JPH11100325A - Composition - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a composition with slight side effects, and useful as e.g. a tonic medicine exhibiting significant efficacy in health maintenance/promotion and the treatment/prevention of diseases, an agent for sensitivity-related diseases, by including a processed product of a plant belonging to the genus Pfaffia and a flavonoid. SOLUTION: This composition is obtained by including (A) 21 processed product of a plant belonging to the genus Pfaffia such as Pfaffia glomerata and (B) a flavonoid such as vitamin P (e.g. enzyme-treated hesperidin, enzyme- treated rutin) in a weight ratio B to A of 0.001-1 on a solid basis; wherein the component A is e. g. a water extract derived from the roots of the above- mentioned plant. This composition is also useful as an immunopotentiator, antiallergic agent, neurotropic agent and/or tonic agent. Preferable usage and dose of this composition are as follows: about 1 mg to 1 g singly, one to four times a day or one to five times a week, for a period of one day to one year, orally administered, or parenterally administered (intracutaneously, subcutaneously, intramuscularly, or intravenously), per adult, in terms of the total amount of the components A and B on a solid basis.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a novel composition,
More specifically, the present invention relates to a novel composition comprising a processed product of a plant belonging to the genus Paffia and a flavonoid.

[0002]

2. Description of the Prior Art The breakthroughs in Western medicine have made it relatively easy to treat many of the diseases affecting humanity. On the other hand, however, the treatments by Western medicine may have adverse effects or serious side effects, and cannot always be said to exert the intended effects. In combination with the recent trend toward health, there is a great expectation for the establishment of a composition that does not adversely affect the human body even when used regularly, and that is useful for maintaining and promoting health and treating and preventing diseases. ing. In order to meet such demands, so-called folk remedies, which have been used by humans based on experience since ancient times, have attracted attention again in recent years. However, folk remedies have a problem in that their efficacy is generally not significant.

[0003] Isolation of an active ingredient from folk remedies and removal of components other than the active ingredient are considered to be effective measures to solve such problems. However, the efficacy of folk remedies is generally not exerted by only a limited number of specific ingredients, and therefore, in most cases, is as prominent as expected even if the specific ingredients that are considered to be active ingredients are isolated. The fact is that it does not show any medicinal effects.

[0004]

SUMMARY OF THE INVENTION In view of such circumstances, an object of the present invention is to provide a composition having low side effects and exerting a remarkable effect on maintenance / promotion of health and treatment / prevention of disease. .

[0005]

Means for Solving the Problems The present inventors have focused on folk remedies which have been used in various parts of the world since ancient times, and plants which have experienced eating since ancient times. I searched extensively from the world. As a result, when a composition is obtained by adding a flavonoid to a plant belonging to the genus Pfaffia, which grows natively in South America and has been used as a folk remedy for a long time in this region, compared to a general folk remedy, It has been found that they show remarkable immunopotentiating and antiallergic effects. Further, the composition has extremely low toxicity, and the bitterness and harshness inherent to paffia are reduced, so that it is extremely easy to take orally.
The present invention has been completed after confirming that it is useful for prevention.

[0006] That is, the present invention solves the above-mentioned problems with a processed product of a plant belonging to the genus Paffia and a composition comprising a flavonoid.

[0007]

BEST MODE FOR CARRYING OUT THE INVENTION The composition of the present invention comprises a processed product of a plant belonging to the genus Paffia (hereinafter sometimes simply referred to as “Paffia”) and a flavonoid. The processed product of Pafia used in the present invention includes all processed products obtained by physically and / or chemically treating plants belonging to the genus Paphia, and the raw materials and production methods are not limited. Examples of plants belonging to the genus Pafia include, for example, Paffia glomerata
ta), Paffia Iresinoides (Pfaffia)
iresinoides), Paffia Jubata (P
faffia jubata, Paffia paniculata, Paffia pulverrenta (Paffia pulverrenta)
ulenta) and paffia spicata (Pfaff)
ia spicata) and the like. The processed product by physical and / or chemical treatment is, for example,
Mention may be made of chopped, crushed, ground, crushed, pressed, fermented and / or extracted products. The processed product usually comprises ecdysterone and / or a derivative thereof such as rubosterone and ptosterosterone.

The method for producing a processed product of paffia used in the present invention will be described. First, as a raw material, one or more selected from the above-mentioned plants belonging to the genus Paphia, or a breeding of these by a conventional method is obtained. Resulting mutants. Such a plant may be a plant such as a natural plant or a cultivated plant, or may be a culture obtained by tissue culture, callus culture, cell culture, or the like. When a plant is used as a raw material, one or more specific ones selected from roots, stems, leaves, corolla, petals, pollen, stamens, pistils, seeds, endosperm, root hair, etc., even in the whole plant, Any part, such as an organ, separated from the whole plant can be advantageously used.
Further, the raw material may be fresh, that is, may contain water or may be dried. In particular, dried roots of Pafia gromelata can be advantageously used in the present invention.

A processed product of paffia used in the present invention can be obtained by subjecting the above-mentioned raw materials to physical and / or chemical treatments generally used in the food industry, the pharmaceutical industry and the like. For example, normal, shredded,
By appropriately combining processes such as crushing, grinding, crushing, squeezing, fermentation, and extraction, and further processes such as filtration, concentration, and drying, the shredded material, crushed material, Crushed, crushed, pressed, fermented, and extractables can be obtained.

[0010] The method for producing a paffia extract as a processed product of paffia used in the present invention will be described in more detail. Usually, the above-mentioned raw material is subjected to appropriate treatment such as shredding, grinding and crushing. Thereafter, a normal extraction treatment is performed using an appropriate solvent. As the extraction solvent, water, a water-soluble organic solvent other than water, a water-insoluble organic solvent, and the like can be used as appropriate, and, particularly, water, a water-soluble organic solvent, or an aqueous solution of the organic solvent can be used. Use of as an extraction solvent is useful in the practice of the present invention. Examples of the water-soluble organic solvent include ethanol, methanol, propanol, 2-propanol, acetone and the like. When an aqueous solution of these organic solvents is used as the extraction solvent, the concentration of the organic solvent is not limited, but an aqueous solution containing 50% or less by volume of the organic solvent is useful for practicing the present invention. The extraction solvent is adjusted to the desired pH with an appropriate buffer etc.
It is optional to keep H. The above-mentioned extraction solvent is added to the above-mentioned raw material in an appropriate amount, usually preferably 0.1 to 30 times by weight, and, if necessary, is subjected to a stirring treatment or a heat treatment to perform extraction. The liquid portion and the residue are separated by an appropriate method such as filtration, centrifugation, decantation, and the like, and the liquid portion is collected, whereby the extract of paffia used in the present invention can be obtained. Optionally, the residue is repeatedly subjected to the same extraction treatment, and the collected liquid portions are combined to obtain an extract. When the raw material and the residue are subjected to two or more extraction treatments, the extract of the paffia used in the present invention can also be obtained by collecting only the desired liquid portions using different extraction solvents or by combining them. Can be obtained.

[0011] The extract may be further subjected to an appropriate purification treatment and used as a processed product of paffia. The extract usually contains secondary metabolites such as alkaloids, terpenoids, steroids, phenols, pigments, and sugars, proteins, amino acids, nucleic acids, peptides, lipids, and the like. When any one of them is applied, one or more appropriate components selected from these are purified. Depending on the type of the target component, purification means, for example, filtration, concentration,
Appropriate methods include centrifugation, crystallization, solvent fractionation, fractional precipitation, dialysis, hydrophobic chromatography, reverse phase chromatography, adsorption chromatography, affinity chromatography, gel filtration chromatography and / or ion exchange chromatography. To be elected.

[0012] The processed product of paffia obtained as described above can be advantageously used in the present invention in the form as obtained, but it can be further subjected to treatments such as concentration and drying. Liquid, solid, powder, paste, semi-solid, emulsion, suspension, etc. in an appropriate form, such as by adding and mixing appropriate physiologically acceptable components as described in detail below. Use is optional. For the concentration and drying, any method commonly used in ordinary food industry, pharmaceutical industry, etc., for example, vacuum concentration, precision membrane concentration, reverse osmosis membrane concentration, ultrafiltration concentration, vacuum drying, freeze drying, spray drying, etc. It can be applied advantageously.

As described above, the processed product of paffia used in the present invention generally contains ecdysterone in a solid content of 0.1%.
To 10% (w / w). In addition, the processed product may include an ecdysterone derivative such as rubrosterone or ptosterosterone. Ecdysterone and / or a derivative thereof in the processed product can be detected by, for example, high performance liquid chromatography using reverse phase chromatography. The solids content of the processed product can be determined, for example, by referring to the “13th Revised Japanese Pharmacopoeia”
(1996), p. 34, and the 13th Revised Japanese Pharmacopoeia (1)
996), and the water content can be calculated by the Karl Fischer method described on pages 51 to 55.

The flavonoids used in the present invention include hesperetin, naringenin, eriodictyol, citronetin, hesperidin, naringin, eriodictin,
In addition to general flavonoids such as flavanones such as citronin, flavonols such as quercetin, myricetin, rutin and myricitrine, flavones such as baicalein, apigenin, baicalin and apiin, isoflavones such as genistein and genistin, and more. And enzyme-treated products obtained by allowing a hydrolase, a glycosyltransferase, or the like to act on a flavonoid as described above. The origin and origin of these flavonoids are not limited. For example, even those obtained from natural sources such as citrus plants,
For example, it may be obtained by chemical synthesis.

In the present invention, any of the above flavonoids can be advantageously used.
Hesperidin, rutin, naringin, eriodictin,
Flavonoids known as vitamin P, such as hesperetin, quercetin, naringenin, eriodictyol, enzyme-treated hesperidin, enzyme-treated rutin, enzyme-treated naringin, and enzyme-treated eriodictin, are advantageously used in the present invention. Among the enzyme-treated products mentioned here, enzyme-treated products obtained by reacting glycosyltransferases are usually flavonoids, monosaccharides such as glucose, fructose and galactose, and furthermore, among these monosaccharides, It is obtained by transferring oligosaccharides or polysaccharides composed of one or more of the above. It has the inherent properties of flavonoids, and its solubility in water is higher than that without enzyme treatment. And the stability to light is also improved, which is useful in practicing the present invention.

The method for preparing such an enzyme-treated product is not limited.
For example, according to the action of an enzyme such as cyclomaltodextrin glucanotransferase, α-glucosidase, β-glucosidase, β-fructofuranosidase, β-galactosidase, such an enzyme-treated product can be obtained. That is, depending on the enzyme used, one or two or more selected from the above flavonoids and one or two or more selected from appropriate saccharides are mixed with an appropriate solvent such as an aqueous solution of water or an organic solvent. After adjusting the pH to a desired value as needed, any of the above-mentioned enzymes may be added, and the mixture may be reacted at a desired temperature. The saccharide, pH, and temperature used for the reaction are selected according to the properties of the enzyme used, that is, substrate specificity, optimal pH, pH stability, optimal temperature, temperature stability, and the like. The properties of these enzymes are described in, for example, "Enzyme Handbook" (1982) published by Asakura Shoten. Japanese Patent Application Laid-Open Nos. 3-7593, 3-115292, 4-136 by the same applicant.
No. 91, JP-A-4-312597 and JP-A-5-32690 describe various methods of preparing these enzyme-treated products using cyclomaltodextrin-glucanotransferase. In addition, it is also advantageous to use a commercially available product such as enzyme-treated rutin or enzyme-treated hesperidin (also called “glycosyltransferred hesperidin” or “glycosyltransferred vitamin P”) manufactured by Toyo Seikado as such an enzyme-treated product. can do.

The composition of the present invention may further comprise a processed product of a caffeine-containing plant and / or a processed product of an indian-containing plant. The processed product of a caffeine-containing plant used in the present invention includes all processed products obtained by physically and / or chemically treating a plant or a plant containing caffeine in cells, and the raw material and production method are not limited. . Examples of caffeine-containing plants include, for example, genus Paulinia and Coffea
Genus, Tea (Sinensis) genus or Kola (C
Plants belonging to the genus ola) can be mentioned. Such a processed plant usually comprises caffeine and / or a derivative thereof. The processed product of an indicane-containing plant used in the present invention includes all processed products obtained by physically and / or chemically treating a plant containing indica in a plant or cell, and the raw material and production method are not limited. . As an indica containing plant, for example, Tate (Perci)
caria) or Indigofer
a) Plants belonging to the genus can be mentioned. Such processed plant products may contain indian and / or its derivatives.

The method for producing a processed product of a caffeine-containing plant and an indicane-containing plant used in the present invention will be described. First, as a raw material, one or more selected from the above-mentioned plants, and these can be prepared by a conventional method. Mutants obtained by breeding can be mentioned. Such a plant may be a plant such as a natural plant or a cultivated plant, or may be a culture obtained by tissue culture, callus culture, cell culture, or the like. When a plant is used as a raw material, one or more specific ones selected from roots, stems, leaves, corolla, petals, pollen, stamens, pistils, seeds, endosperm, root hair, etc., even in the whole plant, Any part, such as an organ, separated from the whole plant can be advantageously used. Also, the raw material is fresh, that is,
It may be a state containing moisture or a state dried. As caffeine-containing plants, in particular, dried seeds of Guarana belonging to Paulinia, and as indica-containing plants, in particular, fresh leaves and / or stems of indigo plant belonging to the genus Tategawa. Useful for practicing the invention.

The above-mentioned raw materials are subjected to physical and / or chemical treatment generally used in the food industry, the pharmaceutical industry and the like to process the caffeine-containing plant and / or the indian-containing plant used in the present invention. Things can be obtained. For example, the usual processing such as shredding, crushing, grinding, crushing, squeezing, fermentation, extraction, and more,
By appropriately combining treatments such as filtration, concentration, and drying, shreds, crushed materials, crushed materials, crushed materials, squeezed materials, pressed products, fermented materials, and extracts can be obtained as the processed product used in the present invention.

The method for producing an extract of a caffeine-containing plant and / or an indicane-containing plant as a processed product used in the present invention will be described in more detail.
Usually, the raw material as described above is subjected to an appropriate treatment such as shredding, grinding, and crushing, and then subjected to a normal extraction treatment using an appropriate solvent. As the extraction solvent, water, a water-soluble organic solvent other than water, a water-insoluble organic solvent, and the like can be used as appropriate, and, particularly, water, a water-soluble organic solvent, or an aqueous solution of the organic solvent can be used. Use of as an extraction solvent is useful in the practice of the present invention. Examples of the water-soluble organic solvent include ethanol, methanol, propanol, 2-propanol, acetone and the like. When an aqueous solution of these organic solvents is used as the extraction solvent, the concentration of the organic solvent is not limited, but an aqueous solution containing 70% or less by volume of the organic solvent is useful for practicing the present invention. It is also optional to keep the extraction solvent at a desired pH with an appropriate buffer or the like. The above-mentioned extraction solvent is added to the above-mentioned raw material in an appropriate amount, usually preferably 0.1 to 50 times by weight, and, if necessary, is subjected to a stirring treatment or a heating treatment for extraction. By separating the liquid portion and the residue by an appropriate method such as filtration, centrifugation, and decantation, and collecting the liquid portion, the extract of the caffeine-containing plant and / or the indican-containing plant used in the present invention can be obtained. it can. Optionally, the residue is repeatedly subjected to the same extraction treatment, and the collected liquid portions are combined to obtain an extract. When the raw material and the residue are subjected to two or more extraction treatments, a different extraction solvent is used to collect only a desired liquid portion, or by combining these,
The extract used in the present invention can be obtained.

The extract may be further subjected to an appropriate purification treatment, and optionally used as a processed product of a caffeine-containing plant and / or an indian-containing plant. The extract is usually a secondary metabolite such as alkaloids, terpenoids, steroids, phenols, pigments, sugars,
Including proteins, amino acids, nucleic acids, peptides, lipids, etc.
When any of the purification means commonly used in the art is applied to this, one or more appropriate components selected from these are purified. Depending on the type of the target component, purification means include, for example, filtration, concentration, centrifugation, crystallization, solvent fractionation, fractional precipitation, dialysis, hydrophobic chromatography, reverse phase chromatography, adsorption chromatography, affinity chromatography, and the like. An appropriate method is selected from, for example, affinity chromatography, gel filtration chromatography, and / or ion exchange chromatography.

The processed product of a caffeine-containing plant and / or an indicane-containing plant obtained as described above can be advantageously used in the present invention as it is in the form as it is. Liquid, solid, powder, paste, semi-solid, emulsion, etc. by further adding or mixing appropriate physiologically acceptable components as described in detail below. It may be optionally used in an appropriate form such as a suspension or the like. For the concentration and drying, any method commonly used in ordinary food industry, pharmaceutical industry, etc., for example, vacuum concentration, precision membrane concentration, reverse osmosis membrane concentration, ultrafiltration concentration, vacuum drying, freeze drying, spray drying, etc. It can be applied advantageously.

As described above, the processed product of a caffeine-containing plant used in the present invention usually contains caffeine and / or a derivative thereof in the range of 0.1 to 20% (w / w) in terms of solid matter. Caffeine and / or a derivative thereof in the processed product can be detected by, for example, high performance liquid chromatography using reverse phase chromatography. The solid matter content of the processed product can be determined, for example, by referring to the 13th revised Japanese Pharmacopoeia published by Daiichi Shiki Shuppan (1996), 34.
The water content can be determined and calculated by the Karl Fischer method described on page 51 to 55, and the dry weight loss test method described on page 51, and the 13th revised Japanese Pharmacopoeia (1996), also published by Daiichi Shiki Shuppan. Wear.

The composition of the present invention is obtained by mixing the above-mentioned processed product of paffia and the flavonoid, and further, if necessary, is selected from the above-mentioned processed products of caffeine-containing plants and processed products of indican-containing plants. It is obtained by mixing one or more kinds. There is no limitation on the method of mixing, and any general technique is advantageously applied in the food industry, pharmaceutical industry and the like. There is no particular limitation on the mixing ratio of each component, and any of them can be advantageously used,
In order to effectively exert the various effects of the composition of the present invention, which will be described in detail later, the flavonoids are preferably 0.001 to 1 in terms of the weight of solid matter with respect to the processed paffia.
It is desirable to mix twice. In the case of further mixing a processed product of a caffeine-containing plant and a processed product of an indian-containing plant, there is no particular limitation on the mixing ratio, and any of them can be advantageously used. , 0.01 to 10 times and 0.0001
The composition obtained by mixing the composition in an amount of 0.1 to 0.1 times is more useful for exhibiting the effect of the composition more effectively.

On the other hand, the composition of the present invention obtained by mixing a flavonoid in an amount of 0.0005 to 0.05 times in terms of the weight of a solid substance with respect to a processed product of paffia is one of the various effects described below, which is particularly effective for immunotherapy. The enhancing effect and the psychotropic effect are particularly remarkable. The composition of the present invention in which a flavonoid is mixed in an amount of 0.01 to 2 times in terms of solid weight with respect to a processed product of paffia has particularly remarkable antiallergic effects. In addition, the strong activity of the composition of the present invention is as follows:
1 to 10 in terms of solid weight, based on the processed material of paffia
This is particularly noticeable when mixing twice the amount of caffeine-containing plants.

The composition of the present invention as described above generally contains flavonoid and ecdysterone in an amount of 0.01 to 20% (w / w) and 0.0001 to 2% (w / w) in terms of solids, respectively. It becomes. When the composition comprises a processed product of a caffeine-containing plant, it usually contains 0.001 to 4% (w / w) of caffeine in terms of solids. The composition is liquid, powdery, solid, semi-solid, depending on the type, shape and preparation method of the components to be blended.
There are various shapes such as paste or suspension, and any of them can be advantageously used.

The composition of the present invention thus obtained has remarkable immunity-enhancing, antiallergic, psychotropic and tonic effects. In addition, the composition of the present invention has a conventionally known action on paffia contained therein, for example, Hashimoto et al., “Dictionary of Brazilian Medicinal Plants” (1996).
), Published by Abbok Publishing Co., Ltd., pp. 24 to 27, tonic effect, laxative effect, healing effect on hemorrhoids, diarrhea, intestinal inflammation, skin wounds, ulcers, etc. I do. Furthermore, the composition of the present invention has improved palatia-like taste such as bitterness and harshness.
It is useful as an oral ingestion that is effective in promoting and treating and preventing diseases. The individual effects as described above work in concert without interfering with each other, and because the composition of the present invention has extremely low toxicity, it increases the resistance of the living body and enhances the physical and / or mental vitality. Enhance, so-called,
Very useful as a tonic. Further, when the composition of the present invention contains a nutrient such as a carbohydrate as described later, the composition is extremely useful as a nutritional tonic. Due to the above-mentioned effects, the composition of the present invention is also useful as an immunopotentiator, an antiallergic agent, a psychotropic agent and / or a strong stimulant for treatment and prevention.

The term "immune enhancing effect" as used herein refers to the promotion of the proliferation of immune-competent cells, the expansion of the cells, the differentiation of the cells, and the activation of the cells in warm-blooded animals including humans. It refers to one or more actions, and specifically, (1) proliferation and / or expansion of phagocytic cells such as macrophages, differentiation from bone marrow stem cells into the cells, foreign substances due to phagocytosis of the cells Of digestion of (2) natural and
(3) proliferation of B cells, differentiation of hematopoietic stem cells into the cells, enhancement of antibody production by the cells,
(4) proliferation of cytotoxic T cells, differentiation of hematopoietic stem cells into the cells, enhancement of lethal effects of the cells on tumor cells and virus-infected cells, (5) proliferation of helper T cells, hematopoietic hepatocytes And / or activation of the immune system by enhancing the production of various cytokines.

The anti-allergic action referred to herein means one or more of the so-called type I to IV allergy-suppressing actions. For example, (1) suppression of IgE antibody production,
Suppression of type I allergy by binding of the antibody to IgE receptor and subsequent suppression of various biological reactions such as histamine release, and (2) type II allergy by suppression of destruction of target cells by phagocytic cells and killer cells (3) by inhibiting the binding of complement to the immune complex generated in the living body and the subsequent activation of the complement system such as anaphylatoxin formation, etc. II
One of the following actions: suppression of type I allergy, (4) suppression of sensitization by T cell antigens, and suppression of type IV allergy by suppression of inflammatory cytokine production from sensitized T cells. Species or two or more species. Among them, the composition of the present invention is particularly effective in suppressing type I allergy.

[0030] The psychotropic action referred to herein means one or two of psychiatric nervous instability and amelioration and treatment of psychiatric disorders.
More specifically, for example, the composition of the present invention exhibits a so-called anxiolytic effect that relieves anxiety and tension, a so-called antidepressant effect that improves depressive mood, and / or a psychostimulant effect. In particular, it is effective in improving or suppressing human fears such as blush.

As used herein, the term "spermic effect" refers to an effect of improving the male and / or female reproductive ability of a warm-blooded animal including a human. For example, the composition of the present invention improves the impotence in males. It is effective in improving sperm vitality, improving spermatogenesis, promoting estrus in men and / or women, and exerts the desired effects.

Thus, the composition of the present invention enhances the immune system, suppresses allergic reactions, improves mental stability and / or
In addition to strengthening the vitality by strengthening the vitality, it also strengthens the body, treats and prevents climacteric disorders, and furthermore, susceptible diseases such as invasion of foreign foreign substances such as bacteria, viruses and fungi into the body, tumor cells Diseases associated with the generation of endogenous foreign substances such as cells and virus-infected cells in vivo, rhinitis, anaphylaxis,
Diseases associated with allergic reactions such as hay fever, food allergy, atopic dermatitis, asthma, autoimmune hemolytic anemia, Goodpasture's syndrome, serum sickness, irritable pneumonitis, contact dermatitis, rheumatism and ulcerative colitis It is effective for the treatment and prevention of various mental and nervous system diseases such as emotional instability, social phobia and blushing, and various diseases associated with decreased reproductive ability such as impotence.

By the way, the composition of the present invention also includes a form usually blended in a general oral ingestion. As an oral ingestion, for example, candy, troche, jelly, gummy, chewing gum, chocolate, juice,
Soft drinks, alcoholic beverages, lactic acid beverages, sports drinks, jams, creams, cookies, biscuits, crackers, crackers, udon, buckwheat, sausages, hams, Kamaboko, bamboo rings, Hanpei, tsukudani, instant juices, instant soups, etc. Can be.

The composition of the present invention comprises components other than those described above, that is, physiologically acceptable components such as carriers, excipients, diluents, adjuvants, stabilizers, According to the present invention, a form as a composition with one or more other physiologically active substances is also included. Examples of stabilizers include proteins such as serum albumin and gelatin,
Glucose, sucrose, lactose, maltose,
Carbohydrates such as trehalose, sorbitol, maltitol, mannitol, sugar alcohols such as lactitol, and buffers mainly comprising citrate or phosphate,
Further, as other physiologically active substances that can be used in combination, for example,
Cyclosporin, FK506, cyclophosphamide,
Nitrogen mustard, triethylene thiophosphamide, buzulfan, ferramin mustard, chlorambucil, azathioprine, 6-mercaptopurine, 6-
Thioguanine, 6-azaguanine, 8-azaguanine,
Fluorouracil, cytarabine, methotrexate, aminopterin, mitomycin C, daunorubicin hydrochloride, actinomycin D, chromomycin A3, bleomycin hydrochloride, doxorubicin hydrochloride, cyclosporin A, L-asparaginase, vincristine, vinblastine, hydroxyurea, procarbazine hydrochloride, adrenal cortex Hormones, Lumin, Vitamin A, Vitamin B, Vitamin C, Vitamin D, Vitamin E, Vitamin K, amino acids, gold preparations, potassium bromide, calcium lactate, calcium glycerophosphate, potassium iodide, reduced iron, heparin sodium, chloral hydrate , Meprovanate, oxazolam, phenytoin, ercinan, nicotinamide, chlorella extract, aloe extract, propolis extract, turtle extract, mosquito Nikuekisu, ginseng extract, lactic acid bacteria, yeast, other such royal jelly, interferon, Tsumoa necrosis factor, erythropoietin, interleukin, cytokine receptor, such antagonists of the receptor.

The compositions of the present invention also include the drug in unit dosage form. The drug in unit dosage form is
The processed product of paffia and the flavonoids may comprise, for example, a single dose or an amount corresponding to an integer multiple thereof (up to 4 times) or a submultiple thereof (up to 1/40), and may be a physically integrated substance suitable for administration. Means the drug in the dosage form. Examples of such dosage unit forms include injections, solutions, powders, granules, tablets, capsules, sublinguals, eye drops, nasal drops, suppositories, and external preparations. The composition of the present invention may be administered orally or parenterally, and in any case, it is effective in treating or preventing a susceptible disease. Depending on the type and symptoms of the susceptibility disease and the composition of the immunological disease drug, specifically, while observing the symptoms of the patient and the course after administration, the total amount of the processed product of paffia and the flavonoids is expressed in terms of solid matter weight. About 0.1 mg to 10 per adult
g / time, desirably 1 to 4 at about 1 mg to 1 g / time.
It may be administered orally at a dose of once / day or 1 to 5 times / week for 1 day to 1 year, or parenterally, intradermally, subcutaneously, intramuscularly or intravenously.

The effects, taste and toxicity of the composition of the present invention will be specifically described with reference to Experimental Examples 1 to 7 below.

[0037]

[Experimental example 1] <Preparation of processed product>

[0038]

EXPERIMENTAL EXAMPLE 1-1 <Paffia extract> 3 kg of dried chips of Paffia glomerata tuberculosis from Brazil and 45 l of deionized water were placed in a 100-liter stainless steel mug, heated over an open flame and kept for 40 minutes after boiling. . The mixture was filtered through a sieve to obtain 28.8 kg of a filtrate. The residue was collected again in the same mug, added with 20 l of deionized water, heated over an open flame and kept for 30 minutes after boiling. 19.6 kg of the filtrate obtained by sieve filtration again was combined with the filtrate obtained previously. After treatment with a basket-type centrifugal filter (manufactured by Hitachi Iron Works) to remove insolubles, a reverse osmosis membrane (Holosep HR manufactured by Toyobo)
5155F1 ") at a permeation rate of about 30 l / h and concentrated to a weight of 10.7 kg. This liquid was kept in a jacketed stainless steel tank at 80 ° C. for 21 and a half hours and further concentrated to obtain a liquid paffia extract as a processed product of puffia weighing 2770 g. The solids concentration was about 50% (w / w).

A part of the paffia extract obtained by the above method is described in N. Nishimoto et al., "Phytochemistry (Phy
Tochemy), Vol. 32, pp. 1,527 to 1,530 (1993), and acicular crystals were obtained by applying the method for purifying ecdysterone. Analysis by a conventional method revealed that the melting point of this crystal was 240 to 24.
At 2 ° C., the specific rotation was [α] _D + 89 °. These values are reported in N. Nishimoto et al., Fight Chemistry (Ph.
ytochemistry), Vol. 26, p. 2505 (1987), and thus the present crystal was identified as ecdysterone.

1 mg of this crystal sample was dissolved in a mixture of acetonitrile and water at a volume ratio of 15:85 to make a total volume of 2 ml.
The solution was filtered through a membrane filter having a pore size of 0.45 μm, and further diluted with the same solvent to obtain 500 μg / m
1, 200 μg / ml, 100 μg / ml, 50 μg / ml
A ml of a standard solution of ecdysterone was prepared. 20 μl of each of these standard solutions was analyzed by high performance liquid chromatography (hereinafter abbreviated as “HPLC”) as follows. That is, "Capc" manufactured by Shiseido as a column
The ell pak C ₁₈ AG120 ", using acetonitrile-water mixture in a volume ratio eighty-five past three p.m. as eluent, to hold the column at 35 ° C., the flow rate was 0.5 ml / min.
Detection was performed using an ultraviolet-visible spectrophotometer (“875-
UV type ”) was used to measure the absorbance at 240 nm. The detection result was obtained by a data processor (Shimadzu “CR”
-4A "). As a result, each of the standard solutions gave a main peak at a position where the elution time was about 17 minutes. This peak is ecdysterone. A standard curve was created based on each peak area.

Next, the Paffia extract 1 obtained by the above method was used.
g, and a mixture of acetonitrile and water having a volume ratio of 15:85 was added to make a total volume of 25 ml, followed by filtration through a membrane filter having a pore size of 0.45 μm to collect a filtrate. 20 μl of the filtrate was subjected to HPLC analysis in the same manner as in the case of the above purified ecdysterone preparation. A peak having the same retention time as the peak observed in the analysis of the above standard solution was detected, and the peak area was interpolated into the standard curve obtained above, and the Paffia extract obtained by the above method was used as a solid. It was confirmed to contain about 1% (w / w) ecdysterone in terms of material.

[0042]

EXPERIMENTAL EXAMPLE 1-2 <Pulverized Guarana> Pulverized guarana ("powdered GUARANA" manufactured by ONOBRAS) was used as a processed guarana. Caffeine was detected by HPLC analysis as shown below. First, 1mg of anhydrous caffeine made by Wako Pure Chemical
/ Ml aqueous solution and dilution of the solution yields 250
μg / ml, 100 μg / ml, 50 μg / ml, 25
Standard solutions of 10 μg / ml were prepared. Portionwise These standard solutions respectively 20 [mu] l, using a Tosoh "TSK gel ODS-80T _M" (inner diameter 4.6 mm × length 15cm) as a column, 5m as eluent
The mixture was subjected to HPLC using a mixture of 50 mM phosphate buffer (pH 6.5) containing M sodium octanesulfonate and methanol at a volume ratio of 4: 1. The flow rate is 1.0 ml / min,
The column temperature was 40 ° C., and the absorbance at 270 nm of the eluate was measured with an ultraviolet-visible spectrophotometer (“87
5-UV type "). The detection results were processed by a data processor (“CR-4A” manufactured by Shimadzu Corporation). Each solution gave a major peak at an elution time of about 7 minutes. This peak is caffeine. A standard curve was created based on each peak area. On the other hand, 75 mg of the above-mentioned "Powder Guarana" was placed in a test tube, about 10 ml of distilled water was added, and the mixture was boiled for about 15 minutes. After cooling, distilled water was further added to make a total volume of 25 ml. The solution is
After centrifugation at 000 rpm for 5 minutes, the supernatant was collected.
The supernatant was filtered through a membrane filter having a pore size of 0.45 μm, and 20 μl of the filtrate was analyzed by HPLC in the same manner as in the analysis of the standard solution. When a peak whose elution time coincided with the peak observed in the analysis of the standard solution was detected, and the area of the peak was interpolated into the standard curve prepared earlier, `` Powder Guarana '' showed solid matter Approximately 4%
(W / w) caffeine.

[0043]

[Experimental example 1-3] <Indigo extract> The above-ground part including indigo leaves and stems of vegetation was harvested, and about 10 kg of fresh weight was obtained. Mixed dead leaves and weeds were removed, washed with tap water, dehydrated, and treated with a chopper ("Model OMC-12" manufactured by Daido Sangyo) to obtain about 10 kg of indigo crushed material. 370 g of the mixture was mixed with 555 g of deionized water, and treated with a blender ("Trioblender" manufactured by Trio Science) for 2 minutes. After centrifugal filtration, 688 g of the supernatant was collected in a stainless steel mug,
After autoclaving at 121 ° C. for 10 minutes,
619 g of a supernatant formed by centrifugation at 15,000 rpm for 20 minutes at ℃ was collected. The solid concentration of this supernatant was about 1.9%. Deionized water was added thereto to prepare an indigo extract having a solid concentration of about 1.0%.

[0044]

[Experimental Example 2] <Immunity-enhancing activity> The paffia extract obtained by the method of Experimental Example 1-1 was used as a flavonoid. αG-rutin PS ”) was appropriately mixed, diluted with purified water, and sterilized by membrane filtration to prepare five kinds of samples (sample numbers 1 to 5) having the compositions shown in Table 1.

[0045]

[Table 1]

The immunopotentiating action of these five samples was examined as follows. In other words, BAL
Macrophages were collected from the peritoneal cavity of B / c mice and
Wells were plated and attached to microplates. The above five kinds of samples prepared in advance were added to 10
% (V / v) fetal bovine serum and RPMI 1640 medium containing 10 mM Hepes buffer (pH 7.4).
Each of the double-diluted solutions was added to a separate well in an amount of 0.1 ml per well, and incubated at 37 ° C. for 5 hours in a 5% CO ₂ incubator. Photographs were taken for each well, and the percentage (%) of the number of expanded macrophages to the total number of macrophages was determined.
As a control, 10% (v
/ V) fetal calf serum and 10 mM Hepes buffer (p
A system was added in which only RPMI1640 medium containing H7.4) was added. Table 2 shows the results.

[0047]

[Table 2]

In the results shown in Table 2, the difference between the value obtained in the system to which each sample (sample Nos. 1 to 5) was added and the value obtained in the control system was taken as the macrophage activating effect of each sample. It is understood that the paffia extract and the flavonoids have a remarkable macrophage activating effect. Furthermore, this macrophage activating effect is synergistically enhanced by the combined use of the Paffia extract and the flavonoid. This indicates that the compositions of the present invention having the compositions of Sample Nos. 4 and 5 show a remarkable immunopotentiating effect. It is well known that the enzyme-treated flavonoid used in this experimental example is converted into the original flavonoid by the action of glucosidase in the living body. FIG. 3 also shows that the present invention can be used.

The paffia extract obtained by the method of Experimental Example 1-1, the guarana crushed product described in Experimental Example 1-2, and Experimental Example 1-
Indigo extract obtained by the method of Example 3 and enzyme-treated hesperidin (“αG Hesperidin P
A ") and enzymatically treated rutin (" αG rutin P "
S ″), diluted with purified water, sterilized by membrane filtration, and treated with 10 samples (sample No. 6) having the composition shown in Table 3.
To 15) were prepared.

[0050]

[Table 3]

The immunity-enhancing effects of these 10 types of samples were
Investigation was carried out in the same manner as described above, and similarly evaluated by the difference from the control. Table 4 shows the results.

[0052]

[Table 4]

By further adding an indigo extract and / or crushed guarana to the composition of Sample Nos. 4 and 5,
The effect of macrophage activation was further enhanced synergistically. This indicates that each of the compositions of the present invention has a remarkable immunopotentiating effect.

A similar test was conducted using any of the extract of Dokudami, Ginkgo biloba and Chlorella extract prepared according to a conventional method in place of the Paffia extract used in Experimental Example 2 described above. These extracts have been used as folk remedies in various places since ancient times. These extracts did not show an effect of enhancing the macrophage activating effect exhibited by the flavonoids, the crushed guarana, and the indigo extract. This result indicates that the composition of the present invention exerts a remarkable medicinal effect while being a combination product of a folk medicine and a natural product.

[0055]

[Experimental Example 3] <Anti-allergic activity> Paphia extract obtained by the method of Experimental Example 1-1, enzyme-treated hesperidin as flavonoid (“αG Hesperidin PA” manufactured by Toyo Seikatsu), Experimental Example 1-
2 and the indigo extract obtained by the method of Experimental Example 1-3 were blended, diluted with purified water, sterilized by membrane filtration, and subjected to eight kinds of samples having the compositions shown in Table 5 ( Sample No. 16
To 23) were prepared.

[0056]

[Table 5]

The antiallergic effects of the eight samples were examined by comparing the effects on passive sensitized cutaneous anaphylaxis of experimental animals. Passive sensitization skin anaphylaxis is published by Hideomi Fukuda et al., Published by Hirokawa Shoten, “Development of Continuing Pharmaceuticals Volume 2, Animal Model for Diseases” (1993),
As described on pages 95 to 96, it is widely used as a screening method for antiallergic agents, and thus can be said to be effective in examining the antiallergic effect of a test sample.

First, 30 6-week-old male Wistar rats (Charles River Japan) were preliminarily reared for one week by a conventional method. The backs of these rats were shaved to give anti 2,4-
Dinitrophenylated Ascaris extract serum (manufactured by LSL, hereinafter referred to as “anti-DNP-AS”)
Serum ”. ) At three places in each skin.
Each 1 ml was injected and sensitized. Forty-seven hours after sensitization, one gram of each of the eight samples prepared above was orally administered to each rat. As a control, a system in which sterile distilled water was orally administered instead of the sample was provided. The same sample was administered to three animals in the same procedure. In addition, 0.4 hours after sensitization.
0.5% containing 5 mg / ml 2,4-dinitrophenylated Ascaris extract (manufactured by LSL, hereinafter abbreviated as "DNP-AS")
(W / v) 1 ml of physiological saline containing Evans blue was administered via the tail vein to induce passive sensitized cutaneous anaphylaxis. Thirty minutes after the administration of DNP-AS, the blood was exsanguinated and killed by a conventional method, the back skin was peeled off, and the pigment spots were cut off to a certain size. S Katayama et al., “Microbiology immunology (Microbiology)
Immunology), Vol. 22, 89-10
According to the method described on page 1 (1978), the amount of dye leaked from the blue dyed part was measured. That is, 1 ml of 1.2N caustic potash was added to each skin piece, and the skin tissue was dissolved by heating at 37 ° C. for 15 hours or more, and then 9 ml of a 0.6N phosphoric acid / acetone mixture (5:13) was added. To extract the pigment. After centrifugation by a conventional method, the absorbance of the supernatant at 620 nm was measured, and the amount of leaked dye was calculated based on the measurement results. Table 6 shows the average value of the amount of leaked dye for each of the administered samples.

[0059]

[Table 6]

As shown in Table 6, the leakage of the pigment from the passively sensitized cutaneous anaphylactic reaction rat was significantly suppressed by the paffia extract and the flavonoid. This suppression is synergistically enhanced by the combined use of the Pafia extract and the flavonoids. By adding the indigo extract and / or guarana crush here, this suppression is further enhanced synergistically. In addition, almost the same results were obtained when enzyme-treated rutin ("αG-rutin PS" manufactured by Toyo Seikagaku) was used as the flavonoid instead of the enzyme-treated hesperidin used here. It is well known that the enzyme-treated flavonoid used in this experimental example is converted into the original flavonoid by the action of glucosidase in the living body. This indicates that the present invention can be used. The above results indicate that the composition of the present invention shows a remarkable antiallergic effect.

The same test was carried out using any of the extract of Dokudami, Ginkgo biloba and Chlorella extract prepared according to a conventional method in place of the Paffia extract used in Experimental example 3 described above. These extracts have been used as folk remedies in various places since ancient times. These extracts did not exhibit the effect of enhancing the anti-allergic action of the flavonoids, guarana crushed product, and indigo extract. This result indicates that the composition of the present invention exerts a remarkable medicinal effect while being a combination product of a folk medicine and a natural product.

[0062]

[Experimental example 4] <Psychotropic effect> Paffia extract obtained by the method of Experimental example 1-1, enzyme-treated hesperidin ("αG hesperidin PA" manufactured by Toyo Seikagaku) as a flavonoid, guarana crushing described in Experimental example 1-2 And the indigo extract obtained by the method of Experimental Example 1-3 were appropriately mixed, diluted with purified water, and sterilized by membrane filtration. Eight kinds of samples having the compositions shown in Table 7 (sample numbers 24 to 31) was prepared.

[0063]

[Table 7]

The psychotropic action of these samples was described by Morimoto et al.
"Nihon Pharmacological Journal", Vol. 104, pp. 39-49 (1994)
Year)). That is, a 5-week-old male Sprague-D
awley) Rats are rotated 6 times per minute, 1.2 cm in diameter
Were placed 5-6 times per animal on wooden sticks. Thereafter, the time required for the rat to fall from the rotating rod (hereinafter, referred to as "reaction time" in this Experimental Example 3) was measured, and a rat having a reaction time almost constant two to three times was selected. Was orally administered. The administration was performed at 1 g per rat, and a control system was provided in which sterilized distilled water was similarly administered as a control. The same sample was administered to each of three rats in the same procedure. One hour after the administration of the sample, the reaction time of each rat was measured, and the average value for each sample was determined. The reaction time of each rat before administration of the sample was set to 1, and the reaction time of each sample administration system was relatively expressed and compared with the control. Table 8 shows the average of the relative values of the reaction time for each of the administered samples.

[0065]

[Table 8]

As shown in Table 8, the reaction time of the rat was significantly prolonged by the paffia extract and the flavonoids as compared with the control. This extended length of reaction time relative to the control is synergistically increased with the combined use of the Paffia extract and the flavonoids. By adding the indigo extract and / or ground guarana here, this extended reaction time is further synergistically increased. In addition, almost the same results were obtained when enzyme-treated rutin ("αG-rutin PS" manufactured by Toyo Seikagaku) was used as the flavonoid instead of the enzyme-treated hesperidin used here. It is well known that the enzyme-treated flavonoid used in this experimental example is converted into the original flavonoid by the action of glucosidase in the living body. This indicates that the present invention can be used. The above results indicate that the composition of the present invention shows a remarkable psychotropic effect.

[0067]

[Experimental Example 5] <Strength action>
The sperm-forming ability of eight types of samples (sample numbers 16 to 23) in experimental mice was compared to examine the tonic effect. First, an 18-week-old male ICR mouse was orally administered with 0.5 g of any one sample per mouse. The administration was continued for 3 weeks on a schedule of 5 times a week, for a total of 15 times. As a control, a system to which sterile distilled water was similarly administered was provided. The same sample was administered to each of three mice. On the day after the end of the administration of the sample, 0.5 ml of the bromodeoxyuridine labeling reagent attached to the Amersham cell proliferation detection kit was intraperitoneally administered to each mouse.
% Buffered formalin solution for 2 days. After immersion, a paraffin-embedded section was prepared by a conventional method, and bromo-incorporated into cells using the anti-bromodeoxyuridine monoclonal antibody attached to the cell proliferation detection kit (Amersham) according to the attached protocol. Deoxyuridine was detected by immunohistochemical staining to examine the number of proliferating cells, that is, the sperm-forming ability of each sample. Proliferating cells were observed under a microscope (× 100), the number of stained cells observed in one visual field was counted, and the average value of the number of stained cells for each sample was determined. Expressed as Table 9 shows the results.

[0068]

[Table 9]

[0069] As shown in Table 9, the number of stained cells was significantly increased by the administration of Paffia extract and flavonoids. This increase is synergistically enhanced by the combined use of the Pafia extract and the flavonoids. Furthermore, the indigo extract and / or
Alternatively, the addition of ground guarana further enhances this increase synergistically. In addition, almost the same results were obtained when enzyme-treated rutin ("αG-rutin PS" manufactured by Toyo Seikagaku) was used as the flavonoid instead of the enzyme-treated hesperidin used here. It is well known that the enzyme-treated flavonoid used in this experimental example is converted into the original flavonoid by the action of glucosidase in the living body. This indicates that the present invention can be used. The above results show that the composition of the present invention has a remarkable tonic effect.

[0070]

[Experimental Example 6] <Taste of the composition> The paffia extract obtained by the method of Experimental Example 1-1, and enzyme-treated hesperidin (“αG Hesperidin PA” manufactured by Toyo Seikagaku) and enzyme-treated rutin (Toyo Seikatsu) as flavonoids (ΑG-Rutin PS)) and sucrose, appropriately diluted with purified water, sterilized by membrane filtration, and treated with seven kinds of samples having the compositions shown in Table 10 (sample No. 32).
To 38) were prepared.

[0071]

[Table 10]

The taste of these seven samples was evaluated by a panel test. That is, first, the above-mentioned samples were set in a room kept at room temperature of 24 ° C., and panelists of 10 men and 6 women were individually tasted about 1 spoonful of each sample as appropriate. (A) Can be taken orally without any resistance, (B) Can be taken orally enough despite having bitterness and savory taste, (C) Bitterness and savory taste is too strong to make oral intake difficult I let it. The number of panelists who gave each evaluation was totaled for each sample. Table 11 shows the results.

[0073]

[Table 11]

As shown in Table 11, the original taste of Pafia is remarkably improved by blending the Pafia extract with the flavonoid. In addition, when a panel test was carried out in the same manner as in Sample Nos. 36 and 37 and further pulverized guarana and an indigo extract were added, it was confirmed that oral ingestion was also easy. The above results indicate that the composition of the present invention has significantly reduced the original bitterness and astringency of paffia.

[0075]

[Experimental Example 7] <Acute toxicity> 7-week-old dd mouse (body weight: about 19 to 2)
1g), freeze-drying the compositions of the compositions of Sample Nos. 8 to 15 prepared in Experimental Example 2 and the compositions of Sample Nos. 20 to 23 prepared in Experimental Example 3, and orally administering As a result, no acute mortality was observed up to a dose of 0.5 g per animal, and further administration was difficult. The above shows that the toxicity of the composition of the present invention is extremely low.

Examples are shown below, and the composition of the present invention will be described more specifically.

[0077]

Example 1 <Powder Composition> 2770 g of a liquid paffia extract having a solid concentration of about 50% and obtained by the method shown in Experimental Example 1-1
And trehalose (“Trehaose” made by Hayashibara) 6879
g was added thereto, and the mixture was processed and mixed in five portions using a universal mixing stirrer (“5DM” manufactured by Dalton), and kept at 60 ° C. for 17 hours in a dryer (“DK83” manufactured by Yamato).
It was dried in a vacuum dryer (manufactured by Yamato) at 60 ° C. under reduced pressure for 4.5 hours. Crusher (Dalton “Power Mill”
P-3 ”) and pulverized with paffia extract-containing powder 8
645 g were obtained.

Enzyme-treated hesperidin (“αG
100 g of Hesperidin PA) and 900 g of trehalose ("Trehaose" manufactured by Hayashibara) are mixed using a universal mixing stirrer ("5DM" manufactured by Dalton), and a pulverizer ("Power Mill P-3" manufactured by Dalton) is used. To obtain a flavonoid-containing powder.

8636 g of trehalose (“Trehaose” manufactured by Hayashibara) was added to 619 g of a liquid indigo extract having a solid concentration of about 1.9% and obtained by the method shown in Experimental Example 1-3, and mixed at room temperature. For 15 hours. The powder was pulverized using a Dalton pulverizer “Power Mill P-3” to obtain 9141 g of an indigo extract-containing powder.

The paffia extract-containing powder 700 g, the flavonoid-containing powder 100 g,
100 g of the indigo extract-containing powder and 100 g of the guarana crushed product described in Experimental Example 1-2 were mixed with a universal mixer ("5DM" manufactured by Dalton) to obtain a powdery composition of the present invention. When the product was analyzed according to the methods described in Experimental Examples 1-1 and 1-3, the product was found to be about 0.05% (w /
w) ecdysterone and ca. 0.4% (w / w) caffeine.

This product has a reduced bitterness and astringency of the original paffia, and has a mild sweetness of trehalose, so that it can be easily taken orally. This product has remarkable immunopotentiating, anti-allergic, psychotropic and tonic effects, and these effects work in harmony with each other without interfering with each other. Gives vitality. Moreover, the product is rich in nutrients by containing trehalose and has extremely low toxicity. The composition of the present invention having the above-mentioned properties is used for maintaining / promoting health and promoting treatment / prevention / recovery of immune diseases, allergic diseases, psychiatric diseases and / or susceptibility diseases such as decreased sexual ability. It can be advantageously used in the food and pharmaceutical fields.

[0082]

Example 2 <Tablet composition> The powder composition obtained by the method of Example 1 and a cell activator "Lumin" manufactured by Japan Photochromic Laboratories
Was mixed and tableted by a conventional method using a 20R rod having a diameter of 12 mm to obtain a tablet-like composition of the present invention containing about 2% of lumine per product weight. This product has remarkable immune-enhancing, anti-allergic, psychotropic, and intense effects, and also has a cell-activating effect, giving vitality to the body physically and mentally when ingested. Moreover,
This product is rich in nutrients by containing trehalose and has extremely low toxicity. The composition of the present invention having the above-mentioned properties is used for maintaining / promoting health and promoting treatment / prevention / recovery of immune diseases, allergic diseases, psychiatric diseases and / or susceptibility diseases such as decreased sexual ability. It can be advantageously used in the food and pharmaceutical fields.

[0083]

Example 3 <Emulsion liquid composition> 1 kg of a liquid paffia extract having a solid concentration of about 50% obtained by the method shown in Experimental Example 1-1 and 50 g of enzyme-treated rutin ("αG-Rutin PA" manufactured by Toyo Seika Sugar Co., Ltd.) ) And lyophilized. This freeze-dried product 10
Trehalose ("Trehaose" made by Hayashibara) for 0g
250 g, polyoxyethylene behenyl ether 50
g, polyoxyethylene sorbitol tetraoleate 100 g, lipophilic glyceryl monostearate 100
g, behenyl alcohol 50 g and avocado oil 100 g
Of vitamin E and an antiseptic, and heat-dissolved according to a conventional method, to which 500 g of 1,3-butylene glycol and 10 g of carboxyvinyl polymer were added.
And 8.5 kg of purified water, and the mixture was emulsified with a homogenizer to prepare an emulsion-type composition of the present invention. When this product is applied to skin, mucous membranes, etc., the immunopotentiating action of this product is exhibited. Furthermore, since this product has an antiallergic effect, it can be applied with confidence. In addition to these effects, the product is also excellent in moisturizing properties, so that it can be advantageously used in the cosmetics and pharmaceutical fields as a treatment / prevention for skin cancer, as a sunscreen, as a skin lightening agent, and the like.

[0084]

Example 4 <Hard candy> 800 g of reduced maltose syrup (25% moisture) was added to 300 g of trehalose-containing syrup ("Trehastar" manufactured by Hayashibara), mixed and dissolved, and the water content was reduced to less than 2% under reduced pressure. And then add 10 citric acid
g and an appropriate amount of lemon flavor and colorant,
10 g of the freeze-dried product obtained by the method shown in Example 3 was added and mixed. Then, the mixture was molded according to a conventional method to prepare a hard candy comprising the composition of the present invention. This product is a crisp hard candy that has moderate bitterness in addition to elegant sweetness, low hygroscopicity, and is less likely to cause dripping. This product has an immunopotentiating effect, anti-allergic effect,
In addition to the remarkable psychotropic and tonic effects, these effects work in concert without interfering with each other, so that when ingested, the body is physically and mentally energized. Overwork, aging,
It is useful for promoting nutrient fortification when various biological functions decline due to cold conditions, malnutrition, and the like, and for promoting the therapeutic effect of other treatment methods.

[0085]

Example 5 <Soft drink> Powdery composition 100 obtained by the method of Example 1
g, 50 g of isomerized sugar, 0.5 g of citric acid and 0.5 g of L-ascorbic acid to make a total amount of 1 kg by adding water to prepare a soft drink containing the composition of the present invention. This product is a product with excellent taste that exhibits a refreshing flavor in addition to a mild sweetness and a moderate bitterness. This product has remarkable immunopotentiating, anti-allergic, psychotropic and tonic effects, and these effects work in harmony with each other without interfering with each other. Gives vitality. It is useful for promoting nutritional tonic when various biological functions decline due to overwork, cold conditions, malnutrition, and the like, and for promoting the therapeutic effect of other treatment methods.

[0086]

Example 6 <Synthetic Sake> 6518 g of a 30 v / v% alcohol aqueous solution,
600 g of 70% glucose aqueous solution, 50 g of maltotetraose-containing syrup (“Trap” manufactured by Hayashibara), succinic acid 1
1.1 g, 3.66 g of a 75% aqueous lactic acid solution, 2.3 g of sodium glutamate, 1.2 g of glycine, 1. Alanine.
2 g, sodium succinate 2.22 g, salt 1.6 g,
1.4 g of natural salt, powder composition 2 obtained by the method of Example 1
By mixing 00 g and 2500 g of water, an original sake having an alcohol content of about 20 v / v% was obtained. This was diluted with water to prepare a synthetic liquor comprising the composition of the present invention having an alcohol content of 15-16 v / v%. This product is an elegantly flavored alcoholic beverage having moderate bitterness in addition to mild sweetness. This product has remarkable immunopotentiating, anti-allergic, psychotropic and tonic effects, and these effects work in harmony with each other without interfering with each other. Gives vitality. It is useful for promoting nutritional tonic when various biological functions decline due to overwork, aging, cold conditions, malnutrition, and the like, and promoting the therapeutic effect of other treatment methods.

[0087]

<Example 7><Chewinggum> 2 parts by weight of the powdery composition obtained by the method of Example 1, 6 parts by weight of glucose, and 2 parts by weight of a gum base heated and melted to a softness are added, mixed and further mixed. After mixing the peppermint flavor, the mixture was kneaded with a roll according to a conventional method, and molded to produce a chewing gum containing the composition of the present invention. This product has excellent texture with a refreshing flavor in addition to mild sweetness and moderate bitterness. This product has remarkable immunopotentiating, anti-allergic, psychotropic and tonic effects, and these effects work in harmony with each other without interfering with each other. Gives vitality. It can be advantageously used tonicity when various biological functions decline due to overwork, cold conditions, malnutrition and the like.

[0088]

Example 8 <Suppository> Solid concentration of about 5 obtained by the method shown in Experimental Example 1-1
After 1 kg of 0% liquid paffia extract and 5 g of enzyme-treated rutin (“αG rutin PA” manufactured by Toyo Seikagaku) were uniformly mixed, the mixture was freeze-dried. To 100 g of the freeze-dried product, 720 g of polyethylene glycol # 1000 and 180 g of polyethylene glycol # 4000 were mixed at a ratio of 180 g to prepare a composition of the present invention as a suppository according to a conventional method. By administering this product, its immunopotentiating effect exerts a remarkable effect on the treatment, prevention and recovery of neoplastic diseases near the colon and rectum, for example, colon cancer and colon cancer.

[0089]

As described above, the present invention provides a composition comprising a processed product of paffia and a flavonoid,
It is based on a completely unique finding that it shows remarkable immunity-enhancing, anti-allergic, psychotropic and tonic effects, and is effective for maintaining and improving health and for treating and preventing diseases. When the composition of the present invention is administered to a living body, the individual actions work in harmony with each other without inhibiting each other, so that the living body is physically and / or mentally energized. Furthermore, the composition of the present invention has reduced bitterness and harshness inherent in paffia and extremely low toxicity. Therefore, the composition of the present invention is extremely useful as an orally used tonic. Further, the composition of the present invention further comprising a nutrient source such as a saccharide is extremely useful as a nutritional tonic. Since the composition of the present invention exhibits the remarkable effects as described above, it is extremely useful as an agent for susceptibility disease for treatment and prevention.

The present invention is an invention having such remarkable functions and effects, and is an invention having a great significance to contribute to the art.

Continued on the front page (51) Int.Cl. ⁶ Identification code FI A61K 31/70 A61K 31/70 // A23G 3/00 101 A23G 3/00 101 3/30 3/30 A23L 2/52 A23L 2/38 C 2/38 C07D 311/30 A61K 9/14 C12G 3/04 101 C07D 311/30 A23L 2/00 F C12G 3/04 101 A61K 9/14 L

Claims (23)

[Claims] 1. A composition comprising a processed product of a plant belonging to the genus Pfaffia and a flavonoid. 2. The processed product of a plant belonging to the genus Paffaia is a chopped, crushed, crushed, crushed, squeezed, fermented, and / or extracted root of the plant. The composition of claim 1. 3. The composition according to claim 2, wherein the extract of a plant belonging to the genus Pfaffia is obtained by extracting the root of the plant with water and / or alcohol. 4. The composition according to claim 1, 2 or 3, wherein the processed product of a plant belonging to the genus Pfaffia comprises ecdysterone and / or a derivative thereof. 5. The composition according to claim 4, which comprises 0.0001 to 2% (w / w) of ecdysterone and / or a derivative thereof in terms of a solid. 6. The composition according to claim 1, wherein the flavonoid is vitamin P. 7. The method according to claim 7, wherein the vitamin P is hesperidin, rutin,
One or two selected from naringin, eriodictin, hesperetin, quercetin, naringenin, eriodictyol, hesperidin enzyme-treated product, rutin enzyme-treated product, naringin enzyme-treated product, and eriodictin enzyme-treated product
7. The composition of claim 6, which is at least one species. 8. A processed product of a plant belonging to the genus Pfaffia, wherein the flavonoid is contained in an amount of 0.001 to 1 times in terms of solid weight in terms of solid matter. 8. The composition according to 5, 6, or 7. 9. The method according to claim 1, comprising 0.01 to 20% (w / w) of flavonoid in terms of solid matter.
9. The composition according to 5, 6, 7 or 8. 10. The composition according to claim 1, further comprising a processed product of a caffeine-containing plant and / or a processed product of an indicane-containing plant. Stuff. 11. A processed product of a caffeine-containing plant, which is obtained by cutting, crushing, grinding, crushing, pressing a seed of the plant.
A fermented product and / or an extract, wherein a processed product of an indica-containing plant is obtained by cutting, crushing, grinding, crushing, pressing, fermenting and / or extracting leaves and / or stems of the plant; The composition according to claim 10, which is a product. 12. An extract of a caffeine-containing plant is obtained by extracting the seed of the plant with water and / or alcohol,
The composition according to claim 11, wherein the extract of the plant containing indica is obtained by extracting leaves and / or stems of the plant with water and / or alcohol. 13. A caffeine-containing plant, comprising:
aullinia), Coffia,
Tea (Thea sinensis) or Kola (Col)
a) A plant belonging to the genus, wherein the indica containing plant is a genus Tate (Pericaria) or a komatsunagi (Indi)
12. A plant belonging to the genus gofera).
Or the composition according to 12. 14. The plant containing caffeine according to claim 1, wherein the plant is a paullinia (P
agarinia (Guarania)
a), and the indica containing plant is
14. The composition according to claim 13, which is an indigo belonging to the genus aria). 15. A processed product of a caffeine-containing plant in a range of 0.01 to 10 times in terms of solids weight, based on a processed product of a plant belonging to the genus Pafia. 13. The composition according to 13 or 14. 16. A processed product of a plant containing Indica, which is 0.1% in terms of solid matter, of a processed product of a plant belonging to the genus Paphia.
The composition according to claim 10, 11, 12, 13, 14, or 15, which is contained in the range of 0001 to 0.1 times the amount. 17. The composition according to claim 10, which comprises caffeine and / or a derivative thereof in an amount of 0.0001 to 4% (w / w) in terms of solid matter. Stuff. 18. The method according to claim 1, further comprising a carbohydrate.
8. The composition according to any one of 7. 19. The composition according to claim 18, wherein the saccharide is one or more selected from trehalose, anhydrous crystalline trehalose, maltose and anhydrous crystalline maltose. 20. The composition according to claim 1, which is in the form of a liquid, solid, powder, semi-solid, paste or suspension. 21. The composition according to claim 1, which is an oral composition. 22. The composition according to claim 1, which is a tonic. 23. The composition according to claim 1, which is used as an immunopotentiator, an antiallergic agent, a psychotropic agent and / or a tonic.