus rhizome, Pinellia rhizome, Rhubarb, Atractylodes rhizome, and Rehmannia root, the contents of the Angelica acutiloba, the Peony Root, the Cnidium Root, and the Ginseng, respectively, relative to the total amount of the component (A), are 25 to 35% by weight, 25 to 35% by weight, 15 to 25% by weight, and 15 to 25% by weight, A pharmaceutical composition having a total content of 30 to 98% by weight of all herbal ingredients and a content of component (A) in the herbal ingredients of 30 to 85% by weight (excluding, however, [i] honey pills, [ii] containing valerian root powder, [iii] containing ginseng powder, saffron, Angelica Root powder, Cnidium Rhizome powder, Peony Root powder, and Peony Pea Powder, [iv] Angelica Root extract powder, Cnidium Rhizome extract powder, Peony Root extract powder, Rehmannia Root extract powder, Astragalus Root extract powder, Cinnamon Bark extract powder, Licorice extract powder, Atractylodes Rhizome extract powder, Ginseng extract powder, Oxgall extract powder, Poria Cocos Root powder, Dioscorea Root powder, Processed Garlic and Hampi powder, and [v] Seika Gouou Seishin Wan).

2. The pharmaceutical composition according to claim 1, which is a blood flow improver.

3. A pharmaceutical composition comprising (A) Angelica Root, Peony Root, Cnidium Root, and Ginseng, wherein the contents of the Angelica Root, Peony Root, Cnidium Root, and Ginseng relative to the total amount of the component (A) are 25 to 35% by weight, 25 to 35% by weight, 15 to 25% by weight, and 15 to 25% by weight, respectively, and wherein the content of all herbal ingredients in the pharmaceutical composition is 30 to 98% by weight, and the content of the component (A) relative to the total amount of the herbal ingredients is 30 to 85% by weight (provided that, in the case of [i] Honey Pills, [ii] when containing valerian root powder; [iii] when containing ginseng powder, saffron, Angelica Root powder, Cnidium Root powder, Peony root powder, and Peony Pea powder; [iv] when containing Angelica Root extract powder, Cnidium Root extract powder, Peony root extract powder, Rehmannia Root extract powder, Astragalus root extract powder, Cinnamon bark extract powder, Licorice extract powder, Atractylodes Root extract powder, Ginseng extract powder, Oxgall extract powder, Poria Cocos Root powder, Dioscorea Root powder, Processed Garlic and Hampi powder; and [v] when excluding Seika Gouou Seishin-gan, The method as described above, wherein the pharmaceutical composition further contains (B) at least one selected from the group consisting of Peony root, Cinnamon bark, Poria cocos, Glycyrrhiza, Atractylodes rhizome, Magnolia rhizome, Kobushi, Euonymus rhizome, Pinellia rhizome, Rhubarb, Atractylodes rhizome, and Rehmannia rhizome.

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