JP2003048847A - Bioactive composition and method for producing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an antitumor composition. SOLUTION: This composition contains Ganoderma lucidum and Coriolus versicolor belonging to Polyporaceae of Basidiomycetes, and a root of a plant belonging to Araliaceae as active ingredients. The weight ratio of the Ganoderma lucidum : the Coriolus versicolor : the root of the plant belonging to the Araliaceae is regulated so as to be (4-6):(8-12):(2.4-3.6).

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a composition having physiological activity such as antitumor activity. In particular, it contains fungi belonging to the basidiomycetes Sarcobidae, particularly fruiting bodies and / or mycelium cultures (including other cultures of mycelia) of Ganoderma lucidum and Pleurotus genus, and roots of Araliaceae plants as active ingredients. It relates to a composition.

[0002]

2. Description of the Related Art Conventionally, fruiting bodies of Ganoderma lucidum (commonly known as Reishi) belonging to the family Basidiomycetes Rhododendronidae (commonly known as Reishi), and mycelium cultures (in addition to mycelia, culture solutions are also referred to simply as cultures). Has been known as a crude drug for a long time and is known to have various medicinal effects. Similarly, various physiologically active substances have been extracted from fruiting bodies of Pleurotus cornucopiae belonging to the family Basidiomycetes Asterulaceae.

Furthermore, the roots of plants belonging to the family Araliaceae such as carrots and their extracted components have been used as crude drugs for a long time, and many of them are known to have medicinal effects. In general, various therapies including treatment and prevention with crude drugs have the merit that side effects are small, but the effects may not be remarkable in some cases. Although basidiomycetes and carrots are empirically and experimentally known to have excellent medicinal effects, by combining these specific components and combining these components, their physiological activities are synergistic. It was not known to improve.

[0004]

Means for Solving the Problems The present invention has found that when a given basidiomycete and a root of a plant belonging to the family Araliaceae are used in a given weight ratio, a remarkably high antitumor activity is found.
Is provided.

The present invention provides the following compositions based on the above findings. (1) One or more kinds of basidiomycetes belonging to the family Basidiomycetes, and roots of plants belonging to the family Araliaceae are contained as active ingredients, and the basidiomycetes are Ganoderma lucidum and Pleurotus cornucopiae. The material composition of the roots of the Araliaceae plant is 4 to 6: 8 to 1 by weight ratio.
The physiologically active composition having antitumor activity, which is 2: 2.4 to 3.6. (2) The plant of the family Araliaceae is medicinal carrot,
The composition according to (1). (3) The composition according to (2), wherein the plant of the family Araliaceae is one kind or two or more kinds selected from the group consisting of Panax ginseng, Chixetuni ginseng, and Densi ginseng. (4) Basidiomycetes containing one or more kinds of Basidiomycetes belonging to the family Sarcobidae and roots of plants belonging to the family Araliaceae as active ingredients, wherein the basidiomycetes are Ganoderma lucidum and Pleurotus cornucopiae. The raw material composition of the roots of the Araliaceae plant is 4 to 6: 4 to 6 by weight.
A composition having antitumor activity, which is 4 to 6. (5) The plant of the family Araliaceae is a medicinal carrot,
(4) The composition as described. (6) The composition according to (4), wherein the plant of the family Araliaceae is one kind or two or more kinds selected from the group consisting of Panax ginseng, Ginseng ginseng and Densin ginseng. (7) Ganoderma lucidum and Ganoderma lucidum belonging to the family Basidiomycetes and roots of plants belonging to the family Araliaceae, the raw material composition of the roots of Ganoderma lucidum, Pleurotus cornucopiae and Araliaceae plants, in a weight ratio of 4 to 6: 8 to 12: 2. 4 to 3.6 or 4 to 6: 4 to 6: 4 to 6 so that it is extracted with water or a mixed liquid of water and alcohol, or Ganoderma lucidum, Pleurotus cornucopiae and Araliaceae plants The roots are extracted with water or a mixed liquid of water and alcohol, and finally, the raw material composition of the roots of Ganoderma lucidum, Pleurotus cornucopiae and Araliaceae plants is 4 to 6: 8 to 12: 2.4 by weight ratio.
A method for producing a physiologically active composition, wherein an extract is prepared so as to be 3.6, or 4 to 6: 4 to 6: 4 to 6.

[0006]

BEST MODE FOR CARRYING OUT THE INVENTION The present invention will be described in detail below.
The composition of the present invention is a fruiting body and / or mycelium culture of Ganoderma lucidum and Ganoderma lucidum belonging to the basidiomycete family Sarcobidae, or an extract component obtained from any of these, and a root of an Araliaceae plant or an extract component obtained therefrom. Is contained as an active ingredient.

(Active ingredient derived from Basidiomycetes) At least Ganoderma lucidum and Kawaratake are used as basidiomycetes. Particularly preferably, only Ganoderma lucidum and Pleurotus cornucopiae are used. The taxonomic identification of the basidiomycetes used in the present specification is based on "Primary color Japanese fungus pictorial book" (Nursing Co.) co-authored by Rokuya Imaseki and Tsugio Hongo.

[0008] In particular, Reishi F
Ungus (Ganoderma Lucidum) can be illustrated.
Although this fungus naturally prefers to propagate on trees, it is rare for native fungi. Note that artificial cultivation is also possible. This bacterium has a glossy, wax-like bulky portion and a shaft portion, and the length of the shaft can reach about 15 cm. The fruit body color is red, blue, yellow, white, purple, or black. This fungus grows on stumps and near the base of trees that are weakened by disease, forming white filaments.

[0009] Coriolus Ver.
sicolor can be illustrated. This fungus grows naturally in western Japan, especially in the Shinshu region (especially Nagano prefecture), the Shikoku region, and the Kyushu region. This fungus is naturally a euphilia,
I especially like hardwood. The basidiomycetes may be naturally occurring, artificially cultivated, or cell cultivated, and are not particularly limited. Preferably, it is naturally occurring.

The form of these fungi to be used in the present invention may be fruit bodies and / or cell cultures.
Preferred is a fruiting body. The fruiting body is preferably air-dried at room temperature while avoiding light. Especially for Ganoderma lucidum, it is preferable to use black fruiting bodies that are naturally matured. Moreover, as for Pleurotus cornucopiae, it is preferable that the fruiting body is an autogenous fruiting body collected in summer, and it is more preferable that it is air-dried at room temperature while avoiding light. The fruiting body is
It is available as a dried solid, an alcohol immersion liquid, a paste or an extract.

The composition of the present invention may contain basidiomycetes as an active ingredient. Therefore, in the case of a fruiting body raw material, the fruiting body may be contained as it is as a solid active ingredient in the form of powder, flakes or the like. Further, in the case of a culture, it may be contained as a liquid such as a culture solution containing mycelial cells or a solid such as a dried product of mycelial cells.

Further, the composition of the present invention can contain, as an active ingredient, an extract component obtained by extracting the fruiting body of basidiomycete or its culture with water and / or alcohol.

(Method for Preparing Extraction Component of Basidiomycetes) At the time of extraction, it is preferable to pulverize the fruiting body of basidiomycete into a powder or a strip. More preferably, it is about 7 mm square or less, and more preferably about 4 mm to about 6 m.
It is a m-square strip. Most preferably, it has a strip shape of about 5 mm. In some cases, a strip shape of 0.5 mm to 2 mm square is preferable. When the mycelial cells are used as a raw material, it is preferable to use a dried powder.

When extracting with water, the water to be used is not particularly limited, but it is preferable to heat during the extraction. It is preferably about 80 to 100 ° C., and more preferably
It is about 90 to 95 ° C. The amount of water relative to the extraction raw material is not particularly limited, but is about 5 to about 25 g of dried raw material (more preferably about 10 to about 20 g, further preferably about 12 to 15 g, most preferably about 10 g). On the other hand, 800 ml of water is preferable. The extraction operation is an open-air type container, in particular, glass, enamel,
In addition to ceramics, it is preferable to use a material in which a metal portion is coated or processed with a corrosion resistant coating. The heat extraction operation is not particularly limited, but in the case of the above-mentioned amount of the raw material to the extraction liquid, the extraction liquid is about 60%. When the amount of water with respect to the extraction raw material is 800 ml, the extraction liquid amount is preferably about 500 ml. This extract has a concentration suitable for oral administration as it is. In addition, it is preferable to use a reflux condenser. In this case, from the beginning, the volume of water to be finally obtained may be added to the raw material for heating. For example, it is possible to add 500 ml of water to 10 g of the dry raw material and perform heat extraction with a reflux condenser.

Although the extraction time is not particularly limited, it is preferably at least 1 hour, more preferably 2 hours or more, further preferably 2.5 hours or more. The upper limit is 3 to 4 hours.

The following operation can be mentioned as a typical example of extracting the basidiomycete raw material with water. About 12 g to 15 g of dried basidiomycete raw material (preferably fruiting bodies, preferably in the form of strips) is added to hot water 800
Add ml and maintain the temperature at 90 to 95 ° C., and brew until the remaining amount of the extract is 500 ml. Preferably, the heating adjustment is performed so that the amount becomes 500 ml in about 3 hours. The extract obtained by such an operation becomes a liquid having a concentration suitable for oral administration as it is.

In the case of extraction with alcohol, the alcohol used is preferably drinkable alcohol, considering that it may be drunk as it is. That is, it is preferable to use ethanol. When extraction is performed using alcohol, extraction may be performed only with alcohol, but it is preferable to perform extraction with a mixed solution by mixing with water. Preferably, the alcohol concentration is 50 v / v%
It is below, and more preferably about 35 v / v%. The alcohol-containing extract is not particularly limited, but it is preferable to heat it during extraction. The temperature is preferably 50 to 80 ° C., more preferably 75 ° C. or lower, and further preferably 70 ° C. or lower. Although the extraction time is not particularly limited, it is preferably 10 hours or longer, more preferably 20 hours or longer, and most preferably about 30 hours or longer. The alcohol concentration is preferably about 20 v / v% at the final oral administration. Therefore, when extraction is performed with an alcohol solution having a concentration exceeding 20 v / v%, it is preferable to dilute with water after the extraction so that the concentration becomes 20 v / v%. Further, the amount of the extraction liquid with respect to the extraction raw material is not particularly limited, but about 50
˜250 g, more preferably 100 to 200 g, and even more preferably about 150 g, and 1000 ml of the extract is preferred. The extract obtained by such an operation is
As it is, it becomes a liquid having a concentration suitable for oral administration. It is preferable to use the same container for extraction as in the case of extracting with water only. The extraction operation is preferably carried out using a reflux condenser.

When alcohol is used for extraction, components that cannot be extracted by water alone are extracted. The ethanol-containing extract of basidiomycetes contains triterpenoids,
Nucleosides (adenosine, guanosine) and polysaccharides include hetero-β-glucan, xylo-β-glucan and manno-β-glucan.

The following operation can be mentioned as a typical example of extracting a basidiomycete raw material with a water / alcohol mixed solution. Basidiomycete raw material crushed into pieces (preferably fruiting bodies, preferably pieces) about 120 g to about 150
To v.g, 35 v / v% ethanol solution is added to make 1000 ml, and this solution is maintained at about 70 ° C. and decocted for about 30 hours. Three
After 0 hours, hot water (or water) is added so that the total amount becomes 1000 ml. In addition, it is preferable that the alcohol concentration finally becomes about 20 v / v%.

The various extracts obtained are filtered and the like, if necessary. The extract may be used as it is as an active ingredient. In addition, if necessary, the product may be concentrated and concentrated to obtain the active ingredient. Further, by evaporating the water content, an extraction component as a solid content is also obtained, and further, if necessary, drying or the like is performed to obtain a desired dry extraction component. When two or more types of basidiomycetes are used, the extracted components can be individually extracted or two or more types can be simultaneously extracted. Furthermore, in consideration of the dosage form and dosage form of the present composition, an additive for stabilizing the extract or the extract may be added when the extract is concentrated or dried.

(Active ingredient derived from roots of Araliaceae) The composition of the present invention also contains an extract of roots or roots of Araliaceae as an active ingredient. As a medicinal carrot of the Araliaceae plant, Panax ginseng CA Meye
r), American ginseng (P. quinquefolium L.), Radix Notoginseng (P. quinquefolium L.), Ginseng Takeshibushi (Chixetsu ginseng) (Tamushi ginseng, P. japonicus CAMeyer)
Etc. are included. In the present invention, one kind or two or more kinds of them can be used in combination, but the roots of plants selected from Panax ginseng and related species (hereinafter referred to as Panax ginseng roots) and Chixetu. It is preferable to use plant roots selected from carrots and related species thereof (hereinafter referred to as roots of Chixetus carrot and the like). The roots of these carrots are usually available in the dry state, including the roots of Panax ginseng and Chixetsu ginseng and their related plants.
Alternatively, it can be obtained as an alcohol immersion liquid, a paste, or an extract.

The roots of Araliaceae plants may be so-called plant roots, or may be cultured cells.
In the case of cultured cells, root-derived cultured cells are preferred. In addition, as long as the raw material derived from the root of the plant is contained, a raw material containing a site other than the root of the plant can also be used.

The composition of the present invention may contain roots of Araliaceae plants as active ingredients. Therefore, in the case of a plant raw material, the roots of Araliaceae plants may be contained as they are as solid active ingredients such as powder and flakes. When derived from cultured cells, it may be contained as a liquid such as a culture solution containing the cultured cells or a solid such as a dried cell product.

(Method for preparing root extract component of Araliaceae plant)
Further, the composition of the present invention can contain, as an active ingredient, an extract component obtained by extracting the roots of Araliaceae plants with water and / or alcohol.
When extracting, crush the carrot root of the plant, etc.
It is preferable to make it into a powder form or a strip form. More preferably,
It is in the form of fragments of about 7 mm square or less, more preferably about 4 mm to about 6 mm, and most preferably about 5 mm in the form of strips. In some cases, a strip shape of 0.5 mm to 2 mm square is preferable. When cultured cells are used as a raw material, it is preferable to use a dried powder.

When extracting with water, the water used is not particularly limited, but it is preferable to heat during extraction. The temperature is preferably about 80 to about 100 ° C, more preferably about 90 to about 95 ° C. Also, the amount of water relative to the extraction raw material is not particularly limited, but the raw material is about 1 to about 1
0 g, preferably about 2 to about 10 g, more preferably about 3 to about 8 g per 800 ml of water is preferred. The extraction operation is carried out in an open-air container, in particular made of glass,
In addition to enamel and ceramics, it is preferable to use a material in which a metal portion is coated or processed with a corrosion resistant coating. The heat extraction operation is not particularly limited, but in the case of the above-mentioned amount of the raw material to the extraction liquid, the extraction liquid is about 60%. When the amount of water with respect to the extraction raw material is 800 ml, the extraction liquid amount is preferably about 500 ml. This extract has a concentration suitable for oral administration as it is. In addition, it is preferable to use a reflux condenser. In this case, from the beginning, the volume of water to be finally obtained may be added to the raw material for heating. For example, it is possible to add 500 ml of water to 3 g of the dry raw material and perform heat extraction with a reflux condenser.

The following operation can be mentioned as a typical example of extracting the roots of the plant Araliaceae plant with water. Dry root of carrot crushed into small pieces About 3g ~ 6g
On the other hand, 800 ml of hot water is added and brewed so that the remaining amount of the extract is 500 ml in the above heating range. Preferably, the temperature of the extract is maintained at 90 to 95 ° C., and the temperature is adjusted to 500 ml in about 3 hours. In particular, it is preferable to carry out the same amount of carrot with 500 ml of water using a reflux condenser. The extract obtained by such an operation becomes a liquid having a concentration suitable for oral administration as it is.

In the case of extraction with alcohol, it is preferable that the alcohol used is a drinkable alcohol, considering that it may be drunk as it is. That is, it is preferable to use ethanol. When extraction is performed using alcohol, extraction may be performed only with alcohol, but it is preferable to perform extraction with a mixed solution by mixing with water. Preferably, the alcohol concentration is 50 v / v%
It is below, and more preferably about 35 v / v%. The alcohol-containing extract is not particularly limited, but it is preferable to heat it during extraction. The temperature is preferably 50 to 80 ° C., more preferably 75 ° C. or lower, and further preferably 70 ° C. or lower. Although the extraction time is not particularly limited, it is preferably 10 hours or longer, more preferably 20 hours or longer, and most preferably about 30 hours or longer. The alcohol concentration is preferably about 20 v / v% at the final oral administration. For example, when extraction is performed with an alcohol solution having a concentration exceeding 20 v / v%, it is preferable to dilute with water after the extraction so that the concentration becomes 20 v / v%. The amount of the extraction liquid for the extraction raw material (carrot root) is also not particularly limited, but it is preferable to use 1000 ml of the extraction liquid for 30 g of the raw material. It is preferable to use the same container for extraction as in the case of extracting with water only. The extraction operation is preferably carried out using a reflux condenser.

The following operation can be mentioned as a typical example for extracting the roots of Araliaceae plants with a water / alcohol mixture. Approximately 30 dried roots of Araliaceae plants crushed into small pieces
A 35 v / v% ethanol solution is added to g to make 1000 ml, and this liquid is maintained at about 70 ° C. and decocted for about 30 hours. Three
After 0 hours, hot water (or water) is added so that the total amount becomes 1000 ml. In addition, it is preferable that the alcohol concentration finally becomes about 20 v / v%. The extract obtained by such an operation becomes a liquid having a concentration suitable for oral administration as it is.

The obtained extract is filtered or the like, if necessary. The extract may be used as it is as an active ingredient. If necessary, it may be concentrated to give a concentrate, which may be used as an active ingredient. Further, by evaporating the water content, an extraction component as a solid content is also obtained, and further, if necessary, drying or the like is performed to obtain a desired dry extraction component. The roots of Araliaceae are not limited to one type, but 2
More than one kind can be used, and in that case, the extract may be prepared for each kind, or the extract may be prepared in any combination of two or more kinds. Furthermore, in consideration of the dosage form and dosage form of the present composition, an additive for stabilizing the extract or the extract may be added when the extract is concentrated or dried.

The basidiomycete raw material and the root material of the Araliaceae plant can be extracted individually, or a raw material composition containing both can be extracted with the same extraction medium and extracted simultaneously. Preferably, they are extracted simultaneously. Also in the case of simultaneous extraction, the extraction conditions for the basidiomycete raw material or the root raw material of Araliaceae plants described above can be adopted. The composition of the present invention can also be obtained by mixing an active ingredient extracted from a basidiomycete raw material and a root raw material of Araliaceae plant with water and an active ingredient extracted with a water / alcohol (ethanol) mixture. In this case, simultaneous extraction may or may not be performed, but simultaneous extraction is preferable in each of water extraction and water / alcohol extraction.

A typical example of simultaneous extraction will be shown below. 7
Approximately 5 g to about 6 g of Ganoderma lucidum fruiting bodies crushed into strips of less than mm square, preferably about 5 mm, similarly about 6 g to about 10 g of fruiting bodies of Pleurotus ostreatus crushed into strips, roots of Araliaceae plants ( Preferably ginseng root) 3 g
To ˜6 g, 800 ml of hot water is added and brewed so that the remaining amount of the extract is 500 ml in the above heating range.
Preferably, the heating adjustment is performed so that the amount becomes 500 ml in about 3 hours. The extract obtained by such an operation is a liquid having a concentration suitable for oral administration as it is. In addition, a raw material mixture having the same form and composition (however, 100 g of Ganoderma lucidum fruiting body, 50 g of Kawaratake fruiting body, and 30 g of root of Araliaceae plant) were mixed with 35 v / v% ethanol solution to make 1000 ml, and this solution was used. Decoction is maintained at about 70 ° C for about 30 hours. After 30 hours, the total amount is 1000m
Hot water (or water) is added to obtain l. In addition, it is preferable that the alcohol concentration finally becomes about 20 v / v%. The extract obtained by such an operation is a liquid having a concentration suitable for oral administration as it is. Since these two kinds of extract liquids each contain the raw material-derived component of the present invention, they can be provided as the present composition independently, but preferably, only the water extract liquid or the water extract liquid is used. Is used relatively often. On the other hand, the two extracts can be mixed in advance to form the present composition as one preparation, or two preparations that are mixed at the time of administration, or both separately but simultaneously administered. It is provided as a planned set of formulations.

Further, the composition of the present invention comprises an extract component of basidiomycetes with water and / or alcohol, an extract component of roots of Araliaceae plants with water and / or alcohol, an active component derived from basidiomycete and an Araliaceae family. It can be appropriately combined so as to include the active ingredient derived from the root of the plant. For example, a water extract component of basidiomycete and an alcohol extract component of roots of Araliaceae plants can be combined.
As described above, in the final administration stage, if the composition contains an active ingredient derived from Basidiomycetes and an active ingredient derived from the roots of Araliaceae plants, only in the case of preparing the composition from only one type of preparation. Alternatively, the present composition can be prepared by combining two or more kinds of preparations.

In the present invention, it is sufficient that both the basidiomycete-derived active ingredient and the root-derived active ingredient of the Araliaceae plant are contained, and as long as these active ingredients are contained, the active ingredient is in the form of an extract. Also, it may be in the form of raw materials such as fruiting bodies and roots, or pulverized products thereof. Further, in the case of a composition containing an active ingredient by containing not the extract but the raw material itself, it may be administered by itself such as edible, but it may be used to obtain an antitumor extract. It can also be provided as a composition for extraction. In the case of a composition containing the active ingredient in the form of an extract, it is more effectively absorbed,
Further, it is expected that the substantial dose (calculated as a raw material) can be reduced. Therefore, the composition of the present invention is preferably a composition containing an active ingredient as an extract fraction. The active ingredient is contained as the extracted fraction and / or the raw material itself, and is contained only in one of the forms, and is selected as necessary.

The composition of the present invention is included in the composition of the present invention as long as it is formed in the following weight ratio of raw material compositions (a ratio in terms of dry weight). The preferred first ratio of active ingredients corresponds to the weight (dry weight) ratio of the extract material. The raw material composition ratio of basidiomycetes and roots of Araliaceae plants is preferably 4 to 6: 8 to 12: 2.4 to 3.6 in terms of weight ratio of Ganoderma lucidum: Kawaratake: Roots of Araliaceae plants. When the weight ratio is within such a range, preferable antitumor activity is exhibited. More preferably, 4.5-5.5: 9-1
1: 2.7 to 3.3, more preferably about 5:
About 10: about 3.

[0035] A preferred second ratio is a weight ratio (dry) of Ganoderma lucidum: Kawaratake: Araliaceae roots.
And 4.8-7.2: 4.8-7.2: 4.8-7.2.
Is preferred. If the weight ratio is in the range,
Shows good antitumor activity. More preferably from 5.4
6.6: 5.4 to 6.6: 5.4 to 6.6, and more preferably about 6: about 6: about 6. ~ 12: 2.
It is preferably 4 to 3.6. More preferably,
It is 4.5-5.5: 9-11: 2.7-3.3, more preferably about 5: about 10: about 3.

A preferred third ratio in the composition of the present invention is that the starting material composition of Ganoderma lucidum: Kawaratake: Araliaceae root is about 28 to about 33: about 56 to about 33: about 17 to about 17 by weight. It is preferably in the range of about 33. In this range, the antitumor activity is higher than that of the raw material composition at a weight ratio of about 56: about 28: about 17.

The composition of the present invention may contain only the basidiomycete extract component and the Araliaceae root extract component, but it does not prevent containing other active ingredients. Other active ingredients may be included in the composition of the present invention as long as they do not interfere with the synergistic action of the above-mentioned two kinds of extraction ingredients.

In any of the above-mentioned formulations,
Preferably, Panax ginseng or Ginseng ginseng is used as the Araliaceae plant. Particularly preferably, Chixetun ginseng is used. In these examples, preferred compositions can be obtained even if ginseng is replaced with ginseng.

In order to produce a composition having a mixing ratio (weight ratio) of Ganoderma lucidum fruiting body: Kawaratake fruiting body: Chixetuni ginseng (root) in the raw material, which is a preferred composition of the present invention, is 1: 1: 1. , For example, Ganoderma lucidum fruit body 6
g, Kawaratake fruiting body 6 g, and Chixetuni ginseng 6 g are respectively collected, mixed and pulverized into pieces of about 5 mm square, and 500 ml of distilled water is added to the pulverized product,
It is boiled for 3 hours using a reflux condenser and filtered to obtain a composition (stock solution) used in the present invention.

Each stock solution or composition stock solution thus prepared can be used as the composition of the present invention by appropriately preparing or diluting it. In the case of the stock solution of the above composition, the dilution ratio is set as necessary, but it is diluted in the range of about 2 to 300 times.
It is preferably 2 to 20 times, more preferably 4 times to
Used at a 16-fold dilution factor. Most preferably, it is about 8 times. It is presumed that the concentration or amount of the composition in the present administration has some effect on the healing effect. The dilution is not particularly limited, but it is preferable to use water as in the extraction. Further, the solvent is removed from the extract containing these various stock solutions or the composition stock solution by an appropriate method, or the solid is dried and solidified (solid, powder) to obtain the above-mentioned extracted component, which is used as a composition. You can also

The composition of the present invention has antitumor activity, especially against leukemia, lymphoma, cervical cancer, lung cancer, ovarian cancer, breast cancer (metastasis), skin cancer (metastasis), breast cancer, skin cancer. Have activity. Examples of leukemia include erythroblastic leukosis. Therefore, the composition of the present invention can be used as an antitumor agent in a wide range of mammals including humans, cows, horses, dogs, cats and the like. Particularly, it is preferable as an antitumor agent which is targeted for leukemia or lymphoma. Further, the composition of the present invention, an immunostimulatory composition, or obesity, myocardial infarction,
It is also a composition effective for arteriosclerosis and the like. The composition of the present invention has been found to have good antitumor activity by using specific basidiomycetes and roots of Araliaceae plants as active ingredients and setting the weight ratio of the raw materials thereof within a predetermined range. It has already been confirmed that the composition of the present invention has an unexpectedly high antitumor activity as compared with the antitumor activity of each of them alone.

Since the composition of the present invention has antitumor activity, it can also be used prophylactically by administering it to a patient at risk of tumor development or a patient at risk of recurrence. Therefore, according to the present invention, a prophylactic pharmaceutical composition for the purpose of preventing recurrence of tumors or prevention of shipping is also provided.

In addition, the composition of the present invention is characterized by having no side effect and reducing or eliminating the side effect of other drugs. In particular, when it is used as an antitumor agent, it has various effects such as tumor healing or degeneration, pain reduction, appetite improvement, and good sleep. When used as a hypoglycemic agent, in addition to lowering blood sugar levels, it also relieves body pain, especially headache, numbness in the extremities is greatly improved, appetite is increased, vision is restored, stress is reduced, and comfort is reduced. It has the effect of good sleep.

The basidiomycete or an extract thereof and the roots of Araliaceae plants or an extract thereof, which are the active ingredients in the present invention, are mixed with a pharmaceutically acceptable carrier or additive to prepare a drug in a form suitable for administration. Used as a composition. The form of the composition is not particularly limited, but a liquid, syrup, suspension, powder, granule, tablet, pill, capsule,
It can be formulated into emulsions, troches, chewable suppositories, suppositories, eye drops, injections, aerosols, elixirs and the like. It is also preferable to add water at the time of use to prepare a solid (powder) agent capable of recovering the liquid material.

Further, the composition of the present invention can be administered orally or parenterally. It is preferably administered orally. The general doses for oral administration are shown below.
The dose is appropriately set depending on the symptoms, the physical strength of the individual, and the like. That is, as a general dose (ordinary dose), for example, basidiomycete (total weight of raw materials of Ganoderma lucidum and Pleurotus cornucopiae) is 200 mg / kg of body weight or more.
2 g and 100 mg to 1 g of the roots of Araliaceae plant roots are taken as a daily dose, and the dose is administered once to three times a day. In particular, when used as an antitumor agent, basidiomycetes and extract components from 0.27 g of roots of Araliaceae / kg
Weight / day is preferred. More preferably, 0.18 g of basidiomycete / kg body weight / day and 0.09 g of roots of Araliaceae plant / kg body weight / day.

The composition of the present invention has a very low toxicity,
Since it does not cause serious side effects, it can be safely administered even at a high dose depending on the symptoms. The preferred dosage form for oral administration is a solution or syrup.
Further, the medium is preferably water.

While the composition of the present invention has the above-mentioned antitumor activity, it has little or no side effects. Furthermore, since it also has a health-promoting effect, the present composition is not only a therapeutic or prophylactic pharmaceutical composition merely for the purpose of antitumor or tumor prevention, but also a health-promoting composition. Alternatively, it can be used as a nutritional supplement composition. That is, by ingesting the composition of the present invention by eating or drinking, or by tube feeding, it is possible to provide a healthy life and an improvement in quality of life. Although the intake amount is not particularly limited, it is preferably lower than the above-mentioned therapeutic or prophylactic dose. It can be set to approximately several fractions to one tenth.

When the composition of the present invention is used for promoting health or supplementing nutrition, it may be in a liquid form or a solid form, and may be appropriately formulated into tablets, capsules, chewable preparations and the like. It is also preferable to add water at the time of use to prepare a solid (powder) agent capable of recovering the liquid material. Furthermore, it may be in a form that can be taken by tube feeding or via the intestinal tract. Selection of such a form and formulation according to the selection are well known to those skilled in the art.

[0049]

INDUSTRIAL APPLICABILITY According to the present invention, a composition having excellent physiological activity, especially antitumor activity is provided. This composition is not only effective for the treatment of tumors (cancers) but also can be used prophylactically by being administered to patients at risk of developing tumors because it has extremely low or no side effects. Further, it is effective not only as a therapeutic or preventive agent but also as a health promoting composition or a nutritional supplementing composition.

[0050]

[Example] (Example 1)Preparation of various composition stock solutions and diluents The present invention will be described below with reference to specific examples.
Ming is interpreted in any limited way by these examples.
Not of. (Test 1: antitumor activity) (Preparation of stock solutions of various compositions) Ganoderma lucidum (Ga
The fruiting body of noderma Lucidum, Kawaritake (Coriolous Ve)
rsicolor) fruiting body and Chixetun ginseng (P. japon
icus C. A. Meyer) was used. Ganoderma lucidum is summer
Mature black pups collected in a forest in northern China during the growing season
The entity was air-dried at room temperature while avoiding light. River
Rattake is a natural fruit body collected in Japan during the summer season at room temperature.
I used air-dried ones to avoid light. Tingling
Gin illuminates the roots of mature bodies collected in Japan in summer at room temperature.
Air-dried ones were used while avoiding.

Three types of stock solutions were prepared. Each of the composition stock solutions is made from Ganoderma lucidum, Pleurotus cornucopiae, and Ginseng radix, but the compounding ratio (dry weight ratio) is different. [Type of composition undiluted solution and raw material composition] Composition undiluted solution RKG1 Ganoderma lucidum 1.0 g, Pleurotus cornucopiae 0.5 g, Chixoutine ginseng 0.3 g Composition undiluted solution RKG2 Ganoderma lucidum 0.5 g, Pleurotus cornucopiae 1.0 g, Chixetuni ginseng 0.3 g Undiluted composition RKG3 0.6 g of Ganoderma lucidum, 0.6 g of Pleurotus cornucopiae, 0.6 g of ginseng ginseng

In each case, each raw material crushed into a piece of about 5 mm square was weighed based on each raw material composition to prepare a mixture of these three kinds. 50 ml of water was added to this mixture, and the mixture was boiled for 3 hours under reflux using a reflux condenser. Then, filter,
Three composition stock solutions were obtained. It should be noted that 1 ml of each composition stock solution contains extracted components corresponding to the weights of the following raw materials.

Composition stock solution RKG1 Ganoderma Lucidum 0.02g Kawaratake 0.01g Chixetun ginseng 0.006g Composition stock solution RKG2 Ganoderma lucidum 0.01 g Kawaratake 0.02g Chixetun ginseng 0.006g Composition stock solution RKG3 Ganoderma lucidum 0.012 g Kawaratake 0.012g Chixetun ginseng 0.012g

Each of these composition stock solutions was further diluted with water to 1 /
Diluted to 8 to prepare diluted solutions RKG1, RKG2, and RKG3.

(Test Example 2)Confirmation of antitumor activity B6D2F1 ((C57B1 / 6JxDBA /
2) F1) males were obtained from the RAMS "Krjukovo" farm.
On day 0, these mice were treated with 5 × 10 5 of T lymphoma EL-4.^Four
Ascites cells were inoculated intraperitoneally (ip). this
For each of these mice,
In the cycle shown below, 0.1 ml / 1 time, 3 times a day
Orally administered, RKG1, RKG1 (1: 8), RK
G2, RKG2 (1: 8), RKG3, RKG3 (1:
Each group of 8) (9 or 10 mice) was formed. From day 1.3 to day 7 2. From 10th to 14th day 3. From the 17th to the 21st day 4. From 24th day to 28th day 5. Day 31 and Day 32

Furthermore, an untreated group (10 animals) which was not treated at all, and cyclophosphamide (CY) 100 mg / k
gip was administered on day 1 in the CY-100 group (10 animals)
And cyclophosphamide (CY) 100 mg / kg ip was administered to the mice on the first day, and each stock solution was further administered according to the above cycle. CY + RKG1, CY + RKG2, CY
+ RKG3 group (10 animals each) and non-inoculated (healthy) group (10
And) respectively. In each group, the observation period was from day 0 to day 90. The rate of weight gain on a specific day, the average number of days to survive and the range of days to survive, the number of days to prolong life (%) relative to the untreated group, and the presence or absence of cure were evaluated. The results are shown in Table 1 and FIGS.

[0057]

[Table 1] In the table, ΔBW _{0 → 13} (%) and ΔBW _{0 → 18} (%) are
Each is represented by the weight gain rate (%) expressed as the ratio of the weight gain on Day 13 and Day 18 to the weight on Day 0, and the survival rate was calculated from the average number of days to survive in each treatment group. The number of days obtained by subtracting the average number of days to live in the treated group is divided by the average number of days to live in the untreated group, and is expressed as a percentage (%).
Further, in the table, a, b, c, and d respectively have the following meanings. a: Significantly different from initial body weight, b: Significantly different from body weight of untreated mice in the same period, c: CY-100
Significantly different from group of mice, d: Significantly different from body weight of corresponding stock solution RKG group of mice.

(Life-prolonging Effect of Composition Stock Solution and Diluted Solution) With respect to the three composition stock solutions, the survival rate of mice was
It worked at about the same level. That is, RKG1 group, RKG
2 group, RKG3 group were 4%, 4%, 4%, respectively. Therefore, it was found that none of these stock solutions of composition were harmful to the degree of identification. Group using 8 times dilution, RKG1 (1: 8) group, RKG2 (1: 8)
In the RKG3 (1: 8) group, the RKG1 (1: 8) group, and the RKG3 (1: 8) group, there did not seem to be a substantial effect on the survival rate of mice (life extension rate: -4% and 4%, respectively)). However, RKG2
In the (1: 8) group, the life extension rate was 12%, and the effect on the life extension rate was recognized.

FIG. 1 shows the RKG1 (1: 8) group, RKG.
A graph showing the survival rate of mice in each of the 2 (1: 8) group and the RKG3 (1: 8) group on the vertical axis and the number of observation days on the horizontal axis is shown. From FIG. 1, RKG2 (1: 8) diluted 8 times.
Only the group had significant overall survival of mice (ρ = 0.021, W
ilkoxon's U standard). On the contrary,
Neither the RKG1 (1: 8) nor RKG3 (1: 8) group appeared to have a reliable effect on the overall survival of mice with ascites lymphoma EL-4.

Effect of Composition on Increased Ascites A suitable parameter for assessing the direct anti-leukemic effect in a given model is the measurement of weight change by day 13 and 18 of the experiment. The weight gain of the animals during this period is explained by the accumulation of ascites (see Table 1, Figures 2 and 3). The RKG1 stock solution composition and diluent delayed ascites accumulation by day 13, with the stock solution being more delayed than the diluent. In addition, in the case of co-administration of CY, a very good inhibitory effect was exhibited (the same as CY-100 or slightly suppressed). Both the RKG2 stock solution composition and the diluted solution delayed the accumulation of ascites, and the diluted solution was delayed more than the stock solution. In addition, when co-administered with CY, a good inhibitory effect was exhibited (the same as CY-100 or slightly suppressed). The RKG3 stock solution composition and the diluent delayed the accumulation of ascites by day 13, and the stock solution was delayed better than the diluent. In addition, when co-administered with CY, a very good inhibitory effect was exhibited (the same as CY-100 or slightly suppressed).

From the above, in each of these composition stock solutions, it is expected that the diluted solution of the RKG2 composition will most preferably have high antitumor activity.
It is speculated that it may be the G3 stock solution or the diluted solution, and then the RKG1 stock solution or the diluted solution. The RKG1 stock solution is
It has already been published as Japanese Patent Laid-Open No. 11-292726. The composition of the present invention, RKG2 and RKG3,
It was found to have higher antitumor activity than RKG1.

[Brief description of drawings]

FIG. 1 shows RKG1 (1: 8) group and RKG in test examples.
FIG. 3 is a graph showing the survival rate of mice in each of the 2 (1: 8) group and the RKG3 (1: 8) group on the vertical axis and the number of observation days on the horizontal axis.

FIG. 2 is a graph showing an increase in ascites on day 13 of each group.

FIG. 3 is a graph showing an increase in ascites on day 18 in each group.

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Claims (7)

[Claims] 1. A basidiomycete containing one or more kinds of basidiomycetes belonging to the family Sarcophaga family and roots of a plant belonging to the family Araliaceae as active ingredients, wherein the basidiomycetes are Ganoderma lucidum and Pleurotus cornucopiae. The raw material composition of the agaricus and the roots of the Araliaceae plants is 4 to 6: 8 to 12: 2.4 by weight.
A bioactive composition having antitumor activity, which is about 3.6. 2. The composition according to claim 1, wherein the plant of the family Araliaceae is medicinal carrot. 3. The plant of the family Araliaceae is ginseng,
The composition according to claim 1, which is one kind or two or more kinds selected from the group consisting of Chixetun ginseng and Densin ginseng. 4. A basidiomycete containing one or more kinds of basidiomycetes belonging to the family Sarcobidae and roots of plants belonging to the family Araliaceae as active ingredients, wherein the basidiomycetes are Ganoderma lucidum and Pleurotus cornucopiae. A physiologically active composition having antitumor activity, wherein the raw material composition of kawaratake and the roots of the Araliaceae plants is 4 to 6: 4 to 6: 4 to 6 by weight. 5. The composition according to claim 4, wherein the plant of the family Araliaceae is medicinal carrot. 6. The plant of the family Araliaceae is ginseng,
The composition according to claim 4, which is one kind or two or more kinds selected from the group consisting of Chixetun ginseng and Densin ginseng. 7. A raw material composition of the roots of Ganoderma lucidum, Pleurotus cornucopiae, and Araliaceae plants, the roots of Ganoderma lucidum, Pleurotus mackerel, and Araliaceae plants belonging to the family Basidiomycetes, Rhizophoraceae, and the roots of plants belonging to the family Araliaceae. : 2.4-3.
6, or 4-6: 4-6: 4-6,
Extract with water or a mixture of water and alcohol,
Alternatively, Ganoderma lucidum, Pleurotus cornucopiae and roots of Araliaceae,
It is extracted with water or a mixture of water and alcohol, and finally the raw material composition of Ganoderma lucidum, Agaricus and roots of Araliaceae plants is 4 to 6: 8 to 12: 2.4 to 3.
6, or the manufacturing method of the physiologically active composition which mix | blends an extract so that it may become 6-6: 4-6: 4-6.