Composition

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex

Reexamination Certificate

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C514S025000, C514S233500

Reexamination Certificate

active

06224872

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a novel composition, and more particularly, to a novel composition comprising a flavonoid and a processed product of a plant of the genus Pfaffia (may be abbreviated as processed Pfaffia product, hereinafter).
2. Description of the Prior Art
Most of the human diseases have become to be relatively-easily cured as the outstanding progress of Western medicine. The treatment of Western medicine, however, may not always sufficiently attain their prescribed effects because they, in some cases, may cause negative results and induce serious side effects. As the increase of recent health consciousness, it is highly required to establish compositions that are effective in the maintenance/promotion of health and in the treatment/prevention of human diseases without serious side effects even if used successively. For such purposes, folk medicines, which are conventionally used for a long time by humans, have become to be refocussed, but they have a demerit of insufficient therapeutic effect.
Isolating effective ingredients from folk medicines and removing ingredients other than the effective ingredients can be considered as an effective means to overcome the above demerit. However, in fact, the therapeutic effect of folk medicines would not generally be exerted with only a specific ingredient, and in most cases, desired therapeutic effect may not be exerted even if a desired effective ingredient was once isolated.
SUMMARY OF THE INVENTION
The present inventors focused on folk medicines which have been used anciently and on habitually-eaten-plants all over the world, and screened for compositions to solve the above object, from the natural world. As a result, they found that plants of the genus Pfaffia, which naturally grow in South America and have been used anciently as folk medicines, exert stronger immunoenhancement and antiallergic activities than other folk medicines in general when prepared into a composition together with flavonoids. Since the composition has an extremely-lower toxicity and a reduced astringency and harshness inherent to Pfaffia, it can be easily administered orally and used in the maintenance/promotion of health and in the treatment/prevention of diseases. Thus the present inventors accomplished this invention.
DETAILED DESCRIPTION OF THE INVENTION
The composition according to the present invention contains a flavonoid and a processed product of a plant of the genus Pfaffia (may be designated as “Pfaffia”, hereinafter). The processed product used in the present invention includes processed products in general which can be obtained by physically and/or chemically treating plants of the genus Pfaffia, and the materials and processes thereof are not specifically restricted. Examples of the plants of the genus Pfaffia are those of the species
Pfaffia glomerata, Pfaffia iresinoides, Pfaffia jubata, Pfaffia paniculata, Pfaffia pulverulenta
, and
Pfaffia spicata
. The processing of physical and/or chemical treatments used in the present invention includes minced, disrupted, ground, pulverized, pressed, fermented and/or extracted products of the plants. The processed products generally contain ecdysterone and/or its derivatives such as rubrosterone and pterosterone.
Explaining the process for producing the processed products according to the present invention, the starting materials therefore include one or more plants selected from the aforesaid plants of the genus Pfaffia and their mutants which are obtainable by conventional breeding of the plants. These plants include naturally and artificially growing plants or cultures of tissue cultures, callus cultures, cell cultures, etc. In the case of using plant bodies as the starting materials, the followings can be used arbitrarily; the whole plant bodies, or one or more specific organs selected from roots, stems, leaves, corollas, petals, pollens, stamens, pistils, seeds, albumens, and fibrils, which are partially separated from of the plant bodies. The materials can be used independently of their forms such as fresh, moisture, and dried forms. Particularly, dried roots of
Pfaffia glomerata
can be advantageously used in the present invention.
The processed Pfaffia product used in the present invention can be obtained by subjecting to the above starting materials physical and/or chemical treatments used in general in the food and pharmaceutical industries; Conventional treatments such as mincing, disruption, grounding, pulverizing, pressing, fermenting, and extracting alone or in an appropriate combination with other techniques such as filtration, concentration, and drying can produce minced, disrupted, ground, pulverized, pressed, fermented and extracted products used as the present processed products.
Explaining in more detail the process for producing Pfaffia extracts used as the processed products of Pfaffia in the present invention, it comprises the steps of treating the starting materials with appropriate treatments of mincing, disruption, pulverization, etc., and treating the resulting mixtures with conventional extraction methods using appropriate solvents. Water, other aqueous organic solvents, and water-insoluble organic solvents can be preferably used as solvents for extraction, and in particular the use of water, aqueous organic solvents, and their aqueous systems facilitates the present process. Examples of the aqueous organic solvents are ethanol, methanol, propanol, 2-propanol, acetone, etc. When used as extracting solvents, the organic solvents in 50 v/v % or lower of their aqueous systems can be used in the present invention. The extracting solvents can be arbitrarily adjusted to a desired pH level by using appropriate buffers, etc. The extracting solvents thus obtained are added to the starting materials in an appropriate amount, usually in an amount of 0.1-30-folds by weight, and if necessary, the materials are treated by stirring and heating methods for extraction. The resulting extracts are then separated into liquid and residual parts by appropriate methods such as filtration, centrifugation, and decantation, followed by collecting the liquid part as the Pfaffia extract used in the present invention. With repeated similar extraction treatment for the residual part, the resulting liquid parts can be freely pooled into the present extract. In the case of applying at least twice extractions to the starting materials and residues, different extraction solvents can be used in each extraction, followed by collecting the desired liquid parts only or pooling them into the Pfaffia extract used in the present invention.
These extracts thus obtained can be arbitrarily used as processed Pfaffia products through appropriate purification treatments. The extract usually contains secondary metabolites such as alkaloids, terpenoids, steroids, phenols, and pigments, as well as saccharides, proteins, amino acids, nucleotides, peptides, and lipids. One or more of these ingredients can be purified by applying purification methods generally used in this field. Depending on the types of the ingredients, an appropriate method can be chosen, for example, from filtration, concentration, centrifugation, crystallization, separationusing solvents, separatory sedimentation, dialysis, hydrophobic chromatography, reverse-phase chromatography, adsorption chromatography, affinity chromatography, gel filtration chromatography, and/or ion-exchange chromatography.
The processed Pfaffia product thus obtained can be arbitrarily used intact in the invention, and can be further concentrated and dried or admixed with the later described physiologically-acceptable appropriate ingredients into liquids, solids, powders, pastes, semi-solids, emulsions, suspensions, etc. In the concentration and drying, conventional methods generally used in the food and pharmaceutical industries can be arbitrarily used; concentration in vacuo, membrane filtration, reverse-osmosis membrane concentration, ultrafiltration membrane filtration, drying in vacuo, freeze-drying, and

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