Neuro-function regulatory agent

Details Neuro-function regulatory agent Neuro-function regulatory agent

1998-12-07

2001-05-15

Wilson, James O. (Department: 1623)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Carbohydrate doai

C514S025000, C514S034000

Reexamination Certificate

active

06232294

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a neuro-function regulatory agent, and more particularly to a neuro-function regulatory agent comprising glycosyl vitamin P as an effective ingredient.
2. Description of the Prior Art
The nervous system consists of nerve cells and fibers, has abilities of accepting and transmitting excitations, and keeps the homeostasis between individual activities and functional correlations in various parts of the body through a specific and highly-complicated neuronetwork. Disorder or disturbance of the neuro-function results in abnormal symptoms of physical and perception abilities and of circulatory and digestive organs, and may cause diseases including nerve diseases if such disorder or troublesome is being continued. Therefore keeping the neuro-function within the normal condition is very important for busy modern humans to spend their lives comfortably and to prevent them from nerve diseases. However, conventionally proposed methods for preventing nerve diseases are merely teachings of daily life such as taking care of living on well-balanced foods and of having regular habits while avoiding excessive stimuli, stresses, and fatigues as mush as possible.
SUMMARY OF THE INVENTION
In view of the foregoing, the object of the present invention is to provide a daily-usable means for effectively regulating the neuro-function with lesser side effects.
The present inventors studied vitamins to solve the above object. As a result, they elucidated the fact that glycosyl vitamin P exerts an unexpected action; it regulates the neuro-function to the desired condition or the normal condition when administered to humans, and found that the action of glycosyl vitamin P is significantly accelerated by trehalose, a disaccharide. Thus the present invention solves the above object by providing a neuro-function regulatory agent comprising glycosyl vitamin P as an effective ingredient.
The glycosyl vitamin P used in the present invention is a known compound, and similarly as vitamin P it is known that the compound has an activity of inhibiting the permeability of capillaries. The present invention was made based on an unexpected finding that the action of glycosyl vitamin P that regulates the human neuro-function independently of the inhibition of capillary permeability. The present invention is novel in that it provides a use of glycosyl vitamin P as a neuro-function regulatory agent.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to a neuro-function regulatory agent comprising glycosyl vitamin P as an effective ingredient. The glycosyl vitamin P used in the present invention generally includes glycosyl hesperidins such as a series of &agr;-monoglucosyl hesperidin, &agr;-diglucosyl hesperidin, &agr;-triglucosyl hesperidin, &agr;-tetraglucosyl hesperidin, and &agr;-pentaglucosyl hesperidin; and glycosyl rutins such as a series of &agr;-monoglucosyl rutin, &agr;-diglucosyl rutin, &agr;-triglucosyl rutin, &agr;-tetraglucosyl rutin, and &agr;-pentaglucosyl rutin. Since these compounds exert substantially the same level of activity of regulating the neuro-function, the present agent should contain one or more of them in an effective amount in total. In this connection, glycosyl hesperidins are superior to glycosyl rutins when compared with their activities on improving nerve disorder or disturbance and on preventing nerve diseases.
The glycosyl vitamin P can be prepared by various methods. With an economical viewpoint, biochemical methods with saccharide-transferring enzymes are advantageous; The aforesaid series of glycosyl vitamin P can be obtained in a relatively-high yield by contacting vitamin P such as hesperidin and rutin with saccharide-transferring enzymes such as &agr;-glucosidase, cyclomaltodextrin glucanotransferase, and &agr;-amylase in the presence of &agr;-glucosyl saccharides such as partial starch hydrolysates and maltooligosaccharides. The reaction products thus obtained usually contain a series of glycosyl vitamin P compounds with glucose polymerization degrees of 1-5 or more in terms of transferred glucoses. These compounds can be hydrolyzed into &agr;-monoglucosyl vitamin P by the action of glucoamylase and optionally in combination with rhamnosidase. Methods using saccharide-transferring enzymes are disclosed in detail in Japanese Patent Kokai Nos. 7,593/91, 27,293/91, 58,790/91, 115,292/91, and 70,994/98 applied by the same applicant as the present invention; and Japanese Patent Application Nos. 22,667/97, and 63,396/98, an application based on a priority of Japanese Patent Application No. 69,588/97 by the same applicant as the present invention. Examples of commercialized products prepared by these methods are “&agr;G RUTIN”, a powdery glycosyl rutin product with a total rutin content of 40-82%, on a dry solid basis (d.s.b.), commercialized by Hayashibara Shoji, Inc., Okayama, Japan; and “&agr;G HESPERIDIN”, a powdery glycosyl hesperidin product with a total hesperidin content of 22-84%, d.s.b., commercialized by Hayashibara Shoji, Inc., Okayama, Japan. The glycosyl vitamin P used in the present invention should not necessarily be those in a highly-purified form and can be those in the form of a composition unseparated from other substances formed depending on the preparation methods used.
As described above, the activity of regulating the neuro-function by glycosyl vitamin P is significantly augmented by coexisting trehalose, which trehalose also stabilizes the glycosyl vitamin P, facilitates the administration of the compound, and exerts an activity of promoting the absorption of the compound. Since there found no natural system where glycosyl vitamin P coexists with trehalose, the fact that trehalose promotes the effective activities of glycosyl vitamin P was nothing but a completely-unpredictable finding. The present embodiment using an artificial combination of an artificially-produced glycosyl vitamin P and trehalose is quite novel at this point.
Explaining the trehalose advantageously usable in the present invention, there found, as it is well known, three types of isomers called &agr;,a&agr;-, &agr;,&bgr;-, and &bgr;,&bgr;-isomers with different bonding forms. Since these isomers exert a similar promoting activity on glycosyl vitamin P, they can be used in the present agent for regulating the neuro-function independently of their preparation, purity, and property as long as one or more of them are incorporated into the present agent in an effective amount in total.
Trehalose can be produced by various methods. Detailed descriptions of such methods are given up because this invention in itself does not relate to the same. However, considering economical benefit, preferable methods are those which comprise of contacting partial starch hydrolysates with a non-reducing saccharide-forming enzyme and a trehalose-releasing enzyme as disclosed in Japanese Patent Kokai Nos. 143,876/95, 213,283/95, 322,883/95, 298,880/95, 66,187/96, 66,188/96, 336,388/96, and 84,586/96. According to these methods, a,&agr;-trehalose can be produced from starches as costless materials in a relatively-high yield; Examples of commercialized products obtainable thereby are “TREHAOSE®”, a crystalline trehalose powder containing at least 98% trehalose, d.s.b., commercialized by Hayashibara Shoji, Inc., Okayama, Japan; and “TREHASTAR®”, a trehalose syrup containing at least 28% trehalose, d.s.b., commercialized by Hayashibara Shoji, Inc., Okayama, Japan. &agr;,&agr;-Trehalose can be produced by contacting partial starch hydrolysates either with a maltose/trehalose converting enzyme as disclosed in Japanese Patent Kokai Nos. 149,980/96 and 9,986/97 or with conventionally known maltose-and trehalose-phosphorylases in combination.
To produce &agr;,&bgr;-trehalose, cyclomaltodextrin glucanotransferase, and &bgr;-galactosidase are allowed in this order to contact with mixtures of partial starch hydrolysates and lactose according to the methods as disclosed in Japanese Patent Kokai Nos. 144,694/92 and 179,490/92

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